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query-laysum
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6869
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[
{
"role": "user",
"content": "Abstract: Background\nPoliomyelitis mainly affects unvaccinated children under five years of age, causing irreversible paralysis or even death. The oral polio vaccine (OPV) contains live attenuated virus, which can, in rare cases, cause a paralysis known as vaccine-associated paralytic polio (VAPP), and also vaccine-derived polioviruses (VDPVs) due to acquired neurovirulence after prolonged duration of replication. The incidence of poliomyelitis caused by wild polio virus (WPV) has declined dramatically since the introduction of OPV and later the inactivated polio vaccine (IPV), however, the cases of paralysis linked to the OPV are currently more frequent than those related to the WPV. Therefore, in 2016, the World Health Organization (WHO) recommended at least one IPV dose preceding routine immunisation with OPV to reduce VAPPs and VDPVs until polio could be eradicated.\nObjectives\nTo assess the effectiveness, safety, and immunogenicity of sequential IPV-OPV immunisation schemes compared to either OPV or IPV alone.\nSearch methods\nIn May 2019 we searched CENTRAL, MEDLINE, Embase, 14 other databases, three trials registers and reports of adverse effects on four web sites. We also searched the references of identified studies, relevant reviews and contacted authors to identify additional references.\nSelection criteria\nRandomised controlled trials (RCTs), quasi-RCTs, controlled before-after studies, nationwide uncontrolled before-after studies (UBAs), interrupted time series (ITS) and controlled ITS comparing sequential IPV-OPV schedules (one or more IPV doses followed by one or more OPV doses) with IPV alone, OPV alone or non-sequential IPV-OPV combinations.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 21 studies: 16 RCTs involving 6407 healthy infants (age range 96 to 975 days, mean 382 days), one ITS with 28,330 infants and four nationwide studies (two ITS, two UBA). Ten RCTs were conducted in high-income countries; five in the USA, two in the UK, and one each in Chile, Israel, and Oman. The remaining six RCTs were conducted in middle-income countries; China, Bangladesh, Guatemala, India, and Thailand. We rated all included RCTs at low or unclear risk of bias for randomisation domains, most at high or unclear risk of attrition bias, and half at high or unclear risk for conflict of interests. Almost all RCTs were at low risk for the remaining domains. ITSs and UBAs were mainly considered at low risk of bias for most domains.\nIPV-OPV versus OPV\nIt is uncertain if an IPV followed by OPV schedule is better than OPV alone at reducing the number of WPV cases (very low-certainty evidence); however, it may reduce VAPP cases by 54% to 100% (three nationwide studies; low-certainty evidence). There is little or no difference in vaccination coverage between IPV-OPV and OPV-only schedules (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.96 to 1.06; 1 ITS study; low-certainty evidence). Similarly, there is little or no difference between the two schedule types for the number of serious adverse events (SAEs) (RR 0.88, 95% CI 0.46 to 1.70; 4 studies, 1948 participants; low-certainty evidence); or the number of people with protective humoral response P1 (moderate-certainty evidence), P2 (for the most studied schedule; two IPV doses followed by OPV; low-certainty evidence), and P3 (low-certainty evidence).\nTwo IPV doses followed by bivalent OPV (IIbO) may reduce P2 neutralising antibodies compared to trivalent OPV (moderate-certainty evidence), but may make little or no difference to P1 or P2 neutralising antibodies following an IIO schedule or OPV alone (low-certainty evidence). Both IIO and IIbO schedules may increase P3 neutralising antibodies compared to OPV (moderate-certainty evidence). It may also lead to lower mucosal immunity given increased faecal excretion of P1 (low-certainty evidence), P2 and P3 (moderate-certainty evidence) after OPV challenge.\nIPV-OPV versus IPV\nIt is uncertain if IPV-OPV is more effective than IPV alone at reducing the number of WPV cases (very low-certainty evidence). There were no data regarding VAPP cases. There is no clear evidence of a difference between IPV-OPV and OPV schedules for the number of people with protective humoral response (low- and moderate-certainty evidence). IPV-OPV schedules may increase mean titres of P1 neutralising antibodies compared to OPV alone (low- and moderate-certainty evidence), but the effect on P2 and P3 titres is not clear (very low- and moderate-certainty evidence).\nIPV-OPV probably reduces the number of people with P3 poliovirus faecal excretion after OPV challenge with IIO and IIOO sequences (moderate-certainty evidence), and may reduce the number with P2 (low-certainty evidence), but not with P1 (very low-certainty evidence). There may be little or no difference between the schedules in number of SAEs (RR 0.92, 95% CI 0.60 to 1.43; 2 studies, 1063 participants, low-certainty evidence).\nThe number of persons with P2 protective humoral immunity and P2 neutralising antibodies are probably lower with most sequential schemes without P2 components (i.e. bOPV) than with trivalent OPV or IVP alone (moderate-certainty evidence).\nIPV (3)-OPV versus IPV (2)-OPV\nOne study (137 participants) showed no clear evidence of a difference between three IPV doses followed by OPV and two IPV doses followed by OPV, on the number of people with P1 (RR 0.98, 95% CI 0.93 to 1.03), P2 (RR 1.00, 95% CI 0.97 to 1.03), or P3 (RR 1.01, 95% CI 0.97 to 1.05) protective humoral and intestinal immunity; all moderate-certainty evidence. This study did not report on any other outcomes.\nAuthors' conclusions\nIPV-OPV compared to OPV may reduce VAPPs without affecting vaccination coverage, safety or humoral response, except P2 with sequential schemes without P2 components, but increase poliovirus faecal excretion after OPV challenge for some polio serotypes. Compared to IPV-only schedules, IPV-OPV may have little or no difference on SAEs, probably has little or no effect on persons with protective humoral response, may increase neutralising antibodies, and probably reduces faecal excretion after OPV challenge of certain polio serotypes.\nUsing three IPV doses as part of a IPV-OPV schedule does not appear to be better than two IPV doses for protective humoral response.\nSequential schedules during the transition from OPV to IPV-only immunisation schedules seems a reasonable option aligned with current WHO recommendations. Findings could help decision-makers to optimise polio vaccination policies, reducing inequities between countries.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched databases of scientific studies and found 21 studies to include in this review. Studies included 16 randomised trials with 6407 infants, one additional study followed 28330 infants over time and another four were nationwide studies."
}
] |
query-laysum
|
6870
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in 2007. Traditionally, after major abdominal gynaecologic surgery postoperative oral intake is withheld until the return of bowel function. There has been concern that early oral intake would result in vomiting and severe paralytic ileus with subsequent aspiration pneumonia, wound dehiscence, and anastomotic leakage. However, evidence-based clinical studies suggest that there may be benefits from early postoperative oral intake.\nObjectives\nTo assess the effects of early versus delayed (traditional) initiation of oral intake of food and fluids after major abdominal gynaecologic surgery.\nSearch methods\nWe searched the Menstrual Disorders and Subfertility Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), electronic databases (MEDLINE, EMBASE, CINAHL), and the citation lists of relevant publications. The most recent search was conducted 1 April 2014. We also searched a registry for ongoing trials (www.clinicaltrials.gov) on 13 May 2014.\nSelection criteria\nRandomised controlled trials (RCTs) were eligible that compared the effect of early versus delayed initiation of oral intake of food and fluids after major abdominal gynaecologic surgery. Early feeding was defined as oral intake of fluids or food within 24 hours post-surgery regardless of the return of bowel function. Delayed feeding was defined as oral intake after 24 hours post-surgery and only after signs of postoperative ileus resolution.\nData collection and analysis\nTwo review authors selected studies, assessed study quality and extracted the data. For dichotomous data, we calculated the risk ratio (RR) with a 95% confidence interval (CI). We examined continuous data using the mean difference (MD) and a 95% CI. We tested for heterogeneity between the results of different studies using a forest plot of the meta-analysis, the statistical tests of homogeneity of 2 x 2 tables and the I² value. We assessed the quality of the evidence using GRADE methods.\nMain results\nRates of developing postoperative ileus were comparable between study groups (RR 0.47, 95% CI 0.17 to 1.29, P = 0.14, 3 RCTs, 279 women, I² = 0%, moderate-quality evidence). When we considered the rates of nausea or vomiting or both, there was no evidence of a difference between the study groups (RR 1.03, 95% CI 0.64 to 1.67, P = 0.90, 4 RCTs, 484 women, I² = 73%, moderate-quality evidence). There was no evidence of a difference between the study groups in abdominal distension (RR 1.07, 95% CI 0.77 to 1.47, 2 RCTs, 301 women, I² = 0%) or a need for postoperative nasogastric tube placement (RR 0.48, 95% CI 0.13 to 1.80, 1 RCT, 195 women).\nEarly feeding was associated with shorter time to the presence of bowel sound (MD -0.32 days, 95% CI -0.61 to -0.03, P = 0.03, 2 RCTs, 338 women, I² = 52%, moderate-quality evidence) and faster onset of flatus (MD -0.21 days, 95% CI -0.40 to -0.01, P = 0.04, 3 RCTs, 444 women, I² = 23%, moderate-quality evidence). In addition, women in the early feeding group resumed a solid diet sooner (MD -1.47 days, 95% CI -2.26 to -0.68, P = 0.0003, 2 RCTs, 301 women, I² = 92%, moderate-quality evidence). There was no evidence of a difference in time to the first passage of stool between the two study groups (MD -0.25 days, 95% CI -0.58 to 0.09, P = 0.15, 2 RCTs, 249 women, I² = 0%, moderate-quality evidence). Hospital stay was shorter in the early feeding group (MD -0.92 days, 95% CI -1.53 to -0.31, P = 0.003, 4 RCTs, 484 women, I² = 68%, moderate-quality evidence). Infectious complications were less common in the early feeding group (RR 0.20, 95% CI 0.05 to 0.73, P = 0.02, 2 RCTs, 183 women, I² = 0%, high-quality evidence). In one study, the satisfaction score was significantly higher in the early feeding group (MD 11.10, 95% CI 6.68 to 15.52, P < 0.00001, 143 women, moderate-quality evidence).\nAuthors' conclusions\nEarly postoperative feeding after major abdominal gynaecologic surgery for either benign or malignant conditions appeared to be safe without increased gastrointestinal morbidities or other postoperative complications. The benefits of this approach include faster recovery of bowel function, lower rates of infectious complications, shorter hospital stay, and higher satisfaction.\n\nGiven the provided abstract, please respond to the following query: \"Key Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included five published studies of 631 women, mainly with gynaecologic cancer.\nRecovery of bowel function was faster in those with early feeding. There was no difference in rates of nausea or vomiting, abdominal distension, need for a postoperative nasogastric tube or time to first bowel movement, but early feeding was associated with a shorter time to bowel sounds and onset of gas. The early feeding group resumed a solid diet 1½ days sooner than those having delayed feeding and the hospital stay was one day shorter. Also, the early feeding group were more satisfied with the feeding schedule, although only one study reported this.\nEarly feeding appeared safe, without increased postoperative complications and with fewer infectious complications overall."
}
] |
query-laysum
|
6871
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[
{
"role": "user",
"content": "Abstract: Background\nDental caries (tooth decay) is a common disease that is preventable by reducing the dietary intake of free sugars and using topical sodium fluoride products. An antibacterial agent known as chlorhexidine may also help prevent caries. A number of over-the-counter and professionally administered chlorhexidine-based preparations are available in a variety of formulations and in a range of strengths. Although previous reviews have concluded that some formulations of chlorhexidine may be effective in inhibiting the progression of established caries in children, there is currently a lack of evidence to either claim or refute a benefit for its use in preventing dental caries.\nObjectives\nTo assess the effects of chlorhexidine-containing oral products (toothpastes, mouthrinses, varnishes, gels, gums and sprays) on the prevention of dental caries in children and adolescents.\nSearch methods\nWe searched the Cochrane Oral Health Group Trials Register (25 February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 12), MEDLINE via OVID (1946 to 25 February 2015), EMBASE via OVID (1980 to 25 February 2015) and CINAHL via EBSCO (1937 to 25 February 2015). We handsearched several journals placed no language restrictions on our search. After duplicate citations were removed, the electronic searches retrieved 1075 references to studies.\nSelection criteria\nWe included parallel-group, randomised controlled trials (RCTs) that compared the caries preventive effects of chlorhexidine gels, toothpastes, varnishes, mouthrinses, chewing gums or sprays with each other, placebo or no intervention in children and adolescents. We excluded trials with combined interventions of chlorhexidine and fluoride or comparisons between chlorhexidine and fluoride interventions.\nData collection and analysis\nTwo review authors independently extracted trial data and assessed risk of bias. We resolved disagreements by consensus. We contacted trial authors for clarification or additional study details when necessary. The number of included studies that were suitable for meta-analysis was limited due to the clinical diversity of the included studies with respect to age, composition of intervention, and variation in outcome measures and follow-up. Where we were unable to conduct meta-analysis, we elected to present a narrative synthesis of the results.\nMain results\nWe included eight RCTs that evaluated the effects of chlorhexidine varnishes (1%, 10% or 40% concentration) and chlorhexidine gel (0.12%) on the primary or permanent teeth, or both, of children from birth to 15 years of age at the start of the study. The studies randomised a total of 2876 participants, of whom 2276 (79%) were evaluated. We assessed six studies as being at high risk of bias overall and two studies as being at unclear risk of bias overall. Follow-up assessment ranged from 6 to 36 months.\nSix trials compared chlorhexidine varnish with placebo or no treatment. It was possible to pool the data from two trials in the permanent dentition (one study using 10% chlorhexidine and the other, 40%). This led to an increase in the DMFS increment in the varnish group of 0.53 (95% confidence interval (CI) -0.47 to 1.53; two trials, 690 participants; very low quality evidence). Only one trial (10% concentration chlorhexidine varnish) provided usable data for elevated mutans streptococci levels > 4 with RR 0.93 (95% CI 0.80 to 1.07, 496 participants; very low quality evidence). One trial measured adverse effects (for example, ulcers or tooth staining) and reported that there were none; another trial reported that no side effects of the treatment were noted. No trials reported on pain, quality of life, patient satisfaction or costs.\nTwo trials compared chlorhexidine gel (0.12% concentration) with no treatment in the primary dentition. The presence of new caries gave rise to a 95% confidence interval that was compatible with either an increase or a decrease in caries incidence (RR 1.00, 95% CI 0.36 to 2.77; 487 participants; very low quality evidence). Similarly, data for the effects of chlorhexidine gel on the prevalence of mutans streptococci were inconclusive (RR 1.26, 95% CI 0.95 to 1.66; two trials, 490 participants; very low quality evidence). Both trials measured adverse effects and did not observe any. Neither of these trials reported on the other secondary outcomes such as measures of pain, quality of life, patient satisfaction or direct and indirect costs of interventions.\nAuthors' conclusions\nWe found little evidence from the eight trials on varnishes and gels included in this review to either support or refute the assertion that chlorhexidine is more effective than placebo or no treatment in the prevention of caries or the reduction of mutans streptococci levels in children and adolescents. There were no trials on other products containing chlorhexidine such as sprays, toothpastes, chewing gums or mouthrinses. Further high quality research is required, in particular evaluating the effects on both the primary and permanent dentition and using other chlorhexidine-containing oral products.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review examined the effectiveness of varnishes and gels containing chlorhexidine in preventing tooth decay in children and young people."
}
] |
query-laysum
|
6872
|
[
{
"role": "user",
"content": "Abstract: Background\nOccupational exposure to hazardous drugs can decrease fertility and result in miscarriages, stillbirths, and cancers in healthcare staff. Several recommended practices aim to reduce this exposure, including protective clothing, gloves, and biological safety cabinets ('safe handling'). There is significant uncertainty as to whether using closed-system drug-transfer devices (CSTD) in addition to safe handling decreases the contamination and risk of staff exposure to infusional hazardous drugs compared to safe handling alone.\nObjectives\nTo assess the effects of closed-system drug-transfer of infusional hazardous drugs plus safe handling versus safe handling alone for reducing staff exposure to infusional hazardous drugs and risk of staff contamination, and to determine if the better reuse of multi-dose vials leads to cost savings.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, OSH-UPDATE, CINAHL, Science Citation Index Expanded, economic evaluation databases, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov to October 2017.\nSelection criteria\nWe included comparative studies of any study design (irrespective of language, blinding, or publication status) that compared CSTD plus safe handling versus safe handling alone for infusional hazardous drugs.\nData collection and analysis\nTwo review authors independently identified trials and extracted data. We calculated the risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CI) using both fixed-effect and random-effects models. We assessed risk of bias according to the risk of bias in non-randomised studies of interventions (ROBINS-I) tool, used an intracluster correlation coefficient of 0.10, and we assessed the quality of the evidence using GRADE.\nMain results\nWe included 24 observational cluster studies (359 hospitals) in this review. We did not find any randomised controlled trials or formal economic evaluations. In 22 studies, the people who used the intervention (CSTD plus safe handling) and control (safe handling alone) were pharmacists or pharmacy technicians; in the other two studies, the people who used the intervention and control were nurses, pharmacists, or pharmacy technicians. Therefore, the evidence is mainly applicable to pharmacists or pharmacy technicians. The CSTD used in the studies were PhaSeal (13 studies), Tevadaptor (2 studies), SpikeSwan (1 study), PhaSeal and Tevadaptor (1 study), varied (5 studies), and not stated (2 studies). Therefore, the evidence is mainly applicable for PhaSeal. The studies' descriptions of the control groups were varied. Twenty-two studies provide data on one or more outcomes for this systematic review. All the studies are at serious risk of bias. The quality of evidence is very low for all the outcomes.\nVery low certainty evidence from small studies is insufficient to determine whether there is any important difference between CSTD and control groups in the proportion of people with positive urine tests for exposure between the CSTD and control groups for any of the drugs: cyclophosphamide alone (RR 0.83, 95% CI 0.46 to 1.52; I² = 12%; 2 studies; 2 hospitals; 20 participants; CSTD: 76.1% versus control: 91.7%); cyclophosphamide or ifosfamide (RR 0.09, 95% CI 0.00 to 2.79; 1 study; 1 hospital; 14 participants; CSTD: 6.4% versus control: 71.4%); and cyclophosphamide, ifosfamide, or gemcitabine (RR not estimable; 1 study; 1 hospital; 36 participants; 0% in both groups).\nVery low certainty evidence from small studies is insufficient to determine whether there is any important difference between CSTD and control groups in the proportion of surfaces contaminated or the quantity of contamination. Overall, out of 24 comparisons in pharmacy areas or patient-care areas, there was a reduction in the proportion of surfaces contaminated in only one comparison and out of 15 comparisons in pharmacy areas or patient-care areas, there was a reduction in the quantity of contamination in only two comparisons.\nNone of the studies report on atmospheric contamination, blood tests, or other measures of exposure to infusional hazardous drugs such as urine mutagenicity, chromosomal aberrations, sister chromatid exchanges, or micronuclei induction.\nNone of the studies report short-term health outcomes such as reduction in skin rashes, medium-term reproductive health outcomes such as fertility and parity, or long-term health outcomes related to the development of any type of cancer or adverse events.\nFive studies (six hospitals) report the potential cost savings through the use of CSTD. The studies used different methods of calculating the costs, and the results were not reported in a format that could be pooled via meta-analysis. There is significant variability between the studies in terms of whether CSTD resulted in cost savings (the point estimates of the average potential cost savings ranged from (2017) USD −642,656 to (2017) USD 221,818).\nThe healthcare professionals in the studies that provide data were mostly pharmacists or pharmacy technicians. Therefore, the evidence is mainly applicable to pharmacists and pharmacy technicians. Most of the studies that provide information for this review evaluated the use of PhaSeal; therefore the findings are mostly applicable to PhaSeal.\nAuthors' conclusions\nCurrently, no firm conclusions can be drawn on the effect of CSTD combined with safe handling versus safe handling alone due to very low certainty evidence available for the main outcomes.\nMulticentre randomised controlled trials may be feasible depending upon the proportion of people with exposure. The next best study design is interrupted time-series. Future studies should evaluate exposure to a relevant selection of hazardous drugs used in the hospital, and they should measure direct short-term health outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included all types of studies that compared CSTD plus safe handling ('CSTD group') and safe handling alone ('control group')."
}
] |
query-laysum
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6873
|
[
{
"role": "user",
"content": "Abstract: Background\nCannulation techniques have been recognized as being important in causing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, considerable controversy exists about the usefulness of the guidewire-assisted cannulation technique for the prevention of PEP.\nObjectives\nTo assess the effectiveness and safety of the guidewire-assisted cannulation technique compared to the conventional contrast-assisted cannulation technique for the prevention of PEP in people undergoing diagnostic or therapeutic ERCP for biliary or pancreatic diseases.\nSearch methods\nFor the previous version of this review, we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL and major conference proceedings, up to February 2012, with no language restrictions. An updated search was performed on 26 February 2021 for the current version of this review. Two clinical trial registries, clinicaltrials.gov and WHO ICTRP, were also searched in this update.\nSelection criteria\nRandomized controlled trials (RCTs) comparing the guidewire-assisted cannulation technique versus the contrast-assisted cannulation technique in people undergoing ERCP.\nData collection and analysis\nTwo review authors conducted study selection, data extraction, and methodological quality assessment independently. Using intention-to-treat analysis with random-effects models, we combined dichotomous data to obtain risk ratios (RR) with 95% confidence intervals (CI). We assessed heterogeneity using the Chi² test (P < 0.10) and I² statistic (> 50%). To explore sources of heterogeneity, we conducted a priori subgroup analyses according to trial design, publication type, risk of bias, use of precut sphincterotomy, inadvertent guidewire insertion or contrast injection of the pancreatic duct (PD), use of a PD stent, cannulation device, and trainee involvement in cannulation. To assess the robustness of our results, we carried out sensitivity analyses using different summary statistics (RR versus odds ratio (OR)) and meta-analytic models (fixed-effect versus random-effects) and per-protocol analysis.\nMain results\n15 RCTs comprising 4426 participants were included. There was moderate heterogeneity among trials for the outcome of PEP (P = 0.08, I² = 36%). Meta-analyses suggest that the guidewire-assisted cannulation technique probably reduces the risk of PEP compared to the contrast-assisted cannulation technique (RR 0.51, 95% CI 0.36 to 0.72, 15 studies, moderate-certainty evidence). In addition, the guidewire-assisted cannulation technique may result in an increase in primary cannulation success (RR 1.06, 95% CI 1.01 to 1.12, 13 studies, low-certainty evidence), and probably reduces the need for precut sphincterotomy (RR 0.79, 95% CI 0.64 to 0.96, 10 studies, moderate-certainty evidence). Compared to the contrast-assisted cannulation technique, the guidewire-assisted cannulation technique may result in little to no difference in the risk of post-sphincterotomy bleeding (RR 0.87, 95% CI 0.49 to 1.54, 7 studies, low-certainty evidence) and perforation (RR 0.93, 95% CI 0.11 to 8.23, 8 studies, very low-certainty evidence). Procedure-related mortality was reported by eight studies, and there were no cases of deaths in both arms (moderate-certainty evidence). Subgroup analyses suggest that the heterogeneity for the outcome of PEP could be explained by differences in trial design. The results were robust in sensitivity analyses.\nAuthors' conclusions\nThere is moderate-certainty evidence that the guidewire-assisted cannulation technique probably reduces the risk of PEP compared to the contrast-assisted cannulation technique. There is low-certainty evidence that the guidewire-assisted cannulation technique may result in an increase in primary cannulation success. There is low- and very low-certainty evidence that the guidewire-assisted cannulation technique may result in little to no difference in the risk of bleeding and perforation. No procedure-related deaths were reported. Therefore, the guidewire-assisted cannulation technique appears to be superior to the contrast-assisted cannulation technique considering the certainty of evidence and the balance of benefits and harms. However, the routine use of guidewires in biliary cannulation will be dependent on local expertise, availability, and cost. Future research should assess the effectiveness and safety of the guidewire-assisted cannulation technique in the context of other pharmacologic or non-pharmacologic interventions for the prevention of PEP.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There are two techniques for gaining access to the bile duct during ERCP. The traditional technique (contrast) involves inserting a catheter into the papilla and injecting contrast dye to confirm access to the bile duct. However, contrast dye may be unintentionally injected into the pancreatic duct. A second technique (guidewire) involves using a guidewire to probe the papilla to gain access to the bile duct. Once an x-ray confirms the guidewire is in the bile duct, contrast dye is injected into the bile duct.\nWe wanted to find out:\n• which technique for gaining access to the bile duct during ERCP works best to reduce the risk of PEP;\n• which technique achieves better success in gaining access to the bile duct; and\n• which technique causes fewer unwanted effects (for example, the need to use advanced techniques involving blind incision into the papilla to gain access to the bile duct, inadvertent entry of the pancreatic duct, bleeding, hole in the bowel wall, and death)."
}
] |
query-laysum
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6874
|
[
{
"role": "user",
"content": "Abstract: Background\nCommunication about end of life (EoL) and EoL care is critically important for providing quality care as people approach death. Such communication is often complex and involves many people (patients, family members, carers, health professionals). How best to communicate with people in the period approaching death is not known, but is an important question for quality of care at EoL worldwide. This review fills a gap in the evidence on interpersonal communication (between people and health professionals) in the last year of life, focusing on interventions to improve interpersonal communication and patient, family member and carer outcomes.\nObjectives\nTo assess the effects of interventions designed to improve verbal interpersonal communication about EoL care between health practitioners and people affected by EoL.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL from inception to July 2018, without language or date restrictions. We contacted authors of included studies and experts and searched reference lists to identify relevant papers. We searched grey literature sources, conference proceedings, and clinical trials registries in September 2019. Database searches were re-run in June 2021 and potentially relevant studies listed as awaiting classification or ongoing.\nSelection criteria\nThis review assessed the effects of interventions, evaluated in randomised and quasi-randomised trials, intended to enhance interpersonal communication about EoL care between patients expected to die within 12 months, their family members and carers, and health practitioners involved in their care. Patients of any age from birth, in any setting or care context (e.g. acute catastrophic injury, chronic illness), and all health professionals involved in their care were eligible. All communication interventions were eligible, as long as they included interpersonal interaction(s) between patients and family members or carers and health professionals. Interventions could be simple or complex, with one or more communication aims (e.g. to inform, skill, engage, support). Effects were sought on outcomes for patients, family and carers, health professionals and health systems, including adverse (unintended) effects.\nTo ensure this review's focus was maintained on interpersonal communication in the last 12 months of life, we excluded studies that addressed specific decisions, shared or otherwise, and the tools involved in such decision-making. We also excluded studies focused on advance care planning (ACP) reporting ACP uptake or completion as the primary outcome. Finally, we excluded studies of communication skills training for health professionals unless patient outcomes were reported as primary outcomes.\nData collection and analysis\nStandard Cochrane methods were used, including dual review author study selection, data extraction and quality assessment of the included studies.\nMain results\nEight trials were included. All assessed intervention effects compared with usual care. Certainty of the evidence was low or very low. All outcomes were downgraded for indirectness based on the review’s purpose, and many were downgraded for imprecision and/or inconsistency. Certainty was not commonly downgraded for methodological limitations.\nA summary of the review's findings is as follows.\nKnowledge and understanding (four studies, low-certainty evidence; one study without usable data): interventions to improve communication (e.g. question prompt list, with or without patient and physician training) may have little or no effect on knowledge of illness and prognosis, or information needs and preferences, although studies were small and measures used varied across trials.\nEvaluation of the communication (six studies measuring several constructs (communication quality, patient-centredness, involvement preferences, doctor-patient relationship, satisfaction with consultation), most low-certainty evidence): across constructs there may be minimal or no effects of interventions to improve EoL communication, and there is uncertainty about effects of interventions such as a patient-specific feedback sheet on quality of communication.\nDiscussions of EoL or EoL care (six studies measuring selected outcomes, low- or very low-certainty evidence): a family conference intervention may increase duration of EoL discussions in an intensive care unit (ICU) setting, while use of a structured serious illness conversation guide may lead to earlier discussions of EoL and EoL care (each assessed by one study). We are uncertain about effects on occurrence of discussions and question asking in consultations, and there may be little or no effect on content of communication in consultations.\nAdverse outcomes or unintended effects (limited evidence): there is insufficient evidence to determine whether there are adverse outcomes associated with communication interventions (e.g. question prompt list, family conference, structured discussions) for EoL and EoL care. Patient and/or carer anxiety was reported by three studies, but judged as confounded. No other unintended consequences, or worsening of desired outcomes, were reported.\nPatient/carer quality of life (four studies, low-certainty evidence; two without useable data): interventions to improve communication may have little or no effect on quality of life.\nHealth practitioner outcomes (three studies, low-certainty evidence; two without usable data): interventions to improve communication may have little or no effect on health practitioner outcomes (satisfaction with communication during consultation; one study); effects on other outcomes (knowledge, preparedness to communicate) are unknown.\nHealth systems impacts: communication interventions (e.g. structured EoL conversations) may have little or no effect on carer or clinician ratings of quality of EoL care (satisfaction with care, symptom management, comfort assessment, quality of care) (three studies, low-certainty evidence), or on patients' self-rated care and illness, or numbers of care goals met (one study, low-certainty evidence). Communication interventions (e.g. question prompt list alone or with nurse-led communication skills training) may slightly increase mean consultation length (two studies), but other health service impacts (e.g. hospital admissions) are unclear.\nAuthors' conclusions\nFindings of this review are inconclusive for practice. Future research might contribute meaningfully by seeking to fill gaps for populations not yet studied in trials; and to develop responsive outcome measures with which to better assess the effects of communication on the range of people involved in EoL communication episodes. Mixed methods and/or qualitative research may contribute usefully to better understand the complex interplay between different parties involved in communication, and to inform development of more effective interventions and appropriate outcome measures. Co-design of such interventions and outcomes, involving the full range of people affected by EoL communication and care, should be a key underpinning principle for future research in this area.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out which ways of communicating with patients and carers might be best for improving people’s knowledge about the EoL (e.g. what to expect, treatment options).\nWhat people thought about the communication (e.g. satisfaction, communication quality, how involved they were and wanted to be in consultations). Discussions about end of life (e.g. how often these happened, and when).\nWe also wanted to find out if communication interventions might increase unwanted or harmful effects, like fear or distress."
}
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query-laysum
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6875
|
[
{
"role": "user",
"content": "Abstract: Background\nA pressure injury (PI), also referred to as a 'pressure ulcer', or 'bedsore', is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.\nObjectives\nTo assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.\nSearch methods\nWe searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nRandomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.\nData collection and analysis\nThree review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. We assessed the certainty of the evidence using GRADE.\nMain results\nWe identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage. Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials.\nPrimary outcomes: proportion of new PI of any stage\nRepositioning frequencies: three trials compared different repositioning frequencies\nWe pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision.\nOne of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision.\nIn one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence). The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision.\nPositioning regimens: four trials compared different tilt positions\nWe pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision.\nOne trial involving 120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence.\nSecondary outcomes\nNo studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction.\nCost analysis\nTwo included trials also performed economic analyses.\nA cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time. The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed.\nA second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR −46.50, 95% CI EUR −1.25 to EUR −74.60).\nAuthors' conclusions\nDespite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base.\nGiven the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus \"usual care\" (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is no clear evidence regarding which particular positions and repositioning frequencies are the most effective for preventing pressure injuries in adults. This is partly due to the low quality of the studies, most of which had small numbers of participants and were lacking in details about study methods. There is also limited evidence to support the cost-effectiveness of different repositioning frequencies and positions. There is a need for further research to measure the effects of repositioning on pressure injury development and to find the best repositioning regimen relative to frequency and position."
}
] |
query-laysum
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6876
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[
{
"role": "user",
"content": "Abstract: Background\nLow vision rehabilitation aims to optimise the use of residual vision after severe vision loss, but also aims to teach skills in order to improve visual functioning in daily life. Other aims include helping people to adapt to permanent vision loss and improving psychosocial functioning. These skills promote independence and active participation in society. Low vision rehabilitation should ultimately improve quality of life (QOL) for people who have visual impairment.\nObjectives\nTo assess the effectiveness of low vision rehabilitation interventions on health-related QOL (HRQOL), vision-related QOL (VRQOL) or visual functioning and other closely related patient-reported outcomes in visually impaired adults.\nSearch methods\nWe searched relevant electronic databases and trials registers up to 18 September 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating HRQOL, VRQOL and related outcomes of adults, with an irreversible visual impairment (World Health Organization criteria). We included studies that compared rehabilitation interventions with active or inactive control.\nData collection and analysis\nWe used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 44 studies (73 reports) conducted in North America, Australia, Europe and Asia. Considering the clinical diversity of low vision rehabilitation interventions, the studies were categorised into four groups of related intervention types (and by comparator): (1) psychological therapies and/or group programmes, (2) methods of enhancing vision, (3) multidisciplinary rehabilitation programmes, (4) other programmes. Comparators were no care or waiting list as an inactive control group, usual care or other active control group. Participants included in the reported studies were mainly older adults with visual impairment or blindness, often as a result of age-related macular degeneration (AMD). Study settings were often hospitals or low vision rehabilitation services. Effects were measured at the short-term (six months or less) in most studies. Not all studies reported on funding, but those who did were supported by public or non-profit funders (N = 31), except for two studies.\nCompared to inactive comparators, we found very low-certainty evidence of no beneficial effects on HRQOL that was imprecisely estimated for psychological therapies and/or group programmes (SMD 0.26, 95% CI -0.28 to 0.80; participants = 183; studies = 1) and an imprecise estimate suggesting little or no effect of multidisciplinary rehabilitation programmes (SMD -0.08, 95% CI -0.37 to 0.21; participants = 183; studies = 2; I2 = 0%); no data were available for methods of enhancing vision or other programmes. Regarding VRQOL, we found low- or very low-certainty evidence of imprecisely estimated benefit with psychological therapies and/or group programmes (SMD -0.23, 95% CI -0.53 to 0.08; studies = 2; I2 = 24%) and methods of enhancing vision (SMD -0.19, 95% CI -0.54 to 0.15; participants = 262; studies = 5; I2 = 34%). Two studies using multidisciplinary rehabilitation programmes showed beneficial but inconsistent results, of which one study, which was at low risk of bias and used intensive rehabilitation, recorded a very large and significant effect (SMD: -1.64, 95% CI -2.05 to -1.24), and the other a small and uncertain effect (SMD -0.42, 95%: -0.90 to 0.07).\nCompared to active comparators, we found very low-certainty evidence of small or no beneficial effects on HRQOL that were imprecisely estimated with psychological therapies and/or group programmes including no difference (SMD -0.09, 95% CI -0.39 to 0.20; participants = 600; studies = 4; I2 = 67%). We also found very low-certainty evidence of small or no beneficial effects with methods of enhancing vision, that were imprecisely estimated (SMD -0.09, 95% CI -0.28 to 0.09; participants = 443; studies = 2; I2 = 0%) and multidisciplinary rehabilitation programmes (SMD -0.10, 95% CI -0.31 to 0.12; participants = 375; studies = 2; I2 = 0%). Concerning VRQOL, low-certainty evidence of small or no beneficial effects that were imprecisely estimated, was found with psychological therapies and/or group programmes (SMD -0.11, 95% CI -0.24 to 0.01; participants = 1245; studies = 7; I2 = 19%) and moderate-certainty evidence of small effects with methods of enhancing vision (SMD -0.24, 95% CI -0.40 to -0.08; participants = 660; studies = 7; I2 = 16%). No additional benefit was found with multidisciplinary rehabilitation programmes (SMD 0.01, 95% CI -0.18 to 0.20; participants = 464; studies = 3; I2 = 0%; low-certainty evidence).\nAmong secondary outcomes, very low-certainty evidence of a significant and large, but imprecisely estimated benefit on self-efficacy or self-esteem was found for psychological therapies and/or group programmes versus waiting list or no care (SMD -0.85, 95% CI -1.48 to -0.22; participants = 456; studies = 5; I2 = 91%). In addition, very low-certainty evidence of a significant and large estimated benefit on depression was found for psychological therapies and/or group programmes versus waiting list or no care (SMD -1.23, 95% CI -2.18 to -0.28; participants = 456; studies = 5; I2 = 94%), and moderate-certainty evidence of a small benefit versus usual care (SMD -0.14, 95% CI -0.25 to -0.04; participants = 1334; studies = 9; I2 = 0%). ln the few studies in which (serious) adverse events were reported, these seemed unrelated to low vision rehabilitation.\nAuthors' conclusions\nIn this Cochrane Review, no evidence of benefit was found of diverse types of low vision rehabilitation interventions on HRQOL. We found low- and moderate-certainty evidence, respectively, of a small benefit on VRQOL in studies comparing psychological therapies or methods for enhancing vision with active comparators.\nThe type of rehabilitation varied among studies, even within intervention groups, but benefits were detected even if compared to active control groups. Studies were conducted on adults with visual impairment mainly of older age, living in high-income countries and often having AMD. Most of the included studies on low vision rehabilitation had a short follow-up,\nDespite these limitations, the consistent direction of the effects in this review towards benefit justifies further research activities of better methodological quality including longer maintenance effects and costs of several types of low vision rehabilitation. Research on the working mechanisms of components of rehabilitation interventions in different settings, including low-income countries, is also needed.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A person who is vision impaired has problems with their eyesight. If the vision loss cannot be corrected by glasses or contact lenses, or otherwise treated, then low vision rehabilitation may help to improve quality of life for people with vision impairment.\nThere are different types of low vision rehabilitation and these include:\n• Psychological therapies and group programmes to help people adapt to permanent vision loss and improve well-being.\n• Methods of enhancing vision such as teaching the use of magnifying devices, or other technologies, or teaching skills to improve the use of residual vision in daily life.\n• Multidisciplinary rehabilitation programmes, which may include the use of magnifying devices and psychological therapies, as well as other services, including at patients’ homes.\n• Other less common types of rehabilitation services such as balance training or home safety programs."
}
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query-laysum
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6877
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[
{
"role": "user",
"content": "Abstract: Background\nLay health workers (LHWs) perform functions related to healthcare delivery, receive some level of training, but have no formal professional or paraprofessional certificate or tertiary education degree. They provide care for a range of issues, including maternal and child health. For LHW programmes to be effective, we need a better understanding of the factors that influence their success and sustainability. This review addresses these issues through a synthesis of qualitative evidence and was carried out alongside the Cochrane review of the effectiveness of LHWs for maternal and child health.\nObjectives\nThe overall aim of the review is to explore factors affecting the implementation of LHW programmes for maternal and child health.\nSearch methods\nWe searched MEDLINE, OvidSP (searched 21 December 2011); MEDLINE Ovid In-Process & Other Non-Indexed Citations, OvidSP (searched 21 December 2011); CINAHL, EBSCO (searched 21 December 2011); British Nursing Index and Archive, OvidSP (searched 13 May 2011). We searched reference lists of included studies, contacted experts in the field, and included studies that were carried out alongside the trials from the LHW effectiveness review.\nSelection criteria\nStudies that used qualitative methods for data collection and analysis and that focused on the experiences and attitudes of stakeholders regarding LHW programmes for maternal or child health in a primary or community healthcare setting.\nData collection and analysis\nWe identified barriers and facilitators to LHW programme implementation using the framework thematic synthesis approach. Two review authors independently assessed study quality using a standard tool. We assessed the certainty of the review findings using the CerQual approach, an approach that we developed alongside this and related qualitative syntheses. We integrated our findings with the outcome measures included in the review of LHW programme effectiveness in a logic model. Finally, we identified hypotheses for subgroup analyses in future updates of the review of effectiveness.\nMain results\nWe included 53 studies primarily describing the experiences of LHWs, programme recipients, and other health workers. LHWs in high income countries mainly offered promotion, counselling and support. In low and middle income countries, LHWs offered similar services but sometimes also distributed supplements, contraceptives and other products, and diagnosed and treated children with common childhood diseases. Some LHWs were trained to manage uncomplicated labour and to refer women with pregnancy or labour complications.\nMany of the findings were based on studies from multiple settings, but with some methodological limitations. These findings were assessed as being of moderate certainty. Some findings were based on one or two studies and had some methodological limitations. These were assessed have low certainty.\nBarriers and facilitators were mainly tied to programme acceptability, appropriateness and credibility; and health system constraints. Programme recipients were generally positive to the programmes, appreciating the LHWs’ skills and the similarities they saw between themselves and the LHWs. However, some recipients were concerned about confidentiality when receiving home visits. Others saw LHW services as not relevant or not sufficient, particularly when LHWs only offered promotional services. LHWs and recipients emphasised the importance of trust, respect, kindness and empathy. However, LHWs sometimes found it difficult to manage emotional relationships and boundaries with recipients. Some LHWs feared blame if care was not successful. Others felt demotivated when their services were not appreciated. Support from health systems and community leaders could give LHWs credibility, at least if the health systems and community leaders had authority and respect. Active support from family members was also important.\nHealth professionals often appreciated the LHWs’ contributions in reducing their workload and for their communication skills and commitment. However, some health professionals thought that LHWs added to their workload and feared a loss of authority.\nLHWs were motivated by factors including altruism, social recognition, knowledge gain and career development. Some unsalaried LHWs wanted regular payment, while others were concerned that payment might threaten their social status or lead recipients to question their motives. Some salaried LHWs were dissatisfied with their pay levels. Others were frustrated when payment differed across regions or institutions. Some LHWs stated that they had few opportunities to voice complaints.\nLHWs described insufficient, poor quality, irrelevant and inflexible training programmes, calling for more training in counselling and communication and in topics outside their current role, including common health problems and domestic problems. LHWs and supervisors complained about supervisors’ lack of skills, time and transportation. Some LHWs appreciated the opportunity to share experiences with fellow LHWs.\nIn some studies, LHWs were traditional birth attendants who had received additional training. Some health professionals were concerned that these LHWs were over-confident about their ability to manage danger signs. LHWs and recipients pointed to other problems, including women’s reluctance to be referred after bad experiences with health professionals, fear of caesarean sections, lack of transport, and cost. Some LHWs were reluctant to refer women on because of poor co-operation with health professionals.\nWe organised these findings and the outcome measures included in the review of LHW programme effectiveness in a logic model. Here we proposed six chains of events where specific programme components lead to specific intermediate or long-term outcomes, and where specific moderators positively or negatively affect this process. We suggest how future updates of the LHW effectiveness review could explore whether the presence of these components influences programme success.\nAuthors' conclusions\nRather than being seen as a lesser trained health worker, LHWs may represent a different and sometimes preferred type of health worker. The close relationship between LHWs and recipients is a programme strength. However, programme planners must consider how to achieve the benefits of closeness while minimizing the potential drawbacks. Other important facilitators may include the development of services that recipients perceive as relevant; regular and visible support from the health system and the community; and appropriate training, supervision and incentives.\n\nGiven the provided abstract, please respond to the following query: \"What the research says\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The studies described the experiences of LHWs, mothers, programme managers, and other health workers with LHW programmes. Many of our findings were based on studies from different settings and had some methodological problems. We judged these findings to have moderate certainty. Some findings were only based on one or two studies that had some methodological problems and were judged to be of low certainty.\nMothers were generally positive about the programmes. They appreciated the LHWs’ skills and the similarities they saw between themselves and the LHWs. However, some mothers were concerned about confidentiality when receiving home visits. Others saw LHW services as not relevant or not sufficient, particularly when LHWs only offered promotional services. LHWs and mothers emphasised the importance of trust, respect, kindness and empathy. However, LHWs sometimes found it difficult to manage emotional relationships and boundaries with mothers. Some LHWs feared blame if health care was not successful. Others felt demotivated when their services were not appreciated. Support from health systems and community leaders could give LHWs credibility if these health systems and community leaders had authority and respect. Active support from family members was also important.\nHealth professionals often appreciated the LHWs' contributions to reducing their workload, and their communication skills and commitment. However, some health professionals thought that LHWs added to their own workloads and feared a loss of authority.\nLHWs were motivated by altruism, social recognition, knowledge gain and career development. Some unsalaried LHWs wanted regular payment. Others were concerned that payment might threaten their social status or lead people to question their motives. Some salaried LHWs were dissatisfied with their pay levels. Others were frustrated when other LHWs had higher salaries. Some LHWs said that they had few opportunities to voice complaints.\nSome LHWs described insufficient, poor quality and irrelevant training programmes. They called for more training in counselling and communication and in topics outside their current role, including common health problems and domestic problems. LHWs and supervisors complained about supervisors’ lack of skills, time and transportation. Some LHWs appreciated the opportunity to share experiences with other LHWs.\nSome LHWs were traditional birth attendants who had received additional training. Some health professionals were concerned that these LHWs were over-confident about their ability to manage danger signs. LHWs and mothers identified women’s reluctance to be referred after bad experiences with health professionals, fear of caesarean sections, lack of transport, and costs. Some LHWs were also reluctant to refer women on because of poor co-operation with health professionals.\nWe organized these findings into chains of events where we have proposed how certain LHW programme elements might lead to greater programme success."
}
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query-laysum
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6878
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[
{
"role": "user",
"content": "Abstract: Background\nPeople with dementia can have feeding and swallowing difficulties (dysphagia). Modification of the consistency of food or fluids, or both, is a common management strategy. However, diet modification can affect quality of life and may lead to dehydration and malnutrition. Evidence on the benefits and risks of modifying food and fluids is mandatory to improve the care of people with dementia and dysphagia.\nObjectives\nTo determine the effectiveness and adverse effects associated with modifying the consistency of food and fluids in improving oral intake and eliminating aspiration in adults with dysphagia and dementia.\nSearch methods\nWe searched ALOIS (the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group), the Cochrane Library, MEDLINE via Ovid SP, Embase via Ovid SP, PsycINFO via Ovid SP, CINAHL via EBSCOhost, LILACS via BIREME, ClinicalTrials.gov and the World Health Organization (WHO) Portal on 9 May 2018. We also checked the reference lists of relevant articles to identify any additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and cluster-RCTs published in any language that measured any of the outcomes of interest. We included trials with adults with a clinical diagnosis of dementia with symptoms and signs of dysphagia confirmed on instrumental assessment. We included participants with all types, stages and severities of dementia. Control groups received either no intervention or interventions not involving diet modification or modification to sensory properties of food.\nData collection and analysis\nTwo review authors independently assessed for inclusion all potential studies identified. Data were extracted independently along with assessment of methodological quality using standard Cochrane methods. We contacted study authors for additional unpublished information.\nMain results\nNo trials on modification of food met the inclusion criteria. We included two studies that examined modification to fluids. Both were part of the same large multicentre trial and included people with dementia and people with or without dementia and Parkinson's disease. Participation in the second trial was determined by results from the first trial. With unpublished data supplied by study authors, we examined data from participants with dementia only. The first study, a cross-over trial, investigated the immediate effects on aspiration of two viscosities of liquids (nectar thick and honey thick) compared to regular liquids in 351 participants with dementia using videofluoroscopy. Regular liquids with a chin down head posture, as well as regular liquids without any intervention were also compared. The sequence of interventions during videofluoroscopy may have influenced response to intervention. The second study, a parallel designed RCT, compared the effect of nectar and honey thick liquids with a chin down head posture over a three-month period in a subgroup of 260 participants with dementia. Outcomes were pneumonia and adverse intervention effects. Honey thick liquids, which are more consistent with descriptors for 'spoon thick' or 'extremely thick' liquids, showed a more positive impact on immediate elimination of aspiration during videofluoroscopy, but this consistency showed more adverse effects in the second follow-up study. During the second three-month follow-up trial, there were a greater number of incidents of pneumonia in participants receiving honey thick liquids than those receiving nectar thick liquids or taking regular liquids with a chin down posture. There were no deaths classified as 'definitely related' to the type of fluids prescribed. Neither trial addressed quality of life. Risk of bias for both studies is high. The overall quality of evidence for outcomes in this review is low.\nAuthors' conclusions\nWe are uncertain about the immediate and long-term effects of modifying the consistency of fluid for swallowing difficulties in dementia as too few studies have been completed. There may be differences in outcomes depending on the grade of thickness of fluids and the sequence of interventions trialled in videofluoroscopy for people with dementia. Clinicians should be aware that while thickening fluids may have an immediate positive effect on swallowing, the long-term impact of thickened fluids on the health of the person with dementia should be considered. Further high-quality clinical trials are required.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There were a number of methodological flaws in both studies in this review and these were acknowledged by the authors. While thickening fluids may have an immediate positive effect on swallow function, clinicians should consider the effects of this intervention on the person with dementia in the longer-term. People with dementia on thickened fluids require long-term follow-up. The overall risk of bias of included studies is high. The quality of evidence is low. Further well-designed research is needed."
}
] |
query-laysum
|
6879
|
[
{
"role": "user",
"content": "Abstract: Background\nBronchiolitis is an acute, viral lower respiratory tract infection affecting infants and is sometimes treated with bronchodilators.\nObjectives\nTo assess the effects of bronchodilators on clinical outcomes in infants (0 to 12 months) with acute bronchiolitis.\nSearch methods\nWe searched CENTRAL 2013, Issue 12, MEDLINE (1966 to January Week 2, 2014) and EMBASE (1998 to January 2014).\nSelection criteria\nRandomized controlled trials (RCTs) comparing bronchodilators (other than epinephrine) with placebo for bronchiolitis.\nData collection and analysis\nTwo authors assessed trial quality and extracted data. We obtained unpublished data from trial authors.\nMain results\nWe included 30 trials (35 data sets) representing 1992 infants with bronchiolitis. In 11 inpatient and 10 outpatient studies, oxygen saturation did not improve with bronchodilators (mean difference (MD) -0.43, 95% confidence interval (CI) -0.92 to 0.06, n = 1242). Outpatient bronchodilator treatment did not reduce the rate of hospitalization (11.9% in bronchodilator group versus 15.9% in placebo group, odds ratio (OR) 0.75, 95% CI 0.46 to 1.21, n = 710). Inpatient bronchodilator treatment did not reduce the duration of hospitalization (MD 0.06, 95% CI -0.27 to 0.39, n = 349).\nEffect estimates for inpatients (MD -0.62, 95% CI -1.40 to 0.16) were slightly larger than for outpatients (MD -0.25, 95% CI -0.61 to 0.11) for oximetry. Oximetry outcomes showed significant heterogeneity (I2 statistic = 81%). Including only studies with low risk of bias had little impact on the overall effect size of oximetry (MD -0.38, 95% CI -0.75 to 0.00) but results were close to statistical significance.\nIn eight inpatient studies, there was no change in average clinical score (standardized MD (SMD) -0.14, 95% CI -0.41 to 0.12) with bronchodilators. In nine outpatient studies, the average clinical score decreased slightly with bronchodilators (SMD -0.42, 95% CI -0.79 to -0.06), a statistically significant finding of questionable clinical importance. The clinical score outcome showed significant heterogeneity (I2 statistic = 73%). Including only studies with low risk of bias reduced the heterogeneity but had little impact on the overall effect size of average clinical score (SMD -0.22, 95% CI -0.41 to -0.03).\nSub-analyses limited to nebulized albuterol or salbutamol among outpatients (nine studies) showed no effect on oxygen saturation (MD -0.19, 95% CI -0.59 to 0.21, n = 572), average clinical score (SMD -0.36, 95% CI -0.83 to 0.11, n = 532) or hospital admission after treatment (OR 0.77, 95% CI 0.44 to 1.33, n = 404).\nAdverse effects included tachycardia, oxygen desaturation and tremors.\nAuthors' conclusions\nBronchodilators such as albuterol or salbutamol do not improve oxygen saturation, do not reduce hospital admission after outpatient treatment, do not shorten the duration of hospitalization and do not reduce the time to resolution of illness at home. Given the adverse side effects and the expense associated with these treatments, bronchodilators are not effective in the routine management of bronchiolitis. This meta-analysis continues to be limited by the small sample sizes and the lack of standardized study design and validated outcomes across the studies. Future trials with large sample sizes, standardized methodology across clinical sites and consistent assessment methods are needed to answer completely the question of efficacy.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of bronchodilators in infants with bronchiolitis. We found 30 trials that included a total of 1922 infants, in several countries. The evidence is current up to January 2014. We analyzed studies done in outpatient and inpatient settings separately. All bronchodilators were included in the review except for epinephrine because it is reviewed in another Cochrane review. Albuterol (otherwise known as salbutamol) is commonly used in studies, so we also reviewed this bronchodilator as a subgroup."
}
] |
query-laysum
|
6880
|
[
{
"role": "user",
"content": "Abstract: Background\nStroke is one of the leading causes of long-lasting disability and mortality and its global burden has increased in the past two decades. Several therapies have been proposed for the recovery from, and treatment of, ischemic stroke. One of them is citicoline. This review assessed the benefits and harms of citicoline for treating patients with acute ischemic stroke.\nObjectives\nTo assess the clinical benefits and harms of citicoline compared with placebo or any other control for treating people with acute ischemic stroke.\nSearch methods\nWe searched in the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS until 29 January 2020. We searched the World Health Organization Clinical Trials Search Portal and ClinicalTrials.gov. Additionally, we also reviewed reference lists of the retrieved publications and review articles, and searched the websites of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).\nSelection criteria\nWe included randomized controlled trials (RCTs) in any setting including participants with acute ischemic stroke. Trials were eligible for inclusion if they compared citicoline versus placebo or no intervention.\nData collection and analysis\nWe selected RCTs, assessed the risk of bias in seven domains, and extracted data by duplicate. Our primary outcomes of interest were all-cause mortality and the degree of disability or dependence in daily activities at 90 days. We estimated risk ratios (RRs) for dichotomous outcomes. We measured statistical heterogeneity using the I² statistic. We conducted our analyses using the fixed-effect and random-effects model meta-analyses. We assessed the overall quality of evidence for six pre-specified outcomes using the GRADE approach.\nMain results\nWe identified 10 RCTs including 4281 participants. In all these trials, citicoline was given either orally, intravenously, or a combination of both compared with placebo or standard care therapy. Citicoline doses ranged between 500 mg and 2000 mg per day. We assessed all the included trials as having high risk of bias. Drug companies sponsored six trials.\nA pooled analysis of eight trials indicates there may be little or no difference in all-cause mortality comparing citicoline with placebo (17.3% versus 18.5%; RR 0.94, 95% CI 0.83 to 1.07; I² = 0%; low-quality evidence due to risk of bias). Four trials showed that citicoline may not increase the proportion of patients with a moderate or lower degree of disability or dependence compared with placebo, according to the Rankin Scale (21.72% versus 19.23%; RR 1.11, 95% CI 0.97 to 1.26; I² = 1%; low-quality evidence due to risk of bias).\nMeta-analysis of three trials indicates there may be little or no difference in serious cardiovascular adverse events comparing citicoline with placebo (8.83% versus 7.77%; RR 1.04, 95% CI 0.84 to 1.29; I² = 0%; low-quality evidence due to risk of bias). Overall, either serious or non-serious adverse events – central nervous system, gastrointestinal, musculoskeletal, etc. – were poorly reported and harms may have been underestimated.\nFour trials suggested that citicoline results in no difference in functional recovery, according to the Barthel Index, compared with placebo (32.78% versus 30.70%; RR 1.03, 95% CI 0.94 to 1.13; I² = 24%; low-quality evidence due to risk of bias). Citicoline may not increase the proportion of patients with a minor impairment (according to ≤ 1 scores in the National Institutes of Health Stroke Scale) (5 trials, 24.31% versus 22.44%; RR 1.08, 95% CI 0.96 to 1.21; I² = 27%, low-quality evidence due to risk of bias). None of the included trials reported data on quality of life.\nA pre-planned Trial Sequential Analysis suggested that no more trials may be needed for the primary outcomes.\nAuthors' conclusions\nThis review assessed the clinical benefits and harms of citicoline compared with placebo or any other standard treatment for people with acute ischemic stroke. The findings of the review suggest there may be little to no difference between citicoline and its controls regarding all-cause mortality, disability or dependence in daily activities, functional recovery, neurological function and severe adverse events, based on low-certainty evidence. None of the included trials assessed quality of life and the safety profile of citicoline remains unknown. The available evidence is of low quality due to either limitations in the design or execution of the trials.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included randomized controlled trials, both published and unpublished. We did not apply any limitation by language, country, or study design. We included people (adults or children) with acute ischemic stroke irrespective of the underlying cause. Stroke was based on the clinical diagnosis confirmed with brain scans. We included trials that compared citicoline with placebo, usual care, or other usual treatment."
