dataset
stringclasses 1
value | id
stringlengths 1
5
| messages
listlengths 2
2
|
|---|---|---|
query-laysum
|
7883
|
[
{
"role": "user",
"content": "Abstract: Background\nVaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring). This is an update of a Chochrane systematic review; the original version was first published in October 2006.\nObjectives\nThe objective of this review was to compare the efficacy and safety of intra-vaginal oestrogenic preparations in relieving the symptoms of vaginal atrophy in postmenopausal women.\nSearch methods\nWe searched the following databases and trials registers to April 2016: Cochrane Gynaecology and Fertility Group Register of trials, The Cochrane Central Register of Controlled Trials (CENTRAL; 2016 issue 4), MEDLINE, Embase, PsycINFO, DARE, the Web of Knowledge, OpenGrey, LILACS, PubMed and reference lists of articles. We also contacted experts and researchers in the field.\nSelection criteria\nThe inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for at least 12 weeks for the treatment of symptoms resulting from vaginal atrophy or vaginitis.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias and extracted the data. The primary review outcomes were improvement in symptoms (participant-assessed), and the adverse event endometrial thickness. Secondary outcomes were improvement in symptoms (clinician-assessed), other adverse events (breast disorders e.g. breast pain, enlargement or engorgement, total adverse events, excluding breast disorders) and adherence to treatment. We combined data to calculate pooled risk ratios (RRs) (dichotomous outcomes) and mean differences (MDs) (continuous outcomes) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I2 statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nWe included 30 RCTs (6235 women) comparing different intra-vaginal oestrogenic preparations with each other and with placebo. The evidence was low to moderate quality; limitations were poor reporting of study methods and serious imprecision (effect estimates with wide confidence intervals)\n1. Oestrogen ring versus other regimens\nOther regimens included oestrogen cream, oestrogen tablets and placebo. There was no evidence of a difference in improvement in symptoms (participant assessment) either between oestrogen ring and oestrogen cream (odds ratio (OR) 1.33, 95% CI 0.80 to 2.19, two RCTs, n = 341, I2 = 0%, low-quality evidence) or between oestrogen ring and oestrogen tablets (OR 0.78, 95% CI 0.53 to 1.15, three RCTs, n = 567, I2 = 0%, low-quality evidence). However, a higher proportion of women reported improvement in symptoms following treatment with oestrogen ring compared with placebo (OR 12.67, 95% CI 3.23 to 49.66, one RCT, n = 67). With respect to endometrial thickness, a higher proportion of women who received oestrogen cream showed evidence of increase in endometrial thickness compared to those who were treated with oestrogen ring (OR 0.36, 95% CI 0.14 to 0.94, two RCTs, n = 273; I2 = 0%, low-quality evidence). This may have been due to the higher doses of cream used.\n2. Oestrogen tablets versus other regimens\nOther regimens in this comparison included oestrogen cream, and placebo. There was no evidence of a difference in the proportions of women who reported improvement in symptoms between oestrogen tablets and oestrogen cream (OR 1.06, 95% CI 0.55 to 2.01, two RCTs, n = 208, I2 = 0% low-quality evidence). A higher proportion of women who were treated with oestrogen tablets reported improvement in symptoms compared to those who received placebo using a fixed-effect model (OR 12.47, 95% CI 9.81 to 15.84, two RCTs, n = 1638, I2 = 83%, low-quality evidence); however, using a random-effect model did not demonstrate any evidence of a difference in the proportions of women who reported improvement between the two treatment groups (OR 5.80, 95% CI 0.88 to 38.29). There was no evidence of a difference in the proportions of women with increase in endometrial thickness between oestrogen tablets and oestrogen cream (OR 0.31, 95% CI 0.06 to 1.60, two RCTs, n = 151, I2 = 0%, low-quality evidence).\n3. Oestrogen cream versus other regimens\nOther regimens identified in this comparison included isoflavone gel and placebo. There was no evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and isoflavone gel (OR 2.08, 95% CI 0.08 to 53.76, one RCT, n = 50, low-quality evidence). However, there was evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and placebo with more women who received oestrogen cream reporting improvement in symptoms compared to those who were treated with placebo (OR 4.10, 95% CI 1.88 to 8.93, two RCTs, n = 198, I2 = 50%, low-quality evidence). None of the included studies in this comparison reported data on endometrial thickness.\nAuthors' conclusions\nThere was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other. However, there was low-quality evidence that intra-vaginal oestrogenic preparations improve the symptoms of vaginal atrophy in postmenopausal women when compared to placebo. There was low-quality evidence that oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring; this may have been due to the higher doses of cream used. However there was no evidence of a difference in the overall body of evidence in adverse events between the various oestrogenic preparations compared with each other or with placebo.\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 researchers reviewed the evidence about the efficacy and safety of intravaginal oestrogenic preparations compared with each other or placebo (inactive or sham treatment) in women undergoing treatment for the symptoms of vaginal atrophy."
}
] |
query-laysum
|
7884
|
[
{
"role": "user",
"content": "Abstract: Background\nDiffuse brainstem glioma is a devastating disease with very poor prognosis. The most commonly used radiological treatment is conventional fractionated radiation. So far, there is no meta-analysis or systematic review available that assesses the benefits or harms of radiation in people with diffuse brainstem glioma.\nObjectives\nTo assess the effects of conventional fractionated radiotherapy (with or without chemotherapy) versus other therapies (including different radiotherapy techniques) for newly diagnosed diffuse brainstem gliomas in children and young adults aged 0 to 21 years.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, and EMBASE to 19 August 2015. We scanned conference proceedings from the International Society for Paediatric Oncology (SIOP), International Symposium on Paediatric Neuro-Oncology (ISPNO), Society of Neuro-Oncology (SNO), and European Association of Neuro-Oncology (EANO) from 1 January 2010 to 19 August 2015. We searched trial registers including the International Standard Randomised Controlled Trial Number (ISRCTN) Register, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and the register of the National Institutes of Health to 19 August 2015. We imposed no language restrictions.\nSelection criteria\nAll randomised controlled trials (RCTs), quasi-randomised trials (QRCTs), or controlled clinical trials (CCTs) that compared conventional fractionated radiotherapy (with or without chemotherapy) versus other therapies (including different radiotherapy techniques) for newly diagnosed diffuse brainstem glioma in children and young adults aged 0 to 21 years.\nData collection and analysis\nTwo review authors independently screened studies for inclusion, extracted data, assessed the risk of bias in each eligible trial, and conducted GRADE assessment of included studies. We resolved disagreements through discussion. We performed analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe identified two RCTs that fulfilled our inclusion criteria. The two trials tested different comparisons.\nOne multi-institutional RCT included 130 participants and compared hyperfractionated radiotherapy (six-week course with twice a day treatment of 117 cGy per fraction to a total dose of 7020 cGy) with conventional radiotherapy (six-week course with once a day treatment of 180 cGy per fraction to a total dose of 5400 cGy). The median time overall survival (OS) was 8.5 months in the conventional group and 8.0 months in the hyperfractionated group. We detected no clear evidence of effect on OS or event-free survival (EFS) in participants receiving hyperfractionated radiotherapy compared with conventional radiotherapy (OS: hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.75 to 1.53; EFS: HR 1.26, 95% CI 0.83 to 1.90). Radiological response (risk ratio (RR) 0.94, 95% CI 0.54 to 1.63) and various types of toxicities were similar in the two groups. There was no information on other outcomes. According to the GRADE approach, we judged the quality of evidence to be low (i.e. further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate) for OS and EFS, and very low (i.e. we are very uncertain about the estimate) for radiological response and toxicities.\nThe second RCT included 71 participants and compared hypofractionated radiotherapy (39 Gy in 13 fractions over 2.6 weeks, 3 Gy per fraction) with conventional radiotherapy (54 Gy in 30 fractions over six weeks, 1.8 Gy per fraction). This trial reported a median OS of 7.8 months for the hypofractionated group and 9.5 months for the conventional group. It reported a progression-free survival (PFS) of 6.3 months for the hypofractionated group and 7.3 months for the conventional group. We found no clear evidence of effect on OS (HR 1.03, 95% CI 0.53 to 2.01) or PFS (HR 1.19, 95% CI 0.63 to 2.22) in participants receiving hypofractionated radiotherapy when compared with participants receiving conventional radiotherapy. The mainly observed adverse effect was local erythema and dry desquamation especially behind the auricles. There were some other toxicities, but there was no statistically significant difference between treatment groups. There was no information on other outcomes. We judged the quality of evidence to be moderate (i.e. further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate) for OS, and low for PFS and toxicities. It should be mentioned that the sample size in this RCT was small, which could lead to insufficient statistical power for a clinically relevant outcome.\nAuthors' conclusions\nWe could make no definitive conclusions from this review based on the currently available evidence. Further research is needed to establish the role of radiotherapy in the management of newly diagnosed diffuse brainstem glioma in children and young adults. Future RCTs should be conducted with adequate power and all relevant outcomes should be taken into consideration. Moreover, international multicentre collaboration is encouraged. Considering the potential advantage of hypofractionated radiotherapy to decrease the treatment burden and increase the quality of remaining life, we suggest that more attention should be paid to hypofractionated radiotherapy.\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": "Diffuse brainstem glioma typically occurs in the pons (part of the brainstem) and expands and infiltrates at least 50% of the pons, with a characteristic appearance on magnetic resonance imaging (MRI). The prognosis is very poor, with a median overall survival (OS; time from cancer diagnosis, or treatment, to death from any cause) ranges from 8 to 11 months. So far, there is no analysis or review available that assessed the benefits or harms of radiation for newly diagnosed diffuse brainstem glioma in children and young adults aged 0 to 21 years."
}
] |
query-laysum
|
7885
|
[
{
"role": "user",
"content": "Abstract: Background\nThe different management strategies for patent ductus arteriosus (PDA) in preterm infants are expectant management, surgery, or medical treatment with non-selective cyclo-oxygenase inhibitors. Randomized controlled trials (RCTs) have suggested that paracetamol may be an effective and safe agent for the closure of a PDA.\nObjectives\nTo determine the efficacy and safety of paracetamol as monotherapy or as part of combination therapy via any route of administration, compared with placebo, no intervention, or another prostaglandin inhibitor, for prophylaxis or treatment of an echocardiographically-diagnosed PDA in preterm or low birth weight infants.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and three trials registers on 13 October 2021, and one other database on 1 March 2022. We also checked references and contacted study authors to identify additional studies.\nSelection criteria\nWe included RCTs and quasi-RCTs in which paracetamol (single-agent or combination therapy) was compared to no intervention, placebo, or other agents used for closure of PDA, irrespective of dose, duration, and mode of administration in preterm infants. Two independent authors reviewed the search results and made a final selection of potentially eligible articles through discussion.\nData collection and analysis\nWe performed data collection and analyses in accordance with the methods of Cochrane Neonatal. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of ductal closure after the first course of treatment; all-cause mortality during initial hospital stay; and necrotizing enterocolitis (NEC).\nMain results\nFor this update, we included 27 studies enrolling 2278 infants. We considered the overall risk of bias in the 27 studies to vary from low to unclear. We identified 24 ongoing studies.\nParacetamol versus ibuprofen\nThere was probably little to no difference between paracetamol and ibuprofen for failure of ductal closure after the first course (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.88 to 1.18; 18 studies, 1535 infants; moderate-certainty evidence). There was likely little to no difference between paracetamol and ibuprofen for all-cause mortality during hospital stay (RR 1.09, 95% CI 0.80 to 1.48; 8 studies, 734 infants; moderate-certainty evidence), and for NEC (RR 1.30, 95% CI 0.87 to 1.94; 10 studies, 1015 infants; moderate-certainty evidence).\nParacetamol versus indomethacin\nThere was little to no difference between paracetamol and indomethacin for failure of ductal closure after the first course (RR 1.02, 95% CI 0.78 to 1.33; 4 studies, 380 infants; low-certainty evidence). There was little to no difference between paracetamol and indomethacin for all-cause mortality during hospital stay (RR 0.86, 95% CI 0.39 to 1.92; 2 studies, 114 infants; low-certainty evidence). The rate of NEC may be lower in the paracetamol group (3.7%) versus the indomethacin group(9.2%) (RR 0.42, 95% CI 0.19 to 0.96; 4 studies, 384 infants; low-certainty evidence).\nProphylactic paracetamol versus placebo/no intervention\nProphylactic paracetamol (17%) compared to placebo/no intervention (61%) may reduce failure of ductal closure after one course (RR 0.27, 95% CI 0.18 to 0.42; 3 studies, 240 infants; low-certainty evidence). There was little to no difference between prophylactic paracetamol and placebo/no intervention for all-cause mortality during hospital stay (RR 0.59, 95% CI 0.24 to 1.44; 3 studies, 240 infants; low-certainty evidence). No studies reported on NEC.\nEarly paracetamol treatment versus placebo/no intervention\nEarly paracetamol treatment (28%) compared to placebo/no intervention (79%) may reduce failure of ductal closure after one course when used before 14 days' postnatal age (RR 0.35, 95% CI 0.23 to 0.53; 2 studies, 127 infants; low-certainty evidence). No studies reported on all-cause mortality during hospital stay or NEC.\nLate paracetamol treatment versus placebo/no intervention\nThere was little to no difference between late paracetamol and placebo for failure of ductal closure after one course of treatment when used at or after 14 days' postnatal age (RR 0.85, 95% CI 0.72 to 1.01; 1 study, 55 infants; low-certainty evidence) or NEC (RR 1.04, 95% CI 0.07 to 15.76; 1 study, 55 infants; low-certainty evidence). No data were reported for all-cause mortality during hospital stay.\nParacetamol combined with ibuprofen versus ibuprofen combined with placebo or no intervention\nThere was little to no difference between paracetamol plus ibuprofen compared to ibuprofen plus placebo or no intervention for failure of ductal closure after the first course (RR 0.77, 95% CI 0.43 to 1.36; 2 studies, 111 infants; low-certainty evidence). There was little to no difference between paracetamol plus ibuprofen compared to ibuprofen plus placebo or no intervention for NEC (RR 0.33, 95% CI 0.01 to 7.45; 1 study, 24 infants; low-certainty evidence). No data were reported for all-cause mortality during hospital stay.\nAuthors' conclusions\nModerate-certainty evidence suggests that there is probably little or no difference in effectiveness between paracetamol and ibuprofen; low-certainty evidence suggests that there is probably little or no difference in effectiveness between paracetamol and indomethacin; low-certainty evidence suggests that prophylactic paracetamol may be more effective than placebo/no intervention; low-certainty evidence suggests that early paracetamol treatment may be more effective than placebo/no intervention; low-certainty evidence suggests that there is probably little or no difference between late paracetamol treatment and placebo, and probably little or no difference in effectiveness between the combination of paracetamol plus ibuprofen versus ibuprofen alone for the closure of PDA after the first course of treatment. The majority of neonates included in these studies were of moderate preterm gestation. Thus, establishing the efficacy and safety of paracetamol for PDA treatment in extremely low birth weight (ELBW: birth weight < 1000 grams) and extremely low gestational age neonates (ELGANs < 28 weeks' gestation) requires further studies.\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 common complication for preterm (premature) or small babies is a patent ductus arteriosus (PDA). Blood circulation to the (as yet) non-functioning lungs is unnecessary before birth. This is because the placenta delivers oxygen to the fetal blood supply. The PDA is a temporary fetal blood vessel that connects the pulmonary artery (the vessel that, after birth, takes blood depleted of oxygen from the heart to the lungs) to the aorta (the vessel that takes freshly oxygenated blood, returned from the lungs to the heart by the pulmonary vein, away from the heart and on the beginning of its journey around the body). In other words, the PDA ‘short-circuits’ the fetal circulation of blood through the lungs. It is necessary to sustain life in the womb, but it should close after birth. Sometimes the PDA remains open because of the baby's immature stage of development.\nA PDA in preterm babies is associated with life-threatening complications. The usual treatment for PDA has been the medicines indomethacin or ibuprofen, which inhibit the production of prostaglandins and promote the closure of the PDA. Prostaglandins are chemical compounds made throughout the body (i.e. not in any one particular organ), particularly wherever soft tissues are damaged. Their production (or 'synthesis') plays a key role in healing processes. They are known to play an important role in keeping the ductus arteriosus open (or 'patent'), so lowering their production would encourage closure of the ductus arteriosus.\nRecently, paracetamol (acetaminophen) – a commonly used medicine to treat fever or pain in infants, children, and adults – has been suggested as an alternative to ibuprofen, with potentially fewer side effects. A number of clinical trials have suggested that paracetamol may be an alternative for the closure of a PDA. Exactly how paracetamol works to close the PDA is not known, but probably involves inhibition of prostaglandin synthesis."
}
] |
query-laysum
|
7886
|
[
{
"role": "user",
"content": "Abstract: Background\nThe rising prevalence of autism spectrum disorder (ASD) has increased the need for evidence-based treatments to lessen the impact of symptoms. Presently, no therapies are available to effectively treat individuals with all of the symptoms of this disorder. It has been suggested that hyperbaric oxygen therapy may alleviate the biochemical dysfunction and clinical symptoms of ASD.\nObjectives\nTo determine whether treatment with hyperbaric oxygen:\n1. improves core symptoms of ASD, including social communication problems and stereotypical and repetitive behaviors;\n2. improves noncore symptoms of ASD, such as challenging behaviors;\n3. improves comorbid states, such as depression and anxiety; and\n4. causes adverse effects.\nSearch methods\nOn 10 December 2015, we searched CENTRAL, Ovid MEDLINE, Embase, and 15 other databases, four of which were Chinese language databases. We also searched multiple trial and research registers.\nSelection criteria\nWe selected randomized controlled trials (RCTs) and quasi-RCTs of any dose, duration, and frequency for hyperbaric oxygen therapy compared with no treatment or sham treatment for children and adults with ASD.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration, in that three review authors independently selected studies, assessed them for risk of bias, and extracted relevant data. We also assessed the quality of the evidence by using the GRADE approach.\nMain results\nWe included one trial with a total of 60 children with a diagnosis of ASD who randomly received hyperbaric oxygen therapy or a sham treatment. Using GRADE criteria, we rated the quality of the evidence as low because of the small sample size and wide confidence intervals (CIs). Other problems included selection bias and short duration or follow-up.\nOverall, study authors reported no improvement in social interaction and communication, behavioral problems, communication and linguistic abilities, or cognitive function. With regard to the safety of hyperbaric oxygen therapy (adverse events), they reported minor-grade ear barotrauma events. Investigators found significant differences between groups in total number of side effect events (Peto odds ratio (OR) 3.87, 95% CI 1.53 to 9.82) and in the number of children who experienced side effects (Peto OR 4.40, 95% CI 1.33 to 14.48).\nAuthors' conclusions\nTo date, there is no evidence that hyperbaric oxygen therapy improves core symptoms and associated symptoms of ASD. It is important to note that adverse effects (minor-grade ear barotrauma events) can occur. Given the absence of evidence of effectiveness and the limited biological plausibility and possible adverse effects, the need for future RCTs of hyperbaric oxygen therapy must be carefully considered.\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": "Autism spectrum disorder (ASD) is associated with problems in social communication and restricted behaviors. High-pressure (hyperbaric) oxygen therapy has been proposed as treatment for these ASD symptoms. We reviewed the evidence on effects of high-pressure (hyperbaric) oxygen therapy among children and adults with ASD. We also assessed the evidence on the safety of high-pressure oxygen therapy."
}
] |
query-laysum
|
7887
|
[
{
"role": "user",
"content": "Abstract: Background\nCOVID-19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose.\nObjectives\nTo assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them.\nSearch methods\nInformation Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.\nSelection criteria\nThis is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.\nWe sought studies comparing antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide – containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo.\nAuthors' conclusions\nWe identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof.\nVery few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.\n\nGiven the provided abstract, please respond to the following query: \"How did we search for evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our team of researchers searched the medical literature for studies that compared the effects of any antimicrobial mouthwash or nasal spray administered to patients with COVID-19 against no treatment, water or a salt solution."
}
] |
query-laysum
|
7888
|
[
{
"role": "user",
"content": "Abstract: Background\nFingolimod was approved in 2010 for the treatment of patients with the relapsing-remitting (RR) form of multiple sclerosis (MS). It was designed to reduce the frequency of exacerbations and to delay disability worsening. Issues on its safety and efficacy, mainly as compared to other disease modifying drugs (DMDs), have been raised.\nObjectives\nTo assess the safety and benefit of fingolimod versus placebo, or other disease-modifying drugs (DMDs), in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS).\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System (CNS) Group's Specialised Trials Register and US Food and Drug Administration reports (15 February 2016).\nSelection criteria\nRandomised controlled trials (RCTs) assessing the beneficial and harmful effects of fingolimod versus placebo or other approved DMDs in people with RRMS.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nSix RCTs met our selection criteria. The overall population included 5152 participants; 1621 controls and 3531 treated with fingolimod at different doses; 2061 with 0.5 mg, 1376 with 1.25 mg, and 94 with 5.0 mg daily. Among the controls, 923 participants were treated with placebo and 698 with others DMDs. The treatment duration was six months in three, 12 months in one, and 24 months in two trials. One study was at high risk of bias for blinding, three studies were at high risk of bias for incomplete outcome reporting, and four studies were at high risk of bias for other reasons (co-authors were affiliated with the pharmaceutical company). We retrieved 10 ongoing trials; four of them have been completed.\nComparing fingolimod administered at the approved dose of 0.5 mg to placebo, we found that the drug at 24 months increased the probability of being relapse-free (risk ratio (RR) 1.44, 95% confidence interval (CI) (1.28 to 1.63); moderate quality of evidence), but it might lead to little or no difference in preventing disability progression (RR 1.07, 95% CI 1.02 to 1.11; primary clinical endpoints; low quality evidence). Benefit was observed for other measures of inflammatory disease activity including clinical (annualised relapse rate): rate ratio 0.50, 95% CI 0.40 to 0.62; moderate quality evidence; and magnetic resonance imaging (MRI) activity (gadolinium-enhancing lesions): RR of being free from (MRI) gadolinium-enhancing lesions: 1.36, 95% CI 1.27 to 1.45; low quality evidence.The mean change of MRI T2-weighted lesion load favoured fingolimod at 12 and 24 months.\nNo significant increased risk of discontinuation due to adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. The risk of fingolimod discontinuation was significantly higher compared to placebo for the dose 1.25 mg at 24 months (RR 1.93, 95% CI 1.48 to 2.52).\nNo significant increased risk of discontinuation due to serious adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. A significant increased risk of discontinuation due to serious adverse events was found for fingolimod 5.0 mg (RR 2.77, 95% CI 1.04 to 7.38) compared to placebo at six months.\nComparing fingolimod 0.5 mg to intramuscular interferon beta-1a, we found moderate quality evidence that the drug at one year slightly increased the number of participants free from relapse (RR 1.18, 95% CI 1.09 to 1.27) or from gadolinium-enhancing lesions (RR 1.12, 95% CI 1.05 to 1.19), and decreased the relapse rate (rate ratio 0.48, 95% CI 0.34 to 0.70). We did not detect any advantage for preventing disability progression (RR 1.02, 95% CI 0.99 to 1.06; low quality evidence). We did not detect any significant difference for MRI T2-weighted lesion load change.\nWe found a greater likelihood of participants discontinuing fingolimod, as compared to other DMDs, due to adverse events in the short-term (six months) (RR 3.21, 95% CI 1.16 to 8.86), but there was no significant difference versus interferon beta-1a at 12 months (RR 1.51, 95% CI 0.81 to 2.80; moderate quality evidence). A higher incidence of adverse events was suggestive of the lower tolerability rate of fingolimod compared to interferon-beta 1a.\nQuality of life was improved in participants after switching from a different DMD to fingolimod at six months, but this effect was not found compared to placebo at 24 months.\nAll studies were sponsored by Novartis Pharma.\nAuthors' conclusions\nTreatment with fingolimod compared to placebo in RRMS patients is effective in reducing inflammatory disease activity, but it may lead to little or no difference in preventing disability worsening. The risk of withdrawals due to adverse events requires careful monitoring of patients over time. The evidence on the risk/benefit profile of fingolimod compared with intramuscular interferon beta-1a was uncertain, based on a low number of head-to-head RCTs with short follow-up duration. The ongoing trial results will possibly satisfy these issues.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The main conclusion of this review was that fingolimod, administered as monotherapy at the approved dose of 0.5 mg once-daily increases the probability of being relapse-free at 24 months compared to placebo. The benefit was confirmed with disease activity measures defined by magnetic resonance imaging (MRI) scans. However, there was no effect on preventing disability worsening; treatment was not associated with an increased risk of patient withdrawals due to adverse events.\nComparing the same dose of fingolimod to intramuscular interferon beta-1a, the drug at one year slightly increased the number of participants free from relapse or from inflammatory enhancing lesions and decreased the relapse rate. Again, we did not detect any advantage for preventing disability progression. We found a greater likelihood of discontinuation due to adverse events in the short-term (six months) for fingolimod as compared to immunomodulating drugs, and no significant difference compared to interferon beta at 12 months.\nThe duration of all studies was equal or inferior to 24 months, so that the efficacy (but mostly the safety) of fingolimod over 24 months remains uncertain. This is a key point for a lifetime disease with the probability of chronic treatments as in MS.\nThe risk of adverse events requires careful monitoring of patients over time and suggests the need for studies with longer follow-up, particularly considering the recent warning on the development of progressive multifocal leukoencephalopathy.\nThe six studies included in this review were sponsored by Novartis Pharma, and most co-authors of the published papers were affiliated to the pharmaceutical company; this is recognised as a potential source of bias."
}
] |
query-laysum
|
7889
|
[
{
"role": "user",
"content": "Abstract: Background\nPostoperative administration of non-steroidal anti-inflammatory drugs (NSAIDs) reduces patient opioid requirements and, in turn, may reduce the incidence and severity of opioid-induced adverse events (AEs).\nObjectives\nTo assess the analgesic efficacy and adverse effects of single-dose intravenous (IV) ibuprofen, compared with placebo or an active comparator, for moderate-to-severe postoperative pain in adults.\nSearch methods\nWe searched the following databases without language restrictions: CENTRAL, MEDLINE, Embase and LILACS on 10 June 2021. We checked clinical trials registers and reference lists of retrieved articles for additional studies.\nSelection criteria\nWe included randomized trials that compared a single postoperative dose of intravenous (IV) ibuprofen with placebo or another active treatment, for treating acute postoperative pain in adults following any surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for review inclusion, assessed risk of bias, and extracted data.\nOur primary outcome was the number of participants in each arm achieving at least 50% pain relief over a 4- and 6-hour period.\nOur secondary outcomes were time to, and number of participants using rescue medication; withdrawals due to lack of efficacy, adverse events (AEs), and for any other cause; and number of participants reporting or experiencing any AE, serious AEs (SAEs), and specific NSAID-related or opioid-related AEs.\nWe were not able to carry out any planned meta-analysis. We assessed the certainty of the evidence using GRADE.\nMain results\nOnly one study met our inclusion criteria, involving 201 total participants, mostly female (mean age 42 years), undergoing primary, unilateral, distal, first metatarsal bunionectomy (with osteotomy and internal fixation). Ibuprofen 300 mg, placebo or acetaminophen 1000 mg was administered intravenously to participants reporting moderate pain intensity the day after surgery. Since we identified only one study for inclusion, we did not perform any quantitative analyses. The study was at low risk of bias for most domains. We downgraded the certainty of the evidence due to serious study limitations, indirectness and imprecision.\nIbuprofen versus placebo\nFindings of the single study found that at both the 4-hour and 6-hour assessment period, the proportion of participants with at least 50% pain relief was 32% (24/76) for those assigned to ibuprofen and 22% (11/50) for those assigned to placebo. These findings produced a risk ratio (RR) of 1.44 (95% confidence interval (CI) 0.77 to 2.66 versus placebo for at least 50% of maximum pain relief over the 4-hour and 6-hour period (very low-certainty evidence).\nMedian time to rescue medication was 101 minutes for ibuprofen and 71 minutes for placebo (1 study, 126 participants; very low-certainty evidence). The number of participants using rescue medication was not reported within the included study.\nDuring the study (1 study, 126 participants), 58/76 (76%) of participants assigned to ibuprofen and 39/50 (78%) assigned to placebo reported or experienced any adverse event (AE), (RR 0.98, 95% CI 0.81 to 1.19; low-certainty evidence).\nNo serious AEs (SAEs) were experienced (1 study, 126 participants; very low-certainty evidence).\nIbuprofen versus active comparators\nIbuprofen (300 mg) was similar to the active comparator, IV acetaminophen (1000 mg) at 4 hours and 6 hours (1 study, 126 participants). For those assigned to active control (acetaminophen), the proportion of participants with at least 50% pain relief was 35% (26/75) at 4 hours and 31% (23/75) at 6 hours. At 4 hours, these findings produced a RR of 0.91 (95% CI 0.58 to 1.43; very low-certainty evidence) versus active comparator (acetaminophen). At 6 hours, these findings produced a RR of 1.03 (95% CI 0.64 to 1.66; very low-certainty evidence) versus active comparator (acetaminophen).\nMedian time to rescue medication was 101 minutes for ibuprofen and 125 minutes for the active comparator, acetaminophen (1 study, 151 participants; very low-certainty evidence). The number of participants using rescue medication was not reported within the included study.\nDuring the study, 58/76 (76%) of participants assigned to ibuprofen and 45/75 (60%) assigned to active control (acetaminophen) reported or experienced any AE, (RR 1.27, 95% CI 1.02 to 1.59; very low-certainty evidence).\nNo SAEs were experienced (1 study, 151 participants; very low-certainty evidence).\nAuthors' conclusions\nThere is insufficient evidence to support or refute the suggestion that IV ibuprofen is effective and safe for acute postoperative pain in adults.\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 only had results from one relatively small study. This limited our confidence in the evidence."
}
] |
query-laysum
|
7890
|
[
{
"role": "user",
"content": "Abstract: Background\nSore throat is a common condition caused by viruses or bacteria, and is a leading cause of antibiotic prescription in primary care. The most common bacterial species is group A streptococcus (’strep throat’). Between 50% to 70% of pharyngitis cases are treated with antibiotics, despite the majority of cases being viral in origin. One strategy to reduce antibiotics is to use rapid tests for group A streptococcus to guide antibiotic prescriptions. Rapid tests can be used alone or in combination with a clinical scoring system.\nObjectives\nTo assess the efficacy and safety of strategies based on rapid tests to guide antibiotic prescriptions for sore throat in primary care settings.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Web of Science, and LILACS, as well as the trial registries ClinicalTrials.gov and the WHO ICTRP on 5 June 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing rapid tests with management based on clinical grounds to guide the prescription of antibiotics for people with a sore throat in ambulatory care settings. We included trials that randomised individuals, as well as cluster-RCTs in which individual practitioners (or practices) or emergency departments were randomised.\nData collection and analysis\nTwo review authors independently extracted data on the primary outcomes (number of participants provided with an antibiotic prescription; number of participants with an antibiotic dispensed) and secondary outcomes (duration of sore throat symptoms; duration of other symptoms; quality of life measures; number of participants with a complication attributed to the index infection; number of participants in need of re-consultation by the end of follow-up; number of participants in need of hospital admission by the end of follow-up; number of satisfied participants; number of participants with an adverse event attributed to the rapid test). We assessed the risk of bias of all included trials and used GRADE to assess the certainty of the evidence. We performed meta-analyses and sensitivity analyses when feasible.\nMain results\nWe included five trials (2891 children and adult participants in total; 2545 participants after adjusting for clustering). Management in the intervention group was as follows: in three trials rapid tests were used in combination with a clinical scoring system; in one trial, some physicians were asked to use rapid tests alone, while others were asked to use rapid tests in combination with a clinical scoring system; in one trial, rapid tests were used alone.\nBased on data from five trials (2545 participants), a large reduction in prescribed antibiotics was found in the rapid test group (481/1197) versus management based on clinical grounds (865/1348), for a summary risk difference (RD) of −25%, 95% confidence interval (CI) −31% to −18%; I2 = 62%; moderate-certainty evidence. Estimates of effect on antibiotic prescription rates were stable in various sensitivity analyses.\nBased on data from two trials (900 people) originating from the same overarching study, the evidence suggests that rapid tests may not reduce dispensed antibiotic treatments: rapid test group (156/445) versus management based on clinical grounds (197/455); summary RD −7%, 95% CI −17% to 2%; I2 = 53%; low-certainty evidence.\nFour trials (2075 participants) reported data on the number of participants with a complication attributed to the index infection; the summary odds ratio (OR) was 0.85, 95% CI 0.03 to 26.65; P = 0.93; I2 = 62%; very low-certainty evidence, which means that people in the rapid testing group were less likely to develop complications of the index infection, but the evidence is very uncertain.\nTwo trials (1161 participants) reported on the number of participants in need of re-consultation by the end of follow-up; the summary OR was 1.12, 95% CI 0.57 to 2.21; P = 0.74; I2 = 59%; low-certainty evidence, which means that participants in the rapid testing group were more likely to be in need of re-consultation by the end of the study follow-up, but the evidence is uncertain.\nLack of data impeded assessment of other secondary outcomes (including safety outcomes) and of sources of heterogeneity.\nAuthors' conclusions\nRapid testing to guide antibiotic treatment for sore throat in primary care probably reduces antibiotic prescription rates by 25% (absolute risk difference), but may have little or no impact on antibiotic dispensing. More studies are needed to assess the efficacy and safety of rapid test-guided antibiotic prescribing, notably to evaluate patient-centred outcomes and variability across subgroups (e.g. adults versus children).\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Compared with usual decision-making based on clinical examination alone, implementing rapid tests can reduce antibiotic prescription rates, but may have little or no impact on antibiotic dispensing. More studies are needed to assess other outcomes that are important to patients, including safety."
}
] |
query-laysum
|
7891
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is a substantial body of evidence that prescribing for care home residents is suboptimal and requires improvement. Consequently, there is a need to identify effective interventions to optimise prescribing and resident outcomes in this context. This is an update of a previously published review (Alldred 2013).\nObjectives\nThe objective of the review was to determine the effect of interventions to optimise overall prescribing for older people living in care homes.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Specialised Register), MEDLINE, EMBASE and CINAHL to May 2015. We also searched clinical trial registries for relevant studies.\nSelection criteria\nWe included randomised controlled trials evaluating interventions aimed at optimising prescribing for older people (aged 65 years or older) living in institutionalised care facilities. Studies were included if they measured one or more of the following primary outcomes: adverse drug events; hospital admissions; mortality; or secondary outcomes, quality of life (using validated instrument); medication-related problems; medication appropriateness (using validated instrument); medicine costs.\nData collection and analysis\nTwo authors independently screened titles and abstracts, assessed studies for eligibility, assessed risk of bias and extracted data. We presented a narrative summary of results.\nMain results\nThe 12 included studies involved 10,953 residents in 355 (range 1 to 85) care homes in ten countries. Nine studies were cluster-randomised controlled trials and three studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of ten studies. Four studies involved multidisciplinary case-conferencing, five studies involved an educational element for health and care professionals and one study evaluated the use of clinical decision support technology. We did not combine the results in a meta-analysis due to heterogeneity across studies. Interventions to optimise prescribing may lead to fewer days in hospital (one study out of eight; low certainty evidence), a slower decline in health-related quality of life (one study out of two; low certainty evidence), the identification and resolution of medication-related problems (seven studies; low certainty evidence), and may lead to improved medication appropriateness (five studies out of five studies; low certainty evidence). We are uncertain whether the intervention improves/reduces medicine costs (five studies; very low certainty evidence) and it may make little or no difference on adverse drug events (two studies; low certainty evidence) or mortality (six studies; low certainty evidence). The risk of bias across studies was heterogeneous.\nAuthors' conclusions\nWe could not draw robust conclusions from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems and improvements in medication appropriateness, however evidence of a consistent effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.\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": "Older people living in care homes (also called nursing homes, residential homes, skilled-nursing facilities, assisted-living facilities or aged-care facilities) have many complex physical and mental health problems. Care home residents are prescribed many medicines compared to people who live in their own homes, with an average of eight medicines being common. International research has shown that these medicines are often not well managed, with some residents prescribed medicines inappropriately. This has the potential to lead to harmful side effects and a loss of benefit. For these reasons, it is important to make sure that care home residents are prescribed the right medicines at the right doses. This is an update of a previously published review (Alldred 2013)."
}
] |
query-laysum
|
7892
|
[
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding without an organic lesion is mainly due to an imbalance of the various hormones which have a regulatory effect on the menstrual cycle. Another cause of heavy menstrual bleeding with no pelvic pathology, is the presence of an acquired or inherited bleeding disorder. The haemostatic system has a central role in controlling the amount and the duration of menstrual bleeding, thus abnormally prolonged or profuse bleeding does occur in most women affected by bleeding disorders. Whereas irregular, pre-menarchal or post-menopausal uterine bleeding is unusual in inherited or acquired haemorrhagic disorders, severe acute bleeding and heavy menstrual bleeding at menarche and chronic heavy menstrual bleeding during the entire reproductive life are common. This is an update of a previously published Cochrane Review.\nObjectives\nTo determine the efficacy and safety of non-surgical interventions versus each other, placebo or no treatment for reducing menstrual blood loss in women with bleeding disorders.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Haemoglobinopathies Trials Register (25 August 2016), Embase (May 2013), LILACS (February 2013) and the WHO International Clinical Trial registry (February 2013).\nSelection criteria\nRandomised controlled studies of non-surgical interventions for treating heavy menstrual bleeding (menorrhagia) in women of reproductive age suffering from a congenital or acquired bleeding disorder.\nData collection and analysis\nTwo authors independently assessed studies for inclusion, extracted data and assessed the risk of bias.\nMain results\nThree cross-over studies, with 175 women were included in the review. All three studies had an unclear risk of bias with regards to trial design and overall, the quality of evidence generated was judged to be poor.\nTwo of the studies (n = 59) compared desmopressin (1-deamino-8-D-arginine vasopressin) with placebo. Menstrual blood loss was the primary outcome for both of these studies. Neither study found clear evidence of a difference between groups. The first of these reported a mean difference in menstrual blood loss in the desmopressin versus placebo group of 21.20 mL (95% confidence interval -19.00 to 61.50)\nThe second study reported that even though there was an improvement of pictorial bleeding assessment chart scores with desmopressin and placebo when compared to pretreatment assessment, there was no clear evidence of difference in these scores when the two were compared to each other (results presented graphically, P = 0.51). The data from these studies could not be combined.\nThe third study (n = 116) compared desmopressin with tranexamic acid (n = 116). This study found a decrease in pictorial bleeding assessment chart scores after both treatments as compared to baseline. The decrease in these scores was greater for tranexamic acid than for desmopressin, with a mean difference of 41.6 mL (95% confidence interval 19.6 to 63) (P < 0.0002).\nIn relation to adverse events, across two studies, there was no clear evidence of a difference when placebo was compared to desmopressin, risk ratio 1.17 (95% confidence interval 0.41 to 3.34) . The same was also true when desmopressin was compared to tranexamic acid, risk ratio 1.17 (95% confidence interval 0.41 to 3.34).\nOnly the study that compared desmopressin to tranexamic acid assessed quality of life. However, we are unable to present any data from this study, since no differences in this outcome between the two intervention groups were reported.\nAuthors' conclusions\nEvidence from randomised controlled studies on the effect of desmopressin when compared to placebo in reducing menstrual blood loss is very limited and inconclusive. Two studies, each with a very limited number of participants, have shown uncertain effects in menstrual blood loss and adverse effects. A non-randomised comparison in one of the studies points to the value of combining desmopressin and tranexamic acid, which needs to be tested in a formal randomised controlled study comparison.\nWhen tranexamic acid was compared to desmopressin, a single study showed a reduction in menstrual blood loss with tranexamic acid use compared to desmopressin.\nThere is a need to evaluate non-surgical methods for treating of menorrhagia in women with bleeding disorders through randomised controlled studies. Such methods would be more acceptable than surgery for women wishing to retain their fertility. Given that women may need to use these treatments throughout their entire reproductive life, long-term side-effects should be evaluated.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 25 August 2016."
}
] |
query-laysum
|
7893
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic pelvic pain (CPP) is a common gynaecological condition accounting for 20% of all gynaecological referrals. There are wide ranges of causes with overlapping symptomatology, therefore the management of the condition is a formidable challenge for clinicians. The aetiology of CPP is heterogeneous and in many cases, no clear diagnosis can be reached. It is in this scenario that the label of chronic pelvic pain syndrome (CPPS) can be applied. We defined women with CPPS as having a minimum duration of pain of at least 6 months, including with a diagnosis of pelvic congestion syndrome, but excluding pain caused by a condition such as endometriosis. Many surgical interventions have been tried in isolation or in conjunction with non-surgical interventions in the management with variable results. Surgical interventions are invasive and carry operative risks. Surgical interventions must be evaluated for their effectiveness prior to their prevalent use in the management of women with CPPS.\nObjectives\nTo review the effectiveness and safety of surgical interventions in the management of women with CPPS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO, on 23 April 2021 for any randomised controlled trials (RCT) for surgical interventions in women with CPPS. We also searched the citation lists of relevant publications, two trial registries, relevant journals, abstracts, conference proceedings and several key grey literature sources.\nSelection criteria\nRCTs with women who had CPPS. The review authors were prepared to consider studies of any surgical intervention used for the management of CPPS. Outcome measures were pain rating scales, adverse events, psychological outcomes, quality of life (QoL) measures and requirement for analgesia.\nData collection and analysis\nTwo review authors independently evaluated studies for inclusion and extracted data using the forms designed according to Cochrane guidelines. For each included trial, we collected information regarding the method of randomisation, allocation concealment, blinding, data reporting and analyses. We reported pooled results as mean difference (MDs) or odds ratios (OR) and 95% confidence interval (CI) by the Mantel-Haenszel method. If similar outcomes were reported on different scales, we calculated the standardised mean difference (SMD). We applied GRADE criteria to judge the overall certainty of the evidence.\nMain results\nFour studies met our inclusion criteria involving 216 women with CPP and no identifiable cause.\nAdhesiolysis compared to no surgery or diagnostic laparoscopy\nWe are uncertain of the effect of adhesiolysis on pelvic pain scores postoperatively at three months (MD −7.3, 95% CI −29.9 to 15.3; 1 study, 43 participants; low-certainty evidence), six months (MD −14.3, 95% CI −35.9 to 7.3; 1 study, 43 participants; low-certainty evidence) and 12 months postsurgery (MD 0.00, 95% CI −4.60 to 4.60; 1 study, 43 participants; very low-certainty evidence).\nAdhesiolysis may improve both the emotional wellbeing (MD 24.90, 95% CI 7.92 to 41.88; 1 study, 43 participants; low-certainty evidence) and social support (MD 23.90, 95% CI −1.77 to 49.57; 1 study, 43 participants; low-certainty evidence) components of the Endometriosis Health Profile-30, and both the emotional component (MD 32.30, 95% CI 13.16 to 51.44; 1 study, 43 participants; low-certainty evidence) and the physical component of the 12-item Short Form (MD 22.90, 95% CI 10.97 to 34.83; 1 study, 43 participants; low-certainty evidence) when compared to diagnostic laparoscopy.\nWe are uncertain of the safety of adhesiolysis compared to comparator groups due to low-certainty evidence and lack of structured adverse event reporting.\nNo studies reported on psychological outcomes or requirements for analgesia.\nLaparoscopic uterosacral ligament ablation or resection compared to diagnostic laparoscopy/other treatment\nWe are uncertain of the effect of laparoscopic uterosacral ligament/nerve ablation (LUNA) or resection compared to other treatments postoperatively at three months (OR 1.26, 95% CI 0.40 to 3.93; 1 study, 51 participants; low-certainty evidence) and six months (MD −2.10, 95% CI −4.38 to 0.18; 1 study, 74 participants; very low-certainty evidence). At 12 months post-surgery, we are uncertain of the effect of LUNA on the rate of successful treatment compared to diagnostic laparoscopy. One study of 56 participants found no difference in the effect of LUNA on non-cyclical pain (P = 0.854) or dyspareunia (P = 0.41); however, there was a difference favouring LUNA on dysmenorrhea (P = 0.045) and dyschezia (P = 0.05). We are also uncertain of the effect of LUNA compared to vaginal uterosacral ligament resection on pelvic pain at 12 months (MD 2.00, 95% CI 0.47 to 3.53; 1 study, 74 participants; very low-certainty evidence).\nWe are uncertain of the safety of LUNA or resection compared to comparator groups due to the lack of structured adverse event reporting.\nWomen undergoing LUNA may require more analgesia postoperatively than those undergoing other treatments (P < 0.001; 1 study, 74 participants).\nNo studies reported psychological outcomes or QoL.\nAuthors' conclusions\nWe are uncertain about the benefit of adhesiolysis or LUNA in management of pain in women with CPPS based on the current literature. There may be a QoL benefit to adhesiolysis in improving both emotional wellbeing and social support, as measured by the validated QoL tools. It was not possible to synthesis evidence on adverse events as these were only reported narratively in some studies, in which none were observed. With the inadequate objective assessment of adverse events, especially long-term adverse events, associated with adhesiolysis or LUNA for CPPS, there is currently little to support these interventions for CPPS.\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": "Adhesiolysis versus no surgery/diagnostic laparoscopy\nWe are uncertain of the effect of adhesiolysis compared with diagnostic laparoscopy on pain scores at three, six and 12 months after surgery. Pain was measured using a visual analogue score (VAS), which is a widely used rating scale where the person ranks pain from 0 (no pain) to 100 (worst pain). Adhesiolysis may improve health-related quality of life at six months after surgery when compared to diagnostic laparoscopy.\nLaparoscopic uterosacral ligament ablation versus other treatment\nWe are uncertain of the effect of laparoscopic uterosacral ligament ablation (LUNA) versus diagnostic laparoscopy or vaginal uterosacral ligament resection, on pain scores measured by VAS at three, six and 12 months. Women undergoing LUNA may require more pain relief after surgery than those undergoing alternative treatments.\nNo studies in either comparison reported on psychological outcomes."
}
] |
query-laysum
|
7894
|
[
{
"role": "user",
"content": "Abstract: Background\nWhen couples are faced with the dilemma of a higher-order multiple pregnancy there are three options. Termination of the entire pregnancy has generally not been acceptable to women, especially for those with a past history of infertility. Attempting to continue with all the fetuses is associated with inherent problems of preterm birth, survival and long-term morbidity. The other alternative relates to reduction in the number of fetuses by selective termination. The acceptability of these options for the couple will depend on their social background and underlying beliefs. This review focused on reduction in the number of fetuses.\nObjectives\nTo assess a policy of multifetal reduction with a policy of expectant management of women with a multiple pregnancy.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 July 2015).\nSelection criteria\nRandomised controlled trials with reported data that compared outcomes in mothers and babies who were managed expectantly with outcomes in women who underwent selective fetal reduction of a multiple pregnancy.\nData collection and analysis\nWe planned that two review authors would independently assess trials for inclusion and risk of bias, extract data and check them for accuracy. However, no randomised trials were identified.\nMain results\nThere were no randomised controlled trials identified.\nAuthors' conclusions\nWe found no available data from randomised trials to inform the risks and benefits of pregnancy reduction procedures for women with a multiple pregnancy. While randomised controlled trials will provide the most reliable evidence about the risks and benefits of fetal reduction procedures, reduction in the number of fetuses by selective termination may not be acceptable to women, particularly couples with a past history of infertility. The acceptability of this option, and willingness to undergo randomisation will depend on the couple's social background and beliefs, and consequently, recruitment to such a trial may prove exceptionally difficult.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For the present, we cannot be sure whether pregnancy reduction does lead to better outcomes for the remaining fetuses, and by how much. We cannot be sure which particular outcomes improve, and what risks may arise. In the future, we may get a better picture, with a different type of study which takes into account parental preference, and which tracks the results. In the meantime, parents can come to a decision about whether they want the option of pregnancy reduction after discussion with their midwives and doctors. The discussion will take into account how acceptable the parents find the intervention, and what outcomes they are hoping to achieve."
}
] |
query-laysum
|
7895
|
[
{
"role": "user",
"content": "Abstract: Background\nHuman milk alone may provide inadequate amounts of protein to meet the growth requirements of preterm infants because of restrictions in the amount of fluid they can tolerate. It has become common practice to feed preterm infants with breast milk fortified with protein and other nutrients but there is debate about the optimal concentration of protein in commercially available fortifiers.\nObjectives\nTo compare the effects of different protein concentrations in human milk fortifier, fed to preterm infants, on growth and neurodevelopment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search CENTRAL (2019, Issue 8), Ovid MEDLINE and CINAHL on 15 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included all published and unpublished randomised, quasi-randomised and cluster-randomised trials comparing two different concentrations of protein in human milk fortifier.\nWe included preterm infants (less than 37 weeks' gestational age). Participants may have been exclusively fed human milk or have been supplemented with formula.\nThe concentration of protein was classified as low (< 1g protein/100 mL expressed breast milk (EBM)), moderate (≥ 1g to < 1.4g protein/100 mL EBM) or high (≥ 1.4g protein/100 mL EBM). We excluded trials that compared two protein concentrations that fell within the same category.\nData collection and analysis\nWe undertook data collection and analyses using the standard methods of Cochrane Neonatal. Two review authors independently evaluated trials. Primary outcomes included growth, neurodevelopmental outcome and mortality. Data were synthesised using risk ratios (RR), risk differences and mean differences (MD), with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe identified nine trials involving 861 infants. There is one trial awaiting classification, and nine ongoing trials. The trials were mostly conducted in infants born < 32 weeks' gestational age or < 1500 g birthweight, or both. All used a fortifier derived from bovine milk. Two trials fed infants exclusively with mother's own milk, three trials gave supplementary feeds with donor human milk and four trials supplemented with preterm infant formula. Overall, trials were small but generally at low or unclear risk of bias.\nHigh versus moderate protein concentration of human milk fortifier\nThere was moderate certainty evidence that a high protein concentration likely increased in-hospital weight gain compared to moderate concentration of human milk fortifier (MD 0.66 g/kg/day, 95% CI 0.51 to 0.82; trials = 6, participants = 606). The evidence was very uncertain about the effect of high versus moderate protein concentration on length gain (MD 0.01 cm/week, 95% CI –0.01 to 0.03; trials = 5, participants = 547; very low certainty evidence) and head circumference gain (MD 0.00 cm/week, 95% CI –0.01 to 0.02; trials = 5, participants = 549; very low certainty evidence).\nOnly one trial reported neonatal mortality, with no deaths in either group (participants = 45).\nModerate versus low protein concentration of human milk fortifier\nA moderate versus low protein concentration fortifier may increase weight gain (MD 2.08 g/kg/day, 95% CI 0.38 to 3.77; trials = 2, participants = 176; very low certainty evidence) with little to no effect on head circumference gain (MD 0.13 cm/week, 95% CI 0.00 to 0.26; I² = 85%; trials = 3, participants = 217; very low certainty evidence), but the evidence is very uncertain. There was low certainty evidence that a moderate protein concentration may increase length gain (MD 0.09 cm/week, 95% CI 0.05 to 0.14; trials = 3, participants = 217).\nOnly one trial reported mortality and found no difference between groups (RR 0.48, 95% CI 0.05 to 5.17; participants = 112).\nNo trials reported long term growth or neurodevelopmental outcomes including cerebral palsy and developmental delay.\nAuthors' conclusions\nFeeding preterm infants with a human milk fortifier containing high amounts of protein (≥ 1.4g/100 mL EBM) compared with a fortifier containing moderate protein concentration (≥ 1 g to < 1.4 g/100 mL EBM) results in small increases in weight gain during the neonatal admission. There may also be small increases in weight and length gain when infants are fed a fortifier containing moderate versus low protein concentration (< 1 g protein/100 mL EBM). The certainty of this evidence is very low to moderate; therefore, results may change when the findings of ongoing studies are available. There is insufficient evidence to assess the impact of protein concentration on adverse effects or long term outcomes such as neurodevelopment. Further trials are needed to determine whether modest increases in weight gain observed with higher protein concentration fortifiers are associated with benefits or harms to long term growth and neurodevelopment.\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": "Among preterm infants, does the amount of protein used to fortify breast milk feeds result in any difference in growth and neurodevelopmental (development of the brain to improve performance or functioning (e.g. intelligence, reading ability, social skills, memory, attention or focus skills) outcomes?"
