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query-laysum
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8084
|
[
{
"role": "user",
"content": "Abstract: Background\nChancroid is a genital ulcerative disease caused by Haemophilus ducreyi. This microorganism is endemic in Africa, where it can cause up to 10% of genital ulcers. Macrolides may be an effective alternative to treat chancroid and, based on their oral administration and duration of therapy, could be considered as first line therapy.\nObjectives\nTo assess the effectiveness and safety of macrolides for treatment of H ducreyi infection in sexually active adults.\nSearch methods\nWe searched the Cochrane STI Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, WHO ICTRP, ClinicalTrials.gov and Web of Science to 30 October 2017. We also handsearched conference proceedings and reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials (RCTs) comparing macrolides in different regimens or with other therapeutic alternatives for chancroid.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved disagreements through consensus. We used the GRADE approach to assess the quality of the evidence.\nMain results\nSeven RCTs (875 participants) met our inclusion criteria, of which four were funded by industry. Five studies (664 participants) compared macrolides with ceftriaxone, ciprofloxacin, spectinomycin or thiamphenicol. Low quality evidence suggested there was no difference between the groups after treatment in terms of clinical cure (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.97 to 1.21; 2 studies, 340 participants with syndromic approach and RR 1.06, 95% CI 0.98 to 1.15; 5 studies, 348 participants with aetiological diagnosis) or improvement (RR 0.89, 95% CI 0.52 to 1.52; 2 studies, 340 participants with syndromic approach and RR 0.80, 95% CI 0.42 to 1.51; 3 studies, 187 participants with aetiological diagnosis). Based on low and very low quality evidence, there was no difference between macrolides and any other antibiotic treatments for microbiological cure (RR 0.93, 95% CI 0.74 to 1.16; 1 study, 45 participants) and minor adverse effects (RR 1.34, 95% CI 0.24 to 7.51; 3 studies, 412 participants).\nTwo trials (269 participants) compared erythromycin with any other macrolide type. Low quality evidence suggested that, compared with azithromycin or rosaramicin, long courses of erythromycin did not increase clinical cure (RR 1.00, 95% CI 0.91 to 1.10; 2 studies, 269 participants with syndromic approach and RR 1.04, 95% CI 0.93 to 1.16; 2 studies, 211 participants with aetiological diagnosis), with a similar frequency of minor adverse effects between the groups (RR 1.14, 95% CI 0.63 to 2.06; 1 trial, 101 participants). For this comparison, subgroup analysis found no difference between HIV-positive participants (RR 1.02, 95% CI 0.73 to 1.43; 1 study, 38 participants) and HIV-negative participants (RR 1.04, 95% CI 0.94 to 1.14; 1 study, 89 participants). We downgraded the quality of evidence to low, because of imprecision, some limitations on risk of bias and heterogeneity.\nNone of the trials reported serious adverse events, cost effectiveness and participant satisfaction.\nAuthors' conclusions\nAt present, the quality of the evidence on the effectiveness and safety of macrolides for treatment of H ducreyi infection in sexually active adults is low, implying that we are uncertain about the estimated treatment effect. There is no statistically significant difference between the available therapeutic alternatives for the treatment of sexually active adults with genital ulcers compatible with chancroid. Low quality evidence suggests that azithromycin could be considered as the first therapeutic alternative, based on their mono-dose oral administration, with a similar safety and effectiveness profile, when it is compared with long-term erythromycin use.\nDue to sparse available evidence about the safety and effectiveness of macrolides to treat H ducreyi infection in people with HIV, these results should be taken with caution.\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": "In this Cochrane Review, we assess the effectiveness and safety of macrolides in different regimens or with other treatments forH ducreyiinfection in adults."