}
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query-laysum
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6882
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[
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"role": "user",
"content": "Abstract: Background\nAcute respiratory infections (ARIs) are by far the most common reason for prescribing an antibiotic in primary care, even though the majority of ARIs are of viral or non-severe bacterial aetiology. It follows that in many cases antibiotic use will not be beneficial to a patient's recovery but may expose them to potential side effects. Furthermore, limiting unnecessary antibiotic use is a key factor in controlling antibiotic resistance. One strategy to reduce antibiotic use in primary care is point-of-care biomarkers. A point-of-care biomarker (test) of inflammation identifies part of the acute phase response to tissue injury regardless of the aetiology (infection, trauma, or inflammation) and may be used as a surrogate marker of infection, potentially assisting the physician in the clinical decision whether to use an antibiotic to treat ARIs. Biomarkers may guide antibiotic prescription by ruling out a serious bacterial infection and help identify patients in whom no benefit from antibiotic treatment can be anticipated. This is an update of a Cochrane Review first published in 2014.\nObjectives\nTo assess the benefits and harms of point-of-care biomarker tests of inflammation to guide antibiotic treatment in people presenting with symptoms of acute respiratory infections in primary care settings regardless of patient age.\nSearch methods\nWe searched CENTRAL (2022, Issue 6), MEDLINE (1946 to 14 June 2022), Embase (1974 to 14 June 2022), CINAHL (1981 to 14 June 2022), Web of Science (1955 to 14 June 2022), and LILACS (1982 to 14 June 2022). We also searched three trial registries (10 December 2021) for completed and ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) in primary care patients with ARIs that compared the use of point-of-care biomarkers with standard care. We included trials that randomised individual participants, as well as trials that randomised clusters of patients (cluster-RCTs).\nData collection and analysis\nTwo review authors independently extracted data on the following primary outcomes: number of participants given an antibiotic prescription at index consultation and within 28 days follow-up; participant recovery within seven days follow-up; and total mortality within 28 days follow-up. We assessed risk of bias using the Cochrane risk of bias tool and the certainty of the evidence using GRADE. We used random-effects meta-analyses when feasible. We further analysed results with considerable heterogeneity in prespecified subgroups of individual and cluster-RCTs.\nMain results\nWe included seven new trials in this update, for a total of 13 included trials. Twelve trials (10,218 participants in total, 2335 of which were children) evaluated a C-reactive protein point-of-care test, and one trial (317 adult participants) evaluated a procalcitonin point-of-care test. The studies were conducted in Europe, Russia, and Asia. Overall, the included trials had a low or unclear risk of bias. However all studies were open-labelled, thereby introducing high risk of bias due to lack of blinding.\nThe use of C-reactive protein point-of-care tests to guide antibiotic prescription likely reduces the number of participants given an antibiotic prescription, from 516 prescriptions of antibiotics per 1000 participants in the control group to 397 prescriptions of antibiotics per 1000 participants in the intervention group (risk ratio (RR) 0.77, 95% confidence interval (CI) 0.69 to 0.86; 12 trials, 10,218 participants; I² = 79%; moderate-certainty evidence).\nOverall, use of C-reactive protein tests also reduce the number of participants given an antibiotic prescription within 28 days follow-up (664 prescriptions of antibiotics per 1000 participants in the control group versus 538 prescriptions of antibiotics per 1000 participants in the intervention group) (RR 0.81, 95% CI 0.76 to 0.86; 7 trials, 5091 participants; I² = 29; high-certainty evidence).\nThe prescription of antibiotics as guided by C-reactive protein tests likely does not reduce the number of participants recovered, within seven or 28 days follow-up (567 participants recovered within seven days follow-up per 1000 participants in the control group versus 584 participants recovered within seven days follow-up per 1000 participants in the intervention group) (recovery within seven days follow-up: RR 1.03, 95% CI 0.96 to 1.12; I² = 0%; moderate-certainty evidence) (recovery within 28 days follow-up: RR 1.02, 95% CI 0.79 to 1.32; I² = 0%; moderate-certainty evidence). The use of C-reactive protein tests may not increase total mortality within 28 days follow-up, from 1 death per 1000 participants in the control group to 0 deaths per 1000 participants in the intervention group (RR 0.53, 95% CI 0.10 to 2.92; I² = 0%; low-certainty evidence).\nWe are uncertain as to whether procalcitonin affects any of the primary or secondary outcomes because there were few participants, thereby limiting the certainty of evidence.\nWe assessed the certainty of the evidence as moderate to high according to GRADE for the primary outcomes for C-reactive protein test, except for mortality, as there were very few deaths, thereby limiting the certainty of the evidence.\nAuthors' conclusions\nThe use of C-reactive protein point-of-care tests as an adjunct to standard care likely reduces the number of participants given an antibiotic prescription in primary care patients who present with symptoms of acute respiratory infection. The use of C-reactive protein point-of-care tests likely does not affect recovery rates. It is unlikely that further research will substantially change our conclusion regarding the reduction in number of participants given an antibiotic prescription, although the size of the estimated effect may change.\nThe use of C-reactive protein point-of-care tests may not increase mortality within 28 days follow-up, but there were very few events. Studies that recorded deaths and hospital admissions were performed in children from low- and middle-income countries and older adults with comorbidities.\nFuture studies should focus on children, immunocompromised individuals, and people aged 80 years and above with comorbidities. More studies evaluating procalcitonin and potential new biomarkers as point-of-care tests used in primary care to guide antibiotic prescription are needed.\nFurthermore, studies are needed to validate C-reactive protein decision algorithms, with a specific focus on potential age group differences.\n\nGiven the provided abstract, please respond to the following query: \"What is inflammation and biomarkers?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Inflammation is a reaction in response to injury such as bacterial or viral infections. Your body naturally produces substances in response to inflammation that can be detected in the blood, which are known as biomarkers. Point-of-care tests that detect biomarkers are often used when patients have signs of an airway infection. Test results can inform doctors when not to suspect a serious bacterial infection that needs antibiotic treatment to prevent serious illness and possibly death. There are currently three types of biomarkers available as point-of-care tests: C-reactive protein, procalcitonin, and leucocytes."
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query-laysum
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6883
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[
{
"role": "user",
"content": "Abstract: Background\nScreening programmes can potentially identify people at high cardiovascular risk and reduce cardiovascular disease (CVD) morbidity and mortality. However, there is currently not enough evidence showing clear clinical or economic benefits of systematic screening-like programmes over the widely practised opportunistic risk assessment of CVD in primary care settings.\nObjectives\nThe primary objective of this review was to assess the effectiveness, costs and adverse effects of systematic risk assessment compared to opportunistic risk assessment for the primary prevention of CVD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, MEDLINE, EMBASE on 30 January 2015, and Web of Science Core Collection and additional databases on the Cochrane Library on 4 December 2014. We also searched two clinical trial registers and checked reference lists of relevant articles. We applied no language restrictions.\nSelection criteria\nWe selected randomised controlled trials (RCTs) that assessed the effects of systematic risk assessment, defined as a screening-like programme involving a predetermined selection process of people, compared with opportunistic risk assessment which ranged from no risk assessment at all to incentivised case finding of CVD and related risk factors. Participants included healthy adults from the general population, including those who are at risk of CVD.\nData collection and analysis\nTwo review authors independently selected studies. One review author extracted data and assessed them for risk of bias and a second checked them. We assessed evidence quality using the GRADE approach and present this in a ’Summary of findings’ table.\nMain results\nNine completed RCTs met the inclusion criteria, of which four were cluster-randomised. We also identified five ongoing trials. The included studies had a high or unclear risk of bias, and the GRADE ratings of overall quality were low or very low. The length of follow-up varied from one year in four studies, three years in one study, five or six years in two studies, and ten years in two studies. Eight studies recruited participants from the general population, although there were differences in the age ranges targeted. One study recruited family members of cardiac patients (high risk assessment). There were considerable differences between the studies in the interventions received by the intervention and control groups. There was insufficient evidence to stratify by the types of risk assessment approaches.\nLimited data were available on all-cause mortality (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.93 to 1.03; 3 studies,103,571 participants, I² = 0%; low-quality evidence) and cardiovascular mortality (RR 1.00, 95% CI 0.90 to 1.11; 2 studies, 43,955 participants, I² = 0%), and suggest that screening has no effect on these outcomes. Data were also limited for combined non-fatal endpoints; overall, evidence indicates no difference in total coronary heart disease (RR 1.01, 95% CI 0.95 to 1.07; 4 studies, 5 comparisons, 110,168 participants, I² = 0%; low-quality evidence), non-fatal coronary heart disease (RR 0.98, 95% CI 0.89 to 1.09; 2 studies, 43,955 participants, I² = 39%), total stroke (RR 0.99, 95% CI 0.90 to 1.10; 2 studies, 79,631 participants, I² = 0%, low-quality evidence), and non-fatal stroke (RR 1.17, 95% CI 0.94 to 1.47; 1 study, 20,015 participants).\nOverall, systematic risk assessment appears to result in lower total cholesterol levels (mean difference (MD) -0.11 mmol/l, 95% CI -0.17 to -0.04, 6 studies, 7 comparisons, 12,591 participants, I² = 57%; very low-quality evidence), lower systolic blood pressure (MD -3.05 mmHg, 95% CI -4.84 to -1.25, 6 studies, 7 comparisons, 12,591 participants, I² = 82%; very low-quality evidence) and lower diastolic blood pressure (MD -1.34 mmHg, 95% CI -1.76 to -0.93, 6 studies, 7 comparisons, 12,591 participants, I² = 0%; low-quality evidence). One study assessed adverse effects and found no difference in psychological distress at five years (1126 participants).\nAuthors' conclusions\nThe results are limited by the heterogeneity between trials in terms of participants recruited, interventions and duration of follow-up. Limited data suggest that systematic risk assessment for CVD has no statistically significant effects on clinical endpoints. There is limited evidence to suggest that CVD systematic risk assessment may have some favourable effects on cardiovascular risk factors. The completion of the five ongoing trials will add to the evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Are systematic risk assessment (screening) programmes helpful in the prevention of cardiovascular disease?"
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query-laysum
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6884
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[
{
"role": "user",
"content": "Abstract: Background\nVestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. These unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of pharmacological interventions have been used or proposed to be used as prophylaxis for this condition, to help reduce the frequency of the attacks. These are predominantly based on treatments that are in use for headache migraine, with the belief that the underlying pathophysiology of these conditions is similar.\nObjectives\nTo assess the benefits and harms of pharmacological treatments used for prophylaxis of vestibular migraine.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing beta-blockers, calcium channel blockers, antiepileptics, antidepressants, diuretics, monoclonal antibodies against calcitonin gene-related peptide (or its receptor), botulinum toxin or hormonal modification with either placebo or no treatment. We excluded studies with a cross-over design, unless data from the first phase of the study could be identified.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 3 months, 3 to < 6 months, > 6 to 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included three studies with a total of 209 participants. One evaluated beta-blockers and the other two evaluated calcium channel blockers. We did not identify any evidence for the remaining interventions of interest.\nBeta-blockers versus placebo\nOne study (including 130 participants, 61% female) evaluated the use of 95 mg metoprolol once daily for six months, compared to placebo. The proportion of people who reported improvement in vertigo was not assessed in this study. Some data were reported on the frequency of vertigo attacks at six months and the occurrence of serious adverse effects. However, this is a single, small study and for all outcomes the certainty of evidence was low or very low. We are unable to draw meaningful conclusions from the numerical results.\nCalcium channel blockers versus no treatment\nTwo studies, which included a total of 79 participants (72% female), assessed the use of 10 mg flunarizine once daily for three months, compared to no intervention. All of the evidence for this comparison was of very low certainty. Most of our outcomes were only reported by a single study, therefore we were unable to conduct any meta-analysis. Some data were reported on improvement in vertigo and change in vertigo, but no information was available regarding serious adverse events. We are unable to draw meaningful conclusions from the numerical results, as these data come from single, small studies and the certainty of the evidence was very low.\nAuthors' conclusions\nThere is very limited evidence from placebo-controlled randomised trials regarding the efficacy and potential harms of pharmacological interventions for prophylaxis of vestibular migraine. We only identified evidence for two of our interventions of interest (beta-blockers and calcium channel blockers) and all evidence was of low or very low certainty. Further research is necessary to identify whether these treatments are effective at improving symptoms and whether there are any harms associated with their use.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This evidence is up-to-date to September 2022."
}
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query-laysum
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6885
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[
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are born with low glycogen stores and require higher glucose intake to match fetal accretion rates. In spite of the myriad benefits of breast milk for preterm infants, it may not adequately meet the needs of these rapidly growing infants. Supplementing human milk with carbohydrates may help. However, there is a paucity of data on assessment of benefits or harms of carbohydrate supplementation of human milk to promote growth in preterm infants. This is a 2020 update of a Cochrane Review first published in 1999.\nObjectives\nTo determine whether human milk supplemented with carbohydrate compared with unsupplemented human milk fed to preterm infants improves growth, body composition, and cardio-metabolic and neurodevelopmental outcomes without significant adverse effects.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 8) in the Cochrane Library and MEDLINE via PubMed on 22 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nPublished and unpublished controlled trials were eligible if they used random or quasi-random methods to allocate preterm infants in hospital fed human milk to supplementation or no supplementation with additional carbohydrate.\nData collection and analysis\nTwo review authors independently abstracted data and assessed trial quality and the quality of evidence at the outcome level using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. We planned to perform meta-analyses using risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data, with their respective 95% confidence intervals (CIs). We planned to use a fixed-effect model and to explore potential causes of heterogeneity via sensitivity analyses. We contacted study authors for additional information.\nMain results\nOne unblinded, quasi-randomised controlled trial (RCT) assessing effects of carbohydrate supplementation of human milk in the form of a prebiotic in 75 preterm infants was eligible for inclusion in this review. We identified two publications of the same trial, which reported different methods regarding blinding and randomisation. Study authors confirmed that these publications pertain to the same trial, but they have not yet clarified which method is correct. Our analyses showed very low certainty evidence of an effect of carbohydrate supplementation on weight by 30 days of age age (MD 160.4 grams, 95% CI 12.4 to 308.4 grams), and no effect on risk of feeding intolerance (RR 0.64, 95% CI 0.36 to 1.15) or necrotising enterocolitis (NEC) (RR 0.2, 95% CI 0.02 to 1.3). Duration of hospital stay was shorter in the prebiotic group than in the control group (median difference 9 days). No data were available for assessing effects of carbohydrate supplementation on long-term growth and neurodevelopment.\nAuthors' conclusions\nWe are uncertain whether carbohydrate supplementation of human milk affects any outcomes in preterm infants. The only trial included in this review presented very low-quality evidence, and study authors provided uncertain information about study methods and analysis. The evidence may be limited in its applicability because researchers included a small sample of preterm infants from a single centre. Future trials could assess the safety and efficacy of different types and concentrations of carbohydrate supplementation for preterm infants fed human milk. However, we do not envisage that further trials of digestible carbohydrates will be conducted, as this is currently done as a component of multi-nutrient human milk fortification.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Evidence on the short- and long-term effects of adding extra carbohydrate to human milk in preterm infants is lacking. This systematic review found very low-quality evidence on the effects of adding prebiotic carbohydrate to human milk in preterm infants, along with uncertainties about methods and analysis. The single trial included a small sample of Iranian preterm infants, and so the evidence may be considered as not generalisable. However, the outcomes assessed are common to all preterm infants, and the trial shows that adding prebiotic carbohydrate to human milk is possible in developing countries. Further research is needed to assess the benefits and harms of different types and concentrations of carbohydrate supplementation for preterm infants fed human milk. Currently, digestible carbohydrate supplementation in preterm infants is provided as a component of multi-nutrient human milk fortification."
}
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query-laysum
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6886
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[
{
"role": "user",
"content": "Abstract: Background\nCommunication is a common element in all medical consultations, affecting a range of outcomes for doctors and patients. The increasing demand for medical students to be trained to communicate effectively has seen the emergence of interpersonal communication skills as core graduate competencies in medical training around the world. Medical schools have adopted a range of approaches to develop and evaluate these competencies.\nObjectives\nTo assess the effects of interventions for medical students that aim to improve interpersonal communication in medical consultations.\nSearch methods\nWe searched five electronic databases: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, and ERIC (Educational Resource Information Centre) in September 2020, with no language, date, or publication status restrictions. We also screened reference lists of relevant articles and contacted authors of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs (C-RCTs), and non-randomised controlled trials (quasi-RCTs) evaluating the effectiveness of interventions delivered to students in undergraduate or graduate-entry medical programmes. We included studies of interventions aiming to improve medical students’ interpersonal communication during medical consultations. Included interventions targeted communication skills associated with empathy, relationship building, gathering information, and explanation and planning, as well as specific communication tasks such as listening, appropriate structure, and question style.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently reviewed all search results, extracted data, assessed the risk of bias of included studies, and rated the quality of evidence using GRADE.\nMain results\nWe found 91 publications relating to 76 separate studies (involving 10,124 students): 55 RCTs, 9 quasi-RCTs, 7 C-RCTs, and 5 quasi-C-RCTs. We performed meta-analysis according to comparison and outcome. Among both effectiveness and comparative effectiveness analyses, we separated outcomes reporting on overall communication skills, empathy, rapport or relationship building, patient perceptions/satisfaction, information gathering, and explanation and planning. Overall communication skills and empathy were further divided as examiner- or simulated patient-assessed. The overall quality of evidence ranged from moderate to very low, and there was high, unexplained heterogeneity.\nOverall, interventions had positive effects on most outcomes, but generally small effect sizes and evidence quality limit the conclusions that can be drawn. Communication skills interventions in comparison to usual curricula or control may improve both overall communication skills (standardised mean difference (SMD) 0.92, 95% confidence interval (CI) 0.53 to 1.31; 18 studies, 1356 participants; I² = 90%; low-quality evidence) and empathy (SMD 0.64, 95% CI 0.23 to 1.05; 6 studies, 831 participants; I² = 86%; low-quality evidence) when assessed by experts, but not by simulated patients. Students’ skills in information gathering probably also improve with educational intervention (SMD 1.07, 95% CI 0.61 to 1.54; 5 studies, 405 participants; I² = 78%; moderate-quality evidence), but there may be little to no effect on students' rapport (SMD 0.18, 95% CI -0.15 to 0.51; 9 studies, 834 participants; I² = 81%; low-quality evidence), and effects on information giving skills are uncertain (very low-quality evidence).\nWe are uncertain whether experiential interventions improve overall communication skills in comparison to didactic approaches (SMD 0.08, 95% CI -0.02 to 0.19; 4 studies, 1578 participants; I² = 4%; very low-quality evidence). Electronic learning approaches may have little to no effect on students’ empathy scores (SMD -0.13, 95% CI -0.68 to 0.43; 3 studies, 421 participants; I² = 82%; low-quality evidence) or on rapport (SMD 0.02, 95% CI -0.33 to 0.38; 3 studies, 176 participants; I² = 19%; moderate-quality evidence) compared to face-to-face approaches. There may be small negative effects of electronic interventions on information giving skills (low-quality evidence), and effects on information gathering skills are uncertain (very low-quality evidence).\nPersonalised/specific feedback probably improves overall communication skills to a small degree in comparison to generic or no feedback (SMD 0.58, 95% CI 0.29 to 0.87; 6 studies, 502 participants; I² = 56%; moderate-quality evidence). There may be small positive effects of personalised feedback on empathy and information gathering skills (low quality), but effects on rapport are uncertain (very low quality), and we found no evidence on information giving skills.\nWe are uncertain whether role-play with simulated patients outperforms peer role-play in improving students’ overall communication skills (SMD 0.17, 95% CI -0.33 to 0.67; 4 studies, 637 participants; I² = 87%; very low-quality evidence). There may be little to no difference between effects of simulated patient and peer role-play on students' empathy (low-quality evidence) with no evidence on other outcomes for this comparison.\nDescriptive syntheses of results that could not be included in meta-analyses across outcomes and comparisons were mixed, as were effects of different interventions and comparisons on specific communication skills assessed by the included trials. Quality of evidence was downgraded due to methodological limitations across several risk of bias domains, high unexplained heterogeneity, and imprecision of results.\nIn general, results remain consistent in sensitivity analysis based on risk of bias and adjustment for clustering. No adverse effects were reported.\nAuthors' conclusions\nThis review represents a substantial body of evidence from which to draw, but further research is needed to strengthen the quality of the evidence base, to consider the long-term effects of interventions on students’ behaviour as they progress through training and into practice, and to assess effects of interventions on patient outcomes. Efforts to standardise assessment and evaluation of interpersonal skills will strengthen future research efforts.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Interpersonal education programmes for medical students had positive effects on most of the interpersonal skills we looked at, although these effects were small and our confidence in some of our results is low.\nProgrammes that include personalised feedback probably improve medical students' overall communication skills more than programmes that involve general or no feedback.\nOnline or self-directed programmes may make little to no difference in improving skills in empathy or rapport compared with face-to-face teaching."
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query-laysum
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6887
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[
{
"role": "user",
"content": "Abstract: Background\nDown's syndrome occurs when a person has three, rather than two copies of chromosome 21; or the specific area of chromosome 21 implicated in causing Down's syndrome. It is the commonest congenital cause of mental disability and also leads to numerous metabolic and structural problems. It can be life-threatening, or lead to considerable ill health, although some individuals have only mild problems and can lead relatively normal lives. Having a baby with Down’s syndrome is likely to have a significant impact on family life.\nNon-invasive screening based on biochemical analysis of maternal serum or urine, or fetal ultrasound measurements, allows estimates of the risk of a pregnancy being affected and provides information to guide decisions about definitive testing.\nBefore agreeing to screening tests, parents need to be fully informed about the risks, benefits and possible consequences of such a test. This includes subsequent choices for further tests they may face, and the implications of both false positive and false negative screening tests (i.e. invasive diagnostic testing, and the possibility that a miscarried fetus may be chromosomally normal). The decisions that may be faced by expectant parents inevitably engender a high level of anxiety at all stages of the screening process, and the outcomes of screening can be associated with considerable physical and psychological morbidity. No screening test can predict the severity of problems a person with Down's syndrome will have.\nObjectives\nTo estimate and compare the accuracy of first trimester ultrasound markers alone, and in combination with first trimester serum tests for the detection of Down’s syndrome.\nSearch methods\nWe carried out extensive literature searches including MEDLINE (1980 to 25 August 2011), Embase (1980 to 25 August 2011), BIOSIS via EDINA (1985 to 25 August 2011), CINAHL via OVID (1982 to 25 August 2011), and The Database of Abstracts of Reviews of Effects (the Cochrane Library 2011, Issue 7). We checked reference lists and published review articles for additional potentially relevant studies.\nSelection criteria\nStudies evaluating tests of first trimester ultrasound screening, alone or in combination with first trimester serum tests (up to 14 weeks' gestation) for Down's syndrome, compared with a reference standard, either chromosomal verification or macroscopic postnatal inspection.\nData collection and analysis\nData were extracted as test positive/test negative results for Down's and non-Down's pregnancies allowing estimation of detection rates (sensitivity) and false positive rates (1-specificity). We performed quality assessment according to QUADAS criteria. We used hierarchical summary ROC meta-analytical methods to analyse test performance and compare test accuracy. Analysis of studies allowing direct comparison between tests was undertaken. We investigated the impact of maternal age on test performance in subgroup analyses.\nMain results\nWe included 126 studies (152 publications) involving 1,604,040 fetuses (including 8454 Down's syndrome cases). Studies were generally good quality, although differential verification was common with invasive testing of only high-risk pregnancies. Sixty test combinations were evaluated formed from combinations of 11 different ultrasound markers (nuchal translucency (NT), nasal bone, ductus venosus Doppler, maxillary bone length, fetal heart rate, aberrant right subclavian artery, frontomaxillary facial angle, presence of mitral gap, tricuspid regurgitation, tricuspid blood flow and iliac angle 90 degrees); 12 serum tests (inhibin A, alpha-fetoprotein (AFP), free beta human chorionic gonadotrophin (ßhCG), total hCG, pregnancy-associated plasma protein A (PAPP-A), unconjugated oestriol (uE3), disintegrin and metalloprotease 12 (ADAM 12), placental growth factor (PlGF), placental growth hormone (PGH), invasive trophoblast antigen (ITA) (synonymous with hyperglycosylated hCG), growth hormone binding protein (GHBP) and placental protein 13 (PP13)); and maternal age. The most frequently evaluated serum markers in combination with ultrasound markers were PAPP-A and free ßhCG.\nComparisons of the 10 most frequently evaluated test strategies showed that a combined NT, PAPP-A, free ßhCG and maternal age test strategy significantly outperformed ultrasound markers alone (with or without maternal age) except nasal bone, detecting about nine out of every 10 Down's syndrome pregnancies at a 5% false positive rate (FPR). In both direct and indirect comparisons, the combined NT, PAPP-A, free ßhCG and maternal age test strategy showed superior diagnostic accuracy to an NT and maternal age test strategy (P < 0.0001). Based on the indirect comparison of all available studies for the two tests, the sensitivity (95% confidence interval) estimated at a 5% FPR for the combined NT, PAPP-A, free ßhCG and maternal age test strategy (69 studies; 1,173,853 fetuses including 6010 with Down's syndrome) was 87% (86 to 89) and for the NT and maternal age test strategy (50 studies; 530,874 fetuses including 2701 Down's syndrome pregnancies) was 71% (66 to 75). Combinations of NT with other ultrasound markers, PAPP-A and free ßhCG were evaluated in one or two studies and showed sensitivities of more than 90% and specificities of more than 95%.\nHigh-risk populations (defined before screening was done, mainly due to advanced maternal age of 35 years or more, or previous pregnancies affected with Down's syndrome) showed lower detection rates compared to routine screening populations at a 5% FPR. Women who miscarried in the over 35 group were more likely to have been offered an invasive test to verify a negative screening results, whereas those under 35 were usually not offered invasive testing for a negative screening result. Pregnancy loss in women under 35 therefore leads to under-ascertainment of screening results, potentially missing a proportion of affected pregnancies and affecting test sensitivity. Conversely, for the NT, PAPP-A, free ßhCG and maternal age test strategy, detection rates and false positive rates increased with maternal age in the five studies that provided data separately for the subset of women aged 35 years or more.\nAuthors' conclusions\nTest strategies that combine ultrasound markers with serum markers, especially PAPP-A and free ßhCG, and maternal age were significantly better than those involving only ultrasound markers (with or without maternal age) except nasal bone. They detect about nine out of 10 Down’s affected pregnancies for a fixed 5% FPR. Although the absence of nasal bone appeared to have a high diagnostic accuracy, only five out of 10 affected Down's pregnancies were detected at a 1% FPR.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For the first 14 weeks of pregnancy, the evidence supports the use of first trimester ultrasound tests in combination with two serum (blood) markers - especially pregnancy-associated plasma protein A (PAPP-A) and free beta human chorionic gonadotrophin (ßhCG) - and maternal age, for Down's syndrome screening. In general, these tests are better than ultrasound markers on their own. They detect nine out of 10 pregnancies affected by Down's syndrome. Five per cent of women undertaking the test will have a high risk test result, however the majority of these pregnancies will not be affected by Down's syndrome.Other important information to considerThe ultrasound tests themselves have no adverse effects for the woman, blood tests can cause discomfort, bruising and rarely infection. However some women who have a ‘high risk’ screening test result, and are given amniocentesis or CVS have a risk of miscarrying a baby unaffected by Down’s. Parents will need to weigh up this risk when deciding whether or not to have an amniocentesis or CVS following a ‘high risk’ screening test result."
}
] |
query-laysum
|
6888
|
[
{
"role": "user",
"content": "Abstract: Background\nIron deficiency is an important micronutrient deficiency contributing to the global burden of disease, and particularly affects children, premenopausal women, and people in low-resource settings. Anaemia is a possible consequence of iron deficiency, although clinical and functional manifestations of anemia can occur without iron deficiency (e.g. from other nutritional deficiencies, inflammation, and parasitic infections). Direct nutritional interventions, such as large-scale food fortification, can improve micronutrient status, especially in vulnerable populations. Given the highly successful delivery of iodine through salt iodisation, fortifying salt with iodine and iron has been proposed as a method for preventing iron deficiency anaemia. Further investigation of the effect of double-fortified salt (i.e. with iron and iodine) on iron deficiency and related outcomes is warranted.\nObjectives\nTo assess the effect of double-fortified salt (DFS) compared to iodised salt (IS) on measures of iron and iodine status in all age groups.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, five other databases, and two trial registries up to April 2021. We also searched relevant websites, reference lists, and contacted the authors of included studies.\nSelection criteria\nAll prospective randomised controlled trials (RCTs), including cluster-randomised controlled trials (cRCTs), and controlled before-after (CBA) studies, comparing DFS with IS on measures of iron and iodine status were eligible, irrespective of language or publication status. Study reports published as abstracts were also eligible.\nData collection and analysis\nThree review authors applied the study selection criteria, extracted data, and assessed risk of bias. Two review authors rated the certainty of the evidence using GRADE. When necessary, we contacted study authors for additional information. We assessed RCTs, cRCTs and CBA studies using the Cochrane RoB 1 tool and Cochrane Effective Practice and Organisation of Care (EPOC) tool across the following domains: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective reporting; and other potential sources of bias due to similar baseline characteristics, similar baseline outcome assessments, and declarations of conflicts of interest and funding sources. We also assessed cRCTs for recruitment bias, baseline imbalance, loss of clusters, incorrect analysis, and comparability with individually randomised studies. We assigned studies an overall risk of bias judgement (low risk, high risk, or unclear).\nMain results\nWe included 18 studies (7 RCTs, 7 cRCTs, 4 CBA studies), involving over 8800 individuals from five countries. One study did not contribute to analyses. All studies used IS as the comparator and measured and reported outcomes at study endpoint.\nWith regards to risk of bias, five RCTs had unclear risk of bias, with some concerns in random sequence generation and allocation concealment, while we assessed two RCTs to have a high risk of bias overall, whereby high risk was noted in at least one or more domain(s). Of the seven cRCTs, we assessed six at high risk of bias overall, with one or more domain(s) judged as high risk and one cRCT had an unclear risk of bias with concerns around allocation and blinding. The four CBA studies had high or unclear risk of bias for most domains.\nThe RCT evidence suggested that, compared to IS, DFS may slightly improve haemoglobin concentration (mean difference (MD) 0.43 g/dL, 95% confidence interval (CI) 0.23 to 0.63; 13 studies, 4564 participants; low-certainty evidence), but DFS may reduce urinary iodine concentration compared to IS (MD −96.86 μg/L, 95% CI −164.99 to −28.73; 7 studies, 1594 participants; low-certainty evidence), although both salts increased mean urinary iodine concentration above the cut-off deficiency. For CBA studies, we found DFS made no difference in haemoglobin concentration (MD 0.26 g/dL, 95% CI −0.10 to 0.63; 4 studies, 1397 participants) or urinary iodine concentration (MD −17.27 µg/L, 95% CI −49.27 to 14.73; 3 studies, 1127 participants). No studies measured blood pressure.\nFor secondary outcomes reported in RCTs, DFS may result in little to no difference in ferritin concentration (MD −3.94 µg/L, 95% CI −20.65 to 12.77; 5 studies, 1419 participants; low-certainty evidence) or transferrin receptor concentration (MD −4.68 mg/L, 95% CI −11.67 to 2.31; 5 studies, 1256 participants; low-certainty evidence) compared to IS. However, DFS may reduce zinc protoporphyrin concentration (MD −27.26 µmol/mol, 95% CI −47.49 to −7.03; 3 studies, 921 participants; low-certainty evidence) and result in a slight increase in body iron stores (MD 1.77 mg/kg, 95% CI 0.79 to 2.74; 4 studies, 847 participants; low-certainty evidence). In terms of prevalence of anaemia, DFS may reduce the risk of anaemia by 21% (risk ratio (RR) 0.79, 95% CI 0.66 to 0.94; P = 0.007; 8 studies, 2593 participants; moderate-certainty evidence). Likewise, DFS may reduce the risk of iron deficiency anaemia by 65% (RR 0.35, 95% CI 0.24 to 0.52; 5 studies, 1209 participants; low-certainty evidence).\nFour studies measured salt intake at endline, although only one study reported this for both groups. Two studies reported prevalence of goitre, while one CBA study measured and reported serum iron concentration. One study reported adverse effects. No studies measured hepcidin concentration.\nAuthors' conclusions\nOur findings suggest DFS may have a small positive impact on haemoglobin concentration and the prevalence of anaemia compared to IS, particularly when considering efficacy studies. Future research should prioritise studies that incorporate robust study designs and outcome measures (e.g. anaemia, iron status measures) to better understand the effect of DFS provision to a free-living population (non-research population), where there could be an added cost to purchase double-fortified salt. Adequately measuring salt intake, both at baseline and endline, and adjusting for inflammation will be important to understanding the true effect on measures of iron status.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We looked for studies that provided double-fortified salt to one group of participants and iodised salt to another. We compared their results, and rated our confidence in the evidence, based on factors such as study methods and sample size."
}
] |
query-laysum
|
6889
|
[
{
"role": "user",
"content": "Abstract: Background\nVitamin B12 deficiency is common, and the incidence increases with age. Most people with vitamin B12 deficiency are treated in primary care with intramuscular (IM) vitamin B12. Doctors may not be prescribing oral vitamin B12 formulations because they may be unaware of this option or have concerns regarding its effectiveness.\nObjectives\nTo assess the effects of oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and LILACS, as well as the WHO ICTRP and ClinicalTrials.gov. The latest search date was 17 July 2017. We applied no language restrictions. We also contacted authors of relevant trials to enquire about other published or unpublished studies and ongoing trials.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the effect of oral versus IM vitamin B12 for vitamin B12 deficiency.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were serum vitamin B12 levels, clinical signs and symptoms of vitamin B12 deficiency, and adverse events. Secondary outcomes were health-related quality of life, acceptability to patients, haemoglobin and mean corpuscular volume, total homocysteine and serum methylmalonic acid levels, and socioeconomic effects. We used GRADE to assess the quality of the evidence for important outcomes. We did not perform meta-analyses due to the small number of included trials and substantial clinical heterogeneity.\nMain results\nThree RCTs met our inclusion criteria. The trials randomised 153 participants (74 participants to oral vitamin B12 and 79 participants to IM vitamin B12). Treatment duration and follow-up ranged between three and four months. The mean age of participants ranged from 38.6 to 72 years. The treatment frequency and daily dose of vitamin B12 in the oral and IM groups varied among trials. Only one trial had low or unclear risk of bias across all domains and outcome measures. Two trials reported data for serum vitamin B12 levels. The overall quality of evidence for this outcome was low due to serious imprecision (low number of trials and participants). In two trials employing 1000 μg/day oral vitamin B12, there was no clinically relevant difference in vitamin B12 levels when compared with IM vitamin B12. One trial used 2000 μg/day vitamin B12 and demonstrated a mean difference of 680 pg/mL (95% confidence interval 392.7 to 967.3) in favour of oral vitamin B12. Two trials reported data on adverse events (very low-quality evidence due to risk of performance bias, detection bias, and serious imprecision). One trial stated that no treatment-related adverse events were seen in both the oral and IM vitamin B12 groups. One trial reported that 2 of 30 participants (6.7%) in the oral vitamin B12 group left the trial early due to adverse events. Orally taken vitamin B12 showed lower treatment-associated costs than IM vitamin B12 in one trial (low-quality evidence due to serious imprecision). No trial reported on clinical signs and symptoms of vitamin B12 deficiency, health-related quality of life, or acceptability of the treatment scheme.\nAuthors' conclusions\nLow quality evidence shows oral and IM vitamin B12 having similar effects in terms of normalising serum vitamin B12 levels, but oral treatment costs less. We found very low-quality evidence that oral vitamin B12 appears as safe as IM vitamin B12. Further trials should conduct better randomisation and blinding procedures, recruit more participants, and provide adequate reporting. Future trials should also measure important outcomes such as the clinical signs and symptoms of vitamin B12 deficiency, health related-quality of life, socioeconomic effects, and report adverse events adequately, preferably in a primary care setting.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found three randomised controlled studies (clinical studies where people are randomly put into one of two or more treatment groups). The studies randomised 153 participants (74 participants to oral vitamin B12 and 79 participants to intramuscular vitamin B12). Treatment duration and follow-up ranged between three and four months. The mean age of participants ranged from 39 to 72 years."
}
] |
query-laysum
|
6890
|
[
{
"role": "user",
"content": "Abstract: Background\nThe sense of taste is very much essential to the overall health of an individual. It is a necessary component to enjoy one's food, which in turn provides nutrition to an individual. Any disturbance in taste perception can hamper quality of life in such patients by influencing their appetite, body weight and psychological well-being. Taste disorders have been treated using different modalities of treatment and there is no consensus for the best intervention. Hence this Cochrane Review was undertaken. This is an update of the Cochrane Review first published in November 2014.\nObjectives\nTo assess the effects of interventions for the management of patients with taste disturbances.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 4 July 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017 Issue 6) in the Cochrane Library (searched 4 July 2017); MEDLINE Ovid (1946 to 4 July 2017); Embase Ovid (1980 to 4 July 2017); CINAHL EBSCO (1937 to 4 July 2017); and AMED Ovid (1985 to 4 July 2017). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for trials. Abstracts from scientific meetings and conferences were searched on 25 September 2017. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing any pharmacological agent with a control intervention or any non-pharmacological agent with a control intervention. We also included cross-over trials in the review.\nData collection and analysis\nTwo pairs of review authors independently, and in duplicate, assessed the quality of trials and extracted data. Wherever possible, we contacted trial authors for additional information. We collected adverse events information from the trials.\nMain results\nWe included 10 trials (581 participants), nine of which we were able to include in the quantitative analyses (566 participants). We assessed three trials (30%) as having a low risk of bias, four trials (40%) at high risk of bias and three trials (30%) as having an unclear risk of bias. We only included studies on taste disorders in this review that were either idiopathic, or resulting from zinc deficiency or chronic renal failure.\nOf these, nine trials with 544 people compared zinc supplements to placebo for patients with taste disorders. The participants in two trials were children and adolescents with respective mean ages of 10 and 11.2 years and the other seven trials had adult participants. Out of these nine, two trials assessed the patient-reported outcome for improvement in taste acuity using zinc supplements (risk ratio (RR) 1.40, 95% confidence interval (CI) 0.94 to 2.09; 119 participants, very low-quality evidence). We meta-analysed for taste acuity improvement using objective outcome (continuous data) in idiopathic and zinc-deficient taste disorder patients (standardised mean difference (SMD) 0.44, 95% CI 0.23 to 0.65; 366 participants, three trials, very low-quality evidence). We also analysed one cross-over trial separately using the first half of the results for taste detection (mean difference (MD) 2.50, 95% CI 0.93 to 4.07; 14 participants, very low-quality evidence), and taste recognition (MD 3.00, 95% CI 0.66 to 5.34; 14 participants, very low-quality evidence). We meta-analysed taste acuity improvement using objective outcome (dichotomous data) in idiopathic and zinc-deficient taste disorder patients (RR 1.42, 95% 1.09 to 1.84; 292 participants, two trials, very low-quality evidence). Out of the nine trials using zinc supplementation, four reported adverse events like eczema, nausea, abdominal pain, diarrhoea, constipation, decrease in blood iron, increase in blood alkaline phosphatase, and minor increase in blood triglycerides.\nOne trial tested taste discrimination using acupuncture (MD 2.80, 95% CI -1.18 to 6.78; 37 participants, very low-quality evidence). No adverse events were reported in the acupuncture trial.\nNone of the included trials could be included in the meta-analysis for health-related quality of life in taste disorder patients.\nAuthors' conclusions\nWe found very low-quality evidence that was insufficient to conclude on the role of zinc supplements to improve taste acuity reported by patients and very low-quality evidence that zinc supplements improve taste acuity in patients with zinc deficiency/idiopathic taste disorders. We did not find any evidence to conclude the role of zinc supplements for improving taste discrimination, or any evidence addressing health-related quality of life due to taste disorders.\nWe found very low-quality evidence that is not sufficient to conclude on the role of acupuncture for improving taste discrimination in cases of idiopathic dysgeusia (distortion of taste) and hypogeusia (reduced ability to taste). We were unable to draw any conclusions regarding the superiority of zinc supplements or acupuncture as none of the trials compared these interventions.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The sense of taste is essential to the health and psychological well-being of an individual. Taste disorders can range from lack of taste, to distortion of taste, to reduced ability to taste. Any disorder in taste perception can lead to conditions like malnutrition and consumption of poisonous food substances. The cause may be due to disease, drugs, radiation treatment, or ageing; or it may result from unknown causes.\nVarious treatment methods have been used to improve taste sensation. These include the use of zinc compounds, pilocarpine, alpha lipoic acid, transcranial magnetic stimulation, ginkgo biloba and acupuncture."
}
] |
query-laysum
|
6891
|
[
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep apnoea (OSA) is a common sleep disorder characterised by partial or complete upper airway occlusion during sleep, leading to intermittent cessation (apnoea) or reduction (hypopnoea) of airflow and dips in arterial oxygen saturation during sleep. Many patients with recognised and unrecognised OSA receive hypnotics, sedatives and opiates/opioids to treat conditions including pain, anxiety and difficulty sleeping. Concerns have been expressed that administration of these drugs to people with co-existing OSA may worsen OSA.\nObjectives\nTo investigate whether administration of sedative and hypnotic drugs exacerbates the severity of OSA (as measured by the apnoea-hypopnoea index (AHI) or the 4% oxygen desaturation index (ODI)) in people with known OSA.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register (CAGR) of trials. The search was current as of March 2015.\nSelection criteria\nRandomised, placebo-controlled trials including adult participants with confirmed OSA, where participants were randomly assigned to use opiates or opioids, sedatives, hypnotics or placebo. We included participants already using continuous positive airway pressure (CPAP) or a mandibular advancement device.\nData collection and analysis\nWe used standard methodological procedures as recommended by The Cochrane Collaboration.\nMain results\nFourteen studies examining the effects of 10 drugs and including a total of 293 participants contributed to this review. Trials were small, with only two trials, which used sodium oxybate, recruiting more than 40 participants, and all but three trials were of only one to three nights in duration. Most participants had mild to moderate OSA with a mean AHI of 11 to 25 events/h, and only two trials recruited patients with severe OSA. Two trials investigating the effects of ramelteon, a treatment option for insomnia, recruited adults over 60 years of age with OSA and concomitant insomnia.\nThe drugs studied in this review included remifentanil (infusion) 0.75 mcg/kg/h, eszopiclone 3 mg, zolpidem 10 and 20 mg, brotizolam 0.25 mg, flurazepam 30 mg, nitrazepam 10 mg to 15 mg, temazepam 10 mg, triazolam 0.25 mg, ramelteon 8 mg and 16 mg and sodium oxybate 4.5 g and 9 g. We were unable to pool most of the data, with the exception of data for eszopiclone and ramelteon.\nNone of the drugs in this review produced a significant increase in AHI or ODI. Two trials have shown a beneficial effect on OSA. One study showed that a single administration of eszopiclone 3 mg significantly decreased AHI compared with placebo (24 ± 4 vs 31 ± 5; P value < 0.05), and a second study of sodium oxybate 4.5 g showed a significant decrease in AHI compared with placebo (mean difference (MD) -7.41, 95% confidence interval (CI) -14.17 to -0.65; N = 48).\nOnly four trials reported outcome data on ODI. No significant increase, in comparison with placebo, was shown with eszopiclone (21 (22 to 37) vs 28.0 (15 to 36); P value = NS), zolpidem (0.81 ± 0.29 vs 1.46 ± 0.53; P value = NS), flurazepam (18.6 ± 19 vs 19.6 ± 15.9; P value = NS) and temazepam (6.53 ± 9.4 vs 6.56 ± 8.3; P value = 0.98).\nA significant decrease in minimum nocturnal peripheral capillary oxygen saturation (SpO2) was observed with zolpidem 20 mg (76.8 vs 85.2; P value = 0.002), flurazepam 30 mg (81.7 vs 85.2; P value = 0.002), remifentanil infusion (MD -7.00, 95% CI -11.95 to -2.05) and triazolam 0.25 mg in both rapid eye movement (REM) and non-REM (NREM) sleep (MD -14.00, 95% CI -21.84 to -6.16; MD -10.20, 95% CI -16.08 to -4.32, respectively.\nOne study investigated the effect of an opiate (remifentanil) on patients with moderate OSA. Remifentanil infusion did not significantly change AHI (MD 10.00, 95% CI -9.83 to 29.83); however it did significantly decrease the number of obstructive apnoeas (MD -9.00, 95% CI -17.40 to -0.60) and significantly increased the number of central apnoeas (MD 16.00, 95% CI -2.21 to 34.21). Similarly, although without significant effect on obstructive apnoeas, central apnoeas were increased in the sodium oxybate 9 g treatment group (MD 7.3 (18); P value = 0.005) in a cross-over trial.\nDrugs studied in this review were generally well tolerated, apart from adverse events reported in 19 study participants prescribed remifentanil (n = 1), eszopiclone (n = 6), sodium oxybate (n = 9) or ramelteon (n = 3).\nAuthors' conclusions\nThe findings of this review show that currently no evidence suggests that the pharmacological compounds assessed have a deleterious effect on the severity of OSA as measured by change in AHI or ODI. Significant clinical and statistical decreases in minimum overnight SpO2 were observed with remifentanil, zolpidem 20 mg and triazolam 0.25 mg. Eszopiclone 3 mg and sodium oxybate 4.5 g showed a beneficial effect on the severity of OSA with a reduction in AHI and may merit further assessment as a potential therapeutic option for a subgroup of patients with OSA. Only one trial assessed the effect of an opioid (remifentanil); some studies included CPAP treatment, whilst in a significant number of participants, previous treatment with CPAP was not stated and thus a residual treatment effect of CPAP could not be excluded. Most studies were small and of short duration, with indiscernible methodological quality.Caution is therefore required when such agents are prescribed for patients with OSA, especially outside the severity of the OSA cohorts and the corresponding dose of compounds given in the particular studies. Larger, longer trials involving patients across a broader spectrum of OSA severity are needed to clarify these results.\n\nGiven the provided abstract, please respond to the following query: \"What we did\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched and reviewed all randomised placebo-controlled trials involving adult patients with known OSA who received these drugs. Most of the trials were short at just one or two nights' duration, involved only a small number of patients and used poorly described methodology. Therefore it was difficult to find out the exact effects of these drugs on patients with OSA."
}
] |
query-laysum
|
6892
|
[
{
"role": "user",
"content": "Abstract: Background\nRemote ischaemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat ischaemic stroke. It usually involves restricting blood flow to limbs and then releasing the ischaemic blood to promote a neuroprotective effect. Preclinical studies have suggested that RIC may have beneficial effects in ischaemic stroke patients and those at risk of ischaemic stroke. However, existing evidence is insufficient to demonstrate the efficacy and safety of RIC in preventing and treating ischaemic stroke.\nObjectives\nTo assess the benefits and harms of RIC for preventing ischaemic stroke and for treating people with ischaemic stroke and those at risk for ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (16 January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 12) in the Cochrane Library (January 2018), MEDLINE Ovid (1946 to January 2018), Embase Ovid (1974 to January 2018), Web of Science Core Collection (1950 to January 2018) and three Chinese databases (January 2018). We also searched four ongoing trials registers, reference lists, and conference proceedings.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing RIC with sham RIC or medical management in people with ischaemic stroke or at risk of ischaemic stroke.\nData collection and analysis\nTwo review authors independently selected studies, assessed trial quality and risk of bias, and extracted data. We used the GRADE approach to assess the quality of the evidence.\nMain results\nWe included seven trials, involving 735 participants, in this review. We analysed the effects of RIC on preventing and treating ischaemic stroke respectively.\nWe evaluated risk of bias and judged it to be low for generation of allocation sequence in six studies and unclear in one study; unclear for allocation concealment in four studies and low in three studies; high for incomplete outcome data (attrition bias) in five studies and low in two studies; high for blinding in three studies and low in four studies; low for selective reporting; and high for other sources of bias in six studies and low in one study.\nWe included three trials (involving 371 participants) in the analysis of the effects of RIC on ischaemic stroke prevention. In people with symptomatic intracerebral artery stenosis, recurrent stroke was significantly reduced by RIC (risk ratio (RR) 0.32, 95% confidence interval (CI) 0.12 to 0.83; 2 trials, 182 participants, low-quality evidence). In people with carotid stenosis undergoing carotid stenting, there was no significant difference in the incidence of ischaemic stroke between participants treated with RIC and non-RIC (RR 0.22, 95% CI 0.01 to 4.03; 1 trial, 189 participants, low-quality evidence); however the stroke severity (assessed by infarct volume) was significantly lower in participants treated with RIC (mean difference (MD) -0.17 mL, 95% CI -0.23 to -0.11; 1 trial, 189 participants, low-quality evidence). Adverse events associated with RIC were significantly higher in participants treated with RIC (RR 10.91; 95% CI 2.01 to 59.28; 3 trials, 371 participants, low-quality evidence), but no severe adverse event was attributable to RIC treatment. No participants experienced death or cardiovascular events during the period of the studies; and no trial reported haemorrhagic stroke or improvement in neurological, phycological or cognitive impairment.\nWe included four trials (involving 364 participants) in the analysis of the effects of RIC on ischaemic stroke treatment. In acute ischaemic stroke, for people receiving intravenous thrombolysis, the rate of death or dependency was significantly increased by RIC treatment compared with non-RIC treatment (RR 2.34; 95% 1.19 to 4.61; 1 trial, 285 participants, low-quality evidence). In people with acute ischaemic stroke, there was no significant difference between RIC and non-RIC for reducing stroke severity as assessed by the National Institutes of Health Stroke Scale score and the final infarct volume (standardised mean difference (SMD) -0.24 mL, 95% CI -1.02 to 0.54; 2 trials, 175 participants, very low quality evidence). There was no significant difference between RIC and non-RIC for improving the psychological impairment (SMD -0.37 points, 95% CI -1.15 to 0.41; 1 trial, 26 participants, very low quality evidence) and the cognitive impairment (SMD -0.26 points; 95% CI -0.72 to 0.21; 3 trials, 79 participants, low-quality evidence) in people with acute ischaemic stroke and cerebral small vessel disease. No trial reported ischaemic stroke, recurrent ischaemic stroke, improvement in neurological impairment, hemorrhagic stroke, cardiovascular events, and RIC associated adverse events.\nAuthors' conclusions\nWe found low-quality evidence that RIC may reduce the risk of recurrent stroke in participants with intracerebral artery stenosis and reduce stroke severity in participants undergoing carotid stenting, but it may increase death or dependence in participants with acute ischaemic stroke who are undergoing intravenous thrombolysis. However, there is considerable uncertainty about these conclusions because of the small number of studies and low quality of the evidence.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is low-quality evidence which suggests that RIC may help prevent recurrent stroke in people with narrowed arteries in the brain, and may increase death or dependency in people with acute ischaemic stroke who received clot dissolving medication. The evidence is less clear for reducing the volume of the stroke (size of brain lesion caused by low blood flow). Further research is likely to have an important impact on our confidence in these findings."
}
] |
query-laysum
|
6893
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in 2001, and last updated in 2013. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy.\nWorldwide, particularly in the developing world, phenytoin and phenobarbitone are commonly used antiepileptic drugs, primarily because they are inexpensive. The aim of this review is to summarise data from existing trials comparing phenytoin and phenobarbitone.\nObjectives\nTo review the time to treatment failure, remission and first seizure with phenobarbitone compared with phenytoin when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised), or generalised onset tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nFor the latest update, we searched the following databases on 21 August 2018: the Cochrane Register of Studies (CRS Web), which includes Cochrane Epilepsy's Specialized Register and CENTRAL; MEDLINE; the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov); and the World Health Organization International Clinical Trials Registry Platform (ICTRP). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators, and experts in the field.\nSelection criteria\nRandomised controlled trials comparing monotherapy with either phenobarbitone or phenytoin in children or adults with focal onset seizures or generalised onset tonic-clonic seizures.\nData collection and analysis\nThis was an individual participant data (IPD), review. Our primary outcome was time to treatment failure. Our secondary outcomes were time to first seizure post-randomisation, time to six-month remission and time to 12-month remission. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs), with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nIndividual participant data were obtained for five studies, which recruited a total of 635 participants, representing 80% of 798 individuals from all seven identified eligible trials. For remission outcomes, an HR of less than 1 indicates an advantage for phenytoin and for first seizure and treatment failure outcomes an HR of less than 1 indicates an advantage for phenobarbitone.\nResults for the primary outcome of the review were: time to treatment failure for any reason related to treatment (pooled HR adjusted for seizure type for 499 participants: 1.61, 95% CI 1.22 to 2.12, low-certainty evidence), time to treatment failure due to adverse events (pooled HR adjusted for seizure type for 499 participants: 1.99, 95% CI 1.37 to 2.87, low-certainty evidence), time to treatment failure due to lack of efficacy (pooled HR adjusted for seizure type for 499 participants: 1.87, 95% CI 1.32 to 2.66, moderate-certainty evidence), showing a statistically significant advantage for phenytoin compared to phenobarbitone.\nFor our secondary outcomes, we did not find any statistically significant differences between phenytoin and phenobarbitone: time to first seizure post-randomisation (pooled HR adjusted for seizure type for 624 participants: 0.85, 95% CI 0.69 to 1.06, moderate-certainty evidence), time to 12-month remission (pooled HR adjusted for seizure type for 588 participants: 0.90, 95% CI 0.69 to 1.19, moderate-certainty evidence), and time to six-month remission pooled HR adjusted for seizure type for 588 participants: 0.91, 95% CI 0.71 to 1.15, moderate-certainty evidence).\nFor individuals with focal onset seizures (73% of individuals contributing to analysis), numerical results were similar and conclusions the same as for analyses of all individuals and for individuals with generalised onset seizures (27% of individuals contributing to analysis), results were imprecise and no clear differences between the drugs were observed.\nSeveral confounding factors, most notably the differences in design of the trials with respect to blinding, were likely to have impacted on the results of the primary outcome 'time to treatment failure', and in turn, the treatment failure rates may have impacted on the secondary efficacy outcomes of time to first seizure and time to 12-month and six-month remission.\nAuthors' conclusions\nLow-certainty evidence from this review suggests that phenytoin may be a more effective drug than phenobarbitone in terms of treatment retention (treatment failures due to lack of efficacy or adverse events or both). Moderate-certainty evidence from this review also indicates no differences between the drugs in terms of time to seizure recurrence and seizure remission.\nHowever, the trials contributing to the analyses had methodological inadequacies and methodological design differences that may have impacted upon the results of this review. Therefore, we do not suggest that results of this review alone should form the basis of a treatment choice for a patient with newly onset seizures. We recommend that future trials should be designed to the highest quality possible with consideration of masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.\n\nGiven the provided abstract, please respond to the following query: \"Methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The last search for trials was in August 2018. We assessed the evidence from seven clinical trials in which people received either phenobarbitone or phenytoin and their treatment was decided randomly. We were able to combine data for 635 people from five of the seven trials; for the remaining 163 people from two trials, data were not available to use in this review"
}
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query-laysum
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6894
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[
{
"role": "user",
"content": "Abstract: Background\nOverweight and obesity are increasing worldwide and are considered to be a major public health issue of the 21st century. Introducing taxation of the fat content in foods is considered a potentially powerful policy tool to reduce consumption of foods high in fat or saturated fat, or both.\nObjectives\nTo assess the effects of taxation of the fat content in food on consumption of total fat and saturated fat, energy intake, overweight, obesity, and other adverse health outcomes in the general population.\nSearch methods\nWe searched CENTRAL, Cochrane Database of Systematic Reviews, MEDLINE, Embase, and 15 other databases and trial registers on 12 September 2019. We handsearched the reference lists of all records of included studies, searched websites of international organizations and institutions (14 October 2019), and contacted review advisory group members to identify planned, ongoing, or unpublished studies (26 February 2020).\nSelection criteria\nIn line with Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria, we included the following study types: randomized controlled trials (RCTs), cluster-randomized controlled trials (cRCTs), non-randomized controlled trials (nRCTs), controlled before-after (CBA) studies, and interrupted time series studies. We included studies that evaluated the effects of taxes on the fat content in foods. Such a tax could be expressed as sales, excise, or special value added tax (VAT) on the final product or an intermediary product. Eligible interventions were taxation at any level, with no restriction on the duration or the implementation level (i.e. local, regional, national, or multinational). Eligible study populations were children (zero to 17 years) and adults (18 years or older) from any country and setting. We excluded studies that focused on specific subgroups only (e.g. people receiving pharmaceutical intervention; people undergoing a surgical intervention; ill people who are overweight or obese as a side effect, such as those with thyroiditis and depression; and people with chronic illness). Primary outcomes were total fat consumption, consumption of saturated fat, energy intake through fat, energy intake through saturated fat, total energy intake, and incidence/prevalence of overweight or obesity. We did not exclude studies based on country, setting, comparison, or population.\nData collection and analysis\nWe used standard Cochrane methods for all phases of the review. Risk of bias of the included studies was assessed using the criteria of Cochrane’s ‘Risk of bias’ tool and the EPOC Group’s guidance. Results of the review are summarized narratively and the certainty of the evidence was assessed using the GRADE approach. These steps were done by two review authors, independently.\nMain results\nWe identified 23,281 records from searching electronic databases and 1173 records from other sources, leading to a total of 24,454 records. Two studies met the criteria for inclusion in the review. Both included studies investigated the effect the Danish tax on saturated fat contained in selected food items between 2011 and 2012. Both studies used an interrupted time series design. Neither included study had a parallel control group from another geographic area. The included studies investigated an unbalanced panel of approximately 2000 households in Denmark and the sales data from a specific Danish supermarket chain (1293 stores). Therefore, the included studies did not address individual participants, and no restriction regarding age, sex, and socioeconomic characteristics were defined. We judged the overall risk of bias of the two included studies as unclear.\nFor the outcome total consumption of fat, a reduction of 41.8 grams per week per person in a household (P < 0.001) was estimated. For the consumption of saturated fat, one study reported a reduction of 4.2% from minced beef sales, a reduction of 5.8% from cream sales, and an increase of 0.5% to sour cream sales (no measures of statistical precision were reported for these estimates). These estimates are based on a restricted number of food types and derived from sales data; they do not measure individual intake. Moreover, these estimates do not account for other relevant sources of fat intake (e.g. packaged or processed food) or other food outlets (e.g. restaurants or cafeterias); hence, we judged the evidence on the effect of taxation on total fat consumption or saturated fat consumption to be very uncertain. We did not identify evidence on the effect of the intervention on energy intake or the incidence or prevalence of overweight or obesity.\nAuthors' conclusions\nGiven the very low quality of the evidence currently available, we are unable to reliably establish whether a tax on total fat or saturated fat is effective or ineffective in reducing consumption of total fat or saturated fat. There is currently no evidence on the effect of a tax on total fat or saturated fat on total energy intake or energy intake through saturated fat or total fat, or preventing the incidence or reducing the prevalence of overweight or obesity.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found two studies from Denmark, conducted during 2011 to 2012. One looked at how a tax on some high-fat foods affected household demand for them; the other looked at information on supermarket sales for certain high-fat foods (minced beef, cream, and sour cream). They compared their results with data from before the tax started.\nBoth studies looked at a small number of foods that people bought, but not what foods people ate. They didn't measure how much total fat or saturated fat were eaten."
