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query-laysum | 909 | [
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep-disordered breathing (oSDB) is a condition that encompasses breathing problems when asleep, due to an obstruction of the upper airways, ranging in severity from simple snoring to obstructive sleep apnoea syndrome (OSAS). It affects both children and adults. In children, hypertrophy of the tonsils and adenoid tissue is thought to be the commonest cause of oSDB. As such, tonsillectomy - with or without adenoidectomy - is considered an appropriate first-line treatment for most cases of paediatric oSDB.\nObjectives\nTo assess the benefits and harms of tonsillectomy with or without adenoidectomy compared with non-surgical management of children with oSDB.\nSearch methods\nWe searched the Cochrane Register of Studies Online, PubMed, EMBASE, CINAHL, Web of Science, Clinicaltrials.gov, ICTRP and additional sources for published and unpublished trials. The date of the search was 5 March 2015.\nSelection criteria\nRandomised controlled trials comparing the effectiveness and safety of (adeno)tonsillectomy with non-surgical management in children with oSDB aged 2 to 16 years.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nThree trials (562 children) met our inclusion criteria. Two were at moderate to high risk of bias and one at low risk of bias. We did not pool the results because of substantial clinical heterogeneity. They evaluated three different groups of children: those diagnosed with mild to moderate OSAS by polysomnography (PSG) (453 children aged five to nine years; low risk of bias; CHAT trial), those with a clinical diagnosis of oSDB but with negative PSG recordings (29 children aged two to 14 years; moderate to high risk of bias; Goldstein) and children with Down syndrome or mucopolysaccharidosis (MPS) diagnosed with mild to moderate OSAS by PSG (80 children aged six to 12 years; moderate to high risk of bias; Sudarsan). Moreover, the trials included two different comparisons: adenotonsillectomy versus no surgery (CHAT trial and Goldstein) or versus continuous positive airway pressure (CPAP) (Sudarsan).\nDisease-specific quality of life and/or symptom score (using a validated instrument): first primary outcome\nIn the largest trial with lowest risk of bias (CHAT trial), at seven months, mean scores for those instruments measuring disease-specific quality of life and/or symptoms were lower (that is, better quality of life or fewer symptoms) in children receiving adenotonsillectomy than in those managed by watchful waiting:\n- OSA-18 questionnaire (scale 18 to 126): 31.8 versus 49.5 (mean difference (MD) -17.7, 95% confidence interval (CI) -21.2 to -14.2);\n- PSQ-SRBD questionnaire (scale 0 to 1): 0.2 versus 0.5 (MD -0.3, 95% CI -0.31 to -0.26);\n- Modified Epworth Sleepiness Scale (scale 0 to 24): 5.1 versus 7.1 (MD -2.0, 95% CI -2.9 to -1.1).\nNo data on this primary outcome were reported in the Goldstein trial.\nIn the Sudarsan trial, the mean OSA-18 score at 12 months did not significantly differ between the adenotonsillectomy and CPAP groups. The mean modified Epworth Sleepiness Scale scores did not differ at six months, but were lower in the surgery group at 12 months: 5.5 versus 7.9 (MD -2.4, 95% CI -3.1 to -1.7).\nAdverse events: second primary outcome\nIn the CHAT trial, 15 children experienced a serious adverse event: 6/194 (3%) in the adenotonsillectomy group and 9/203 (4%) in the control group (RD -1%, 95% CI -5% to 2%).\nNo major complications were reported in the Goldstein trial.\nIn the Sudarsan trial, 2/37 (5%) developed a secondary haemorrhage after adenotonsillectomy, while 1/36 (3%) developed a rash on the nasal dorsum secondary to the CPAP mask (RD -3%, 95% CI -6% to 12%).\nSecondary outcomes\nIn the CHAT trial, at seven months, mean scores for generic caregiver-rated quality of life were higher in children receiving adenotonsillectomy than in those managed by watchful waiting. No data on this outcome were reported by Sudarsan and Goldstein.\nIn the CHAT trial, at seven months, more children in the surgery group had normalisation of respiratory events during sleep as measured by PSG than those allocated to watchful waiting: 153/194 (79%) versus 93/203 (46%) (RD 33%, 95% CI 24% to 42%). In the Goldstein trial, at six months, PSG recordings were similar between groups and in the Sudarsan trial resolution of OSAS (Apnoea/Hypopnoea Index score below 1) did not significantly differ between the adenotonsillectomy and CPAP groups.\nIn the CHAT trial, at seven months, neurocognitive performance and attention and executive function had not improved with surgery: scores were similar in both groups. In the CHAT trial, at seven months, mean scores for caregiver-reported ratings of behaviour were lower (that is, better behaviour) in children receiving adenotonsillectomy than in those managed by watchful waiting, however, teacher-reported ratings of behaviour did not significantly differ.\nNo data on these outcomes were reported by Goldstein and Sudarsan.\nAuthors' conclusions\nIn otherwise healthy children, without a syndrome, of older age (five to nine years), and diagnosed with mild to moderate OSAS by PSG, there is moderate quality evidence that adenotonsillectomy provides benefit in terms of quality of life, symptoms and behaviour as rated by caregivers and high quality evidence that this procedure is beneficial in terms of PSG parameters. At the same time, high quality evidence indicates no benefit in terms of objective measures of attention and neurocognitive performance compared with watchful waiting. Furthermore, PSG recordings of almost half of the children managed non-surgically had normalised by seven months, indicating that physicians and parents should carefully weigh the benefits and risks of adenotonsillectomy against watchful waiting in these children. This is a condition that may recover spontaneously over time.\nFor non-syndromic children classified as having oSDB on purely clinical grounds but with negative PSG recordings, the evidence on the effects of adenotonsillectomy is of very low quality and is inconclusive.\nLow-quality evidence suggests that adenotonsillectomy and CPAP may be equally effective in children with Down syndrome or MPS diagnosed with mild to moderate OSAS by PSG.\nWe are unable to present data on the benefits of adenotonsillectomy in children with oSDB aged under five, despite this being a population in whom this procedure is often performed for this purpose.\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 three studies, with a total of 562 children. Two were at moderate to high risk and one at low risk of bias. We did not combine the results of the studies because the trials differed substantially; they evaluated three different groups of children: those with mild to moderate OSAS (453 children aged five to nine years; CHAT trial), those who had symptoms and signs suggestive of oSDB (29 children aged two to 14 years; Goldstein) and children with Down syndrome or mucopolysaccharidosis and mild to moderate OSAS (80 children aged six to 12 years; Sudarsan). The studies compared: adenotonsillectomy versus no surgery (CHAT trial and Goldstein) or adenotonsillectomy versus a breathing mask (continuous positive airway pressure; CPAP) during sleep (Sudarsan)."
}
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query-laysum | 910 | [
{
"role": "user",
"content": "Abstract: Background\nThere are many commonly employed forms of treatment for shoulder disorders. This review of acupuncture is one in a series of reviews of varying interventions for shoulder disorders including adhesive capsulitis (frozen shoulder), rotator cuff disease and osteoarthritis. Acupuncture to treat musculoskeletal pain is being used increasingly to confer an analgesic effect and to date its use in shoulder disorder has not been evaluated in a systematic review.\nObjectives\nTo determine the efficacy and safety of acupuncture in the treatment of adults with shoulder pain.\nSearch methods\nThe Cochrane Controlled Trials Register, MEDLINE, EMBASE and CINAHL were searched from inception to December 2003, and reference lists from relevant trials were reviewed.\nSelection criteria\nRandomised and quasi-randomised trials, in all languages, of acupuncture compared to placebo or another intervention in adults with shoulder pain. Specific exclusions were duration of shoulder pain less than three weeks, rheumatoid arthritis, polymyalgia rheumatica, cervically referred pain and fracture.\nData collection and analysis\nTwo reviewers independently extracted trial and outcome data. For continuous outcome measures where the standard deviations were not reported it was either calculated from the raw data or converted from the standard error of the mean. If neither of these was reported, authors were contacted. Where results were reported as median and range, the trial was not included in the meta-analysis, but presented in Additional Tables. Effect sizes were calculated and combined in a pooled analysis if the study end-points population and intervention were homogenous. Results are presented separately for rotator cuff disease, adhesive capsulitis, full thickness rotator cuff tear and mixed diagnoses, and, where possible, combined in meta-analysis to indicate effect of acupuncture across all shoulder disorders.\nMain results\nNine trials of varying methodological quality met the inclusion criteria. For all trials there was poor description of interventions. Varying placebos were used in the different trials. Two trials assessed short-term success (post intervention) of acupuncture for rotator cuff disease and could be combined in meta analysis. There was no significant difference in short-term improvement associated with acupuncture when compared to placebo, but due to small sample sizes this may be explained by Type II error. Acupuncture was of benefit over placebo in improving the Constant Murley Score (a measure of shoulder function) at four weeks (WMD 17.3 (7.79, 26.81)). However, by four months, the difference between the acupuncture and placebo groups, whilst still statistically significant, was no longer likely to be clinically significant (WMD 3.53 (0.74, 6.32)). The Constant Murley Score is graded out of 100, hence a change of 3.53 is unlikely to be of substantial benefit. The results of a small pilot study demonstrated some benefit of both traditional and ear acupuncture plus mobilization over mobilization alone. There was no difference in adverse events related to acupuncture when compared to placebo, however this was assessed by only one trial\nAuthors' conclusions\nDue to a small number of clinical and methodologically diverse trials, little can be concluded from this review. There is little evidence to support or refute the use of acupuncture for shoulder pain although there may be short-term benefit with respect to pain and function. There is a need for further well designed clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"What causes shoulder pain and how can acupuncture help?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Shoulder pain can be caused by a number of different conditions. It can be caused by rotator cuff disease, periarthritis or adhesive capsulitis (frozen shoulder). Shoulder pain can sometimes go away on its own but may last up to 12 to 18 months. Drug and non-drug treatments are used to relieve pain and/or swelling. Acupuncture is a non-drug therapy being used more and more to treat shoulder pain. It is thought that acupuncture works either by releasing chemical compounds in the body that relieve pain, by overriding pain signals in the nerves or by allowing energy (Qi) or blood to flow freely through the body. It is not known whether acupuncture works or is safe."
}
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query-laysum | 911 | [
{
"role": "user",
"content": "Abstract: Background\nRoot canal treatment (RoCT), or endodontic treatment, is a common procedure in dentistry. The main indications for RoCT are irreversible pulpitis and necrosis of the dental pulp caused by carious processes, coronal crack or fracture, or dental trauma. Successful RoCT is characterised by an absence of symptoms (i.e. pain) and clinical signs (i.e. swelling and sinus tract) in teeth without radiographic evidence of periodontal involvement (i.e. normal periodontal ligament). The success of RoCT depends on a number of variables related to the preoperative condition of the tooth, as well as the endodontic procedures. RoCT can be carried out with a single-visit approach, which involves root canal system obturation (filling and sealing) directly after instrumentation and irrigation, or with a multiple-visits approach, in which the treatment is completed in two or more sessions and obturation is performed in the last session. This review updates the previous versions published in 2007 and 2016.\nObjectives\nTo evaluate the benefits and harms of completion of root canal treatment (RoCT) in a single visit compared to RoCT over two or more visits, with or without medication, in people aged over 10 years.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 25 April 2022.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised controlled trials in people needing RoCT comparing completion of RoCT in a single visit compared to RoCT over two or more visits.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. tooth extraction and 2. radiological failure after at least one year (i.e. periapical radiolucency). Our secondary outcomes were 3. postoperative and postobturation pain; 4. swelling or flare-up; 5. analgesic use and 6. presence of sinus track or fistula after at least one month. We used GRADE to assess certainty of evidence for each outcome.\nWe excluded five studies that were included in the previous version of the review because they did not meet the current standard of care (i.e. rubber dam isolation and irrigation with sodium hypochlorite).\nMain results\nWe included 47 studies with 5805 participants and 5693 teeth analysed. We judged 10 studies at low risk of bias, 17 at high risk of bias and 20 at unclear risk of bias.\nOnly two studies reported data on tooth extraction. We found no evidence of a difference between treatment in one visit or treatment over multiple visits, but we had very low certainty about the findings (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.09 to 2.50; I2 = 0%; 2 studies, 402 teeth). We found no evidence of a difference between single-visit and multiple-visit treatment in terms of radiological failure (RR 0.93, 95% CI 0.81 to 1.07; I2 = 0%; 13 studies, 1505 teeth; moderate-certainty evidence).\nWe found evidence of a higher proportion of participants reporting pain within one week in single-visit groups compared to multiple visit groups (RR 1.55, 95% CI 1.14 to 2.09; I2 = 18%; 5 studies, 638 teeth; moderate-certainty evidence).\nWe found no evidence of a difference in the proportion of participants reporting pain until 72 hours postobturation (RR 0.97, 95% CI 0.81 to 1.16; I2 = 70%; 12 studies, 1329 teeth; low-certainty evidence), pain intensity until 72 hours postobturation (mean difference (MD) 0.26, 95% CI โ4.76 to 5.29; I2 = 98%; 12 studies, 1258 teeth; low-certainty evidence) or pain at one week postobturation (RR 1.05, 95% CI 0.67 to 1.67; I2 = 61%; 9 studies, 1139 teeth; very low-certainty evidence). We found no evidence of a difference in swelling or flare-up incidence (RR 0.56 95% CI 0.16 to 1.92; I2 = 0%; 6 studies; 605 teeth; very low-certainty evidence), analgesic use (RR 1.25 95% CI 0.75 to 2.09; I2 = 36%; 6 studies, 540 teeth; very low-certainty evidence) or sinus tract or fistula presence (RR 1.00, 95% CI 0.24 to 4.28; I2 = 0%; 5 studies, 650 teeth; very low-certainty evidence).\nSubgroup analysis found no differences between single-visit and multiple-visit RoCT for considered outcomes other than proportion of participants reporting post-treatment pain within one week, which was higher in the single-visit groups for vital teeth (RR 2.16, 95% CI 1.39 to 3.36; I2 = 0%; 2 studies, 316 teeth), and when instrumentation was mechanical (RR 1.80, 95% CI 1.10 to 2.92; I2 = 56%; 2 studies, 278 teeth).\nAuthors' conclusions\nAs in the previous two versions of the review, there is currently no evidence to suggest that one treatment regimen (single-visit or multiple-visit RoCT) is more effective than the other. Neither regimen can prevent pain and other complications in the 12-month postoperative period. There was moderate-certainty evidence of higher proportion of participants reporting pain within one week in single-visit groups compared to multiple-visit groups. In contrast to the results of the last version of the review, there was no difference in analgesic use.\n\nGiven the provided abstract, please respond to the following query: \"What studies did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 47 studies with 5805 participants. The studies compared root canal treatment performed at a single appointment with root canal treatment performed over two or more appointments on vital permanent teeth, non-vital permanent teeth, or both. The biggest study involved 390 teeth and the smallest study involved 26 teeth. The studies were conducted in countries around the world, with the largest number (12) in India."
}
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query-laysum | 912 | [
{
"role": "user",
"content": "Abstract: Background\nIt is controversial whether compulsory community treatment (CCT) for people with severe mental illness (SMI) reduces health service use, or improves clinical outcome and social functioning.\nObjectives\nTo examine the effectiveness of compulsory community treatment (CCT) for people with severe mental illness (SMI).\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (2003, 2008, 2012, 8 November 2013, 3 June 2016). We obtained all references of identified studies and contacted authors where necessary.\nSelection criteria\nAll relevant randomised controlled clinical trials (RCTs) of CCT compared with standard care for people with SMI (mainly schizophrenia and schizophrenia-like disorders, bipolar disorder, or depression with psychotic features). Standard care could be voluntary treatment in the community or another pre-existing form of CCT such as supervised discharge.\nData collection and analysis\nAuthors independently selected studies, assessed their quality and extracted data. We used Cochrane's tool for assessing risk of bias. For binary outcomes, we calculated a fixed-effect risk ratio (RR), its 95% confidence interval (95% CI) and, where possible, the number needed to treat for an additional beneficial outcome (NNTB). For continuous outcomes, we calculated a fixed-effect mean difference (MD) and its 95% CI. We used the GRADE approach to create 'Summary of findings' tables for key outcomes and assessed the risk of bias of these findings.\nMain results\nThe review included three studies (n = 749). Two were based in the USA and one in England. The English study had the least bias, meeting three out of the seven criteria of Cochrane's tool for assessing risk of bias. The two other studies met only one criterion, the majority being rated unclear.\nTwo trials from the USA (n = 416) compared court-ordered 'outpatient commitment' (OPC) with entirely voluntary community treatment. There were no significant differences between OPC and voluntary treatment by 11 to 12 months in any of the main health service or participant level outcome indices: service use - readmission to hospital (2 RCTs, n= 416, RR 0.98, 95% CI 0.79 to 1.21, low-quality evidence); service use - compliance with medication (2 RCTs, n = 416, RR 0.99, 95% CI 0.83 to 1.19, low-quality evidence); social functioning - arrested at least once (2 RCTs, n = 416, RR 0.97, 95% CI 0.62 to 1.52, low-quality evidence); social functioning - homelessness (2 RCTs, n = 416, RR 0.67, 95% CI 0.39 to 1.15, low-quality evidence); or satisfaction with care - perceived coercion (2 RCTs, n = 416, RR 1.36, 95% CI 0.97 to 1.89, low-quality evidence). However, one trial found the risk of victimisation decreased with OPC (1 RCT, n = 264, RR 0.50, 95% CI 0.31 to 0.80, low-quality evidence).\nThe other RCT compared community treatment orders (CTOs) with less intensive and briefer supervised discharge (Section 17) in England. The study found no difference between the two groups for either the main health service outcomes including readmission to hospital by 12 months (1 RCT, n = 333, RR 0.99, 95% CI 0.74 to 1.32, moderate-quality evidence), or any of the participant level outcomes. The lack of any difference between the two groups persisted at 36 months' follow-up.\nCombining the results of all three trials did not alter these results. For instance, participants on any form of CCT were no less likely to be readmitted than participants in the control groups whether on entirely voluntary treatment or subject to intermittent supervised discharge (3 RCTs, n = 749, RR for readmission to hospital by 12 months 0.98, 95% CI 0.82 to 1.16 moderate-quality evidence). In terms of NNTB, it would take 142 orders to prevent one readmission. There was no clear difference between groups for perceived coercion by 12 months (3 RCTs, n = 645, RR 1.30, 95% CI 0.98 to 1.71, moderate-quality evidence).\nThere were no data for adverse effects.\nAuthors' conclusions\nThese review data show CCT results in no clear difference in service use, social functioning or quality of life compared with voluntary care or brief supervised discharge. People receiving CCT were, however, less likely to be victims of violent or non-violent crime. It is unclear whether this benefit is due to the intensity of treatment or its compulsory nature. Short periods of conditional leave may be as effective (or non-effective) as formal compulsory treatment in the community. Evaluation of a wide range of outcomes should be considered when this legislation is introduced. However, conclusions are based on three relatively small trials, with high or unclear risk of blinding bias, and low- to moderate-quality evidence. In addition, clinical trials may not fully reflect the potential benefits of this complex intervention.\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": "Results from the trials showed overall CCT was no more likely to result in better service use, social functioning, mental state or quality of life compared with standard 'voluntary' care. People in the trial receiving CCT were less likely to be victims of violent or non-violent crime. Short periods of conditional leave may be as effective (or non-effective) as compulsory treatment in the community."
}
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query-laysum | 913 | [
{
"role": "user",
"content": "Abstract: Background\nFollowing surgery, incisions are usually closed by fixing the edges together with sutures (stitches), staples, adhesive glue or clips. This process helps the cut edges heal together and is called 'healing by primary intention'. However, not all incised wounds are closed in this way: where there is high risk of infection, or when there has been significant tissue loss, wounds may be left open to heal from the 'bottom up'. This delayed healing is known as 'healing by secondary intention'. Negative pressure wound therapy (NPWT) is one treatment option for surgical wounds that are healing by secondary intention.\nObjectives\nTo assess the effects of negative pressure wound therapy (NPWT) on the healing of surgical wounds healing by secondary intention (SWHSI) in any care setting.\nSearch methods\nFor this review, in May 2015 we searched the following databases: the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials; Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations; Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) comparing the effects of NPWT with alternative treatments or different types of NPWT in the treatment of SWHSI. We excluded open abdominal wounds from this review as they are the subject of a separate Cochrane review that is in draft.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction.\nMain results\nWe located two studies (69 participants) for inclusion in this review. One study compared NPWT with an alginate dressing in the treatment of open, infected groin wounds. and one study compared NPWT with a silicone dressing in the treatment of excised pilonidal sinus. The trials reported limited outcome data on healing, adverse events and resource use.\nAuthors' conclusions\nThere is currently no rigorous RCT evidence available regarding the clinical effectiveness of NPWT in the treatment of surgical wounds healing by secondary intention as defined in this review. The potential benefits and harms of using this treatment for this wound type remain largely uncertain.\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": "Despite extensive searching for all relevant medical studies that might provide evidence about the effectiveness of NPWT for treating surgical wounds healing by secondary intention, we found only two eligible studies. One study compared NPWT with use of an alginate dressing in surgical wounds healing by secondary intention. The study was small, with only 20 participants, and reported very limited information (data) for wound healing, which was the outcome in which we were most interested. Time to healing was shorter for participants in the NPWT group than participants in the alginate dressing group (median of 57 days to healing for NPWT group compared with 104 days for alginate dressing group). Although some participants in this very small study needed an amputation or died, there was no difference between treatments for the number of amputations or number of deaths. A second study compared NPWT with a silicone dressing in participants who had undergone surgical removal of a pilonidal sinus: median time to healing in the NPWT group was 84 days compared to 93 days in the dressing group.\nThere is currently a lack of evidence for both the benefits and potential harms of NPWT. More, better quality research is needed to determine the effectiveness of using NPWT on surgical wounds that are healing by secondary intention.\nThis research was assessed as being up to date in May 2015."
}
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query-laysum | 914 | [
{
"role": "user",
"content": "Abstract: Background\nIntramedullary nails may be used for the surgical fixation of extracapsular hip fractures in adults. This is an update of a Cochrane review first published in 2005 and last updated in 2008.\nObjectives\nTo assess the effects (benefits and harms) of different designs of intramedullary nails for treating extracapsular hip fractures in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (6 January 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 12, 2013), MEDLINE (1966 to November Week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (3 January 2014), EMBASE (1988 to 2014, Week 1) and the World Health Organization (WHO) International Clinical Trials Registry Platform (accessed January 2014).\nSelection criteria\nAll randomised or quasi-randomised trials comparing different types, or design modifications, of intramedullary nails in the treatment of extracapsular hip fractures in adults.\nData collection and analysis\nAt least two review authors independently selected studies, assessed risk of bias and extracted data. We performed limited meta-analysis using the fixed-effect model.\nMain results\nWe included eight new trials, testing seven new comparisons in this update. Overall, we included 17 trials, testing 12 comparisons of different cephalocondylic nail designs. The trials involved a total of 2130 adults (predominantly female and older people) with mainly unstable trochanteric fractures.\nAll trials were at unclear risk of bias for most domains, with the majority at high risk of detection bias for subjective outcomes. The three quasi-randomised trials were at high risk for selection bias.\nFour trials (910 participants) compared the proximal femoral nail (PFN) with the Gamma nail. There was no significant difference between the two implants in functional outcome (the very low quality evidence being limited to results from single trials), mortality (low quality evidence: 86/415 versus 80/415; risk ratio (RR) 1.08, 95% confidence interval (CI) 0.82 to 1.41), serious fixation complications (operative fracture of the femur, cut-out, non-union and later fracture of the femur) nor re-operations (low quality evidence: 45/455 versus 36/455; RR 1.25, 95% CI 0.83 to 1.90).\nTwo trials (185 participants) provided very low quality evidence of a lack of clinically significant difference in outcome (functional score, mortality, fracture fixation complications and re-operation) between the ACE trochanteric nail and the Gamma nail.\nTwo trials (200 participants) provided very low quality evidence of a lack of significant difference in outcome (mobility score, pain, fracture fixation complications or re-operations) between the proximal femoral nail antirotation (PFNA) nail and the Gamma 3 nail.\nSeven of the nine trials evaluating different comparisons provided very low quality evidence of a lack of significant between-group differences in all of the reported main outcomes for the following comparisons: ACE trochanteric nail versus Gamma 3 nail (112 participants); gliding nail versus Gamma nail (80 participants); Russell-Taylor Recon nail versus long Gamma nail (34 participants, all under 50 years); proximal femoral nail antirotation (PFNA) nail versus Targon PF nail (80 participants); dynamically versus statically locked intramedullary hip screw (IMHS) nail (81 participants); sliding versus non-sliding Gamma 3 nail (80 participants, all under 60 years); and long versus standard PFNA nails (40 participants with reverse oblique fractures).\nThe other two single comparison trials also provided very low quality evidence of a lack of significant between-group differences in all of the main outcomes with single exceptions. The trial (215 participants) comparing the ENDOVIS nail versus the IMHS nail found low quality evidence of poorer mobility in the ENDOVIS nail group, where more participants in this group were bedridden after their operation (29/105 versus 18/110; RR 1.69, 95% CI 1.00 to 2.85; P = 0.05). The trial (113 participants) comparing the InterTan nail versus the PFNA II nail found very low quality evidence that more PFNA II group participants experienced thigh pain (3/47 versus 12/46; RR: 0.24, 95% CI 0.07 to 0.81).\nAuthors' conclusions\nThe limited evidence from the randomised trials undertaken to date is insufficient to determine whether there are important differences in outcome between different designs of intramedullary nails used in treating extracapsular hip fractures. Given the evidence of superiority of the sliding hip screw compared with intramedullary nails for extracapsular hip fractures, further studies comparing different designs of intramedullary nails are not a priority. Any new design should be evaluated in a randomised comparison with the sliding hip screw.\n\nGiven the provided abstract, please respond to the following query: \"What treatments are available?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The majority of these fractures are fixed surgically using metal implants. One increasingly used implant is the 'intramedullary nail'. This consists of a metal rod, which is usually inserted from the upper end of the femur into the inner cavity (medulla) of the femur bone and held in place with screws. There are several different types of nails, usually made by different manufacturers, in use."
}
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query-laysum | 915 | [
{
"role": "user",
"content": "Abstract: Background\nFocal segmental glomerulosclerosis (FSGS) can be separated into primary, genetic or secondary causes. Primary disease results in nephrotic syndrome while genetic and secondary forms may be associated with asymptomatic proteinuria or with nephrotic syndrome. Overall only about 20% of patients with FSGS experience a partial or complete remission of nephrotic syndrome with treatment. FSGS progresses to kidney failure in about half of the cases. This is an update of a review first published in 2008.\nObjectives\nTo assess the benefits and harms of immunosuppressive and non-immunosuppressive treatment regimens in adults with FSGS.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies to 21 June 2021 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 of any intervention for FSGS in adults were included. Studies comparing different types, routes, frequencies, and duration of immunosuppressive agents and non-immunosuppressive agents were assessed.\nData collection and analysis\nAt least two authors independently assessed study quality and extracted data. Statistical analyses were performed using the random-effects model and results were expressed as a risk ratio (RR) for dichotomous outcomes, or mean difference (MD) for continuous data with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nFifteen studies (560 participants) were included. No studies specifically evaluating corticosteroids compared with placebo or supportive therapy were identified. Studies evaluated participants with steroid-resistant FSGS. Five studies (240 participants) compared cyclosporin with or without prednisone with different comparators (no specific treatment, prednisone, methylprednisolone, mycophenolate mofetil (MMF), dexamethasone). Three small studies compared monoclonal antibodies (adalimumab, fresolimumab) with other agents or placebo. Six single small studies compared rituximab with tacrolimus, cyclosporin plus valsartan with cyclosporin alone, MMF with prednisone, chlorambucil plus methylprednisolone and prednisone with no specific treatment, different regimens of dexamethasone and CCX140-B (an antagonist of the chemokine receptor CCR2) with placebo. The final study (109 participants) compared sparsentan, a dual inhibitor of endothelin Type A receptor and of the angiotensin II Type 1 receptor, with irbesartan. In the risk of bias assessment, seven and five studies were at low risk of bias for sequence generation and allocation concealment, respectively. Four studies were at low risk of performance bias and 14 studies were at low risk of detection bias. Thirteen, six and five studies were at low risk of attrition bias, reporting bias and other bias, respectively.\nOf five studies evaluating cyclosporin, four could be included in our meta-analyses (231 participants). Cyclosporin with or without prednisone compared with different comparators may increase the likelihood of complete remission (RR 2.31, 95% CI 1.13 to 4.73; Iยฒ = 1%; low certainty evidence) and of complete or partial remission (RR 1.64, 95% CI 1.10 to 2.44; Iยฒ = 19%) but not of partial remission (RR 1.36, 95% CI 0.78 to 2.39, Iยฒ = 22%). In Individual studies, cyclosporin with prednisone versus prednisone may increase the likelihood of partial (49 participants: RR 7.96, 95% CI 1.09 to 58.15) or complete or partial remission (49 participants: RR 8.85, 95% CI 1.22 to 63.92) but not of complete remission. The remaining individual comparisons may make little or no difference to the likelihood of complete remission, partial remission or complete or partial remission compared with no treatment, methylprednisolone, MMF, or dexamethasone. Individual study data and combined data showed that cyclosporin may make little or no difference to the outcomes of chronic kidney disease or kidney failure. It is uncertain whether cyclosporin compared with these comparators in individual or combined analyses makes any difference to the outcomes of hypertension or infection.\nMMF compared with prednisone may make little or no difference to the likelihood of complete remission (33 participants: RR 1.05, 95% CI 0.58 to 1.88; low certainty evidence), partial remission, complete or partial remission, glomerular filtration rate, or infection. It is uncertain whether other interventions make any difference to outcomes as the certainty of the evidence is very low. It is uncertain whether sparsentan reduces proteinuria to a greater extent than irbesartan.\nAuthors' conclusions\nNo RCTs, which evaluated corticosteroids, were identified although the KDIGO guidelines recommend corticosteroids as the first treatment for adults with FSGS. The studies identified included participants with steroid-resistant FSGS. Treatment with cyclosporin for at least six months was more likely to achieve complete remission of proteinuria compared with other treatments but there was considerable imprecision due to few studies and small participant numbers. In future studies of existing or new interventions, the investigators must clearly define the populations included in the study to provide appropriate recommendations for patients with primary, genetic or secondary FSGS.\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": "We found limited information that cyclosporin may reduce the amount of protein in the urine in some people with FSGS but the data are uncertain because the studies enrolled too few participants. We need new agents for the treatment of FSGS with nephrotic syndrome to prevent kidney failure."
}
]
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query-laysum | 916 | [
{
"role": "user",
"content": "Abstract: Background\nThe common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore throat, and fever (usually < 37.8 ยบC). Whilst the common cold is generally not harmful, it is a cause of economic burden due to school and work absenteeism. In the United States, economic loss due to the common cold is estimated at more than USD 40 billion per year, including an estimate of 70 million workdays missed by employees, 189 million school days missed by children, and 126 million workdays missed by parents caring for children with a cold. Additionally, data from Europe show that the total cost per episode may be up to EUR 1102. There is also a large expenditure due to inappropriate antimicrobial prescription. Vaccine development for the common cold has been difficult due to antigenic variability of the common cold viruses; even bacteria can act as infective agents. Uncertainty remains regarding the efficacy and safety of interventions for preventing the common cold in healthy people, thus we performed an update of this Cochrane Review, which was first published in 2011 and updated in 2013 and 2017.\nObjectives\nTo assess the clinical effectiveness and safety of vaccines for preventing the common cold in healthy people.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (April 2022), MEDLINE (1948 to April 2022), Embase (1974 to April 2022), CINAHL (1981 to April 2022), and LILACS (1982 to April 2022). We also searched three trials registers for ongoing studies, and four websites for additional trials (April 2022). We did not impose any language or date restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) of any virus vaccine compared with placebo to prevent the common cold in healthy people.\nData collection and analysis\nWe used Cochraneโs Screen4Me workflow to assess the initial search results. Four review authors independently performed title and abstract screening to identify potentially relevant studies. We retrieved the full-text articles for those studies deemed potentially relevant, and the review authors independently screened the full-text reports for inclusion in the review, recording reasons for exclusion of the excluded studies. Any disagreements were resolved by discussion or by consulting a third review author when needed. Two review authors independently collected data on a data extraction form, resolving any disagreements by consensus or by involving a third review author. We double-checked data transferred into Review Manager 5 software. Three review authors independently assessed risk of bias using RoB 1 tool as outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We carried out statistical analysis using Review Manager 5. We did not conduct a meta-analysis, and we did not assess publication bias. We used GRADEpro GDT software to assess the certainty of the evidence and to create a summary of findings table.\nMain results\nWe did not identify any new RCTs for inclusion in this update. This review includes one RCT conducted in 1965 with an overall high risk of bias. The RCT included 2307 healthy young men in a military facility, all of whom were included in the analyses, and compared the effect of three adenovirus vaccines (live, inactivated type 4, and inactivated type 4 and 7) against a placebo (injection of physiological saline or gelatin capsule). There were 13 (1.14%) events in 1139 participants in the vaccine group, and 14 (1.19%) events in 1168 participants in the placebo group. Overall, we do not know if there is a difference between the adenovirus vaccine and placebo in reducing the incidence of the common cold (risk ratio 0.95, 95% confidence interval 0.45 to 2.02; very low-certainty evidence). Furthermore, no difference in adverse events when comparing live vaccine preparation with placebo was reported. We downgraded the certainty of the evidence to very low due to unclear risk of bias, indirectness because the population of this study was only young men, and imprecision because confidence intervals were wide and the number of events was low. The included study did not assess vaccine-related or all-cause mortality.\nAuthors' conclusions\nThis Cochrane Review was based on one study with very low-certainty evidence, which showed that there may be no difference between the adenovirus vaccine and placebo in reducing the incidence of the common cold. We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Future trials on interventions for preventing the common cold should assess a variety of virus vaccines for this condition, and should measure such outcomes as common cold incidence, vaccine safety, and mortality (all-cause and related to the vaccine).\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": "The common cold is mainly caused by a viral infection of the upper respiratory tract. People with the common cold feel unwell, have a runny nose, nasal congestion, sneezing, cough with or without sore throat, and have slightly elevated temperatures. However, people usually recover when their immune system controls the impact of the viral infection. Treatment for this condition is aimed at relieving symptoms. Globally, the common cold causes widespread illness and large economic loss. In the United States, economic loss due to the common cold is estimated at more than USD 40 billion per year, including millions of workdays and school days missed. In Europe, the total cost per episode may be up to EUR 1102. There is also a large expenditure on inappropriate antimicrobial prescriptions. It has been difficult to manufacture vaccines to prevent the common cold because it is caused by several viruses. The effect of vaccines for preventing the common cold in healthy people is still unknown."
}
]
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query-laysum | 917 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with Down syndrome are vulnerable to developing dementia at an earlier age than the general population. Alzheimer's disease and cognitive decline in people with Down syndrome can place a significant burden on both the person with Down syndrome and their family and carers. Various pharmacological interventions, including donepezil, galantamine, memantine and rivastigmine, appear to have some effect in treating cognitive decline in people without Down syndrome, but their effectiveness for those with Down syndrome remains unclear.\nObjectives\nTo assess the effectiveness of anti-dementia pharmacological interventions and nutritional supplements for treating cognitive decline in people with Down syndrome.\nSearch methods\nIn January 2015, we searched CENTRAL, ALOIS (the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group), Ovid MEDLINE, Embase, PsycINFO, seven other databases, and two trials registers. In addition, we checked the references of relevant reviews and studies and contacted study authors, other researchers and relevant drug manufacturers to identify additional studies.\nSelection criteria\nRandomised controlled trials (RCTs) of anti-dementia pharmacological interventions or nutritional supplements for adults (aged 18 years and older) with Down syndrome, in which treatment was administered and compared with either placebo or no treatment.\nData collection and analysis\nTwo review authors independently assessed the risk of bias of included trials and extracted the relevant data. Review authors contacted study authors to obtain missing information where necessary.\nMain results\nOnly nine studies (427 participants) met the inclusion criteria for this review. Four of these (192 participants) assessed the effectiveness of donepezil, two (139 participants) assessed memantine, one (21 participants) assessed simvastatin, one study (35 participants) assessed antioxidants, and one study (40 participants) assessed acetyl-L-carnitine.\nFive studies focused on adults aged 45 to 55 years, while the remaining four studies focused on adults aged 20 to 29 years. Seven studies were conducted in either the USA or UK, one between Norway and the UK, and one in Japan. Follow-up periods in studies ranged from four weeks to two years. The reviewers judged all included studies to be at low or unclear risk of bias.\nAnalyses indicate that for participants who received donepezil, scores in measures of cognitive functioning (standardised mean difference (SMD) 0.52, 95% confidence interval (CI) -0.27 to 1.13) and measures of behaviour (SMD 0.42, 95% CI -0.06 to 0.89) were similar to those who received placebo. However, participants who received donepezil were significantly more likely to experience an adverse event (odds ratio (OR) 0.32, 95% CI 0.16 to 0.62). The quality of this body of evidence was low. None of the included donepezil studies reported data for carer stress, institutional/home care, or death.\nFor participants who received memantine, scores in measures of cognitive functioning (SMD 0.05, 95% CI -0.43 to 0.52), behaviour (SMD -0.17, 95% CI -0.46 to 0.11), and occurrence of adverse events (OR 0.45, 95% CI 0.18 to 1.17) were similar to those who received placebo. The quality of this body of evidence was low. None of the included memantine studies reported data for carer stress, institutional/home care, or death.\nDue to insufficient data, it was possible to provide a narrative account only of the outcomes for simvastatin, antioxidants, and acetyl-L-carnitine. Results from one pilot study suggest that participants who received simvastatin may have shown a slight improvement in cognitive measures.\nAuthors' conclusions\nDue to the low quality of the body of evidence in this review, it is difficult to draw conclusions about the effectiveness of any pharmacological intervention for cognitive decline in people with Down syndrome.\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": "In January 2015, we, a team of Cochrane researchers, searched for all medical studies that investigated the effect of any medicine or nutritional supplement on cognitive decline in adults with Down syndrome. We found nine relevant randomised controlled trials (this design produces the most reliable results) that we could include in this overview. These studies tested:\n- donepezil, a medicine used to treat Alzheimer's disease (four studies);\n- memantine, a medicine used to treat Alzheimer's disease (two studies);\n- simvastatin, a (statin) medicine used to prevent heart disease (one study);\n- a mixture of antioxidants, including forms of vitamins C and E, and alpha-lipoic acid (one study); and\n- acetyl-L-carnitine, a dietary supplement that has previously been used to treat dementia (one study).\nFive of the studies focused on adults aged 45 to 55 years and four focused on adults aged 20 to 29 years. Seven studies were conducted in either the USA or UK, one took place in Norway and the UK, and one study was conducted in Japan."
}
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query-laysum | 918 | [
{
"role": "user",
"content": "Abstract: Background\nEight out of 10 major antihypertensive trials in older adults attempted to achieve a target systolic blood pressure (BP) less than 160 mmHg. Collectively these trials demonstrated benefit for treatment, as compared to no treatment, for an older adult with BP greater than 160 mmHg. However an even lower BP target of less than 140 mmHg is commonly applied to all age groups. At the present time it is not known whether a lower or higher BP target is associated with better cardiovascular outcomes in older adults.\nObjectives\nTo assess the effects of a higher (less than 150 to 160/95 to 105 mmHg) BP target compared to the lower BP target of less than 140/90 mmHg in hypertensive adults 65 years of age or older.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to February 2017: the Cochrane Hypertension Specialised Register, MEDLINE, Embase, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We also contacted authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nRandomised trials, of at least one year's duration, conducted on hypertensive adults aged 65 years or older, which report the effect on mortality and morbidity of a higher systolic or diastolic BP treatment target (whether ambulatory, home, or office measurements) in the range of systolic BP less than 150 to 160 mmHg or diastolic BP less than 95 to 105 mmHg as compared to a lower BP treatment target of less than 140/90 mmHg or lower.\nData collection and analysis\nTwo authors independently screened and selected trials for inclusion, assessed risk of bias, and extracted data. We combined data for dichotomous outcomes using the risk ratio (RR) with 95% confidence interval (CI) and for continuous outcomes we used mean difference (MD). Primary outcomes were all-cause mortality, stroke, institutionalisation, and cardiovascular serious adverse events. Secondary outcomes included cardiovascular mortality, non-cardiovascular mortality, unplanned hospitalisation, each component of cardiovascular serious adverse events separately (including cerebrovascular disease, cardiac disease, vascular disease, and renal failure), total serious adverse events, total minor adverse events, withdrawals due to adverse effects, systolic BP achieved, and diastolic BP achieved.\nMain results\nWe found and included three unblinded randomised trials in 8221 older adults (mean age 74.8 years), in which higher BP targets of less than 150/90 mmHg (two trials) and less than 160/90 mmHg (one trial) were compared to a lower target of less than 140/90 mmHg. Treatment to the two different BP targets over two to four years failed to produce a difference in any of our primary outcomes, including all-cause mortality (RR 1.24 95% CI 0.99 to 1.54), stroke (RR 1.25 95% CI 0.94 to 1.67) and total cardiovascular serious adverse events (RR 1.19 95% CI 0.98 to 1.45). However, the 95% confidence intervals of these outcomes suggest the lower BP target is probably not worse, and might offer a clinically important benefit. We judged all comparisons to be based on low-quality evidence. Data on adverse effects were not available from all trials and not different, including total serious adverse events, total minor adverse events, and withdrawals due to adverse effects.\nAuthors' conclusions\nAt the present time there is insufficient evidence to know whether a higher BP target (less than150 to 160/95 to 105 mmHg) or a lower BP target (less than 140/90 mmHg) is better for older adults with high BP. Additional good-quality trials assessing BP targets in this population 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": "We systematically retrieved all randomised trials that compared the effect of a higher BP target (upper BP number less than 150 to 160 mmHg) with a conventional lower BP target (upper BP number less than140 mmHg) in people over the age of 65 years. The evidence is current to February 2017."
}
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query-laysum | 919 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original Cochrane Review published in Issue 4, 2011.\nAttention deficit hyperactivity disorder (ADHD) is the most prevalent of the comorbid psychiatric disorders that complicate tic disorders. Medications commonly used to treat ADHD symptoms include stimulants such as methylphenidate and amphetamine; non-stimulants, such as atomoxetine; tricyclic antidepressants; and alpha agonists. Alpha agonists are also used as a treatment for tics. Due to the impact of ADHD symptoms on the child with tic disorder, treatment of ADHD is often of greater priority than the medical management of tics.ย However, for many decades, clinicians have been reluctant to use stimulants to treat children with ADHD and tics for fear of worsening their tics.\nObjectives\nTo assess the effects of pharmacological treatments for ADHD in children with comorbid tic disorders on symptoms of ADHD and tics.\nSearch methods\nIn September 2017, we searched CENTRAL, MEDLINE, Embase, and 12 other databases. We also searched two trial registers and contacted experts in the field for any ongoing or unpublished studies.\nSelection criteria\nWe included randomized, double-blind, controlled trials of any pharmacological treatment for ADHD used specifically in children with comorbid tic disorders. We included both parallel-group and cross-over study designs.\nData collection and analysis\nWe used standard methodological procedures of Cochrane, in that two review authors independently selected studies, extracted data using standardized forms, assessed risk of bias, and graded the overall quality of the evidence by using the GRADE approach.\nMain results\nWe included eight randomized controlled trials (four of which were cross-over trials) with 510 participants (443 boys, 67 girls) in this review. Participants in these studies were children with both ADHD and a chronic tic disorder. All studies took place in the USA and ranged from three to 22 weeks in duration. Five of the eight studies were funded by charitable organizations or government agencies, or both. One study was funded by the drug manufacturer. The other two studies did not specify the source of funding. Risk of bias of included studies was low for blinding; low or unclear for random sequence generation, allocation concealment, and attrition bias; and low or high for selective outcome reporting. We were unable to combine any of the studies in a meta-analysis due to important clinical heterogeneity and unit-of-analysis issues.\nSeveral of the trials assessed multiple agents. Medications assessed included methylphenidate, clonidine, desipramine, dextroamphetamine, guanfacine, atomoxetine, and deprenyl. There was low-quality evidence for methylphenidate, atomoxetine, and clonidine, and very low-quality evidence for desipramine, dextroamphetamine, guanfacine and deprenyl in the treatment of ADHD in children with tics. All studies, with the exception of a study using deprenyl, reported improvement in symptoms of ADHD. Tic symptoms also improved in children treated with guanfacine, desipramine, methylphenidate, clonidine, and a combination of methylphenidate and clonidine. In one study, tics limited further dosage increases of methylphenidate. High-dose dextroamphetamine appeared to worsen tics in one study, although the length of this study was limited to three weeks. There was appetite suppression or weight loss in association with methylphenidate, dextroamphetamine, atomoxetine, and desipramine. There was insomnia associated with methylphenidate and dextroamphetamine, and sedation associated with clonidine.\nAuthors' conclusions\nFollowing an updated search of potentially relevant studies, we found no new studies that matched our inclusion criteria and thus our conclusions have not changed.\nMethylphenidate, clonidine, guanfacine, desipramine, and atomoxetine appear to reduce ADHD symptoms in children with tics though the quality of the available evidence was low to very low.ย Although stimulants have not been shown to worsen tics in most people with tic disorders, they may, nonetheless, exacerbate tics in individual cases.ย In these instances, treatment with alpha agonists or atomoxetine may be an alternative. Although there is evidence that desipramine may improve tics and ADHD in children, safety concerns will likely continue to limit its use in this 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 trials in this review suggested that several stimulant and non-stimulant medications may improve ADHD symptoms in children with ADHD and tics. At high doses, dextroamphetamine may initially worsen tics in some children, and dose increases of both dextroamphetamine and methylphenidate may be limited due to tic exacerbation. However, for most children, both tics and ADHD symptoms can improve with use of stimulant medications."
}
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query-laysum | 920 | [
{
"role": "user",
"content": "Abstract: Background\nRice fortification with vitamins and minerals has the potential to increase the nutrition in rice-consuming countries where micronutrient deficiencies exist. Globally, 490 million metric tonnes of rice are consumed annually. It is the dominant staple food crop of around three billion people.\nObjectives\nTo determine the benefits and harms of rice fortification with vitamins and minerals (iron, vitamin A, zinc or folic acid) on micronutrient status and health-related outcomes in the general population.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, and 16 other databases all up to 10 December 2018. We searched ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (ICTRP) on 10 December 2018.\nSelection criteria\nWe included randomised and quasi-randomised trials (with either individual or cluster randomisation) and controlled before-and-after studies. Participants were populations older than two years of age (including pregnant women) from any country. The intervention was rice fortified with at least one micronutrient or a combination of several micronutrients (iron, folic acid, zinc, vitamin A or other vitamins and minerals) compared with unfortified rice or no intervention.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently screened studies and extracted data.\nMain results\nWe included 17 studies (10,483 participants) and identified two ongoing studies. Twelve included studies were randomised-controlled trials (RCTs), with 2238 participants after adjusting for clustering in two cluster-RCTs, and five were non-randomised studies (NRS) with four controlled before-and-after studies and one cross-sectional study with a control (8245 participants). Four studies were conducted in India, three in Thailand, two in the Philippines, two in Brazil, one each in Bangladesh, Burundi, Cambodia, Indonesia, Mexico and the USA. Two studies involved non-pregnant, non-lactating women and 10 involved pre-school or school-age children.\nAll 17 studies reported fortification with iron. Of these, six studies fortified rice with iron only; 11 studies had other micronutrients added (iron, zinc and vitamin A, and folic acid). One study had one arm each with vitamin A alone and carotenoid alone. Elemental iron content ranged from 0.2 to 112.8 mg/100 g uncooked rice given for a period varying from two weeks to 48 months.\nThirteen studies did not clearly describe either sequence generation or allocation concealment. Eleven studies had a low attrition rate. There was no indication of selective reporting in the studies. We considered two RCTs at low overall risk of bias and 10 at high overall risk of bias. One RCT was at high or unclear risk of bias for most of the domains. All controlled before-and-after studies had a high risk or unclear risk of bias in most domains. The included studies were funded by Government, private and non-governmental organisations, along with other academic institutions. The source of funding does not appear to have altered the results. We used the NRS in the qualitative synthesis but we excluded them from the quantitative analysis and review conclusions since they provided mostly contextual information and limited quantitative information.\nRice fortified with iron alone or in combination with other micronutrients versus unfortified rice (no micronutrients added)\nFortification of rice with iron (alone or in combination with other micronutrients) may make little or no difference in the risk of having anaemia (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.54 to 0.97; I2 = 74%; 7 studies, 1634 participants; low-certainty evidence) and may reduce the risk of iron deficiency (RR 0.66, 95% CI 0.51 to 0.84; 8 studies, 1733 participants; low-certainty evidence). Rice fortification may increase mean haemoglobin (mean difference (MD) 1.83, 95% CI 0.66 to 3.00; I2 = 54%; 11 studies, 2163 participants; low-certainty evidence) and it may make little or no difference to vitamin A deficiency (with vitamin A as one of the micronutrients in the fortification arm) (RR 0.68, 95% CI 0.36 to 1.29; I2 = 37%; 4 studies, 927 participants; low-certainty evidence). One study reported that fortification of rice (with folic acid as one of the micronutrients) may improve serum or plasma folate (nmol/L) (MD 4.30, 95% CI 2.00 to 6.60; 215 participants; low-certainty evidence). One study reported that fortification of rice with iron alone or with other micronutrients may slightly increase hookworm infection (RR 1.78, 95% CI 1.18 to 2.70; 785 participants; low-certainty evidence). We are uncertain about the effect of fortified rice on diarrhoea (RR 3.52, 95% CI 0.18 to 67.39; 1 study, 258 participants; very low-certainty evidence).\nRice fortified with vitamin A alone or in combination with other micronutrients versus unfortified rice (no micronutrients added)\nOne study had one arm providing fortified rice with vitamin A only versus unfortified rice. Fortification of rice with vitamin A (in combination with other micronutrients) may increase mean haemoglobin (MD 10.00, 95% CI 8.79 to 11.21; 1 study, 74 participants; low-certainty evidence). Rice fortified with vitamin A may slightly improve serum retinol concentration (MD 0.17, 95% CI 0.13 to 0.21; 1 study, 74 participants; low-certainty evidence).\nNo studies contributed data to the comparisons of rice fortification versus no intervention. The studies involving folic acid and zinc also involved iron in the fortification arms and hence we reported them as part of the first comparison.\nAuthors' conclusions\nFortification of rice with iron alone or in combination with other micronutrients may make little or no difference in the risk of having anaemia or presenting iron deficiency and we are uncertain about an increase in mean haemoglobin concentrations in the general population older than 2 years of age. Fortification of rice with iron and other micronutrients such as vitamin A or folic acid may make little or no difference in the risk of having vitamin A deficiency or on the serum folate concentration. There is limited evidence on any adverse effects of rice fortification.\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 review authors searched for studies that had been published up to 10 December 2018."
}
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query-laysum | 921 | [
{
"role": "user",
"content": "Abstract: Background\nCardiac complications are not uncommon in patients undergoing non-cardiac surgery, especially in patients with coronary artery disease (CAD) or at high risk of CAD. Perioperative cardiac complications can lead to mortality and morbidity, as well as higher costs for patient care. Nitrates, which are among the most commonly used cardiovascular drugs, perform the function of decreasing cardiac preload while improving cardiac blood perfusion. Sometimes, nitrates are administered to patients undergoing non-cardiac surgery to reduce the incidence of cardiac complications, especially for patients with CAD. However, their effects on patients' relevant outcomes remain controversial.\nObjectives\nโข To assess effects of nitrates as compared with other interventions or placebo in reducing cardiac risk (such as death caused by cardiac factors, angina pectoris, acute myocardial infarction, acute heart failure and cardiac arrhythmia) in patients undergoing non-cardiac surgery.\nโข To identify the influence of different routes and dosages of nitrates on patient outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Chinese BioMedical Database until June 2014. We also searched relevant conference abstracts of important anaesthesiology or cardiology scientific meetings, the database of ongoing trials and Google Scholar.\nWe reran the search in January 2016. We added three potential new studies of interest to the list of โStudies awaiting classification' and will incorporate them into our formal review findings for the review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing nitrates versus no treatment, placebo or other pharmacological interventions in participants (15 years of age and older) undergoing non-cardiac surgery under any type of anaesthesia.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane. Two review authors selected trials, extracted data from included studies and assessed risk of bias. We resolved differences by discussion and, when necessary, sought help and suggestions from a third review author. We used a random-effects model for data analysis.\nMain results\nWe included 27 randomized controlled trials (RCTs) (8244 participants analysed). Investigators reported 12 different comparisons of three different nitrates (nitroglycerin, isosorbide dinitrate and nicorandil) versus no treatment, placebo or other pharmacological interventions. All participants were older than 15 years of age. More than half of the trials used general anaesthesia. Surgical procedures in most trials were at low to moderate risk for perioperative cardiac complications. Only two comparisons including three studies reported the primary outcome - all-cause mortality up to 30 days post operation. Researchers reported other morbidity outcomes and adverse events in a variable and heterogeneous way, resulting in limited available data for inclusion in the meta-analysis. We determined that the overall methodological quality of included studies was fair to low, in accordance with risk of bias in most domains.\nIn summary, we found no difference in the primary outcome - all-cause mortality up to 30 days post operation - when nitroglycerin was compared with no treatment (one study, 60 participants, 0/30 vs 1/30; (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.01 to 7.87, very low-quality evidence based on GRADE criteria) or with placebo (two studies, 89 participants, 1/45 vs 0/44; RR 2.81, 95% CI 0.12 to 63.83, very low-quality evidence). Regarding our secondary outcomes, we noted no statistically significant differences in angina pectoris, acute myocardial infarction, acute heart failure, cardiac arrhythmia or cardiac arrest in any comparisons. In comparisons versus nitroglycerin, although more events of cardiac ischaemia were observed in participants receiving no treatment or placebo, we found no statistically significant differences in any comparisons, except the comparison of nicorandil versus placebo. One study revealed a potential dose-dependent protective effect of nicorandil for cardiac ischaemia.\nAdverse events were reported in a heterogeneous way among the comparisons. In general, more participants treated with nitrates had hypotension, tachycardia and headache, but investigators reported no statistically significant differences between groups in any comparisons.\nAuthors' conclusions\nThis systematic review suggests that nitroglycerin or isosorbide dinitrate is not associated with improvement in mortality and cardiac complications among patients undergoing non-cardiac surgery. Limited evidence suggests that nicorandil may reduce the risk of cardiac ischaemia in participants undergoing non-cardiac surgery. Additional studies are needed to consolidate the evidence.\nHowever, the data included in many of the analyses in this review are sparse - that is, adequate data are few - resulting in very low power to detect differences between nitrates and comparators. Thus, a more objective conclusion would state that available evidence is insufficient to show whether nitrates are associated with improvement in mortality and cardiac complications among patients undergoing non-cardiac surgery.\nOver the past decade, no high-quality studies have focused on association of cardiac mortality and morbidity with use of nitrates during non-cardiac surgery. This review underlines the need for well-designed trials in this field.\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 on effects of nitrates on death and cardiac complications in people undergoing non-cardiac surgery (that is, surgery on any part of the body except the heart)."