}
] |
query-laysum
|
8085
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in the Cochrane Library (2010, Issue 7).\nTo increase the success rate of assisted reproductive technologies (ARTs), adherence compounds such as hyaluronic acid (HA) have been introduced into subfertility management. Adherence compounds are added to the embryo transfer medium to increase the likelihood of embryo implantation, with the potential for higher clinical pregnancy and live birth rates.\nObjectives\nTo determine whether adding adherence compounds to embryo transfer media could improve pregnancy outcomes, including improving live birth and decreasing miscarriage, in women undergoing assisted reproduction.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Trials Register, CENTRAL, MEDLINE, Embase, and PsycINFO electronic databases on 7 January 2020 for randomised controlled trials that examined the effects of adherence compounds in embryo transfer media on pregnancy outcomes. Furthermore, we communicated with experts in the field, searched trials registries, checked reference lists of relevant studies, and conference abstracts were handsearched.\nSelection criteria\nOnly truly randomised controlled trials comparing embryo transfer media containing functional concentrations of adherence compounds to media with no or low adherence compound concentrations were included.\nData collection and analysis\nTwo review authors selected trials for inclusion according to the above criteria, after which the same two review authors independently extracted data for subsequent analysis. Statistical analysis was performed according to the guidelines developed by Cochrane. We combined data to calculate pooled risk ratios (RRs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We used GRADE methods to assess the overall quality of evidence for the main comparisons.\nMain results\nWe analysed 26 studies with a total of 6704 participants. Overall, the certainty of evidence was low to moderate: the main limitations were imprecision and/or heterogeneity. Compared to embryos transferred in media containing no or low (0.125 mg/mL) HA, the addition of functional (0.5 mg/mL) HA concentrations to the transfer media probably increases the live birth rate (RR 1.21, 95% CI 1.1 to 1.31; 10 RCTs, N = 4066; I² = 33%; moderate-quality evidence). This suggests that if the chance of live birth following no HA addition in media is assumed to be 33%, the chance following HA addition would be between 37% and 44%. The addition of HA may slightly decrease miscarriage rates (RR 0.82, 95% CI 0.67 to 1.00; 7 RCTs, N = 3091; I² = 66%; low-quality evidence). Nevertheless, when only studies with low risk of bias were included in the analysis, there was no conclusive evidence of a difference in miscarriage rates (RR 0.96, 95% CI 0.75 to 1.23; N = 2219; I² = 36%).\nAdding HA to transfer media probably results in an increase in both clinical pregnancy (RR 1.16, 95% CI 1.09 to 1.23; 17 studies, N = 5247; I² = 40%; moderate-quality evidence) and multiple pregnancy rates (RR 1.45, 95% CI 1.24 to 1.70; 7 studies, N = 3337; I² = 36%; moderate-quality evidence). We are uncertain of the effect of HA added to transfer media on the rate of total adverse events (RR 0.86, 95% CI 0.40 to 1.84; 3 studies, N = 1487; I² = 0%; low-quality evidence).\nAuthors' conclusions\nModerate-quality evidence shows improved clinical pregnancy and live birth rates with the addition of HA as an adherence compound in embryo transfer media in ART. Low-quality evidence suggests that adding HA may slightly decrease miscarriage rates, but when only studies at low risk of bias were included in the analysis, the results were inconclusive. HA had no clear effect on the rate of total adverse events. The increase in multiple pregnancy rates may be due to combining an adherence compound and transferring more than one embryo. Further studies of adherence compounds with single embryo transfer need to be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Embryo transfer using media with high concentrations of hyaluronic acid probably increases the number of live births compared with using solutions with low concentrations or no hyaluronic acid (10 studies). If transfer media with low concentrations or no hyaluronic acid have a 33% chance of resulting in a live birth, solutions with high concentrations increase the chance of a live birth to between 37% and 44%. There would probably be 1 additional live birth for every 14 embryos transferred in a high-concentration hyaluronic acid solution.\nHigh concentrations of hyaluronic acid in the embryo transfer solution probably also increase the number of clinical pregnancies (17 studies) and the number of multiple pregnancies (7 studies).\nUsing transfer solutions containing high concentrations of hyaluronic acid may result in slightly fewer miscarriages (7 studies). But our analysis did not show a clear difference if we left out studies whose results varied widely.\nReported adverse events included ectopic pregnancies (when an embryo becomes implanted outside the womb) and abnormalities affecting the embryo or the foetus. Similar numbers of adverse events were reported for both types of transfer solution (high and low concentrations of hyaluronic acid): we found no evidence that the concentration of hyaluronic acid in the transfer solution affected the number of adverse events reported."