}
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query-laysum
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6895
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[
{
"role": "user",
"content": "Abstract: Background\nCognitive behavioural therapy (CBT) is an evidence-based treatment for anxiety disorders. Many people have difficulty accessing treatment, due to a variety of obstacles. Researchers have therefore explored the possibility of using the Internet to deliver CBT; it is important to ensure the decision to promote such treatment is grounded in high quality evidence.\nObjectives\nTo assess the effects of therapist-supported Internet CBT (ICBT) on remission of anxiety disorder diagnosis and reduction of anxiety symptoms in adults as compared to waiting list control, unguided CBT, or face-to-face CBT. Effects of treatment on quality of life and patient satisfaction with the intervention were also assessed.\nSearch methods\nWe searched the Cochrane Depression, Anxiety and Neurosis Review Group Specialised Register (CCDANCTR) to 16 March 2015. The CCDANCTR includes relevant randomised controlled trials from MEDLINE, EMBASE, PsycINFO and CENTRAL. We also searched online clinical trial registries and reference lists of included studies. We contacted authors to locate additional trials.\nSelection criteria\nEach identified study was independently assessed for inclusion by two authors. To be included, studies had to be randomised controlled trials of therapist-supported ICBT compared to a waiting list, attention, information, or online discussion group; unguided CBT (that is, self-help); or face-to-face CBT. We included studies that treated adults with an anxiety disorder (panic disorder, agoraphobia, social phobia, post-traumatic stress disorder, acute stress disorder, generalized anxiety disorder, obsessive compulsive disorder, and specific phobia) defined according to the Diagnostic and Statistical Manual of Mental Disorders III, III-R, IV, IV-TR or the International Classification of Disesases 9 or 10.\nData collection and analysis\nTwo authors independently assessed the risk of bias of included studies and judged overall study quality. We used data from intention-to-treat analyses wherever possible. We assessed treatment effect for the dichotomous outcome of clinically important improvement in anxiety using a risk ratio (RR) with 95% confidence interval (CI). For disorder-specific and general anxiety symptom measures and quality of life we assessed continuous scores using standardized mean differences (SMD). We examined statistical heterogeneity using the I2 statistic.\nMain results\nWe screened 1736 citations and selected 38 studies (3214 participants) for inclusion. The studies examined social phobia (11 trials), panic disorder with or without agoraphobia (8 trials), generalized anxiety disorder (5 trials), post-traumatic stress disorder (2 trials), obsessive compulsive disorder (2 trials), and specific phobia (2 trials). Eight remaining studies included a range of anxiety disorder diagnoses. Studies were conducted in Sweden (18 trials), Australia (14 trials), Switzerland (3 trials), the Netherlands (2 trials), and the USA (1 trial) and investigated a variety of ICBT protocols. Three primary comparisons were identified, therapist-supported ICBT versus waiting list control, therapist-supported versus unguided ICBT, and therapist-supported ICBT versus face-to-face CBT.\nLow quality evidence from 11 studies (866 participants) contributed to a pooled risk ratio (RR) of 3.75 (95% CI 2.51 to 5.60; I2 = 50%) for clinically important improvement in anxiety at post-treatment, favouring therapist-supported ICBT over a waiting list, attention, information, or online discussion group only. The SMD for disorder-specific symptoms at post-treatment (28 studies, 2147 participants; SMD -1.06, 95% CI -1.29 to -0.82; I2 = 83%) and general anxiety symptoms at post-treatment (19 studies, 1496 participants; SMD -0.75, 95% CI -0.98 to -0.52; I2 = 78%) favoured therapist-supported ICBT; the quality of the evidence for both outcomes was low.\nOne study compared unguided CBT to therapist-supported ICBT for clinically important improvement in anxiety at post-treatment, showing no difference in outcome between treatments (54 participants; very low quality evidence). At post-treatment there were no clear differences between unguided CBT and therapist-supported ICBT for disorder-specific anxiety symptoms (5 studies, 312 participants; SMD -0.22, 95% CI -0.56 to 0.13; I2 = 58%; very low quality evidence) or general anxiety symptoms (2 studies, 138 participants; SMD 0.28, 95% CI -2.21 to 2.78; I2 = 0%; very low quality evidence).\nCompared to face-to-face CBT, therapist-supported ICBT showed no significant differences in clinically important improvement in anxiety at post-treatment (4 studies, 365 participants; RR 1.09, 95% CI 0.89 to 1.34; I2 = 0%; low quality evidence). There were also no clear differences between face-to-face and therapist supported ICBT for disorder-specific anxiety symptoms at post-treatment (7 studies, 450 participants; SMD 0.06, 95% CI -0.25 to 0.37; I2 = 60%; low quality evidence) or general anxiety symptoms at post-treatment (5 studies, 317 participants; SMD 0.17, 95% CI -0.35 to 0.69; I2 = 78%; low quality evidence).\nOverall, risk of bias in included studies was low or unclear for most domains. However, due to the nature of psychosocial intervention trials, blinding of participants and personnel, and outcome assessment tended to have a high risk of bias. Heterogeneity across a number of the meta-analyses was substantial, some was explained by type of anxiety disorder or may be meta-analytic measurement artefact due to combining many assessment measures. Adverse events were rarely reported.\nAuthors' conclusions\nTherapist-supported ICBT appears to be an efficacious treatment for anxiety in adults. The evidence comparing therapist-supported ICBT to waiting list, attention, information, or online discussion group only control was low to moderate quality, the evidence comparing therapist-supported ICBT to unguided ICBT was very low quality, and comparisons of therapist-supported ICBT to face-to-face CBT were low quality. Further research is needed to better define and measure any potential harms resulting from treatment. These findings suggest that therapist-supported ICBT is more efficacious than a waiting list, attention, information, or online discussion group only control, and that there may not be a significant difference in outcome between unguided CBT and therapist-supported ICBT; however, this latter finding must be interpreted with caution due to imprecision. The evidence suggests that therapist-supported ICBT may not be significantly different from face-to-face CBT in reducing anxiety. Future research should explore heterogeneity among studies which is reducing the quality of the evidence body, involve equivalence trials comparing ICBT and face-to-face CBT, examine the importance of the role of the therapist in ICBT, and include effectiveness trials of ICBT in real-world settings. A timely update to this review is needed given the fast pace of this area of research.\n\nGiven the provided abstract, please respond to the following query: \"Which studies were included in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Databases were searched to find all high quality studies of ICBT with therapist support for anxiety published until March 2015. To be included in the review, studies had to be randomised controlled trials involving adults over 18 years with a main diagnosis of an anxiety disorder; 38 studies with a total of 3214 participants were included in the review."
}
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query-laysum
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6896
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[
{
"role": "user",
"content": "Abstract: Background\nRisperidone is the first new-generation antipsychotic drug made available in the market in its generic form.\nObjectives\nTo determine the clinical effects, safety and cost-effectiveness of risperidone compared with placebo for treating schizophrenia.\nSearch methods\nOn 19th October 2015, we searched the Cochrane Schizophrenia Group Trials Register, which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. We checked the references of all included studies and contacted industry and authors of included studies for relevant studies and data.\nSelection criteria\nRandomised clinical trials (RCTs) comparing oral risperidone with placebo treatments for people with schizophrenia and/or schizophrenia-like psychoses.\nData collection and analysis\nTwo review authors independently screened studies, assessed the risk of bias of included studies and extracted data. For dichotomous data, we calculated the risk ratio (RR), and the 95% confidence interval (CI) on an intention-to-treat basis. For continuous data, we calculated mean differences (MD) and the 95% CI. We created a 'Summary of findings table' using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nThe review includes 15 studies (N = 2428). Risk of selection bias is unclear in most of the studies, especially concerning allocation concealment. Other areas of risk such as missing data and selective reporting also caused some concern, although not affected on the direction of effect of our primary outcome, as demonstrated by sensitivity analysis. Many of the included trials have industry sponsorship of involvement. Nonetheless, generally people in the risperidone group are more likely to achieve a significant clinical improvement in mental state (6 RCTs, N = 864, RR 0.64, CI 0.52 to 0.78, very low-quality evidence). The effect withstood, even when three studies with >50% attrition rate were removed from the analysis (3 RCTs, N = 589, RR 0.77, CI 0.67 to 0.88). Participants receiving placebo were less likely to have a clinically significant improvement on Clinical Global Impression scale (CGI) than those receiving risperidone (4 RCTs, N = 594, RR 0.69, CI 0.57 to 0.83, very low-quality evidence). Overall, the risperidone group was 31% less likely to leave early compared to placebo group (12 RCTs, N = 2261, RR 0.69, 95% CI 0.62 to 0.78, low-quality evidence), but Incidence of significant extrapyramidal side effect was more likely to occur in the risperidone group (7 RCTs, N = 1511, RR 1.56, 95% CI 1.13 to 2.15, very low-quality evidence).\nWhen risperidone and placebo were augmented with clozapine, there is no significant differences between groups for clinical response as defined by a less than 20% reduction in PANSS/BPRS scores (2 RCTs, N = 98, RR 1.15, 95% CI 0.93 to 1.42, low-quality evidence) and attrition (leaving the study early for any reason) (3 RCTs, N = 167, RR 1.13, 95% CI 0.53 to 2.42, low quality evidence). One study measured clinically significant responses using the CGI, no effect was evident (1 RCT, N = 68, RR 1.12 95% CI 0.87 to 1.44, low quality evidence). No data were available for extrapyramidal adverse effects.\nAuthors' conclusions\nBased on low quality evidence, risperidone appears to be benefitial in improving mental state compared with placebo, but it also causes more adverse events. Eight out of the 15 included trials were funded by pharmaceutical companies. The currently available evidence isvery low to low quality.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with schizophrenia often hear voices and see things (hallucinations) and have strange beliefs (delusions). These are called ‘positive symptoms’. Mental illness also causes tiredness, apathy, emotional numbness, and withdrawal. These are called ‘negative symptoms’. The main treatment for the symptoms of schizophrenia are antipsychotic drugs. Antipsychotic drugs can be classified into typical (older) and atypical (newer) drugs. Typical antipsychotics such as chlorpromazine and haloperidol have been the mainstay of treatment for decades, and have been effective in reducing the positive symptoms of schizophrenia. Negative symptoms, however, have been fairly resistant to treatment. In addition, drug treatments are associated with unpleasant side effects that cause people to stop taking medication, which may lead to relapse. It is thought that newer atypical antipsychotics, such as risperidone, are more effective than the older antipsychotics as they reduce the positive symptoms but cause fewer side effects."
}
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query-laysum
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6897
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[
{
"role": "user",
"content": "Abstract: Background\nBurn injuries are an important health problem. They occur frequently in the head and neck region. The face is the area central to a person's identity that provides our most expressive means of communication. Topical interventions are currently the cornerstone of treatment of burns to the face.\nObjectives\nTo assess the effects of topical interventions on wound healing in people with facial burns of any depth.\nSearch methods\nIn December 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nRandomised controlled trials (RCTs) that evaluated the effects of topical treatment for facial burns were eligible for inclusion in this review.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, risk of bias assessment and GRADE assessment of the certainty of the evidence.\nMain results\nIn this first update, we included 12 RCTs, comprising 507 participants.\nMost trials included adults admitted to specialised burn centres after recent burn injuries.\nTopical agents included antimicrobial agents (silver sulphadiazine (SSD), Aquacel-Ag, cerium-sulphadiazine, gentamicin cream, mafenide acetate cream, bacitracin), non-antimicrobial agents (Moist Exposed Burn Ointment (MEBO), saline-soaked dressings, skin substitutes (including bioengineered skin substitute (TransCyte), allograft, and xenograft (porcine Xenoderm), and miscellaneous treatments (growth hormone therapy, recombinant human granulocyte-macrophage colony-stimulating factor hydrogel (rhGMCS)), enzymatic debridement, and cream with Helix Aspersa extract).\nAlmost all the evidence included in this review was assessed as low or very low-certainty, often because of high risk of bias due to unclear randomisation procedures (i.e. sequence generation and allocation concealment); lack of blinding of participants, providers and sometimes outcome assessors; and imprecision resulting from few participants, low event rates or both, often in single studies.\nTopical antimicrobial agents versus topical non-antimicrobial agents\nThere is moderate-certainty evidence that there is probably little or no difference between antimicrobial agents and non-antimicrobial agents (SSD and MEBO) in time to complete wound healing (hazard ratio (HR) 0.84 (95% confidence interval (CI) 0.78 to 1.85, 1 study, 39 participants). Topical antimicrobial agents may make little or no difference to the proportion of wounds completely healed compared with topical non-antimicrobial agents (comparison SSD and MEBO, risk ratio (RR) 0.94, 95% CI 0.68 to 1.29; 1 study, 39 participants; low-certainty evidence). We are uncertain whether there is a difference in wound infection (comparison topical antimicrobial agent (Aquacel-Ag) and MEBO; RR 0.38, 95% CI 0.12 to 1.21; 1 study, 40 participants; very low-certainty evidence). No trials reported change in wound surface area over time or partial wound healing. There is low-certainty evidence for the secondary outcomes scar quality and patient satisfaction. Two studies assessed pain but it was incompletely reported.\nTopical antimicrobial agents versus other topical antimicrobial agents\nIt is uncertain whether topical antimicrobial agents make any difference in effects as the evidence is low to very low-certainty. For primary outcomes, there is low-certainty evidence for time to partial (i.e. greater than 90%) wound healing (comparison SSD versus cerium SSD: mean difference (MD) –7.10 days, 95% CI –16.43 to 2.23; 1 study, 142 participants). There is very low-certainty evidence regarding whether topical antimicrobial agents make a difference to wound infection (RR 0.73, 95% CI 0.46 to 1.17; 1 study, 15 participants). There is low to very low-certainty evidence for the proportion of facial burns requiring surgery, pain, scar quality, adverse effects and length of hospital stay.\nSkin substitutes versus topical antimicrobial agents\nThere is low-certainty evidence that a skin substitute may slightly reduce time to partial (i.e. greater than 90%) wound healing, compared with a non-specified antibacterial agent (MD –6.00 days, 95% CI –8.69 to –3.31; 1 study, 34 participants).\nWe are uncertain whether skin substitutes in general make any other difference in effects as the evidence is very low certainty. Outcomes included wound infection, pain, scar quality, adverse effects of treatment and length of hospital stay.\nSingle studies showed contrasting low-certainty evidence. A bioengineered skin substitute may slightly reduce procedural pain (MD –4.00, 95% CI –5.05 to –2.95; 34 participants) and background pain (MD –2.00, 95% CI –3.05 to –0.95; 34 participants) compared with an unspecified antimicrobial agent. In contrast, a biological dressing (porcine Xenoderm) might slightly increase pain in superficial burns (MD 1.20, 95% CI 0.65 to 1.75; 15 participants (30 wounds)) as well as deep partial thickness burns (MD 3.00, 95% CI 2.34 to 3.66; 10 participants (20 wounds)), compared with antimicrobial agents (Physiotulle Ag (Coloplast)).\nMiscellaneous treatments versus miscellaneous treatments\nSingle studies show low to very low-certainty effects of interventions. Low-certainty evidence shows that MEBO may slightly reduce time to complete wound healing compared with saline soaked dressing (MD –1.7 days, 95% CI –3.32 to –0.08; 40 participants). In addition, a cream containing Helix Aspersa may slightly increase the proportion of wounds completely healed at 14 days compared with MEBO (RR 4.77, 95% CI 1.87 to 12.15; 43 participants). We are uncertain whether any miscellaneous treatment in the included studies makes a difference in effects for the outcomes wound infection, scar quality, pain and patient satisfaction as the evidence is low to very low-certainty.\nAuthors' conclusions\nThere is mainly low to very low-certainty evidence on the effects of any topical intervention on wound healing in people with facial burns. The number of RCTs in burn care is growing, but the body of evidence is still hampered due to an insufficient number of studies that follow appropriate evidence-based standards of conducting and reporting RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, the certainty of the evidence about the effectiveness of topical treatments for facial burns is low to very low. There is insufficient reliable evidence as to whether topical treatments improve outcomes for people with facial burns including improving wound healing, or rates of infection. Better trial design and reporting of these studies is required to contribute to evidence-based burn care."
}
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query-laysum
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6898
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[
{
"role": "user",
"content": "Abstract: Background\nWith the emergence of SARS-CoV-2 in late 2019, governments worldwide implemented a multitude of non-pharmaceutical interventions in order to control the spread of the virus. Most countries have implemented measures within the school setting in order to reopen schools or keep them open whilst aiming to contain the spread of SARS-CoV-2. For informed decision-making on implementation, adaptation, or suspension of such measures, it is not only crucial to evaluate their effectiveness with regard to SARS-CoV-2 transmission, but also to assess their unintended consequences.\nObjectives\nTo comprehensively identify and map the evidence on the unintended health and societal consequences of school-based measures to prevent and control the spread of SARS-CoV-2. We aimed to generate a descriptive overview of the range of unintended (beneficial or harmful) consequences reported as well as the study designs that were employed to assess these outcomes. This review was designed to complement an existing Cochrane Review on the effectiveness of these measures by synthesising evidence on the implications of the broader system-level implications of school measures beyond their effects on SARS-CoV-2 transmission.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, four non-health databases, and two COVID-19 reference collections on 26 March 2021, together with reference checking, citation searching, and Google searches.\nSelection criteria\nWe included quantitative (including mathematical modelling), qualitative, and mixed-methods studies of any design that provided evidence on any unintended consequences of measures implemented in the school setting to contain the SARS-CoV-2 pandemic. Studies had to report on at least one unintended consequence, whether beneficial or harmful, of one or more relevant measures, as conceptualised in a logic model.\nData collection and analysis\nWe screened the titles/abstracts and subsequently full texts in duplicate, with any discrepancies between review authors resolved through discussion. One review author extracted data for all included studies, with a second review author reviewing the data extraction for accuracy. The evidence was summarised narratively and graphically across four prespecified intervention categories and six prespecified categories of unintended consequences; findings were described as deriving from quantitative, qualitative, or mixed-method studies.\nMain results\nEighteen studies met our inclusion criteria. Of these, 13 used quantitative methods (3 experimental/quasi-experimental; 5 observational; 5 modelling); four used qualitative methods; and one used mixed methods. Studies looked at effects in different population groups, mainly in children and teachers. The identified interventions were assigned to four broad categories: 14 studies assessed measures to make contacts safer; four studies looked at measures to reduce contacts; six studies assessed surveillance and response measures; and one study examined multiple measures combined. Studies addressed a wide range of unintended consequences, most of them considered harmful. Eleven studies investigated educational consequences. Seven studies reported on psychosocial outcomes. Three studies each provided information on physical health and health behaviour outcomes beyond COVID-19 and environmental consequences. Two studies reported on socio-economic consequences, and no studies reported on equity and equality consequences.\nAuthors' conclusions\nWe identified a heterogeneous evidence base on unintended consequences of measures implemented in the school setting to prevent and control the spread of SARS-CoV-2, and summarised the available study data narratively and graphically. Primary research better focused on specific measures and various unintended outcomes is needed to fill knowledge gaps and give a broader picture of the diverse unintended consequences of school-based measures before a more thorough evidence synthesis is warranted. The most notable lack of evidence we found was regarding psychosocial, equity, and equality outcomes. We also found a lack of research on interventions that aim to reduce the opportunity for contacts. Additionally, study investigators should provide sufficient data on contextual factors and demographics in order to ensure analyses of such are feasible, thus assisting stakeholders in making appropriate, informed decisions for their specific circumstances.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Firstly, we searched nine databases for studies that assessed any measure put in place in the school settings (primary or secondary schools, or both) to prevent transmission of the virus. We considered all types of studies and a broad range of outcomes.\nSecondly, we grouped the identified studies according to the types of measures they examined. We then described which approaches were used in the studies, where these were conducted, and which unintended consequences were evaluated."
}
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query-laysum
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6899
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[
{
"role": "user",
"content": "Abstract: Background\nGuidelines have provided positive recommendations for pulmonary rehabilitation after exacerbations of chronic obstructive pulmonary disease (COPD), but recent studies indicate that postexacerbation rehabilitation may not always be effective in patients with unstable COPD.\nObjectives\nTo assess effects of pulmonary rehabilitation after COPD exacerbations on hospital admissions (primary outcome) and other patient-important outcomes (mortality, health-related quality of life (HRQL) and exercise capacity).\nSearch methods\nWe identified studies through searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PEDro (Physiotherapy Evidence Database) and the Cochrane Airways Review Group Register of Trials. Searches were current as of 20 October 2015, and handsearches were run up to 5 April 2016.\nSelection criteria\nRandomised controlled trials (RCTs) comparing pulmonary rehabilitation of any duration after exacerbation of COPD versus conventional care. Pulmonary rehabilitation programmes had to include at least physical exercise (endurance or strength exercise, or both). We did not apply a criterion for the minimum number of exercise sessions a rehabilitation programme had to offer to be included in the review. Control groups received conventional community care without rehabilitation.\nData collection and analysis\nWe expected substantial heterogeneity across trials in terms of how extensive rehabilitation programmes were (i.e. in terms of number of completed exercise sessions; type, intensity and supervision of exercise training; and patient education), duration of follow-up (< 3 months vs ≥ 3 months) and risk of bias (generation of random sequence, concealment of random allocation and blinding); therefore, we performed subgroup analyses that were defined before we carried them out. We used standard methods expected by Cochrane in preparing this update, and we used GRADE for assessing the quality of evidence.\nMain results\nFor this update, we added 11 studies and included a total of 20 studies (1477 participants). Rehabilitation programmes showed great diversity in terms of exercise training (number of completed exercise sessions; type, intensity and supervision), patient education (from none to extensive self-management programmes) and how they were organised (within one setting, e.g. pulmonary rehabilitation, to across several settings, e.g. hospital, outpatient centre and home). In eight studies, participants completed extensive pulmonary rehabilitation, and in 12 studies, participants completed pulmonary rehabilitation ranging from not extensive to moderately extensive.\nEight studies involving 810 participants contributed data on hospital readmissions. Moderate-quality evidence indicates that pulmonary rehabilitation reduced hospital readmissions (pooled odds ratio (OR) 0.44, 95% confidence interval (CI) 0.21 to 0.91), but results were heterogenous (I2 = 77%). Extensiveness of rehabilitation programmes and risk of bias may offer an explanation for the heterogeneity, but subgroup analyses were not statistically significant (P values for subgroup effects were between 0.07 and 0.11). Six studies including 670 participants contributed data on mortality. The quality of evidence was low, and the meta-analysis did not show a statistically significant effect of rehabilitation on mortality (pooled OR 0.68, 95% CI 0.28 to 1.67). Again, results were heterogenous (I2 = 59%). Subgroup analyses showed statistically significant differences in subgroup effects between trials with more and less extensive rehabilitation programmes and between trials at low and high risk for bias, indicating possible explanations for the heterogeneity. Hospital readmissions and mortality studies newly included in this update showed, on average, significantly smaller effects of rehabilitation than were seen in earlier studies.\nHigh-quality evidence suggests that pulmonary rehabilitation after an exacerbation improves health-related quality of life. The eight studies that used St George's Respiratory Questionnaire (SGRQ) reported a statistically significant effect on SGRQ total score, which was above the minimal important difference (MID) of four points (mean difference (MD) -7.80, 95% CI -12.12 to -3.47; I2 = 64%). Investigators also noted statistically significant and important effects (greater than MID) for the impact and activities domains of the SGRQ. Effects were not statistically significant for the SGRQ symptoms domain. Again, all of these analyses showed heterogeneity, but most studies showed positive effects of pulmonary rehabilitation, some studies showed large effects and others smaller but statistically significant effects. Trials at high risk of bias because of lack of concealment of random allocation showed statistically significantly larger effects on the SGRQ than trials at low risk of bias. High-quality evidence shows that six-minute walk distance (6MWD) improved, on average, by 62 meters (95% CI 38 to 86; I2 = 87%). Heterogeneity was driven particularly by differences between studies showing very large effects and studies showing smaller but statistically significant effects. For both health-related quality of life and exercise capacity, studies newly included in this update showed, on average, smaller effects of rehabilitation than were seen in earlier studies, but the overall results of this review have not changed to an important extent compared with results reported in the earlier version of this review.\nFive studies involving 278 participants explicitly recorded adverse events, four studies reported no adverse events during rehabilitation programmes and one study reported one serious event.\nAuthors' conclusions\nOverall, evidence of high quality shows moderate to large effects of rehabilitation on health-related quality of life and exercise capacity in patients with COPD after an exacerbation. Some recent studies showed no benefit of rehabilitation on hospital readmissions and mortality and introduced heterogeneity as compared with the last update of this review. Such heterogeneity of effects on hospital readmissions and mortality may be explained to some extent by the extensiveness of rehabilitation programmes and by the methodological quality of the included studies. Future researchers must investigate how the extent of rehabilitation programmes in terms of exercise sessions, self-management education and other components affects the outcomes, and how the organisation of such programmes within specific healthcare systems determines their effects after COPD exacerbations on hospital readmissions and mortality.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Quality of life and exercise capacity were improved by rehabilitation, and the effect was substantially larger than the minimal important difference. Results for hospital readmissions and mortality were diverse, with some studies showing that pulmonary rehabilitation reduced hospital admissions and mortality compared with usual community care (no rehabilitation), and other studies not showing such effects."
}
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query-laysum
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6900
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[
{
"role": "user",
"content": "Abstract: Background\nHypertension is the leading preventable risk factor for cardiovascular disease and premature death worldwide. One of the clinical effects of hypertension is left ventricular hypertrophy (LVH), a process of cardiac remodelling. It is estimated that over 30% of people with hypertension also suffer from LVH, although the prevalence rates vary according to the LVH diagnostic criteria. Severity of LVH is associated with a higher prevalence of cardiovascular disease and an increased risk of death.\nThe role of antihypertensives in the regression of left ventricular mass has been extensively studied. However, uncertainty exists regarding the role of antihypertensive therapy compared to placebo in the morbidity and mortality of individuals with hypertension-induced LVH.\nObjectives\nTo assess the effect of antihypertensive pharmacotherapy compared to placebo or no treatment on morbidity and mortality of adults with hypertension-induced LVH.\nSearch methods\nCochrane Hypertension’s Information Specialist searched the following databases for studies: Cochrane Hypertension Specialised Register (to 26 September 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2020, Issue 9), Ovid MEDLINE (1946 to 22 September 2020), and Ovid Embase (1974 to 22 September 2020). We searched the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov for ongoing trials. We also searched Epistemonikos (to 19 February 2021), LILACS BIREME (to 19 February 2021), and Clarivate Web of Science (to 26 February 2021), and contacted authors and funders of the identified trials to obtain additional information and individual participant data. There were no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) with at least 12 months’ follow-up comparing antihypertensive pharmacological therapy (monotherapy or in combination) with placebo or no treatment in adults (18 years of age or older) with hypertension-induced LVH were eligible for inclusion. The trials must have analysed at least one primary outcome (all-cause mortality, cardiovascular events, or total serious adverse events) to be considered for inclusion.\nData collection and analysis\nTwo review authors screened the search results, with any disagreements resolved by consensus amongst all review authors. Two review authors carried out the data extraction and analyses. We assessed risk of bias of the included studies following Cochrane methodology. We used the GRADE approach to assess the certainty of the body of evidence.\nMain results\nWe included three multicentre RCTs. We selected 930 participants from the included studies for the analyses, with a mean follow-up of 3.8 years (range 3.5 to 4.3 years). All of the included trials performed an intention-to-treat analysis. We obtained evidence for the review by identifying the population of interest from the trials' total samples. None of the trials provided information on the cause of LVH. The intervention varied amongst the included trials: hydrochlorothiazide plus triamterene with the possibility of adding alpha methyldopa, spironolactone, or olmesartan. Placebo was administered to participants in the control arm in two trials, whereas participants in the control arm of the remaining trial did not receive any add-on treatment.\nThe evidence is very uncertain regarding the effect of additional antihypertensive pharmacological therapy compared to placebo or no treatment on mortality (14.3% intervention versus 13.6% control; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.74 to 1.40; 3 studies; 930 participants; very low-certainty evidence); cardiovascular events (12.6% intervention versus 11.5% control; RR 1.09, 95% CI 0.77 to 1.55; 3 studies; 930 participants; very low-certainty evidence); and hospitalisation for heart failure (10.7% intervention versus 12.5% control; RR 0.82, 95% CI 0.57 to 1.17; 2 studies; 915 participants; very low-certainty evidence). Although both arms yielded similar results for total serious adverse events (48.9% intervention versus 48.1% control; RR 1.02, 95% CI 0.89 to 1.16; 3 studies; 930 participants; very low-certainty evidence) and total adverse events (68.3% intervention versus 67.2% control; RR 1.07, 95% CI 0.86 to 1.34; 2 studies; 915 participants), the incidence of withdrawal due to adverse events may be significantly higher with antihypertensive drug therapy (15.2% intervention versus 4.9% control; RR 3.09, 95% CI 1.69 to 5.66; 1 study; 522 participants; very low-certainty evidence). Sensitivity analyses limited to blinded trials, trials with low risk of bias in core domains, and trials with no funding from the pharmaceutical industry did not change the results of the main analyses. Limited evidence on the change in left ventricular mass index prevented us from drawing any firm conclusions.\nAuthors' conclusions\nWe are uncertain about the effects of adding additional antihypertensive drug therapy on the morbidity and mortality of participants with LVH and hypertension compared to placebo. Although the incidence of serious adverse events was similar between study arms, additional antihypertensive therapy may be associated with more withdrawals due to adverse events. Limited and low-certainty evidence requires that caution be used when interpreting the findings. High-quality clinical trials addressing the effect of antihypertensives on clinically relevant variables and carried out specifically in individuals with hypertension-induced LVH are warranted.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our confidence in the evidence is lacking because of the small number of identified studies. The available evidence is based on a small percentage of people with thickening of the heart muscle and high blood pressure identified from larger populations in the included studies. Further evidence may change our results."
}
] |
query-laysum
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6901
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[
{
"role": "user",
"content": "Abstract: Background\nMany women, and other females, with epithelial ovarian cancer (EOC) develop resistance to conventional chemotherapy drugs. Drugs that inhibit angiogenesis (development of new blood vessels), essential for tumour growth, control cancer growth by denying blood supply to tumour nodules.\nObjectives\nTo compare the effectiveness and toxicities of angiogenesis inhibitors for treatment of epithelial ovarian cancer (EOC).\nSearch methods\nWe identified randomised controlled trials (RCTs) by searching CENTRAL, MEDLINE and Embase (from 1990 to 30 September 2022). We searched clinical trials registers and contacted investigators of completed and ongoing trials for further information.\nSelection criteria\nRCTs comparing angiogenesis inhibitors with standard chemotherapy, other types of anti-cancer treatment, other angiogenesis inhibitors with or without other treatments, or placebo/no treatment in a maintenance setting, in women with EOC.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our outcomes were overall survival (OS), progression-free survival (PFS), quality of life (QoL), adverse events (grade 3 and above) and hypertension (grade 2 and above).\nMain results\nWe identified 50 studies (14,836 participants) for inclusion (including five studies from the previous version of this review): 13 solely in females with newly-diagnosed EOC and 37 in females with recurrent EOC (nine studies in platinum-sensitive EOC; 19 in platinum-resistant EOC; nine with studies with mixed or unclear platinum sensitivity). The main results are presented below.\nNewly-diagnosed EOC\nBevacizumab, a monoclonal antibody that binds vascular endothelial growth factor (VEGF), given with chemotherapy and continued as maintenance, likely results in little to no difference in OS compared to chemotherapy alone (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.88 to 1.07; 2 studies, 2776 participants; moderate-certainty evidence). Evidence is very uncertain for PFS (HR 0.82, 95% CI 0.64 to 1.05; 2 studies, 2746 participants; very low-certainty evidence), although the combination results in a slight reduction in global QoL (mean difference (MD) -6.4, 95% CI -8.86 to -3.94; 1 study, 890 participants; high-certainty evidence). The combination likely increases any adverse event (grade ≥ 3) (risk ratio (RR) 1.16, 95% CI 1.07 to 1.26; 1 study, 1485 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 2) (RR 4.27, 95% CI 3.25 to 5.60; 2 studies, 2707 participants; low-certainty evidence).\nTyrosine kinase inhibitors (TKIs) to block VEGF receptors (VEGF-R), given with chemotherapy and continued as maintenance, likely result in little to no difference in OS (HR 0.99, 95% CI 0.84 to 1.17; 2 studies, 1451 participants; moderate-certainty evidence) and likely increase PFS slightly (HR 0.88, 95% CI 0.77 to 1.00; 2 studies, 2466 participants; moderate-certainty evidence). The combination likely reduces QoL slightly (MD -1.86, 95% CI -3.46 to -0.26; 1 study, 1340 participants; moderate-certainty evidence), but it increases any adverse event (grade ≥ 3) slightly (RR 1.31, 95% CI 1.11 to 1.55; 1 study, 188 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 3) (RR 6.49, 95% CI 2.02 to 20.87; 1 study, 1352 participants; low-certainty evidence).\nRecurrent EOC (platinum-sensitive)\nModerate-certainty evidence from three studies (with 1564 participants) indicates that bevacizumab with chemotherapy, and continued as maintenance, likely results in little to no difference in OS (HR 0.90, 95% CI 0.79 to 1.02), but likely improves PFS (HR 0.56, 95% CI 0.50 to 0.63) compared to chemotherapy alone. The combination may result in little to no difference in QoL (MD 0.8, 95% CI -2.11 to 3.71; 1 study, 486 participants; low-certainty evidence), but it increases the rate of any adverse event (grade ≥ 3) slightly (RR 1.11, 1.07 to 1.16; 3 studies, 1538 participants; high-certainty evidence). Hypertension (grade ≥ 3) was more common in arms with bevacizumab (RR 5.82, 95% CI 3.84 to 8.83; 3 studies, 1538 participants).\nTKIs with chemotherapy may result in little to no difference in OS (HR 0.86, 95% CI 0.67 to 1.11; 1 study, 282 participants; low-certainty evidence), likely increase PFS (HR 0.56, 95% CI 0.44 to 0.72; 1 study, 282 participants; moderate-certainty evidence), and may have little to no effect on QoL (MD 6.1, 95% CI -0.96 to 13.16; 1 study, 146 participants; low-certainty evidence). Hypertension (grade ≥ 3) was more common with TKIs (RR 3.32, 95% CI 1.21 to 9.10).\nRecurrent EOC (platinum-resistant)\nBevacizumab with chemotherapy and continued as maintenance increases OS (HR 0.73, 95% CI 0.61 to 0.88; 5 studies, 778 participants; high-certainty evidence) and likely results in a large increase in PFS (HR 0.49, 95% CI 0.42 to 0.58; 5 studies, 778 participants; moderate-certainty evidence). The combination may result in a large increase in hypertension (grade ≥ 2) (RR 3.11, 95% CI 1.83 to 5.27; 2 studies, 436 participants; low-certainty evidence). The rate of bowel fistula/perforation (grade ≥ 2) may be slightly higher with bevacizumab (RR 6.89, 95% CI 0.86 to 55.09; 2 studies, 436 participants).\nEvidence from eight studies suggest TKIs with chemotherapy likely result in little to no difference in OS (HR 0.85, 95% CI 0.68 to 1.08; 940 participants; moderate-certainty evidence), with low-certainty evidence that it may increase PFS (HR 0.70, 95% CI 0.55 to 0.89; 940 participants), and may result in little to no meaningful difference in QoL (MD ranged from -0.19 at 6 weeks to -3.40 at 4 months). The combination increases any adverse event (grade ≥ 3) slightly (RR 1.23, 95% CI 1.02 to 1.49; 3 studies, 402 participants; high-certainty evidence). The effect on bowel fistula/perforation rates is uncertain (RR 2.74, 95% CI 0.77 to 9.75; 5 studies, 557 participants; very low-certainty evidence).\nAuthors' conclusions\nBevacizumab likely improves both OS and PFS in platinum-resistant relapsed EOC. In platinum-sensitive relapsed disease, bevacizumab and TKIs probably improve PFS, but may or may not improve OS. The results for TKIs in platinum-resistant relapsed EOC are similar. The effects on OS or PFS in newly-diagnosed EOC are less certain, with a decrease in QoL and increase in adverse events. Overall adverse events and QoL data were more variably reported than were PFS data.\nThere appears to be a role for anti-angiogenesis treatment, but given the additional treatment burden and economic costs of maintenance treatments, benefits and risks of anti-angiogenesis treatments should be carefully considered.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This is a rapidly moving field and evidence may change with further studies and longer follow-up of studies."
}
] |
query-laysum
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6902
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[
{
"role": "user",
"content": "Abstract: Background\nInfectious diseases are a major cause of illness and death among older adults. Vaccines can prevent infectious diseases, including against seasonal influenza, pneumococcal diseases, herpes zoster and COVID-19. However, the uptake of vaccination among older adults varies across settings and groups.\nCommunication with healthcare workers can play an important role in older people's decisions to vaccinate. To support an informed decision about vaccination, healthcare workers should be able to identify the older person's knowledge gaps, needs and concerns. They should also be able to share and discuss information about the person's disease risk and disease severity; the vaccine's effectiveness and safety; and practical information about how the person can access vaccines. Therefore, healthcare workers need good communication skills and to actively keep up-to-date with the latest evidence. An understanding of their perceptions and experiences of this communication can help us train and support healthcare workers and design good communication strategies.\nObjectives\nTo explore healthcare workers' perceptions and experiences of communicating with older adults about vaccination.\nSearch methods\nWe searched MEDLINE, CINAHL and Scopus on 21 March 2020. We also searched Epistemonikos for related reviews, searched grey literature sources, and carried out reference checking and citation searching to identify additional studies. We searched for studies in any language.\nSelection criteria\nWe included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored the perceptions and experiences of healthcare workers and other health system staff towards communication with adults over the age of 50 years or their informal caregivers about vaccination.\nData collection and analysis\nWe extracted data using a data extraction form designed for this review. We assessed methodological limitations using a list of predefined criteria. We extracted and assessed data regarding study authors' motivations for carrying out their study. We used a thematic synthesis approach to analyse and synthesise the evidence. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. We examined each review finding to identify factors that may influence intervention implementation and we developed implications for practice.\nMain results\nWe included 11 studies in our review. Most studies explored healthcare workers' views and experiences about vaccination of older adults more broadly but also mentioned communication issues specifically. All studies were from high-income countries. The studies focused on doctors, nurses, pharmacists and others working in hospitals, clinics, pharmacies and nursing homes. These healthcare workers discussed different types of vaccines, including influenza, pneumococcal and herpes zoster vaccines. The review was carried out before COVID-19 vaccines were available.\nWe downgraded our confidence in several of the findings from high confidence to moderate, low or very low confidence. One reason for this was that some findings were based on only small amounts of data. Another reason was that the findings were based on studies from only a few countries, making us unsure about the relevance of these findings to other settings.\nHealthcare workers reported that older adults asked about vaccination to different extents, ranging from not asking about vaccines at all, to great demand for information (high confidence finding). When the topic of vaccination was discussed, healthcare workers described a lack of information, and presence of misinformation, fears and concerns about vaccines among older adults (moderate confidence).\nThe ways in which healthcare workers discussed vaccines with older adults appeared to be linked to what they saw as the aim of vaccination communication. Healthcare workers differed among themselves in their perceptions of this aim and about their own roles and the roles of older adults in vaccine decisions. Some healthcare workers thought it was important to provide information but emphasised the right and responsibility of older adults to decide for themselves. Others used information to persuade and convince older adults to vaccinate in order to increase 'compliance' and 'improve' vaccination rates, and in some cases to gain financial benefits. Other healthcare workers tailored their approach to what they believed the older adult needed or wanted (moderate confidence).\nHealthcare workers believed that older adults' decisions could be influenced by several factors, including the nature of the healthcare worker–patient relationship, the healthcare worker's status, and the extent to which healthcare workers led by example (low confidence).\nOur review also identified factors that are likely to influence how communication between healthcare workers and older adults take place. These included issues tied to healthcare workers' views and experiences regarding the diseases in question and the vaccines; as well as their views and experiences of the organisational and practical implementation of vaccine services.\nAuthors' conclusions\nThere is little research focusing specifically on healthcare workers' perceptions and experiences of communication with older adults about vaccination. The studies we identified suggest that healthcare workers differed among themselves in their perceptions about the aim of this communication and about the role of older adults in vaccine decisions. Based on these findings and the other findings in our review, we have developed a set of questions or prompts that may help health system planners or programme managers when planning or implementing strategies for vaccination communication between healthcare workers and older adults.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 21 March 2020."
}
] |
query-laysum
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6903
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[
{
"role": "user",
"content": "Abstract: Background\nEndocrine therapy is effective at preventing or treating breast cancer. Some forms of endocrine therapy have been shown to reduce mammographic density. Reduced mammographic density for women receiving endocrine therapy could be used to estimate the chance of breast cancer returning or developing breast cancer in the first instance (a prognostic biomarker). In addition, changes in mammographic density might be able to predict how well a woman responds to endocrine therapy (a predictive biomarker). The role of breast density as a prognostic or predictive biomarker could help improve the management of breast cancer.\nObjectives\nTo assess the evidence that a reduction in mammographic density following endocrine therapy for breast cancer prevention in women without previous breast cancer, or for treatment in women with early-stage hormone receptor-positive breast cancer, is a prognostic or predictive biomarker.\nSearch methods\nWe searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registers on 3 August 2020 along with reference checking, bibliographic searching, and contact with study authors to obtain further data.\nSelection criteria\nWe included randomised, cohort and case-control studies of adult women with or without breast cancer receiving endocrine therapy. Endocrine therapy agents included were selective oestrogen receptor modulators and aromatase inhibitors. We required breast density before start of endocrine therapy and at follow-up. We included studies published in English.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently extracted data and assessed risk of bias using adapted Quality in Prognostic Studies (QUIPS) and Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tools. We used the GRADE approach to evaluate the certainty of the evidence. We did not perform a quantitative meta-analysis due to substantial heterogeneity across studies.\nMain results\nEight studies met our inclusion criteria, of which seven provided data on outcomes listed in the protocol (5786 women). There was substantial heterogeneity across studies in design, sample size (349 to 1066 women), participant characteristics, follow-up (5 to 14 years), and endocrine therapy agent. There were five breast density measures and six density change definitions. All studies had at least one domain as at moderate or high risk of bias. Common concerns were whether the study sample reflected the review target population, and likely post hoc definitions of breast density change.\nMost studies on prognosis for women receiving endocrine therapy reported a reduced risk associated with breast density reduction. Across endpoints, settings, and agents, risk ratio point estimates (most likely value) were between 0.1 and 1.5, but with substantial uncertainty. There was greatest consistency in the direction and magnitude of the effect for tamoxifen (across endpoints and settings, risk ratio point estimates were between 0.3 and 0.7). The findings are summarised as follows.\nPrognostic biomarker findings:\nTreatment\nBreast cancer mortality\nTwo studies of 823 women on tamoxifen (172 breast cancer deaths) reported risk ratio point estimates of ~0.4 and ~0.5 associated with a density reduction. The certainty of the evidence was low.\nRecurrence\nTwo studies of 1956 women on tamoxifen reported risk ratio point estimates of ~0.4 and ~0.7 associated with a density reduction. There was risk of bias in methodology for design and analysis of the studies and considerable uncertainty over the size of the effect.\nOne study of 175 women receiving an aromatase inhibitor reported a risk ratio point estimate of ~0.1 associated with a density reduction. There was considerable uncertainty about the effect size and a moderate or high risk of bias in all domains.\nOne study of 284 women receiving exemestane or tamoxifen as part of a randomised controlled trial reported risk ratio point estimates of ~1.5 (loco-regional recurrence) and ~1.3 (distance recurrence) associated with a density reduction. There was risk of bias in reporting and study confounding, and uncertainty over the size of the effects.\nThe certainty of the evidence for all recurrence endpoints was very low.\nIncidence of a secondary primary breast cancer\nTwo studies of 451 women on exemestane, tamoxifen, or unknown endocrine therapy reported risk ratio point estimates of ~0.5 and ~0.6 associated with a density reduction. There was risk of bias in reporting and study confounding, and uncertainty over the effect size. The certainty of the evidence was very low.\nWe were unable to find data regarding the remaining nine outcomes prespecified in the review protocol.\nPrevention\nIncidence of invasive breast cancer and ductal carcinoma in situ (DCIS)\nOne study of 507 women without breast cancer who were receiving preventive tamoxifen as part of a randomised controlled trial (51 subsequent breast cancers) reported a risk ratio point estimate of ~0.3 associated with a density reduction. The certainty of the evidence was low.\nPredictive biomarker findings:\nOne study of a subset of 1065 women from a randomised controlled trial assessed how much the effect of endocrine therapy could be explained by breast density declines in those receiving endocrine therapy. This study evaluated the prevention of invasive breast cancer and DCIS. We found some evidence to support the hypothesis, with a risk ratio interaction point estimate ~0.5. However, the 95% confidence interval included unity, and data were based on 51 women with subsequent breast cancer in the tamoxifen group. The certainty of the evidence was low.\nAuthors' conclusions\nThere is low-/very low-certainty evidence to support the hypothesis that breast density change following endocrine therapy is a prognostic biomarker for treatment or prevention. Studies suggested a potentially large effect size with tamoxifen, but the evidence was limited. There was less evidence that breast density change following tamoxifen preventive therapy is a predictive biomarker than prognostic biomarker. Evidence for breast density change as a prognostic treatment biomarker was stronger for tamoxifen than aromatase inhibitors. There were no studies reporting mammographic density change following endocrine therapy as a predictive biomarker in the treatment setting, nor aromatase inhibitor therapy as a prognostic or predictive biomarker in the preventive setting. Further research is warranted to assess mammographic density as a biomarker for all classes of endocrine therapy and review endpoints.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, we assessed the certainty of the available evidence as low or very low."
}
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query-laysum
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6904
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[
{
"role": "user",
"content": "Abstract: Background\nCatheter malfunction, including thrombosis, is associated with reduced dialysis adequacy, as well as an increased risk of catheter-related bacteraemia and mortality. The role of anticoagulants in the prevention of catheter malfunction remains uncertain.\nObjectives\nThis review aimed to compare the prophylactic effect of different anticoagulant agents, preparations, doses and administration on the incidence of central venous haemodialysis catheter-related malfunction and sepsis in patients with end-stage kidney disease (ESKD).\nSearch methods\nWe searched the Cochrane Renal Group's Specialised Register to 7 January 2016 through contact with the Trials' Search Co-ordinator using search terms relevant to this review.\nSelection criteria\nWe included all randomised controlled trials (RCT) assessing anticoagulants compared with conventional care for the prevention of catheter malfunction in adult patients receiving haemodialysis for ESKD.\nData collection and analysis\nThe primary outcome was catheter malfunction defined as a catheter blood flow of 200 mL/min or less, or as defined by study authors. Secondary outcomes were catheter-related bacteraemia, all-cause mortality and bleeding events. Relative risks (RR) with 95% confidence intervals (CI) for individual studies were pooled using random effects models within treatment classes. Analyses were conducted by class, with subgroup analyses performed of individual agents within classes.\nMain results\nWe included 27 studies (3003 participants) that were followed up for a median of six months. Study interventions included alternative anticoagulant locking solutions (19 studies, 2216 patients), systemic agents (6 studies, 664 patients) and low or no dose heparin (2 studies, 123 patients). The most common comparison treatment was a locking solution of heparin 5000 IU/mL, used in 17 studies. No significant effect on catheter malfunction was observed for alternative anticoagulant locking solutions (RR 0.96, 95% CI 0.74 to 1.26), systemic agents (RR 0.59, 95% CI 0.28 to 1.23), or low or no dose heparin (RR 0.90, 95% CI 0.10 to 8.31). A significant reduction on incidence of catheter-related bacteraemia was observed for alternative anticoagulant locking solutions (RR 0.46, 95% CI 0.32 to 0.66) but not systemic agents (RR 2.41, 95% CI 0.89 to 6.55), and could not be assessed in reports of low or no dose heparin studies. No significant effect on all-cause mortality was observed for alternative anticoagulant locking solutions (RR 0.88, 95% CI 0.54 to 1.43) or systemic agents (RR 0.78, 95% CI 0.37 to 1.65), and was not reported in studies of low or no dose heparin. Bleeding events were only reported in eight studies, including only 2/5 studies of systemic warfarin, with no clear effect demonstrated (RR 1.43, 95% CI 0.86 to 2.39). For individual agents, recombinant tissue plasminogen (rt-PA) was the only locking solution shown to reduce catheter malfunction (RR 0.58, 95% CI 0.37 to 0.91) based on the results of a single study. No significant on catheter malfunction was observed for other individual classes of alternative anticoagulant locking solutions (citrate: RR 1.14, 95% CI 0.76 to 1.69; antibiotic: RR 1.48, 95% CI 0.79 to 2.77; ethanol: RR 0.88, 95% CI 0.21 to 3.67). On the other hand, all individual classes of alternative anticoagulant locking solutions, except ethanol, reduced catheter-related bacteraemia (citrate: RR 0.49, 95% CI 0.36 to 0.68; antibiotic: RR 0.27, 95% CI 0.11 to 0.70; rt-PA: RR 0.35, 95% CI 0.13 to 0.93; ethanol: RR 0.33, 95% CI 0.03 to 4.05). No significant effect on all-cause mortality was observed for any individual agent within the class of alternative locking solutions. Studies were mainly of low quality and underpowered with an average participant number of 75 and study duration of six months. The interpretation of the study evidence was further limited by the variation in tested interventions and outcome reporting.\nAuthors' conclusions\nThe relative net benefit of anticoagulant therapies for prevention of catheter malfunction remains uncertain. Multiple agents appear to reduce catheter-related bacteraemia although the lack of clear assessment of harms and the limitations of study quality mean these results should be interpreted with caution. Methodological approaches can be used to avoid methods of reporting unduly affecting on the results of meta-analyses incorporating studies employed mixed reporting methods. Further high quality randomised studies, including safety outcomes, are needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review focused on randomised controlled trials (RCTs) of anticoagulants compared with conventional care for the prevention of catheter malfunction patients receiving haemodialysis."
}
] |
query-laysum
|
6905
|
[
{
"role": "user",
"content": "Abstract: Background\nUrinary catheterisation is a common procedure, with approximately 15% to 25% of all people admitted to hospital receiving short-term (14 days or less) indwelling urethral catheterisation at some point during their care. However, the use of urinary catheters is associated with an increased risk of developing urinary tract infection. Catheter-associated urinary tract infection (CAUTI) is one of the most common hospital-acquired infections. It is estimated that around 20% of hospital-acquired bacteraemias arise from the urinary tract and are associated with mortality of around 10%.\nThis is an update of a Cochrane Review first published in 2005 and last published in 2007.\nObjectives\nTo assess the effects of strategies for removing short-term (14 days or less) indwelling catheters in adults.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP, and handsearching of journals and conference proceedings (searched 17 March 2020), and reference lists of relevant articles.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs that evaluated the effectiveness of practices undertaken for the removal of short-term indwelling urethral catheters in adults for any reason in any setting.\nData collection and analysis\nTwo review authors performed abstract and full-text screening of all relevant articles. At least two review authors independently performed risk of bias assessment, data abstraction and GRADE assessment.\nMain results\nWe included 99 trials involving 12,241 participants. We judged the majority of trials to be at low or unclear risk of selection and detection bias, with a high risk of performance bias. We also deemed most trials to be at low risk of attrition and reporting bias. None of the trials reported on quality of life. The majority of participants across the trials had undergone some form of surgical procedure.\nThirteen trials involving 1506 participants compared the removal of short-term indwelling urethral catheters at one time of day (early morning removal group between 6 am to 7 am) versus another (late night removal group between 10 pm to midnight). Catheter removal late at night may slightly reduce the risk of requiring recatheterisation compared with early morning (RR 0.71, 95% CI 0.53 to 0.96; 10 RCTs, 1920 participants; low-certainty evidence). We are uncertain if there is any difference between early morning and late night removal in the risk of developing symptomatic CAUTI (RR 1.00, 95% CI 0.61 to 1.63; 1 RCT, 41 participants; very low-certainty evidence). We are uncertain whether the time of day makes a difference to the risk of dysuria (RR 2.20; 95% CI 0.70 to 6.86; 1 RCT, 170 participants; low-certainty evidence).\nSixty-eight trials involving 9247 participants compared shorter versus longer durations of catheterisation. Shorter durations may increase the risk of requiring recatheterisation compared with longer durations (RR 1.81, 95% CI 1.35 to 2.41; 44 trials, 5870 participants; low-certainty evidence), but probably reduce the risk of symptomatic CAUTI (RR 0.52, 95% CI 0.45 to 0.61; 41 RCTs, 5759 participants; moderate-certainty evidence) and may reduce the risk of dysuria (RR 0.42, 95% CI 0.20 to 0.88; 7 RCTs; 1398 participants; low-certainty evidence).\nSeven trials involving 714 participants compared policies of clamping catheters versus free drainage. There may be little to no difference between clamping and free drainage in terms of the risk of requiring recatheterisation (RR 0.82, 95% CI 0.55 to 1.21; 5 RCTs; 569 participants; low-certainty evidence). We are uncertain if there is any difference in the risk of symptomatic CAUTI (RR 0.99, 95% CI 0.60 to 1.63; 2 RCTs, 267 participants; very low-certainty evidence) or dysuria (RR 0.84, 95% CI 0.46 to 1.54; 1 trial, 79 participants; very low-certainty evidence).\nThree trials involving 402 participants compared the use of prophylactic alpha blockers versus no intervention or placebo. We are uncertain if prophylactic alpha blockers before catheter removal has any effect on the risk of requiring recatheterisation (RR 1.18, 95% CI 0.58 to 2.42; 2 RCTs, 184 participants; very low-certainty evidence) or risk of symptomatic CAUTI (RR 0.20, 95% CI 0.01 to 4.06; 1 trial, 94 participants; very low-certainty evidence). None of the included trials investigating prophylactic alpha blockers reported the number of participants with dysuria.\nAuthors' conclusions\nThere is some evidence to suggest the removal of indwelling urethral catheters late at night rather than early in the morning may reduce the number of people who require recatheterisation. It appears that catheter removal after shorter compared to longer durations probably reduces the risk of symptomatic CAUTI and may reduce the risk of dysuria. However, it may lead to more people requiring recatheterisation. The other evidence relating to the risk of symptomatic CAUTI and dysuria is too uncertain to allow us to draw any conclusions.\nDue to the low certainty of the majority of the evidence presented here, the results of further research are likely to change our findings and to have a further impact on clinical practice. This systematic review has highlighted the need for a standardised set of core outcomes, which should be measured and reported by all future trials comparing strategies for the removal of short-term urinary catheters. Future trials should also study the effects of short-term indwelling urethral catheter removal on non-surgical patients.\n\nGiven the provided abstract, please respond to the following query: \"Treatment to relax the prostate\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain whether giving alpha-blockers before the catheter is removed has any effect on the need to have catheters reinserted or the risk of developing UTIs. There was no evidence about the risk of experiencing painful urination."