}
] |
query-laysum
|
7896
|
[
{
"role": "user",
"content": "Abstract: Background\nAging populations are at increased risk of postoperative complications. New methods to provide care for older people recovering from surgery may reduce surgery-related complications. Comprehensive geriatric assessment (CGA) has been shown to improve some outcomes for medical patients, such as enabling them to continue living at home, and has been proposed to have positive impacts for surgical patients. CGA is a coordinated, multidisciplinary collaboration that assesses the medical, psychosocial and functional capabilities and limitations of an older person, with the goal of establishing a treatment plan and long-term follow-up.\nObjectives\nTo assess the effectiveness of CGA interventions compared to standard care on the postoperative outcomes of older people admitted to hospital for surgical care.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two clinical trials registers on 13 January 2017. We also searched grey literature for additional citations.\nSelection criteria\nRandomized trials of people undergoing surgery aged 65 years and over comparing CGA with usual surgical care and reporting any of our primary (mortality and discharge to an increased level of care) or secondary (length of stay, re-admission, total cost and postoperative complication) outcomes. We excluded studies if the participants did not receive a complete CGA, did not undergo surgery, and if the study recruited participants aged less than 65 years or from a setting other than an acute care hospital.\nData collection and analysis\nTwo review authors independently screened, assessed risk of bias, extracted data and assessed certainty of evidence from identified articles. We expressed dichotomous treatment effects as risk ratio (RR) with 95% confidence intervals and continuous outcomes as mean difference (MD).\nMain results\nWe included eight randomised trials, seven recruited people recovering from a hip fracture (N = 1583) and one elective surgical oncology trial (N = 260), conducted in North America and Europe. For two trials CGA was done pre-operatively and postoperatively for the remaining. Six trials had adequate randomization, five had low risk of performance bias and four had low risk of detection bias. Blinding of participants was not possible. All eight trials had low attrition rates and seven reported all expected outcomes.\nCGA probably reduces mortality in older people with hip fracture (RR 0.85, 95% CI 0.68 to 1.05; 5 trials, 1316 participants, I² = 0%; moderate-certainty evidence). The intervention reduces discharge to an increased level of care (RR 0.71, 95% CI 0.55 to 0.92; 5 trials, 941 participants, I² = 0%; high-certainty evidence).\nLength of stay was highly heterogeneous, with mean difference between participants allocated to the intervention and the control groups ranging between -12.8 and 8.3 days. CGA probably leads to slightly reduced length of stay (4 trials, 841 participants, moderate-certainty evidence). The intervention probably makes little or no difference in re-admission rates (RR 1.00, 95% CI 0.76 to 1.32; 3 trials, 741 participants, I² = 37%; moderate-certainty evidence).\nCGA probably slightly reduces total cost (1 trial, 397 participants, moderate-certainty evidence). The intervention may make little or no difference for major postoperative complications (2 trials, 579 participants, low-certainty evidence) and delirium rates (RR 0.75, 95% CI 0.60 to 0.94, 3 trials, 705 participants, I² = 0%; low-certainty evidence).\nAuthors' conclusions\nThere is evidence that CGA can improve outcomes in people with hip fracture. There are not enough studies to determine when CGA is most effective in relation to surgical intervention or if CGA is effective in surgical patients presenting with conditions other than hip fracture.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The world's population is getting older; more and more people are now over the age of 65 years and are at increased risk of complications after surgery, which include infection, heart attacks and even death. CGA is known to lower complications in hospitalized older people, but no reviews looked specifically into older people who have had surgery. We conducted this review to address that gap. We compared people who received CGA either before (2 studies) or after surgery (6 studies) to people who received traditional postoperative care from their surgeon."
}
] |
query-laysum
|
7897
|
[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease (SCD) is one of the most common inherited diseases worldwide. It is associated with lifelong morbidity and a reduced life expectancy. Hydroxyurea (hydroxycarbamide), an oral chemotherapeutic drug, ameliorates some of the clinical problems of SCD, in particular that of pain, by raising foetal haemoglobin (HbF). This is an update of a previously published Cochrane Review.\nObjectives\nThe aims of this review are to determine through a review of randomised or quasi-randomised studies whether the use of hydroxyurea in people with SCD alters the pattern of acute events, including pain; prevents, delays or reverses organ dysfunction; alters mortality and quality of life; or is associated with adverse effects.\nIn addition, we hoped to assess whether the response to hydroxyurea in SCD varies with the type of SCD, age of the individual, duration and dose of treatment, and healthcare setting.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries. The date of the most recent search was 17 February 2022.\nSelection criteria\nRandomised and quasi-randomised controlled trials (RCTs and quasi-RCTs), of one month or longer, comparing hydroxyurea with placebo or standard therapy in people with SCD.\nData collection and analysis\nAuthors independently assessed studies for inclusion, carried out data extraction, assessed the risk of bias and assessed the quality of the evidence using GRADE.\nMain results\nWe included nine RCTs recruiting 1104 adults and children with SCD (haemoglobin SS (HbSS), haemoglobin SC (HbSC) or haemoglobin Sβºthalassaemia (HbSβºthal) genotypes). Studies lasted from six to 30 months.\nWe judged the quality of the evidence for the first two comparisons below as moderate to low as the studies contributing to these comparisons were mostly large and well-designed (and at low risk of bias); however, the evidence was limited and imprecise for some outcomes such as quality of life, deaths during the studies and adverse events, and the results are applicable only to individuals with HbSS and HbSβºthal genotypes. We judged the quality of the evidence for the third and fourth comparisons to be very low due to the limited number of participants, the lack of statistical power (both studies were terminated early with approximately only 20% of their target sample size recruited) and the lack of applicability to all age groups and genotypes.\nHydroxyurea versus placebo\nFive studies (784 adults and children with HbSS or HbSβºthal) compared hydroxyurea to placebo; four recruited individuals with only severe disease and one recruited individuals with all disease severities. Hydroxyurea probably improves pain alteration (using measures such as pain crisis frequency, duration, intensity, hospital admissions and opoid use) and life-threatening illness, but we found no difference in death rates (10 deaths occurred during the studies, but the rates did not differ by treatment group) (all moderate-quality evidence). Hydroxyurea may improve measures of HbF (low-quality evidence) and probably decreases neutrophil counts (moderate-quality evidence). There were no consistent differences in terms of quality of life and adverse events (including serious or life-threatening events) (low-quality evidence). There were fewer occurrences of acute chest syndrome and blood transfusions in the hydroxyurea groups.\nHydroxyurea and phlebotomy versus transfusion and chelation\nTwo studies (254 children with HbSS or HbSβºthal also with risk of primary or secondary stroke) contributed to this comparison. There were no consistent differences in terms of pain alteration, death or adverse events (low-quality evidence) or life-threatening illness (moderate-quality evidence). Hydroxyurea with phlebotomy probably increased HbF and decreased neutrophil counts (moderate-quality evidence), but there were more occurrences of acute chest syndrome and infections. Quality of life was not reported. In the primary prevention study, no strokes occurred in either treatment group but in the secondary prevention study, seven strokes occurred in the hydroxyurea and phlebotomy group (none in the transfusion and chelation group) and the study was terminated early.\nHydroxyurea versus observation\nOne study (22 children with HbSS or HbSβºthal also at risk of stoke) compared hydroxyurea to observation. Pain alteration and quality of life were not reported. There were no differences in life-threatening illness, death (no deaths reported in either group) or adverse events (very low-quality evidence). We are uncertain if hydroxyurea improves HbF or decreases neutrophil counts (very low-quality evidence).\nTreatment regimens with and without hydroxyurea\nOne study (44 adults and children with HbSC) compared treatment regimens with and without hydroxyurea. Pain alteration, life-threatening illness and quality of life were not reported. There were no differences in death rates (no deaths reported in either group), adverse events or neutrophil levels (very low-quality evidence). We are uncertain if hydroxyurea improves HbF (very low-quality evidence).\nAuthors' conclusions\nThere is evidence to suggest that hydroxyurea may be effective in decreasing the frequency of pain episodes and other acute complications in adults and children with sickle cell anaemia of HbSS or HbSβºthal genotypes and in preventing life-threatening neurological events in those with sickle cell anaemia at risk of primary stroke by maintaining transcranial Doppler velocities. However, there is still insufficient evidence on the long-term benefits of hydroxyurea, particularly with regard to preventing chronic complications of SCD, or recommending a standard dose or dose escalation to maximum tolerated dose. There is also insufficient evidence about the long-term risks of hydroxyurea, including its effects on fertility and reproduction. Evidence is also limited on the effects of hydroxyurea on individuals with the HbSC genotype. Future studies should be designed to address such uncertainties.\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": "The evidence shows that hydroxyurea is likely to be effective in the short term at decreasing the frequency of painful episodes and raising HbF levels in the blood in people with SCD. Hydroxyurea is also likely to be effective in preventing first strokes for those at an increased risk of stroke and does not seem to be associated with an increase in any adverse effects (including serious and life-threatening effects).\nThere is currently little evidence from the studies that we examined on whether hydroxyurea is beneficial over a long period of time, what the best dose to take is, or whether treatment causes any long-term or serious side effects. More studies are needed to answer these questions."
}
] |
query-laysum
|
7898
|
[
{
"role": "user",
"content": "Abstract: Background\nCataract surgery is the most common ambulatory incisional surgery performed in the USA. Cystoid macular edema (CME), the accumulation of fluid in the central retina due to leakage from dilated capillaries, is the most common cause of vision impairment following cataract surgery. Acute CME, defined as CME of less than four months' duration, often resolves spontaneously. CME that persists for four months or longer is termed chronic CME. Non-steroidal anti-inflammatory drugs (NSAIDs) have been used to treat CME. This update adds new evidence and analyses to the previously published review.\nObjectives\nTo examine the effectiveness of NSAIDs in the treatment of CME following cataract surgery.\nSearch methods\nWe searched the CENTRAL (2022, Issue 3); Ovid MEDLINE; Embase; PubMed; LILACS; mRCT (discontinued in 2014, last searched August 2011), ClinicalTrials.gov, and WHO ICTRP databases. We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 20 March 2022.\nSelection criteria\nWe included randomized controlled trials evaluating the effects of NSAIDs for CME following cataract surgery.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts, reviewed full-text publications against eligibility criteria, independently extracted data from newly included trials and assessed risk of bias for each included trial. We contacted trial authors for clarification or to request missing information. We provided a narrative synthesis of all included trials and their results. For continuous and dichotomous outcomes, we separately performed pooled analysis and reported mean difference (MD) and risk ratio (RR) as well as the associated 95% confidence interval (CI) whenever feasible. Two review authors independently graded the overall certainty of the evidence for each outcome using the GRADE approach.\nMain results\nWe included nine trials with a total of 390 participants (393 eyes). Study participants' mean age was 72.2 years (interquartile range [IQR] 68.8 to 73.6) and 72% were women (IQR 69% to 74%). Three trials included participants with acute CME, and four included participants with chronic CME; the remaining two trials enrolled both participants with acute and chronic CME or participants with unknown CME duration. We assessed trials as having unclear (33%) or high risk of bias (67%).\nVisual improvement of two or more lines at the end of treatment\nData from one trial in participants with acute CME show no treatment effect of topical ketorolac compared to placebo (RR 2.00, 95% CI 0.46 to 8.76; 22 participants). Data from a three-arm trial in participants with acute CME demonstrate that, when compared with topical prednisolone, topical ketorolac (RR 1.33, 95% CI 0.58 to 3.07; 17 participants) or topical ketorolac and prednisolone combination therapy (RR 1.78, 95% CI 0.86 to 3.69; 17 participants) may have little or no effect on visual improvement. Results of subgroup analysis from two studies in participants with chronic CME suggest that, after treatment for 90 days or longer, NSAIDs may increase participants' likelihood of visual improvement by 1.87 fold (RR 2.87, 95% CI 1.58 to 5.22; I2 = 33%; 2 trials, 121 participants) relative to placebo. However, there was no evidence of treatment effects in the subgroup with two months of treatment or less (RR 0.72, 95% CI 0.30 to 1.73; P = 0.19, I2 = 41%; 2 trials, 34 participants). Overall, this evidence is very low certainty.\nA single-study estimate in patients with mixed CME indicates that topical diclofenac may increase the likelihood of visual improvement by 40% when compared to topical ketorolac (RR 1.40, 95% CI 1.02 to 1.94; 68 participants). However, the same trial reported no difference between the groups in mean final visual acuity in Snellen lines (MD 0.40, 95% CI −0.93 to 1.73). A three-arm trial in patients with mixed CME reporting visual changes in ETDRS letters in comparisons between ketorolac and diclofenac (34 participants) or bromfenac (34 participants) suggests no evidence of effects. Overall, NSAIDs may slightly improve visual acuity in participants with mixed CME but the evidence is very uncertain.\nPersistence of improvement of vision one month after discontinuation of treatment\nOne trial of participants with chronic CME tested oral indomethacin (RR 0.40, 95% CI 0.10 to 1.60; 20 participants) and the other compared topical ketorolac to placebo (RR 4.00, 95% CI 0.51 to 31.1; 26 participants). While there is no evidence of treatment effects, evidence suggests substantial between-group heterogeneity (P = 0.07, I2 = 69.9%; very low-certainty evidence). None of the trials in patients with acute or mixed CME reported this outcome.\nProportion of participants with improvement in leakage on fundus fluorescein angiography\nOne three-arm trial in participants with acute CME shows that, when compared with topical prednisolone, there is no treatment benefit of topical ketorolac (RR 1.11, 95% CI 0.45 to 2.75; 17 participants) or topical ketorolac and topical prednisolone combination therapy (RR 1.56, 95% CI 0.72 to 3.38; 17 participants). This evidence is very low certainty.\nThe combined estimate from two trials in participants with chronic CME indicates NSAIDs have little to no effect over placebo on improving leakage (RR 1.93, 95% CI 0.62 to 6.02; 40 participants; very low-certainty evidence). Neither of the trials in patients with mixed CME reported this outcome.\nProportion of participants with improved contrast sensitivity\nVery low-certainty evidence from one trial in participants with acute CME shows no treatment benefit of ketorolac (RR 1.11, 95% CI 0.45 to 2.75; 17 participants) or ketorolac and prednisolone combination therapy (RR 1.78, 95% CI 0.86 to 3.69; 17 participants) compared with topical prednisolone. None of the trials in patients with chronic or mixed CME reported this outcome.\nProportion of participants with improved central macular thickness on optical coherence tomography; measures of quality of life\nNo included trial reported these outcomes.\nAdverse effects\nMost trials observed no differences in ocular adverse events, such as corneal toxicity or elevated intraocular pressure, between comparison groups.\nAuthors' conclusions\nEvidence on effects of NSAIDs in patients with CME is very uncertain and further investigation is warranted. Our findings are limited by small sample sizes, and heterogeneity in interventions, assessments, and reporting of clinically important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"• Length of time with CME not known\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "topical NSAID might have little or no effects on vision compared to a different NSAID.\nMost of the included studies either did not report data on unwanted effects or did not report differences in unwanted effects between groups receiving different treatments."
}
] |
query-laysum
|
7899
|
[
{
"role": "user",
"content": "Abstract: Background\nAlveolar osteitis (dry socket) is a complication of dental extractions more often involving mandibular molar teeth. It is associated with severe pain developing 2 to 3 days postoperatively with or without halitosis, a socket that may be partially or totally devoid of a blood clot, and increased postoperative visits. This is an update of the Cochrane Review first published in 2012.\nObjectives\nTo assess the effects of local interventions used for the prevention and treatment of alveolar osteitis (dry socket) following tooth extraction.\nSearch methods\nAn Information Specialist searched four bibliographic databases up to 28 September 2021 and used additional search methods to identify published, unpublished, and ongoing studies.\nSelection criteria\nWe included randomised controlled trials of adults over 18 years of age who were having permanent teeth extracted or who had developed dry socket postextraction. We included studies with any type of local intervention used for the prevention or treatment of dry socket, compared to a different local intervention, placebo or no treatment. We excluded studies reporting on systemic use of antibiotics or the use of surgical techniques because these interventions are evaluated in separate Cochrane Reviews.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We followed Cochrane statistical guidelines and reported dichotomous outcomes as risk ratios (RR) and calculated 95% confidence intervals (CI) using random-effects models. For some of the split-mouth studies with sparse data, it was not possible to calculate RR so we calculated the exact odds ratio (OR) instead. We used GRADE to assess the certainty of the body of evidence.\nMain results\nWe included 49 trials with 6771 participants; 39 trials (with 6219 participants) investigated prevention of dry socket and 10 studies (with 552 participants) looked at the treatment of dry socket. 16 studies were at high risk of bias, 30 studies at unclear risk of bias, and 3 studies at low risk of bias.\nChlorhexidine in the prevention of dry socket\nWhen compared to placebo, rinsing with chlorhexidine mouthrinses (0.12% and 0.2% concentrations) both before and 24 hours after extraction(s) substantially reduced the risk of developing dry socket with an OR of 0.38 (95% CI 0.25 to 0.58; P < 0.00001; 6 trials, 1547 participants; moderate-certainty evidence). The prevalence of dry socket varies from 1% to 5% in routine dental extractions to upwards of 30% in surgically extracted third molars. The number of patients needed to be treated (NNT) with chlorhexidine rinse to prevent one patient having dry socket was 162 (95% CI 155 to 240), 33 (95% CI 27 to 49), and 7 (95% CI 5 to 10) for control prevalence of dry socket 0.01, 0.05, and 0.30 respectively.\nCompared to placebo, placing chlorhexidine gel intrasocket after extractions reduced the odds of developing a dry socket by 58% with an OR of 0.44 (95% CI 0.27 to 0.71; P = 0.0008; 7 trials, 753 participants; moderate-certainty evidence). The NNT with chlorhexidine gel (0.2%) to prevent one patient developing dry socket was 180 (95% CI 137 to 347), 37 (95% CI 28 to 72), and 7 (95% CI 5 to 15) for control prevalence of dry socket of 0.01, 0.05, and 0.30 respectively.\nCompared to chlorhexidine rinse (0.12%), placing chlorhexidine gel (0.2%) intrasocket after extractions was not superior in reducing the risk of dry socket (RR 0.74, 95% CI 0.46 to 1.20; P = 0.22; 2 trials, 383 participants; low-certainty evidence).\nThe present review found some evidence for the association of minor adverse reactions with use of 0.12%, 0.2% chlorhexidine mouthrinses (alteration in taste, staining of teeth, stomatitis) though most studies were not designed explicitly to detect the presence of hypersensitivity reactions to mouthwash as part of the study protocol. No adverse events were reported in relation to the use of 0.2% chlorhexidine gel placed directly into a socket.\nPlatelet rich plasma in the prevention of dry socket\nCompared to placebo, placing platelet rich plasma after extractions was not superior in reducing the risk of having a dry socket (RR 0.51, 95% CI 0.19 to 1.33; P = 0.17; 2 studies, 127 participants; very low-certainty evidence).\nA further 21 intrasocket interventions to prevent dry socket were each evaluated in single studies, and there is insufficient evidence to determine their effects.\nZinc oxide eugenol versus Alvogyl in the treatment of dry socket\nTwo studies, with 80 participants, showed that Alvogyl (old formulation) is more effective than zinc oxide eugenol at reducing pain at day 7 (mean difference (MD) -1.40, 95% CI -1.75 to -1.04; P < 0.00001; 2 studies, 80 participants; very low-certainty evidence)\nA further nine interventions for the treatment of dry socket were evaluated in single studies, providing insufficient evidence to determine their effects.\nAuthors' conclusions\nTooth extractions are generally undertaken by dentists for a variety of reasons, however, all but five studies included in the present review included participants undergoing extraction of third molars, most of which were undertaken by oral surgeons. There is moderate-certainty evidence that rinsing with chlorhexidine (0.12% and 0.2%) or placing chlorhexidine gel (0.2%) in the sockets of extracted teeth, probably results in a reduction in dry socket. There was insufficient evidence to determine the effects of the other 21 preventative interventions each evaluated in single studies. There was limited evidence of very low certainty that Alvogyl (old formulation) may reduce pain at day 7 in patients with dry socket when compared to zinc oxide eugenol.\n\nGiven the provided abstract, please respond to the following query: \"What causes dry socket?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It is thought to be linked to the loss of some or all of the blood clot that forms at the bottom of a tooth socket after a tooth is taken out."
}
] |
query-laysum
|
7900
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with liver cirrhosis who have had one episode of variceal bleeding are at risk for repeated episodes of bleeding. Endoscopic intervention and portosystemic shunts are used to prevent further bleeding, but there is no consensus as to which approach is preferable.\nObjectives\nTo compare the benefits and harms of shunts (surgical shunts (total shunt (TS), distal splenorenal shunt (DSRS), or transjugular intrahepatic portosystemic shunt (TIPS)) versus endoscopic intervention (endoscopic sclerotherapy or banding, or both) with or without medical treatment (non-selective beta blockers or nitrates, or both) for prevention of variceal rebleeding in people with liver cirrhosis.\nSearch methods\nWe searched the CHBG Controlled Trials Register; CENTRAL, in the Cochrane Library; MEDLINE Ovid; Embase Ovid; LILACS (Bireme); Science Citation Index - Expanded (Web of Science); and Conference Proceedings Citation Index - Science (Web of Science); as well as conference proceedings and the references of trials identified until 22 June 2020. We contacted study investigators and industry researchers.\nSelection criteria\nRandomised clinical trials comparing shunts versus endoscopic interventions with or without medical treatment in people with cirrhosis who had recovered from a variceal haemorrhage.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. When possible, we collected data to allow intention-to-treat analysis. For each outcome, we estimated a meta-analysed estimate of treatment effect across trials (risk ratio for binary outcomes). We used random-effects model meta-analysis as our main analysis and as a means of presenting results. We reported differences in means for continuous outcomes without a meta-analytic estimate due to high variability in their assessment among all trials. We assessed the certainty of evidence using GRADE.\nMain results\nWe identified 27 randomised trials with 1828 participants. Three trials assessed TSs, five assessed DSRSs, and 19 trials assessed TIPSs. The endoscopic intervention was sclerotherapy in 16 trials, band ligation in eight trials, and a combination of band ligation and either sclerotherapy or glue injection in three trials. In eight trials, endoscopy was combined with beta blockers (in one trial plus isosorbide mononitrate). We judged all trials to be at high risk of bias. We assessed the certainty of evidence for all the outcome review results as very low (i.e. the true effects of the results are likely to be substantially different from the results of estimated effects). The very low evidence grading is due to the overall high risk of bias for all trials, and to imprecision and publication bias for some outcomes. Therefore, we are very uncertain whether portosystemic shunts versus endoscopy interventions with or without medical treatment have effects on all-cause mortality (RR 0.99, 95% CI 0.86 to 1.13; 1828 participants; 27 trials), on rebleeding (RR 0.40, 95% CI 0.33 to 0.50; 1769 participants; 26 trials), on mortality due to rebleeding (RR 0.51, 95% CI 0.34 to 0.76; 1779 participants; 26 trials), and on occurrence of hepatic encephalopathy, both acute (RR 1.60, 95% CI 1.33 to 1.92; 1649 participants; 24 trials) and chronic (RR 2.51, 95% CI 1.38 to 4.55; 956 participants; 13 trials). No data were available regarding health-related quality of life.\nAnalysing each modality of portosystemic shunts individually (i.e. TS, DSRS, and TIPS) versus endoscopic interventions with or without medical treatment, we are very uncertain if each type of shunt has effect on all-cause mortality: TS, RR 0.46, 95% CI 0.19 to 1.13; 164 participants; 3 trials; DSRS, RR 0.93, 95% CI 0.65 to 1.33; 352 participants; 4 trials; and TIPS, RR 1.10, 95% CI 0.92 to 1.31; 1312 participants; 19 trial; on rebleeding: TS, RR 0.28, 95% CI 0.14 to 0.56; 127 participants; 2 trials; DSRS, RR 0.26, 95% CI 0.11 to 0.65; 330 participants; 5 trials; and TIPS, RR 0.44, 95% CI 0.36 to 0.55; 1312 participants; 19 trials; on mortality due to rebleeding: TS, RR 0.25, 95% CI 0.06 to 0.96; 164 participants; 3 trials; DSRS, RR 0.31, 95% CI 0.13 to 0.74; 352 participants; 5 trials; and TIPS, RR 0.65, 95% CI 0.40 to 1.04; 1263 participants; 18 trials; on acute hepatic encephalopathy: TS, RR 1.66, 95% CI 0.70 to 3.92; 115 participants; 2 trials; DSRS, RR 1.70, 95% CI 0.94 to 3.08; 287 participants; 4 trials, TIPS, RR 1.61, 95% CI 1.29 to 1.99; 1247 participants; 18 trials; and chronic hepatic encephalopathy: TS, Fisher's exact test P = 0.11; 69 participants; 1 trial; DSRS, RR 4.87, 95% CI 1.46 to 16.23; 170 participants; 2 trials; and TIPS, RR 1.88, 95% CI 0.93 to 3.80; 717 participants; 10 trials.\nThe proportion of participants with shunt occlusion or dysfunction was overall 37% (95% CI 33% to 40%). It was 3% (95% CI 0.8% to 10%) following TS, 7% (95% CI 3% to 13%) following DSRS, and 47.1% (95% CI 43% to 51%) following TIPS. Shunt dysfunction in trials utilising polytetrafluoroethylene-covered stents was 17% (95% CI 11% to 24%).\nLength of inpatient hospital stay and cost were not comparable across trials.\nFunding was unclear in 16 trials; 11 trials were funded by government, local hospitals, or universities.\nAuthors' conclusions\nEvidence on whether portosystemic shunts versus endoscopy interventions with or without medical treatment in people with cirrhosis and previous hypertensive portal bleeding have little or no effect on all-cause mortality is very uncertain. Evidence on whether portosystemic shunts may reduce bleeding and mortality due to bleeding while increasing hepatic encephalopathy is also very uncertain. We need properly conducted trials to assess effects of these interventions not only on assessed outcomes, but also on quality of life, costs, and length of hospital stay.\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 cannot say for sure that portosystemic shunts when compared with endoscopic treatment associated sometimes with medical treatment modify the risk of overall death (all-cause mortality), reduce the risk of repeated episodes of bleeding, or increase the risk of developing hepatic encephalopathy. We need properly conducted trials assessing important outcomes for people with cirrhosis and health providers."
}
] |
query-laysum
|
7901
|
[
{
"role": "user",
"content": "Abstract: Background\nIvermectin, an antiparasitic agent, inhibits the replication of viruses in vitro. The molecular hypothesis of ivermectin's antiviral mode of action suggests an inhibitory effect on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in early stages of infection. Currently, evidence on ivermectin for prevention of SARS-CoV-2 infection and COVID-19 treatment is conflicting.\nObjectives\nTo assess the efficacy and safety of ivermectin plus standard of care compared to standard of care plus/minus placebo, or any other proven intervention for people with COVID-19 receiving treatment as inpatients or outpatients, and for prevention of an infection with SARS-CoV-2 (postexposure prophylaxis).\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, Web of Science (Emerging Citation Index and Science Citation Index), WHO COVID-19 Global literature on coronavirus disease, and HTA database weekly to identify completed and ongoing trials without language restrictions to 16 December 2021. Additionally, we included trials with > 1000 participants up to April 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing ivermectin to standard of care, placebo, or another proven intervention for treatment of people with confirmed COVID-19 diagnosis, irrespective of disease severity or treatment setting, and for prevention of SARS-CoV-2 infection. Co-interventions had to be the same in both study arms.\nFor this review update, we reappraised eligible trials for research integrity: only RCTs prospectively registered in a trial registry according to WHO guidelines for clinical trial registration were eligible for inclusion.\nData collection and analysis\nWe assessed RCTs for bias, using the Cochrane RoB 2 tool. We used GRADE to rate the certainty of evidence for outcomes in the following settings and populations: 1) to treat inpatients with moderate-to-severe COVID-19, 2) to treat outpatients with mild COVID-19 (outcomes: mortality, clinical worsening or improvement, (serious) adverse events, quality of life, and viral clearance), and 3) to prevent SARS-CoV-2 infection (outcomes: SARS-CoV-2 infection, development of COVID-19 symptoms, admission to hospital, mortality, adverse events and quality of life).\nMain results\nWe excluded seven of the 14 trials included in the previous review version; six were not prospectively registered and one was non-randomized. This updated review includes 11 trials with 3409 participants investigating ivermectin plus standard of care compared to standard of care plus/minus placebo. No trial investigated ivermectin for prevention of infection or compared ivermectin to an intervention with proven efficacy. Five trials treated participants with moderate COVID-19 (inpatient settings); six treated mild COVID-19 (outpatient settings). Eight trials were double-blind and placebo-controlled, and three were open-label. We assessed around 50% of the trial results as low risk of bias.\nWe identified 31 ongoing trials. In addition, there are 28 potentially eligible trials without publication of results, or with disparities in the reporting of the methods and results, held in ‘awaiting classification’ until the trial authors clarify questions upon request.\nIvermectin for treating COVID-19 in inpatient settings with moderate-to-severe disease\nWe are uncertain whether ivermectin plus standard of care compared to standard of care plus/minus placebo reduces or increases all-cause mortality at 28 days (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.14 to 2.51; 3 trials, 230 participants; very low-certainty evidence); or clinical worsening, assessed by participants with new need for invasive mechanical ventilation or death at day 28 (RR 0.82, 95% CI 0.33 to 2.04; 2 trials, 118 participants; very low-certainty evidence); or serious adverse events during the trial period (RR 1.55, 95% CI 0.07 to 35.89; 2 trials, 197 participants; very low-certainty evidence). Ivermectin plus standard of care compared to standard of care plus placebo may have little or no effect on clinical improvement, assessed by the number of participants discharged alive at day 28 (RR 1.03, 95% CI 0.78 to 1.35; 1 trial, 73 participants; low-certainty evidence); on any adverse events during the trial period (RR 1.04, 95% CI 0.61 to 1.79; 3 trials, 228 participants; low-certainty evidence); and on viral clearance at 7 days (RR 1.12, 95% CI 0.80 to 1.58; 3 trials, 231 participants; low-certainty evidence). No trial investigated quality of life at any time point.\nIvermectin for treating COVID-19 in outpatient settings with asymptomatic or mild disease\nIvermectin plus standard of care compared to standard of care plus/minus placebo probably has little or no effect on all-cause mortality at day 28 (RR 0.77, 95% CI 0.47 to 1.25; 6 trials, 2860 participants; moderate-certainty evidence) and little or no effect on quality of life, measured with the PROMIS Global-10 scale (physical component mean difference (MD) 0.00, 95% CI -0.98 to 0.98; and mental component MD 0.00, 95% CI -1.08 to 1.08; 1358 participants; high-certainty evidence). Ivermectin may have little or no effect on clinical worsening, assessed by admission to hospital or death within 28 days (RR 1.09, 95% CI 0.20 to 6.02; 2 trials, 590 participants; low-certainty evidence); on clinical improvement, assessed by the number of participants with all initial symptoms resolved up to 14 days (RR 0.90, 95% CI 0.60 to 1.36; 2 trials, 478 participants; low-certainty evidence); on serious adverse events (RR 2.27, 95% CI 0.62 to 8.31; 5 trials, 1502 participants; low-certainty evidence); on any adverse events during the trial period (RR 1.24, 95% CI 0.87 to 1.76; 5 trials, 1502 participants; low-certainty evidence); and on viral clearance at day 7 compared to placebo (RR 1.01, 95% CI 0.69 to 1.48; 2 trials, 331 participants; low-certainty evidence). None of the trials reporting duration of symptoms were eligible for meta-analysis.\nAuthors' conclusions\nFor outpatients, there is currently low- to high-certainty evidence that ivermectin has no beneficial effect for people with COVID-19. Based on the very low-certainty evidence for inpatients, we are still uncertain whether ivermectin prevents death or clinical worsening or increases serious adverse events, while there is low-certainty evidence that it has no beneficial effect regarding clinical improvement, viral clearance and adverse events. No evidence is available on ivermectin to prevent SARS-CoV-2 infection. In this update, certainty of evidence increased through higher quality trials including more participants. According to this review's living approach, we will continually update our search.\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"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
7902
|
[
{
"role": "user",
"content": "Abstract: Background\nLengthy duration of use may be a risk factor for umbilical venous catheter-associated bloodstream infection in newborn infants. Early planned removal of umbilical venous catheters (UVCs) is recommended to reduce the incidence of infection and associated morbidity and mortality.\nObjectives\nTo compare the effectiveness of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.\nTo perform subgroup analyses by gestational age at birth and prespecified planned duration of UVC placement (see \"Subgroup analysis and investigation of heterogeneity\").\nSearch methods\nWe used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4), Ovid MEDLINE, Embase, and the Maternity & Infant Care Database (until May 2017), as well as conference proceedings and previous reviews.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared effects of early planned removal of UVCs (up to two weeks after insertion) versus an expectant approach or a longer fixed duration in preventing bloodstream infection and other complications in newborn infants.\nData collection and analysis\nTwo review authors assessed trial eligibility and risk of bias and independently undertook data extraction. We analysed treatment effects and reported risk ratio (RR) and risk difference (RD) for dichotomous data, and mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We planned to use a fixed-effect model in meta-analyses and to explore potential causes of heterogeneity in sensitivity analyses. We assessed the quality of evidence for the main comparison at the outcome level using GRADE methods.\nMain results\nWe found one eligible trial. Participants were 210 newborn infants with birth weight less than 1251 grams. The trial was unblinded but otherwise of good methodological quality. This trial compared removal of an umbilical venous catheter within 10 days after insertion (and replacement with a peripheral cannula or a percutaneously inserted central catheter as required) versus expectant management (UVC in place up to 28 days). More infants in the early planned removal group than in the expectant management group (83 vs 33) required percutaneous insertion of a central catheter (PICC). Trial results showed no difference in the incidence of catheter-related bloodstream infection (RR 0.65, 95% CI 0.35 to 1.22), in hospital mortality (RR 1.12, 95% CI 0.42 to 2.98), in catheter-associated thrombus necessitating removal (RR 0.33, 95% confidence interval 0.01 to 7.94), or in other morbidity. GRADE assessment indicated that the quality of evidence was \"low\" at outcome level principally as the result of imprecision and risk of surveillance bias due to lack of blinding in the included trial.\nAuthors' conclusions\nCurrently available trial data are insufficient to show whether early planned removal of umbilical venous catheters reduces risk of infection, mortality, or other morbidity in newborn infants. A large, simple, and pragmatic randomised controlled trial is needed to resolve this ongoing uncertainty.\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": "Preterm and sick term newborn babies may require an umbilical venous catheter (UVC) - a fine plastic tube that is inserted via the infant's umbilical vein (in the tummy button) several centimetres into the infant's major blood vessel to deliver nutrition and drugs. Infection in the bloodstream is a frequent and harmful complication for newborn infants who have a UVC in place. One method that may be used to reduce the risk of this and other serious complications is removal of the UVC within about two weeks after insertion (rather than leaving it until no longer required) and replacement with a cannula or a catheter inserted via a small vein (usually in the arm or leg)."
}
] |
query-laysum
|
7903
|
[
{
"role": "user",
"content": "Abstract: Background\nSmoking rates in people with alcohol and other drug dependencies are two to four times those of the general population. Concurrent treatment of tobacco dependence has been limited due to concern that these interventions are not successful in this population or that recovery from other addictions could be compromised if tobacco cessation was combined with other drug dependency treatment.\nObjectives\nTo evaluate whether interventions for tobacco cessation are associated with tobacco abstinence for people in concurrent treatment for or in recovery from alcohol and other drug dependence.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and clinicaltrials.gov databases, with the most recent search completed in August 2016. A grey literature search of conference abstracts from the Society on Nicotine Research and Treatment and the ProQuest database of digital dissertations yielded one additional study, which was excluded.\nSelection criteria\nWe included randomised controlled trials assessing tobacco cessation interventions among people in concurrent treatment for alcohol or other drug dependence or in outpatient recovery programmes.\nData collection and analysis\nTwo review authors independently assessed study risk of bias and extracted data. We resolved disagreements by consensus. The primary outcome was abstinence from tobacco use at the longest period of follow-up, and the secondary outcome was abstinence from alcohol or other drugs, or both. We reported the strictest definition of abstinence. We summarised effects as risk ratios and 95% confidence intervals (CI). Two clustered studies did not provide intraclass correlation coefficients, and were excluded from the sensitivity analysis. We used the I2 statistic to assess heterogeneity.\nMain results\nThirty-five randomised controlled trials, one ongoing, involving 5796 participants met the criteria for inclusion in this review. Included studies assessed the efficacy of tobacco cessation interventions, including counselling, and pharmacotherapy consisting of nicotine replacement therapy (NRT) or non-NRT, or the two combined, in both inpatient and outpatient settings for participants in treatment and in recovery. Most studies did not report information to assess the risk of allocation, selection, and attrition bias, and were classified as unclear.\nAnalyses considered the nature of the intervention, whether participants were in treatment or recovery and the type of dependency. Of the 34 studies included in the meta-analysis, 11 assessed counselling, 11 assessed pharmacotherapy, and 12 assessed counselling in combination with pharmacotherapy, compared to usual care or no intervention. Tobacco cessation interventions were significantly associated with tobacco abstinence for two types of interventions. Pharmacotherapy appeared to increase tobacco abstinence (RR 1.88, 95% CI 1.35 to 2.57, 11 studies, 1808 participants, low quality evidence), as did combined counselling and pharmacotherapy (RR 1.74, 95% CI 1.39 to 2.18, 12 studies, 2229 participants, low quality evidence) at the period of longest follow-up, which ranged from six weeks to 18 months. There was moderate evidence of heterogeneity (I2 = 56% with pharmacotherapy and 43% with counselling plus pharmacotherapy). Counselling interventions did not significantly increase tobacco abstinence (RR 1.33, 95% CI 0.90 to 1.95).\nInterventions were significantly associated with tobacco abstinence for both people in treatment (RR 1.99, 95% CI 1.59 to 2.50) and people in recovery (RR 1.33, 95% CI 1.06 to 1.67), and for people with alcohol dependence (RR 1.47, 95% CI 1.20 to 1.81) and people with other drug dependencies (RR 1.85, 95% CI 1.43 to 2.40).\nOffering tobacco cessation therapy to people in treatment or recovery for other drug dependence was not associated with a difference in abstinence rates from alcohol and other drugs (RR 0.97, 95% CI 0.91 to 1.03, 11 studies, 2231 participants, moderate evidence of heterogeneity (I2 = 66%)).\nData on adverse effect of the interventions were limited.\nAuthors' conclusions\nThe studies included in this review suggest that providing tobacco cessation interventions targeted to smokers in treatment and recovery for alcohol and other drug dependencies increases tobacco abstinence. There was no evidence that providing interventions for tobacco cessation affected abstinence from alcohol and other drugs. The association between tobacco cessation interventions and tobacco abstinence was consistent for both pharmacotherapy and combined counselling and pharmacotherapy, for participants both in treatment and in recovery, and for people with alcohol dependency or other drug dependency. The evidence for the interventions was low quality due primarily to incomplete reporting of the risks of bias and clinical heterogeneity in the nature of treatment. Certain results were sensitive to the length of follow-up or the type of pharmacotherapy, suggesting that further research is warranted regarding whether tobacco cessation interventions are associated with tobacco abstinence for people in recovery, and the outcomes associated with NRT versus non-NRT or combined pharmacotherapy. Overall, the results suggest that tobacco cessation interventions incorporating pharmacotherapy should be incorporated into clinical practice to reduce tobacco addiction among people in treatment for or recovery from alcohol and other drug dependence.\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": "Tobacco use is a leading preventable cause of death worldwide, and smoking rates are especially high among people who are dependent on alcohol or other drugs. People who are being treated for alcohol or other drug addictions have not usually been offered treatment to help them stop smoking at the same time. There has been concern that trying to stop smoking might make people in treatment less likely to recover from other addictions."
}
] |
query-laysum
|
7904
|
[
{
"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: \"Why is the question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who have asthma that is not well controlled often have attacks that require extra treatment and time in hospital.\nLABA are inhaled drugs that can improve symptoms and reduce the likelihood of asthma attacks when inhaled corticosteroids are not helpful alone, but they can have serious side effects. LAMA, another type of inhaled drug that is already used for other lung diseases, are a possible new treatment option for this group of people with asthma."
}
] |
query-laysum
|
7905
|
[
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is frequently a chronic and disabling illness with a heterogeneous range of symptoms. The positive symptoms usually respond to antipsychotics but the cognitive and negative symptoms of schizophrenia are difficult to treat with conventional antipsychotics and significantly impact on quality of life and social outcomes. Selective noradrenaline reuptake inhibitors (NRIs) increase prefrontal dopamine and noradrenaline levels without significantly affecting subcortical dopamine levels, making them an attractive candidate for treating cognitive and negative symptoms.\nObjectives\nTo investigate the effects of selective noradrenaline reuptake inhibitors (NRIs), compared with a placebo or control treatment, for people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group’s Trials Register (up to 7 February 2017) which is based on regular searches of MEDLINE, Embase, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and registries of clinical trials. There are no language, date, document type, or publication status limitation for inclusion of records into the register. We inspected references of all included studies for further relevant studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing NRIs with either a control treatment or placebo for people with schizophrenia or related disorders (such as schizoaffective disorder) by any means of diagnosis. We included trials that met our selection criteria and provided useable information.\nData collection and analysis\nWe independently inspected all citations from searches, identified relevant abstracts, and independently extracted data from all included studies. For binary data we calculated risk ratio (RR), for continuous data we calculated mean difference (MD), and for cognitive outcomes we derived standardised mean difference (SMD) effect sizes, all with 95% confidence intervals (CI) and using a random-effects model. We assessed risk of bias for the included studies and used the GRADE approach to produce a 'Summary of findings' table which included our prespecified main outcomes of interest.\nMain results\nSearching identified 113 records. We obtained the full text of 48 of these records for closer inspection. Sixteen trials, randomising a total of 919 participants are included. The majority of trials included adults with schizophrenia or similar illness who were inpatients, and while they were poorly characterised, most appeared to include patients with a chronic presentation. The intervention NRI in nine of the 16 trials was reboxetine, with atomoxetine and viloxazine used in the remaining trials. 14 trials compared NRIs with placebo. Only two trials provided data to compare NRIs against an active control and both compared reboxetine to citalopram but at 4 weeks and 24 weeks respectively so they could not be combined in a meta-analysis.\nOne trial was described as 'open' and we considered it to be at high risk of bias for randomisation and blinding, three trials were at high risk of bias for attrition, six for reporting, and two for other sources of bias. Our main outcomes of interest were significant response or improvement in positive/negative mental state, global state and cognitive functioning, average cognitive functioning scores, significant response or improvement in quality of life and incidence of nausea. All data for main outcomes were short term.\nNRIs versus placebo\nMental state results showed significantly greater rates of improvement in negative symptoms scores (1 RCT, n = 50; RR 3.17, 95% CI 1.52 to 6.58; very low quality evidence) with NRIs on the PANSS negative. No data were reported for significant response or improvement in positive symptoms, but average endpoint PANSS positive scores were available and showed no difference between NRIs and placebo (5 RCTs, n = 294; MD −0.16, 95% CI −0.96 to 0.63; low-quality evidence). Improvement in clinical global status was similar between groups (1 RCT, n = 28; RR 0.99, 95% CI 0.45 to 2.20; very low quality evidence). Significant response or improvement in cognitive functioning data were not reported. Average composite cognitive scores showed no difference between NRIs and placebo (4 RCTs, n = 180; SMD 0.04, 95% CI −0.28 to 0.36; low-quality evidence). Significant response or improvement in quality of life data were not reported, however average endpoint scores from the GQOLI-74 were reported. Those receiving NRIs had better quality of life scores compared to placebo (1 RCT, n = 114; MD 9.36, 95% CI 7.89 to 10.83; very low quality evidence). All-cause withdrawals did not differ between the treatment groups (8 RCTs, n = 401, RR 0.94 95% CI 0.63 to 1.39; moderate-quality evidence). Rates of nausea were not greater with NRIs (3 RCTs, n = 176; RR 0.49, 95% CI 0.10 to 2.41; low-quality evidence).\nAuthors' conclusions\nOur results provide tentative very low quality evidence that compared to placebo, NRIs (specifically reboxetine) may have a benefit on the negative symptoms of schizophrenia. Limited evidence also suggests that NRIs have no effect on the positive symptoms of schizophrenia or cognitive functioning. NRIs appear generally well tolerated with no real differences in adverse effects such as nausea noted between NRIs and placebo. However, these results are based on short-term follow-up and are poor quality — there is need for more good-quality evidence. A large RCT of reboxetine over a longer period of time, focusing specifically on negative and cognitive symptoms as well as more detailed and comprehensive reporting of outcomes, including adverse events, is required.\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": "The results of our review should be viewed with caution as the quality of evidence available is very low due to the small size of studies and poor quality of the trials. In order to make firm conclusions regarding the effectiveness of NRIs for people with schizophrenia we need larger and better quality trials of NRIs. These should be long term and look particularly at negative and cognitive symptoms as well as side-effects."
}
] |
query-laysum
|
7906
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute liver failure is a rare and serious disease. Acute liver failure may be paracetamol-induced or non-paracetamol-induced. Acute liver failure not caused by paracetamol (acetaminophen) has a poor prognosis with limited treatment options. N-acetylcysteine has been successful in treating paracetamol-induced acute liver failure and reduces the risk of needing to undergo liver transplantation. Recent randomised clinical trials have explored whether the benefit can be extrapolated to treat non-paracetamol-related acute liver failure. The American Association for the Study of Liver Diseases (AASLD) 2011 guideline suggested that N-acetylcysteine could improve spontaneous survival when given during early encephalopathy stages for patients with non-paracetamol-related acute liver failure.\nObjectives\nTo assess the benefits and harms of N-acetylcysteine compared with placebo or no N-acetylcysteine, as an adjunct to usual care, in people with non-paracetamol-related acute liver failure.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register (searched 25 June 2020), Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 6) in The Cochrane Library, MEDLINE Ovid (1946 to 25 June 2020), Embase Ovid (1974 to 25 June 2020), Latin American and Caribbean Health Science Information database (LILACS) (1982 to 25 June 2020), Science Citation Index Expanded (1900 to 25 June 2020), and Conference Proceedings Citation Index – Science (1990 to 25 June 2020).\nSelection criteria\nWe included randomised clinical trials that compared N-acetylcysteine at any dose or route with placebo or no intervention in participants with non-paracetamol-induced acute liver failure.\nData collection and analysis\nWe used standard methodological procedures as described in the Cochrane Handbook for Systematic Reviews of Interventions. We conducted meta-analyses and presented results using risk ratios (RR) with 95% confidence intervals (CIs). We quantified statistical heterogeneity by calculating I2. We assessed bias using the Cochrane risk of bias tool and determined the certainty of the evidence using the GRADE approach.\nMain results\nWe included two randomised clinical trials: one with 183 adults and one with 174 children (birth through age 17 years). We classified both trials at overall high risk of bias. One unregistered study in adults is awaiting classification while we are awaiting responses from study authors for details on trial methodology (e.g. randomisation processes).\nWe did not meta-analyse all-cause mortality because of significant clinical heterogeneity in the two trials. For all-cause mortality at 21 days between adults receiving N-acetylcysteine versus placebo, there was inconclusive evidence of effect (N-acetylcysteine 24/81 (29.6%) versus placebo 31/92 (33.7%); RR 0.88, 95% CI 0.57 to 1.37; low certainty evidence). The certainty of the evidence was low due to risk of bias and imprecision. Similarly, for all-cause mortality at one year between children receiving N-acetylcysteine versus placebo, there was inconclusive evidence of effect (25/92 (27.2%) versus 17/92 (18.5%); RR 1.47, 95% CI 0.85 to 2.53; low certainty evidence). We downgraded the certainty of evidence due to very serious imprecision.\nWe did not meta-analyse serious adverse events and liver transplantation at one year due to incomplete reporting and clinical heterogeneity. For liver transplantation at 21 days in the trial with adults, there was inconclusive evidence of effect (RR 0.72, 95% CI 0.49 to 1.06; low certainty evidence). We downgraded the certainty of the evidence due to serious risk of bias and imprecision. For liver transplantation at one year in the trial with children, there was inconclusive evidence of effect (RR 1.23, 95% CI 0.84 to 1.81; low certainty of evidence). We downgraded the certainty of the evidence due to very serious imprecision.\nThere was inconclusive evidence of effect on serious adverse events in the trial with children (RR 1.25, 95% CI 0.35 to 4.51; low certainty evidence). We downgraded the certainty of the evidence due to very serious imprecision.\nWe did not meta-analyse non-serious adverse events due to clinical heterogeneity. There was inconclusive evidence of effect on non-serious adverse events in adults (RR 1.07, 95% CI 0.79 to 1.45; 173 participants; low certainty of evidence) and children (RR 1.19, 95% CI 0.62 to 2.16; 184 participants; low certainty of evidence). None of the trials reported outcomes of proportion of participants with resolution of encephalopathy and coagulopathy or health-related quality of life.\nThe National Institute of Health in the United States funded both trials through grants. One of the trials received additional funding from two hospital foundations' grants. Pharmaceutical companies provided the study drug and matching placebo, but they did not have input into study design nor involvement in analysis.\nAuthors' conclusions\nThe available evidence is inconclusive regarding the effect of N-acetylcysteine compared with placebo or no N-acetylcysteine, as an adjunct to usual care, on mortality or transplant rate in non-paracetamol-induced acute liver failure. Current evidence does not support the guideline suggestion to use N-acetylcysteine in adults with non-paracetamol-related acute liver failure, nor the rising use observed in clinical practice. The uncertainty based on current scanty evidence warrants additional randomised clinical trials with non-paracetamol-related acute liver failure evaluating N-acetylcysteine versus placebo, as well as investigations to identify predictors of response and the optimal N-acetylcysteine dose and duration.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "25 June 2020"
}
] |
query-laysum
|
7907
|
[
{
"role": "user",
"content": "Abstract: Background\nDepression is an important consequence of stroke that influences recovery yet often is not detected, or is inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and previously updated in 2008.\nObjectives\nThe primary objective is to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation, or combinations of these interventions reduce the incidence of diagnosable depression after stroke. Secondary objectives are to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation or combinations of these interventions reduce levels of depressive symptoms and dependency, and improve physical functioning after stroke. We also aim to determine the safety of, and adherence to, the interventions.\nSearch methods\nWe searched the Specialised Register of Cochrane Stroke and the Cochrane Depression Anxiety and Neurosis (last searched August 2018). In addition, we searched the following databases; Cochrane Central Register of Controlled Trials, CENTRAL (the Cochrane Library, 2018, Issue 8), MEDLINE (1966 to August 2018), Embase (1980 to August 2018), PsycINFO (1967 to August 2018), CINAHL (1982 to August 2018) and three Web of Science indexes (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); to August 2018 and ClinicalTrials.gov; to August 2018), conference proceedings; we also contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) one of various forms of psychological therapy with usual care and/or attention control; 3) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; 4) a pharmacological intervention and one of various forms of psychological therapy with a pharmacological intervention and usual care and/or attention control; 5) non-invasive brain stimulation and pharmacological intervention with a pharmacological intervention and sham stimulation or usual care; 6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; 7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; 8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and 9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of preventing depression after stroke.\nData collection and analysis\nReview authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data and risk ratio (RR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic and assessed the certainty of evidence using GRADE.\nMain results\nWe included 19 RCTs (21 interventions), with 1771 participants in the review. Data were available for 12 pharmacological trials (14 interventions) and seven psychological trials. There were no trials of non-invasive brain stimulation compared with sham stimulation or usual care, a combination of pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy, or a combination of non-invasive brain stimulation and a pharmacological intervention with a pharmacological intervention and sham stimulation or usual care to prevent depression after stroke. Treatment effects were observed on the primary outcome of meeting the study criteria for depression at the end of treatment: there is very low-certainty evidence from eight trials (nine interventions) that pharmacological interventions decrease the number of people meeting the study criteria for depression (RR 0.50, 95% CI 0.37 to 0.68; 734 participants) compared to placebo. There is very low-certainty evidence from two trials that psychological interventions reduce the proportion of people meeting the study criteria for depression (RR 0.68, 95% CI 0.49 to 0.94, 607 participants) compared to usual care and/or attention control.\nEight trials (nine interventions) found no difference in death and other adverse events between pharmacological intervention and placebo groups (RR 1.25, 95% CI 0.32 to 4.91; 496 participants) based on very low-certainty evidence. Five trials found no difference in psychological intervention and usual care and/or attention control groups for death and other adverse events (RR 1.18, 95% CI 0.73 to 1.91; 975 participants) based on very low-certainty evidence.\nAuthors' conclusions\nThe available evidence suggests that pharmacological interventions and psychological therapy may prevent depression and improve mood after stroke. However, there is very low certainty in these conclusions because of the very low-certainty evidence. More trials are required before reliable recommendations can be made about the routine use of such treatments after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our ability to generalise these findings to all stroke survivors is limited due to the small proportion of survivors who were eligible to participate in these clinical trials. More well-designed clinical trials are needed that test practical interventions for preventing depression across all stroke survivors."