}
] |
query-laysum
|
8086
|
[
{
"role": "user",
"content": "Abstract: Background\nThe dystrophinopathies include Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), and X-linked dilated cardiomyopathy (XLDCM). In recent years, co-ordinated multidisciplinary management for these diseases has improved the quality of care, with early corticosteroid use prolonging independent ambulation, and the routine use of non-invasive ventilation signficantly increasing survival. The next target to improve outcomes is optimising treatments to delay the onset or slow the progression of cardiac involvement and so prolong survival further.\nObjectives\nTo assess the effects of interventions for preventing or treating cardiac involvement in DMD, BMD, and XLDCM, using measures of change in cardiac function over six months.\nSearch methods\nOn 16 October 2017 we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE and Embase, and on 12 December 2017, we searched two clinical trials registries. We also searched conference proceedings and bibliographies.\nSelection criteria\nWe considered only randomised controlled trials (RCTs), quasi-RCTs and randomised cross-over trials for inclusion. In the Discussion, we reviewed open studies, longitudinal observational studies and individual case reports but only discussed studies that adequately described the diagnosis, intervention, pretreatment, and post-treatment states and in which follow-up lasted for at least six months.\nData collection and analysis\nTwo authors independently reviewed the titles and abstracts identified from the search and performed data extraction. All three authors assessed risk of bias independently, compared results, and decided which trials met the inclusion criteria. They assessed the certainty of evidence using GRADE criteria.\nMain results\nWe included five studies (N = 205) in the review; four studies included participants with DMD only, and one study included participants with DMD or BMD. All studied different interventions, and meta-analysis was not possible. We found no studies for XLDCM. None of the trials reported cardiac function as improved or stable cardiac versus deteriorated.\nThe randomised first part of a two-part study of perindopril (N = 28) versus placebo (N = 27) in boys with DMD with normal heart function at baseline showed no difference in the number of participants with a left ventricular ejection fraction (LVEF%) of less than 45% after three years of therapy (n = 1 in each group; risk ratio (RR) 1.04, 95% confidence interval (CI) 0.07 to 15.77). This result is uncertain because of study limitations, indirectness and imprecision. In a non-randomised follow-up study, after 10 years, more participants who had received placebo from the beginning had reduced LVEF% (less than 45%). Adverse event rates were similar between the placebo and treatment groups (low-certainty evidence).\nA study comparing treatment with lisinopril versus losartan in 23 boys newly diagnosed with Duchenne cardiomyopathy showed that after 12 months, both were equally effective in preserving or improving LVEF% (lisinopril 54.6% (standard deviation (SD) 5.19), losartan 55.2% (SD 7.19); mean difference (MD) −0.60% CI −6.67 to 5.47: N = 16). The certainty of evidence was very low because of very serious imprecision and study limitations (risk of bias). Two participants in the losartan group were withdrawn due to adverse events: one participant developed an allergic reaction, and a second exceeded the safety standard with a fall in ejection fraction greater than 10%. Authors reported no other adverse events related to the medication (N = 22; very low-certainty evidence).