}
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query-laysum | 922 | [
{
"role": "user",
"content": "Abstract: Background\nBreathlessness is a common and disabling symptom which affects many people with advanced cardiorespiratory disease and cancer. The most effective treatments are aimed at treating the underlying disease. However, this may not always be possible, and symptomatic treatment is often required in addition to maximal disease-directed therapy. Opioids are increasingly being used to treat breathlessness, although their mechanism of action is still not completely known. A few good sized, high quality trials have been conducted in this area.\nObjectives\nTo determine the effectiveness of opioid drugs in relieving the symptom of breathlessness in people with advanced disease due to malignancy, respiratory or cardiovascular disease, or receiving palliative care for any other disease.\nSearch methods\nWe performed searches on CENTRAL, MEDLINE, EMBASE, CINAHL, and Web of Science up to 19 October 2015. We handsearched review articles, clinical trial registries, and reference lists of retrieved articles.\nSelection criteria\nWe included randomised double-blind controlled trials that compared the use of any opioid drug against placebo or any other intervention for the relief of breathlessness. The intervention was any opioid, given by any route, in any dose.\nData collection and analysis\nWe imported studies identified by the search into a reference manager database. We retrieved the full-text version of relevant studies, and two review authors independently extracted data. The primary outcome measure was breathlessness and secondary outcome measures included exercise tolerance, oxygen saturations, adverse events, and mortality. We analysed all studies together and also performed subgroup analyses, by route of administration, type of opioid administered, and cause of breathlessness. Where appropriate, we performed meta-analysis. We assessed the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and created three 'Summary of findings' tables.\nMain results\nWe included 26 studies with 526 participants. We assessed the studies as being at high or unclear risk of bias overall. We only included randomised controlled trials (RCTs), although the description of randomisation was incomplete in some included studies. We aimed to include double blind RCTs, but two studies were only single blinded. There was inconsistency in the reporting of outcome measures. We analysed the data using a fixed-effect model, and for some outcomes heterogeneity was high. There was a risk of imprecise results due to the low numbers of participants in the included studies. For these reasons we downgraded the quality of the evidence from high to either low or very low.\nFor the primary outcome of breathlessness, the standardised mean post-treatment dyspnoea score was 0.32 points better in the opioid group compared to the placebo group (ranging from a 0.53 point reduction to a 0.10 point reduction) (12 RCTs, 338 participants, low quality evidence). The standardised mean change from baseline dyspnoea score was 0.11 points better in the opioids group compared to the placebo group (ranging from a 0.40 point reduction to a 0.19 increase) (six RCTs, 194 participants, very low quality evidence). A lower score indicates an improvement in breathlessness.\nThe evidence for the six-minute walk test (6MWT) was conflicting. The total distance in 6MWT was 28 metres (m) better in the opioids group compared to placebo (ranging from 113 m to 58 m) (one RCT, 11 participants, very low quality evidence). However, the change in baseline was 48 m worse in the opioids group (ranging from 36 m to 60 m) (two RCTs, 26 participants, very low quality evidence).\nThe adverse effects reported included drowsiness, nausea and vomiting, and constipation. In those studies, participants were 4.73 times more likely to experience nausea and vomiting compared to placebo, three times more likely to experience constipation, and 2.86 times more likely to experience drowsiness (nine studies, 162 participants, very low quality evidence).\nOnly four studies assessed quality of life, and none demonstrated any significant change.\nAuthors' conclusions\nThere is some low quality evidence that shows benefit for the use of oral or parenteral opioids to palliate breathlessness, although the number of included participants was small. We found no evidence to support the use of nebulised opioids. Further research with larger numbers of participants, using standardised protocols and with quality of life measures included, is 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"
},
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"role": "assistant",
"content": "We rated the quality of the evidence using one of the following grades: very low, low, moderate, or high. Very low quality evidence means we are uncertain about the results. High quality evidence means we are very certain about the results. For this Cochrane review, we found that the evidence was of low to very low quality. We included randomised controlled trials which were blinded, which means that participants and those people that assessed the results did not know whether the participants had received the opioid drug or a placebo. However, the trials were of small size, and some studies did not give enough information to allow us to assess whether they were of good quality."
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query-laysum | 923 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization declared the COVID-19 pandemic on 11 March 2020. Vaccine development and deployment were swiftly prioritised as a method to manage and control disease spread. The development of an effective vaccine relies on people's participation in randomised trials. Recruitment to vaccine trials is particularly challenging as it involves healthy volunteers who may have concerns around the potential risks and benefits associated with rapidly developed vaccines.\nObjectives\nTo explore the factors that influence a person's decision to participate in a vaccine trial in the context of a pandemic or epidemic.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was June 2021.\nSelection criteria\nWe included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored the perspectives of adults aged 18 years or older who were invited to take part in vaccine trials in the context of a pandemic or epidemic.\nData collection and analysis\nWe assessed the title, abstracts and full texts identified by the search. We used a sampling frame to identify data-rich studies that represented a range of diseases and geographical spread. We used QSR NVivo to manage extracted data. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool for qualitative studies. We used the 'best-fit framework approach' to analyse and synthesise the evidence from our included studies. We then used the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) assessment to assess our confidence in each finding and develop implications for practice.\nMain results\nWe included 34 studies in our review. Most studies related to HIV vaccine trials. The other studies related to Ebola virus, tuberculosis, Zika virus and COVID-19. We developed 20 key findings, under three broad themes (with seven subthemes), that described the factors that people consider when deciding whether to take part in a vaccine trial for a pandemic or epidemic disease.\nOur GRADE-CERQual confidence was high in nine of the key findings, moderate in 10 key findings and low in one key finding. The main reason for downgrading review findings were concerns regarding the relevance and adequacy of the underlying data. As a result of the over-representation of HIV studies, our GRADE-CERQual assessment of some findings was downgraded in terms of relevance because the views described may not reflect those of people regarding vaccine trials for other pandemic or epidemic diseases. Adequacy relates to the degree of richness and quantity of data supporting a review finding. Moderate concerns about adequacy resulted in a downgrading of some review findings.\nSome factors were considered to be under the control of the trial team. These included how trial information was communicated and the inclusion of people in the community to help with trial information dissemination. Aspects of trial design were also considered under control of the trial team and included convenience of participation, provision of financial incentives and access to additional support services for those taking part in the trial.\nOther factors influencing people's decision to take part could be personal, from family, friends or wider society. From a personal perceptive, people had concerns about vaccine side effects, vaccine efficacy and possible impact on their daily lives (carer responsibilities, work, etc.). People were also influenced by their families, and the impact participation may have on relationships. The fear of stigma from society influenced the decision to take part. Also, from a societal perspective, the level of trust in governments' involvement in research and trial may influence a person's decision.\nFinally, the perceived rewards, both personal and societal, were influencing factors on the decision to participate. Personal rewards included access to a vaccine, improved health and improved disease knowledge, and a return to normality in the context of a pandemic or epidemic. Potential societal rewards included helping the community and contributing to science, often motivated by the memories of family and friends who had died from the disease.\nAuthors' conclusions\nThis review identifies many of the factors that influence a person's decision to take part in a vaccine trial, and these reflect findings from reviews that examine trials more broadly. However, we also recognise some factors that become more important in connection with a vaccine trial in the context of a pandemic or epidemic. These factors include the potential stigma of taking part, the possible adverse effects of a vaccine, the added motivation for helping society, the role of community leaders in trial dissemination, and the level of trust placed in governments and companies developing vaccines. These specific influences need to be considered by trial teams when designing, and communicating about, vaccine trials in the context of a pandemic or epidemic.\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"
},
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"role": "assistant",
"content": "Many factors influence a person's decision to take part in a vaccine trial during a pandemic or epidemic. People are influenced by the way in which the trial is set up and how information about the trial is communicated. People are also influenced by what they think the possible risks and side effects are. Friends and family may also have influenced their decision. A fear of stigma and distrust in governments may prevent people from taking part in a vaccine trial. People may often see the chance to help others and prevent the spread of disease as a reason to take part in a vaccine trial."
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query-laysum | 924 | [
{
"role": "user",
"content": "Abstract: Background\nPhysical exercise is effective in managing Parkinson's disease (PD), but the relative benefit of different exercise types remains unclear.\nObjectives\nTo compare the effects of different types of physical exercise in adults with PD on the severity of motor signs, quality of life (QoL), and the occurrence of adverse events, and to generate a clinically meaningful treatment ranking using network meta-analyses (NMAs).\nSearch methods\nAn experienced information specialist performed a systematic search for relevant articles in CENTRAL, MEDLINE, Embase, and five other databases to 17 May 2021. We also searched trial registries, conference proceedings, and reference lists of identified studies up to this date.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing one type of physical exercise for adults with PD to another type of exercise, a control group, or both.\nData collection and analysis\nTwo review authors independently extracted data. A third author was involved in case of disagreements.\nWe categorized the interventions and analyzed their effects on the severity of motor signs, QoL, freezing of gait, and functional mobility and balance up to six weeks after the intervention using NMAs. Two review authors independently assessed the risk of bias using the risk of bias 2 (RoB 2) tool and rated the confidence in the evidence using the CINeMA approach for results on the severity of motor signs and QoL. We consulted a third review author to resolve any disagreements.\nDue to heterogeneous reporting of adverse events, we summarized safety data narratively and rated our confidence in the evidence using the GRADE approach.\nMain results\nWe included 156 RCTs with a total of 7939 participants with mostly mild to moderate disease and no major cognitive impairment. The number of participants per study was small (mean 51, range from 10 to 474). The NMAs on the severity of motor signs and QoL included data from 71 (3196 participants), and 55 (3283 participants) trials, respectively. Eighty-five studies (5192 participants) provided safety data. Here, we present the main results.\nWe observed evidence of beneficial effects for most types of physical exercise included in our review compared to a passive control group. The effects on the severity of motor signs and QoL are expressed as scores on the motor scale of the Unified Parkinson Disease Rating Scale (UPDRS-M) and the Parkinson's Disease Questionnaire 39 (PDQ-39), respectively. For both scales, higher scores denote higher symptom burden. Therefore, negative estimates reflect improvement (minimum clinically important difference: -2.5 for UPDRS-M and -4.72 for PDQ-39).\nSeverity of motor signs\nThe evidence from the NMA (71 studies; 3196 participants) suggests that dance has a moderate beneficial effect on the severity of motor signs (mean difference (MD) -10.32, 95% confidence interval (CI) -15.54 to -4.96; high confidence), and aqua-based, gait/balance/functional, and multi-domain training might have a moderate beneficial effect on the severity of motor signs (aqua-based: MD -7.77, 95% CI -13.27 to -2.28; gait/balance/functional: MD -7.37, 95% CI -11.39 to -3.35; multi-domain: MD -6.97, 95% CI -10.32 to -3.62; low confidence). The evidence also suggests that mind-body training and endurance training might have a small beneficial effect on the severity of motor signs (mind-body: MD -6.57, 95% CI -10.18 to -2.81; endurance: MD -6.43, 95% CI -10.72 to -2.28; low confidence). Flexibility training might have a trivial or no effect on the severity of motor signs (MD 2.01, 95% CI -4.82 to 8.98; low confidence). The evidence is very uncertain about the effects of strength/resistance training and \"Lee Silverman Voice training BIG\" (LSVT BIG) on the severity of motor signs (strength/resistance: MD -6.97, 95% CI -11.93 to -2.01; LSVT BIG: MD -5.49, 95% CI -14.74 to 3.62; very low confidence).\nQuality of life\nThe evidence from the NMA (55 studies; 3283 participants) suggests that aqua-based training probably has a large beneficial effect on QoL (MD -14.98, 95% CI -23.26 to -6.52; moderate confidence). The evidence also suggests that endurance training might have a moderate beneficial effect, and that gait/balance/functional and multi-domain training might have a small beneficial effect on QoL (endurance: MD -9.16, 95% CI -15.68 to -2.82; gait/balance/functional: MD -5.64, 95% CI -10.04 to -1.23; multi-domain: MD -5.29, 95% CI -9.34 to -1.06; low confidence). The evidence is very uncertain about the effects of mind-body training, gaming, strength/resistance training, dance, LSVT BIG, and flexibility training on QoL (mind-body: MD -8.81, 95% CI -14.62 to -3.00; gaming: MD -7.05, 95% CI -18.50 to 4.41; strength/resistance: MD -6.34, 95% CI -12.33 to -0.35; dance: MD -4.05, 95% CI -11.28 to 3.00; LSVT BIG: MD 2.29, 95% CI -16.03 to 20.44; flexibility: MD 1.23, 95% CI -11.45 to 13.92; very low confidence).\nAdverse events\nOnly 85 studies (5192 participants) provided some kind of safety data, mostly only for the intervention groups. No adverse events (AEs) occurred in 40 studies and no serious AEs occurred in four studies. AEs occurred in 28 studies. The most frequently reported events were falls (18 studies) and pain (10 studies). The evidence is very uncertain about the effect of physical exercise on the risk of adverse events (very low confidence).\nAcross outcomes, we observed little evidence of differences between exercise types.\nAuthors' conclusions\nWe found evidence of beneficial effects on the severity of motor signs and QoL for most types of physical exercise for people with PD included in this review, but little evidence of differences between these interventions. Thus, our review highlights the importance of physical exercise regarding our primary outcomes severity of motor signs and QoL, while the exact exercise type might be secondary. Notably, this conclusion is consistent with the possibility that specific motor symptoms may be treated most effectively by PD-specific programs. Although the evidence is very uncertain about the effect of exercise on the risk of adverse events, the interventions included in our review were described as relatively safe. Larger, well-conducted studies are needed to increase confidence in the evidence. Additional studies recruiting people with advanced disease severity and cognitive impairment might help extend the generalizability of our findings to a broader range of people with PD.\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"
},
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"role": "assistant",
"content": "The evidence is up to date to May 2021."
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query-laysum | 925 | [
{
"role": "user",
"content": "Abstract: Background\nShock wave lithotripsy (SWL) is a widely used method to treat renal and ureteral stone. It fragments stones into smaller pieces that are then able to pass spontaneously down the ureter and into the bladder. Alpha-blockers may assist in promoting the passage of stone fragments, but their effectiveness remainsย uncertain.\nObjectives\nTo assess the effects of alpha-blockers as adjuvant medical expulsive therapy plus usual care compared to placebo and usual care or usual care aloneย in adults undergoing shock wave lithotripsy for renal or ureteral stones.\nSearch methods\nWe performed a comprehensive literature search of the Cochrane Library, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, several clinical trial registries and grey literature for published and unpublished studies irrespective of language. The date of the most recent search was 27 February 2020.\nSelection criteria\nWe included randomized controlled trials of adults undergoing SWL. Participants in the intervention group had to have received an alpha-blocker as adjuvant medical expulsive therapy plus usual care. For the comparator group, we considered studies in which participants received placebo.\nData collection and analysis\nTwo review authors independently selected studies for inclusion/exclusion, and performed data abstraction and risk of bias assessment. We conducted meta-analysis for the identified dichotomous and continuous outcomes using RevManWeb according to Cochrane methods using a random-effects model. We judged the certainty of evidence on a per outcome basis using GRADE.\nMain results\nWe included 40 studies with 4793 participants randomized to usualย care and an alpha-blocker versus usual care alone. Only four studies were placebo controlled. The mean age of participants was 28.6 to 56.8ย years and the mean stone size prior to SWL was 7.1 mm to 13.2ย mm. The most widely usedย alpha-blocker was tamsulosin; others wereย silodosin, doxazosin, terazosin and alfuzosin.\nAlpha-blockers may improve clearance of stone fragments after SWL (risk ratio (RR) 1.16, 95% confidence interval (CI) 1.09 to 1.23; Iยฒ = 78%; studies = 36; participants = 4084; low certainty evidence). Based on the stone clearance rate of 69.3% observed in the control arm, an alpha-blocker may increase stone clearance to 80.4%. This corresponds to 111 more (62 more to 159 more) participants per 1000 clearing their stone fragments.\nAlpha-blockers may reduce the need for auxiliary treatments after SWL (RR 0.67, 95% CI 0.45ย to 1.00; Iยฒ = 16%; studies = 12; participants = 1251; low certainty evidence), but also includes the possibility of no effect. Based on a rate of auxiliary treatments in the usual care arm of 9.7%, alpha-blockers may reduce the rate to 6.5%. This corresponds 32ย fewer (53 fewer to 0ย fewer) participants per 1000 undergoing auxiliary treatments.\nAlpha-blockers may reduce major adverse events (RR 0.60, 95% CI 0.46 to 0.80; Iยฒ = 0%; studies = 7; participants = 747; low certainty evidence). Major adverse events occurred in 25.8% of participants in the usual care group; alpha-blockers would reduce this to 15.5%. This corresponds to 103 fewer (139 fewer to 52 fewer) major adverse events per 1000 with alpha-blocker treatment. None of the reported major adverse events appeared drug-related; most were emergency room visits or rehospitalizations.\nAlpha-blockers may reduce stone clearance timeย in days (mean difference (MD) โ3.74, 95% CI โ5.25 to โ2.23; Iยฒ = 86%; studies = 14; participants = 1790; low certainty evidence). We found no evidence for the outcome of quality of life.\nFor those outcomes for which we were able to perform subgroup analyses, we found no evidence of interaction with stone location, stone size or type of alpha-blocker. We were unable to conduct an analysis by lithotripter type. The results were also largely unchanged when the analyses were limited to placebo controlled studies and those in which participants explicitly only received a single SWL session.\nAuthors' conclusions\nBased on low certainty evidence, adjuvant alpha-blocker therapy following SWL in addition to usual care may resultย in improved stone clearance, less need for auxiliary treatments, fewerย major adverse events and a reducedย stone clearance time compared to usual care alone. We did not find evidence for quality of life. The low certainty of evidence means that our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Compared with usual care or a placebo treatment, alpha-blockers may:\nclear kidney stones in more people: in 111 more people for every 1000 people treated (36 studies);\nclear stones faster: by nearly four days (14 studies);\nreduce the need for extra treatments to clear stones: in 32 fewer people for every 1000 people treated (12 studies); and\ncause fewer unwanted effects: affecting 103ย fewer people for every 1000 people treated (seven studies).\nMost unwanted effects were emergency visits to hospitals, and people going back into hospital for stone related problems. Unwanted effects were more common in people who had usual care or a placebo treatment than in people given alpha-blockers.\nNone of the studies looked at people's quality of life (well-being)."
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query-laysum | 926 | [
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"role": "user",
"content": "Abstract: Background\nAcute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary embolism (post-PE) syndrome.\nAPE can be classified according to the short-term (30-day) risk of mortality, based on a variety of clinical, imaging and laboratory findings. Most mortality and morbidity is concentrated in high-risk (massive) and intermediate-risk (submassive) APE. The first-line treatment for APE is systemic anticoagulation.\nHigh-risk (massive) APE accounts for less than 10% of APE cases and is a life-threatening medical emergency, requiring immediate reperfusion treatment to prevent death. Systemic thrombolysis is the recommended treatment for high-risk (massive) APE. However, only a minority of the people affected receive systemic thrombolysis, due to comorbidities or the 10% risk of major haemorrhagic side effects. Of those who do receive systemic thrombolysis, 8% do not respond in a timely manner. Surgical pulmonary embolectomy is an alternative reperfusion treatment, but is not widely available.\nIntermediate-risk (submassive) APE represents 45% to 65% of APE cases, with a short-term mortality rate of around 3%. Systemic thrombolysis is not recommended for this group, as major haemorrhagic complications outweigh the benefit. However, the people at higher risk within this group have a short-term mortality of around 12%, suggesting that anticoagulation alone is not an adequate treatment. Identification and more aggressive treatment of people at intermediate to high risk, who have a more favourable risk profile for reperfusion treatments, could reduce short-term mortality and potentially reduce post-PE syndrome.\nCatheter-directed treatments (catheter-directed thrombolysis and catheter embolectomy) are minimally invasive reperfusion treatments for high- and intermediate-risk APE. Catheter-directed treatments can be used either as the primary treatment or as salvage treatment after failure of systemic thrombolysis. Catheter-directedย thrombolysis administers 10% to 20% of the systemic thrombolysis dose directly into the thrombus in the lungs, potentially reducing the risks of haemorrhagic side effects. Catheter embolectomy mechanically removes the thrombus without the need for thrombolysis, and may be useful for people with contraindications for thrombolysis.\nCurrently, the benefits of catheter-based APE treatments compared with existing medical and surgical treatment are unclear despite increasing adoption of catheter treatments by PE response teams. This review examines the evidence for the use of catheter-directed treatments in high- and intermediate-risk APE. This evidence could help guide the optimal treatment strategy for people affected by this common and life-threatening condition.\nObjectives\nTo assess the effects of catheter-directed therapies versus alternative treatments for high-risk (massive) and intermediate-risk (submassive) APE.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 15 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of catheter-directed therapies for the treatment of high-risk (massive) and intermediate-risk (submassive) APE. We excluded catheter-directed treatments for non-PE. We applied no restrictions on participant age or on the date, language or publication status of RCTs.\nData collection and analysis\nWe used standard Cochrane methods. The main outcomes were all-cause mortality, treatment-associated major and minor haemorrhage rates based on two established clinical definitions, recurrent APE requiring retreatment or change to a different APE treatment, length of hospital stay, and quality of life. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified one RCT (59 participants) of (ultrasound-augmented) catheter-directed thrombolysis for intermediate-risk (submassive) APE.\nWe found no trials of any catheter-directed treatments (thrombectomy or thrombolysis) in people with high-risk (massive) APE or of catheter-based embolectomy in people with intermediate-risk (submassive) APE.\nThe included trial compared ultrasound-augmented catheter-directed thrombolysis with alteplase and systemic heparinisation versus systemic heparinisation alone. In the treatment group, each participant received an infusion of alteplase 10 mg or 20 mg over 15 hours. We identified a high risk of selection and performance bias, low risk of detection and reporting bias, and unclear risk of attrition and other bias. Certainty of evidence was very low because of risk of bias and imprecision.\nBy 90 days, there was no clear difference in all-cause mortality between the treatment group and control group. A single death occurred in the control group at 20 days after randomisation, but it was unrelated to the treatment or to APE (odds ratio (OR) 0.31, 95% confidence interval (CI) 0.01 to 7.96; 59 participants).\nBy 90 days, there were no episodes of treatment-associated major haemorrhage in either the treatment or control group. There was no clear difference in treatment-associated minor haemorrhage between the treatment and control group by 90 days (OR 3.11, 95% CI 0.30 to 31.79; 59 participants).\nBy 90 days, there were no episodes of recurrent APE requiring retreatment or change to a different APE treatment in the treatment or control group.\nThere was no clear difference in the length of mean total hospital stay between the treatment and control groups. Mean stay was 8.9 (standard deviation (SD) 3.4) days in the treatment group versus 8.6 (SD 3.9) days in the control group (mean difference 0.30, 95% CI โ1.57 to 2.17; 59 participants).\nThe included trial did not investigate quality of life measures.\nAuthors' conclusions\nThere is a lack of evidence to support widespread adoption of catheter-based interventional therapies for APE. We identified one small trial showing no clear differences between ultrasound-augmented catheter-directed thrombolysis with alteplase plus systemic heparinisation versus systemic heparinisation alone in all-cause mortality, major and minor haemorrhage rates, recurrent APE and length of hospital stay. Quality of life was not assessed.\nMultiple small retrospective case series, prospective patient registries and single-arm studies suggest potential benefits of catheter-based treatments, but they provide insufficient evidence to recommend this approach over other evidence-based treatments.\nResearchers should consider clinically relevant primary outcomes (e.g. mortality and exercise tolerance), rather than surrogate markers (e.g. right ventricular to left ventricular (RV:LV) ratio or thrombus burden), which have limited clinical utility. Trials must include a control group to determine if the effects are specific to the treatment.\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": ""
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query-laysum | 927 | [
{
"role": "user",
"content": "Abstract: Background\nNasopharyngeal cancer is endemic in a few well-defined populations. The prognosis for advanced nasopharyngeal cancer is poor, but early-stage disease is curable and a high survival rate can be achieved. Screening for early-stage disease could lead to improved outcomes. Epstein-Barr virus (EBV) serology and nasopharyngoscopy are most commonly used for screening. The efficacy and true benefit of screening remain uncertain due to potential selection, lead-time and length-time biases.\nObjectives\nTo determine the effectiveness of screening of asymptomatic individuals by EBV serology and/or nasopharyngoscopy in reducing the mortality of nasopharyngeal cancer compared to no screening. To assess the impact of screening for nasopharyngeal cancer on incidence, survival, adverse effects, cost-effectiveness and quality of life.\nSearch methods\nThe Cochrane Ear, Nose and Throat Disorders Group (CENTDG) Trials Search Co-ordinator searched the CENTDG Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 6); PubMed; EMBASE; CINAHL; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 6 July 2015.\nSelection criteria\nRandomised controlled trials (RCT) and controlled clinical trials (CCT) evaluating screening for nasopharyngeal cancer versus no screening. Randomisation either by clusters or individuals was acceptable.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration. Our primary outcome measure was nasopharyngeal cancer-specific mortality. Secondary outcomes were incidence of nasopharyngeal cancer by stage and histopathological classification at diagnosis, survival (two-year, three-year, five-year and 10-year), harms of screening (physical and psychosocial), quality of life (via validated tools such as the SF-36 and patient satisfaction), cost-effectiveness and all-cause mortality.\nMain results\nWe identified no trials that met the review inclusion criteria. We retrieved 31 full-text studies for further investigation following the search. However, none met the eligibility criteria for a RCT or CCT investigation on the efficacy of screening for nasopharyngeal cancer.\nAuthors' conclusions\nNo data from RCTs or CCTs are available to allow us to determine the efficacy of screening for nasopharyngeal cancer, or the cost-effectiveness and cost-benefit of a screening strategy. High-quality studies with long-term follow-up of mortality and cost-effectiveness are needed.\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": "Nasopharyngeal cancer is a rare cancer worldwide, but it is common in the Cantonese population of southern China. Due to its deep location in the nose and non-specific initial symptoms nasopharyngeal cancer is often detected late. While the prognosis for advanced nasopharyngeal cancer is very poor, early-stage nasopharyngeal cancer is potentially curable. Therefore early identification by screening might lead to improved outcomes. There are two common screening tests: the Epstein-Barr virus (EBV) blood test and nasopharyngoscopy (a procedure that allows the internal surfaces of the nose and throat to be examined with a fibre-optic instrument). Studying the benefits of screening for nasopharyngeal cancer started in the 1970s, but the value of this approach remains uncertain."
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query-laysum | 928 | [
{
"role": "user",
"content": "Abstract: Background\nHelicobacter pylori (H pylori) is one of the most common pathogens to establish and cause infection in human beings, affecting about 50% of the world's population. Prevalence may be as high as 83% in Latin American countries and as low as 17% in North America. Approximately 20% of infected people will manifest disease; people at high risk include those who live in low- and middle-income countries with poor sanitary conditions, since the mechanism of transmission seems to be oral-oral or faecal-oral (mostly during infancy). There are several antibiotic regimens to treat the infection, but antibiotic resistance is growing around the world. New adjuvant drugs โ such as probiotics, statins, curcumin, and N-acetylcysteine (NAC) โ are being tested to enhance eradication rates.\nN-acetylcysteine can destabilise the biofilm structure; it also has synergic action with antibiotics, and bactericidal effects. In addition, NAC has antioxidant properties, and has a primary mucolytic effect by reducing the thickness of the gastric mucus layer, both of which may exert beneficial adjuvant effects on H pylori eradication.\nObjectives\nTo assess the efficacy and safety of N-acetylcysteine as an adjuvant therapy to antibiotics for Helicobacter pylori eradication.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to April 2018), Embase (1988 to April 2018), CINAHL (1982 to April 2018), LILACS (1982 to April 2018), grey literature databases and trials registries. We handsearched the reference lists of relevant studies. We screened 726 articles and assessed 18 for eligibility.\nSelection criteria\nWe included randomised controlled trials (RCTs) of any antibiotic regimen plus NAC, in adults infected with H pylori. To be included, trials had to use a control consisting of the same antibiotic regimen with or without placebo. Outcomes of interest were eradication rates, and gastrointestinal, toxic, and allergic adverse events. Reporting of the primary outcomes listed here was not an inclusion criterion for the review.\nData collection and analysis\nTwo review authors independently reviewed and extracted data and completed the 'Risk of bias' assessments. A third review author independently confirmed the 'Risk of bias' assessments. We used Review Manager 5 software for data analysis. We contacted study authors if there was missing information.\nMain results\nWe included eight RCTs (with a total of 559 participants) in this review. The studies recruited outpatients aged between 17 and 76 years who were referred to endoscopy centres in several different countries. The certainty of evidence was reduced for most outcomes due to the poor methodological quality of included studies; issues mainly related to the generation of allocation sequence, allocation concealment, and blinding (this last domain related specifically to adverse outcomes).\nWe are uncertain whether the addition of NAC to antibiotics improves H pylori eradication rates, compared with the addition of placebo or no NAC (38.8% versus 49.1%, risk ratio (RR) 0.74, 95% confidence interval (CI) 0.51 to 1.08; participants = 559; studies = eight; very low-certainty evidence). A post-hoc sensitivity analysis, in which we removed studies that tested antibiotic regimens no longer recommended in clinical practice, showed that the addition of NAC may improve eradication rates compared to control (27.2% versus 37.6%, RR 0.71, 95% CI 0.53 to 0.94; participants = 397; published studies = five).\nWe are uncertain whether NAC is associated with a higher risk of gastrointestinal adverse events compared to control (23.9% versus 18.9%, RR 1.25, 95% CI 0.85 to 1.85; participants = 336; studies = five; very low-certaintyevidence), or allergic adverse events (2% versus 0%, RR 2.98, 95% CI 0.32 to 27.74; participants = 336; studies = five; very low-certainty evidence). There were no reports of toxic adverse events amongst included studies.\nAuthors' conclusions\nWe are uncertain whether the addition of NAC to antibiotics improves H pylori eradication rates compared with the addition of placebo or no NAC. Due to the clinical, statistical and methodological heterogeneity found in included studies, and the uncertainty observed when analysing therapy subgroups, any possible beneficial effect of NAC should be regarded cautiously.\nWe are uncertain whether NAC is associated with a higher risk of gastrointestinal or allergic adverse events compared with placebo or no NAC. There were no reports of toxic adverse events amongst the included studies.\nFurther large, well-designed, randomised clinical studies should be conducted, with good reporting standards and appropriate collection of efficacy and safety outcomes, especially for current recommended antibiotic regimens.\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 eight studies (specifically, randomised controlled trials (RCTs)) with a total of 559 people aged between 17 and 76 years old. The evidence is current to April 2018. All studies recruited outpatients from endoscopy centres (centres that specialise in an examination done with a flexible tube with a camera that is inserted into stomach) in several countries. The antibiotic combinations tested were very different in the included studies, as were the doses of NAC (600 mg to 1800 mg per day). NAC was compared with placebo (dummy pill) or nothing."
}
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query-laysum | 929 | [
{
"role": "user",
"content": "Abstract: Background\nThe scientific literature examining effective treatments for opioid-dependent adults clearly indicates that pharmacotherapy is a necessary and acceptable component. Nevertheless, no reviews have been published that systematically assess the effectiveness of pharmacological maintenance treatment in adolescents.\nObjectives\nTo assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for retaining adolescents in treatment, reducing the use of substances and improving health and social status.\nSearch methods\nWe searched the Cochrane Drugs and Alcohol Group's Trials Register (January 2014), the Cochrane Central Register of Controlled Trials (2014, Issue 1), PubMed (January 1966 to January 2014), EMBASE (January 1980 to January 2014), CINAHL (January 1982 to January 2014), Web of Science (1991 to January 2014) and reference lists of articles.\nSelection criteria\nRandomised and controlled clinical trials of any maintenance pharmacological interventions either alone or associated with psychosocial intervention compared with no intervention, placebo, other pharmacological intervention, pharmacological detoxification or psychosocial intervention in adolescents (13 to 18 years).\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included two trials involving 189 participants. One study, with 35 participants, compared methadone with levo-alpha-acetylmethadol (LAAM) for maintenance treatment lasting 16 weeks, after which patients were detoxified. The other study, with 154 participants, compared maintenance treatment with buprenorphine-naloxone and detoxification with buprenorphine. We did not perform meta-analysis because the two studies assessed different comparisons.\nIn the study comparing methadone and LAAM, the authors declared that there was no difference in the use of a substance of abuse or social functioning (data not shown). The quality of the evidence was very low. No side effects, such as nausea, vomiting, constipation, weakness or fatigue, were reported by study participants.\nIn the comparison between buprenorphine maintenance and buprenorphine detoxification, maintenance treatment appeared to be more efficacious in retaining patients in treatment (drop-out risk ratio (RR) 0.37; 95% confidence interval (CI) 0.26 to 0.54), but not in reducing the number of patients with a positive urine test at the end of the study (RR 0.97; 95% CI 0.78 to 1.22). Self reported opioid use at one-year follow-up was significantly lower in the maintenance group, even though both groups reported a high level of opioid use (RR 0.73; 95% CI 0.57 to 0.95). More patients in the maintenance group were enrolled in other addiction treatment programmes at 12-month follow-up (RR 1.33; 95% CI 0.94 to 1.88). The quality of the evidence was low. No serious side effects attributable to buprenorphine-naloxone were reported by study participants and no patients were removed from the study due to side effects. The most common side effect was headache, which was reported by 16% to 21% of patients in both groups\nAuthors' conclusions\nIt is difficult to draft conclusions on the basis of only two trials. One of the possible reasons for the lack of evidence could be the difficulty of conducting trials with young people for practical and ethical reasons.\nThere is an urgent need for further randomised controlled trials comparing maintenance treatment with detoxification treatment or psychosocial treatment alone before carrying out studies that compare different pharmacological maintenance treatments. These studies should have long follow-up and measure relapse rates after the end of treatment and social functioning (integration at school or at work, family relationships).\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"
},
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"role": "assistant",
"content": "This review was limited by the very low number of trials retrieved. The quality of the evidence was very low for the comparison between methadone and LAAM and low for the comparison between buprenorphine detoxification and buprenorphine maintenance. The evidence is current to January 2014."
}
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query-laysum | 930 | [
{
"role": "user",
"content": "Abstract: Background\nThere is evidence that the process of transition from paediatric (child) to adult health services is often associated with deterioration in the health of adolescents with chronic conditions.Transitional care is the term used to describe services that seek to bridge this care gap. It has been defined as โthe purposeful, planned movement of adolescents and young adults with chronic physical and medical conditions from child-centred to adult-oriented health care systemsโ. In order to develop appropriate services for adolescents, evidence of what works and what factors act as barriers and facilitators of effective interventions is needed.\nObjectives\nTo evaluate the effectiveness of interventions designed to improve the transition of care for adolescents from paediatric to adult health services.\nSearch methods\nWe searched The Cochrane Central Register of Controlled Trials 2015, Issue 1, (including the Cochrane Effective Practice and Organisation of Care Group Specialised Register), MEDLINE, EMBASE, PsycINFO, and Web of Knowledge to 19 June 2015. We also searched reference lists of included studies and relevant reviews, and contacted experts and study authors for additional studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs), controlled before- and after-studies (CBAs), and interrupted time-series studies (ITSs) that evaluated the effectiveness of any intervention (care model or clinical pathway), that aimed to improve the transition of care for adolescents from paediatric to adult health services. We considered adolescents with any chronic condition that required ongoing clinical care, who were leaving paediatric services and going on to receive services in adult healthcare units, and their families. Participating providers included all health professionals responsible for the care of young people.\nData collection and analysis\nTwo review authors independently extracted data from included papers, assessed the risk of bias of each study, and assessed the certainty of the evidence for the main comparisons using GRADE. Discrepancies were resolved by discussion. Authors were contacted for missing data. We reported the findings of the studies as pre- and post-intervention means and calculated the unadjusted absolute change from baseline with 95% confidence intervals (CI).\nMain results\nWe included four RCTs (N = 238 participants) that explored: a two-day workshop-based transition preparation training for adolescents with spina bifida; a nurse-led, one-on-one, teaching session with the additional support of a โhealth passportโ for adolescents with heart disease; a web- and SMS-based educational intervention for adolescents with a range of different conditions; and a structured comprehensive transition programme with a transition co-ordinator for adolescents with type 1 diabetes.\nOne study evaluating a one-on-one nurse-led intervention, and one evaluating a technology-based intervention suggested that these interventions may lead to slight improvements in transitional readiness and chronic disease self-management measured at six- to eight-month follow-ups (low certainty evidence). Results with the TRAQ self-management tool were: MD 0.20; 95% CI -0.16 to 0.56 and MD 0.43; 95% CI; -0.09 to 0.95; with the TRAQ self-advocacy tool: MD 0.37; 95% CI -0.06 to 0.80; and with the PAM tool were: MD 10; 95% CI 2.96 to 17.04. In contrast, transition-preparation training delivered via a two-day workshop for patients with spina bifida may lead to little or no difference in measures of self-care practice and general health behaviours when measured using the DSCPI-90ยฉ.\nTwo studies evaluated the use of health services. One study evaluated a technology-based intervention and another a comprehensive transition programme; these interventions may lead to slightly more young people taking positive steps to initiate contact with health professionals themselves (Relative risk (RR): 4.87; 95% CI 0.24 to 98.12 and RR 1.50; 95% CI 0.32 to 6.94, respectively; low certainty evidence.\nYoung peopleโs knowledge of their disease may slightly improve with a nurse-led, one-on-one intervention to prepare young people for transition to an adult congenital heart programme (MD 14; 95% CI 2.67 to 25.33; one study; low certainty evidence).\nDisease-specific outcome measures were reported in two studies, both of which led to little or no difference in outcomes (low certainty evidence). One study found little or no difference between intervention and control groups. A second study found that follow-up HbA1c in young people with type 1 diabetes mellitus increased by 1.2% for each percentage increase in baseline HbA1c, independent of treatment group (1.2%; 95% CI 0.4 to 1.9; P = 0.01).\nTransition interventions may lead to little or no difference in well-being or quality of life as measured with the PARS III or PedsQ (two studies; low certainty evidence). Both the technology-based intervention and the two-day workshop for young people with spina bifida found little or no difference between intervention and control groups (MD 1.29; 95% CI -4.49 to 7.07). One study did not report the data.\nFour telephone support calls from a transition co-ordinator may lead to little or no difference in rates of transfer from paediatric to adult diabetes services (one study; low certainty evidence). At 12-month follow-up, there was little or no difference between groups of young people receiving usual care or a telephone support (RR 0.80; 95% CI 0.59 to 1.08)). They may slightly reduce the risk of disease-related hospital admissions at 12-month follow-up (RR 0.29; 95% CI 0.03 to 2.40).\nAuthors' conclusions\nThe available evidence (four small studies; N = 238), covers a limited range of interventions developed to facilitate transition in a limited number of clinical conditions, with only four to 12 months follow-up. These follow-up periods may not be long enough for any changes to become apparent as transition is a lengthy process. There was evidence of improvement in patients' knowledge of their condition in one study, and improvements in self-efficacy and confidence in another, but since few studies were eligible for this review, and the overall certainty of the body of this evidence is low, no firm conclusions can be drawn about the effectiveness of the evaluated interventions. Further research is very likely to have an important impact on our confidence in the intervention effect and likely could change our conclusions. There is considerable scope for the rigorous evaluation of other models of transitional care, reporting on clinical outcomes with longer term follow-up.\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": "While there is a wide range of transition programmes that are being developed in different countries, often within particular clinical specialties, this review only identified four small studies that provided low certainty evidence about educational interventions targeting participating adolescents, and no studies of interventions that targeted the organisation of care (for example, joint clinics or provision of a key worker). Other limitations with the evidence are the small number of adolescents recruited, the limited number of clinical conditions studied, the short follow up (12 months or less), and the fact that only two of the included studies reported on the primary outcome (that is, condition-specific clinical outcomes). Despite the challenges in designing studies that can test these types of interventions, such as evaluating a complex intervention, a stronger evidence base is needed to inform the development of these services."
}
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query-laysum | 931 | [
{
"role": "user",
"content": "Abstract: Background\nCurrent international treatment guidelines recommending therapeutic exercise for people with symptomatic hip osteoarthritis (OA) report are based on limited evidence.\nObjectives\nTo determine whether land-based therapeutic exercise is beneficial for people with hip OA in terms of reduced joint pain and improved physical function and quality of life.\nSearch methods\nWe searched five databases from inception up to February 2013.\nSelection criteria\nAll randomised controlled trials (RCTs) recruiting people with hip OA and comparing some form of land-based therapeutic exercise (as opposed to exercises conducted in water) with a non-exercise group.\nData collection and analysis\nFour review authors independently selected studies for inclusion. We resolved disagreements through consensus. Two review authors independently extracted data, assessed risk of bias and the quality of the body of evidence for each outcome using the GRADE approach. We conducted analyses on continuous outcomes (pain, physical function and quality of life) and dichotomous outcomes (proportion of study withdrawals).\nMain results\nWe considered that seven of the 10 included RCTs had a low risk of bias. However, the results may be vulnerable to performance and detection bias as none of the RCTs were able to blind participants to treatment allocation and, while most RCTs reported blinded outcome assessment, pain, physical function and quality of life were participant self reported. One of the 10 RCTs was only reported as a conference abstract and did not provide sufficient data for the evaluation of bias risk.\nHigh-quality evidence from nine trials (549 participants) indicated that exercise reduced pain (standardised mean difference (SMD) -0.38, 95% confidence interval (CI) -0.55 to -0.20) and improved physical function (SMD -0.38, 95% CI -0.54 to -0.05) immediately after treatment. Pain and physical function were estimated to be 29 points on a 0- to 100-point scale (0 was no pain or loss of physical function) in the control group; exercise reduced pain by an equivalent of 8 points (95% CI 4 to 11 points; number needed to treat for an additional beneficial outcome (NNTB) 6) and improved physical function by an equivalent of 7 points (95% CI 1 to 12 points; NNTB 6). Only three small studies (183 participants) evaluated quality of life, with overall low quality evidence, with no benefit of exercise demonstrated (SMD -0.07, 95% CI -0.23 to 0.36). Quality of life was estimated to be 50 points on a norm-based mean (standard deviation (SD)) score of 50 (10) in the general population in the control group; exercise improved quality of life by 0 points. Moderate-quality evidence from seven trials (715 participants) indicated an increased likelihood of withdrawal from the exercise allocation (event rate 6%) compared with the control group (event rate 3%), but this difference was not significant (risk difference 1%; 95% CI -1% to 4%). Of the five studies reporting adverse events, each study reported only one or two events and all were related to increased pain attributed to the exercise programme.\nThe reduction in pain was sustained at least three to six months after ceasing monitored treatment (five RCTs, 391 participants): pain (SMD -0.38, 95% CI -0.58 to -0.18). Pain was estimated to be 29 points on a 0- to 100-point scale (0 was no pain) in the control group, the improvement in pain translated to a sustained reduction in pain intensity of 8 points (95% CI 4 to 12 points) compared with the control group (0 to 100 scale). The improvement in physical function was also sustained (five RCTs, 367 participants): physical function (SMD -0.37, 95% CI -0.57 to -0.16). Physical function was estimated to be 24 points on a 0- to 100-point scale (0 was no loss of physical function) in the control group, the improvement translated to a mean of 7 points (95% CI 4 to 13) compared with the control group.\nOnly five of the 10 RCTs exclusively recruited people with symptomatic hip OA (419 participants). There was no significant difference in pain or physical function outcomes compared with five studies recruiting participants with hip or knee OA (130 participants).\nAuthors' conclusions\nPooling the results of these 10 RCTs demonstrated that land-based therapeutic exercise programmes can reduce pain and improve physical function among people with symptomatic hip OA.\n\nGiven the provided abstract, please respond to the following query: \"Background - what is OA of the hip and what is exercise?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "OA is a disease of the joints, such as your hip. When the joint loses cartilage, the bone grows to try to repair the damage. However, instead of making things better, the bone grows abnormally and makes things worse. For example, the bone can become misshapen and make the joint painful and unstable. Doctors used to think that osteoarthritis (OA) simply resulted in thinning of the cartilage. However, it is now known that OA is a disease of the whole joint.\nOA is one of the most common forms of arthritis and affects men and women equally. OA is one of the main causes of disability as people grow older.\nExercise can be any activity that enhances or maintains muscle strength, physical fitness and overall health. People exercise for many different reasons including weight loss, strengthening muscles and to relieve the symptoms of OA."
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query-laysum | 932 | [
{
"role": "user",
"content": "Abstract: Background\nCocaine dependence is a major public health problem that is characterised by recidivism and a host of medical and psychosocial complications. Although effective pharmacotherapy is available for alcohol and heroin dependence, none is currently available for cocaine dependence, despite two decades of clinical trials primarily involving antidepressant, anticonvulsivant and dopaminergic medications. Extensive consideration has been given to optimal pharmacological approaches to the treatment of individuals with cocaine dependence, and both dopamine antagonists and agonists have been considered. Anticonvulsants have been candidates for use in the treatment of addiction based on the hypothesis that seizure kindling-like mechanisms contribute to addiction.\nObjectives\nTo evaluate the efficacy and safety of anticonvulsants for individuals with cocaine dependence.\nSearch methods\nWe searched the Cochrane Drugs and Alcohol Group Trials Register (June 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 6), MEDLINE (1966 to June 2014), EMBASE (1988 to June 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to June 2014), Web of Science (1991 to June 2014) and the reference lists of eligible articles.\nSelection criteria\nAll randomised controlled trials and controlled clinical trials that focus on the use of anticonvulsant medications to treat individuals with cocaine dependence.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included a total of 20 studies with 2068 participants. We studied the anticonvulsant drugs carbamazepine, gabapentin, lamotrigine, phenytoin, tiagabine, topiramate and vigabatrin. All studies compared anticonvulsants versus placebo. Only one study had one arm by which the anticonvulsant was compared with the antidepressant desipramine. Upon comparison of anticonvulsant versus placebo, we found no significant differences for any of the efficacy and safety measures. Dropouts: risk ratio (RR) 0.95, 95% confidence interval (CI) 0.86 to 1.05, 17 studies, 20 arms, 1695 participants, moderate quality of evidence. Use of cocaine: RR 0.92, 95% CI 0.84 to 1.02, nine studies, 11 arms, 867 participants, moderate quality of evidence; side effects: RR 1.39, 95% CI 1.01 to 1.90, eight studies, 775 participants; craving: standardised mean difference (SMD) -0.25, 95% CI -0.59 to 0.09, seven studies, eight arms, 428 participants, low quality of evidence.\nAuthors' conclusions\nAlthough caution is needed when results from a limited number of small clinical trials are assessed, no current evidence supports the clinical use of anticonvulsant medications in the treatment of patients with cocaine dependence. Although the findings of new trials will improve the quality of study results, especially in relation to specific medications, anticonvulsants as a category cannot be considered first-, second- or third-line treatment for cocaine dependence.\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": "The review authors searched scientific databases and Internet resources to identify randomised controlled trials (in which participants were allocated at random to any anticonvulsant drug or placebo or another type of drug or non-pharmacological intervention intended to reduce,the use of cocaine). We assessed also dropout from treatment and frequency of side effects .We included people of any gender, age or ethnicity."
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query-laysum | 933 | [
{
"role": "user",
"content": "Abstract: Background\nIntestinal dysbiosis may contribute to the pathogenesis of necrotising enterocolitis (NEC) in very preterm or very low birth weight (VLBW) infants. Dietary supplementation with probiotics to modulate the intestinal microbiome has been proposed as a strategy to reduce the risk of NEC and associated mortality and morbidity in very preterm or VLBW infants.\nObjectives\nTo determine the effect of supplemental probiotics on the risk of NEC and associated mortality and morbidity in very preterm or very low birth weight infants.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the Maternity and Infant Care database, and CINAHL from inception to July 2022. We searched clinical trials databases and conference proceedings, and examined the reference lists of retrieved articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing probiotics with placebo or no probiotics in very preterm infants (born before 32 weeks' gestation) and VLBW infants (weighing less than 1500 g at birth).\nData collection and analysis\nTwo review authors independently evaluated risk of bias of the trials, extracted data, and synthesised effect estimates using risk ratios (RRs), risk differences (RDs), and mean differences (MDs), with associated 95% confidence intervals (CIs). The primary outcomes were NEC and all-cause mortality; secondary outcome measures were late-onset invasive infection (more than 48 hours after birth), duration of hospitalisation from birth, and neurodevelopmental impairment. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 60 trials with 11,156 infants. Most trials were small (median sample size 145 infants). The main potential sources of bias were unclear reporting of methods for concealing allocation and masking caregivers or investigators in about half of the trials. The formulation of the probiotics varied across trials. The most common preparations contained Bifidobacterium spp., Lactobacillus spp., Saccharomyces spp., andStreptococcus spp., alone or in combination.\nVery preterm or very low birth weight infants\nProbiotics may reduce the risk of NEC (RR 0.54, 95% CI 0.46 to 0.65; Iยฒ = 17%; 57 trials, 10,918 infants; low certainty). The number needed to treat for an additional beneficial outcome (NNTB) was 33 (95% CI 25 to 50). Probiotics probably reduce mortality slightly (RR 0.77, 95% CI 0.66 to 0.90; Iยฒ = 0%; 54 trials, 10,484 infants; moderate certainty); the NNTB was 50 (95% CI 50 to 100). Probiotics probably have little or no effect on the risk of late-onset invasive infection (RR 0.89, 95% CI 0.82 to 0.97; Iยฒ = 22%; 49 trials, 9876 infants; moderate certainty). Probiotics may have little or no effect on neurodevelopmental impairment (RR 1.03, 95% CI 0.84 to 1.26; Iยฒ = 0%; 5 trials, 1518 infants; low certainty).\nExtremely preterm or extremely low birth weight infants\nFew data were available for extremely preterm or extremely low birth weight (ELBW) infants. In this population, probiotics may have little or no effect on NEC (RR 0.92, 95% CI 0.69 to 1.22, Iยฒ = 0%; 10 trials, 1836 infants; low certainty), all-cause mortality (RR 0.92, 95% CI 0.72 to 1.18; Iยฒ = 0%; 7 trials, 1723 infants; low certainty), or late-onset invasive infection (RR 0.93, 95% CI 0.78 to 1.09; Iยฒ = 0%; 7 trials, 1533 infants; low certainty). No trials provided data for measures of neurodevelopmental impairment in extremely preterm or ELBW infants.\nAuthors' conclusions\nGiven the low to moderate certainty of evidence for the effects of probiotic supplements on the risk of NEC and associated morbidity and mortality for very preterm or VLBW infants, and particularly for extremely preterm or ELBW infants, there is a need for further large, high-quality trials to provide evidence of sufficient validity and applicability to inform policy and practice.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The methods used in the included trials may have exaggerated the benefits of giving probiotics to very preterm and very low birth weight infants. Furthermore, the effect could have been biased by small trials with unreliable methods.\nBecause we have little confidence or moderate confidence in the evidence for the effects of probiotic supplements in very preterm or very low birth weight infants, there is a need for additional large, high-quality trials to provide evidence of sufficient validity and applicability to inform policy and practice."