}
] |
query-laysum
|
6906
|
[
{
"role": "user",
"content": "Abstract: Background\nRemoving dental plaque may play a key role maintaining oral health. There is conflicting evidence for the relative merits of manual and powered toothbrushing in achieving this. This is an update of a Cochrane review first published in 2003, and previously updated in 2005.\nObjectives\nTo compare manual and powered toothbrushes in everyday use, by people of any age, in relation to the removal of plaque, the health of the gingivae, staining and calculus, dependability, adverse effects and cost.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 23 January 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE via OVID (1946 to 23 January 2014), EMBASE via OVID (1980 to 23 January 2014) and CINAHL via EBSCO (1980 to 23 January 2014). We searched the US National Institutes of Health Trials Register and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials of at least four weeks of unsupervised powered toothbrushing versus manual toothbrushing for oral health in children and adults.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. Random-effects models were used provided there were four or more studies included in the meta-analysis, otherwise fixed-effect models were used. Data were classed as short term (one to three months) and long term (greater than three months).\nMain results\nFifty-six trials met the inclusion criteria; 51 trials involving 4624 participants provided data for meta-analysis. Five trials were at low risk of bias, five at high and 46 at unclear risk of bias.\nThere is moderate quality evidence that powered toothbrushes provide a statistically significant benefit compared with manual toothbrushes with regard to the reduction of plaque in both the short term (standardised mean difference (SMD) -0.50 (95% confidence interval (CI) -0.70 to -0.31); 40 trials, n = 2871) and long term (SMD -0.47 (95% CI -0.82 to -0.11; 14 trials, n = 978). These results correspond to an 11% reduction in plaque for the Quigley Hein index (Turesky) in the short term and 21% reduction long term. Both meta-analyses showed high levels of heterogeneity (I2 = 83% and 86% respectively) that was not explained by the different powered toothbrush type subgroups.\nWith regard to gingivitis, there is moderate quality evidence that powered toothbrushes again provide a statistically significant benefit when compared with manual toothbrushes both in the short term (SMD -0.43 (95% CI -0.60 to -0.25); 44 trials, n = 3345) and long term (SMD -0.21 (95% CI -0.31 to -0.12); 16 trials, n = 1645). This corresponds to a 6% and 11% reduction in gingivitis for the Löe and Silness index respectively. Both meta-analyses showed high levels of heterogeneity (I2 = 82% and 51% respectively) that was not explained by the different powered toothbrush type subgroups.\nThe number of trials for each type of powered toothbrush varied: side to side (10 trials), counter oscillation (five trials), rotation oscillation (27 trials), circular (two trials), ultrasonic (seven trials), ionic (four trials) and unknown (five trials). The greatest body of evidence was for rotation oscillation brushes which demonstrated a statistically significant reduction in plaque and gingivitis at both time points.\nAuthors' conclusions\nPowered toothbrushes reduce plaque and gingivitis more than manual toothbrushing in the short and long term. The clinical importance of these findings remains unclear. Observation of methodological guidelines and greater standardisation of design would benefit both future trials and meta-analyses.\nCost, reliability and side effects were inconsistently reported. Any reported side effects were localised and only temporary.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence relating to plaque and gingivitis was considered to be of moderate quality."
}
] |
query-laysum
|
6907
|
[
{
"role": "user",
"content": "Abstract: Background\nSoft tissue sarcomas (STS) are a highly heterogeneous group of rare malignant solid tumors. Nonrhabdomyosarcoma soft tissue sarcomas (NRSTS) comprise all STS except rhabdomyosarcoma. In people with advanced local or metastatic disease, autologous hematopoietic stem cell transplantation (HSCT) applied after high-dose chemotherapy (HDCT) is a planned rescue therapy for HDCT-related severe hematologic toxicity. The rationale for this update is to determine whether any randomized controlled trials (RCTs) have been conducted and to clarify whether HDCT followed by autologous HSCT has a survival advantage.\nObjectives\nTo assess the efficacy and safety of high-dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation (HSCT) for all stages of nonrhabdomyosarcoma soft tissue sarcomas (NRSTS) in children and adults.\nSearch methods\nFor this update, we revised the search strategy to improve the precision and reduce the number of irrelevant hits. We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8), PubMed from 2012 to 6 September 2016, and Embase from 2012 to 26 September 2016. We searched online trial registries and congress proceedings from 2012 to 26 September 2016.\nSelection criteria\nTerms representing STS and autologous HSCT were required in the title or abstract. We restricted the study design to RCTs. We included studies if at least 80% of participants had a diagnosis listed in any version of the World Health Organization (WHO) classification and classified as malignant. The search included children and adults with no age limits.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane. The primary outcomes were overall survival and treatment-related mortality.\nMain results\nWe identified 1549 records; 85 items from electronic databases, 45 from study registries, and 1419 from congress proceedings. The revised search strategy did not identify any additional RCTs. In the previous version of the review, we identified one RCT comparing HDCT followed by autologous HSCT versus standard-dose chemotherapy (SDCT). The trial randomized 87 participants who were considerably heterogeneous with respect to 19 different tumor entities. The data from 83 participants were available for analysis.\nIn the single included trial, overall survival at three years was 32.7% in the HDCT arm versus 49.4% in the SDCT arm and there was no difference between the treatment groups (hazard ratio (HR) 1.26, 95% confidence interval (CI) 0.70 to 2.29, P = 0.44; 1 study, 83 participants; high quality evidence). In a subgroup of participants who had a complete response before HDCT, overall survival was higher in both treatment groups and overall survival at three years was 42.8% in the HDCT arm versus 83.9% in the SDCT arm and favored the SDCT group (HR 2.92, 95% CI 1.1 to 7.6, P = 0.028; 1 study, 39 participants).\nIn the single included trial, the authors reported one treatment-related leukemia death two years after HDCT. They also evaluated severe adverse events WHO grade 3 to 4 in 22 participants in the HDCT arm and in 51 participants in the SDCT arm. The authors reported 11 events concerning digestive-, infection-, pain-, or asthenia-related toxicity in the HDCT arm and one event in the SDCT arm (moderate quality evidence). The development of secondary neoplasia was not addressed. We judged the study to have an overall unclear risk of bias as three of seven items had unclear and four items had low risk of bias. For GRADE, we judged three items as high quality and three items were not reported.\nAuthors' conclusions\nThe limited data of a single RCT with an unclear risk of bias and moderate to high quality evidence showed no survival advantage for HDCT. If this treatment is offered it should only be given after careful consideration on an individual person basis and possibly only as part of a well-designed RCT.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of the RCT did not favor either of the two treatment arms with respect to overall survival. There was one death related to treatment in the transplantation group and none in the chemotherapy-only group. There were eight cases of severe nonhematologic (not related to the blood) side effects in the transplantation group and one in the chemotherapy-only group."
}
] |
query-laysum
|
6908
|
[
{
"role": "user",
"content": "Abstract: Background\nVaricose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is characterised by oedema, pigmentation, eczema, lipodermatosclerosis, atrophie blanche, and healed or active venous ulcers. Injection sclerotherapy (liquid or foam) is widely used for treatment of varicose veins aiming to transform the varicose veins into a fibrous cord. However, there is limited evidence regarding its effectiveness and safety, especially in patients with more severe disease. This is the second update of the review first published in 2002.\nObjectives\nTo assess the effectiveness and safety of injection sclerotherapy for the treatment of varicose veins.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 20 July 2021.\nSelection criteria\nWe included all randomised controlled trials (RCTs) (including cluster-randomised trials and first phase cross-over studies) that used injection sclerotherapy for the treatment of varicose veins.\nData collection and analysis\nTwo review authors independently assessed, selected and extracted data. Disagreements were cross-checked by a third review author. We used Cochrane's Risk of bias tool to assess the risk of bias. The outcomes of interest were cosmetic appearance, complications, residual varicose veins, quality of life (QoL), persistence of symptoms, and recurrent varicose veins. We calculated risk ratios (RRs) or mean difference (MD) with 95% confidence intervals (CIs). We used the worst-case-scenario for dichotomous data imputation for intention-to-treat analyses. For continuous outcomes, we used the 'last-observation-carried-forward' for data imputation if there was balanced loss to follow-up. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 23 new RCTs for this update, bringing the total to 28 studies involving 4278 participants. The studies differed in their design, and in which sclerotherapy method, agent or concentration was used. None of the included RCTs compared sclerotherapy to no intervention or to any pharmacological therapy. The certainty of the evidence was downgraded for risk of bias, low number of studies providing information for each outcome, low number of participants, clinical differences between the study participants, and wide CIs.\nSclerotherapy versus placebo\nFoam sclerotherapy may improve cosmetic appearance as measured by IPR-V (independent photography review - visible varicose veins scores) compared to placebo (polidocanol 1%: mean difference (MD) -0.76, 95% CI -0.91 to -0.60; 2 studies, 223 participants; very low-certainty evidence); however, deep vein thrombosis (DVT) rates may be slightly increased in this intervention group (RR 5.10, 95% CI 1.30 to 20.01; 3 studies, 302 participants; very low-certainty evidence). Residual varicose vein rates may be decreased following polidocanol 1% compared to placebo (RR 0.19, 95% CI 0.13 to 0.29; 2 studies, 225 participants; very low-certainty evidence). Following polidocanol 1% use, there may be a possible improvement in QoL as assessed using the VEINES-QOL/Sym questionnaire (MD 12.41, 95% CI 9.56 to 15.26; 3 studies, 299 participants; very low-certainty evidence), and possible improvement in varicose vein symptoms as assessed using the Venous Clinical Severity Score (VCSS) (MD -3.25, 95% CI -3.90 to -2.60; 2 studies, 223 participants; low-certainty evidence). Recurrent varicose veins were not reported for this comparison.\nFoam sclerotherapy versus foam sclerotherapy with different concentrations\nThree individual RCTs reported no evidence of a difference in cosmetic appearance after comparing different concentrations of the intervention; data could not be pooled for two of the three studies (RR 1.11, 95% CI 0.84 to 1.47; 1 study, 80 participants; very low-certainty evidence). Similarly, there was no clear difference in rates of thromboembolic complications when comparing one foam concentration with another (RR 1.47, 95% CI 0.41 to 5.33; 3 studies, 371 participants; very low-certainty evidence). Three RCTs investigating higher concentrations of polidocanol foam indicated the rate of residual varicose veins may be slightly decreased in the polidocanol 3% foam group compared to 1% (RR 0.67, 95% CI 0.43 to 1.04; 3 studies, 371 participants; moderate-certainty evidence). No clear improvement in QoL was detected. Two RCTs reported improved VCSS scores with increasing concentrations of foam. Persistence of symptoms were not reported for this comparison. There was no clear difference in recurrent varicose vein rates (RR 0.91, 95% CI 0.62 to 1.32; 1 study, 148 participants; low-certainty evidence).\nFoam sclerotherapy versus liquid sclerotherapy\nOne RCT reported on cosmetic appearance with no evidence of a difference between foam or liquid sclerotherapy (patient satisfaction scale MD 0.2, 95% CI -0.27 to 0.67; 1 study, 126 participants; very low-certainty evidence). None of the RCTs investigated thromboembolic complications, QoL or persistence of symptoms. Six studies individually showed there may be a benefit to polidocanol 3% foam over liquid sclerotherapy in reducing residual varicose vein rate; pooling data from two studies showed a RR of 0.51, with 95% CI 0.41 to 0.65; 203 participants; very low-certainty evidence. One study reported no clear difference in recurrent varicose vein rates when comparing sodium tetradecyl sulphate (STS) foam or liquid (RR 1.10, 95% CI 0.86 to 1.42; 1 study, 286 participants; very low-certainty evidence).\nSclerotherapy versus sclerotherapy with different substances\nFour RCTs compared sclerotherapy versus sclerotherapy with any other substance. We were unable to combine the data due to heterogeneity or assess the certainty of the evidence due to insufficient data.\nAuthors' conclusions\nThere is a very low to low-certainty evidence that, compared to placebo, sclerotherapy is an effective and safe treatment for varicose veins concerning cosmetic appearance, residual varicose veins, QoL, and persistence of symptoms. Rates of DVT may be slightly increased and there were no data concerning recurrent varicose veins. There was limited or no evidence for one concentration of foam compared to another; foam compared to liquid sclerotherapy; foam compared to any other substance; or one technique compared to another. There is a need for high-quality trials using standardised sclerosant doses, with clearly defined core outcome sets, and measurement time points to increase the certainty of the evidence.\n\nGiven the provided abstract, please respond to the following query: \"Reliability of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was graded as very low to moderate for all outcomes. The reliability of the evidence was downgraded due to concerns about how the studies were designed (risk of bias), the low number of studies providing information for each outcome, the low number of participants, clinical differences between the study participants, and wide confidence intervals. There is a need for more high-quality trials using standardised methods to increase our confidence in the results."
}
] |
query-laysum
|
6909
|
[
{
"role": "user",
"content": "Abstract: Background\nDisseminated intravascular coagulation (DIC) is an acquired syndrome characterized by systemic intravascular activation of coagulation, leading to deposition of fibrin in the bloodstream. It may occur in patients with acute and chronic leukemia and is particularly associated with acute promyelocytic leukemia (a subtype of acute myeloid leukemia).\nObjectives\nTo assess the clinical benefits and harms of any pharmacological intervention for treating DIC in patients with acute or chronic leukemia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2015, Issue 05), MEDLINE (1946 to 7 May 2015), LILACS (1982 to 7 May 2015) and African Index Medicus (7 May 2015). There was no language restrictions. We sought additional randomized controlled trials (RCTs) from the World Health Organization International Clinical Trials Registry Platform and the reference lists of primary studies identified.\nSelection criteria\nRCTs assessing the clinical benefits and harms of interventions for treating DIC in patients with acute and chronic leukemia.\nData collection and analysis\nTwo review authors independently performed trial selection, 'Risk of bias' assessment and data extraction. Primary outcomes were overall mortality, in-hospital mortality from any cause (15-day and 30-day) and adverse events.\nMain results\nIn this Cochrane Review update we did not include any new RCT compared with the first review version. Accordingly, four RCTs (388 participants) met the inclusion criteria. These trials evaluated the human activated protein C, recombinant human soluble thrombomodulin, tranexamic acid and dermatan sulphate. Included trials reported data on mortality and bleeding. The studies were conducted in Japan, Italy and the Netherlands. We classified the included trials as: 1) including patients with or without leukemia which did not report data for the leukemia subgroup (366 participants); and 2) only including patients with leukemia (22 participants). Overall, the risk of bias of the included trials was high, since the trial authors did not provide a detailed description about trial design and execution.\nAccording to the GRADE recommendations, we judged the overall quality of the body of evidence for all prefixed outcomes as 'very low', due to methodological limitations and very small sample size.\nOne trial, including 10 participants with leukemia and comparing dermatan sulphate with heparin, reported no deaths during trial treatment.\nIn terms of bleeding data, we were unable to pool results from two studies that were only conducted with leukemia patients due to the inconsistency in the measurement and reporting of this outcome. One trial, including 12 participants with leukemia, found very low quality evidence that tranexamic acid can reduce the cumulative hemorrhagic score in participants compared with those assigned to placebo (P = 0.0015, very low quality evidence). On the contrary, there is no evidence that dermatan sulphate compared with placebo reduces new events of hemorrhagic diathesis (1/5 (20%) versus 2/5 (40%); RR 0.50; 95% CI 0.06 to 3.91; P = 0.51, very low quality evidence).\nNo thromboembolic complications were reported in either trial that included patients with leukemia only (very low quality evidence). The safety profile was inconclusive.\nThe included trials did not assess overall mortality, resolution of respiratory failure, renal failure or shock.\nAuthors' conclusions\nDue to a lack of new RCTs, our conclusions in this Cochrane Review update are the same as the previous review version. We included four RCTs which reported mortality and bleeding data. It is not possible to determine whether human activated protein C, recombinant human soluble thrombomodulin, tranexamic acid and dermatan sulphate are effective or harmful for patients presenting with DIC related to acute or chronic leukemia. The quality of the evidence was low to very low. Therefore, prescription of these interventions for treating DIC in patients with acute and chronic leukemia can neither be supported nor rejected, unless new evidence from a large high-quality trial alters this conclusion.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "DIC is a thrombo-hemorrhagic complication (involving blood clotting or bleeding) characterized by deposition of fibrin (a fibrous protein) in the bloodstream, which occurs in the course of various diseases including acute and chronic leukemia and is particularly associated with acute promyelocytic leukemia (a subtype of acute myeloid leukemia). DIC is never considered as an isolated clinical entity and represents a hematological emergency. Therefore, DIC requires treatment and resolution of the underlying disease in addition to other approaches, such as antibiotic therapy, replacement of blood products and fluid therapy, which are considered 'primary' or 'conventional care' interventions. DIC is accompanied by hyperfibrinolysis (increased dissolution of blood clots) and reduction of natural anticoagulants (proteins of the coagulation cascade). Hence, pharmacological interventions such as tranexamic acid (an antifibrinolytic agent) and heparin (an anticoagulant) have been used for treating patients with this acquired disorder. However, this practice is not considered as standard care and there is a lot of controversy about its clinical benefits."
}
] |
query-laysum
|
6910
|
[
{
"role": "user",
"content": "Abstract: Background\nHomocystinuria is a rare inherited disorder due to a deficiency in cystathionine beta synthase. Individuals with this condition appear normal at birth but develop serious complications in childhood. Diagnosis and treatment started sufficiently early in life can effectively prevent or reduce the severity of these complications. This is an update of a previously published review.\nObjectives\nTo determine if newborn population screening for the diagnosis of homocystinuria due to cystathionine beta synthase deficiency leads to clinical benefit compared to later clinical diagnosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register.\nDate of the most recent search of the Inborn Errors of Metabolism Register: 08 June 2015.\nSelection criteria\nRandomised controlled trials and controlled clinical trials assessing the use of any neonatal screening test to diagnose infants with homocystinuria before the condition becomes clinically evident. Eligible studies compare a screened population versus a non-screened population.\nData collection and analysis\nNo studies were identified for inclusion in the review.\nMain results\nNo studies were identified for inclusion in the review.\nAuthors' conclusions\nWe were unable to identify eligible studies for inclusion in this review and hence it is not possible to draw any conclusions based on controlled studies; however, we are aware of uncontrolled case-series which support the efficacy of newborn screening for homocystinuria and its early treatment. Any future randomised controlled trial would need to be both multicentre and long term in order to provide robust evidence for or against screening and to allow a cost effectiveness analysis to be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence to determine if newborn population screening for the diagnosis of homocystinuria due to cystathionine beta synthase deficiency leads to clinical improvement compared to later clinical diagnosis and to determine the psychological effects on parents or carers of newborn population screening for homocystinuria. This is an update of a previously published review."
}
] |
query-laysum
|
6911
|
[
{
"role": "user",
"content": "Abstract: Background\nVertebral artery stenosis (narrowing of the vertebral artery) is an important cause of posterior circulation ischaemic stroke. Medical treatment (MT) e.g. controlling risk-factors and drug treatment, surgery, and endovascular treatment (ET) are the prevailing treatment strategies for symptomatic vertebral artery stenosis. ET consist s of percutaneous transluminal angioplasty (balloon catheter through the skin), with or without stenting. However, optimal management of people with symptomatic vertebral artery stenosis has not yet been established.\nObjectives\nTo assess the safety and efficacy of percutaneous transluminal angioplasty, with or without stenting, combined with MT, compared to MT alone, in people with episodes of cerebral ischaemia due to vertebral artery stenosis.\nSearch methods\nWe searched the Cochrane Stroke Group, MEDLINE, Embase, BIOSIS, and two other indexes in Web of Science, China Biological Medicine Database, Chinese Science and Technique Journals Database, China National Knowledge Infrastructure and Wanfang Data, as well as ClinicalTrials.gov trials register and the World Health Organization (WHO) International Clinical Trials Registry Platform to 23 July 2021.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared ET plus MT with MT alone in treating people aged 18 years or over with symptomatic vertebral artery stenosis. We included all types of ET modalities (e.g. angioplasty alone, balloon-mounted stenting, and angioplasty followed by placement of a self-expanding stent). MT included risk factor control, antiplatelet therapy, lipid-lowering therapy, and individualised management for people with hypertension or diabetes.\nData collection and analysis\nTwo review authors independently screened potentially eligible studies, extracted data, and assessed trial quality and risk of bias. We applied the GRADE approach to assess the certainty of evidence. The primary outcomes were 30-day post-randomisation death/stroke (short-term outcome) and fatal/non-fatal stroke after 30 days post-randomisation to completion of follow-up (long-term outcome).\nMain results\nWe included three RCTs with 349 participants with symptomatic vertebral artery stenosis with a mean age of 64.4 years. The included RCTs were at low risk of bias overall. However, all included studies had a high risk of performance bias because blinding of the ET was not feasible.\nThere was no significant difference in 30-day post-randomisation deaths/strokes between ET plus MT and MT alone (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.77 to 7.07; 3 studies, 349 participants; low-certainty evidence). There were no significant differences between ET plus MT and MT alone in fatal/non-fatal strokes in the territory of the treated vertebral artery stenosis after 30 days post-randomisation to completion of follow-up (RR 0.51, 95% CI 0.26 to 1.01; 3 studies, 349 participants; moderate-certainty evidence), ischaemic or haemorrhagic stroke during the entire follow-up period (RR 0.77, 95% CI 0.44 to 1.32; 3 studies, 349 participants; moderate-certainty evidence), death during the entire follow-up period (RR 0.78, 95% CI 0.37 to 1.62; 3 studies, 349 participants; low-certainty evidence), and stroke or transient ischaemic attack (TIA) during the entire follow-up period (RR 0.65, 95% CI 0.39 to 1.06; 2 studies, 234 participants; moderate-certainty evidence).\nAuthors' conclusions\nThis Cochrane Review provides low- to moderate-certainty evidence indicating that there are no significant differences in either short- or long-term risks of stroke, death, or TIA between people with symptomatic vertebral artery stenosis treated with ET plus MT and those treated with MT alone.\n\nGiven the provided abstract, please respond to the following query: \"Question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is endovascular treatment plus medical treatment beneficial for people with symptomatic vertebral artery stenosis compared to medical treatment alone?"
}
] |
query-laysum
|
6912
|
[
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers, also known as pressure injuries and bed sores, are localised areas of injury to the skin or underlying tissues, or both. Dressings made from a variety of materials, including foam, are used to treat pressure ulcers. An evidence-based overview of dressings for pressure ulcers is needed to enable informed decision-making on dressing use. This review is part of a suite of Cochrane Reviews investigating the use of dressings in the treatment of pressure ulcers. Each review will focus on a particular dressing type.\nObjectives\nTo assess the clinical and cost effectiveness of foam wound dressings for healing pressure ulcers in people with an existing pressure ulcer in any care setting.\nSearch methods\nIn February 2017 we searched: the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase; EBSCO CINAHL Plus and the NHS Economic Evaluation Database (NHS EED). We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) and cluster-RCTs, that compared the clinical and cost effectiveness of foam wound dressings for healing pressure ulcers (Category/Stage II or above).\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias and data extraction. A third reviewer resolved discrepancies between the review authors.\nMain results\nWe included nine trials with a total of 483 participants, all of whom were adults (59 years or older) with an existing pressure ulcer Category/Stage II or above. All trials had two arms, which compared foam dressings with other dressings for treating pressure ulcers.\nThe certainty of evidence ranged from low to very low due to various combinations of selection, performance, attrition, detection and reporting bias, and imprecision due to small sample sizes and wide confidence intervals. We had very little confidence in the estimate of effect of included studies. Where a foam dressing was compared with another foam dressing, we established that the true effect was likely to be substantially less than the study's estimated effect.\nWe present data for four comparisons.\nOne trial compared a silicone foam dressing with another (hydropolymer) foam dressing (38 participants), with an eight-week (short-term) follow-up. It was uncertain whether alternate types of foam dressing affected the incidence of healed pressure ulcers (RR 0.89, 95% CI 0.45 to 1.75) or adverse events (RR 0.37, 95% CI 0.04 to 3.25), as the certainty of evidence was very low, downgraded for serious limitations in study design and very serious imprecision.\nFour trials with a median sample size of 20 participants (230 participants), compared foam dressings with hydrocolloid dressings for eight weeks or less (short-term). It was uncertain whether foam dressings affected the probability of healing in comparison to hydrocolloid dressings over a short follow-up period in three trials (RR 0.85, 95% CI 0.54 to 1.34), very low-certainty evidence, downgraded for very serious study limitations and serious imprecision. It was uncertain if there was a difference in risk of adverse events between groups (RR 0.88, 95% CI 0.37 to 2.11), very low-certainty evidence, downgraded for serious study limitations and very serious imprecision. Reduction in ulcer size, patient satisfaction/acceptability, pain and cost effectiveness data were also reported but we assessed the evidence as being of very low certainty.\nOne trial (34 participants), compared foam and hydrogel dressings over an eight-week (short-term) follow-up. It was uncertain if the foam dressing affected the probability of healing (RR 1.00, 95% CI 0.78 to 1.28), time to complete healing (MD 5.67 days 95% CI -4.03 to 15.37), adverse events (RR 0.33, 95% CI 0.01 to 7.65) or reduction in ulcer size (MD 0.30 cm2 per day, 95% CI -0.15 to 0.75), as the certainty of the evidence was very low, downgraded for serious study limitations and very serious imprecision.\nThe remaining three trials (181 participants) compared foam with basic wound contact dressings. Follow-up times ranged from short-term (8 weeks or less) to medium-term (8 to 24 weeks). It was uncertain whether foam dressings affected the probability of healing compared with basic wound contact dressings, in the short term (RR 1.33, 95% CI 0.62 to 2.88) or medium term (RR 1.17, 95% CI 0.79 to 1.72), or affected time to complete healing in the medium term (MD -35.80 days, 95% CI -56.77 to -14.83), or adverse events in the medium term (RR 0.58, 95% CI 0.33 to 1.05). This was due to the very low-certainty evidence, downgraded for serious to very serious study limitations and imprecision. Reduction in ulcer size, patient satisfaction/acceptability, pain and cost effectiveness data were also reported but again, we assessed the evidence as being of very low certainty.\nNone of the included trials reported quality of life or pressure ulcer recurrence.\nAuthors' conclusions\nIt is uncertain whether foam dressings are more clinically effective, more acceptable to users, or more cost effective compared to alternative dressings in treating pressure ulcers. It was difficult to make accurate comparisons between foam dressings and other dressings due to the lack of data on reduction of wound size, complete wound healing, treatment costs, or insufficient time-frames. Quality of life and patient (or carer) acceptability/satisfaction associated with foam dressings were not systematically measured in any of the included studies. We assessed the certainty of the evidence in the included trials as low to very low. Clinicians need to carefully consider the lack of robust evidence in relation to the clinical and cost-effectiveness of foam dressings for treating pressure ulcers when making treatment decisions, particularly when considering the wound management properties that may be offered by each dressing type and the care context.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to find out whether foam dressings (designed to absorb fluid from wounds whilst keeping them moist) have any advantages or disadvantages in healing pressure ulcers compared with other dressings (such as silicone foam dressings, hydrocolloid, hydrogel or basic wound dressings). Researchers from Cochrane collected and analysed all relevant studies (randomised controlled trials) to answer this question and found nine relevant studies."
}
] |
query-laysum
|
6913
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[
{
"role": "user",
"content": "Abstract: Background\nRetrospective analyses suggest that capecitabine may carry superior activity in hormone receptor-positive relative to hormone receptor-negative metastatic breast cancer. This review examined the veracity of that finding and explored whether this differential activity extends to early breast cancer.\nObjectives\nTo assess effects of chemotherapy regimens containing capecitabine compared with regimens not containing capecitabine for women with hormone receptor-positive versus hormone receptor-negative breast cancer across the three major treatment scenarios: neoadjuvant, adjuvant, metastatic.\nSearch methods\nOn 4 June 2019, we searched the Cochrane Breast Cancer Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) in the Cochrane Library; MEDLINE; Embase; the World Health Organization International Clinical Trials Registry Platform; and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials looking at chemotherapy regimens containing capecitabine alone or in combination with other agents versus a control or similar regimen without capecitabine for treatment of breast cancer at any stage. The primary outcome measure for metastatic and adjuvant trials was overall survival (OS), and for neoadjuvant studies pathological complete response (pCR).\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. Hazard ratios (HRs) were derived for time-to-event outcomes, and odds ratios (ORs) for dichotomous outcomes, and meta-analysis was performed using a fixed-effect model.\nMain results\nWe included 26 studies with outcome data by hormone receptor: 12 metastatic studies (n = 4325), 6 neoadjuvant trials (n = 3152), and 8 adjuvant studies (n = 13,457).\nCapecitabine treatment was added in several different ways across studies. These could be classified as capecitabine alone compared to another treatment, capecitabine substituted for part of the control chemotherapy, and capecitabine added to control chemotherapy.\nIn the metastatic setting, the effect of capecitabine was heterogenous between hormone receptor-positive and -negative tumours. For OS, no difference between capecitabine-containing and non-capecitabine-containing regimens was observed for all participants taken together (HR 1.01, 95% confidence interval (CI) 0.98 to 1.05; 12 studies, 4325 participants; high-certainty evidence), for those with hormone receptor-positive disease (HR 0.93, 95% CI 0.84 to 1.04; 7 studies, 1834 participants; high-certainty evidence), and for those with hormone receptor-negative disease (HR 1.00, 95% CI 0.88 to 1.13; 8 studies, 1577 participants; high-certainty evidence). For progression-free survival (PFS), a small improvement was seen for all people (HR 0.89, 95% CI 0.82 to 0.96; 12 studies, 4325 participants; moderate-certainty evidence). This was largely accounted for by a moderate improvement in PFS for inclusion of capecitabine in hormone receptor-positive cancers (HR 0.82, 95% CI 0.73 to 0.91; 7 studies, 1594 participants; moderate-certainty evidence) compared to no difference in PFS for hormone receptor-negative cancers (HR 0.96, 95% CI 0.83 to 1.10; 7 studies, 1122 participants; moderate-certainty evidence). Quality of life was assessed in five studies; in general there did not seem to be differences in global health scores between the two treatment groups at around two years' follow-up.\nNeoadjuvant studies were highly variable in design, having been undertaken to test various experimental regimens using pathological complete response (pCR) as a surrogate for disease-free survival (DFS) and OS. Across all patients, capecitabine-containing regimens resulted in little difference in pCR in comparison to non-capecitabine-containing regimens (odds ratio (OR) 1.12, 95% CI 0.94 to 1.33; 6 studies, 3152 participants; high-certainty evidence). By subtype, no difference in pCR was observed for either hormone receptor-positive (OR 1.22, 95% CI 0.76 to 1.95; 4 studies, 964 participants; moderate-certainty evidence) or hormone receptor-negative tumours (OR 1.28, 95% CI 0.61 to 2.66; 4 studies, 646 participants; moderate-certainty evidence). Four studies with 2460 people reported longer-term outcomes: these investigators detected no difference in either DFS (HR 1.02, 95% CI 0.86 to 1.21; high-certainty evidence) or OS (HR 0.97, 95% CI 0.77 to 1.23; high-certainty evidence).\nIn the adjuvant setting, a modest improvement in OS was observed across all participants (HR 0.89, 95% CI 0.81 to 0.98; 8 studies, 13,547 participants; moderate-certainty evidence), and no difference in OS was seen in hormone receptor-positive cancers (HR 0.86, 95% CI 0.68 to 1.09; 3 studies, 3683 participants), whereas OS improved in hormone receptor-negative cancers (HR 0.72, 95% CI 0.59 to 0.89; 5 studies, 3432 participants). No difference in DFS or relapse-free survival (RFS) was observed across all participants (HR 0.93, 95% CI 0.86 to 1.01; 8 studies, 13,457 participants; moderate-certainty evidence). As was observed for OS, no difference in DFS/RFS was seen in hormone receptor-positive cancers (HR 1.03, 95% CI 0.91 to 1.17; 5 studies, 5604 participants; moderate-certainty evidence), and improvements in DFS/RFS with inclusion of capecitabine were observed for hormone receptor-negative cancers (HR 0.74, 95% CI 0.64 to 0.86; 7 studies, 3307 participants; moderate-certainty evidence).\nAdverse effects were reported across all three scenarios. When grade 3 or 4 febrile neutropenia was considered, no difference was seen for capecitabine compared to non-capecitabine regimens in neoadjuvant studies (OR 1.31, 95% CI 0.97 to 1.77; 4 studies, 2890 participants; moderate-certainty evidence), and a marked reduction was seen for capecitabine in adjuvant studies (OR 0.55, 95% CI 0.47 to 0.64; 5 studies, 8086 participants; moderate-certainty evidence). There was an increase in diarrhoea and hand-foot syndrome in neoadjuvant (diarrhoea: OR 1.95, 95% CI 1.32 to 2.89; 3 studies, 2686 participants; hand-foot syndrome: OR 6.77, 95% CI 4.89 to 9.38; 5 studies, 3021 participants; both moderate-certainty evidence) and adjuvant trials (diarrhoea: OR 2.46, 95% CI 2.01 to 3.01; hand-foot syndrome: OR 13.60, 95% CI 10.65 to 17.37; 8 studies, 11,207 participants; moderate-certainty evidence for both outcomes).\nAuthors' conclusions\nIn summary, a moderate PFS benefit by including capecitabine was seen only in hormone receptor-positive cancers in metastatic studies. No benefit of capecitabine for pCR was noted overall or in hormone receptor subgroups when included in neoadjuvant therapy. In contrast, the addition of capecitabine in the adjuvant setting led to improved outcomes for OS and DFS in hormone receptor-negative cancer. Future studies should stratify by hormone receptor and triple-negative breast cancer (TNBC) status to clarify the differential effects of capecitabine in these subgroups across all treatment scenarios, to optimally guide capecitabine inclusion.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aims of this Cochrane Review were to find out whether capecitabine is more useful in hormone receptor-positive or -negative breast cancers, and to see whether this differs depending on how advanced the cancer is. We collected and analysed all relevant studies to answer this question."
}
] |
query-laysum
|
6914
|
[
{
"role": "user",
"content": "Abstract: Background\nComplex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve lesion has not been identified and type II (CRPS II) where there is an identifiable nerve lesion. Guidelines recommend the inclusion of a variety of physiotherapy interventions as part of the multimodal treatment of people with CRPS. This is the first update of the review originally published in Issue 2, 2016.\nObjectives\nTo determine the effectiveness of physiotherapy interventions for treating pain and disability associated with CRPS types I and II in adults.\nSearch methods\nFor this update we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL, PsycINFO, LILACS, PEDro, Web of Science, DARE and Health Technology Assessments from February 2015 to July 2021 without language restrictions, we searched the reference lists of included studies and we contacted an expert in the field. We also searched additional online sources for unpublished trials and trials in progress.\nSelection criteria\nWe included randomised controlled trials (RCTs) of physiotherapy interventions compared with placebo, no treatment, another intervention or usual care, or other physiotherapy interventions in adults with CRPS I and II. Primary outcomes were pain intensity and disability. Secondary outcomes were composite scores for CRPS symptoms, health-related quality of life (HRQoL), patient global impression of change (PGIC) scales and adverse effects.\nData collection and analysis\nTwo review authors independently screened database searches for eligibility, extracted data, evaluated risk of bias and assessed the certainty of evidence using the GRADE system.\nMain results\nWe included 16 new trials (600 participants) along with the 18 trials from the original review totalling 34 RCTs (1339 participants). Thirty-three trials included participants with CRPS I and one trial included participants with CRPS II. Included trials compared a diverse range of interventions including physical rehabilitation, electrotherapy modalities, cortically directed rehabilitation, electroacupuncture and exposure-based approaches. Most interventions were tested in small, single trials. Most were at high risk of bias overall (27 trials) and the remainder were at 'unclear' risk of bias (seven trials). For all comparisons and outcomes where we found evidence, we graded the certainty of the evidence as very low, downgraded due to serious study limitations, imprecision and inconsistency. Included trials rarely reported adverse effects.\nPhysiotherapy compared with minimal care for adults with CRPS I\nOne trial (135 participants) of multimodal physiotherapy, for which pain data were unavailable, found no between-group differences in pain intensity at 12-month follow-up. Multimodal physiotherapy demonstrated a small between-group improvement in disability at 12 months follow-up compared to an attention control (Impairment Level Sum score, 5 to 50 scale; mean difference (MD) -3.7, 95% confidence interval (CI) -7.13 to -0.27) (very low-certainty evidence). Equivalent data for pain were not available. Details regarding adverse events were not reported.\nPhysiotherapy compared with minimal care for adults with CRPS II\nWe did not find any trials of physiotherapy compared with minimal care for adults with CRPS II.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of physiotherapy interventions on pain and disability in CRPS. This conclusion is similar to our 2016 review. Large-scale, high-quality RCTs with longer-term follow-up are required to test the effectiveness of physiotherapy-based interventions for treating pain and disability in adults with CRPS I and II.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 33 clinical trials that involved 1317 people in total with CRPS type I of the upper or lower limb, or both. The trials investigated the effect of a range of physiotherapy treatments. We found only one trial involving 22 people with CRPS type II.\nHere we present the findings from comparisons between different physiotherapy treatments and placebo treatments or routine care and for comparisons of different physiotherapy treatments to each other.\nReducing pain\nWe are uncertain if any of the physiotherapy treatments investigated in the clinical trials we identified help reduce the pain associated with CRPS.\nReducing disability\nWe are uncertain if any of the physiotherapy treatments investigated in the clinical trials we identified help reduce the disability associated with CRPS.\nSide effects\nWe are uncertain if any of the physiotherapy treatments investigated in the clinical trials we identified cause any unwanted side effects."
}
] |
query-laysum
|
6915
|
[
{
"role": "user",
"content": "Abstract: Background\nCurrent and expected problems such as ageing, increased prevalence of chronic conditions and multi-morbidity, increased emphasis on healthy lifestyle and prevention, and substitution for care from hospitals by care provided in the community encourage countries worldwide to develop new models of primary care delivery. Owing to the fact that many tasks do not necessarily require the knowledge and skills of a doctor, interest in using nurses to expand the capacity of the primary care workforce is increasing. Substitution of nurses for doctors is one strategy used to improve access, efficiency, and quality of care. This is the first update of the Cochrane review published in 2005.\nObjectives\nOur aim was to investigate the impact of nurses working as substitutes for primary care doctors on:\n• patient outcomes;\n• processes of care; and\n• utilisation, including volume and cost.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of the Cochrane Library (www.cochranelibrary.com), as well as MEDLINE, Ovid, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and EbscoHost (searched 20.01.2015). We searched for grey literature in the Grey Literature Report and OpenGrey (21.02.2017), and we searched the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov trial registries (21.02.2017). We did a cited reference search for relevant studies (searched 27.01 2015) and checked reference lists of all included studies. We reran slightly revised strategies, limited to publication years between 2015 and 2017, for CENTRAL, MEDLINE, and CINAHL, in March 2017, and we have added one trial to ‘Studies awaiting classification’.\nSelection criteria\nRandomised trials evaluating the outcomes of nurses working as substitutes for doctors. The review is limited to primary healthcare services that provide first contact and ongoing care for patients with all types of health problems, excluding mental health problems. Studies which evaluated nurses supplementing the work of primary care doctors were excluded.\nData collection and analysis\nTwo review authors independently carried out data extraction and assessment of risk of bias of included studies. When feasible, we combined study results and determined an overall estimate of the effect. We evaluated other outcomes by completing a structured synthesis.\nMain results\nFor this review, we identified 18 randomised trials evaluating the impact of nurses working as substitutes for doctors. One study was conducted in a middle-income country, and all other studies in high-income countries. The nursing level was often unclear or varied between and even within studies. The studies looked at nurses involved in first contact care (including urgent care), ongoing care for physical complaints, and follow-up of patients with a particular chronic conditions such as diabetes. In many of the studies, nurses could get additional support or advice from a doctor. Nurse-doctor substitution for preventive services and health education in primary care has been less well studied.\nStudy findings suggest that care delivered by nurses, compared to care delivered by doctors, probably generates similar or better health outcomes for a broad range of patient conditions (low- or moderate-certainty evidence):\n• Nurse-led primary care may lead to slightly fewer deaths among certain groups of patients, compared to doctor-led care. However, the results vary and it is possible that nurse-led primary care makes little or no difference to the number of deaths (low-certainty evidence).\n• Blood pressure outcomes are probably slightly improved in nurse-led primary care. Other clinical or health status outcomes are probably similar (moderate-certainty evidence).\n• Patient satisfaction is probably slightly higher in nurse-led primary care (moderate-certainty evidence). Quality of life may be slightly higher (low-certainty evidence).\nWe are uncertain of the effects of nurse-led care on process of care because the certainty of this evidence was assessed as very low.\nThe effect of nurse-led care on utilisation of care is mixed and depends on the type of outcome. Consultations are probably longer in nurse-led primary care (moderate-certainty evidence), and numbers of attended return visits are slightly higher for nurses than for doctors (high-certainty evidence). We found little or no difference between nurses and doctors in the number of prescriptions and attendance at accident and emergency units (high-certainty evidence). There may be little or no difference in the number of tests and investigations, hospital referrals and hospital admissions between nurses and doctors (low-certainty evidence).\nWe are uncertain of the effects of nurse-led care on the costs of care because the certainty of this evidence was assessed as very low.\nAuthors' conclusions\nThis review shows that for some ongoing and urgent physical complaints and for chronic conditions, trained nurses, such as nurse practitioners, practice nurses, and registered nurses, probably provide equal or possibly even better quality of care compared to primary care doctors, and probably achieve equal or better health outcomes for patients. Nurses probably achieve higher levels of patient satisfaction, compared to primary care doctors. Furthermore, consultation length is probably longer when nurses deliver care and the frequency of attended return visits is probably slightly higher for nurses, compared to doctors. Other utilisation outcomes are probably the same. The effects of nurse-led care on process of care and the costs of care are uncertain, and we also cannot ascertain what level of nursing education leads to the best outcomes when nurses are substituted for doctors.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out what happens when primary healthcare services are delivered by nurses instead of doctors. We collected and analysed all relevant studies to answer this question and found 18 studies for inclusion in the review."
}
] |
query-laysum
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6916
|
[
{
"role": "user",
"content": "Abstract: Background\nClinical guidelines recommend outpatient care for the majority of people with an eating disorder. The optimal use of inpatient treatment or combination of inpatient and partial hospital care is disputed and practice varies widely.\nObjectives\nTo assess the effects of treatment setting (inpatient, partial hospitalisation, or outpatient) on the reduction of symptoms and increase in remission rates in people with:\n1. Anorexia nervosa and atypical anorexia nervosa;\n2. Bulimia nervosa and other eating disorders.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 2 July 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 20 November 2015). We also searched the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov (6 July 2018). We ran a forward citation search on the Web of Science to identify additional reports citing any of the included studies, and screened reference lists of included studies and relevant reviews identified during our searches.\nSelection criteria\nWe included randomised controlled trials that tested the efficacy of inpatient, outpatient, or partial hospital settings for treatment of eating disorder in adults, adolescents, and children, whose diagnoses were determined according to the DSM-5, or other internationally accepted diagnostic criteria. We excluded trials of treatment setting for medical or psychiatric complications or comorbidities (e.g. hypokalaemia, depression) of an eating disorder.\nData collection and analysis\nWe followed standard Cochrane procedures to select studies, extract and analyse data, and interpret and present results. We extracted data according to the DSM-5 criteria. We used the Cochrane tool to assess risk of bias. We used the mean (MD) or standardised mean difference (SMD) for continuous data outcomes, and the risk ratio (RR) for binary outcomes. We included the 95% confidence interval (CI) with each result. We presented the quality of the evidence and estimate of effect for weight or body mass index (BMI) and acceptability (number who completed treatment), in a 'Summary of findings' table for the comparison for which we had sufficient data to conduct a meta-analysis.\nMain results\nWe included five trials in our review. Four trials included a total of 511 participants with anorexia nervosa, and one trial had 55 participants with bulimia nervosa. Three trials are awaiting classification, and may be included in future versions of this review. We assessed a risk of bias from lack of blinding of participants and therapists in all trials, and unclear risk for allocation concealment and randomisation in one study.\nWe had planned four comparisons, and had data for meta-analyses for one. For anorexia nervosa, there may be little or no difference between specialist inpatient care and active outpatient or combined brief hospital and outpatient care in weight gain at 12 months after the start of treatment (standardised mean difference (SMD) -0.22, 95% CI -0.49 to 0.05; 2 trials, 232 participants; low-quality evidence). People may be more likely to complete treatment when randomised to outpatient care settings, but this finding is very uncertain (risk ratio (RR) 0.75, 95% CI 0.64 to 0.88; 3 trials, 319 participants; very low-quality evidence). We downgraded the quality of the evidence for these outcomes because of risks of bias, small numbers of participants and events, and variable level of specialist expertise and intensity of treatment.\nWe had no data, or data from only one trial for the primary outcomes for each of the other three comparisons.\nNo trials measured weight or acceptance of treatment for anorexia nervosa, when comparing inpatient care provided by a specialist eating disorder service and health professionals and a waiting list, no active treatment, or treatment as usual.\nThere was no clear difference in weight gain between settings, and only slightly more acceptance for the partial hospital setting over specialist inpatient care for weight restoration in anorexia nervosa.\nThere was no clear difference in weight gain or acceptability of treatment between specialist inpatient care and partial hospital care for bulimia nervosa, and other binge eating disorders.\nAuthors' conclusions\nThere was insufficient evidence to conclude whether any treatment setting was superior for treating people with moderately severe (or less) anorexia nervosa, or other eating disorders.\nMore research is needed for all comparisons of inpatient care versus alternate care.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was not enough evidence from trials to support any one setting for people with anorexia nervosa, bulimia nervosa, or other eating disorders. There was no clear difference in weight gain for people with anorexia nervosa who were treated in different settings, but they seemed more likely to complete treatment when some or all of it was offered in settings outside the hospital. The evidence was low or very low-quality, so we are uncertain about these results."
}
] |
query-laysum
|
6917
|
[
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is important to guide appropriate management, to reduce morbidity and to improve survival. Basal cell carcinoma (BCC) is almost always a localised skin cancer with potential to infiltrate and damage surrounding tissue, whereas a minority of cutaneous squamous cell carcinomas (cSCCs) and invasive melanomas are higher-risk skin cancers with the potential to metastasise and cause death. Dermoscopy has become an important tool to assist specialist clinicians in the diagnosis of melanoma, and is increasingly used in primary-care settings. Dermoscopy is a precision-built handheld illuminated magnifier that allows more detailed examination of the skin down to the level of the superficial dermis. Establishing the value of dermoscopy over and above visual inspection for the diagnosis of BCC or cSCC in primary- and secondary-care settings is critical to understanding its potential contribution to appropriate skin cancer triage, including referral of higher-risk cancers to secondary care, the identification of low-risk skin cancers that might be treated in primary care and to provide reassurance to those with benign skin lesions who can be safely discharged.\nObjectives\nTo determine the diagnostic accuracy of visual inspection and dermoscopy, alone or in combination, for the detection of (a) BCC and (b) cSCC, in adults. We separated studies according to whether the diagnosis was recorded face-to-face (in person) or based on remote (image-based) assessment.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nStudies of any design that evaluated visual inspection or dermoscopy or both in adults with lesions suspicious for skin cancer, compared with a reference standard of either histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic thresholds were missing. We estimated accuracy using hierarchical summary ROC methods. We undertook analysis of studies allowing direct comparison between tests. To facilitate interpretation of results, we computed values of sensitivity at the point on the SROC curve with 80% fixed specificity and values of specificity with 80% fixed sensitivity. We investigated the impact of in-person test interpretation; use of a purposely-developed algorithm to assist diagnosis; and observer expertise.\nMain results\nWe included 24 publications reporting on 24 study cohorts, providing 27 visual inspection datasets (8805 lesions; 2579 malignancies) and 33 dermoscopy datasets (6855 lesions; 1444 malignancies). The risk of bias was mainly low for the index test (for dermoscopy evaluations) and reference standard domains, particularly for in-person evaluations, and high or unclear for participant selection, application of the index test for visual inspection and for participant flow and timing. We scored concerns about the applicability of study findings as of ‘high’ or 'unclear' concern for almost all studies across all domains assessed. Selective participant recruitment, lack of reproducibility of diagnostic thresholds and lack of detail on observer expertise were particularly problematic.\nThe detection of BCC was reported in 28 datasets; 15 on an in-person basis and 13 image-based. Analysis of studies by prior testing of participants and according to observer expertise was not possible due to lack of data. Studies were primarily conducted in participants referred for specialist assessment of lesions with available histological classification. We found no clear differences in accuracy between dermoscopy studies undertaken in person and those which evaluated images. The lack of effect observed may be due to other sources of heterogeneity, including variations in the types of skin lesion studied, in dermatoscopes used, or in the use of algorithms and varying thresholds for deciding on a positive test result.\nMeta-analysis found in-person evaluations of dermoscopy (7 evaluations; 4683 lesions and 363 BCCs) to be more accurate than visual inspection alone for the detection of BCC (8 evaluations; 7017 lesions and 1586 BCCs), with a relative diagnostic odds ratio (RDOR) of 8.2 (95% confidence interval (CI) 3.5 to 19.3; P < 0.001). This corresponds to predicted differences in sensitivity of 14% (93% versus 79%) at a fixed specificity of 80% and predicted differences in specificity of 22% (99% versus 77%) at a fixed sensitivity of 80%. We observed very similar results for the image-based evaluations.\nWhen applied to a hypothetical population of 1000 lesions, of which 170 are BCC (based on median BCC prevalence across studies), an increased sensitivity of 14% from dermoscopy would lead to 24 fewer BCCs missed, assuming 166 false positive results from both tests. A 22% increase in specificity from dermoscopy with sensitivity fixed at 80% would result in 183 fewer unnecessary excisions, assuming 34 BCCs missed for both tests. There was not enough evidence to assess the use of algorithms or structured checklists for either visual inspection or dermoscopy.\nInsufficient data were available to draw conclusions on the accuracy of either test for the detection of cSCCs.\nAuthors' conclusions\nDermoscopy may be a valuable tool for the diagnosis of BCC as an adjunct to visual inspection of a suspicious skin lesion following a thorough history-taking including assessment of risk factors for keratinocyte cancer. The evidence primarily comes from secondary-care (referred) populations and populations with pigmented lesions or mixed lesion types. There is no clear evidence supporting the use of currently-available formal algorithms to assist dermoscopy diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most of our studies made a reliable final diagnosis by lesion biopsy and by following people up over time to make sure the skin lesion remained negative for skin cancer. Some studies used expert diagnosis to confirm the absence of skin cancer, which is less reliable*. Poor reporting of what was done in the studies made it difficult for us to judge how reliable they were. Some studies excluded certain types of skin lesion and some did not describe how a positive test result to trigger referral to a specialist or treatment was defined."
}
] |
query-laysum
|
6918
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic rhinosinusitis, with or without nasal polyps, can have a major impact on a person's quality of life. Treatment is usually conservative and may include nasal saline, intranasal corticosteroids, antibiotics or systemic corticosteroids. If these treatments fail endoscopic sinus surgery can be considered. During surgery, visibility of the surgical field is important for the identification of important anatomic landmarks and structures that contribute to safety. Impaired visualisation can lead to complications during surgery, inability to complete the operation or a longer duration of surgery. Different methods are used to decrease intraoperative bleeding, including induced hypotension, topical or systemic vasoconstrictors or total intravenous anaesthesia. Another option is tranexamic acid, an antifibrinolytic agent, which can be administered topically or intravenously.\nObjectives\nTo assess the effects of peri-operative tranexamic acid versus no therapy or placebo on operative parameters in patients with chronic rhinosinusitis (with or without nasal polyps) who are undergoing functional endoscopic sinus surgery (FESS).\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 10 February 2022.\nSelection criteria\nRandomised controlled trials (RCTs) comparing intravenous, oral or topical tranexamic acid with no therapy or placebo in the treatment of patients (adults and children) with chronic rhinosinusitis, with or without nasal polyps, undergoing FESS.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Primary outcome measures were surgical field bleeding score (e.g. Wormald or Boezaart grading system), intraoperative blood loss and significant adverse effects (seizures or thromboembolism within 12 weeks of surgery). Secondary outcomes were duration of surgery, incomplete surgery, surgical complications and postoperative bleeding (placing of packing or revision surgery) in the first two weeks after surgery. We performed subgroup analyses for methods of administration, different dosages, different forms of anaesthesia, use of thromboembolic prophylaxis and children versus adults. We evaluated each included study for risk of bias and used GRADE to assess the certainty of the evidence.\nMain results\nWe included 14 studies in the review, with a total of 942 participants. Sample sizes in the included studies ranged from 10 to 170. All but two studies included adult patients (≥ 18 years). Two studies included children. Most studies had more male patients (range 46.6% to 80%). All studies were placebo-controlled and four studies had three treatment arms. Three studies investigated topical tranexamic acid; the other studies reported the use of intravenous tranexamic acid.\nFor our primary outcome, surgical field bleeding score measured with the Boezaart or Wormald grading score, we pooled data from 13 studies. The pooled result demonstrated that tranexamic acid probably reduces the surgical field bleeding score, with a standardised mean difference (SMD) of -0.87 (95% confidence interval (CI) -1.23 to -0.51; 13 studies, 772 participants; moderate-certainty evidence). A SMD below -0.70 represents a large effect (in either direction).\nTranexamic acid may result in a slight reduction in blood loss during surgery compared to placebo with a mean difference (MD) of -70.32 mL (95% CI -92.28 to -48.35 mL; 12 studies, 802 participants; low-certainty evidence).\nTranexamic acid probably has little to no effect on the development of significant adverse events (seizures or thromboembolism) within 24 hours of surgery, with no events in either group and a risk difference (RD) of 0.00 (95% CI -0.02 to 0.02; 8 studies, 664 participants; moderate-certainty evidence). However, there were no studies reporting significant adverse event data with a longer duration of follow-up.\nTranexamic acid probably results in little difference in the duration of surgery with a MD of -13.04 minutes (95% CI -19.27 to -6.81; 10 studies, 666 participants; moderate-certainty evidence). Tranexamic acid probably results in little to no difference in the incidence of incomplete surgery, with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence) and likely results in little to no difference in surgical complications, again with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence), although these numbers are too small to draw robust conclusions. Tranexamic acid may result in little to no difference in the likelihood of postoperative bleeding (placement of packing or revision surgery within three days of surgery) (RD -0.01, 95% CI -0.04 to 0.02; 6 studies, 404 participants; low-certainty evidence). There were no studies with longer follow-up.\nAuthors' conclusions\nThere is moderate-certainty evidence to support the beneficial value of topical or intravenous tranexamic acid during endoscopic sinus surgery with respect to surgical field bleeding score. Low- to moderate-certainty evidence suggests a slight decrease in total blood loss during surgery and duration of surgery. Whilst there is moderate-certainty evidence that tranexamic acid does not lead to more immediate significant adverse events compared to placebo, there is no evidence regarding the risk of serious adverse events more than 24 hours after surgery. There is low-certainty evidence that tranexamic acid may not change postoperative bleeding. There is not enough evidence available to draw robust conclusions about incomplete surgery or surgical complications.\n\nGiven the provided abstract, please respond to the following query: \"What is chronic rhinosinusitis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic rhinosinusitis is an inflammation of the sinuses that has lasted for at least 12 weeks. People with chronic rhinosinusitis can experience symptoms such as a blocked or runny nose, a feeling of facial pain or pressure, or a reduction or loss of the sense of smell. Some people may also have polyps in their nose, which can worsen the symptoms."