\nA study comparing idebenone versus placebo in 21 boys with DMD showed little or no difference in mean change in cardiac function between the two groups from baseline to 12 months; for fractional shortening the mean change was 1.4% (SD 4.1) in the idebenone group and 1.6% (SD 2.6) in the placebo group (MD −0.20%, 95% CI −3.07 to 2.67, N = 21), and for ejection fraction the mean change was −1.9% (SD 9.8) in the idebenone group and 0.4% (SD 5.5) in the placebo group (MD −2.30%, 95% CI −9.18 to 4.58, N = 21). The certainty of evidence was very low because of study limitations and very serious imprecision. Reported adverse events were similar between the treatment and placebo groups (low-certainty evidence).\nA multicentre controlled study added eplerenone or placebo to 42 patients with DMD with early cardiomyopathy but preserved left ventricular function already established on ACEI or ARB therapy. Results showed that eplerenone slowed the rate of decline of magnetic resonance (MR)-assessed left ventricular circumferential strain at 12 months (eplerenone group median 1.0%, interquartile range (IQR) 0.3 to −2.2; placebo group median 2.2%, IQR 1.3 to −3.1%; P = 0.020). The median decline in LVEF over the same period was also less in the eplerenone group (−1.8%, IQR −2.9 to 6.0) than in the placebo group (−3.7%, IQR −10.8 to 1.0; P = 0.032). We downgraded the certainty of evidence to very low for study limitations and serious imprecision. Serious adverse events were reported in two patients given placebo but none in the treatment group (very low-certainty evidence).\nA randomised placebo-controlled study of subcutaneous growth hormone in 16 participants with DMD or BMD showed an increase in left ventricular mass after three months' treatment but no significant improvement in cardiac function. The evidence was of very low certainty due to imprecision, indirectness, and study limitations. There were no clinically significant adverse events (very low-certainty evidence).\nSome studies were at risk of bias, and all were small. Therefore, although there is some evidence from non-randomised data to support the prophylactic use of perindopril for cardioprotection ahead of detectable cardiomyopathy, and for lisinopril or losartan plus eplerenone once cardiomyopathy is detectable, this must be considered of very low certainty. Findings from non-randomised studies, some of which have been long term, have led to the use of these drugs in daily clinical practice.\nAuthors' conclusions\nBased on the available evidence from RCTs, early treatment with ACE inhibitors or ARBs may be comparably beneficial for people with a dystrophinopathy; however, the certainty of evidence is very low. Very low-certainty evidence indicates that adding eplerenone might give additional benefit when early cardiomyopathy is detected. No clinically meaningful effect was seen for growth hormone or idebenone, although the certainty of the evidence is also very low.\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 protein dystrophin is essential for muscles to work normally. DMD, BMD and XLDCM are inherited muscle diseases caused by changes in the gene that controls production of dystrophin. People with these conditions develop muscle wasting and weakness. In the heart, a lack of dystrophin causes muscle damage and scarring, which over time causes the heart to fail. Eventually the heart chambers enlarge, which is known as dilated cardiomyopathy. This serious complication can be a cause of death. There are a number of possible treatments for heart problems in these muscle conditions. One option is to reduce the workload of the heart with drugs that lower blood pressure (angiotensin-converting-enzyme inhibitors, ACE inhibitors) or slow the heart rate (beta blockers or ivabradine). Another approach is to reduce muscle damage with antioxidants (e.g. idebenone) or medicines that target inflammation (e.g. corticosteroids). Recently, drugs that increase dystrophin have been developed, including ataluren and eteplirsen."