}
] |
query-laysum
|
7908
|
[
{
"role": "user",
"content": "Abstract: Background\nExercise-based cardiac rehabilitation may benefit adults with atrial fibrillation or those who had been treated for atrial fibrillation. Atrial fibrillation is caused by multiple micro re-entry circuits within the atrial tissue, which result in chaotic rapid activity in the atria.\nObjectives\nTo assess the benefits and harms of exercise-based rehabilitation programmes, alone or with another intervention, compared with no-exercise training controls in adults who currently have AF, or have been treated for AF.\nSearch methods\nWe searched the following electronic databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness (DARE) in the Cochrane Library, MEDLINE Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and three clinical trial registers on 14 July 2016. We also checked the bibliographies of relevant systematic reviews identified by the searches. We imposed no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCT) that investigated exercise-based interventions compared with any type of no-exercise control. We included trials that included adults aged 18 years or older with atrial fibrillation, or post-treatment for atrial fibrillation.\nData collection and analysis\nTwo authors independently extracted data. We assessed the risk of bias using the domains outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed clinical and statistical heterogeneity by visual inspection of the forest plots, and by using standard Chi² and I² statistics. We performed meta-analyses using fixed-effect and random-effects models; we used standardised mean differences where different scales were used for the same outcome. We assessed the risk of random errors with trial sequential analysis (TSA) and used the GRADE methodology to rate the quality of evidence, reporting it in the 'Summary of findings' table.\nMain results\nWe included six RCTs with a total of 421 patients with various types of atrial fibrillation. All trials were conducted between 2006 and 2016, and had short follow-up (eight weeks to six months). Risks of bias ranged from high risk to low risk.The exercise-based programmes in four trials consisted of both aerobic exercise and resistance training, in one trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training.\nFor mortality, very low-quality evidence from six trials suggested no clear difference in deaths between the exercise and no-exercise groups (relative risk (RR) 1.00, 95% confidence interval (CI) 0.06 to 15.78; participants = 421; I² = 0%; deaths = 2). Very low-quality evidence from five trials suggested no clear difference between groups for serious adverse events (RR 1.01, 95% CI 0.98 to 1.05; participants = 381; I² = 0%; events = 8). Low-quality evidence from two trials suggested no clear difference in health-related quality of life for the Short Form-36 (SF-36) physical component summary measure (mean difference (MD) 1.96, 95% CI -2.50 to 6.42; participants = 224; I² = 69%), or the SF-36 mental component summary measure (MD 1.99, 95% CI -0.48 to 4.46; participants = 224; I² = 0%). Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by six minute walking test, or ergospirometry testing measuring VO2 peak. We found moderate-quality evidence from two studies that exercise-based rehabilitation increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95% CI 1.37 to 6.15; participants = 208; I² = 0%); and very low-quality evidence from four studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the six-minute walking test (MD 75.76, 95% CI 14.00 to 137.53; participants = 272; I² = 85%). When we combined the different assessment tools for exercise capacity, we found very low-quality evidence from six trials that exercise-based rehabilitation increased exercise capacity more than no exercise (standardised mean difference (SMD) 0.86, 95% CI 0.46 to 1.26; participants = 359; I² = 65%). Overall, the quality of the evidence for the outcomes ranged from moderate to very-low.\nAuthors' conclusions\nDue to few randomised patients and outcomes, we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events. The evidence showed no clinically relevant effect on health-related quality of life. Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, we could not be certain of the magnitude of the effect. Future high-quality randomised trials are needed to assess the benefits and harms of exercise-based cardiac rehabilitation for adults with atrial fibrillation on patient-relevant outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence ranged from moderate to very low for all outcomes. It was possible for people in the trials to know to which intervention group they were randomised, the reporting of the results was not complete in many trials, and for some outcomes, the results varied across trials. These considerations limit our confidence in the overall results of the review."
}
] |
query-laysum
|
7909
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough exercise is recommended as part of the cystic fibrosis (CF) therapeutic routine, adherence to exercise is still limited. Digital health technologies can provide easy-to-access health information and may help improve healthcare and outcomes in individuals with long-term conditions. However, its effects for delivering and monitoring exercise programs in CF have not yet been synthesized.\nObjectives\nTo evaluate the benefits and harms of digital health technologies for delivering and monitoring exercise programs, increasing adherence to exercise regimens, and improving key clinical outcomes in people with CF.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 21 November 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) or quasi-RCTs of digital health technologies for delivering or monitoring exercise programs in CF.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. physical activity, 2. self-management behavior, and 3. pulmonary exacerbations. Our secondary outcomes were 4. usability of technologies, 5. quality of life, 6. lung function, 7. muscle strength, 8. exercise capacity, 9. physiologic parameters, and 10. adverse events. We used GRADE to assess certainty of evidence.\nMain results\nWe identified four parallel RCTs (three single-center and one multicenter with 231 participants aged six years or older). The RCTs evaluated different modes of digital health technologies with distinct purposes, combined with diverse interventions.\nWe identified important methodologic concerns in the RCTs, including insufficient information on the randomization process, blinding of outcome assessors, balance of non-protocol interventions across groups, and whether the analyses performed corrected for bias due to missing outcome data. Non-reporting of results may also be a concern, especially because some planned outcome results were reported incompletely. Furthermore, each trial had a small number of participants, resulting in imprecise effects. These limitations on the risk of bias, and on the precision of effect estimates resulted in overall low- to very low-certainty evidence. We undertook four comparisons and present the findings for our primary outcomes below. There is no information on the effectiveness of other modes of digital health technologies for monitoring physical activity or delivering exercise programs in people with CF, on adverse events related to the use of digital health technologies either for delivering or monitoring exercise programs in CF, and on their long-term effects (more than one year).\nDigital health technologies for monitoring physical activity\nWearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone\nOne trial (40 adults with CF) evaluated this outcome, but did not report data for any of our primary outcomes.\nWearable fitness tracker plus text message for personalized feedback and goal setting compared to wearable fitness tracker alone\nThe evidence is very uncertain about the effects of a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to wearable technology alone on physical activity measured by step count at six-month follow-up (mean difference [MD] 675.00 steps, 95% confidence interval [CI] −2406.37 to 3756.37; 1 trial, 32 participants). The same study measured pulmonary exacerbation rates and reported finding no difference between groups.\nWeb-based application to record, monitor, and set goals on physical activity plus usual care compared to usual care alone\nUsing a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference on time spent in moderate-to-vigorous physical activity measured via accelerometry compared to usual care alone at six-month follow-up (MD −4 minutes/day, 95% CI −37 to 29; 1 trial, 63 participants). Low certainty-evidence from the same trial suggests that the intervention may result in little to no difference on pulmonary exacerbations during 12 months of follow-up (median 1 respiratory hospitalization, interquartile range [IQR] 0 to 3) versus control (median 1 respiratory hospitalization, IQR 0 to 2; P = 0.6).\nDigital health technologies for delivering exercise programs\nWeb-based versus face-to-face exercise delivery\nThe evidence is very uncertain about the effects of web-based compared to face-to-face exercise delivery on adherence to physical activity as assessed by the number of participants who completed all exercise sessions after three months of intervention (risk ratio 0.92, 95% CI 0.69 to 1.23; 1 trial, 51 participants).\nAuthors' conclusions\nThe evidence is very uncertain about the effects of an exercise program plus the use of a wearable fitness tracker integrated with a social media platform compared with exercise prescription alone and on the effects of receiving a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to a wearable fitness tracker alone. Low-certainty evidence suggests that using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference in time spent in moderate-to-vigorous physical activity, total time spent in activity, pulmonary exacerbations, quality of life, lung function, and exercise capacity compared to usual care alone. Regarding the use of digital health technologies for delivering exercise programs in CF, the evidence is very uncertain about the effects of using a wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone.\nFurther high-quality RCTs, with blinded outcome assessors, reporting the effects of digital health technologies on clinically important outcome measures, such as physical activity participation and intensity, self-management behavior, and the occurrence of pulmonary exacerbations in the long term are needed. The results of six ongoing RCTs identified through our searches may help clarify the effects of different modes of digital health technologies for delivering and monitoring exercise programs in people with CF.\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"
},
{
"role": "assistant",
"content": "One trial used a web-based application to record, monitor, and set goals on physical activity plus usual care and investigators found there may be little to no difference on the amount of physical activity undertaken or on the number of pulmonary exacerbations that people experienced compared to usual care alone.\nWe are not confident in the results of the trial looking at whether a wearable fitness tracker with an exercise prescription can provide important benefits to people with CF compared to using only exercise prescription. We also cannot be sure whether using a wearable fitness tracker plus text message for personalized feedback and goal setting is effective compared to a wearable fitness tracker alone.\nFurthermore, we are very uncertain on the effects of web-based compared to face-to-face exercise delivery.\nNo trials formally evaluated whether digital interventions could lead to harms and we found little or no data on other important outcomes such as participation in physical activity, self-management behavior (the ability to manage our actions), and the occurrence of pulmonary exacerbations.\nThere is no information on the effectiveness of other types of digital health technologies for monitoring physical activity or delivering exercise programs in people with CF, and on their long-term effects (more than one year)."
}
] |
query-laysum
|
7910
|
[
{
"role": "user",
"content": "Abstract: Background\nUpper gastrointestinal (GI) bleeding due to stress ulcers contributes to increased morbidity and mortality in people admitted to intensive care units (ICUs). Stress ulceration refers to GI mucosal injury related to the stress of being critically ill. ICU patients with major bleeding as a result of stress ulceration might have mortality rates approaching 48.5% to 65%. However, the incidence of stress-induced GI bleeding in ICUs has decreased, and not all critically ill patients need prophylaxis. Stress ulcer prophylaxis can result in adverse events such as ventilator-associated pneumonia; therefore, it is necessary to evaluate strategies that safely decrease the incidence of GI bleeding.\nObjectives\nTo assess the effect and risk-benefit profile of interventions for preventing upper GI bleeding in people admitted to ICUs.\nSearch methods\nWe searched the following databases up to 23 August 2017, using relevant search terms: MEDLINE; Embase; the Cochrane Central Register of Controlled Trials; Latin American Caribbean Health Sciences Literature; and the Cochrane Upper Gastrointestinal and Pancreatic Disease Group Specialised Register, as published in the Cochrane Library (2017, Issue 8). We searched the reference lists of all included studies and those from relevant systematic reviews and meta-analyses to identify additional studies. We also searched the World Health Organization International Clinical Trials Registry Platform search portal and contacted individual researchers working in this field, as well as organisations and pharmaceutical companies, to identify unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs with participants of any age and gender admitted to ICUs for longer than 48 hours. We excluded studies in which participants were admitted to ICUs primarily for the management of GI bleeding and studies that compared different doses, routes, and regimens of one drug in the same class because we were not interested in intraclass effects of drugs.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane.\nMain results\nWe identified 2292 unique records.We included 129 records reporting on 121 studies, including 12 ongoing studies and two studies awaiting classification.\nWe judged the overall risk of bias of two studies as low. Selection bias was the most relevant risk of bias domain across the included studies, with 78 studies not clearly reporting the method used for random sequence generation. Reporting bias was the domain with least risk of bias, with 12 studies not reporting all outcomes that researchers intended to investigate.\nAny intervention versus placebo or no prophylaxis\nIn comparison with placebo, any intervention seems to have a beneficial effect on the occurrence of upper GI bleeding (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.39 to 0.57; moderate certainty of evidence). The use of any intervention reduced the risk of upper GI bleeding by 10% (95% CI -12.0% to -7%). The effect estimate of any intervention versus placebo or no prophylaxis with respect to the occurrence of nosocomial pneumonia, all-cause mortality in the ICU, duration of ICU stay, duration of intubation (all with low certainty of evidence), the number of participants requiring blood transfusions (moderate certainty of evidence), and the units of blood transfused was consistent with benefits and harms. None of the included studies explicitly reported on serious adverse events.\nIndividual interventions versus placebo or no prophylaxis\nIn comparison with placebo or no prophylaxis, antacids, H2 receptor antagonists, and sucralfate were effective in preventing upper GI bleeding in ICU patients. Researchers found that with H2 receptor antagonists compared with placebo or no prophylaxis, 11% less developed upper GI bleeding (95% CI -0.16 to -0.06; RR 0.50, 95% CI 0.36 to 0.70; 24 studies; 2149 participants; moderate certainty of evidence). Of ICU patients taking antacids versus placebo or no prophylaxis, 9% less developed upper GI bleeding (95% CI -0.17 to -0.00; RR 0.49, 95% CI 0.25 to 0.99; eight studies; 774 participants; low certainty of evidence). Among ICU patients taking sucralfate versus placebo or no prophylaxis, 5% less had upper GI bleeding (95% CI -0.10 to -0.01; RR 0.53, 95% CI 0.32 to 0.88; seven studies; 598 participants; moderate certainty of evidence). The remaining interventions including proton pump inhibitors did not show a significant effect in preventing upper GI bleeding in ICU patients when compared with placebo or no prophylaxis.\nRegarding the occurrence of nosocomial pneumonia, the effects of H2 receptor antagonists (RR 1.12, 95% CI 0.85 to 1.48; eight studies; 945 participants; low certainty of evidence) and of sucralfate (RR 1.33, 95% CI 0.86 to 2.04; four studies; 450 participants; low certainty of evidence) were consistent with benefits and harms when compared with placebo or no prophylaxis. None of the studies comparing antacids versus placebo or no prophylaxis provided data regarding nosocomial pneumonia.\nH2 receptor antagonists versus proton pump inhibitors\nH2 receptor antagonists and proton pump inhibitors are most commonly used in practice to prevent upper GI bleeding in ICU patients. Proton pump inhibitors significantly more often prevented upper GI bleeding in ICU patients compared with H2 receptor antagonists (RR 2.90, 95% CI 1.83 to 4.58; 18 studies; 1636 participants; low certainty of evidence). When taking H2 receptor antagonists, 4.8% more patients might experience upper GI bleeding (95% CI 2.1% to 9%). Nosocomial pneumonia occurred in similar proportions of participants taking H2 receptor antagonists and participants taking proton pump inhibitors (RR 1.02, 95% CI 0.77 to 1.35; 10 studies; 1256 participants; low certainty of evidence).\nAuthors' conclusions\nThis review shows that antacids, sucralfate, and H2 receptor antagonists might be more effective in preventing upper GI bleeding in ICU patients compared with placebo or no prophylaxis. The effect estimates of any treatment versus no prophylaxis on nosocomial pneumonia were consistent with benefits and harms. Evidence of low certainty suggests that proton pump inhibitors might be more effective than H2 receptor antagonists. Therefore, patient-relevant benefits and especially harms of H2 receptor antagonists compared with proton pump inhibitors need to be assessed by larger, high-quality RCTs to confirm the results of previously conducted, smaller, and older studies.\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": "Our certainty in the evidence ranged from low to moderate. For effects of different interventions compared with placebo or no prophylaxis, the certainty of evidence was moderate (H2 receptor antagonists) or low (antacids and sucralfate). For effects of H2 receptor antagonists compared with placebo or no preventive treatment on risk of hospital-acquired pneumonia, the certainty of evidence was low. For effects of H2 receptor antagonists compared with proton pump inhibitors on hospital-acquired pneumonia, the certainty of evidence was also low."
}
] |
query-laysum
|
7911
|
[
{
"role": "user",
"content": "Abstract: Background\nHuman milk as compared to formula reduces morbidity in preterm infants but requires fortification to meet their nutritional needs and to reduce the risk of extrauterine growth failure. Standard fortification methods are not individualized to the infant and assume that breast milk is uniform in nutritional content. Strategies for individualizing fortification are available; however it is not known whether these are safe, or if they improve outcomes in preterm infants.\nObjectives\nTo determine whether individualizing fortification of breast milk feeds in response to infant blood urea nitrogen (adjustable fortification) or to breast milk macronutrient content as measured with a milk analyzer (targeted fortification) reduces mortality and morbidity and promotes growth and development compared to standard, non-individualized fortification for preterm infants receiving human milk at < 37 weeks' gestation or at birth weight < 2500 grams.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 9), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), on September 20, 2019. We also searched clinical trials databases and the reference lists of retrieved articles for pertinent randomized controlled trials (RCTs) and quasi-randomized trials.\nSelection criteria\nWe considered randomized, quasi-randomized, and cluster-randomized controlled trials of preterm infants fed exclusively breast milk that compared a standard non-individualized fortification strategy to individualized fortification using a targeted or adjustable strategy. We considered studies that examined any use of fortification in eligible infants for a minimum duration of two weeks, initiated at any time during enteral feeding, and providing any regimen of human milk feeding.\nData collection and analysis\nData were collected using the standard methods of Cochrane Neonatal. Two review authors evaluated the quality of the studies and extracted data. We reported analyses of continuous data using mean differences (MDs), and dichotomous data using risk ratios (RRs). We used the GRADE approach to assess the certainty of evidence.\nMain results\nData were extracted from seven RCTs, resulting in eight publications (521 total participants were enrolled among these studies), with duration of study interventions ranging from two to seven weeks. As compared to standard non-individualized fortification, individualized (targeted or adjustable) fortification of enteral feeds probably increased weight gain during the intervention (typical mean difference [MD] 1.88 g/kg/d, 95% confidence interval [CI] 1.26 to 2.50; 6 studies, 345 participants), may have increased length gain during the intervention (typical MD 0.43 mm/d, 95% CI 0.32 to 0.53; 5 studies, 242 participants), and may have increased head circumference gain during the intervention (typical MD 0.14 mm/d, 95% CI 0.06 to 0.23; 5 studies, 242 participants). Compared to standard non-individualized fortification, targeted fortification probably increased weight gain during the intervention (typical MD 1.87 g/kg/d, 95% CI 1.15 to 2.58; 4 studies, 269 participants) and may have increased length gain during the intervention (typical MD 0.45 mm/d, 95% CI 0.32 to 0.57; 3 studies, 166 participants). Adjustable fortification probably increased weight gain during the intervention (typical MD 2.86 g/kg/d, 95% CI 1.69 to 4.03; 3 studies, 96 participants), probably increased gain in length during the intervention (typical MD 0.54 mm/d, 95% CI 0.38 to 0.7; 3 studies, 96 participants), and increased gain in head circumference during the intervention (typical MD 0.36 mm/d, 95% CI 0.21 to 0.5; 3 studies, 96 participants). We are uncertain whether there are differences between individualized versus standard fortification strategies in the incidence of in-hospital mortality, bronchopulmonary dysplasia, necrotizing enterocolitis, culture-proven late-onset bacterial sepsis, retinopathy of prematurity, osteopenia, length of hospital stay, or post-hospital discharge growth. No study reported severe neurodevelopmental disability as an outcome. One study that was published after our literature search was completed is awaiting classification.\nAuthors' conclusions\nWe found moderate- to low-certainty evidence suggesting that individualized (either targeted or adjustable) fortification of enteral feeds in very low birth weight infants increases growth velocity of weight, length, and head circumference during the intervention compared with standard non-individualized fortification. Evidence showing important in-hospital and post-discharge clinical outcomes was sparse and of very low certainty, precluding inferences regarding safety or clinical benefits beyond short-term growth.\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": "does individualized rather than standard, non-individualized addition of nutrients and calories to breast milk feeds safely improve growth and other outcomes in preterm infants?"
}
] |
query-laysum
|
7912
|
[
{
"role": "user",
"content": "Abstract: Background\nMiscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining placental tissues in the uterus ('evacuation of uterus'). However, medical treatments, or expectant care (no treatment), may also be effective, safe, and acceptable.\nObjectives\nTo assess the effectiveness, safety, and acceptability of any medical treatment for incomplete miscarriage (before 24 weeks).\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (13 May 2016) and reference lists of retrieved papers.\nSelection criteria\nWe included randomised controlled trials comparing medical treatment with expectant care or surgery, or alternative methods of medical treatment. We excluded quasi-randomised trials.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion, assessed risk of bias, and carried out data extraction. Data entry was checked. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included 24 studies (5577 women). There were no trials specifically of miscarriage treatment after 13 weeks' gestation.\nThree trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; 2 studies, 150 women, random-effects; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. For unplanned surgical intervention, we did not identify any difference between misoprostol and expectant care (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence).\nSixteen trials involving 4044 women addressed the comparison of misoprostol (7 studies used oral administration, 6 studies used vaginal, 2 studies sublingual, 1 study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, 3862 women, random-effects; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, 3070 women, random-effects; very low-quality evidence) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, 2690 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. Nausea was more common with misoprostol (average RR 2.50, 95% CI 1.53 to 4.09; 11 studies, 3015 women, random-effects; low-quality evidence). We did not identify any difference in women's satisfaction between misoprostol and surgery (average RR 1.00, 95% CI 0.99 to 1.00; 9 studies, 3349 women, random-effects; moderate-quality evidence). More women had vomiting and diarrhoea with misoprostol compared with surgery (vomiting: average RR 1.97, 95% CI 1.36 to 2.85; 10 studies, 2977 women, random-effects; moderate-quality evidence; diarrhoea: average RR 4.82, 95% CI 1.09 to 21.32; 4 studies, 757 women, random-effects; moderate-quality evidence).\nFive trials compared different routes of administration, or doses, or both, of misoprostol. There was no clear evidence of one regimen being superior to another.\nLimited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches.\nAuthors' conclusions\nThe available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Further studies, including long-term follow-up, are clearly needed to confirm these findings. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The cause of miscarriage is often unknown, but most are likely to be due to abnormalities in the baby’s chromosomes. Women experiencing miscarriage may be quite distressed, and there can be feelings of emptiness, guilt, and failure. Fathers can also be affected emotionally. Traditionally, surgery (curettage or vacuum aspiration) has been the treatment used to remove any retained tissue and it is quick to perform. It has now been suggested that medical treatments (usually misoprostol) may be as effective and may carry less risk of infection."
}
] |
query-laysum
|
7913
|
[
{
"role": "user",
"content": "Abstract: Background\n'Keratinocyte cancer' is now the preferred term for the most commonly identified skin cancers basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), which were previously commonly categorised as non-melanoma skin cancers (NMSC). Keratinocyte cancer (KC) represents about 95% of malignant skin tumours. Lifestyle changes have led to increased exposure to the sun, which has, in turn, led to a significant increase of new cases of KC, with a worldwide annual incidence of between 3% and 8%. The successful use of preventive measures could mean a significant reduction in the resources used by health systems, compared with the high cost of the treatment of these conditions. At present, there is no information about the quality of the evidence for the use of these sun protection strategies with an assessment of their benefits and risks.\nObjectives\nTo assess the effects of sun protection strategies (i.e. sunscreen and barrier methods) for preventing keratinocyte cancer (that is, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) of the skin) in the general population.\nSearch methods\nWe searched the following databases up to May 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registries and the bibliographies of included studies for further references to relevant trials.\nSelection criteria\nWe included randomised controlled clinical trials (RCTs) of preventive strategies for keratinocyte cancer, such as physical barriers and sunscreens, in the general population (children and adults), which may provide information about benefits and adverse events related to the use of solar protection measures. We did not include trials focused on educational strategies to prevent KC or preventive strategies in high-risk groups. Our prespecified primary outcomes were BCC or cSCC confirmed clinically or by histopathology at any follow-up and adverse events.\nData collection and analysis\nTwo review authors independently selected studies for eligibility using Early Review Organizing Software (EROS). Similarly, two review authors independently used predesigned data collection forms to extract information from the original study reports about the participants, methods of randomisation, blinding, comparisons of interest, number of participants originally randomised by arm, follow-up losses, and outcomes, and they assessed the risk of bias. We resolved any disagreement by consulting a third author and contacted trial investigators of identified trials to obtain additional information. We used standard methodological procedures expected by Cochrane.\nMain results\nWe included one RCT (factorial design) that randomised 1621 participants.\nThis study compared the daily application of sunscreen compared with discretionary use of sunscreen, with or without beta-carotene administration, in the general population. The study was undertaken in Australia; 55.2% of participants had fair skin, and they were monitored for 4.5 years for new cases of BCC or cSCC assessed by histopathology. We found this study to be at low risk of bias for domains such as allocation, blinding, and incomplete outcome data. However, we found multiple unclear risks related to other biases, including an unclear assessment of possible interactions between the effects of the different interventions evaluated (that is, sunscreen and beta-carotene). We found no difference in terms of the number of participants developing BCC (n = 1621; risk ratio (RR) 1.03, 95% confidence interval (CI) 0.74 to 1.43) or cSCC (n = 1621; RR 0.88, 95% CI 0.50 to 1.54) when comparing daily application of sunscreen with discretionary use, even when analyses were restricted to groups without beta-carotene supplementation. This evidence was of low quality, which means that there is some certainty that future studies may alter our confidence in this evidence.\nWe reported adverse events in a narrative way and included skin irritation or contact allergy.\nWe identified no studies that evaluated other sun protection measures, such as the use of sun-protective clothing, sunglasses, or hats, or seeking the shade when outdoors.\nAuthors' conclusions\nIn this review, we assessed the effect of solar protection in preventing the occurrence of new cases of keratinocyte cancer. We only found one study that was suitable for inclusion. This was a study of sunscreens, so we were unable to assess any other forms of sun protection. The study addressed our prespecified primary outcomes, but not most of our secondary outcomes. We were unable to demonstrate from the available evidence whether sunscreen was effective for the prevention of basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).\nOur certainty in the evidence was low because there was a lack of histopathological confirmation of BCC or cSCC in a significant percentage of cases. Amongst other sources of bias, it was not clear whether the study authors had assessed any interaction effects between the sunscreen and beta-carotene interventions. We think that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Keratinocyte cancer (BCC and cSCC of the skin) is the most commonly identified type of skin cancer. The main risk is exposure to ultraviolet radiation, which is a component of sunlight. Prevention has become an important way to manage this cancer, so it is important to assess the effectiveness of methods used to prevent keratinocyte cancer in the general population. In this review, we assessed the effects of using topical sunscreen and physical barrier methods (such as sun-protective clothing, hats, sunglasses, and the active search for shade when outdoors) compared with no specific precautionary interventions aimed at preventing the development of BCC and cSCC in adults and children.\nWe searched the medical literature up to May 2016 for randomised controlled trials that evaluated preventive strategies. We found only one study suitable for inclusion. This study compared the daily application of sunscreen (with or without beta-carotene, which is a precursor of vitamin A) compared with the occasional use of sunscreen (with or without beta-carotene) in the general population, without restriction by gender or age. The study was undertaken in Australia, where 1621 participants, 55% of them with fair skin, were monitored for 4.5 years for new cases of BCC or cSCC assessed by histopathology (which is a method used to detect cancerous cells under the microscope)."
}
] |
query-laysum
|
7914
|
[
{
"role": "user",
"content": "Abstract: Background\nStaphylococcus aureus causes pulmonary infection in young children with cystic fibrosis. Prophylactic antibiotics are prescribed hoping to prevent such infection and lung damage. Antibiotics have adverse effects and long-term use might lead to infection with Pseudomonas aeruginosa. This is an update of a previously published review.\nObjectives\nTo assess continuous oral antibiotic prophylaxis to prevent the acquisition of Staphylococcus aureus versus no prophylaxis in people with cystic fibrosis, we tested the following hypotheses to investigate whether prophylaxis:\n1. improves clinical status, lung function and survival;\n2. leads to fewer isolates of Staphylococcus aureus;\n3. causes adverse effects (e.g. diarrhoea, skin rash, candidiasis);\n4. leads to fewer isolates of other common pathogens from respiratory secretions;\n5. leads to the emergence of antibiotic resistance and colonisation of the respiratory tract with Pseudomonas aeruginosa.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Companies manufacturing anti-staphylococcal antibiotics were contacted.\nMost recent search of the Group's Register: 27 February 2020.\nOnline trials registries were also searched. Most recent search of online trials registries: 15 September 2020.\nSelection criteria\nRandomised trials of continuous oral prophylactic antibiotics (given for at least one year) compared to intermittent antibiotics given 'as required', in people with cystic fibrosis of any disease severity.\nData collection and analysis\nThe authors assessed studies for eligibility and methodological quality and extracted data. The quality of the evidence was assessed using the GRADE criteria. The review's primary outcomes of interest were lung function by spirometry (forced expiratory volume in one second (FEV1)) and the number of people with one or more isolates of Staphylococcus aureus (sensitive strains).\nMain results\nWe included four studies, with a total of 401 randomised participants aged zero to seven years on enrolment; one study is ongoing. The two older included studies generally had a higher risk of bias across all domains, but in particular due to a lack of blinding and incomplete outcome data, than the two more recent studies. We only regarded the most recent study as being generally free of bias, although even here we were not certain of the effect of the per protocol analysis on the study results. Evidence quality was judged to be low for all outcomes assessed after being downgraded based on GRADE assessments. Downgrading decisions were due to limitations in study design (all outcomes), for imprecision and for inconsistency .\nProphylactic anti-staphylococcal antibiotics probably make little or no difference to lung function measured as FEV1 % predicted after six years (mean difference (MD) -2.30, 95% confidence interval (CI) -13.59 to 8.99, one study, n = 119, low-quality evidence); but may reduce the number of children having one or more isolates of Staphylococcus aureus at two years (odds ratio (OR) 0.21, 95% CI 0.13 to 0.35, three studies, n = 315, low-quality evidence). At the same time point, there may be little or no effect on nutrition as reported using weight z score (MD 0.06, 95% CI -0.33 to 0.45, two studies, n = 140, low-quality evidence), additional courses of antibiotics (OR 0.18, 95% CI 0.01 to 3.60, one study, n = 119, low-quality evidence) or adverse effects (low-quality evidence). There was no difference in the number of isolates of Pseudomonas aeruginosa between groups at two years (OR 0.74, 95% CI 0.45 to 1.23, three studies, n = 312, low-quality evidence), though there was a trend towards a lower cumulative isolation rate of Pseudomonas aeruginosa in the prophylaxis group at two and three years and towards a higher rate from four to six years. As the studies reviewed lasted six years or less, conclusions cannot be drawn about the long-term effects of prophylaxis.\nAuthors' conclusions\nAnti-staphylococcal antibiotic prophylaxis may lead to fewer children having isolates of Staphylococcus aureus, when commenced early in infancy and continued up to six years of age. The clinical importance of this finding is uncertain. Further research may establish whether the trend towards more children with CF with Pseudomonas aeruginosa, after four to six years of prophylaxis, is a chance finding and whether choice of antibiotic or duration of treatment might influence this.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the benefits and adverse effects of giving regular antibiotics to people with cystic fibrosis to prevent lung infection with a germ called Staphylococcus aureus."
}
] |
query-laysum
|
7915
|
[
{
"role": "user",
"content": "Abstract: Background\nPenetrating abdominal trauma (PAT) is a common type of trauma leading to admission to hospital, which often progresses to septic complications. Antibiotics are commonly administered as prophylaxis prior to laparotomy for PAT. However, an earlier Cochrane Review intending to compare antibiotics with placebo identified no relevant randomised controlled trials (RCTs). Despite this, many RCTs have been carried out that compare different agents and durations of antibiotic therapy. To date, no systematic review of these trials has been performed.\nObjectives\nTo assess the effects of antibiotics in penetrating abdominal trauma, with respect to the type of agent administered and the duration of therapy.\nSearch methods\nWe searched the following electronic databases for relevant randomised controlled trials, from database inception to 23 July 2019; Cochrane Injuries Group's Specialised Register, CENTRAL, MEDLINE Ovid, MEDLINE Ovid In-Process & Other Non-Indexed Citations, MEDLINE Ovid Daily and Ovid OLDMEDLINE, Embase Classic + Embase Ovid, ISI Web of Science (SCI-EXPANDED, SSCI, CPCI-S & CPSI-SSH), and two clinical trials registers. We also searched reference lists from included studies. We applied no restrictions on language or date of publication.\nSelection criteria\nWe included RCTs only. We included studies involving participants of all ages, which were conducted in secondary care hospitals only. We included studies of participants who had an isolated penetrating abdominal wound that breached the peritoneum, who were not already taking antibiotics.\nData collection and analysis\nTwo study authors independently extracted data and assessed risk of bias. We used standard Cochrane methods. We aggregated study results using a random-effects model. We also conducted trial sequential analysis (TSA) to help reduce type I and II errors in our analyses.\nMain results\nWe included 29 RCTs, involving a total of 4458 participants. We deemed 23 trials to be at high risk of bias in at least one domain.\nWe are uncertain of the effect of a long course of antibiotic prophylaxis (> 24 hours) compared to a short course (≤ 24 hours) on abdominal surgical site infection (RR 1.00, 95% CI 0.81 to 1.23; I² = 0%; 7 studies, 1261 participants; very low-quality evidence), mortality (Peto OR 1.67, 95% CI 0.73 to 3.82; I² = 8%; 7 studies, 1261 participants; very low-quality evidence), or intra-abdominal infection (RR 1.23, 95% CI 0.84 to 1.80; I² = 0%; 6 studies, 111 participants; very-low quality evidence).\nBased on very low-quality evidence from fifteen studies, involving 2020 participants, which compared different drug regimens with activity against three classes of gastrointestinal flora (gram positive, gram negative, anaerobic), we are uncertain whether there is a benefit of one regimen over another.\nTSA showed the majority of comparisons did not cross the alpha adjusted boundary for benefit or harm, or reached the required information size, indicating that further studies are required for these analyses. However, in the three analyses which crossed the boundary for futility, further studies are unlikely to show benefit or harm.\nAuthors' conclusions\nVery low-quality evidence means that we are uncertain about the effect of either the duration of antibiotic prophylaxis, or the superiority of one drug regimen over another for penetrating abdominal trauma on abdominal surgical site infection rates, mortality, or intra-abdominal infections.\nFuture RCTs should be adequately powered, test currently used antibiotics, known to be effective against gut flora, use methodology to minimise the risk of bias, and adequately report the level of peritoneal contamination encountered at laparotomy.\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": "Penetrating abdominal trauma (gunshot or stab wounds to the abdomen) are a major cause of admission to hospital and often require an operation. If a person survives the initial injury, they may subsequently develop infections, which can lead to death. Before antibiotics were available, the majority of people with these injuries died from infections."
}
] |
query-laysum
|
7916
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is now a rising commitment to acknowledge the role patients and families play in contributing to their safety. This review focuses on one type of involvement in safety - patient and family involvement in escalation of care for serious life-threatening conditions i.e. helping secure a step-up to urgent or emergency care - which has been receiving increasing policy and practice attention. This review was concerned with the negotiation work that patient and family members undertake across the emergency care escalation pathway, once contact has been made with healthcare staff. It includes interventions aiming to improve detection of symptoms, communication of concerns and staff response to these concerns.\nObjectives\nTo assess the effects of interventions designed to increase patient and family involvement in escalation of care for acute life-threatening illness on patient and family outcomes, treatment outcomes, clinical outcomes, patient and family experience and adverse events.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP) ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform from 1 Jan 2000 to 24 August 2018. The search was updated on 21 October 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster-randomised controlled trials where the intervention focused on patients and families working with healthcare professionals to ensure care received for acute deterioration was timely and appropriate. A key criterion was to include an interactive element of rehearsal, role play, modelling, shared language, group work etc. to the intervention to help patients and families have agency in the process of escalation of care. The interventions included components such as enabling patients and families to detect changes in patients' conditions and to speak up about these changes to staff. We also included studies where the intervention included a component targeted at enabling staff response.\nData collection and analysis\nSeven of the eight authors were involved in screening; two review authors independently extracted data and assessed the risk of bias of included studies, with any disagreements resolved by discussion to reach consensus. Primary outcomes included patient and family outcomes, treatment outcomes, clinical outcomes, patient and family experience and adverse events. Our advisory group (four users and four providers) ensured that the review was of relevance and could inform policy and practice.\nMain results\nWe included nine studies involving 436,684 patients and family members and one ongoing study. The published studies focused on patients with specific conditions such as coronary artery disease, ischaemic stroke, and asthma, as well as pregnant women, inpatients on medical surgical wards, older adults and high-risk patients with a history of poor self-management.\nWhile all studies tested interventions versus usual care, for four studies the usual care group also received educational or information strategies. Seven of the interventions involved face-to-face, interactional education/coaching sessions aimed at patients/families while two provided multi-component education programmes which included components targeted at staff as well as patients/families. All of the interventions included: (1) an educational component about the acute condition and preparedness for future events such as stroke or change in fetal movements: (2) an engagement element (self-monitoring, action plans); while two additionally focused on shared language or communication skills.\nWe had concerns about risk of bias for all but one of the included studies in respect of one or more criteria, particularly regarding blinding of participants and personnel. Our confidence in results regarding the effectiveness of interventions was moderate to low.\nLow-certainty evidence suggests that there may be moderate improvement in patients’ knowledge of acute life-threatening conditions, danger signs, appropriate care-seeking responses, and preparedness capacity between interactional patient-facing interventions and multi-component programmes and usual care at 12 months (MD 4.20, 95% CI 2.44 to 5.97, 2 studies, 687 participants). Four studies in total assessed knowledge (3,086 participants) but we were unable to include two other studies in the pooled analysis due to differences in the way outcome measures were reported. One found no improvement in knowledge but higher symptom preparedness at 12 months. The other study found an improvement in patients’ knowledge about symptoms and appropriate care-seeking responses in the intervention group at 18 months compared with usual care.\nLow-certainty evidence from two studies, each using a different measure, meant that we were unable to determine the effects of patient-based interventions on self-efficacy. Self-efficacy was higher in the intervention group in one study but there was no difference in the other compared with usual care.\nWe are uncertain whether interactional patient-facing and multi-component programmes improve time from the start of patient symptoms to treatment due to low-certainty evidence for this outcome. We were unable to combine the data due to differences in outcome measures. Three studies found that arrival times or prehospital delay time was no different between groups. One found that delay time was shorter in the intervention group.\nModerate-certainty evidence suggests that multi-component interventions probably have little or no impact on mortality rates. Only one study on a pregnant population was eligible for inclusion in the review, which found no difference between groups in rates of stillbirth. In terms of unintended events, we found that interactional patient-facing interventions to increase patient and family involvement in escalation of care probably have few adverse effects on patient's anxiety levels (moderate-certainty evidence).\nNone of the studies measured or reported patient and family perceptions of involvement in escalation of care or patient and family experience of patient care. Reported outcomes related to healthcare professionals were also not reported in any studies.\nAuthors' conclusions\nOur review identified that interactional patient-facing interventions and multi-component programmes (including staff) to increase patient and family involvement in escalation of care for acute life-threatening illness may improve patient and family knowledge about danger signs and care-seeking responses, and probably have few adverse effects on patient’s anxiety levels when compared to usual care. Multi-component interventions probably have little impact on mortality rates. Further high-quality trials are required using multi-component interventions and a focus on relational elements of care. Cognitive and behavioural outcomes should be included at patient and staff level.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found nine relevant studies in different healthcare settings in which 436,684 patients and family members took part. Seven of the strategies studied involved face-to-face education or coaching sessions for patients and families, and two involved education programmes aimed at healthcare staff as well as patients and their families. All strategies had an educational part and an engagement part (for example, self-monitoring; using action plans); two strategies additionally focused on communication skills and using shared language.\nAll studies compared usual care against receiving strategies to increase involvement of patients and their families in seeking emergency care. In four studies, people in the usual care group also received information or educational strategies. The studies varied in design and in their assessments, making it difficult to compare all their results.\nWe did not find any studies that looked at patients', or their families', satisfaction with care, or what they thought of their involvement in seeking emergency care."
}
] |
query-laysum
|
7917
|
[
{
"role": "user",
"content": "Abstract: Background\nElectroconvulsive therapy (ECT) involves the induction of a seizure by the administration of an electrical stimulus via electrodes usually placed bilaterally on the scalp and was introduced as a treatment for schizophrenia in 1938. However, ECT is a controversial treatment with concerns about long-term side effects such a memory loss. Therefore, it is important to determine its clinical efficacy and safety for people with schizophrenia who are not responding to their treatment.\nObjectives\nOur primary objective was to assess the effects (benefits and harms) of ECT for people with treatment-resistant schizophrenia.\nOur secondary objectives were to determine whether ECT produces a differential response in people: who are treated with unilateral compared to bilateral ECT; who have had a long (more than 12 sessions) or a short course of ECT; who are given continuation or maintenance ECT; who are diagnosed with well-defined treatment-resistant schizophrenia as opposed to less rigorously defined treatment-resistant schizophrenia (who would be expected to have a greater affective component to their illness).\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including clinical trial registries on 9 September 2015 and 4 August 2017. There were no limitations on language, date, document type, or publication status for the inclusion of records in the register. We also inspected references of all the included records to identify further relevant studies.\nSelection criteria\nRandomised controlled trials investigating the effects of ECT in people with treatment-resistant schizophrenia.\nData collection and analysis\nTwo review authors independently extracted data. For binary outcomes, we calculated the risk ratio (RR) and its 95% confidence intervals (CIs), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between the groups and its 95% CIs. We employed the fixed-effect model for all analyses. We assessed risk of bias for the included studies and created 'Summary of findings' tables using the GRADE framework.\nMain results\nWe included 15 studies involving 1285 participants (1264 completers with an average age of 18 to 46 years) with treatment-resistant schizophrenia. We rated most studies (14/15, 93.3%) as at high risk of bias due to issues related to the blinding of participants and personnel. Our main outcomes of interest were: (i) clinically important response to treatment; (ii) clinically important change in cognitive functioning; (iii) leaving the study early; (iv) clinically important change in general mental state; (v) clinically important change in general functioning; (vi) number hospitalised; and (vii) death. No trial reported data on death.\nThe included trials reported useable data for four comparisons: ECT plus standard care compared with sham-ECT added to standard care; ECT plus standard care compared with antipsychotic added to standard care; ECT plus standard care compared with standard care; and ECT alone compared with antipsychotic alone.\nFor the comparison ECT plus standard care versus sham-ECT plus standard care, only average endpoint BPRS (Brief Psychiatric Rating Scale) scores from one study were available for mental state; no clear difference between groups was observed (short term; MD 3.60, 95% CI -3.69 to 10.89; participants = 25; studies = 1; very low-quality evidence). One study reported data for service use, measured as number readmitted; there was a clear difference favouring the ECT group (short term; RR 0.29, 95% CI 0.10 to 0.85; participants = 25; studies = 1; low-quality evidence).\nWhen ECT plus standard care was compared with antipsychotics (clozapine) plus standard care, data from one study showed no clear difference for clinically important response to treatment (medium term; RR 1.23, 95% CI 0.95 to 1.58; participants = 162; studies = 1; low-quality evidence). Clinically important change in mental state data were not available, but average endpoint BPRS scores were reported. A positive effect for the ECT group was found (short-term BPRS; MD -5.20, 95% CI -7.93 to -2.47; participants = 162; studies = 1; very low-quality evidence).\nWhen ECT plus standard care was compared with standard care, more participants in the ECT group had a clinically important response (medium term; RR 2.06, 95% CI 1.75 to 2.42; participants = 819; studies = 9; moderate-quality evidence). Data on clinically important change in cognitive functioning were not available, but data for memory deterioration were reported. Results showed that adding ECT to standard care may increase the risk of memory deterioration (short term; RR 27.00, 95% CI 1.67 to 437.68; participants = 72; studies = 1; very low-quality evidence). There were no clear differences between groups in satisfaction and acceptability of treatment, measured as leaving the study early (medium term; RR 1.18, 95% CI 0.38 to 3.63; participants = 354; studies = 3; very low-quality evidence). Only average endpoint scale scores were available for mental state (BPRS) and general functioning (Global Assessment of Functioning). There were clear differences in scores, favouring ECT group for mental state (medium term; MD -11.18, 95% CI -12.61 to -9.76; participants = 345; studies = 2; low-quality evidence) and general functioning (medium term; MD 10.66, 95% CI 6.98 to 14.34; participants = 97; studies = 2; very low-quality evidence).\nFor the comparison ECT alone versus antipsychotics (flupenthixol) alone, only average endpoint scale scores were available for mental state and general functioning. Mental state scores were similar between groups (medium-term BPRS; MD -0.93, 95% CI -6.95 to 5.09; participants = 30; studies = 1; very low-quality evidence); general functioning scores were also similar between groups (medium-term Global Assessment of Functioning; MD -0.66, 95% CI -3.60 to 2.28; participants = 30; studies = 1; very low-quality evidence).\nAuthors' conclusions\nModerate-quality evidence indicates that relative to standard care, ECT has a positive effect on medium-term clinical response for people with treatment-resistant schizophrenia. However, there is no clear and convincing advantage or disadvantage for adding ECT to standard care for other outcomes. The available evidence was also too weak to indicate whether adding ECT to standard care is superior or inferior to adding sham-ECT or other antipsychotics to standard care, and there was insufficient evidence to support or refute the use of ECT alone. More good-quality evidence is needed before firm conclusions can be made.\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 electroconvulsive therapy (ECT) a safe and effective treatment for people with schizophrenia who have not responded to their previous treatment?"
}
] |
query-laysum
|
7918
|
[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is a multisystem disease; the importance of growth and nutritional status is well established given their implications for lung function and overall survivability. Furthermore, it has been established that intestinal microbial imbalance and inflammation are present in people with CF. Oral prebiotics are commercially available substrates that are selectively utilised by host intestinal micro-organisms and may improve both intestinal and overall health.\nObjectives\nTo evaluate the benefits and harms of prebiotics for improving health outcomes in children and adults with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. Date of last search: 19 October 2022.\nWe also searched PubMed and online trials registries. Date of last search: 13 January 2023.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs assessing the efficacy of prebiotics in children and adults with CF. We planned to only include the first treatment period from cross-over RCTs, regardless of washout period.\nData collection and analysis\nWe did not identify any relevant trials.\nMain results\nWe did not identify any relevant trials for inclusion in this review.\nAuthors' conclusions\nThis review did not find any evidence for the use of prebiotics in people with CF. Until such evidence is available, it is reasonable for clinicians to follow any local guidelines and to discuss the use of dietary prebiotics with their patients.\nLarge and robust RCTs assessing the dietary prebiotics of inulin or galacto-oligosaccharides or fructo-oligosaccharides, or any combination of these, are needed. Such studies should be of at least 12 months in duration and assess outcomes such as growth and nutrition, gastrointestinal symptoms, pulmonary exacerbations, lung function, inflammatory biomarkers, hospitalisations, intestinal microbial profiling, and faecal short-chain fatty acids. Trials should include both children and adults and aim to be adequately powered to allow for subgroup analysis by age.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Growth and nutritional status can impact lung function and overall survival in people with cystic fibrosis (CF), and prebiotics, a source of food for healthy bacteria in the gut, might be of benefit.\nWe did not find any trials that looked at how prebiotics affect people with CF, and such trials are needed."
}
] |
query-laysum
|
7919
|
[
{
"role": "user",
"content": "Abstract: Background\nApproximately 30% of hospitalised older adults experience hospital-associated functional decline. Exercise interventions that promote in-hospital activity may prevent deconditioning and thereby maintain physical function during hospitalisation. This is an update of a Cochrane Review first published in 2007.\nObjectives\nTo evaluate the benefits and harms of exercise interventions for acutely hospitalised older medical inpatients on functional ability, quality of life (QoL), participant global assessment of success and adverse events compared to usual care or a sham-control intervention.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was May 2021.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials evaluating an in-hospital exercise intervention in people aged 65 years or older admitted to hospital with a general medical condition. We excluded people admitted for elective reasons or surgery.\nData collection and analysis\nWe used standard Cochrane methods. Our major outcomes were 1. independence with activities of daily living; 2. functional mobility; 3. new incidence of delirium during hospitalisation; 4. QoL; 5. number of falls during hospitalisation; 6. medical deterioration during hospitalisation and 7. participant global assessment of success. Our minor outcomes were 8. death during hospitalisation; 9. musculoskeletal injuries during hospitalisation; 10. hospital length of stay; 11. new institutionalisation at hospital discharge; 12. hospital readmission and 13. walking performance. We used GRADE to assess certainty of evidence for each major outcome.\nWe categorised exercise interventions as: rehabilitation-related activities (interventions designed to increase physical activity or functional recovery, but did not follow a specified exercise protocol); structured exercise (interventions that included an exercise intervention protocol but did not include progressive resistance training); and progressive resistance exercise (interventions that included an element of progressive resistance training).\nMain results\nWe included 24 studies (nine rehabilitation-related activity interventions, six structured exercise interventions and nine progressive resistance exercise interventions) with 7511 participants. All studies compared exercise interventions to usual care; two studies, in addition to usual care, used sham interventions. Mean ages ranged from 73 to 88 years, and 58% of participants were women.\nSeveral studies were at high risk of bias. The most common domain assessed at high risk of bias was measurement of the outcome, and five studies (21%) were at high risk of bias arising from the randomisation process.\nExercise may have no clinically important effect on independence in activities of daily living at discharge from hospital compared to controls (16 studies, 5174 participants; low-certainty evidence). Five studies used the Barthel Index (scale: 0 to 100, higher scores representing greater independence). Mean scores at discharge in the control groups ranged from 42 to 96 points, and independence in activities of daily living was 1.8 points better (0.43 worse to 4.12 better) with exercise compared to controls. The minimally clinical important difference (MCID) is estimated to be 11 points.\nWe are uncertain regarding the effect of exercise on functional mobility at discharge from the hospital compared to controls (8 studies, 2369 participants; very low-certainty evidence). Three studies used the Short Physical Performance Battery (SPPB) (scale: 0 to 12, higher scores representing better function) to measure functional mobility. Mean scores at discharge in the control groups ranged from 3.7 to 4.9 points on the SPPB, and the estimated effect of the exercise interventions was 0.78 points better (0.02 worse to 1.57 better). A change of 1 point on the SPPB represents an MCID.\nWe are uncertain regarding the effect of exercise on the incidence of delirium during hospitalisation compared to controls (7 trials, 2088 participants; very low-certainty evidence). The incidence of delirium during hospitalisation was 88/1091 (81 per 1000) in the control group compared with 70/997 (73 per 1000; range 47 to 114) in the exercise group (RR 0.90, 95% CI 0.58 to 1.41).\nExercise interventions may result in a small clinically unimportant improvement in QoL at discharge from the hospital compared to controls (4 studies, 875 participants; low-certainty evidence). Mean QoL on the EuroQol 5 Dimensions (EQ-5D) visual analogue scale (VAS) (scale: 0 to 100, higher scores representing better QoL) ranged between 48.9 and 64.7 in the control group at discharge from the hospital, and QoL was 6.04 points better (0.9 better to 11.18 better) with exercise. A change of 10 points on the EQ-5D VAS represents an MCID.\nNo studies measured participant global assessment of success.\nExercise interventions did not affect the risk of falls during hospitalisation (moderate-certainty evidence). The incidence of falls was 31/899 (34 per 1000) in the control group compared with 31/888 (34 per 1000; range 20 to 57) in the exercise group (RR 0.99, 95% CI 0.59 to 1.65).\nWe are uncertain regarding the effect of exercise on the incidence of medical deterioration during hospitalisation (very low-certainty evidence). The incidence of medical deterioration in the control group was 101/1417 (71 per 1000) compared with 96/1313 (73 per 1000; range 44 to 120) in the exercise group (RR 1.02, 95% CI 0.62 to 1.68).\nSubgroup analyses by different intervention categories and by the use of a sham intervention were not meaningfully different from the main analyses.\nAuthors' conclusions\nExercise may make little difference to independence in activities of daily living or QoL, but probably does not result in more falls in older medical inpatients. We are uncertain about the effect of exercise on functional mobility, incidence of delirium and medical deterioration. Certainty of evidence was limited by risk of bias and inconsistency. Future primary research on the effect of exercise on acute hospitalisation could focus on more consistent and uniform reporting of participant's characteristics including their baseline level of functional ability, as well as exercise dose, intensity and adherence that may provide an insight into the reasons for the observed inconsistencies in findings.\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": "Does helping older people to exercise whilst in hospital improve their recovery and ability to manage their usual day-to-day activities when they are discharged?"
}
] |
query-laysum
|
7920
|
[
{
"role": "user",
"content": "Abstract: Background\nCarpal tunnel syndrome (CTS) is a very common clinical syndrome manifested by signs and symptoms of irritation of the median nerve at the carpal tunnel in the wrist. Direct and indirect costs of CTS are substantial, with estimated costs of two billion US dollars for CTS surgery in the USA in 1995 alone. Local corticosteroid injection has been used as a non-surgical treatment for CTS many years, but its effectiveness is still debated.\nObjectives\nTo evaluate the benefits and harms of corticosteroids injected in or around the carpal tunnel for the treatment of carpal tunnel syndrome compared to no treatment or a placebo injection.\nSearch methods\nWe used standard, extensive Cochrane search Methods. The searches were 7 June 2020 and 26 May 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-randomised trials of adults with CTS that included at least one comparison group of local injection of corticosteroid (LCI) into the wrist and one group that received a placebo or no treatment.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was 1. improvement in symptoms at up to three months of follow-up. Our secondary outcomes were 2. functional improvement, 3. improvement in symptoms at greater than three months of follow-up, 4. improvement in neurophysiological parameters, 5. improvement in imaging parameters, 6. requirement for carpal tunnel surgery, 7. improvement in quality of life and 8. adverse events. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included 14 trials with 994 participants/hands with CTS. Only nine studies (639 participants/hands) had useable data quantitatively and in general, these studies were at low risk of bias except for one quite high-risk study. The trials were conducted in hospital-based clinics across North America, Europe, Asia and the Middle East. All trials used participant-reported outcome measures for symptoms, function and quality of life.\nThere is probably an improvement in symptoms measured at up to three months of follow-up favouring LCI (standardised mean difference (SMD) −0.77, 95% confidence interval (CI) −0.94 to −0.59; 8 RCTs, 579 participants; moderate-certainty evidence). Up to six months this was still evident favouring LCI (SMD −0.58, 95% CI −0.89 to −0.28; 4 RCTs, 234 participants/hands; moderate-certainty evidence).\nThere is probably an improvement in function measured at up to three months favouring LCI (SMD −0.62, 95% CI −0.87 to −0.38; 7 RCTs, 499 participants; moderate-certainty evidence). We are uncertain if there is a difference in median nerve DML at up to three months of follow-up (mean difference (MD) −0.37 ms, 95% CI −0.75 to 0.02; 6 RCTs, 359 participants/hands; very low-certainty evidence). The requirement for surgery probably reduces slightly in the LCI group at one year (risk ratio 0.84, 95% CI 0.72 to 0.98; 1 RCT, 111 participants, moderate-certainty evidence). Quality of life, measured at up to three months of follow-up using the Short-Form 6 Dimensions questionnaire (scale from 0.29 to 1.0; higher is better) probably improved slightly in the LCI group (MD 0.07, 95% CI 0.02 to 0.12; 1 RCT, 111 participants; moderate-certainty evidence). Adverse events were uncommon (low-certainty evidence). One study reported 2/364 injections resulted in severe pain which resolved over \"several weeks\" and 1/364 injections caused a \"sympathetic reaction\" with a cool, pale hand that completely resolved in 20 minutes. One study (111 participants) reported no serious adverse events, but 65% of LCI-injected and 16% of the placebo-injected participants experienced mild-to-moderate pain lasting less than two weeks. About 9% of participants experienced localised swelling lasting less than two weeks. Four studies (229 participants) reported that they experienced no adverse events in their studies. Three studies (220 participants) did not specifically report adverse events.\nAuthors' conclusions\nLocal corticosteroid injection is effective for the treatment of mild and moderate CTS with benefits lasting up to six months and a reduced need for surgery up to 12 months. Where serious adverse events were reported, they were rare.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Corticosteroid injection into the wrist probably improves symptoms of carpal tunnel syndrome (compression of a nerve in the wrist) and function of the hand for up to six months. Quality of life assessments, and tests of nerve conduction measured up to three months after injection, may also improve. Corticosteroid injection may reduce the need for surgery, assessed at one-year follow-up. Side effects appear to be rare. However, spontaneous improvement without treatment can occur in up to a third of people."