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query-laysum | 934 | [
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"role": "user",
"content": "Abstract: Background\nGerminal matrix hemorrhage and intraventricular hemorrhage (GMH-IVH) may contribute to neonatal morbidity and mortality and result in long-term neurodevelopmental sequelae. Appropriate pain and sedation management in ventilated preterm infants may decrease the risk of GMH-IVH; however, it might be associated with harms.\nObjectives\nTo summarize the evidence from systematic reviews regarding the effects and safety of pharmacological interventions related to pain and sedation management in order to prevent GMH-IVH in ventilated preterm infants.\nMethods\nWe searched the Cochrane Library August 2022 for reviews on pharmacological interventions for pain and sedation management to prevent GMH-IVH in ventilated preterm infants (< 37 weeks' gestation). We included Cochrane Reviews assessing the following interventions administered within the first week of life: benzodiazepines, paracetamol, opioids, ibuprofen, anesthetics, barbiturates, and antiadrenergics. Primary outcomes were any GMH-IVH (aGMH-IVH), severe IVH (sIVH), all-cause neonatal death (ACND), and major neurodevelopmental disability (MND). We assessed the methodological quality of included reviews using the AMSTAR-2 tool. We used GRADE to assess the certainty of evidence.\nMain results\nWe included seven Cochrane Reviews and one Cochrane Review protocol. The reviews on clonidine and paracetamol did not include randomized controlled trials (RCTs) matching our inclusion criteria. We included 40 RCTs (3791 infants) from reviews on paracetamol for patent ductus arteriosus (3), midazolam (3), phenobarbital (9), opioids (20), and ibuprofen (5). The quality of the included reviews was high. The certainty of the evidence was moderate to very low, because of serious imprecision and study limitations.\nGerminal matrix hemorrhage-intraventricular hemorrhage (any grade)\nCompared to placebo or no intervention, the evidence is very uncertain about the effects of paracetamol on aGMH-IVH (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.38 to 2.07; 2 RCTs, 82 infants; very low-certainty evidence); midazolam may result in little to no difference in the incidence of aGMH-IVH (RR 1.68, 95% CI 0.87 to 3.24; 3 RCTs, 122 infants; low-certainty evidence); the evidence is very uncertain about the effect of phenobarbital on aGMH-IVH (RR 0.99, 95% CI 0.83 to 1.19; 9 RCTs, 732 infants; very low-certainty evidence); opioids may result in little to no difference in aGMH-IVH (RR 0.85, 95% CI 0.65 to 1.12; 7 RCTs, 469 infants; low-certainty evidence); ibuprofen likely results in little to no difference in aGMH-IVH (RR 0.99, 95% CI 0.81 to 1.21; 4 RCTs, 759 infants; moderate-certainty evidence).\nCompared to ibuprofen, the evidence is very uncertain about the effects of paracetamol on aGMH-IVH (RR 1.17, 95% CI 0.31 to 4.34; 1 RCT, 30 infants; very low-certainty evidence). Compared to midazolam, morphine may result in a reduction in aGMH-IVH (RR 0.28, 95% CI 0.09 to 0.87; 1 RCT, 46 infants; low-certainty evidence). Compared to diamorphine, the evidence is very uncertain about the effect of morphine on aGMH-IVH (RR 0.65, 95% CI 0.40 to 1.07; 1 RCT, 88 infants; very low-certainty evidence).\nSevere intraventricular hemorrhage (grade 3 to 4)\nCompared to placebo or no intervention, the evidence is very uncertain about the effect of paracetamol on sIVH (RR 1.80, 95% CI 0.43 to 7.49; 2 RCTs, 82 infants; very low-certainty evidence) and of phenobarbital (grade 3 to 4) (RR 0.91, 95% CI 0.66 to 1.25; 9 RCTs, 732 infants; very low-certainty evidence); opioids may result in little to no difference in sIVH (grade 3 to 4) (RR 0.98, 95% CI 0.71 to 1.34; 6 RCTs, 1299 infants; low-certainty evidence); ibuprofen may result in little to no difference in sIVH (grade 3 to 4) (RR 0.82, 95% CI 0.54 to 1.26; 4 RCTs, 747 infants; low-certainty evidence). No studies on midazolam reported this outcome.\nCompared to ibuprofen, the evidence is very uncertain about the effects of paracetamol on sIVH (RR 2.65, 95% CI 0.12 to 60.21; 1 RCT, 30 infants; very low-certainty evidence). Compared to midazolam, the evidence is very uncertain about the effect of morphine on sIVH (grade 3 to 4) (RR 0.08, 95% CI 0.00 to 1.43; 1 RCT, 46 infants; very low-certainty evidence). Compared to fentanyl, the evidence is very uncertain about the effect of morphine on sIVH (grade 3 to 4) (RR 0.59, 95% CI 0.18 to 1.95; 1 RCT, 163 infants; very low-certainty evidence).\nAll-cause neonatal death\nCompared to placebo or no intervention, the evidence is very uncertain about the effect of phenobarbital on ACND (RR 0.94, 95% CI 0.51 to 1.72; 3 RCTs, 203 infants; very low-certainty evidence); opioids likely result in little to no difference in ACND (RR 1.12, 95% CI 0.80 to 1.55; 5 RCTs, 1189 infants; moderate-certainty evidence); the evidence is very uncertain about the effect of ibuprofen on ACND (RR 1.00, 95% CI 0.38 to 2.64; 2 RCTs, 112 infants; very low-certainty evidence).\nCompared to midazolam, the evidence is very uncertain about the effect of morphine on ACND (RR 0.31, 95% CI 0.01 to 7.16; 1 RCT, 46 infants; very low-certainty evidence). Compared to diamorphine, the evidence is very uncertain about the effect of morphine on ACND (RR 1.17, 95% CI 0.43 to 3.19; 1 RCT, 88 infants; very low-certainty evidence).\nMajor neurodevelopmental disability\nCompared to placebo, the evidence is very uncertain about the effect of opioids on MND at 18 to 24 months (RR 2.00, 95% CI 0.39 to 10.29; 1 RCT, 78 infants; very low-certainty evidence) and at five to six years (RR 1.6, 95% CI 0.56 to 4.56; 1 RCT, 95 infants; very low-certainty evidence). No studies on other drugs reported this outcome.\nAuthors' conclusions\nNone of the reported studies had an impact on aGMH-IVH, sIVH, ACND, or MND. The certainty of the evidence ranged from moderate to very low.\nLarge RCTs of rigorous methodology are needed to achieve an optimal information size to assess the effects of pharmacological interventions for pain and sedation management for the prevention of GMH-IVH and mortality in preterm infants. Studies might compare interventions against either placebo or other drugs. Reporting of the outcome data should include the assessment of GMH-IVH and long-term neurodevelopment.\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": "We are moderately confident in the evidence for ibuprofen on less severe brain bleeding and opioids on deaths (from any cause) compared to placebo. We are not confident in the evidence for the other comparisons and outcomes. The studies either did not report information that we could use or produced findings in which we have very little confidence. These studies were small and used methods likely to introduce errors in their results."
}
]
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query-laysum | 935 | [
{
"role": "user",
"content": "Abstract: Background\nNeuropsychiatric involvement in systemic lupus erythematosus (SLE) is complex and it is an important cause of morbidity and mortality. Management of nervous system manifestations of SLE remains unsatisfactory. This is an update of a Cochrane review first published in 2000 and previously updated in 2006.\nObjectives\nTo assess the benefits and harms of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of SLE.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, SCOPUS and WHO up to and including June 2012. We sought additional articles through handsearching in relevant journals as well as contact with experts. There were no language restrictions.\nSelection criteria\nWe included all randomised controlled trials that compared cyclophosphamide to methylprednisolone in patients with SLE of any age and gender and presenting with any kind of neuropsychiatric manifestations.\nData collection and analysis\nTwo review authors independently extracted, assessed and cross-checked data. We produced a 'Summary of findings' table. We presented dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs).\nMain results\nWe did not include any new trials in this update. One randomised controlled trial of 32 patients is included. Concerning risk of bias, generation of the allocation sequence was at low risk; however, allocation concealment, blinding and selective reporting were at high risk. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in 94.7% (18/19) of patients using cyclophosphamide compared with 46.2% (6/13) in the methylprednisolone group at 24 months (RR 2.05, 95% CI 1.13 to 3.73). This was statistically significant and the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is three. We found no statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)). The median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups.\nAuthors' conclusions\nThis systematic review found one randomised controlled trial with a small number of patients in the different clinical subgroups of neurological manifestation. There is very low-quality evidence that cyclophosphamide is more effective in reducing symptoms of neuropsychiatric involvement in SLE compared with methylprednisolone. However, properly designed randomised controlled trials that involve large numbers of individuals, with explicit clinical and laboratory diagnostic criteria, sufficient duration of follow-up and description of all relevant outcome measures, are necessary to guide practice. As we did not find any new trials to include in this review at update, the conclusions of the review did not change.\n\nGiven the provided abstract, please respond to the following query: \"What happens to people with central nervous system lupus who take cyclophosphamide compared to methylprednisolone?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- 49 more people who took cyclophosphamide improved than people who took methylprednisolone.\n- 95 out of 100 people had at least a 20% improvement in symptoms with cyclophosphamide.\n- 46 out of 100 people had at least a 20% improvement in symptoms with methylprednisolone."
}
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query-laysum | 936 | [
{
"role": "user",
"content": "Abstract: Background\nAntipsychotic drugs are the mainstay treatment for schizophrenia, yet they are associated with diverse and potentially dose-related side effects which can reduce quality of life. For this reason, the lowest possible doses of antipsychotics are generally recommended, but higher doses are often used in clinical practice. It is still unclear if and how antipsychotic doses could be reduced safely in order to minimise the adverse-effect burden without increasing the risk of relapse.\nObjectives\nTo assess the efficacy and safety of reducing antipsychotic dose compared to continuing the current dose for people with schizophrenia.\nSearch methods\nWe conducted a systematic search on 10 February 2021 at the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PubMed, ClinicalTrials.gov, ISRCTN, and WHO ICTRP. We also inspected the reference lists of included studies and previous reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing any dose reduction against continuation in people with schizophrenia or related disorders who were stabilised on their current antipsychotic treatment.\nData collection and analysis\nAt least two review authors independently screened relevant records for inclusion, extracted data from eligible studies, and assessed the risk of bias using RoB 2. We contacted study authors for missing data and additional information. Our primary outcomes were clinically important change in quality of life, ย rehospitalisations and dropouts due to adverse effects; key secondary outcomes were clinically important change in functioning, relapse, dropouts for any reason, and at least one adverse effect. We also examined scales measuring symptoms, quality of life, and functioning as well as a comprehensive list of specific adverse effects. We pooled outcomes at the endpoint preferably closest to one year. We evaluated the certainty of the evidence using the GRADE approach.\nMain results\nWe included 25 RCTs, of which 22 studies provided data with 2635 participants (average age 38.4 years old). The median study sample size was 60 participants (ranging from 18 to 466 participants) and length was 37 weeks (ranging from 12 weeks to 2 years). There were variations in the dose reduction strategies in terms of speed of reduction (i.e. gradual in about half of the studies (within 2 to 16 weeks) and abrupt in the other half), and in terms of degree of reduction (i.e. median planned reduction of 66% of the dose up to complete withdrawal in three studies). We assessed risk of bias across outcomes predominantly as some concerns or high risk.\nNo study reported data on the number of participants with a clinically important change in quality of life or functioning, and only eight studies reported continuous data on scales measuring quality of life or functioning. There was no difference between dose reduction and continuation on scales measuring quality of life (standardised mean difference (SMD) โ0.01, 95% confidence interval (CI) โ0.17 to 0.15, 6 RCTs, n = 719, I2 = 0%, moderate certainty evidence) and scales measuring functioning (SMD 0.03, 95% CI โ0.10 to 0.17, 6 RCTs, n = 966, I2 = 0%, high certainty evidence).\nDose reduction in comparison to continuation may increase the risk of rehospitalisation based on data from eight studies with estimable effect sizes; however, the 95% CI does not exclude the possibility of no difference (risk ratio (RR) 1.53, 95% CI 0.84 to 2.81, 8 RCTs, n = 1413, I2 = 59% (moderate heterogeneity), very low certainty evidence). Similarly, dose reduction increased the risk of relapse based on data from 20 studies (RR 2.16, 95% CI 1.52 to 3.06, 20 RCTs, n = 2481, I2 = 70% (substantial heterogeneity), low certainty evidence).\nMore participants in the dose reduction group in comparison to the continuation group left the study early due to adverse effects (RR 2.20, 95% CI 1.39 to 3.49, 6 RCTs with estimable effect sizes, n = 1079, I2 = 0%, moderate certainty evidence) and for any reason (RR 1.38, 95% CI 1.05 to 1.81, 12 RCTs, n = 1551, I2 = 48% (moderate heterogeneity), moderate certainty evidence).\nLastly, there was no difference between the dose reduction and continuation groups in the number of participants with at least one adverse effect based on data from four studies with estimable effect sizes (RR 1.03, 95% CI 0.94 to 1.12, 5 RCTs, n = 998 (4 RCTs, n = 980 with estimable effect sizes), I2 = 0%, moderate certainty evidence).\nAuthors' conclusions\nThis review synthesised the latest evidence on the reduction of antipsychotic doses for stable individuals with schizophrenia. There was no difference between dose reduction and continuation groups in quality of life, functioning, and number of participants with at least one adverse effect. However, there was a higher risk for relapse and dropouts, and potentially for rehospitalisations, with dose reduction. Of note, the majority of the trials focused on relapse prevention rather potential beneficial outcomes on quality of life, functioning, and adverse effects, and in some studies there was rapid and substantial reduction of doses. Further well-designed RCTs are therefore needed to provide more definitive answers.\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 know if reducing the dose of antipsychotics is better than keeping the same dose, in order to improve:\n- quality of life;\n- number of participants readmitted to hospital;\n- number of participants leaving the study early because of side effects;\n- functioning;\n- relapse;\n- number of participants leaving the study early for any reason;\n- number of participants with at least one side effect."
}
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query-laysum | 937 | [
{
"role": "user",
"content": "Abstract: Background\nMost cases of stroke are caused by impairment of blood flow to the brain (ischaemia), which results in a reduction in available oxygen and subsequent cell death. It has been postulated that hyperbaric oxygen therapy (HBOT) may reduce the volume of brain that will die by greatly increasing available oxygen, and it may further improve outcomes by reducing brain swelling. Some centres are using HBOT routinely to treat people with stroke. This is an update of a Cochrane Review first published in 2005.\nObjectives\nTo assess the effectiveness and safety of adjunctive HBOT in the treatment of people with acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched April 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (April 2014), MEDLINE (1966 to April 2014), EMBASE (1980 to April 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to April 2014), the Database of Randomised Controlled Trials in Hyperbaric Medicine (DORCTIHM) (searched April 2014) and the reference lists of articles. We handsearched relevant publications and contacted researchers to identify additional published and unpublished studies.\nSelection criteria\nRandomised controlled trials (RCTs) that compared the effects of adjunctive HBOT versus those of no HBOT (no treatment or sham).\nData collection and analysis\nThree review authors independently extracted data, assessed each trial for internal validity and resolved differences by discussion.\nMain results\nWe included 11 RCTs involving 705 participants. The methodological quality of the trials varied. We could pool data only for case fatalities. No significant differences were noted in the case fatality rate at six months in those receiving HBOT compared with the control group (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.34 to 2.75, P value 0.96). Four of 14 scale measures of disability and functional performance indicated improvement following HBOT, for example, the mean Trouillas Disability Scale score was lower with HBOT (mean difference (MD) 2.2 point reduction with HBOT, 95% CI 0.15 to 4.3, P value 0.04), and the mean Orgogozo Scale score was higher (MD 27.9 points, 95% CI 4.0 to 51.8, P value 0.02).\nAuthors' conclusions\nWe found no good evidence to show that HBOT improves clinical outcomes when applied during acute presentation of ischaemic stroke. Although evidence from the 11 RCTs is insufficient to provide clear guidelines for practice, the possibility of clinical benefit has not been excluded. Further research is required to better define the role of HBOT in this condition.\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 11 studies, involving 705 participants, up to April 2014. All studies included adult participants (41% female) who had suffered an acute stroke within the past two weeks, although most studies enrolled participants within three days of the stroke. All trials evaluated the addition of HBOT to standard practice for study participants. Most trials reported the number of deaths and some measure of functional ability, although the actual measures used varied considerably, making comparisons between trials difficult. Follow-up periods varied from 90 days to one year."
}
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query-laysum | 938 | [
{
"role": "user",
"content": "Abstract: Background\nThe management of postoperative pain and recovery is still unsatisfactory in a number of cases in clinical practice. Opioids used for postoperative analgesia are frequently associated with adverse effects, including nausea and constipation, preventing smooth postoperative recovery. Not all patients are suitable for, and benefit from, epidural analgesia that is used to improve postoperative recovery. The non-opioid, lidocaine, was investigated in several studies for its use in multimodal management strategies to reduce postoperative pain and enhance recovery. This review was published in 2015 and updated in January 2017.\nObjectives\nTo assess the effects (benefits and risks) of perioperative intravenous (IV) lidocaine infusion compared to placebo/no treatment or compared to epidural analgesia on postoperative pain and recovery in adults undergoing various surgical procedures.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, and reference lists of articles in January 2017. We searched one trial registry contacted researchers in the field, and handsearched journals and congress proceedings. We updated this search in February 2018, but have not yet incorporated these results into the review.\nSelection criteria\nWe included randomized controlled trials comparing the effect of continuous perioperative IV lidocaine infusion either with placebo, or no treatment, or with thoracic epidural analgesia (TEA) in adults undergoing elective or urgent surgery under general anaesthesia. The IV lidocaine infusion must have been started intraoperatively, prior to incision, and continued at least until the end of surgery.\nData collection and analysis\nWe used Cochrane's standard methodological procedures. Our primary outcomes were: pain score at rest; gastrointestinal recovery and adverse events. Secondary outcomes included: postoperative nausea and postoperative opioid consumption. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included 23 new trials in the update. In total, the review included 68 trials (4525 randomized participants). Two trials compared IV lidocaine with TEA. In all remaining trials, placebo or no treatment was used as a comparator. Trials involved participants undergoing open abdominal (22), laparoscopic abdominal (20), or various other surgical procedures (26). The application scheme of systemic lidocaine strongly varies between the studies related to both dose (1 mg/kg/h to 5 mg/kg/h) and termination of the infusion (from the end of surgery until several days after).\nThe risk of bias was low with respect to selection bias (random sequence generation), performance bias, attrition bias, and detection bias in more than 50% of the included studies. For allocation concealment and selective reporting, the quality assessment yielded low risk of bias for only approximately 20% of the included studies.\nIV Lidocaine compared to placebo or no treatment\nWe are uncertain whether IV lidocaine improves postoperative pain compared to placebo or no treatment at early time points (1 to 4 hours) (standardized mean difference (SMD) โ0.50, 95% confidence interval (CI) โ0.72 to โ0.28; 29 studies, 1656 participants; very low-quality evidence) after surgery. Due to variation in the standard deviation (SD) in the studies, this would equate to an average pain reduction of between 0.37 cm and 2.48 cm on a 0 to 10 cm visual analogue scale . Assuming approximately 1 cm on a 0 to 10 cm pain scale is clinically meaningful, we ruled out a clinically relevant reduction in pain with lidocaine at intermediate (24 hours) (SMD โ0.14, 95% CI โ0.25 to โ0.04; 33 studies, 1847 participants; moderate-quality evidence), and at late time points (48 hours) (SMD โ0.11, 95% CI โ0.25 to 0.04; 24 studies, 1404 participants; moderate-quality evidence). Due to variation in the SD in the studies, this would equate to an average pain reduction of between 0.10 cm to 0.48 cm at 24 hours and 0.08 cm to 0.42 cm at 48 hours. In contrast to the original review in 2015, we did not find any significant subgroup differences for different surgical procedures.\nWe are uncertain whether lidocaine reduces the risk of ileus (risk ratio (RR) 0.37, 95% CI 0.15 to 0.87; 4 studies, 273 participants), time to first defaecation/bowel movement (mean difference (MD) โ7.92 hours, 95% CI โ12.71 to โ3.13; 12 studies, 684 participants), risk of postoperative nausea (overall, i.e. 0 up to 72 hours) (RR 0.78, 95% CI 0.67 to 0.91; 35 studies, 1903 participants), and opioid consumption (overall) (MD โ4.52 mg morphine equivalents , 95% CI โ6.25 to โ2.79; 40 studies, 2201 participants); quality of evidence was very low for all these outcomes.\nThe effect of IV lidocaine on adverse effects compared to placebo treatment is uncertain, as only a small number of studies systematically analysed the occurrence of adverse effects (very low-quality evidence).\nIV Lidocaine compared to TEA\nThe effects of IV lidocaine compared with TEA are unclear (pain at 24 hours (MD 1.51, 95% CI โ0.29 to 3.32; 2 studies, 102 participants), pain at 48 hours (MD 0.98, 95% CI โ1.19 to 3.16; 2 studies, 102 participants), time to first bowel movement (MD โ1.66, 95% CI โ10.88 to 7.56; 2 studies, 102 participants); all very low-quality evidence). The risk for ileus and for postoperative nausea (overall) is also unclear, as only one small trial assessed these outcomes (very low-quality evidence). No trial assessed the outcomes, 'pain at early time points' and 'opioid consumption (overall)'. The effect of IV lidocaine on adverse effects compared to TEA is uncertain (very low-quality evidence).\nAuthors' conclusions\nWe are uncertain whether IV perioperative lidocaine, when compared to placebo or no treatment, has a beneficial impact on pain scores in the early postoperative phase, and on gastrointestinal recovery, postoperative nausea, and opioid consumption. The quality of evidence was limited due to inconsistency, imprecision, and study quality. Lidocaine probably has no clinically relevant effect on pain scores later than 24 hours. Few studies have systematically assessed the incidence of adverse effects. There is a lack of evidence about the effects of IV lidocaine compared with epidural anaesthesia in terms of the optimal dose and timing (including the duration) of the administration. We identified three ongoing studies, and 18 studies are awaiting classification; the results of the review may change when these studies are published and included in the review.\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 are uncertain whether lidocaine infusion reduces pain, one to four hours after surgery when compared to placebo or usual care (29 studies, over 1600 participants). There was probably no difference in pain at 24 hours (33 studies, 1847 participants) and at 48 hours (24 studies, 1404 participants) between participants in the lidocaine and the placebo group. We are uncertain whether lidocaine infusion improves recovery of bowel function, with a reduction in the time to first defaecation or bowel movements (12 studies, 684 participants), and reduced risk of stopping the passage of food in the gut (4 studies, 273 participants). We are also uncertain whether lidocaine reduces postoperative nausea (35 studies, 1903 participants), and the requirement for opioids for pain relief (40 studies, 2201 participants). Only a limited number of studies systematically analysed adverse effects of intravenous lidocaine infusion. The side effects of intravenous lidocaine were unclear.\nIn the two studies that investigated intravenous lidocaine compared to epidural analgesia (102 participants), the effect on pain at 24 and 48 hours, and on the time to first bowel movement, remains unclear. The effect of lidocaine on the risk of stopping the passage of food in the gut and for postoperative nausea is also unclear, as only one small trial assessed these outcomes. Neither study investigated the effect on pain immediately after surgery, or on opioid consumption. Both studies looked at adverse effects associated with lidocaine, but the effect is uncertain."
}
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query-laysum | 939 | [
{
"role": "user",
"content": "Abstract: Background\nMedication-related osteonecrosis of the jaw (MRONJ) is a severe adverse reaction experienced by some individuals to certain medicines commonly used in the treatment of cancer and osteoporosis (e.g. bisphosphonates, denosumab, and antiangiogenic agents), and involves the progressive destruction of bone in the mandible or maxilla. Depending on the drug, its dosage, and the duration of exposure, this adverse drug reaction may occur rarely (e.g. following the oral administration of bisphosphonate or denosumab treatments for osteoporosis, or antiangiogenic agent-targeted cancer treatment), or commonly (e.g. following intravenous bisphosphonate for cancer treatment). MRONJ is associated with significant morbidity, adversely affects quality of life (QoL), and is challenging to treat. This is an update of our review first published in 2017.\nObjectives\nTo assess the effects of interventions versus no treatment, placebo, or an active control for the prophylaxis of MRONJ in people exposed to antiresorptive or antiangiogenic drugs.\nTo assess the effects of non-surgical or surgical interventions (either singly or in combination) versus no treatment, placebo, or an active control for the treatment of people with manifest MRONJ.\nSearch methods\nCochrane Oral Healthโs Information Specialist searched four bibliographic databases up to 16 June 2021 and used additional search methods to identify published, unpublished, and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing one modality of intervention with another for the prevention or treatment of MRONJ. For 'prophylaxis of MRONJ', the primary outcome of interest was the incidence of MRONJ; secondary outcomes were QoL, time-to-event, and rate of complications and side effects of the intervention. For 'treatment of established MRONJ', the primary outcome of interest was healing of MRONJ; secondary outcomes were QoL, recurrence, and rate of complications and side effects of the intervention.\nData collection and analysis\nTwo review authors independently screened the search results, extracted the data, and assessed the risk of bias in the included studies. For dichotomous outcomes, we reported the risk ratio (RR) (or rate ratio) and 95% confidence intervals (CIs).\nMain results\nWe included 13 RCTs (1668 participants) in this updated review, of which eight were new additions. The studies were clinically diverse and examined very different interventions, so meta-analyses could not be performed.\nWe have low or very low certainty about available evidence on interventions for the prophylaxis or treatment of MRONJ.\nProphylaxis of MRONJ\nFive RCTs examined different interventions to prevent the occurrence of MRONJ.\nOne RCT compared standard care with regular dental examinations at three-month intervals and preventive treatments (including antibiotics before dental extractions and the use of techniques for wound closure that avoid exposure and contamination of bone) in men with metastatic prostate cancer treated with zoledronic acid. The intervention seemed to lower the risk of MRONJ (RR 0.10, 95% CI 0.02 to 0.39, 253 participants). Secondary outcomes were not evaluated.\nDentoalveolar surgery is considered a common predisposing event for developing MRONJ and five RCTs tested various preventive measures to reduce the risk of postoperative MRONJ. The studies evaluated plasma rich in growth factors inserted into the postextraction alveolus in addition to standardised medical and surgical care versus standardised medical and surgical care alone (RRย 0.08, 95% CI 0.00 to 1.51, 176 participants); delicate surgery and closure by primary intention versus non-traumatic tooth avulsion and closure by secondary intention (no case of postoperative MRONJ in either group); primary closure of the extraction socket with a mucoperiosteal flap versus application of platelet-rich fibrin without primary wound closure (no case of postoperative MRONJ in either group); and subperiosteal wound closure versus epiperiosteal wound closure (RR 0.09, 95% CI 0.00 to 1.56, 132 participants).\nTreatment of MRONJ\nEight RCTs examined different interventions for the treatment of established MRONJ; that is, the effect on MRONJ cure rates.\nOne RCT analysed hyperbaric oxygen (HBO) treatment used in addition to standard care (antiseptic rinses, antibiotics, and surgery) compared with standard care alone (at last follow-up: RR 1.56, 95% CI 0.77 to 3.18, 46 participants).\nHealing rates from MRONJ were not significantly different between autofluorescence-guided bone surgery and conventional bone surgery (RR 1.08, 95% CI 0.85 to 1.37, 30 participants). Another RCT that compared autofluorescence- with tetracycline fluorescence-guided sequestrectomy for the surgical treatment of MRONJ found no significant difference (at one-year follow-up: RR 1.05, 95% CI 0.86 to 1.30, 34 participants).\nThree RCTs investigated the effect of growth factors and autologous platelet concentrates on healing rates of MRONJ: platelet-rich fibrin after bone surgery versus surgery alone (RR 1.05, 95% CI 0.90 to 1.22, 47 participants), bone morphogenetic protein-2 together with platelet-rich fibrin versus platelet-rich fibrin alone (RR 1.10, 95% CI 0.94 to 1.29, 55 participants), and concentrated growth factor and primary wound closure versus primary wound closure only (RR 1.38, 95% CI 0.81 to 2.34, 28 participants).\nTwo RCTs focused on pharmacological treatment with teriparatide: teriparatide 20 ฮผg daily versus placebo in addition to standard care (RRย 0.96, 95% CI 0.31 to 2.95, 33 participants) and teriparatide 56.5 ฮผg weekly versus teriparatide 20 ฮผg daily in addition to standard care (RR 1.60, 95% CI 0.25 to 1.44, 12 participants).\nAuthors' conclusions\nProphylaxis of medication-related osteonecrosis of the jaw\nOne open-label RCT provided some evidence that dental examinations at three-month intervals and preventive treatments may be more effective than standard care for reducing the incidence of medication-related osteonecrosis of the jaw (MRONJ) in individuals taking intravenous bisphosphonates for advanced cancer. We assessed the certainty of the evidence to be very low.\nThere is insufficient evidence to either claim or refute a benefit of the interventions tested for prophylaxis of MRONJ in patients with antiresorptive therapy undergoing dentoalveolar surgery. Although some interventions suggested a potential large effect, the studies were underpowered to show statistical significance, and replication of the results in larger studies is pending.\nTreatment of medication-related osteonecrosis of the jaw\nThe available evidence is insufficient to either claim or refute a benefit, in addition to standard care, of any of the interventions studied for the treatment of MRONJ.\n\nGiven the provided abstract, please respond to the following query: \"Key\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "results\nOne study provided very low-certainty evidence that dental examinations at three-month intervals and preventive treatments (antibiotics before dental extractions and the use of techniques for wound closure that avoid exposure and contamination of bone) are more effective than standard care for reducing the number of cases with MRONJ in a group of people receiving intravenous bisphosphonates for cancer-related conditions. In the experimental group, which received preventive care consisting of antibiotics and specific wound closure, fewer people developed MRONJ: two participants per 100 who underwent close monitoring developed MRONJ compared to 23 participants per 100 in the control group (standard care).\nThere was insufficient evidence to conclude that the use of the other interventions investigated would reduce the risk of MRONJ or would improve healing of MRONJ."
}
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query-laysum | 940 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking cessation is the most important treatment for smokers with chronic obstructive pulmonary disease (COPD), but little is known about the effectiveness of different smoking cessation interventions for this particular group of smokers.\nObjectives\nTo evaluate the effectiveness of behavioural or pharmacological smoking cessation interventions, or both, in smokers with COPD.\nSearch methods\nWe searched all records in the Cochrane Airways Group Specialised Register of Trials. In addition to this electronic search, we searched clinical trial registries for planned, ongoing, and unpublished trials. We searched all databases from their inception. We checked the reference lists of all included studies and of other systematic reviews in relevant topic areas. We searched for errata or retractions from eligible trials on PubMed. We conducted our most recent search in March 2016.\nSelection criteria\nWe included randomised controlled trials assessing the effectiveness of any behavioural or pharmacological treatment, or both, in smokers with COPD reporting at least six months of follow-up abstinence rates.\nData collection and analysis\nTwo review authors independently extracted the data and performed the methodological quality assessment for each study. We resolved any disagreements by consensus.\nMain results\nWe included 16 studies (involving 13,123 participants) in this systematic review, two of which were of high quality. These two studies showed that nicotine sublingual tablet and varenicline increased the quit rate over placebo (risk ratio (RR) 2.60 (95% confidence interval (CI) 1.29 to 5.24) and RR 3.34 (95% CI 1.88 to 5.92)). Pooled results of two studies also showed a positive effect of bupropion compared with placebo (RR 2.03 (95% CI 1.26 to 3.28)). When pooling these four studies, we found high-quality evidence for the effectiveness of pharmacotherapy plus high-intensity behavioural treatment compared with placebo plus high-intensity behavioural treatment (RR 2.53 (95% CI 1.83 to 3.50)). Furthermore, we found some evidence that high-intensity behavioural treatment increased abstinence rates when compared with usual care (RR 25.38 (95% CI 8.03 to 80.22)) or low-intensity behavioural treatment (RR 2.18 (95% CI 1.05 to 4.49)). Finally, the results showed effectiveness of various combinations of psychosocial and pharmacological interventions.\nAuthors' conclusions\nWe found high-quality evidence in a meta-analysis including four (1,540 participants) of the 16 included studies that a combination of behavioural treatment and pharmacotherapy is effective in helping smokers with COPD to quit smoking. Furthermore, we conclude that there is no convincing evidence for preferring any particular form of behavioural or pharmacological treatment.\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 high-quality evidence from a collection of four (1,540 participants) of the total 16 included studies (13,123 participants) in this review. Overall, we found evidence that smokers with COPD who receive a combination of high-intensity behavioural support and medication are more than twice as likely to quit as people who receive behavioural support alone. We found no clear evidence that one particular form of behavioural support or medication is better than another. It is still unclear whether smokers with COPD are different from smokers without COPD with regard to which treatments work best to help them stop smoking."
}
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query-laysum | 941 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane review first published in 2002. Osteoarthritis is a disease that affects the synovial joints, causing degeneration and destruction of hyaline cartilage and subchondral bone. Electromagnetic field therapy is currently used by physiotherapists and may promote growth and repair of bone and cartilage. It is based on principles of physics which include Wolff's law, the piezoelectric effect and the concept of streaming potentials.\nObjectives\nTo assess the benefits and harms of electromagnetic fields for the treatment of osteoarthritis as compared to placebo or sham.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), PreMEDLINE for trials published before 1966, MEDLINE from 1966 to October 2013, CINAHL and PEDro up to and including October 2013. Electronic searches were complemented by handsearches.\nSelection criteria\nRandomised controlled trials of electromagnetic fields in osteoarthritis, with four or more weeks treatment duration. We included papers in any language.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in the review and resolved differences by consensus with a third review author. We extracted data using pre-developed data extraction forms. The same review authors assessed the risk of bias of the trials independently using the Cochrane 'Risk of bias' tool. We extracted outcomes for osteoarthritis from the publications according to Outcome Measures in Rheumatology Clinical Trials (OMERACT) guidelines. We expressed results for continuous outcome measures as mean difference (MD) or standardised mean difference (SMD) with 95% confidence interval (CI). We pooled dichotomous outcome measures using risk ratio (RR) and calculated the number needed to treat (NNT).\nMain results\nNine studies with a total of 636 participants with osteoarthritis were included, six of which were added in this update of the review. Selective outcome reporting was unclear in all nine included studies due to inadequate reporting of study design and conduct, and there was high risk of bias for incomplete outcome data in three studies. The overall risk of bias across the nine studies was low for the other domains.\nParticipants who were randomised to electromagnetic field treatment rated their pain relief 15.10 points more on a scale of 0 to 100 (MD 15.10, 95% CI 9.08 to 21.13; absolute improvement 15%) after 4 to 26 weeks' treatment compared with placebo. Electromagnetic field treatment had no statistically significant effect on physical function (MD 4.55, 95% CI -2.23 to 11.32; absolute improvement 4.55%) based on the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scale from 0 to 100 after 12 to 26 weeks' treatment. We also found no statistically significant difference in quality of life on a scale from 0 to 100 (SMD 0.09, 95% CI -0.36 to 0.54; absolute improvement 0.09%) after four to six weeks' treatment, based on the SF-36. No data were available for analysis of radiographic changes. Safety was evaluated in four trials including up to 288 participants: there was no difference in the experience of any adverse event after 4 to 12 weeks of treatment compared with placebo (RR 1.17, 95% CI 0.72 to 1.92). There was no difference in participants who withdrew because of adverse events (measured in one trial) after four weeks of treatment (RR 0.90, 95% CI 0.06 to 13.92). No participants experienced any serious adverse events.\nAuthors' conclusions\nCurrent evidence suggests that electromagnetic field treatment may provide moderate benefit for osteoarthritis sufferers in terms of pain relief. Further studies are required to confirm whether this treatment confers clinically important benefits in terms of physical function and quality of life. Our conclusions are unchanged from the previous review conducted in 2002.\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": "After searching for all relevant studies up to October 2013, we found nine studies that reviewed the effect of electromagnetic field treatment compared to a sham or fake treatment in 636 adults with osteoarthritis for a duration of 4 to 26 weeks."
}
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query-laysum | 942 | [
{
"role": "user",
"content": "Abstract: Background\nBreast-conserving therapy, involving breast-conserving surgery followed by whole-breast irradiation and optionally a boost to the tumour bed, is a standard therapeutic option for women with early-stage breast cancer. A boost to the tumour bed means that an extra dose of radiation is applied that covers the initial tumour site. The rationale for a boost of radiotherapy to the tumour bed is that (i) local recurrence occurs mostly at the site of the primary tumour because remaining microscopic tumour cells are most likely situated there; and (ii) radiation can eliminate these causative microscopic tumour cells. The boost continues to be used in women at high risk of local recurrence, but is less widely accepted for women at lower risk. Reasons for questioning the boost are twofold. Firstly, the boost brings higher treatment costs. Secondly, the potential adverse events are not negligible. In this Cochrane Review, we investigated the effect of the tumour bed boost on local control and side effects.\nObjectives\nTo assess the effects of tumour bed boost radiotherapy after breast-conserving surgery and whole-breast irradiation for the treatment of breast cancer.\nSearch methods\nWe searched the Cochrane Breast Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (January 1966 to 1 March 2017), Embase (1980 to 1 March 2017), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov on 1 March 2017. We also searched the European Society of Radiotherapy and Oncology Annual Meeting, the St Gallen Oncology Conferences, and the American Society for Radiation Oncology Annual Meeting for abstracts.\nSelection criteria\nRandomised controlled trials comparing the addition and the omission of breast cancer tumour bed boost radiotherapy.\nData collection and analysis\nTwo review authors (IK and CW) performed data extraction and assessed risk of bias using Cochrane's 'Risk of bias' tool, resolving any disagreements through discussion. We entered data into Review Manager 5 for analysis and applied GRADE to assess the quality of the evidence.\nMain results\nWe included 5 randomised controlled trials analysing a total of 8325 women.\nLocal control appeared to be better for women receiving a tumour bed boost compared to no tumour bed boost (hazard ratio (HR) 0.64, 95% confidence interval (CI) 0.55 to 0.75; 5 studies, 8315 women, low-quality evidence). Overall survival did not differ with or without a tumour bed boost (HR 1.04, 95% CI 0.94 to 1.14; 2 studies, 6342 women, moderate-quality evidence). Disease-free survival did not differ with or without a tumour bed boost (HR 0.94, 95% CI 0.87 to 1.02; 3 studies, 6549 women, low-quality evidence). Late toxicity scored by means of percentage of breast retraction assessment did not differ with or without a tumour bed boost (mean difference 0.38, 95% CI -0.18 to 0.93; 2 studies, 1526 women, very low-quality evidence). Cosmesis scored by a panel was better (i.e. excellent or good compared to fair or poor) in the no-boost group (odds ratio (OR) 1.41, 95% CI 1.07 to 1.85; 2 studies, 1116 women, low-quality evidence). Cosmesis scored by a physician did not differ with or without a tumour bed boost (OR 1.58, 95% CI 0.93 to 2.69; 2 studies, 592 women, very low-quality evidence).\nWe excluded two studies in a sensitivity analysis of local recurrence (because the biological equivalent dose (BED) to the tumour bed was lower, in situ tumours were included, or there was a high risk of selective reporting bias or blinding of outcome assessment bias), which resulted in a HR of 0.62 (95% CI 0.52 to 0.73; 3 studies, 6963 women, high-quality evidence). Subgroup analysis including women older than 40 years of age yielded a HR of 0.65 (95% CI 0.53 to 0.81; 2 studies, 5058 women, high-quality evidence).\nWe found no data for the outcomes of acute toxicity, quality of life, or costs.\nAuthors' conclusions\nIt appears that local control rates are increased with the boost to the tumour bed, but we found no evidence of a benefit for other oncological outcomes. Subgroup analysis including women older than 40 years of age yielded similarly significant results. Objective percentage of breast retraction assessment appears similar between groups. It appears that the cosmetic outcome is worse with the boost to the tumour bed, but only when measured by a panel, not when assessed by a physician.\n\nGiven the provided abstract, please respond to the following query: \"Why does it matter?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Guidelines for use of the tumour bed boost are often not clear-cut. Even though it is technically feasible to treat all women with a boost to the tumour bed after whole-breast irradiation, it remains unclear whether this is necessary or whether it may do more harm than good. Possible consequences of adding a boost dose to the tumour bed are poor cosmesis, as well as higher treatment costs and increased treatment times."
}
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query-laysum | 943 | [
{
"role": "user",
"content": "Abstract: Background\nChronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.\nObjectives\nTo assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.\nSearch methods\nFor this second update we searched the Cochrane Wounds Group Specialised Register (searched 18 February 2015); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 1); Ovid MEDLINEย (1946 to 17 February 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 17 February 2015); Ovid EMBASE (1974 to 17 February 2015); and EBSCO CINAHL (1982 to 17 February 2015).\nSelection criteria\nRandomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).\nData collection and analysis\nThree review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.\nMain results\nWe included twelve trials (577 participants). Ten trials (531 participants) enrolled people with a diabetic foot ulcer: pooled data of five trials with 205 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.19 to 4.62; P = 0.01) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We identified one trial (30 participants) which enrolled patients with non-healing diabetic ulcers as well as venous ulcers (\"mixed ulcers types\") and patients were treated for 30 days. For this \"mixed ulcers\" there was a significant benefit of HBOT in terms of reduction in ulcer area at the end of treatment (30 days) (MD 61.88%, 95% CI 41.91 to 81.85, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.\nAuthors' conclusions\nIn people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.\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 included twelve randomised trials (577 participants) in this updated review. Most of the included trials studied foot ulcers in people with diabetes (10 trials).\nFor diabetes-related foot ulcers, we found that HBOT seemed to improve the chance of healing in the short term (up to six weeks), but not with longer term follow-up. HBOT may reduce the number of major amputations in people with diabetes who have chronic foot ulcers.\nFor chronic wounds caused by disease to the veins of the leg, we found that HBOT may reduce the size of wounds.\nFor chronic wounds caused by lack of blood supply through the arteries or chronic pressure ulcers, we found no evidence to confirm or refute any effects of HBOT.\nWe could not assess safety as none of the trials included in our review reported whether there were any major adverse events.\nThis plain language summary is up-to-date as of 23/1/15"
}
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query-laysum | 944 | [
{
"role": "user",
"content": "Abstract: Background\nChronic pain is common in adults, and often has a detrimental impact upon physical ability, well-being, and quality of life. Previous reviews have shown that certain antidepressants may be effective in reducing pain with some benefit in improving patientsโ global impression of change for certain chronic pain conditions. However, there has not been a network meta-analysis (NMA) examining all antidepressants across all chronic pain conditions.\nObjectives\nTo assess the comparative efficacy and safety of antidepressants for adults with chronic pain (except headache).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, AMED and PsycINFO databases, and clinical trials registries, for randomised controlled trials (RCTs) of antidepressants for chronic pain conditions in January 2022.\nSelection criteria\nWe included RCTs that examined antidepressants for chronic pain against any comparator. If the comparator was placebo, another medication, another antidepressant, or the same antidepressant at different doses, then we required the study to be double-blind. We included RCTs with active comparators that were unable to be double-blinded (e.g. psychotherapy) but rated them as high risk of bias. We excluded RCTs where the follow-up was less than two weeks and those with fewer than 10 participants in each arm.\nData collection and analysis\nTwo review authors separately screened, data extracted, and judged risk of bias. We synthesised the data using Bayesian NMA and pairwise meta-analyses for each outcome and ranked the antidepressants in terms of their effectiveness using the surface under the cumulative ranking curve (SUCRA). We primarily used Confidence in Meta-Analysis (CINeMA) and Risk of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) to assess the certainty of the evidence. Where it was not possible to use CINeMA and ROB-MEN due to the complexity of the networks, we used GRADE to assess the certainty of the evidence.\nOur primary outcomes were substantial (50%) pain relief, pain intensity, mood, and adverse events. Our secondary outcomes were moderate pain relief (30%), physical function, sleep, quality of life, Patient Global Impression of Change (PGIC), serious adverse events, and withdrawal.\nMain results\nThis review and NMA included 176 studies with a total of 28,664 participants. The majority of studies were placebo-controlled (83), and parallelโarmed (141). The most common pain conditions examined were fibromyalgia (59 studies); neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The average length of RCTs was 10 weeks. Seven studies provided no useable data and were omitted from the NMA. The majority of studies measured short-term outcomes only and excluded people with low mood and other mental health conditions.\nAcross efficacy outcomes, duloxetine was consistently the highest-ranked antidepressant with moderate- to high-certainty evidence. In duloxetine studies, standard dose was equally efficacious as high dose for the majority of outcomes. Milnacipran was often ranked as the next most efficacious antidepressant, although the certainty of evidence was lower than that of duloxetine. There was insufficient evidence to draw robust conclusions for the efficacy and safety of any other antidepressant for chronic pain.\nPrimary efficacy outcomes\nDuloxetine standard dose (60 mg) showed a small to moderate effect for substantial pain relief (odds ratio (OR) 1.91, 95% confidence interval (CI) 1.69 to 2.17; 16 studies, 4490 participants; moderate-certainty evidence) and continuous pain intensity (standardised mean difference (SMD) โ0.31, 95% CI โ0.39 to โ0.24; 18 studies, 4959 participants; moderate-certainty evidence). For pain intensity, milnacipran standard dose (100 mg) also showed a small effect (SMD โ0.22, 95% CI โ0.39 to 0.06; 4 studies, 1866 participants; moderate-certainty evidence). Mirtazapine (30 mg) had a moderate effect on mood (SMD โ0.5, 95% CI โ0.78 to โ0.22; 1 study, 406 participants; low-certainty evidence), while duloxetine showed a small effect (SMD โ0.16, 95% CI โ0.22 to โ0.1; 26 studies, 7952 participants; moderate-certainty evidence); however it is important to note that most studies excluded participants with mental health conditions, and so average anxiety and depression scores tended to be in the 'normal' or 'subclinical' ranges at baseline already.\nSecondary efficacy outcomes\nAcross all secondary efficacy outcomes (moderate pain relief, physical function, sleep, quality of life, and PGIC), duloxetine and milnacipran were the highest-ranked antidepressants with moderate-certainty evidence, although effects were small. For both duloxetine and milnacipran, standard doses were as efficacious as high doses.\nSafety\nThere was very low-certainty evidence for all safety outcomes (adverse events, serious adverse events, and withdrawal) across all antidepressants. We cannot draw any reliable conclusions from the NMAs for these outcomes.\nAuthors' conclusions\nOur review and NMAs show that despite studies investigating 25 different antidepressants, the only antidepressant we are certain about for the treatment of chronic pain is duloxetine. Duloxetine was moderately efficacious across all outcomes at standard dose. There is also promising evidence for milnacipran, although further high-quality research is needed to be confident in these conclusions. Evidence for all other antidepressants was low certainty. As RCTs excluded people with low mood, we were unable to establish the effects of antidepressants for people with chronic pain and depression. There is currently no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point.\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 if antidepressants were effective for managing chronic pain and whether they cause unwanted effects."
}
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query-laysum | 946 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple myeloma is a malignancy of plasma cells accounting for approximately 1% of cancers and 12% of haematological malignancies. The first-in-class proteasome inhibitor, bortezomib, is commonly used to treat newly diagnosed as well as relapsed/refractory myeloma, either as single agent or combined with other therapies.\nObjectives\nWe conducted a systematic review and meta-analysis to assess the effects of bortezomib on overall survival (OS), progression-free survival (PFS), response rate (RR), health-related quality of life (HRQoL), adverse events (AEs) and treatment-related death (TRD).\nSearch methods\nWe searched MEDLINE, the Cochrane Central Register of Controlled Trials and EMBASE (till 27 January 2016) as well as conference proceedings and clinical trial registries for randomised controlled trials (RCTs).\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared i) bortezomib versus no bortezomib with the same background therapy in each arm; ii) bortezomib versus no bortezomib with different background therapy in each arm or compared to other agent(s) and iii) bortezomib dose comparisons and comparisons of different treatment administrations and schedules.\nData collection and analysis\nTwo review authors independently extracted outcomes data and assessed risk of bias. We extracted hazard ratios (HR) and their confidence intervals for OS and PFS and odds ratios (OR) for response rates, AEs and TRD. We contacted trial authors to provide summary statistics if missing. We estimated Logrank statistics which were not available. We extracted HRQoL data, where available.\nMain results\nWe screened a total of 3667 records, identifying 16 relevant RCTs involving 5626 patients and included 12 trials in the meta-analyses. All trials were randomised and open-label studies. Two trials were published in abstract form and therefore we were unable to assess potential risk of bias in full.\nThere is moderate-quality evidence that bortezomib prolongs OS (four studies, 1586 patients; Peto OR 0.77, 95% CI 0.65 to 0.92) and PFS (five studies, 1855 patients; Peto OR 0.65, 95% CI 0.57 to 0.74) from analysing trials of bortezomib versus no bortezomib with the same background therapy in each arm.\nThere is high-quality evidence that bortezomib prolongs OS (five studies, 2532 patients; Peto OR 0.76, 95% CI 0.67 to 0.88) but low-quality evidence for PFS (four studies, 2489 patients; Peto OR 0.67, 95% CI 0.61 to 0.75) from analysing trials of bortezomib versus no bortezomib with different background therapy in each arm or compared to other agent(s).\nFour trials (N = 716) examined different doses, methods of administrations and treatment schedules and were reviewed qualitatively only.\nWe identified four trials in the meta-analysis that measured time to progression (TTP) and were able to extract and analyse PFS data for three of the studies, while in the case of one study, we included TTP data as PFS data were not available. We therefore did not analyse TTP separately in this review.\nPatients treated with bortezomib have increased risk of thrombocytopenia, neutropenia, gastro-intestinal toxicities, peripheral neuropathy, infection and fatigue with the quality of evidence highly variable. There is high-quality evidence for increased risk of cardiac disorders from analysing trials of bortezomib versus no bortezomib with different background therapy in each arm or versus other agents. The risk of TRD in either comparison group analysed is uncertain due to the low quality of the evidence.\nOnly four trials analysed HRQoL and the data could not be meta-analysed.\nSubgroup analyses by disease setting revealed improvements in all outcomes, whereas for therapy setting, an improved benefit for bortezomib was observed in all outcomes and subgroups except for OS following consolidation therapy.\nAuthors' conclusions\nThis meta-analysis found that myeloma patients receiving bortezomib benefited in terms of OS, PFS and response rate compared to those who did not receive bortezomib. This benefit was observed in trials of bortezomib versus no bortezomib with the same background therapy and in trials of bortezomib versus no bortezomib with different background therapy in each arm or compared to other agent(s). Further evaluation of newer proteasome inhibitors is required to ascertain whether these agents offer an improved risk-benefit profile, while more studies of HRQoL are also required.\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 judged quality of the evidence as high to moderate for mortality or number of deaths, whereas it was considered low-quality evidence for progression-free survival. the quality of evidence for adverse events was highly variable (low to high). For assessment of treatment-related death, there was no evidence of a difference, with low-quality evidence in one comparison (bortezomib compared to no bortezomib with the same background therapy) and very low-quality evidence in comparison two (bortezomib compared to no bortezomib with different background therapy or compared to other drugs)."
}
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query-laysum | 947 | [
{
"role": "user",
"content": "Abstract: Background\nFriedreich ataxia is a rare inherited autosomal recessive neurological disorder, characterised initially by unsteadiness in standing and walking, slowly progressing to wheelchair dependency usually in the late teens or early twenties. It is associated with slurred speech, scoliosis, and pes cavus. Heart abnormalities cause premature death in 60% of people with the disorder. There is no easily defined clinical or biochemical marker and no known treatment. This is the second update of a review first published in 2009 and previously updated in 2012.\nObjectives\nTo assess the effects of pharmacological treatments for Friedreich ataxia.\nSearch methods\nOn 29 February 2016 we searched The Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, EMBASE and CINAHL Plus. On 7 March 2016 we searched ORPHANET and TRIP. We also checked clinical trials registers for ongoing studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs) or quasi-RCTs of pharmacological treatments (including vitamins) in people with genetically-confirmed Friedreich ataxia. The primary outcome was change in a validated Friedreich ataxia neurological score after 12 months. Secondary outcomes were changes in cardiac status as measured by magnetic resonance imaging or echocardiography, quality of life, mild and serious adverse events, and survival. We excluded trials of duration shorter than 12 months.\nData collection and analysis\nThree review authors selected trials and two review authors extracted data. We obtained missing data from the two RCTs that met our inclusion criteria. We collected adverse event data from included studies. We used standard methodological procedures expected by Cochrane.\nMain results\nWe identified more than 12 studies that used antioxidants in the treatment of Friedreich ataxia, but only two small RCTs, with a combined total of 72 participants, both fulfilled the selection criteria for this review and published results. One of these trials compared idebenone with placebo, the other compared high-dose versus low-dose coenzyme Q10 and vitamin E (the trialists considered the low-dose medication to be the placebo). We identified two other completed RCTs, which remain unpublished; the interventions in these trials were pioglitazone (40 participants) and idebenone (232 participants). Other RCTs were of insufficient duration for inclusion.\nIn the included studies, the primary outcome specified for the review, change in a validated Friedreich ataxia rating score, was measured using the International Co-operative Ataxia Rating Scale (ICARS). The results did not reveal any significant difference between the antioxidant-treated and the placebo groups (mean difference 0.79 points, 95% confidence interval -1.97 to 3.55 points; low-quality evidence).\nThe published included studies did not assess the first secondary outcome, change in cardiac status as measured by magnetic resonance imaging. Both studies reported changes in cardiac measurements assessed by echocardiogram. The ejection fraction was not measured in the larger of the included studies (44 participants). In the smaller study (28 participants), it was normal at baseline and did not change with treatment. End-diastolic interventricular septal thickness showed a small decrease in the smaller of the two included studies. In the larger included study, there was no decrease, showing significant heterogeneity in the study results; our overall assessment of the quality of evidence for this outcome was very low. Left ventricular mass (LVM) was only available for the smaller RCT, which showed a significant decrease. The relevance of this change is unclear and the quality of evidence low.\nThere were no deaths related to the treatment with antioxidants. We considered the published included studies at low risk of bias in six of seven domains assessed. One unpublished included RCT, a year-long study using idebenone (232 participants), published an interim report in May 2010 stating that the study reached neither its primary endpoint, which was change in the ICARS score, nor a key cardiological secondary endpoint, but data were not available for verification and analysis.\nAuthors' conclusions\nLow-quality evidence from two small, published, randomised controlled trials neither support nor refute an effect from antioxidants (idebenone, or a combination of coenzyme Q10 and vitamin E) on the neurological status of people with Friedreich ataxia, measured with a validated neurological rating scale. A large unpublished study of idebenone that reportedly failed to meet neurological or key cardiological endpoints, and a trial of pioglitazone remain unpublished, but on publication will very likely influence quality assessments and conclusions. A single study of idebenone provided low-quality evidence for a decrease in LVM, which is of uncertain clinical significance but of potential importance that needs to be clarified. According to low-quality evidence, serious and non-serious adverse events were rare in both antioxidant and placebo groups. No non-antioxidant agents have been investigated in RCTs of 12 months' duration.\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": "Friedreich ataxia is a rare inherited neurological condition, which first presents between 5 and 15 years of age. It initially causes clumsiness of movement, and progresses to unsteadiness in standing and walking, with wheelchair dependency by late teens or early twenties. Speech usually becomes slurred. A specific faulty gene must be inherited from each parent for the disease to develop in their child (autosomal recessive inheritance). Other major problems which can develop include a curved spine (scoliosis), foot deformity (a high arch), and heart problems, which are a cause of death in 60% of people. Friedreich ataxia has no known effective treatment. Clinical examination and laboratory tests are not very useful for assessing disease progression, and this in turn makes interpreting clinical trial results difficult.\nAntioxidants are thought to reduce damage to cells from harmful 'free radicals'. Antioxidants occur naturally in foods in very low levels. Recent studies have found conflicting results about the effect that the antioxidants idebenone, coenzyme Q10 and vitamin E have on the heart in Friedreich ataxia, as measured by thickening of the interventricular septum (the wall between two chambers of the heart), and increased left ventricular mass (the left ventricle is the chamber of the heart that pumps blood around the body)."