}
] |
query-laysum
|
6919
|
[
{
"role": "user",
"content": "Abstract: Background\nStarting in late 2019, COVID-19, caused by the novel coronavirus SARS-CoV-2, spread around the world. Long-term care facilities are at particularly high risk of outbreaks, and the burden of morbidity and mortality is very high among residents living in these facilities.\nObjectives\nTo assess the effects of non-pharmacological measures implemented in long-term care facilities to prevent or reduce the transmission of SARS-CoV-2 infection among residents, staff, and visitors.\nSearch methods\nOn 22 January 2021, we searched the Cochrane COVID-19 Study Register, WHO COVID-19 Global literature on coronavirus disease, Web of Science, and CINAHL.\nWe also conducted backward citation searches of existing reviews.\nSelection criteria\nWe considered experimental, quasi-experimental, observational and modelling studies that assessed the effects of the measures implemented in long-term care facilities to protect residents and staff against SARS-CoV-2 infection. Primary outcomes were infections, hospitalisations and deaths due to COVID-19, contaminations of and outbreaks in long-term care facilities, and adverse health effects.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full texts. One review author performed data extractions, risk of bias assessments and quality appraisals, and at least one other author checked their accuracy. Risk of bias and quality assessments were conducted using the ROBINS-I tool for cohort and interrupted-time-series studies, the Joanna Briggs Institute (JBI) checklist for case-control studies, and a bespoke tool for modelling studies. We synthesised findings narratively, focusing on the direction of effect. One review author assessed certainty of evidence with GRADE, with the author team critically discussing the ratings.\nMain results\nWe included 11 observational studies and 11 modelling studies in the analysis. All studies were conducted in high-income countries.\nMost studies compared outcomes in long-term care facilities that implemented the measures with predicted or observed control scenarios without the measure (but often with baseline infection control measures also in place). Several modelling studies assessed additional comparator scenarios, such as comparing higher with lower rates of testing.\nThere were serious concerns regarding risk of bias in almost all observational studies and major or critical concerns regarding the quality of many modelling studies. Most observational studies did not adequately control for confounding. Many modelling studies used inappropriate assumptions about the structure and input parameters of the models, and failed to adequately assess uncertainty.\nOverall, we identified five intervention domains, each including a number of specific measures.\nEntry regulation measures (4 observational studies; 4 modelling studies)\nSelf-confinement of staff with residents may reduce the number of infections, probability of facility contamination, and number of deaths. Quarantine for new admissions may reduce the number of infections. Testing of new admissions and intensified testing of residents and of staff after holidays may reduce the number of infections, but the evidence is very uncertain. The evidence is very uncertain regarding whether restricting admissions of new residents reduces the number of infections, but the measure may reduce the probability of facility contamination. Visiting restrictions may reduce the number of infections and deaths. Furthermore, it may increase the probability of facility contamination, but the evidence is very uncertain. It is very uncertain how visiting restrictions may adversely affect the mental health of residents.\nContact-regulating and transmission-reducing measures (6 observational studies; 2 modelling studies)\nBarrier nursing may increase the number of infections and the probability of outbreaks, but the evidence is very uncertain. Multicomponent cleaning and environmental hygiene measures may reduce the number of infections, but the evidence is very uncertain. It is unclear how contact reduction measures affect the probability of outbreaks. These measures may reduce the number of infections, but the evidence is very uncertain. Personal hygiene measures may reduce the probability of outbreaks, but the evidence is very uncertain. \nMask and personal protective equipment usage may reduce the number of infections, the probability of outbreaks, and the number of deaths, but the evidence is very uncertain. Cohorting residents and staff may reduce the number of infections, although evidence is very uncertain. Multicomponent contact -regulating and transmission -reducing measures may reduce the probability of outbreaks, but the evidence is very uncertain.\nSurveillance measures (2 observational studies; 6 modelling studies)\nRoutine testing of residents and staff independent of symptoms may reduce the number of infections. It may reduce the probability of outbreaks, but the evidence is very uncertain. Evidence from one observational study suggests that the measure may reduce, while the evidence from one modelling study suggests that it probably reduces hospitalisations. The measure may reduce the number of deaths among residents, but the evidence on deaths among staff is unclear. \nSymptom-based surveillance testing may reduce the number of infections and the probability of outbreaks, but the evidence is very uncertain.\nOutbreak control measures (4 observational studies; 3 modelling studies)\nSeparating infected and non-infected residents or staff caring for them may reduce the number of infections. The measure may reduce the probability of outbreaks and may reduce the number of deaths, but the evidence for the latter is very uncertain. Isolation of cases may reduce the number of infections and the probability of outbreaks, but the evidence is very uncertain.\nMulticomponent measures (2 observational studies; 1 modelling study)\nA combination of multiple infection-control measures, including various combinations of the above categories, may reduce the number of infections and may reduce the number of deaths, but the evidence for the latter is very uncertain.\nAuthors' conclusions\nThis review provides a comprehensive framework and synthesis of a range of non-pharmacological measures implemented in long-term care facilities. These may prevent SARS-CoV-2 infections and their consequences. However, the certainty of evidence is predominantly low to very low, due to the limited availability of evidence and the design and quality of available studies. Therefore, true effects may be substantially different from those reported here.\nOverall, more studies producing stronger evidence on the effects of non-pharmacological measures are needed, especially in low- and middle-income countries and on possible unintended consequences of these measures. Future research should explore the reasons behind the paucity of evidence to guide pandemic research priority setting in the future.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review includes studies published up to 22 January 2021."
}
] |
query-laysum
|
6920
|
[
{
"role": "user",
"content": "Abstract: Background\nHalitosis or bad breath is a symptom in which a noticeably unpleasant breath odour is present due to an underlying oral or systemic disease. 50% to 60% of the world population has experienced this problem which can lead to social stigma and loss of self-confidence. Multiple interventions have been tried to control halitosis ranging from mouthwashes and toothpastes to lasers. This new Cochrane Review incorporates Cochrane Reviews previously published on tongue scraping and mouthrinses for halitosis.\nObjectives\nThe objectives of this review were to assess the effects of various interventions used to control halitosis due to oral diseases only. We excluded studies including patients with halitosis secondary to systemic disease and halitosis-masking interventions.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 8 April 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 3) in the Cochrane Library (searched 8 April 2019), MEDLINE Ovid (1946 to 8 April 2019), and Embase Ovid (1980 to 8 April 2019). We also searched LILACS BIREME (1982 to 19 April 2019), the National Database of Indian Medical Journals (1985 to 19 April 2019), OpenGrey (1992 to 19 April 2019), and CINAHL EBSCO (1937 to 19 April 2019). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (8 April 2019), the World Health Organization International Clinical Trials Registry Platform (8 April 2019), the ISRCTN Registry (19 April 2019), the Clinical Trials Registry - India (19 April 2019), were searched for ongoing trials. We also searched the cross-references of included studies and systematic reviews published on the topic. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) which involved adults over the age of 16, and any intervention for managing halitosis compared to another or placebo, or no intervention. The active interventions or controls were administered over a minimum of one week and with no upper time limit. We excluded quasi-randomised trials, trials comparing the results for less than one week follow-up, and studies including advanced periodontitis.\nData collection and analysis\nTwo pairs of review authors independently selected trials, extracted data, and assessed risk of bias. We estimated mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 44 trials in the review with 1809 participants comparing an intervention with a placebo or a control. The age of participants ranged from 17 to 77 years. Most of the trials reported on short-term follow-up (ranging from one week to four weeks). Only one trial reported long-term follow-up (three months).\nThree studies were at low overall risk of bias, 16 at high overall risk of bias, and the remaining 25 at unclear overall risk of bias.\nWe compared different types of interventions which were categorised as mechanical debridement, chewing gums, systemic deodorising agents, topical agents, toothpastes, mouthrinse/mouthwash, tablets, and combination methods.\nMechanical debridement: for mechanical tongue cleaning versus no tongue cleaning, the evidence was very uncertain for the outcome dentist-reported organoleptic test (OLT) scores (MD -0.20, 95% CI -0.34 to -0.07; 2 trials, 46 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nChewing gums: for 0.6% eucalyptus chewing gum versus placebo chewing gum, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.10, 95% CI -0.31 to 0.11; 1 trial, 65 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nSystemic deodorising agents: for 1000 mg champignon versus placebo, the evidence was very uncertain for the outcome patient-reported visual analogue scale (VAS) scores (MD -1.07, 95% CI -14.51 to 12.37; 1 trial, 40 participants; very low-certainty evidence). No data were reported for dentist-reported OLT score or adverse events.\nTopical agents: for hinokitiol gel versus placebo gel, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.27, 95% CI -1.26 to 0.72; 1 trial, 18 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nToothpastes: for 0.3% triclosan toothpaste versus control toothpaste, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -3.48, 95% CI -3.77 to -3.19; 1 trial, 81 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nMouthrinse/mouthwash: for mouthwash containing chlorhexidine and zinc acetate versus placebo mouthwash, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.20, 95% CI -0.58 to 0.18; 1 trial, 44 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nTablets: no data were reported on key outcomes for this comparison.\nCombination methods: for brushing plus cetylpyridium mouthwash versus brushing, the evidence was uncertain for the outcome dentist-reported OLT scores (MD -0.48, 95% CI -0.72 to -0.24; 1 trial, 70 participants; low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nAuthors' conclusions\nWe found low- to very low-certainty evidence to support the effectiveness of interventions for managing halitosis compared to placebo or control for the OLT and patient-reported outcomes tested. We were unable to draw any conclusions regarding the superiority of any intervention or concentration. Well-planned RCTs need to be conducted by standardising the interventions and concentrations.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was very uncertain for mechanical tongue cleaning versus no tongue cleaning, 0.6% eucalyptus chewing gum versus placebo chewing gum, 1000 mg mushroom extract versus placebo, hinokitiol gel versus placebo gel, 0.3% triclosan toothpaste versus control toothpaste, mouthwash containing chlorhexidine and zinc acetate versus placebo mouthwash, and brushing plus cetylpyridium mouthwash versus brushing.\nHarmful effects of the different interventions were not reported or were not important."
}
] |
query-laysum
|
6921
|
[
{
"role": "user",
"content": "Abstract: Background\nTinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. Hearing aids, sound generators and combination devices (amplification and sound generation within one device) are a component of many tinnitus management programmes and together with information and advice are a first line of management in audiology departments for someone who has tinnitus.\nObjectives\nTo assess the effects of sound therapy (using amplification devices and/or sound generators) for tinnitus in adults.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 July 2018.\nSelection criteria\nRandomised controlled trials (RCTs) recruiting adults with acute or chronic subjective idiopathic tinnitus. We included studies where the intervention involved hearing aids, sound generators or combination hearing aids and compared them to waiting list control, placebo or education/information only with no device. We also included studies comparing hearing aids to sound generators, combination hearing aids to hearing aids, and combination hearing aids to sound generators.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were tinnitus symptom severity as measured as a global score on multi-item tinnitus questionnaire and significant adverse effects as indicated by an increase in self-reported tinnitus loudness. Our secondary outcomes were depressive symptoms, symptoms of generalised anxiety, health-related quality of life and adverse effects associated with wearing the device such as pain, discomfort, tenderness or skin irritation, or ear infections. We used GRADE to assess the quality of evidence for each outcome; this is indicated in italics.\nMain results\nThis review included eight studies (with a total of 590 participants). Seven studies investigated the effects of hearing aids, four combination hearing aids and three sound generators. Seven studies were parallel-group RCTs and one had a cross-over design. In general, risk of bias was unclear due to lack of detail about sequence generation and allocation concealment. There was also little or no use of blinding.\nNo data for our outcomes were available for any of our three main comparisons (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). Data for our additional comparisons (comparing these devices with each other) were also few, with limited potential for data pooling.\nHearing aid only versus sound generator device only\nOne study compared patients fitted with sound generators versus those fitted with hearing aids and found no difference between them in their effects on our primary outcome, tinnitus symptom severity measured with the Tinnitus Handicap Inventory (THI) at 3, 6 or 12 months (low-quality evidence). The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity.\nCombination hearing aid versus hearing aid only\nThree studies compared combination hearing aids with hearing aids and measured tinnitus symptom severity using the THI or Tinnitus Functional Index. When we pooled the data we found no difference between them (standardised mean difference -0.15, 95% confidence interval -0.52 to 0.22; three studies; 114 participants) (low-quality evidence). The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.\nAdverse effects were not assessed in any of the included studies.\nNone of the studies measured the secondary outcomes of depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life as measured by a validated instrument, nor the newly developed core outcomes tinnitus intrusiveness, ability to ignore, concentration, quality of sleep and sense of control.\nAuthors' conclusions\nThere is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options (hearing aid, sound generator or combination hearing aid) over each other. The quality of evidence for the reported outcomes, assessed using GRADE, was low. Using a combination device, hearing aid or sound generator might result in little or no difference in tinnitus symptom severity.\nFuture research into the effectiveness of sound therapy in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.\n\nGiven the provided abstract, please respond to the following query: \"Combination hearing aid versus hearing aid only\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three studies compared combination hearing aids/sound generators with hearing aids alone and measured tinnitus symptom severity. When we combined the data for tinnitus symptom severity we found no difference between them. The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.\nAdverse effects were not assessed in any of the included studies.\nNone of the studies measured depressive symptoms or depression, anxiety symptoms or generalised anxiety, or other important outcomes of interest in this review."
}
] |
query-laysum
|
6922
|
[
{
"role": "user",
"content": "Abstract: Background\nHigh blood pressure constitutes one of the leading causes of mortality and morbidity all over the world. At the same time, heavy drinking increases the risk for developing cardiovascular diseases, including cardiomyopathy, hypertension, atrial arrhythmias, or stroke. Several studies have already assessed specifically the relationship between alcohol intake and hypertension. However, the potential effect on blood pressure of alcohol intake reduction interventions is largely unknown.\nObjectives\nTo assess the effect of any intervention to reduce alcohol intake in terms of blood pressure decrease in hypertensive people with alcohol consumption compared to a control intervention or no intervention at all. To determine additional effects related to mortality, major cardiovascular events, serious adverse events, or quality of life.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to June 2020: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2020), MEDLINE Ovid (from 1946), MEDLINE Ovid Epub Ahead of Print, and MEDLINE Ovid In-Process, Embase Ovid (from 1974), ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. Trial authors were contacted when needed and no language restrictions were applied.\nSelection criteria\nWe included randomised controlled trials with minimum 12 weeks duration and including 50 or more subjects per group with quantitative measurement of alcohol consumption and/or biological measurement of the outcomes of interest.\nParticipants were adults (16 years of age or older) with systolic blood pressure (SBP) greater than 140 mmHg and diastolic blood pressure (DBP) greater than 90 mmHg, and SBP ≥ 130 or DBP ≥ 80 mmHg in participants with diabetes. We included any intervention implemented to reduce their alcohol intake.\nData collection and analysis\nTwo review authors independently assessed search results and extracted data using standard methodological procedures adopted by Cochrane.\nMain results\nA total of 1210 studies were screened. We included one randomised controlled trial involving a total of 269 participants with a two-year follow-up. Individual patient data for all participants were provided and used in this review.\nNo differences were found between the cognitive-behavioural intervention group and the control group for overall mortality (RR 0.72, 95% CI 0.16 to 3.17; low-certainty evidence), cardiovascular mortality (not estimable) and cardiovascular events (RR 0.80, 95% CI 0.36 to 1.79; very low-certainty evidence). There was no statistical difference in systolic blood pressure (SBP) reduction (Mean Difference (MD) -0.92 mmHg, 95% confidence interval (CI) -5.66 to 3.82 mmHg; very low-certainty evidence) or diastolic blood pressure (DBP) decrease (MD 0.98 mmHg, 95% CI -1.69 to 3.65 mmHg; low-certainty evidence) between the cognitive-behavioural intervention group and the control group. We also did not find any differences in the proportion of subjects with SBP < 140 mmHg and DBP < 90 mmHg (Risk Ratio (RR) 1.21, 95% CI 0.88 to 1.65; very low-certainty evidence).\nConcerning secondary outcomes, the alcohol intake was significantly reduced in the cognitive-behavioural intervention compared with the control group (MD 191.33 g, 95% CI 85.36 to 297.30 g). We found no differences between the active and control intervention in the proportion of subjects with lower-risk alcohol intake versus higher-risk and extreme drinkers at the end of the study (RR 1.04, 95% CI 0.68 to 1.60). There were no estimable results for the quality of life outcome.\nAuthors' conclusions\nAn intervention for decreasing alcohol intake consumption did not result in differences in systolic and diastolic blood pressure when compared with a control intervention, although there was a reduction in alcohol intake favouring the active intervention. No differences were found either for overall mortality, cardiovascular mortality or cardiovascular events. No data on serious adverse events or quality of life were available to assess. Adequate randomised controlled trials are needed to provide additional evidence on this specific question.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Based on this limited information, although those participants who received psychological assistance were able to reduce their alcohol intake more than those without such assistance, we found no differences in the number of deaths, total heart problems and total vascular problems between people receiving psychological assistance to decrease alcohol intake and those not receiving such help. We also found no differences in blood pressure reduction. Data on quality of life or serious adverse effects were not available."
}
] |
query-laysum
|
6923
|
[
{
"role": "user",
"content": "Abstract: Background\nRupture of the anterior cruciate ligament (ACL) is a common injury, mainly affecting young, physically active individuals. The injury is characterised by joint instability, leading to decreased activity, which can lead to poor knee-related quality of life. It is also associated with increased risk of secondary osteoarthritis of the knee. It is unclear whether stabilising the knee surgically via ACL reconstruction produces a better overall outcome than non-surgical (conservative) treatment.\nObjectives\nTo assess the effects of surgical versus conservative interventions for treating ACL injuries.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (18 January 2016), the Cochrane Central Register of Controlled Trials (2016, Issue 1), MEDLINE (1946 to January Week 1 2016), MEDLINE In-Process & Other Non-Indexed Citations (18 January 2016), EMBASE (1974 to 15 January 2016), trial registers (February 2016) and reference lists.\nSelection criteria\nWe included randomised controlled trials that compared the use of surgical and conservative interventions in participants with an ACL rupture. We included any trial that evaluated surgery for ACL reconstruction using any method of reconstruction, type of reconstruction technique, graft fixation or type of graft.\nData collection and analysis\nThree review authors independently screened all titles and abstracts for potentially eligible studies, for which we then obtained full-text reports. Two authors then independently confirmed eligibility, extracted data and assessed the risk of bias using the Cochrane 'Risk of bias' tool. We used the GRADE approach to assess the overall quality of the evidence.\nMain results\nWe identified one study in which 141 young, active adults with acute ACL injury were randomised to either ACL reconstruction followed by structured rehabilitation (results reported for 62 participants) or conservative treatment comprising structured rehabilitation alone (results reported for 59 participants). Built into the study design was a formal option for subsequent (delayed) ACL reconstruction in the conservative treatment group, if the participant requested surgery and met pre-specified criteria.\nThis study was deemed at low risk of selection and reporting biases, at high risk of performance and detection biases because of the lack of blinding and at unclear risk of attrition bias because of an imbalance in the post-randomisation exclusions. According to GRADE methodology, the overall quality of the evidence was low across different outcomes.\nThis study identified no difference in subjective knee score (measured using the average score on four of the five sub-scales of the KOOS score (range from 0 (extreme symptoms) to 100 (no symptoms)) between ACL reconstruction and conservative treatment at two years (difference in KOOS-4 change from baseline scores: MD -0.20, 95% confidence interval (CI) -6.78 to 6.38; N = 121 participants; low-quality evidence), or at five years (difference in KOOS-4 final scores: MD -2.0, 95% CI -8.27 to 4.27; N = 120 participants; low-quality evidence). The total number of participants incurring one or more complications in each group was not reported; serious events reported in the surgery group were predominantly surgery-related, while those in conservative treatment group were predominantly knee instability. There were also incomplete data for total participants with treatment failure, including subsequent surgery. In the surgical group at two years, there was low-quality evidence of far fewer ACL-related treatment failures, when defined as either graft rupture or subsequent ACL reconstruction. This result is dominated by the uptake by 39% (23/59) of the participants in the conservative treatment group of ACL reconstruction for knee instability at two years and by 51% (30/59) of the participants at five years. There was low-quality evidence of little difference between the two groups in participants who had undergone meniscal surgery at anytime up to five years. There was low-quality evidence of no clinically important between-group differences in SF-36 physical component scores at two years. There was low-quality evidence of a higher return to the same or greater level of sport activity at two years in the ACL reconstruction group, but the wide 95% CI also included the potential for a higher return in the conservative treatment group. Based on an illustrative return to sport activities of 382 per 1000 conservatively treated patients, this amounts to an extra 84 returns per 1000 ACL-reconstruction patients (95% CI 84 fewer to 348 more). There was very low-quality evidence of a higher incidence of radiographically-detected osteoarthritis in the surgery group (19/58 (35%) versus 10/55 (18%)).\nAuthors' conclusions\nFor adults with acute ACL injuries, we found low-quality evidence that there was no difference between surgical management (ACL reconstruction followed by structured rehabilitation) and conservative treatment (structured rehabilitation only) in patient-reported outcomes of knee function at two and five years after injury. However, these findings need to be viewed in the context that many participants with an ACL rupture remained symptomatic following rehabilitation and later opted for ACL reconstruction surgery. Further research, including the two identified ongoing trials, will help to address the limitations in the current evidence, which is from one small trial in a young, active, adult population.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The study found there was no difference between surgery and conservative treatment in patient-reported knee scores at two or five years. The study failed to report on the number of participants in each group who had any type of serious or non-serious complications. However, surgery-related complications included three cases of graft rupture in the surgery group and several participants of the conservative treatment group had unstable knees. Twenty-three of the 59 participants in the conservative treatment group (39%) had either reconstruction of the ACL or repair of a meniscus tear within two years and 30 (51%) underwent surgery within five years. There was some evidence that similar numbers of participants in the two groups had surgical treatment of knee meniscal injuries at five years. There was very low-quality evidence that more participants in the surgery group had damage to the knee that could mean that they were at greater risk of developing osteoarthritis."
}
] |
query-laysum
|
6924
|
[
{
"role": "user",
"content": "Abstract: Background\nSymptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored.\nObjectives\nTo determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding.\nMain results\nWe included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision.\nAuthors' conclusions\nHigh-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "According to GRADE (a method used to score the certainty of trials supporting each outcome), high-certainty evidence shows that indomethacin is effective in closing a PDA in a preterm infant with symptoms. However, there is not enough evidence to say if indomethacin helps to reduce death or lung injury. Also, there is not enough evidence to say if indomethacin causes increased harm compared to no treatment or placebo. More studies are needed to see if indomethacin can reduce death or lung injury in infants with symptomatic PDA."
}
] |
query-laysum
|
6925
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review previously published in 2013. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy.\nWorldwide, phenytoin is a commonly used antiepileptic drug. It is important to know how newer drugs, such as oxcarbazepine, compare with commonly used standard treatments.\nObjectives\nTo review the time to treatment failure, remission and first seizure with oxcarbazepine compared to phenytoin, when used as monotherapy in people with focal onset seizures or generalised tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nWe searched the following databases on 20 August 2018: the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid, 1946 to 20 August 2018), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators and experts in the field.\nSelection criteria\nWe included randomised controlled trials comparing monotherapy with either oxcarbazepine or phenytoin in children or adults with focal onset seizures or generalised onset tonic-clonic seizures.\nData collection and analysis\nThis was an individual participant data (IPD) review. Our primary outcome was time to treatment failure and our secondary outcomes were time to first seizure post-randomisation, time to six-month and 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs) with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nIndividual participant data were available for 480 out of a total of 517 participants (93%), from two out of three included trials. For remission outcomes, a HR of less than one indicated an advantage for phenytoin; and for first seizure and treatment failure outcomes, a HR of less than one indicated an advantage for oxcarbazepine.\nThe results for time to treatment failure for any reason related to treatment showed a potential advantage of oxcarbazepine over phenytoin, but this was not statistically significant (pooled HR adjusted for epilepsy type: 0.78 95% CI 0.53 to 1.14, 476 participants, two trials, moderate-quality evidence). Our analysis showed that treatment failure due to adverse events occurred later on with oxcarbazepine than phenytoin (pooled HR for all participants: 0.22 (95% CI 0.10 to 0.51, 480 participants, two trials, high-quality evidence). Our analysis of time to treatment failure due to lack of efficacy showed no clear difference between the drugs (pooled HR for all participants: 1.17 (95% CI 0.31 to 4.35), 480 participants, two trials, moderate-quality evidence).\nWe found no clear or statistically significant differences between drugs for any of the secondary outcomes of the review: time to first seizure post-randomisation (pooled HR adjusted for epilepsy type: 0.97 95% CI 0.75 to 1.26, 468 participants, two trials, moderate-quality evidence); time to 12-month remission (pooled HR adjusted for epilepsy type 1.04 95% CI 0.77 to 1.41, 468 participants, two trials, moderate-quality evidence) and time to six-month remission (pooled HR adjusted for epilepsy type: 1.06 95% CI 0.82 to 1.36, 468 participants, two trials, moderate-quality evidence).\nThe most common adverse events reported in more than 10% of participants on either drug were somnolence (28% of total participants, with similar rates for both drugs), headache (15% of total participants, with similar rates for both drugs), dizziness (14.5% of total participants, reported by slightly more participants on phenytoin (18%) than oxcarbazepine (11%)) and gum hyperplasia (reported by substantially more participants on phenytoin (18%) than oxcarbazepine (2%)).\nThe results of this review are applicable mainly to individuals with focal onset seizures; 70% of included individuals experienced seizures of this type at baseline. The two studies included in IPD meta-analysis were generally of good methodological quality but the design of the studies may have biased the results for the secondary outcomes (time to first seizure post-randomisation, time to six-month and 12-month remission) as seizure recurrence data were not collected following treatment failure or withdrawal from the study. In addition, misclassification of epilepsy type may have impacted on results, particularly for individuals with generalised onset seizures.\nAuthors' conclusions\nHigh-quality evidence provided by this review indicates that treatment failure due to adverse events occurs significantly later with oxcarbazepine than phenytoin. For individuals with focal onset seizures, moderate-quality evidence suggests that oxcarbazepine may be superior to phenytoin in terms of treatment failure for any reason, seizure recurrence and seizure remission. Therefore, oxcarbazepine may be a preferable alternative treatment than phenytoin, particularly for individuals with focal onset seizures. The evidence in this review which relates to individuals with generalised onset seizures is of low quality and does not inform current treatment policy.\nWe recommend that future trials should be designed to the highest quality possible with regards to choice of population, classification of seizure type, duration of follow-up (including continued follow-up after failure or withdrawal of randomised treatment), choice of outcomes and analysis, and presentation of results.\n\nGiven the provided abstract, please respond to the following query: \"Methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We assessed the evidence from three studies (specifically, randomised controlled trials) comparing oxcarbazepine with phenytoin. We were able to combine information for 480 people from two of the three trials. For the remaining 37 people from one trial, information was not available to use in this review. The evidence is current to 20 August 2018."
}
] |
query-laysum
|
6926
|
[
{
"role": "user",
"content": "Abstract: Background\nIt has been suggested that the severity of autism spectrum disorder (ASD) symptoms is positively correlated with the level of circulating or stored toxic metals, and that excretion of these heavy metals, brought about by the use of pharmaceutical chelating agents, results in improved symptoms.\nObjectives\nTo assess the potential benefits and adverse effects of pharmaceutical chelating agents (referred to as chelation therapy throughout this review) for autism spectrum disorder (ASD) symptoms.\nSearch methods\nWe searched the following databases on 6 November 2014: CENTRAL, Ovid MEDLINE, Ovid MEDLINE In-Process, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and 15 other databases, including three trials registers. In addition we checked references lists and contacted experts.\nSelection criteria\nAll randomised controlled trials of pharmaceutical chelating agents compared with placebo in individuals with ASD.\nData collection and analysis\nTwo review authors independently selected studies, assessed them for risk of bias and extracted relevant data. We did not conduct a meta-analysis, as only one study was included.\nMain results\nWe excluded nine studies because they were non-randomised trials or were withdrawn before enrolment. We included one study, which was conducted in two phases. During the first phase of the study, 77 children with ASD were randomly assigned to receive seven days of glutathione lotion or placebo lotion, followed by three days of oral dimercaptosuccinic acid (DMSA). Forty-nine children who were found to be high excreters of heavy metals during phase one continued on to phase two to receive three days of oral DMSA or placebo followed by 11 days off, with the cycle repeated up to six times. The second phase thus assessed the effectiveness of multiple doses of oral DMSA compared with placebo in children who were high excreters of heavy metals and who received a three-day course of oral DMSA. Overall, no evidence suggests that multiple rounds of oral DMSA had an effect on ASD symptoms.\nAuthors' conclusions\nThis review included data from only one study, which had methodological limitations. As such, no clinical trial evidence was found to suggest that pharmaceutical chelation is an effective intervention for ASD. Given prior reports of serious adverse events, such as hypocalcaemia, renal impairment and reported death, the risks of using chelation for ASD currently outweigh proven benefits. Before further trials are conducted, evidence that supports a causal link between heavy metals and autism and methods that ensure the safety of participants are needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence is poor, with only one study, which had methodological shortcomings, included in this review. These factors, when combined, preclude confidence in the findings. However, before further trials are conducted, more evidence is needed to show that heavy metals cause or worsen the severity of autism, and the safety of pharmaceutical chelating agents for participants must be established."
}
] |
query-laysum
|
6927
|
[
{
"role": "user",
"content": "Abstract: Background\nMany media are commercially available for culturing pre-implantation human embryos in assisted reproductive technology (ART) cycles. It is unknown which culture medium leads to the best success rates after ART.\nObjectives\nTo evaluate the safety and effectiveness of different human pre-implantation embryo culture media in used for in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) cycles.\nSearch methods\nWe searched the Cochrane Menstrual Disorders and Subfertility Group's Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the National Research Register, the Medical Research Council's Clinical Trials Register and the NHS Center for Reviews and Dissemination databases from January 1985 to March 2015. We also examined the reference lists of all known primary studies, review articles, citation lists of relevant publications and abstracts of major scientific meetings.\nSelection criteria\nWe included all randomised controlled trials which randomised women, oocytes or embryos and compared any two commercially available culture media for human pre-implantation embryos in an IVF or ICSI programme.\nData collection and analysis\nTwo review authors independently selected the studies, assessed their risk of bias and extracted data. We sought additional information from the authors if necessary. We assessed the quality of the evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods. The primary review outcome was live birth or ongoing pregnancy.\nMain results\nWe included 32 studies in this review. Seventeen studies randomised women (total 3666), three randomised cycles (total 1018) and twelve randomised oocytes (over 15,230). It was not possible to pool any of the data because each study compared different culture media.\nOnly seven studies reported live birth or ongoing pregnancy. Four of these studies found no evidence of a difference between the media compared, for either day three or day five embryo transfer. The data from the fifth study did not appear reliable.\nSix studies reported clinical pregnancy rate. One of these found a difference between the media compared, suggesting that for cleavage-stage embryo transfer, Quinn's Advantage was associated with higher clinical pregnancy rates than G5 (odds ratio (OR) 1.56; 95% confidence interval (CI) 1.12 to 2.16; 692 women). This study was available only as an abstract and the quality of the evidence was low.\nWith regards to adverse effects, three studies reported multiple pregnancies and six studies reported miscarriage. None of them found any evidence of a difference between the culture media used. None of the studies reported on the health of offspring.\nMost studies (22/32) failed to report their source of funding and none described their methodology in adequate detail. The overall quality of the evidence was rated as very low for nearly all comparisons, the main limitations being imprecision and poor reporting of study methods.\nAuthors' conclusions\nAn optimal embryo culture medium is important for embryonic development and subsequently the success of IVF or ICSI treatment. There has been much controversy about the most appropriate embryo culture medium. Numerous studies have been performed, but no two studies compared the same culture media and none of them found any evidence of a difference between the culture media used. We conclude that there is insufficient evidence to support or refute the use of any specific culture medium. Properly designed and executed randomised trials are necessary.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Embryo culture refers to the culture of human gametes and embryos during in vitro fertilisation treatments. The procedure is initiated when eggs and sperm are combined in a culture dish and it ends with the transfer of the resulting embryo to the uterus. The culture period varies between one and six days, and the embryo culture process is vital to the success of any IVF or ICSI procedure. The type of culture medium used may affect embryo quality and hence the success rate of the treatment. Despite its importance, it is unknown which culture medium is most effective and safest."
}
] |
query-laysum
|
6928
|
[
{
"role": "user",
"content": "Abstract: Background\nAutologous stem cell transplantation is widely used to restore functioning bone marrow in people with malignant lymphoma or multiple myeloma after myeloablative chemotherapy. Results of some clinical trials indicate that plerixafor in addition to granulocyte colony-stimulating factors (G-CSF) compared to G-CSF only could lead to an increased mobilisation and release of CD34-positive cells, facilitating effective apheresis.\nObjectives\nTo evaluate the efficacy and safety of additional plerixafor to G-CSF for haematopoietic stem cell mobilisation in people with malignant lymphoma or multiple myeloma.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1990 to September 2015), as well as conference proceedings (American Society of Hematology; American Society of Clinical Oncology; European Hematology Association; American Society for Blood and Marrow Transplantation; European Group for Blood and Marrow Transplantation) for studies. Two review authors independently screened search results.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing plerixafor in addition to G-CSF compared to G-CSF only for stem cell mobilisation in people with malignant lymphoma or multiple myeloma of all stages and ages. We included full text as well as abstracts and unpublished data if sufficient information on study design, participant characteristics, interventions, and outcomes was available. We excluded cross-over trials, quasi-randomised trials, and post-hoc retrospective trials.\nData collection and analysis\nTwo review authors independently screened the results of the search strategies, extracted data, assessed quality, and analysed data according to standard Cochrane methods. We performed final interpretation with an experienced clinician.\nMain results\nWe identified four RCTs fitting the inclusion criteria. However, two of these closed prematurely due to low recruitment and did not report results. The remaining two trials evaluated 600 participants with multiple myeloma or non-Hodgkin lymphoma. In both studies the experimental group received G-CSF plus plerixafor and the control group received G-CSF plus placebo.\nThe meta-analysis showed no evidence for differences between plerixafor and placebo group regarding mortality at 12 months (600 participants; risk ratio (RR) 1.00, 95% confidence interval (CI) 0.59 to 1.69; P = 1.00; moderate-quality evidence) and adverse events during stem cell mobilisation and collection (593 participants; RR 1.02, 95% CI 0.99 to 1.06; P = 0.19; high-quality evidence).\nRegarding the outcome successful stem cell collection, the meta-analysis showed an advantage for those participants randomised to the plerixafor group (600 participants; RR 2.42, 95% CI 1.98 to 2.96; P < 0.00001; high-quality evidence).\nAs there was high heterogeneity between studies for the number of transplanted participants, we did not meta-analyse these data. In the multiple myeloma study, 95.9% (142 participants) in the plerixafor arm and 88.3% (136 participants) in the placebo arm underwent transplantation (RR 1.09, 95% CI 1.02 to 1.16); in the non-Hodgkin lymphoma trial, 90% (135 participants) in the plerixafor group versus 55.4% (82 participants) in the placebo group could be transplanted (RR 1.62, 95% CI 1.39 to 1.89). In both trials there was no evidence for a difference between participants in the plerixafor and placebo group in terms of time to neutrophil and platelet engraftment in transplanted participants.\nNone of the trials reported on the outcomes quality of life and progression-free survival.\nAuthors' conclusions\nThe results of the analysed data suggest that additional plerixafor leads to increased stem cell collection in a shorter time. There was insufficient evidence to determine whether additional plerixafor affects survival or adverse events.\nThe two trials included in the meta-analysis, both of which were conducted by the Genzyme Corporation, the manufacturer of plerixafor, were published several times. Two more RCTs examining the addition of plerixafor to a G-CSF mobilisation regimen terminated early without publishing any outcome. The trials included nine and five participants, respectively. Another RCT with 100 participants was recently completed, but has not yet published outcomes. Due to the unpublished RCTs, it is possible that our review is affected by publication bias, even though two trials failed to recruit a sufficient number of participants to analyse any data.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was high for adverse events and successful stem cell collection and moderate for mortality at 12 months. The main limitation was a wide confidence interval."
}
] |
query-laysum
|
6929
|
[
{
"role": "user",
"content": "Abstract: Background\nKeratoconus is an ectatic (weakening) disease of the cornea, which is the clear surface at the front of the eye. Approximately 10% to 15% of patients diagnosed with keratoconus require corneal transplantation. This may be full-thickness (penetrating) or partial-thickness (lamellar).\nObjectives\nTo compare visual outcomes after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty for keratoconus, and to compare additional outcomes relating to factors which may contribute to poor visual outcomes (e.g. astigmatism, graft rejection and failure).\nSearch methods\nWe searched a number of electronic databases including CENTRAL, PubMed and EMBASE without using any date or language restrictions. We last searched the electronic databases on 31 October 2013. We also handsearched the proceedings of several international ophthalmic conferences.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing the outcomes of DALK and penetrating keratoplasty in the treatment of keratoconus.\nData collection and analysis\nTwo authors assessed trial quality and extracted data independently. For dichotomous data (graft failure, rejection, achievement of functional vision) results were expressed as odds ratios (ORs) and 95% confidence intervals (CIs). For continuous data (postoperative best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), keratometric astigmatism and spherical equivalent) results were expressed as mean differences (MDs) and 95% CIs.\nMain results\nWe identified two completed studies, with a total of 111 participants (n = 30 and n = 81), both conducted in Iran, that met our inclusion criteria. Participants had moderate to severe keratoconus pre-operatively and were randomly allocated to receive either DALK or penetrating keratoplasty. Only one eye of each participant was treated as part of the trials. The smaller study had 12 month follow-up data for all participants. For the larger study, four DALK surgeries had to be abandoned due to technical failure and visual and refractive outcomes were not measured in these participants. Follow-up length for the remaining 77 participants ranged from 6.8 to 36.4 months, with all 77 followed for at least three months post-suture removal. Details of the randomisation procedure were unavailable for the smaller study and so sensitivity analyses were conducted to determine if the results from this study had affected the overall results of the review.\nNeither of the included studies reported a difference between groups on any of the measures of post-graft visual achievement, keratometric astigmatism or spherical equivalent. A single case of graft failure in a penetrating keratoplasty was reported. No postoperative graft failures were reported in the DALK group of either study.\nInstances of graft rejection were reported in both groups, in both studies. The majority of these cases were successfully treated with steroids. The data, which related to all cases in each study - given that the four cases that did not go ahead as planned had already technically failed without presence of rejection - showed that rejection was less likely to occur in DALK (odds ratio (OR): 0.33, 95% confidence interval (CI) 0.14 to 0.81, GRADE rating: moderate).\nResults of the sensitivity analysis indicated that inclusion of the Razmju 2011 study did not bias the results with regards to rejection episodes. While sensitivity analysis showed altered results with regards to failure rates, the data available from the Javadi 2010 study alone had a very wide 95% CI, suggesting an imprecise estimate. Therefore, even after removal of the Razmju 2011 data, it is still difficult to draw conclusions regarding superiority of one technique over another with regards to graft failure.\nDALK was unable to be completed as planned in four cases and in a further three cases, complications during dissection required further intervention. Other adverse events, of varying severity, were reported in both intervention groups with similar frequency. For both types of surgery, these included postoperative astigmatism, steroid induced ocular hypertension and persistent epithelial defects. In recipients of DALK, one participant had interface neovascularisation (a proliferation of blood vessels where the host and donor cornea come together) and one had wrinkling of Descemet's membrane, the basement membrane separating the corneal stroma from the corneal endothelium. In the penetrating keratoplasty groups, one participant required graft resuturing and one had an atonic pupil, a condition in which the pupil dilates and is non-reactive.\nOverall, the quality of the evidence was rated as very low to moderate, with methodological limitations, incomplete data analysis and imprecision of findings, as well as high risk of bias in several areas for both studies.\nAuthors' conclusions\nWe found no evidence to support a difference in outcomes with regards to BCVA at three months post-graft or at any of the other time points analysed (GRADE rating: very low). We also found no evidence of a difference in outcomes with regards to graft survival, final UCVA or keratometric outcomes. We found some evidence that rejection is more likely to occur following penetrating keratoplasty than DALK (GRADE rating: moderate). The small number of studies included in the review and methodological issues relating to the two, mean that the overall quality of the evidence in this review is low. There is currently insufficient evidence to determine which technique may offer better overall outcomes - final visual acuity and time to attain this, keratometric stabilisation, risk of rejection or failure, or both, and risk of other adverse events - for patients with keratoconus. Large randomised trials comparing the outcomes of penetrating keratoplasty and DALK in the treatment of keratoconus are needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of deep anterior lamellar keratoplasty (DALK) (new technique) versus penetrating keratoplasty (standard technique) in people with keratoconus."
}
] |
query-laysum
|
6930
|
[
{
"role": "user",
"content": "Abstract: Background\nTracheal intubation is a common procedure performed to secure the airway in adults undergoing surgery or those who are critically ill. Intubation is sometimes associated with difficulties and complications that may result in patient harm. While it is traditionally achieved by performing direct laryngoscopy, the past three decades have seen the advent of rigid indirect videolaryngoscopes (VLs). A mounting body of evidence comparing the two approaches to tracheal intubation has been acquired over this period of time. This is an update of a Cochrane Review first published in 2016.\nObjectives\nTo assess whether use of different designs of VLs in adults requiring tracheal intubation reduces the failure rate compared with direct laryngoscopy, and assess the benefits and risks of these devices in selected population groups, users and settings.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL and Web of Science on 27 February 2021. We also searched clinical trials databases, conference proceedings and conducted forward and backward citation searches.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs with adults undergoing laryngoscopy performed with either a VL or a Macintosh direct laryngoscope (DL) in any clinical setting. We included parallel and cross-over study designs.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We collected data for the following outcomes: failed intubation, hypoxaemia, successful first attempt at tracheal intubation, oesophageal intubation, dental trauma, Cormack-Lehane grade, and time for tracheal intubation.\nMain results\nWe included 222 studies (219 RCTs, three quasi-RCTs) with 26,149 participants undergoing tracheal intubation. Most studies recruited adults undergoing elective surgery requiring tracheal intubation. Twenty-one studies recruited participants with a known or predicted difficult airway, and an additional 25 studies simulated a difficult airway. Twenty-one studies were conducted outside the operating theatre environment; of these, six were in the prehospital setting, seven in the emergency department and eight in the intensive care unit.\nWe report here the findings of the three main comparisons according to videolaryngoscopy device type.\nWe downgraded the certainty of the outcomes for imprecision, study limitations (e.g. high or unclear risks of bias), inconsistency when we noted substantial levels of statistical heterogeneity and publication bias.\nMacintosh-style videolaryngoscopy versus direct laryngoscopy (61 studies, 9883 participants)\nWe found moderate-certainty evidence that a Macintosh-style VL probably reduces rates of failed intubation (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.26 to 0.65; 41 studies, 4615 participants) and hypoxaemia (RR 0.72, 95% CI 0.52 to 0.99; 16 studies, 2127 participants). These devices may also increase rates of success on the first intubation attempt (RR 1.05, 95% CI 1.02 to 1.09; 42 studies, 7311 participants; low-certainty evidence) and probably improve glottic view when assessed as Cormack-Lehane grade 3 and 4 (RR 0.38, 95% CI 0.29 to 0.48; 38 studies, 4368 participants; moderate-certainty evidence). We found little or no clear difference in rates of oesophageal intubation (RR 0.51, 95% CI 0.22 to 1.21; 14 studies, 2404 participants) but this finding was supported by low-certainty evidence. We were unsure of the findings for dental trauma because the certainty of this evidence was very low (RR 0.68, 95% CI 0.16 to 2.89; 18 studies, 2297 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I2 = 96%).\nHyperangulated videolaryngoscopy versus direct laryngoscopy (96 studies, 11,438 participants)\nWe found moderate-certainty evidence that hyperangulated VLs probably reduce rates of failed intubation (RR 0.51, 95% CI 0.34 to 0.76; 63 studies, 7146 participants) and oesophageal intubation (RR 0.39, 95% CI 0.18 to 0.81; 14 studies, 1968 participants). In subgroup analysis, we noted that hyperangulated VLs were more likely to reduce failed intubation when used on known or predicted difficult airways (RR 0.29, 95% CI 0.17 to 0.48; P = 0.03 for subgroup differences; 15 studies, 1520 participants). We also found that these devices may increase rates of success on the first intubation attempt (RR 1.03, 95% CI 1.00 to 1.05; 66 studies, 8086 participants; low-certainty evidence) and the glottic view is probably also improved (RR 0.15, 95% CI 0.10 to 0.24; 54 studies, 6058 participants; data for Cormack-Lehane grade 3/4 views; moderate-certainty evidence). However, we found low-certainty evidence of little or no clear difference in rates of hypoxaemia (RR 0.49, 95% CI 0.22 to 1.11; 15 studies, 1691 participants), and the findings for dental trauma were unclear because the certainty of this evidence was very low (RR 0.51, 95% CI 0.16 to 1.59; 30 studies, 3497 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I2 = 99%).\nChannelled videolaryngoscopy versus direct laryngoscopy (73 studies, 7165 participants)\nWe found moderate-certainty evidence that channelled VLs probably reduce rates of failed intubation (RR 0.43, 95% CI 0.30 to 0.61; 53 studies, 5367 participants) and hypoxaemia (RR 0.25, 95% CI 0.12 to 0.50; 15 studies, 1966 participants). They may also increase rates of success on the first intubation attempt (RR 1.10, 95% CI 1.05 to 1.15; 47 studies, 5210 participants; very low-certainty evidence) and probably improve glottic view (RR 0.14, 95% CI 0.09 to 0.21; 40 studies, 3955 participants; data for Cormack-Lehane grade 3/4 views; moderate-certainty evidence). We found little or no clear difference in rates of oesophageal intubation (RR 0.54, 95% CI 0.17 to 1.75; 16 studies, 1756 participants) but this was supported by low-certainty evidence. We were unsure of the findings for dental trauma because the certainty of the evidence was very low (RR 0.52, 95% CI 0.13 to 2.12; 29 studies, 2375 participants). We were not able to pool data for time required for tracheal intubation owing to considerable heterogeneity (I2 = 98%).\nAuthors' conclusions\nVLs of all designs likely reduce rates of failed intubation and result in higher rates of successful intubation on the first attempt with improved glottic views. Macintosh-style and channelled VLs likely reduce rates of hypoxaemic events, while hyperangulated VLs probably reduce rates of oesophageal intubation. We conclude that videolaryngoscopy likely provides a safer risk profile compared to direct laryngoscopy for all adults undergoing tracheal intubation.\n\nGiven the provided abstract, please respond to the following query: \"What is laryngoscopy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Laryngoscopy is a medical procedure in which a device called a laryngoscope is used to examine the voice box and help with insertion of a breathing tube into the windpipe to protect the airways during anaesthesia or when patients have breathing difficulties. 'Direct laryngoscopes' rely on a direct line of sight to the voice box to achieve this. A 'videolaryngoscope' incorporates video technology that allows the voice box to be viewed on a screen during the procedure."
}
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query-laysum
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6931
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic plaque psoriasis is an immune-mediated, chronic, inflammatory skin disease, which can impair quality of life and social interaction. Disease severity can be classified by the psoriasis area and severity index (PASI) score ranging from 0 to 72 points. Indoor artificial salt bath with or without artificial ultraviolet B (UVB) light is used to treat psoriasis, simulating sea bathing and sunlight exposure; however, the evidence base needs clear evaluation.\nObjectives\nTo assess the effects of indoor (artificial) salt water baths followed by exposure to artificial UVB for treating chronic plaque psoriasis in adults.\nSearch methods\nWe searched the following databases up to June 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registers, and checked the reference lists of included studies, recent reviews, and relevant papers for further references to relevant trials.\nSelection criteria\nRandomised controlled trials (RCTs) of salt bath indoors followed by exposure to artificial UVB in adults who have been diagnosed with chronic plaque type psoriasis. We included studies reporting between-participant data and within-participant data. We evaluated two different comparisons: 1) salt bath + UVB versus other treatment without UVB; eligible comparators were exposure to psoralen bath, psoralen bath + artificial ultraviolet A UVA) light, topical treatment, systemic treatment, or placebo, and 2) salt bath + UVB versus other treatment + UVB or UVB only; eligible comparators were exposure to bath containing other compositions or concentrations + UVB or UVB only.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence.\nThe primary efficacy outcome was PASI-75, to detect people with a 75% or more reduction in PASI score from baseline. The primary adverse outcome was treatment-related adverse events requiring withdrawal. For the dichotomous variables PASI-75 and treatment-related adverse events requiring withdrawal, we estimated the proportion of events among the assessed participants.\nThe secondary outcomes were health-related quality of life using the Dermatology Life Quality Index, (DLQI) pruritus severity measured using a visual analogue scale, time to relapse, and secondary malignancies.\nMain results\nWe included eight RCTs: six reported between-participant data (2035 participants; 1908 analysed), and two reported within-participant data (70 participants, 68 analysed; 140 limbs; 136 analysed). One study reported data for the comparison salt bath with UVB versus other treatment without UVB; and eight studies reported data for salt bath with UVB versus other treatment with UVB or UVB only. Of these eight studies, only five reported any of our pre-specified outcomes and assessed the comparison of salt bath with UVB versus UVB only. The one included trial that assessed salt bath plus UVB versus other treatment without UVB (psoralen bath + UVA) did not report any of our primary outcomes. The mean age of the participants ranged from 41 to 50 years of age in 75% of the studies. None of the included studies reported on the predefined secondary outcomes of this review. We judged seven of the eight studies as at high risk of bias in at least one domain, most commonly performance bias. Total trial duration ranged between at least two months and up to 13 months.\nIn five studies, the median participant PASI score at baseline ranged from 15 to 18 and was balanced between treatment arms. Three studies did not report PASI score. Most studies were conducted in Germany; all were set in Europe. Half of the studies were multi-centred (set in spa centres or outpatient clinics); half were set in a single centre in either an unspecified settings, a psoriasis daycare centre, or a spa centre. Commercial spa or salt companies sponsored three of eight studies, health insurance companies funded another, the association of dermatologists funded another, and three did not report on funding.\nWhen comparing salt bath plus UVB versus UVB only, two between-participant studies found that salt bath plus UVB may improve psoriasis when measured using PASI 75 (achieving a 75% or more reduction in PASI score from baseline) (risk ratio (RR) 1.71, 95% confidence interval (CI) 1.24 to 2.35; 278 participants; low-certainty evidence). Assessment was conducted at the end of treatment, which was equivalent to six to eight weeks after start of treatment. The two trials which contributed data for the primary efficacy outcome were conducted by the same group, and did not blind outcome assessors. The German Spas Association funded one of the trials and the funding source was not stated for the other trial.\nTwo other between-participant studies found salt bath plus UVB may make little to no difference to outcome treatment-related adverse events requiring withdrawal compared with UVB only (RR 0.96, 95% CI 0.35 to 2.64; 404 participants; low-certainty evidence). One of the studies reported adverse events, but did not specify the type of events; the other study reported skin irritation. One within-participant study found similar results, with one participant reporting severe itch immediately after Dead Sea salt soak in the salt bath and UVB group and two instances of inadequate response to phototherapy and conversion to psoralen bath + UVA reported in the UVB only group (low-certainty evidence).\nAuthors' conclusions\nSalt bath with artificial ultraviolet B (UVB) light may improve psoriasis in people with chronic plaque psoriasis compared with UVB light treatment alone, and there may be no difference in the occurrence of treatment-related adverse events requiring withdrawal. Both results are based on data from a limited number of studies, which provided low-certainty evidence, so we cannot draw any clear conclusions.\nThe reporting of our pre-specified outcomes was either non-existent or limited, with a maximum of two studies reporting a given outcome.\nThe same group conducted the two trials which contributed data for the primary efficacy outcome, and the German Spas Association funded one of these trials. We recommend further RCTs that assess PASI-75, with detailed reporting of the outcome and time point, as well as treatment-related adverse events. Risk of bias was an issue; future studies should ensure blinding of outcome assessors and full reporting.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of indoor bathing in salt water for adults with chronic plaque psoriasis followed by artificial ultraviolet B (UVB) light treatment. We evaluated two different comparisons: 1) Salt bath with UVB versus other treatment without UVB; eligible comparators were exposure to psoralen bath, psoralen bath + artificial ultraviolet A (UVA) light, topical treatment, systemic treatment (oral or injected medicines that work throughout the entire body), or placebo (an inactive substance). 2) Salt bath with UVB versus other treatment with UVB or UVB only; eligible comparators were exposure to bath containing other compositions or concentrations + UVB or UVB only. The degree of severity of psoriasis can be measured by the psoriasis area and severity index (PASI). Improvement can be indicated by a reduction of PASI. We requested at least a 75% reduction in PASI-75 score to evaluate a potential beneficial effect. To evaluate a potential harmful effect, we chose treatment-related side effects severe enough to stop treatment."
}
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query-laysum
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6932
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[
{
"role": "user",
"content": "Abstract: Background\nHaloperidol used alone is recommended to help calm situations of aggression or agitation for people with psychosis. It is widely accessible and may be the only antipsychotic medication available in limited-resource areas.\nObjectives\nTo examine whether haloperidol alone is an effective treatment for psychosis-induced aggression or agitation, wherein clinicians are required to intervene to prevent harm to self and others.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (26th May 2016). This register is compiled by systematic searches of major resources (including AMED, BIOSIS CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings, with no language, date, document type, or publication status limitations for inclusion of records into the register.\nSelection criteria\nRandomised controlled trials (RCTs) involving people exhibiting aggression and/or agitation thought to be due to psychosis, allocated rapid use of haloperidol alone (by any route), compared with any other treatment. Outcomes of interest included tranquillisation or asleep by 30 minutes, repeated need for rapid tranquillisation within 24 hours, specific behaviours (threat or injury to others/self), adverse effects. We included trials meeting our selection criteria and providing useable data.\nData collection and analysis\nWe independently inspected all citations from searches, identified relevant abstracts, and independently extracted data from all included studies. For binary data we calculated risk ratio (RR), for continuous data we calculated mean difference (MD), and for cognitive outcomes we derived standardised mean difference (SMD) effect sizes, all with 95% confidence intervals (CI) and using a fixed-effect model. We assessed risk of bias for the included studies and used the GRADE approach to produce 'Summary of findings' tables which included our pre-specified main outcomes of interest.\nMain results\nWe found nine new RCTs from the 2016 update search, giving a total of 41 included studies and 24 comparisons. Few studies were undertaken in circumstances that reflect real-world practice, and, with notable exceptions, most were small and carried considerable risk of bias. Due to the large number of comparisons, we can only present a summary of main results.\nCompared with placebo, more people in the haloperidol group were asleep at two hours (2 RCTs, n=220, RR 0.88, 95%CI 0.82 to 0.95, very low-quality evidence) and experienced dystonia (2 RCTs, n=207, RR 7.49, 95%CI 0.93 to 60.21, very low-quality evidence).\nCompared with aripiprazole, people in the haloperidol group required fewer injections than those in the aripiprazole group (2 RCTs, n=473, RR 0.78, 95%CI 0.62 to 0.99, low-quality evidence). More people in the haloperidol group experienced dystonia (2 RCTs, n=477, RR 6.63, 95%CI 1.52 to 28.86, very low-quality evidence).\nFour trials (n=207) compared haloperidol with lorazepam with no significant differences with regard to number of participants asleep at one hour (1 RCT, n=60, RR 1.05, 95%CI 0.76 to 1.44, very low-quality of evidence) or those requiring additional injections (1 RCT, n=66, RR 1.14, 95%CI 0.91 to 1.43, very low-quality of evidence).\nHaloperidol's adverse effects were not offset by addition of lorazepam (e.g. dystonia 1 RCT, n=67, RR 8.25, 95%CI 0.46 to 147.45, very low-quality of evidence).\nAddition of promethazine was investigated in two trials (n=376). More people in the haloperidol group were not tranquil or asleep by 20 minutes (1 RCT, n=316, RR 1.60, 95%CI 1.18 to 2.16, moderate-quality evidence). Acute dystonia was too common in the haloperidol alone group for the trial to continue beyond the interim analysis (1 RCT, n=316, RR 19.48, 95%CI 1.14 to 331.92, low-quality evidence).\nAuthors' conclusions\nAdditional data from new studies does not alter previous conclusions of this review. If no other alternative exists, sole use of intramuscular haloperidol could be life-saving. Where additional drugs are available, sole use of haloperidol for extreme emergency could be considered unethical. Addition of the sedating promethazine has support from better-grade evidence from within randomised trials. Use of an alternative antipsychotic drug is only partially supported by fragmented and poor-grade evidence. Adding a benzodiazepine to haloperidol does not have strong evidence of benefit and carries risk of additional harm.\nAfter six decades of use for emergency rapid tranquillisation, this is still an area in need of good independent trials relevant to real-world practice.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Forty-one studies are now included in the review but information in these is of low-quality. Main results show that when compared with placebo or no treatment, more people having haloperidol were asleep after two hours. However, evidence is not strong. Results are made more complex by large variety of available treatments (24 comparisons)."
}
] |
query-laysum
|
6933
|
[
{
"role": "user",
"content": "Abstract: Background\nFingolimod was approved in 2010 for the treatment of patients with the relapsing-remitting (RR) form of multiple sclerosis (MS). It was designed to reduce the frequency of exacerbations and to delay disability worsening. Issues on its safety and efficacy, mainly as compared to other disease modifying drugs (DMDs), have been raised.\nObjectives\nTo assess the safety and benefit of fingolimod versus placebo, or other disease-modifying drugs (DMDs), in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS).\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System (CNS) Group's Specialised Trials Register and US Food and Drug Administration reports (15 February 2016).\nSelection criteria\nRandomised controlled trials (RCTs) assessing the beneficial and harmful effects of fingolimod versus placebo or other approved DMDs in people with RRMS.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nSix RCTs met our selection criteria. The overall population included 5152 participants; 1621 controls and 3531 treated with fingolimod at different doses; 2061 with 0.5 mg, 1376 with 1.25 mg, and 94 with 5.0 mg daily. Among the controls, 923 participants were treated with placebo and 698 with others DMDs. The treatment duration was six months in three, 12 months in one, and 24 months in two trials. One study was at high risk of bias for blinding, three studies were at high risk of bias for incomplete outcome reporting, and four studies were at high risk of bias for other reasons (co-authors were affiliated with the pharmaceutical company). We retrieved 10 ongoing trials; four of them have been completed.\nComparing fingolimod administered at the approved dose of 0.5 mg to placebo, we found that the drug at 24 months increased the probability of being relapse-free (risk ratio (RR) 1.44, 95% confidence interval (CI) (1.28 to 1.63); moderate quality of evidence), but it might lead to little or no difference in preventing disability progression (RR 1.07, 95% CI 1.02 to 1.11; primary clinical endpoints; low quality evidence). Benefit was observed for other measures of inflammatory disease activity including clinical (annualised relapse rate): rate ratio 0.50, 95% CI 0.40 to 0.62; moderate quality evidence; and magnetic resonance imaging (MRI) activity (gadolinium-enhancing lesions): RR of being free from (MRI) gadolinium-enhancing lesions: 1.36, 95% CI 1.27 to 1.45; low quality evidence.The mean change of MRI T2-weighted lesion load favoured fingolimod at 12 and 24 months.\nNo significant increased risk of discontinuation due to adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. The risk of fingolimod discontinuation was significantly higher compared to placebo for the dose 1.25 mg at 24 months (RR 1.93, 95% CI 1.48 to 2.52).\nNo significant increased risk of discontinuation due to serious adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. A significant increased risk of discontinuation due to serious adverse events was found for fingolimod 5.0 mg (RR 2.77, 95% CI 1.04 to 7.38) compared to placebo at six months.\nComparing fingolimod 0.5 mg to intramuscular interferon beta-1a, we found moderate quality evidence that the drug at one year slightly increased the number of participants free from relapse (RR 1.18, 95% CI 1.09 to 1.27) or from gadolinium-enhancing lesions (RR 1.12, 95% CI 1.05 to 1.19), and decreased the relapse rate (rate ratio 0.48, 95% CI 0.34 to 0.70). We did not detect any advantage for preventing disability progression (RR 1.02, 95% CI 0.99 to 1.06; low quality evidence). We did not detect any significant difference for MRI T2-weighted lesion load change.\nWe found a greater likelihood of participants discontinuing fingolimod, as compared to other DMDs, due to adverse events in the short-term (six months) (RR 3.21, 95% CI 1.16 to 8.86), but there was no significant difference versus interferon beta-1a at 12 months (RR 1.51, 95% CI 0.81 to 2.80; moderate quality evidence). A higher incidence of adverse events was suggestive of the lower tolerability rate of fingolimod compared to interferon-beta 1a.\nQuality of life was improved in participants after switching from a different DMD to fingolimod at six months, but this effect was not found compared to placebo at 24 months.\nAll studies were sponsored by Novartis Pharma.\nAuthors' conclusions\nTreatment with fingolimod compared to placebo in RRMS patients is effective in reducing inflammatory disease activity, but it may lead to little or no difference in preventing disability worsening. The risk of withdrawals due to adverse events requires careful monitoring of patients over time. The evidence on the risk/benefit profile of fingolimod compared with intramuscular interferon beta-1a was uncertain, based on a low number of head-to-head RCTs with short follow-up duration. The ongoing trial results will possibly satisfy these issues.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Six studies, published between 2006 and 2014, were included in this review, comprising a total of 5152 participants suffering from RRMS. The treatment duration was six months in three studies, 12 months in one study, and 24 months in two studies."