}
] |
query-laysum
|
7921
|
[
{
"role": "user",
"content": "Abstract: Background\nApproximately 2.5% of all hospitalisations in people with liver cirrhosis are for spontaneous bacterial peritonitis. Spontaneous bacterial peritonitis is associated with significant short-term mortality; therefore, it is important to prevent spontaneous bacterial peritonitis in people at high risk of developing it. Antibiotic prophylaxis forms the mainstay preventive method, but this has to be balanced against the development of drug-resistant spontaneous bacterial peritonitis, which is difficult to treat, and other adverse events. Several different prophylactic antibiotic treatments are available; however, there is uncertainty surrounding their relative efficacy and optimal combination.\nObjectives\nTo compare the benefits and harms of different prophylactic antibiotic treatments for prevention of spontaneous bacterial peritonitis in people with liver cirrhosis using a network meta-analysis and to generate rankings of the different prophylactic antibiotic treatments 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 November 2018 to identify randomised clinical trials in people with cirrhosis at risk of developing spontaneous bacterial peritonitis.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or status) in adults with cirrhosis undergoing prophylactic treatment to prevent spontaneous bacterial peritonitis. We excluded randomised clinical trials in which participants had previously undergone liver transplantation, or were receiving antibiotics for treatment of spontaneous bacterial peritonitis or other purposes.\nData collection and analysis\nWe performed a network meta-analysis with OpenBUGS using Bayesian methods and calculated the odds ratio, rate ratio, and hazard ratio (HR) with 95% credible intervals (CrI) based on an available-case analysis, according to National Institute of Health and Care Excellence Decision Support Unit guidance.\nMain results\nWe included 29 randomised clinical trials (3896 participants; nine antibiotic regimens (ciprofloxacin, neomycin, norfloxacin, norfloxacin plus neomycin, norfloxacin plus rifaximin, rifaximin, rufloxacin, sparfloxacin, sulfamethoxazole plus trimethoprim), and 'no active intervention' in the review. Twenty-three trials (2587 participants) were included in one or more outcomes in the review. The trials that provided the information included people with cirrhosis due to varied aetiologies, with or without other features of decompensation, having ascites with low protein or previous history of spontaneous bacterial peritonitis. The follow-up in the trials ranged from 1 to 12 months. Many of the trials were at high risk of bias, and the overall certainty of evidence was low or very low. Overall, approximately 10% of trial participants developed spontaneous bacterial peritonitis and 15% of trial participants died.\nThere was no evidence of differences between any of the antibiotics and no intervention in terms of mortality (very low certainty) or number of serious adverse events (very low certainty). However, because of the wide CrIs, clinically important differences in these outcomes cannot be ruled out. None of the trials reported health-related quality of life or the proportion of people with serious adverse events.\nThere was no evidence of differences between any of the antibiotics and no intervention in terms of proportion of people with 'any adverse events' (very low certainty), liver transplantation (very low certainty), or the proportion of people who developed spontaneous bacterial peritonitis (very low certainty). The number of 'any' adverse events per participant was fewer with norfloxacin (rate ratio 0.74, 95% CrI 0.59 to 0.94; 4 trials, 546 participants; low certainty) and sulfamethoxazole plus trimethoprim (rate ratio 0.19, 95% CrI 0.02 to 0.81; 1 trial, 60 participants; low certainty) versus no active intervention. There was no evidence of differences between the other antibiotics and no intervention in the number of 'any' adverse events per participant (very low certainty). There were fewer other decompensation events with rifaximin versus no active intervention (rate ratio 0.61, 65% CrI 0.46 to 0.80; 3 trials, 575 participants; low certainty) and norfloxacin plus neomycin (rate ratio 0.06, 95% CrI 0.00 to 0.33; 1 trial, 22 participants; low certainty). There was no evidence of differences between the other antibiotics and no intervention in the number of decompensations events per participant (very low certainty). None of the trials reported health-related quality of life or development of symptomatic spontaneous bacterial peritonitis.\nOne would expect some correlation between the above outcomes, with interventions demonstrating effectiveness across several outcomes. This was not the case. The possible reasons for this include sparse data and selective reporting bias, which makes the results unreliable. Therefore, one cannot draw any conclusions from these inconsistent differences based on sparse data.\nThere was no evidence of any differences in the subgroup analyses (performed when possible) based on whether the prophylaxis was primary or secondary.\nFunding: the source of funding for five trials were organisations who would benefit from the results of the study; six trials received no additional funding or were funded by neutral organisations; and the source of funding for the remaining 18 trials was unclear.\nAuthors' conclusions\nBased on very low-certainty evidence, there is considerable uncertainty about whether antibiotic prophylaxis is beneficial, and if beneficial, which antibiotic prophylaxis is most beneficial in people with cirrhosis and ascites with low protein or history of spontaneous bacterial peritonitis.\nFuture randomised clinical trials should be adequately powered, employ blinding, avoid postrandomisation dropouts (or perform intention-to-treat analysis), and use clinically important outcomes such as mortality, health-related quality of life, and decompensation events.\n\nGiven the provided abstract, please respond to the following query: \"What did the review study?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We studied adults with advanced liver disease due to various causes, and who were undergoing preventive treatment to avoid developing spontaneous bacterial peritonitis. Participants received different antibiotics or no antibiotics. We excluded studies in people who had previously undergone liver transplantation, and where people received antibiotics for the treatment of spontaneous bacterial peritonitis or for any other reason. The average age of participants, when reported, ranged from 42 to 63 years. The administered antibiotic types were quinolones, rifamycins, sulfonamides, and aminoglycosides. The authors wanted to gather and analyse data on death, quality of life, serious and non-serious side effects, time to liver transplantation, time to development of spontaneous bacterial peritonitis, time to development of other complications of advanced liver disease, and length of hospital stay."
}
] |
query-laysum
|
7922
|
[
{
"role": "user",
"content": "Abstract: Background\nPain is a common feature of childhood and adolescence around the world, and for many young people, that pain is chronic. The World Health Organization guidelines for pharmacological treatments for children's persisting pain acknowledge that pain in children is a major public health concern of high significance in most parts of the world. While in the past, pain was largely dismissed and was frequently left untreated, views on children's pain have changed over time, and relief of pain is now seen as important.\nWe designed a suite of seven reviews on chronic non-cancer pain and cancer pain (looking at antidepressants, antiepileptic drugs, non-steroidal anti-inflammatory drugs, opioids, and paracetamol as priority areas) in order to review the evidence for children's pain utilising pharmacological interventions in children and adolescents.\nAs the leading cause of morbidity in children and adolescents in the world today, chronic disease (and its associated pain) is a major health concern. Chronic pain (lasting three months or longer) can arise in the paediatric population in a variety of pathophysiological classifications: nociceptive, neuropathic, idiopathic, visceral, nerve damage pain, chronic musculoskeletal pain, and chronic abdominal pain, and other unknown reasons.\nOpioids are used worldwide for the treatment of pain. They bind to opioid receptors in the central nervous system (mu, kappa, delta, and sigma) and can be agonists, antagonists, mixed agonist-antagonists, or partial agonists. Opioids are generally available in healthcare settings across most high-income countries, but access may be restricted in low- and middle-income countries. For example, opioids currently available in the UK include: buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, and tramadol. Opioids are used in varying doses (generally based on body weight for paediatric patients) by means of parenteral, transmucosal, transdermal, or oral administration (immediate release or modified release). To achieve adequate pain relief in children using opioids, with an acceptable grade of adverse effects, the recommended method is a lower dose gradually titrated to effect in the child.\nObjectives\nTo assess the analgesic efficacy and adverse events of opioids used to treat chronic non-cancer pain in children and adolescents aged between birth and 17 years, in any setting.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Library, MEDLINE via Ovid, and Embase via Ovid from inception to 6 September 2016. We also searched the reference lists of retrieved studies and reviews, and searched online clinical trial registries.\nSelection criteria\nRandomised controlled trials, with or without blinding, of any dose and any route, treating chronic non-cancer pain in children and adolescents, comparing opioids with placebo or an active comparator.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility. We planned to use dichotomous data to calculate risk ratio and number needed to treat, using standard methods. We planned to assess GRADE (Grading of Recommendations Assessment, Development and Evaluation) and planned to create a 'Summary of findings' table.\nMain results\nNo studies were eligible for inclusion in this review.\nThere is no evidence to support or refute the use of opioids for treating chronic non-cancer pain in children and adolescents.\nAuthors' conclusions\nWe are unable to comment about efficacy or harm from the use of opioids to treat chronic non-cancer pain in children and adolescents.\nWe know from adult randomised controlled trials that some opioids, such as morphine and codeine, can be effective in certain chronic pain conditions.\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 September 2016 we searched for clinical trials where any opioids were used to treat chronic pain (potentially from either nerve pain, musculoskeletal problems, menstrual cramps, or abdominal discomfort).\nWe found no studies that met the requirements for this review. Several studies tested opioids in adults with chronic pain, but none in participants from birth to 17 years old."
}
] |
query-laysum
|
7923
|
[
{
"role": "user",
"content": "Abstract: Background\nLow back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide.\nObjectives\nTo evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up.\nSearch methods\nThis is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004.\nSelection criteria\nWe included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment.\nData collection and analysis\nWe used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias.\nThere is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) −0.80, 95% confidence interval (CI) −5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group.\nThere is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI −2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group.\nWe downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants).\nThere is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity.\nIn two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.\nAuthors' conclusions\nExercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).\n\nGiven the provided abstract, please respond to the following query: \"Limitations of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We have very little confidence in the evidence because the studies were poorly designed and included few people."
}
] |
query-laysum
|
7924
|
[
{
"role": "user",
"content": "Abstract: Background\nHuman milk alone may provide inadequate amounts of protein to meet the growth requirements of preterm infants because of restrictions in the amount of fluid they can tolerate. It has become common practice to feed preterm infants with breast milk fortified with protein and other nutrients but there is debate about the optimal concentration of protein in commercially available fortifiers.\nObjectives\nTo compare the effects of different protein concentrations in human milk fortifier, fed to preterm infants, on growth and neurodevelopment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search CENTRAL (2019, Issue 8), Ovid MEDLINE and CINAHL on 15 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included all published and unpublished randomised, quasi-randomised and cluster-randomised trials comparing two different concentrations of protein in human milk fortifier.\nWe included preterm infants (less than 37 weeks' gestational age). Participants may have been exclusively fed human milk or have been supplemented with formula.\nThe concentration of protein was classified as low (< 1g protein/100 mL expressed breast milk (EBM)), moderate (≥ 1g to < 1.4g protein/100 mL EBM) or high (≥ 1.4g protein/100 mL EBM). We excluded trials that compared two protein concentrations that fell within the same category.\nData collection and analysis\nWe undertook data collection and analyses using the standard methods of Cochrane Neonatal. Two review authors independently evaluated trials. Primary outcomes included growth, neurodevelopmental outcome and mortality. Data were synthesised using risk ratios (RR), risk differences and mean differences (MD), with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe identified nine trials involving 861 infants. There is one trial awaiting classification, and nine ongoing trials. The trials were mostly conducted in infants born < 32 weeks' gestational age or < 1500 g birthweight, or both. All used a fortifier derived from bovine milk. Two trials fed infants exclusively with mother's own milk, three trials gave supplementary feeds with donor human milk and four trials supplemented with preterm infant formula. Overall, trials were small but generally at low or unclear risk of bias.\nHigh versus moderate protein concentration of human milk fortifier\nThere was moderate certainty evidence that a high protein concentration likely increased in-hospital weight gain compared to moderate concentration of human milk fortifier (MD 0.66 g/kg/day, 95% CI 0.51 to 0.82; trials = 6, participants = 606). The evidence was very uncertain about the effect of high versus moderate protein concentration on length gain (MD 0.01 cm/week, 95% CI –0.01 to 0.03; trials = 5, participants = 547; very low certainty evidence) and head circumference gain (MD 0.00 cm/week, 95% CI –0.01 to 0.02; trials = 5, participants = 549; very low certainty evidence).\nOnly one trial reported neonatal mortality, with no deaths in either group (participants = 45).\nModerate versus low protein concentration of human milk fortifier\nA moderate versus low protein concentration fortifier may increase weight gain (MD 2.08 g/kg/day, 95% CI 0.38 to 3.77; trials = 2, participants = 176; very low certainty evidence) with little to no effect on head circumference gain (MD 0.13 cm/week, 95% CI 0.00 to 0.26; I² = 85%; trials = 3, participants = 217; very low certainty evidence), but the evidence is very uncertain. There was low certainty evidence that a moderate protein concentration may increase length gain (MD 0.09 cm/week, 95% CI 0.05 to 0.14; trials = 3, participants = 217).\nOnly one trial reported mortality and found no difference between groups (RR 0.48, 95% CI 0.05 to 5.17; participants = 112).\nNo trials reported long term growth or neurodevelopmental outcomes including cerebral palsy and developmental delay.\nAuthors' conclusions\nFeeding preterm infants with a human milk fortifier containing high amounts of protein (≥ 1.4g/100 mL EBM) compared with a fortifier containing moderate protein concentration (≥ 1 g to < 1.4 g/100 mL EBM) results in small increases in weight gain during the neonatal admission. There may also be small increases in weight and length gain when infants are fed a fortifier containing moderate versus low protein concentration (< 1 g protein/100 mL EBM). The certainty of this evidence is very low to moderate; therefore, results may change when the findings of ongoing studies are available. There is insufficient evidence to assess the impact of protein concentration on adverse effects or long term outcomes such as neurodevelopment. Further trials are needed to determine whether modest increases in weight gain observed with higher protein concentration fortifiers are associated with benefits or harms to long term growth and neurodevelopment.\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": "The certainty of this evidence was very low to moderate due to inconsistent results reported by some trials and potential bias related to the way some trials were conducted."
}
] |
query-laysum
|
7925
|
[
{
"role": "user",
"content": "Abstract: Background\nOral poisoning is a major cause of mortality and disability worldwide, with estimates of over 100,000 deaths due to unintentional poisoning each year and an overrepresentation of children below five years of age. Any effective intervention that laypeople can apply to limit or delay uptake or to evacuate, dilute or neutralize the poison before professional help arrives may limit toxicity and save lives.\nObjectives\nTo assess the effects of pre-hospital interventions (alone or in combination) for treating acute oral poisoning, available to and feasible for laypeople before the arrival of professional help.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, ISI Web of Science, International Pharmaceutical Abstracts, and three clinical trials registries to 4 December 2018, and we also carried out reference checking and citation searching.\nSelection criteria\nWe included randomized controlled trials comparing interventions (alone or in combination) that are feasible in a pre-hospital setting for treating acute oral poisoning patients, including but potentially not limited to activated charcoal (AC), emetics, cathartics, diluents, neutralizing agents and body positioning.\nData collection and analysis\nTwo review authors independently performed study selection, data collection and assessment. Primary outcomes of this review were incidence of mortality and adverse events, plus incidence and severity of symptoms of poisoning. Secondary outcomes were duration of symptoms of poisoning, drug absorption, and incidence of hospitalization and ICU admission.\nMain results\nWe included 24 trials involving 7099 participants. Using the Cochrane 'Risk of bias' tool, we assessed no study as being at low risk of bias for all domains. Many studies were poorly reported, so the risk of selection and detection biases were often unclear. Most studies reported important outcomes incompletely, and we judged them to be at high risk of reporting bias.\nAll but one study enrolled oral poisoning patients in an emergency department; the remaining study was conducted in a pre-hospital setting. Fourteen studies included multiple toxic syndromes or did not specify, while the other studies specifically investigated paracetamol (2 studies), carbamazepine (2 studies), tricyclic antidepressant (2 studies), yellow oleander (2 studies), benzodiazepine (1 study), or toxic berry intoxication (1 study). Twenty-one trials investigated the effects of activated charcoal (AC), administered as a single dose (SDAC) or in multiple doses (MDAC), alone or in combination with other first aid interventions (a cathartic) and/or hospital treatments. Six studies investigated syrup of ipecac plus other first aid interventions (SDAC + cathartic) versus ipecac alone. The collected evidence was mostly of low to very low certainty, often downgraded for indirectness, risk of bias or imprecision due to low numbers of events.\nFirst aid interventions that limit or delay the absorption of the poison in the body\nWe are uncertain about the effect of SDAC compared to no intervention on the incidence of adverse events in general (zero events in both treatment groups; 1 study, 451 participants) or vomiting specifically (Peto odds ratio (OR) 4.17, 95% confidence interval (CI) 0.30 to 57.26, 1 study, 25 participants), ICU admission (Peto OR 7.77, 95% CI 0.15 to 391.93, 1 study, 451 participants) and clinical deterioration (zero events in both treatment groups; 1 study, 451 participants) in participants with mixed types or paracetamol poisoning, as all evidence for these outcomes was of very low certainty. No studies assessed SDAC for mortality, duration of symptoms, drug absorption or hospitalization.\nOnly one study compared SDAC to syrup of ipecac in participants with mixed types of poisoning, providing very low-certainty evidence. Therefore we are uncertain about the effects on Glasgow Coma Scale scores (mean difference (MD) −0.15, 95% CI −0.43 to 0.13, 1 study, 34 participants) or incidence of adverse events (risk ratio (RR) 1.24, 95% CI 0.26 to 5.83, 1 study, 34 participants). No information was available concerning mortality, duration of symptoms, drug absorption, hospitalization or ICU admission.\nThis review also considered the added value of SDAC or MDAC to hospital interventions, which mostly included gastric lavage. No included studies investigated the use of body positioning in oral poisoning patients.\nFirst aid interventions that evacuate the poison from the gastrointestinal tract\nWe found one study comparing ipecac versus no intervention in toxic berry ingestion in a pre-hospital setting. Low-certainty evidence suggests there may be an increase in the incidence of adverse events, but the study did not report incidence of mortality, incidence or duration of symptoms of poisoning, drug absorption, hospitalization or ICU admission (103 participants).\nIn addition, we also considered the added value of syrup of ipecac to SDAC plus a cathartic and the added value of a cathartic to SDAC.\nNo studies used cathartics as an individual intervention.\nFirst aid interventions that neutralize or dilute the poison\nNo included studies investigated the neutralization or dilution of the poison in oral poisoning patients.\nAuthors' conclusions\nThe studies included in this review provided mostly low- or very low-certainty evidence about the use of first aid interventions for acute oral poisoning. A key limitation was the fact that only one included study actually took place in a pre-hospital setting, which undermines our confidence in the applicability of these results to this setting. Thus, the amount of evidence collected was insufficient to draw any conclusions.\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 the effects of first aid treatments for poisoning that could be feasibly given by people who are not health professionals."
}
] |
query-laysum
|
7926
|
[
{
"role": "user",
"content": "Abstract: Background\nFractures of the distal femur (the far end of the thigh bone just above the knee) are a considerable cause of morbidity. Various different surgical and non-surgical treatments have been used in the management of these injuries but the best treatment remains unknown.\nObjectives\nTo evaluate the benefits and harms of interventions for treating fractures of the distal femur in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was October 2021.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials in adults comparing interventions for treating fractures of the distal femur. Interventions included surgical implants (retrograde intramedullary nail (RIMN), fixed-angle devices, non-locking plate fixation, locking plate, internal fixation, distal femoral replacement, mono-axial plates, poly-axial plates and condylar buttress plates) and non-surgical management.\nData collection and analysis\nWe used standard Cochrane methods. Our critical outcomes were validated patient-reported outcome measures (PROMs), direct adverse events, participant-reported quality of life (QoL) and pain scores. Our other important outcomes were adverse events indirectly related to intervention, symptomatic non-union, malunion and resource use. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included 14 studies with 753 participants: 13 studies compared different surgical interventions, and one study compared surgical with non-surgical management. Here, we report the effects for RIMN compared with locking plates. Three studies (221 participants) reported this comparison; it included the largest study population and these are the two most commonly used devices in contemporary orthopaedic trauma practice.\nStudies used three different tools to assess PROMs. We found very-low certainty evidence for lower Disability Rating Index scores after RIMN at short-term follow-up favouring RIMN (mean difference (MD) −21.90, 95% confidence interval (CI) −38.16 to −5.64; 1 study, 12 participants) and low-certainty evidence of little or no difference at long-term follow-up (standardised mean difference (SMD) −0.22, 95% CI −0.50 to 0.06; 2 studies, 198 participants). Re-expressing the SMD of the long-term follow-up data to Knee Society Score (KSS) used by one study found no clinical benefit of RIMN, based on a minimal clinically important difference of 9 points (MD 2.47, 95% CI −6.18 to 0.74). The effect on QoL was very uncertain at four months (MD 0.01, 95% CI −0.42 to 0.44; 1 study, 14 participants) and one year (MD 0.10, 95% CI −0.01 to 0.21; 1 study, 156 participants); this evidence was very low certainty.\nFor direct adverse events, studies reported reoperation, loss of fixation, superficial and deep infection, haematoma formation and implant loosening. Effects for all events were imprecise with the possibility of benefit or harm for both treatments. We considered reoperation the most clinically relevant. There was very low-certainty evidence of little or no difference in reoperation between the two implants (risk ratio (RR) 1.48, 95% CI 0.55 to 4.00; 1 study, 104 participants).\nNo studies reported pain.\nFor other important outcomes, we noted that people treated with RIMN may be more likely to have varus/valgus deformity (RR 2.18, 95% CI 1.09 to 4.37; 1 study, 33 participants; low-certainty evidence). However, we found no evidence of any important differences between treatments in terms of bony union, indirect adverse events, or resource use.\nOther comparisons of surgical interventions included in the review were: RIMN versus single fixed-angle device (3 studies, 175 participants); RIMN versus non-locking plate fixation (1 study, 18 participants); locking plate versus single fixed-angle device (2 studies, 130 participants); internal fixation versus distal femoral replacement (1 study, 23 participants); mono-axial plates versus poly-axial plates (2 studies, 67 participants); mono-axial plate versus condylar buttress plate (1 study, 78 participants). The certainty of the evidence for outcomes in these comparisons was low to very low, and most effect estimates were imprecise.\nAuthors' conclusions\nThis review highlights the major limitations of the available evidence concerning current treatment interventions for fractures of the distal femur. The currently available evidence is incomplete and insufficient to inform clinical practice. Priority should be given to randomised controlled trials comparing contemporary treatments for people with fractures of the distal femur. At a minimum, these should report validated patient-reported functional and quality-of-life outcomes at one and two years, with an agreed core outcome set. All trials should be reported in full using the CONSORT guidelines.\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 want to find out the effects of different methods for treating fractures of the lower femur in adults. Effects included: function scores, pain, quality of life (QoL) and any complications that arose as a result of the management method."
}
] |
query-laysum
|
7927
|
[
{
"role": "user",
"content": "Abstract: Background\nFrey's syndrome is characterised by transient flushing and sometimes facial sweating in the area of the auriculotemporal nerve. It most commonly occurs after parotidectomy, but other causes may include submandibular gland surgery, mandibular condylar fracture, obstetric (forceps) trauma, sympathectomy and metabolic disease. Although the pathophysiology of Frey's syndrome remains controversial, the generally accepted hypothesis is that it occurs as the result of injury to the auriculotemporal nerve.\nThere is currently no clear evidence to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome, therefore the prevention of this symptom during surgery is important. The main method used for prevention is the interposition of a graft between the skin flap and the parotid bed during surgery. Biomaterials, allograft or autograft can be used for this purpose.\nObjectives\nTo evaluate the effects and safety of biomaterial, allograft or autograft interposition for the prevention of Frey's syndrome in patients undergoing parotidectomy, and to identify its effect on prevention and delayed occurrence.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Cochrane Register of Controlled Trials (CENTRAL; 2019, Issue 2); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 5 February 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) in patients with parotid disease (including tumours, inflammation, trauma etc.) undergoing parotidectomy with a minimal follow-up period of six months. We planned to include trials with interventions including biomaterial, allograft or autograft interposition alone or in combination with other surgical techniques. We included trials that compared any graft interposition and no graft interposition, or different graft interpositions.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcome measures were incidence rate of Frey's syndrome assessed clinically (Minor's starch-iodine test) and other complications (postoperative infection, subjective painful or restricted cervical movement, scar spread, rejection of the graft, complications related to the donor site such as accessory nerve injury and haematoma). Our secondary outcome measures were incidence rate of Frey's syndrome assessed by participants (by questionnaire) and sweating area assessed by Minor's starch-iodine test. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included three RCTs (124 participants), two of which we assessed as at high risk of bias and one at unclear risk of bias. All studies were hospital-based and recruited participants undergoing superficial parotidectomy. Most participants were diagnosed with benign lesions of the parotid gland. Participants were followed up for more than six months. The studies evaluated the two comparisons shown below:\nSternocleidomastoid muscle flap versus no flap\nTwo studies assessed this comparison. Both assessed the effects of the sternocleidomastoid muscle flap procedure on the incidence rate of Frey's syndrome assessed clinically but neither showed a significant difference between groups (risk ratio (RR) 0.08, 95% confidence interval (CI) 0.00 to 1.23; 24 participants and RR 1.23, 95% CI 0.88 to 1.73; 36 participants; very low-certainty evidence). We did not pool the data due to the high heterogeneity (I² = 87%).\nOne study found that the sternocleidomastoid muscle flap may result in little or no difference in other complications including haematoma (RR 2.18, 95% CI 0.09 to 50.16; 36 participants; low-certainty evidence), subjective painful or restricted cervical movement (RR 0.54, 95% CI 0.14 to 2.05; 36 participants; low-certainty evidence) and scar spread in the cervical region (RR 0.71, 95% CI 0.05 to 10.54; 36 participants; low-certainty evidence). Both studies reported the incidence rate of Frey's syndrome assessed by participants, with one reporting no events in either group and the other finding no evidence of a difference (RR 0.63, 95% CI 0.32 to 1.26; 36 participants; low-certainty evidence).\nAcellular dermal matrix versus no graft\nOnly one study assessed this comparison. Use of an acellular dermal matrix graft may result in little or no difference to the incidence rate of Frey's syndrome (assessed clinically) in comparison with the no graft group, but the evidence is very uncertain (RR 0.08, 95% CI 0.00 to 1.25; 30 participants; very low-certainty evidence).\nAcellular dermal matrix may slightly increase the wound infection rate compared with control (RR 17.00, 95% CI 1.02 to 282.67; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence of seromas or sialoceles (RR 2.33, 95% CI 0.66 to 8.23; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence rate of Frey's syndrome (assessed by participants) in comparison with the no graft group (RR 0.33, 95% CI 0.04 to 3.04; 64 participants; low-certainty evidence).\nAuthors' conclusions\nThe evidence for the effectiveness of graft interposition in preventing Frey's syndrome is of low or very low certainty. The use of acellular dermal matrix may be associated with an increase in the wound infection rate, and little or no difference in the incidence of seromas or sialoceles. Further studies are needed to draw reliable conclusions.\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 124 participants in this review, but the quality of these studies was not ideal. All of the participants in the studies had tumours of the parotid glands and were undergoing surgery to part of the glands. The studies assessed two types of grafts, tissue obtained from the sternocleidomastoid muscle and a biomaterial (a collagen framework without cells)."
}
] |
query-laysum
|
7928
|
[
{
"role": "user",
"content": "Abstract: Background\nActive management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. This is an update of a review last published in 2015.\nObjectives\nTo compare the effects of active versus expectant management of the third stage of labour on severe primary postpartum haemorrhage (PPH) and other maternal and infant outcomes.\nTo compare the effects of variations in the packages of active and expectant management of the third stage of labour on severe primary PPH and other maternal and infant outcomes.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the World health Organization International Clinical Trials Registry Platform (ICTRP), on 22 January 2018, and reference lists of retrieved studies.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. Cluster-randomised trials were eligible for inclusion, but none were identified.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion, assessed risk of bias, carried out data extraction and assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included eight studies, involving analysis of data from 8892 women. The studies were all undertaken in hospitals, seven in higher-income countries and one in a lower-income country. Four studies compared active versus expectant management, and four compared active versus a mixture of managements. We used a random-effects model in the analyses because of clinical heterogeneity. Of the eight studies included, we considered three studies as having low risk of bias in the main aspects of sequence generation, allocation concealment and completeness of data collection. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes, which is reflected in the cautious language below.\nThe evidence suggested that, for women at mixed levels of risk of bleeding, it is uncertain whether active management reduces the average risk of maternal severe primary PPH (more than 1000 mL) at time of birth (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, 3 studies, 4636 women, I2 = 60%; GRADE: very low quality). For incidence of maternal haemoglobin (Hb) less than 9 g/dL following birth, active management of the third stage may reduce the number of women with anaemia after birth (average RR 0.50, 95% CI 0.30 to 0.83, 2 studies, 1572 women; GRADE: low quality). We also found that active management of the third stage may make little or no difference to the number of babies admitted to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, 2 studies, 3207 infants; GRADE: low quality). It is uncertain whether active management of the third stage reduces the number of babies with jaundice requiring treatment (RR 0.96, 95% CI 0.55 to 1.68, 2 studies, 3142 infants, I2 = 66%; GRADE: very low quality). There were no data on our other primary outcomes of very severe PPH at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.\nActive management reduces mean maternal blood loss at birth and probably reduces the rate of primary blood loss greater than 500 mL, and the use of therapeutic uterotonics. Active management also probably reduces the mean birthweight of the baby, reflecting the lower blood volume from interference with placental transfusion. In addition, it may reduce the need for maternal blood transfusion. However, active management may increase maternal diastolic blood pressure, vomiting after birth, afterpains, use of analgesia from birth up to discharge from the labour ward, and more women returning to hospital with bleeding (outcome not pre-specified).\nIn the comparison of women at low risk of excessive bleeding, there were similar findings, except it was uncertain whether there was a difference identified between groups for severe primary PPH (average RR 0.31, 95% CI 0.05 to 2.17; 2 studies, 2941 women, I2 = 71%), maternal Hb less than 9 g/dL at 24 to 72 hours (average RR 0.17, 95% CI 0.02 to 1.47; 1 study, 193 women) or the need for neonatal admission (average RR 1.02, 95% CI 0.55 to 1.88; 1 study, 1512 women). In this group, active management may make little difference to the rate of neonatal jaundice requiring phototherapy (average RR 1.31, 95% CI 0.78 to 2.18; 1 study, 1447 women).\nHypertension and interference with placental transfusion might be avoided by using modifications to the active management package, for example, omitting ergot and deferring cord clamping, but we have no direct evidence of this here.\nAuthors' conclusions\nAlthough the data appeared to show that active management reduced the risk of severe primary PPH greater than 1000 mL at the time of birth, we are uncertain of this finding because of the very low-quality evidence. Active management may reduce the incidence of maternal anaemia (Hb less than 9 g/dL) following birth, but harms such as postnatal hypertension, pain and return to hospital due to bleeding were identified.\nIn women at low risk of excessive bleeding, it is uncertain whether there was a difference between active and expectant management for severe PPH or maternal Hb less than 9 g/dL (at 24 to 72 hours). Women could be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.\nIt must be emphasised that this review includes only a small number of studies with relatively small numbers of participants, and the quality of evidence for primary outcomes is low or very low.\n\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": "The aim of this Cochrane Review was to look at different ways of delivering the placenta after the birth of the baby; expectant, active or mixed management. We asked, what are the benefits and harms for all women, but specifically for women at low risk of severe bleeding (haemorrhage)? We collected and analysed all relevant studies to answer this question (22 January 2018)."
}
] |
query-laysum
|
7929
|
[
{
"role": "user",
"content": "Abstract: Background\nAnterior cruciate ligament (ACL) reconstruction is one of the most frequently performed orthopaedic procedures. The most common technical cause of reconstruction failure is graft malpositioning. Computer-assisted surgery (CAS) aims to improve the accuracy of graft placement. Although posterior cruciate ligament (PCL) injury and reconstruction are far less common, PCL reconstruction has comparable difficulties relating to graft placement. This is an update of a Cochrane review first published in 2011.\nObjectives\nTo assess the effects of computer-assisted reconstruction surgery versus conventional operating techniques for ACL or PCL injuries in adults.\nSearch methods\nFor this update, we searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (from 2010 to July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2013), MEDLINE (from 2010 to July 2013), EMBASE (from 2010 to July 2013), CINAHL (from 2010 to July 2013), article references and prospective trial registers.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized controlled trials that compared CAS for ACL or PCL reconstruction versus conventional operating techniques not involving CAS.\nData collection and analysis\nTwo authors independently screened search results, assessed the risk of bias in the studies and extracted data. Where appropriate, we pooled data using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CI).\nMain results\nThe updated search resulted in the inclusion of one new study. This review now includes five RCTs with 366 participants. There were more female than male participants (70% were female); their ages ranged from 14 to 53 years. All trials involved ACL reconstructions performed by experienced surgeons.\nAssessing the studies' risk of bias was hampered by poor reporting of trial methods, and consequently several studies were judged to be 'unclear' for several types of bias. One trial presenting primary outcome data was at high risk of detection bias from lack of clinician blinding and attrition bias from an unaccounted loss to follow-up at two years.\nWe found moderate quality evidence (three trials, 193 participants) of no clinically relevant difference between CAS and conventional surgery in International Knee Documentation Committee (IKDC) subjective scores (self-reported measure of knee function; scale of 0 to 100 where 100 was best function). Pooled data from two of these trials (120 participants) showed a small, but clinically irrelevant difference favouring CAS (MD 2.05, 95% CI -2.16 to 6.25). A third trial (73 participants) also found minimal difference in IKDC subjective scores (reported MD 0.2).\nWe found low quality evidence (two trials, 120 participants) showing no difference between the two groups in Lysholm scores, also measured on a scale 0 to 100 where 100 is best function (MD 0.25, 95% CI -3.75 to 4.25). We found very low quality evidence (one trial, 40 participants) showing no difference between the two groups in Tegner scores. We found low quality evidence (three trials, 173 participants) showing the majority of participants in both groups were assessed as having normal or nearly normal knee function (86/87 with CAS versus 84/86 with no CAS; RR 1.01, 95% CI 0.96 to 1.06).\nSimilarly, no differences were found for our secondary outcome measures of knee stability, loss in range of motion and tunnel placement. None of the trials reported on re-operation.\nNo adverse post-surgical events were reported in two trials (133 participants); this outcome was not reported by the other three trials.\nCAS use was associated with longer operating times compared with conventional operating techniques: the mean difference in operating times reported in the studies ranged between 9 and 27 minutes.\nAuthors' conclusions\nFrom the available evidence, we are unable to demonstrate or refute a favourable effect of CAS for cruciate ligament reconstructions of the knee compared with conventional reconstructions. However, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome. There is a need for improved reporting of future studies of this technology.\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 comprehensive search of medical literature up to 5 July 2013 to find randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) and quasi-randomized controlled trials (e.g. allocation by hospital record number or date of birth) comparing computer-assisted surgery (CAS) of the ACL or PCL with conventional operating techniques not involving CAS in adults."
}
] |
query-laysum
|
7930
|
[
{
"role": "user",
"content": "Abstract: Background\nReal-time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking.\nObjectives\nTo assess the effectiveness of real-time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real-time video counselling.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real-time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real-time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both.\nData collection and analysis\nTwo authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random-effects meta-analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow-up. Analysis was based on the intention-to-treat principle. We considered participants with missing data at follow-up for the primary outcome of smoking cessation to be smokers.\nMain results\nWe included two randomised trials with 615 participants. Both studies delivered real-time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow-up) across the two included studies when real-time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real-time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between-group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants).\nAuthors' conclusions\nThere is very little evidence about the effectiveness of real-time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High-quality randomised trials comparing real-time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real-time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation.\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": "We rated the quality of the evidence for smoking cessation to be very low. There were only two studies, and the limitations in these studies made it difficult to draw reliable conclusions about whether video counselling can help people to quit smoking. This should be taken into account when looking at these findings."
}
] |
query-laysum
|
7931
|
[
{
"role": "user",
"content": "Abstract: Background\nIt has been suggested that low serum zinc levels may be associated with suboptimal outcomes of pregnancy, such as prolonged labour, atonic postpartum haemorrhage, pregnancy-induced hypertension, preterm labour and post-term pregnancies, although these associations have not yet been established. This is an update of a review first published in 1997 and subsequently updated in 2007, 2012 and 2015.\nObjectives\n1. To compare the effects on maternal, fetal, neonatal and infant outcomes in healthy pregnant women receiving zinc supplementation versus no zinc supplementation, or placebo.\n2. To assess the above outcomes in a subgroup analysis reviewing studies performed in women who are, or are likely to be, zinc-deficient.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (3 July 2020), and reference lists of retrieved studies.\nSelection criteria\nRandomised trials of zinc supplementation versus no zinc supplementation or placebo administration during pregnancy, earlier than 27 weeks' gestation. We excluded quasi-randomised controlled trials. We intended to include studies presented only as abstracts, if they provided enough information or, if necessary, by contacting authors to analyse them against our criteria; we did not find any such studies.\nData collection and analysis\nThree review authors applied the study selection criteria, assessed trial quality and extracted data. When necessary, we contacted study authors for additional information. We assessed the certainty of the evidence using GRADE.\nMain results\nFor this update, we included 25 randomised controlled trials (RCTs) involving over 18,000 women and their babies. The overall risk of bias was low in half of the studies. The evidence suggests that zinc supplementation may result in little or no difference in reducing preterm births (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.74 to 1.03; 21 studies, 9851 participants; low-certainty evidence). Further, zinc supplementation may make little or no difference in reducing the risk of stillbirth (RR 1.22, 95% CI 0.80 to 1.88; 7 studies, 3295 participants; low-certainty evidence), or perinatal deaths (RR 1.10, 95% CI 0.81 to 1.51; 2 studies, 2489 participants; low-certainty evidence). It is unclear whether zinc supplementation reduces neonatal death, because the certainty of the evidence is very low. Finally, for other birth outcomes, zinc supplementation may make little or no difference to mean birthweight (MD 13.83, 95% CI -15.81 to 43.46; 22 studies, 7977 participants; low-certainty evidence), and probably makes little or no difference in reducing the risk of low birthweight (RR 0.94, 95% CI 0.79 to 1.13; 17 studies, 7399 participants; moderate-certainty evidence) and small-for-gestational age babies when compared to placebo or no zinc supplementation (RR 1.02, 95% CI 0.92 to 1.12; 9 studies, 5330 participants; moderate-certainty evidence). We did not conduct subgroup analyses, as very few studies used normal zinc populations.\nAuthors' conclusions\nThere is not enough evidence that zinc supplementation during pregnancy results in improvements in maternal or neonatal outcomes. Future research to address ways of improving the overall nutritional status of pregnant women, particularly in low-income regions, and not looking at zinc in isolation, should be an urgent priority.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is not enough evidence that zinc supplementation during pregnancy results in better outcomes for women and their babies. Finding ways to improve women's overall nutritional status, particularly in low-income areas, will do more to improve the health of mothers and babies than supplementing pregnant women with zinc alone. This should be an urgent research priority for the future."
}
] |
query-laysum
|
7932
|
[
{
"role": "user",
"content": "Abstract: Background\nAccurate diagnosis of tuberculosis in people living with HIV is difficult. HIV-positive individuals have higher rates of extrapulmonary tuberculosis and the diagnosis of tuberculosis is often limited to imaging results. Ultrasound is such an imaging test that is widely used as a diagnostic tool (including point-of-care) in people suspected of having abdominal tuberculosis or disseminated tuberculosis with abdominal involvement.\nObjectives\nTo determine the diagnostic accuracy of abdominal ultrasound for detecting abdominal tuberculosis or disseminated tuberculosis with abdominal involvement in HIV-positive individuals.\nTo investigate potential sources of heterogeneity in test accuracy, including clinical setting, ultrasound training level, and type of reference standard.\nSearch methods\nWe searched for publications in any language up to 4 April 2019 in the following databases: MEDLINE, Embase, BIOSIS, Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Conference Proceedings Citation Index- Science (CPCI-S), and also ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform to identify ongoing trials.\nSelection criteria\nWe included cross-sectional, cohort, and diagnostic case-control studies (prospective and retrospective) that compared the result of the index test (abdominal ultrasound) with one of the reference standards. We only included studies that allowed for extraction of numbers of true positives (TPs), true negatives (TNs), false positives (FPs), and false negatives (FNs). Participants were HIV-positive individuals aged 15 years and older. A higher-quality reference standard was the bacteriological confirmation of Mycobacterium tuberculosis from any clinical specimen, and a lower-quality reference standard was a clinical diagnosis of tuberculosis without microbiological confirmation. We excluded genitourinary tuberculosis.\nData collection and analysis\nFor each study, two review authors independently extracted data using a standardized form. We assessed the quality of studies using a tailored Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. We used the bivariate model to estimate pooled sensitivity and specificity. When studies were few we simplified the bivariate model to separate univariate random-effects logistic regression models for sensitivity and specificity. We explored the influence of the type of reference standard on the accuracy estimates by conducting separate analyses for each type of reference standard. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 11 studies. The risks of bias and concern about applicability were often high or unclear in all domains. We included six studies in the main analyses of any abnormal finding on abdominal ultrasound; five studies reported only individual lesions.\nThe six studies of any abnormal finding were cross-sectional or cohort studies. Five of these (83%) were conducted in low- or middle-income countries, and one in a high-income country. The proportion of participants on antiretroviral therapy was none (1 study), fewer then 50% (4 studies), more than 50% (1 study), and not reported (5 studies). The first main analysis, studies using a higher-quality reference standard (bacteriological confirmation), had a pooled sensitivity of 63% (95% confidence interval (CI) 43% to 79%; 5 studies, 368 participants; very low-certainty evidence) and a pooled specificity of 68% (95% CI 42% to 87%; 5 studies, 511 participants; very low-certainty evidence). If the results were to be applied to a hypothetical cohort of 1000 people with HIV where 200 (20%) have tuberculosis then:\n- About 382 individuals would have an ultrasound result indicating tuberculosis; of these, 256 (67%) would be incorrectly classified as having tuberculosis (false positives).\n- Of the 618 individuals with a result indicating that tuberculosis is not present, 74 (12%) would be incorrectly classified as not having tuberculosis (false negatives).\nIn the second main analysis involving studies using a lower-quality reference standard (clinical diagnosis), the pooled sensitivity was 68% (95% CI 45% to 85%; 4 studies, 195 participants; very low-certainty evidence) and the pooled specificity was 73% (95% CI 41% to 91%; 4 studies, 202 participants; very low-certainty evidence).\nAuthors' conclusions\nIn HIV-positive individuals thought to have abdominal tuberculosis or disseminated tuberculosis with abdominal involvement, abdominal ultrasound appears to have 63% sensitivity and 68% specificity when tuberculosis was bacteriologically confirmed. These estimates are based on data that is limited, varied, and low-certainty.\nThe low sensitivity of abdominal ultrasound means clinicians should not use a negative test result to rule out the disease, but rather consider the result in combination with other diagnostic strategies (including clinical signs, chest x-ray, lateral flow urine lipoarabinomannan assay (LF-LAM), and Xpert MTB/RIF). Research incorporating the test into tuberculosis diagnostic algorithms will help in delineating more precisely its value in diagnosing abdominal tuberculosis or disseminated tuberculosis with abdominal involvement.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Microbiological confirmation is likely to be a reliable method for deciding whether people really have tuberculosis; clinical diagnosis is likely to be less trustworthy. We found problems in both groups with how studies were conducted. Decreasing the number of false positive results may make abdominal ultrasound appear more accurate than it is. Numbers shown are an average across studies. As estimates from individual studies varied, we cannot be sure that abdominal ultrasound will always produce these results. Not enough people have been studied for us to be confident about the results."
}
] |
query-laysum
|
7933
|
[
{
"role": "user",
"content": "Abstract: Background\nInspiratory muscle training (IMT) aims to improve respiratory muscle strength and endurance. Clinical trials used various training protocols, devices and respiratory measurements to check the effectiveness of this intervention. The current guidelines reported a possible advantage of IMT, particularly in people with respiratory muscle weakness. However, it remains unclear to what extent IMT is clinically beneficial, especially when associated with pulmonary rehabilitation (PR).\nObjectives\nTo assess the effect of inspiratory muscle training (IMT) on chronic obstructive pulmonary disease (COPD), as a stand-alone intervention and when combined with pulmonary rehabilitation (PR).\nSearch methods\nWe searched the Cochrane Airways trials register, CENTRAL, MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCO, Physiotherapy Evidence Database (PEDro) ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 20 October 2022. We also checked reference lists of all primary studies and review articles.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared IMT in combination with PR versus PR alone and IMT versus control/sham. We included different types of IMT irrespective of the mode of delivery. We excluded trials that used resistive devices without controlling the breathing pattern or a training load of less than 30% of maximal inspiratory pressure (PImax), or both.\nData collection and analysis\nWe used standard methods recommended by Cochrane including assessment of risk of bias with RoB 2. Our primary outcomes were dyspnea, functional exercise capacity and health-related quality of life.\nMain results\nWe included 55 RCTs in this review. Both IMT and PR protocols varied significantly across the trials, especially in training duration, loads, devices, number/ frequency of sessions and the PR programs. Only eight trials were at low risk of bias.\nPR+IMT versus PR\nWe included 22 trials (1446 participants) in this comparison. Based on a minimal clinically important difference (MCID) of −1 unit, we did not find an improvement in dyspnea assessed with the Borg scale at submaximal exercise capacity (mean difference (MD) 0.19, 95% confidence interval (CI) −0.42 to 0.79; 2 RCTs, 202 participants; moderate-certainty evidence).\nWe also found no improvement in dyspnea assessed with themodified Medical Research Council dyspnea scale (mMRC) according to an MCID between −0.5 and −1 unit (MD −0.12, 95% CI −0.39 to 0.14; 2 RCTs, 204 participants; very low-certainty evidence).\nPooling evidence for the 6-minute walk distance (6MWD) showed an increase of 5.95 meters (95% CI −5.73 to 17.63; 12 RCTs, 1199 participants; very low-certainty evidence) and failed to reach the MCID of 26 meters. In subgroup analysis, we divided the RCTs according to the training duration and mean baseline PImax. The test for subgroup differences was not significant. Trials at low risk of bias (n = 3) demonstrated a larger effect estimate than the overall.\nThe summary effect of the St George's Respiratory Questionnaire (SGRQ) revealed an overall total score below the MCID of 4 units (MD 0.13, 95% CI −0.93 to 1.20; 7 RCTs, 908 participants; low-certainty evidence).\nThe summary effect of COPD Assessment Test (CAT) did not show an improvement in the HRQoL (MD 0.13, 95% CI −0.80 to 1.06; 2 RCTs, 657 participants; very low-certainty evidence), according to an MCID of −1.6 units.\nPooling the RCTs that reported PImax showed an increase of 11.46 cmH2O (95% CI 7.42 to 15.50; 17 RCTs, 1329 participants; moderate-certainty evidence) but failed to reach the MCID of 17.2 cmH2O. In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.\nOne abstract reported some adverse effects that were considered \"minor and self-limited\".\nIMT versus control/sham\nThirty-seven RCTs with 1021 participants contributed to our second comparison. There was a trend towards an improvement when Borg was calculated at submaximal exercise capacity (MD −0.94, 95% CI −1.36 to −0.51; 6 RCTs, 144 participants; very low-certainty evidence). Only one trial was at a low risk of bias.\nEight studies (nine arms) used the Baseline Dyspnea Index - Transition Dyspnea Index (BDI-TDI). Based on an MCID of +1 unit, they showed an improvement only with the 'total score' of the TDI (MD 2.98, 95% CI 2.07 to 3.89; 8 RCTs, 238 participants; very low-certainty evidence). We did not find a difference between studies classified as with and without respiratory muscle weakness. Only one trial was at low risk of bias.\nFour studies reported the mMRC, revealing a possible improvement in dyspnea in the IMT group (MD −0.59, 95% CI −0.76 to −0.43; 4 RCTs, 150 participants; low-certainty evidence). Two trials were at low risk of bias.\nCompared to control/sham, the MD in the 6MWD following IMT was 35.71 (95% CI 25.68 to 45.74; 16 RCTs, 501 participants; moderate-certainty evidence). Two studies were at low risk of bias. In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.\nSix studies reported theSGRQ total score, showing a larger effect in the IMT group (MD −3.85, 95% CI −8.18 to 0.48; 6 RCTs, 182 participants; very low-certainty evidence). The lower limit of the 95% CI exceeded the MCID of −4 units. Only one study was at low risk of bias.\nThere was an improvement in life quality with CAT (MD −2.97, 95% CI −3.85 to −2.10; 2 RCTs, 86 participants; moderate-certainty evidence). One trial was at low risk of bias.\nThirty-two RCTs reported PImax, showing an improvement without reaching the MCID (MD 14.57 cmH2O, 95% CI 9.85 to 19.29; 32 RCTs, 916 participants; low-certainty evidence). In subgroup analysis, we did not find a difference between different training durations and between studies judged with and without respiratory muscle weakness.\nNone of the included RCTs reported adverse events.\nAuthors' conclusions\nIMT may not improve dyspnea, functional exercise capacity and life quality when associated with PR. However, IMT is likely to improve these outcomes when provided alone.\nFor both interventions, a larger effect in participants with respiratory muscle weakness and with longer training durations is still to be confirmed.\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": "The studies used different training durations, resistance, devices, number and frequency of sessions, and physical training programs. This makes it hard to draw firm conclusions. Overall our confidence in the conclusions is reduced because the studies were small, some participants may have been aware of which treatment they were receiving, and generally, there was some diversity in the studies."