}
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query-laysum | 948 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the second updated version of the original Cochrane review published in the Cochrane Library 2009, Issue 3.\nMost women with early cervical cancer (stages I to IIA) are cured with surgery or radiotherapy, or both. We performed this review originally because it was unclear whether cisplatin-based chemotherapy after surgery, radiotherapy or both, in women with early stage disease with risk factors for recurrence, was associated with additional survival benefits or risks.\nObjectives\nTo evaluate the effectiveness and safety of adjuvant platinum-based chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer.\nSearch methods\nFor the original 2009 review, we searched the Cochrane Gynaecological Cancer Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library 2009, Issue 1), MEDLINE, Embase, LILACS, BIOLOGICAL ABSTRACTS and CancerLit, the National Research Register and Clinical Trials register, with no language restriction. We handsearched abstracts of scientific meetings and other relevant publications. We extended the database searches to November 2011 for the first update and to September 2016 for the second update.\nSelection criteria\nRandomised controlled trials (RCTs) comparing adjuvant cisplatin-based chemotherapy (after radical surgery, radiotherapy or both) with no adjuvant chemotherapy, in women with early stage cervical cancer (stage IA2-IIA) with at least one risk factor for recurrence.\nData collection and analysis\nTwo review authors extracted data independently. Meta-analysis was performed using a random-effects model, with death and disease progression as outcomes.\nMain results\nFor this second updated version we identified only one small trial reporting grade 4 toxicity results, without disease-free or overall survival data with a median follow-up of 16 months.\nFrom the first updated version, we identified three trials that were ongoing, and remain so in 2016.\nFour trials including 401 women with evaluable results with early cervical cancer were included in the meta-analyses. The median follow-up period in these trials ranged from 29 to 42 months. All women had undergone surgery first. Three trials compared chemotherapy combined with radiotherapy versus radiotherapy alone; and one trial compared chemotherapy followed by radiotherapy versus radiotherapy alone. It was not possible to perform subgroup analyses by stage or tumour size.\nCompared with adjuvant radiotherapy, chemotherapy combined with radiotherapy significantly reduced the risk of death (two trials, 297 women; hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.36 to 0.87) and disease progression (two trials, 297 women; HR = 0.47, 95% CI 0.30 to 0.74), with no heterogeneity between trials (Iยฒ = 0% for both meta-analyses). Acute grade 4 toxicity occurred significantly more frequently in the chemotherapy plus radiotherapy group than in the radiotherapy group (three trials, 321 women; risk ratio (RR) 6.26, 95% CI 2.50 to 15.67). We considered the evidence for all three outcomes to be of a moderate quality, using the GRADE approach due to small numbers and limited follow-up in the included studies. In addition, it was not possible to separate data for bulky early stage disease.\nIn the one small trial that compared adjuvant chemotherapy followed by radiotherapy with adjuvant radiotherapy alone there was no difference in disease recurrence between the groups (one trial, 71 women; HR = 1.34; 95% CI 0.24 to 7.66) and overall survival was not reported. We considered this evidence to be of a low quality.\nNo trials compared adjuvant platinum-based chemotherapy with no adjuvant chemotherapy after surgery for early cervical cancer with risk factors for recurrence.\nAuthors' conclusions\nThe addition of platinum-based chemotherapy to adjuvant radiotherapy (chemoradiation) may improve survival in women with early stage cervical cancer (IA2-IIA) and risk factors for recurrence. Adjuvant chemoradiation is associated with an increased risk of severe acute toxicity, although it is not clear whether this toxicity is significant in the long term due to a lack of long-term data. This evidence is limited by the small numbers and low to moderate methodological quality of the included studies. We await the results of three ongoing trials, which are likely to have an important impact on our confidence in this evidence.\n\nGiven the provided abstract, please respond to the following query: \"Main Findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this review, we analysed data from four small trials of unclear quality. It was not possible to separate data of bulky early stage disease (stage IB2 and IIA lesions greater than 4 cm) from the overall results. We found limited evidence to suggest that the addition of cisplatin chemotherapy to radiotherapy prolongs survival (time to death) and delays progression of the cancer when given after surgery to women with cervical cancer stage IA2 to IIA with risk factors for recurrence. The combined therapy was associated with more severe side effects than radiotherapy alone."
}
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query-laysum | 949 | [
{
"role": "user",
"content": "Abstract: Background\nSurgery remains an acceptable treatment modality for tubal infertility despite the rise in usage of in vitro fertilisation (IVF). Estimated livebirth rates after surgery range from 9% for women with severe tubal disease to 69% for those with mild disease; however, the effectiveness of surgery has not been rigorously evaluated in comparison with other treatments such as IVF and expectant management (no treatment). Livebirth rates have not been adequately assessed in relation to the severity of tubal damage. It is important to determine the effectiveness of surgery against other treatment options in women with tubal infertility because of concerns about adverse outcomes, intraoperative complications and costs associated with tubal surgery, as well as alternative treatments, mainly IVF.\nObjectives\nThe aim of this review was to determine the effectiveness and safety of surgery compared with expectant management or IVF in improving the probability of livebirth in the context of tubal infertility (regardless of grade of severity).\nSearch methods\nWe searched the following databases in October 2016: the Cochrane Gynaecology and Fertility (CGF) Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO; as well as clinical trials registries, sources of unpublished literature and reference lists of included trials and related systematic reviews.\nSelection criteria\nWe considered only randomised controlled trials to be eligible for inclusion, with livebirth rate per participant as the primary outcome of interest.\nData collection and analysis\nWe planned that two review authors would independently assess trial eligibility and risk of bias and would extract study data. The primary review outcome was cumulative livebirth rate. Pregnancy rate and adverse outcomes, including miscarriage rate, rate of ectopic pregnancy and rate of procedure-related complications, were secondary outcomes. We planned to combine data to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). We planned to assess statistical heterogeneity using the I2 statistic and to assess the overall quality of evidence for the main comparisons using GRADE methods.\nMain results\nWe identified no suitable randomised controlled trials.\nAuthors' conclusions\nThe effectiveness of tubal surgery relative to expectant management and IVF in terms of livebirth rates for women with tubal infertility remains unknown. Large trials with adequate power are warranted to establish the effectiveness of surgery in these women. Future trials should not only report livebirth rates per patient but should compare adverse effects and costs of treatment over a longer time. Factors that have a major effect on these outcomes, such as fertility treatment, female partner's age, duration of infertility and previous pregnancy history, should be considered. Researchers should report livebirth rates in relation to severity of tubal damage and different techniques used for tubal repair, including microsurgery and laparoscopic methods.\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": "Tubal surgery to overcome infertility caused by tubal disease is becoming popular, in part because of risks and costs related to IVF, which offers another option for overcoming tubal infertility. Benefits obtained from tubal surgery would potentially be sustained over multiple cycles and many years, even resulting in multiple livebirths. However, tubal surgery is expensive, as it requires additional specialist training and experience among gynaecologists who perform the procedure, and it can involve adverse effects (including ectopic pregnancies) and operative risks. The effectiveness of tubal surgery in comparison with no treatment (expectant management) or IVF in women with tubal infertility is unknown."
}
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query-laysum | 950 | [
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of obesity is increasing worldwide, yet nutritional management remains contentious. It has been suggested that low glycaemic index (GI) or low glycaemic load (GL) diets may stimulate greater weight loss than higher GI/GL diets or other weight reduction diets. The previous version of this review, published in 2007, found mainly short-term intervention studies. Since then, randomised controlled trials (RCTs) with longer-term follow-up have become available, warranting an update of this review.\nObjectives\nTo assess the effects of low glycaemic index or low glycaemic load diets on weight loss in people with overweight or obesity.\nSearch methods\nWe searched CENTRAL, MEDLINE, one other database, and two clinical trials registers from their inception to 25 May 2022. We did not apply any language restrictions.\nSelection criteria\nWe included RCTs with a minimum duration of eight weeks comparing low GI/GL diets to higher GI/GL diets or any other diets in people with overweight or obesity.\nData collection and analysis\nWe used standard Cochrane methods. We conducted two main comparisons: low GI/GL diets versus higher GI/GL diets and low GI/GL diets versus any other diet. Our main outcomes included change in body weight and body mass index, adverse events, health-related quality of life, and mortality. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nIn this updated review, we included 10 studies (1210 participants); nine were newly-identified studies. We included only one study from the previous version of this review, following a revision of inclusion criteria. We listed five studies as 'awaiting classification' and one study as 'ongoing'. Of the 10 included studies, seven compared low GI/GL diets (233 participants) with higher GI/GL diets (222 participants) and three studies compared low GI/GL diets (379 participants) with any other diet (376 participants). One study included children (50 participants); one study included adults aged over 65 years (24 participants); the remaining studies included adults (1136 participants). The duration of the interventions varied from eight weeks to 18 months. All trials had an unclear or high risk of bias across several domains.\nLow GI/GL diets versus higher GI/GL diets\nLow GI/GL diets probably result in little to no difference in change in body weight compared to higher GI/GL diets (mean difference (MD) -0.82 kg, 95% confidence interval (CI) -1.92 to 0.28; I2 = 52%; 7 studies, 403 participants; moderate-certainty evidence). Evidence from four studies reporting change in body mass index (BMI) indicated low GI/GL diets may result in little to no difference in change in BMI compared to higher GI/GL diets (MD -0.45 kg/m2, 95% CI -1.02 to 0.12; I2 = 22%; 186 participants; low-certainty evidence)at the end of the study periods. One study assessing participants' mood indicated that low GI/GL diets may improve mood compared to higher GI/GL diets, but the evidence is very uncertain (MD -3.5, 95% CI -9.33 to 2.33;ย 42 participants; very low-certainty evidence). Two studies assessing adverse events did not report any adverse events; we judged this outcome to have very low-certainty evidence. No studies reported on all-cause mortality.\nFor the secondary outcomes, low GI/GL diets may result in little to no difference in fat mass compared to higher GI/GL diets (MD -0.86 kg, 95% CI -1.52 to -0.20; I2 = 6%; 6 studies, 295 participants; low certainty-evidence). Similarly, low GI/GL diets may result in little to no difference in fasting blood glucose level compared to higher GI/GL diets (MD 0.12 mmol/L, 95% CI 0.03 to 0.21; I2 = 0%; 6 studies, 344 participants; low-certainty evidence).\nLow GI/GL diets versus any other diet\nLow GI/GL diets probably result in little to no difference in change in body weight compared to other diets (MD -1.24 kg, 95% CI -2.82 to 0.34; I2 = 70%; 3 studies, 723 participants; moderate-certainty evidence). The evidence suggests that low GI/GL diets probably result in little to no difference in change in BMI compared to other diets (MD -0.30 kg in favour of low GI/GL diets, 95% CI -0.59 to -0.01; I2 = 0%; 2 studies, 650 participants; moderate-certainty evidence). Two adverse events were reported in one study: one was not related to the intervention, and the other, an eating disorder, may have been related to the intervention. Another study reported 11 adverse events, including hypoglycaemia following an oral glucose tolerance test. The same study reported seven serious adverse events, including kidney stones and diverticulitis. We judged this outcome to have low-certainty evidence. No studies reported on health-related quality of life or all-cause mortality.\nFor the secondary outcomes, none of the studies reported on fat mass. Low GI/GL diets probably do not reduce fasting blood glucose level compared to other diets (MD 0.03 mmol/L, 95% CI -0.05 to 0.12; I2 = 0%; 3 studies, 732 participants; moderate-certainty evidence).\nAuthors' conclusions\nThe current evidence indicates there may be little to no difference for all main outcomes between low GI/GL diets versus higher GI/GL diets or any other diet. There is insufficient information to draw firm conclusions about the effect of low GI/GL diets on people with overweight or obesity. Most studies had a small sample size, with only a few participants inย each comparison group. We rated the certainty of the evidence as moderate to very low. More well-designed and adequately-powered studies are needed. They should follow a standardised intervention protocol, adopt objective outcome measurement since blinding may be difficult to achieve, and make efforts to minimise loss to follow-up. Furthermore, studies in people from a wide range of ethnicities and with a wide range of dietary habits, as well as studies in low- and middle-income countries, are needed.\n\nGiven the provided abstract, please respond to the following query: \"What is a low glycaemic index or a low glycaemic load diet?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Low glycaemic index and low glycaemic load diets consist of foods that produce a milder or delayed peak in blood sugar. This may cause the body to produce less insulin, which could lead to weight loss."
}
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query-laysum | 951 | [
{
"role": "user",
"content": "Abstract: Background\nGroin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is uncertain whether insertion of a drain reduces complication rates, and, if used, the optimum time for drain removal after surgery is also unknown.\nObjectives\nTo assess the current level of evidence to determine whether placement of a drain is beneficial after groin dissection in terms of reducing seroma, haematoma, wound dehiscence and wound infection rates, and to determine the optimal type and duration of drainage following groin dissection if it is shown to be beneficial.\nSearch methods\nIn September 2014 we searched the following electronic databases using a pre-designed search strategy: the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library). In November 2013 we searched Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting.\nSelection criteria\nWe considered all randomised controlled trials (RCTs) comparing wound drainage with no wound drainage in individuals undergoing groin dissection, where the most superior node excised was Cloquet's node (the most superior inguinal lymph node). No limits were applied to language of publication or trial location. Two review authors independently determined the eligibility of each trial.\nData collection and analysis\nTwo review authors, working independently, screened studies identified from the search; there were no disagreements.\nMain results\nWe did not identify any RCTs that met the inclusion criteria for the review.\nAuthors' conclusions\nThere is a need for high quality RCTs to guide clinical practice in this under-researched area.\n\nGiven the provided abstract, please respond to the following query: \"Why insert drainage tubes after surgery?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Surgeons can insert plastic drainage tubes into the area from which the lymph nodes have been removed. These tubes are inserted towards the end of the operation, once the lymph glands have been removed. The aim of the drainage tubes is to drain away any fluid or blood that may collect in the wounds and cause complications. The drains are usually left in place until the amount of fluid draining out of them in a 24-hour period has reduced to a certain volume (typically less than 30 mL to 100 mL), although some surgeons will remove the drains at a particular time point after surgery (this can vary from 1 day to more than 1 week). Patients can remain in hospital while the drain is in place, although many surgeons will let patients leave hospital and have the drain managed on an outpatient basis.\nHowever, it is unclear whether placement of a drainage tube reduces, increases or has no effect on complications following this type of surgery. Furthermore the best timing for removal of drainage tubes is unknown."
}
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query-laysum | 952 | [
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is important to guide appropriate management and improve morbidity and survival. Basal cell carcinoma (BCC) is usually a localised skin cancer but with potential to infiltrate and damage surrounding tissue, whereas cutaneous squamous cell carcinoma (cSCC) and melanoma are higher risk skin cancers with the potential to metastasise and ultimately lead to death. When used in conjunction with clinical or dermoscopic suspicion of malignancy, or both, reflectance confocal microscopy (RCM) may help to identify cancers eligible for non-surgical treatment without the need for a diagnostic biopsy, particularly in people with suspected BCC. Any potential benefit must be balanced against the risk of any misdiagnoses.\nObjectives\nTo determine the diagnostic accuracy of RCM for the detection of BCC, cSCC, or any skin cancer in adults with any suspicious lesion and lesions that are difficult to diagnose (equivocal); and to compare its accuracy with that of usual practice (visual inspection or dermoscopy, or both).\nSearch methods\nWe undertook a comprehensive search of the following databases from inception 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 the accuracy of RCM alone, or RCM in comparison to 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, or both.\nData collection and analysis\nTwo review authors independently extracted 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 threshold were missing. We estimated summary sensitivities and specificities using the bivariate hierarchical model. For computation of likely numbers of true-positive, false-positive, false-negative, and true-negative findings in the 'Summary of findings' tables, we applied summary sensitivity and specificity estimates to lower quartile, median and upper quartiles of the prevalence observed in the study groups. We also investigated the impact of observer experience.\nMain results\nThe review included 10 studies reporting on 11 study cohorts. All 11 cohorts reported data for the detection of BCC, including 2037 lesions (464 with BCC); and four cohorts reported data for the detection of cSCC, including 834 lesions (71 with cSCC). Only one study also reported data for the detection of BCC or cSCC using dermoscopy, limiting comparisons between RCM and dermoscopy. Studies were at high or unclear risk of bias across almost all methodological quality domains, and were of high or unclear concern regarding applicability of the evidence. Selective participant recruitment, unclear blinding of the reference test, and exclusions due to image quality or technical difficulties were observed. It was unclear whether studies were representative of populations eligible for testing with RCM, and test interpretation was often undertaken using images, remotely from the participant and the interpreter blinded to clinical information that would normally be available in practice.\nMeta-analysis found RCM to be more sensitive but less specific for the detection of BCC in studies of participants with equivocal lesions (sensitivity 94%, 95% confidence interval (CI) 79% to 98%; specificity 85%, 95% CI 72% to 92%; 3 studies) compared to studies that included any suspicious lesion (sensitivity 76%, 95% CI 45% to 92%; specificity 95%, 95% CI 66% to 99%; 4 studies), although CIs were wide. At the median prevalence of disease of 12.5% observed in studies including any suspicious lesion, applying these results to a hypothetical population of 1000 lesions results in 30 BCCs missed with 44 false-positive results (lesions misdiagnosed as BCCs). At the median prevalence of disease of 15% observed in studies of equivocal lesions, nine BCCs would be missed with 128 false-positive results in a population of 1000 lesions. Across both sets of studies, up to 15% of these false-positive lesions were observed to be melanomas mistaken for BCCs. There was some suggestion of higher sensitivities in studies with more experienced observers. Summary sensitivity and specificity could not be estimated for the detection of cSCC due to paucity of data.\nAuthors' conclusions\nThere is insufficient evidence for the use of RCM for the diagnosis of BCC or cSCC in either population group. A possible role for RCM in clinical practice is as a tool to avoid diagnostic biopsies in lesions with a relatively high clinical suspicion of BCC. The potential for, and consequences of, misclassification of other skin cancers such as melanoma as BCCs requires further research. Importantly, data are lacking that compare RCM to standard clinical practice (with or without dermoscopy).\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 10 studies that included information on 11 groups of people with lesions suspicious for skin cancer. The main results were based on seven of the 11 sets of data: four in any lesion suspicious for skin cancer and three in particularly difficult to diagnose skin lesions.\nFor the comparison of RCM versus dermoscopy, we found four sets of data that included 912 suspicious skin lesions. The results suggested that in a group of 1000 people with any suspicious lesion, of whom 125 (12.5%) really do have BCC:\n- an estimated 139 people will have an RCM result indicating BCC is present;\n- of these, 44 (32%) people will not have BCC (false-positive results) including one person with a melanoma mistaken for a BCC;\n- of the 861 people with an RCM result indicating that BCC is not present, 30 (3%) will actually have BCC.\nThe review also included three sets of data on people that had 668 particularly difficult to diagnose skin lesions, one comparing RCM to dermoscopy. The results suggested that if RCM was to be used by skin specialists in a group of 1000 people, of whom 150 (15%) really do have BCC:\n- an estimated 269 people will have an RCM result indicating BCC is present;\n- of these, 128 (48%) people will not have a BCC (known as a false-positive result), including as many as 19 people with melanomas mistaken for BCCs;\n- of the 732 people with an RCM result indicating that BCC is not present, nine (1%) will actually have BCC.\nThere was not enough evidence to determine the accuracy of RCM for the detection of cSCC in either population group."
}
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query-laysum | 953 | [
{
"role": "user",
"content": "Abstract: Background\nEditor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. Further information is available at www.vioxx.com. \n\nRheumatoid arthritis (RA) is a systemic auto-immune disorder, in which the synovial lining of many joints and tendon sheaths are persistently inflamed.\nObjectives\nTo assess the efficacy and toxicity of rofecoxib for treating RA.\nSearch methods\nWe searched the following electronic databases up to December 2000: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment database. The bibliographies of retrieved papers were scanned for additional references. The manufacturers of rofecoxib, MSD, were also approached by the UK National Institute for Clinical Excellence to submit additional evidence to inform it's appraisal on the use of cyclo-oxygenase inhibitors for arthritis.\nSelection criteria\nWe included randomised controlled trials of parallel group design evaluating the efficacy and/or toxicity of rofecoxib in RA, both placebo based and comparative trials were eligible. Relevant outcome criteria had to be available to evaluate efficacy and/or toxicity, such as the OMERACT outcomes.\nData collection and analysis\nData were abstracted independently by two reviewers and the results were compared for the degree of agreement. A validated tool (Jadad 1996) was used to score the quality of the randomised controlled trials. The planned analysis was to pool, where appropriate, continuous outcome measures using mean or standardized mean differences, and dichotomous outcome measures using relative risk ratios.\nMain results\nTwo randomised controlled trials evaluating rofecoxib for the treatment of RA were identified and met the inclusion criteria. One compared rofecoxib to placebo and was designed to assess the safety and efficacy of several doses of rofecoxib. The second trial compared rofecoxib to naproxen and was primarily designed to assess the safety of rofecoxib so did not include all the recommended RA efficacy measures. The overall number of ACR 20 responders who had received 25mg (82/ 171 = 48%) or 50mg (86/161 = 53%) was statistically significantly more than those receiving placebo (58/168 = 35% ) (RR 1.39 CI: 1.07, 1.80 and RR 1.55 CI: 1.20, 1.99 respectively) with no statistically significant differences between the 25 and 50 mg doses. The safety profile of rofecoxib was similar to that of placebo. In the comparative trial, rofecoxib at a dosage of 50 mg/day demonstrated similar efficacy to naproxen at a dosage of 500 mg twice daily. However, the combined rate of clinically significant complicated gastro-intestinal events (GI) (perforations, ulcers, bleeds, or obstructions) was lower with rofecoxib than with naproxen (RR 0.46, 95% CI, 0.34 to 0.63) due to a reduction in the number of ulcers and bleeds. Compared to patients taking naproxen, patients taking rofecoxib had a greater risk of having any cardiovascular event (45/4047 = 1.1% vs 19/4029 =0.47%) (RR 2.36 CI 1.38 to 4.02) and had greater risk of having a non-fatal myocardial infarction (MI) (18/4047 =0 .44% and 4/4029 =0.1%) (RR 4.48, 95% CI, 1.52 to 13.23).\nAuthors' conclusions\nIn patients with RA, rofecoxib demonstrates a greater degree of efficacy than placebo, while having a comparable safety profile. Rofecoxib demonstrates a similar degree of efficacy as naproxen, but with a significantly lower rate of ulceration and gastrointestinal bleeding. Rofecoxib was associated with a greater risk for MI, but the exact significance and pathophysiology of this possible relationship is unclear.\nRofecoxib was voluntarily withdrawn from global markets in October 2004. It cannot therefore be prescribed and therefore there are no implications for practice concerning its use. None the less when considering which NSAID to use, it must be borne in mind that the toxicity of NSAIDs is variable amongst patients and drugs and it tends to be dose related and associated with variation in the mode of action, absorption, distribution and metabolism.There remains a number of questions over both the benefits and risks associated with Cox II selective agents and further work is ongoing. It is likely that this issue will not be resolved until research has enabled a fuller understanding of the complex mechanism by which the Cox system operates.\n\nGiven the provided abstract, please respond to the following query: \"How well does it work?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The studies show that more people with RA who took rofecoxib for 8 weeks had relief from their symptoms than people who took a 'sugar pill' or placebo. In fact, people showed a 20% improvement in the number of tender and swollen joints plus a 20% improvement in at least three out of five other measures such as the level of pain they reported, the level of disease activity they described, their ability to do everyday activities, their physical check-up and their results on blood tests.\nIt was also found that 25 mg of rofecoxib worked just as well as 50 mg over 8 weeks.\nThe studies also show that rofecoxib worked just as well as naproxen over 9 months."
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query-laysum | 954 | [
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"role": "user",
"content": "Abstract: Background\nMindfulness interventions are increasingly popular as an approach to improve mental well-being. To date, no Cochrane Review examines the effectiveness of mindfulness in medical students and junior doctors. Thus, questions remain regarding the efficacy of mindfulness interventionsย as a preventative mechanism in this population, which is at high risk for poor mental health.\nObjectives\nTo assess the effects of psychological interventions with a primary focus on mindfulnessย on the mental well-being and academic performance of medical students and junior doctors.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL),ย MEDLINE, Embase and five other databases (to October 2021) and conducted grey literature searches.\nSelection criteria\nWe included randomised controlled trials of mindfulness that involved medical students of any year level and junior doctors in postgraduateย years one, two or three.ย We included any psychological intervention with a primary focus on teaching the fundamentals of mindfulness as a preventative intervention. Our primary outcomes were anxiety and depression, and our secondary outcomes included stress, burnout, academic performance, suicidal ideationย and quality of life.\nData collection and analysis\nWe used standard methods as recommended by Cochrane, including Cochrane's risk of bias 2 tool (RoB2).\nMain results\nWe included 10 studies involving 731 participants in quantitative analysis.\nCompared with waiting-list control or no intervention, mindfulness interventions did not result in a substantial differenceย immediately post-intervention for anxietyย (standardised mean difference (SMD) 0.09, 95% CI -0.33 toย 0.52; P = 0.67, I2ย = 57%; 4 studies, 255 participants; very low-certainty evidence). Converting the SMD back to the Depression, Anxiety and Stress Scale 21-item self-report questionnaire (DASS-21) showed an estimated effect size which is unlikely to be clinically important. Similarly, there was noย substantial differenceย immediately post-intervention for depression (SMDย 0.06, 95% CI -0.19ย toย 0.31; P = 0.62, I2 = 0%; 4 studies, 250 participants; low-certainty evidence). Converting the SMD back to DASS-21 showed an estimated effect size which is unlikely to be clinically important. No studies reported longer-term assessment ofย the impact of mindfulness interventionsย on these outcomes.\nFor the secondary outcomes,ย the meta-analysis showed a small, substantial differenceย immediately post-intervention for stress, favouring the mindfulness intervention (SMD -0.36, 95% CI -0.60ย toย -0.13; P < 0.05, I2ย = 33%; 8 studies, 474 participants; low-certainty evidence); however, this difference is unlikely to be clinically important.ย The meta-analysis foundย no substantialย differenceย immediately post-intervention for burnout (SMD -0.42, 95% CI -0.84 to 0.00; P = 0.05, Iยฒ = 0%; 3 studies, 91 participants; very low-certainty evidence). The meta-analysis foundย a small, substantial differenceย immediately post-intervention for academic performanceย (SMDย -0.60, 95% CI -1.05ย to -0.14; P < 0.05, Iยฒ = 0%; 2 studies, 79 participants; very low-certainty evidence); however, this difference is unlikely to be clinically important. Lastly, there was noย substantial differenceย immediatelyย post-intervention for quality of life (mean differenceย (MD) 0.02, 95% CI -0.28 toย 0.32; 1 study, 167 participants; low-certainty evidence). There were no data available for three pre-specified outcomes of this review: deliberate self-harm, suicidal ideation and suicidal behaviour.\nWe assessed theย certainty of evidence to range from low to very low across all outcomes. Across most outcomes, we most frequently judged the risk of bias as having 'some concerns'. There were no studies with a low risk of bias across all domains.\nAuthors' conclusions\nThe effectiveness of mindfulness in our target population remains unconfirmed. There have been relatively few studies of mindfulness interventions for junior doctors and medical students. The available studies are small, and we have some concerns about their risk of bias. Thus, there is not much evidence on which to draw conclusions on effects of mindfulness interventionsย in this population. There was no evidence to determine the effects of mindfulness in the long term.\n\nGiven the provided abstract, please respond to the following query: \"Which studies were included in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched databases to find all studies of mindfulness in medical students and junior doctors published up to October 2021. In order to be included in this review, studies had to be randomised controlled trials (a type of study in which participants are assigned to groups using a random method). Studies needed to include medical students from any year level or junior doctors in postgraduate years one, two or three. We did not exclude any studies based on participants'ย age, nationality or pre-existing health conditions. We included 10 studies with a total of 731 participants in the analysis."
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query-laysum | 955 | [
{
"role": "user",
"content": "Abstract: Background\nHepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that, compared with placebo, terlipressin may reduce mortality and improve renal function in people with hepatorenal syndrome, but we need current evidence from systematic reviews on the benefits and harms of terlipressin versus other vasoactive drugs.\nObjectives\nTo evaluate the beneficial and harmful effects of terlipressin versus other vasoactive drugs for people with hepatorenal syndrome.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and Science Citation Index Expanded; conducted manual searches of references in relevant literature; and wrote to experts and pharmaceutical companies (date of last search November 2016).\nSelection criteria\nRandomised clinical trials comparing terlipressin versus any other type of vasoactive drugs for hepatorenal syndrome. We allowed albumin and other cointerventions if provided equally in the comparison groups.\nData collection and analysis\nThree authors independently extracted data. The primary outcomes were mortality, hepatorenal syndrome (persistent hepatorenal syndrome despite treatment), and serious adverse events. We conducted meta-analyses and present the results as risk ratios (RR) with 95% confidence intervals (CI). We performed sensitivity, subgroup, and Trial Sequential Analyses and evaluated bias control based on the Cochrane Hepato-Biliary Group domains.\nMain results\nWe included 10 randomised clinical trials with 474 participants. The trials compared terlipressin versus noradrenaline (seven trials), octreotide (one trial), midodrine and octreotide (one trial), or dopamine (one trial). All participants in both groups received albumin as cointervention. We classified two trials at low risk of bias and eight trials at high risk of bias in the assessment of mortality and all trials at high risk of bias for remaining outcomes. In five trials, investigators specifically stated that they did not receive funding from for-profit organisations. We had no information about the funding source from the remaining five trials.\nTerlipressin was not superior or inferior compared with other vasoactive drugs in regard to mortality when including the two trials with a low risk of bias (RR 0.92, 95% CI 0.63 to 1.36; 94 participants, very low quality evidence) or when including all 10 trials (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; Iยฒ = 0%; very low quality evidence). One meta-analysis including nine trials suggested a beneficial effect of terlipressin on hepatorenal syndrome (RR 0.79, 95% CI 0.63 to 0.99; 394 participants; Iยฒ = 26%; very low quality evidence). Due to the high mortality of hepatorenal syndrome, the registration of other serious adverse events is uncertain, but comparing terlipressin and other vasoactive drugs we found no significant difference (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; Iยฒ = 0%; very low quality evidence). Several trials did not report systematically of adverse events, but terlipressin seemed to increase the risks of diarrhoea or abdominal pain, or both (RR 3.50, 95% CI 1.19 to 10.27; 221 participants; 5 trials, Iยฒ = 0%). However, Trial Sequential Analyses found insufficient evidence to support or refute any differences between interventions for all outcomes. Considering reversal of hepatorenal syndrome, subgroup analyses on the type of other vasoactive drugs found that terlipressin was superior compared with midodrine and octreotide (RR 0.47, 95% CI 0.30 to 0.72) or octreotide alone (RR 0.56, 95% CI 0.33 to 0.96), but each subgroup only included one small trial. None of the remaining subgroup or sensitivity analyses found differences between terlipressin and other vasoactive drugs. We downgraded the evidence to very low quality because of the high risk of bias, imprecision, and the results of the Trial Sequential Analyses.\nAuthors' conclusions\nThis review found insufficient evidence to support or refute beneficial or harmful effects of terlipressin and albumin versus other vasoactive drugs and albumin. Additional research is needed to evaluate if clinically meaningful differences exist between interventions.\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 found that the evidence was of very low quality due to the high risk of bias and the small number of participants."
}
]
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query-laysum | 956 | [
{
"role": "user",
"content": "Abstract: Background\nSepsis is a life-threatening condition that is usually diagnosed when a patient has a suspected or documented infection, and meets two or more criteria for systemic inflammatory response syndrome (SIRS). The incidence of sepsis is higher among people admitted to critical care settings such as the intensive care unit (ICU) than among people in other settings. If left untreated sepsis can quickly worsen; severe sepsis has a mortality rate of 40% or higher, depending on definition. Recognition of sepsis can be challenging as it usually requires patient data to be combined from multiple unconnected sources, and interpreted correctly, which can be complex and time consuming to do. Electronic systems that are designed to connect information sources together, and automatically collate, analyse, and continuously monitor the information, as well as alerting healthcare staff when pre-determined diagnostic thresholds are met, may offer benefits by facilitating earlier recognition of sepsis and faster initiation of treatment, such as antimicrobial therapy, fluid resuscitation, inotropes, and vasopressors if appropriate. However, there is the possibility that electronic, automated systems do not offer benefits, or even cause harm. This might happen if the systems are unable to correctly detect sepsis (meaning that treatment is not started when it should be, or it is started when it shouldn't be), or healthcare staff may not respond to alerts quickly enough, or get 'alarm fatigue' especially if the alarms go off frequently or give too many false alarms.\nObjectives\nTo evaluate whether automated systems for the early detection of sepsis can reduce the time to appropriate treatment (such as initiation of antibiotics, fluids, inotropes, and vasopressors) and improve clinical outcomes in critically ill patients in the ICU.\nSearch methods\nWe searched CENTRAL; MEDLINE; Embase; CINAHL; ISI Web of science; and LILACS, clinicaltrials.gov, and the World Health Organization trials portal. We searched all databases from their date of inception to 18 September 2017, with no restriction on country or language of publication.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared automated sepsis-monitoring systems to standard care (such as paper-based systems) in participants of any age admitted to intensive or critical care units for critical illness. We defined an automated system as any process capable of screening patient records or data (one or more systems) automatically at intervals for markers or characteristics that are indicative of sepsis. We defined critical illness as including, but not limited to postsurgery, trauma, stroke, myocardial infarction, arrhythmia, burns, and hypovolaemic or haemorrhagic shock. We excluded non-randomized studies, quasi-randomized studies, and cross-over studies . We also excluded studies including people already diagnosed with sepsis.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were: time to initiation of antimicrobial therapy; time to initiation of fluid resuscitation; and 30-day mortality. Secondary outcomes included: length of stay in ICU; failed detection of sepsis; and quality of life. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included three RCTs in this review. It was unclear if the RCTs were three separate studies involving 1199 participants in total, or if they were reports from the same study involving fewer participants. We decided to treat the studies separately, as we were unable to make contact with the study authors to clarify.\nAll three RCTs are of very low study quality because of issues with unclear randomization methods, allocation concealment and uncertainty of effect size. Some of the studies were reported as abstracts only and contained limited data, which prevented meaningful analysis and assessment of potential biases.\nThe studies included participants who all received automated electronic monitoring during their hospital stay. Participants were randomized to an intervention group (automated alerts sent from the system) or to usual care (no automated alerts sent from the system).\nEvidence from all three studies reported 'Time to initiation of antimicrobial therapy'. We were unable to pool the data, but the largest study involving 680 participants reported median time to initiation of antimicrobial therapy in the intervention group of 5.6 hours (interquartile range (IQR) 2.3 to 19.7) in the intervention group (n = not stated) and 7.8 hours (IQR 2.5 to 33.1) in the control group (n = not stated).\nNo studies reported 'Time to initiation of fluid resuscitation' or the adverse event 'Mortality at 30 days'. However very low-quality evidence was available where mortality was reported at other time points. One study involving 77 participants reported 14-day mortality of 20% in the intervention group and 21% in the control group (numerator and denominator not stated). One study involving 442 participants reported mortality at 28 days, or discharge was 14% in the intervention group and 10% in the control group (numerator and denominator not reported). Sample sizes were not reported adequately for these outcomes and so we could not estimate confidence intervals.\nVery low-quality evidence from one study involving 442 participants reported 'Length of stay in ICU'. Median length of stay was 3.0 days in the intervention group (IQR = 2.0 to 5.0), and 3.0 days (IQR 2.0 to 4.0 in the control).\nVery low-quality evidence from one study involving at least 442 participants reported the adverse effect 'Failed detection of sepsis'. Data were only reported for failed detection of sepsis in two participants and it wasn't clear which group(s) this outcome occurred in.\nNo studies reported 'Quality of life'.\nAuthors' conclusions\nIt is unclear what effect automated systems for monitoring sepsis have on any of the outcomes included in this review. Very low-quality evidence is only available on automated alerts, which is only one component of automated monitoring systems. It is uncertain whether such systems can replace regular, careful review of the patient's condition by experienced healthcare staff.\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 conducted a search to identify evidence published before September 2017. Studies were eligible for inclusion if they compared automated sepsis monitoring to standard care (such as paper-based systems) in people admitted to intensive or critical care units for critical illness. We did not include non-randomized studies (studies where participants were not allocated to treatment groups by chance), quasi-randomized studies (studies where participants were allocated to treatment groups by a method that is not truly down to chance, such as date of birth or medical number), and cross-over studies (where participants first receive one treatment and then cross over to receive the other treatment). Studies including people already diagnosed with sepsis were also excluded."
}
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query-laysum | 957 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 40% to 95% of people with cirrhosis have oesophageal varices. About 15% to 20% of oesophageal varices bleed in about one to three years. There are several different treatments to prevent bleeding, including: beta-blockers, endoscopic sclerotherapy, and variceal band ligation. However, there is uncertainty surrounding their individual and relative benefits and harms.\nObjectives\nTo compare the benefits and harms of different treatments for prevention of first variceal bleeding from oesophageal varices in adults with liver cirrhosis through a network meta-analysis and to generate rankings of the different treatments for prevention of first variceal bleeding from oesophageal varices according to their safety and efficacy.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and trials registers to December 2019 to identify randomised clinical trials in people with cirrhosis and oesophageal varices with no history of bleeding.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or status) in adults with cirrhosis and oesophageal varices with no history of bleeding. We excluded randomised clinical trials in which participants had previous bleeding from oesophageal varices and those who had previously undergone liver transplantation or previously received prophylactic treatment for oesophageal varices.\nData collection and analysis\nWe performed a network meta-analysis with OpenBUGS using Bayesian methods and calculated the differences in treatments using hazard ratios (HR), odds ratios (OR), and rate ratios with 95% credible intervals (CrI) based on an available-case analysis, according to National Institute for Health and Care Excellence Decision Support Unit guidance. We performed the direct comparisons from randomised clinical trials using the same codes and the same technical details.\nMain results\nWe included 66 randomised clinical trials (6653 participants) in the review. Sixty trials (6212 participants) provided data for one or more comparisons in the review. The trials that provided the information included people with cirrhosis due to varied aetiologies and those at high risk of bleeding from oesophageal varices. The follow-up in the trials that reported outcomes ranged from 6 months to 60 months. All but one of the trials were at high risk of bias. The interventions compared included beta-blockers, no active intervention, variceal band ligation, sclerotherapy, beta-blockers plus variceal band ligation, beta-blockers plus nitrates, nitrates, beta-blockers plus sclerotherapy, and portocaval shunt.\nOverall, 21.2% of participants who received non-selective beta-blockers ('beta-blockers') โ the reference treatment (chosen because this was the most common treatment compared in the trials) โ died during 8-month to 60-month follow-up.\nBased on low-certainty evidence, beta-blockers, variceal band ligation, sclerotherapy, and beta-blockers plus nitrates all had lower mortality versus no active intervention (beta-blockers: HR 0.49, 95% CrI 0.36 to 0.67; direct comparison HR: 0.59, 95% CrI 0.42 to 0.83; 10 trials, 1200 participants; variceal band ligation: HR 0.51, 95% CrI 0.35 to 0.74; direct comparison HR 0.49, 95% CrI 0.12 to 2.14; 3 trials, 355 participants; sclerotherapy: HR 0.66, 95% CrI 0.51 to 0.85; direct comparison HR 0.61, 95% CrI 0.41 to 0.90; 18 trials, 1666 participants; beta-blockers plus nitrates: HR 0.41, 95% CrI 0.20 to 0.85; no direct comparison). No trials reported health-related quality of life. Based on low-certainty evidence, variceal band ligation had a higher number of serious adverse events (number of events) than beta-blockers (rate ratio 10.49, 95% CrI 2.83 to 60.64; 1 trial, 168 participants).\nBased on low-certainty evidence, beta-blockers plus nitrates had a higher number of 'any adverse events (number of participants)' than beta-blockers alone (OR 3.41, 95% CrI 1.11 to 11.28; 1 trial, 57 participants). Based on low-certainty evidence, adverse events (number of events) were higher in sclerotherapy than in beta-blockers (rate ratio 2.49, 95% CrI 1.53 to 4.22; direct comparison rate ratio 2.47, 95% CrI 1.27 to 5.06; 2 trials, 90 participants), and in beta-blockers plus variceal band ligation than in beta-blockers (direct comparison rate ratio 1.72, 95% CrI 1.08 to 2.76; 1 trial, 140 participants).\nBased on low-certainty evidence, any variceal bleed was lower in beta-blockers plus variceal band ligation than in beta-blockers (direct comparison HR 0.21, 95% CrI 0.04 to 0.71; 1 trial, 173 participants). Based on low-certainty evidence, any variceal bleed was higher in nitrates than beta-blockers (direct comparison HR 6.40, 95% CrI 1.58 to 47.42; 1 trial, 52 participants).\nThe evidence indicates considerable uncertainty about the effect of the interventions in the remaining comparisons.\nAuthors' conclusions\nBased on low-certainty evidence, beta-blockers, variceal band ligation, sclerotherapy, and beta-blockers plus nitrates may decrease mortality compared to no intervention in people with high-risk oesophageal varices in people with cirrhosis and no previous history of bleeding. Based on low-certainty evidence, variceal band ligation may result in a higher number of serious adverse events than beta-blockers. The evidence indicates considerable uncertainty about the effect of beta-blockers versus variceal band ligation on variceal bleeding. The evidence also indicates considerable uncertainty about the effect of the interventions in most of the remaining comparisons.\n\nGiven the provided abstract, please respond to the following query: \"What are our conclusions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Beta-blockers, variceal band ligation, sclerotherapy, and beta-blockers plus nitrates may decrease the death rate compared to no treatment in people with high-risk oesophageal varices in people with cirrhosis and no history of bleeding. Variceal band ligation may result in a higher number of serious side effects than beta-blockers. The evidence indicates considerable uncertainty about the effect of beta-blockers versus variceal band ligation on variceal bleeding. The evidence also indicates considerable uncertainty about the effect of the interventions in most of the remaining comparisons. Future well designed trials are needed to find out the best treatment to prevent first bleeding from people with cirrhosis and oesophageal varices."
}
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query-laysum | 958 | [
{
"role": "user",
"content": "Abstract: Background\nNonarteritic anterior ischemic optic neuropathy (NAION) is characterized by sudden and painless loss of vision in the eye, accompanied by pallid swelling of the optic disc. Its etiology is unknown and no medical therapy has been proven effective in treating this condition. Optic nerve decompression surgery, a proposed treatment for NAION, involves making two or more slits or a window in the tissue surrounding the optic nerve, thereby allowing cerebrospinal fluid to escape, and theoretically reducing the pressure surrounding the optic nerve.\nObjectives\nThe objective of this review was to assess the safety and efficacy of surgery compared with other treatment or no treatment in people with NAION.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2014), EMBASE (January 1980 to October 2014), PubMed (1948 to October 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 23 October 2014.\nSelection criteria\nAll randomized trials of surgical treatment of NAION were eligible for inclusion in this review.\nData collection and analysis\nFrom full-text copies of all reports from relevant trials, one author extracted data which were verified by another author. No data synthesis was required.\nMain results\nThe one included trial, in which 258 participants were randomized, was stopped early for futility. At the time of the 24-month report the follow-up rate was 95.3% for six months and 67.4% for 24 months (174 participants; 89 careful follow-up and 85 surgery). There was no evidence of a benefit of surgery on visual acuity. Measurements of visual acuity and visual fields were performed by a technician masked to the treatment received. At six months 32.0% of the surgery group had improved visual acuity by 3 or more lines compared with 42.6% of the careful follow-up group (unadjusted risk ratio (RR) 0.75, 95% confidence interval (CI) 0.54 to 1.04). At 24 months 29.4% of the surgery group had improved compared with 31.0% of the careful follow-up group (unadjusted RR 0.95, 95% CI 0.60 to 1.49). Participants who underwent surgery more often lost 3 or more lines of visual acuity in the study eye, although the increased risk was not statistically significant. At six months 18.9% in the surgery group had worsened visual acuity in the study eye compared with 14.8% in the careful follow-up group (RR 1.28; 95% CI 0.73 to 2.24). At 24 months 20.0% in the surgery group had worsened visual acuity in the study eye compared with 21.8% in the careful follow-up group (RR 0.92; 95% CI 0.51 to 1.64). Participants who received surgery experienced both intraoperative and postoperative adverse events, including central retinal artery occlusion during surgery and light perception vision at six months (one participant); and immediate loss of light perception following surgery and loss of vision that persisted to the 12-month visit (two participants). In the careful follow-up group, two participants had no light perception at the six-month follow-up visit; one of these had improved to light perception at 12 months. Pain was the most common adverse event in the surgery group (17% in surgery group versus 3% in the careful follow-up group at one week). Diplopia (double vision) was the next most common complication (8% in the surgery group versus 1% in the careful follow-up group at one week); at three months there was no statistically significant difference in proportion of participants with diplopia between the two groups.\nAuthors' conclusions\nThe only eligible trial provided no evidence of a beneficial effect of optic nerve decompression surgery for NAION. Future research should focus on increasing our understanding of the etiology and prognosis of NAION. New treatment options should be examined in the context of randomized clinical 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"
},
{
"role": "assistant",
"content": "The search for studies was done on 23 October 2014. One study (a randomized controlled trial) was found. There were 258 participants in the trial. These 258 people were randomly divided into two groups. One group received the optic nerve decompression surgery along with careful follow-up. The other group received careful follow-up alone. Careful follow-up included an ophthalmologic examination at each study visit and visual field testing at 12 months and as needed. The technician performing the follow-up tests did not know to which group the participants belonged (surgery or no surgery). Funding for this trial was provided by National Eye Institute, USA."
}
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query-laysum | 959 | [
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease comprises a group of genetic haemoglobin disorders. The predominant symptom associated with sickle cell disease is pain resulting from the occlusion of small blood vessels by abnormally 'sickle-shaped' red blood cells. There are other complications, including chronic organ damage and prolonged painful erection of the penis, known as priapism. Severity of sickle cell disease is variable, and treatment is usually symptomatic. Priapism affects up to half of all men with sickle cell disease, however, there is no consistency in treatment. We therefore need to know the best way of treating this complication in order to offer an effective interventional approach to all affected individuals. This is an update of a previously published review.\nObjectives\nTo assess the benefits and risks of different treatments for stuttering (repeated short episodes) and fulminant (lasting for six hours or more) priapism in sickle cell disease.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched trial registries.\nDate of the most recent search of the Group's Haemoglobinopathies Trials Register: 09 September 2019.\nDate of most recent search of trial registries and of Embase: 01 October 2019.\nSelection criteria\nAll randomised or quasi-randomised controlled trials comparing non-surgical or surgical treatment with placebo or no treatment, or with another intervention for stuttering or fulminant priapism.\nData collection and analysis\nThe authors independently extracted data and assessed the risk of bias of the trials.\nMain results\nThree trials with 102 participants were identified and met the criteria for inclusion in this review. These trials compared stilboestrol to placebo, sildenafil to placebo and a four-arm trial which compared ephedrine or etilefrine to placebo and ranged in duration from two weeks to six months. All of the trials were conducted in an outpatient setting in Jamaica, Nigeria and the UK. None of the trials measured our first primary outcome, detumescence. However, all three trials reported on the reduction in frequency of stuttering priapism, our second primary outcome; and from the evidence included in this review, we are uncertain whether stilboestrol, etilefrine or ephedrine reduce the frequency of stuttering priapism as the certainty of the evidence has been assessed as very low. Additionally, we conclude that sildenafil may make little or no difference (low-certainty evidence). Two trials reported on immediate side effects and we are uncertain whether etilefrine or ephedrine reduce the occurrence of these (very low-certainty of evidence) and also conclude that sildenafil may make little or no difference in side effects (low-quality evidence). Given that all of the trials were at risk of bias and all had low participant numbers, we considered the certainty of the evidence to be low to very low.\nAuthors' conclusions\nThere is a lack of evidence for the benefits or risks of the different treatments for both stuttering and fulminant priapism in sickle cell disease. This systematic review has clearly identified the need for well-designed, adequately-powered, multicentre randomised controlled trials assessing the effectiveness of specific interventions for priapism in sickle cell disease.\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": "In the trials, four different drug treatments (stilboestrol, sildenafil, ephedrine and etilefrine) were compared to placebo. The trials all looked at whether the treatments reduced how often attacks of priapism occurred. There was no difference between any of the treatments compared to placebo. Due to lack of high-quality evidence, we are not able to conclude the best treatment of priapism in sickle cell disease. More research is needed. This is an update of a previously published review."
}
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query-laysum | 960 | [
{
"role": "user",
"content": "Abstract: Background\nSkin and soft-tissue infections (SSTIs) are common infections of the epidermis, dermis or subcutaneous tissue. SSTIs range in severity from minor, self-limiting, superficial infections to deep, aggressive, gangrenous, life-threatening infections. Some classifications divide SSTIs into 'complicated' and 'uncomplicated' infections based on clinical severity. Treatments of SSTIs involves antibiotic therapy, surgical debridement or drainage, and resuscitation if required. Sometimes these treatments are limited by high treatment costs, bacterial resistance to antibiotics and side effects, therefore, many people with SSTIs are turning to Chinese herbal medicines to treat this problem.\nChinese herbal medicines are natural substances that have been used for centuries in China where they are generally considered to be effective for SSTIs. Some Chinese herbal medicines have been shown to have antibacterial and anti-inflammatory properties, although a few herbal medicines have been reported to have side effects. Therefore there is a need to review the current clinical evidence systematically to inform current practice and guide future studies on Chinese herbal medicines for SSTIs.\nObjectives\nTo evaluate the benefits and harms of Chinese herbal medicines for treating skin and soft-tissue infections (SSTIs).\nSearch methods\nSearches were not restricted by date, language or publication status. In July 2014 we searched the following electronic databases: the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; Ovid AMED (Allied and Complementary Medicine); and EBSCO CINAHL.\nSelection criteria\nAll randomised controlled trials (RCTs) in people with SSTIs that compared Chinese herbal medicines with another intervention or control.\nData collection and analysis\nTwo review authors screened the literature search results independently; there were no disagreements.\nMain results\nWe identified no RCTs that met the inclusion criteria.\nAuthors' conclusions\nThere is currently no information available from RCTs to support or refute the use of Chinese herbal medicines in treating people with SSTIs.\n\nGiven the provided abstract, please respond to the following query: \"What are skin and soft-tissue infections?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Skin and soft-tissue infections (SSTIs) are common infections of the skin or the tissue beneath the skin. They include impetigo, abscesses, cellulitis, erysipelas, necrotising (flesh-killing) skin infections, infections caused by animal or human bites or by animal contact, and infections after surgery.\nMost SSTIs do not require treatment, but heal by themselves. Some SSTIs are more serious and can become life-threatening, and these need medical treatment."
}
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query-laysum | 961 | [
{
"role": "user",
"content": "Abstract: Background\nInositol is an essential nutrient required by human cells in culture for growth and survival. Inositol promotes maturation of several components of surfactant and may play a critical role in fetal and early neonatal life. A drop in inositol levels in infants with respiratory distress syndrome (RDS) can be a sign that their illness will be severe.\nObjectives\nTo assess the effectiveness and safety of supplementary inositol in preterm infants with or without respiratory distress syndrome (RDS) in reducing adverse neonatal outcomes including: death (neonatal and infant deaths), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC) and sepsis.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 11), MEDLINE via PubMed (1966 to 5 November 2018), Embase (1980 to 5 November 2018), and CINAHL (1982 to 5 November 2018). We searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCT) and quasi-randomised trials.\nSelection criteria\nWe included all randomised controlled trials of inositol supplementation of preterm infants compared with a control group that received a placebo or no intervention. Outcomes included neonatal death, infant death, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC) and sepsis.\nData collection and analysis\nThe three review authors independently abstracted data on neonatal outcomes and resolved any disagreements through discussion and consensus. Outcomes were reported as typical risk ratio (RR), risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH). We used the GRADE approach to assess the quality of evidence.\nMain results\nSix published randomised controlled trials were identified, with a total of 1177 infants. Study quality varied for the comparison 'Inositol supplementation to preterm infants (repeat doses in any amount and any duration of treatment) versus control' and interim analyses had occurred in several trials for the outcomes of interest. In this comparison, neonatal death was found to be significantly reduced (typical RR 0.53, 95% CI 0.31 to 0.91; typical RD โ0.09, 95% CI โ0.16 to โ0.01; NNTB 11, 95% CI 6 to 100; 3 trials, 355 neonates). Infant deaths were not reduced (typical RR 0.89, 95% CI 0.71 to 1.13; typical RD โ0.02, 95% CI โ0.07 to 0.02; 5 trials, 1115 infants) (low-quality evidence). ROP stage 2 or higher or stage 3 or higher was not significantly reduced (typical RR 0.89, 95% CI 0.75 to 1.06; typical RD โ0.04, 95% CI โ0.10 to 0.02; 3 trials, 810 infants) (moderate-quality evidence). There were no significant findings for ROP (any stage), NEC (suspected or proven), sepsis, IVH grade greater than II (moderate-quality evidence). For the comparison 'Inositol supplementation IV initially followed by enteral administration (repeat doses of 80 mg/kg/day) in preterm infants born at less than 30 weeks' postmenstrual age (PMA) compared to placebo for preterm infants at risk for or having respiratory distress syndrome' the results from two studies of high quality were included (N = 760 neonates). Recruitment to the larger study (N = 638) was terminated because of a higher rate of deaths in the inositol group. We did not downgrade the quality of the study. The meta-analyses of the outcomes of 'Type 1 ROP or death before determination of ROP outcome using the adjudicated ROP outcome', 'Type 1 ROP including adjudicated ROP outcome', 'All-cause mortality (outcome collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth)' and 'Severe IVH (grade 3 or 4)' did not show significant findings (moderate-quality evidence). There were no significant findings for the outcomes 'BPD or death by it prior to 37 weeks' postmenstrual age (outcomes collected through first event: death, hospital discharge, hospital transfer, or 120 days after birth)', 'Late onset sepsis (> 72 hours of age)', and 'Suspected or proven NEC' (high-quality evidence).\nAuthors' conclusions\nBased on the evidence from randomised controlled trials to date, inositol supplementation does not result in important reductions in the rates of infant deaths, ROP stage 3 or higher, type 1 ROP, IVH grades 3 or 4, BPD, NEC, or sepsis. These conclusions are based mainly on two recent randomised controlled trials in neonates less than 30 weeks' postmenstrual age (N = 760), the most vulnerable population. Currently inositol supplementation should not be routinely instituted as part of the nutritional management of preterm infants with or without RDS. It is important that infants who have been enrolled in the trials included in this review are followed to assess any effects of inositol supplementation on long-term outcomes in childhood. We do not recommend any additional trials in neonates.\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 published randomised controlled trials met our inclusion criteria, with a total of 1177 infants enrolled. This update includes the results from two high-quality studies conducted in 760 infants of less than 30 weeks' postmenstrual age (PMA)."