}
] |
query-laysum
|
8087
|
[
{
"role": "user",
"content": "Abstract: Background\nOpioid dependence (OD) is an increasing clinical and public health problem worldwide. International guidelines recommend opioid substitution treatment (OST), such as methadone and buprenorphine, as first-line medication treatment for OD. A negative aspect of OST is that the medication used can be diverted both through sale on the black market, and the unsanctioned use of medications. Daily supervised administration of medications used in OST has the advantage of reducing the risk of diversion, and may promote therapeutic engagement, potentially enhancing the psychosocial aspect of OST, but costs more and is more restrictive on the client than dispensing for off-site consumption.\nObjectives\nThe objective of this systematic review is to compare the effectiveness of OST with supervised dosing relative to dispensing of medication for off-site consumption.\nSearch methods\nWe searched in Cochrane Drugs and Alcohol Group Specialised Register and Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science from inception up to April 2016. Ongoing and unpublished studies were searched via ClinicalTrials.gov (www.clinicaltrials.gov) and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/).\nAll searches included non-English language literature. We handsearched references on topic-related systematic reviews.\nSelection criteria\nRandomised controlled trials (RCTs), controlled clinical trials (CCTs), and prospective controlled cohort studies, involving people who are receiving OST (methadone, buprenorphine) and comparing supervised dosing with dispensing of medication to be consumed away from the dispensing point, usually without supervision.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nSix studies (four RCTs and two prospective observational cohort studies), involving 7999 participants comparing supervised OST treatment with unsupervised treatment, met the inclusion criteria. The risk of bias was generally moderate across trials, but the results reported on outcomes that we planned to consider were limited. Overall, we judged the quality of the evidence from very low to low for all the outcomes.\nWe found no difference in retention at any duration with supervised compared to unsupervised dosing (RR 0.99, 95% CI 0.88 to 1.12, 716 participants, four trials, low-quality evidence) or in retention in the shortest follow-up period, three months (RR 0.94; 95% CI 0.84 to 1.05; 472 participants, three trials, low-quality evidence). Additional data at 12 months from one observational study found no difference in retention between groups (RR 0.94, 95% CI 0.77 to 1.14; n = 300).There was no difference in abstinence at the end of treatment (self-reported drug use) (67% versus 60%, P = 0.33, 293 participants, one trial, very low-quality evidence); and in diversion of medication (5% versus 2%, 293 participants, one trial, very low-quality evidence).\nRegarding our secondary outcomes, we did not found a difference in the incidence of adverse effects in the supervised compared to unsupervised control group (RR 0.63; 96% CI 0.10 to 3.86; 363 participants, two trials, very low-quality evidence). Data on severity of dependence were very limited (244 participants, one trial) and showed no difference between the two approaches. Data on deaths were reported in two studies. One trial reported two deaths in the supervised group (low-quality evidence), while in the cohort study all-cause mortality was found lower in regular supervision group (crude mortality rate 0.60 versus 0.81 per 100 person-years), although after adjustment insufficient evidence existed to suggest that regular supervision was protective (mortality rate ratio = 1.23, 95% CI = 0.67 to 2.27).\nNo studies reported pain symptoms, drug craving, aberrant opioid-related behaviours, days of unsanctioned opioid use and overdose.\nAuthors' conclusions\nTake-home medication strategies are attractive to treatment services due to lower costs, and place less restrictions on clients, but it is unknown whether they may be associated with increased risk of diversion and unsanctioned use of medication. There is uncertainty about the effects of supervised dosing compared with unsupervised medication due to the low and very low quality of the evidence for the primary outcomes of interest for this review. Data on defined secondary outcomes were similarly limited. More research comparing supervised and take-home medication strategies is needed to support decisions on the relative effectiveness of these strategies. The trials should be designed and conducted with high quality and over a longer follow-up period to support comparison of strategies at different stages of treatment. In particular, there is a need for studies assessing in more detail the risk of diversion and safety outcomes of using supervised OST to manage opioid dependence.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, the studies were moderately well-conducted, but there was a small number of studies reporting outcomes of interest, therefore insufficient to evaluate the efficacy of intervention such as diversion, opoid use reduction, retention in treatment and frequency of unsanctioned opioid use, Furthermore, low rates of occurrence of some events between studies resulted in the overall quality of the evidence being assessed as low and very low. This indicates that further evidence would be likely to change the estimates of relative effect made in this review."