}
] |
query-laysum
|
7934
|
[
{
"role": "user",
"content": "Abstract: Background\nCataract surgery is the most common ambulatory incisional surgery performed in the USA. Cystoid macular edema (CME), the accumulation of fluid in the central retina due to leakage from dilated capillaries, is the most common cause of vision impairment following cataract surgery. Acute CME, defined as CME of less than four months' duration, often resolves spontaneously. CME that persists for four months or longer is termed chronic CME. Non-steroidal anti-inflammatory drugs (NSAIDs) have been used to treat CME. This update adds new evidence and analyses to the previously published review.\nObjectives\nTo examine the effectiveness of NSAIDs in the treatment of CME following cataract surgery.\nSearch methods\nWe searched the CENTRAL (2022, Issue 3); Ovid MEDLINE; Embase; PubMed; LILACS; mRCT (discontinued in 2014, last searched August 2011), ClinicalTrials.gov, and WHO ICTRP databases. We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 20 March 2022.\nSelection criteria\nWe included randomized controlled trials evaluating the effects of NSAIDs for CME following cataract surgery.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts, reviewed full-text publications against eligibility criteria, independently extracted data from newly included trials and assessed risk of bias for each included trial. We contacted trial authors for clarification or to request missing information. We provided a narrative synthesis of all included trials and their results. For continuous and dichotomous outcomes, we separately performed pooled analysis and reported mean difference (MD) and risk ratio (RR) as well as the associated 95% confidence interval (CI) whenever feasible. Two review authors independently graded the overall certainty of the evidence for each outcome using the GRADE approach.\nMain results\nWe included nine trials with a total of 390 participants (393 eyes). Study participants' mean age was 72.2 years (interquartile range [IQR] 68.8 to 73.6) and 72% were women (IQR 69% to 74%). Three trials included participants with acute CME, and four included participants with chronic CME; the remaining two trials enrolled both participants with acute and chronic CME or participants with unknown CME duration. We assessed trials as having unclear (33%) or high risk of bias (67%).\nVisual improvement of two or more lines at the end of treatment\nData from one trial in participants with acute CME show no treatment effect of topical ketorolac compared to placebo (RR 2.00, 95% CI 0.46 to 8.76; 22 participants). Data from a three-arm trial in participants with acute CME demonstrate that, when compared with topical prednisolone, topical ketorolac (RR 1.33, 95% CI 0.58 to 3.07; 17 participants) or topical ketorolac and prednisolone combination therapy (RR 1.78, 95% CI 0.86 to 3.69; 17 participants) may have little or no effect on visual improvement. Results of subgroup analysis from two studies in participants with chronic CME suggest that, after treatment for 90 days or longer, NSAIDs may increase participants' likelihood of visual improvement by 1.87 fold (RR 2.87, 95% CI 1.58 to 5.22; I2 = 33%; 2 trials, 121 participants) relative to placebo. However, there was no evidence of treatment effects in the subgroup with two months of treatment or less (RR 0.72, 95% CI 0.30 to 1.73; P = 0.19, I2 = 41%; 2 trials, 34 participants). Overall, this evidence is very low certainty.\nA single-study estimate in patients with mixed CME indicates that topical diclofenac may increase the likelihood of visual improvement by 40% when compared to topical ketorolac (RR 1.40, 95% CI 1.02 to 1.94; 68 participants). However, the same trial reported no difference between the groups in mean final visual acuity in Snellen lines (MD 0.40, 95% CI −0.93 to 1.73). A three-arm trial in patients with mixed CME reporting visual changes in ETDRS letters in comparisons between ketorolac and diclofenac (34 participants) or bromfenac (34 participants) suggests no evidence of effects. Overall, NSAIDs may slightly improve visual acuity in participants with mixed CME but the evidence is very uncertain.\nPersistence of improvement of vision one month after discontinuation of treatment\nOne trial of participants with chronic CME tested oral indomethacin (RR 0.40, 95% CI 0.10 to 1.60; 20 participants) and the other compared topical ketorolac to placebo (RR 4.00, 95% CI 0.51 to 31.1; 26 participants). While there is no evidence of treatment effects, evidence suggests substantial between-group heterogeneity (P = 0.07, I2 = 69.9%; very low-certainty evidence). None of the trials in patients with acute or mixed CME reported this outcome.\nProportion of participants with improvement in leakage on fundus fluorescein angiography\nOne three-arm trial in participants with acute CME shows that, when compared with topical prednisolone, there is no treatment benefit of topical ketorolac (RR 1.11, 95% CI 0.45 to 2.75; 17 participants) or topical ketorolac and topical prednisolone combination therapy (RR 1.56, 95% CI 0.72 to 3.38; 17 participants). This evidence is very low certainty.\nThe combined estimate from two trials in participants with chronic CME indicates NSAIDs have little to no effect over placebo on improving leakage (RR 1.93, 95% CI 0.62 to 6.02; 40 participants; very low-certainty evidence). Neither of the trials in patients with mixed CME reported this outcome.\nProportion of participants with improved contrast sensitivity\nVery low-certainty evidence from one trial in participants with acute CME shows no treatment benefit of ketorolac (RR 1.11, 95% CI 0.45 to 2.75; 17 participants) or ketorolac and prednisolone combination therapy (RR 1.78, 95% CI 0.86 to 3.69; 17 participants) compared with topical prednisolone. None of the trials in patients with chronic or mixed CME reported this outcome.\nProportion of participants with improved central macular thickness on optical coherence tomography; measures of quality of life\nNo included trial reported these outcomes.\nAdverse effects\nMost trials observed no differences in ocular adverse events, such as corneal toxicity or elevated intraocular pressure, between comparison groups.\nAuthors' conclusions\nEvidence on effects of NSAIDs in patients with CME is very uncertain and further investigation is warranted. Our findings are limited by small sample sizes, and heterogeneity in interventions, assessments, and reporting of clinically important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our confidence in the evidence was limited because studies did not include many participants, and they used different medications in different amounts for different durations. The studies did not examine all the outcomes of interest. The findings were also limited by the fact that the trials were published from 1977 to 2006, and many advances in cataract surgery techniques have occurred throughout and since that time."
}
] |
query-laysum
|
7935
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic kidney disease (CKD) is associated with high morbidity and death, which increases as CKD progresses to end-stage kidney disease (ESKD). There has been increasing interest in developing innovative, effective and cost-efficient methods to engage with patient populations and improve health behaviours and outcomes. Worldwide there has been a tremendous increase in the use of technologies, with increasing interest in using eHealth interventions to improve patient access to relevant health information, enhance the quality of healthcare and encourage the adoption of healthy behaviours.\nObjectives\nThis review aims to evaluate the benefits and harms of using eHealth interventions to change health behaviours in people with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 14 January 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs using an eHealth intervention to promote behaviour change in people with CKD were included. There were no restrictions on outcomes, language or publication type.\nData collection and analysis\nTwo authors independently assessed trial eligibility, extracted data and assessed the risk of bias. The certainty of the evidence was assessed using GRADE.\nMain results\nWe included 43 studies with 6617 participants that evaluated the impact of an eHealth intervention in people with CKD. Included studies were heterogeneous in terms of eHealth modalities employed, type of intervention, CKD population studied and outcomes assessed. The majority of studies (39 studies) were conducted in an adult population, with 16 studies (37%) conducted in those on dialysis, 11 studies (26%) in the pre-dialysis population, 15 studies (35%) in transplant recipients and 1 studies (2%) in transplant candidates We identified six different eHealth modalities including: Telehealth; mobile or tablet application; text or email messages; electronic monitors; internet/websites; and video or DVD. Three studies used a combination of eHealth interventions. Interventions were categorised into six types: educational; reminder systems; self-monitoring; behavioural counselling; clinical decision-aid; and mixed intervention types. We identified 98 outcomes, which were categorised into nine domains: blood pressure (9 studies); biochemical parameters (6 studies); clinical end-points (16 studies); dietary intake (3 studies); quality of life (9 studies); medication adherence (10 studies); behaviour (7 studies); physical activity (1 study); and cost-effectiveness (7 studies).\nOnly three outcomes could be meta-analysed as there was substantial heterogeneity with respect to study population and eHealth modalities utilised. There was found to be a reduction in interdialytic weight gain of 0.13kg (4 studies, 335 participants: MD -0.13, 95% CI -0.28 to 0.01; I2 = 0%) and a reduction in dietary sodium intake of 197 mg/day (2 studies, 181 participants: MD -197, 95% CI -540.7 to 146.8; I2 = 0%). Both dietary sodium and fluid management outcomes were graded as being of low evidence due to high or unclear risk of bias and indirectness (interdialytic weight gain) and high or unclear risk of bias and imprecision (dietary sodium intake). Three studies reported death (2799 participants, 146 events), with 45 deaths/1000 cases compared to standard care of 61 deaths/1000 cases (RR 0.74, CI 0.53 to 1.03; P = 0.08). We are uncertain whether using eHealth interventions, in addition to usual care, impact on the number of deaths as the certainty of this evidence was graded as low due to high or unclear risk of bias, indirectness and imprecision.\nAuthors' conclusions\neHealth interventions may improve the management of dietary sodium intake and fluid management. However, overall these data suggest that current evidence for the use of eHealth interventions in the CKD population is of low quality, with uncertain effects due to methodological limitations and heterogeneity of eHealth modalities and intervention types. Our review has highlighted the need for robust, high quality research that reports a core (minimum) data set to enable meaningful evaluation of the literature.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain whether using eHealth interventions improves outcomes for people with CKD. We need large and good quality research studies to help understand the impact of eHealth on the health of people with CKD."
}
] |
query-laysum
|
7936
|
[
{
"role": "user",
"content": "Abstract: Background\nHealthcare workers can suffer from work-related stress as a result of an imbalance of demands, skills and social support at work. This may lead to stress, burnout and psychosomatic problems, and deterioration of service provision. This is an update of a Cochrane Review that was last updated in 2015, which has been split into this review and a review on organisational-level interventions.\nObjectives\nTo evaluate the effectiveness of stress-reduction interventions targeting individual healthcare workers compared to no intervention, wait list, placebo, no stress-reduction intervention or another type of stress-reduction intervention in reducing stress symptoms.\nSearch methods\nWe used the previous version of the review as one source of studies (search date: November 2013). We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL, Web of Science and a trials register from 2013 up to February 2022.\nSelection criteria\nWe included randomised controlled trials (RCT) evaluating the effectiveness of stress interventions directed at healthcare workers. We included only interventions targeted at individual healthcare workers aimed at reducing stress symptoms.\nData collection and analysis\nReview authors independently selected trials for inclusion, assessed risk of bias and extracted data. We used standard methodological procedures expected by Cochrane. We categorised interventions into ones that:\n1. focus one’s attention on the (modification of the) experience of stress (thoughts, feelings, behaviour);\n2. focus one’s attention away from the experience of stress by various means of psychological disengagement (e.g. relaxing, exercise);\n3. alter work-related risk factors on an individual level; and ones that\n4. combine two or more of the above.\nThe crucial outcome measure was stress symptoms measured with various self-reported questionnaires such as the Maslach Burnout Inventory (MBI), measured at short term (up to and including three months after the intervention ended), medium term (> 3 to 12 months after the intervention ended), and long term follow-up (> 12 months after the intervention ended).\nMain results\nThis is the second update of the original Cochrane Review published in 2006, Issue 4. This review update includes 89 new studies, bringing the total number of studies in the current review to 117 with a total of 11,119 participants randomised.\nThe number of participants per study arm was ≥ 50 in 32 studies. The most important risk of bias was the lack of blinding of participants.\nFocus on the experience of stress versus no intervention/wait list/placebo/no stress-reduction intervention\nFifty-two studies studied an intervention in which one's focus is on the experience of stress. Overall, such interventions may result in a reduction in stress symptoms in the short term (standardised mean difference (SMD) -0.37, 95% confidence interval (CI) -0.52 to -0.23; 41 RCTs; 3645 participants; low-certainty evidence) and medium term (SMD -0.43, 95% CI -0.71 to -0.14; 19 RCTs; 1851 participants; low-certainty evidence). The SMD of the short-term result translates back to 4.6 points fewer on the MBI-emotional exhaustion scale (MBI-EE, a scale from 0 to 54). The evidence is very uncertain (one RCT; 68 participants, very low-certainty evidence) about the long-term effect on stress symptoms of focusing one's attention on the experience of stress.\nFocus away from the experience of stress versus no intervention/wait list/placebo/no stress-reduction intervention\nForty-two studies studied an intervention in which one's focus is away from the experience of stress. Overall, such interventions may result in a reduction in stress symptoms in the short term (SMD -0.55, 95 CI -0.70 to -0.40; 35 RCTs; 2366 participants; low-certainty evidence) and medium term (SMD -0.41 95% CI -0.79 to -0.03; 6 RCTs; 427 participants; low-certainty evidence). The SMD on the short term translates back to 6.8 fewer points on the MBI-EE. No studies reported the long-term effect.\nFocus on work-related, individual-level factors versus no intervention/no stress-reduction intervention\nSeven studies studied an intervention in which the focus is on altering work-related factors. The evidence is very uncertain about the short-term effects (no pooled effect estimate; three RCTs; 87 participants; very low-certainty evidence) and medium-term effects and long-term effects (no pooled effect estimate; two RCTs; 152 participants, and one RCT; 161 participants, very low-certainty evidence) of this type of stress management intervention.\nA combination of individual-level interventions versus no intervention/wait list/no stress-reduction intervention\nSeventeen studies studied a combination of interventions. In the short-term, this type of intervention may result in a reduction in stress symptoms (SMD -0.67 95%, CI -0.95 to -0.39; 15 RCTs; 1003 participants; low-certainty evidence). The SMD translates back to 8.2 fewer points on the MBI-EE. On the medium term, a combination of individual-level interventions may result in a reduction in stress symptoms, but the evidence does not exclude no effect (SMD -0.48, 95% CI -0.95 to 0.00; 6 RCTs; 574 participants; low-certainty evidence). The evidence is very uncertain about the long term effects of a combination of interventions on stress symptoms (one RCT, 88 participants; very low-certainty evidence).\nFocus on stress versus other intervention type\nThree studies compared focusing on stress versus focusing away from stress and one study a combination of interventions versus focusing on stress. The evidence is very uncertain about which type of intervention is better or if their effect is similar.\nAuthors' conclusions\nOur review shows that there may be an effect on stress reduction in healthcare workers from individual-level stress interventions, whether they focus one's attention on or away from the experience of stress. This effect may last up to a year after the end of the intervention. A combination of interventions may be beneficial as well, at least in the short term. Long-term effects of individual-level stress management interventions remain unknown. The same applies for interventions on (individual-level) work-related risk factors.\nThe bias assessment of the studies in this review showed the need for methodologically better-designed and executed studies, as nearly all studies suffered from poor reporting of the randomisation procedures, lack of blinding of participants and lack of trial registration. Better-designed trials with larger sample sizes are required to increase the certainty of the evidence. Last, there is a need for more studies on interventions which focus on work-related risk factors.\n\nGiven the provided abstract, please respond to the following query: \"away\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "awayfrom the experience of stress, for example by yoga, Tai Chi, drawing, or acupuncture;\n- alter work-related risk factors on an individual level, such as alterations in work demands."
}
] |
query-laysum
|
7937
|
[
{
"role": "user",
"content": "Abstract: Background\nImprovements in diagnostics and treatment for paediatric malignancies resulted in a major increase in survival. However, childhood cancer survivors (CCS) are at risk of developing adverse effects caused by multimodal treatment for their malignancy. Nephrotoxicity is a known side effect of several treatments, including cisplatin, carboplatin, ifosfamide, radiotherapy and nephrectomy, and can cause glomerular filtration rate (GFR) impairment, proteinuria, tubulopathy, and hypertension. Evidence about the long-term effects of these treatments on renal function remains inconclusive. It is important to know the risk of, and risk factors for, early and late adverse renal effects, so that ultimately treatment and screening protocols can be adjusted. This review is an update of a previously published Cochrane Review.\nObjectives\nTo evaluate existing evidence on the effects of potentially nephrotoxic treatment modalities on the prevalence of renal dysfunction in survivors treated for childhood cancer with a median or mean survival of at least one year after cessation of treatment, where possible in comparison with the general population or CCS treated without potentially nephrotoxic treatment. In addition, to evaluate evidence on associated risk factors, such as follow-up duration, age at time of diagnosis and treatment combinations, as well as the effect of doses.\nSearch methods\nOn 31 March 2017 we searched the following electronic databases: CENTRAL, MEDLINE and Embase. In addition, we screened reference lists of relevant studies and we searched the congress proceedings of the International Society of Pediatric Oncology (SIOP) and The American Society of Pediatric Hematology/Oncology (ASPHO) from 2010 to 2016/2017.\nSelection criteria\nExcept for case reports, case series and studies including fewer than 20 participants, we included studies with all study designs that reported on renal function (one year or longer after cessation of treatment), in CCS treated before the age of 21 years with cisplatin, carboplatin, ifosfamide, radiation involving the kidney region, a nephrectomy, or a combination of two or more of these treatments. When not all treatment modalities were described or the study group of interest was unclear, a study was not eligible for the evaluation of prevalence. We still included it for the assessment of risk factors if it had performed a multivariable analysis.\nData collection and analysis\nTwo review authors independently performed study selection, 'Risk of bias' assessment and data extraction using standardised data collection forms. We performed analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nApart from the remaining 37 studies included from the original review, the search resulted in the inclusion of 24 new studies. In total, we included 61 studies; 46 for prevalence, six for both prevalence and risk factors, and nine not meeting the inclusion criteria, but assessing risk factors. The 52 studies evaluating the prevalence of renal dysfunction included 13,327 participants of interest, of whom at least 4499 underwent renal function testing. The prevalence of adverse renal effects ranged from 0% to 84%. This variation may be due to diversity of included malignancies, received treatments, reported outcome measures, follow-up duration and the methodological quality of available evidence.\nSeven out of 52 studies, including 244 participants, reported the prevalence of chronic kidney disease, which ranged from 2.4% to 32%.\nOf these 52 studies, 36 studied a decreased (estimated) GFR, including at least 432 CCS, and found it was present in 0% to 73.7% of participants. One eligible study reported an increased risk of glomerular dysfunction after concomitant treatment with aminoglycosides and vancomycin in CCS receiving total body irradiation (TBI). Four non-eligible studies assessing a total cohort of CCS, found nephrectomy and (high-dose (HD)) ifosfamide as risk factors for decreased GFR. The majority also reported cisplatin as a risk factor. In addition, two non-eligible studies showed an association of a longer follow-up period with glomerular dysfunction.\nTwenty-two out of 52 studies, including 851 participants, studied proteinuria, which was present in 3.5% to 84% of participants. Risk factors, analysed by three non-eligible studies, included HD cisplatin, (HD) ifosfamide, TBI, and a combination of nephrectomy and abdominal radiotherapy. However, studies were contradictory and incomparable.\nEleven out of 52 studies assessed hypophosphataemia or tubular phosphate reabsorption (TPR), or both. Prevalence ranged between 0% and 36.8% for hypophosphataemia in 287 participants, and from 0% to 62.5% for impaired TPR in 246 participants. One non-eligible study investigated risk factors for hypophosphataemia, but could not find any association.\nFour out of 52 studies, including 128 CCS, assessed the prevalence of hypomagnesaemia, which ranged between 13.2% and 28.6%. Both non-eligible studies investigating risk factors identified cisplatin as a risk factor. Carboplatin, nephrectomy and follow-up time were other reported risk factors.\nThe prevalence of hypertension ranged from 0% to 50% in 2464 participants (30/52 studies). Risk factors reported by one eligible study were older age at screening and abdominal radiotherapy. A non-eligible study also found long follow-up time as risk factor. Three non-eligible studies showed that a higher body mass index increased the risk of hypertension. Treatment-related risk factors were abdominal radiotherapy and TBI, but studies were inconsistent.\nBecause of the profound heterogeneity of the studies, it was not possible to perform meta-analyses. Risk of bias was present in all studies.\nAuthors' conclusions\nThe prevalence of adverse renal effects after treatment with cisplatin, carboplatin, ifosfamide, radiation therapy involving the kidney region, nephrectomy, or any combination of these, ranged from 0% to 84% depending on the study population, received treatment combination, reported outcome measure, follow-up duration and methodological quality. With currently available evidence, it was not possible to draw solid conclusions regarding the prevalence of, and treatment-related risk factors for, specific adverse renal effects. Future studies should focus on adequate study designs and reporting, including large prospective cohort studies with adequate control groups when possible. In addition, these studies should deploy multivariable risk factor analyses to correct for possible confounding. Next to research concerning known nephrotoxic therapies, exploring nephrotoxicity after new therapeutic agents is advised for future studies. Until more evidence becomes available, CCS should preferably be enrolled into long-term follow-up programmes to monitor their renal function and blood pressure.\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 March 2017. We included 61 studies; 46 on prevalence, six for both prevalence and risk factors, and nine studies that did not meet all the requirements for this review, but evaluated risk factors (non-eligible studies). Participants in the studies had been treated before the age of 21 years with chemotherapy (i.e. cisplatin, carboplatin, ifosfamide), radiation, or surgery involving the kidneys, or a combination of these treatments. The studies took place at least one year after the participants had finished their treatment. The 52 studies that evaluated prevalence of adverse kidney effects included 13,327 participants, of whom 4499 underwent kidney function tests. The studies were very different from each other, in the types of participants and treatments, length of follow-up and how they measured treatment results, and their methods were of variable quality."
}
] |
query-laysum
|
7938
|
[
{
"role": "user",
"content": "Abstract: Background\nPreterm birth remains the major risk factor for the development of intraventricular haemorrhage, an injury that occurs in 25% of very low birth weight infants. Intraventricular haemorrhage is thought to be venous in origin and intrinsic thromboses in the germinal matrix are likely to play a triggering role. Heparin activates antithrombin and promotes the inactivation of thrombin and other target proteinases. The administration of anticoagulants such as heparin may offset the increased risk of developing intraventricular haemorrhage and may also reduce the risk of developing parenchymal venous infarct, a condition known to complicate intraventricular haemorrhage.\nObjectives\nTo assess whether the prophylactic administration of heparin reduces the incidence of germinal matrix-intraventricular haemorrhage in very preterm neonates when compared to placebo, no treatment, or other anticoagulants.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015), MEDLINE (1996 to 22 November 2015), EMBASE (1980 to 22 November 2015) and CINAHL (1982 to 22 November 2015), applying no language restrictions. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015.\nSelection criteria\nRandomised controlled trials, quasi-randomised controlled trials and cluster trials comparing the administration of early, i.e. within the first 24 hours of life, heparin in very preterm infants (gestational age < 32 weeks).\nData collection and analysis\nFor each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, dose of heparin, mode of administration, and duration of therapy, etc.) and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow up). The primary outcomes considered in this review are intraventricular haemorrhage, severe intraventricular haemorrhage and neonatal mortality.\nMain results\nTwo randomised controlled trials enrolling a total of 155 infants met the inclusion criteria of this review. Both trials compared low-dose heparin to the same solution without heparin in very preterm newborns requiring umbilical catheterisation. No trials were identified that specifically studied the use of heparin in infants at risk of germinal matrix-intraventricular haemorrhage.\nWe found no differences in the rates of intraventricular haemorrhage (typical RR 0.93, 95% CI 0.61 to 1.41; typical RD −0.03, 95% CI −0.17 to 0.12; 2 studies, 155 infants; I² = 57% for RR and I² = 65% for RD), severe intraventricular haemorrhage (typical RR 1.01, 95% CI 0.46 to 2.23; typical RD 0.00, 95% CI −0.11 to 0.11; 2 studies, 155 infants; I² = 0% for RR and I² = 0% for RD) and neonatal mortality (typical RR 0.69, 95% CI 0.28 to 1.67; typical RD −0.04, 95% CI −0.14 to 0.06; 2 studies, 155 infants; I² = 28% for RR and I² = 50% for RD). We judged the quality of the evidence supporting these findings as very low (rates of intraventricular haemorrhage) and low (severe intraventricular haemorrhage and neonatal mortality) mainly because of limitations in the study designs and the imprecision of estimates. We found very few data on other relevant outcomes, such as bronchopulmonary dysplasia, pulmonary haemorrhage and patent ductus arteriosus; and no study assessing long-term outcomes (e.g. neurodevelopmental disability).\nAuthors' conclusions\nThere is very limited data on the effect of prophylactic administration of heparin on the incidence and severity of IVH in very preterm neonates. Both the identified trials used heparin in the context of maintaining umbilical line patency and not specifically as an agent to prevent germinal matrix-intraventricular haemorrhage. Given the imprecision of our estimates, the results of this systematic review are consistent with either a benefit or a detrimental effect of heparin and do not provide a definitive answer to the review question. Limited evidence is available on other clinically relevant outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The use of heparin does not reduce the risks of bleeding in the brain, mortality or any other relevant outcomes in very preterm neonates when compared to solution without heparin."
}
] |
query-laysum
|
7939
|
[
{
"role": "user",
"content": "Abstract: Background\nCardiovascular disease (CVD) is the leading cause of death worldwide. Lifestyle changes are at the forefront of preventing the disease. This includes advice such as increasing physical activity and having a healthy balanced diet to reduce risk factors. Intermittent fasting (IF) is a popular dietary plan involving restricting caloric intake to certain days in the week such as alternate day fasting and periodic fasting, and restricting intake to a number of hours in a given day, otherwise known as time-restricted feeding. IF is being researched for its benefits and many randomised controlled trials have looked at its benefits in preventing CVD.\nObjectives\nTo determine the role of IF in preventing and reducing the risk of CVD in people with or without prior documented CVD.\nSearch methods\nWe conducted our search on 12 December 2019; we searched CENTRAL, MEDLINE and Embase. We also searched three trials registers and searched the reference lists of included papers. Systematic reviews were also viewed for additional studies. There was no language restriction applied.\nSelection criteria\nWe included randomised controlled trials comparing IF to ad libitum feeding (eating at any time with no specific caloric restriction) or continuous energy restriction (CER). Participants had to be over the age of 18 and included those with and without cardiometabolic risk factors. Intermittent fasting was categorised into alternate-day fasting, modified alternate-day fasting, periodic fasting and time-restricted feeding.\nData collection and analysis\nFive review authors independently selected studies for inclusion and extraction. Primary outcomes included all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, and heart failure. Secondary outcomes include the absolute change in body weight, and glucose. Furthermore, side effects such as headaches and changes to the quality of life were also noted. For continuous data, pooled mean differences (MD) (with 95% confidence intervals (CIs)) were calculated. We contacted trial authors to obtain missing data. We used GRADE to assess the certainty of the evidence.\nMain results\nOur search yielded 39,165 records after the removal of duplicates. From this, 26 studies met our criteria, and 18 were included in the pooled analysis. The 18 studies included 1125 participants and observed outcomes ranging from four weeks to six months. Of quantitatively analysed data, seven studies compared IF with ab libitum feeding, eight studies compared IF with CER, and three studies compared IF with both ad libitum feeding and CER. Outcomes were reported at short term (≤ 3 months) and medium term (> 3 months to 12 months) follow-up.\nNone of the included studies reported on all-cause mortality, cardiovascular mortality, stroke, myocardial infarction or heart failure.\nBody weight was reduced with IF compared to ad libitum feeding in the short term (MD -2.88 kg, 95% CI -3.96 to -1.80; 224 participants; 7 studies; low-certainty evidence). We are uncertain of the effect of IF when compared to CER in the short term (MD -0.88 kg, 95% CI -1.76 to 0.00; 719 participants; 10 studies; very low-certainty evidence) and there may be no effect in the medium term (MD -0.56 kg, 95% CI -1.68 to 0.56; 279 participants; 4 studies; low-certainty evidence).\nWe are uncertain about the effect of IF on glucose when compared to ad libitum feeding in the short term (MD -0.03 mmol/L, 95% CI -0.26 to 0.19; 95 participants; 3 studies; very-low-certainty of evidence) and when compared to CER in the short term: MD -0.02 mmol/L, 95% CI -0.16 to 0.12; 582 participants; 9 studies; very low-certainty; medium term: MD 0.01, 95% CI -0.10 to 0.11; 279 participants; 4 studies; low-certainty evidence).\nThe changes in body weight and glucose were not deemed to be clinically significant.\nFour studies reported data on side effects, with some participants complaining of mild headaches. One study reported on the quality of life using the RAND SF-36 score. There was a modest increase in the physical component summary score.\nAuthors' conclusions\nWe are uncertain about the effects of intermittent fasting on clinical events such as mortality, myocardial infarction and heart failure due to lack of data for these outcomes. The individual meta-analyses show that intermittent fasting may be effective in reducing weight when compared to ad libitum feeding and may be as effective as continuous energy restriction. Despite this, these changes appear to be clinically insignificant at short-term follow-up. The quality of the available evidence is low to very low which means that many areas of uncertainty remain. Further research is needed to understand which patient groups would and would not benefit from intermittent fasting (e.g. patients with diabetes or eating disorders) as well as the effect on longer-term outcomes such as all-cause mortality and myocardial infarction.\n\nGiven the provided abstract, please respond to the following query: \"Why we did this Cochrane Review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diets that involve intermittent fasting are becoming popular. We wanted to find out if intermittent fasting could reduce or prevent CVD."
}
] |
query-laysum
|
7940
|
[
{
"role": "user",
"content": "Abstract: Background\nParaproteinaemic neuropathy refers to those neuropathies associated with a monoclonal gammopathy or paraprotein. The most common of these present with a chronic, predominantly sensory, symmetrical neuropathy, similar to chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) but with relatively more sensory involvement, both clinically and neurophysiologically. The optimal treatment for neuropathies associated with IgG and IgA monoclonal gammopathy of uncertain significance is not known. This is an update of a review first published in 2007.\nObjectives\nTo assess the effects of any treatment for IgG or IgA paraproteinaemic peripheral neuropathy.\nSearch methods\nOn 18 January 2014 we searched the Cochrane Neuromuscular Disease Group Trials Specialized Register, CENTRAL, MEDLINE and EMBASE. We also checked bibliographies for controlled trials of treatments for IgG or IgA paraproteinaemic peripheral neuropathy. We checked clinical trials registries for ongoing studies in November 2014.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) and quasi-RCTs using any treatment for IgG or IgA paraproteinaemic peripheral neuropathy. We excluded people with IgM paraproteins. We excluded people where the monoclonal gammopathy was considered secondary to an underlying disorder. We included participants of any age with a diagnosis of monoclonal gammopathy of uncertain significance with a paraprotein of the IgG or IgA class and a neuropathy. Included participants were not required to fulfil specific electrophysiological diagnostic criteria.\nData collection and analysis\nWe used standard Cochrane methodology to select studies, extract data and analyse results. One trial author provided additional data and clarification.\nMain results\nWe identified one RCT, with 18 participants, that fulfilled the predetermined inclusion criteria. The trial compared plasma exchange to sham plasma exchange in participants with IgG or IgA paraproteinaemic neuropathy over a three-week follow-up period. We identified four other studies but these were not RCTs or quasi-RCTs. The included RCT did not report our predefined primary outcome measure, change in disability six months after randomisation. The trial revealed a modest benefit of plasma exchange in the weakness component of the Neuropathy Disability Score (NDS, now the Neuropathy Impairment Score); the mean improvement with plasma exchange was 17 points (95% confidence interval (CI) 5.2 to 28.8 points) versus 1 point (95% CI -7.7 to 9.7 points) in the sham exchange group at three weeks' follow-up (mean difference (MD) 16.00; 95% CI 1.37 to 30.63, low quality evidence). There was no statistically significant difference in the overall NDS (MD 18.00; 95% CI -2.03 to 38.03, low quality evidence), vibration thresholds or neurophysiological indices. Adverse events were not reported. The trial was at low risk of bias overall, although limitations of trial size and duration reduce the quality of the evidence in support of its conclusions.\nAuthors' conclusions\nThe evidence from RCTs for the treatment of IgG or IgA paraproteinaemic neuropathy is currently inadequate. More RCTs of treatments are required. These should have adequate follow-up periods and contain larger numbers of participants, perhaps through multicentre collaboration, considering the relative infrequency of this condition. Observational or open trial data provide limited support for the use of treatments such as plasma exchange, cyclophosphamide combined with prednisolone, intravenous immunoglobulin, and corticosteroids. These interventions show potential therapeutic promise but the potential benefits must be weighed against adverse effects. Their optimal use and the long-term benefits need to be considered and validated with well-designed RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The trial did not report our primary outcome measure, which was improvement in disability measured by a validated scale six months after randomisation, or our other specified outcomes at six months. The trial demonstrated a modest benefit in improvement of weakness and overall disability as measured by the neuropathy disability score (NDS) over a period of three weeks. There was no improvement in this timescale in measures of sensory disturbance or electrical studies of the nerves. Adverse events were not reported. Further RCTs of this and other treatments with larger numbers of participants are needed.\nThis is an update of a review first published in 2007. We found no additional trials for inclusion. The evidence is current to January 2014."
}
] |
query-laysum
|
7941
|
[
{
"role": "user",
"content": "Abstract: Background\nThe removal of the acute appendix is one of the most frequently performed surgical procedures. Open surgery associated with therapeutic efficacy has been the treatment of choice for acute appendicitis. However, in consequence of the evolution of endoscopic surgery, the operation can also be performed with minimally invasive surgery. Due to smaller incisions, the laparoscopic approach may be associated with reduced postoperative pain, reduced wound infection rate, and shorter time until return to normal activity.\nThis is an update of the review published in 2010.\nObjectives\nTo compare the effects of laparoscopic appendectomy (LA) and open appendectomy (OA) with regard to benefits and harms.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE and Embase (9 February 2018). We identified proposed and ongoing studies from World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and EU Clinical Trials Register (9 February 2018). We handsearched reference lists of identified studies and the congress proceedings of endoscopic surgical societies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing LA versus OA in adults or children.\nData collection and analysis\nTwo review authors independently selected studies, assessed the risk of bias, and extracted data. We performed the meta-analyses using Review Manager 5. We calculated the Peto odds ratio (OR) for very rare outcomes, and the mean difference (MD) for continuous outcomes (or standardised mean differences (SMD) if researchers used different scales such as quality of life) with 95% confidence intervals (CI). We used GRADE to rate the quality of the evidence.\nMain results\nWe identified 85 studies involving 9765 participants. Seventy-five trials included 8520 adults and 10 trials included 1245 children. Most studies had risk of bias issues, with attrition bias being the largest source across studies due to incomplete outcome data.\nIn adults, pain intensity on day one was reduced by 0.75 cm on a 10 cm VAS after LA (MD -0.75, 95% CI -1.04 to -0.45; 20 RCTs; 2421 participants; low-quality evidence). Wound infections were less likely after LA (Peto OR 0.42, 95% CI 0.35 to 0.51; 63 RCTs; 7612 participants; moderate-quality evidence), but the incidence of intra-abdominal abscesses was increased following LA (Peto OR 1.65, 95% CI 1.12 to 2.43; 53 RCTs; 6677 participants; moderate-quality evidence).\nThe length of hospital stay was shortened by one day after LA (MD -0.96, 95% CI -1.23 to -0.70; 46 RCTs; 5127 participant; low-quality evidence). The time until return to normal activity occurred five days earlier after LA than after OA (MD -4.97, 95% CI -6.77 to -3.16; 17 RCTs; 1653 participants; low-quality evidence). Two studies showed better quality of life scores following LA, but used different scales, and therefore no pooled estimates were presented. One used the SF-36 questionnaire two weeks after surgery and the other used the Gastro-intestinal Quality of Life Index six weeks and six months after surgery (both low-quality evidence).\nIn children, we found no differences in pain intensity on day one (MD -0.80, 95% CI -1.65 to 0.05; 1 RCT; 61 participants; low-quality evidence), intra-abdominal abscesses after LA (Peto OR 0.54, 95% CI 0.24 to 1.22; 9 RCTs; 1185 participants; low-quality evidence) or time until return to normal activity (MD -0.50, 95% CI -1.30 to 0.30; 1 RCT; 383 participants; moderate-quality evidence). However, wound infections were less likely after LA (Peto OR 0.25, 95% CI 0.15 to 0.42; 10 RCTs; 1245 participants; moderate-quality evidence) and the length of hospital stay was shortened by 0.8 days after LA (MD -0.81, 95% CI -1.01 to -0.62; 6 RCTs; 316 participants; low-quality evidence). Quality of life was not reported in any of the included studies.\nAuthors' conclusions\nExcept for a higher rate of intra-abdominal abscesses after LA in adults, LA showed advantages over OA in pain intensity on day one, wound infections, length of hospital stay and time until return to normal activity in adults. In contrast, LA showed advantages over OA in wound infections and length of hospital stay in children. Two studies reported better quality of life scores in adults. No study reported this outcome in children. However, the quality of evidence ranged from very low to moderate and some of the clinical effects of LA were small and of limited clinical relevance. Future studies with low risk of bias should investigate, in particular, the quality of life in children.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence varied from moderate to low because of poorly conducted studies."
}
] |
query-laysum
|
7942
|
[
{
"role": "user",
"content": "Abstract: Background\nOvarian cancer has the highest mortality rate of all gynaecological malignancies with an overall five-year survival rate of 30% to 40%. In the past two decades it has become apparent and more commonly accepted that a majority of ovarian cancers originate in the fallopian tube epithelium and not from the ovary itself. This paradigm shift introduced new possibilities for ovarian cancer prevention. Salpingectomy during a hysterectomy for benign gynaecological indications (also known as opportunistic salpingectomy) might reduce the overall incidence of ovarian cancer. Aside from efficacy, safety is of utmost importance, especially due to the preventive nature of opportunistic salpingectomy. Most important are safety in the form of surgical adverse events and postoperative hormonal status. Therefore, we compared the benefits and risks of hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy.\nObjectives\nTo assess the effect and safety of hysterectomy with opportunistic salpingectomy versus hysterectomy without salpingectomy for ovarian cancer prevention in women undergoing hysterectomy for benign gynaecological indications; outcomes of interest include the incidence of epithelial ovarian cancer, surgery-related adverse events and postoperative ovarian reserve.\nSearch methods\nThe Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two clinical trial registers were searched in January 2019 together with reference checking and contact with study authors.\nSelection criteria\nWe intended to include both randomised controlled trials (RCTs) and non-RCTs that compared ovarian cancer incidence after hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For assessment of surgical and hormonal safety, we included RCTs that compared hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were ovarian cancer incidence, intraoperative and short-term postoperative complication rate and postoperative hormonal status. Secondary outcomes were total surgical time, estimated blood loss, conversion rate to open surgery (applicable only to laparoscopic and vaginal approaches), duration of hospital admission, menopause-related symptoms and quality of life.\nMain results\nWe included seven RCTs (350 women analysed). The evidence was of very low to low quality: the main limitations being a low number of included women and surgery-related adverse events, substantial loss to follow-up and a large variety in outcome measures and timing of measurements.\nNo studies reported ovarian cancer incidence after hysterectomy with opportunistic salpingectomy compared to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For surgery-related adverse events, there were insufficient data to assess whether there was any difference in both intraoperative (odds ratio (OR) 0.66, 95% confidence interval (CI) 0.11 to 3.94; 5 studies, 286 participants; very low-quality evidence) and short-term postoperative (OR 0.13, 95% CI 0.01 to 2.14; 3 studies, 152 participants; very low-quality evidence) complication rates between hysterectomy with opportunistic salpingectomy and hysterectomy without opportunistic salpingectomy because the number of surgery-related adverse events was very low. For postoperative hormonal status, the results were compatible with no difference, or with a reduction in anti-Müllerian hormone (AMH) that would not be clinically relevant (mean difference (MD) -0.94, 95% CI -1.89 to 0.01; I2 = 0%; 5 studies, 283 participants; low-quality evidence). A reduction in AMH would be unfavourable, but due to wide CIs, the postoperative change in AMH can still vary from a substantial decrease to even a slight increase.\nAuthors' conclusions\nThere were no eligible studies reporting on one of our primary outcomes - the incidence of ovarian cancer specifically after hysterectomy with or without opportunistic salpingectomy. In our meta-analyses we found insufficient data to assess whether there was any difference in surgical adverse events, with a very low number of events in women undergoing hysterectomy with and without opportunistic salpingectomy. For postoperative hormonal status we found no evidence of a difference between the groups. The maximum difference in time to menopause, calculated from the lower limit of the 95% CI and the natural average AMH decline, would be approximately 20 months, which we consider to be not clinically relevant. However, the results should be interpreted with caution and even more so in very young women for whom a difference in postoperative hormonal status is potentially more clinically relevant. Therefore, there is a need for research on the long-term effects of opportunistic salpingectomy during hysterectomy, particularly in younger women, as results are currently limited to six months postoperatively. This limit is especially important as AMH, the most frequently used marker for ovarian reserve, recovers over the course of several months following an initial sharp decline after surgery. In light of the available evidence, addition of opportunistic salpingectomy should be discussed with each woman undergoing a hysterectomy for benign indication, with provision of a clear overview of benefits and risks.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was of very low to low quality. The main limitations in the evidence were a low number of complications, meaning no comparison could be made, and differences in outcome measures of the included studies. Also, the total numbers of included studies and included women were low."
}
] |
query-laysum
|
7943
|
[
{
"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-directed 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 −1.57 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: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One trial met our inclusion criteria. This trial looked at the benefit of the addition of catheter-directed thrombolysis to anticoagulation with heparin in 59 people with intermediate-risk APE. The trial showed no clear differences between catheter-directed thrombolysis plus anticoagulation versus anticoagulation alone in deaths, major and minor bleeding, recurrent APE and length of hospital stay. Quality of life was not assessed."
}
] |
query-laysum
|
7944
|
[
{
"role": "user",
"content": "Abstract: Background\nReducing saturated fat reduces serum cholesterol, but effects on other intermediate outcomes may be less clear. Additionally, it is unclear whether the energy from saturated fats eliminated from the diet are more helpfully replaced by polyunsaturated fats, monounsaturated fats, carbohydrate or protein.\nObjectives\nTo assess the effect of reducing saturated fat intake and replacing it with carbohydrate (CHO), polyunsaturated (PUFA), monounsaturated fat (MUFA) and/or protein on mortality and cardiovascular morbidity, using all available randomised clinical trials.\nSearch methods\nWe updated our searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and Embase (Ovid) on 15 October 2019, and searched Clinicaltrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) on 17 October 2019.\nSelection criteria\nIncluded trials fulfilled the following criteria: 1) randomised; 2) intention to reduce saturated fat intake OR intention to alter dietary fats and achieving a reduction in saturated fat; 3) compared with higher saturated fat intake or usual diet; 4) not multifactorial; 5) in adult humans with or without cardiovascular disease (but not acutely ill, pregnant or breastfeeding); 6) intervention duration at least 24 months; 7) mortality or cardiovascular morbidity data available.\nData collection and analysis\nTwo review authors independently assessed inclusion, extracted study data and assessed risk of bias. We performed random-effects meta-analyses, meta-regression, subgrouping, sensitivity analyses, funnel plots and GRADE assessment.\nMain results\nWe included 15 randomised controlled trials (RCTs) (16 comparisons, 56,675 participants), that used a variety of interventions from providing all food to advice on reducing saturated fat. The included long-term trials suggested that reducing dietary saturated fat reduced the risk of combined cardiovascular events by 17% (risk ratio (RR) 0.83; 95% confidence interval (CI) 0.70 to 0.98, 12 trials, 53,758 participants of whom 8% had a cardiovascular event, I² = 67%, GRADE moderate-quality evidence). Meta-regression suggested that greater reductions in saturated fat (reflected in greater reductions in serum cholesterol) resulted in greater reductions in risk of CVD events, explaining most heterogeneity between trials. The number needed to treat for an additional beneficial outcome (NNTB) was 56 in primary prevention trials, so 56 people need to reduce their saturated fat intake for ~four years for one person to avoid experiencing a CVD event. In secondary prevention trials, the NNTB was 53. Subgrouping did not suggest significant differences between replacement of saturated fat calories with polyunsaturated fat or carbohydrate, and data on replacement with monounsaturated fat and protein was very limited.\nWe found little or no effect of reducing saturated fat on all-cause mortality (RR 0.96; 95% CI 0.90 to 1.03; 11 trials, 55,858 participants) or cardiovascular mortality (RR 0.95; 95% CI 0.80 to 1.12, 10 trials, 53,421 participants), both with GRADE moderate-quality evidence.\nThere was little or no effect of reducing saturated fats on non-fatal myocardial infarction (RR 0.97, 95% CI 0.87 to 1.07) or CHD mortality (RR 0.97, 95% CI 0.82 to 1.16, both low-quality evidence), but effects on total (fatal or non-fatal) myocardial infarction, stroke and CHD events (fatal or non-fatal) were all unclear as the evidence was of very low quality. There was little or no effect on cancer mortality, cancer diagnoses, diabetes diagnosis, HDL cholesterol, serum triglycerides or blood pressure, and small reductions in weight, serum total cholesterol, LDL cholesterol and BMI. There was no evidence of harmful effects of reducing saturated fat intakes.\nAuthors' conclusions\nThe findings of this updated review suggest that reducing saturated fat intake for at least two years causes a potentially important reduction in combined cardiovascular events. Replacing the energy from saturated fat with polyunsaturated fat or carbohydrate appear to be useful strategies, while effects of replacement with monounsaturated fat are unclear. The reduction in combined cardiovascular events resulting from reducing saturated fat did not alter by study duration, sex or baseline level of cardiovascular risk, but greater reduction in saturated fat caused greater reductions in cardiovascular events.\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": "Health guidance suggests that reducing the amount of saturated fat we eat, by cutting down on animal fats, is good for our health. We wanted to combine all available evidence to see whether following this advice leads to a reduced risk of dying or getting cardiovascular disease (heart disease or stroke)."
}
] |
query-laysum
|
7945
|
[
{
"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 remains 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 alone 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 usual care and an alpha-blocker versus usual care alone. Only four studies were placebo controlled. The mean age of participants was 28.6 to 56.8 years and the mean stone size prior to SWL was 7.1 mm to 13.2 mm. The most widely used alpha-blocker was tamsulosin; others were 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; I² = 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 0.45 to 1.00; I² = 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 32 fewer (53 fewer to 0 fewer) participants per 1000 undergoing auxiliary treatments.\nAlpha-blockers may reduce major adverse events (RR 0.60, 95% CI 0.46 to 0.80; I² = 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 time in days (mean difference (MD) –3.74, 95% CI –5.25 to –2.23; I² = 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 result in improved stone clearance, less need for auxiliary treatments, fewer major adverse events and a reduced 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: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain about these results because they were based on studies in which it was unclear how people were chosen to take part; it was unclear if results were reported fully; some results were inconsistent and in some studies the results varied widely. Our results are likely to change if further evidence becomes available."
}
] |
query-laysum
|
7946
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is a common acute infection in children. Pain is its most prominent and distressing symptom. Antibiotics are commonly prescribed for AOM, although they have only a modest effect in reducing pain at two to three days. There is insufficient evidence for benefits of other treatment options, including systemic corticosteroids. However, systemic corticosteroids are potent anti-inflammatory drugs, and so theoretically could be effective, either alone or as an addition to antibiotics.\nObjectives\nTo assess the effects of systemic corticosteroids (oral or parenteral), with or without antibiotics, for AOM in children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) which contains the Cochrane ARI Group's Specialised Register, MEDLINE (Ovid), Embase (Elsevier), CINAHL (EBSCO), Web of Science (Thomson Reuters), and LILACS (BIREME) for published studies, and ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for completed and ongoing studies, to 20 February 2018. We checked the reference lists of all primary studies and review articles for additional references and contacted experts in the field to identify additional unpublished materials.\nSelection criteria\nWe included randomised controlled trials of children with AOM that compared any systemic corticosteroid (oral or parenteral) with placebo, either with antibiotics (corticosteroid plus antibiotic versus placebo plus antibiotic) or without antibiotics (corticosteroid versus placebo).\nData collection and analysis\nThree review authors (EDS, RR, YP) independently screened the titles and abstracts and retrieved the full texts of potentially relevant studies. We independently extracted study characteristics and outcome data from the included studies, and assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed study quality using the GRADE method.\nMain results\nWe included two studies involving 252 children with AOM aged from three months to six years receiving hospital ambulatory care who were treated with intramuscular ceftriaxone, and who were then randomised to the corticosteroid group (corticosteroid and corticosteroid plus antihistamine) or the placebo group (antihistamine and double placebo). In one study, children also had a needle aspiration of middle ear fluid. Both studies were at unclear risk of bias for allocation concealment, and unclear to high risk of bias for selective reporting.\nOne study (N = 179) included pain as an outcome, but we were unable to derive the proportion of children with persistent pain at Day 5 and Day 14. Reduction of overall or specific symptoms was presented as improvement in clinical symptoms and resolution of inflamed tympanic membranes without the need for additional antibiotic treatment: at Day 5 (94% of children in the treatment group (N = 89) versus 89% in the placebo group (N = 90); risk ratio (RR) 1.06, 95% confidence interval (CI) 0.97 to 1.16) and Day 14 (91% versus 87%; RR 1.05, 95% CI 0.95 to 1.17). Low-quality evidence meant that we are uncertain of the effectiveness of corticosteroids for this outcome.\nThe second study (N = 73) reported a reduction of overall or specific symptoms without additional antibiotic treatment during the first two weeks as a favourable outcome. Children in the treatment group had more favourable outcomes (adjusted odds ratio 65.9, 95% CI 1.28 to 1000; P = 0.037), although the numbers were small. We were unable to pool the results with the other study because it did not report the proportion of children with this outcome by treatment group. Only one study reported adverse effects of corticosteroids (e.g. drowsiness, nappy rash), but did not quantify incidence, so we were unable to draw conclusions about adverse effects. Neither study reported a reduction in overall or specific symptom duration.\nAuthors' conclusions\nThe evidence for the effect of systemic corticosteroids on AOM is of low to very low quality, meaning the effect of systemic corticosteroids on important clinical outcomes in AOM remains uncertain. Large, high-quality studies are required to resolve the question.\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": "Acute otitis media is common in children and causes ear pain and non-specific symptoms such as fever, irritability, and deafness. It is often treated with antibiotics, although ear pain generally resolves within two days, and antibiotics help symptoms only slightly. Other treatments (such as over-the-counter antihistamines and decongestants) do not help very much.\nCorticosteroids are often prescribed to reduce inflammation in children for other illnesses, and so may also help symptoms of AOM, which is an inflammatory process. We investigated whether using corticosteroids was better or worse than nothing in improving AOM-related symptoms."
}
] |
query-laysum
|
7947
|
[
{
"role": "user",
"content": "Abstract: Background\nCurrent recommendations for people with irritable bowel syndrome (IBS) to partake in physical activity are based on low-level evidence, do not incorporate evidence from all available randomised controlled trials (RCTs) and provide little information regarding potential adverse effects.\nObjectives\nTo assess the benefits and harms of physical activity interventions in adults diagnosed with irritable bowel syndrome and to explore possible effect moderators including type, setting and nature of physical activity interventions.\nSearch methods\nWe searched nine electronic databases including CENTRAL, MEDLINE and Embase to 5 November 2021. We handsearched reference lists and sought unpublished studies through trial registries.\nSelection criteria\nWe included RCTs involving adults (aged 18 years or older) diagnosed with IBS and conducted in any setting comparing a physical activity intervention with no intervention, usual care or wait-list control group or another physical activity intervention group and assessing a validated measure of symptoms, quality of life or bowel movement.\nData collection and analysis\nAt least two review authors independently selected studies for inclusion, extracted study data, and performed risk of bias and GRADE assessments to assess the certainty of evidence. We pooled studies that evaluated similar outcomes using a random-effects meta-analysis, and synthesised data from other studies narratively.\nMain results\nWe included 11 RCTs with data for 622 participants. Most (10/11) were set in high- or middle- to high-income countries, with five involving supervised physical activity, three unsupervised activity and three a mix of supervised and unsupervised activity. No trial was at low risk of bias. Four trials specified a minimally important difference for at least one assessed outcome measure. Data for 10 trials were obtained from published journal articles, with data for one obtained from an unpublished Masters degree thesis.\nIrritable bowel syndrome symptoms\nSix RCTs assessed the effectiveness of a physical activity intervention compared with usual care on global symptoms of IBS. Meta-analysis of five studies showed an observed improvement in reported symptoms following physical activity (standardised mean difference (SMD) –0.93, 95% confidence interval (CI) –1.44 to –0.42; 185 participants). We rated the certainty of evidence for this outcome as very low due to unclear and high risk of bias, inconsistency and imprecision from sparse data. This means physical activity may improve IBS symptoms but the evidence is very uncertain. The results of the remaining study supported the meta-analysis but were at unclear risk of bias and sample size was small.\nTwo studies assessed the effectiveness of a yoga intervention compared with a walking intervention on global IBS symptoms. Meta-analysis of these two studies found no conclusive evidence of an effect of yoga compared with walking on IBS symptoms (SMD –1.16, 95% CI –3.93 to 1.62; 124 participants). We rated the certainty of evidence as very low, meaning the evidence is very uncertain about the effect of yoga interventions compared with walking interventions on IBS symptoms.\nTwo studies assessed the effectiveness of a physical activity intervention (yoga) compared with medication. One reported no observed difference in global IBS symptoms, though CIs were wide, suggesting uncertainty in the observed estimates and risk of bias was high (MD –1.20, 95% CI –2.65 to 0.25; 21 participants). We excluded IBS symptom data for the remaining study as it used a non-validated method.\nOne study compared a yoga intervention with a dietary intervention and reported an observed improvement in symptoms with both interventions but neither intervention was superior to the other.\nQuality of life\nFive RCTs assessed the impact of physical activity on self-reported quality of life compared with usual care. Meta-analysis of data from four studies found no improvement in quality of life following a physical activity intervention (SMD 1.17, 95% CI –0.30 to 2.64; 134 participants; very low certainty due to risk of bias, inconsistency and imprecision). We rated the certainty of evidence as very low, meaning the evidence is very uncertain about the effect of physical activity interventions on quality-of-life outcomes in people with IBS.\nOne study assessed the impact on quality of life of a yoga intervention compared with walking and observed an improvement in the yoga group (MD 53.45, 95% CI 38.85 to 68.05; 97 participants ).\nOne study reported no observed difference in quality of life between a yoga and a dietary intervention.\nAbdominal pain\nTwo trials assessed the impact of physical activity compared with usual care on reported abdominal pain. Meta-analysis found no improvement in abdominal pain with physical activity compared with usual care (SMD 0.01, 95% CI –0.48 to 0.50; 64 participants). We rated the certainty of the evidence as very low due to risk of bias and imprecision, meaning the evidence is very uncertain about the effect of physical activity interventions on abdominal pain in people with IBS.\nOne study assessing the impact of a yoga intervention compared with walking advice reported no observed differences between groups on abdominal pain.\nOne study comparing a yoga intervention with a dietary intervention found neither intervention had a more beneficial impact than the other and both interventions did not conclusively reduce abdominal pain.\nThere was insufficient evidence to adequately assess adverse effects associated with physical activity due to a lack of reporting in trials. One study reported a musculoskeletal injury in a yoga intervention group but this did not result in withdrawal from the study.\nAuthors' conclusions\nFindings from a small body of evidence suggest that physical activity comprising of yoga, treadmill exercise or support to increase physical activity may improve symptoms but not quality of life or abdominal pain in people diagnosed with IBS but we have little confidence in these conclusions due to the very low certainty of evidence.\nThe numbers of reported adverse events were low and the certainty of these findings was very low for all comparisons, so no conclusions can be drawn.\nDiscussions with patients considering physical activity as part of symptom management should address the uncertainty in the evidence to ensure fully informed decisions. If deemed sufficiently important to patients and healthcare providers, higher quality research is needed to enable more certain conclusions.\n\nGiven the provided abstract, please respond to the following query: \"What is irritable bowel syndrome\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Irritable bowel syndrome is a common bowel disorder characterised by symptoms that include episodes of abdominal pain, bloating and changes in bowel habit. About 10% to 20% of adults in Western countries are diagnosed with irritable bowel syndrome. The management of irritable bowel syndrome follows no clear pathway and involves managing individual symptoms including laxatives for constipation, medicines to prevent gut spasms for pain, medicines to slow gut activity for diarrhoea, dietary changes, fluid intake, psychological management, antidepressants for low mood and physical activity."