}
]
|
query-laysum | 962 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes mellitus is a metabolic disorder resulting from a defect in insulin secretion, function, or both. Hyperglycaemia in non-critically ill hospitalised people is associated with poor clinical outcomes (infections, prolonged hospital stay, poor wound healing, higher morbidity and mortality). In the hospital setting people diagnosed with diabetes receive insulin therapy as part of their treatment in order to achieve metabolic control. However, insulin therapy can be provided by different strategies (sliding scale insulin (SSI), basal-bolus insulin, and other modalities). Sliding scale insulin is currently the most commonly used method, however there is uncertainty about which strategy provides the best patient outcomes.\nObjectives\nTo assess the effects of SSI for non-critically ill hospitalised adults with diabetes mellitus.\nSearch methods\nWe identified eligible trials by searching MEDLINE, Embase, LILACS, and the Cochrane Library. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov trial registers. The date of the last search for all databases was December 2017. We also examined reference lists of identified randomised controlled trials (RCTs) and systematic reviews, and contacted trial authors.\nSelection criteria\nWe included RCTs comparing SSI with other strategies for glycaemic control in non-critically ill hospitalised adult participants of any sex with diabetes mellitus.\nData collection and analysis\nTwo review authors independently extracted data, assessed trials for risk of bias, and evaluated the overall certainty of evidence utilising the GRADE instrument. We synthesised data using a random-effects model meta-analysis with 95% prediction intervals, if possible, or descriptive analysis, as appropriate.\nMain results\nOf 720 records screened, we included eight trials that randomised 1048 participants with type 2 diabetes (387 SSI participants and 615 participants in comparator groups were available for final analysis). We included non-critically ill medical and surgical adults with the diagnosis of diabetes mellitus. The mean follow-up time was measured by the mean length of hospital stay and ranged between five and 24 days. The mean age of participants was 44.5 years to 71 years.\nOverall, we judged the risk of bias on the trial level as unclear for selection bias, high for outcome-related performance and detection bias with regard to hypoglycaemic episodes, other adverse events, and mean glucose levels, and low for all-cause mortality and length of hospital stay. Attrition bias was low for all outcome measures.\nSix trials compared SSI with a basal-bolus insulin scheme, three of which investigating 64% of all participants in this category also applying an SSI approach in the bolus comparator part. One trial had a basal insulin-only comparator arm, and the remaining trial used continuous insulin infusion as the comparator. For our main comparison of SSI versus basal-bolus insulin, the results were as follows. Four trials reported mortality data. One out of 268 participants in the SSI group (0.3%) compared with two out of 334 participants in the basal-bolus group (0.6%) died (low-certainty evidence). Severe hypoglycaemic episodes, defined as blood glucose levels below 40 mg/dL (2.2 mmol/L), showed a risk ratio (RR) of 0.22, 95% confidence interval (CI) 0.05 to 1.00; P = 0.05; 5 trials; 667 participants; very low-certainty evidence. The 95% prediction interval ranged between 0.02 and 2.57. All nine severe hypoglycaemic episodes were observed among the 369 participants on basal-bolus insulin (2.4%). The mean length of hospital stay was 0.5 days longer for the SSI group, 95% CI -0.5 to 1.4; P = 0.32; 6 trials; 717 participants; very low-certainty evidence. The 95% prediction interval ranged between -1.7 days and 2.7 days. Adverse events other than hypoglycaemic episodes, such as postoperative infections, showed a RR of 1.16, 95% CI 0.25 to 5.37; P = 0.85; 3 trials; 481 participants; very low-certainty evidence. The mean blood glucose levels ranged across basal-bolus groups from 156 mg/dL (8.7 mmol/L) to 221 mg/dL (12.3 mmol/L). The mean blood glucose level in the SSI groups was 14.8 mg/dL (0.8 mmol/L) higher (95% CI 7.8 (0.4) to 21.8 (1.2); P < 0.001; 6 trials; 717 participants; low-certainty evidence). The 95% prediction interval ranged between -3.6 mg/dL (-0.2 mmol/L) and 33.2 mg/dL (1.8 mmol/L). No trial reported on diabetes-related mortality or socioeconomic effects.\nAuthors' conclusions\nWe are uncertain which insulin strategy (SSI or basal-bolus insulin) is best for non-critically hospitalised adults with diabetes mellitus. A basal-bolus insulin strategy in these patients might result in better short-term glycaemic control but could increase the risk for severe hypoglycaemic episodes. The certainty of the body of evidence comparing SSI with basal-bolus insulin was low to very low and needs to be improved by adequately performed, well-powered RCTs in different hospital environments with well-educated medical staff using identical short-acting insulins in both intervention and comparator arms to compare the rigid SSI approach with flexible insulin application strategies.\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, our confidence in the results for all analysed outcomes was low or very low mainly due to the low number of studies and participants and because the results were not precise, that is they could change in any direction once new studies are published."
}
]
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query-laysum | 963 | [
{
"role": "user",
"content": "Abstract: Background\nEmergency departments (EDs) are facing serious and significant issues in the delivery of effective and efficient care to patients. Acute assessment services have been implemented at many hospitals internationally to assist in maintaining patient flow for identified groups of patients attending the ED. Identifying the risks and benefits, and optimal configurations of these services may be beneficial to those wishing to utilise an acute assessment service to improve patient flow.\nObjectives\nTo assess the effects of acute assessment services on patient flow following attendance at a hospital ED.\nSearch methods\nWe searched MEDLINE, CENTRAL, Embase and two trials registers on 24 September 2022 to identify studies. No restrictions were imposed on publication year, publication type, or publication language.\nSelection criteria\nStudies eligible for inclusion were randomised trials and cluster-randomised trials with at least two intervention and two control sites. Participants were adults (as defined by study authors) receiving care either in the ED or the acute assessment service, where both were based in the hospital setting. The comparison was hospital-based acute assessment services with usual, ED-only care. The outcomes of this review were mortality at time point closest to 30 days, length of stay in the service (in minutes), and waiting time to see a doctor (in minutes).\nData collection and analysis\nWe followed the standard procedures of Cochrane Effective Practice and Organisation of Care for this review (https://epoc.cochrane.org/resources).\nMain results\nWe identified a total of 5754 records in the search. Following assessment of 3609 de-duplicated records, none were found to be eligible for inclusion in this review.\nAuthors' conclusions\nAt present there are no randomised controlled trials exploring the effects of acute assessment services on patient flow in hospital-based emergency departments compared to usual, ED-only care.\n\nGiven the provided abstract, please respond to the following query: \"What is an acute assessment service?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The acute assessment service is an alternative to the emergency department for some patients. They are thought to help in reducing long waiting times by grouping together people who have similar reasons for going to the emergency department and moving them to be seen by a doctor elsewhere. It is important to know if the acute assessment service does reduce waiting times for people who come to the emergency department, if it can help to reduce how long someone is admitted to the hospital, and if it is safe for people who are patients."
}
]
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query-laysum | 964 | [
{
"role": "user",
"content": "Abstract: Background\nClinical egg allergy is a common food allergy. Current management relies upon strict allergen avoidance. Oral immunotherapy might be an optional treatment, through desensitization to egg allergen.\nObjectives\nTo determine the efficacy and safety of oral and sublingual immunotherapy in children and adults with immunoglobulin E (IgE)-mediated egg allergy as compared to a placebo treatment or an avoidance strategy.\nSearch methods\nWe searched 13 databases for journal articles, conference proceedings, theses and trials registers using a combination of subject headings and text words (last search 31 March 2017).\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing oral immunotherapy or sublingual immunotherapy administered by any protocol with placebo or an elimination diet. Participants were children or adults with clinical egg allergy.\nData collection and analysis\nWe retrieved 97 studies from the electronic searches. We selected studies, extracted data and assessed the methodological quality. We attempted to contact the study investigators to obtain the unpublished data, wherever possible. We used the Iยฒ statistic to assess statistical heterogeneity. We estimated a pooled risk ratio (RR) with 95% confidence interval (CI) for each outcome using a Mantel-Haenzel fixed-effect model if statistical heterogeneity was low (Iยฒ value less than 50%). We rated the quality of evidence for all outcomes using GRADE.\nMain results\nWe included 10 RCTs that met our inclusion criteria, that involved a total of 439 children (oral immunotherapy 249; control intervention 190), aged 1 year to 18 years. Each study used a different oral immunotherapy protocol; none used sublingual immunotherapy. Three studies used placebo and seven used an egg avoidance diet as the control. Primary outcomes were: an increased amount of egg that can be ingested and tolerated without adverse events while receiving allergen-specific oral immunotherapy or sublingual immunotherapy, compared to control; and a complete recovery from egg allergy after completion of oral immunotherapy or sublingual immunotherapy, compared to control. Most children (82%) in the oral immunotherapy group could ingest a partial serving of egg (1 g to 7.5 g) compared to 10% of control group children (RR 7.48, 95% CI 4.91 to 11.38; RD 0.73, 95% CI 0.67 to 0.80). Fewer than half (45%) of children receiving oral immunotherapy were able to tolerate a full serving of egg compared to 10% of the control group (RR 4.25, 95% CI 2.77 to 6.53; RD 0.35, 95% CI 0.28 to 0.43). All 10 trials reported numbers of children with serious adverse events (SAEs) and numbers of children with mild-to-severe adverse events. SAEs requiring epinephrine/adrenaline presented in 21/249 (8.4%) of children in the oral immunotherapy group, and none in the control group. Mild-to-severe adverse events were frequent; 75% of children presented mild-to-severe adverse events during oral immunotherapy treatment versus 6.8% of the control group (RR 8.35, 95% CI 5.31 to 13.12). Of note, seven studies used an egg avoidance diet as the control. Adverse events occurred in 4.2% of children, which may relate to accidental ingestion of egg-containing food. Three studies used a placebo control with adverse events present in 2.6% of children. Overall, there was inconsistent methodological rigour in the trials. All studies enrolled small numbers of children and used different methods to provide oral immunotherapy. Eight included studies were judged to be at high risk of bias in at least one domain. Furthermore, the quality of evidence was judged to be low due to small numbers of participants and events, and possible biases.\nAuthors' conclusions\nFrequent and increasing exposure to egg over one to two years in people who are allergic to egg builds tolerance, with almost everyone becoming more tolerant compared with a minority in the control group and almost half of people being totally tolerant of egg by the end of treatment compared with 1 in 10 people who avoid egg. However, nearly all who received treatment experienced adverse events, mainly allergy-related. We found that 1 in 12 children had serious allergic reactions requiring adrenaline, and some people gave up oral immunotherapy. It appears that oral immunotherapy for egg allergy is effective, but confidence in the trade-off between benefits and harms is low; because there was a small number of trials with few participants, and methodological problems with some trials.\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": "Until recently, the only practical option for people with food allergies was strict avoidance of foods to which they are allergic. It is difficult to avoid egg because it is found in many foods. Even with avoidance, the fear of accidentally eating foods with egg because of mislabelling or cross-contamination is an ever-present fear for even the most careful of people with food allergy. Accidentally eating egg-containing foods can cause life-threatening events.\nOral immunotherapy is a new type of treatment for egg allergy, which is also known as oral desensitization or vaccination. Treatment involves consuming a small amount of egg protein daily, which is gradually increased over time until a full serving is reached. This method could alter the allergic response to the egg protein by the bodyโs immune system, increasing the amount of egg that can be eaten without inducing adverse reactions."
}
]
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query-laysum | 965 | [
{
"role": "user",
"content": "Abstract: Background\nPancreatic trauma in children is a serious condition with high morbidity. Blunt traumatic pancreatic lesions in children can be treated non-operatively or operatively. For less severe, grade I and II, blunt pancreatic trauma a non-operative or conservative approach is usually employed. Currently, the optimal treatment, of whether to perform operative or non-operative treatment of severe, grade III to V, blunt pancreatic injury in children is unclear.\nObjectives\nTo assess the benefits and harms of operative versus non-operative treatment of blunt pancreatic trauma in children.\nSearch methods\nWe searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (Issue 5, 2013), MEDLINE (OvidSP), EMBASE (OvidSP), ISI Web of Science (SCI-EXPANDED and CPCI-S) and ZETOC. In addition, we searched bibliographies of relevant articles, conference proceeding abstracts and clinical trials registries. We conducted the search on the 21 June 2013.\nSelection criteria\nWe planned to select all randomised clinical trials investigating non-operative versus operative treatment of blunt pancreatic trauma in children, irrespective of blinding, publication status or language of publication.\nData collection and analysis\nWe used relevant search strategies to obtain the titles and abstracts of studies that were relevant for the review. Two review authors independently assessed trial eligibility.\nMain results\nThe search found 83 relevant references. We excluded all of the references and found no randomised clinical trials investigating treatment of blunt pancreatic trauma in children.\nAuthors' conclusions\nThis review shows that strategies regarding non-operative versus operative treatment of severe blunt pancreatic trauma in children are not based on randomised clinical trials. We recommend that multi-centre trials evaluating non-operative versus operative treatment of paediatric pancreatic trauma are conducted to establish firm evidence in this field of medicine.\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": "Optimal treatment of severe blunt pancreatic trauma in children has long been debated, some doctors advocate operation while others prefer a conservative approach without operation as primary treatment. We conducted this systematic review to assess which strategy should be preferred. Blunt trauma to the pancreas typically occurs after crashes involving a bicycle handlebar, road traffic crashes or other types of injury that cause a blow to the upper abdomen."
}
]
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query-laysum | 966 | [
{
"role": "user",
"content": "Abstract: Background\nInsomnia is a major public health issue affecting between 6% to 10% of the adult population in Western countries. Eszopiclone is a hypnotic drug belonging to a newer group of hypnotic agents, known as new generation hypnotics, which was marketed as being just as effective as benzodiazepines for this condition, while being safer and having a lower risk for abuse and dependence. It is the aim of the review to integrate evidence from randomised controlled trials and to draw conclusions on eszopiclone's efficacy and safety profile, while taking methodological features and bias risks into consideration.\nObjectives\nTo assess the efficacy and safety of eszopiclone for the treatment of insomnia compared to placebo or active control.\nSearch methods\nWe searched the Cochrane Central Register of Controlled trials (CENTRAL), MEDLINE, Embase, PsycINFO, PSYNDEX and registry databases (WHO trials portal, ClinicalTrials.gov) with results incorporated from searches to 10 February 2016. To identify trials not registered in electronic databases, we contacted key informants and searched reference lists of identified studies. We ran an update search (21 February 2018) and have placed studies of interest in awaiting classification/ongoing studies. These will be incorporated into the next version of the review, as appropriate.\nSelection criteria\nParallel group randomised controlled trials (RCTs) comparing eszopiclone with either placebo or active control were included in the review. Participants were adults with insomnia, as diagnosed with a standardised diagnostic system, including primary insomnia and comorbid insomnia.\nData collection and analysis\nTwo authors independently extracted outcome data; one reviewer assessed trial quality and the second author cross-checked it.\nMain results\nA total of 14 RCTs, with 4732 participants, were included in this review covering short-term (โค 4 weeks; 6 studies), medium-term (> 4 weeks โค 6 months; 6 studies) and long-term treatment (> 6 months; 2 studies) with eszopiclone. Most RCTs included in the review included participants aged between 18 and 64 years, three RCTs only included elderly participants (64 to 85 years) and one RCT included participants with a broader age range (35 to 85 years). Seven studies considered primary insomnia; the remaining studies considered secondary insomnia comorbid with depression (2), generalised anxiety (1), back pain (1), Parkinson's disease (1), rheumatoid arthritis (1) and menopausal transition (1).\nMeta-analytic integrations of participant-reported data on sleep efficacy outcomes demonstrated better results for eszopiclone compared to placebo: a 12-minute decrease of sleep onset latency (mean difference (MD) -11.94 min, 95% confidence interval (CI) -16.03 to -7.86; 9 studies, 2890 participants, moderate quality evidence), a 17-minute decrease of wake time after sleep onset (MD -17.02 min, 95% CI -24.89 to -9.15; 8 studies, 2295 participants, moderate quality evidence) and a 28-minute increase of total sleep time (MD 27.70 min, 95% CI 20.30 to 35.09; 10 studies, 2965 participants, moderate quality evidence). There were no significant changes from baseline to the first three nights after drug discontinuation for sleep onset latency (MD 17.00 min, 95% CI -4.29 to 38.29; 1 study, 291 participants, low quality evidence) and wake time after sleep onset (MD -6.71 min, 95% CI -21.25 to 7.83; 1 study, 291 participants, low quality evidence). Adverse events during treatment that were documented more frequently under eszopiclone compared to placebo included unpleasant taste (risk difference (RD) 0.18, 95% CI 0.14 to 0.21; 9 studies, 3787 participants), dry mouth (RD 0.04, 95% CI 0.02 to 0.06; 6 studies, 2802 participants), somnolence (RD 0.04, 95% CI 0.02 to 0.06; 8 studies, 3532 participants) and dizziness (RD 0.03, 95% CI 0.01 to 0.05; 7 studies, 2933 participants). According to the GRADE criteria, evidence was rated as being of moderate quality for sleep efficacy outcomes and adverse events and of low quality for rebound effects and next-day functioning.\nAuthors' conclusions\nEszopiclone appears to be an efficient drug with moderate effects on sleep onset and maintenance. There was no or little evidence of harm if taken as recommended. However, as certain patient subgroups were underrepresented in RCTs included in the review, findings might not have displayed the entire spectrum of possible adverse events. Further, increased caution is required in elderly individuals with cognitive and motor impairments and individuals who are at increased risk of using eszopiclone in a non-recommended way.\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": "On average, people taking eszopiclone fell asleep 12 minutes faster than those taking placebo, were 17 minutes less awake during the night and had, in total, about half an hour more sleep than people in the placebo group. As side effects, eszopiclone can cause unpleasant taste, dizziness, dry mouth, and tiredness during the day. Clinical studies did not find evidence that eszopiclone was causing serious harm or withdrawal symptoms or whether it was addictive if it was stopped and not taken after several weeks or months of treatment. Nevertheless, as clinical studies included in the review did not cover certain groups (e.g. elderly people with cognitive or motor problems or certain conditions of medication intake), it is important for patients to consult their doctor who knows their medical history and condition."
}
]
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query-laysum | 967 | [
{
"role": "user",
"content": "Abstract: Background\nInsomnia is a major public health issue affecting between 6% to 10% of the adult population in Western countries. Eszopiclone is a hypnotic drug belonging to a newer group of hypnotic agents, known as new generation hypnotics, which was marketed as being just as effective as benzodiazepines for this condition, while being safer and having a lower risk for abuse and dependence. It is the aim of the review to integrate evidence from randomised controlled trials and to draw conclusions on eszopiclone's efficacy and safety profile, while taking methodological features and bias risks into consideration.\nObjectives\nTo assess the efficacy and safety of eszopiclone for the treatment of insomnia compared to placebo or active control.\nSearch methods\nWe searched the Cochrane Central Register of Controlled trials (CENTRAL), MEDLINE, Embase, PsycINFO, PSYNDEX and registry databases (WHO trials portal, ClinicalTrials.gov) with results incorporated from searches to 10 February 2016. To identify trials not registered in electronic databases, we contacted key informants and searched reference lists of identified studies. We ran an update search (21 February 2018) and have placed studies of interest in awaiting classification/ongoing studies. These will be incorporated into the next version of the review, as appropriate.\nSelection criteria\nParallel group randomised controlled trials (RCTs) comparing eszopiclone with either placebo or active control were included in the review. Participants were adults with insomnia, as diagnosed with a standardised diagnostic system, including primary insomnia and comorbid insomnia.\nData collection and analysis\nTwo authors independently extracted outcome data; one reviewer assessed trial quality and the second author cross-checked it.\nMain results\nA total of 14 RCTs, with 4732 participants, were included in this review covering short-term (โค 4 weeks; 6 studies), medium-term (> 4 weeks โค 6 months; 6 studies) and long-term treatment (> 6 months; 2 studies) with eszopiclone. Most RCTs included in the review included participants aged between 18 and 64 years, three RCTs only included elderly participants (64 to 85 years) and one RCT included participants with a broader age range (35 to 85 years). Seven studies considered primary insomnia; the remaining studies considered secondary insomnia comorbid with depression (2), generalised anxiety (1), back pain (1), Parkinson's disease (1), rheumatoid arthritis (1) and menopausal transition (1).\nMeta-analytic integrations of participant-reported data on sleep efficacy outcomes demonstrated better results for eszopiclone compared to placebo: a 12-minute decrease of sleep onset latency (mean difference (MD) -11.94 min, 95% confidence interval (CI) -16.03 to -7.86; 9 studies, 2890 participants, moderate quality evidence), a 17-minute decrease of wake time after sleep onset (MD -17.02 min, 95% CI -24.89 to -9.15; 8 studies, 2295 participants, moderate quality evidence) and a 28-minute increase of total sleep time (MD 27.70 min, 95% CI 20.30 to 35.09; 10 studies, 2965 participants, moderate quality evidence). There were no significant changes from baseline to the first three nights after drug discontinuation for sleep onset latency (MD 17.00 min, 95% CI -4.29 to 38.29; 1 study, 291 participants, low quality evidence) and wake time after sleep onset (MD -6.71 min, 95% CI -21.25 to 7.83; 1 study, 291 participants, low quality evidence). Adverse events during treatment that were documented more frequently under eszopiclone compared to placebo included unpleasant taste (risk difference (RD) 0.18, 95% CI 0.14 to 0.21; 9 studies, 3787 participants), dry mouth (RD 0.04, 95% CI 0.02 to 0.06; 6 studies, 2802 participants), somnolence (RD 0.04, 95% CI 0.02 to 0.06; 8 studies, 3532 participants) and dizziness (RD 0.03, 95% CI 0.01 to 0.05; 7 studies, 2933 participants). According to the GRADE criteria, evidence was rated as being of moderate quality for sleep efficacy outcomes and adverse events and of low quality for rebound effects and next-day functioning.\nAuthors' conclusions\nEszopiclone appears to be an efficient drug with moderate effects on sleep onset and maintenance. There was no or little evidence of harm if taken as recommended. However, as certain patient subgroups were underrepresented in RCTs included in the review, findings might not have displayed the entire spectrum of possible adverse events. Further, increased caution is required in elderly individuals with cognitive and motor impairments and individuals who are at increased risk of using eszopiclone in a non-recommended way.\n\nGiven the provided abstract, please respond to the following query: \"What should happen next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Future research needs to compare eszopiclone with other sleep medications to help physicians and patients decide which of the available treatment options to prefer. In addition, sleep medications that are also well tolerated by elderly individuals and individuals with alcohol or drug problems need to be identified."
}
]
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query-laysum | 968 | [
{
"role": "user",
"content": "Abstract: Background\nEarly enteral feeding practices are potentially modifiable risk factors for necrotising enterocolitis (NEC) in very preterm or very low birth weight (VLBW) infants. Observational studies suggest that conservative feeding regimens, including slowly advancing enteral feed volumes, reduce the risk of NEC. However, it is unclear whetherย slow feed advancement may delay establishment of full enteral feeding, andย if itย could be associated with infectious morbidities secondary to prolonged exposure to parenteral nutrition.\nObjectives\nTo determine the effects of slow rates of enteral feed advancement on the risk of NEC, mortality, and other morbidities in very preterm or VLBW infants.\nSearch methods\nWe searched CENTRAL (2020, Issue 10), Ovid MEDLINE (1946 to October 2020), Embase via Ovid (1974 to October 2020), Maternity and Infant Care database (MIDIRS) (1971 to October 2020), CINAHL (1982 to October 2020), and clinical trials databases and reference lists of retrieved articles for eligible trials.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that assessed effects of slow (up to 24 mL/kg/d) versus faster rates of advancement of enteral feed volumes on the risk of NEC in very preterm or VLBW infants.\nData collection and analysis\nTwo review authors separately evaluated trial risk of bias, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of evidence. Outcomes of interest were NEC, all-cause mortality, feed intolerance, and invasive infection.\nMain results\nWe included 14 trials involving a total of 4033 infants (2804 infants participated in one large trial). None of the trials masked parents, caregivers, or investigators. Risk of bias was otherwise low. Most infants were stable very preterm or VLBW infants of birth weight appropriate for gestation. About one-third of all infants were extremely preterm or extremely low birth weight (ELBW), and about one-fifth were small for gestational age, growth-restricted, or compromised as indicated by absent or reversed end-diastolic flow velocity in the foetal umbilical artery. Trials typically defined slow advancement as daily increments of 15 to 24 mL/kg, and faster advancement as daily increments of 30 to 40 mL/kg.\nMeta-analyses showed that slow advancement of enteral feed volumes probably has little or no effect on the risk of NEC (RR 1.06, 95% confidence interval (CI) 0.83 to 1.37; RD 0.00, 95% CI โ0.01 to 0.02; 14 trials, 4026 infants; moderate-certainty evidence) or all-cause mortality prior to hospital discharge (RR 1.13, 95% CI 0.91 to 1.39; RD 0.01, 95% CI โ0.01 to 0.02; 13 trials, 3860 infants; moderate-certainty evidence). Meta-analyses suggested that slow advancement may slightly increase feed intolerance (RR 1.18, 95% CI 0.95 to 1.46; RD 0.05, 95% CI โ0.02 to 0.12; 9 trials, 719 infants; low-certainty evidence) and may slightly increase the risk of invasive infection (RR 1.14, 95% CI 0.99 to 1.31; RD 0.02, 95% CI โ0.00 to 0.05; 11 trials, 3583 infants; low-certainty evidence).\nAuthors' conclusions\nThe available trial data indicate that advancing enteral feed volumes slowly (daily increments up to 24 mL/kg) compared with faster rates probably does not reduce the risk of NEC, death, or feed intolerance in very preterm or VLBW infants. Advancing the volume of enteral feeds at a slow rate may slightly increase the risk of invasive infection.\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 for randomised controlled trials (a type of study where participants are randomly assigned to one of two or more treatment groups) comparing slow versus faster rates of increase in the amount of milk fed to newborn infants who were very preterm or very low birth weight. We included 14 trials involving a total of 4033 infants (2804 infants participated in one large trial). The search is up-to-date as of October 2020."
}
]
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query-laysum | 969 | [
{
"role": "user",
"content": "Abstract: Background\nTransthoracic defibrillation is a potentially life-saving treatment for people with ventricular fibrillation (VF) and haemodynamically unstable ventricular tachycardia (VT). In recent years, biphasic waveforms have become more commonly used for defibrillation than monophasic waveforms. Clinical trials of internal defibrillation and transthoracic defibrillation of short-duration arrhythmias of up to 30 seconds have demonstrated the superiority of biphasic waveforms over monophasic waveforms. However, out-of-hospital cardiac arrest (OHCA) involves a duration of VF/VT of several minutes before defibrillation is attempted.\nObjectives\nTo determine the efficacy and safety of biphasic defibrillation waveforms, compared to monophasic, for resuscitation of people experiencing out-of-hospital cardiac arrest.\nSearch methods\nWe searched the following electronic databases for potentially relevant studies up to 10 September 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Also we checked the bibliographies of relevant studies and review articles, contacted authors of published reviews and reviewed webpages (including those of device manufacturers) relevant to the review topic. We handsearched the abstracts of conference proceedings for the American Heart Association, American College of Cardiology, European Society of Cardiology, European Resuscitation Council, Society of Critical Care Medicine and European Society of Intensive Care Medicine. Regarding language restrictions, we did not apply any.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared biphasic and monophasic waveform defibrillation in adults with OHCA. Two review authors independently screened the literature search results.\nData collection and analysis\nTwo review authors independently extracted data from the included trials and performed 'Risk of bias' assessments. We resolved any disagreements by discussion and consensus. The primary outcome was the risk of failure to achieve return of spontaneous circulation (ROSC). Secondary outcomes included risk of failure to revert VF to an organised rhythm following the first shock or up to three shocks, survival to hospital admission and survival to discharge.\nMain results\nWe included four trials (552 participants) that compared biphasic and monophasic waveform defibrillation in people with OHCA. Based on the assessment of five quality domains, we identified two trials that were at high risk of bias, one trial at unclear risk of bias and one trial at low risk of bias. The risk ratio (RR) for failure to achieve ROSC after biphasic compared to monophasic waveform defibrillation was 0.86 (95% CI 0.62 to 1.20; four trials, 552 participants). The RR for failure to defibrillate on the first shock following biphasic defibrillation compared to monophasic was 0.84 (95% CI 0.70 to 1.01; three trials, 450 participants); and 0.81 (95% CI 0.61 to 1.09; two trials, 317 participants) for one to three stacked shocks. The RR for failure to achieve ROSC after the first shock was 0.92 (95% CI 0.81 to 1.04; two trials, 285 participants). Biphasic waveforms did not reduce the risk of death before hospital admission (RR 1.05, 95% CI 0.90 to 1.23; three trials, 383 participants) or before hospital discharge (RR 1.05, 95% CI 0.78 to 1.42; four trials, 550 participants). There was no statistically significant heterogeneity in any of the pooled analyses. None of the included trials reported adverse events.\nAuthors' conclusions\nIt is uncertain whether biphasic defibrillators have an important effect on defibrillation success in people with OHCA. Further large studies are needed to provide adequate statistical power.\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": "Four trials (552 participants) met the inclusion criteria of our review. Several included trials were potentially at risk of misleading results due to features of their study design. When we combined these trial results, we found that using the newer biphasic waveform defibrillators may be associated with lower failure rates of restarting a person's heart, but these results were imprecise. There was no difference in the number of people who were alive on arrival at the hospital or who were discharged from the hospital alive. No included trials reported on side effects or operator safety."
}
]
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query-laysum | 970 | [
{
"role": "user",
"content": "Abstract: Background\nWorldwide, many countries have adopted colorectal cancer (CRC) screening programmes, often based on faecal occult blood tests (FOBTs). CRC screening aims to detect advanced neoplasia (AN), which is defined as CRC or advanced adenomas. FOBTs fall into two categories based on detection technique and the detected blood component: qualitative guaiac-based FOBTs (gFOBTs) and faecal immunochemical tests (FITs), which can be qualitative and quantitative. Screening with gFOBTs reduces CRC-related mortality.\nObjectives\nTo compare the diagnostic test accuracy of gFOBT and FIT screening for detecting advanced colorectal neoplasia in average-risk individuals.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, BIOSIS Citation Index, Science Citation Index Expanded, and Google Scholar. We searched the reference lists and PubMed-related articles of included studies to identify additional studies.\nSelection criteria\nWe included prospective and retrospective studies that provided the number of true positives, false positives, false negatives, and true negatives for gFOBTs, FITs, or both, with colonoscopy as reference standard. We excluded case-control studies. We included studies in which all participants underwent both index test and reference standard (\"reference standard: all\"), and studies in which only participants with a positive index test underwent the reference standard while participants with a negative test were followed for at least one year for development of interval carcinomas (\"reference standard: positive\"). The target population consisted of asymptomatic, average-risk individuals undergoing CRC screening. The target conditions were CRC and advanced neoplasia (advanced adenomas and CRC combined).\nData collection and analysis\nTwo review authors independently screened and selected studies for inclusion. In case of disagreement, a third review author made the final decision. We used the Rutter and Gatsonis hierarchical summary receiver operating characteristic model to explore differences between tests and identify potential sources of heterogeneity, and the bivariate hierarchical model to estimate sensitivity and specificity at common thresholds: 10 ยตg haemoglobin (Hb)/g faeces and 20 ยตg Hb/g faeces. We performed indirect comparisons of the accuracy of the two tests and direct comparisons when both index tests were evaluated in the same population.\nMain results\nWe ran the initial search on 25 June 2019, which yielded 63 studies for inclusion. We ran a top-up search on 14 September 2021, which yielded one potentially eligible study, currently awaiting classification.\nWe included a total of 33 \"reference standard: all\" published articles involving 104,640 participants. Six studies evaluated only gFOBTs, 23 studies evaluated only FITs, and four studies included both gFOBTs and FITs. The cut-off for positivity of FITs varied between 2.4 ฮผg and 50 ยตg Hb/g faeces. For each Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability than gFOBTs for AN (P < 0.001) and CRC (P = 0.004). For the detection of AN, the summary sensitivity of gFOBTs was 15% (95% confidence interval (CI) 12% to 20%), which was significantly lower than FITs at both 10 ฮผg and 20 ฮผg Hb/g cut-offs with summary sensitivities of 33% (95% CI 27% to 40%; P < 0.001) and 26% (95% CI 21% to 31%, P = 0.002), respectively. Results were simulated in a hypothetical cohort of 10,000 screening participants with 1% CRC prevalence and 10% AN prevalence. Out of 1000 participants with AN, gFOBTs missed 850, while FITs missed 670 (10 ฮผg Hb/g cut-off) and 740 (20 ฮผg Hb/g cut-off). No significant differences in summary specificity for AN detection were found between gFOBTs (94%; 95% CI 92% to 96%), and FITs at 10 ฮผg Hb/g cut-off (93%; 95% CI 90% to 95%) and at 20 ฮผg Hb/g cut-off (97%; 95% CI 95% to 98%). So, among 9000 participants without AN, 540 were offered (unnecessary) colonoscopy with gFOBTs compared to 630 (10 ฮผg Hb/g) and 270 (20 ฮผg Hb/g) with FITs. Similarly, for the detection of CRC, the summary sensitivity of gFOBTs, 39% (95% CI 25% to 55%), was significantly lower than FITs at 10 ฮผg and 20 ฮผg Hb/g cut-offs: 76% (95% CI 57% to 88%: P = 0.001) and 65% (95% CI 46% to 80%; P = 0.035), respectively. So, out of 100 participants with CRC, gFOBTs missed 61, and FITs missed 24 (10 ฮผg Hb/g) and 35 (20 ฮผg Hb/g). No significant differences in summary specificity for CRC were found between gFOBTs (94%; 95% CI 91% to 96%), and FITs at the 10 ฮผg Hb/g cut-off (94%; 95% CI 87% to 97%) and 20 ฮผg Hb/g cut-off (96%; 95% CI 91% to 98%). So, out of 9900 participants without CRC, 594 were offered (unnecessary) colonoscopy with gFOBTs versus 594 (10 ฮผg Hb/g) and 396 (20 ฮผg Hb/g) with FITs.\nIn five studies that compared FITs and gFOBTs in the same population, FITs showed a higher discriminative ability for AN than gFOBTs (P = 0.003).\nWe included a total of 30 \"reference standard: positive\" studies involving 3,664,934 participants. Of these, eight were gFOBT-only studies, 18 were FIT-only studies, and four studies combined both gFOBTs and FITs. The cut-off for positivity of FITs varied between 5 ยตg to 250 ยตg Hb/g faeces. For each QUADAS-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability for detecting CRC than gFOBTs (P < 0.001). The summary sensitivity for CRC of gFOBTs, 59% (95% CI 55% to 64%), was significantly lower than FITs at the 10 ฮผg Hb/g cut-off, 89% (95% CI 80% to 95%; P < 0.001) and the 20 ฮผg Hb/g cut-off, 89% (95% CI 85% to 92%; P < 0.001). So, in the hypothetical cohort with 100 participants with CRC, gFOBTs missed 41, while FITs missed 11 (10 ฮผg Hb/g) and 11 (20 ฮผg Hb/g). The summary specificity of gFOBTs was 98% (95% CI 98% to 99%), which was higher than FITs at both 10 ฮผg and 20 ฮผg Hb/g cut-offs: 94% (95% CI 92% to 95%; P < 0.001) and 95% (95% CI 94% to 96%; P < 0.001), respectively. So, out of 9900 participants without CRC, 198 were offered (unnecessary) colonoscopy with gFOBTs compared to 594 (10 ฮผg Hb/g) and 495 (20 ฮผg Hb/g) with FITs. At a specificity of 90% and 95%, FITs had a higher sensitivity than gFOBTs.\nAuthors' conclusions\nFITs are superior to gFOBTs in detecting AN and CRC in average-risk individuals. Specificity of both tests was similar in \"reference standard: all\" studies, whereas specificity was significantly higher for gFOBTs than FITs in \"reference standard: positive\" studies. However, at pre-specified specificities, the sensitivity of FITs was significantly higher than gFOBTs.\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 analysed 63 studies including almost 4 million individuals. The results of this review indicate that if, in theory, 10,000 people take part in screening with a faecal blood test and 100 people in this group have CRC:\n- out of the 100 people with CRC, 24 will be missed in those being screened with FITs.\n- out of the 100 people with CRC, 61 will be missed in those being screened with gFOBTs.\nWe also looked at participants with large polyps, CRC, or both. If, in theory, 10,000 people take part in screening with a faecal blood test and 1000 people in this group have large polyps, CRC, or both:\n- out of the 1000 people with large polyps, CRC, or both, 850 will be missed in those being screened with gFOBTs.\n- out of the 1000 people with large polyps, CRC, or both, 670 will be missed in those being screened with FITs.\nIn this theoretical group of 10,000 screenees:\n- 594 people being screened with FITs will be offered an 'unnecessary' colonoscopy โ unnecessary because they do not have CRC; and\n- 594 people being screened with gFOBTs will be offered an 'unnecessary' colonoscopy.\nFrom the results described above, we can see that FITs miss less CRC than gFOBTs, while an equal number of screenees from each type of blood test undergo an unnecessary colonoscopy."
}
]
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query-laysum | 971 | [
{
"role": "user",
"content": "Abstract: Background\nDyspepsia is a common condition associated with gastrointestinal (GI) disease. Prokinetics are the treatment of choice for functional dyspepsia (FD). However, the role of prokinetics in FD treatment is still controversial.\nObjectives\nWe conducted a systematic review and meta-analysis of randomised control trials (RCTs) examining the efficacy of prokinetics in the treatment of FD. The primary outcome was overall absence of or improvement of symptoms and symptom scores at the end of treatment. We also evaluated quality of life (QoL) and adverse events as secondary outcomes.\nSearch methods\nWe performed a systematic search of MEDLINE, Embase, the Cochrane Library, and CINAHL, from 1946 until September 2017. RevMan 5.3 was used to calculate pooled risk ratios (RR) of symptoms persisting or without improved QoL or adverse events, mean difference (MD) or standardised mean difference (SMD) of post-treatment symptoms scores, changes of symptom scores, and QoL, when appropriate with 95% confidence intervals (CI), using a random-effects model. Quality of evidence was evaluated using GRADE methodology.\nSelection criteria\nWe included studies that were parallel group RCTs comparing one prokinetic with either placebo or another prokinetic of the same or different class for the treatment of FD. Studies involved adults who presented with dyspepsia symptoms and who had negative or insignificant findings on endoscopy as well as no other organic and metabolic disorders. Studies only including participants with primarily reflux or heartburn symptoms were excluded.\nData collection and analysis\nTwo review authors independently assessed study eligibility, study quality and performed data extraction.\nMain results\nFrom an initial 1388 citations, we identified 43 studies in 40 papers. Of those, 29 studies with 10,044 participants compared six prokinetics with placebo for the outcome of absence of symptoms or symptom improvement. There was a statistically significant effect of prokinetic treatment in reducing global symptoms of FD (RR of remaining dyspeptic = 0.81, 95% CI 0.74 to 0.89; number needed to treat for an additional beneficial outcome (NNTB) =7, very low-quality evidence) with considerable heterogeneity; I2 = 91% (P < 0.00001). After removing cisapride from the analysis, the effect of prokinetics in global symptom improvement still persisted, compared to placebo (RR 0.87, 95% CI 0.80 to 0.94), but was still based on very low-quality evidence. The result showed persistence of significant improvement in subgroups of studies at unclear or at low risk of bias (RR 0.86, 95% CI 0.80-0.92), and in subgroups by molecules of cisapride (RR 0.71, 95% CI 0.54 to 0.93; NNTB = 4), acotiamide (RR 0.94, 95% CI 0.91 to 0.98; NNTB = 20) and tegaserod(RR 0.89, 95% CI 0.82 to 0.96; NNTB = 14).\nTen studies compared different types of prokinetics with each other and the most commonly used comparator was domperidone, 10 mg three times a day (eight of the 10 studies). There was a significantly better post-treatment symptom score in other prokinetics, compared to domperidone (SMD -0.19, 95% CI -0.35 to -0.03, very low-quality evidence), but no difference in reducing global symptom (RR 0.94, 95% CI 0.83 to 1.07), and mean difference symptom scores (SMD -0.13, 95% CI -0.31 to 0.05). We found five studies that assessed quality of life, but there was no benefit in improving quality of life with prokinetic treatment (SMD 0.11, 95% CI -0.10 to 0.33; participants = 1774). The adverse events in individual prokinetics was not different from placebo (RR 1.09, 95% CI 0.95 to 1.25; participants = 3811; studies = 17). However, when we looked at the adverse effects by each prokinetic, there were overall greater adverse effects in the active treatment group with cisapride (RR 1.31, 95% CI 1.03 to 1.65; P = 0.03). The most common side effects were diarrhoea, abdominal discomfort and nausea. The funnel plot was asymmetric (Egger's test, P = 0.02) implying reporting bias or other small-study effects may be, in part, driving the benefit of prokinetics compared to placebo in this meta-analysis. The GRADE assessment of the quality of the evidence in each outcome are mostly low or very low due to concerns around risk of bias in study design, unexplained heterogeneity and possible publication bias.\nAuthors' conclusions\nDue to low, or very low, quality of evidence, we are unable to say whether prokinetics are effective for the treatment of functional dyspepsia . We are uncertain which of the individual prokinetic drugs is the most effective as well as whether prokinetics can improve quality of life. Apart from cisapride, prokinetics are well-tolerated. Good quality RCTs are needed to verify the efficacy of prokinetics.\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": "Functional dyspepsia occurs in people with upper abdominal discomfort that does not have an obvious, specific cause. Prokinetics may help people with functional dyspepsia, by promoting stomach movement."
}
]
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query-laysum | 972 | [
{
"role": "user",
"content": "Abstract: Background\nNeuroblastoma is a rare malignant disease and mainly affects infants and very young children. The tumours mainly develop in the adrenal medullary tissue, with an abdominal mass as the most common presentation. About 50% of patients have metastatic disease at diagnosis. The high-risk group is characterised by metastasis and other features that increase the risk of an adverse outcome. High-risk patients have a five-year event-free survival of less than 50%. Retinoic acid has been shown to inhibit growth of human neuroblastoma cells and has been considered as a potential candidate for improving the outcome of patients with high-risk neuroblastoma. This review is an update of a previously published Cochrane Review.\nObjectives\nTo evaluate the efficacy and safety of additional retinoic acid as part of a postconsolidation therapy after high-dose chemotherapy (HDCT) followed by autologous haematopoietic stem cell transplantation (HSCT), compared to placebo retinoic acid or to no additional retinoic acid in people with high-risk neuroblastoma (as defined by the International Neuroblastoma Risk Group (INRG) classification system).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (2016, Issue 11), MEDLINE in PubMed (1946 to 24 November 2016), and Embase in Ovid (1947 to 24 November 2016). Further searches included trial registries (on 22 December 2016), conference proceedings (on 23 March 2017) and reference lists of recent reviews and relevant studies. We did not apply limits by publication year or languages.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating additional retinoic acid after HDCT followed by HSCT for people with high-risk neuroblastoma compared to placebo retinoic acid or to no additional retinoic acid. Primary outcomes were overall survival and treatment-related mortality. Secondary outcomes were progression-free survival, event-free survival, early toxicity, late toxicity, and health-related quality of life.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThe update search did not identify any additional studies. We identified one RCT that included people with high-risk neuroblastoma who received HDCT followed by autologous HSCT (N = 98) after a first random allocation and who received retinoic acid (13-cis-retinoic acid; N = 50) or no further therapy (N = 48) after a second random allocation. These 98 participants had no progressive disease after HDCT followed by autologous HSCT. There was no clear evidence of difference between the treatment groups either in overall survival (hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.46 to 1.63; one trial; P = 0.66) or in event-free survival (HR 0.86, 95% CI 0.50 to 1.49; one trial; P = 0.59). We calculated the HR values using the complete follow-up period of the trial. The study also reported overall survival estimates at a fixed point in time. At the time point of five years, the survival estimate was reported to be 59% for the retinoic acid group and 41% for the no-further-therapy group (P value not reported). We did not identify results for treatment-related mortality, progression-free survival, early or late toxicity, or health-related quality of life. We could not rule out the possible presence of selection bias, performance bias, attrition bias, and other bias. We judged the evidence to be of low quality for overall survival and event-free survival, downgraded because of study limitations and imprecision.\nAuthors' conclusions\nWe identified one RCT that evaluated additional retinoic acid as part of a postconsolidation therapy after HDCT followed by autologous HSCT versus no further therapy in people with high-risk neuroblastoma. There was no clear evidence of a difference in overall survival and event-free survival between the treatment alternatives. This could be the result of low power. Information on other outcomes was not available. This trial was performed in the 1990s, since when many changes in treatment and risk classification have occurred. Based on the currently available evidence, we are therefore uncertain about the effects of retinoic acid in people with high-risk neuroblastoma. More research is needed for a definitive conclusion.\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 update search did not identify any new studies. Overall survival and event-free survival were no different between the two treatment alternatives. Other outcomes, including those concerning adverse events, were not adequately reported. Additional retinoic acid as part of a postconsolidation therapy after high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation may not improve survival in people with high-risk neuroblastoma, and we lack information on its safety. More research is needed before we can draw solid conclusions."
}
]
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query-laysum | 973 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the third update of the original Cochrane Review published in July 2005 and updated previously in 2012 and 2016.\nCancer is a significant global health issue. Radiotherapy is a treatment modality for many malignancies, and about 50% of people having radiotherapy will be long-term survivors. Some will experience late radiation tissue injury (LRTI), developing months or years following radiotherapy. Hyperbaric oxygen therapy (HBOT) has been suggested as a treatment for LRTI based on the ability to improve the blood supply to these tissues. It is postulated that HBOT may result in both healing of tissues and the prevention of complications following surgery and radiotherapy.\nObjectives\nTo evaluate the benefits and harms of hyperbaric oxygen therapy (HBOT) for treating or preventing late radiation tissue injury (LRTI) compared to regimens that excluded HBOT.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 24 January 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effect of HBOT versus no HBOT on LRTI prevention or healing.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. survival from time of randomisation to death from any cause; 2. complete or substantial resolution of clinical problem; 3. site-specific outcomes; and 4. adverse events. Our secondary outcomes were 5. resolution of pain; 6. improvement in quality of life, function, or both; and 7. site-specific outcomes. We used GRADE to assess certainty of evidence.\nMain results\nEighteen studies contributed to this review (1071 participants) with publications ranging from 1985 to 2022. We added four new studies to this updated review and evidence for the treatment of radiation proctitis, radiation cystitis, and the prevention and treatment of osteoradionecrosis (ORN).\nHBOT may not prevent death at one year (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.47 to 1.83; I2 = 0%; 3 RCTs, 166 participants; low-certainty evidence). There is some evidence that HBOT may result in complete resolution or provide significant improvement of LRTI (RR 1.39, 95% CI 1.02 to 1.89; I2 = 64%; 5 RCTs, 468 participants; low-certainty evidence) and HBOT may result in a large reduction in wound dehiscence following head and neck soft tissue surgery (RR 0.24, 95% CI 0.06 to 0.94; I2 = 70%; 2 RCTs, 264 participants; low-certainty evidence). In addition, pain scores in ORN improve slightly after HBOT at 12 months (mean difference (MD) โ10.72, 95% CI โ18.97 to โ2.47; I2 = 40%; 2 RCTs, 157 participants; moderate-certainty evidence).\nRegarding adverse events, HBOT results in a higher risk of a reduction in visual acuity (RR 4.03, 95% CI 1.65 to 9.84; 5 RCTs, 438 participants; high-certainty evidence). There was a risk of ear barotrauma in people receiving HBOT when no sham pressurisation was used for the control group (RR 9.08, 95% CI 2.21 to 37.26; I2 = 0%; 4 RCTs, 357 participants; high-certainty evidence), but no such increase when a sham pressurisation was employed (RR 1.07, 95% CI 0.52 to 2.21; I2 = 74%; 2 RCTs, 158 participants; high-certainty evidence).\nAuthors' conclusions\nThese small studies suggest that for people with LRTI affecting tissues of the head, neck, bladder and rectum, HBOT may be associated with improved outcomes (low- to moderate-certainty evidence). HBOT may also result in a reduced risk of wound dehiscence and a modest reduction in pain following head and neck irradiation. However, HBOT is unlikely to influence the risk of death in the short term. HBOT also carries a risk of adverse events, including an increased risk of a reduction in visual acuity (usually temporary) and of ear barotrauma on compression. Hence, the application of HBOT to selected participants may be justified.\nThe small number of studies and participants, and the methodological and reporting inadequacies of some of the primary studies included in this review demand a cautious interpretation. More information is required on the subset of disease severity and tissue type affected that is most likely to benefit from this therapy, the time for which we can expect any benefits to persist and the most appropriate oxygen dose. Further research is required to establish the optimum participant selection and timing of any therapy. An economic evaluation should also be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"What are the problems after radiation treatment and how can it be treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is a risk of serious complications developing in the months and years after radiation treatment (radiotherapy) for cancer. These problems are collectively called LRTI and are due to progressive damage to normal tissue (cells within the body) that has been exposed to radiation. These problems can be very difficult to resolve, and there is some doubt as to the best approaches to treatment. HBOT involves breathing oxygen in a specially designed pressurised chamber. It is used to improve oxygen supply to damaged tissue and support healing."
}
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query-laysum | 974 | [
{
"role": "user",
"content": "Abstract: Background\nChildren with developmental speech sound disorders have difficulties in producing the speech sounds of their native language. These speech difficulties could be due to structural, sensory or neurophysiological causes (e.g. hearing impairment), but more often the cause of the problem is unknown. One treatment approach used by speech-language therapists/pathologists is non-speech oral motor treatment (NSOMT). NSOMTs are non-speech activities that aim to stimulate or improve speech production and treat specific speech errors. For example, using exercises such as smiling, pursing, blowing into horns, blowing bubbles, and lip massage to target lip mobility for the production of speech sounds involving the lips, such as /p/, /b/, and /m/. The efficacy of this treatment approach is controversial, and evidence regarding the efficacy of NSOMTs needs to be examined.\nObjectives\nTo assess the efficacy of non-speech oral motor treatment (NSOMT) in treating children with developmental speech sound disorders who have speech errors.\nSearch methods\nIn April 2014 we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (R) and Ovid MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Education Resources Information Center (ERIC), PsycINFO and 11 other databases. We also searched five trial and research registers, checked the reference lists of relevant titles identified by the search and contacted researchers to identify other possible published and unpublished studies.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared (1) NSOMT versus placebo or control; and (2) NSOMT as adjunctive treatment or speech intervention versus speech intervention alone, for children aged three to 16 years with developmental speech sound disorders, as judged by a speech and language therapist. Individuals with an intellectual disability (e.g. Down syndrome) or a physical disability were not excluded.\nData collection and analysis\nThe Trials Search Co-ordinator of the Cochrane Developmental, Psychosocial and Learning Problems Group and one review author ran the searches. Two review authors independently screened titles and abstracts to eliminate irrelevant studies, extracted data from the included studies and assessed risk of bias in each of these studies. In cases of ambiguity or information missing from the paper, we contacted trial authors.\nMain results\nThis review identified three studies (from four reports) involving a total of 22 children that investigated the efficacy of NSOMT as adjunctive treatment to conventional speech intervention versus conventional speech intervention for children with speech sound disorders. One study, a randomised controlled trial (RCT), included four boys aged seven years one month to nine years six months - all had speech sound disorders, and two had additional conditions (one was diagnosed as \"communication impaired\" and the other as \"multiply disabled\"). Of the two quasi-randomised controlled trials, one included 10 children (six boys and four girls), aged five years eight months to six years nine months, with speech sound disorders as a result of tongue thrust, and the other study included eight children (four boys and four girls), aged three to six years, with moderate to severe articulation disorder only. Two studies did not find NSOMT as adjunctive treatment to be more effective than conventional speech intervention alone, as both intervention and control groups made similar improvements in articulation after receiving treatments. One study reported a change in postintervention articulation test results but used an inappropriate statistical test and did not report the results clearly. None of the included studies examined the effects of NSOMTs on any other primary outcomes, such as speech intelligibility, speech physiology and adverse effects, or on any of the secondary outcomes such as listener acceptability.\nThe RCT was judged at low risk for selection bias. The two quasi-randomised trials used randomisation but did not report the method for generating the random sequence and were judged as having unclear risk of selection bias. The three included studies were deemed to have high risk of performance bias as, given the nature of the intervention, blinding of participants was not possible. Only one study implemented blinding of outcome assessment and was at low risk for detection bias. One study showed high risk of other bias as the baseline characteristics of participants seemed to be unequal. The sample size of each of the included studies was very small, which means it is highly likely that participants in these studies were not representative of its target population. In the light of these serious limitations in methodology, the overall quality of the evidence provided by the included trials is judged to be low. Therefore, further research is very likely to have an important impact on our confidence in the estimate of treatment effect and is likely to change the estimate.\nAuthors' conclusions\nThe three included studies were small in scale and had a number of serious methodological limitations. In addition, they covered limited types of NSOMTs for treating children with speech sound disorders of unknown origin with the sounds /s/ and /z/. Hence, we judged the overall applicability of the evidence as limited and incomplete. Results of this review are consistent with those of previous reviews: Currently no strong evidence suggests that NSOMTs are an effective treatment or an effective adjunctive treatment for children with developmental speech sound disorders. Lack of strong evidence regarding the treatment efficacy of NSOMTs has implications for clinicians when they make decisions in relation to treatment plans. Well-designed research is needed to carefully investigate NSOMT as a type of treatment for children with speech sound disorders.\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 three included studies were small in scale and had a number of serious methodological limitations. Moreover, these studies covered limited types of NSOMTs for treating just one class of speech sounds - 's' with or without 'z' - in children with speech sound disorders. Hence, the overall applicability of the evidence is limited, and the evidence is believed to be incomplete and of low quality. To conclude, currently no strong evidence indicates whether NSOMTs are effective as treatment or adjunctive treatment for children with developmental speech sound disorders."