}
] |
query-laysum
|
8088
|
[
{
"role": "user",
"content": "Abstract: Background\nDiabetic macular edema (DME) is secondary to leakage from diseased retinal capillaries with thickening of central retina, and is an important cause of poor central visual acuity in people with diabetic retinopathy. Intravitreal steroids have been used to reduce retinal thickness and improve vision in people with DME.\nObjectives\nTo assess the effectiveness and safety of intravitreal steroid therapy compared with other treatments for DME.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase on 15 May, 2019. We also searched reference lists, Science Citation Index, conference proceedings, and relevant trial registers. We conducted a top up search on 21 October, 2020.\nSelection criteria\nWe included randomized controlled trials that evaluated any type of intravitreal steroids as monotherapy against any other intervention (e.g. observation, laser photocoagulation, anti-vascular endothelial growth factor (antiVEGF) for DME.\nData collection and analysis\nTwo review authors independently assessed study eligibility and risk of bias and extracted data. Where appropriate, we performed meta-analyses.\nMain results\nWe included 10 trials (4348 participants, 4505 eyes). These trials compared intravitreal steroid therapies versus other treatments, including intravitreal antiVEGF therapy, laser photocoagulation, and sham injection. Most trials had an overall unclear or high risk of bias.\nOne trial (701 eyes ) compared intravitreal dexamethasone implant 0.7mg with sham. We found moderate-certainty evidence that dexamethasone leads to slightly more improvement of visual acuity than sham at 12 months (mean difference [MD] −0.08 logMAR, 95% confidence interval [CI] −0.12 to −0.05 logMAR). Regarding improvement of three or more lines of visual acuity, there was moderate-certainty evidence in favor of dexamethasone at 12 months, but the CI covered the null value (risk ratio (RR) 1.39, 95% CI 0.91 to 2.12). Regarding adverse events, dexamethasone increased by about four times the risk of cataract progression and the risk of using intraocular pressure (IOP)-lowering medications compared to sham (RR 3.89, 95% CI 2.75 to 5.50 and RR 4.54, 95% CI 3.19 to 6.46, respectively; moderate-certainty evidence); about 4 in 10 participants treated with dexamethasone needed IOP-lowering medications.\nTwo trials (451 eyes) compared intravitreal dexamethasone implant 0.7mg with intravitreal antiVEGF (bevacizumab and ranibizumab). There was moderate-certainty evidence that visual acuity improved slightly less with dexamethasone compared with antiVEGF at 12 months (MD 0.07 logMAR, 95% CI 0.04 to 0.09 logMAR; 2 trials; 451 participants/eyes; I2 = 0%). The RR of gain of three or more lines of visual acuity was inconsistent between trials, with one trial finding no evidence of a difference between dexamethasone and bevacizumab at 12 months (RR 0.99, 95% CI 0.70 to 1.40; 1 trial; 88 eyes), and the other, larger trial finding the chances of vision gain were half with dexamethasone compared with ranibizumab (RR 0.50, 95% CI 0.32 to 0.79; 1 trial; 432 participants). The certainty of evidence was low. Cataract progression and the need for IOP-lowering medications increased more than 4 times with dexamethasone implant compared to antiVEGF (moderate-certainty evidence).\nOne trial (560 eyes) compared intravitreal fluocinolone implant 0.19mg with sham. There was moderate-certainty evidence that visual acuity improved slightly more with fluocinolone at 12 months (MD −0.04 logMAR, 95% CI −0.06 to −0.01 logMAR). There was moderate-certainty evidence that an improvement in visual acuity of three or more lines was more common with fluocinolone than with sham at 12 months (RR 1.79, 95% CI 1.16 to 2.78). Fluocinolone also increased the risk of cataract progression (RR 1.63, 95% CI 1.35 to 1.97; participants = 335; moderate-certainty evidence), which occurred in about 8 in 10 participants, and the use of IOP-lowering medications (RR 2.72, 95% CI 1.87 to 3.98; participants = 558; moderate-certainty evidence), which were needed in 2 to 3 out of 10 participants.\nOne small trial with 43 participants (69 eyes) compared intravitreal triamcinolone acetonide injection 4 mg with sham. There may be a benefit in visual acuity at 24 months (MD −0.11 logMAR, 95% CI −0.20 to −0.03 logMAR), but the certainty of evidence is low. Differences in adverse effects were poorly reported in this trial.