}
] |
query-laysum
|
7948
|
[
{
"role": "user",
"content": "Abstract: Background\nAbstracts of presentations at scientific meetings are usually available only in conference proceedings. If subsequent full publication of results reported in these abstracts is based on the magnitude or direction of the results, publication bias may result. Publication bias creates problems for those conducting systematic reviews or relying on the published literature for evidence about health and social care.\nObjectives\nTo systematically review reports of studies that have examined the proportion of meeting abstracts and other summaries that are subsequently published in full, the time between meeting presentation and full publication, and factors associated with full publication.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Library, Science Citation Index, reference lists, and author files. The most recent search was done in February 2016 for this substantial update to our earlier Cochrane Methodology Review (published in 2007).\nSelection criteria\nWe included reports of methodology research that examined the proportion of biomedical results initially presented as abstracts or in summary form that were subsequently published. Searches for full publications had to be at least two years after meeting presentation.\nData collection and analysis\nTwo review authors extracted data and assessed risk of bias. We calculated the proportion of abstracts published in full using a random-effects model. Dichotomous variables were analyzed using risk ratio (RR), with multivariable models taking into account various characteristics of the reports. We assessed time to publication using Kaplan-Meier survival analyses.\nMain results\nCombining data from 425 reports (307,028 abstracts) resulted in an overall full publication proportion of 37.3% (95% confidence interval (CI), 35.3% to 39.3%) with varying lengths of follow-up. This is significantly lower than that found in our 2007 review (44.5%. 95% CI, 43.9% to 45.1%). Using a survival analyses to estimate the proportion of abstracts that would be published in full by 10 years produced proportions of 46.4% for all studies; 68.7% for randomized and controlled trials and 44.9% for other studies. Three hundred and fifty-three reports were at high risk of bias on one or more items, but only 32 reports were considered at high risk of bias overall.\nForty-five reports (15,783 abstracts) with 'positive' results (defined as any 'significant' result) showed an association with full publication (RR = 1.31; 95% CI 1.23 to 1.40), as did 'positive' results defined as a result favoring the experimental treatment (RR =1.17; 95% CI 1.07 to 1.28) in 34 reports (8794 abstracts). Results emanating from randomized or controlled trials showed the same pattern for both definitions (RR = 1.21; 95% CI 1.10 to 1.32 (15 reports and 2616 abstracts) and RR = 1.17; 95% CI, 1.04 to 1.32 (13 reports and 2307 abstracts), respectively.\nOther factors associated with full publication include oral presentation (RR = 1.46; 95% CI 1.40 to 1.52; studied in 143 reports with 115,910 abstracts); acceptance for meeting presentation (RR = 1.65; 95% CI 1.48 to 1.85; 22 reports with 22,319 abstracts); randomized trial design (RR = 1.51; 95% CI 1.36 to 1.67; 47 reports with 28,928 abstracts); and basic research (RR = 0.78; 95% CI 0.74 to 0.82; 92 reports with 97,372 abstracts). Abstracts originating at an academic setting were associated with full publication (RR = 1.60; 95% CI 1.34 to 1.92; 34 reports with 16,913 abstracts), as were those considered to be of higher quality (RR = 1.46; 95% CI 1.23 to 1.73; 12 reports with 3364 abstracts), or having high impact (RR = 1.60; 95% CI 1.41 to 1.82; 11 reports with 6982 abstracts). Sensitivity analyses excluding reports that were abstracts themselves or classified as having a high risk of bias did not change these findings in any important way.\nIn considering the reports of the methodology research that we included in this review, we found that reports published in English or from a native English-speaking country found significantly higher proportions of studies published in full, but that there was no association with year of report publication. The findings correspond to a proportion of abstracts published in full of 31.9% for all reports, 40.5% for reports in English, 42.9% for reports from native English-speaking countries, and 52.2% for both these covariates combined.\nAuthors' conclusions\nMore than half of results from abstracts, and almost a third of randomized trial results initially presented as abstracts fail to be published in full and this problem does not appear to be decreasing over time. Publication bias is present in that 'positive' results were more frequently published than 'not positive' results. Reports of methodology research written in English showed that a higher proportion of abstracts had been published in full, as did those from native English-speaking countries, suggesting that studies from non-native English-speaking countries may be underrepresented in the scientific literature. After the considerable work involved in adding in the more than 300 additional studies found by the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change these overall conclusions in any important way.\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": "Investigators prepare and submit abstracts for presentation at scientific meetings. Abstracts selected for presentation are usually collated as conference proceedings, but these are not easily found. Thus, it is important to know whether the work submitted and presented is later published as a journal article, which can easily be identified and contains more study information than the abstract. It is also important to know if the publication of the study depends on the size or direction of results or other factors. If so, systematic reviews relying on the published literature for evidence about health and social care will have incomplete or unbalanced information, leading to inaccurate or biased estimates of the effects of the interventions studied."
}
] |
query-laysum
|
7949
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough exercise is recommended as part of the cystic fibrosis (CF) therapeutic routine, adherence to exercise is still limited. Digital health technologies can provide easy-to-access health information and may help improve healthcare and outcomes in individuals with long-term conditions. However, its effects for delivering and monitoring exercise programs in CF have not yet been synthesized.\nObjectives\nTo evaluate the benefits and harms of digital health technologies for delivering and monitoring exercise programs, increasing adherence to exercise regimens, and improving key clinical outcomes in people with CF.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 21 November 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) or quasi-RCTs of digital health technologies for delivering or monitoring exercise programs in CF.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. physical activity, 2. self-management behavior, and 3. pulmonary exacerbations. Our secondary outcomes were 4. usability of technologies, 5. quality of life, 6. lung function, 7. muscle strength, 8. exercise capacity, 9. physiologic parameters, and 10. adverse events. We used GRADE to assess certainty of evidence.\nMain results\nWe identified four parallel RCTs (three single-center and one multicenter with 231 participants aged six years or older). The RCTs evaluated different modes of digital health technologies with distinct purposes, combined with diverse interventions.\nWe identified important methodologic concerns in the RCTs, including insufficient information on the randomization process, blinding of outcome assessors, balance of non-protocol interventions across groups, and whether the analyses performed corrected for bias due to missing outcome data. Non-reporting of results may also be a concern, especially because some planned outcome results were reported incompletely. Furthermore, each trial had a small number of participants, resulting in imprecise effects. These limitations on the risk of bias, and on the precision of effect estimates resulted in overall low- to very low-certainty evidence. We undertook four comparisons and present the findings for our primary outcomes below. There is no information on the effectiveness of other modes of digital health technologies for monitoring physical activity or delivering exercise programs in people with CF, on adverse events related to the use of digital health technologies either for delivering or monitoring exercise programs in CF, and on their long-term effects (more than one year).\nDigital health technologies for monitoring physical activity\nWearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone\nOne trial (40 adults with CF) evaluated this outcome, but did not report data for any of our primary outcomes.\nWearable fitness tracker plus text message for personalized feedback and goal setting compared to wearable fitness tracker alone\nThe evidence is very uncertain about the effects of a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to wearable technology alone on physical activity measured by step count at six-month follow-up (mean difference [MD] 675.00 steps, 95% confidence interval [CI] −2406.37 to 3756.37; 1 trial, 32 participants). The same study measured pulmonary exacerbation rates and reported finding no difference between groups.\nWeb-based application to record, monitor, and set goals on physical activity plus usual care compared to usual care alone\nUsing a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference on time spent in moderate-to-vigorous physical activity measured via accelerometry compared to usual care alone at six-month follow-up (MD −4 minutes/day, 95% CI −37 to 29; 1 trial, 63 participants). Low certainty-evidence from the same trial suggests that the intervention may result in little to no difference on pulmonary exacerbations during 12 months of follow-up (median 1 respiratory hospitalization, interquartile range [IQR] 0 to 3) versus control (median 1 respiratory hospitalization, IQR 0 to 2; P = 0.6).\nDigital health technologies for delivering exercise programs\nWeb-based versus face-to-face exercise delivery\nThe evidence is very uncertain about the effects of web-based compared to face-to-face exercise delivery on adherence to physical activity as assessed by the number of participants who completed all exercise sessions after three months of intervention (risk ratio 0.92, 95% CI 0.69 to 1.23; 1 trial, 51 participants).\nAuthors' conclusions\nThe evidence is very uncertain about the effects of an exercise program plus the use of a wearable fitness tracker integrated with a social media platform compared with exercise prescription alone and on the effects of receiving a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to a wearable fitness tracker alone. Low-certainty evidence suggests that using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference in time spent in moderate-to-vigorous physical activity, total time spent in activity, pulmonary exacerbations, quality of life, lung function, and exercise capacity compared to usual care alone. Regarding the use of digital health technologies for delivering exercise programs in CF, the evidence is very uncertain about the effects of using a wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone.\nFurther high-quality RCTs, with blinded outcome assessors, reporting the effects of digital health technologies on clinically important outcome measures, such as physical activity participation and intensity, self-management behavior, and the occurrence of pulmonary exacerbations in the long term are needed. The results of six ongoing RCTs identified through our searches may help clarify the effects of different modes of digital health technologies for delivering and monitoring exercise programs in people with CF.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To answer this question, we searched medical databases for all relevant trials on the topic. We collected and analyzed all the data currently available from the trials."
}
] |
query-laysum
|
7950
|
[
{
"role": "user",
"content": "Abstract: Background\nPersistent postural-perceptual dizziness (PPPD) is a chronic balance disorder, which is characterised by subjective unsteadiness or dizziness that is worse on standing and with visual stimulation. The condition was only recently defined and therefore the prevalence is currently unknown. However, it is likely to include a considerable number of people with chronic balance problems. The symptoms can be debilitating and have a profound impact on quality of life. At present, little is known about the optimal way to treat this condition. A variety of medications may be used, as well as other treatments, such as vestibular rehabilitation.\nObjectives\nTo evaluate the benefits and harms of pharmacological interventions for persistent postural-perceptual dizziness (PPPD).\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 21 November 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with PPPD, which compared selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) with either placebo or no treatment. We excluded studies that did not use the Bárány Society criteria to diagnose PPPD and studies that followed up participants for less than three months.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vestibular symptoms (assessed as a dichotomous outcome - improved or not improved), 2) change in vestibular symptoms (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) generic health-related quality of life and 6) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We planned to use GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified no studies that met our inclusion criteria.\nAuthors' conclusions\nAt present, there is no evidence from placebo-controlled randomised trials regarding pharmacological treatments - specifically SSRIs and SNRIs - for PPPD. Consequently, there is great uncertainty over the use of these treatments for this condition. Further work is needed to establish whether any treatments are effective at improving the symptoms of PPPD, and whether their use is associated with any adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to November 2022."
}
] |
query-laysum
|
7951
|
[
{
"role": "user",
"content": "Abstract: Background\nEczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and has a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.\nObjectives\nTo assess the effects of moisturisers for eczema.\nSearch methods\nWe searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and GREAT. We searched five trials registers and checked references of included and excluded studies for further relevant trials.\nSelection criteria\nRandomised controlled trials in people with eczema.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 77 studies (mean duration: 6.7 weeks; 6603 participants, mean age: 18.6 years). Thirty-six studies were at high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome of participant-assessed disease severity, 13 assessed satisfaction, and 41 assessed adverse events. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).\nSix studies evaluated moisturiser versus no moisturiser. Participant-assessed disease severity and satisfaction were not assessed. Moisturiser use yielded lower SCORing Atopic Dermatitis (SCORAD) scores than no moisturiser (3 studies, 276 participants; mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) was unmet. Moisturiser use resulted in fewer flares (2 studies, 87 participants; RR 0.40, 95% CI 0.23 to 0.70), prolonged time to flare (median: 180 versus 30 days), and reduced use of topical corticosteroids (2 studies, 222 participants; MD -9.30 g, 95% CI -15.3 to -3.27). There was no clear difference in adverse events (1 study, 173 participants; risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.\nWith Atopiclair, 174/232 participants reported improvement in disease severity versus 27/158 using vehicle (3 studies; RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (4 studies, 396 participants; MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (2 studies, 248 participants; RR 2.14, 95% CI 1.58 to 2.89), fewer flares (3 studies, 397 participants; RR 0.18, 95% CI 0.11 to 0.31), and lower Eczema Area and Severity Index (EASI) scores (4 studies, 426 participants; MD -4.0, 95% CI -5.42 to -2.57), but the MID was unmet. The number of participants reporting adverse events was not statistically different (4 studies, 430 participants; RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.\nParticipants reported skin improvement more frequently with urea-containing cream than placebo (1 study, 129 participants; RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (1 study, 38 participants; low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) (1 study, 128 participants; RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence), and produced fewer flares (1 study, 44 participants; RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but caused more adverse events (1 study, 129 participants; RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).\nThree studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (1 study, 134 participants; RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), which also included improved investigator-assessed SCORAD scores (1 study, 249 participants; MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but the MID was unmet. Participant satisfaction was not addressed. The number of adverse events reported was not statistically significant (2 studies, 385 participants; RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).\nFour studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (1 study, 50 participants; RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (1 study, 50 participants; RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), or investigator-assessed disease severity (3 studies, 272 participants; standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (1 study, 43 participants; RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and reduced use of topical corticosteroids (2 studies, 222 participants; MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events (1 study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).\nWe compared all moisturisers to placebo, vehicle, or no moisturiser. Participants considered moisturisers to be more effective for reducing eczema (5 studies, 572 participants; RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (7 studies, 749 participants; SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (3 studies, 296 participants; RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity scores (12 studies, 1281 participants; SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (6 studies, 607 participants; RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), without a difference in adverse events (10 studies, 1275 participants; RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).\nTopical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity scores (3 studies, 192 participants; SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (1 study, 105 participants; RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no clear difference in number of adverse events (1 study, 125 participants; RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.\nAuthors' conclusions\nMost moisturisers showed some beneficial effects; prolonging time to flare, reducing the number of flares and the amount of topical corticosteroids needed to achieve similar reductions in eczema severity. Moisturisers combined with active treatment gave better results than active treatment alone. We did not find reliable evidence that one moisturiser is better than another.\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": "Eczema is a chronic (long-lasting) skin disorder. Its main symptoms are dry skin and intense itching. Affected areas appear red, with crusts and scratches, and may ooze fluid. Moisturisers are considered important in eczema treatment, but there is uncertainty about how well they work, and whether any one moisturiser works better - and is preferable - to another."
}
] |
query-laysum
|
7952
|
[
{
"role": "user",
"content": "Abstract: Background\nTheoretically, autologous serum eye drops (AS) offer a potential advantage over traditional therapies on the assumption that AS not only serve as a lacrimal substitute to provide lubrication but contain other biochemical components that allow them to mimic natural tears more closely. Application of AS has gained popularity as second-line therapy for patients with dry eye. Published studies on this subject indicate that autologous serum could be an effective treatment for dry eye.\nObjectives\nWe conducted this review to evaluate the efficacy and safety of AS given alone or in combination with artificial tears as compared with artificial tears alone, saline, placebo, or no treatment for adults with dry eye.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2016), Embase (January 1980 to July 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to July 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 also searched the Science Citation Index Expanded database (December 2016) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 5 July 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared AS versus artificial tears for treatment of adults with dry eye.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts and assessed full-text reports of potentially eligible trials. Two review authors extracted data and assessed risk of bias and characteristics of included trials. We contacted investigators to ask for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals (CIs) for continuous outcomes. We did not perform meta-analysis owing to differences in outcome assessments across trials.\nMain results\nWe identified five eligible RCTs (92 participants) that compared AS versus artificial tears or saline in individuals with dry eye of various origins (Sjögren's syndrome-related dry eye, non-Sjögren's syndrome dry eye, and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). We assessed the certainty of evidence as low or very low because of lack of reporting of quantitative data for most outcomes and unclear or high risk of bias among trials. We judged most risk of bias domains to have unclear risk in two trials owing to insufficient reporting of trial characteristics, and we considered one trial to have high risk of bias for most domains. We judged the remaining two trials to have low risk of bias; however, these trials used a cross-over design and did not report data in a way that could be used to compare outcomes between treatment groups appropriately. Incomplete outcome reporting and heterogeneity among outcomes and follow-up periods prevented inclusion of these trials in a summary meta-analysis.\nThree trials compared AS with artificial tears; however, only one trial reported quantitative data for analysis. Low-certainty evidence from one trial suggested that AS might provide some improvement in participant-reported symptoms compared with artificial tears after two weeks of treatment; the mean difference in mean change in symptom score measured on a visual analogue scale (range 0 to 100, with higher scores representing worse symptoms) was -12.0 (95% confidence interval (CI) -20.16 to -3.84; 20 participants). This same trial found mixed results with respect to ocular surface outcomes; the mean difference in mean change in scores between AS and artificial tears was -0.9 (95% CI -1.47 to -0.33; 20 participants; low-certainty evidence) for fluorescein staining and -2.2 (95% CI -2.73 to -1.67; 20 participants; low-certainty evidence) for Rose Bengal staining. Both staining scales range from 0 to 9, with higher scores indicating worse results. The mean change in tear film break-up time was 2.00 seconds longer (95% CI 0.99 to 3.01; 20 participants; low-certainty evidence) in the AS group than in the artificial tears group. Investigators reported no clinically meaningful differences in Schirmer’s test scores between groups (mean difference -0.40 mm, 95% CI -2.91 to 2.11; 20 participants; low-certainty evidence). None of these three trials reported tear hyperosmolarity and adverse events.\nTwo trials compared AS versus saline; however, only one trial reported quantitative data for analysis of only one outcome (Rose Bengal staining). Trial investigators of the two studies reported no differences in symptom scores, fluorescein staining scores, tear film break-up times, or Schirmer's test scores between groups at two to four weeks' follow-up. Very low-certainty evidence from one trial suggested that AS might provide some improvement in Rose Bengal staining scores compared with saline after four weeks of treatment; the mean difference in Rose Bengal staining score (range from 0 to 9, with higher scores showing worse results) was -0.60 (95% CI -1.11 to -0.09; 35 participants). Neither trial reported tear hyperosmolarity outcomes. One trial reported adverse events; two of 12 participants had signs of conjunctivitis with negative culture that did resolve.\nAuthors' conclusions\nOverall, investigators reported inconsistency in possible benefits of AS for improving participant-reported symptoms and other objective clinical measures. There might be some benefit in symptoms with AS compared with artificial tears in the short-term, but we found no evidence of an effect after two weeks of treatment. Well-planned, large, high-quality RCTs are warranted to examine participants with dry eye of different severities by using standardized questionnaires to measure participant-reported outcomes, as well as objective clinical tests and objective biomarkers to assess the benefit of AS therapy for dry eye.\n\nGiven the provided abstract, please respond to the following query: \"What are the key messages of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eye drops containing autologous serum might be better at improving dry eye symptoms than artificial tear drops in the short term (two weeks). We found very little information as to whether autologous serum eye drops work long term or for clinical measures of dry eye."
}
] |
query-laysum
|
7953
|
[
{
"role": "user",
"content": "Abstract: Background\nApproximately 1 in 10 pregnancies is affected by meconium passage at delivery, which can result in meconium aspiration syndrome (MAS). MAS can cause respiratory complications and, very rarely, death. Antibiotics have been prescribed for neonates exposed to meconium in amniotic fluid, with the intention of preventing infection due to potential bacterial contaminants.\nObjectives\nWe conducted this review to assess the efficacy and safety of antibiotics for:\n1. prevention of infection, morbidity, and mortality among infants born through meconium-stained amniotic fluid (MSAF) who are asymptomatic at birth; and\n2. prevention of infection, morbidity, and mortality among infants born through MSAF who have signs and symptoms compatible with meconium aspiration syndrome (MAS).\nSearch methods\nWe performed a literature search using the following databases: MEDLINE (1966 to July 2016); Embase (1980 to July 2016); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to July 2016); and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 7) in the Cochrane Library. We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials that compared antibiotics administered via any route versus placebo or no treatment for prevention of infection among neonates exposed to MSAF, or who developed MAS. We excluded cohort, case control, and any other non-randomised studies and applied no language restrictions. We included studies of term and preterm infants, and we included studies examining use of any antibacterial antibiotics. We included studies that reported on any outcomes of interest.\nData collection and analysis\nWe assessed the methodological quality of included trials by reviewing information provided in study reports and obtained by personal communication with study authors. We extracted data on relevant outcomes, estimated effect size, and reported values as risk ratios (RRs), risk differences (RDs), and mean differences (MDs), as appropriate. We conducted subgroup analyses for treatment of MAS and for prophylaxis (asymptomatic neonates exposed to meconium).\nMain results\nFour randomised controlled studies including a total of 695 participants were eligible for inclusion. Three studies evaluated neonates with MAS, and one study assessed asymptomatic neonates exposed to meconium in amniotic fluid. These studies exhibited varying degrees of methodological rigour: Two studies were at low risk of bias, and two were at unclear risk. We graded evidence derived from these studies as low quality. We downgraded overall evidence owing to the large number of participants lost to follow-up in one trial, the small sample sizes of all trials, and unclear methodological details provided for two trials.\nThe primary outcome was risk of early- and late-onset neonatal sepsis. Antibiotics did not decrease the risk of sepsis in neonates with a diagnosis of MAS (RR 1.54, 95% confidence interval (CI) 0.27 to 8.96; RD 0.00, 95% CI -0.02 to 0.03; 445 participants, three studies; I² = 0%) nor in asymptomatic neonates exposed to meconium in amniotic fluid (RR 0.76, 95% CI 0.25 to 2.34; RD -0.01, 95% CI -0.07 to 0.04; 250 participants, one study; I² = 0%). Results show no significant differences in mortality or duration of stay in hospital between groups given antibiotics and control groups of symptomatic and asymptomatic neonates. One study in asymptomatic neonates reported a significant reduction in duration of mechanical ventilation for the control group compared with the antibiotic group (MD 0.26, 95% CI 0.15 to 0.37; 250 participants, one study; I² = 0%).\nAuthors' conclusions\nUpon review of available evidence, we found no differences in infection rates following antibiotic treatment among neonates born through meconium-stained fluid and those with meconium aspiration syndrome. The overall quality of evidence is low owing to the small number of included studies. Well-controlled studies of adequate power are needed.\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 the medical literature for eligible studies through June 2016. We found four studies that compared antibiotics versus placebo for reducing infection among babies born with meconium-stained amniotic fluid. Two studies were of good quality, and two studies were missing some details regarding study methods. These four studies included 695 babies, who were given various antibiotics or were placed in the control group (no antibiotics). Researchers evaluated several different antibiotic types and treatment lengths. Overall, we found no differences in rate of infection or death between the two groups. We graded the evidence as low quality owing to a poor quality study design and the small number of included babies."
}
] |
query-laysum
|
7954
|
[
{
"role": "user",
"content": "Abstract: Background\nNeonatal parenteral nutrition may be delivered via peripheral cannulas or central venous catheters (umbilical or percutaneous). As the result of complications associated with umbilical catheters, many neonatal units prefer to use percutaneous catheters after initial stabilisation. Although they can be difficult to place, these catheters may be more stable than peripheral cannulae and require less frequent replacement. These delivery methods may be associated with different risks of adverse events, including acquired invasive infection and extravasation injury.\nObjectives\nTo determine the effects of infusion of parenteral nutrition via percutaneous central venous catheters versus peripheral cannulae on nutrient input, growth and development and complications among hospitalised neonates receiving parenteral nutrition in terms of adverse consequences such as bacteraemia or invasive fungal infection, cardiac tamponade or other extravasation injuries.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5), MEDLINE (1966 to June 2015) and EMBASE (1980 to June 2015), as well as conference proceedings and previous reviews.\nSelection criteria\nRandomised controlled trials that compared delivery of intravenous fluids (primarily parenteral nutrition) via percutaneous central venous catheters versus peripheral cannulae in hospitalised neonates.\nData collection and analysis\nWe extracted data using standard methods of the Cochrane Neonatal Group, with separate evaluation of trial quality and data extraction by two review authors.\nMain results\nWe found six trials recruiting a total of 549 infants. One trial showed that use of a percutaneous central venous catheter was associated with a smaller deficit between prescribed and actual nutrient intake during the trial period (mean difference (MD) -7.1%, 95% confidence interval (CI) -11.02 to -3.2). Infants in the percutaneous central venous catheter group needed significantly fewer catheters/cannulae (MD -4.3, 95% CI -5.24, -3.43). Meta-analysis of data from all trials revealed no evidence of an effect on the incidence of invasive infection (typical risk ratio (RR) 0.95, 95% CI 0.72 to 1.25; typical risk difference (RD) -0.01, 95% CI -0.08 to 0.06).\nAuthors' conclusions\nData from one small trial suggest that use of percutaneous central venous catheters to deliver parenteral nutrition increases nutrient input. The significance of this in relation to long-term growth and developmental outcomes is unclear. Three trials suggest that use of percutaneous central venous catheters decreases the number of catheters/cannulae needed to deliver nutrition. No evidence suggests that percutaneous central venous catheter use increases risks of adverse events, particularly invasive infection, although none of the included trials was large enough to rule out an effect on uncommon severe adverse events such as pericardial effusion.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found six small randomised controlled trials (enrolling 549 infants in total) that addressed this question. The trials generally were of good methodological quality, although study findings may be biased by the inability to blind caregivers and investigators to the type of intervention provided."
}
] |
query-laysum
|
7955
|
[
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is a common gynaecological condition affecting 10% to 15% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is combining surgery and medical therapy to reduce the recurrence of endometriosis. Though the combination of surgery and medical therapy appears to be beneficial, there is a lack of clarity about the appropriate timing of when medical therapy should be used in relation with surgery, that is, before, after, or both before and after surgery, to maximize treatment response.\nObjectives\nTo determine the effectiveness of medical therapies for hormonal suppression before, after, or both before and after surgery for endometriosis for improving painful symptoms, reducing disease recurrence, and increasing pregnancy rates.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in November 2019 together with reference checking and contact with study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomized controlled trials (RCTs) which compared medical therapies for hormonal suppression before, after, or before and after, therapeutic surgery for endometriosis.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. Where possible, we combined data using risk ratio (RR), standardized mean difference or mean difference (MD) and 95% confidence intervals (CI). Primary outcomes were: painful symptoms of endometriosis as measured by a visual analogue scale (VAS) of pain, other validated scales or dichotomous outcomes; and recurrence of disease as evidenced by EEC (Endoscopic Endometriosis Classification), rAFS (revised American Fertility Society), or rASRM (revised American Society for Reproductive Medicine) scores at second-look laparoscopy.\nMain results\nWe included 25 trials with 3378 women with endometriosis. We used the term \"surgery alone\" to refer to placebo or no medical therapy.\nPresurgical medical therapy compared with placebo or no medical therapy\nCompared to surgery alone, we are uncertain if presurgical medical hormonal suppression reduces pain recurrence at 12 months or less (dichotomous) (RR 1.10, 95% CI 0.72 to 1.66; 1 RCT, n = 262; very low-quality evidence) or whether it reduces disease recurrence at 12 months – total (AFS score) (MD –9.6, 95% CI –11.42 to –7.78; 1 RCT, n = 80; very low-quality evidence).\nWe are uncertain if presurgical medical hormonal suppression decreases disease recurrence at 12 months or less (EEC stage) compared to surgery alone (RR 1.11, 95% CI 0.86 to 1.43; 1 RCT, n = 262; very low-quality evidence). We are uncertain if presurgical medical hormonal suppression improves pregnancy rates compared to surgery alone (RR 1.18, 95% CI 0.97 to 1.45; 1 RCT, n = 262; very low-quality evidence). No trials reported pelvic pain at 12 months or less (continuous) or disease recurrence at 12 months or less.\nPostsurgical medical therapy compared with placebo or no medical therapy\nWe are uncertain about the improvement observed in pelvic pain at 12 months or less (continuous) between postsurgical medical hormonal suppression and surgery alone (SMD -0.79, 95% CI -1.02 to -0.56; 3 RCTs, n = 340; I2 = 91%; very low-quality evidence).\nCompared to surgery alone, postsurgical medical therapy may decrease pain recurrence at 12 months or less (dichotomous) (RR 0.70, 95% CI 0.52 to 0.94; 5 RCTs, n = 657; I2 = 0%; low-quality evidence).\nWe are uncertain if postsurgical medical hormonal suppression improves disease recurrence at 12 months – total (AFS score) compared to surgery alone (MD –2.29, 95% CI –4.01 to –0.57; 1 RCT, n = 51; very low-quality evidence).\nDisease recurrence at 12 months or less may be reduced with postsurgical medical hormonal suppression compared to surgery alone (RR 0.30, 95% CI 0.17 to 0.54; 4 RCTs, n = 433; I2 = 58%; low-quality evidence).\nWe are uncertain if postsurgical medical hormonal suppression improves disease recurrence at 12 months or less (EEC stage) (RR 0.88, 95% CI 0.67 to 1.15; 1 RCT, n = 285; very low-quality evidence).\nPregnancy rate is probably increased with postsurgical medical hormonal suppression compared to surgery alone (RR 1.19, 95% CI 1.02 to 1.38; 11 RCTs, n = 955; I2 = 27%; moderate-quality evidence).\nPre- and postsurgical medical therapy compared with surgery alone or surgery and placebo\nThere were no trials identified in the search for this comparison.\nPresurgical medical therapy compared with postsurgical medical therapy\nWe are uncertain about the difference in pain recurrence at 12 months or less (dichotomous) between postsurgical and presurgical medical hormonal suppression therapy (RR 1.40, 95% CI 0.95 to 2.07; 2 RCTs, n = 326; I2 = 2%; low-quality evidence).\nWe are uncertain about the difference in disease recurrence at 12 months or less (EEC stage) between postsurgical and presurgical medical hormonal suppression therapy (RR 1.26, 95% CI 0.97 to 1.65; 1 RCT, n = 273; very low-quality evidence).\nWe are uncertain about the difference in pregnancy rate between postsurgical and presurgical medical hormonal suppression therapy (RR 1.08, 95% CI 0.90 to 1.30; 1 RCT, n = 273; very low-quality evidence).\nNo trials reported pelvic pain at 12 months or less (continuous), disease recurrence at 12 months – total (AFS score) or disease recurrence at 12 months or less (dichotomous).\nPostsurgical medical therapy compared with pre- and postsurgical medical therapy\nThere were no trials identified in the search for this comparison.\nSerious adverse effects for medical therapies reviewed\nThere was insufficient evidence to reach a conclusion regarding serious adverse effects, as no studies reported data suitable for analysis.\nAuthors' conclusions\nOur results indicate that the data about the efficacy of medical therapy for endometriosis are inconclusive, related to the timing of hormonal suppression therapy relative to surgery for endometriosis. In our various comparisons of the timing of hormonal suppression therapy, women who receive postsurgical medical therapy compared with no medical therapy or placebo may experience benefit in terms of pain recurrence, disease recurrence, and pregnancy. There is insufficient evidence regarding hormonal suppression therapy at other time points in relation to surgery for women with endometriosis.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 25 randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 3378 women who underwent surgery with or without medical therapy. We used the term \"surgery alone\" to refer to placebo or no medical therapy. The evidence is current to November 2019."
}
] |
query-laysum
|
7956
|
[
{
"role": "user",
"content": "Abstract: Background\nThe diagnostic challenges associated with the COVID-19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS-CoV-2 infection. Serology tests to detect the presence of antibodies to SARS-CoV-2 enable detection of past infection and may detect cases of SARS-CoV-2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS-CoV-2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS-CoV-2 epidemiology.\nObjectives\nTo assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS-CoV-2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS-CoV-2. Sources of heterogeneity investigated included: timing of test, test method, SARS-CoV-2 antigen used, test brand, and reference standard for non-SARS-CoV-2 cases.\nSearch methods\nThe COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) ‘COVID-19: Living map of the evidence’ and the Norwegian Institute of Public Health ’NIPH systematic and living map on COVID-19 evidence’. We did not apply language restrictions.\nSelection criteria\nWe included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT-PCR test. Small studies with fewer than 25 SARS-CoV-2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction tests (RT-PCR), clinical diagnostic criteria, and pre-pandemic samples).\nData collection and analysis\nWe use standard screening procedures with three reviewers. Quality assessment (using the QUADAS-2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta-analysis, we fitted univariate random-effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and summarised results for tests that were evaluated in 200 or more samples and that met a modification of UK Medicines and Healthcare products Regulatory Agency (MHRA) target performance criteria.\nMain results\nWe included 178 separate studies (described in 177 study reports, with 45 as pre-prints) providing 527 test evaluations. The studies included 64,688 samples including 25,724 from people with confirmed SARS-CoV-2; most compared the accuracy of two or more assays (102/178, 57%). Participants with confirmed SARS-CoV-2 infection were most commonly hospital inpatients (78/178, 44%), and pre-pandemic samples were used by 45% (81/178) to estimate specificity. Over two-thirds of studies recruited participants based on known SARS-CoV-2 infection status (123/178, 69%). All studies were conducted prior to the introduction of SARS-CoV-2 vaccines and present data for naturally acquired antibody responses. Seventy-nine percent (141/178) of studies reported sensitivity by week after symptom onset and 66% (117/178) for convalescent phase infection. Studies evaluated enzyme-linked immunosorbent assays (ELISA) (165/527; 31%), chemiluminescent assays (CLIA) (167/527; 32%) or lateral flow assays (LFA) (188/527; 36%).\nRisk of bias was high because of participant selection (172, 97%); application and interpretation of the index test (35, 20%); weaknesses in the reference standard (38, 21%); and issues related to participant flow and timing (148, 82%). We judged that there were high concerns about the applicability of the evidence related to participants in 170 (96%) studies, and about the applicability of the reference standard in 162 (91%) studies.\nAverage sensitivities for current SARS-CoV-2 infection increased by week after onset for all target antibodies. Average sensitivity for the combination of either IgG or IgM was 41.1% in week one (95% CI 38.1 to 44.2; 103 evaluations; 3881 samples, 1593 cases), 74.9% in week two (95% CI 72.4 to 77.3; 96 evaluations, 3948 samples, 2904 cases) and 88.0% by week three after onset of symptoms (95% CI 86.3 to 89.5; 103 evaluations, 2929 samples, 2571 cases). Average sensitivity during the convalescent phase of infection (up to a maximum of 100 days since onset of symptoms, where reported) was 89.8% for IgG (95% CI 88.5 to 90.9; 253 evaluations, 16,846 samples, 14,183 cases), 92.9% for IgG or IgM combined (95% CI 91.0 to 94.4; 108 evaluations, 3571 samples, 3206 cases) and 94.3% for total antibodies (95% CI 92.8 to 95.5; 58 evaluations, 7063 samples, 6652 cases). Average sensitivities for IgM alone followed a similar pattern but were of a lower test accuracy in every time slot.\nAverage specificities were consistently high and precise, particularly for pre-pandemic samples which provide the least biased estimates of specificity (ranging from 98.6% for IgM to 99.8% for total antibodies).\nSubgroup analyses suggested small differences in sensitivity and specificity by test technology however heterogeneity in study results, timing of sample collection, and smaller sample numbers in some groups made comparisons difficult. For IgG, CLIAs were the most sensitive (convalescent-phase infection) and specific (pre-pandemic samples) compared to both ELISAs and LFAs (P < 0.001 for differences across test methods). The antigen(s) used (whether from the Spike-protein or nucleocapsid) appeared to have some effect on average sensitivity in the first weeks after onset but there was no clear evidence of an effect during convalescent-phase infection.\nInvestigations of test performance by brand showed considerable variation in sensitivity between tests, and in results between studies evaluating the same test. For tests that were evaluated in 200 or more samples, the lower bound of the 95% CI for sensitivity was 90% or more for only a small number of tests (IgG, n = 5; IgG or IgM, n = 1; total antibodies, n = 4). More test brands met the MHRA minimum criteria for specificity of 98% or above (IgG, n = 16; IgG or IgM, n = 5; total antibodies, n = 7). Seven assays met the specified criteria for both sensitivity and specificity.\nIn a low-prevalence (2%) setting, where antibody testing is used to diagnose COVID-19 in people with symptoms but who have had a negative PCR test, we would anticipate that 1 (1 to 2) case would be missed and 8 (5 to 15) would be falsely positive in 1000 people undergoing IgG or IgM testing in week three after onset of SARS-CoV-2 infection.\nIn a seroprevalence survey, where prevalence of prior infection is 50%, we would anticipate that 51 (46 to 58) cases would be missed and 6 (5 to 7) would be falsely positive in 1000 people having IgG tests during the convalescent phase (21 to 100 days post-symptom onset or post-positive PCR) of SARS-CoV-2 infection.\nAuthors' conclusions\nSome antibody tests could be a useful diagnostic tool for those in whom molecular- or antigen-based tests have failed to detect the SARS-CoV-2 virus, including in those with ongoing symptoms of acute infection (from week three onwards) or those presenting with post-acute sequelae of COVID-19. However, antibody tests have an increasing likelihood of detecting an immune response to infection as time since onset of infection progresses and have demonstrated adequate performance for detection of prior infection for sero-epidemiological purposes. The applicability of results for detection of vaccination-induced antibodies is uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 178 relevant studies. Studies took place in Europe (94), Asia (45), North America (35), Australia (2), and South America (2).\nSeventy-eight studies included people who were in hospital with suspected or confirmed COVID-19 infection and 14 studies included people in community settings. Several studies included people from multiple settings (35) or did not report where the participants were recruited from (39).\nOne hundred and forty-one studies included recent infection cases (mainly week 1 to week 3 after onset of symptoms), and many also included people tested later (from day 21 onwards after infection) (117)."
}
] |
query-laysum
|
7957
|
[
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a central nervous system disorder (neurological disorder). Epileptic seizures are the result of excessive and abnormal cortical nerve cell electrical activity in the brain. Despite the development of more than 10 new antiepileptic drugs (AEDs) since the early 2000s, approximately a third of people with epilepsy remain resistant to pharmacotherapy, often requiring treatment with a combination of AEDs. In this review, we summarised the current evidence regarding rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication when used as an add-on treatment for drug-resistant epilepsy. In January 2009, rufinamide was approved by the US Food and Drug Administration for the treatment of children four years of age and older with Lennox-Gastaut syndrome. It is also approved as an add-on treatment for adults and adolescents with focal seizures.\nThis is an updated version of the original Cochrane Review published in 2018.\nObjectives\nTo evaluate the efficacy and tolerability of rufinamide when used as an add-on treatment for people with drug-resistant epilepsy.\nSearch methods\nWe imposed no language restrictions. We contacted the manufacturers of rufinamide and authors in the field to identify any relevant unpublished studies.\nSelection criteria\nRandomised, double-blind, placebo-controlled, add-on trials of rufinamide, recruiting people (of any age or gender) with drug-resistant epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 50% or greater reduction in seizure frequency (primary outcome); seizure freedom; treatment withdrawal; and adverse effects (secondary outcomes). Primary analyses were intention-to-treat (ITT) and we presented summary risk ratios (RRs) with 95% confidence intervals (CIs). We evaluated dose response in regression models. We carried out a risk of bias assessment for each included study using the Cochrane 'Risk of bias' tool and assessed the overall certainty of evidence using the GRADE approach.\nMain results\nThe review included six trials, representing 1759 participants. Four trials (1563 participants) included people with uncontrolled focal seizures. Two trials (196 participants) included individuals with established Lennox-Gastaut syndrome. Overall, the age of adults ranged from 18 to 80 years and the age of children ranged from 4 to 16 years. Baseline phases ranged from 28 to 56 days and double-blind phases from 84 to 96 days. Five of the six included trials described adequate methods of concealment of randomisation, and only three described adequate blinding. All analyses were by ITT. Overall, five studies were at low risk of bias and one had unclear risk of bias due to lack of reported information around study design. All trials were sponsored by the manufacturer of rufinamide and therefore were at high risk of funding bias.\nThe overall RR for 50% or greater reduction in seizure frequency was 1.79 (95% CI 1.44 to 2.22; 6 randomised controlled trials (RCTs), 1759 participants; moderate-certainty evidence), indicating that rufinamide (plus conventional AED) was significantly more effective than placebo (plus conventional AED) in reducing seizure frequency by at least 50% when added to conventionally used AEDs in people with drug-resistant focal epilepsy. Data from only one study (73 participants) reported seizure freedom: RR 1.32 (95% CI 0.36 to 4.86; 1 RCT, 73 participants; moderate-certainty evidence). The overall RR for treatment withdrawal (for any reason and due to AED) was 1.83 (95% CI 1.45 to 2.31; 6 RCTs, 1759 participants; moderate-certainty evidence), showing that rufinamide was significantly more likely to be withdrawn than placebo. Most adverse effects were significantly more likely to occur in the rufinamide-treated group. Adverse events significantly associated with rufinamide were headache, dizziness, somnolence, vomiting, nausea, fatigue, and diplopia. The RRs for these adverse effects were as follows: headache 1.36 (95% Cl 1.08 to 1.69; 3 RCTs, 1228 participants; high-certainty evidence); dizziness 2.52 (95% Cl 1.90 to 3.34; 3 RCTs, 1295 participants; moderate-certainty evidence); somnolence 1.94 (95% Cl 1.44 to 2.61; 6 RCTs, 1759 participants; moderate-certainty evidence); vomiting 2.95 (95% Cl 1.80 to 4.82; 4 RCTs, 777 participants; low-certainty evidence); nausea 1.87 (95% Cl 1.33 to 2.64; 3 RCTs, 1295 participants; moderate-certainty evidence); fatigue 1.46 (95% Cl 1.08 to 1.97; 3 RCTs, 1295 participants; moderate-certainty evidence); and diplopia 4.60 (95% Cl 2.53 to 8.38; 3 RCTs, 1295 participants; low-certainty evidence). There was no important heterogeneity between studies for any outcomes. Overall, we assessed the evidence as moderate to low certainty due to wide CIs and potential risk of bias from some studies contributing to the analysis.\nAuthors' conclusions\nFor people with drug-resistant focal epilepsy, rufinamide when used as an add-on treatment was effective in reducing seizure frequency. However, the trials reviewed were of relatively short duration and provided no evidence for long-term use of rufinamide. In the short term, rufinamide as an add-on was associated with several adverse events. This review focused on the use of rufinamide in drug-resistant focal epilepsy, and the results cannot be generalised to add-on treatment for generalised epilepsies. Likewise, no inference can be made about the effects of rufinamide when used as monotherapy.\n\nGiven the provided abstract, please respond to the following query: \"What is drug-resistant epilepsy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Epilepsy is a condition in which sudden bursts of intense electrical activity happen in the brain and cause the brain's messages to get mixed up, resulting in a seizure. Seizures affect people in different ways: they may cause unusual sensations, movements or feelings, loss of awareness, falls, stiffness or jerking. Epileptic seizures can occur repeatedly and without any triggers. Seizures can happen anytime and anywhere; they can come on suddenly and can happen often.\nTreatments for epilepsy focus on stopping or reducing the number of seizures a person has with as few unwanted effects as possible. Most seizures are controlled by taking a single antiepileptic medicine. But some people's epilepsy does not respond (drug-resistant epilepsy) and they may need more than one medicine to control the seizures. Drug-resistant epilepsy is more common if the seizures involve one area of the brain (focal epilepsy) rather than the whole outer area of the brain (generalised epilepsy)."
}
] |
query-laysum
|
7958
|
[
{
"role": "user",
"content": "Abstract: Background\nAcetylcholinesterase inhibitors, such as neostigmine, have traditionally been used for reversal of non-depolarizing neuromuscular blocking agents. However, these drugs have significant limitations, such as indirect mechanisms of reversal, limited and unpredictable efficacy, and undesirable autonomic responses. Sugammadex is a selective relaxant-binding agent specifically developed for rapid reversal of non-depolarizing neuromuscular blockade induced by rocuronium. Its potential clinical benefits include fast and predictable reversal of any degree of block, increased patient safety, reduced incidence of residual block on recovery, and more efficient use of healthcare resources.\nObjectives\nThe main objective of this review was to compare the efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade caused by non-depolarizing neuromuscular agents in adults.\nSearch methods\nWe searched the following databases on 2 May 2016: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (WebSPIRS Ovid SP), Embase (WebSPIRS Ovid SP), and the clinical trials registries www.controlled-trials.com, clinicaltrials.gov, and www.centerwatch.com. We re-ran the search on 10 May 2017.\nSelection criteria\nWe included randomized controlled trials (RCTs) irrespective of publication status, date of publication, blinding status, outcomes published, or language. We included adults, classified as American Society of Anesthesiologists (ASA) I to IV, who received non-depolarizing neuromuscular blocking agents for an elective in-patient or day-case surgical procedure. We included all trials comparing sugammadex versus neostigmine that reported recovery times or adverse events. We included any dose of sugammadex and neostigmine and any time point of study drug administration.\nData collection and analysis\nTwo review authors independently screened titles and abstracts to identify trials for eligibility, examined articles for eligibility, abstracted data, assessed the articles, and excluded obviously irrelevant reports. We resolved disagreements by discussion between review authors and further disagreements through consultation with the last review author. We assessed risk of bias in 10 methodological domains using the Cochrane risk of bias tool and examined risk of random error through trial sequential analysis. We used the principles of the GRADE approach to prepare an overall assessment of the quality of evidence. For our primary outcomes (recovery times to train-of-four ratio (TOFR) > 0.9), we presented data as mean differences (MDs) with 95 % confidence intervals (CIs), and for our secondary outcomes (risk of adverse events and risk of serious adverse events), we calculated risk ratios (RRs) with CIs.\nMain results\nWe included 41 studies (4206 participants) in this updated review, 38 of which were new studies. Twelve trials were eligible for meta-analysis of primary outcomes (n = 949), 28 trials were eligible for meta-analysis of secondary outcomes (n = 2298), and 10 trials (n = 1647) were ineligible for meta-analysis.\nWe compared sugammadex 2 mg/kg and neostigmine 0.05 mg/kg for reversal of rocuronium-induced moderate neuromuscular blockade (NMB). Sugammadex 2 mg/kg was 10.22 minutes (6.6 times) faster then neostigmine 0.05 mg/kg (1.96 vs 12.87 minutes) in reversing NMB from the second twitch (T2) to TOFR > 0.9 (MD 10.22 minutes, 95% CI 8.48 to 11.96; I2 = 84%; 10 studies, n = 835; GRADE: moderate quality).\nWe compared sugammadex 4 mg/kg and neostigmine 0.07 mg/kg for reversal of rocuronium-induced deep NMB. Sugammadex 4 mg/kg was 45.78 minutes (16.8 times) faster then neostigmine 0.07 mg/kg (2.9 vs 48.8 minutes) in reversing NMB from post-tetanic count (PTC) 1 to 5 to TOFR > 0.9 (MD 45.78 minutes, 95% CI 39.41 to 52.15; I2 = 0%; two studies, n = 114; GRADE: low quality).\nFor our secondary outcomes, we compared sugammadex, any dose, and neostigmine, any dose, looking at risk of adverse and serious adverse events. We found significantly fewer composite adverse events in the sugammadex group compared with the neostigmine group (RR 0.60, 95% CI 0.49 to 0.74; I2 = 40%; 28 studies, n = 2298; GRADE: moderate quality). Risk of adverse events was 28% in the neostigmine group and 16% in the sugammadex group, resulting in a number needed to treat for an additional beneficial outcome (NNTB) of 8. When looking at specific adverse events, we noted significantly less risk of bradycardia (RR 0.16, 95% CI 0.07 to 0.34; I2= 0%; 11 studies, n = 1218; NNTB 14; GRADE: moderate quality), postoperative nausea and vomiting (PONV) (RR 0.52, 95% CI 0.28 to 0.97; I2 = 0%; six studies, n = 389; NNTB 16; GRADE: low quality) and overall signs of postoperative residual paralysis (RR 0.40, 95% CI 0.28 to 0.57; I2 = 0%; 15 studies, n = 1474; NNTB 13; GRADE: moderate quality) in the sugammadex group when compared with the neostigmine group. Finally, we found no significant differences between sugammadex and neostigmine regarding risk of serious adverse events (RR 0.54, 95% CI 0.13 to 2.25; I2= 0%; 10 studies, n = 959; GRADE: low quality).\nApplication of trial sequential analysis (TSA) indicates superiority of sugammadex for outcomes such as recovery time from T2 to TOFR > 0.9, adverse events, and overall signs of postoperative residual paralysis.\nAuthors' conclusions\nReview results suggest that in comparison with neostigmine, sugammadex can more rapidly reverse rocuronium-induced neuromuscular block regardless of the depth of the block. Sugammadex 2 mg/kg is 10.22 minutes (˜ 6.6 times) faster in reversing moderate neuromuscular blockade (T2) than neostigmine 0.05 mg/kg (GRADE: moderate quality), and sugammadex 4 mg/kg is 45.78 minutes (˜ 16.8 times) faster in reversing deep neuromuscular blockade (PTC 1 to 5) than neostigmine 0.07 mg/kg (GRADE: low quality). With an NNTB of 8 to avoid an adverse event, sugammadex appears to have a better safety profile than neostigmine. Patients receiving sugammadex had 40% fewer adverse events compared with those given neostigmine. Specifically, risks of bradycardia (RR 0.16, NNTB 14; GRADE: moderate quality), PONV (RR 0.52, NNTB 16; GRADE: low quality), and overall signs of postoperative residual paralysis (RR 0.40, NNTB 13; GRADE: moderate quality) were reduced. Both sugammadex and neostigmine were associated with serious adverse events in less than 1% of patients, and data showed no differences in risk of serious adverse events between groups (RR 0.54; GRADE: low quality).\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Different levels of induced paralysis are sometimes necessary when patients are put to sleep or are prepared for operations. When the operation is finished, paralysis should be reversed in a fast, reliable, and safe way. Neostigmine is a medication that is traditionally used to reverse induced paralysis. However, its use can be associated with incomplete or slow reversal as well as changes in lung function, heart function, and vomiting and nausea. Sugammadex is a relatively new medication specifically designed to reverse rocuronium-induced paralysis in a faster, more reliable, and safer way when compared with neostigmine."