}
]
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query-laysum | 975 | [
{
"role": "user",
"content": "Abstract: Background\nIn developing countries, diarrhoea causes around 500,000 child deaths annually. Zinc supplementation during acute diarrhoea is currently recommended by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF).\nObjectives\nTo evaluate oral zinc supplementation for treating children with acute or persistent diarrhoea.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (the Cochrane Library 2016, Issue 5), MEDLINE, Embase, LILACS, CINAHL, mRCT, and reference lists up to 30 September 2016. We also contacted researchers.\nSelection criteria\nRandomized controlled trials (RCTs) that compared oral zinc supplementation with placebo in children aged one month to five years with acute or persistent diarrhoea, including dysentery.\nData collection and analysis\nBoth review authors assessed trial eligibility and risk of bias, extracted and analysed data, and drafted the review. The primary outcomes were diarrhoea duration and severity. We summarized dichotomous outcomes using risk ratios (RR) and continuous outcomes using mean differences (MD) with 95% confidence intervals (CI). Where appropriate, we combined data in meta-analyses (using either a fixed-effect or random-effects model) and assessed heterogeneity.\nWe assessed the certainty of the evidence using the GRADE approach.\nMain results\nThirty-three trials that included 10,841 children met our inclusion criteria. Most included trials were conducted in Asian countries that were at high risk of zinc deficiency.\nAcute diarrhoea\nThere is currently not enough evidence from well-conducted RCTs to be able to say whether zinc supplementation during acute diarrhoea reduces death or number of children hospitalized (very low certainty evidence).\nIn children older than six months of age, zinc supplementation may shorten the average duration of diarrhoea by around half a day (MD โ11.46 hours, 95% CI โ19.72 to โ3.19; 2581 children, 9 trials, low certainty evidence), and probably reduces the number of children whose diarrhoea persists until day seven (RR 0.73, 95% CI 0.61 to 0.88; 3865 children, 6 trials, moderate certainty evidence). In children with signs of malnutrition the effect appears greater, reducing the duration of diarrhoea by around a day (MD โ26.39 hours, 95% CI โ36.54 to โ16.23; 419 children, 5 trials, high certainty evidence).\nConversely, in children younger than six months of age, the available evidence suggests zinc supplementation may have no effect on the mean duration of diarrhoea (MD 5.23 hours, 95% CI โ4.00 to 14.45; 1334 children, 2 trials, low certainty evidence), or the number of children who still have diarrhoea on day seven (RR 1.24, 95% CI 0.99 to 1.54; 1074 children, 1 trial, low certainty evidence).\nNone of the included trials reported serious adverse events. However, zinc supplementation increased the risk of vomiting in both age groups (children greater than six months of age: RR 1.57, 95% CI 1.32 to 1.86; 2605 children, 6 trials, moderate certainty evidence; children less than six months of age: RR 1.54, 95% CI 1.05 to 2.24; 1334 children, 2 trials, moderate certainty evidence).\nPersistent diarrhoea\nIn children with persistent diarrhoea, zinc supplementation probably shortens the average duration of diarrhoea by around 16 hours (MD โ15.84 hours, 95% CI โ25.43 to โ6.24; 529 children, 5 trials, moderate certainty evidence).\nAuthors' conclusions\nIn areas where the prevalence of zinc deficiency or the prevalence of malnutrition is high, zinc may be of benefit in children aged six months or more. The current evidence does not support the use of zinc supplementation in children less six months of age, in well-nourished children, and in settings where children are at low risk of zinc deficiency.\n\nGiven the provided abstract, please respond to the following query: \"What is oral zinc and how may it shorten the duration and severity of diarrhoea\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Zinc is usually given as zinc sulphate, zinc acetate, or zinc gluconate, which are all water-soluble compounds. The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend 10 mg to 20 mg of zinc per day for children with diarrhoea. There are several mechanism of action of zinc on acute diarrhoea, some of which are specific to the gastrointestinal system: zinc restores mucosal barrier integrity and enterocyte brush-border enzyme activity, it promotes the production of antibodies and circulating lymphocytes against intestinal pathogens, and has a direct effect on ion channels, acting as a potassium channel blocker of adenosine 3-5-cyclic monophosphate-mediated chlorine secretion. Cochrane researchers examined the evidence available up to 30 September 2016."
}
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query-laysum | 976 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis is the primary cause of hospital admission in people living with HIV, and the likelihood of death in the hospital is unacceptably high. The Alere Determine TB LAM Ag test (AlereLAM) is a point-of-care test and the only lateral flow lipoarabinomannan assay (LF-LAM) assay currently commercially available and recommended by the World Health Organization (WHO).ย A 2019 Cochrane Review summarised the diagnostic accuracy of LF-LAMย for tuberculosis in people living with HIV. This systematic review assesses the impact of the use of LF-LAM (AlereLAM) on mortality and other patient-important outcomes.\nObjectives\nTo assess the impact of the use of LF-LAM (AlereLAM) on mortality in adults living with HIVย in inpatient and outpatient settings.\nTo assess the impact of the use of LF-LAM (AlereLAM) on other patient-important outcomes in adults living with HIV, including time to diagnosis of tuberculosis, and time to initiation of tuberculosis treatment.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); Science Citation Index Expanded (Web of Science), BIOSIS Previews, Scopus, LILACS; ProQuest Dissertations and Theses; ClinicalTrials.gov; and the WHO ICTRP up to 12 March 2021.\nSelection criteria\nRandomized controlled trials that compared a diagnostic intervention including LF-LAM with diagnostic strategies that used smear microscopy, mycobacterial culture, a nucleic acid amplification test such asย Xpert MTB/RIF, or a combination of these tests. We includedย adults (โฅ 15 years) living with HIV.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility, extracted data, and analysed risk of bias using the Cochrane tool for assessing risk of bias in randomized studies. We contacted study authors for clarification as needed. We used risk ratio (RR)ย with 95% confidence intervals (CI). We used a fixed-effect model except in the presence of clinical or statistical heterogeneity, in which case we used a random-effects model. We assessed the certainty of the evidence using GRADE.\nMain results\nWe includedย three trials, twoย in inpatient settings and one in outpatient settings. All trialsย were conducted in sub-Saharan Africa and assessed the impact of diagnostic strategies that included LF-LAM on mortality when the test was used in conjunction with other tuberculosis diagnostic tests or clinical assessment for clinical decision-making in adults living with HIV.\nInpatient settings\nIn inpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy likely reducesย mortality in people living with HIV at eight weeks compared to routine tuberculosis diagnostic testing without LF-LAM (pooled RR 0.85, 95% CI 0.76 to 0.94; 5102 participants, 2 trials; moderate-certainty evidence).ย That is, people living with HIV who received LF-LAM had 15% lower risk of mortality. The absolute effect was 34ย fewer deaths per 1000 (from 14 fewer to 55 fewer).\nIn inpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy probably results in a slight increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF-LAM (pooled RR 1.26, 95% CI 0.94 to 1.69; 5102 participants, 2 trials; moderate-certainty evidence).\nOutpatient settings\nIn outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality in people living with HIV at six months compared to routine tuberculosis diagnostic testing without LF-LAM (RR 0.89, 95% CI 0.71 to 1.11; 2972 participants, 1 trial; low-certainty evidence). Although this trial did not detect a difference in mortality, the direction of effect was towards a mortality reduction, and the effect size was similar to that in inpatient settings.\nIn outpatient settings, the useย of LF-LAM testing as part of a tuberculosis diagnostic strategy may result in a large increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF-LAM (RR 5.44, 95% CI 4.70 to 6.29, 3022 participants, 1 trial; low-certainty evidence).\nOther patient-important outcomes\nAssessment of other patient-important and implementation outcomes in the trials varied. The included trials demonstrated that a higher proportion of people living with HIV were able to produce urine compared to sputum for tuberculosis diagnostic testing; a higher proportion of people living with HIV were diagnosed with tuberculosis in the group that received LF-LAM; and the incremental diagnostic yield was higher for LF-LAM than for urine or sputum Xpert MTB/RIF.\nAuthors' conclusions\nIn inpatient settings, the use of LF-LAM as part of a tuberculosis diagnostic testing strategy likely reducesย mortality and probably results in a slight increase in tuberculosis treatment initiation in people living with HIV. The reduction in mortality may be due to earlier diagnosis, which facilitates prompt treatment initiation. In outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality and may result in a large increase in tuberculosis treatment initiation in people living with HIV.ย Our results support the implementation of LF-LAM to be used in conjunction with other WHO-recommended tuberculosis diagnostic tests to assist in the rapid diagnosis of tuberculosis in people living with HIV.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified three trials, two in inpatient settings and one in outpatient settings.\nInpatient settings\nIn inpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy likely reducesย mortality in people living with HIV at eight weeks compared to routine tuberculosis diagnostic testing without LF-LAM (2 trials, 5102 participants, moderate-certainty evidence).\nIn inpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy probably results in a slight increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF-LAM (2 trials, 5102 participants moderate-certainty evidence).\nOutpatient settings\nIn outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality in people living with HIV at six months compared to routine tuberculosis diagnostic testing without LF-LAM (1 trial, 2972 participants, low-certainty evidence).\nIn outpatient settings, the useย of LF-LAM testing as part of a tuberculosis diagnostic strategy may result in a large increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF-LAM (1 trial, 3022 participants, low-certainty evidence).\nOther patient-important outcomes\nThe included studies assessed other patient-important outcomes in different ways. The studies demonstrated that more people living with HIV were able to produce urine compared to sputum for tuberculosis diagnostic testing, and more people living with HIV were diagnosed with tuberculosis in the group that received LF-LAM."
}
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query-laysum | 977 | [
{
"role": "user",
"content": "Abstract: Background\nThe treatment of people with pancreatic necrosis differs from that of people with oedematous pancreatitis. It is important to know the diagnostic accuracy of serum C-reactive protein (CRP), serum procalcitonin, and serum lactate dehydrogenase (LDH) as a triage test for the detection of pancreatic necrosis in people with acute pancreatitis, so that an informed decision can be made as to whether the person with pancreatic necrosis needs further investigations such as computed tomography (CT) scan or magnetic resonance imaging (MRI) scan and treatment for pancreatic necrosis started. There is currently no standard clinical practice, although CRP, particularly an increasing trend of CRP, is often used as a triage test to determine whether the person requires further imaging. There is also currently no systematic review of the diagnostic test accuracy of CRP, procalcitonin, and LDH for the diagnosis of pancreatic necrosis in people with acute pancreatitis.\nObjectives\nTo compare the diagnostic accuracy of CRP, procalcitonin, or LDH (index test), either alone or in combination, in the diagnosis of necrotising pancreatitis in people with acute pancreatitis and without organ failure.\nSearch methods\nWe searched MEDLINE, Embase, Science Citation Index Expanded, National Institute for Health Research (NIHR HTA and DARE), and other databases until March 2017. We searched the references of the included studies to identify additional studies. We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively. We also performed a 'related search' and 'citing reference' search in MEDLINE and Embase.\nSelection criteria\nWe included all studies that evaluated the diagnostic test accuracy of CRP, procalcitonin, and LDH for the diagnosis of pancreatic necrosis in people with acute pancreatitis using the following reference standards, either alone or in combination: radiological features of pancreatic necrosis (contrast-enhanced CT or MRI), surgeon's judgement of pancreatic necrosis during surgery, or histological confirmation of pancreatic necrosis. Had we found case-control studies, we planned to exclude them because they are prone to bias; however, we did not locate any. Two review authors independently identified the relevant studies from the retrieved references.\nData collection and analysis\nTwo review authors independently extracted data, including methodological quality assessment, from the included studies. As the included studies reported CRP, procalcitonin, and LDH on different days of admission and measured at different cut-off levels, it was not possible to perform a meta-analysis using the bivariate model as planned. We have reported the sensitivity, specificity, post-test probability of a positive and negative index test along with 95% confidence interval (CI) on each of the different days of admission and measured at different cut-off levels.\nMain results\nA total of three studies including 242 participants met the inclusion criteria for this review. One study reported the diagnostic performance of CRP for two threshold levels (> 200 mg/L and > 279 mg/L) without stating the day on which the CRP was measured. One study reported the diagnostic performance of procalcitonin on day 1 (1 day after admission) using a threshold level of 0.5 ng/mL. One study reported the diagnostic performance of CRP on day 3 (3 days after admission) using a threshold level of 140 mg/L and LDH on day 5 (5 days after admission) using a threshold level of 290 U/L. The sensitivities and specificities varied: the point estimate of the sensitivities ranged from 0.72 to 0.88, while the point estimate of the specificities ranged from 0.75 to 1.00 for the different index tests on different days of hospital admission. However, the confidence intervals were wide: confidence intervals of sensitivities ranged from 0.51 to 0.97, while those of specificities ranged from 0.18 to 1.00 for the different tests on different days of hospital admission. Overall, none of the tests assessed in this review were sufficiently accurate to suggest that they could be useful in clinical practice.\nAuthors' conclusions\nThe paucity of data and methodological deficiencies in the studies meant that it was not possible to arrive at any conclusions regarding the diagnostic test accuracy of the index test because of the uncertainty of the results. Further well-designed diagnostic test accuracy studies with prespecified index test thresholds of CRP, procalcitonin, LDH; appropriate follow-up (for at least two weeks to ensure that the person does not have pancreatic necrosis, as early scans may not indicate pancreatic necrosis); and clearly defined reference standards (of surgical or radiological confirmation of pancreatic necrosis) are important to reliably determine the diagnostic accuracy of CRP, procalcitonin, and LDH.\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": "All of the studies were of unclear or low methodological quality, which may result in arriving at false conclusions."
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query-laysum | 978 | [
{
"role": "user",
"content": "Abstract: Background\nCaring for people with dementia is highly challenging, and family carers are recognised as being at increased risk of physical and mental ill-health. Most current interventions have limited success in reducing stress among carers of people with dementia. Mindfulness-based stress reduction (MBSR) draws on a range of practices and may be a promising approach to helping carers of people with dementia.\nObjectives\nTo assess the effectiveness of MBSR in reducing the stress of family carers of people with dementia.\nSearch methods\nWe searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (all years to Issue 9 of 12, 2017), MEDLINE (Ovid SP 1950 to September 2017), Embase (Ovid SP 1974 to Sepetmber 2017), Web of Science (ISI Web of Science 1945 to September 2017), PsycINFO (Ovid SP 1806 to September 2017), CINAHL (all dates to September 2017), LILACS (all dates to September 2017), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and Dissertation Abstracts International (DAI) up to 6 September 2017, with no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) of MBSR for family carers of people with dementia.\nData collection and analysis\nTwo review authors independently screened references for inclusion criteria, extracted data, assessed the risk of bias of trials with the Cochrane 'Risk of bias' tool, and evaluated the quality of the evidence using the GRADE instrument. We contacted study authors for additional information, then conducted meta-analyses, or reported results narratively in the case of insufficient data. We used standard methodological procedures expected by Cochrane.\nMain results\nWe included five RCTs involving 201 carers assessing the effectiveness of MBSR. Controls used in included studies varied in structure and content. Mindfulness-based stress reduction programmes were compared with either active controls (those matched for time and attention with MBSR, i.e. education, social support, or progressive muscle relaxation), or inactive controls (those not matched for time and attention with MBSR, i.e. self help education or respite care). One trial used both active and inactive comparisons with MBSR. All studies were at high risk of bias in terms of blinding of outcome assessment. Most studies provided no information about selective reporting, incomplete outcome data, or allocation concealment.\n1. Compared with active controls, MBSR may reduce depressive symptoms of carers at the end of the intervention (3 trials, 135 participants; standardised mean difference (SMD) -0.63, 95% confidence interval (CI) -0.98 to -0.28; P<0.001; low-quality evidence). We could not be certain of any effect on clinically significant depressive symptoms (very low-quality evidence).\nMindfulness-based stress reduction compared with active control may decrease carer anxiety at the end of the intervention (1 trial, 78 participants; mean difference (MD) -7.50, 95% CI -13.11 to -1.89; P<0.001; low-quality evidence) and may slightly increase carer burden (3 trials, 135 participants; SMD 0.24, 95% CI -0.11 to 0.58; P=0.18; low-quality evidence), although both results were imprecise, and we could not exclude little or no effect. Due to the very low quality of the evidence, we could not be sure of any effect on carers' coping style, nor could we determine whether carers were more or less likely to drop out of treatment.\n2. Compared with inactive controls, MBSR showed no clear evidence of any effect on depressive symptoms (2 trials, 50 participants; MD -1.97, 95% CI -6.89 to 2.95; P=0.43; low-quality evidence). We could not be certain of any effect on clinically significant depressive symptoms (very low-quality evidence).\nIn this comparison, MBSR may also reduce carer anxiety at the end of the intervention (1 trial, 33 participants; MD -7.27, 95% CI -14.92 to 0.38; P=0.06; low-quality evidence), although we were unable to exclude little or no effect. Due to the very low quality of the evidence, we could not be certain of any effects of MBSR on carer burden, the use of positive coping strategies, or dropout rates.\nWe found no studies that looked at quality of life of carers or care-recipients, or institutionalisation.\nOnly one included study reported on adverse events, noting a single adverse event related to yoga practices at home\nAuthors' conclusions\nAfter accounting for non-specific effects of the intervention (i.e. comparing it with an active control), low-quality evidence suggests that MBSR may reduce carers' depressive symptoms and anxiety, at least in the short term.\nThere are significant limitations to the evidence base on MBSR in this population. Our GRADE assessment of the evidence was low to very low quality. We downgraded the quality of the evidence primarily because of high risk of detection or performance bias, and imprecision.\nIn conclusion, MBSR has the potential to meet some important needs of the carer, but more high-quality studies in this field are needed to confirm its efficacy.\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": "Dementia has become a public health burden worldwide. Caring for people with dementia is highly stressful, thus carers are more likely to suffer from psychological problems, such as depression and anxiety, than general population. Mindfulness-based stress reduction is a potentially promising intervention to target these issues. More information is needed about whether MBSR can help family carers of people with dementia."
}
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query-laysum | 979 | [
{
"role": "user",
"content": "Abstract: Background\nMind-body interventions are based on the holistic principle that mind, body and behaviour are all interconnected. Mind-body interventions incorporate strategies that are thought to improve psychological and physical well-being, aim to allow patients to take an active role in their treatment, and promote people's ability to cope. Mind-body interventions are widely used by people with fibromyalgia to help manage their symptoms and improve well-being. Examples of mind-body therapies include psychological therapies, biofeedback, mindfulness, movement therapies and relaxation strategies.\nObjectives\nTo review the benefits and harms of mind-body therapies in comparison to standard care and attention placebo control groups for adults with fibromyalgia, post-intervention and at three and six month follow-up.\nSearch methods\nElectronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), AMED (EBSCO) and CINAHL (Ovid) were conducted up to 30 October 2013. Searches of reference lists were conducted and authors in the field were contacted to identify additional relevant articles.\nSelection criteria\nAll relevant randomised controlled trials (RCTs) of mind-body interventions for adults with fibromyalgia were included.\nData collection and analysis\nTwo authors independently selected studies, extracted the data and assessed trials for low, unclear or high risk of bias. Any discrepancy was resolved through discussion and consensus. Continuous outcomes were analysed using mean difference (MD) where the same outcome measure and scoring method was used and standardised mean difference (SMD) where different outcome measures were used. For binary data standard estimation of the risk ratio (RR) and its 95% confidence interval (CI) was used.\nMain results\nSeventy-four papers describing 61 trials were identified, with 4234 predominantly female participants. The nature of fibromyalgia varied from mild to severe across the study populations. Twenty-six studies were classified as having a low risk of bias for all domains assessed. The findings of mind-body therapies compared with usual care were prioritised.\nThere is low quality evidence that in comparison to usual care controls psychological therapies have favourable effects on physical functioning (SMD -0.4, 95% CI -0.6 to -0.3, -7.5% absolute change, 2 point shift on a 0 to 100 scale), pain (SMD -0.3, 95% CI -0.5 to -0.2, -3.5% absolute change, 2 point shift on a 0 to 100 scale) and mood (SMD -0.5, 95% CI -0.6 to -0.3, -4.8% absolute change, 3 point shift on a 20 to 80 scale). There is very low quality evidence of more withdrawals in the psychological therapy group in comparison to usual care controls (RR 1.38, 95% CI 1.12 to 1.69, 6% absolute risk difference). There is lack of evidence of a difference between the number of adverse events in the psychological therapy and control groups (RR 0.38, 95% CI 0.06 to 2.50, 4% absolute risk difference).\nThere was very low quality evidence that biofeedback in comparison to usual care controls had an effect on physical functioning (SMD -0.1, 95% CI -0.4 to 0.3, -1.2% absolute change, 1 point shift on a 0 to 100 scale), pain (SMD -2.6, 95% CI -91.3 to 86.1, -2.6% absolute change) and mood (SMD 0.1, 95% CI -0.3 to 0.5, 1.9% absolute change, less than 1 point shift on a 0 to 90 scale) post-intervention. In view of the quality of evidence we cannot be certain that biofeedback has a little or no effect on these outcomes. There was very low quality evidence that biofeedback led to more withdrawals from the study (RR 4.08, 95% CI 1.43 to 11.62, 20% absolute risk difference). No adverse events were reported.\nThere was no advantage observed for mindfulness in comparison to usual care for physical functioning (SMD -0.3, 95% CI -0.6 to 0.1, -4.8% absolute change, 4 point shift on a scale 0 to 100), pain (SMD -0.1, CI -0.4 to 0.3, -1.3% absolute change, less than 1 point shift on a 0 to 10 scale), mood (SMD -0.2, 95% CI -0.5 to 0.0, -3.7% absolute change, 2 point shift on a 20 to 80 scale) or withdrawals (RR 1.07, 95% CI 0.67 to 1.72, 2% absolute risk difference) between the two groups post-intervention. However, the quality of the evidence was very low for pain and moderate for mood and number of withdrawals. No studies reported any adverse events.\nVery low quality evidence revealed that movement therapies in comparison to usual care controls improved pain (MD -2.3, CI -4.2 to -0.4, -23% absolute change) and mood (MD -9.8, 95% CI -18.5 to -1.2, -16.4% absolute change) post-intervention. There was no advantage for physical functioning (SMD -0.2, 95% CI -0.5 to 0.2, -3.4% absolute change, 2 point shift on a 0 to 100 scale), participant withdrawals (RR 1.95, 95% CI 1.13 to 3.38, 11% absolute difference) or adverse events (RR 4.62, 95% CI 0.23 to 93.92, 4% absolute risk difference) between the two groups, however rare adverse events may include worsening of pain.\nLow quality evidence revealed that relaxation based therapies in comparison to usual care controls showed an advantage for physical functioning (MD -8.3, 95% CI -10.1 to -6.5, -10.4% absolute change) and pain (SMD -1.0, 95% CI -1.6 to -0.5, -3.5% absolute change, 2 point shift on a 0 to 78 scale) but not for mood (SMD -4.4, CI -14.5 to 5.6, -7.4% absolute change) post-intervention. There was no difference between the groups for number of withdrawals (RR 4.40, 95% CI 0.59 to 33.07, 31% absolute risk difference) and no adverse events were reported.\nAuthors' conclusions\nPsychological interventions therapies may be effective in improving physical functioning, pain and low mood for adults with fibromyalgia in comparison to usual care controls but the quality of the evidence is low. Further research on the outcomes of therapies is needed to determine if positive effects identified post-intervention are sustained. The effectiveness of biofeedback, mindfulness, movement therapies and relaxation based therapies remains unclear as the quality of the evidence was very low or low. The small number of trials and inconsistency in the use of outcome measures across the trials restricted the analysis.\n\nGiven the provided abstract, please respond to the following query: \"- Side effects\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Nineteen people out of 1000 who received psychological therapies experienced a side effect compared with 51 out of 1000 who had usual care (4% absolute improvement). This may have happened by chance.\nWe do not have precise information about side effects and complications of mind-body therapies. Rare adverse events may include worsening of pain."
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query-laysum | 980 | [
{
"role": "user",
"content": "Abstract: Background\nDementia, a global health priority, has no current cure. Around 50 million people worldwide currently live with dementia, and this number is expected to treble by 2050. Some health conditions and lifestyle behaviours can increase or decrease the risk of dementia and are known as 'predictors'. Prognostic models combine such predictors to measure the risk of future dementia. Models that can accurately predict future dementia would help clinicians select high-risk adults in middle age and implement targeted risk reduction.\nObjectives\nOur primary objective was to identify multi-domain prognostic models used in middle-aged adults (aged 45 to 65 years) for predicting dementia or cognitive impairment. Eligible multi-domain prognostic models involved two or more of the modifiable dementia predictors identified in a 2020 Lancet Commission report and a 2019 World Health Organization (WHO) report (less education, hearing loss, traumatic brain injury, hypertension, excessive alcohol intake, obesity, smoking, depression, social isolation, physical inactivity, diabetes mellitus, air pollution, poor diet, and cognitive inactivity). Our secondary objectives were to summarise the prognostic models, to appraise their predictive accuracy (discrimination and calibration) as reported in the development and validation studies, and to identify the implications of using dementia prognostic models for the management of people at a higher risk for future dementia.\nSearch methods\nWe searched MEDLINE, Embase, PsycINFO, CINAHL, and ISI Web of Science Core Collection from inception until 6 June 2022. We performed forwards and backwards citation tracking of included studies using the Web of Science platform.\nSelection criteria\nWe included development and validation studies of multi-domain prognostic models. The minimum eligible follow-up was five years. Our primary outcome was an incident clinical diagnosis of dementia based on validated diagnostic criteria, and our secondary outcome was dementia or cognitive impairment determined by any other method.\nData collection and analysis\nTwo review authors independently screened the references, extracted data using a template based on the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS), and assessed risk of bias and applicability of included studies using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). We synthesised the C-statistics of models that had been externally validated in at least three comparable studies.\nMain results\nWe identified 20 eligible studies; eight were development studies and 12 were validation studies. There were 14 unique prognostic models: seven models with validation studies and seven models with development-only studies. The models included a median of nine predictors (range 6 to 34); the median number of modifiable predictors was five (range 2 to 11). The most common modifiable predictors in externally validated models were diabetes, hypertension, smoking, physical activity, and obesity. In development-only models, the most common modifiable predictors were obesity, diabetes, hypertension, and smoking. No models included hearing loss or air pollution as predictors. Nineteen studies had a high risk of bias according to the PROBAST assessment, mainly because of inappropriate analysis methods, particularly lack of reported calibration measures. Applicability concerns were low for 12 studies, as their population, predictors, and outcomes were consistent with those of interest for this review. Applicability concerns were high for nine studies, as they lacked baseline cognitive screening or excluded an age group within the range of 45 to 65 years.\nOnly one model, Cardiovascular Risk Factors, Ageing, and Dementia (CAIDE), had been externally validated in multiple studies, allowing for meta-analysis. The CAIDE model included eight predictors (four modifiable predictors): age, education, sex, systolic blood pressure, body mass index (BMI), total cholesterol, physical activity and APOEฦ4 status. Overall, our confidence in the prediction accuracy of CAIDE was very low; our main reasons for downgrading the certainty of the evidence were high risk of bias across all the studies, high concern of applicability, non-overlapping confidence intervals (CIs), and a high degree of heterogeneity.\nThe summary C-statistic was 0.71 (95% CI 0.66 to 0.76; 3 studies; very low-certainty evidence) for the incident clinical diagnosis of dementia, and 0.67 (95% CI 0.61 to 0.73; 3 studies; very low-certainty evidence) for dementia or cognitive impairment based on cognitive scores. Meta-analysis of calibration measures was not possible, as few studies provided these data.\nAuthors' conclusions\nWe identified 14 unique multi-domain prognostic models used in middle-aged adults for predicting subsequent dementia. Diabetes, hypertension, obesity, and smoking were the most common modifiable risk factors used as predictors in the models. We performed meta-analyses of C-statistics for one model (CAIDE), but the summary values were unreliable. Owing to lack of data, we were unable to meta-analyse the calibration measures of CAIDE. This review highlights the need for further robust external validations of multi-domain prognostic models for predicting future risk of dementia in middle-aged adults.\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"
},
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"role": "assistant",
"content": "โข We found 14 tools used in middle-aged people to predict future dementia.\nโข Seven studies tested a prediction tool named Cardiovascular Risk Factors, Ageing, and Dementia (CAIDE).\nโข The benefits of using these tools to predict dementia later in life are unclear, because the studies provided little high-quality evidence."
}
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query-laysum | 981 | [
{
"role": "user",
"content": "Abstract: Background\nAntibiotics provide only modest benefit in treating sore throat, although their effectiveness increases in people with positive throat swabs for group A beta-haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated. This is an update of a review first published in 2010, and updated in 2013, 2016, and 2020.\nObjectives\nTo assessย the comparative efficacy of different antibiotics in: (a) alleviating symptoms (pain, fever); (b) shortening the duration of the illness; (c) preventing clinical relapse (i.e. recurrence of symptoms after initial resolution); and (d) preventing complications (suppurative complications, acute rheumatic fever, post-streptococcal glomerulonephritis). To assess the evidence on the comparative incidence of adverse effects and the risk-benefit of antibiotic treatment for streptococcal pharyngitis.\nSearch methods\nWe searched the following databases up to 3 September 2020: CENTRAL (2020, Issue 8), MEDLINE Ovid (from 1946), Embase Elsevier (from 1974), and Web of Science Thomson Reuters (from 2010). We also searched clinical trialย registers on 3 September 2020.\nSelection criteria\nRandomised, double-blind trials comparing different antibiotics, and reporting at least one of the following: clinical cure, clinical relapse, or complications and/or adverse events.\nData collection and analysis\nTwo review authors independently screened trials for inclusion and extracted data using standard methodological procedures as recommended by Cochrane. We assessed the risk of bias of included studies according to the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions, and used the GRADE approach to assess the overall certainty of the evidence for the outcomes. We have reported the intention-to-treat analysis, and also performedย an analysis of evaluable participants to explore the robustness of the intention-to-treat results.\nMain results\nWe included 19 trials reported in 18 publications (5839 randomised participants): six trials compared penicillin with cephalosporins; six compared penicillin with macrolides; three compared penicillin with carbacephem; one compared penicillin with sulphonamides; one compared clindamycin with ampicillin; and one compared azithromycin with amoxicillin in children. All participants had confirmed acute GABHS tonsillopharyngitis,ย and ages ranged from one month to 80 years. Nine trials included only, or predominantly, children. Most trials were conducted in an outpatient setting. Reporting of randomisation, allocation concealment, and blinding was poor in all trials.ย We downgraded the certainty of the evidence mainly due to lack of (or poor reporting of) randomisation or blinding, or both; heterogeneity; and wide confidence intervals.\nCephalosporins versus penicillin\nWe are uncertain if there is a difference in symptom resolution (at 2 to 15 days) for cephalosporins versus penicillin (odds ratio (OR) for absence of symptom resolution 0.79, 95% confidence interval (CI) 0.55 to 1.12; 5 trials; 2018 participants; low-certainty evidence).ย Results of the sensitivity analysis of evaluable participants differed (ORย 0.51, 95% CIย 0.27 to 0.97;ย 5 trials; 1660 participants; very low-certainty evidence).ย We are uncertain if clinical relapse may be lower for cephalosporins compared with penicillin (OR 0.55, 95% CI 0.30 to 0.99; number needed to treat for an additional beneficial outcome (NNTB) 50; 4 trials; 1386 participants; low-certainty evidence). Very low-certainty evidence showed no difference in reported adverse events.\nMacrolides versus penicillin\nWe are uncertain if there is a difference between macrolides and penicillin for resolution of symptoms (ORย 1.11, 95% CI 0.92 to 1.35; 6 trials;ย 1728 participants; low-certainty evidence). Sensitivity analysis of evaluable participants resulted in anย ORย of 0.79, 95% CI 0.57 to 1.09; 6 trials; 1159 participants). We are uncertain if clinical relapse may be differentย (ORย 1.21, 95% CI 0.48 to 3.03; 6 trials; 802 participants; low-certainty evidence).\nAzithromycin versus amoxicillin\nBased on oneย unpublished trial in children, we are uncertain ifย resolution of symptoms is better withย azithromycin in a single dose versus amoxicillin for 10 days (ORย 0.76, 95% CI 0.55 to 1.05; 1 trial; 673 participants; very low-certainty evidence). Sensitivity analysisย for per-protocol analysis resulted in an OR of 0.29, 95% CI 0.11 to 0.73;ย 1 trial; 482 participants; very low-certainty evidence). We are also uncertain if there was a difference in relapse between groupsย (OR 0.88, 95% CI 0.43 to 1.82; 1 trial; 422 participants; very low-certainty evidence). Adverse events were more common with azithromycin compared to amoxicillin (OR 2.67, 95% CI 1.78 to 3.99; 1 trial; 673 participants; very low-certainty evidence).\nCarbacephem versus penicillin\nThere is low-certainty evidence that compared with penicillin, carbacephem may provide betterย symptom resolution post-treatment in adults and children (OR 0.70, 95% CI 0.49 to 0.99; NNTB 14.3; 3 trials; 795 participants).\nStudies did not report on long-term complications, so it was unclear if any class of antibiotics was better in preventing serious but rare complications.\nAuthors' conclusions\nWe are uncertain if there areย clinically relevant differences in symptom resolution when comparing cephalosporins and macrolides with penicillin in the treatment of GABHS tonsillopharyngitis. Low-certainty evidence in children suggests that carbacephem may be more effective than penicillin for symptom resolution. There is insufficient evidence to draw conclusions regarding the other comparisons in this review. Data on complications were too scarce to draw conclusions. These results do not demonstrate that other antibiotics are more effective thanย penicillin in the treatment of GABHS pharyngitis. All studies were conducted in high-income countries with a low risk of streptococcal complications, so there is a need for trials in low-income countries and Aboriginal communities, where the risk of complications remains high.\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": "We judged the certainty of the evidence as low or very low for all outcomes when macrolides or cephalosporins were compared with penicillin. We have concerns about the rigour of the study methods, the fact that estimates were not very precise and about the differences between studies."
}
]
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query-laysum | 982 | [
{
"role": "user",
"content": "Abstract: Background\nHelminthiasis is an infestation of the human body with parasitic worms. It is estimated to affect 44 million pregnancies, globally, each year. Intestinal helminthiasis (hookworm infestation) is associated with blood loss and decreased supply of nutrients for erythropoiesis, resulting in iron-deficiency anaemia. Over 50% of the pregnant women in low- and middle-income countries (LMIC) suffer from iron-deficiency anaemia. Though iron-deficiency anaemia is multifactorial, hookworm infestation is a major contributory cause in women of reproductive age in endemic areas. Antihelminthics are highly efficacious, but evidence of their beneficial effect and safety when given during pregnancy has not been established. This is an update of a Cochrane Review last published in 2015.\nObjectives\nTo determine the effects of mass deworming with antihelminthics for soil-transmitted helminths (STH) during the second or third trimester of pregnancy on maternal and pregnancy outcomes.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirthโs Trials Register, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) (8 March 2021) and reference lists of retrieved studies.\nSelection criteria\nWe included all prospective randomised controlled trials evaluating the effect of administration of antihelminthics versus placebo or no treatment during the second or third trimester of pregnancy; both individual-randomised and cluster-randomised trials were eligible. We excluded quasi-randomised trials and studies that were only available as abstracts with insufficient information.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, checked accuracy and assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included a total of six trials (24 reports) that randomised 7873 pregnant women. All of the included trials were conducted in antenatal clinics within hospitals in LMICs (Uganda, Nigeria, Peru, India, Sierra Leone and Tanzania). Among primary outcomes, five trials reported maternal anaemia, one trial reported preterm birth and three trials reported perinatal mortality. Among secondary outcomes, included trials reported maternal worm prevalence, low birthweight (LBW) and birthweight. None of the included studies reported maternal anthropometric measures or infant survival at six months. Overall, we judged the included trials to be generally at low risk of bias for most domains, while the certainty of evidence ranged from low to moderate.\nAnalysis suggests that administration of a single dose of antihelminthics in the second trimester of pregnancy may reduce maternal anaemia by 15% (average risk ratio (RR) 0.85, 95% confidence interval (CI) 0.72 to 1.00; Iยฒ= 86%; 5 trials, 5745 participants; low-certainty evidence). We are uncertain of the effect of antihelminthics during pregnancy on preterm birth (RR 0.84, 95% CI 0.38 to 1.86; 1 trial, 1042 participants; low-certainty evidence) or perinatal mortality (RR 1.01, 95% CI 0.67 to 1.52; 3 trials, 3356 participants; low-certainty evidence).\nWe are uncertain of the effect of antihelminthics during pregnancy on hookworm (average RR 0.31, 95% CI 0.05 to 1.93; Tauยฒ = 1.76, Iยฒ = 99%; 2 trials, 2488 participants; low-certainty evidence). Among other secondary outcomes, findings suggest that administration of antihelminthics during pregnancy may reduce the prevalence of trichuris (average RR 0.68, 95% CI 0.48 to 0.98; Iยฒ=75%; 2 trials, 2488 participants; low-certainty evidence) and ascaris (RR 0.24, 95% CI 0.19 to 0.29; Iยฒ= 0%; 2 trials, 2488 participants; moderate-certainty evidence). Antihelminthics during pregnancy probably make little or no difference to LBW (RR 0.89, 95% CI 0.69 to 1.16; 3 trials, 2960 participants; moderate-certainty evidence) and birthweight (mean difference 0.00 kg, 95% CI -0.03 kg to 0.04 kg; 3 trials, 2960 participants; moderate-certainty evidence).\nAuthors' conclusions\nThe evidence suggests that administration of a single dose of antihelminthics in the second trimester of pregnancy may reduce maternal anaemia and worm prevalence when used in settings with high prevalence of maternal helminthiasis. Further data is needed to establish the benefit of antihelminthic treatment on other maternal and pregnancy outcomes.\nFuture research should focus on evaluating the effect of these antihelminthics among various subgroups in order to assess whether the effect varies. Future studies could also assess the effectiveness of co-interventions and health education along with antihelminthics for maternal and pregnancy outcomes.\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": "Parasitic worm infections from contaminated soil include hookworm, roundworm, and whipworm. These intestinal worms (helminths) feed on blood and can contribute to iron-deficiency anaemia in women of reproductive age. Parasitic worms also release substances that stop blood from clotting, so cause further bleeding. Affected women often experience anorexia, vomiting and diarrhoea, which reduces the supply of essential nutrients for producing blood cells. As a result, the health of pregnant women and their unborn babies can be affected.\nAntihelminthics are drugs that force parasitic worms out of the body, either by stunning or killing them, without causing damage to the host. Antihelminthics are highly effective against these worms, but evidence of their beneficial effect and safety when given during pregnancy is limited."
}
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query-laysum | 983 | [
{
"role": "user",
"content": "Abstract: Background\nPoorly controlled asthma and preventable exacerbations place a significant strain on healthcare, often requiring additional medications, hospital stays or treatment in the emergency department.\nLong-acting beta2-agonists (LABA) are the preferred add-on treatment for adults with asthma whose symptoms are not well controlled on inhaled corticosteroids (ICS), but have important safety concerns in asthma. Long-acting muscarinic antagonists (LAMA) have confirmed efficacy in chronic obstructive pulmonary disease and are now being considered as an alternative add-on therapy for people with uncontrolled asthma.\nObjectives\nTo assess the efficacy and safety of adding a LAMA to ICS compared with adding a LABA for adults whose asthma is not well controlled on ICS alone.\nSearch methods\nWe searched the Cochrane Airways Group's Specialised Register (CAGR) from inception to April 2015, and imposed no restriction on language of publication. We searched additional resources to pick up unpublished studies, including ClinicalTrials.gov, World Health Organization trials portal, reference lists of primary studies and existing reviews, and manufacturers' trial registries. The most recent search was conducted in April 2015.\nSelection criteria\nWe searched for parallel and cross-over RCTs in which adults whose asthma was not well controlled with ICS alone were randomised to receive LAMA add-on or LABA add-on for at least 12 weeks.\nData collection and analysis\nTwo review authors independently screened the electronic and additional searches and extracted data from study reports. We used Covidence for duplicate screening, extraction of study characteristics and numerical data, and risk of bias ratings.\nThe pre-specified primary outcomes were exacerbations requiring oral corticosteroids (OCS), quality of life and serious adverse events.\nMain results\nWe included eight studies meeting the inclusion criteria, but four double-blind, double-dummy studies of around 2000 people dominated the analyses. These four trials were between 14 and 24 weeks long, all comparing tiotropium (usually Respimat) with salmeterol on top of medium doses of ICS.\nStudies reporting exacerbations requiring OCS showed no difference between the two add-ons, but our confidence in the effect was low due to inconsistency between studies and because the confidence intervals (CI) included significant benefit of either treatment (odds ratio (OR) 1.05, 95% CI 0.50 to 2.18; 1753 participants; 3 studies); three more people per 1000 might have an exacerbation on LAMA, but the CIs ranged from 29 fewer to 61 more. Imprecision was also an issue for serious adverse events and exacerbations requiring hospital admission, rated low (serious adverse events) and very low quality (exacerbations requiring hospital admission), because there were so few events in the analyses.\nPeople taking LAMA scored slightly worse on two scales measuring quality of life (Asthma Quality of Life Questionnaire; AQLQ) and asthma control (Asthma Control Questionnaire; ACQ); the evidence was rated high quality but the effects were small and unlikely to be clinically significant (AQLQ: mean difference (MD) -0.12, 95% CI -0.18 to -0.05; 1745 participants; 1745; 4 studies; ACQ: MD 0.06, 95% CI 0.00 to 0.13; 1483 participants; 3 studies).\nThere was some evidence to support small benefits of LAMA over LABA on lung function, including on our pre-specified preferred measure trough forced expiratory volume in one second (FEV1) (MD 0.05 L, 95% CI 0.01 to 0.09; 1745 participants, 4 studies). However, the effects on other measures varied, and it is not clear whether the magnitude of the differences were clinically significant.\nMore people had adverse events on LAMA but the difference with LABA was not statistically significant.\nAuthors' conclusions\nDirect evidence of LAMA versus LABA as add-on therapy is currently limited to studies of less than six months comparing tiotropium (Respimat) to salmeterol, and we do not know how they compare in terms of exacerbations and serious adverse events. There was moderate quality evidence that LAMAs show small benefits over LABA on some measures of lung function, and high quality evidence that LABAs are slightly better for quality of life, but the differences were all small. Given the much larger evidence base for LABA versus placebo for people whose asthma is not well controlled on ICS, the current evidence is not strong enough to say that LAMA can be substituted for LABA as add-on therapy.\nThe results of this review, alongside pending results from related reviews assessing the use of LAMA in other clinical scenarios, will help to define the role of these drugs in asthma and it is important that they be updated as results from ongoing and planned trials emerge.\n\nGiven the provided abstract, please respond to the following query: \"What did we find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We could not tell whether people taking LAMA were more or less likely to need oral corticosteroids for an asthma attack than people taking LABA because not many people needed them and the studies showed different results; overall three more people in 1000 might have an asthma attack on LAMA, but the real result could be anywhere between 29 fewer and 61 more than if you took a LABA. Similarly, too few people in the studies had serious side effects or asthma attacks that required urgent medical treatment to judge whether one treatment was better than the other.\nThe studies showed that LAMAs might be a bit better than LABA for lung function (how well your lungs work), and LABAs slightly better for quality of life, but the differences were small and we could not tell if one was better than the other for most outcomes.\nThe results were mostly based on four good studies of around 2000 people, which were between 14 and 24 weeks of duration. All of the studies looked at a LAMA drug called tiotropium."
}
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query-laysum | 984 | [
{
"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 lightย and Gecko Nanoplast (a silicone gel bandage). Six trials had a split-site design and three trials had an unclearย design (resulting in aย 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 โ1.26, 95% CI โ2.26 to โ0.26; 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 levelsย compared with pressure garments (MD โ1.90, 95% CI โ2.99 to โ0.81; ย 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 โ0.88 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 โ0.12, 95% CI โ0.18 to โ0.06). 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 ย -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: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A scar is a mark left on the skin after a wound or injury has healed, for example, after surgery or after a burn. Most scars will fade and become paler over time, but some scars may become red and raised (called hypertrophic scars). Hypertrophic scars may take several years to flatten and fade.\nScars can be itchy, painful or unsightly, and may restrict movement. Scarring can affect people physically and emotionally, and can affect a person's well-being.\nTreatments aim to improve a scarโs appearance and help to make it less visible. They include: wearing clothing that fits tightly around the skin (pressure garments); treatments applied to the scar; laser therapy and silicone gel sheets.\nSilicone gel sheets are soft wound dressings containing an elastic form of silicone. They have a soft, rubbery texture and stick to the skin. They are commonly used on healing skin to help soften and flatten a hypertrophic scar."
}
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query-laysum | 985 | [
{
"role": "user",
"content": "Abstract: Background\nOcular infection caused by Toxoplasma gondii, a parasite, may result in inflammation in the retina, choroid, and uvea, and consequently lead to complications such as glaucoma, cataract, and posterior synechiae.\nObjectives\nThe objective of this systematic review was to assess the effects of adjunctive use of corticosteroids to anti-parasitic therapy versus anti-parasitic therapy alone for ocular toxoplasmosis.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register (2016; Issue 11)), MEDLINE Ovid, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, MEDLINE Ovid Daily (January 1946 to December 2016), Embase (January 1980 to December 2016), Latin American and Caribbean Literature on Health Sciences (LILACS (January 1982 to December 2016)), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP; www.who.int/ictrp/search/en). We used no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 7 December 2016.\nSelection criteria\nWe had planned to include randomized and quasi-randomized controlled trials. Eligible trials would have enrolled participants of any age who were immunocompetent and were diagnosed with acute ocular toxoplasmosis. Included trials would have compared anti-parasitic therapy plus corticosteroids versus anti-parasitic therapy alone, different doses or times of initiation of corticosteroids.\nData collection and analysis\nTwo authors independently screened titles and abstracts retrieved through the electronic searches. We retrieved full-text reports of studies categorized as 'unsure' or 'include' after we reviewed the abstracts. Two authors independently reviewed each full-text report for eligibility. Discrepancies were resolved through discussion.\nMain results\nWe identified no completed or ongoing trial that was eligible for this Cochrane review.\nAuthors' conclusions\nAlthough research has identified a wide variation in practice regarding the use of corticosteroids, our review did not identify any evidence from randomized controlled trials for or against the role of corticosteroids in the management of ocular toxoplasmosis. Several questions remain unanswered by well-conducted randomized trials in this context, including whether the use of corticosteroids as an adjunctive agent is more effective than the use of anti-parasitic therapy alone; if so, when corticosteroids should be initiated in the treatment regimen (early versus late course of treatment), and what would be the best dose and duration of steroid use.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane researchers searched multiple electronic databases for studies of the addition of corticosteroids to standard treatment for toxoplasmosis in the eye. They found no relevant studies\nPeople affected by toxoplasma, and doctors and nurses treating them, need evidence as to whether it is useful to take corticosteroids for toxoplasmosis in the eye. They need more information on how much to take, for how long, and when to start taking them alongside standard treatment. Future studies need to collect information on outcomes relevant to people affected by the condition, such as the time it takes to recover from signs and symptoms of vision loss."
}
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query-laysum | 986 | [
{
"role": "user",
"content": "Abstract: Background\nInappropriate polypharmacy is a particular concern in older people and is associated with negative health outcomes. Choosing the best interventions to improve appropriate polypharmacy is a priority, so that many medicines may be used to achieve better clinical outcomes for patients. This is the third update of this Cochrane Review.\nObjectives\nTo assess the effects of interventions, alone or in combination, in improving the appropriate use of polypharmacy and reducing medication-related problems in older people.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers up until 13 January 2021, together with handsearching of reference lists to identify additional studies. We ran updated searches in February 2023 and have added potentially eligible studies to 'Characteristics of studies awaiting classification'.\nSelection criteria\nFor this update, we included randomised trials only. Eligible studies described interventions affecting prescribing aimed at improving appropriate polypharmacy (four or more medicines) in people aged 65 years and older, which used a validated tool to assess prescribing appropriateness. These tools can be classified as either implicit tools (judgement-based/based on expert professional judgement) or explicit tools (criterion-based, comprising lists of drugs to be avoided in older people).\nData collection and analysis\nFour review authors independently reviewed abstracts of eligible studies, and two authors extracted data and assessed the risk of bias of the included studies. We pooled study-specific estimates, and used a random-effects model to yield summary estimates of effect and 95% confidence intervals (CIs). We assessed the overall certainty of evidence for each outcome using the GRADE approach.\nMain results\nWe identified 38 studies, which includes an additional 10 in this update. The included studies consisted of 24 randomised trials and 14 cluster-randomised trials. Thirty-six studies examined complex, multi-faceted interventions of pharmaceutical care (i.e. the responsible provision of medicines to improve patients' outcomes), in a variety of settings. Interventions were delivered by healthcare professionals such as general physicians, pharmacists, nurses and geriatricians, and most were conducted in high-income countries. Assessments using the Cochrane risk of bias tool found that there was a high and/or unclear risk of bias across a number of domains. Based on the GRADE approach, the overall certainty of evidence for each pooled outcome ranged from low to very low.\nIt is uncertain whether pharmaceutical care improves medication appropriateness (as measured by an implicit tool) (mean difference (MD) -5.66, 95% confidence interval (CI) -9.26 to -2.06; I2 = 97%; 8 studies, 947 participants; very low-certainty evidence). It is uncertain whether pharmaceutical care reduces the number of potentially inappropriate medications (PIMs) (standardised mean difference (SMD) -0.19, 95% CI -0.34 to -0.05; I2 = 67%; 9 studies, 2404 participants; very low-certainty evidence). It is uncertain whether pharmaceutical care reduces the proportion of patients with one or more PIM (risk ratio (RR) 0.81, 95% CI 0.68 to 0.98; I2 = 84%; 13 studies, 4534 participants; very low-certainty evidence). Pharmaceutical care may slightly reduce the number of potential prescribing omissions (PPOs) (SMD -0.48, 95% CI -1.05 to 0.09; I2 = 92%; 3 studies, 691 participants; low-certainty evidence), however it must be noted that this effect estimate is based on only three studies, which had serious limitations in terms of risk of bias. Likewise, it is uncertain whether pharmaceutical care reduces the proportion of patients with one or more PPO (RR 0.50, 95% CI 0.27 to 0.91; I2 = 95%; 7 studies, 2765 participants; very low-certainty evidence).\nPharmaceutical care may make little or no difference to hospital admissions (data not pooled; 14 studies, 4797 participants; low-certainty evidence). Pharmaceutical care may make little or no difference to quality of life (data not pooled; 16 studies, 7458 participants; low-certainty evidence). Medication-related problems were reported in 10 studies (6740 participants) using different terms (e.g. adverse drug reactions, drug-drug interactions). No consistent intervention effect on medication-related problems was noted across studies. This also applied to studies examining adherence to medication (nine studies, 3848 participants).\nAuthors' conclusions\nIt is unclear whether interventions to improve appropriate polypharmacy resulted in clinically significant improvement. Since the last update of this review in 2018, there appears to have been an increase in the number of studies seeking to address potential prescribing omissions and more interventions being delivered by multidisciplinary teams.\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": "This review examines studies in which healthcare professionals have taken action to make sure that older people are receiving the most effective and safest medicines for their illness. Actions taken included providing a service, known as pharmaceutical care. This involves promoting the correct use of medicines by identifying, preventing and resolving medication-related problems. Another strategy that we were interested in was using computerised decision support. This involves a program on the doctorโs computer that aids the selection of appropriate treatment(s) or strategies - and can involve different healthcare professionals working together."
}
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query-laysum | 987 | [
{
"role": "user",
"content": "Abstract: Background\nProgressive lung damage causes most deaths in cystic fibrosis. Non-steroidal anti-inflammatory drugs (such as ibuprofen) may prevent progressive pulmonary deterioration and morbidity in cystic fibrosis. This is an update of a previously published review.\nObjectives\nTo assess the effectiveness of treatment with oral non-steroidal anti-inflammatory drugs in cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, hand searches of relevant journals and abstract books of conference proceedings. We contacted manufacturers of non-steroidal anti-inflammatory drugs and searched online trials registries.\nLatest search of the Group's Trials Register: 21 November 2018.\nSelection criteria\nRandomized controlled trials comparing oral non-steroidal anti-inflammatory drugs, at any dose for at least two months, to placebo in people with cystic fibrosis.\nData collection and analysis\nTwo authors independently assessed trials for inclusion the review and their potential risk of bias. Two authors independently rated the quality of the evidence for each outcome using the GRADE guidelines.\nMain results\nThe searches identified 17 trials; four are included (287 participants aged five to 39 years; maximum follow-up of four years) and one is currently awaiting classification pending publication of the full trial report and two are ongoing. Three trials compared ibuprofen to placebo (two from the same center with some of the same participants); one trial assessed piroxicam versus placebo.\nThe three ibuprofen trials were deemed to have good or adequate methodological quality, but used various outcomes and summary measures. Reviewers considered measures of lung function, nutritional status, radiological assessment of pulmonary involvement, intravenous antibiotic usage, hospital admissions, survival and adverse effects. Combined data from the two largest ibuprofen trials showed a lower annual rate of decline for lung function, % predicted forced expiratory volume in one second (FEV1), mean difference (MD) 1.32 (95% confidence interval (CI) 0.21 to 2.42) (moderate-quality evidence); forced vital capacity (FVC), MD 1.27 (95% CI 0.26 to 2.28) (moderate-quality evidence); forced expiratory flow (FEF25%-75%), MD 1.80 (95% CI 0.15 to 3.45). The post hoc analysis of data from two trials split by age showed a slower rate of annual decline of FEV1 % predicted and FVC in the ibuprofen group in younger children, MD 1.41% (95% CI 0.03 to 2.80) (moderate-quality evidence) and MD 1.32% (95% CI 0.04 to 2.60) (moderate-quality evidence) respectively. Data from four trials demonstrated the proportion of participants with at least one hospitalization may be slightly lower in the ibuprofen group compared to placebo, Peto odds ratio 0.61 (95% CI 0.37 to 1.01) (moderate-quality evidence). In one trial, long-term use of high-dose ibuprofen was associated with reduced intravenous antibiotic usage, improved nutritional and radiological pulmonary status. No major adverse effects were reported, but the power of the trials to identify clinically important differences in the incidence of adverse effects was low.\nWe did not have any concerns with regards to risk of bias for the trial comparing piroxicam to placebo. However, the trial did not report many data in a form that we could analyze in this review. No data were available for the review's primary outcome of lung function; available data for hospital admissions showed no difference between the groups. No analyzable data were available for any other review outcome.\nAuthors' conclusions\nHigh-dose ibuprofen can slow the progression of lung disease in people with cystic fibrosis, especially in children, which suggests that strategies to modulate lung inflammation can be beneficial for people with cystic fibrosis.\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 looked for trials comparing oral non-steroidal anti-inflammatory drugs to a a placebo (a tablet that contained no active medicine). We looked for any dose level. but the trial had to run for at least two months in people with cystic fibrosis. We found 17 trials and included four of these with a total of 287 people aged five to 39 years; one further trial has not yet been published in full and two are still ongoing; we will assess these when we have more information. Three of the four included trials compared ibuprofen to a placebo; two of these trials were run in the same center and used some of the same people. One trial compared a drug called piroxicam to placebo. The longest trial lasted four years.\nWe aimed to report on lung function, nutritional status, lung x-rays, how often intravenous antibiotics were needed, details about hospital admissions, survival and side effects."