}
] |
query-laysum
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6934
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[
{
"role": "user",
"content": "Abstract: Background\nAnimal-derived surfactants have been shown to have several advantages over the first generation synthetic surfactants and are the most commonly used surfactant preparations. The animal-derived surfactants in clinical use are minced or lavaged and modified or purified from bovine or porcine lungs. It is unclear whether significant differences in clinical outcome exist among the available bovine (modified minced or lavage) and porcine (minced or lavage) surfactant extracts.\nObjectives\nTo compare the effect of administration of different animal-derived surfactant extracts on the risk of mortality, chronic lung disease, and other morbidities associated with prematurity in preterm infants at risk for or having respiratory distress syndrome (RDS).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), MEDLINE via PubMed (1966 to July 31, 2015), EMBASE (1980 to July 31, 2015), and CINAHL (1982 to July 31, 2015). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nRandomized or quasi-randomized controlled trials that compared the effect of animal-derived surfactant extract treatment administered to preterm infants at risk for or having RDS to prevent complications of prematurity and mortality.\nData collection and analysis\nData regarding clinical outcomes were excerpted from the reports of the clinical trials by the review authors. Subgroup analyses were performed based on gestational age, surfactant dosing and schedule, treatment severity and treatment strategy. Data analysis was performed in accordance with the standards of the Cochrane Neonatal Review Group.\nMain results\nSixteen randomized controlled trials were included in the analysis.\nBovine lung lavage surfactant extract to modified bovine minced lung surfactant extract: Seven treatment studies and two prevention studies compared bovine lung lavage surfactant extract to modified bovine minced lung surfactant extract. The meta-analysis did not demonstrate any significant differences in death or chronic lung disease in the prevention trials (typical RR 1.02, 95% CI 0.89 to 1.17; typical RD 0.01, 95% CI −0.05 to 0.06; 2 studies and 1123 infants; high quality evidence) or treatment trials (typical RR 0.95, 95% CI 0.86 to 1.06; typical RD −0.02 , 95% CI −0.06 to 0.02; 3 studies and 2009 infants; high quality evidence)\nModified bovine minced lung surfactant extract compared with porcine minced lung surfactant extract: Nine treatment studies compared modified bovine minced lung surfactant extract to porcine minced lung surfactant extract. Meta-analysis of these trials demonstrate a significant increase in the risk of mortality prior to hospital discharge (typical RR 1.44, 95% CI 1.04 to 2.00; typical RD 0.05, 95% CI 0.01 to 0.10; NNTH 20, 95% CI 10 to 100; 9 studies and 901 infants; moderate quality evidence), death or oxygen requirement at 36 weeks' postmenstrual age (typical RR 1.30, 95% CI 1.04 to 1.64; typical RD 0.11, 95% CI 0.02 to 0.20; NNTH 9, 95% CI 5 to 50; 3 studies and 448 infants; moderate quality evidence), receiving more than one dose of surfactant (typical RR 1.57, 95% CI 1.29 to 1.92; typical RD 0.14, 95% CI 0.08 to 0.20; NNTH 7, 95% CI 5 to 13; 6 studies and 786 infants), and patent ductus arteriosus (PDA) requiring treatment (typical RR 1.86, 95% CI 1.28 to 2.70; typical RD 0.28, 95% CI 0.13 to 0.43; NNTH 4, 95% CI 2 to 8; 3 studies and 137 infants) in infants treated with modified bovine minced lung surfactant extract compared with porcine minced lung surfactant extract. In the subgroup analysis based on initial dose of surfactant, improvement in mortality prior to discharge (typical RR 1.62, 95% CI 1.11 to 2.38; typical RD 0.06, 95% CI 0.01 to 0.11; NNTH 16, 95% CI 9 to 100) and risk of death or oxygen requirement at 36 weeks' postmenstrual age (typical RR 1.39, 95% CI 1.08 to 1.79; typical RD 0.13, 95% 0.03 to 0.23; NNTH 7, 95% CI 4 to 33) was limited to higher initial dose of porcine minced lung surfactant (> 100 mg/kg).\nOther comparisons: No difference in outcome was noted between bovine lung lavage surfactant extract versus porcine minced lung surfactant extract. There were no studies comparing bovine lung lavage surfactant extract versus porcine lung lavage surfactant; or porcine minced lung surfactant extract versus porcine lung lavage surfactant.\nAuthors' conclusions\nSignificant differences in clinical outcome were noted in the comparison trials of modified minced lung surfactant extract (beractant) compared with porcine minced lung surfactant extract (poractant alfa) including a significant increase in the risk of mortality prior to discharge, death or oxygen requirement at 36 weeks' postmenstrual age, PDA requiring treatment and \"receiving > 1 dose of surfactant\" in infants treated with modified bovine minced lung surfactant extract compared with porcine minced lung surfactant extract. The difference in these outcomes was limited to studies using a higher initial dose of porcine minced lung surfactant extract. It is uncertain whether the observed differences are from differences in dose or from source of extraction (porcine vs. bovine) because of the lack of dose-equivalent comparison groups with appropriate sample size. No differences in clinical outcomes were observed in comparative trials between bovine lung lavage surfactant and modified bovine minced lung surfactants.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A wide variety of surfactant preparations are used to prevent or treat respiratory distress syndrome (RDS) in preterm infants. All commercially available animal-derived surfactant products are effective for prevention and treatment of respiratory distress syndrome in preterm infants. However, it is unclear whether significant differences in clinical outcome exist among the available animal-derived surfactant extracts. This review compared different animal-derived surfactant products based on their source (bovine vs. porcine) and method of extraction (minced lung vs. lung lavage)."
}
] |
query-laysum
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6935
|
[
{
"role": "user",
"content": "Abstract: Background\nThis an update of the review first published in 2009.\nMajor abdominal and pelvic surgery carries a high risk of venous thromboembolism (VTE). The efficacy of thromboprophylaxis with low molecular weight heparin (LMWH) administered during the in-hospital period is well-documented, but the optimal duration of prophylaxis after surgery remains controversial. Some studies suggest that patients undergoing major abdominopelvic surgery benefit from prolongation of the prophylaxis up to 28 days after surgery.\nObjectives\nTo evaluate the efficacy and safety of prolonged thromboprophylaxis with LMWH for at least 14 days after abdominal or pelvic surgery compared with thromboprophylaxis administered during the in-hospital period only in preventing late onset VTE.\nSearch methods\nWe performed electronic searches on 28 October 2017 in the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, LILACS and registered trials (Clinicaltrials.gov October 28, 2017 and World Health Organization International Clinical Trials Registry Platform (ICTRP) 28 October 2017). Abstract books from major congresses addressing thromboembolism were handsearched from 1976 to 28 October 2017, as were reference lists from relevant studies.\nSelection criteria\nWe assessed randomized controlled clinical trials (RCTs) comparing prolonged thromboprophylaxis (≥ fourteen days) with any LMWH agent to thromboprophylaxis during the admission period only followed by placebo or no thromoprophylaxis after discharge. The population consisted of persons undergoing abdominal or pelvic surgery for both benign and malignant pathology. The outcome measures included VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE)) as assessed by objective means (venography, ultrasonography, pulmonary ventilation/perfusion scintigraphy, spiral computed tomography (CT) scan or autopsy). We excluded studies exclusively reporting on clinical diagnosis of VTE without objective confirmation.\nData collection and analysis\nReview authors identified studies and extracted data. Outcomes were VTE (DVT or PE) assessed by objective means. Safety outcomes were defined as bleeding complications and mortality within three months after surgery. Sensitivity analyses were also performed with unpublished studies excluded, and with study participants limited to those undergoing solely open and not laparoscopic surgery. We used a fixed-effect model for analysis.\nMain results\nWe identified seven RCTs (1728 participants) evaluating prolonged thromboprophylaxis with LMWH compared with in-hospital thromoprophylaxis followed by placebo or no thromboprophylaxis after discharge. The searches resulted in 1632 studies, of which we excluded 1528. One hundred and four abstracts, eligible for inclusion, were assessed of which seven studies met the inclusion criteria.\nFor the primary outcome, the incidence of overall VTE after major abdominal or pelvic surgery was 13.2% in the control group compared to 5.3% in the patients receiving out-of-hospital LMWH (Mantel Haentzel (M-H) odds ratio (OR) 0.38, 95% confidence interval (CI) 0.26 to 0.54; I2 = 28%; moderate-quality evidence).\nFor the secondary outcome of all DVT, seven studies, n = 1728, showed prolonged thromboprophylaxis with LMWH to be associated with a statistically significant reduction in the incidence of all DVT (M-H OR 0.39, 95% CI 0.27 to 0.55; I2 = 28%; moderate-quality evidence).\nWe found a similar reduction when analysis was limited to incidence in proximal DVT (M-H OR 0.22, 95% CI 0.10 to 0.47; I2 = 0%; moderate-quality evidence).\nThe incidence of symptomatic VTE was also reduced from 1.0% in the control group to 0.1% in patients receiving prolonged thromboprophylaxis, which approached significance (M-H OR 0.30, 95% CI 0.08 to 1.11; I2 = 0%; moderate-quality evidence).\nNo difference in the incidence of bleeding between the control and LMWH group was found, 2.8% and 3.4%, respectively (M-H OR 1.10, 95% CI 0.67 to 1.81; I2 = 0%; moderate-quality evidence).\nNo difference in mortality between the control and LMWH group was found, 3.8% and 3.9%, respectively (M-H OR 1.15, 95% CI 0.72 to 1.84; moderate-quality evidence).\nEstimates of heterogeneity ranged between 0% and 28% depending on the analysis, suggesting low or unimportant heterogeneity.\nAuthors' conclusions\nProlonged thromboprophylaxis with LMWH significantly reduces the risk of VTE compared to thromboprophylaxis during hospital admittance only, without increasing bleeding complications or mortality after major abdominal or pelvic surgery. This finding also holds true for DVT alone, and for both proximal and symptomatic DVT. The quality of the evidence is moderate and provides moderate support for routine use of prolonged thromboprophylaxis. Given the low heterogeneity between studies and the consistent and moderate evidence of a decrease in risk for VTE, our findings suggest that additional studies may help refine the degree of risk reduction but would be unlikely to significantly influence these findings. This updated review provides additional evidence and supports the previous results reported in the 2009 review.\n\nGiven the provided abstract, please respond to the following query: \"What was found?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Seven studies were found that addressed this question, including a total of 1728 patients. Continuing blood thinning injections after hospital discharge decreased the risk of both blood clots in the limbs and in the lungs. This review determined that the overall incidence of having a blood clot is reduced from 13.2%, when no post-discharge blood thinner injections are used, to 5.3% when a blood thinner injection is prescribed for at least 14 days following discharge in 30 days follow-up. Both symptomatic and asymptomatic blood clots decreased with the use of prolonged duration blood thinner injections in postoperative patients. No increase in bleeding complications or death, common concerns when blood thinners are used, were observed in patients treated with prolonged duration blood thinner injections."
}
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query-laysum
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6936
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[
{
"role": "user",
"content": "Abstract: Background\nThere are several treatment options for managing acute asthma exacerbations (sustained worsening of symptoms that do not subside with regular treatment and require a change in management). Guidelines advocate the use of inhaled short acting beta2-agonists (SABAs) in children experiencing an asthma exacerbation. Anticholinergic agents, such as ipratropium bromide and atropine sulfate, have a slower onset of action and weaker bronchodilating effect, but may specifically relieve cholinergic bronchomotor tone and decrease mucosal edema and secretions. Therefore, the combination of inhaled anticholinergics with SABAs may yield enhanced and prolonged bronchodilation.\nObjectives\nTo determine whether the addition of inhaled anticholinergics to SABAs provides clinical improvement and affects the incidence of adverse effects in children with acute asthma exacerbations.\nSearch methods\nWe searched MEDLINE (1966 to April 2000), EMBASE (1980 to April 2000), CINAHL (1982 to April 2000) and reference lists of studies of previous versions of this review. We also contacted drug manufacturers and trialists. For the 2012 review update, we undertook an 'all years' search of the Cochrane Airways Group's register on the 18 April 2012.\nSelection criteria\nRandomized parallel trials comparing the combination of inhaled anticholinergics and SABAs with SABAs alone in children (aged 18 months to 18 years) with an acute asthma exacerbation.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We used the GRADE rating system to assess the quality of evidence for our primary outcome (hospital admission).\nMain results\nTwenty trials met the review eligibility criteria, generated 24 study comparisons and comprised 2697 randomised children aged one to 18 years, presenting predominantly with moderate or severe exacerbations. Most studies involved both preschool-aged children and school-aged children; three studies also included a small proportion of infants less than 18 months of age. Nine trials (45%) were at a low risk of bias. Most trials used a fixed-dose protocol of three doses of 250 mcg or two doses of 500 mcg of nebulized ipratropium bromide in combination with a SABA over 30 to 90 minutes while three trials used a single dose and two used a flexible-dose protocol according to the need for SABA.\nThe addition of an anticholinergic to a SABA significantly reduced the risk of hospital admission (risk ratio (RR) 0.73; 95% confidence interval (CI) 0.63 to 0.85; 15 studies, 2497 children, high-quality evidence). In the group receiving only SABAs, 23 out of 100 children with acute asthma were admitted to hospital compared with 17 (95% CI 15 to 20) out of 100 children treated with SABAs plus anticholinergics. This represents an overall number needed to treat for an additional beneficial outcome (NNTB) of 16 (95% CI 12 to 29).\nTrends towards a greater effect with increased treatment intensity and with increased asthma severity were observed, but did not reach statistical significance. There was no effect modification due to concomitant use of oral corticosteroids and the effect of age could not be explored. However, exclusion of the one trial that included infants (< 18 months) and contributed data to the main outcome, did not affect the results. Statistically significant group differences favoring anticholinergic use were observed for lung function, clinical score at 120 minutes, oxygen saturation at 60 minutes, and the need for repeat use of bronchodilators prior to discharge from the emergency department. No significant group difference was seen in relapse rates.\nFewer children treated with anticholinergics plus SABA reported nausea and tremor compared with SABA alone; no significant group difference was observed for vomiting.\nAuthors' conclusions\nChildren with an asthma exacerbation experience a lower risk of admission to hospital if they are treated with the combination of inhaled SABAs plus anticholinergic versus SABA alone. They also experience a greater improvement in lung function and less risk of nausea and tremor. Within this group, the findings suggested, but did not prove, the possibility of an effect modification, where intensity of anticholinergic treatment and asthma severity, could be associated with greater benefit.\nFurther research is required to identify the characteristics of children that may benefit from anticholinergic use (e.g. age and asthma severity including mild exacerbation and impending respiratory failure) and the treatment modalities (dose, intensity, and duration) associated with most benefit from anticholinergic use better.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In an asthma attack, the airways (small tubes in the lungs) narrow because of inflammation (swelling), muscle spasms and mucus secretions. Other symptoms include wheezing, coughing and chest tightness. This makes breathing difficult. Reliever inhalers typically contain short-acting beta2-agonists (SABAs) that relax the muscles in the airways, opening the airways so that breathing is easier. Anticholinergic drugs work by opening the airways and decreasing mucus secretions.Review questionWe looked at randomised controlled trials to find out whether giving inhaled anticholinergics plus SABAs (instead of SABAs on their own) in the emergency department provides benefits or harms in children having an asthma attack.Key resultsWe found that children with a moderate or severe asthma attack who were given both drugs in the emergency department were less likely to be admitted to the hospital than those who only had SABAs. In the group receiving only SABAs, on average 23 out of 100 children with acute asthma were admitted to hospital compared with an average of 17 (95% CI 15 to 20) out of 100 children treated with SABAs plus anticholinergics. Taking both drugs was also better at improving lung function. Taking both drugs did not seem to reduce the possibility of another asthma attack. Fewer children treated with anticholinergics reported nausea and tremor, but no significant group difference was observed for vomiting.Quality of the evidence and further researchMost of the studies were in preschool- and school-aged children; three studies also included a small proportion of infants under 18 months of age, although there was no evidence that inclusion of these infants with wheezy episodes affected the results. Nine trials (45%) were at a low risk of bias and we regarded the evidence for hospitalisation as high quality. Physicians can administer the dose of anticholinergic and SABA in several different ways; as a single dose, or as a certain number of doses or more flexibly. Most of the trials gave the children two or three doses and we think that more research is needed to improve characterization of children that benefit from, and the most effective number and frequency of doses of, anticholinergic treatment."
}
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query-laysum
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6937
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[
{
"role": "user",
"content": "Abstract: Background\nPrevious systematic reviews and randomised controlled trials have investigated the effect of post-stroke trunk training. Findings suggest that trunk training improves trunk function and activity or the execution of a task or action by an individual. But it is unclear what effect trunk training has on daily life activities, quality of life, and other outcomes.\nObjectives\nTo assess the effectiveness of trunk training after stroke on activities of daily living (ADL), trunk function, arm-hand function or activity, standing balance, leg function, walking ability, and quality of life when comparing with both dose-matched as non-dose-matched control groups.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, and five other databases to 25 October 2021. We searched trial registries to identify additional relevant published, unpublished, and ongoing trials. We hand searched the bibliographies of included studies.\nSelection criteria\nWe selected randomised controlled trials comparing trunk training versus non-dose-matched or dose-matched control therapy including adults (18 years or older) with either ischaemic or haemorrhagic stroke. Outcome measures of trials included ADL, trunk function, arm-hand function or activity, standing balance, leg function, walking ability, and quality of life.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nTwo main analyses were carried out. The first analysis included trials where the therapy duration of control intervention was non-dose-matched with the therapy duration of the experimental group and the second analysis where there was comparison with a dose-matched control intervention (equal therapy duration in both the control as in the experimental group).\nMain results\nWe included 68 trials with a total of 2585 participants.\nIn the analysis of the non-dose-matched groups (pooling of all trials with different training duration in the experimental as in the control intervention), we could see that trunk training had a positive effect on ADL (standardised mean difference (SMD) 0.96; 95% confidence interval (CI) 0.69 to 1.24; P < 0.001; 5 trials; 283 participants; very low-certainty evidence), trunk function (SMD 1.49, 95% CI 1.26 to 1.71; P < 0.001; 14 trials, 466 participants; very low-certainty evidence), arm-hand function (SMD 0.67, 95% CI 0.19 to 1.15; P = 0.006; 2 trials, 74 participants; low-certainty evidence), arm-hand activity (SMD 0.84, 95% CI 0.009 to 1.59; P = 0.03; 1 trial, 30 participants; very low-certainty evidence), standing balance (SMD 0.57, 95% CI 0.35 to 0.79; P < 0.001; 11 trials, 410 participants; very low-certainty evidence), leg function (SMD 1.10, 95% CI 0.57 to 1.63; P < 0.001; 1 trial, 64 participants; very low-certainty evidence), walking ability (SMD 0.73, 95% CI 0.52 to 0.94; P < 0.001; 11 trials, 383 participants; low-certainty evidence) and quality of life (SMD 0.50, 95% CI 0.11 to 0.89; P = 0.01; 2 trials, 108 participants; low-certainty evidence). Non-dose-matched trunk training led to no difference for the outcome serious adverse events (odds ratio: 7.94, 95% CI 0.16 to 400.89; 6 trials, 201 participants; very low-certainty evidence).\nIn the analysis of the dose-matched groups (pooling of all trials with equal training duration in the experimental as in the control intervention), we saw that trunk training had a positive effect on trunk function (SMD 1.03, 95% CI 0.91 to 1.16; P < 0.001; 36 trials, 1217 participants; very low-certainty evidence), standing balance (SMD 1.00, 95% CI 0.86 to 1.15; P < 0.001; 22 trials, 917 participants; very low-certainty evidence), leg function (SMD 1.57, 95% CI 1.28 to 1.87; P < 0.001; 4 trials, 254 participants; very low-certainty evidence), walking ability (SMD 0.69, 95% CI 0.51 to 0.87; P < 0.001; 19 trials, 535 participants; low-certainty evidence) and quality of life (SMD 0.70, 95% CI 0.29 to 1.11; P < 0.001; 2 trials, 111 participants; low-certainty evidence), but not for ADL (SMD 0.10; 95% confidence interval (CI) -0.17 to 0.37; P = 0.48; 9 trials; 229 participants; very low-certainty evidence), arm-hand function (SMD 0.76, 95% CI -0.18 to 1.70; P = 0.11; 1 trial, 19 participants; low-certainty evidence), arm-hand activity (SMD 0.17, 95% CI -0.21 to 0.56; P = 0.38; 3 trials, 112 participants; very low-certainty evidence). Trunk training also led to no difference for the outcome serious adverse events (odds ratio (OR): 7.39, 95% CI 0.15 to 372.38; 10 trials, 381 participants; very low-certainty evidence).\nTime post stroke led to a significant subgroup difference for standing balance (P < 0.001) in non-dose-matched therapy. In non-dose-matched therapy, different trunk therapy approaches had a significant effect on ADL (< 0.001), trunk function (P < 0.001) and standing balance (< 0.001).\nWhen participants received dose-matched therapy, analysis of subgroup differences showed that the trunk therapy approach had a significant effect on ADL (P = 0.001), trunk function (P < 0.001), arm-hand activity (P < 0.001), standing balance (P = 0.002), and leg function (P = 0.002). Also for dose-matched therapy, subgroup analysis for time post stroke resulted in a significant difference for the outcomes standing balance (P < 0.001), walking ability (P = 0.003) and leg function (P < 0.001), time post stroke significantly modified the effect of intervention.\nCore-stability trunk (15 trials), selective-trunk (14 trials) and unstable-trunk (16 trials) training approaches were mostly applied in the included trials.\nAuthors' conclusions\nThere is evidence to suggest that trunk training as part of rehabilitation improves ADL, trunk function, standing balance, walking ability, upper and lower limb function, and quality of life in people after stroke. Core-stability, selective-, and unstable-trunk training were the trunk training approaches mostly applied in the included trials. When considering only trials with a low risk of bias, results were mostly confirmed, with very low to moderate certainty, depending on the outcome.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that training of the torso may result in improvements of activities of daily living, torso function, standing balance, functional use of the affected arm and hand, movements of the affected lower limb, the ability to walk, and well-being."
}
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query-laysum
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6938
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[
{
"role": "user",
"content": "Abstract: Background\nMechanical ventilation often causes major distress and anxiety in patients. The sensation of breathlessness, frequent suctioning, inability to talk, uncertainty regarding surroundings or condition, discomfort, isolation from others, and fear contribute to high levels of anxiety. Side effects of analgesia and sedation may lead to the prolongation of mechanical ventilation and, subsequently, to a longer length of hospitalization and increased cost. Therefore, non-pharmacological interventions should be considered for anxiety and stress management. Music interventions have been used to reduce anxiety and distress and improve physiological functioning in medical patients; however, their efficacy for mechanically ventilated patients needs to be evaluated. This review was originally published in 2010 and was updated in 2014.\nObjectives\nTo update the previously published review that examined the effects of music therapy or music medicine interventions (as defined by the authors) on anxiety and other outcomes in mechanically ventilated patients. Specifically, the following objectives are addressed in this review.\n1. To conduct a meta-analysis to compare the effects of participation in standard care combined with music therapy or music medicine interventions with standard care alone.\n2. To compare the effects of patient-selected music with researcher-selected music.\n3. To compare the effects of different types of music interventions (e.g., music therapy versus music medicine).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 2), MEDLINE (1950 to March 2014), CINAHL (1980 to March 2014), EMBASE (1980 to March 2014), PsycINFO (1967 to March 2014), LILACS (1982 to March 2014), Science Citation Index (1980 to March 2014), www.musictherapyworld.net (1 March 2008) (database is no longer functional), CAIRSS for Music (to March 2014), Proquest Digital Dissertations (1980 to March 2014), ClinicalTrials.gov (2000 to March 2014), Current Controlled Trials (1998 to March 2014), the National Research Register (2000 to September 2007), and NIH CRISP (all to March 2014). We handsearched music therapy journals and reference lists, and contacted relevant experts to identify unpublished manuscripts. There was no language restriction. The original search was performed in January 2010.\nSelection criteria\nWe included all randomized and quasi-randomized controlled trials that compared music interventions and standard care with standard care alone for mechanically ventilated patients.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the methodological quality of included studies. We contacted authors to obtain missing data where needed. Where possible, results for continuous outcomes were presented in meta-analyses using mean differences and standardized mean differences. Post-test scores were used. In cases of significant baseline difference, we used change scores. For dichotomous outcomes, we presented the results as risk ratios.\nMain results\nWe identified six new trials for this update. In total, the evidence for this review rests on 14 trials (805 participants). Music listening was the main intervention used, and 13 of the studies did not include a trained music therapist. Results indicated that music listening may be beneficial for anxiety reduction in mechanically ventilated patients. Specifically, music listening resulted, on average, in an anxiety reduction that was 1.11 standard deviation units greater (95% CI -1.75 to -0.47, P = 0.0006) than in the standard care group. This is considered a large and clinically significant effect. Findings indicated that listening to music consistently reduced respiratory rate and systolic blood pressure, suggesting a relaxation response. Furthermore, one large-scale study reported greater reductions in sedative and analgesic intake in the music listening group compared to the control group, and two other studies reported trends for reduction in sedative and analgesic intake for the music group. One study found significantly higher sedation scores in the music listening group compared to the control group.\nNo strong evidence was found for reduction in diastolic blood pressure and mean arterial pressure. Furthermore, inconsistent results were found for reduction in heart rate with seven studies reporting greater heart rate reductions in the music listening group and one study a slightly greater reduction in the control group. Music listening did not improve oxygen saturation levels.\nFour studies examined the effects of music listening on hormone levels but the results were mixed and no conclusions could be drawn.\nNo strong evidence was found for an effect of music listening on mortality rate but this evidence rested on only two trials.\nMost trials were assessed to be at high risk of bias because of lack of blinding. Blinding of outcome assessors is often impossible in music therapy and music medicine studies that use subjective outcomes, unless the music intervention is compared to another treatment intervention. Because of the high risk of bias, these results need to be interpreted with caution.\nNo studies could be found that examined the effects of music interventions on quality of life, patient satisfaction, post-discharge outcomes, or cost-effectiveness. No adverse events were identified.\nAuthors' conclusions\nThis updated systematic review indicates that music listening may have a beneficial effect on anxiety in mechanically ventilated patients. These findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. The review furthermore suggests that music listening consistently reduces respiratory rate and systolic blood pressure. Finally, results indicate a possible beneficial impact on the consumption of sedatives and analgesics. Therefore, we conclude that music interventions may provide a viable anxiety management option to mechanically ventilated patients.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included 14 controlled trials involving 805 critically ill participants on mechanical ventilation. All participants were alert. Slightly more patients (58%) included in these studies were male and their average age was 58 years.\nThe majority of the studies examined the effects of patients listening to pre-recorded music. Most studies offered one 20 to 30-minute music session to the participants."
}
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query-laysum
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6939
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[
{
"role": "user",
"content": "Abstract: Background\nWhen treating elevated blood pressure (BP), doctors often want to know what blood pressure target they should try to achieve. The standard blood pressure target in clinical practice for some time has been less than 140 - 160/90 - 100 mmHg for the general population of people with elevated blood pressure. Several clinical guidelines published in recent years have recommended lower targets (less than 130/80 mmHg) for people with diabetes mellitus. It is not known whether attempting to achieve targets lower than the standard target reduces mortality and morbidity in those with elevated blood pressure and diabetes.\nObjectives\nTo determine if 'lower' BP targets (any target less than 130/85 mmHg) are associated with reduction in mortality and morbidity compared with 'standard' BP targets (less than 140 - 160/90 - 100 mmHg) in people with diabetes.\nSearch methods\nWe searched the Database of Abstracts of Reviews of Effectiveness (DARE) and the Cochrane Database of Systematic Reviews for related reviews. We conducted electronic searches of the Hypertension Group Specialised Register (January 1946 - October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 9), MEDLINE (January 1946 - October 2013), EMBASE (January 1974 - October 2013) and ClinicalTrials.gov. The most recent search was performed on October 4, 2013.\nOther search sources were the International Clinical Trials Registry Platform (WHO ICTRP), and reference lists of all papers and relevant reviews.\nSelection criteria\nRandomized controlled trials comparing people with diabetes randomized to lower or to standard BP targets as previously defined, and providing data on any of the primary outcomes below.\nData collection and analysis\nTwo review authors independently assessed and established the included trials and data entry. Primary outcomes were total mortality; total serious adverse events; myocardial infarction, stroke, congestive heart failure and end-stage renal disease. Secondary outcomes were achieved mean systolic and diastolic BP, and withdrawals due to adverse effects.\nMain results\nWe found five randomized trials, recruiting a total of 7314 participants and with a mean follow-up of 4.5 years. Only one trial (ACCORD) compared outcomes associated with 'lower' (< 120 mmHg) or 'standard' (< 140 mmHg) systolic blood pressure targets in 4734 participants. Despite achieving a significantly lower BP (119.3/64.4 mmHg vs 133.5/70.5 mmHg, P < 0.0001), and using more antihypertensive medications, the only significant benefit in the group assigned to 'lower' systolic blood pressure (SBP) was a reduction in the incidence of stroke: risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.88, P = 0.009, absolute risk reduction 1.1%. The effect of SBP targets on mortality was compatible with both a reduction and increase in risk: RR 1.05 CI 0.84 to 1.30, low quality evidence. Trying to achieve the 'lower' SBP target was associated with a significant increase in the number of other serious adverse events: RR 2.58, 95% CI 1.70 to 3.91, P < 0.00001, absolute risk increase 2.0%.\nFour trials (ABCD-H, ABCD-N, ABCD-2V, and a subgroup of HOT) specifically compared clinical outcomes associated with 'lower' versus 'standard' targets for diastolic blood pressure (DBP) in people with diabetes. The total number of participants included in the DBP target analysis was 2580. Participants assigned to 'lower' DBP had a significantly lower achieved BP: 128/76 mmHg vs 135/83 mmHg, P < 0.0001. There was a trend towards reduction in total mortality in the group assigned to the 'lower' DBP target (RR 0.73, 95% CI 0.53 to 1.01), mainly due to a trend to lower non-cardiovascular mortality. There was no difference in stroke (RR 0.67, 95% CI 0.42 to 1.05), in myocardial infarction (RR 0.95, 95% CI 0.64 to 1.40) or in congestive heart failure (RR 1.06, 95% CI 0.58 to 1.92), low quality evidence. End-stage renal failure and total serious adverse events were not reported in any of the trials. A sensitivity analysis of trials comparing DBP targets < 80 mmHg (as suggested in clinical guidelines) versus < 90 mmHg showed similar results. There was a high risk of selection bias for every outcome analyzed in favor of the 'lower' target in the trials included for the analysis of DBP targets.\nAuthors' conclusions\nAt the present time, evidence from randomized trials does not support blood pressure targets lower than the standard targets in people with elevated blood pressure and diabetes. More randomized controlled trials are needed, with future trials reporting total mortality, total serious adverse events as well as cardiovascular and renal events.\n\nGiven the provided abstract, please respond to the following query: \"Review Question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We conducted this review to find and assess all trials designed to evaluate whether lower blood pressure targets are better than standard blood pressure targets for people with diabetes. We found and analyzed five studies."
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query-laysum
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6940
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[
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep-disordered breathing (oSDB) is a condition encompassing breathing problems when asleep due to upper airway obstruction. In children, hypertrophy of the tonsils and/or adenoids is thought to be the commonest cause. As such, (adeno)tonsillectomy has long been the treatment of choice. A rise in partial removal of the tonsils over the last decade is due to the hypothesis that tonsillotomy is associated with lower postoperative morbidity and fewer complications.\nObjectives\nTo assess whether partial removal of the tonsils (intracapsular tonsillotomy) is as effective as total removal of the tonsils (extracapsular tonsillectomy) in relieving signs and symptoms of oSDB in children, and has lower postoperative morbidity and fewer complications.\nSearch methods\nWe searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The search date was 22 July 2019.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the effectiveness of (adeno)tonsillectomy with (adeno)tonsillotomy in children aged 2 to 16 years with oSDB.\nData collection and analysis\nWe used standard Cochrane methods and assessed the certainty of the evidence for our pre-defined outcomes using GRADE. Our primary outcomes were disease-specific quality of life, peri-operative blood loss and the proportion of children requiring postoperative medical intervention (with or without hospitalisation). Secondary outcomes included postoperative pain, return to normal activity, recurrence of oSDB symptoms as a result of tonsil regrowth and reoperation rates.\nMain results\nWe included 22 studies (1984 children), with predominantly unclear or high risk of bias. Three studies used polysomnography as part of their inclusion criteria. Follow-up duration ranged from six days to six years. Although 19 studies reported on some of our outcomes, we could only pool the results from a few due both to the variety of outcomes and the measurement instruments used, and an absence of combinable data.\nDisease-specific quality of life\nFour studies (540 children; 484 (90%) analysed) reported this outcome; data could not be pooled due to the different outcome measurement instruments used. It is very uncertain whether there is any difference in disease-specific quality of life between the two surgical procedures in the short (0 to 6 months; 3 studies, 410 children), medium (7 to 13 months; 2 studies, 117 children) and long term (13 to 24 months; 1 study, 67 children) (very low-certainty evidence).\nPeri-operative blood loss\nWe are uncertain whether tonsillotomy reduces peri-operative blood loss by a clinically meaningful amount (mean difference (MD) 14.06 mL, 95% CI 1.91 to 26.21 mL; 8 studies, 610 children; very low-certainty evidence). In sensitivity analysis (restricted to three studies with low risk of bias) there was no evidence of a difference between the groups.\nPostoperative complications requiring medical intervention (with or without hospitalisation)\nThe risk of postoperative complications in the first week after surgery was probably lower in children who underwent tonsillotomy (4.9% versus 2.6%, risk ratio (RR) 1.75, 95% CI 1.06 to 2.91; 16 studies, 1416 children; moderate-certainty evidence).\nPostoperative pain\nEleven studies (1017 children) reported this outcome. Pain was measured using various scales and scored by either children, parents, clinicians or study personnel.\nWhen considering postoperative pain there was little or no difference between tonsillectomy and tonsillotomy at 24 hours (10-point scale) (MD 1.09, 95% CI 0.88 to 1.29; 4 studies, 368 children); at two to three days (MD 0.93, 95% CI -0.14 to 2.00; 3 studies, 301 children); or at four to seven days (MD 1.07, 95% CI -0.40 to 2.53; 4 studies, 370 children) (all very low-certainty evidence). In sensitivity analysis (restricted to studies with low risk of bias), we found no evidence of a difference in mean pain scores between groups.\nReturn to normal activity\nTonsillotomy probably results in a faster return to normal activity. Children who underwent tonsillotomy were able to return to normal activity four days earlier (MD 3.84 days, 95% CI 0.23 to 7.44; 3 studies, 248 children; moderate-certainty evidence).\nRecurrence of oSDB and reoperation rates\nWe are uncertain whether there is a difference between the groups in the short (RR 0.26, 95% CI 0.03 to 2.22; 3 studies, 186 children), medium (RR 0.35, 95% CI 0.04 to 3.23; 4 studies, 206 children) or long term (RR 0.21 95% CI 0.01 to 4.13; 1 study, 65 children) (all very low-certainty evidence).\nAuthors' conclusions\nFor children with oSDB selected for tonsil surgery, tonsillotomy probably results in a faster return to normal activity (four days) and in a slight reduction in postoperative complications requiring medical intervention in the first week after surgery.\nThis should be balanced against the clinical effectiveness of one operation over the other. However, this is not possible to determine in this review as data on the long-term effects of the two operations on oSDB symptoms, quality of life, oSDB recurrence and need for reoperation are limited and the evidence is of very low quality leading to a high degree of uncertainty about the results.\nMore robust data from high-quality cohort studies, which may be more appropriate for detecting differences in less common events in the long term, are required to inform guidance on which tonsil surgery technique is best for children with oSDB requiring surgery.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 22 studies, with a total of 1984 children aged 2 to 16 years with symptoms of obstructive sleep-disordered breathing. In three studies, a sleep study was also performed as part of the diagnosis. Children underwent tonsillectomy or tonsillotomy, with or without removal of the adenoid, and were followed after the operation for six days to six years. Nineteen of these studies measured some of the data we were looking to collect and analyse. However, we could only combine results from a limited number of studies as each study measured different outcomes and used different measurement instruments to do this. There were also difficulties in accessing the raw data from lots of studies."
}
] |
query-laysum
|
6941
|
[
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is a chronic disease characterized by joint pain, tenderness, and limitation of movement. At present, no cure is available. Thus only treatment of the person's symptoms and treatment to prevent further development of the disease are possible. Clinical trials indicate that aquatic exercise may have advantages for people with osteoarthritis. This is an update of a published Cochrane review.\nObjectives\nTo evaluate the effects of aquatic exercise for people with knee or hip osteoarthritis, or both, compared to no intervention.\nSearch methods\nWe searched the following databases up to 28 April 2015: the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library Issue 1, 2014), MEDLINE (from 1949), EMBASE (from 1980), CINAHL (from 1982), PEDro (Physiotherapy Evidence Database), and Web of Science (from 1945). There was no language restriction.\nSelection criteria\nRandomized controlled clinical trials of aquatic exercise compared to a control group (e.g. usual care, education, social attention, telephone call, waiting list for surgery) of participants with knee or hip osteoarthritis.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed risk of bias of the included trials. We analysed the pooled results using standardized mean difference (SMD) values.\nMain results\nNine new trials met the inclusion criteria and we excluded two earlier included trials. Thus the number of participants increased from 800 to 1190 and the number of included trials increased from six to 13. Most participants were female (75%), with an average age of 68 years and a body mass index (BMI) of 29.4. Osteoarthritis duration was 6.7 years, with a great variation of the included participants. The mean aquatic exercise duration was 12 weeks. We found 12 trials at low to unclear risk of bias for all domains except blinding of participants and personnel. They showed that aquatic exercise caused a small short term improvement compared to control in pain (SMD −0.31, 95% CI −0.47 to −0.15; 12 trials, 1076 participants) and disability (SMD −0.32, 95% CI −0.47 to −0.17; 12 trials, 1059 participants). Ten trials showed a small effect on quality of life (QoL) (SMD −0.25, 95% CI −0.49 to −0.01; 10 trials, 971 participants). These effects on pain and disability correspond to a five point lower (95% CI three to eight points lower) score on mean pain and mean disability compared to the control group (scale 0 to 100), and a seven point higher (95% CI 0 to 13 points higher) score on mean QoL compared with control group (scale 0 to 100). No included trials performed a radiographic evaluation. No serious adverse events were reported in the included trials with relation to aquatic exercise.\nAuthors' conclusions\nThere is moderate quality evidence that aquatic exercise may have small, short-term, and clinically relevant effects on patient-reported pain, disability, and QoL in people with knee and hip OA. The conclusions of this review update does not change those of the previous published version of this Cochrane review.\n\nGiven the provided abstract, please respond to the following query: \"Serious adverse events\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No serious side effects were reported with relation to participating in aquatic exercise"
}
] |
query-laysum
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6942
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[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease (SCD) is one of the commonest severe monogenic disorders in the world, due to the inheritance of two abnormal haemoglobin (beta globin) genes. SCD can cause severe pain, significant end-organ damage, pulmonary complications, and premature death. Surgical interventions are more common in people with SCD, and occur at much younger ages than in the general population. Blood transfusions are frequently used prior to surgery and several regimens are used but there is no consensus over the best method or the necessity of transfusion in specific surgical cases. This is an update of a Cochrane Review.\nObjectives\nTo determine whether there is evidence that preoperative blood transfusion in people with SCD undergoing elective or emergency surgery reduces mortality and perioperative or sickle cell-related serious adverse events.\nTo compare the effectiveness of different transfusion regimens (aggressive or conservative) if preoperative transfusions are indicated in people with SCD.\nSearch methods\nWe searched for relevant trials in the Cochrane Library, MEDLINE (from 1946), Embase (from 1974), the Transfusion Evidence Library (from 1980), and ongoing trial databases; all searches current to 28 January 2020\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register: 19 September 2019.\nSelection criteria\nAll randomised controlled trials and quasi-randomised controlled trials comparing preoperative blood transfusion regimens to different regimens or no transfusion in people with SCD undergoing elective or emergency surgery. There was no restriction by outcomes examined, language or publication status.\nData collection and analysis\nTwo authors independently assessed trial eligibility and the risk of bias and extracted data.\nMain results\nThree trials with 990 participants were eligible for inclusion in the review. There were no ongoing trials identified. These trials were conducted between 1988 and 2011. The majority of people included had haemoglobin (Hb) SS SCD. The majority of surgical procedures were considered low or intermediate risk for developing sickle cell-related complications.\nAggressive versus simple red blood cell transfusions\nOne trial (551 participants) compared an aggressive transfusion regimen (decreasing sickle haemoglobin to less than 30%) to a simple transfusion regimen (increasing haemoglobin to 100 g/L). This trial re-randomised participants and therefore quantitative analysis was only possible on two subsets of data: participants undergoing cholecystectomy (230 participants); and participants undergoing tonsillectomy or adenoidectomy surgeries (107 participants). Data were not combined as we do not know if any participant received both surgeries. Overall, the quality of the evidence was very low across different outcomes according to GRADE methodology. This was due to the trial being at high risk of bias primarily due to lack of blinding, indirectness and the outcome estimates being imprecise. Cholecystectomy subgroup results are reported in the abstract. Results for both subgroups were similar.\nThere was no difference in all-cause mortality between people receiving aggressive transfusions and those receiving conservative transfusions. No deaths occurred in either subgroup.\nThere were no differences between the aggressive transfusion group and conservative transfusion group in the number of people developing:\n• an acute chest syndrome, risk ratio (RR) 0.84 (95% confidence interval (CI) 0.38 to 1.84) (one trial, 230 participants, very low-quality evidence);\n• vaso-occlusive crisis, risk ratio 0.30 (95% CI 0.09 to 1.04) (one trial, 230 participants, very low quality evidence);\n• serious infection, risk ratio 1.75 (95% CI 0.59 to 5.18) (one trial, 230 participants, very low-quality evidence);\n• any perioperative complications, RR 0.75 (95% CI 0.36 to 1.55) (one trial, 230 participants, very low-quality evidence);\n• a transfusion-related complication, RR 1.85 (95% CI 0.89 to 3.88) (one trial, 230 participants, very low-quality evidence).\nPreoperative transfusion versus no preoperative transfusion\nTwo trials (434 participants) compared a preoperative transfusion plus standard care to a group receiving standard care. Overall, the quality of the evidence was low to very low across different outcomes according to GRADE methodology. This was due to the trials being at high risk of bias due to lack of blinding, and outcome estimates being imprecise. One trial was stopped early because more people in the no transfusion arm developed an acute chest syndrome.\nThere was no difference in all-cause mortality between people receiving preoperative transfusions and those receiving no preoperative transfusions (two trials, 434 participants, no deaths occurred).\nThere was significant heterogeneity between the two trials in the number of people developing an acute chest syndrome, a meta-analysis was therefore not performed. One trial showed a reduced number of people developing acute chest syndrome between people receiving preoperative transfusions and those receiving no preoperative transfusions, risk ratio 0.11 (95% confidence interval 0.01 to 0.80) (65 participants), whereas the other trial did not, RR 4.81 (95% CI 0.23 to 99.61) (369 participants).\nThere were no differences between the preoperative transfusion groups and the groups without preoperative transfusion in the number of people developing:\n• a vaso-occlusive crisis, Peto odds ratio (OR) 1.91 (95% confidence interval 0.61 to 6.04) (two trials, 434 participants, very low-quality evidence).\n• a serious infection, Peto OR 1.29 (95% CI 0.29 to 5.71) (two trials, 434 participants, very low-quality evidence);\n• any perioperative complications, RR 0.24 (95% CI 0.03 to 2.05) (one trial, 65 participants, low-quality evidence).\nThere was an increase in the number of people developing circulatory overload in those receiving preoperative transfusions compared to those not receiving preoperative transfusions in one of the two trials, and no events were seen in the other trial (no meta-analysis performed).\nAuthors' conclusions\nThere is insufficient evidence from randomised trials to determine whether conservative preoperative blood transfusion is as effective as aggressive preoperative blood transfusion in preventing sickle-related or surgery-related complications in people with HbSS disease. There is very low quality evidence that preoperative blood transfusion may prevent development of acute chest syndrome.\nDue to lack of evidence this review cannot comment on management for people with HbSC or HbSβ+ disease or for those with high baseline haemoglobin concentrations.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to determine if blood transfusions given to people with sickle cell disease before routine or emergency surgery prevent complications due to sickle cell disease or surgery without causing any severe side effects. We also wanted to determine if any particular type of transfusion regimen is better in people with sickle cell disease undergoing surgery. This is an update of a previously published Cochrane Review."
}
] |
query-laysum
|
6943
|
[
{
"role": "user",
"content": "Abstract: Background\nHealth systems need timely and reliable access to essential medicines and health commodities, but problems with access are common in many settings. Mobile technologies offer potential low-cost solutions to the challenge of drug distribution and commodity availability in primary healthcare settings. However, the evidence on the use of mobile devices to address commodity shortages is sparse, and offers no clear way forward.\nObjectives\nPrimary objective\nTo assess the effects of strategies for notifying stock levels and digital tracking of healthcare-related commodities and inventory via mobile devices across the primary healthcare system\nSecondary objectives\nTo describe what mobile device strategies are currently being used to improve reporting and digital tracking of health commodities\nTo identify factors influencing the implementation of mobile device interventions targeted at reducing stockouts of health commodities\nSearch methods\nWe searched CENTRAL, MEDLINE Ovid, Embase Ovid, Global Index Medicus WHO, POPLINE K4Health, and two trials registries in August 2019. We also searched Epistemonikos for related systematic reviews and potentially eligible primary studies. We conducted a grey literature search using mHealthevidence.org, and issued a call for papers through popular digital health communities of practice. Finally, we conducted citation searches of included studies. We searched for studies published after 2000, in any language.\nSelection criteria\nFor the primary objective, we included individual and cluster-randomised trials, controlled before-after studies, and interrupted time series studies. For the secondary objectives, we included any study design, which could be quantitative, qualitative, or descriptive, that aimed to describe current strategies for commodity tracking or stock notification via mobile devices; or aimed to explore factors that influenced the implementation of these strategies, including studies of acceptability or feasibility.\nWe included studies of all cadres of healthcare providers, including lay health workers, and others involved in the distribution of health commodities (administrative staff, managerial and supervisory staff, dispensary staff); and all other individuals involved in stock notification, who may be based in a facility or a community setting, and involved with the delivery of primary healthcare services.\nWe included interventions aimed at improving the availability of health commodities using mobile devices in primary healthcare settings. For the primary objective, we included studies that compared health commodity tracking or stock notification via mobile devices with standard practice. For the secondary objectives, we included studies of health commodity tracking and stock notification via mobile device, if we could extract data relevant to our secondary objectives.\nData collection and analysis\nFor the primary objective, two authors independently screened all records, extracted data from the included studies, and assessed the risk of bias. For the analyses of the primary objectives, we reported means and proportions where appropriate. We used the GRADE approach to assess the certainty of the evidence, and prepared a 'Summary of findings' table. For the secondary objective, two authors independently screened all records, extracted data from the included studies, and applied a thematic synthesis approach to synthesise the data. We assessed methodological limitation using the Ways of Evaluating Important and Relevant Data (WEIRD) tool. We used the GRADE-CERQual approach to assess our confidence in the evidence, and prepared a 'Summary of qualitative findings' table.\nMain results\nPrimary objective\nFor the primary objective, we included one controlled before-after study conducted in Malawi.\nWe are uncertain of the effect of cStock plus enhanced management, or cStock plus effective product transport on the availability of commodities, quality and timeliness of stock management, and satisfaction and acceptability, because we assessed the evidence as very low-certainty. The study did not report on resource use or unintended consequences.\nSecondary objective\nFor the secondary objectives, we included 16 studies, using a range of study designs, which described a total of eleven interventions. All studies were conducted in African (Tanzania, Kenya, Malawi, Ghana, Ethiopia, Cameroon, Zambia, Liberia, Uganda, South Africa, and Rwanda) and Asian (Pakistan and India) countries.\nMost of the interventions aimed to make data about stock levels and potential stockouts visible to managers, who could then take corrective action to address them.\nWe identified several factors that may influence the implementation of stock notification and tracking via mobile device.\nThese include challenges tied to infrastructural issues, such as poor access to electricity or internet, and broader health systems issues, such as drug shortages at the national level which cannot be mitigated by interventions at the primary healthcare level (low confidence). Several factors were identified as important, including strong partnerships with local authorities, telecommunication companies, technical system providers, and non-governmental organizations (very low confidence); availability of stock-level data at all levels of the health system (low confidence); the role of supportive supervision and responsive management (moderate confidence); familiarity and training of health workers in the use of the digital devices (moderate confidence); availability of technical programming expertise for the initial development and ongoing maintenance of the digital systems (low confidence); incentives, such as phone credit for personal use, to support regular use of the system (low confidence); easy-to-use systems built with user participation (moderate confidence); use of basic or personal mobile phones to support easier adoption (low confidence); consideration for software features, such as two-way communication (low confidence); and data availability in an easy-to-use format, such as an interactive dashboard (moderate confidence).\nAuthors' conclusions\nWe need more, well-designed, controlled studies comparing stock notification and commodity management via mobile devices with paper-based commodity management systems. Further studies are needed to understand the factors that may influence the implementation of such interventions, and how implementation considerations differ by variations in the intervention.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this Cochrane Review, we aimed to assess if health workers would have better access to medicines and other supplies, if they used mobile phones or other mobile devices to keep track of the amount of supplies they had available, and to notify superiors when they needed more supplies. We also described how health workers are currently using these mobile systems, and what factors influence their use."
}
] |
query-laysum
|
6944
|
[
{
"role": "user",
"content": "Abstract: Background\nRoutine monitoring of gastric residuals in preterm infants on tube feeds is a common practice in neonatal intensive care units used to guide initiation and advancement of enteral feeding. There is a paucity of consensus on whether to re-feed or discard the aspirated gastric residuals. While re-feeding gastric residuals may aid in digestion and promote gastrointestinal motility and maturation by replacing partially digested milk, gastrointestinal enzymes, hormones, and trophic substances, abnormal residuals may result in vomiting, necrotising enterocolitis, or sepsis.\nObjectives\nTo assess the efficacy and safety of re-feeding when compared to discarding gastric residuals in preterm infants.\nSearch methods\nSearches were conducted in February 2022 in Cochrane CENTRAL via CRS, Ovid MEDLINE and Embase, and CINAHL. We also searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe selected RCTs that compared re-feeding versus discarding gastric residuals in preterm infants.\nData collection and analysis\nReview authors assessed trial eligibility and risk of bias and extracted data, in duplicate. We analysed treatment effects in individual trials and reported the risk ratio (RR) for dichotomous data and the mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe found one eligible trial that included 72 preterm infants. The trial was unmasked but was otherwise of good methodological quality.\nRe-feeding gastric residual may have little or no effect on time to regain birth weight (MD 0.40 days, 95% CI −2.89 to 3.69; 59 infants; low-certainty evidence), risk of necrotising enterocolitis stage ≥ 2 or spontaneous intestinal perforation (RR 0.71, 95% CI 0.25 to 2.04; 72 infants; low-certainty evidence), all-cause mortality before hospital discharge (RR 0.50, 95% CI 0.14 to 1.85; 72 infants; low-certainty evidence), time to establish enteral feeds ≥ 120 mL/kg/d (MD −1.30 days, 95% CI −2.93 to 0.33; 59 infants; low-certainty evidence), number of total parenteral nutrition days (MD −0.30 days, 95% CI −2.07 to 1.47; 59 infants; low-certainty evidence), and risk of extrauterine growth restriction at discharge (RR 1.29, 95% CI 0.38 to 4.34; 59 infants; low-certainty evidence). We are uncertain as to the effect of re-feeding gastric residual on number of episodes of feed interruption lasting for ≥ 12 hours (RR 0.80, 95% CI 0.42 to 1.52; 59 infants; very low-certainty evidence).\nAuthors' conclusions\nWe found only limited data from one small unmasked trial on the efficacy and safety of re-feeding gastric residuals in preterm infants. Low-certainty evidence suggests re-feeding gastric residual may have little or no effect on important clinical outcomes such as necrotising enterocolitis, all-cause mortality before hospital discharge, time to establish enteral feeds, number of total parenteral nutrition days, and in-hospital weight gain. A large RCT is needed to assess the efficacy and safety of re-feeding of gastric residuals in preterm infants with adequate certainty of evidence to inform policy and practice.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that investigated re-feeding of stomach aspirates in premature babies. We compared and summarised the results of the studies. We rated our confidence in the evidence, based on factors such as the size of the study and the methods used."