}
] |
query-laysum
|
7959
|
[
{
"role": "user",
"content": "Abstract: Background\nTension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headache days per month), and chronic TTH (15 headache days per month or more). Aspirin is one of a number of analgesics suggested for acute treatment of episodic TTH.\nObjectives\nTo assess the efficacy and safety of aspirin for acute treatment of episodic tension-type headache (TTH) in adults compared with placebo or any active comparator.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Oxford Pain Relief Database from inception to September 2016, and also reference lists of relevant published studies and reviews. We sought unpublished studies by asking personal contacts and searching online clinical trial registers and manufacturers' websites.\nSelection criteria\nWe included randomised, double-blind, placebo-controlled studies (parallel-group or cross-over) using oral aspirin for symptomatic relief of an acute episode of TTH. Studies had to be prospective, with participants aged 18 years or over, and include at least 10 participants per treatment arm.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and extracted data. For various outcomes (predominantly those recommended by the International Headache Society (IHS)), we calculated the risk ratio (RR) and number needed to treat for one additional beneficial outcome (NNT), one additional harmful outcome (NNH), or to prevent one event (NNTp) for oral aspirin compared to placebo or an active intervention.\nWe assessed the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe included five studies enrolling adults with frequent episodic TTH; 1812 participants took medication, of which 767 were included in comparisons of aspirin 1000 mg with placebo, and 405 in comparisons of aspirin 500 mg or 650 mg with placebo. Not all of these participants provided data for outcomes of interest in this review. Four studies specified using IHS diagnostic criteria; one predated commonly recognised criteria, but described comparable characteristics and excluded migraine. All participants treated headaches of at least moderate pain intensity.\nNone of the included studies were at low risk of bias across all domains considered, although for most studies and domains this was likely to be due to inadequate reporting rather than poor methods. We judged one study to be at high risk of bias due to small size.\nThere were no data for aspirin at any dose for the IHS preferred outcome of being pain free at two hours, or for being pain free at any other time, and only one study provided data equivalent to having no or mild pain at two hours (very low quality evidence). Use of rescue medication was lower with aspirin 1000 mg than with placebo (2 studies, 397 participants); 14% of participants used rescue medication with aspirin 1000 mg compared with 31% with placebo (NNTp 6.0, 95% confidence interval (CI) 4.1 to 12) (low quality evidence). Two studies (397 participants) reported a Patient Global Evaluation at the end of the study; we combined the top two categories for both studies to determine the number of participants who were 'satisfied' with treatment. Aspirin 1000 mg produced more satisfied participants (55%) than did placebo (37%) (NNT 5.7, 95% CI 3.7 to 12) (very low quality evidence).\nAdverse events were not different between aspirin 1000 mg and placebo (RR 1.1, 95% CI 0.8 to 1.5), or aspirin 500 mg or 650 mg and placebo (RR 1.3, 95% CI 0.8 to 2.0) (low quality evidence). Studies reported no serious adverse events.\nThe quality of the evidence using GRADE comparing aspirin doses between 500 mg and 1000 mg with placebo was low or very low. Evidence was downgraded because of the small number of studies and events, and because the most important measures of efficacy were not reported.\nThere were insufficient data to compare aspirin with any active comparator (paracetamol alone, paracetamol plus codeine, peppermint oil, or metamizole) at any of the doses tested.\nAuthors' conclusions\nA single dose of aspirin between 500 mg and 1000 mg provided some benefit in terms of less frequent use of rescue medication and more participants satisfied with treatment compared with placebo in adults with frequent episodic TTH who have an acute headache of moderate or severe intensity. There was no difference between a single dose of aspirin and placebo for the number of people experiencing adverse events. The amount and quality of the evidence was very limited and should be interpreted with caution.\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": "None of the studies reported on participants being pain free at two hours, and only one study reported an outcome we judged equivalent to being pain free or having only mild pain at two hours. For aspirin 1000 mg, about 10 participants in 100 used additional painkillers, compared with 30 in 100 with placebo (very low quality evidence). At the end of the study 55 in 100 participants were 'satisfied' with treatment compared with 37 in 100 with placebo (very low quality evidence). About 15 in 100 people taking aspirin 1000 mg reported having a side effect after one dose, which was the same as with placebo (low quality evidence)."
}
] |
query-laysum
|
7960
|
[
{
"role": "user",
"content": "Abstract: Background\nCholangiocarcinoma (cancer in the bile duct) is an aggressive tumour for which surgical resection is a mainstay of treatment. Despite complete resection, recurrences of the cancer are common and lead to poor prognosis in patients. Postoperative adjuvant chemotherapy given after surgical resection may reduce the risk of cancer recurrence by eradicating residual cancer and micrometastatic lesions. The benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies are unclear.\nObjectives\nTo assess the benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies for people with cholangiocarcinoma after curative-intent resection.\nSearch methods\nWe performed electronic searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index - Science for trials that met the inclusion criteria up to 28 April 2021.\nSelection criteria\nRandomised clinical trials irrespective of blinding, publication status, or language comparing postoperative adjuvant chemotherapy versus placebo, no intervention, or a different postoperative adjuvant chemotherapy regimen for participants with curative-intent resection for cholangiocarcinoma.\nData collection and analysis\nWe used standard Cochrane methods to develop and conduct the review. We conducted meta-analyses and presented results, where feasible, using a random-effects model and risk ratios (RR) with 95% confidence intervals (CI). We assessed risk of bias according to predefined domains suggested by Cochrane. We rated the certainty of evidence using the GRADE approach and presented outcome results in a summary of findings table.\nMain results\nWe included five published randomised clinical trials. The trials included 931 adults (18 to 83 years old) who underwent curative-intent resection for cholangiocarcinoma. Four trials compared postoperative adjuvant chemotherapy (mitomycin-C and 5-fluorouracil (5-FU); gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy (surgery alone) in 867 participants with cholangiocarcinoma only. A fifth trial compared postoperative adjuvant S-1 (a novel oral fluoropyrimidine derivative) chemotherapy versus gemcitabine in 70 participants with intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma (64 participants), and gallbladder carcinoma (6 participants). We assessed all of the included trials at overall high risk of bias. One trial was conducted in France, three in Japan, and one in the United Kingdom. We could not perform all planned comparison analyses due to lack of data. Three trials used intention-to-treat analyses. Another trial used per-protocol analysis. In the remaining trial one participant in the intervention group and one in the control group were lost to follow-up. However, the outcomes of these two participants were not described.\nPostoperative adjuvant chemotherapy versus no postoperative adjuvant chemotherapy\nWe are very uncertain as to whether postoperative adjuvant chemotherapy has little to no effect on all-cause mortality versus no postoperative adjuvant chemotherapy (RR 0.92, 95% CI 0.84 to 1.01; 4 trials, 867 participants, very low-certainty evidence). We are very uncertain of the effect of postoperative adjuvant chemotherapy on serious adverse events (RR 17.82, 95% CI 2.43 to 130.82; 1 trial, 219 participants, very low-certainty evidence). The trial indicated that postoperative adjuvant chemotherapy could increase serious adverse events, as 19/113 (20.5%) of participants developed an adverse event, compared to 1/106 (1.1%) of participants in the no-postoperative adjuvant chemotherapy group. None of the included trials reported data on health-related quality of life, cancer-related mortality, time to recurrence of the tumour, and non-serious adverse events in participants with only cholangiocarcinoma.\nAdjuvant S-1 chemotherapy (fluoropyrimidine derivative) versus adjuvant gemcitabine-based chemotherapy\nThe only available trial analysed all participants with intrahepatic, perihilar cholangiocarcinoma and gallbladder carcinoma together, with data on participants with cholangiocarcinoma not provided separately. The authors reported that one-year overall mortality after adjuvant S-1 therapy was lower than with adjuvant gemcitabine-based therapy following major hepatectomy for biliary tract cancer. There were no differences in two-year overall mortality.\nFunding: two trials received support from drug companies; one trial received funding from the Japan Society of Clinical Oncology; one trial received support from \"Programme Hospitalier de Recherche Clinique (PHRC2009) and Ligue Nationale Contre le Cancer\"; and one trial did not provide information on support or sponsorship.\nWe identified six ongoing randomised clinical trials.\nAuthors' conclusions\nBased on the very low-certainty evidence found in four trials in people with curative-intent resection for cholangiocarcinoma, we are very uncertain of the effects of postoperative adjuvant chemotherapy (mitomycin-C and 5-FU; gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy on mortality. The effects of postoperative adjuvant chemotherapy compared with no postoperative adjuvant chemotherapy on serious adverse events are also very uncertain, but the result of the single trial showed 20% higher occurrences of haematologic adverse events. We assessed the certainty of the evidence as very low due to overall high risk of bias, and imprecision. Due to insufficient power of the only identified trial, the best postoperative adjuvant chemotherapy regimen in people with only cholangiocarcinoma could not be established. We also lack randomised clinical trials with outcome data on adjuvant S-1 chemotherapy versus adjuvant gemcitabine-based chemotherapy in people with cholangiocarcinoma alone. There is a need for further randomised clinical trials designed to be at low risk of bias and with adequate sample size exploring the best adjuvant chemotherapy treatment after surgery in people with cholangiocarcinoma.\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 very unsure as to whether postoperative adjuvant chemotherapy has any effect on death from any cause. Only one trial reported on adverse events. Whilst this trial indicated that postoperative adjuvant chemotherapy could increase serious adverse events, this result is very uncertain due to the lack of studies (i.e. only one found) and the low number of participants. No information was available on quality of life, death from cancer, time to tumour recurrence, and non-serious adverse events."
}
] |
query-laysum
|
7961
|
[
{
"role": "user",
"content": "Abstract: Background\nDiaphragm-triggered non-invasive respiratory support, commonly referred to as NIV-NAVA (non-invasive neurally adjusted ventilatory assist), uses the electrical activity of the crural diaphragm to trigger the start and end of a breath. It provides variable inspiratory pressure that is proportional to an infant's changing inspiratory effort. NIV-NAVA has the potential to provide effective, non-invasive, synchronised, multilevel support and may reduce the need for invasive ventilation; however, its effects on short- and long-term outcomes, especially in the preterm infant, are unclear.\nObjectives\nTo assess the effectiveness and safety of diaphragm-triggered non-invasive respiratory support in preterm infants (< 37 weeks' gestation) when compared to other non-invasive modes of respiratory support (nasal intermittent positive pressure ventilation (NIPPV); nasal continuous positive airway pressure (nCPAP); high-flow nasal cannulae (HFNC)), and to assess preterm infants with birth weight less than 1000 grams or less than 28 weeks' corrected gestation at the time of intervention as a sub-group.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 5), MEDLINE via PubMed (1946 to 10 May 2019), Embase (1947 to 10 May 2019), and CINAHL (1982 to 10 May 2019). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared diaphragm-triggered non-invasive versus other non-invasive respiratory support in preterm infants.\nData collection and analysis\nTwo review authors independently selected trials, assessed trial quality and extracted data from included studies. We performed fixed-effect analyses and expressed treatment effects as mean difference (MD), risk ratio (RR), and risk difference (RD) with 95% confidence intervals (CIs). We used the generic inverse variance method to analyse specific outcomes for cross-over trials. We used the GRADE approach to assess the certainty of evidence.\nMain results\nThere were two small randomised controlled trials including a total of 23 infants eligible for inclusion in the review. Only one trial involving 16 infants included in the analysis reported on either of the primary outcomes of the review. This found no difference in failure of modality between NIV-NAVA and NIPPV (RR 0.33, 95% CI 0.02 to 7.14; RD −0.13, 95% CI -0.41 to 0.16; 1 study, 16 infants; heterogeneity not applicable).\nBoth trials reported on secondary outcomes of the review, specific for cross-over trials (total 22 infants; 1 excluded due to failure of initial modality). One study involving seven infants reported a significant reduction in maximum FiO₂ with NIV-NAVA compared to NIPPV (MD −4.29, 95% CI −5.47 to −3.11; heterogeneity not applicable). There was no difference in maximum electric activity of the diaphragm (Edi) signal between modalities (MD −1.75, 95% CI −3.75 to 0.26; I² = 0%) and a significant increase in respiratory rate with NIV-NAVA compared to NIPPV (MD 7.22, 95% CI 0.21 to 14.22; I² = 72%) on a meta-analysis of two studies involving a total of 22 infants. The included studies did not report on other outcomes of interest.\nAuthors' conclusions\nDue to limited data and very low certainty evidence, we were unable to determine if diaphragm-triggered non-invasive respiratory support is effective or safe in preventing respiratory failure in preterm infants. Large, adequately powered randomised controlled trials are needed to determine if diaphragm-triggered non-invasive respiratory support in preterm infants is effective or safe.\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": "There is limited data from randomised controlled trials to determine the effect of diaphragm-triggered non-invasive respiratory support on important outcomes. We were able to include only two small randomised controlled trials in the review. Both studies involved infants switching from one type of support to the other and were focused on short-term changes in breathing patterns."
}
] |
query-laysum
|
7962
|
[
{
"role": "user",
"content": "Abstract: Background\nCervical intra-epithelial neoplasia (CIN) typically occurs in young women of reproductive age. Although several studies have reported the impact that cervical conservative treatment may have on obstetric outcomes, there is much less evidence for fertility and early pregnancy outcomes.\nObjectives\nTo assess the effect of cervical treatment for CIN (excisional or ablative) on fertility and early pregnancy outcomes.\nSearch methods\nWe searched in January 2015 the following databases: the Cochrane Gynaecological Cancer Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library, Issue 12, 2014), MEDLINE (up to November week 3, 2014) and EMBASE (up to week 52, 2014).\nSelection criteria\nWe included all studies reporting on fertility and early pregnancy outcomes (less than 24 weeks of gestation) in women with a history of CIN treatment (excisional or ablative) as compared to women that had not received treatment.\nData collection and analysis\nStudies were classified according to the treatment method used and the fertility or early pregnancy endpoint. Pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated using a random-effects model and inter-study heterogeneity was assessed with I2. Two review authors (MK, AM) independently assessed the eligibility of retrieved papers and risk of bias. The two review authors then compared their results and any disagreements were resolved by discussion. If still unresolved, a third review author (MA) was involved until consensus was reached.\nMain results\nFifteen studies (2,223,592 participants - 25,008 treated and 2,198,584 untreated) that fulfilled the inclusion criteria for this review were identified from the literature search. The meta-analysis demonstrated that treatment for CIN did not adversely affect the chances of conception. The overall pregnancy rate was higher for treated (43%) versus untreated women (38%; RR 1.29, 95% CI 1.02 to 1.64; 4 studies, 38,050 participants, very low quality), although the inter-study heterogeneity was considerable (P < 0.01). The pregnancy rates in treated and untreated women with an intention to conceive (88% versus 95%, RR 0.93, 95% CI 0.80 to 1.08; 2 studies, 70 participants, very low quality) and the number of women requiring more than 12 months to conceive (14% versus 9%, RR 1.45, 95% CI 0.89 to 2.37; 3 studies, 1348 participants, very low quality) were no different. Although the total miscarriage rate (4.6% versus 2.8%, RR 1.04, 95% CI 0.90 to 1.21; 10 studies, 39,504 participants, low quality) and first trimester miscarriage rate (9.8% versus 8.4%, RR 1.16, 95% CI 0.80 to 1.69, 4 studies, 1103 participants, low quality) was similar for treated and untreated women, CIN treatment was associated with an increased risk of second trimester miscarriage, (1.6% versus 0.4%, RR 2.60, 95% CI 1.45 to 4.67; 8 studies, 2,182,268 participants, low quality). The number of ectopic pregnancies (1.6% versus 0.8%, RR 1.89, 95% CI 1.50 to 2.39; 6 studies, 38,193 participants, low quality) and terminations (12.2% versus 7.4%, RR 1.71, 95% CI 1.31 to 2.22; 7 studies, 38,208 participants, low quality) were also higher in treated women.\nThe results should be interpreted with caution. The included studies were often small with heterogenous design. Most of these studies were retrospective and of low or very low quality (GRADE assessment) and were therefore prone to bias. Subgroup analyses for the individual treatment methods and comparison groups and analysis to stratify for the cone length was not possible.\nAuthors' conclusions\nThis meta-analysis suggests that treatment for CIN does not adversely affect fertility, although treatment was associated with an increased risk of miscarriage in the second trimester. These results should be interpreted with caution as the included studies were non-randomised and many were of low or very low quality and therefore at high risk of bias. Research should explore mechanisms that may explain the increase in mid-trimester miscarriage risk and stratify this impact of treatment by the length of the cone and the treatment method used.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to assess whether treatment for this cancer - cervical intra-epithelial neoplasia (CIN) - adversely affects the chances of a successful conception and pregnancy outcomes in the first and second trimesters (less than 24 weeks of gestation)."
}
] |
query-laysum
|
7963
|
[
{
"role": "user",
"content": "Abstract: Background\nSpecialised disease management programmes for heart failure aim to improve care, clinical outcomes and/or reduce healthcare utilisation. Since the last version of this review in 2010, several new trials of structured telephone support and non-invasive home telemonitoring have been published which have raised questions about their effectiveness.\nObjectives\nTo review randomised controlled trials (RCTs) of structured telephone support or non-invasive home telemonitoring compared to standard practice for people with heart failure, in order to quantify the effects of these interventions over and above usual care.\nSearch methods\nWe updated the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology AsseFssment Database (HTA) on the Cochrane Library; MEDLINE (OVID), EMBASE (OVID), CINAHL (EBSCO), Science Citation Index Expanded (SCI-EXPANDED), Conference Proceedings Citation Index- Science (CPCI-S) on Web of Science (Thomson Reuters), AMED, Proquest Theses and Dissertations, IEEE Xplore and TROVE in January 2015. We handsearched bibliographies of relevant studies and systematic reviews and abstract conference proceedings. We applied no language limits.\nSelection criteria\nWe included only peer-reviewed, published RCTs comparing structured telephone support or non-invasive home telemonitoring to usual care of people with chronic heart failure. The intervention or usual care could not include protocol-driven home visits or more intensive than usual (typically four to six weeks) clinic follow-up.\nData collection and analysis\nWe present data as risk ratios (RRs) with 95% confidence intervals (CIs). Primary outcomes included all-cause mortality, all-cause and heart failure-related hospitalisations, which we analysed using a fixed-effect model. Other outcomes included length of stay, health-related quality of life, heart failure knowledge and self care, acceptability and cost; we described and tabulated these. We performed meta-regression to assess homogeneity (the null hypothesis) in each subgroup analysis and to see if the effect of the intervention varied according to some quantitative variable (such as year of publication or median age).\nMain results\nWe include 41 studies of either structured telephone support or non-invasive home telemonitoring for people with heart failure, of which 17 were new and 24 had been included in the previous Cochrane review. In the current review, 25 studies evaluated structured telephone support (eight new studies, plus one study previously included but classified as telemonitoring; total of 9332 participants), 18 evaluated telemonitoring (nine new studies; total of 3860 participants). Two of the included studies trialled both structured telephone support and telemonitoring compared to usual care, therefore 43 comparisons are evident.\nNon-invasive telemonitoring reduced all-cause mortality (RR 0.80, 95% CI 0.68 to 0.94; participants = 3740; studies = 17; I² = 24%, GRADE: moderate-quality evidence) and heart failure-related hospitalisations (RR 0.71, 95% CI 0.60 to 0.83; participants = 2148; studies = 8; I² = 20%, GRADE: moderate-quality evidence). Structured telephone support reduced all-cause mortality (RR 0.87, 95% CI 0.77 to 0.98; participants = 9222; studies = 22; I² = 0%, GRADE: moderate-quality evidence) and heart failure-related hospitalisations (RR 0.85, 95% CI 0.77 to 0.93; participants = 7030; studies = 16; I² = 27%, GRADE: moderate-quality evidence).\nNeither structured telephone support nor telemonitoring demonstrated effectiveness in reducing the risk of all-cause hospitalisations (structured telephone support: RR 0.95, 95% CI 0.90 to 1.00; participants = 7216; studies = 16; I² = 47%, GRADE: very low-quality evidence; non-invasive telemonitoring: RR 0.95, 95% CI 0.89 to 1.01; participants = 3332; studies = 13; I² = 71%, GRADE: very low-quality evidence).\nSeven structured telephone support studies reported length of stay, with one reporting a significant reduction in length of stay in hospital. Nine telemonitoring studies reported length of stay outcome, with one study reporting a significant reduction in the length of stay with the intervention. One telemonitoring study reported a large difference in the total number of hospitalisations for more than three days, but this was not an analysis of length of stay per hospitalisation. Nine of 11 structured telephone support studies and five of 11 telemonitoring studies reported significant improvements in health-related quality of life. Nine structured telephone support studies and six telemonitoring studies reported costs of the intervention or cost effectiveness. Three structured telephone support studies and one telemonitoring study reported a decrease in costs and two telemonitoring studies reported increases in cost, due both to the cost of the intervention and to increased medical management. Adherence was rated between 55.1% and 98.5% for those structured telephone support and telemonitoring studies which reported this outcome. Participant acceptance of the intervention was reported in the range of 76% to 97% for studies which evaluated this outcome. Seven of nine studies that measured these outcomes reported significant improvements in heart failure knowledge and self-care behaviours.\nAuthors' conclusions\nFor people with heart failure, structured telephone support and non-invasive home telemonitoring reduce the risk of all-cause mortality and heart failure-related hospitalisations; these interventions also demonstrated improvements in health-related quality of life and heart failure knowledge and self-care behaviours. Studies also demonstrated participant satisfaction with the majority of the interventions which assessed this outcome.\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": "In the context of limited health funding and a rapidly expanding population of older people, it is increasingly difficult for healthcare systems to provide high-quality care to those with heart failure. Multidisciplinary specialist heart failure clinics are available only to a minority of people and do not have the capacity for frequent patient review. Patients may be unwilling or unable to make frequent clinic attendance due to cost, difficulty with transport or disability and frailty. Structured telephone support and telemonitoring can provide specialised heart failure care to a large number of people with limited access to healthcare services."
}
] |
query-laysum
|
7964
|
[
{
"role": "user",
"content": "Abstract: Background\nVirtual reality (VR) computer technology creates a simulated environment, perceived as comparable to the real world, with which users can actively interact. The effectiveness of VR distraction on acute pain intensity in children is uncertain.\nObjectives\nTo assess the effectiveness and adverse effects of virtual reality (VR) distraction interventions for children (0 to 18 years) with acute pain in any healthcare setting.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and four trial registries to October 2019. We also searched reference lists of eligible studies, handsearched relevant journals and contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs), including cross-over and cluster-RCTs, comparing VR distraction to no distraction, non-VR distraction or other VR distraction.\nData collection and analysis\nWe used standard Cochrane methodological processes. Two reviewers assessed risk of bias and extracted data independently. The primary outcome was acute pain intensity (during procedure, and up to one hour post-procedure). Secondary outcomes were adverse effects, child satisfaction with VR, pain-related distress, parent anxiety, rescue analgesia and cost. We used GRADE and created 'Summary of findings' tables.\nMain results\nWe included 17 RCTs (1008 participants aged four to 18 years) undergoing various procedures in healthcare settings. We did not pool data because the heterogeneity in population (i.e. diverse ages and developmental stages of children and their different perceptions and reactions to pain) and variations in procedural conditions (e.g. phlebotomy, burn wound dressings, physical therapy sessions), and consequent level of pain experienced, made statistical pooling of data impossible. We narratively describe results.\nWe judged most studies to be at unclear risk of selection bias, high risk of performance and detection bias, and high risk of bias for small sample sizes. Across all comparisons and outcomes, we downgraded the certainty of evidence to low or very low due to serious study limitations and serious or very serious indirectness. We also downgraded some of the evidence for very serious imprecision.\n1: VR distraction versus no distraction\nAcute pain intensity: during procedure\nSelf-report: one study (42 participants) found no beneficial effect of non-immersive VR (very low-certainty evidence).\nObserver-report: no data.\nBehavioural measurements (observer-report): two studies, 62 participants; low-certainty evidence. One study (n = 42) found no beneficial effect of non-immersive VR. One study (n = 20) found a beneficial effect favouring immersive VR.\nAcute pain intensity: post-procedure\nSelf-report: 10 studies, 461 participants; very low-certainty evidence. Four studies (n = 95) found no beneficial effect of immersive and semi-immersive or non-immersive VR. Five studies (n = 357) found a beneficial effect favouring immersive VR. Another study (n = 9) reported less pain in the VR group.\nObserver-report: two studies (216 participants; low-certainty evidence) found a beneficial effect of immersive VR, as reported by primary caregiver/parents or nurses. One study (n = 80) found a beneficial effect of immersive VR, as reported by researchers.\nBehavioural measurements (observer-report): one study (42 participants) found no beneficial effect of non-immersive VR (very low-certainty evidence).\nAdverse effects: five studies, 154 participants; very low-certainty evidence. Three studies (n = 53) reported no adverse effects. Two studies (n = 101) reported mild adverse effects (e.g. nausea) in the VR group.\n2: VR distraction versus other non-VR distraction\nAcute pain intensity:during procedure\nSelf-report, observer-report and behavioural measurements (observer-report): two studies, 106 participants:\nSelf-report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (very low-certainty evidence).\nObserver-report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (low-certainty evidence).\nBehavioural measurements (observer-report): one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) reported a difference in mean pain change scores with fewer pain behaviours in VR group (low-certainty evidence).\nAcute pain intensity: post-procedure\nSelf-report: eight studies, 575 participants; very low-certainty evidence. Two studies (n = 146) found a beneficial effect favouring immersive VR. Two studies (n = 252) reported a between-group difference favouring immersive VR. One study (n = 59) found no beneficial effect of immersive VR versus television and Child Life non-VR distraction. One study (n = 18) found no beneficial effect of semi-immersive VR. Two studies (n = 100) reported no between-group difference.\nObserver-report: three studies, 187 participants; low-certainty evidence. One study (n = 81) found a beneficial effect favouring immersive VR for parent, nurse and researcher reports. One study (n = 65) found a beneficial effect favouring immersive VR for caregiver reports. Another study (n = 41) reported no evidence of a difference in mean pain change scores.\nBehavioural measurements (observer-report): two studies, 106 participants; low-certainty evidence. One study (n = 65) found a beneficial effect favouring immersive VR. Another study (n = 41) reported no evidence of a difference in mean pain change scores.\nAdverse effects: six studies, 429 participants; very low-certainty evidence. Three studies (n = 229) found no evidence of a difference between groups. Two studies (n = 141) reported no adverse effects in VR group. One study (n = 59) reported no beneficial effect in reducing estimated cyber-sickness before and after VR immersion.\n3: VR distraction versus other VR distraction\nWe did not identify any studies for this comparison.\nAuthors' conclusions\nWe found low-certainty and very low-certainty evidence of the effectiveness of VR distraction compared to no distraction or other non-VR distraction in reducing acute pain intensity in children in any healthcare setting. This level of uncertainty makes it difficult to interpret the benefits or lack of benefits of VR distraction for acute pain in children. Most of the review primary outcomes were assessed by only two or three small studies. We found limited data for adverse effects and other secondary outcomes. Future well-designed, large, high-quality trials may have an important impact on our confidence in the results.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Medical procedures, such as health examinations or injections, can cause children to experience pain. In these situations, it is common practice to distract children using toys or play, in order to minimise distress and fear of pain.\nOne form of distraction that can be used is virtual reality. Virtual reality is an artificial environment with scenes and objects that appear to be real (for example a frozen world, or a wildlife park). Virtual reality can be:\n- Fully-immersive: users typically wear a headset with headphones and a screen, and interact with the virtual environment as if they were really in it.\n- Semi-immersive: users interact with a partially virtual environment (for example, a flight simulator where the controls are real, but the windows display virtual images).\n- Non-immersive: the user is connected to the virtual world by a separate monitor (for example, a computer) but can still experience the real world.\nTo find out whether virtual reality can distract children from pain, and whether it is associated with any adverse (unwanted) effects, we reviewed the research evidence."
}
] |
query-laysum
|
7965
|
[
{
"role": "user",
"content": "Abstract: Background\nStillbirth affects at least 2.6 million families worldwide every year and has enduring consequences for parents and health services. Parents entering a subsequent pregnancy following stillbirth face a risk of stillbirth recurrence, alongside increased risks of other adverse pregnancy outcomes and psychosocial challenges. These parents may benefit from a range of interventions to optimise their short- and longer-term medical health and psychosocial well-being.\nObjectives\nTo assess the effects of different interventions or models of care prior to and during subsequent pregnancies following stillbirth on maternal, fetal, neonatal and family health outcomes, and health service utilisation.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 June 2018), along with ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (18 June 2018).\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised controlled trials (qRCTs). Trials using a cluster-randomised design were eligible for inclusion, but we found no such reports. We included trials published as abstract only, provided sufficient information was available to allow assessment of trial eligibility and risk of bias. We excluded cross-over trials.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and undertook data extraction and 'Risk of bias' assessments. We extracted data from published reports, or sourced data directly from trialists. We checked the data for accuracy and resolved discrepancies by discussion or correspondence with trialists, or both. We conducted an assessment of the quality of the evidence using the GRADE approach.\nMain results\nWe included nine RCTs and one qRCT, and judged them to be at low to moderate risk of bias. Trials were carried out between the years 1964 and 2015 and took place predominantly in high-income countries in Europe. All trials assessed medical interventions; no trials assessed psychosocial interventions or incorporated psychosocial aspects of care. Trials evaluated the use of antiplatelet agents (low-dose aspirin (LDA) or low-molecular-weight heparin (LMWH), or both), third-party leukocyte immunisation, intravenous immunoglobulin, and progestogen. Trial participants were women who were either pregnant or attempting to conceive following a pregnancy loss, fetal death, or adverse outcome in a previous pregnancy.\nWe extracted data for 222 women who had experienced a previous stillbirth of 20 weeks' gestation or more from the broader trial data sets, and included them in this review. Our GRADE assessments of the quality of evidence ranged from very low to low, due largely to serious imprecision in effect estimates as a result of small sample sizes, low numbers of events, and wide confidence intervals (CIs) crossing the line of no effect. Most of the analyses in this review were not sufficiently powered to detect differences in the outcomes assessed. The results presented are therefore largely uncertain.\nMain comparisons\nLMWH versus no treatment/standard care (three RCTs, 123 women, depending on the outcome)\nIt was uncertain whether LMWH reduced the risk of stillbirth (risk ratio (RR) 2.58, 95% CI 0.40 to 16.62; 3 trials; 122 participants; low-quality evidence), adverse perinatal outcome (RR 0.81, 95% CI 0.20 to 3.32; 2 trials; 77 participants; low-quality evidence), adverse maternal psychological effects (RR 1.00, 95% CI 0.07 to 14.90; 1 trial; 40 participants; very low-quality evidence), perinatal mortality (RR 2.58, 95% CI 0.40 to 16.62; 3 trials; 122 participants; low-quality evidence), or any preterm birth (< 37 weeks) (RR 1.01, 0.58 to 1.74; 3 trials; 114 participants; low-quality evidence). No neonatal deaths were reported in the trials assessed and no data were available for maternal-infant attachment. There was no clear evidence of a difference between the groups among the remaining secondary outcomes.\nLDA versus placebo (one RCT, 24 women)\nIt was uncertain whether LDA reduced the risk of stillbirth (RR 0.85, 95% CI 0.06 to 12.01), neonatal death (RR 0.29, 95% CI 0.01 to 6.38), adverse perinatal outcome (RR 0.28, 95% CI 0.03 to 2.34), perinatal mortality, or any preterm birth (< 37 weeks) (both of the latter RR 0.42, 95% CI 0.04 to 4.06; all very low-quality evidence). No data were available for adverse maternal psychological effects or maternal-infant attachment. LDA appeared to be associated with an increase in birthweight (mean difference (MD) 790.00 g, 95% CI 295.03 to 1284.97 g) when compared to placebo, but this result was very unstable due to the extremely small sample size. Whether LDA has any effect on the remaining secondary outcomes was also uncertain.\nOther comparisons\nLDA appeared to be associated with an increase in birthweight when compared to LDA + LMWH (MD −650.00 g, 95% CI −1210.33 to −89.67 g; 1 trial; 29 infants), as did third-party leukocyte immunisation when compared to placebo (MD 1195.00 g, 95% CI 273.35 to 2116.65 g; 1 trial, 4 infants), but these results were again very unstable due to extremely small sample sizes. The effects of the interventions on the remaining outcomes were also uncertain.\nAuthors' conclusions\nThere is insufficient evidence in this review to inform clinical practice about the effectiveness of interventions to improve care prior to and during subsequent pregnancies following a stillbirth. There is a clear and urgent need for well-designed trials addressing this research question. The evaluation of medical interventions such as LDA, in the specific context of stillbirth prevention (and recurrent stillbirth prevention), is warranted. However, appropriate methodologies to evaluate such therapies need to be determined, particularly where clinical equipoise may be lacking. Careful trial design and multicentre collaboration is necessary to carry out trials that would be sufficiently large to detect differences in statistically rare outcomes such as stillbirth and neonatal death. The evaluation of psychosocial interventions addressing maternal-fetal attachment and parental anxiety and depression is also an urgent priority. In a randomised-trial context, such trials may allocate parents to different forms of support, to determine which have the greatest benefit with the least financial cost. Importantly, consistency in nomenclature and in data collection across all future trials (randomised and non-randomised) may be facilitated by a core outcomes data set for stillbirth research. All future trials should assess short- and longer-term psychosocial outcomes for parents and families, alongside economic costs of interventions.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Parents who have had a stillborn baby are more likely to have another stillbirth than parents who have not had a stillborn baby before. In their next pregnancy, parents often experience anxiety and depression, and ongoing worry about whether their baby will survive. It is important to be able to work out from high-quality clinical studies which interventions are helpful in preventing stillbirth from happening again, and in improving the health and well-being of these parents and families."
}
] |
query-laysum
|
7966
|
[
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not achieve a satisfactory treatment response with their initial antipsychotic drug treatment. Sometimes a second antipsychotic, in combination with the first, is used in these situations.\nObjectives\nTo examine whether:\n1. treatment with antipsychotic combinations is effective for schizophrenia; and\n2. treatment with antipsychotic combinations is safe for the same illness.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's register which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. There are no language, time, document type, or publication status limitations for inclusion of records in the register. We ran searches in September 2010, August 2012 and January 2016. We checked for additional trials in the reference lists of included trials.\nSelection criteria\nWe included all randomised and quasi-randomised controlled trials comparing antipsychotic combinations with antipsychotic monotherapy for the treatment of schizophrenia and/or schizophrenia-like psychoses.\nData collection and analysis\nWe independently extracted data from the included studies. We analysed dichotomous data using risk ratios (RR) and the 95% confidence intervals (CI). We analysed continuous data using mean difference (MD) with a 95% CIs. For the meta-analysis we used a random-effects model. We used GRADE to complete a 'Summary of findings' table and assessed risk of bias for included studies.\nMain results\nSixty-two studies are included in the review, 31 of these compared clozapine monotherapy with clozapine combination. We considered the risk of bias in the included studies to be moderate to high. The majority of trials had unclear allocation concealment, method of randomisation and blinding, and were not free of selective reporting.\nThere is some limited evidence that combination therapy may be superior to monotherapy in reducing the risk of no clinical response (RR 0.73 CI 0.64 to 0.83; participants = 2398; studies = 29; very low-quality evidence), subgroup analyses show that the positive result was due to the studies with clozapine in both the monotherapy and combination groups (RR 0.66 CI 0.53 to 0.83; participants = 1127; studies = 17) and typical in both groups (RR 0.64 CI 0.49 to 0.84; participants = 597; studies = 5). The subgroup with atypical antipsychotics in both groups did not showed a difference between the two interventions (RR 0.95 CI 0.83 to 1.09; participants = 674; studies = 7). Three studies provided data regarding relapse, the pooled data showed high heterogeneity (I² = 82%) and therefore the results were not pooled. Two studies showed no difference between the interventions and one study showed that antipsychotics combination might decrease the risk of relapse. A combination of antipsychotics was not superior or inferior to antipsychotic monotherapy in reducing the number of participants discontinuing treatment early (RR 0.90 CI 0.76 to 1.07; participants = 3137; studies = 43, low-quality evidence). No difference was found between treatment groups in the number of participants hospitalised (RR 0.96 CI 0.36 to 2.55; participants = 202; studies = 3, very low-quality evidence). We did not find evidence of a difference between treatment groups in serious adverse events or those requiring discontinuation (RR 1.05 CI 0.65 to 1.69; participants = 2398; studies = 30, very low-quality evidence). There is a lack of evidence on clinically important change in quality of life, with only four studies reporting average endpoint or change data for this outcome on three different scales, none of which showed a difference between treatment groups.\nAuthors' conclusions\nCurrently, most evidence regarding the use of antipsychotic combinations comes from short-term trials, limiting the assessment of long-term efficacy and safety. We found very low-quality evidence that a combination of antipsychotics may improve the clinical response. We also found very low-quality evidence that a combination of antipsychotics may make no difference at preventing participants from leaving the study early, preventing relapse and/or causing more serious adverse events than monotherapy.\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": "These results show that there may be some clinical benefit for combination therapy in that more people receiving a combination of antipsychotic showed an improvement in symptoms. For other important outcomes such as relapse, hospitalisation, adverse events, discontinuing treatment or leaving the study early, no clear differences between the two treatment options were observed. However, these results are based on very low or low-quality evidence and more research providing high-quality evidence is needed before firm conclusions can be made.\nThis plain language summary has been adapted from an original summary by Benjamin Gray, Service User and Service User Expert, Rethink Mental Illness. Email: [email protected]"
}
] |
query-laysum
|
7967
|
[
{
"role": "user",
"content": "Abstract: Background\nNutrition is an important aspect of management in severe acute pancreatitis. Enteral nutrition has advantages over parenteral nutrition and is the preferred method of feeding. Enteral feeding via nasojejunal tube is often recommended, but its benefits over nasogastric feeding are unclear. The placement of a nasogastric tube is technically simpler than the placement of a nasojejunal tube.\nObjectives\nTo compare the mortality, morbidity, and nutritional status outcomes of people with severe acute pancreatitis fed via nasogastric tube versus nasojejunal tube.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and LILACS on 17 October 2019 without using any language restrictions. We also searched reference lists and conference proceedings for relevant studies and clinical trial registries for ongoing trials. We contacted authors for additional information.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing enteral feeding by nasogastric and nasojejunal tubes in participants with severe acute pancreatitis.\nData collection and analysis\nTwo review authors independently screened studies for inclusion, assessed risk of bias of the included studies, and extracted data. This information was independently verified by the other review authors. We used standard methods expected by Cochrane to assess the risk of bias and perform data synthesis. We rated the certainty of evidence according to GRADE.\nMain results\nWe included five RCTs that randomised a total of 220 adult participants from India, Scotland, and the USA. Two of the trial reports were available only as abstracts. The trials differed in the criteria used to rate the severity of acute pancreatitis, and three trials excluded those who presented in severe shock. The duration of onset of symptoms before presentation in the trials ranged from within one week to four weeks. The trials also differed in the methods used to confirm the placement of the tubes and in what was considered to be nasojejunal placement. We assessed none of the trials as at high risk of bias, though reporting of methods in four trials was insufficient to judge the risk of bias for one or more of the domains assessed.\nThere was no evdence of effect with nasogastric or nasojejunal placement on the primary outcome of mortality (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.36 to 1.17; I2 = 0%; 5 trials, 220 participants; very low-certainty evidence due to indirectness and imprecision). Similarly, there was no evidence of effect on the secondary outcomes for which data were available. These included organ failure (3 trials, 145 participants), rate of infection (2 trials, 108 participants), success rate (3 trials, 159 participants), complications associated with the procedure (2 trials, 80 participants), need for surgical intervention (3 trials, 145 participants), requirement of parenteral nutrition (2 trials, 80 participants), complications associated with feeds (4 trials, 195 participants), and exacerbation of pain (4 trials, 195 participants). However, the certainty of the evidence for these secondary outcomes was also very low due to indirectness and imprecision. Three trials (117 participants) reported on length of hospital stay, but the data were not suitable for meta-analysis. None of the trials reported data suitable for meta-analysis for the other secondary outcomes of this review, which included days taken to achieve full nutrition requirement, duration of tube feeding, and duration of analgesic requirement after feeding tube placement.\nAuthors' conclusions\nThere is insufficient evidence to conclude that there is superiority, inferiority, or equivalence between the nasogastric and nasojejunal mode of enteral tube feeding in people with severe acute pancreatitis.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of evidence was very low for all outcomes. Our confidence in the evidence was reduced due to the small numbers of people studied, which led to imprecise results, and the methods used in some of the studies for diagnosis and treatment which differed from currently accepted methods."
}
] |
query-laysum
|
7968
|
[
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers are treated by reducing pressure on the areas of damaged skin. Special support surfaces (including beds, mattresses and cushions) designed to redistribute pressure, are widely used as treatments. The relative effects of different support surfaces are unclear. This is an update of an existing review.\nObjectives\nTo assess the effects of pressure-relieving support surfaces in the treatment of pressure ulcers.\nSearch methods\nIn September 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase 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 published or unpublished randomised controlled trials (RCTs), that assessed the effects of support surfaces for treating pressure ulcers, in any participant group or setting.\nData collection and analysis\nData extraction, assessment of 'Risk of bias' and GRADE assessments were performed independently by two review authors. Trials with similar participants, comparisons and outcomes were considered for meta-analysis. Where meta-analysis was inappropriate, we reported the results of the trials narratively. Where possible, we planned to report data as either risk ratio or mean difference as appropriate.\nMain results\nFor this update we identified one new trial of support surfaces for pressure ulcer treatment, bringing the total to 19 trials involving 3241 participants. Most trials were small, with sample sizes ranging from 20 to 1971, and were generally at high or unclear risk of bias.\nPrimary outcome: healing of existing pressure ulcers\nLow-tech constant pressure support surfaces\nIt is uncertain whether profiling beds increase the proportion of pressure ulcer which heal compared with standard hospital beds as the evidence is of very low certainty: (RR 3.96, 95% CI 1.28 to 12.24), downgraded for serious risk of bias, serious imprecision and indirectness (1 study; 70 participants).\nThere is currently no clear difference in ulcer healing between water-filled support surfaces and foam replacement mattresses: (RR 0.93, 95% CI 0.63 to 1.37); low-certainty evidence downgraded for serious risk of bias and serious imprecision (1 study; 120 participants).\nFurther analysis could not be performed for polyester overlays versus gel overlays (1 study; 72 participants), non-powered mattresses versus low-air-loss mattresses (1 study; 20 participants) or standard hospital mattresses with sheepskin overlays versus standard hospital mattresses (1 study; 36 participants).\nHigh-tech pressure support surfaces\nIt is currently unclear whether high-tech pressure support surfaces (such as low-air-loss beds, air suspension beds, and alternating pressure surfaces) improve the healing of pressure ulcers (14 studies; 2923 participants) or which intervention may be more effective. The certainty of the evidence is generally low, downgraded mostly for risk of bias, indirectness and imprecision.\nSecondary outcomes\nNo analyses were undertaken with respect to secondary outcomes including participant comfort and surface reliability and acceptability as reporting of these within the included trials was very limited.\nOverall, the evidence is of low to very low certainty and was primarily downgraded due to risk of bias and imprecision with some indirectness.\nAuthors' conclusions\nBased on the current evidence, it is unclear whether any particular type of low- or high-tech support surface is more effective at healing pressure ulcers than standard support surfaces.\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": "In September 2017, we searched for trials looking at support surfaces for treating pressure ulcers and which reported their effects on wound healing. We found 19 trials involving 3241 participants, all adults, the majority of whom were older people and bed-bound in hospitals or nursing homes. In studies where participants' sex was reported, the majority were women. Not all studies reported their funding sources, but two of those who did were funded by device manufacturers.\nFive studies involving 318 participants compared low-tech constant low-pressure (CLP) support surfaces such as foam mattresses. We cannot be certain how these different support surfaces affect pressure ulcer healing as the evidence is mainly of low certainty. Fourteen studies involving 2923 participants compared different high-tech support surfaces such as air-fluidised beds. Again, we cannot be certain how these different support surfaces affect ulcer healing rates as the certainty of the evidence is mainly low.\nWe are not able to draw firm conclusions about the effects of different support surfaces for treating pressure ulcers because the overall quality of the evidence is low to very low. Many of the studies included only small numbers of people, did not provide adequate information on their results, or were not well designed. Further, better conducted trials are necessary to determine which support surfaces are most effective in treating pressure ulcers."
}
] |
query-laysum
|
7969
|
[
{
"role": "user",
"content": "Abstract: Background\nTopically-applied fluoride varnishes have been used extensively as an operator-applied caries-preventive intervention for over three decades. This review updates the first Cochrane review of fluoride varnishes for preventing dental caries in children and adolescents, which was first published in 2002.\nObjectives\nTo determine the effectiveness and safety of fluoride varnishes in preventing dental caries in children and adolescents, and to examine factors potentially modifying their effect.\nSearch methods\nWe searched the Cochrane Oral Health Group's Trials Register (to 13 May 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 4), MEDLINE via OVID (1946 to 13 May 2013), EMBASE via OVID (1980 to 13 May 2013), CINAHL via EBSCO (1980 to 13 May 2013), LILACS and BBO via the BIREME Virtual Health Library (1980 to 13 May 2013), ProQuest Dissertations and Theses (1861 to 13 May 2013), and Web of Science Conference Proceedings (1945 to 13 May 2013). A search for ongoing trials was undertaken on ClinicalTrials.gov on 13 May 2013. There were no restrictions on language or date of publication in the search of the electronic databases.\nSelection criteria\nRandomised or quasi-randomised controlled trials with blind outcome assessment used or indicated, comparing topically-applied fluoride varnish with placebo or no treatment in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in both permanent (D(M)FS) and primary (d(e/m)fs) teeth.\nData collection and analysis\nAt least two review authors assessed all search results, extracted data and undertook risk of bias independently. Study authors were contacted for additional information. The primary measure of effect was the prevented fraction, that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. The caries increments nearest to three years were used from each included study. Random-effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random-effects meta-regression analyses. Adverse effects information was collected from the included trials.\nMain results\nTwenty-two trials with 12,455 participants randomised (9595 used in analyses) were included. For the 13 that contributed data for the permanent tooth surfaces meta-analysis, the pooled D(M)FS prevented fraction estimate comparing fluoride varnish with placebo or no treatment was 43% (95% confidence interval (CI) 30% to 57%; P < 0.0001). There was substantial heterogeneity, confirmed statistically (P < 0.0001; I2 = 75%), however this body of evidence was assessed as of moderate quality. The pooled d(e/m)fs prevented fraction estimate was 37% (95% CI 24% to 51%; P < 0.0001) for the 10 trials that contributed data for the primary tooth surfaces meta-analysis, also with some heterogeneity (P = 0.009; I2 = 59%). Once again this body of evidence was assessed as of moderate quality. No significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the pre-specified factors of baseline caries severity, background exposure to fluorides, application features such as prior prophylaxis, concentration of fluoride, frequency of application were found. There was also no significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the post hoc factors: whether a placebo or no treatment control was used, length of follow-up, or whether individual or cluster randomisation was used, in the meta-regression models. A funnel plot of the trials in the main meta-analyses indicated no clear relationship between prevented fraction and study precision. In both methods, power is limited when few trials are included. There was little information concerning possible adverse effects or acceptability of treatment.\nAuthors' conclusions\nThe conclusions of this updated review remain the same as those when it was first published. The review suggests a substantial caries-inhibiting effect of fluoride varnish in both permanent and primary teeth, however the quality of the evidence was assessed as moderate, as it included mainly high risk of bias studies, with considerable heterogeneity.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review of existing studies was carried out by the Cochrane Oral Health Group and the evidence is current up to 13 May 2013.\nIn this updated review there are now 22 trials published between 1975 and 2012 in which a total of 12,455 children were randomised to treatment with either fluoride varnish or placebo/no treatment. Study duration ranged from one to five years among included trials (12 of these lasted two years)."
}
] |
query-laysum
|
7970
|
[
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding is one of the most common reasons for referral of premenopausal women to a gynaecologist. Although medical therapy is generally first line, many women eventually will require further treatment. Endometrial ablation by hysteroscopic and more recent \"second-generation\" devices such as balloon, radiofrequency or microwave ablation offers a day-case surgical alternative to hysterectomy. Complete endometrial destruction is one of the main determinants of treatment success. Surgery is most effective if undertaken when endometrial thickness is less than four millimeters. One option is to perform the surgery in the immediate postmenstrual phase, which is not always practical. The other option is to use hormonal agents that induce endometrial thinning pre-operatively. The most commonly evaluated agents are goserelin (a gonadotrophin-releasing hormone analogue, or GnRHa) and danazol. Other GnRH analogues and progestogens have also been studied, although fewer data are available. It has been suggested that these agents will reduce operating time, improve the intrauterine operating environment and reduce absorption of fluid used for intraoperative uterine cavity distension. They may also improve long-term outcomes, including menstrual loss and dysmenorrhoea.\nObjectives\nTo investigate the effectiveness and safety of pre-operative endometrial thinning agents (GnRH agonists, danazol, estrogen-progestins and progestogens) versus another agent or placebo when given before endometrial destruction in premenopausal women with heavy menstrual bleeding.\nSearch methods\nThe following electronic databases were searched to April 2013 for published and unpublished randomised controlled trials that met the inclusion criteria: the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of controlled trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO.\nOther electronic sources of trials included trial registers for ongoing and registered trials; citation indexes; conference abstracts in the Web of Knowledge; the LILACS database for trials from the Portuguese- and Spanish-speaking world; PubMed; and the OpenSIGLE database and Google for grey literature.\nAll searches were performed in consultation with the MDSG Trials Search Co-ordinator.\nSelection criteria\nRandomised controlled trials (RCTs) were included if they compared the effects of these agents with one other, or with placebo or no treatment, on relevant intraoperative and postoperative treatment outcomes. Selection of trials was carried out independently by two review authors.\nData collection and analysis\nTwo review authors independently assessed studies for risk of bias and extracted data on surgical outcomes, effectiveness outcomes, proportion of women requiring further surgical therapy during follow-up, endometrial outcome measures, acceptability of use outcomes and quality of life. Data were analysed on an intention-to-treat basis. Dichotomous data were combined for meta-analysis with RevMan software using the Mantel-Haenszel method to estimate pooled risk ratios (RRs). Continuous data were combined for meta-analysis with RevMan software using an inverse variance method to estimate the pooled mean difference (MD) with 95% confidence interval (CI). The overall quality of evidence for the main findings was assessed with the use of GRADE working group methods.\nMain results\nTwenty studies with 1969 women were included in this review. These studies compared GnRHa, danazol and progestogens versus placebo or no treatment; GnRHa versus danazol, progestogens, GnRH antagonists or dilatation & curettage; and danazol versus progestogens. Four studies performed more than one comparison.\nWhen compared with no treatment, GnRHa used before hysteroscopic resection were associated with a higher rate of postoperative amenorrhoea at 12 months (RR 1.6, 95% CI 1.2 to 2.0, 7 RCTs, 605 women, moderate heterogeneity; I2 = 40%) and at 24 months (RR 1.62, 95% CI 1.04 to 2.52, 2 RCTs, 357 women, no heterogeneity; I2 = 0%), a slightly shorter duration of surgery (-3.5 minutes, 95% CI -4.7 to -2.3, 5 RCTs, 156 women, substantial heterogeneity; I2 = 72%) and greater ease of surgery (RR 0.32, 95% CI 0.22 to 0.46, 2 RCTs, 415 women, low heterogeneity; I2 = 4%). Postoperative dysmenorrhoea was reduced (RR 0.59, 95% CI 0.40 to 0.87, 2 RCTs, 133 women, no heterogeneity; I2 = 0%). The use of GnRHa had no effect on intraoperative complication rates (RR 1.47, 95% CI 0.35 to 6.06, 5 RCTs, 592 women, no heterogeneity; I2 = 0%), and participant satisfaction with this surgery was high irrespective of the use of pre-operative endometrial thinning agents (RR 0.99, 95% CI 0.93 to 1.05, 6 RCTs, 599 women, low heterogeneity; I2 = 11%). GnRHa produced more consistent endometrial atrophy than was produced by danazol (RR 1.84, 95% CI 1.23 to 2.75, 2 RCTs, 142 women, no heterogeneity; I2 = 0%). For other intraoperative and postoperative outcomes, any differences were minimal, and no benefits of GnRHa pretreatment were noted in studies in which women underwent second-generation ablation techniques. Both GnRHa and danazol produced side effects in a significant proportion of women, although few studies reported these in detail. Few randomised data were available to allow assessment of the effectiveness of progestogens as endometrial thinning agents. When reported, the long-term effects of endometrial thinning agents on benefits such as postoperative amenorrhoea were reduced with time.\nThe main study weaknesses were that most participants received no follow-up beyond 24 months and that the studies used a small sample size. Heterogeneity for outcomes reported ranged from none to substantial. More than half the trials had no blinding of participants or outcome assessment. Most of the trials were determined to have uncertain selection and reporting bias, as they did not report allocation concealment and evidence of selective reporting was noted. The quality of reporting of adverse events was generally poor, but, when described in the studies, they included menopausal symptoms such as hot flushes, vaginal dryness, hirsutism, decreased libido and voice changes, as well as other side effects such as headache and weight gain.\nAuthors' conclusions\nLow-quality evidence suggests that endometrial thinning with GnRHa and danazol before hysteroscopic surgery improves operating conditions and short-term postoperative outcomes. GnRHa produced slightly more consistent endometrial thinning than was produced by danazol, although both achieved satisfactory results. The effect of these agents on longer-term postoperative outcomes was reduced with time. No benefits of GnRHa pretreatment were apparent with second-generation ablation techniques. Also, side effects were more common when these agents were used.\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": "Heavy menstrual bleeding is one of the most common reasons why premenopausal women are referred to a gynaecologist; this condition can cause significant physical, emotional and social stress in a woman's life. Surgery to ablate the endometrium is a treatment option available for this condition that is less invasive than removal of the womb (i.e. hysterectomy). We wanted to discover whether using medications to thin the lining of the womb before endometrial destruction enhanced the effectiveness of surgery in reducing symptoms and improved operating conditions for the surgeon. We also wanted to evaluate the safety of these medications (i.e. observe whether side effects or surgical complications were increased). These medications included gonadotrophin-releasing hormone analogues (GnRH analogues), danazol and progestogens. Endometrial destruction surgery included either the older 'hysteroscopic' technique, whereby the lining of the womb is destroyed under direct vision, or the newer second-generation techniques, which include balloon, radiofrequency and microwave ablation."