}
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query-laysum | 988 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin D deficiency is often reported in people with chronic liver diseases. Improving vitamin D status could therefore be beneficial for people with chronic liver diseases.\nObjectives\nTo assess the beneficial and harmful effects of vitamin D supplementation in adults with chronic liver diseases.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index-Science. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We scanned bibliographies of relevant publications and enquired experts and pharmaceutical companies as to additional trials. All searches were up to November 2020.\nSelection criteria\nRandomised clinical trials that compared vitamin D at any dose, duration, and route of administration versus placebo or no intervention in adults with chronic liver diseases. Vitamin D could have been administered as supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)), or an active form of vitamin D (1ฮฑ-hydroxyvitamin D (alfacalcidol), 25-hydroxyvitamin D (calcidiol), or 1,25-dihydroxyvitamin D (calcitriol)).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of evidence.\nMain results\nWe included 27 randomised clinical trials with 1979 adult participants. This review update added 12 trials with 945 participants. We assessed all trials at high risk of bias. All trials had a parallel-group design. Eleven trials were conducted in high-income countries and 16 trials in middle-income countries. Ten trials included participants with chronic hepatitis C, five trials participants with liver cirrhosis, 11 trials participants with non-alcoholic fatty liver disease, and one trial liver transplant recipients. All of the included trials reported the baseline vitamin D status of participants. Participants in nine trials had baseline serum 25-hydroxyvitamin D levels at or above vitamin D adequacy (20 ng/mL), whilst participants in the remaining 18 trials were vitamin D insufficient (less than 20 ng/mL). Twenty-four trials administered vitamin D orally, two trials intramuscularly, and one trial intramuscularly and orally. In all 27 trials, the mean duration of vitamin D supplementation was 6 months, and the mean follow-up of participants from randomisation was 7 months. Twenty trials (1592 participants; 44% women; mean age 48 years) tested vitamin D3 (cholecalciferol); three trials (156 participants; 28% women; mean age 54 years) tested vitamin D2; four trials (291 participants; 60% women; mean age 52 years) tested 1,25-dihydroxyvitamin D; and one trial (18 participants; 0% women; mean age 52 years) tested 25-hydroxyvitamin D. One trial did not report the form of vitamin D. Twelve trials used a placebo, whilst the other 15 trials used no intervention in the control group. Fourteen trials appeared to be free of vested interest. Eleven trials did not provide any information on clinical trial support or sponsorship. Two trials were funded by industry.\nWe are very uncertain regarding the effect of vitamin D versus placebo or no intervention on all-cause mortality (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.51 to 1.45; 27 trials; 1979 participants). The mean follow-up was 7 months (range 1 to 18 months). We are very uncertain regarding the effect of vitamin D versus placebo or no intervention on liver-related mortality (RR 1.62, 95% CI 0.08 to 34.66; 1 trial; 18 participants) (follow-up: 12 months); serious adverse events such as hypercalcaemia (RR 5.00, 95% CI 0.25 to 100.8; 1 trial; 76 participants); myocardial infarction (RR 0.75, 95% CI 0.08 to 6.81; 2 trials; 86 participants); thyroiditis (RR 0.33, 95% CI 0.01 to 7.91; 1 trial; 68 participants); circular haemorrhoidal prolapse (RR 3.00, 95% CI 0.14 to 65.9; 1 trial; 20 participants); bronchopneumonia (RR 0.33, 95% CI 0.02 to 7.32; 1 trial 20 participants); and non-serious adverse events. The certainty of evidence for all outcomes is very low.\nWe found no data on liver-related morbidity such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, ascites, or liver cancer. There were also no data on health-related quality of life.\nThe evidence is also very uncertain regarding the effect of vitamin D versus placebo or no intervention on rapid, early, and sustained virological response in people with chronic hepatitis C.\nAuthors' conclusions\nGiven the high risk of bias and insufficient power of the included trials and the very low certainty of the available evidence, vitamin D supplementation versus placebo or no intervention may increase or reduce all-cause mortality, liver-related mortality, serious adverse events, or non-serious adverse events in adults with chronic liver diseases. There is a lack of data on liver-related morbidity and health-related quality of life. Further evidence on clinically important outcomes analysed in this review is 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": "Is vitamin D supplementation beneficial or harmful for adults with chronic liver diseases?"
}
]
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query-laysum | 989 | [
{
"role": "user",
"content": "Abstract: Background\nTrigger finger is a common hand condition that occurs when movement of a finger flexor tendon through the first annular (A1) pulley is impaired by degeneration, inflammation, and swelling. This causes pain and restricted movement of the affected finger. Non-surgical treatment options include activity modification, oral and topical non-steroidal anti-inflammatory drugs (NSAIDs), splinting, and local injections with anti-inflammatory drugs.\nObjectives\nTo review the benefits and harms of non-steroidal anti-inflammatory drugs (NSAIDs) versus placebo, glucocorticoids, or different NSAIDs administered by the same route for trigger finger.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, CNKI (China National Knowledge Infrastructure), ProQuest Dissertations and Theses, www.ClinicalTrials.gov, and the WHO trials portal until 30 September 2020. We applied no language or publication status restrictions.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) and quasi-randomised trials of adult participants with trigger finger that compared NSAIDs administered topically, orally, or by injection versus placebo,ย glucocorticoid, or different NSAIDs administered by the same route.\nData collection and analysis\nTwo or more review authors independently screened the reports, extracted data, and assessed risk of bias and GRADE certainty of evidence. The seven major outcomes were resolution of trigger finger symptoms, persistent moderate or severe symptoms, recurrence of symptoms, total active range of finger motion, residual pain, patient satisfaction, and adverse events. Treatment effects were reported as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs).\nMain results\nTwo RCTs conducted in an outpatient hospital setting were included (231ย adult participants, mean age 58.6 years, 60% female, 95% to 100% moderate to severe disease). Both studies compared a single injection of a non-selective NSAID (12.5 mg diclofenac or 15.0 mg ketorolac) given at lower than normal dosesย with a single injection of a glucocorticoid (triamcinoloneย 20 mg or 5 mg),ย with maximum follow-up duration of 12 weeks or 24 weeks.\nIn both studies, we detected risk of attrition and performance bias. One study also had risk of selection bias. The effects of treatment were sensitive to assumptions about missing outcomes. All seven outcomes were reported in one study, and five in the other.\nNSAID injection may offer little to no benefit over glucocorticoid injection, based on low- to very low-certainty evidence from two trials. Evidence was downgraded for bias and imprecision. There may be little to no difference between groups in resolution of symptoms at 12 to 24 weeks (34% with NSAIDs, 41% with glucocorticoids; absolute effect 7% lower, 95% confidence interval (CI) 16% lower to 5% higher; 2 studies, 231 participants; RR 0.83, 95% CI 0.62 to 1.11; low-certainty evidence). The rate of persistent moderate to severe symptoms may be higher at 12 to 24 weeks in the NSAIDs group (28%) compared to the glucocorticoid group (14%) (absolute effect 14% higher, 95% CI 2% to 33% higher; 2 studies, 231 participants; RR 2.03, 95% CI 1.19 to 3.46; low-certainty evidence). We are uncertain whether NSAIDs result in fewer recurrences at 12 to 24 weeks (1%) compared to glucocorticoid (21%) (absolute effect 20% lower, 95% CI 21% to 13% lower; 2 studies, 231 participants; RR 0.07, 95% CI 0.01 to 0.38; very low-certainty evidence). There may be little to no difference between groups in mean total active motion at 24 weeks (235 degrees with NSAIDs, 240 degrees with glucocorticoid) (absolute effect 5% lower, 95% CI 34.54% lower to 24.54% higher; 1 study, 99 participants; MD -5.00, 95% CI -34.54 to 24.54; low-certainty evidence). There may be little to no difference between groups in residual pain at 12 to 24 weeks (20% with NSAIDs, 24% with glucocorticoid) (absolute effect 4% lower, 95% CI 11% lower to 7% higher; 2 studies, 231 participants; RR 0.84, 95% CI 0.54 to 1.31; low-certainty evidence). There may be little to no difference between groups in participant-reported treatment success at 24 weeks (64% with NSAIDs, 68% with glucocorticoid) (absolute effect 4% lower, 95% CI 18% lower to 15% higher; 1 study, 121 participants; RR 0.95, 95% CI 0.74 to 1.23; low-certainty evidence).\nWe are uncertain whether NSAID injection has an effect on adverse events at 12 to 24 weeks (1% with NSAIDs, 1% with glucocorticoid) (absolute effect 0% difference, 95% CI 2% lower to 3% higher; 2 studies, 231 participants; RR 2.00, 95% CI 0.19 to 21.42; very low-certainty evidence).\nAuthors' conclusions\nFor adults with trigger finger, by 24 weeks' follow-up, results from two trials show that compared to glucocorticoid injection, NSAID injection offered little to no benefit in the treatment of trigger finger. Specifically, there was no difference in resolution, symptoms, recurrence, total active motion, residual pain, participant-reported treatment success, or adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What is trigger finger?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Trigger finger is a condition that affects one or more of the tendons in your hand. Tendons are tissues that join muscle to bone, to let you move your joints. When a tendon in your hand is swollen and inflamed, bending the affected finger is difficult and painful. Without treatment, the affected finger may become permanently bent, making everyday tasks difficult."
}
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query-laysum | 990 | [
{
"role": "user",
"content": "Abstract: Background\nIn most Western countries, obstetricians and midwives induce labour in about 25% of pregnant women. Oxytocin is an effective drug for this purpose, but associated with serious adverse effects of which uterine tachysystole, fetal distress and the need for immediate delivery are the most common. Various administration regimens such as reduced or pulsatile dosing have been suggested to minimise these. Discontinuation in the active phase of labour, i.e. when contractions are well-established and the cervix is dilated at least 5 cm is another method which may reduce adverse effects.\nObjectives\nTo assess whether birth outcomes can be improved by discontinuation of intravenous (IV) oxytocin, initiated in the latent phase of induced labour, once active phase of labour is established.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2018), Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) (23 January 2018) together with reference checking, citation searching, and contact with study authors to identify additional studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing discontinued IV with continuous IV oxytocin in the active phase of induced labour.\nNo exclusion criteria were applied in terms of parity, maternal age, ethnicity, co-morbidity status, labour setting, gestational age, and prior caesarean delivery.\nStudies comparing different dosage regimens are outside the scope of this review.\nData collection and analysis\nWe used standard Cochrane methods.\nMain results\nWe found 10 completed RCTs involving 1888 women. One additional trial is ongoing. The included trials were conducted in hospital settings between February 1998 and January 2016, two in Europe (Denmark, and Greece), two in Turkey, and one each in Israel, Iran, USA, Bangladesh, India, and Thailand. Most trials included full-term singleton pregnancies with a fetus in vertex presentation. Some excluded women with cervical priming prior to induction and some excluded women with a history of prior caesarean delivery. When reported, the average age of the women ranged from 22 to 31 years, nulliparity from 45% to 68%, and pre-pregnancy body mass index from 22 to 32.\nMany of the included trials had design limitations and were judged to be at either high or unclear risk of bias across a number of 'Risk of bias' domains.\nFour trials included a Consort flow diagram. In three, this gave details of participants delivered before the active phase of labour, and treatment compliance for those who reached that stage. One Consort diagram only provided the latter information. The data in many of the trials without such a flow diagram were implausibly compliant with treatment allocation, suggesting that there had been silent post randomisation exclusions of women delivered before the active phase of labour. We therefore conducted a secondary analysis (not in our protocol) of caesarean section among women who reached the active phase of labour and were therefore eligible for the intervention.\nOur analysis by 'intention-to-treat' found that, compared with continuation of IV oxytocin stimulation, discontinuation of IV oxytocin may reduce the caesarean delivery rate, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.56 to 0.86, 9 trials, 1784 women, low-level certainty. However, restricting our analysis to women who reached the active phase of labour (using 'reached active phase' as our denominator) suggests there is probably little or no difference between groups (RR 0.92, 95% CI 0.65 to 1.29, 4 trials, 787 women, moderate-certainty evidence).\nDiscontinuation of IV oxytocin probably reduces the risk ofuterine tachysystole combined with abnormal fetal heart rate (FHR) compared with continued IV oxytocin (RR 0.15, 95% CI 0.05 to 0.46, 3 trials, 486 women, moderate-level certainty). We are uncertain about whether or not discontinuation increases the risk of chorioamnionitis (average RR 2.32, 95% CI 0.99 to 5.45, 1 trial, 252 women, very low-level certainty). Discontinuation of IV oxytocin may have little or no impact on the use of analgesia and epidural during labour compared to the use of continued IV oxytocin (RR 1.04 95% CI 0.95 to 1.14, 3 trials, 556 women, low-level certainty). Intrapartum cardiotocography (CTG) abnormalities (suspicious/pathological CTGs) are probably reduced by discontinuing IV oxytocin (RR 0.65, 95% CI 0.51 to 0.83, 7 trials, 1390 women, moderate-level certainty). Compared to continuing IV oxytocin, discontinuing IV oxytocin probably has little or no impact on the incidence of Apgar < 7 at five minutes (RR 0.78, 95% CI 0.27 to 2.21, 4 trials, 893 women, low-level certainty), or and acidotic cord gasses at birth (arterial umbilical pH < 7.10), (RR 1.03, 95% CI 0.50 to 2.13, 4 trials, 873 women, low-level certainty).\nMany of this review's maternal and infant secondary outcomes (including maternal and neonatal mortality) were not reported in the included trials.\nAuthors' conclusions\nDiscontinuing IV oxytocin stimulation after the active phase of labour has been established may reduce caesarean delivery but the evidence for this was low certainty. When restricting our analysis to those trials that separately reported participants who reached the active phase of labour, our results showed there is probably little or no difference between groups. Discontinuing IV oxytocin may reduce uterine tachysystole combined with abnormal FHR.\nMost of the trials had 'Risk of bias' concerns which means that these results should be interpreted with caution. Our GRADE assessments ranged from very low certainty to moderate certainty. Downgrading decisions were based on study limitations, imprecision and indirectness.\nFuture research could account for all women randomised and, in particular, note those who delivered before the point at which they would be eligible for the intervention (i.e. those who had caesareans in the latent phase), or because labour was so rapid that the infusion could not be stopped in time.\nFuture trials could adopt the outcomes listed in this review including maternal and neonatal mortality, maternal satisfaction, and breastfeeding.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence (January 2018) and found 10 randomised controlled studies (1888 women and their babies) conducted between February 1998 and January 2016 at hospitals in Denmark, Greece, Turkey, Israel, Iran, USA, Bangladesh, India, and Thailand. We cannot be confident in the results because of study design limitations and how the findings were reported.\nStopping IV oxytocin during active labour may reduce the number of women who have a caesarean section (nine trials, 1784 women). However, when we performed another analysis including only those women who were actually in active labour, we found that there is probably little or no difference between the two groups (four trials, 787 women).\nDiscontinuing IV oxytocin probably reduces the risk of women having contractions that become too long or too strong resulting in changes to the babyโs heart rate (three trials, 486 women). We are uncertain about whether stopping IV oxytocin or not affects the risk of having a bacterial infection of the membranes or sac inside the womb) (one trial, 252 women). Stopping IV oxytocin during labour may have little or no impact on womenโs use of analgesia and epidural compared to women who continued to receive IV oxytocin (three trials, 556 women).\nThere were probably fewer babies in the discontinued IV oxytocin group with abnormal cardiotocography results (an electronic method of measuring both the womenโs contractions and the babyโs heartbeat) compared to women who continued to receive IV oxytocin (seven trials, 1390 women).\nCompared to continued IV oxytocin, discontinuing IV oxytocin probably has little or no impact on the number of babies with a low score on a standard test of well-being for newborn babies (Apgar), five minutes after being born (four trials, 893 women), or another other measure of infant well-being involving analysing blood taken from the umbilical cord once (four trials, 873 women).\nThe included trials did not report on many of this review's outcomes, including death of the mother or her baby."
}
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query-laysum | 991 | [
{
"role": "user",
"content": "Abstract: Background\nAcceptable, effective and feasible support strategies (interventions) for parents experiencing complex post-traumatic stress disorder (CPTSD) symptoms or with a history of childhood maltreatment may offer an opportunity to support parental recovery, reduce the risk of intergenerational transmission of trauma and improve life-course trajectories for children and future generations. However, evidence relating to the effect of interventions has not been synthesised to provide a comprehensive review of available support strategies. This evidence synthesis is critical to inform further research, practice and policy approaches in this emerging area.\nObjectives\nTo assess the effects of interventions provided to support parents who were experiencing CPTSD symptoms or who had experienced childhood maltreatment (or both), on parenting capacity and parental psychological or socio-emotional wellbeing.\nSearch methods\nIn October 2021 we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, together with checking references and contacting experts to identify additional studies.\nSelection criteria\nAll variants of randomised controlled trials (RCTs) comparing any intervention delivered in the perinatal period designed to support parents experiencing CPTSD symptoms or with a history of childhood maltreatment (or both), to any active or inactive control. Primary outcomes were parental psychological or socio-emotional wellbeing and parenting capacity between pregnancy and up to two years postpartum.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials for inclusion, extracted data using a pre-designed data extraction form, and assessed risk of bias and certainty of evidence. We contacted study authors for additional information as required. We analysed continuous data using mean difference (MD) for outcomes using a single measure, and standardised mean difference (SMD) for outcomes using multiple measures, and risk ratios (RR) for dichotomous data. All data are presented with 95% confidence intervals (CIs). We undertook meta-analyses using random-effects models.\nMain results\nWe included evidence from 1925 participants in 15 RCTs that investigated the effect of 17 interventions. All included studies were published after 2005. Interventions included seven parenting interventions, eight psychological interventions and two service system approaches. The studies were funded by major research councils, government departments and philanthropic/charitable organisations. All evidence was of low or very low certainty.\nParenting interventions\nEvidence was very uncertain from a study (33 participants) assessing the effects of a parenting intervention compared to attention control on trauma-related symptoms, and psychological wellbeing symptoms (postpartum depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Evidence suggested that parenting interventions may improve parent-child relationships slightly compared to usual service provision (SMD 0.45, 95% CI -0.06 to 0.96; I2 = 60%; 2 studies, 153 participants; low-certainty evidence). There may be little or no difference between parenting interventions and usual perinatal service in parenting skills including nurturance, supportive presence and reciprocity (SMD 0.25, 95% CI -0.07 to 0.58; I2 = 0%; 4 studies, 149 participants; low-certainty evidence). No studies assessed the effects of parenting interventions on parents' substance use, relationship quality or self-harm.\nPsychological interventions\nPsychological interventions may result in little or no difference in trauma-related symptoms compared to usual care (SMD -0.05, 95% CI -0.40 to 0.31; I2 = 39%; 4 studies, 247 participants; low-certainty evidence). Psychological interventions may make little or no difference compared to usual care to depression symptom severity (8 studies, 507 participants, low-certainty evidence, SMD -0.34, 95% CI -0.66 to -0.03; I2 = 63%). An interpersonally focused cognitive behavioural analysis system of psychotherapy may slightly increase the number of pregnant women who quit smoking compared to usual smoking cessation therapy and prenatal care (189 participants, low-certainty evidence). A psychological intervention may slightly improve parents' relationship quality compared to usual care (1 study, 67 participants, low-certainty evidence). Benefits for parent-child relationships were very uncertain (26 participants, very low-certainty evidence), while there may be a slight improvement in parenting skills compared to usual care (66 participants, low-certainty evidence). No studies assessed the effects of psychological interventions on parents' self-harm.\nService system approaches\nOne service system approach assessed the effect of a financial empowerment education programme, with and without trauma-informed peer support, compared to usual care for parents with low incomes. The interventions increased depression slightly (52 participants, low-certainty evidence). No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills.\nAuthors' conclusions\nThere is currently a lack of high-quality evidence regarding the effectiveness of interventions to improve parenting capacity or parental psychological or socio-emotional wellbeing in parents experiencing CPTSD symptoms or who have experienced childhood maltreatment (or both). This lack of methodological rigour and high risk of bias made it difficult to interpret the findings of this review. Overall, results suggest that parenting interventions may slightly improve parent-child relationships but have a small, unimportant effect on parenting skills. Psychological interventions may help some women stop smoking in pregnancy, and may have small benefits on parents' relationships and parenting skills. A financial empowerment programme may slightly worsen depression symptoms. While potential beneficial effects were small, the importance of a positive effect in a small number of parents must be considered when making treatment and care decisions. There is a need for further high-quality research into effective strategies for this population.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found that most of the studies did not use rigorous methods (to account for dropout) and therefore the results were uncertain.\nParenting interventions\nEvidence was very uncertain from a study of a parenting intervention compared to a control on trauma-related symptoms, and psychological wellbeing symptoms (postnatal depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Two studies found that parenting interventions may slightly improve the relationship between mothers and their child compared to usual care. Four studies found little to no difference between a parenting intervention and usual care in parenting skills. No studies assessed the effects of parenting interventions on parent's substance use, relationship quality or self-harm.\nPsychological interventions\nFour studies found little or no difference in trauma-related symptoms from a psychological intervention compared to usual care. Eight studies found little or no difference between a psychological intervention and usual care in parents psychological wellbeing (depression). Another study showed that the addition of a psychological intervention may help slightly more women quit smoking in pregnancy than usual prenatal care and smoking cessation counselling. Another found that a psychological intervention may help parents' relationship quality slightly. The evidence from one study was very uncertain about whether a psychological intervention made any difference to parent-child relationships compared to usual care. Another study found that there may be small improvements in parenting skills when parents received a psychological intervention compared to usual care. No studies assessed the effects of psychological interventions on parents' self-harm.\nService system approaches\nOne financial education programme for parents with low incomes and childhood maltreatment histories increased depression symptoms slightly compared to usual care. No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills."
}
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query-laysum | 992 | [
{
"role": "user",
"content": "Abstract: Background\nCrohnโs disease is a transmural, relapsing inflammatory condition afflicting the digestive tract. Opioid signalling, long known to affect secretion and motility in the gut, has been implicated in the inflammatory cascade of Crohnโs disease. Low dose naltrexone, an opioid antagonist, has garnered interest as a potential therapy.\nObjectives\nThe primary objective was to evaluate the efficacy and safety of low dose naltrexone for induction of remission in Crohnโs disease.\nSearch methods\nA systematic search of MEDLINE, Embase, PubMed, CENTRAL, and the Cochrane IBD Group Specialized Register was performed from inception to 15 January 2018 to identify relevant studies. Abstracts from major gastroenterology conferences including Digestive Disease Week and United European Gastroenterology Week and reference lists from retrieved articles were also screened.\nSelection criteria\nRandomized controlled trials of low dose naltrexone (LDN) for treatment of active Crohnโs disease were included.\nData collection and analysis\nData were analyzed on an intention-to-treat basis using Review Manager (RevMan 5.3.5). The primary outcome was induction of clinical remission defined by a Crohnโs disease activity index (CDAI) of < 150 or a pediatric Crohn's disease activity index (PCDAI) of < 10. Secondary outcomes included clinical response (70- or 100-point decrease in CDAI from baseline), endoscopic remission or response, quality of life, and adverse events as defined by the included studies. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The methodological quality of included studies was evaluated using the Cochrane risk of bias tool. The overall quality of the evidence supporting the primary outcome and selected secondary outcomes was assessed using the GRADE criteria.\nMain results\nTwo studies were identified (46 participants). One study assessed the efficacy and safety of 12 weeks of LDN (4.5 mg/day) treatment compared to placebo in adult patients (N = 34). The other study assessed eight weeks of LDN (0.1 mg/kg, maximum 4.5 mg/day) treatment compared to placebo in pediatric patients (N = 12). The primary purpose of the pediatric study was to assess safety and tolerability. Both studies were rated as having a low risk of bias. The study in adult patients reported that 30% (5/18) of LDN treated patients achieved clinical remission at 12 weeks compared to 18% (3/16) of placebo patients, a difference that was not statistically significant (RR 1.48, 95% CI 0.42 to 5.24). The study in children reported that 25% of LDN treated patients achieved clinical remission (PCDAI < 10) compared to none of the patients in the placebo group, although it was unclear if this result was for the randomized placebo-controlled trial or for the open label extension study. In the adult study 70-point clinical response rates were significantly higher in those treated with LDN than placebo. Eighty-three per cent (15/18) of LDN patients had a 70-point clinical response at week 12 compared to 38% (6/16) of placebo patients (RR 2.22, 95% CI 1.14 to 4.32). The effect of LDN on the proportion of adult patients who achieved a 100-point clinical response was uncertain. Sixty-one per cent (11/18) of LDN patients achieved a 100-point clinical response compared to 31% (5/16) of placebo patients (RR 1.96, 95% CI 0.87 to 4.42). The proportion of patients who achieved endoscopic response (CDEIS decline > 5 from baseline) was significantly higher in the LDN group compared to placebo. Seventy-two per cent (13/18) of LDN patients achieved an endoscopic response compared to 25% (4/16) of placebo patients (RR 2.89; 95% CI 1.18 to 7.08). However, there was no statistically significant difference in the proportion of patients who achieved endoscopic remission. Endoscopic remission (CDEIS < 3) was achieved in 22% (4/18) of the LDN group compared to 0% (0/16) of the placebo group (RR 8.05; 95% CI 0.47 to 138.87). Pooled data from both studies show no statistically significant differences in withdrawals due to adverse events or specific adverse events including sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue. No serious adverse events were reported in either study. GRADE analyses rated the overall quality of the evidence for the primary and secondary outcomes (i.e. clinical remission, clinical response, endoscopic response, and adverse events) as low due to serious imprecision (sparse data).\nAuthors' conclusions\nCurrently, there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of LDN used to treat patients with active Crohn's disease. Data from one small study suggests that LDN may provide a benefit in terms of clinical and endoscopic response in adult patients with active Crohnโs disease. Data from two small studies suggest that LDN does not increase the rate of specific adverse events relative to placebo. However, these results need to be interpreted with caution as they are based on very small numbers of patients and the overall quality of the evidence was rated as low due to serious imprecision. Further randomized controlled trials are required to assess the efficacy and safety of LDN therapy in active Crohn's disease in both adults and children.\n\nGiven the provided abstract, please respond to the following query: \"What is Crohn's disease?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Crohnโs disease is a chronic inflammatory condition of the gut, which can affect people anywhere from the mouth to anus. Common symptoms include abdominal pain, diarrhea and weight loss. People with Crohn's disease who are experiencing symptoms have 'active' disease. When the symptoms stop, it is called 'remission'."
}
]
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query-laysum | 993 | [
{
"role": "user",
"content": "Abstract: Background\nNutritional rickets is a disease which affects children, especially in low- and middle-income countries. It causes problems such as skeletal deformities and impaired growth. The most common cause of nutritional rickets is vitamin D deficiency. Vitamin D administered with or without calcium is commonly regarded as the mainstay of treatment. In some sunny countries, however, where children are believed to have adequate vitamin D production from exposure to ultraviolet light, but who are deficient in calcium due to low dietary intake, calcium alone has also been used in the treatment of nutritional rickets. Therefore, it is important to compare the effects of vitamin D, calcium or a combination of vitamin D and calcium for the treatment of nutritional rickets in children living in different settings.\nObjectives\nTo assess the effects of vitamin D, calcium or a combination of vitamin D and calcium for the treatment of nutritional rickets in children.\nSearch methods\nWe searched CENTRAL, MEDLINE, LILACS, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 25 July 2019. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCT) involving children aged 0 to 18 years with nutritional rickets which compared treatment with vitamin D, calcium or a combination of vitamin D and calcium.\nData collection and analysis\nTwo review authors independently screened the title and abstracts of all studies, extracted data and assessed the risk of bias of included studies. We resolved any disagreements by consensus or recourse to a third review author. We conducted meta-analyses for the outcomes reported by study authors. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (CI) and, for continuous outcomes, we calculated mean differences (MD) with 95% CIs. We assessed the certainty of the evidence of the included studies using GRADE.\nMain results\nWe identified 4562 studies; of these, we included four RCTs with 286 participants. The studies compared two or more of the following: vitamin D, calcium or vitamin D plus calcium. The number of participants randomised to receive vitamin D was 64, calcium was 102 and vitamin D plus calcium was 120. Two studies were conducted in India and two were conducted in Nigeria. None of the included studies had a low risk of bias in all domains. Three studies had a high risk of bias in at least one domain. The age of the participants ranged between six months and 14 years. The duration of follow-up ranged between 12 weeks and 24 weeks.\nTwo studies compared vitamin D to calcium. There is low-certainty evidence that, at 24 weeks' follow-up, calcium alone improved the healing of rickets compared to vitamin D alone (RR 3.26, 95% CI 1.59 to 6.69; P = 0.001; 1 study, 71 participants). Comparing vitamin D to calcium showed no firm evidence of an advantage or disadvantage in reducing morbidity (fractures) (RR 0.27, 95% CI 0.03 to 2.32; P = 0.23; 1 study, 71 participants; very low-certainty evidence). Adverse events were not reported.\nTwo studies compared vitamin D plus calcium to vitamin D at 12 or 24 weeks. Vitamin D plus calcium improved healing of rickets compared to vitamin D alone at 24 weeks' follow-up (RR 3.06, 95% CI 1.49 to 6.29; P = 0.002; 1 study, 75 participants; low-certainty evidence). There is no conclusive evidence in favour of either intervention for reducing morbidity (fractures) (RR 0.24, 95% CI 0.03 to 2.08; P = 0.20; 1 study, 71 participants; very low-certainty evidence) or adverse events (RR 4.76, 95% CI 0.24 to 93.19; P = 0.30; 1 study, 39 participants; very low-certainty evidence).\nAll four included studies compared vitamin D plus calcium to calcium at different follow-up times. There is no conclusive evidence on whether vitamin D plus calcium in comparison to calcium alone improved healing of rickets at 24 weeks' follow-up (RR 1.17, 95% CI 0.72 to 1.90; P = 0.53; 2 studies, 140 participants; very low-certainty evidence). Evidence is also inconclusive for morbidity (fractures) (RR 0.89, 95% CI 0.06 to 13.76; P = 0.94; 1 study, 72 participants; very low-certainty evidence) and adverse events (RR 4.29, 0.22 to 83.57; P = 0.34; 1 study, 37 participants; very low-certainty evidence).\nMost of the evidence in the review is low or very low certainty due to risk of bias, imprecision or both.\nNone of the included studies assessed all-cause mortality, health-related quality of life or socioeconomic effects. One study assessed growth pattern but this was not measured at the time-point stipulated in the protocol of our review (one or more years after commencement of therapy).\nAuthors' conclusions\nThis review provides low-certainty evidence that vitamin D plus calcium or calcium alone improve healing in children with nutritional rickets compared to vitamin D alone. We are unable to make conclusions on the effects of the interventions on adverse events or morbidity (fractures).\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": "To assess the effects of vitamin D, calcium or a combination of vitamin D and calcium for the treatment of nutritional rickets in children."
}
]
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query-laysum | 994 | [
{
"role": "user",
"content": "Abstract: Background\nPost-stroke fatigue (PSF) is a common and distressing problem after stroke. The best ways to prevent or treat PSF are uncertain. Several different interventions can be argued to have a rational basis.\nObjectives\nTo determine whether, among people with stroke, any intervention reduces the proportion of people with fatigue, fatigue severity, or both; and to determine the effect of intervention on health-related quality of life, disability, dependency and death, and whether such intervention is cost effective.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched May 2014), Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014, Issue 4), MEDLINE (1950 to May 2014), EMBASE (1980 to May 2014), CINAHL (1982 to May 2014), AMED (1985 to May 2014), PsycINFO (1967 to May 2014), Digital Dissertations (1861 to May 2014), British Nursing Index (1985 to May 2014), PEDro (searched May 2014) and PsycBITE (searched May 2014). We also searched four ongoing trials registries, scanned reference lists, performed citation tracking of included trials and contacted experts.\nSelection criteria\nTwo review authors independently scrutinised all titles and abstracts and excluded obviously irrelevant studies. We obtained the full texts for potentially relevant studies and three review authors independently applied the inclusion criteria. We included randomised controlled trials (RCTs) that compared an intervention with a control, or compared different interventions for PSF.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias for each included trial. The primary outcomes were severity of fatigue, or proportion of people with fatigue after treatment. We performed separate analyses for trials investigating efficacy in treating PSF, trials investigating efficacy in preventing PSF and trials not primarily investigating efficacy in PSF but which reported fatigue as an outcome. We pooled results from trials that had a control arm. For trials that compared different potentially active interventions without a control arm, we performed analyses for individual trials without pooling.\nWe calculated standardised mean difference (SMD) as the effect size for continuous outcomes and risk ratio (RR) for dichotomous outcomes. We pooled the results using a random-effects model and assessed heterogeneity using the I2 statistic. We performed separate subgroup analyses for pharmacological and non-pharmacological interventions. We also performed sensitivity analyses to assess the influence of methodological quality.\nMain results\nWe retrieved 12,490 citations, obtained full texts for 58 studies and included 12 trials (three from the 2008 search and nine from the 2014 search) with 703 participants. Eight trials primarily investigated the efficacy in treating PSF, of which six trials with seven comparisons provided data suitable for meta-analysis (five pharmacological interventions: fluoxetine, enerion, (-)-OSU6162, citicoline and a combination of Chinese herbs; and two non-pharmacological interventions: a fatigue education programme and a mindfulness-based stress reduction programme). The fatigue severity was lower in the intervention groups than in the control groups (244 participants, pooled SMD -1.07, 95% confidence interval (CI) -1.93 to -0.21), with significant heterogeneity between trials (I2 = 87%, degrees of freedom (df) = 6, P value < 0.00001). The beneficial effect was not seen in trials that had used adequate allocation concealment (two trials, 89 participants, SMD -0.38, 95% CI -0.80 to 0.04) or trials that had used adequate blinding of outcome assessors (four trials, 198 participants, SMD -1.10, 95% CI -2.31 to 0.11).\nNo trial primarily investigated the efficacy in preventing PSF.\nFour trials (248 participants) did not primarily investigate the efficacy on fatigue but other symptoms after stroke. None of these interventions showed any benefit on reducing PSF, which included tirilazad mesylate, continuous positive airway pressure for sleep apnoea, antidepressants and a self management programme for recovery from chronic diseases.\nAuthors' conclusions\nThere was insufficient evidence on the efficacy of any intervention to treat or prevent fatigue after stroke. Trials to date have been small and heterogeneous, and some have had a high risk of bias. Some of the interventions described were feasible in people with stroke, but their efficacy should be investigated in RCTs with a more robust study design and adequate sample sizes.\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 evidence is current to May 2014. We found 12 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 703 people with stroke. Of these 12 trials, eight trials recruited only people with fatigue and were primarily intended to treat fatigue, no trial was primarily intended to prevent fatigue and the other four trials were not primarily intended to treat or prevent fatigue but reported fatigue as an outcome."
}
]
|
query-laysum | 995 | [
{
"role": "user",
"content": "Abstract: Background\nInvasive fungal infections are important causes of morbidity and mortality among critically ill patients. Early institution of antifungal therapy is pivotal for mortality reduction. Starting a targeted antifungal therapy after culture positivity and fungi identification requires a long time. Therefore, alternative strategies (globally defined as 'untargeted antifungal treatments') for antifungal therapy institution in patients without proven microbiological evidence of fungal infections have been discussed by international guidelines. This review was originally published in 2006 and updated in 2016. This updated review provides additional evidence for the clinician dealing with suspicion of fungal infection in critically ill, non-neutropenic patients, taking into account recent findings in this field.\nObjectives\nTo assess the effects of untargeted treatment with any antifungal drug (either systemic or nonabsorbable) compared to placebo or no antifungal or any other antifungal drug (either systemic or nonabsorbable) in non-neutropenic, critically ill adults and children. We assessed effectiveness in terms of total (all-cause) mortality and incidence of proven invasive fungal infections as primary outcomes.\nSearch methods\nWe searched the following databases to February 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), and EMBASE (OVID). We also searched reference lists of identified studies and major reviews, abstracts of conference proceedings, scientific meetings and clinical trials registries. We contacted experts in the field, study authors and pharmaceutical companies as part of the search strategy.\nSelection criteria\nWe included randomized controlled trials (RCTs) (irrespective of language or publication status) comparing the use of untargeted treatment with any antifungal drug (either systemic or nonabsorbable) to placebo, no antifungal, or another antifungal agent in non-neutropenic critically ill participants.\nData collection and analysis\nThree authors independently applied selection criteria, extracted data and assessed the risk of bias. We resolved any discrepancies by discussion. We synthesized data using the random-effects model and expressed the results as risk ratios (RR) with 95% confidence intervals. We assessed overall evidence quality using the GRADE approach.\nMain results\nWe included 22 studies (total of 2761 participants). Of those 22 studies, 12 were included in the original published review and 10 were newly identified. Eleven trials compared the use of fluconazole to placebo or no antifungal treatment. Three trials compared ketoconazole versus placebo. One trial compared anidulafungin with placebo. One trial compared caspofungin to placebo. Two trials compared micafungin to placebo. One trial compared amphotericin B to placebo. Two trials compared nystatin to placebo and one trial compared the effect of clotrimazole, ketoconazole, nystatin and no treatment. We found two new ongoing studies and four new studies awaiting classification. The RCTs included participants of both genders with wide age range, severity of critical illness and clinical characteristics. Funding sources from pharmaceutical companies were reported in 11 trials and one trial reported funding from a government agency. Most of the studies had an overall unclear risk of bias for key domains of this review (random sequence generation, allocation concealment, incomplete outcome data). Two studies had a high risk of bias for key domains. Regarding the other domains (blinding of participants and personnel, outcome assessment, selective reporting, other bias), most of the studies had a low or unclear risk but four studies had a high risk of bias.\nThere was moderate grade evidence that untargeted antifungal treatment did not significantly reduce or increase total (all-cause) mortality (RR 0.93, 95% CI 0.79 to 1.09, P value = 0.36; participants = 2374; studies = 19). With regard to the outcome of proven invasive fungal infection, there was low grade evidence that untargeted antifungal treatment significantly reduced the risk (RR 0.57, 95% CI 0.39 to 0.83, P value = 0.0001; participants = 2024; studies = 17). The risk of fungal colonization was significantly reduced (RR 0.71, 95% CI 0.52 to 0.97, P value = 0.03; participants = 1030; studies = 12) but the quality of evidence was low. There was no difference in the risk of developing superficial fungal infection (RR 0.69, 95% CI 0.37 to 1.29, P value = 0.24; participants = 662; studies = 5; low grade of evidence) or in adverse events requiring cessation of treatment between the untargeted treatment group and the other group (RR 0.89, 95% CI 0.62 to 1.27, P value = 0.51; participants = 1691; studies = 11; low quality of evidence). The quality of evidence for the outcome of total (all-cause) mortality was moderate due to limitations in study design. The quality of evidence for the outcome of invasive fungal infection, superficial fungal infection, fungal colonization and adverse events requiring cessation of therapy was low due to limitations in study design, non-optimal total population size, risk of publication bias, and heterogeneity across studies.\nAuthors' conclusions\nThere is moderate quality evidence that the use of untargeted antifungal treatment is not associated with a significant reduction in total (all-cause) mortality among critically ill, non-neutropenic adults and children compared to no antifungal treatment or placebo. The untargeted antifungal treatment may be associated with a reduction of invasive fungal infections but the quality of evidence is low, and both the heterogeneity and risk of publication bias is high.\nFurther high-quality RCTs are needed to improve the strength of the evidence, especially for more recent and less studied drugs (e.g. echinocandins). Future trials should adopt standardized definitions for microbiological outcomes (e.g. invasive fungal infection, colonization) to reduce heterogeneity. Emergence of resistance to antifungal drugs should be considered as outcome in studies investigating the effects of untargeted antifungal treatment to balance risks and benefit.\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 randomized controlled trials (RCTs) (total of 2761 participants). Eleven trials compared the use of fluconazole to placebo or no antifungal treatment. Three trials compared ketoconazole versus placebo. One trial compared anidulafungin with placebo. One trial compared caspofungin to placebo. Two trials compared micafungin to placebo. One trial compared amphotericin B to placebo. Two trials compared nystatin to placebo and one trial compared the effect of clotrimazole, ketoconazole, nystatin and no treatment. The RCTs included participants of both genders with a wide age range and severity of critical illness."
}
]
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query-laysum | 996 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.\nChemotherapy has significantly improved prognosis for women with malignant and some non-malignant conditions. This treatment, however, is associated with ovarian toxicity. The use of gonadotropin-releasing hormone (GnRH) analogues, both agonists and antagonists, may have a protective effect on the ovaries. The primary mechanism of action of GnRH analogues is to suppress the gonadotropin levels to simulate pre-pubertal hormonal milieu and subsequently prevent primordial follicles from maturation and therefore decrease the number of follicles that are more vulnerable to chemotherapy.\nObjectives\nTo assess the efficacy and safety of GnRH analogues given before or in parallel to chemotherapy to prevent chemotherapy-related ovarian damage in premenopausal women with malignant or non-malignant conditions.\nSearch methods\nThe search was run for the original review in July 2011, and for the first update in July 2014. For this update we searched the following databases in November 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Chinese Biomedicine Database (CBM).\nSelection criteria\nRandomised controlled trials (RCTs), in all languages, which examined the effect of GnRH analogues for chemotherapy-induced ovarian failure in premenopausal women, were eligible for inclusion in the review.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality using the Cochrane 'Risk of bias' tool. We analysed binary data using risk ratios (RRs) with 95% confidence intervals (CI) and for continuous data, we used the standardized mean difference (SMD) to combine trials. We applied the random-effects model in our analyses. We used the GRADE approach to produce a 'Summary of findings' table for our main outcomes of interest.\nMain results\nWe included 12 RCTs involving 1369 women between the ages of 12 and 51.1 years. Participants were diagnosed with breast malignancy, ovarian malignancy, or Hodgkin's lymphoma, and most of them received alkylating, or platinum complexes, based chemotherapy. The included studies were funded by a university (n = 1), research centres (n = 4), and pharmaceutical companies (n = 1). Trials were at high or unclear risk of bias.\n\nComparison 1: GnRH agonist plus chemotherapy versus chemotherapy alone\nThe incidence of menstruation recovery or maintenance was 178 of 239 (74.5%) in the GnRH agonist group and 110 of 221 (50.0%) in the control group during a follow-up period no longer than 12 months (RR 1.60, 95% CI 1.14 to 2.24; 5 studies, 460 participants; I2 = 79%; low-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P = 0.006). However, we observed no difference during a follow-up period longer than 12 months between these two groups (P = 0.24). In the GnRH agonist group, 326 of 447 participants had menstruation recovery or maintenance (72.9%) in comparison to the control group, in which 276 of 422 participants had menstruation recovery or maintenance (65.4%) during a follow-up period longer than 12 months (RR 1.08, 95% CI 0.95 to 1.22; 8 studies, 869 participants; I2 = 56%; low-certainty evidence).\nThe incidence of premature ovarian failure was 43 of 401 (10.7%) in the GnRH agonist group and 96 of 379 (25.3%) in the control group (RR 0.44, 95% CI 0.31 to 0.61; 4 studies, 780 participants; I2 = 0%; moderate-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P < 0.00001).\nThe incidence of pregnancy was 32 of 356 (9.0%) in the GnRH agonist group and 22 of 347 (6.3%) in the control group (RR 1.59, 95% CI 0.93 to 2.70; 7 studies, 703 participants; I2 = 0%; low-certainty evidence), with no difference between groups (P = 0.09). However, we are cautious about this conclusion because there were insufficient data about whether the participants intended to become pregnant.\nThe incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I2 = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).\nThe most common adverse effects of GnRH analogues included hot flushes, vaginal dryness, urogenital symptoms, and mood swings. The pooled analysis of safety data showed no difference in adverse effects between GnRH agonist group and control group.\n\nComparison 2: GnRH agonist-antagonist cotreatment plus chemotherapy versus chemotherapy alone\nOnly one RCT discussed GnRH agonist-antagonist cotreatment. The limited evidence showed the incidence of menstruation recovery or maintenance was 20 of 25 (80%) in both cotreatment group and control group during a 12-month follow-up period (RR 1.00, 95% CI 0.76 to 1.32; 50 participants; very low-certainty evidence), with no difference between groups (P = 1.00). In the cotreatment group, 13 of 25 participants had menstruation recovery or maintenance (52.0%) in comparison to the control group, in which 14 of 25 participants had menstruation recovery or maintenance (56.0%) during a follow-up period longer than 12 months (RR 0.93, 95% CI 0.56 to 1.55; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.78). The incidence of pregnancy was 1 of 25 (4.0%) in the cotreatment group and 0 of 25 (0%) in the control group (RR 3.00, 95% CI 0.13 to 70.30; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.49).\nAuthors' conclusions\nGnRH agonist appears to be effective in protecting the ovaries during chemotherapy, in terms of maintenance and resumption of menstruation, treatment-related premature ovarian failure and ovulation. Evidence for protection of fertility was insufficient and needs further investigation. Evidence was also insufficient to assess the effect of GnRH agonist and GnRH antagonist cotreatment on ovarian protection against chemotherapy. The included studies differed in some important aspects of design, and most of these studies had no age-determined subgroup analysis. Large and well-designed RCTs with longer follow-up duration should be conducted to clarify the effects of GnRH analogues in preventing chemotherapy-induced ovarian failure, especially on different age groups or different chemotherapy regimens. Furthermore, studies should address the effects on pregnancy rates and anti-tumour therapy.\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": "GnRH agonist appears to be effective in protecting the ovaries during chemotherapy, in terms of menstruation recovery or maintenance, premature ovarian failure and ovulation. Evidence for rates of pregnancy was insufficient and needs further investigation. Evidence was also insufficient to assess the effect of GnRH agonist-antagonist cotreatment on ovarian function with chemotherapy."
}
]
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query-laysum | 997 | [
{
"role": "user",
"content": "Abstract: Background\nRestless legs syndrome (RLS) is a common neurologic disorder that is associated with peripheral iron deficiency in a subgroup of patients. It is unclear whether iron therapy is effective treatment for RLS.\nObjectives\nTo evaluate the efficacy and safety of oral or parenteral iron for the treatment of restless legs syndrome (RLS) when compared with placebo or other therapies.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycNFO, and CINAHL for the time period January 1995 to September 2017. We searched reference lists for additional published studies. We searched Clinicaltrials.gov and other clinical trial registries (September 2017) for ongoing or unpublished studies.\nSelection criteria\nControlled trials comparing any formulation of iron with placebo, other medications, or no treatment, in adults diagnosed with RLS according to expert clinical interview or explicit diagnostic criteria.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality, with discussion to reach consensus in the case of any disagreement. The primary outcome considered in this review was restlessness or unpleasant sensations, as experienced subjectively by the patient. We combined treatment/control differences in the outcomes across studies using random-effects meta-analyses. We analysed continuous data using mean differences (MDs) where possible and performed standardised mean difference (SMD) analyses when different measurements were used across studies. We calculated risk ratios (RRs) for dichotomous data using the Mantel-Haenszel method and 95% confidence intervals (CIs). We analysed study heterogeneity using the I2 statistic. We used standard methodological procedures expected by Cochrane. We performed GRADE analysis using GRADEpro.\nMain results\nWe identified and included 10 studies (428 total participants, followed for 2-16 weeks) in this review. Our primary outcome was restlessness or uncomfortable leg sensations, which was quantified using the International Restless Legs Scale (IRLS) (range, 0 to 40) in eight trials and a different RLS symptom scale in a ninth trial. Nine studies compared iron to placebo and one study compared iron to a dopamine agonist (pramipexole). The possibility for bias among the trials was variable. Three studies had a single element with high risk of bias, which was lack of blinding in two and incomplete outcome data in one. All studies had at least one feature resulting in unclear risk of bias.\nCombining data from the seven trials using the IRLS to compare iron and placebo, use of iron resulted in greater improvement in IRLS scores (MD -3.78, 95% CI -6.25 to -1.31; I2= 66%, 7 studies, 345 participants) measured 2 to 12 weeks after treatment. Including an eighth study, which measured restlessness using a different scale, use of iron remained beneficial compared to placebo (SMD -0.74, 95% CI -1.26 to -0.23; I2 = 80%, 8 studies, 370 participants). The GRADE assessment of certainty for this outcome was moderate.\nThe single study comparing iron to a dopamine agonist (pramipexole) found a similar reduction in RLS severity in the two groups (MD -0.40, 95% CI -5.93 to 5.13, 30 participants).\nAssessment of secondary outcomes was limited by small numbers of trials assessing each outcome. Iron did not improve quality of life as a dichotomous measure (RR 2.01, 95% CI 0.54 to 7.45; I2=54%, 2 studies, 39 participants), but did improve quality of life measured on continuous scales (SMD 0.51, 95% CI 0.15 to 0.87; I2= 0%, 3 studies, 128 participants), compared to placebo. Subjective sleep quality was no different between iron and placebo groups (SMD 0.19, 95% CI -0.18 to 0.56; I2 = 9%, 3 studies, 128 participants), nor was objective sleep quality, as measured by change in sleep efficiency in a single study (-35.5 +/- 92.0 versus -41.4 +/- 98.2, 18 participants). Periodic limb movements of sleep were not significantly reduced with iron compared to placebo ( SMD -0.19, 95% CI -0.70 to 0.32; I2 = 0%, 2 studies, 60 participants). Iron did not improve sleepiness compared to placebo, as measured on the Epworth Sleepiness Scale (data not provided, 1 study, 60 participants) but did improve the daytime tiredness item of the RLS-6 compared to placebo (least squares mean difference -1.5, 95% CI -2.5 to -0.6; 1 study, 110 participants). The GRADE rating for secondary outcomes ranged from low to very low.\nPrespecified subgroup analyses showed more improvement with iron in those trials studying participants on dialysis. The use of low serum ferritin levels as an inclusion criteria and the use or oral versus intravenous iron did not show significant subgroup differences.\nIron did not result in significantly more adverse events than placebo (RR 1.48, 95% CI 0.97 to 2.25; I2=45%, 6 studies, 298 participants). A single study reported that people treated with iron therapy experienced fewer adverse events than the active comparator pramipexole.\nAuthors' conclusions\nIron therapy probably improves restlessness and RLS severity in comparison to placebo. Iron therapy may not increase the risk of side effects in comparison to placebo. We are uncertain whether iron therapy improves quality of life in comparison to placebo. Iron therapy may make little or no difference to pramipexole in restlessness and RLS severity, as well as in the risk of adverse events. The effect on secondary outcomes such as quality of life, daytime functioning, and sleep quality, the optimal timing and formulation of administration, and patient characteristics predicting response require additional study.\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": "Restless legs syndrome is a common medical condition that causes uncomfortable urges to move the legs. These urges happen in the evening and at night and can keep people from sleeping well. Low blood levels of iron are often seen in people who have restless legs syndrome. Low blood iron levels may be part of the cause of restless legs syndrome. Iron can be taken as a pill or given as an injection into the bloodstream. We performed this review to see if iron treatment reduces the symptoms of restless legs syndrome."
}
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query-laysum | 998 | [
{
"role": "user",
"content": "Abstract: Background\nOnychomycosis refers to fungal infections of the nail apparatus that may cause pain, discomfort, and disfigurement. This is an update of a Cochrane Review published in 2007; a substantial amount of new research warrants a review exclusively on toenails.\nObjectives\nTo assess the clinical and mycological effects of topical drugs and device-based therapies for toenail onychomycosis.\nSearch methods\nWe searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials.\nSelection criteria\nRandomised controlled trials of topical and device-based therapies for onychomycosis in participants with toenail onychomycosis, confirmed by positive cultures, direct microscopy, or histological nail examination. Eligible comparators were placebo, vehicle, no treatment, or an active topical or device-based treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcomes were complete cure rate (normal-looking nail plus fungus elimination, determined with laboratory methods) and number of participants reporting treatment-related adverse events.\nMain results\nWe included 56 studies (12,501 participants, average age: 27 to 68 years), with mainly mild-to-moderate onychomycosis without matrix involvement (where reported). Participants had more than one toenail affected. Most studies lasted 48 to 52 weeks; 23% reported disease duration (variable). Thirty-five studies specifically examined dermatophyte-caused onychomycosis. Forty-three studies were carried out in outpatient settings. Most studies assessed topical treatments, 9% devices, and 11% both.\nWe rated three studies at low risk of bias across all domains. The most common high-risk domain was performance bias. We present results for key comparisons, where treatment duration was 36 or 48 weeks, and clinical outcomes were measured at 40 to 52 weeks.\nBased on two studies (460 participants), compared with vehicle, ciclopirox 8% lacquer may be more effective in achieving complete cure (risk ratio (RR) 9.29, 95% confidence interval (CI) 1.72 to 50.14; low-quality evidence) and is probably more effective in achieving mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence). Ciclopirox lacquer may lead to increased adverse events, commonly application reactions, rashes, and nail alteration (e.g. colour, shape). However, the 95% CI indicates that ciclopirox lacquer may actually make little or no difference (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence).\nEfinaconazole 10% solution is more effective than vehicle in achieving complete cure (RR 3.54, 95% CI 2.24 to 5.60; 3 studies, 1716 participants) and clinical cure (RR 3.07, 95% CI 2.08 to 4.53; 2 studies, 1655 participants) (both high-quality evidence) and is probably more effective in achieving mycological cure (RR 2.31, 95% CI 1.08 to 4.94; 3 studies, 1716 participants; moderate-quality evidence). Risk of adverse events (such as dermatitis and vesicles) was slightly higher with efinaconazole (RR 1.10, 95% CI 1.01 to 1.20; 3 studies, 1701 participants; high-quality evidence). No other key comparison measured clinical cure.\nBased on two studies, compared with vehicle, tavaborole 5% solution is probably more effective in achieving complete cure (RR 7.40, 95% CI 2.71 to 20.24; 1198 participants), but probably has a higher risk of adverse events (application site reactions were most commonly reported) (RR 3.82, 95% CI 1.65 to 8.85; 1186 participants (both moderate-quality evidence)). Tavaborole improves mycological cure (RR 3.40, 95% CI 2.34 to 4.93; 1198 participants; high-quality evidence).\nModerate-quality evidence from two studies (490 participants) indicates that P-3051 (ciclopirox 8% hydrolacquer) is probably more effective than the comparators ciclopirox 8% lacquer or amorolfine 5% in achieving complete cure (RR 2.43, 95% CI 1.32 to 4.48), but there is probably little or no difference between the treatments in achieving mycological cure (RR 1.08, 95% CI 0.85 to 1.37). We found no difference in the risk of adverse events (RR 0.60, 95% CI 0.19 to 1.92; 2 studies, 487 participants; low-quality evidence). The most common events were erythema, rash, and burning.\nThree studies (112 participants) compared 1064-nm Nd:YAG laser to no treatment or sham treatment. We are uncertain if there is a difference in adverse events (very low-quality evidence) (two studies; 85 participants). There may be little or no difference in mycological cure at 52 weeks (RR 1.04, 95% CI 0.59 to 1.85; 2 studies, 85 participants; low-quality evidence). Complete cure was not measured.\nOne study (293 participants) compared luliconazole 5% solution to vehicle. We are uncertain whether luliconazole leads to higher rates of complete cure (very low-quality evidence). Low-quality evidence indicates there may be little or no difference in adverse events (RR 1.02, 95% CI 0.90 to 1.16) and there may be increased mycological cure with luliconazole; however, the 95% CI indicates that luliconazole may make little or no difference to mycological cure (RR 1.39, 95% CI 0.98 to 1.97). Commonly-reported adverse events were dry skin, paronychia, eczema, and hyperkeratosis, which improved or resolved post-treatment.\nAuthors' conclusions\nAssessing complete cure, high-quality evidence supports the effectiveness of efinaconazole, moderate-quality evidence supports P-3051 (ciclopirox 8% hydrolacquer) and tavaborole, and low-quality evidence supports ciclopirox 8% lacquer. We are uncertain whether luliconazole 5% solution leads to complete cure (very low-quality evidence); this outcome was not measured by the 1064-nm Nd:YAG laser comparison. Although evidence supports topical treatments, complete cure rates with topical treatments are relatively low.\nWe are uncertain if 1064-nm Nd:YAG laser increases adverse events compared with no treatment or sham treatment (very low-quality evidence). Low-quality evidence indicates that there is no difference in adverse events between P-3051 (ciclopirox hydrolacquer), luliconazole 5% solution, and their comparators. Ciclopirox 8% lacquer may increase adverse events (low-quality evidence). High- to moderate-quality evidence suggests increased adverse events with efinaconazole 10% solution or tavaborole 5% solution.\nWe downgraded evidence for heterogeneity, lack of blinding, and small sample sizes. There is uncertainty about the effectiveness of device-based treatments, which were under-represented; 80% of studies assessed topical treatments, but we were unable to evaluate all of the currently relevant topical treatments.\nFuture studies of topical and device-based therapies should be blinded, with patient-centred outcomes and an adequate sample size. They should specify the causative organism and directly compare treatments.\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"
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"role": "assistant",
"content": "For the following key results, treatment lasted 36 or 48 weeks, and outcomes were measured at 40 to 52 weeks (side effects were measured throughout the study).\nCompared to vehicle (no treatment), efinaconazole 10% topical solution is better at achieving complete cure (i.e. normal-looking nail coupled with fungus elimination determined using laboratory methods) (high-quality evidence). Tavaborole 5% solution (when compared to vehicle) and P-3051 (ciclopirox 8% hydrolacquer) (when compared to two other treatments: ciclopirox 8% lacquer or amorolfine 5%) are probably better at achieving this outcome (both moderate-quality evidence). Ciclopirox 8% lacquer may lead to higher complete cure rates than vehicle, but rates are low (not all patients can be expected to achieve complete cure) (low-quality evidence).\nCiclopirox 8% lacquer and efinaconazole 10% are probably more effective at eliminating the fungus (mycological cure) than vehicle, but for P-3051 (ciclopirox 8% hydrolacquer) there is probably little or no difference compared to the two comparator treatments (all moderate-quality evidence). Tavaborole 5% improves mycological cure compared to vehicle (high-quality evidence).\nWe found no evidence of a difference in side effects, including redness, rash, and burning, between P-3051 (ciclopirox 8% hydrolacquer) and the two other treatments (low-quality evidence), and ciclopirox 8% lacquer may increase side effects, including application-site reactions, rashes, and changes in the nail compared with vehicle, although treatment effects vary, so it is possible that it may actually make little or no difference (low-quality evidence). Compared to vehicle, participants were slightly more likely to experience side effects (commonly dermatitis and fluid-filled sacs) with efinaconazole 10% (high-quality evidence) and probably more likely to experience side effects with tavaborole 5% (commonly, application-site reactions, such as dermatitis, redness, and pain) (moderate-quality evidence).\nWe are uncertain of the effect of luliconazole 5% on complete cure when compared to vehicle (very low-quality evidence); there may be little or no difference between these groups in side effects (dry skin, eczema, and thickening of the skin were commonly reported, but improved after stopping treatment), and luliconazole 5% solution might increase mycological cure; however, the effects of this treatment vary, so it is possible that it may actually make little or no difference to mycological cure (both low-quality evidence).\nThree studies compared laser to no treatment or sham treatment, and there may be little or no difference in mycological cure (low-quality evidence). Complete cure was not measured, and we are uncertain if there is a difference in side effects between groups (very low-quality evidence).\nEfinaconazole 10% solution is more effective in achieving clinical cure than vehicle (high-quality evidence); none of the other key comparisons measured this outcome."