}
] |
query-laysum
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6945
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[
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep apnoea (OSA) is a common sleep disorder characterised by partial or complete upper airway occlusion during sleep, leading to intermittent cessation (apnoea) or reduction (hypopnoea) of airflow and dips in arterial oxygen saturation during sleep. Many patients with recognised and unrecognised OSA receive hypnotics, sedatives and opiates/opioids to treat conditions including pain, anxiety and difficulty sleeping. Concerns have been expressed that administration of these drugs to people with co-existing OSA may worsen OSA.\nObjectives\nTo investigate whether administration of sedative and hypnotic drugs exacerbates the severity of OSA (as measured by the apnoea-hypopnoea index (AHI) or the 4% oxygen desaturation index (ODI)) in people with known OSA.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register (CAGR) of trials. The search was current as of March 2015.\nSelection criteria\nRandomised, placebo-controlled trials including adult participants with confirmed OSA, where participants were randomly assigned to use opiates or opioids, sedatives, hypnotics or placebo. We included participants already using continuous positive airway pressure (CPAP) or a mandibular advancement device.\nData collection and analysis\nWe used standard methodological procedures as recommended by The Cochrane Collaboration.\nMain results\nFourteen studies examining the effects of 10 drugs and including a total of 293 participants contributed to this review. Trials were small, with only two trials, which used sodium oxybate, recruiting more than 40 participants, and all but three trials were of only one to three nights in duration. Most participants had mild to moderate OSA with a mean AHI of 11 to 25 events/h, and only two trials recruited patients with severe OSA. Two trials investigating the effects of ramelteon, a treatment option for insomnia, recruited adults over 60 years of age with OSA and concomitant insomnia.\nThe drugs studied in this review included remifentanil (infusion) 0.75 mcg/kg/h, eszopiclone 3 mg, zolpidem 10 and 20 mg, brotizolam 0.25 mg, flurazepam 30 mg, nitrazepam 10 mg to 15 mg, temazepam 10 mg, triazolam 0.25 mg, ramelteon 8 mg and 16 mg and sodium oxybate 4.5 g and 9 g. We were unable to pool most of the data, with the exception of data for eszopiclone and ramelteon.\nNone of the drugs in this review produced a significant increase in AHI or ODI. Two trials have shown a beneficial effect on OSA. One study showed that a single administration of eszopiclone 3 mg significantly decreased AHI compared with placebo (24 ± 4 vs 31 ± 5; P value < 0.05), and a second study of sodium oxybate 4.5 g showed a significant decrease in AHI compared with placebo (mean difference (MD) -7.41, 95% confidence interval (CI) -14.17 to -0.65; N = 48).\nOnly four trials reported outcome data on ODI. No significant increase, in comparison with placebo, was shown with eszopiclone (21 (22 to 37) vs 28.0 (15 to 36); P value = NS), zolpidem (0.81 ± 0.29 vs 1.46 ± 0.53; P value = NS), flurazepam (18.6 ± 19 vs 19.6 ± 15.9; P value = NS) and temazepam (6.53 ± 9.4 vs 6.56 ± 8.3; P value = 0.98).\nA significant decrease in minimum nocturnal peripheral capillary oxygen saturation (SpO2) was observed with zolpidem 20 mg (76.8 vs 85.2; P value = 0.002), flurazepam 30 mg (81.7 vs 85.2; P value = 0.002), remifentanil infusion (MD -7.00, 95% CI -11.95 to -2.05) and triazolam 0.25 mg in both rapid eye movement (REM) and non-REM (NREM) sleep (MD -14.00, 95% CI -21.84 to -6.16; MD -10.20, 95% CI -16.08 to -4.32, respectively.\nOne study investigated the effect of an opiate (remifentanil) on patients with moderate OSA. Remifentanil infusion did not significantly change AHI (MD 10.00, 95% CI -9.83 to 29.83); however it did significantly decrease the number of obstructive apnoeas (MD -9.00, 95% CI -17.40 to -0.60) and significantly increased the number of central apnoeas (MD 16.00, 95% CI -2.21 to 34.21). Similarly, although without significant effect on obstructive apnoeas, central apnoeas were increased in the sodium oxybate 9 g treatment group (MD 7.3 (18); P value = 0.005) in a cross-over trial.\nDrugs studied in this review were generally well tolerated, apart from adverse events reported in 19 study participants prescribed remifentanil (n = 1), eszopiclone (n = 6), sodium oxybate (n = 9) or ramelteon (n = 3).\nAuthors' conclusions\nThe findings of this review show that currently no evidence suggests that the pharmacological compounds assessed have a deleterious effect on the severity of OSA as measured by change in AHI or ODI. Significant clinical and statistical decreases in minimum overnight SpO2 were observed with remifentanil, zolpidem 20 mg and triazolam 0.25 mg. Eszopiclone 3 mg and sodium oxybate 4.5 g showed a beneficial effect on the severity of OSA with a reduction in AHI and may merit further assessment as a potential therapeutic option for a subgroup of patients with OSA. Only one trial assessed the effect of an opioid (remifentanil); some studies included CPAP treatment, whilst in a significant number of participants, previous treatment with CPAP was not stated and thus a residual treatment effect of CPAP could not be excluded. Most studies were small and of short duration, with indiscernible methodological quality.Caution is therefore required when such agents are prescribed for patients with OSA, especially outside the severity of the OSA cohorts and the corresponding dose of compounds given in the particular studies. Larger, longer trials involving patients across a broader spectrum of OSA severity are needed to clarify these results.\n\nGiven the provided abstract, please respond to the following query: \"'Z drugs' (a treatment for insomnia, inability to fall asleep or inability to maintain sleep)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eszopiclone and zolpidem\nEszopiclone did not worsen OSA as measured by the numbers and duration of pauses in breathing during sleep. In one study, it reduced the severity of OSA, and it might be beneficial in treating this condition, although further studies are needed to assess this effect.\nZolpidem did not significantly worsen OSA as measured by the numbers and duration of pauses in breathing during sleep, but in one trial, it significantly lowered minimum oxygen levels during the night when compared with placebo."
}
] |
query-laysum
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6946
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic antipsychotic drug treatment may cause tardive dyskinesia (TD), a long-term movement disorder. Gamma-aminobutyric acid (GABA) agonist drugs, which have intense sedative properties and may exacerbate psychotic symptoms, have been used to treat TD.\nObjectives\n1. Primary objective\nThe primary objective was to determine whether using non-benzodiazepine GABA agonist drugs for at least six weeks was clinically effective for the treatment of antipsychotic-induced TD in people with schizophrenia, schizoaffective disorder or other chronic mental illnesses.\n2. Secondary objectives\nThe secondary objectives were as follows.\nTo examine whether any improvement occurred with short periods of intervention (less than six weeks) and, if this did occur, whether this effect was maintained at longer periods of follow-up.\nTo examine whether there was a differential effect between the various compounds.\nTo test the hypothesis that GABA agonist drugs are most effective for a younger age group (less than 40 years old).\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (last searched April 2017), inspected references of all identified studies for further trials, and, when necessary, contacted authors of trials for additional information.\nSelection criteria\nWe included randomised controlled trials of non-benzodiazepine GABA agonist drugs in people with antipsychotic-induced TD and schizophrenia or other chronic mental illness.\nData collection and analysis\nTwo review authors independently selected and critically appraised studies, extracted and analysed data on an intention-to-treat basis. Where possible and appropriate we calculated risk ratios (RRs) and their 95% confidence intervals (CIs). For continuous data we calculated mean differences (MD). We assumed that people who left early had no improvement. We contacted investigators to obtain missing information. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.\nMain results\nWe included 11 studies that randomised 343 people. Overall, the risk of bias in the included studies was unclear, mainly due to poor reporting; allocation concealment was not described, generation of the sequence was not explicit, participants and outcome assessors were not clearly blinded. For some studies we were unsure if data were complete, and data were often poorly or selectively reported.\nData from six trials showed that there may be a clinically important improvement in TD symptoms after GABA agonist treatment compared with placebo at six to eight weeks follow-up (6 RCTs, n = 258, RR 0.83, CI 0.74 to 0.92; low-quality evidence). Data from five studies showed no difference between GABA agonist treatment and placebo for deterioration of TD symptoms (5 RCTs, n = 136, RR 1.90, CI 0.70 to 5.16; very low-quality evidence). Studies reporting adverse events found a significant effect favouring placebo compared with baclofen, sodium valproate or progabide for dizziness/confusion (3 RCTs, n = 62 RR 4.54, CI 1.14 to 18.11; very low-quality evidence) and sedation/drowsiness (4 RCTS, n = 144, RR 2.29, CI 1.08 to 4.86; very low-quality evidence). Studies reporting on akathisia (RR 1.05, CI 0.32 to 3.49, 2 RCTs, 80 participants), ataxia (RR 3.25, CI 0.36 to 29.73, 2 RCTs, 95 participants), nausea/vomiting (RR 2.61, CI 0.79 to 8.67, 2 RCTs, 64 participants), loss of muscle tone (RR 3.00, CI 0.15 to 59.89, 1 RCT, 10 participants), seizures (RR 3.00, CI 0.24 to 37.67, 1 RCT, 2 participants), hypotension (RR 3.04, CI 0.33 to 28.31, 2 RCTs, 119 participants) found no significant difference between GABA drug and placebo (very low-quality evidence). Evidence on mental state also showed no effect between treatment groups (6 RCTS, n = 121, RR 2.65, CI 0.71 to 9.86; very low-quality evidence) as did data for leaving the study early (around 10% in both groups, 6 RCTS, n = 218, RR 1.47, CI 0.69 to 3.15; very low-quality evidence). No study reported on social confidence, social inclusion, social networks, or personalised quality of life, a group of outcomes selected as being of particular importance to patients.\nAuthors' conclusions\nWe are uncertain about the evidence of the effects of baclofen, progabide, sodium valproate or tetrahydroisoxazolopyridinol (THIP) for people with antipsychotic-induced TD. Evidence is inconclusive and unconvincing. The quality of data available for main outcomes ranges from very low to low. Any possible benefits are likely to be outweighed by the adverse effects associated with their use.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ".\nEvidence of the effects of GABA agonist drugs in the treatment of tardive dyskinesia is not conclusive and not convincing. Any possible benefits of GABA agonist drugs are likely to be outweighed by the adverse effects associated with their use."
}
] |
query-laysum
|
6948
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[
{
"role": "user",
"content": "Abstract: Background\nContractures are a common complication of neurological and non-neurological conditions, and are characterised by a reduction in joint mobility. Stretch is widely used for the treatment and prevention of contractures. However, it is not clear whether stretch is effective. This review is an update of the original 2010 version of this review.\nObjectives\nThe aim of this review was to determine the effects of stretch on contractures in people with, or at risk of developing, contractures.The outcomes of interest were joint mobility, quality of life, pain, activity limitations, participation restrictions, spasticity and adverse events.\nSearch methods\nIn November 2015 we searched CENTRAL, DARE, HTA; MEDLINE; Embase; CINAHL; SCI-EXPANDED; PEDro and trials registries.\nSelection criteria\nWe included randomised controlled trials and controlled clinical trials of stretch applied for the purpose of treating or preventing contractures.\nData collection and analysis\nTwo review authors independently selected trials, extracted data, and assessed risk of bias. The outcomes of interest were joint mobility, quality of life, pain, activity limitations, participation restrictions and adverse events. We evaluated outcomes in the short term (up to one week after the last stretch) and in the long term (more than one week). We expressed effects as mean differences (MD) or standardised mean differences (SMD) with 95% confidence intervals (CI). We conducted meta-analyses with a random-effects model. We assessed the quality of the body of evidence for the main outcomes using GRADE.\nMain results\nForty-nine studies with 2135 participants met the inclusion criteria. No study performed stretch for more than seven months. Just over half the studies (51%) were at low risk of selection bias; all studies were at risk of detection bias for self reported outcomes such as pain and at risk of performance bias due to difficulty of blinding the intervention. However, most studies were at low risk of detection bias for objective outcomes including range of motion, and the majority of studies were free from attrition and selective reporting biases. The effect of these biases were unlikely to be important, given that there was little benefit with treatment. There was high-quality evidence that stretch did not have clinically important short-term effects on joint mobility in people with neurological conditions (MD 2°; 95% CI 0° to 3°; 26 studies with 699 participants) or non-neurological conditions (SMD 0.2, 95% CI 0 to 0.3, 19 studies with 925 participants).\nIn people with neurological conditions, it was uncertain whether stretch had clinically important short-term effects on pain (SMD 0.2; 95% CI -0.1 to 0.5; 5 studies with 174 participants) or activity limitations (SMD 0.2; 95% CI -0.1 to 0.5; 8 studies with 247 participants). No trials examined the short-term effects of stretch on quality of life or participation restrictions in people with neurological conditions. Five studies involving 145 participants reported eight adverse events including skin breakdown, bruising, blisters and pain but it was not possible to statistically analyse these data.\nIn people with non-neurological conditions, there was high-quality evidence that stretch did not have clinically important short-term effects on pain (SMD -0.2, 95% CI -0.4 to 0.1; 7 studies with 422 participants) and moderate-quality evidence that stretch did not have clinically important short-term effects on quality of life (SMD 0.3, 95% CI -0.1 to 0.7; 2 studies with 97 participants). The short-term effect of stretch on activity limitations (SMD 0.1; 95% CI -0.2 to 0.3; 5 studies with 356 participants) and participation restrictions were uncertain (SMD -0.2; 95% CI -0.6 to 0.1; 2 studies with 192 participants). Nine studies involving 635 participants reported 41 adverse events including numbness, pain, Raynauds’ phenomenon, venous thrombosis, need for manipulation under anaesthesia, wound infections, haematoma, flexion deficits and swelling but it was not possible to statistically analyse these data.\nAuthors' conclusions\nThere was high-quality evidence that stretch did not have clinically important effects on joint mobility in people with or without neurological conditions if performed for less than seven months. Sensitivity analyses indicate results were robust in studies at risk of selection and detection biases in comparison to studies at low risk of bias. Sub-group analyses also suggest the effect of stretch is consistent in people with different types of neurological or non-neurological conditions. The effects of stretch performed for periods longer than seven months have not been investigated. There was moderate- and high-quality evidence that stretch did not have clinically important short-term effects on quality of life or pain in people with non-neurological conditions, respectively. The short-term effects of stretch on quality of life and pain in people with neurological conditions, and the short-term effects of stretch on activity limitations and participation restrictions for people with and without neurological conditions are uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "this Cochrane review is current to November 2015. It includes the results of 49 randomised controlled trials involving 2135 participants. The participants had a variety of neurological and non-neurological conditions including stroke, acquired brain injury and spinal cord injury, arthritis, wrist fracture and burns.\nStudies compared stretch to no stretch, often delivered with standard care for the disorder or another co-intervention such as exercise or botulinum toxin injection in the case of spasticity.\nThe stretch was administered in a variety of different ways including through passive stretching (self-administered, therapist-administered and device-administered), positioning, splinting and serial casting.\nThe stretch dosage was highly variable, ranging from five minutes to 24 hours per day (median 420 minutes, IQR 38 to 600) for between two days and seven months (median 35 days, IQR 23 to 84). The total cumulative time that stretch was administered ranged from 23 minutes to 1456 hours (median 168 hours, IQR 24 to 672).\nThe outcomes of interest were joint range of motion, spasticity, pain, ability to move, ability to participate in life, quality of life and adverse events. The short-term (less than one week) and long-term (more than one week) effects were investigated separately."
}
] |
query-laysum
|
6949
|
[
{
"role": "user",
"content": "Abstract: Background\nOvereating and harmful alcohol and tobacco use have been linked to the aetiology of various non-communicable diseases, which are among the leading global causes of morbidity and premature mortality. As people are repeatedly exposed to varying sizes and shapes of food, alcohol and tobacco products in environments such as shops, restaurants, bars and homes, this has stimulated public health policy interest in product size and shape as potential targets for intervention.\nObjectives\n1) To assess the effects of interventions involving exposure to different sizes or sets of physical dimensions of a portion, package, individual unit or item of tableware on unregulated selection or consumption of food, alcohol or tobacco products in adults and children.\n2) To assess the extent to which these effects may be modified by study, intervention and participant characteristics.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PsycINFO, eight other published or grey literature databases, trial registries and key websites up to November 2012, followed by citation searches and contacts with study authors. This original search identified eligible studies published up to July 2013, which are fully incorporated into the review. We conducted an updated search up to 30 January 2015 but further eligible studies are not yet fully incorporated due to their minimal potential to change the conclusions.\nSelection criteria\nRandomised controlled trials with between-subjects (parallel-group) or within-subjects (cross-over) designs, conducted in laboratory or field settings, in adults or children. Eligible studies compared at least two groups of participants, each exposed to a different size or shape of a portion of a food (including non-alcoholic beverages), alcohol or tobacco product, its package or individual unit size, or of an item of tableware used to consume it, and included a measure of unregulated selection or consumption of food, alcohol or tobacco.\nData collection and analysis\nWe applied standard Cochrane methods to select eligible studies for inclusion and to collect data and assess risk of bias. We calculated study-level effect sizes as standardised mean differences (SMDs) between comparison groups, measured as quantities selected or consumed. We combined these results using random-effects meta-analysis models to estimate summary effect sizes (SMDs with 95% confidence intervals (CIs)) for each outcome for size and shape comparisons. We rated the overall quality of evidence using the GRADE system. Finally, we used meta-regression analysis to investigate statistical associations between summary effect sizes and variant study, intervention or participant characteristics.\nMain results\nThe current version of this review includes 72 studies, published between 1978 and July 2013, assessed as being at overall unclear or high risk of bias with respect to selection and consumption outcomes. Ninety-six per cent of included studies (69/72) manipulated food products and 4% (3/72) manipulated cigarettes. No included studies manipulated alcohol products. Forty-nine per cent (35/72) manipulated portion size, 14% (10/72) package size and 21% (15/72) tableware size or shape. More studies investigated effects among adults (76% (55/72)) than children and all studies were conducted in high-income countries - predominantly in the USA (81% (58/72)). Sources of funding were reported for the majority of studies, with no evidence of funding by agencies with possible commercial interests in their results.\nA meta-analysis of 86 independent comparisons from 58 studies (6603 participants) found a small to moderate effect of portion, package, individual unit or tableware size on consumption of food (SMD 0.38, 95% CI 0.29 to 0.46), providing moderate quality evidence that exposure to larger sizes increased quantities of food consumed among children (SMD 0.21, 95% CI 0.10 to 0.31) and adults (SMD 0.46, 95% CI 0.40 to 0.52). The size of this effect suggests that, if sustained reductions in exposure to larger-sized food portions, packages and tableware could be achieved across the whole diet, this could reduce average daily energy consumed from food by between 144 and 228 kcal (8.5% to 13.5% from a baseline of 1689 kcal) among UK children and adults. A meta-analysis of six independent comparisons from three studies (108 participants) found low quality evidence for no difference in the effect of cigarette length on consumption (SMD 0.25, 95% CI -0.14 to 0.65).\nOne included study (50 participants) estimated a large effect on consumption of exposure to differently shaped tableware (SMD 1.17, 95% CI 0.57 to 1.78), rated as very low quality evidence that exposure to shorter, wider bottles (versus taller, narrower bottles) increased quantities of water consumed by young adult participants.\nA meta-analysis of 13 independent comparisons from 10 studies (1164 participants) found a small to moderate effect of portion or tableware size on selection of food (SMD 0.42, 95% CI 0.24 to 0.59), rated as moderate quality evidence that exposure to larger sizes increased the quantities of food people selected for subsequent consumption. This effect was present among adults (SMD 0.55, 95% CI 0.35 to 0.75) but not children (SMD 0.14, 95% CI -0.06 to 0.34).\nIn addition, a meta-analysis of three independent comparisons from three studies (232 participants) found a very large effect of exposure to differently shaped tableware on selection of non-alcoholic beverages (SMD 1.47, 95% CI 0.52 to 2.43), rated as low quality evidence that exposure to shorter, wider (versus taller, narrower) glasses or bottles increased the quantities selected for subsequent consumption among adults (SMD 2.31, 95% CI 1.79 to 2.83) and children (SMD 1.03, 95% CI 0.41 to 1.65).\nAuthors' conclusions\nThis review found that people consistently consume more food and drink when offered larger-sized portions, packages or tableware than when offered smaller-sized versions. This suggests that policies and practices that successfully reduce the size, availability and appeal of larger-sized portions, packages, individual units and tableware can contribute to meaningful reductions in the quantities of food (including non-alcoholic beverages) people select and consume in the immediate and short term. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. We are unable to highlight clear implications for tobacco or alcohol policy due to identified gaps in the current evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Effects of shape on consumption\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study found that adults provided with shorter, wider bottles drank larger amounts of water from them, having already poured more, compared with those provided with taller, narrower bottles. However, we rated the quality of this evidence as very low, due to very serious concerns about study limitations and not having enough evidence (only one study with outcome data from 50 participants)."
}
] |
query-laysum
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6950
|
[
{
"role": "user",
"content": "Abstract: Background\nContinual improvement in adjuvant therapies has resulted in a better prognosis for women diagnosed with breast cancer. A surrogate marker used to detect the spread of disease after treatment of breast cancer is local and regional recurrence. The risk of local and regional recurrence after mastectomy increases with the number of axillary lymph nodes affected by cancer. There is a consensus to use radiotherapy as an adjuvant treatment after mastectomy (postmastectomy radiotherapy (PMRT)) in women diagnosed with breast cancer and found to have disease in four or more positive axillary lymph nodes. Despite data showing almost double the risk of local and regional recurrence in women treated with mastectomy and found to have one to three positive lymph nodes, there is a lack of international consensus on the use of PMRT in this group.\nObjectives\nTo assess the effects of PMRT in women diagnosed with early breast cancer and found to have one to three positive axillary lymph nodes.\nSearch methods\nWe searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov up to 24 September 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs). The inclusion criteria included women diagnosed with breast cancer treated with simple or modified radical mastectomy and axillary surgery (sentinel lymph node biopsy (SLNB) alone or those undergoing axillary lymph node clearance with or without prior SLNB). We included only women receiving PMRT using X-rays (electron and photon radiation), and we defined the radiotherapy dose to reflect what is currently being recommended (i.e. 40 Gray (Gy) to 50 Gy in 15 to 25/28 fractions in 3 to 5 weeks. The included studies did not administer any boost to the tumour bed. In this review, we excluded studies using neoadjuvant chemotherapy as a supportive treatment before surgery.\nData collection and analysis\nWe used Covidence to screen records. We collected data on tumour characteristics, adjuvant treatments and the outcomes of local and regional recurrence, overall survival, disease-free survival, time to progression, short- and long-term adverse events and quality of life. We reported on time-to-event outcome measures using the hazard ratio (HR) and subdistribution HR. We used Cochrane's risk of bias tool (RoB 1), and we presented overall certainty of the evidence using the GRADE approach.\nMain results\nThe RCTs included in this review were subgroup analyses of original RCTs conducted in the 1980s to assess the effectiveness of PMRT. Hence, the type and duration of adjuvant systemic treatments used in the studies included in this review were suboptimal compared to the current standard of care.\nThe review involved three RCTs with a total of 829 women diagnosed with breast cancer and low-volume axillary disease. Amongst the included studies, only a single study pertained to the modern-day radiotherapy practice. The results from this one study showed a reduction of local and regional recurrence (HR 0.20, 95% confidence interval (CI) 0.13 to 0.33, 1 study, 522 women; low-certainty evidence) and improvement in overall survival with PMRT (HR 0.76, 95% CI 0.60 to 0.97, 1 study, 522 women; moderate-certainty evidence). One of the other studies using radiotherapy techniques that do not reflect modern-day practice reported on disease-free survival in women with low-volume axillary disease (subdistribution HR 0.63, 95% CI 0.41 to 0.96, 1 study, 173 women). None of the included studies reported on PMRT side effects or quality-of-life outcome measures.\nAuthors' conclusions\nBased on one study, the use of PMRT in women diagnosed with breast cancer and low-volume axillary disease indicated a reduction in locoregional recurrence and an improvement in survival. There is a need for more research to be conducted using modern-day radiotherapy equipment and methods to support and supplement the review findings.\n\nGiven the provided abstract, please respond to the following query: \"What is the role of additional supportive treatment in the management of breast cancer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Radiotherapy is a well-established supportive targeted treatment that reduces region-specific recurrence after surgery in women diagnosed with breast cancer. However, researchers over the last 2 to 3 decades were not able to show without doubt that the reduction in recurrence central to a location with radiotherapy leads to fewer breast cancer-related deaths."
}
] |
query-laysum
|
6951
|
[
{
"role": "user",
"content": "Abstract: Background\nPouchitis occurs in approximately 50% of patients following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis (UC).\nObjectives\nThe primary objective was to determine the efficacy and safety of medical therapies for prevention or treatment of acute or chronic pouchitis.\nSearch methods\nWe searched MEDLINE, Embase and CENTRAL from inception to 25 July 2018. We also searched references, trials registers, and conference proceedings.\nSelection criteria\nRandomized controlled trials of prevention or treatment of acute or chronic pouchitis in adults who underwent IPAA for UC were considered for inclusion.\nData collection and analysis\nTwo authors independently screened studies for eligibility, extracted data and assessed the risk of bias. The certainty of the evidence was evaluated using GRADE. The primary outcome was clinical improvement or remission in participants with acute or chronic pouchitis, or the proportion of participants with no episodes of pouchitis after IPAA. Adverse events (AEs) was a secondary outcome. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for each dichotomous outcome.\nMain results\nFifteen studies (547 participants) were included. Four studies assessed treatment of acute pouchitis. Five studies assessed treatment of chronic pouchitis. Six studies assessed prevention of pouchitis. Three studies were low risk of bias. Three studies were high risk of bias and the other studies were unclear.\nAcute pouchitis: All ciprofloxacin participants (7/7) achieved remission at two weeks compared to 33% (3/9) of metronidazole participants (RR 2.68, 95% CI 1.13 to 6.35, very low certainty evidence). No ciprofloxacin participants (0/7) had an AE compared to 33% (3/9) of metronidazole participants (RR 0.18, 95% CI 0.01 to 2.98; very low certainty evidence). AEs included vomiting, dysgeusia or transient peripheral neuropathy. Forty-three per cent (6/14) of metronidazole participants achieved remission at 6 weeks compared to 50% (6/12) of budesonide enema participants (RR 0.86, 95% CI 0.37 to 1.96, very low certainty evidence). Fifty per cent (7/14) of metronidazole participants improved clinically at 6 weeks compared to 58% (7/12) of budesonide enema participants (RR 0.86, 95% CI 0.42 to 1.74, very low certainty evidence). Fifty-seven per cent (8/14) of metronidazole participants had an AE compared to 25% (3/12) of budesonide enema participants (RR 2.29, 95% CI 0.78 to 6.73, very low certainty evidence). AEs included anorexia, nausea, headache, asthenia, metallic taste, vomiting, paraesthesia, and depression. Twenty-five per cent (2/8) of rifaximin participants achieved remission at 4 weeks compared to 0% (0/10) of placebo participants (RR 6.11, 95% CI 0.33 to 111.71, very low certainty evidence). Thirty-eight per cent (3/8) of rifaximin participants improved clinically at 4 weeks compared to 30% (3/10) of placebo participants (RR 1.25, 95% CI 0.34 to 4.60, very low certainty evidence). Seventy-five per cent (6/8) of rifaximin participants had an AE compared to 50% (5/10) of placebo participants (RR 1.50, 95% CI 0.72 to 3.14, very low certainty evidence). AEs included diarrhea, flatulence, nausea, proctalgia, vomiting, thirst, candida, upper respiratory tract infection, increased hepatic enzyme, and cluster headache. Ten per cent (1/10) of Lactobacillus GG participants improved clinically at 12 weeks compared to 0% (0/10) of placebo participants (RR 3.00, 95% CI 0.14 to 65.90, very low certainty evidence).\nChronic pouchitis: Eighty-five per cent (34/40) of De Simone Formulation (a probiotic formulation) participants maintained remission at 9 to 12 months compared to 3% (1/36) of placebo participants (RR 20.24, 95% CI 4.28 to 95.81, 2 studies; low certainty evidence). Two per cent (1/40) of De Simone Formulation participants had an AE compared to 0% (0/36) of placebo participants (RR 2.43, 95% CI 0.11 to 55.89; low certainty evidence). AEs included abdominal cramps, vomiting and diarrhea. Fifty per cent (3/6) of adalimumab patients achieved clinical improvement at 4 weeks compared to 43% (3/7) of placebo participants (RR, 1.17, 95% CI 0.36 to 3.76, low certainty evidence). Sixty per cent (6/10) of glutamine participants maintained remission at 3 weeks compared to 33% (3/9) of butyrate participants (RR 1.80, 95% CI 0.63 to 5.16, very low certainty evidence). Forty-five per cent (9/20) of patients treated with bismuth carbomer foam enema improved clinically at 3 weeks compared to 45% (9/20) of placebo participants (RR 1.00, 95% CI 0.50 to 1.98, very low certainty evidence). Twenty-five per cent (5/20) of participants in the bismuth carbomer foam enema group had an AE compared to 35% (7/20) of placebo participants (RR 0.71, 95% CI 0.27 to 1.88, very low certainty evidence). Adverse events included diarrhea, worsening symptoms, cramping, sinusitis, and abdominal pain.\nPrevention: At 12 months, 90% (18/20) of De Simone Formulation participants had no episodes of acute pouchitis compared to 60% (12/20) of placebo participants (RR 1.50, 95% CI 1.02 to 2.21, low certainty evidence). Another study found 100% (16/16) of De Simone Formulation participants had no episodes of acute pouchitis at 12 months compared to 92% (11/12) of the no treatment control group (RR 1.10, 95% 0.89 to 1.36, very low certainty evidence). Eighty-six per cent (6/7) of Bifidobacterium longum participants had no episodes of acute pouchitis at 6 months compared to 60% (3/5) of placebo participants (RR 1.43, 95% CI 0.66 to 3.11, very low certainty evidence). Eleven per cent (1/9) of Clostridium butyricum MIYAIRI participants had no episodes of acute pouchitis at 24 months compared to 50% (4/8) of placebo participants (RR 0.22, 95% CI 0.03 to 1.60, very low certainty evidence). Forty-six per cent (43/94) of allopurinol participants had no episodes of pouchitis at 24 months compared to 43% (39/90) of placebo participants (RR 1.06, 95% CI 0.76 to 1.46; low certainty evidence). Eighty-one per cent (21/26) of tinidazole participants had no episodes of pouchitis over 12 months compared to 58% (7/12) of placebo participants (RR 1.38, 95% CI 0.83 to 2.31, very low certainty evidence).\nAuthors' conclusions\nThe effects of antibiotics, probiotics and other interventions for treating and preventing pouchitis are uncertain. Well designed, adequately powered studies are needed to determine the optimal therapy for the treatment and prevention of pouchitis.\n\nGiven the provided abstract, please respond to the following query: \"What did the researchers find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 15 studies with a total of 547 participants. Four studies assessed treatment of acute pouchitis. Five studies assessed treatment of chronic pouchitis. Six studies assessed prevention of pouchitis."
}
] |
query-laysum
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6952
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[
{
"role": "user",
"content": "Abstract: Background\nGonadotrophin-releasing hormone (GnRH) antagonists can be used to prevent a luteinizing hormone (LH) surge during controlled ovarian hyperstimulation (COH) without the hypo-oestrogenic side-effects, flare-up, or long down-regulation period associated with agonists. The antagonists directly and rapidly inhibit gonadotrophin release within several hours through competitive binding to pituitary GnRH receptors. This property allows their use at any time during the follicular phase. Several different regimens have been described including multiple-dose fixed (0.25 mg daily from day six to seven of stimulation), multiple-dose flexible (0.25 mg daily when leading follicle is 14 to 15 mm), and single-dose (single administration of 3 mg on day 7 to 8 of stimulation) protocols, with or without the addition of an oral contraceptive pill. Further, women receiving antagonists have been shown to have a lower incidence of ovarian hyperstimulation syndrome (OHSS). Assuming comparable clinical outcomes for the antagonist and agonist protocols, these benefits would justify a change from the standard long agonist protocol to antagonist regimens. This is an update of a Cochrane review first published in 2001, and previously updated in 2006 and 2011.\nObjectives\nTo evaluate the effectiveness and safety of gonadotrophin-releasing hormone (GnRH) antagonists compared with the standard long protocol of GnRH agonists for controlled ovarian hyperstimulation in assisted conception cycles.\nSearch methods\nWe searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched from inception to May 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, inception to 28 April 2015), Ovid MEDLINE (1966 to 28 April 2015), EMBASE (1980 to 28 April 2015), PsycINFO (1806 to 28 April 2015), CINAHL (to 28 April 2015) and trial registers to 28 April 2015, and handsearched bibliographies of relevant publications and reviews, and abstracts of major scientific meetings, for example the European Society of Human Reproduction and Embryology (ESHRE) and American Society for Reproductive Medicine (ASRM). We contacted the authors of eligible studies for missing or unpublished data. The evidence is current to 28 April 2015.\nSelection criteria\nTwo review authors independently screened the relevant citations for randomised controlled trials (RCTs) comparing different GnRH agonist versus GnRH antagonist protocols in women undergoing in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias, and extracted the data. The primary review outcomes were live birth and ovarian hyperstimulation syndrome (OHSS). Other adverse effects (miscarriage and cycle cancellation) were secondary outcomes. We combined data to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I2 statistic. We assessed the overall quality of the evidence for each comparison using GRADE methods.\nMain results\nWe included 73 RCTs, with 12,212 participants, comparing GnRH antagonist to long-course GnRH agonist protocols. The quality of the evidence was moderate: limitations were poor reporting of study methods.\nLive birth\nThere was no evidence of a difference in live birth rate between GnRH antagonist and long course GnRH agonist (OR 1.02, 95% CI 0.85 to 1.23; 12 RCTs, n = 2303, I2= 27%, moderate quality evidence). The evidence suggested that if the chance of live birth following GnRH agonist is assumed to be 29%, the chance following GnRH antagonist would be between 25% and 33%.\nOHSS\nGnRH antagonist was associated with lower incidence of any grade of OHSS than GnRH agonist (OR 0.61, 95% C 0.51 to 0.72; 36 RCTs, n = 7944, I2 = 31%, moderate quality evidence). The evidence suggested that if the risk of OHSS following GnRH agonist is assumed to be 11%, the risk following GnRH antagonist would be between 6% and 9%.\nOther adverse effects\nThere was no evidence of a difference in miscarriage rate per woman randomised between GnRH antagonist group and GnRH agonist group (OR 1.03, 95% CI 0.82 to 1.29; 34 RCTs, n = 7082, I2 = 0%, moderate quality evidence).\nWith respect to cycle cancellation, GnRH antagonist was associated with a lower incidence of cycle cancellation due to high risk of OHSS (OR 0.47, 95% CI 0.32 to 0.69; 19 RCTs, n = 4256, I2 = 0%). However cycle cancellation due to poor ovarian response was higher in women who received GnRH antagonist than those who were treated with GnRH agonist (OR 1.32, 95% CI 1.06 to 1.65; 25 RCTs, n = 5230, I2 = 68%; moderate quality evidence).\nAuthors' conclusions\nThere is moderate quality evidence that the use of GnRH antagonist compared with long-course GnRH agonist protocols is associated with a substantial reduction in OHSS without reducing the likelihood of achieving live birth.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was of moderate quality for both live birth and OHSS. The main limitations of the evidence were the possibility of publication bias for live birth (with small studies likely to report favourable outcomes for GnRH antagonist) and poor reporting of study methods for OHSS."
}
] |
query-laysum
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6953
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[
{
"role": "user",
"content": "Abstract: Background\nGlioblastoma (GBM) is a highly malignant brain tumour that almost inevitably progresses or recurs after first line standard of care. There is no consensus regarding the best treatment/s to offer people upon disease progression or recurrence. For the purposes of this review, progression and recurrence are considered as one entity.\nObjectives\nTo evaluate the effectiveness of further treatment/s for first and subsequent progression or recurrence of glioblastoma (GBM) among people who have received the standard of care (Stupp protocol) for primary treatment of the disease; and to prepare a brief economic commentary on the available evidence.\nSearch methods\nWe searched MEDLINE and Embase electronic databases from 2005 to December 2019 and the Cochrane Central Register of Controlled Trials (CENTRAL, in the Cochrane Library; Issue 12, 2019). Economic searches included the National Health Service Economic Evaluation Database (NHS EED) up to 2015 (database closure) and MEDLINE and Embase from 2015 to December 2019.\nSelection criteria\nRandomised controlled trials (RCTs) and comparative non-randomised studies (NRSs) evaluating effectiveness of treatments for progressive/recurrent GBM. Eligible studies included people with progressive or recurrent GBM who had received first line radiotherapy with concomitant and adjuvant temozolomide (TMZ).\nData collection and analysis\nTwo review authors independently selected studies and extracted data to a pre-designed data extraction form. We conducted network meta-analyses (NMA) and ranked treatments according to effectiveness for each outcome using the random-effects model and Stata software (version 15). We rated the certainty of evidence using the GRADE approach.\nMain results\nWe included 42 studies: these comprised 34 randomised controlled trials (RCTs) and 8 non-randomised studies (NRSs) involving 5236 participants. We judged most RCTs to be at a low risk of bias and NRSs at high risk of bias. Interventions included chemotherapy, re-operation, re-irradiation and novel therapies either used alone or in combination. For first recurrence, we included 11 interventions in the network meta-analysis (NMA) for overall survival (OS), and eight in the NMA for progression-free survival (PFS). Lomustine (LOM; also known as CCNU) was the most common comparator and was used as the reference treatment. No studies in the NMA evaluated surgery, re-irradiation, PCV (procarbazine, lomustine, vincristine), TMZ re-challenge or best supportive care. We could not perform NMA for second or later recurrence due to insufficient data. Quality-of-life data were sparse.\nFirst recurrence (NMA findings)\nMedian OS across included studies in the NMA ranged from 5.5 to 12.6 months and median progression-free survival (PFS) ranged from 1.5 months to 4.2 months. We found no high-certainty evidence that any treatments tested were better than lomustine. These treatments included the following.\nBevacizumab plus lomustine: Evidence suggested probably little or no difference in OS between bevacizumab (BEV) combined with lomustine (LOM) and LOM monotherapy (hazard ratio (HR) 0.91, 0.75 to 1.10; moderate-certainty evidence), although BEV + LOM may improve PFS (HR 0.57, 95% confidence interval (CI) 0.44 to 0.74; low-certainty evidence).\nBevacizumab monotherapy: Low-certainty evidence suggested there may be little or no difference in OS (HR 1.22, 95% CI 0.84 to 1.76) and PFS (HR 0.90, 95% CI 0.58 to 1.38; low-certainty evidence) between BEV and LOM monotherapies; more evidence on BEV is needed.\nRegorafenib (REG): REG may improve OS compared with LOM (HR 0.50, 95% CI 0.33 to 0.76; low-certainty evidence). Evidence on PFS was very low certainty and more evidence on REG is needed.\nTemozolomide (TMZ) plus Depatux-M (ABT414): For OS, low-certainty evidence suggested that TMZ plus ABT414 may be more effective than LOM (HR 0.66, 95% CI 0.47 to 0.92) and may be more effective than BEV (HR 0.54, 95% CI 0.33 to 0.89; low-certainty evidence). This may be due to the TMZ component only and more evidence is needed.\nFotemustine (FOM): FOM and LOM may have similar effects on OS (HR 0.89, 95% CI 0.51 to 1.57, low-certainty evidence).\nBevacizumab and irinotecan (IRI): Evidence on BEV + irinotecan (IRI) versus LOM for both OS and PFS is very uncertain and there is probably little or no difference between BEV + IRI versus BEV monotherapy (OS: HR 0.95, 95% CI 0.70 to 1.30; moderate-certainty evidence).\nWhen treatments were ranked for OS, FOM ranked first, BEV + LOM second, LOM third, BEV + IRI fourth, and BEV fifth. Ranking does not take into account the certainty of the evidence, which also suggests there may be little or no difference between FOM and LOM.\nOther treatments\nThree studies evaluated re-operation versus no re-operation, with or without re-irradiation and chemotherapy, and these suggested possible survival advantages with re-operation within the context of being able to select suitable candidates for re-operation. A cannabinoid treatment in the early stages of evaluation, in combination with TMZ, merits further evaluation.\nSecond or later recurrence\nLimited evidence from three heterogeneous studies suggested that radiotherapy with or without BEV may have a beneficial effect on survival but more evidence is needed. Evidence was insufficient to draw conclusions about the best radiotherapy dosage. Other evidence suggested that there may be little difference in survival with tumour-treating fields compared with physician's best choice of treatment. We found no reliable evidence on best supportive care.\nSevere adverse events (SAEs)\nThe BEV+LOM combination was associated with significantly greater risk of SAEs than LOM monotherapy (RR 2.51, 95% CI 1.72 to 3.66, high-certainty evidence), and ranked joint worst with cediranib + LOM (RR 2.51, 95% CI 1.29 to 4.90; high-certainty evidence). LOM ranked best and REG ranked second best. Adding novel treatments to BEV was generally associated with a higher risk of severe adverse events compared with BEV alone.\nAuthors' conclusions\nFor treatment of first recurrence of GBM, among people previously treated with surgery and standard chemoradiotherapy, the combination treatments evaluated did not improve overall survival compared with LOM monotherapy and were often associated with a higher risk of severe adverse events. Limited evidence suggested that re-operation with or without re-irradiation and chemotherapy may be suitable for selected candidates. Evidence on second recurrence is sparse. Re-irradiation with or without bevacizumab may be of value in selected individuals, but more evidence is needed.\n\nGiven the provided abstract, please respond to the following query: \"Objectives\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To evaluate which are the most effective treatments for people with progressive or recurrent GBM who have already received surgery, radiotherapy and chemotherapy. We looked at effectiveness in terms of length of overall survival (OS), survival without disease progression (progression free survival, PFS), serious side effects, and whether treatments affected quality of life. We looked at treatments given when the disease first progressed or recurred (first recurrence) and when it came back again after that (second or subsequent recurrences)."
}
] |
query-laysum
|
6954
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic kidney disease (CKD) is associated with high morbidity and death, which increases as CKD progresses to end-stage kidney disease (ESKD). There has been increasing interest in developing innovative, effective and cost-efficient methods to engage with patient populations and improve health behaviours and outcomes. Worldwide there has been a tremendous increase in the use of technologies, with increasing interest in using eHealth interventions to improve patient access to relevant health information, enhance the quality of healthcare and encourage the adoption of healthy behaviours.\nObjectives\nThis review aims to evaluate the benefits and harms of using eHealth interventions to change health behaviours in people with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 14 January 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs using an eHealth intervention to promote behaviour change in people with CKD were included. There were no restrictions on outcomes, language or publication type.\nData collection and analysis\nTwo authors independently assessed trial eligibility, extracted data and assessed the risk of bias. The certainty of the evidence was assessed using GRADE.\nMain results\nWe included 43 studies with 6617 participants that evaluated the impact of an eHealth intervention in people with CKD. Included studies were heterogeneous in terms of eHealth modalities employed, type of intervention, CKD population studied and outcomes assessed. The majority of studies (39 studies) were conducted in an adult population, with 16 studies (37%) conducted in those on dialysis, 11 studies (26%) in the pre-dialysis population, 15 studies (35%) in transplant recipients and 1 studies (2%) in transplant candidates We identified six different eHealth modalities including: Telehealth; mobile or tablet application; text or email messages; electronic monitors; internet/websites; and video or DVD. Three studies used a combination of eHealth interventions. Interventions were categorised into six types: educational; reminder systems; self-monitoring; behavioural counselling; clinical decision-aid; and mixed intervention types. We identified 98 outcomes, which were categorised into nine domains: blood pressure (9 studies); biochemical parameters (6 studies); clinical end-points (16 studies); dietary intake (3 studies); quality of life (9 studies); medication adherence (10 studies); behaviour (7 studies); physical activity (1 study); and cost-effectiveness (7 studies).\nOnly three outcomes could be meta-analysed as there was substantial heterogeneity with respect to study population and eHealth modalities utilised. There was found to be a reduction in interdialytic weight gain of 0.13kg (4 studies, 335 participants: MD -0.13, 95% CI -0.28 to 0.01; I2 = 0%) and a reduction in dietary sodium intake of 197 mg/day (2 studies, 181 participants: MD -197, 95% CI -540.7 to 146.8; I2 = 0%). Both dietary sodium and fluid management outcomes were graded as being of low evidence due to high or unclear risk of bias and indirectness (interdialytic weight gain) and high or unclear risk of bias and imprecision (dietary sodium intake). Three studies reported death (2799 participants, 146 events), with 45 deaths/1000 cases compared to standard care of 61 deaths/1000 cases (RR 0.74, CI 0.53 to 1.03; P = 0.08). We are uncertain whether using eHealth interventions, in addition to usual care, impact on the number of deaths as the certainty of this evidence was graded as low due to high or unclear risk of bias, indirectness and imprecision.\nAuthors' conclusions\neHealth interventions may improve the management of dietary sodium intake and fluid management. However, overall these data suggest that current evidence for the use of eHealth interventions in the CKD population is of low quality, with uncertain effects due to methodological limitations and heterogeneity of eHealth modalities and intervention types. Our review has highlighted the need for robust, high quality research that reports a core (minimum) data set to enable meaningful evaluation of the literature.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic kidney disease (CKD) is a condition where kidneys have reduced function over a period of time. To remain well people with CKD need to follow complex diet, lifestyle and medication advice and often need to use several specialist medical services. Some people with advanced CKD may need dialysis or treatment with a kidney transplant. Enabling patients to manage this condition by themselves improves quality and length of life and reduces healthcare costs. Electronic health (eHealth) interventions may improve patients’ ability to look after themselves and improve care provided by healthcare services. eHealth interventions refer to \"health services and information delivered or enhanced through the Internet and related technologies\". However, there is little research evaluating the impact of eHealth interventions in CKD."
}
] |
query-laysum
|
6955
|
[
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Beds, overlays or mattresses are widely used with the aim of treating pressure ulcers.\nObjectives\nTo assess the effects of beds, overlays and mattresses on pressure ulcer healing in people with pressure ulcers of any stage, in any setting.\nSearch methods\nIn November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials that allocated participants of any age to pressure-redistributing beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for treating pressure ulcers.\nData collection and analysis\nAt least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology.\nMain results\nWe included 13 studies (972 participants) in the review. Most studies were small (median study sample size: 72 participants). The average age of participants ranged from 64.0 to 86.5 years (median: 82.7 years) and all studies recruited people with existing pressure ulcers (the baseline ulcer area size ranging from 4.2 to 18.6 cm2,median 6.6 cm2). Participants were recruited from acute care settings (six studies) and community and long-term care settings (seven studies). Of the 13 studies, three (224 participants) involved surfaces that were not well described and therefore could not be classified. Additionally, six (46.2%) of the 13 studies presented findings which were considered at high overall risk of bias. We synthesised data for four comparisons in the review: alternating pressure (active) air surfaces versus foam surfaces; reactive air surfaces versus foam surfaces; reactive water surfaces versus foam surfaces, and a comparison between two types of alternating pressure (active) air surfaces. We summarise key findings for these four comparisons below.\n(1) Alternating pressure (active) air surfaces versus foam surfaces: we are uncertain if there is a difference between alternating pressure (active) air surfaces and foam surfaces in the proportion of participants whose pressure ulcers completely healed (two studies with 132 participants; the reported risk ratio (RR) in one study was 0.97, 95% confidence interval (CI) 0.26 to 3.58). There is also uncertainty for the outcomes of patient comfort (one study with 83 participants) and adverse events (one study with 49 participants). These outcomes have very low-certainty evidence. Included studies did not report time to complete ulcer healing, health-related quality of life, or cost effectiveness.\n(2) Reactive air surfaces versus foam surfaces: it is uncertain if there is a difference in the proportion of participants with completely healed pressure ulcers between reactive air surfaces and foam surfaces (RR 1.32, 95% CI 0.96 to 1.80; I2 = 0%; 2 studies, 156 participants; low-certainty evidence). When time to complete pressure ulcer healing is considered using a hazard ratio, data from one small study (84 participants) suggests a greater hazard for complete ulcer healing on reactive air surfaces (hazard ratio 2.66, 95% CI 1.34 to 5.17; low-certainty evidence). These results are sensitive to the choice of outcome measure so should be interpreted as uncertain. We are also uncertain whether there is any difference between these surfaces in patient comfort responses (1 study, 72 participants; very low-certainty evidence) and in adverse events (2 studies, 156 participants; low-certainty evidence). There is low-certainty evidence that reactive air surfaces may cost an extra 26 US dollars for every ulcer-free day in the first year of use (1 study, 87 participants). Included studies did not report health-related quality of life.\n(3) Reactive water surfaces versus foam surfaces: it is uncertain if there is a difference between reactive water surfaces and foam surfaces in the proportion of participants with healed pressure ulcers (RR 1.07, 95% CI 0.70 to 1.63; 1 study, 101 participants) and in adverse events (1 study, 120 participants). All these have very low-certainty evidence. Included studies did not report time to complete ulcer healing, patient comfort, health-related quality of life, or cost effectiveness.\n(4) Comparison between two types of alternating pressure (active) air surfaces: it is uncertain if there is a difference between Nimbus and Pegasus alternating pressure (active) air surfaces in the proportion of participants with healed pressure ulcers, in patient comfort responses and in adverse events: each of these outcomes had four studies (256 participants) but very low-certainty evidence. Included studies did not report time to complete ulcer healing, health-related quality of life, or cost effectiveness.\nAuthors' conclusions\nWe are uncertain about the relative effects of most different pressure-redistributing surfaces for pressure ulcer healing (types directly compared are alternating pressure air surfaces versus foam surfaces, reactive air surfaces versus foam surfaces, reactive water surfaces versus foam surfaces, and Nimbus versus Pegasus alternating pressure (active) air surfaces). There is also uncertainty regarding the effects of these different surfaces on the outcomes of comfort and adverse events. However, people using reactive air surfaces may be more likely to have pressure ulcers completely healed than those using foam surfaces over 37.5 days' follow-up, and reactive air surfaces may cost more for each ulcer-free day than foam surfaces.\nFuture research in this area could consider the evaluation of alternating pressure air surfaces versus foam surfaces as a high priority. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Further review using network meta-analysis adds to the findings reported here.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence in this Cochrane Review is current to November 2019."
}
] |
query-laysum
|
6956
|
[
{
"role": "user",
"content": "Abstract: Background\nVitamin E supplementation may help reduce the risk of pregnancy complications involving oxidative stress, such as pre-eclampsia. There is a need to evaluate the efficacy and safety of vitamin E supplementation in pregnancy.\nObjectives\nTo assess the effects of vitamin E supplementation, alone or in combination with other separate supplements, on pregnancy outcomes, adverse events, side effects and use of health services.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies.\nSelection criteria\nAll randomised or quasi-randomised controlled trials evaluating vitamin E supplementation in pregnant women. We excluded interventions using a multivitamin supplement that contained vitamin E.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nTwenty-one trials, involving 22,129 women were eligible for this review. Four trials did not contribute data. All of the remaining 17 trials assessed vitamin E in combination with vitamin C and/or other agents. Overall the risk of bias ranged from low to unclear to high; 10 trials were judged to be at low risk of bias, six trials to be at unclear risk of bias and five trials to be at high risk of bias. No clear difference was found between women supplemented with vitamin E in combination with other supplements during pregnancy compared with placebo for the risk of stillbirth (risk ratio (RR) 1.17, 95% confidence interval (CI) 0.88 to 1.56, nine studies, 19,023 participants, I² = 0%; moderate quality evidence), neonatal death (RR 0.81, 95% CI 0.58 to 1.13, nine trials, 18,617 participants, I² = 0%), pre-eclampsia (average RR 0.91, 95% CI 0.79 to 1.06; 14 trials, 20,878 participants; I² = 48%; moderate quality evidence), preterm birth (average RR 0.98, 95% CI 0.88 to 1.09, 11 trials, 20,565 participants, I² = 52%; high quality evidence) or intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06, 11 trials, 20,202 participants, I² = 17%; high quality evidence). Women supplemented with vitamin E in combination with other supplements compared with placebo were at decreased risk of having a placental abruption (RR 0.64, 95% CI 0.44 to 0.93, seven trials, 14,922 participants, I² = 0%; high quality evidence). Conversely, supplementation with vitamin E was associated with an increased risk of self-reported abdominal pain (RR 1.66, 95% CI 1.16 to 2.37, one trial, 1877 participants) and term prelabour rupture of membranes (PROM) (average RR 1.77, 95% CI 1.37 to 2.28, two trials, 2504 participants, I² = 0%); however, there was no corresponding increased risk for preterm PROM (average RR 1.27, 95% CI 0.93 to 1.75, five trials, 1999 participants, I² = 66%; low quality evidence). There were no clear differences between the vitamin E and placebo or control groups for any other maternal or infant outcomes. There were no clear differing patterns in subgroups of women based on the timing of commencement of supplementation or baseline risk of adverse pregnancy outcomes. The GRADE quality of the evidence was high for preterm birth, intrauterine growth restriction and placental abruption, moderate for stillbirth and clinical pre-eclampsia, and low for preterm PROM.\nAuthors' conclusions\nThe data do not support routine vitamin E supplementation in combination with other supplements for the prevention of stillbirth, neonatal death, preterm birth, pre-eclampsia, preterm or term PROM or poor fetal growth. Further research is required to elucidate the possible role of vitamin E in the prevention of placental abruption. There was no convincing evidence that vitamin E supplementation in combination with other supplements results in other important benefits or harms.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The large body of evidence does not support taking vitamin E supplements, alone or in combination, during pregnancy. This is because taking vitamin E in combination with other supplements during pregnancy does not help to prevent problems in pregnancy including stillbirth, baby death, preterm birth, pre-eclampsia or low birthweight babies. In fact, it may increase abdominal pain for women and also increase the number of women having early rupture of membranes at term."
}
] |
query-laysum
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6957
|
[
{
"role": "user",
"content": "Abstract: Background\nVirtual reality and interactive video gaming have emerged as recent treatment approaches in stroke rehabilitation with commercial gaming consoles in particular, being rapidly adopted in clinical settings. This is an update of a Cochrane Review published first in 2011 and then again in 2015.\nObjectives\nPrimary objective: to determine the efficacy of virtual reality compared with an alternative intervention or no intervention on upper limb function and activity.\nSecondary objectives: to determine the efficacy of virtual reality compared with an alternative intervention or no intervention on: gait and balance, global motor function, cognitive function, activity limitation, participation restriction, quality of life, and adverse events.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (April 2017), CENTRAL, MEDLINE, Embase, and seven additional databases. We also searched trials registries and reference lists.\nSelection criteria\nRandomised and quasi-randomised trials of virtual reality (\"an advanced form of human-computer interface that allows the user to 'interact' with and become 'immersed' in a computer-generated environment in a naturalistic fashion\") in adults after stroke. The primary outcome of interest was upper limb function and activity. Secondary outcomes included gait and balance and global motor function.\nData collection and analysis\nTwo review authors independently selected trials based on pre-defined inclusion criteria, extracted data, and assessed risk of bias. A third review author moderated disagreements when required. The review authors contacted investigators to obtain missing information.\nMain results\nWe included 72 trials that involved 2470 participants. This review includes 35 new studies in addition to the studies included in the previous version of this review. Study sample sizes were generally small and interventions varied in terms of both the goals of treatment and the virtual reality devices used. The risk of bias present in many studies was unclear due to poor reporting. Thus, while there are a large number of randomised controlled trials, the evidence remains mostly low quality when rated using the GRADE system. Control groups usually received no intervention or therapy based on a standard-care approach. Primary outcome: results were not statistically significant for upper limb function (standardised mean difference (SMD) 0.07, 95% confidence intervals (CI) -0.05 to 0.20, 22 studies, 1038 participants, low-quality evidence) when comparing virtual reality to conventional therapy. However, when virtual reality was used in addition to usual care (providing a higher dose of therapy for those in the intervention group) there was a statistically significant difference between groups (SMD 0.49, 0.21 to 0.77, 10 studies, 210 participants, low-quality evidence). Secondary outcomes: when compared to conventional therapy approaches there were no statistically significant effects for gait speed or balance. Results were statistically significant for the activities of daily living (ADL) outcome (SMD 0.25, 95% CI 0.06 to 0.43, 10 studies, 466 participants, moderate-quality evidence); however, we were unable to pool results for cognitive function, participation restriction, or quality of life. Twenty-three studies reported that they monitored for adverse events; across these studies there were few adverse events and those reported were relatively mild.\nAuthors' conclusions\nWe found evidence that the use of virtual reality and interactive video gaming was not more beneficial than conventional therapy approaches in improving upper limb function. Virtual reality may be beneficial in improving upper limb function and activities of daily living function when used as an adjunct to usual care (to increase overall therapy time). There was insufficient evidence to reach conclusions about the effect of virtual reality and interactive video gaming on gait speed, balance, participation, or quality of life. This review found that time since onset of stroke, severity of impairment, and the type of device (commercial or customised) were not strong influencers of outcome. There was a trend suggesting that higher dose (more than 15 hours of total intervention) was preferable as were customised virtual reality programs; however, these findings were not statistically significant.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 72 studies involving 2470 people after stroke. A wide range of virtual reality programs were used, with most aimed to improve either arm function or walking ability. The evidence is current to April 2017."
}
] |
query-laysum
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6958
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[
{
"role": "user",
"content": "Abstract: Background\nAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. While AIS can progress during growth and cause a surface deformity, it is usually not symptomatic. However, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Interventions for the prevention of AIS progression include scoliosis-specific exercises, bracing, and surgery. The main aims of all types of interventions are to correct the deformity and prevent further deterioration of the curve and to restore trunk asymmetry and balance, while minimising morbidity and pain, allowing return to full function. Surgery is normally recommended for curvatures exceeding 40 to 50 degrees to stop curvature progression with a view to achieving better truncal balance and cosmesis. Short-term results of the surgical treatment of people with AIS demonstrate the ability of surgery to improve various outcome measures. However there is a clear paucity of information on long-term follow-up of surgical treatment of people with AIS.\nObjectives\nTo examine the impact of surgical versus non-surgical interventions in people with AIS who have severe curves of over 45 degrees, with a focus on trunk balance, progression of scoliosis, cosmetic issues, quality of life, disability, psychological issues, back pain, and adverse effects, at both the short term (a few months) and the long term (over 20 years).\nSearch methods\nWe searched the Cochrane Back Review Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, four other databases, and three trials registers up to August 2014 with no language limitations. We also checked the reference lists of relevant articles and conducted an extensive handsearch of the grey literature.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) and prospective controlled trials comparing spinal fusion surgery with non-surgical interventions in people with AIS with a Cobb angle greater than 45 degrees. We were interested in all types of instrumented surgical interventions with fusion that aimed to provide curve correction and spine stabilisation.\nData collection and analysis\nWe found no RCTs or prospective controlled trials that met our inclusion criteria.\nMain results\nWe did not identify any evidence comparing surgical to non-surgical interventions for AIS with severe curves of over 45 degrees.\nAuthors' conclusions\nWe cannot draw any conclusions.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Scoliosis is a condition where the spine is curved in three dimensions (from the back the spine appears to be shaped like a 'c' or an 's'). It is often idiopathic, or of unknown cause. The most common type of scoliosis, adolescent idiopathic scoliosis (AIS), is discovered around 10 years of age or older, and is defined as a curve that measures at least 10 degrees (known as a Cobb angle, which is measured on an x-ray).\nPeople with AIS usually have no symptoms, however the resulting surface deformity frequently negatively impacts adolescents. In addition, increased curvature of the spine can present health risks in adulthood. Different types of treatment, including physical therapy, bracing, and surgery, are advocated depending on the magnitude of the curvature and area affected, truncal balance, general health, level of function and satisfaction, and patient’s and parent’s treatment desire.\nSurgery is normally recommended in curvatures exceeding 40 to 50 degrees to stop the progression of the curvature. Short-term results of surgical treatment are improvements on outcome measures relating to self image, some functional aspects, and pain. However, the structured long-term follow-up needed to make meaningful conclusions is lacking. Recent papers highlight the long-term complications of surgery, while other papers postulate that the medium- and long-term complication rates following modern scoliosis surgery are low when compared to older techniques."