}
] |
query-laysum
|
7971
|
[
{
"role": "user",
"content": "Abstract: Background\nSince the approval of tyrosine kinase inhibitors, angiogenesis inhibitors and immune checkpoint inhibitors, the treatment landscape for advanced renal cell carcinoma (RCC) has changed fundamentally. Today, combined therapies from different drug categories have a firm place in a complex first-line therapy. Due to the large number of drugs available, it is necessary to identify the most effective therapies, whilst considering their side effects and impact on quality of life (QoL).\nObjectives\nTo evaluate and compare the benefits and harms of first-line therapies for adults with advanced RCC, and to produce a clinically relevant ranking of therapies. Secondary objectives were to maintain the currency of the evidence by conducting continuous update searches, using a living systematic review approach, and to incorporate data from clinical study reports (CSRs).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, conference proceedings and relevant trial registries up until 9 February 2022. We searched several data platforms to identify CSRs.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating at least one targeted therapy or immunotherapy for first-line treatment of adults with advanced RCC. We excluded trials evaluating only interleukin-2 versus interferon-alpha as well as trials with an adjuvant treatment setting. We also excluded trials with adults who received prior systemic anticancer therapy if more than 10% of participants were previously treated, or if data for untreated participants were not separately extractable.\nData collection and analysis\nAll necessary review steps (i.e. screening and study selection, data extraction, risk of bias and certainty assessments) were conducted independently by at least two review authors. Our outcomes were overall survival (OS), QoL, serious adverse events (SAEs), progression-free survival (PFS), adverse events (AEs), the number of participants who discontinued study treatment due to an AE, and the time to initiation of first subsequent therapy. Where possible, analyses were conducted for the different risk groups (favourable, intermediate, poor) according to the International Metastatic Renal-Cell Carcinoma Database Consortium Score (IMDC) or the Memorial Sloan Kettering Cancer Center (MSKCC) criteria. Our main comparator was sunitinib (SUN). A hazard ratio (HR) or risk ratio (RR) lower than 1.0 is in favour of the experimental arm.\nMain results\nWe included 36 RCTs and 15,177 participants (11,061 males and 4116 females). Risk of bias was predominantly judged as being 'high' or 'some concerns' across most trials and outcomes. This was mainly due to a lack of information about the randomisation process, the blinding of outcome assessors, and methods for outcome measurements and analyses. Additionally, study protocols and statistical analysis plans were rarely available.\nHere we present the results for our primary outcomes OS, QoL, and SAEs, and for all risk groups combined for contemporary treatments: pembrolizumab + axitinib (PEM+AXI), avelumab + axitinib (AVE+AXI), nivolumab + cabozantinib (NIV+CAB), lenvatinib + pembrolizumab (LEN+PEM), nivolumab + ipilimumab (NIV+IPI), CAB, and pazopanib (PAZ). Results per risk group and results for our secondary outcomes are reported in the summary of findings tables and in the full text of this review. The evidence on other treatments and comparisons can also be found in the full text.\nOverall survival (OS)\nAcross risk groups, PEM+AXI (HR 0.73, 95% confidence interval (CI) 0.50 to 1.07, moderate certainty) and NIV+IPI (HR 0.69, 95% CI 0.69 to 1.00, moderate certainty) probably improve OS, compared to SUN, respectively. LEN+PEM may improve OS (HR 0.66, 95% CI 0.42 to 1.03, low certainty), compared to SUN. There is probably little or no difference in OS between PAZ and SUN (HR 0.91, 95% CI 0.64 to 1.32, moderate certainty), and we are uncertain whether CAB improves OS when compared to SUN (HR 0.84, 95% CI 0.43 to 1.64, very low certainty). The median survival is 28 months when treated with SUN. Survival may improve to 43 months with LEN+PEM, and probably improves to: 41 months with NIV+IPI, 39 months with PEM+AXI, and 31 months with PAZ. We are uncertain whether survival improves to 34 months with CAB. Comparison data were not available for AVE+AXI and NIV+CAB.\nQuality of life (QoL)\nOne RCT measured QoL using FACIT-F (score range 0 to 52; higher scores mean better QoL) and reported that the mean post-score was 9.00 points higher (9.86 lower to 27.86 higher, very low certainty) with PAZ than with SUN. Comparison data were not available for PEM+AXI, AVE+AXI, NIV+CAB, LEN+PEM, NIV+IPI, and CAB.\nSerious adverse events (SAEs)\nAcross risk groups, PEM+AXI probably increases slightly the risk for SAEs (RR 1.29, 95% CI 0.90 to 1.85, moderate certainty) compared to SUN. LEN+PEM (RR 1.52, 95% CI 1.06 to 2.19, moderate certainty) and NIV+IPI (RR 1.40, 95% CI 1.00 to 1.97, moderate certainty) probably increase the risk for SAEs, compared to SUN, respectively. There is probably little or no difference in the risk for SAEs between PAZ and SUN (RR 0.99, 95% CI 0.75 to 1.31, moderate certainty). We are uncertain whether CAB reduces or increases the risk for SAEs (RR 0.92, 95% CI 0.60 to 1.43, very low certainty) when compared to SUN. People have a mean risk of 40% for experiencing SAEs when treated with SUN. The risk increases probably to: 61% with LEN+PEM, 57% with NIV+IPI, and 52% with PEM+AXI. It probably remains at 40% with PAZ. We are uncertain whether the risk reduces to 37% with CAB. Comparison data were not available for AVE+AXI and NIV+CAB.\nAuthors' conclusions\nFindings concerning the main treatments of interest comes from direct evidence of one trial only, thus results should be interpreted with caution. More trials are needed where these interventions and combinations are compared head-to-head, rather than just to SUN. Moreover, assessing the effect of immunotherapies and targeted therapies on different subgroups is essential and studies should focus on assessing and reporting relevant subgroup data. The evidence in this review mostly applies to advanced clear cell RCC.\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 use the most up-to-date information from clinical studies to measure the benefits and harms of different treatments for people with advanced RCC. We also wanted to learn if the drugs worked better for some people than others."
}
] |
query-laysum
|
7972
|
[
{
"role": "user",
"content": "Abstract: Background\nPopliteal artery aneurysm (PAA) is a focal dilatation and weakening of the popliteal artery. If left untreated, the aneurysm may thrombose, rupture or the clot within the aneurysm may embolise causing severe morbidity. PAA may be treated surgically by performing a bypass from the arterial segment proximal to the aneurysm to the arterial segment below the aneurysm, which excludes the aneurysm from the circulation. It may also be treated by a stent graft that is inserted percutaneously or through a small cut in the groin. The success of the procedure is gauged by the ability of the graft to stay patent over an extended duration. While surgical treatment is usually preferred in an emergency, the evidence on first line treatment in a non-emergency setting is unclear. This is an update of a review first published in 2014.\nObjectives\nTo assess the effectiveness of an endovascular stent graft versus conventional open surgery for the treatment of asymptomatic popliteal artery aneurysms (PAA) on primary and assisted patency rates, hospital stay, length of the procedure and local complications.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 29 January 2019.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing endovascular stent grafting versus conventional open surgical repair in patients undergoing unilateral or bilateral prophylactic repair of asymptomatic PAAs.\nData collection and analysis\nWe collected data on primary and assisted primary patency rates (primary endpoints) as well as operating time, the length of hospital stay, limb salvage and local wound complications (secondary endpoints). We presented results as risk ratio or mean difference with 95% confidence intervals and assessed the certainty of the evidence using GRADE.\nMain results\nNo new studies were identified for this update. A single RCT with a total of 30 PAAs met the inclusion criteria. There was a low risk of selection bias and detection bias. However, the risks of performance bias, attrition bias and reporting bias were unclear from the study. Despite being an RCT, the certainty of the evidence was downgraded to moderate due to the small sample size, resulting in wide confidence intervals (CIs); only 30 PAAs were randomised over a period of five years (15 PAAs each in the groups receiving endovascular stent graft and undergoing conventional open surgery). The primary patency rate at one year was 93.3% in the endovascular group and 100% in the surgery group (RR 0.94, 95% CI 0.78 to 1.12; moderate-certainty evidence). The assisted patency rate at one year was similar in both groups (RR 1.00, 95% CI 0.88 to 1.13; moderate-certainty evidence). There was no clear evidence of a difference between the two groups in the primary or assisted patency rates at four years (13 grafts were patent from 15 PAA treatments in each group; RR 1.00, 95% CI 0.76 to 1.32; moderate-certainty evidence); the effects were imprecise and compatible with the benefit of either endovascular stent graft or surgery or no difference. Mean hospital stay was shorter in the endovascular group (4.3 days for the endovascular group versus 7.7 days for the surgical group; mean difference (MD) -3.40 days, 95% CI -4.42 to -2.38; P < 0.001; moderate-certainty evidence). Mean operating time was also reduced in the endovascular group (75.4 minutes in the endovascular group versus 195.3 minutes in the surgical group; MD -119.90 minutes, 95% CI -137.71 to -102.09; P < 0.001; moderate-certainty evidence). Limb salvage was 100% in both groups. Data on local wound complications were not published in the trial report.\nAuthors' conclusions\nEvidence to determine the effectiveness of endovascular stent graft versus conventional open surgery for the treatment of asymptomatic PAAs is limited to data from one small study. At one year there is moderate-certainty evidence that primary patency may be improved in the surgery group but assisted primary patency rates were similar between groups. At four years there was no clear benefit from either endovascular stent graft or surgery to primary or assisted primary patency (moderate-certainty evidence). As both operating time and hospital stay were reduced in the endovascular group (moderate-certainty evidence), it may represent a viable alternative to open repair of PAA. A large multicenter RCT may provide more information in the future. However, difficulties in recruiting enough patients are likely, unless it is an international collaboration including a number of high volume vascular centres.\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 popliteal artery is a blood vessel situated behind the knee joint. Sometimes it weakens and expands like a balloon, known as an aneurysm. If left untreated, the blood clot within the aneurysm may migrate or the aneurysm may rupture or get blocked. Any of these complications can lead to limb loss or even death. Traditionally, popliteal artery aneurysm (PAA) has been treated surgically. However, it is also possible to treat the condition by a minimally invasive technique in which, a fabric lined metal mesh (stent graft), is placed across the aneurysm through a small puncture in the groin. The stent graft forms a seal within the artery. The success of the procedure is determined by the ability of the surgically applied graft or the stent graft to keep functioning and not get blocked (known as patency). Blockage of the graft decreases the leg circulation, which may require emergency surgery. Some consider the conventional surgical technique to be the gold standard, although the feasibility of the minimally invasive technique has been well documented in many studies where the data was analysed in retrospect. However, high quality evidence is only obtained when two techniques are pitted against each other in a clinical trial where data is collective prospectively, also known as a randomised clinical trial (RCT).\nThe purpose of this review was to combine the data from all the RCTs performed to date that compare the surgical technique versus the minimally invasive (endovascular) technique for the treatment of non-emergency PAA."
}
] |
query-laysum
|
7973
|
[
{
"role": "user",
"content": "Abstract: Background\nOpen-angle glaucoma (OAG) is an important cause of blindness worldwide. Laser trabeculoplasty, a treatment modality, still does not have a clear position in the treatment sequence.\nObjectives\nTo assess the effects of laser trabeculoplasty for treating OAG and ocular hypertension (OHT) when compared to medication, glaucoma surgery or no intervention. We also wished to compare the effectiveness of different laser trabeculoplasty technologies for treating OAG and OHT.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; LILACS, ClinicalTrials.gov and the WHO ICTRP. The date of the search was 28 October 2021. We also contacted researchers in the field.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing laser trabeculoplasty with no intervention, with medical treatment, or with surgery in people with OAG or OHT. We also included trials comparing different types of laser trabeculoplasty technologies.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two authors screened search results and extracted data independently. We considered the following outcomes at 24 months: failure to control intraocular pressure (IOP), failure to stabilise visual field progression, failure to stabilise optic neuropathy progression, adverse effects, quality of life, and costs. We graded the 'certainty' of the evidence using GRADE.\nMain results\nWe included 40 studies (5613 eyes of 4028 people) in this review. The majority of the studies were conducted in Europe and in the USA. Most of the studies were at risk of performance and/or detection bias as they were unmasked. None of the studies were judged as having low risk of bias for all domains. We did not identify any studies of laser trabeculoplasty alone versus no intervention.\nLaser trabeculoplasty versus medication\nFourteen studies compared laser trabeculoplasty with medication in either people with primary OAG (7 studies) or primary or secondary OAG (7 studies); five of the 14 studies also included participants with OHT. Six studies used argon laser trabeculoplasty and eight studies used selective laser trabeculoplasty. There was considerable clinical and methodological diversity in these studies leading to statistical heterogeneity in results for the primary outcome \"failure to control IOP\" at 24 months. Risk ratios (RRs) ranged from 0.43 in favour of laser trabeculoplasty to 1.87 in favour of medication (5 studies, I2 = 89%). Studies of argon laser compared with medication were more likely to show a beneficial effect compared with studies of selective laser (test for interaction P = 0.0001) but the argon laser studies were older and the medication comparator group in those studies may have been less effective. We considered this to be low-certainty evidence because the trials were at risk of bias (they were not masked) and there was unexplained heterogeneity. There was evidence from two studies (624 eyes) that argon laser treatment was associated with less failure to stabilise visual field progression compared with medication (7% versus 11%, RR 0.70, 95% CI 0.42 to 1.16) at 24 months and one further large recent study of selective laser also reported a reduced risk of failure at 48 months (17% versus 26%) RR 0.65, 95% CI 0.52 to 0.81, 1178 eyes). We judged this outcome as moderate-certainty evidence, downgrading for risk of bias. There was only very low-certainty evidence on optic neuropathy progression. Adverse effects were more commonly seen in the laser trabeculoplasty group including peripheral anterior synechiae (PAS) associated with argon laser (32% versus 26%, RR 11.74, 95% CI 5.94 to 23.22; 624 eyes; 2 RCTs; low-certainty evidence); 5% of participants treated with laser in three studies of selective laser group had early IOP spikes (moderate-certainty evidence). One UK-based study provided moderate-certainty evidence that laser trabeculoplasty was more cost-effective.\nLaser trabeculoplasty versus trabeculectomy\nThree studies compared laser trabeculoplasty with trabeculectomy. All three studies enrolled participants with OAG (primary or secondary) and used argon laser. People receiving laser trabeculoplasty may have a higher risk of uncontrolled IOP at 24 months compared with people receiving trabeculectomy (16% versus 8%, RR 2.12, 95% CI 1.44 to 3.11; 901 eyes; 2 RCTs). We judged this to be low-certainty evidence because of risk of bias (trials were not masked) and there was inconsistency between the two trials (I2 = 68%). There was limited evidence on visual field progression suggesting a higher risk of failure with laser trabeculoplasty. There was no information on optic neuropathy progression, quality of life or costs. PAS formation and IOP spikes were not reported but in one study trabeculectomy was associated with an increased risk of cataract (RR 1.78, 95% CI 1.46 to 2.16) (very low-certainty evidence).\nAuthors' conclusions\nLaser trabeculoplasty may work better than topical medication in slowing down the progression of open-angle glaucoma (rate of visual field loss) and may be similar to modern eye drops in controlling eye pressure at a lower cost. It is not associated with serious unwanted effects, particularly for the newer types of trabeculoplasty, such as selective laser trabeculoplasty.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane researchers found 40 studies. These studies were mainly from Europe and the USA.\nThe results were as follows:\n• Different studies found different effects on eye pressure when comparing laser trabeculoplasty with eye drops. Older studies were more likely to show a benefit of laser trabeculoplasty which may be because the eye drops in these older studies did not work as well as modern eye drops (low-certainty evidence). Three studies showed a benefit of trabeculoplasty over eye drops for avoiding visual field progression at 24 months (argon) and 48 months (selective) (moderate-certainty evidence, downgraded for risk bias).\n• Harmful effects were more common in the laser trabeculoplasty group and included more cases where the iris was stuck to the edge of the drainage mechanism inside the eye (peripheral anterior synaechiae) but this was seen only with older types of laser (argon) trabeculoplasty (low-certainty evidence).\n• People receiving laser trabeculoplasty may be more likely to have pressure in the eye that is too high compared with people who had surgery (trabeculectomy) (low-certainty evidence).\n• Surgery (trabeculectomy) may increase the risk of cataract compared with laser (very low-certainty evidence).\n• A number of studies compared different types of laser (argon, selective, diode, excimer, pattern scanning, titanium-sapphire, and micropulse) but with inconclusive results."
}
] |
query-laysum
|
7974
|
[
{
"role": "user",
"content": "Abstract: Background\nAllergic rhinitis is a common condition affecting both adults and children. Patients experience symptoms of nasal obstruction, rhinorrhoea, sneezing and nasal itching, which may affect their quality of life.\nNasal irrigation with saline (salty water), also known as nasal douching, washing or lavage, is a procedure that rinses the nasal cavity with isotonic or hypertonic saline solutions. It can be performed with low positive pressure from a spray, pump or squirt bottle, with a nebuliser or with gravity-based pressure in which the person instils saline into one nostril and allows it to drain out of the other. Saline solutions are available over the counter and can be used alone or as an adjunct to other therapies.\nObjectives\nTo evaluate the effects of nasal saline irrigation in people with allergic rhinitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL; Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 November 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing nasal saline irrigation, delivered by any means and with any volume, tonicity and alkalinity, with (a) no nasal saline irrigation or (b) other pharmacological treatments in adults and children with allergic rhinitis. We included studies comparing nasal saline versus no saline, where all participants also received pharmacological treatment (intranasal corticosteroids or oral antihistamines).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Primary outcomes were patient-reported disease severity and a common adverse effect - epistaxis. Secondary outcomes were disease-specific health-related quality of life (HRQL), individual symptom scores, general HRQL, the adverse effects of local irritation or discomfort, ear symptoms (pain or pressure) and nasal endoscopy scores. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included 14 studies (747 participants). The studies included children (seven studies, 499 participants) and adults (seven studies, 248 participants). No studies reported outcomes beyond three months follow-up. Saline volumes ranged from 'very low' to 'high' volume. Where stated, studies used either hypertonic or isotonic saline solution.\nNasal saline versus no saline treatment\nAll seven studies (112 adults; 332 children) evaluating this comparison used different scoring systems for patient-reported disease severity, so we pooled the data using the standardised mean difference (SMD). Saline irrigation may improve patient-reported disease severity compared with no saline at up to four weeks (SMD -1.32, 95% confidence interval (CI) -1.84 to -0.81; 407 participants; 6 studies; low quality) and between four weeks and three months (SMD -1.44, 95% CI -2.39 to -0.48; 167 participants; 5 studies; low quality). Although the evidence was low quality the SMD values at both time points are considered large effect sizes. Subgroup analysis showed the improvement in both adults and children. Subgroup analyses for volume and tonicity were inconclusive due to heterogeneity.\nTwo studies reported methods for recording adverse effects and five studies mentioned them. Two studies (240 children) reported no adverse effects (epistaxis or local discomfort) in either group and three only reported no adverse effects in the saline group.\nOne study (48 children) reported disease-specific HRQL using a modified RCQ-36 scale. It was uncertain whether there was a difference between the groups at any of the specified time points (very low quality). No other secondary outcomes were reported.\nNasal saline versus no saline with adjuvant use of intranasal steroids or oral antihistamines\nThree studies (40 adults; 79 children) compared saline with intranasal steroids versus intranasal steroids alone; one study (14 adults) compared saline with oral antihistamines versus oral antihistamines alone. It is uncertain if there is a difference in patient-reported disease severity at up to four weeks (SMD -0.60, 95% CI -1.34 to 0.15; 32 participants; 2 studies; very low quality) or from four weeks to three months (SMD -0.32, 95% CI -0.85 to 0.21; 58 participants; 2 studies; very low quality). Although none of the studies reported methods for recording adverse effects, three mentioned them: one study (40 adults; adjuvant intranasal steroids) reported no adverse effects (epistaxis or local discomfort) in either group; the other two only reported no adverse effects in the saline group.\nIt is uncertain if saline irrigation in addition to pharmacological treatment improved disease-specific HRQL at four weeks to three months, compared with pharmacological treatment alone (SMD -1.26, 95% CI -2.47 to -0.05; 54 participants; 2 studies; very low quality). No other secondary outcomes were reported.\nNasal saline versus intranasal steroids\nIt is uncertain if there was a difference in patient-reported disease severity between nasal saline and intranasal steroids at up to four weeks (MD 1.06, 95% CI -1.65 to 3.77; 14 participants; 1 study), or between four weeks and three months (SMD 1.26, 95% CI -0.92 to 3.43; 97 participants; 3 studies), or indisease-specific HRQL between four weeks and three months (SMD 0.01, 95% CI -0.73 to 0.75; 83 participants; 2 studies). Only one study reported methods for recording adverse effects although three studies mentioned them. One (21 participants) reported two withdrawals due to adverse effects but did not describe these or state which group. Three studies reported no adverse effects (epistaxis or local discomfort) with saline, although one study reported that 27% of participants experienced local discomfort with steroid use. No other secondary outcomes were reported.\nAuthors' conclusions\nSaline irrigation may reduce patient-reported disease severity compared with no saline irrigation at up to three months in both adults and children with allergic rhinitis, with no reported adverse effects. No data were available for any outcomes beyond three months. The overall quality of evidence was low or very low. The included studies were generally small and used a range of different outcome measures to report disease severity scores, with unclear validation. This review did not include direct comparisons of saline types (e.g. different volume, tonicity).\nSince saline irrigation could provide a cheap, safe and acceptable alternative to intranasal steroids and antihistamines further high-quality, adequately powered research in this area is warranted.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Seven studies did not say how they were funded. The other seven were funded either by the investigators' department or research grants from regional or national government. No studies were funded by pharmaceutical companies."
}
] |
query-laysum
|
7975
|
[
{
"role": "user",
"content": "Abstract: Background\nAdequate haemodialysis (HD) in people with end-stage kidney disease (ESKD) is reliant upon establishment of vascular access, which may consist of arteriovenous fistula, arteriovenous graft, or central venous catheters (CVC). Although discouraged due to high rates of infectious and thrombotic complications as well as technical issues that limit their life span, CVC have the significant advantage of being immediately usable and are the only means of vascular access in a significant number of patients. Previous studies have established the role of thrombolytic agents (TLA) in the prevention of catheter malfunction. Systematic review of different thrombolytic agents has also identified their utility in restoration of catheter patency following catheter malfunction. To date the use and efficacy of fibrin sheath stripping and catheter exchange have not been evaluated against thrombolytic agents.\nObjectives\nThis review aimed to evaluate the benefits and harms of TLA, preparations, doses and administration as well as fibrin-sheath stripping, over-the-wire catheter exchange or any other intervention proposed for management of tunnelled CVC malfunction in patients with ESKD on HD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register up to 17 August 2017 through contact with the Information Specialist using search terms relevant to this review. Studies in the Specialised 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\nWe included all studies conducted in people with ESKD who rely on tunnelled CVC for either initiation or maintenance of HD access and who require restoration of catheter patency following late-onset catheter malfunction and evaluated the role of TLA, fibrin sheath stripping or over-the-wire catheter exchange to restore catheter function. The primary outcome was be restoration of line patency defined as ≥ 300 mL/min or adequate to complete a HD session or as defined by the study authors. Secondary outcomes included dialysis adequacy and adverse outcomes.\nData collection and analysis\nTwo authors independently assessed retrieved studies to determine which studies satisfy the inclusion criteria and carried out data extraction. Included studies were assessed for risk of bias. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using GRADE.\nMain results\nOur search strategy identified 8 studies (580 participants) as eligible for inclusion in this review. Interventions included: thrombolytic therapy versus placebo (1 study); low versus high dose thrombolytic therapy (1); alteplase versus urokinase (1); short versus long thrombolytic dwell (1); thrombolytic therapy versus percutaneous fibrin sheath stripping (1); fibrin sheath stripping versus over-the-wire catheter exchange (1); and over-the-wire catheter exchange versus exchange with and without angioplasty sheath disruption (1). No two studies compared the same interventions. Most studies had a high risk of bias due to poor study design, broad inclusion criteria, low patient numbers and industry involvement.\nBased on low certainty evidence, thrombolytic therapy may restore catheter function when compared to placebo (149 participants: RR 4.05, 95% CI 1.42 to 11.56) but there is no data available to suggest an optimal dose or administration method. The certainty of this evidence is reduced due to the fact that it is based on only a single study with wide confidence limits, high risk of bias and imprecision in the estimates of adverse events (149 participants: RR 2.03, 95% CI 0.38 to 10.73).\nBased on the available evidence, physical disruption of a fibrin sheath using interventional radiology techniques appears to be equally efficacious as the use of a pharmaceutical thrombolytic agent for the immediate management of dysfunctional catheters (57 participants: RR 0.92, 95% CI 0.80 to 1.07).\nCatheter patency is poor following use of thrombolytic agents with studies reporting median catheter survival rates of 14 to 42 days and was reported to improve significantly by fibrin sheath stripping or catheter exchange (37 participants: MD -27.70 days, 95% CI -51.00 to -4.40). Catheter exchange was reported to be superior to sheath disruption with respect to catheter survival (30 participants: MD 213.00 days, 95% CI 205.70 to 220.30).\nThere is insufficient evidence to suggest any specific intervention is superior in terms of ensuring either dialysis adequacy or reduced risk of adverse events.\nAuthors' conclusions\nThrombolysis, fibrin sheath disruption and over-the-wire catheter exchange are effective and appropriate therapies for immediately restoring catheter patency in dysfunctional cuffed and tunnelled HD catheters. On current data there is no evidence to support physical intervention over the use of pharmaceutical agents in the acute setting. Pharmacological interventions appear to have a bridging role and long-term catheter survival may be improved by fibrin sheath disruption and is probably superior following catheter exchange. There is no evidence favouring any of these approaches with respect to dialysis adequacy or risk of adverse events.\nThe current review is limited by the small number of available studies with limited numbers of patients enrolled. Most of the studies included in this review were judged to have a high risk of bias and were potentially influenced by pharmaceutical industry involvement.\nFurther research is required to adequately address the question of the most efficacious and clinically appropriate technique for HD catheter dysfunction.\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": "Patients who rely on haemodialysis due to kidney failure require vascular access and although not optimal, a tunnelled haemodialysis catheter is frequently used. Unfortunately, along with infection issues these lines are prone to dysfunction due to clotting and fibrin sheath formation. Medications such as alteplase have a recognised role in preventing line dysfunction but the best approach to treating established line dysfunction has not been found."
}
] |
query-laysum
|
7976
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in 2017.\nEpilepsy is a common neurological condition with a worldwide prevalence of around 1%. Approximately 60% to 70% of people with epilepsy will achieve a longer-term remission from seizures, and most achieve that remission shortly after starting antiepileptic drug treatment. Most people with epilepsy are treated with a single antiepileptic drug (monotherapy) and current guidelines from the National Institute for Health and Care Excellence (NICE) in the United Kingdom for adults and children recommend carbamazepine or lamotrigine as first-line treatment for focal onset seizures and sodium valproate for generalised onset seizures; however, a range of other antiepileptic drug (AED) treatments are available, and evidence is needed regarding their comparative effectiveness in order to inform treatment choices.\nObjectives\nTo compare the time to treatment failure, remission and first seizure of 12 AEDs (carbamazepine, phenytoin, sodium valproate, phenobarbitone, oxcarbazepine, lamotrigine, gabapentin, topiramate, levetiracetam, zonisamide, eslicarbazepine acetate, lacosamide) currently used as monotherapy in children and adults with focal onset seizures (simple focal, complex focal or secondary generalised) or generalised tonic-clonic seizures with or without other generalised seizure types (absence, myoclonus).\nSearch methods\nFor the latest update, we searched the following databases on 12 April 2021: the Cochrane Register of Studies (CRS Web), which includes PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Epilepsy Group Specialised Register and MEDLINE (Ovid, 1946 to April 09, 2021). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators and experts in the field.\nSelection criteria\nWe included randomised controlled trials of a monotherapy design in adults or children with focal onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types).\nData collection and analysis\nThis was an individual participant data (IPD) and network meta-analysis (NMA) review. Our primary outcome was 'time to treatment failure', and our secondary outcomes were 'time to achieve 12-month remission', 'time to achieve six-month remission', and 'time to first seizure post-randomisation'.\nWe performed frequentist NMA to combine direct evidence with indirect evidence across the treatment network of 12 drugs. We investigated inconsistency between direct 'pairwise' estimates and NMA results via node splitting.\nResults are presented as hazard ratios (HRs) with 95% confidence intervals (CIs) and we assessed the certainty of the evidence using the CiNeMA approach, based on the GRADE framework. We have also provided a narrative summary of the most commonly reported adverse events.\nMain results\nIPD were provided for at least one outcome of this review for 14,789 out of a total of 22,049 eligible participants (67% of total data) from 39 out of the 89 eligible trials (43% of total trials). We could not include IPD from the remaining 50 trials in analysis for a variety of reasons, such as being unable to contact an author or sponsor to request data, data being lost or no longer available, cost and resources required to prepare data being prohibitive, or local authority or country-specific restrictions. No IPD were available from a single trial of eslicarbazepine acetate, so this AED could not be included in the NMA.\nNetwork meta-analysis showed high-certainty evidence that for our primary outcome, ‘time to treatment failure’, for individuals with focal seizures; lamotrigine performs better than most other treatments in terms of treatment failure for any reason and due to adverse events, including the other first-line treatment carbamazepine; HRs (95% CIs) for treatment failure for any reason for lamotrigine versus: levetiracetam 1.01 (0.88 to 1.20), zonisamide 1.18 (0.96 to 1.44), lacosamide 1.19 (0.90 to 1.58), carbamazepine 1.26 (1.10 to 1.44), oxcarbazepine 1.30 (1.02 to 1.66), sodium valproate 1.35 (1.09 to 1.69), phenytoin 1.44 (1.11 to 1.85), topiramate 1.50 (1.23 to 1.81), gabapentin 1.53 (1.26 to 1.85), phenobarbitone 1.97 (1.45 to 2.67). No significant difference between lamotrigine and levetiracetam was shown for any treatment failure outcome, and both AEDs seemed to perform better than all other AEDs.\nFor people with generalised onset seizures, evidence was more limited and of moderate certainty; no other treatment performed better than first-line treatment sodium valproate, but there were no differences between sodium valproate, lamotrigine or levetiracetam in terms of treatment failure; HRs (95% CIs) for treatment failure for any reason for sodium valproate versus: lamotrigine 1.06 (0.81 to 1.37), levetiracetam 1.13 (0.89 to 1.42), gabapentin 1.13 (0.61 to 2.11), phenytoin 1.17 (0.80 to 1.73), oxcarbazepine 1.24 (0.72 to 2.14), topiramate 1.37 (1.06 to 1.77), carbamazepine 1.52 (1.18 to 1.96), phenobarbitone 2.13 (1.20 to 3.79), lacosamide 2.64 (1.14 to 6.09).\nNetwork meta-analysis also showed high-certainty evidence that for secondary remission outcomes, few notable differences were shown for either seizure type; for individuals with focal seizures, carbamazepine performed better than gabapentin (12-month remission) and sodium valproate (six-month remission). No differences between lamotrigine and any AED were shown for individuals with focal seizures, or between sodium valproate and other AEDs for individuals with generalised onset seizures.\nNetwork meta-analysis also showed high- to moderate-certainty evidence that, for ‘time to first seizure,’ in general, the earliest licensed treatments (phenytoin and phenobarbitone) performed better than the other treatments for individuals with focal seizures; phenobarbitone performed better than both first-line treatments carbamazepine and lamotrigine. There were no notable differences between the newer drugs (oxcarbazepine, topiramate, gabapentin, levetiracetam, zonisamide and lacosamide) for either seizure type.\nGenerally, direct evidence (where available) and network meta-analysis estimates were numerically similar and consistent with confidence intervals of effect sizes overlapping. There was no important indication of inconsistency between direct and network meta-analysis results.\nThe most commonly reported adverse events across all drugs were drowsiness/fatigue, headache or migraine, gastrointestinal disturbances, dizziness/faintness and rash or skin disorders; however, reporting of adverse events was highly variable across AEDs and across studies.\nAuthors' conclusions\nHigh-certainty evidence demonstrates that for people with focal onset seizures, current first-line treatment options carbamazepine and lamotrigine, as well as newer drug levetiracetam, show the best profile in terms of treatment failure and seizure control as first-line treatments. For people with generalised tonic-clonic seizures (with or without other seizure types), current first-line treatment sodium valproate has the best profile compared to all other treatments, but lamotrigine and levetiracetam would be the most suitable alternative first-line treatments, particularly for those for whom sodium valproate may not be an appropriate treatment option. Further evidence from randomised controlled trials recruiting individuals with generalised tonic-clonic seizures (with or without other seizure types) is needed.\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": "The results of this review support the NICE guidelines that carbamazepine and lamotrigine are suitable first treatment options for individuals with focal onset seizures, and also show that levetiracetam would be a suitable first treatment. Results of this review also support the use of sodium valproate as the first treatment for individuals with generalised tonic-clonic seizures and show that lamotrigine and levetiracetam would be suitable alternative first treatments, particularly for those who are pregnant or considering becoming pregnant, for whom sodium valproate may not be an appropriate treatment option."
}
] |
query-laysum
|
7977
|
[
{
"role": "user",
"content": "Abstract: Background\nCancer is a leading cause of death worldwide. Gynaecologic cancer treatment is known to have the potential for a major impact on quality of life (QoL). Patient-reported outcome measures (PROMs) is an umbrella term that covers a range of potential types of measurement but is used specifically to refer to self reports by the patient of their health and well-being. Use of QoL and cancer-specific questionnaires as alternatives to follow-up may have immense psychological benefit to the patient and cost benefit to the healthcare system.\nObjectives\nTo evaluate the effectiveness of PROMs as an alternative to routine follow-up of women after treatment for gynaecological cancers to identify recurrences, affect overall survival and assess psychological benefit.\nSearch methods\nWe searched the Cochrane Gynaecological Cancer Group Trials Register, MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) up to November 2012. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) and non-RCTs with concurrent comparison groups (of adequate quality that used statistical adjustment for baseline case mix using multivariable analyses) that compared PROMs or QoL questionnaires versus traditional follow-up with multiple visits to the hospital in women after treatment for gynaecological cancers. Studies that involved women completing PROMs at intervals and submitting results for assessment by their cancer care team or structured interviews of women during their follow-up were included in the analysis.\nData collection and analysis\nTwo review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies and therefore analysed no data.\nMain results\nThe search strategy identified 2524 unique references, of which all were excluded.\nAuthors' conclusions\nWe found no evidence to make an informed decision about PROMs for follow-up after gynaecological cancer. Ideally, RCTs which are multicentre or multinational or both, or well-designed non-randomised studies are needed that use multivariable analysis to adjust for baseline imbalances, to compare follow-up strategies and improve current knowledge.\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": "Cancer is a leading cause of death worldwide. The traditional method of follow-up involves multiple visits to the hospital to check, for example, whether the cancer has come back (recurrence). This may cause anxiety among the patients and its cost effectiveness is questionable. Clinician and patient groups have asked for a consideration of alternative model approaches; since most recurrences are symptomatic, follow-up of patients after treatment for gynaecological cancer may be accomplished by patient-related outcome measures (PROMs) rather than routine follow-up visits. PROMs is an umbrella term that covers a range of potential types of measurements, but is used specifically to refer to self reports by the patient of their health and well-being. Use of PROMs as alternatives to follow-up may have immense psychological benefits for the patient and cost benefit to the healthcare system. There is currently no evidence to determine whether PROMs are better or worse in helping women to live longer and better after gynaecological cancer rather than follow-up visits. It is also unclear whether PROMs are beneficial in terms of patient satisfaction or quality of life."
}
] |
query-laysum
|
7978
|
[
{
"role": "user",
"content": "Abstract: Background\nBiliary atresia is a life-threatening disease characterised by progressive destruction of both intra- and extra-hepatic biliary ducts. The mainstay of treatment is Kasai portoenterostomy, as soon as the disease has been confirmed. Glucocorticosteroids are steroid hormones which act on the glucocorticoid receptor and have a range of metabolic and immunomodulatory effects. Glucocorticosteroids are used to improve the postoperative outcomes in infants who have undergone Kasai portoenterostomy.\nObjectives\nTo assess the beneficial and harmful effects of glucocorticosteroid administration versus placebo or no intervention following Kasai portoenterostomy in infants with biliary atresia.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded (Web of Science), and online trial registries (last search: 20 December 2017) for randomised controlled trials.\nSelection criteria\nWe included randomised clinical trials which assessed glucocorticosteroids for infants who have undergone Kasai portoenterostomy. For harm, we also considered quasi-randomised studies, observational studies, and case-control studies that were identified amongst the search results.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We assessed the risk of bias for each trial according to prespecified domains. We analysed data using both random-effects and fixed-effect models. We performed the analyses using Review Manager 5.3 and Trial Sequental Analysis software. We considered a P value of 0.025 or less, two-tailed, as statistically significant. We planned to calculate risk ratios (RRs) for dichotomous outcomes, and the mean difference (MD) for continuous outcomes. For all association measures, we planned to use 95% confidence intervals (CIs) as well as Trial Sequential Analysis-adjusted CIs. We used Trial Sequential Analyisis to control the risks of random errors; however, we were often unable to implement this beyond calculating the required information size as there were few trials and data. We assessed the certainty of the evidence using GRADE.\nMain results\nWe found two randomised controlled trials fulfilling the inclusion criteria of our review. The trials provided data for meta-analysis. We judged the two trials as trials at low risk of bias. The two trials randomised a total of 213 infants to glucocorticosteroids versus placebo. In our Trial Sequential Analysis, the required information size (that is, the meta-analytic sample size) was not reached for any outcome. Trials were funded by charities, public organisations, and received support from private sector companies, none of which seemed to have an interest in the outcome of the respective trials. The effect of glucocorticosteroids after Kasai portoenterostomy on all-cause mortality is uncertain; the confidence interval is consistent with appreciable benefit and harm (RR 1.00; 95% CI 0.14 to 6.90; low-certainty evidence). The results showed little or no difference in adverse effects between the use of glucocorticosteroids or placebo after Kasai portoenterostomy, however this analysis was based on a single trial and we have low certainty in the result (RR 1.02; 95% CI 0.87 to 1.20;). Available data suggest that the proportions of infants who do not clear their jaundice at six months is similar between the two groups (RR 0.89; 95% CI 0.67 to 1.17; low-certainty evidence). All-cause mortality or liver transplantation did not differ at two years between the two groups (RR 1.00; 95% CI 0.72 to 1.39; low-certainty evidence). There were no data regarding health-related quality of life.\nOur searches also yielded 19 observational studies, some of them containing limited information on harmful effects of glucocorticosteroid treatment. We presented the extracted information narratively. We identified one further ongoing trial with no currently available results.\nAuthors' conclusions\nThe two meta-analysed randomised clinical trials present insufficient evidence to determine the effects of using glucocorticosteroids versus placebo after Kasai portoenterostomy in infants with biliary atresia on any of the primary or secondary review outcomes. There is insufficient evidence to support glucocorticosteroid use in the postoperative management of infants with biliary atresia for long-term outcomes of all-cause mortality or liver transplantation. It is also unclear if glucocorticosteroids are able to reduce the numbers of infants who did not clear their jaundice by six months. Further randomised, placebo-controlled trials are required to be able to determine if glucocorticosteroids may be of benefit in the postoperative management of infants with biliary atresia treated with Kasai portoenterostomy. Such trials need to be conducted as multicentre trials.\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": "Do medications, called glucocorticosteroids (steroids), have beneficial or harmful effects in the health of infants with biliary atresia operated by the Kasai surgical procedure (that is, portoenterostomy)? We reviewed if there was any difference in death, need for a liver transplant, postoperative jaundice (yellowish or greenish pigmentation of the skin and whites of the eyes), and harmful effects."
}
] |
query-laysum
|
7979
|
[
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is a chronic, disabling and severe mental disorder, characterised by disturbance in perception, thought, language, affect and motor behaviour. Chlorpromazine and clotiapine are among antipsychotic drugs used for the treatment of people with schizophrenia.\nObjectives\nTo determine the clinical effects, safety and cost-effectiveness of chlorpromazine compared with clotiapine for adults with schizophrenia.\nSearch methods\nWe searched Cochrane Schizophrenia's Trials Register (last update search 16/01/2016), which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the Register.\nSelection criteria\nAll randomised clinical trials focusing on chlorpromazine versus clotiapine for schizophrenia. We included trials meeting our selection criteria and reporting useable data.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.\nMain results\nWe have included four studies, published between 1974 and 2003, randomising 276 people with schizophrenia to receive either chlorpromazine or clotiapine. The studies were poor at concealing allocation of treatment and blinding of outcome assessment. Our main outcomes of interest were clinically important change in global and mental state, specific change in negative symptoms, incidence of movement disorder (dyskinesia), leaving the study early for any reason, and costs. All reported data were short-term (under six months' follow-up).\nThe trials did not report data for the important outcomes of clinically important change in global or mental state, or cost of care. Improvement in mental state was reported using the Positive and Negative Syndrome Scale (PANSS). When chlorpromazine was compared with clotiapine the average improvement scores for mental state using the PANSS total was higher in the clotiapine group (1 RCT, N = 31, MD 11.50 95% CI 9.42 to 13.58, very low-quality evidence). The average change scores on the PANSS negative sub-scale were similar between treatment groups (1 RCT, N = 21, MD -0.97 95% CI -2.76 to 0.82, very low-quality evidence). There was no clear difference in incidence of dyskinesia (1 RCT, N = 68, RR 3.00 95% CI 0.13 to 71.15, very low-quality evidence). Similar numbers of participants left the study early from each treatment group (3 RCTs, N = 158, RR 0.68 95% CI 0.24 to 1.88, very low-quality evidence).\nAuthors' conclusions\nClinically important changes in global and mental state were not reported. Only one trial reported the average change in overall mental state; results favour clotiapine but these limited data are very difficult to trust due to methodological limitations of the study. The comparative effectiveness of chlorpromazine compared to clotiapine on change in global state remains unanswered. Results in this review suggest chlorpromazine and clotiapine cause similar adverse effects, although again, the quality of evidence for this is poor, making firm conclusions difficult.\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": "Chlorpromazine is one of the first antipsychotics to successfully alleviate the symptoms of psychosis. It was introduced in the 1950s and is still one of the most commonly used antipsychotics. However, chlorpromazine can cause serious side effects, particularly unpleasant movement disorders, causing many people with schizophrenia to stop taking chlorpromazine. During the past 70 years newer medications have been developed and most clinicians now have a wide choice of drugs for managing schizophrenia, however, none cure, and all cause some sort of side effect. The choice of treatment is still challenging. Clotiapine is a newer antipsychotic drug, found to be effective for treating the symptoms of schizophrenia and also known to be effective for treating people with schizophrenia who are resistant to other medications, however, like chlorpromazine it can cause serious movement disorders."
}
] |
query-laysum
|
7980
|
[
{
"role": "user",
"content": "Abstract: Background\nTransient tachypnea of the newborn (TTN) is caused by delayed clearance of lung fluid at birth. TTN typically appears within the first two hours of life in term and late preterm neonates and is characterized by tachypnea and signs of respiratory distress. Although it is usually a self-limited condition, admission to a neonatal unit is frequently required for monitoring and providing respiratory support. Restricting intake of fluids administered to these infants in the first days of life might improve clearance of lung liquid, thus reducing the effort required to breathe, improving respiratory distress, and potentially reducing the duration of tachypnea.\nObjectives\nTo evaluate the efficacy and safety of restricted fluid therapy as compared to standard fluid therapy in decreasing the duration of oxygen administration and the need for noninvasive or invasive ventilation among neonates with TTN.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 12), in the Cochrane Library; Ovid MEDLINE and electronic ahead of print publications, in-process & other non-indexed citations, Daily and Versions(R); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), on December 6, 2019. We also searched clinical trial databases and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs, and cluster trials on fluid restriction in term and preterm neonates with the diagnosis of TTN or delayed adaptation during the first week after birth.\nData collection and analysis\nFor each of the included trials, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy, need for continuous positive airway pressure [CPAP], need for mechanical ventilation, duration of mechanical ventilation) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcome considered in this review was the duration of supplemental oxygen therapy in hours or days. We used the GRADE approach to assess the certainty of evidence.\nMain results\nFour trials enrolling 317 infants met the inclusion criteria. Three trials enrolled late preterm and term infants with TTN, and the fourth trial enrolled only term infants with TTN. Infants were on various methods of respiratory support at the time of enrollment including room air, oxygen, or nasal CPAP. Infants in the fluid-restricted group received 15 to 20 mL/kg/d less fluid than those in the control group for varying durations after enrollment. Two studies had high risk of selection bias, and three out of four had high risk of performance bias. Only one study had low risk of detection bias, with two at high risk and one at unclear risk.\nThe certainty of evidence for all outcomes was very low due to imprecision of estimates and unclear risk of bias. Two trials reported the primary duration of supplemental oxygen therapy. We are uncertain whether fluid restriction decreases or increases the duration of supplemental oxygen therapy (mean difference [MD] -12.95 hours, 95% confidence interval [CI] -32.82 to 6.92; I² = 98%; 172 infants). Similarly, there is uncertainty for various secondary outcomes including incidence of hypernatremia (serum sodium > 145 mEq/L, risk ratio [RR] 4.0, 95% CI 0.46 to 34.54; test of heterogeneity not applicable; 1 trial, 100 infants), hypoglycemia (blood glucose < 40 mg/dL, RR 1.0, 95% CI 0.15 to 6.82; test of heterogeneity not applicable; 2 trials, 164 infants), endotracheal ventilation (RR 0.73, 95% CI 0.24 to 2.23; I² = 0%; 3 trials, 242 infants), need for noninvasive ventilation (RR 0.40, 95% CI 0.14 to 1.17; test of heterogeneity not applicable; 2 trials, 150 infants), length of hospital stay (MD -0.92 days, 95% CI -1.53 to -0.31; test of heterogeneity not applicable; 1 trial, 80 infants), and cumulative weight loss at 72 hours of age (%) (MD 0.24, 95% CI -1.60 to 2.08; I² = 89%; 2 trials, 156 infants). We did not identify any ongoing trials; however, one trial is awaiting classification.\nAuthors' conclusions\nWe found limited evidence to establish the benefits and harms of fluid restriction in the management of TTN. Given the very low certainty of available evidence, it is impossible to determine whether fluid restriction is safe or effective for management of TTN. However, given the simplicity of the intervention, a well-designed trial is justified.\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 and included four studies (317 babies in total) comparing the use of restricted versus standard fluid administration. We found no ongoing studies; however, one trial is awaiting classification. Evidence is current to December 6, 2019."
}
] |
query-laysum
|
7981
|
[
{
"role": "user",
"content": "Abstract: Background\nHospitalised patients are at increased risk of developing deep vein thrombosis (DVT) in the lower limb and pelvic veins, on a background of prolonged immobilisation associated with their medical or surgical illness. Patients with DVT are at increased risk of developing a pulmonary embolism (PE). The use of graduated compression stockings (GCS) in hospitalised patients has been proposed to decrease the risk of DVT. This is an update of a Cochrane Review first published in 2000, and last updated in 2014.\nObjectives\nTo evaluate the effectiveness and safety of graduated compression stockings in preventing deep vein thrombosis in various groups of hospitalised patients.\nSearch methods\nFor this review the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and trials registries on 21 March 2017; and the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE Ovid, Embase Ovid, CINAHL Ebsco, AMED Ovid , and trials registries on 12 June 2018.\nSelection criteria\nRandomised controlled trials (RCTs) involving GCS alone, or GCS used on a background of any other DVT prophylactic method. We combined results from both of these groups of trials.\nData collection and analysis\nTwo review authors (AS, MD) assessed potentially eligible trials for inclusion. One review author (AS) extracted the data, which a second review author (MD) cross-checked and authenticated. Two review authors (AS, MD) assessed the methodological quality of trials with the Cochrane 'Risk of bias' tool. Any disagreements were resolved by discussion with the senior review author (TL). For dichotomous outcomes, we calculated the Peto odds ratio and corresponding 95% confidence interval. We pooled data using a fixed-effect model. We used the GRADE system to evaluate the overall quality of the evidence supporting the outcomes assessed in this review.\nMain results\nWe included 20 RCTs involving a total of 1681 individual participants and 1172 individual legs (2853 analytic units). Of these 20 trials, 10 included patients undergoing general surgery; six included patients undergoing orthopaedic surgery; three individual trials included patients undergoing neurosurgery, cardiac surgery, and gynaecological surgery, respectively; and only one trial included medical patients. Graduated compression stockings were applied on the day before surgery or on the day of surgery and were worn up until discharge or until the participants were fully mobile. In the majority of the included studies DVT was identified by the radioactive I125 uptake test. Duration of follow-up ranged from seven to 14 days. The included studies were at an overall low risk of bias.\nWe were able to pool the data from 20 studies reporting the incidence of DVT. In the GCS group, 134 of 1445 units developed DVT (9%) in comparison to the control group (without GCS), in which 290 of 1408 units developed DVT (21%). The Peto odds ratio (OR) was 0.35 (95% confidence interval (CI) 0.28 to 0.43; 20 studies; 2853 units; high-quality evidence), showing an overall effect favouring treatment with GCS (P < 0.001).\nBased on results from eight included studies, the incidence of proximal DVT was 7 of 517 (1%) units in the GCS group and 28 of 518 (5%) units in the control group. The Peto OR was 0.26 (95% CI 0.13 to 0.53; 8 studies; 1035 units; moderate-quality evidence) with an overall effect favouring treatment with GCS (P < 0.001). Combining results from five studies, all based on surgical patients, the incidence of PE was 5 of 283 (2%) participants in the GCS group and 14 of 286 (5%) in the control group. The Peto OR was 0.38 (95% CI 0.15 to 0.96; 5 studies; 569 participants; low-quality evidence) with an overall effect favouring treatment with GCS (P = 0.04). We downgraded the quality of the evidence for proximal DVT and PE due to low event rate (imprecision) and lack of routine screening for PE (inconsistency).\nWe carried out subgroup analysis by speciality (surgical or medical patients). Combining results from 19 trials focusing on surgical patients, 134 of 1365 (9.8%) units developed DVT in the GCS group compared to 282 of 1328 (21.2%) units in the control group. The Peto OR was 0.35 (95% CI 0.28 to 0.44; high-quality evidence), with an overall effect favouring treatment with GCS (P < 0.001). Based on results from seven included studies, the incidence of proximal DVT was 7 of 437 units (1.6%) in the GCS group and 28 of 438 (6.4%) in the control group. The Peto OR was 0.26 (95% CI 0.13 to 0.53; 875 units; moderate-quality evidence) with an overall effect favouring treatment with GCS (P < 0.001). We downgraded the evidence for proximal DVT due to low event rate (imprecision).\nBased on the results from one trial focusing on medical patients admitted following acute myocardial infarction, 0 of 80 (0%) legs developed DVT in the GCS group and 8 of 80 (10%) legs developed DVT in the control group. The Peto OR was 0.12 (95% CI 0.03 to 0.51; low-quality evidence) with an overall effect favouring treatment with GCS (P = 0.004). None of the medical patients in either group developed a proximal DVT, and the incidence of PE was not reported.\nLimited data were available to accurately assess the incidence of adverse effects and complications with the use of GCS as these were not routinely quantitatively reported in the included studies.\nAuthors' conclusions\nThere is high-quality evidence that GCS are effective in reducing the risk of DVT in hospitalised patients who have undergone general and orthopaedic surgery, with or without other methods of background thromboprophylaxis, where clinically appropriate. There is moderate-quality evidence that GCS probably reduce the risk of proximal DVT, and low-quality evidence that GCS may reduce the risk of PE. However, there remains a paucity of evidence to assess the effectiveness of GCS in diminishing the risk of DVT in medical patients.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics and key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 20 randomised controlled trials (studies in which participants are assigned to a treatment group using a random method) (2853 analytic units consisting of 1681 individual patients and 1172 individual legs) in our most recent search on 12 June 2018. Nine trials compared wearing stockings to no stockings, and 11 compared stockings plus another method with that method alone. The other methods used were dextran 70, aspirin, heparin, and mechanical sequential compression. Of the 20 trials, 10 included patients undergoing general surgery; six included patients undergoing orthopaedic surgery; three individual trials included patients undergoing neurosurgery, cardiac surgery, and gynaecological surgery, respectively; and only one trial included medical patients (patients who were admitted to the hospital for reasons other than surgery). The compression stockings were applied on the day before surgery or on the day of surgery and were worn up until discharge or until the patients were fully mobile. Thigh-length stockings were used in the vast majority of included studies. The included studies were of good quality overall. We found that wearing GCS reduced the overall risk of developing DVT, and probably also DVT in the thighs. We found that GCS may also reduce the risk of PE amongst patients undergoing surgery. As only one trial included medical patients, results for this population are limited. The occurrence of problems associated with wearing GCS was poorly reported in the included studies."
}
] |
query-laysum
|
7982
|
[
{
"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: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is high-certainty evidence that bupropion helps people to quit smoking, meaning further research is very unlikely to change this conclusion. However, there is also high-certainty evidence to suggest that people using bupropion are more likely to stop taking the medicine because of unpleasant effects than those taking a pill without medication (a placebo) or no medication. The certainty of the evidence was moderate or low for the other key questions we looked at. This means that the findings of those questions may change when more research is carried out. In most cases, this was because there were not enough studies or studies were too small."
}
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.