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query-laysum | 999 | [
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"content": "Abstract: Background\nIncontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and procedures are the same for both prevention and treatment of IAD.\nObjectives\nThe objective of this review was to assess the effectiveness of various products and procedures to prevent\nand treat incontinence-associated dermatitis in adults.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Trials 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 28 September 2016). Additionally we searched other electronic databases: CENTRAL(2015, Issue 4), MEDLINE (January 1946 to May Week 3 2015), MEDLINE In-Process (inception to 26 May 2015), CINAHL(December 1981 to 28 May 2015), Web of Science (WoS; inception to 28 May 2015) and handsearched conference proceedings (to June 2015) and the reference lists of relevant articles, and contacted authors and experts in the field.\nSelection criteria\nWe selected randomised controlled trials (RCTs) and quasi-RCTs, performed in any healthcare setting, with included participants over 18 years of age, with or without IAD. We included trials comparing the (cost) effectiveness of topical skin care products such as skin cleansers, moisturisers, and skin protectants of different compositions and skin care procedures aiming to prevent and treat IAD.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-texts, extracted data, and assessed the risk of bias of the included trials.\nMain results\nWe included 13 trials with 1316 participants in a qualitative synthesis. Participants were incontinent for urine, stool, or both, and were residents in a nursing home or were hospitalised.\nEleven trials had a small sample size and short follow-up periods. .The overall risk of bias in the included studies was high. The data were not suitable for meta-analysis due to heterogeneity in participant population, skin care products, skin care procedures, outcomes, and measurement tools.\nNine trials compared different topical skin care products, including a combination of products. Two trials tested a structured skin care procedure. One trial compared topical skin care products alongside frequencies of application. One trial compared frequencies of application of topical skin care products.\nWe found evidence in two trials, being of low and moderate quality, that soap and water performed poorly in the prevention and treatment of IAD (primary outcomes of this review). The first trial indicated that the use of a skin cleanser might be more effective than the use of soap and water (risk ratio (RR) 0.39, 95% confidence interval (CI) 0.17 to 0.87; low quality evidence). The second trial indicated that a structured skin care procedure, being a washcloth with cleansing, moisturising, and protecting properties, might be more effective than soap and water (RR 0.31, 95% CI 0.12 to 0.79; moderate quality evidence). Findings from the other trials, all being of low to very low quality, suggest that applying a leave-on product (moisturiser, skin protectant, or a combination) might be more effective than not applying a leave-on product. No trial reported on the third primary outcome 'number of participants not satisfied with treatment' or on adverse effects.\nAuthors' conclusions\nLittle evidence, of very low to moderate quality, exists on the effects of interventions for preventing and treating IAD in adults. Soap and water performed poorly in the prevention and treatment of IAD. Application of leave-on products (moisturisers, skin protectants, or a combination) and avoiding soap seems to be more effective than withholding these products. The performance of leave-on products depends on the combination of ingredients, the overall formulation and the usage (e.g. amount applied). High quality confirmatory trials using standardised, and comparable prevention and treatment regimens in different settings/regions are required. Furthermore, to increase the comparability of trial results, we recommend the development of a core outcome set, including validated measurement tools. The evidence in this review is current up to 28 September 2016.\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": "This review clarified the effect of various skin care products and procedures to prevent and treat IAD."
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query-laysum | 1000 | [
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"role": "user",
"content": "Abstract: Background\nResilience can be defined as the maintenance or quick recovery of mental health during or after periods of stressor exposure, which may result from a potentially traumatising event, challenging life circumstances, a critical life transition phase, or physical illness. Healthcare professionals, such as nurses, physicians, psychologists and social workers, are exposed to various work-related stressors (e.g. patient care, time pressure, administration) and are at increased risk of developing mental disorders. This population may benefit from resilience-promoting training programmes.\nObjectives\nTo assess the effects of interventions to foster resilience in healthcare professionals, that is, healthcare staff delivering direct medical care (e.g. nurses, physicians, hospital personnel) and allied healthcare staff (e.g. social workers, psychologists).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 11 other databases and three trial registries from 1990 to June 2019. We checked reference lists and contacted researchers in the field. We updated this search in four key databases in June 2020, but we have not yet incorporated these results.\nSelection criteria\nRandomised controlled trials (RCTs) in adults aged 18 years and older who are employed as healthcare professionals, comparing any form of psychological intervention to foster resilience, hardiness or post-traumatic growth versus no intervention, wait-list, usual care, active or attention control. Primary outcomes were resilience, anxiety, depression, stress or stress perception and well-being or quality of life. Secondary outcomes were resilience factors.\nData collection and analysis\nTwo review authors independently selected studies, extracted data, assessed risks of bias, and rated the certainty of the evidence using the GRADE approach (at post-test only).\nMain results\nWe included 44 RCTs (high-income countries: 36). Thirty-nine studies solely focused on healthcare professionals (6892 participants), including both healthcare staff delivering direct medical care and allied healthcare staff. Four studies investigated mixed samples (1000 participants) with healthcare professionals and participants working outside of the healthcare sector, and one study evaluated training for emergency personnel in general population volunteers (82 participants). The included studies were mainly conducted in a hospital setting and included physicians, nurses and different hospital personnel (37/44 studies).\nParticipants mainly included women (68%) from young to middle adulthood (mean age range: 27 to 52.4 years). Most studies investigated group interventions (30 studies) of high training intensity (18 studies; > 12 hours/sessions), that were delivered face-to-face (29 studies). Of the included studies, 19 compared a resilience training based on combined theoretical foundation (e.g. mindfulness and cognitive-behavioural therapy) versus unspecific comparators (e.g. wait-list). The studies were funded by different sources (e.g. hospitals, universities), or a combination of different sources. Fifteen studies did not specify the source of their funding, and one study received no funding support.\nRisk of bias was high or unclear for most studies in performance, detection, and attrition bias domains.\nAt post-intervention, very-low certainty evidence indicated that, compared to controls, healthcare professionals receiving resilience training may report higher levels of resilience (standardised mean difference (SMD) 0.45, 95% confidence interval (CI) 0.25 to 0.65; 12 studies, 690 participants), lower levels of depression (SMD โ0.29, 95% CI โ0.50 to โ0.09; 14 studies, 788 participants), and lower levels of stress or stress perception (SMD โ0.61, 95% CI โ1.07 to โ0.15; 17 studies, 997 participants). There was little or no evidence of any effect of resilience training on anxiety (SMD โ0.06, 95% CI โ0.35 to 0.23; 5 studies, 231 participants; very-low certainty evidence) or well-being or quality of life (SMD 0.14, 95% CI โ0.01 to 0.30; 13 studies, 1494 participants; very-low certainty evidence). Effect sizes were small except for resilience and stress reduction (moderate). Data on adverse effects were available for three studies, with none reporting any adverse effects occurring during the study (very-low certainty evidence).\nAuthors' conclusions\nFor healthcare professionals, there is very-low certainty evidence that, compared to control, resilience training may result in higher levels of resilience, lower levels of depression, stress or stress perception, and higher levels of certain resilience factors at post-intervention.\nThe paucity of medium- or long-term data, heterogeneous interventions and restricted geographical distribution limit the generalisability of our results. Conclusions should therefore be drawn cautiously. The findings suggest positive effects of resilience training for healthcare professionals, but the evidence is very uncertain. There is a clear need for high-quality replications and improved study designs.\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": "The work of healthcare professionals (e.g. nurses, physicians, psychologists, social workers) can be very stressful. They often carry a lot of responsibility and are required to work under pressure. This can adversely affect their physical and mental health. Interventions to protect them against such stresses are known as resilience interventions. Previous systematic reviews suggest that resilience interventions can help workers cope with stress and protect them against adverse consequences for their physical and mental health."
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"role": "user",
"content": "Abstract: Background\nThe pharmacological profiles and mechanisms of antidepressants are varied. However, there are common reasons why they might help people to stop smoking tobacco: nicotine withdrawal can produce short-term low mood that antidepressants may relieve; and some antidepressants may have a specific effect on neural pathways or receptors that underlie nicotine addiction.\nObjectives\nTo assess the evidence for the efficacy, harms, and tolerability of medications with antidepressant properties in assisting long-term tobacco smoking cessation in people who smoke cigarettes.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register, most recently on 29 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) in people who smoked, comparing antidepressant medications with placebo or no pharmacological treatment, an alternative pharmacotherapy, or the same medication used differently. We excluded trials with fewer than six months of follow-up from efficacy analyses. We included trials with any follow-up length for our analyses of harms.\nData collection and analysis\nWe extracted data and assessed risk of bias using standard Cochrane methods.\nOur primary outcome measure was smoking cessation after at least six months' follow-up. We used the most rigorous definition of abstinence available in each trial, and biochemically validated rates if available. Our secondary outcomes were harms and tolerance outcomes, including adverse events (AEs), serious adverse events (SAEs), psychiatric AEs, seizures, overdoses, suicide attempts, death by suicide, all-cause mortality, and trial dropouts due to treatment. We carried out meta-analyses where appropriate.\nMain results\nWe included a total of 124 studies (48,832 participants) in this review, with 10 new studies added to this update version. Most studies recruited adults from the community or from smoking cessation clinics; four studies focused on adolescents (with participants between 12 and 21 years old). We judged 34 studies to be at high risk of bias; however, restricting analyses only to studies at low or unclear risk of bias did not change clinical interpretation of the results.\nThere was high-certainty evidence that bupropion increased smoking cessation rates when compared to placebo or no pharmacological treatment (RR 1.60, 95% CI 1.49 to 1.72; I2 = 16%; 50 studies, 18,577 participants). There was moderate-certainty evidence that a combination of bupropion and varenicline may have resulted in superior quit rates to varenicline alone (RR 1.21, 95% CI 0.95 to 1.55; I2 = 15%; 3 studies, 1057 participants). However, there was insufficient evidence to establish whether a combination of bupropion and nicotine replacement therapy (NRT) resulted in superior quit rates to NRT alone (RR 1.17, 95% CI 0.95 to 1.44; I2 = 43%; 15 studies, 4117 participants; low-certainty evidence).\nThere was moderate-certainty evidence that participants taking bupropion were more likely to report SAEs than those taking placebo or no pharmacological treatment. However, results were imprecise and the CI also encompassed no difference (RR 1.16, 95% CI 0.90 to 1.48; I2 = 0%; 23 studies, 10,958 participants). Results were also imprecise when comparing SAEs between people randomised to a combination of bupropion and NRT versus NRT alone (RR 1.52, 95% CI 0.26 to 8.89; I2 = 0%; 4 studies, 657 participants) and randomised to bupropion plus varenicline versus varenicline alone (RR 1.23, 95% CI 0.63 to 2.42; I2 = 0%; 5 studies, 1268 participants). In both cases, we judged evidence to be of low certainty.\nThere was high-certainty evidence that bupropion resulted in more trial dropouts due to AEs than placebo or no pharmacological treatment (RR 1.44, 95% CI 1.27 to 1.65; I2 = 2%; 25 studies, 12,346 participants). However, there was insufficient evidence that bupropion combined with NRT versus NRT alone (RR 1.67, 95% CI 0.95 to 2.92; I2 = 0%; 3 studies, 737 participants) or bupropion combined with varenicline versus varenicline alone (RR 0.80, 95% CI 0.45 to 1.45; I2 = 0%; 4 studies, 1230 participants) had an impact on the number of dropouts due to treatment. In both cases, imprecision was substantial (we judged the evidence to be of low certainty for both comparisons).\nBupropion resulted in inferior smoking cessation rates to varenicline (RR 0.73, 95% CI 0.67 to 0.80; I2 = 0%; 9 studies, 7564 participants), and to combination NRT (RR 0.74, 95% CI 0.55 to 0.98; I2 = 0%; 2 studies; 720 participants). However, there was no clear evidence of a difference in efficacy between bupropion and single-form NRT (RR 1.03, 95% CI 0.93 to 1.13; I2 = 0%; 10 studies, 7613 participants). We also found evidence that nortriptyline aided smoking cessation when compared with placebo (RR 2.03, 95% CI 1.48 to 2.78; I2 = 16%; 6 studies, 975 participants), and some evidence that bupropion resulted in superior quit rates to nortriptyline (RR 1.30, 95% CI 0.93 to 1.82; I2 = 0%; 3 studies, 417 participants), although this result was subject to imprecision.\nFindings were sparse and inconsistent as to whether antidepressants, primarily bupropion and nortriptyline, had a particular benefit for people with current or previous depression.\nAuthors' conclusions\nThere is high-certainty evidence that bupropion can aid long-term smoking cessation. However, bupropion may increase SAEs (moderate-certainty evidence when compared to placebo/no pharmacological treatment). There is high-certainty evidence that people taking bupropion are more likely to discontinue treatment compared with people receiving placebo or no pharmacological treatment. Nortriptyline also appears to have a beneficial effect on smoking quit rates relative to placebo, although bupropion may be more effective. Evidence also suggests that bupropion may be as successful as single-form NRT in helping people to quit smoking, but less effective than combination NRT and varenicline. In most cases, a paucity of data made it difficult to draw conclusions regarding harms and tolerability.\nFurther studies investigating the efficacy of bupropion versus placebo are unlikely to change our interpretation of the effect, providing no clear justification for pursuing bupropion for smoking cessation over other licensed smoking cessation treatments; namely, NRT and varenicline. However, it is important that future studies of antidepressants for smoking cessation measure and report on harms and tolerability.\n\nGiven the provided abstract, please respond to the following query: \"What are antidepressants?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Antidepressants are medicines and supplements used to treat depression. Some have also been tested to see whether they can help people to stop smoking. Two of these treatments โ bupropion (sometimes called Zyban) and nortriptyline โ are sometimes given to help people quit smoking."
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query-laysum | 1002 | [
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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 interventions have been used, or proposed to be used, as prophylaxis for this condition, to help reduce the frequency of the attacks. Many of these interventions include dietary, lifestyle or behavioural changes, rather than medication.\nObjectives\nTo assess the benefits and harms of non-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 dietary modifications, sleep improvement techniques, vitamin and mineral supplements, herbal supplements, talking therapies, mind-body interventions or vestibular rehabilitation 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 in this review with a total of 319 participants. Each study addressed a different comparison and these are outlined below. We did not identify any evidence for the remaining comparisons of interest in this review.\nDietary interventions (probiotics) versus placebo\nWe identified one study with 218 participants (85% female). The use of a probiotic supplement was compared to a placebo and participants were followed up for two years. Some data were reported on the change in vertigo frequency and severity over the duration of the study. However, there were no data regarding improvement of vertigo or serious adverse events.\nCognitive behavioural therapy (CBT) versus no intervention\nOne study compared CBT to no treatment in 61 participants (72% female). Participants were followed up for eight weeks. Data were reported on the change in vertigo over the course of the study, but no information was reported on the proportion of people whose vertigo improved, or on the occurrence of serious adverse events.\nVestibular rehabilitation versus no intervention\nThe third study compared the use of vestibular rehabilitation to no treatment in a group of 40 participants (90% female) and participants were followed up for six months. Again, this study reported some data on change in the frequency of vertigo during the study, but no information on the proportion of participants who experienced an improvement in vertigo or the number who experienced serious adverse events.\nWe are unable to draw meaningful conclusions from the numerical results of these studies, as the data for each comparison of interest come from single, small studies and the certainty of the evidence was low or very low.\nAuthors' conclusions\nThere is a paucity of evidence for non-pharmacological interventions that may be used for prophylaxis of vestibular migraine. Only a limited number of interventions have been assessed by comparing them to no intervention or a placebo treatment, and the evidence from these studies is all of low or very low certainty. We are therefore unsure whether any of these interventions may be effective at reducing the symptoms of vestibular migraine and we are also unsure whether they have the potential to cause harm.\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"
},
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"role": "assistant",
"content": "We found three studies, which included a total of 319 people (84% were female). These studies looked at three different types of treatments, to assess whether they might help to prevent vestibular migraine attacks, or help to reduce the symptoms when episodes occur.\nProbiotics\nThe first study looked at the use of probiotics - these are a type of bacteria that can be taken as a supplement to the normal diet. It was unclear whether this treatment made any difference to vertigo symptoms in people with vestibular migraine, or changed the frequency of attacks. The study did not report any information on possible harms, so we do not know if there are any risks associated with taking this treatment.\nCognitive behavioural therapy (CBT)\nCBT is a type of talking therapy, which aims to help improve problems by changing the way people think and behave. One small study assessed whether CBT helps to prevent attacks of vestibular migraine. However, it was not clear whether this treatment had an effect on people's symptoms or the frequency of vertigo attacks. Again, no information was reported on possible harms of the treatment.\nVestibular rehabilitation\nVestibular rehabilitation is a form of physiotherapy that includes specific exercises to try and improve problems with balance. Another small study compared vestibular rehabilitation to no treatment in people with vestibular migraine. Again, the results were inconclusive and we cannot be sure whether this treatment has any effect on changing people's symptoms, or the frequency of attacks. No information was reported on potential harms of the treatment."
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query-laysum | 1003 | [
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"role": "user",
"content": "Abstract: Background\nAvailable evidence has been inconclusive on whether pulmonary artery perfusion during cardiopulmonary bypass (CPB) is associated with decreased or increased mortality, pulmonary events, and serious adverse events (SAEs) after open heart surgery. To our knowledge, no previous systematic reviews have included meta-analyses of these interventions.\nObjectives\nTo assess the benefits and harms of single-shot or continuous pulmonary artery perfusion with blood (oxygenated or deoxygenated) or a preservation solution compared with no perfusion during cardiopulmonary bypass (CPB) in terms of mortality, pulmonary events, serious adverse events (SAEs), and increased inflammatory markers for adult surgical patients.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, and advanced Google for relevant studies. We handsearched retrieved study reports and scanned citations of included studies and relevant reviews to ensure that no relevant trials were missed. We searched for ongoing trials and unpublished trials in the World Health Organization International Clinical Trials Registry Platform (ICTRP) and at clinicaltrials.gov (4 July 2017). We contacted medicinal firms producing preservation solutions to retrieve additional studies conducted to examine relevant interventions.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared pulmonary artery perfusion versus no perfusion during CPB in adult patients (โง 18 years).\nData collection and analysis\nTwo independent review authors extracted data, conducted fixed-effect and random-effects meta-analyses, and calculated risk ratios (RRs) or odds ratios (ORs) for dichotomous outcomes. For continuous data, we have presented mean differences (MDs) and 95% confidence intervals (CIs) as estimates of the intervention effect. To minimize the risk of systematic error, we assessed risk of bias of included trials. To reduce the risk of random errors caused by sparse data and repetitive updating of cumulative meta-analyses, we applied Trial Sequential Analyses (TSAs). We used GRADE principles to assess the quality of evidence.\nMain results\nWe included in this review four RCTs (210 participants) reporting relevant outcomes. Investigators randomly assigned participants to pulmonary artery perfusion with blood versus no perfusion during CPB. Only one trial included the pulmonary artery perfusion intervention with a preservation solution; therefore we did not perform meta-analysis. Likewise, only one trial reported patient-specific data for the outcome \"pulmonary events\"; therefore we have provided no results from meta-analysis. Instead, review authors added two explorative secondary outcomes for this version of the review: the ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2); and intubation time. Last, review authors found no comparable data for the secondary outcome inflammatory markers.\nThe effect of pulmonary artery perfusion on all-cause mortality was uncertain (Peto OR 1.78, 95% CI 0.43 to 7.40; TSA adjusted CI 0.01 to 493; 4 studies, 210 participants; GRADE: very low quality). Sensitivity analysis of one trial with overall low risk of bias (except for blinding of personnel during the surgical procedure) yielded no evidence of a difference for mortality (Peto OR 1.65, 95% CI 0.27 to 10.15; 1 study, 60 participants). The TSA calculated required information size was not reached and the futility boundaries did not cross; thus this analysis cannot refute a 100% increase in mortality.\nThe effect of pulmonary artery perfusion with blood on SAEs was likewise uncertain (RR 1.12, 95% CI 0.66 to 1.89; 3 studies, 180 participants; GRADE: very low quality). Data show an association between pulmonary artery perfusion with blood during CPB and a higher postoperative PaO2/FiO2 ratio (MD 27.80, 95% CI 5.67 to 49.93; 3 studies, 119 participants; TSA adjusted CI 5.67 to 49.93; GRADE: very low quality), although TSA could not confirm or refute a 10% increase in the PaO2/FiO2 ratio, as the required information size was not reached.\nAuthors' conclusions\nThe effects of pulmonary artery perfusion with blood during cardiopulmonary bypass (CPB) are uncertain owing to the small numbers of participants included in meta-analyses. Risks of death and serious adverse events may be higher with pulmonary artery perfusion with blood during CPB, and robust evidence for any beneficial effects is lacking. Future randomized controlled trials (RCTs) should provide long-term follow-up and patient stratification by preoperative lung function and other documented risk factors for mortality. One study that is awaiting classification (epub abstract with preliminary results) may change the results of this review when full study details have been published.\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": "Pulmonary complications are often seen after open heart surgery with ECC when insufficient perfusion of the lungs leads to reduced tissue oxygenation. Previous trials have led to different conclusions on whether additional perfusion of the pulmonary circuit during ECC may decrease or increase risks of death, serious adverse events, and pulmonary events. This systematic review follows the Cochrane method for systematic reviews to access evidence from randomized controlled trials (RCTs).\nWe identified four RCTs (210 participants) reporting on risk of death and mechanical ventilation time. Three trials reported on serious adverse events and oxygenation after surgery. All trials were conducted without direct industry funding. The number of participants in each trial ranged from 30 to 89. The mean age of participants was 59 years (range 37 to 70 years), and 65% were women. Types of surgery included coronary artery bypass graft and valve replacement surgery. Only one trial included the intervention pulmonary perfusion with a preservation solution. Therefore, in this version of the review, we report only results of the intervention pulmonary perfusion with blood compared with no perfusion during ECC."
}
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query-laysum | 1004 | [
{
"role": "user",
"content": "Abstract: Background\nFollowing surgery, incisions are usually closed by fixing the edges together with sutures (stitches), staples, adhesives (glue) or clips. This process helps the cut edges heal together and is called 'healing by primary intention'. However, a minority of surgical wounds are not closed in this way. Where the risk of infection is high or there has been significant loss of tissue, wounds may be left open to heal by the growth of new tissue rather than by primary closure; this is known as 'healing by secondary intention'. There is a risk of infection in open wounds, which may impact on wound healing, and antiseptic or antibiotic treatments may be used with the aim of preventing or treating such infections. This review is one of a suite of Cochrane reviews investigating the evidence on antiseptics and antibiotics in different types of wounds. It aims to present current evidence related to the use of antiseptics and antibiotics for surgical wounds healing by secondary intention (SWHSI).\nObjectives\nTo assess the effects of systemic and topical antibiotics, and topical antiseptics for the treatment of surgical wounds healing by secondary intention.\nSearch methods\nIn November 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nRandomised controlled trials which enrolled adults with a surgical wound healing by secondary intention and assessed treatment with an antiseptic or antibiotic treatment. Studies enrolling people with skin graft donor sites were not included, neither were studies of wounds with a non-surgical origin which had subsequently undergone sharp or surgical debridement or other surgical treatments or wounds within the oral or aural cavities.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction.\nMain results\nEleven studies with a total of 886 participants were included in the review. These evaluated a range of comparisons in a range of surgical wounds healing by secondary intention. In general studies were small and some did not present data or analyses that could be easily interpreted or related to clinical outcomes. These factors reduced the quality of the evidence.\nTwo comparisons compared different iodine preparations with no antiseptic treatment and found no clear evidence of effects for these treatments. The outcome data available were limited and what evidence there was low quality.\nOne study compared a zinc oxide mesh dressing with a plain mesh dressing. There was no clear evidence of a difference in time to wound healing between groups. There was some evidence of a difference in measures used to assess wound infection (wound with foul smell and number of participants prescribed antibiotics) which favoured the zinc oxide group. This was low quality evidence.\nOne study reported that sucralfate cream increased the likelihood of healing open wounds following haemorrhoidectomy compared to a petrolatum cream (RR: 1.50, 95% CI 1.13 to 1.99) over a three week period. This evidence was graded as being of moderate quality. The study also reported lower wound pain scores in the sucralfate group.\nThere was a reduction in time to healing of open wounds following haemorrhoidectomy when treated with Triclosan post-operatively compared with a standard sodium hypochlorite solution (mean difference -1.70 days, 95% CI -3.41 to 0.01). This was classed as low quality evidence.\nThere was moderate quality evidence that more open wounds resulting from excision of pyomyositis abscesses healed when treated with a honey-soaked gauze compared with a EUSOL-soaked gauze over three weeks' follow-up (RR: 1.58, 95% CI 1.03 to 2.42). There was also some evidence of a reduction in the mean length of hospital stay in the honey group. Evidence was taken from one small study that only had 43 participants.\nThere was moderate quality evidence that more Dermacymยฎ-treated post-operative foot wounds in people with diabetes healed compared to those treated with iodine (RR 0.61, 95% CI 0.40 to 0.93). Again estimates came from one small study with 40 participants.\nAuthors' conclusions\nThere is no robust evidence on the relative effectiveness of any antiseptic/antibiotic/anti-bacterial preparation evaluated to date for use on SWHSI. Where some evidence for possible treatment effects was reported, it stemmed from single studies with small participant numbers and was classed as moderate or low quality evidence. This means it is likely or very likely that further research will have an important impact on our confidence in the estimate of effect, and may change this estimate.\n\nGiven the provided abstract, please respond to the following query: \"Why use antibiotics and antiseptics to treat surgical wounds healing by secondary intention?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One reason for allowing a wound to heal by secondary intention after surgery is that the risk of infection in that wound is thought to be high. If a wound has already become infected, then antibiotics or antiseptics are used to kill or slow the growth of the micro-organisms causing the infection and prevent it from getting worse or spreading. This may also help the wound to heal. Even where wounds are not clearly infected, they usually have populations of micro-organisms present. It is thought that they may heal better if these populations are reduced by antibacterial agents. However, the relationship between infection and micro-organism populations in wounds and wound healing is not very clear."
}
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query-laysum | 1005 | [
{
"role": "user",
"content": "Abstract: Background\nDysmenorrhoea refers to painful menstrual cramps and is a common gynaecological complaint. Conventional treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs), which both reduce myometrial activity (contractions of the uterus). A suggested alternative approach is dietary supplements. We used the term 'dietary supplement' to include herbs or other botanical, vitamins, minerals, enzymes, and amino acids. We excluded traditional Chinese medicines.\nObjectives\nTo determine the efficacy and safety of dietary supplements for treating dysmenorrhoea.\nSearch methods\nWe searched sources including the Cochrane Gynaecology and Fertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, PsycINFO (all from inception to 23 March 2015), trial registries, and the reference lists of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) of dietary supplements for moderate or severe primary or secondary dysmenorrhoea. We excluded studies of women with an intrauterine device. Eligible comparators were other dietary supplements, placebo, no treatment, or conventional analgesia.\nData collection and analysis\nTwo review authors independently performed study selection, performed data extraction and assessed the risk of bias in the included trials. The primary outcomes were pain intensity and adverse effects. We used a fixed-effect model to calculate odds ratios (ORs) for dichotomous data, and mean differences (MDs) or standardised mean differences (SMDs) for continuous data, with 95% confidence intervals (CIs). We presented data that were unsuitable for analysis either descriptively or in additional tables. We assessed the quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods.\nMain results\nWe included 27 RCTs (3101 women). Most included studies were conducted amongst cohorts of students with primary dysmenorrhoea in their late teens or early twenties. Twenty-two studies were conducted in Iran and the rest were performed in other middle-income countries. Only one study addressed secondary dysmenorrhoea. Interventions included 12 different herbal medicines (German chamomile (Matricaria chamomilla, M recutita, Chamomilla recutita), cinnamon (Cinnamomum zeylanicum, C. verum), Damask rose (Rosa damascena), dill (Anethum graveolens), fennel (Foeniculum vulgare), fenugreek (Trigonella foenum-graecum), ginger (Zingiber officinale), guava (Psidium guajava), rhubarb (Rheum emodi), uzara (Xysmalobium undulatum), valerian (Valeriana officinalis), and zataria (Zataria multiflora)) and five non-herbal supplements (fish oil, melatonin, vitamins B1 and E, and zinc sulphate) in a variety of formulations and doses. Comparators included other supplements, placebo, no treatment, and NSAIDs.\nWe judged all the evidence to be of low or very low quality. The main limitations were imprecision due to very small sample sizes, failure to report study methods, and inconsistency. For most comparisons there was only one included study, and very few studies reported adverse effects.\nEffectiveness of supplements for primary dysmenorrhoea\nWe have presented pain scores (all on a visual analogue scale (VAS) 0 to 10 point scale) or rates of pain relief, or both, at the first post-treatment follow-up.\nSupplements versus placebo or no treatment\nThere was no evidence of effectiveness for vitamin E (MD 0.00 points, 95% CI โ0.34 to 0.34; two RCTs, 135 women).\nThere was no consistent evidence of effectiveness for dill (MD -1.15 points, 95% CI โ2.22 to โ0.08, one RCT, 46 women), guava (MD 0.59, 95% CI โ0.13 to 1.31; one RCT, 151 women); one RCT, 73 women), or fennel (MD โ0.34 points, 95% CI โ0.74 to 0.06; one RCT, 43 women).\nThere was very limited evidence of effectiveness for fenugreek (MD โ1.71 points, 95% CI โ2.35 to โ1.07; one RCT, 101 women), fish oil (MD 1.11 points, 95% CI 0.45 to 1.77; one RCT, 120 women), fish oil plus vitamin B1 (MD โ1.21 points, 95% CI โ1.79 to โ0.63; one RCT, 120 women), ginger (MD โ1.55 points, 95% CI โ2.43 to โ0.68; three RCTs, 266 women; OR 5.44, 95% CI 1.80 to 16.46; one RCT, 69 women), valerian (MD โ0.76 points, 95% CI โ1.44 to โ0.08; one RCT, 100 women), vitamin B1 alone (MD โ2.70 points, 95% CI โ3.32 to โ2.08; one RCT, 120 women), zataria (OR 6.66, 95% CI 2.66 to 16.72; one RCT, 99 women), and zinc sulphate (MD โ0.95 points, 95% CI โ1.54 to โ0.36; one RCT, 99 women).\nData on chamomile and cinnamon versus placebo were unsuitable for analysis.\nSupplements versus NSAIDS\nThere was no evidence of any difference between NSAIDs and dill (MD 0.13 points, 95% CI โ1.01 to 1.27; one RCT, 47 women), fennel (MD โ0.70 points, 95% CI โ1.81 to 0.41; one RCT, 59 women), guava (MD 1.19, 95% CI 0.42 to 1.96; one RCT, 155 women), rhubarb (MD โ0.20 points, 95% CI โ0.44 to 0.04; one RCT, 45 women), or valerian (MD points 0.62 , 95% CI 0.03 to 1.21; one RCT, 99 women),\nThere was no consistent evidence of a difference between Damask rose and NSAIDs (MD โ0.15 points, 95% CI โ0.55 to 0.25; one RCT, 92 women).\nThere was very limited evidence that chamomile was more effective than NSAIDs (MD โ1.42 points, 95% CI โ1.69 to โ1.15; one RCT, 160 women).\nSupplements versus other supplements\nThere was no evidence of a difference in effectiveness between ginger and zinc sulphate (MD 0.02 points, 95% CI โ0.58 to 0.62; one RCT, 101 women). Vitamin B1 may be more effective than fish oil (MD โ1.59 points, 95% CI โ2.25 to โ0.93; one RCT, 120 women).\nEffectiveness of supplements for secondary dysmenorrhoea\nThere was no strong evidence of benefit for melatonin compared to placebo for dysmenorrhoea secondary to endometriosis (data were unsuitable for analysis).\nSafety of supplements\nOnly four of the 27 included studies reported adverse effects in both treatment groups. There was no evidence of a difference between the groups but data were too scanty to reach any conclusions about safety.\nAuthors' conclusions\nThere is no high quality evidence to support the effectiveness of any dietary supplement for dysmenorrhoea, and evidence of safety is lacking. However for several supplements there was some low quality evidence of effectiveness and more research is justified.\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": "Cochrane authors reviewed the evidence of the effect of dietary supplements (e.g. vitamins, minerals, herbs) on period pain (dysmenorrhoea)."
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query-laysum | 1006 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original Cochrane Review, last published in 2012 (Loy 2012). Children and youths with disruptive behaviour disorders may present to health services, where they may be treated with atypical antipsychotics. There is increasing usage of atypical antipsychotics in the treatment of disruptive behaviour disorders.\nObjectives\nTo evaluate the effect and safety of atypical antipsychotics, compared to placebo, for treating disruptive behaviour disorders in children and youths. The aim was to evaluate each drug separately rather than the class effect, on the grounds that each atypical antipsychotic has different pharmacologic binding profile (Stahl 2013) and that this is clinically more useful.\nSearch methods\nIn January 2017, we searched CENTRAL, MEDLINE, Embase, five other databases and two trials registers.\nSelection criteria\nRandomised controlled trials of atypical antipsychotics versus placebo in children and youths aged up to and including 18 years, with a diagnosis of disruptive behaviour disorders, including comorbid ADHD. The primary outcomes were aggression, conduct problems and adverse events (i.e. weight gain/changes and metabolic parameters). The secondary outcomes were general functioning, noncompliance, other adverse events, social functioning, family functioning, parent satisfaction and school functioning.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors (JL and KS) independently collected, evaluated and extracted data. We used the GRADE approach to assess the quality of the evidence. We performed meta-analyses for each of our primary outcomes, except for metabolic parameters, due to inadequate outcome data.\nMain results\nWe included 10 trials (spanning 2000 to 2014), involving a total of 896 children and youths aged five to 18 years. Bar two trials, all came from an outpatient setting. Eight trials assessed risperidone, one assessed quetiapine and one assessed ziprasidone. Nine trials assessed acute efficacy (over four to 10 weeks); one of which combined treatment with stimulant medication and parent training. One trial was a six-month maintenance trial assessing symptom recurrence.\nThe quality of the evidence ranged from low to moderate. Nine studies had some degree of pharmaceutical support/funding.\nPrimary outcomes\nUsing the mean difference (MD), we combined data from three studies (238 participants) in a meta-analysis of aggression, as assessed using the Aberrant Behaviour Checklist (ABC) โ Irritability subscale. We found that youths treated with risperidone show reduced aggression compared to youths treated with placebo (MD โ6.49, 95% confidence interval (CI) โ8.79 to โ4.19; low-quality evidence). Using the standardised mean difference (SMD), we pooled data from two risperidone trials (190 participants), which used different scales: the Overt Aggression Scale โ Modified (OAS-M) Scale and the Antisocial Behaviour Scale (ABS); as the ABS had two subscales that could not be combined (reactive and proactive aggression), we performed two separate analyses. When we combined the ABS Reactive subscale and the OAS-M, the SMD was โ1.30 in favour of risperidone (95% CI โ2.21 to โ0.40, moderate-quality evidence). When we combined the ABS Proactive subscale and OAS-M, the SMD was โ1.12 (95% CI โ2.30 to 0.06, moderate-quality evidence), suggesting uncertainty about the estimate of effect, as the confidence intervals overlapped the null value. In summary, there was some evidence that aggression could be reduced by risperidone. Data were lacking on other atypical antipsychotics, like quetiapine and ziprasidone, with regard to their effects on aggression.\nWe pooled data from two risperidone trials (225 participants) in a meta-analysis of conduct problems, as assessed using the Nisonger Child Behaviour Rating Form โ Conduct Problem subscale (NCBRF-CP). This yielded a final mean score that was 8.61 points lower in the risperidone group compared to the placebo group (95% CI โ11.49 to โ5.74; moderate-quality evidence).\nWe investigated the effect on weight by performing two meta-analyses. We wanted to distinguish between the effects of antipsychotic medication only and the combined effect with stimulants, since the latter can have a counteracting effect on weight gain due to appetite suppression. Pooling two trials with risperidone only (138 participants), we found that participants on risperidone gained 2.37 kilograms (kg) more (95% CI 0.26 to 4.49; moderate-quality evidence) than those on placebo. When we added a trial where all participants received a combination of risperidone and stimulants, we found that those on the combined treatment gained 2.14 kg more (95% CI 1.04 to 3.23; 3 studies; 305 participants; low-quality evidence) than those on placebo.\nSecondary outcomes\nOut of the 10 included trials, three examined general functioning, social functioning and parent satisfaction. No trials examined family or school functioning. Data on non-compliance/attrition rate and other adverse events were available from all 10 trials.\nAuthors' conclusions\nThere is some evidence that in the short term risperidone may reduce aggression and conduct problems in children and youths with disruptive behaviour disorders There is also evidence that this intervention is associated with significant weight gain.\nFor aggression, the difference in scores of 6.49 points on the ABC โ Irritability subscale (range 0 to 45) may be clinically significant. It is challenging to interpret the clinical significance of the differential findings on two different ABS subscales as it may be difficult to distinguish between reactive and proactive aggression in clinical practice. For conduct problems, the difference in scores of 8.61 points on the NCBRF-CP (range 0 to 48) is likely to be clinically significant. Weight gain remains a concern.\nCaution is required in interpreting the results due to the limitations of current evidence and the small number of high-quality trials. There is a lack of evidence to support the use of quetiapine, ziprasidone or any other atypical antipsychotic for disruptive behaviour disorders in children and youths and no evidence for children under five years of age. It is uncertain to what degree the efficacy found in clinical trials will translate into real-life clinical practice. Given the effectiveness of parent-training interventions in the management of these disorders, and the somewhat equivocal evidence on the efficacy of medication, it is important not to use medication alone. This is consistent with current clinical guidelines.\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": "To review the effect and safety of atypical antipsychotics (which are newer-generation major tranquillisers), compared to placebo (dummy pill), for treating disruptive behaviour disorders (e.g. defiance, disobedience, hostility) in children and youths."
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query-laysum | 1007 | [
{
"role": "user",
"content": "Abstract: Background\nAnxiety in relation to surgery is a well-known problem. Melatonin offers an alternative treatment to benzodiazepines for ameliorating this condition in the preoperative and postoperative periods.\nObjectives\nTo assess the effects of melatonin on preoperative and postoperative anxiety compared to placebo or benzodiazepines.\nSearch methods\nWe searched the following databases on 10 July 2020: CENTRAL, MEDLINE, Embase, CINAHL, and Web of Science. For ongoing trials and protocols, we searched clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nWe included randomized, placebo-controlled or standard treatment-controlled (or both) studies that evaluated the effects of preoperatively administered melatonin on preoperative or postoperative anxiety. We included adult patients of both sexes (15 to 90 years of age) undergoing any kind of surgical procedure for which it was necessary to use general, regional, or topical anaesthesia.\nData collection and analysis\nOne review author conducted data extraction in duplicate. Data extracted included information about study design, country of origin, number of participants and demographic details, type of surgery, type of anaesthesia, intervention and dosing regimens, preoperative anxiety outcome measures, and postoperative anxiety outcome measures.\nMain results\nWe included 27 randomized controlled trials (RCTs), involving 2319 participants, that assessed melatonin for treating preoperative anxiety, postoperative anxiety, or both.\nTwenty-four studies compared melatonin with placebo. Eleven studies compared melatonin to a benzodiazepine (seven studies with midazolam, three studies with alprazolam, and one study with oxazepam). Other comparators in a small number of studies were gabapentin, clonidine, and pregabalin.\nNo studies were judged to be atย low risk of bias for all domains. Most studies were judged to be at unclear risk of bias overall. Eight studies were judged to be at high risk of bias in one or more domain, and thus,ย to be at high risk of bias overall.\nMelatonin versus placebo\nMelatonin probably results in a reduction in preoperative anxiety measured by a visual analogue scale (VAS, 0 to 100 mm) compared to placebo (mean difference (MD) -11.69, 95% confidence interval (CI) -13.80 to -9.59; 18 studies, 1264 participants; moderate-certainty evidence), based on a meta-analysis of 18 studies.\nMelatonin may reduceย immediate postoperative anxiety measured on a 0 to 100 mm VAS compared to placebo (MD -5.04, 95% CI -9.52 to -0.55; 7 studies, 524 participants; low-certainty evidence), and may reduce delayed postoperative anxiety measured six hours after surgery using the State-Trait Anxiety Inventory (STAI) (MD -5.31, 95% CI -8.78 to -1.84; 2 studies; 73 participants; low-certainty evidence).\nMelatonin versus benzodiazepines (midazolam and alprazolam)\nMelatonin probably results in little or no difference in preoperative anxiety measured on a 0 to 100 mm VAS (MD 0.78, 95% CI -2.02 to 3.58; 7 studies, 409 participants; moderate-certainty evidence) and there may be little or no difference in immediate postoperative anxiety (MD -2.12, 95% CI -4.61 to 0.36; 3 studies, 176 participants; low-certainty evidence).\nAdverse events\nFourteen studies did not report on adverse events. Six studies specifically reported that no side effects were observed, and the remaining seven studies reported cases of nausea, sleepiness, dizziness, and headache; however, no serious adverse events were reported. Eleven studies measured psychomotor and cognitive function, or both, and in general, these studies found that benzodiazepines impaired psychomotor and cognitive function more than placebo and melatonin. Fourteen studies evaluated sedation and generally found that benzodiazepine caused the highest degree of sedation, but melatonin also showed sedative properties compared to placebo. Several studies did not report on adverse events; therefore, it is not possible to conclude with certainty, from the data on adverse effects collected in this review, that melatonin is better tolerated than benzodiazepines.\nAuthors' conclusions\nWhen compared with placebo, melatonin given as premedication (as tablets or sublingually) probably reduces preoperative anxiety in adults (measured 50 to 120 minutes after administration), which is potentially clinically relevant. The effect of melatonin on postoperative anxiety compared to placebo (measured in the recovery room and six hours after surgery) was also evident but was much smaller, and the clinical relevance of this finding is uncertain. There was little or no difference in anxiety when melatonin was compared with benzodiazepines. Thus, melatonin may have a similar effect to benzodiazepines in reducing preoperative and postoperative anxiety in adults.\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 from randomized controlled trials about the effects of melatonin on preoperative and postoperative anxiety in adults undergoing surgery when compared with placebo or benzodiazepine sedative drugs."
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query-laysum | 1008 | [
{
"role": "user",
"content": "Abstract: Background\nMoxibustion, a common treatment in traditional Chinese medicine, involves burning herbal preparations containing Artemisia vulgaris on or above the skin at acupuncture points. Its intended effect is to enhance body function, and it could reduce the side effects of chemotherapy or radiotherapy and improve quality of life (QoL) in people with cancer.\nObjectives\nTo assess the effects of moxibustion for alleviating side effects associated with chemotherapy, radiotherapy or both in people with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE via Ovid, Embase via Ovid and AMED (Allied and Complementary Medicine Database) from their inception to February 2018. We also searched databases in China including the Chinese BioMedical Literature Database (CBM), Chinese Medical Current Contents (CMCC), TCMonline, Chinese Dissertation Database (CDDB), China Medical Academic Conference (CMAC) and Index to Chinese Periodical Literature from inception to August 2017. Registries for clinical trials and other resources were also searched.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing moxibustion treatment, including moxa cone and moxa stick, versus sham, no treatment or conventional treatment.\nData collection and analysis\nTwo review authors (HWZ and FC) independently extracted data on study design, participants, treatment and control intervention, and outcome measures, and they also assessed risk of bias in the included studies. We performed meta-analyses, expressing dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean differences (MD), with 95% confidence intervals (CI).\nMain results\nWe included 29 RCTs involving 2569 participants. Five RCTs compared moxibustion versus no treatment, 15 compared moxibustion plus conventional treatment versus conventional treatment, one compared moxibustion versus sham moxibustion, and eight compared moxibustion versus conventional medicine. The overall risk of bias was high in 18 studies and unclear in 11 studies. Studies measured outcomes in various ways, and we could rarely pool data.\nMoxibustion versus no treatment: low-certainty evidence from single small studies suggested that moxibustion was associated with higher white blood cell counts (MD 1.77 ร 109/L; 95% CI 0.76 to 2.78; 80 participants, low-certainty evidence) and higher serum haemoglobin concentrations (MD 1.33 g/L; 95% CI 0.59 to 2.07; 66 participants, low-certainty evidence) in people with cancer, during or after chemotherapy/radiotherapy, compared with no treatment. There was no evidence of an effect on leukopenia (RR 0.50, 95% CI 0.10 to 2.56; 72 participants, low-certainty evidence) between study groups. The effects on immune function (CD3, CD4, and CD8 counts) were inconsistent.\nMoxibustion versus sham moxibustion: low-certainty evidence from one study (50 participants) suggested that moxibustion improved QoL (measured as the score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)) compared with sham treatment (MD 14.88 points; 95% CI 4.83 to 24.93). Low-certainty evidence from this study also showed reductions in symptom scores for nausea and vomiting (MD โ38.57 points, 95% CI โ48.67 to โ28.47) and diarrhoea (MD โ13.81, 95% CI โ27.52 to โ0.10), and higher mean white blood cell count (MD 1.72 ร 109/L, 95% CI 0.97 to 2.47), serum haemoglobin (MD 2.06 g/L, 95% CI 1.26 to 2.86) and platelets (MD 210.79 ร 109/L, 95% CI 167.02 to 254.56) when compared with sham moxibustion.\nMoxibustion versus conventional medicines: low-certainty evidence from one study (90 participants) suggested that moxibustion improved WBC count eight days after treatment ended compared with conventional medicines (MD 0.40 ร 109/L; 95% CI 0.15 to 0.65). Low-certainty evidence from two studies (235 participants) suggested moxibustion improved serum haemoglobin concentrations compared with conventional medicines (MD 10.28 g/L; 95% CI 4.51 to 16.05).\nMoxibustion plus conventional treatment versus conventional treatment alone: low-certainty evidence showed that moxibustion plus conventional treatment was associated with lower incidence and severity of leukopenia (WHO grade 3 to 4) (RR 0.14, 95% CI 0.01 to 2.64; 1 study, 56 participants), higher QoL scores on the EORTC QLQ-C30 (MD 8.85 points, 95% CI 4.25 to 13.46; 3 studies, 134 participants, Iยฒ = 26%), lower symptom scores for nausea and vomiting (RR 0.43, 95% CI 0.25 to 0.74; 7 studies, 801participants; Iยฒ = 19%), higher white blood cell counts (data not pooled due to heterogeneity), higher serum haemoglobin (MD 3.97 g/L, 95% CI 1.40 to 6.53; 2 studies, 142 participants, Iยฒ = 0%). There was no difference in platelet counts between the two groups (MD 13.48 ร 109/L; 95% CI โ16.00 to 42.95; 2 studies, 142 participants; Iยฒ = 34%).\nMost included studies did not report related adverse events, such as burning or allergic reactions.\nAuthors' conclusions\nLimited, low-certainty evidence suggests that moxibustion treatment may help to reduce the haematological and gastrointestinal toxicities of chemotherapy or radiotherapy, improving QoL in people with cancer; however, the evidence is not conclusive, and we cannot rule out benefits or risks with this treatment. High-quality studies that report adverse effects are needed.\n\nGiven the provided abstract, please respond to the following query: \"What is the certainty of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was of low or very low-certainty."
}
]
|
query-laysum | 1009 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin A is necessary for normal lung growth and the integrity of respiratory tract epithelial cells. Preterm infants have low vitamin A status at birth and this has been associated with an increased risk of developing chronic lung disease.\nObjectives\nTo evaluate supplementation with vitamin A on the incidence of death or neonatal chronic lung disease and long-term neurodevelopmental disability in very low birth weight (VLBW) infants compared with a control (placebo or no supplementation), and to consider the effect of the supplementation route, dose, and timing.\nSearch methods\nFor the original review and subsequent updates, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE, Science Citation Index, and the Oxford Database of Perinatal Trials. The reference lists of relevant trials, paediatric and nutrition journals, and conference abstracts and proceedings were handsearched up to 2010.\nFor the 2016 update, we used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 4), MEDLINE via PubMed (1 May 2016), EMBASE (1 May 2016), and CINAHL (1 May 2016). We also searched clinical trials' databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised controlled trials comparing vitamin A supplementation with a control (placebo or no supplementation) or other dosage regimens in VLBW infants (birth weight โค 1500 grams or less than 32 weeks' gestation).\nData collection and analysis\nTwo review authors screened the search results, extracted data, and assessed the trials for risk of bias. Results were reported as risk ratios (RR), risk differences (RD), and number needed to treat to benefit (NNTB), all with 95% confidence intervals (CI). Trialists were contacted for additional data.\nMain results\nEleven trials met the inclusion criteria. Ten trials (1460 infants) compared vitamin A supplementation with a control and one (120 infants) compared different regimens of vitamin A supplementation. Compared to the control group, vitamin A appeared to have a small benefit in reducing the risk of death or oxygen requirement at one month of age (typical RR 0.93, 95% CI 0.88 to 0.99; typical RD โ0.05, 95% CI โ0.10 to โ0.01; NNTB 20, 95% CI 10 to 100; 6 studies, 1165 infants) and the risk of chronic lung disease (oxygen requirement) at 36 weeks' postmenstrual age (typical RR 0.87, 95% CI 0.77 to 0.99; typical RD โ0.07, 95% CI โ0.13 to โ0.01; NNTB 11, 95% CI 6 to 100; 5 studies, 986 infants) (moderate-quality evidence). There was a marginal reduction of the combined outcome of death or chronic lung disease (typical RR 0.92, 95% CI 0.84 to 1.01; typical RD โ0.05, 95% CI โ0.11 to 0.01; 4 studies, 1089 infants). Neurodevelopmental assessment of 88% of the surviving infants in the largest trial showed no difference between the groups at 18 to 22 months of age, corrected for prematurity (low-quality evidence). There is no evidence to support different vitamin A dosing regimens. No adverse effects of vitamin A supplementation were reported, but it was noted that intramuscular injections of vitamin A were painful.\nAuthors' conclusions\nWhether clinicians decide to utilise repeat intramuscular doses of vitamin A to prevent chronic lung disease may depend upon the local incidence of this outcome and the value attached to achieving a modest reduction in the outcome balanced against the lack of other proven benefits and the acceptability of the treatment. Information on long-term neurodevelopmental status suggests no evidence of either benefit or harm from the intervention.\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": "Eleven trials were included in this review, ten comparing vitamin A with a control (placebo or no supplementation) and one comparing different vitamin A regimens. The search for eligible trials was updated in May 2016."
}
]
|
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