}
] |
query-laysum
|
6959
|
[
{
"role": "user",
"content": "Abstract: Background\nEpidural analgesia offers greater pain relief compared to systemic opioid-based medications, but its effect on morbidity and mortality is unclear. This review was originally published in 2006 and was updated in 2012 and again in 2016.\nObjectives\nTo assess the benefits and harms of postoperative epidural analgesia in comparison with postoperative systemic opioid-based analgesia for adults undergoing elective abdominal aortic surgery.\nSearch methods\nIn the updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and five trial registers in November 2014, together with reference checking to identify additional studies. We reran the search in March 2017. One potential new trial of interest was added to a list of ‘Studies awaiting Classification' and will be incorporated into the formal review findings during the review update.\nSelection criteria\nWe included all randomized controlled trials comparing postoperative epidural analgesia and postoperative systemic opioid-based analgesia for adults who underwent elective open abdominal aortic surgery.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data. We contacted study authors for additional information and data when required. We assessed the level of evidence according to the scale provided by the GRADE working group.\nMain results\nWe included 15 trials published from 1987 to 2009 with 1498 participants in this updated review. Participants had a mean age between 60.5 and 71.3 years. The percentage of women in the included studies varied from 0% to 28.1%. Adding an epidural to general anaesthesia for people undergoing abdominal aortic repair reduced myocardial infarction (risk ratio (RR) 0.54 (95% confidence interval (CI) 0.30 to 0.97); I2 statistic = 0%; number needed to treat for one additional beneficial outcome (NNTB) 28 (95% CI 19 to 1423), visual or verbal analogical scale (VAS) scores up to three days after the surgery (mean difference (MD) -1.78 (95% CI -2.32 to -1.25); I2 statistic = 0% for VAS scores on movement at postoperative day one), time to tracheal extubation (standardized mean difference (SMD) -0.42 (95% CI -0.70 to -0.15); I2 statistic = 83%; equivalent to a mean reduction of 36 hours), postoperative respiratory failure (RR 0.69 (95% CI 0.56 to 0.85); I2 statistic = 0%; NNTB 8 (95% CI 6 to 16)), gastrointestinal bleeding (OR 0.20 (95% CI 0.06 to 0.65); I2 statistic = 0%; NNTB 32 (95% CI 27 to 74)) and time spent in the intensive care unit (SMD -0.23 (95% CI -0.41 to -0.06); I2 statistic = 0%; equivalent to a mean reduction of six hours). We did not demonstrate a reduction in the mortality rate up to 30 days (RR 1.06 (95% CI 0.60 to 1.86); I2 statistic = 0%). The level of evidence was low for mortality and time before tracheal extubation; moderate for myocardial infarction, respiratory failure and intensive care unit length of stay; and high for gastrointestinal bleeding and VAS scores.\nAuthors' conclusions\nEpidural analgesia provided better pain management, reduced myocardial infarction, time to tracheal extubation, postoperative respiratory failure, gastrointestinal bleeding, and intensive care unit length of stay compared with systemic opioid-based drugs. For mortality, we did not find a difference at 30 days.\n\nGiven the provided abstract, please respond to the following query: \"Objectives\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review evaluated the effect of these two methods of pain relief and the risks of postoperative complications and deaths after open abdominal aortic surgery. The review was originally published in 2006, updated in 2012, and again in 2015."
}
] |
query-laysum
|
6960
|
[
{
"role": "user",
"content": "Abstract: Background\nPrenatal exposure to certain anti-seizure medications (ASMs) is associated with an increased risk of major congenital malformations (MCM). The majority of women with epilepsy continue taking ASMs throughout pregnancy and, therefore, information on the potential risks associated with ASM treatment is required.\nObjectives\nTo assess the effects of prenatal exposure to ASMs on the prevalence of MCM in the child.\nSearch methods\nFor the latest update of this review, we searched the following databases on 17 February 2022: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to February 16, 2022), SCOPUS (1823 onwards), and ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP). No language restrictions were imposed.\nSelection criteria\nWe included prospective cohort controlled studies, cohort studies set within pregnancy registries, randomised controlled trials and epidemiological studies using routine health record data. Participants were women with epilepsy taking ASMs; the two control groups were women without epilepsy and untreated women with epilepsy.\nData collection and analysis\nFive authors independently selected studies for inclusion. Eight authors completed data extraction and/or risk of bias assessments. The primary outcome was the presence of an MCM. Secondary outcomes included specific types of MCM. Where meta-analysis was not possible, we reviewed included studies narratively.\nMain results\nFrom 12,296 abstracts, we reviewed 283 full-text publications which identified 49 studies with 128 publications between them. Data from ASM-exposed pregnancies were more numerous for prospective cohort studies (n = 17,963), than data currently available for epidemiological health record studies (n = 7913). The MCM risk for children of women without epilepsy was 2.1% (95% CI 1.5 to 3.0) in cohort studies and 3.3% (95% CI 1.5 to 7.1) in health record studies.\nThe known risk associated with sodium valproate exposure was clear across comparisons with a pooled prevalence of 9.8% (95% CI 8.1 to 11.9) from cohort data and 9.7% (95% CI 7.1 to 13.4) from routine health record studies. This was elevated across almost all comparisons to other monotherapy ASMs, with the absolute risk differences ranging from 5% to 9%. Multiple studies found that the MCM risk is dose-dependent. Children exposed to carbamazepine had an increased MCM prevalence in both cohort studies (4.7%, 95% CI 3.7 to 5.9) and routine health record studies (4.0%, 95% CI 2.9 to 5.4) which was significantly higher than that for the children born to women without epilepsy for both cohort (RR 2.30, 95% CI 1.47 to 3.59) and routine health record studies (RR 1.14, 95% CI 0.80 to 1.64); with similar significant results in comparison to the children of women with untreated epilepsy for both cohort studies (RR 1.44, 95% CI 1.05 to 1.96) and routine health record studies (RR 1.42, 95% CI 1.10 to 1.83).\nFor phenobarbital exposure, the prevalence was 6.3% (95% CI 4.8 to 8.3) and 8.8% (95% CI 0.0 to 9277.0) from cohort and routine health record data, respectively. This increased risk was significant in comparison to the children of women without epilepsy (RR 3.22, 95% CI 1.84 to 5.65) and those born to women with untreated epilepsy (RR 1.64, 95% CI 0.94 to 2.83) in cohort studies; data from routine health record studies was limited. For phenytoin exposure, the prevalence of MCM was elevated for cohort study data (5.4%, 95% CI 3.6 to 8.1) and routine health record data (6.8%, 95% CI 0.1 to 701.2). The prevalence of MCM was higher for phenytoin-exposed children in comparison to children of women without epilepsy (RR 3.81, 95% CI 1.91 to 7.57) and the children of women with untreated epilepsy (RR 2.01. 95% CI 1.29 to 3.12); there were no data from routine health record studies.\nPooled data from cohort studies indicated a significantly increased MCM risk for children exposed to lamotrigine in comparison to children born to women without epilepsy (RR 1.99, 95% CI 1.16 to 3.39); with a risk difference (RD) indicating a 1% increased risk of MCM (RD 0.01. 95% CI 0.00 to 0.03). This was not replicated in the comparison to the children of women with untreated epilepsy (RR 1.04, 95% CI 0.66 to 1.63), which contained the largest group of lamotrigine-exposed children (> 2700). Further, a non-significant difference was also found both in comparison to the children of women without epilepsy (RR 1.19, 95% CI 0.86 to 1.64) and children born to women with untreated epilepsy (RR 1.00, 95% CI 0.79 to 1.28) from routine data studies. For levetiracetam exposure, pooled data provided similar risk ratios to women without epilepsy in cohort (RR 2.20, 95% CI 0.98 to 4.93) and routine health record studies (RR 0.67, 95% CI 0.17 to 2.66). This was supported by the pooled results from both cohort (RR 0.71, 95% CI 0.39 to 1.28) and routine health record studies (RR 0.82, 95% CI 0.39 to 1.71) when comparisons were made to the offspring of women with untreated epilepsy. For topiramate, the prevalence of MCM was 3.9% (95% CI 2.3 to 6.5) from cohort study data and 4.1% (0.0 to 27,050.1) from routine health record studies. Risk ratios were significantly higher for children exposed to topiramate in comparison to the children of women without epilepsy in cohort studies (RR 4.07, 95% CI 1.64 to 10.14) but not in a smaller comparison to the children of women with untreated epilepsy (RR 1.37, 95% CI 0.57 to 3.27); few data are currently available from routine health record studies. Exposure in utero to topiramate was also associated with significantly higher RRs in comparison to other ASMs for oro-facial clefts. Data for all other ASMs were extremely limited.\nGiven the observational designs, all studies were at high risk of certain biases, but the biases observed across primary data collection studies and secondary use of routine health records were different and were, in part, complementary. Biases were balanced across the ASMs investigated, and it is unlikely that the differential results observed across the ASMs are solely explained by these biases.\nAuthors' conclusions\nExposure in the womb to certain ASMs was associated with an increased risk of certain MCMs which, for many, is dose-dependent.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The amount of data available from the studies reviewed varied greatly depending on the type of anti-seizure medication used, and this could account for some findings.\nThe rate of malformations in children born to women without epilepsy was between 2.1% and 3.3% and, for children born to women with an untreated epilepsy, this rate was between 3.0% and 3.2%. Therefore, we consider that the background risk of being born with a malformation is between 2% and 3%. Overall, the data did not show a higher rate of malformation in infants exposed to either lamotrigine (2.7% to 3.5%) or levetiracetam (2.6% to 2.8%). However, in one well-designed study, higher doses of lamotrigine were linked to a higher risk of malformations. There were fewer data regarding oxcarbazepine exposure but, based on current experience, there is not a significant increase of malformations in exposed infants (2.8% to 4.8%).\nChildren exposed to sodium valproate were at the highest risk of having a malformation with 9.7% to 9.8% of exposed children having one or more malformation(s). Specifically, risks were higher for spinal, skeletal, cardiac and facial malformations. The level of the risk was associated with the dose of the valproate taken; higher doses of valproate were linked to higher rates of malformation. The risk associated with valproate exposure was higher than that seen for other ASM exposures, including those with a higher risk themselves (for example, topiramate or phenobarbital).\nChildren exposed to phenobarbital had a higher rate of malformation with 6.3% to 8.8% of children being born with a malformation. This was higher than certain groups not exposed to anti-seizure medications and children born exposed to other anti-seizure medications. However, the risk was lower than that associated with valproate. Children exposed to phenobarbital were specially at risk of cardiac malformations.\nChildren exposed to phenytoin had a higher rate of malformation with 5.4% to 6.8% of children being born with a malformation. This risk was higher than unexposed children and children exposed to certain other anti-seizure medications. Data were too few to understand which specific types of malformation were most likely to occur following exposure in the womb to phenytoin.\nChildren exposed to carbamazepine had a higher rate of malformation with 4.0% to 4.7% of children being born with a malformation. This was higher than unexposed children and children exposed to other anti-seizure medications. The risk of malformation was found to increase at higher doses of carbamazepine.\nThere were fewer pregnancies in women exposed to topiramate, but a higher rate of malformation was noted with 3.9% to 4.1% of exposed children having a malformation. This was higher than in children born to women without epilepsy. The data demonstrated that children exposed to topiramate were at particular risk of facial malformations.\nThe data were too limited for other anti-seizure medications to be certain about their results at this time."
}
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query-laysum
|
6961
|
[
{
"role": "user",
"content": "Abstract: Background\nMajor depressive disorder is a common mental disorder affecting a person's mind, behaviour and body. It is expressed as a variety of symptoms and is associated with substantial impairment. Despite a range of pharmacological and non-pharmacological treatment options, there is still room for improvement of the pharmacological treatment of depression in terms of efficacy and tolerability. The latest available antidepressant is vortioxetine. It is assumed that vortioxetine's antidepressant action is related to a direct modulation of serotonergic receptor activity and inhibition of the serotonin transporter. The mechanism of action is not fully understood, but it is claimed to be novel. Vortioxetine was placed in the category of \"Other\" antidepressants and may therefore provide an alternative to existing antidepressant drugs.\nObjectives\nTo assess the efficacy and acceptability of vortioxetine compared with placebo and other antidepressant drugs in the treatment of acute depression in adults.\nSearch methods\nWe searched Cochrane's Depression, Anxiety and Neurosis Review Group's Specialised Register to May 2016 without applying any restrictions to date, language or publication status. We checked reference lists of relevant studies and reviews, regulatory agency reports and trial databases.\nSelection criteria\nWe included randomised controlled trials comparing the efficacy, tolerability, or both of vortioxetine versus placebo or any other antidepressant agent in the treatment of acute depression in adults.\nData collection and analysis\nTwo review authors independently selected the studies and extracted data. We extracted data on study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability. We analysed intention-to-treat (ITT) data only and used risk ratios (RR) as effect sizes for dichotomous data and mean differences (MD) for continuous data with 95% confidence intervals (CI). Meta-analyses used random-effects models.\nMain results\nWe included 15 studies (7746 participants) in this review. Seven studies were placebo controlled; eight studies compared vortioxetine to serotonin-norepinephrine reuptake inhibitors (SNRIs). We were unable to identify any study that compared vortioxetine to antidepressant drugs from other classes, such as selective serotonin reuptake inhibitors (SSRIs).\nVortioxetine may be more effective than placebo across the three efficacy outcomes: response (Mantel-Haenszel RR 1.35, 95% CI 1.22 to 1.49; 14 studies, 6220 participants), remission (RR 1.32, 95% CI 1.15 to 1.53; 14 studies, 6220 participants) and depressive symptoms measured using the Montgomery-Åsberg Depression Scale (MADRS) (score range: 0 to 34; higher score means worse outcome: MD -2.94, 95% CI -4.07 to -1.80; 14 studies, 5566 participants). The quality of the evidence was low for response and remission and very low for depressive symptoms. We found no evidence of a difference in total dropout rates (RR 1.05, 95% CI 0.93 to 1.19; 14 studies, 6220 participants). More participants discontinued vortioxetine than placebo because of adverse effects (RR 1.41, 95% CI 1.09 to 1.81; 14 studies, 6220 participants) but fewer discontinued due to inefficacy (RR 0.56, 95% CI 0.34 to 0.90, P = 0.02; 14 studies, 6220 participants). The quality of the evidence for dropouts was moderate.The subgroup and sensitivity analyses did not reveal factors that significantly influenced the results.\nIn comparison with other antidepressants, very low-quality evidence from eight studies showed no clinically significant difference between vortioxetine and SNRIs as a class for response (RR 0.91, 95% CI 0.82 to 1.00; 3159 participants) or remission (RR 0.89, 95% CI 0.77 to 1.03; 3155 participants). There was a small difference favouring SNRIs for depressive symptom scores on the MADRS (MD 1.52, 95% CI 0.50 to 2.53; 8 studies, 2807 participants). Very low quality evidence from eight studies (3159 participants) showed no significant differences between vortioxetine and the SNRIs as a class for total dropout rates (RR 0.89, 95% CI 0.73 to 1.08), dropouts due to adverse events (RR 0.74, 95% CI 0.51 to 1.08) and dropouts due to inefficacy (RR 1.52, 95% CI 0.70 to 3.30).\nAgainst individual antidepressants, analyses suggested that vortioxetine may be less effective than duloxetine in terms of response rates (RR 0.86, 95% CI 0.79 to 0.94; 6 studies, 2392 participants) and depressive symptoms scores on the MADRS scale (MD 1.99, 95% CI 1.15 to 2.83; 6 studies; 2106 participants). Against venlafaxine, meta-analysis of two studies found no statistically significant differences (response: RR 1.03, 95% CI 0.85 to 1.25; 767 participants; depressive symptom scores: MD 0.02, 95% CI -2.49 to 2.54; 701 participants). In terms of number of participants reporting at least one adverse effect (tolerability), vortioxetine was better than the SNRIs as a class (RR 0.90, 95% CI 0.86 to 0.94; 8 studies, 3134 participants) and duloxetine (RR 0.89, 95% CI 0.84 to 0.95; 6 studies; 2376 participants). However, the sensitivity analysis casts some doubts on this result, as only two studies used comparable dosing.\nWe judged none of the studies to have a high risk of bias for any domain, but we rated all studies to have an unclear risk of bias of selective reporting and other biases.\nAuthors' conclusions\nThe place of vortioxetine in the treatment of acute depression is unclear. Our analyses showed vortioxetine may be more effective than placebo in terms of response, remission and depressive symptoms, but the clinical relevance of these effects is uncertain. Furthermore, the quality of evidence to support these findings was generally low. In comparison to SNRIs, we found no advantage for vortioxetine. Vortioxetine was less effective than duloxetine, but fewer people reported adverse effects when treated with vortioxetine compared to duloxetine. However, these findings are uncertain and not well supported by evidence. A major limitation of the current evidence is the lack of comparisons with the SSRIs, which are usually recommended as first-line treatments for acute depression. Studies with direct comparisons to SSRIs are needed to address this gap and may be supplemented by network meta-analyses to define the role of vortioxetine in the treatment of depression.\n\nGiven the provided abstract, please respond to the following query: \"Which studies were included in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In May 2016, we searched electronic medical databases to find trials that compared vortioxetine to placebo or other antidepressants. We included only studies that used a randomised controlled design (where people were randomly put into one of two or more treatment groups) and had adults (aged over 18 years) with a diagnosis of major depression. We included 15 trials, involving 7746 participants in the review."
}
] |
query-laysum
|
6962
|
[
{
"role": "user",
"content": "Abstract: Background\nIntermittent catheterisation (IC) is a commonly recommended procedure for people with incomplete bladder emptying. Frequent complications are urinary tract infection (UTI), urethral trauma and discomfort during catheter use. Despite the many designs of intermittent catheter, including different lengths, materials and coatings, it is unclear which catheter techniques, strategies or designs affect the incidence of UTI and other complications, measures of satisfaction/quality of life and cost-effectiveness.\nThis is an update of a Cochrane Review first published in 2007.\nObjectives\nTo assess the clinical and cost-effectiveness of different catheterisation techniques, strategies and catheter designs, and their impact, on UTI and other complications, and measures of satisfaction/quality of life among adults and children whose long-term bladder condition is managed by intermittent catheterisation.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 April 2021), the reference lists of relevant articles and conference proceedings, and we attempted to contact other investigators for unpublished data or for clarification.\nSelection criteria\nRandomised controlled trials (RCTs) or randomised cross-over trials comparing at least two different catheterisation techniques, strategies or catheter designs.\nData collection and analysis\nAs per standard Cochrane methodological procedures, two review authors independently extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE. Outcomes included the number of people with symptomatic urinary tract infections, complications such as urethral trauma/bleeding, comfort and ease of use of catheters, participant satisfaction and preference, quality of life measures and economic outcomes.\nMain results\nWe included 23 trials (1339 randomised participants), including twelve RCTs and eleven cross-over trials. Most were small (fewer than 60 participants completed), although three trials had more than 100 participants. Length of follow-up ranged from one month to 12 months and there was considerable variation in definitions of UTI. Most of the data from cross-over trials were not presented in a useable form for this review.\nRisk of bias was unclear in many domains due to insufficient information in the trial reports and several trials were judged to have a high risk of performance bias due to lack of blinding and a high risk of attrition bias. The certainty of evidence was downgraded for risk of bias, and imprecision due to low numbers of participants.\nAseptic versus clean technique\nWe are uncertain if there is any difference between aseptic and clean techniques in the risk of symptomatic UTI because the evidence is low-certainty and the 95% confidence interval (CI) is consistent with possible benefit and possible harm (RR 1.20 95% CI 0.54 to 2.66; one study; 36 participants). We identified no data relating to the risk of adverse events comparing aseptic and clean techniques or participant satisfaction or preference.\nSingle-use (sterile) catheter versus multiple-use (clean)\nWe are uncertain if there is any difference between single-use and multiple-use catheters in terms of the risk of symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.98, 95% CI 0.55, 1.74; two studies; 97 participants). One study comparing single-use catheters to multiple-use catheters reported zero adverse events in either group; no other adverse event data were reported for this comparison. We identified no data for participant satisfaction or preference.\nHydrophilic-coated catheters versus uncoated catheters\nWe are uncertain if there is any difference between hydrophilic and uncoated catheters in terms of the number of people with symptomatic UTI because the certainty of evidence is low and the 95% CI is consistent with possible benefit and possible harm (RR 0.89, 95% CI 0.69 to 1.14; two studies; 98 participants). Uncoated catheters probably slightly reduce the risk of urethral trauma and bleeding compared to hydrophilic-coated catheters (RR 1.37, 95% CI 1.01 to 1.87; moderate-certainty evidence). The evidence is uncertain if hydrophilic-coated catheters compared with uncoated catheters has any effect on participant satisfaction measured on a 0-10 scale (MD 0.7 higher, 95% CI 0.19 to 1.21; very low-certainty evidence; one study; 114 participants). Due to the paucity of data, we could not assess the certainty of evidence relating to participant preference (one cross-over trial of 29 participants reported greater preference for a hydrophilic-coated catheter (19/29) compared to an uncoated catheter (10/29)).\nAuthors' conclusions\nDespite a total of 23 trials, the paucity of useable data and uncertainty of the evidence means that it remains unclear whether the incidence of UTI or other complications is affected by use of aseptic or clean technique, single (sterile) or multiple-use (clean) catheters, coated or uncoated catheters or different catheter lengths. The current research evidence is uncertain and design and reporting issues are significant. More well-designed trials are needed. Such trials should include analysis of cost-effectiveness because there are likely to be substantial differences associated with the use of different catheterisation techniques and strategies, and catheter designs.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 23 trials (involving a total of 1339 children and adults using intermittent catheterisation for bladder emptying) comparing different catheterisation techniques and catheter designs."
}
] |
query-laysum
|
6963
|
[
{
"role": "user",
"content": "Abstract: Background\nFluvastatin is thought to be the least potent statin on the market, however, the dose-related magnitude of effect of fluvastatin on blood lipids is not known.\nObjectives\nPrimary objective\nTo quantify the effects of various doses of fluvastatin on blood total cholesterol, low-density lipoprotein (LDL cholesterol), high-density lipoprotein (HDL cholesterol), and triglycerides in participants with and without evidence of cardiovascular disease.\nSecondary objectives\nTo quantify the variability of the effect of various doses of fluvastatin.\n\nTo quantify withdrawals due to adverse effects (WDAEs) in randomised placebo-controlled trials.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to February 2017: the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 1), MEDLINE (1946 to February Week 2 2017), MEDLINE In-Process, MEDLINE Epub Ahead of Print, Embase (1974 to February Week 2 2017), the World Health Organization International Clinical Trials Registry Platform, CDSR, DARE, Epistemonikos and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. No language restrictions were applied.\nSelection criteria\nRandomised placebo-controlled and uncontrolled before and after trials evaluating the dose response of different fixed doses of fluvastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without evidence of cardiovascular disease.\nData collection and analysis\nTwo review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered data from placebo-controlled and uncontrolled before and after trials into Review Manager 5 as continuous and generic inverse variance data, respectively. WDAEs information was collected from the placebo-controlled trials. We assessed all trials using the 'Risk of bias' tool under the categories of sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other potential biases.\nMain results\nOne-hundred and forty-five trials (36 placebo controlled and 109 before and after) evaluated the dose-related efficacy of fluvastatin in 18,846 participants. The participants were of any age with and without evidence of cardiovascular disease, and fluvastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 2.5 mg to 80 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and a weak linear dose-related effect on blood triglycerides. There was no dose-related effect of fluvastatin on blood HDL cholesterol. Fluvastatin 10 mg/day to 80 mg/day reduced LDL cholesterol by 15% to 33%, total cholesterol by 11% to 25% and triglycerides by 3% to 17.5%. For every two-fold dose increase there was a 6.0% (95% CI 5.4 to 6.6) decrease in blood LDL cholesterol, a 4.2% (95% CI 3.7 to 4.8) decrease in blood total cholesterol and a 4.2% (95% CI 2.0 to 6.3) decrease in blood triglycerides. The quality of evidence for these effects was judged to be high. When compared to atorvastatin and rosuvastatin, fluvastatin was about 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin at reducing LDL cholesterol. Very low quality of evidence showed no difference in WDAEs between fluvastatin and placebo in 16 of 36 of these short-term trials (risk ratio 1.52 (95% CI 0.94 to 2.45).\nAuthors' conclusions\nFluvastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, fluvastatin is 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin. This review did not provide a good estimate of the incidence of harms associated with fluvastatin because of the short duration of the trials and the lack of reporting of adverse effects in 56% of the placebo-controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"What is the effect of various doses of fluvastatin on blood lipids?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The effects of various doses of fluvastatin on blood lipids were quantified in 145 studies."
}
] |
query-laysum
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6964
|
[
{
"role": "user",
"content": "Abstract: Background\nAnaemia occurs in chronic kidney disease (CKD) and is more prevalent with lower levels of kidney function. Anaemia in CKD is associated with death related to cardiovascular (CV) disease and infection. Established treatments include erythropoiesis-stimulating agents (ESAs), iron supplementation and blood transfusions. Oral hypoxia-inducible factors (HIF) stabilisers are now available to manage anaemia in people with CKD.\nObjectives\nWe aimed to assess the benefits and potential harms of HIF stabilisers for the management of anaemia in people with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 22 November 2021 through contact with the Information Specialist using search terms relevant to our review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nRandomised and quasi-randomised studies evaluating hypoxia-inducible factors stabilisers compared to placebo, standard care, ESAs or iron supplementation in people with CKD were included.\nData collection and analysis\nFive authors independently extracted data and assessed the risk of bias. Treatment estimates were summarised using random effects pair-wise meta-analysis and expressed as a relative risk (RR) or mean difference (MD), with a corresponding 95% confidence interval (CI). Evidence certainty was assessed using GRADE.\nMain results\nWe included 51 studies randomising 30,994 adults. These studies compared HIF stabilisers to either placebo or an ESA.\nCompared to placebo, HIF stabiliser therapy had uncertain effects on CV death (10 studies, 1114 participants): RR 3.68, 95% CI 0.19 to 70.21; very low certainty evidence), and nonfatal myocardial infarction (MI) (3 studies, 822 participants): RR 1.29, 95% CI 0.31 to 5.36; I² = 0%; very low certainty evidence), probably decreases the proportion of patients requiring blood transfusion (8 studies, 4329 participants): RR 0.51, 95% CI 0.44 to 0.60; I² = 0%; moderate certainty evidence), and increases the proportion of patients reaching the target haemoglobin (Hb) (10 studies, 5102 participants): RR 8.36, 95% CI 6.42 to 10.89; I² = 37%; moderate certainty evidence).\nCompared to ESAs, HIF stabiliser therapy may make little or no difference to CV death (17 studies, 10,340 participants): RR 1.05, 95% CI 0.88 to 1.26; I² = 0%; low certainty evidence), nonfatal MI (7 studies, 7765 participants): RR 0.91, 95% CI 0.76 to 1.10; I² = 0%; low certainty evidence), and nonfatal stroke (5 studies, 7285 participants): RR 1.06, 95% CI 0.71 to 1.56; I² = 8%; low certainty evidence), and had uncertain effects on fatigue (2 studies, 3471 participants): RR 0.80, 95% CI 0.56 to 1.16; I² = 0%; very low certainty evidence). HIF stabiliser therapy probably decreased the proportion of patients requiring blood transfusion (11 studies, 10,786 participants): RR 0.87, 95% CI 0.76 to 1.00; I² = 25%; moderate certainty evidence), but may make little or no difference on the proportion of patients reaching the target Hb (14 studies, 4601 participants): RR 1.00, 95% CI 0.93 to 1.07; I² = 70%; low certainty evidence), compared to ESA.\nThe effect of HIF stabilisers on hospitalisation for heart failure, peripheral arterial events, loss of unassisted dialysis vascular access patency, access intervention, cancer, infection, pulmonary hypertension and diabetic nephropathy was uncertain.\nNone of the included studies reported life participation. Adverse events were rarely and inconsistently reported.\nAuthors' conclusions\nHIF stabiliser management of anaemia had uncertain effects on CV death, fatigue, death (any cause), CV outcomes, and kidney failure compared to placebo or ESAs. Compared to placebo or ESAs, HIF stabiliser management of anaemia probably decreased the proportion of patients requiring blood transfusions, and probably increased the proportion of patients reaching the target Hb when compared to placebo.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We evaluated whether HIF stabilisers are beneficial for children and adults with CKD to manage anaemia. We evaluated all clinical studies for hypoxia-inducible factor stabilisers and summarised the results. We evaluated how certain we could be about the evidence related to hypoxia-inducible factors stabiliser using a system called \"GRADE\"."
}
] |
query-laysum
|
6965
|
[
{
"role": "user",
"content": "Abstract: Background\nDietary antioxidants, such as vitamin C, in the epithelial lining and lining fluids of the lung may be beneficial in the reduction of oxidative damage (Arab 2002). They may therefore be of benefit in reducing symptoms of inflammatory airway conditions such as asthma, and may also be beneficial in reducing exercise-induced bronchoconstriction, which is a well-recognised feature of asthma and is considered a marker of airways inflammation. However, the association between dietary antioxidants and asthma severity or exercise-induced bronchoconstriction is not fully understood.\nObjectives\nTo examine the effects of vitamin C supplementation on exacerbations and health-related quality of life (HRQL) in adults and children with asthma or exercise-induced bronchoconstriction compared to placebo or no vitamin C.\nSearch methods\nWe identified trials from the Cochrane Airways Group's Specialised Register (CAGR). The Register contains trial reports identified through systematic searches of a number of bibliographic databases, and handsearching of journals and meeting abstracts. We also searched trial registry websites. The searches were conducted in December 2012.\nSelection criteria\nWe included randomised controlled trials (RCTs). We included both adults and children with a diagnosis of asthma. In separate analyses we considered trials with a diagnosis of exercise-induced bronchoconstriction (or exercise-induced asthma). We included trials comparing vitamin C supplementation with placebo, or vitamin C supplementation with no supplementation. We included trials where the asthma management of both treatment and control groups provided similar background therapy. The primary focus of the review is on daily vitamin C supplementation to prevent exacerbations and improve HRQL. The short-term use of vitamin C at the time of exacerbations or for cold symptoms in people with asthma are outside the scope of this review.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of potential studies, and subsequently screened full text study reports for inclusion. We used standard methods expected by The Cochrane Collaboration.\nMain results\nA total of 11 trials with 419 participants met our inclusion criteria. In 10 studies the participants were adults and only one was in children. Reporting of study design was inadequate to determine risk of bias for most of the studies and poor availability of data for our key outcomes may indicate some selective outcome reporting. Four studies were parallel-group and the remainder were cross-over studies. Eight studies included people with asthma and three studies included 40 participants with exercise-induced asthma. Five studies reported results using single-dose regimes prior to bronchial challenges or exercise tests. There was marked heterogeneity in vitamin C dosage regimes used in the selected studies, compounding the difficulties in carrying out meaningful analyses.\nOne study on 201 adults with asthma reported no significant difference in our primary outcome, health-related quality of life (HRQL), and overall the quality of this evidence was low. There were no data available to evaluate the effects of vitamin C supplementation on our other primary outcome, exacerbations in adults. One small study reported data on asthma exacerbations in children and there were no exacerbations in either the vitamin C or placebo groups (very low quality evidence). In another study conducted in 41 adults, exacerbations were not defined according to our criteria and the data were not available in a format suitable for evaluation by our methods. Lung function and symptoms data were contributed by single studies. We rated the quality of this evidence as moderate, but further research is required to assess any clinical implications that may be related to the changes in these parameters. In each of these outcomes there was no significant difference between vitamin C and placebo. No adverse events at all were reported; again this is very low quality evidence.\nStudies in exercise-induced bronchoconstriction suggested some improvement in lung function measures with vitamin C supplementation, but theses studies were few and very small, with limited data and we judged the quality of the evidence to be low.\nAuthors' conclusions\nCurrently, evidence is not available to provide a robust assessment on the use of vitamin C in the management of asthma or exercise-induced bronchoconstriction. Further research is very likely to have an important impact on our confidence in the estimates of effect and is likely to change the estimates. There is no indication currently that vitamin C can be recommended as a therapeutic agent in asthma. There was some indication that vitamin C was helpful in exercise-induced breathlessness in terms of lung function and symptoms; however, as these findings were provided only by small studies they are inconclusive. Most published studies to date are too small and inconsistent to provide guidance. Well-designed trials with good quality clinical endpoints, such as exacerbation rates and health-related quality of life scores, are required.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Asthma is an inflammatory lung condition characterised by the narrowing of airways and is associated with wheezing, breathlessness, cough and chest tightness. Vitamin C has been suggested as a possible treatment for asthma."
}
] |
query-laysum
|
6966
|
[
{
"role": "user",
"content": "Abstract: Background\nDeviation from a normal bite can be defined as malocclusion. Orthodontic treatment takes 20 months on average to correct malocclusion. Accelerating the rate of tooth movement may help to reduce the duration of orthodontic treatment and associated unwanted effects including orthodontically induced inflammatory root resorption (OIIRR), demineralisation and reduced patient motivation and compliance. Several non-surgical adjuncts have been advocated with the aim of accelerating the rate of orthodontic tooth movement (OTM).\nObjectives\nTo assess the effect of non-surgical adjunctive interventions on the rate of orthodontic tooth movement and the overall duration of treatment.\nSearch methods\nAn information specialist searched five bibliographic databases up to 6 September 2022 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of people receiving orthodontic treatment using fixed or removable appliances along with non-surgical adjunctive interventions to accelerate tooth movement. We excluded split-mouth studies and studies that involved people who were treated with orthognathic surgery, or who had cleft lip or palate, or other craniofacial syndromes or deformities.\nData collection and analysis\nTwo review authors were responsible for study selection, risk of bias assessment and data extraction; they carried out these tasks independently. Disagreements were resolved by discussion amongst the review team to reach consensus.\nMain results\nWe included 23 studies, none of which were rated as low risk of bias overall. We categorised the included studies as testing light vibrational forces or photobiomodulation, the latter including low level laser therapy and light emitting diode. The studies assessed non-surgical interventions added to fixed or removable orthodontic appliances compared to treatment without the adjunct. A total of 1027 participants (children and adults) were recruited with loss to follow-up ranging from 0% to 27% of the original samples.\nCertainty of the evidence\nFor all comparisons and outcomes presented below, the certainty of the evidence is low to very low.\nLight vibrational forces\nEleven studies assessed how applying light vibrational forces (LVF) affected orthodontic tooth movement (OTM). There was no evidence of a difference between the intervention and control groups for duration of orthodontic treatment (MD -0.61 months, 95% confidence interval (CI) -2.44 to 1.22; 2 studies, 77 participants); total number of orthodontic appliance adjustment visits (MD -0.32 visits, 95% CI -1.69 to 1.05; 2 studies, 77 participants); orthodontic tooth movement during the early alignment stage (reduction of lower incisor irregularity (LII)) at 4-6 weeks (MD 0.12 mm, 95% CI -1.77 to 2.01; 3 studies, 144 participants), or 10-16 weeks (MD -0.18 mm, 95% CI -1.20 to 0.83; 4 studies, 175 participants); rate of canine distalisation (MD -0.01 mm/month, 95% CI -0.20 to 0.18; 2 studies, 40 participants); or rate of OTM during en masse space closure (MD 0.10 mm per month, 95% CI -0.08 to 0.29; 2 studies, 81 participants). No evidence of a difference was found between LVF and control groups in rate of OTM when using removable orthodontic aligners. Nor did the studies show evidence of a difference between groups for our secondary outcomes, including patient perception of pain, patient-reported need for analgesics at different stages of treatment and harms or side effects.\nPhotobiomodulation\nTen studies assessed the effect of applying low level laser therapy (LLLT) on rate of OTM. We found that participants in the LLLT group had a statistically significantly shorter length of time for the teeth to align in the early stages of treatment (MD -50 days, 95% CI -58 to -42; 2 studies, 62 participants) and required fewer appointments (-2.3, 95% CI -2.5 to -2.0; 2 studies, 125 participants). There was no evidence of a difference between the LLLT and control groups in OTM when assessed as percentage reduction in LII in the first month of alignment (1.63%, 95% CI -2.60 to 5.86; 2 studies, 56 participants) or in the second month (percentage reduction MD 3.75%, 95% CI -1.74 to 9.24; 2 studies, 56 participants). However, LLLT resulted in an increase in OTM during the space closure stage in the maxillary arch (MD 0.18 mm/month, 95% CI 0.05 to 0.33; 1 study; 65 participants; very low level of certainty) and the mandibular arch (right side MD 0.16 mm/month, 95% CI 0.12 to 0.19; 1 study; 65 participants). In addition, LLLT resulted in an increased rate of OTM during maxillary canine retraction (MD 0.01 mm/month, 95% CI 0 to 0.02; 1 study, 37 participants). These findings were not clinically significant. The studies showed no evidence of a difference between groups for our secondary outcomes, including OIIRR, periodontal health and patient perception of pain at early stages of treatment.\nTwo studies assessed the influence of applying light-emitting diode (LED) on OTM. Participants in the LED group required a significantly shorter time to align the mandibular arch compared to the control group (MD -24.50 days, 95% CI -42.45 to -6.55, 1 study, 34 participants). There is no evidence that LED application increased the rate of OTM during maxillary canine retraction (MD 0.01 mm/month, 95% CI 0 to 0.02; P = 0.28; 1 study, 39 participants ). In terms of secondary outcomes, one study assessed patient perception of pain and found no evidence of a difference between groups.\nAuthors' conclusions\nThe evidence from randomised controlled trials concerning the effectiveness of non-surgical interventions to accelerate orthodontic treatment is of low to very low certainty. It suggests that there is no additional benefit of light vibrational forces or photobiomodulation for reducing the duration of orthodontic treatment. Although there may be a limited benefit from photobiomodulation application for accelerating discrete treatment phases, these results have to be interpreted with caution due to their questionable clinical significance. Further well-designed, rigorous RCTs with longer follow-up periods spanning from start to completion of orthodontic treatment are required to determine whether non-surgical interventions may reduce the duration of orthodontic treatment by a clinically significant amount, with minimal adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our certainty about the evidence is low to very low."
}
] |
query-laysum
|
6967
|
[
{
"role": "user",
"content": "Abstract: Background\nThe main goal of enteral nutrition (EN) is to manage malnutrition in order to improve clinical outcomes. However, EN may increase the risks of vomiting or aspiration pneumonia during gastrointestinal dysfunction. Consequently, monitoring of gastric residual volume (GRV), that is, to measure GRV periodically and modulate the speed of enteral feeding according to GRV, has been recommended as a management goal in many intensive care units. Yet, there is a lack of robust evidence that GRV monitoring reduces the level of complications during EN. The best protocol of GRV monitoring is currently unknown, and thus the precise efficacy and safety profiles of GRV monitoring remain to be ascertained.\nObjectives\nTo investigate the efficacy and safety of GRV monitoring during EN.\nSearch methods\nWe searched electronic databases including CENTRAL, MEDLINE, Embase, and CINAHL for relevant studies on 3 May 2021. We also checked reference lists of included studies for additional information and contacted experts in the field.\nSelection criteria\nWe included randomized controlled trials (RCTs), randomized cross-over trials, and cluster-RCTs investigating the effects of GRV monitoring during EN. We imposed no restrictions on the language of publication.\nData collection and analysis\nTwo review authors independently screened the search results for eligible studies and extracted trial-level information from each included study, including methodology and design, characteristics of study participants, interventions, and outcome measures. We assessed risk of bias for each study using Cochrane's risk of bias tool. We followed guidance from the GRADE framework to assess the overall certainty of evidence across outcomes. We used a random-effects analytical model to perform quantitative synthesis of the evidence. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous and mean difference (MD) with 95% CIs for continuous outcomes.\nMain results\nWe included eight studies involving 1585 participants. All studies were RCTs conducted in ICU settings.\nTwo studies (417 participants) compared less-frequent (less than eight hours) monitoring of GRV against a regimen of more-frequent (eight hours or greater) monitoring. The evidence is very uncertain about the effect of frequent monitoring of GRV on mortality rate (RR 0.91, 95% CI 0.60 to 1.37; I² = 8%; very low-certainty evidence), incidence of pneumonia (RR 1.08, 95% CI 0.64 to 1.83; heterogeneity not applicable; very low-certainty evidence), length of hospital stay (MD 2.00 days, 95% CI –2.15 to 6.15; heterogeneity not applicable; very low-certainty evidence), and incidence of vomiting (RR 0.14, 95% CI 0.02 to 1.09; heterogeneity not applicable; very low-certainty evidence).\nTwo studies (500 participants) compared no GRV monitoring with frequent (12 hours or less) monitoring. Similarly, the evidence is very uncertain about the effect of no monitoring of GRV on mortality rate (RR 0.87, 95% CI 0.62 to 1.23; I² = 51%; very low-certainty evidence), incidence of pneumonia (RR 0.70, 95% CI 0.43 to 1.13; heterogeneity not applicable; very low-certainty evidence), length of hospital stay (MD –1.53 days, 95% CI –4.47 to 1.40; I² = 0%; very low-certainty evidence), and incidence of vomiting (RR 1.47, 95% CI 1.13 to 1.93; I² = 0%; very low-certainty evidence).\nOne study (322 participants) assessed the impact of GRV threshold (500 mL per six hours) on clinical outcomes. The evidence is very uncertain about the effect of the threshold for GRV at time of aspiration on mortality rate (RR 1.01, 95% CI 0.74 to 1.38; heterogeneity not applicable; very low-certainty evidence), incidence of pneumonia (RR 1.03, 95% CI 0.72 to 1.46; heterogeneity not applicable; very low-certainty evidence), and length of hospital stay (MD –0.90 days, 95% CI –2.60 to 4.40; heterogeneity not applicable; very low-certainty evidence).\nTwo studies (140 participants) explored the effects of returning or discarding the aspirated/drained GRV. The evidence is uncertain about the effect of discarding or returning the aspirated/drained GRV on the incidence of vomiting (RR 1.00, 95% CI 0.06 to 15.63; heterogeneity not applicable; very low-certainty evidence) and volume aspirated from the stomach (MD –7.30 mL, 95% CI –26.67 to 12.06, I² = 0%; very low-certainty evidence)\nWe found no studies comparing the effects of protocol-based EN strategies that included GRV-related criteria against strategies that did not include such criteria.\nAuthors' conclusions\nThe evidence is very uncertain about the effect of GRV on clinical outcomes including mortality, pneumonia, vomiting, and length of hospital stay.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with acute illnesses may not be able to consume food due to several reasons (e.g. unconsciousness, need for mechanical ventilation). To maintain sufficient levels of energy and nutrients for this population, tube feeding, that is, administering liquidized dense nutrients through a flexible tube that reaches the stomach via the nose, is commonly used. Tube feeding is currently recommended as a first-line treatment for critically ill people with acute illnesses because such a technique can provide non-nutritional (e.g. protecting the immune system against suppression due to acute disease) as well as nutritional benefits.\nHowever, people with acute illnesses often have a dysfunction of the stomach and intestines, and thus are unable to empty stomach contents. When increasing amounts of liquid nutrients are fed into the stomach via a tube, it can cause reflux (where contents travel back up the food pipe) or vomiting and may lead to aspiration pneumonia (when contents are breathed into the lungs or airways leading to the lungs).\nOne method to avoid these complications of tube feeding is to periodically monitor the gastric residual volume (GRV), which is the amount of liquid contents drained from the stomach. The speed of tube feeding can then be adjusted according to the volume.\nAlthough monitoring of GRV may minimize the complications of tube feeding, and this technique has been recommended in many intensive care units (ICUs) for decades, we lack sufficient data to support a universal approach. Some research findings show that monitoring of GRV had no effects on tube-feeding complications; moreover, the technique was found to reduce the amount of nutrients delivered, thereby affecting the overall treatment goals of tube feeding.\nWe designed this review in the hope of answering the following questions. Is monitoring of GRV effective and safe? What is the best way to monitor GRV (how often should GRV be measured per day; how large a threshold should be set for GRV)?"
}
] |
query-laysum
|
6968
|
[
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not achieve a satisfactory treatment response with ordinary anti-psychotic drug treatment. In these cases, various add-on medications are used, among them lithium.\nObjectives\nTo assess whether:\n1. Lithium alone is an effective treatment for schizophrenia, schizophrenia-like psychoses and schizoaffective psychoses; and\n2. Lithium augmentation of antipsychotic medication is an effective treatment for the same illnesses.\nSearch methods\nIn July 2012, we searched the Cochrane Schizophrenia Group’s Study-Based Register of Trials which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. This search was updated on January 20, 2015. For the first version of the review, we also contacted pharmaceutical companies and authors of relevant studies to identify further trials and obtain original participant data.\nSelection criteria\nRandomised controlled trials (RCTs) of lithium compared with antipsychotics or placebo (or no intervention), whether as sole treatment or as an adjunct to antipsychotic medication, in the treatment of schizophrenia or schizophrenia-like psychoses or both.\nData collection and analysis\nWe extracted data independently. For dichotomous data, we calculated random-effects meta-analyses, risk ratios (RRs), and 95% confidence intervals (CI) on an intention-to-treat basis. For continuous data, we calculated mean differences (MD) and 95% confidence intervals. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) to create 'Summary of findings' tables and assessed risk of bias for included studies.\nMain results\nThe update search in 2012 detected two further studies that met our inclusion criteria. We did not find any further studies that met our inclusion criteria in the 2015 search. This review now includes 22 studies, with a total of 763 participants (median mean age: 35 years, range: 26 to 72 years). Most studies were small, of short duration, and incompletely reported. As we detected a high risk of bias in many studies, the overall methodological quality of the included sample was rather low.\nThree small studies comparing lithium with placebo as the sole treatment showed no difference in any of the outcomes we analysed.\nIn eight studies comparing lithium with antipsychotic drugs as the sole treatment, more participants in the lithium group left the studies early (eight RCTs; n = 270, RR 1.77, 95% CI 1.01 to 3.11, low quality evidence).\nThirteen studies examined whether the augmentation of antipsychotic drugs with lithium salts is more effective than antipsychotic drugs alone. More participants who received lithium augmentation had a clinically significant response (10 RCTs; n = 396, RR 1.81, 95% CI 1.10 to 2.97, low quality evidence). However, this effect became non-significant when we excluded participants with schizoaffective disorders in a sensitivity analysis (seven RCTs; n = 272, RR 1.64, 95% CI 0.95 to 2.81), when we excluded non-double-blind studies (seven RCTs; n = 224, RR 1.82, 95% CI 0.84 to 3.96), or when we excluded studies with high attrition (nine RCTs; n = 355, RR 1.67, CI 0.93 to 3.00). The overall acceptability of treatment (measured by the number of participants leaving the studies early) was not significantly different between groups (11 RCTs; n = 320, RR 1.89, CI 0.93 to 3.84, very low quality evidence). Few studies reported on side effects. There were no significant differences, but the database is too limited to make any judgement in this regard. For example, there were no data on thyroid dysfunction and kidney problems - two major and well-known side effects of lithium.\nAuthors' conclusions\nThe evidence base for the use of lithium in schizophrenia is limited to 22 studies of overall low methodological quality. There is no randomised trial-based evidence that lithium on its own is an effective treatment for people with schizophrenia. There is some GRADE low quality evidence that augmentation of antipsychotics with lithium is effective, but the effects are not significant when more prone-to-bias open RCTs are excluded. Nevertheless, further large and well-designed trials are justified. These should concentrate on two target groups: (1) people with no affective symptoms, so that trialists can determine whether lithium has an effect on the core symptoms of schizophrenia, and (2) people with schizoaffective disorders for whom lithium is widely used in clinical practice, although there is no evidence to support this use.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The update search in 2012 detected two further studies that met required standards, and no further studies were found in the 2015 search. This review now includes 22 randomised studies, with a total of 763 participants. The studies randomised people with schizophrenia or similar illnesses into groups that received either lithium or placebo (dummy drug), lithium or antipsychotic drugs, lithium plus antipsychotic drugs, or antipsychotic drugs alone."
}
] |
query-laysum
|
6969
|
[
{
"role": "user",
"content": "Abstract: Background\nEach year, in high-income countries alone, approximately 100 million people develop scars. Excessive scarring can cause pruritus, pain, contractures, and cosmetic disfigurement, and can dramatically affect people's quality of life, both physically and psychologically. Hypertrophic scars are visible and elevated scars that do not spread into surrounding tissues and that often regress spontaneously. Silicone gel sheeting (SGS) is made from medical-grade silicone reinforced with a silicone membrane backing and is one of the most commonly used treatments for hypertrophic scars.\nObjectives\nTo assess the effects of silicone gel sheeting for the treatment of hypertrophic scars in any care setting.\nSearch methods\nIn April 2021 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) that enrolled people with any hypertrophic scars and assessed the use of SGS.\nData collection and analysis\nTwo review authors independently performed study selection, 'Risk of bias' assessment, data extraction and GRADE assessment of the certainty of evidence. We resolved initial disagreements by discussion, or by consulting a third review author when necessary.\nMain results\nThirteen studies met the inclusion criteria. Study sample sizes ranged from 10 to 60 participants. The trials were clinically heterogeneous with differences in duration of follow-up, and scar site. We report 10 comparisons, SGS compared with no SGS treatment and SGS compared with the following treatments: pressure garments; silicone gel; topical onion extract; polyurethane; propylene glycol and hydroxyethyl cellulose sheeting; Kenalog injection; flashlamp-pumped pulsed-dye laser; intense pulsed light and Gecko Nanoplast (a silicone gel bandage). Six trials had a split-site design and three trials had an unclear design (resulting in a mix of paired and clustered data).\nIncluded studies reported limited outcome data for the primary review outcomes of severity of scarring measured by health professionals and adverse events (limited data reported by some included studies, but further analyses of these data was not possible) and no data were reported for severity of scarring reported by patients. For secondary outcomes some pain data were reported, but health-related quality of life and cost effectiveness were not reported. Many trials had poorly-reported methodology, meaning the risk of bias was unclear. We rated all evidence as being either of low or very low certainty, often because of imprecision resulting from few participants, low event rates, or both, all in single studies.\nSGS compared with no SGS\nSeven studies with 177 participants compared SGS with no SGS for hypertrophic scars. Two studies with 31 participants (32 scars) reported severity of scarring assessed by health professionals, and it is uncertain whether there is a difference in severity of scarring between the two groups (mean difference (MD) -1.83, 95% confidence interval (CI) -3.77 to 0.12; very low-certainty evidence, downgraded once for risk of bias, and twice for serious imprecision). One study with 34 participants suggests SGS may result in a slight reduction in pain level compared with no SGS treatment (MD −1.26, 95% CI −2.26 to −0.26; low-certainty evidence, downgraded once for risk of bias and once for imprecision).\nSGS compared with pressure garments\nOne study with 54 participants was included in this comparison. The study reported that SGS may reduce pain levels compared with pressure garments (MD −1.90, 95% CI −2.99 to −0.81; low-certainty evidence, downgraded once for risk of bias and once for imprecision).\nSGS compared with silicone gel\nOne study with 32 participants was included in this comparison. It is unclear if SGS impacts on severity of scarring assessed by health professionals compared with silicone gel (MD 0.40, 95% CI −0.88 to 1.68; very low-certainty evidence, downgraded once for risk of bias, twice for imprecision).\nSGS compared with topical onion extract\nOne trial (32 participants) was included in this comparison. SGS may slightly reduce severity of scarring compared with topical onion extract (MD -1.30, 95% CI -2.58 to -0.02; low-certainty evidence, downgraded once for risk of bias, and once for imprecision).\nSGS compared with polyurethane\nOne study with 60 participants was included in this comparison. It is unclear if SGS impacts on the severity of scarring assessed by health professionals compared with polyurethane (MD 0.50, 95% CI -2.96 to 3.96; very low-certainty evidence, downgraded once for risk of bias, and twice for imprecision).\nSGS compared with self-adhesive propylene glycol and hydroxyethyl cellulose sheeting\nOne study with 38 participants was included in this comparison. It is uncertain if SGS reduces pain compared with self-adhesive propylene glycol and hydroxyethyl cellulose sheeting (MD −0.12, 95% CI −0.18 to −0.06). This is very low-certainty evidence, downgraded once for risk of bias, once for imprecision and once for indirectness.\nSGS compared with Gecko Nanoplast\nOne study with 60 participants was included in this comparison. It is unclear if SGS impacts on pain compared with Gecko Nanoplast (MD 0.70, 95% CI -0.28 to 1.68; very low-certainty evidence, downgraded once for risk of bias and twice for imprecision.\nThere was a lack of reportable data from the other three comparisons of SGS with Kenalog injection, flashlamp-pumped pulsed-dye laser or intense pulsed light.\nAuthors' conclusions\nThere is currently limited rigorous RCT evidence available about the clinical effectiveness of SGS in the treatment of hypertrophic scars. None of the included studies provided evidence on severity of scarring validated by participants, health-related quality of life, or cost effectiveness. Reporting was poor, to the extent that we are not confident that most trials are free from risk of bias. The limitations in current RCT evidence suggest that further trials are required to reduce uncertainty around decision-making in the use of SGS to treat hypertrophic scars.\n\nGiven the provided abstract, please respond to the following query: \"Our methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that investigated the use of silicone gel sheets to treat hypertrophic scars. We searched for randomised controlled trials only, in which the treatment each person receives is chosen at random. These studies give the most reliable evidence about the effects of a treatment."
}
] |
query-laysum
|
6970
|
[
{
"role": "user",
"content": "Abstract: Background\nOpioid drugs, including fentanyl, are commonly used to treat neuropathic pain, and are considered effective by some professionals. Most reviews have examined all opioids together. This review sought evidence specifically for fentanyl, at any dose, and by any route of administration. Other opioids are considered in separate reviews.\nObjectives\nTo assess the analgesic efficacy of fentanyl for chronic neuropathic pain in adults, and the adverse events associated with its use in clinical trials.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to June 2016, together with the reference lists of retrieved articles, and two online study registries.\nSelection criteria\nWe included randomised, double-blind studies of two weeks' duration or longer, comparing fentanyl (in any dose, administered by any route, and in any formulation) with placebo or another active treatment in chronic neuropathic pain.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE.\nMain results\nOnly one study met our inclusion criteria. Participants were men and women (mean age 67 years), with postherpetic neuralgia, complex regional pain syndrome, or chronic postoperative pain. They were experiencing inadequate relief from non-opioid analgesics, and had not previously taken opioids for their neuropathic pain. The study used an enriched enrolment randomised withdrawal design. It was adequately blinded, but we judged it at unclear risk of bias for other criteria.\nTransdermal fentanyl (one-day fentanyl patch) was titrated over 10 to 29 days to establish the maximum tolerated and effective dose (12.5 to 50 µg/h). Participants who achieved a prespecified good level of pain relief with a stable dose of fentanyl, without excessive use of rescue medication or intolerable adverse events ('responders'), were randomised to continue with fentanyl or switch to placebo for 12 weeks, under double-blind conditions. Our prespecified primary outcomes were not appropriate for this study design, but the measures reported do give an indication of the efficacy of fentanyl in this condition.\nIn the titration phase, 1 in 3 participants withdrew because of adverse events or inadequate pain relief, and almost 90% experienced adverse events. Of 258 participants who underwent open-label titration, 163 were 'responders' and entered the randomised withdrawal phase. The number of participants completing the study (and therefore continuing on treatment) without an increase of pain by more than 15/100 was 47/84 (56%) with fentanyl and 28/79 (35%) with placebo. Because only 63% responded sufficiently to enter the randomised withdrawal phase, this implies that only a maximum of 35% of participants entering the study would have had useful pain relief and tolerability with transdermal fentanyl, compared with 22% with placebo. Almost 60% of participants taking fentanyl were 'satisfied' and 'very satisfied' with their treatment at the end of the study, compared with about 40% with placebo. This outcome approximates to our primary outcome of moderate benefit using the Patient Global Impression of Change scale, but the group was enriched for responders and the method of analysis was not clear. The most common adverse events were constipation, nausea, somnolence, and dizziness.\nThere was no information about other types of neuropathic pain, other routes of administration, or comparisons with other treatments.\nWe downgraded the quality of the evidence to very low because there was only one study, with few participants and events, and there was no information about how data from people who withdrew were analysed.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the suggestion that fentanyl works in any neuropathic pain condition.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the quality of the evidence as very low because there was only one study, with few participants and events, and an unusual design. Very-low-quality evidence means that we are very uncertain about the results."
}
] |
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