\nTwo trials (615 eyes) compared intravitreal triamcinolone acetonide injection 4mg with laser photocoagulation and reached discordant results. The smaller trial (31 eyes followed up to 9 months) found more visual acuity improvement with triamcinolone (MD −0.18 logMAR, 95% CI −0.29 to −0.07 logMAR), but a larger, multicenter trial (584 eyes, 12-month follow-up) found no evidence of a difference regarding change in visual acuity (MD 0.02 logMAR, 95% CI -0.03 to 0.07 logMAR) or gain of three or more lines of visual acuity (RR 0.85, 95% CI 0.55 to 1.30) (overall low-certainty evidence). Cataract progression was about three times more likely (RR 2.68, 95% CI 2.21 to 3.24; moderate-certainty evidence) and the use of IOP-lowering medications was about four times more likely (RR 3.92, 95% CI 2.59 to 5.96; participants = 627; studies = 2; I2 = 0%; moderate-certainty evidence) with triamcinolone. About 1 in 3 participants needed IOP-lowering medication.\nOne small trial (30 eyes) compared intravitreal triamcinolone acetonide injection 4mg with intravitreal antiVEGF (bevacizumab or ranibizumab). Visual acuity may be worse with triamcinolone at 12 months (MD 0.18 logMAR, 95% CI 0.10 to 0.26 logMAR); the certainty of evidence is low. Adverse effects were poorly reported in this trial.\nFour trials reported data on pseudophakic participants, for whom cataract is not a concern. These trials found no decrease in visual acuity in the second treatment year due to cataract progression.\nAuthors' conclusions\nIntravitreal steroids may improve vision in people with DME compared to sham or control. Effects were small, about one line of vision or less in most comparisons. More evidence is available for dexamethasone or fluocinolone implants when compared to sham, and the evidence is limited and inconsistent for the comparison of dexamethasone with antiVEGF treatment. Any benefits should be weighed against IOP elevation, the use of IOP-lowering medication and, in phakic patients, the progression of cataract. The need for glaucoma surgery is also increased, but remains rare.\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 identified 10 studies on 4348 people with diabetic macular edema. Participants were followed for nine to 36 months. The studies investigated three different injected steroids: dexamethasone, fluocinolone, and triamcinolone. Six studies were funded by pharmaceutical manufacturers.\nBenefits (measured 12 or 24 months after treatment)\nCompared to a sham treatment:\n• Dexamethasone and fluocinolone probably improve visual sharpness and reduce thickness of the retina more; triamcinolone may also do this.\n• It is probable that more people’s vision improves by three lines or more on a vision chart with fluocinolone. Evidence is insufficient to tell whether dexamethasone or triamcinolone has the same effect.\nCompared to antiangiogenics (medicines that prevent new blood vessels forming behind the retina):\n• Dexamethasone probably improves visual sharpness similarly or slightly less but may reduce thickness of the retina slightly more. Triamcinolone may improve visual sharpness less too; we do not know how it affects thickness of the retina because the evidence is of very low-certainty.\n• We cannot tell whether more people’s vision improves by three lines or more on a vision chart with dexamethasone or triamcinolone. This is because the evidence on dexamethasone is inconsistent and of low-certainty, and no studies on triamcinolone evaluated this.\nCompared to laser therapy:\n• Triamcinolone may make little or no difference to whether people’s vision improves by three lines or more on a vision chart.\n• We do not know whether triamcinolone increases visual sharpness or reduces thickness of the retina more due to insufficient evidence.\nRisks (measured nine to 36 months after treatment)\nCompared to a sham treatment:\n• It is probable that cataracts progress in more people with dexamethasone or fluocinolone; cataract may be more likely with triamcinolone too.\n• It is probable that more people treated with dexamethasone or fluocinolone need drops that lower eye pressure. The evidence is too imprecise to show if triamcinolone affects the need for such drops.\n• Fluocinolone may increase the risk of needing surgery for glaucoma (optic nerve damage caused by high pressure in the eye). There is insufficient evidence to show if dexamethasone or triamcinolone affects the need for glaucoma surgery.\nCompared to antiangiogenics:\n• Cataract progression and the need for pressure-lowering eye drops is probably greater with dexamethasone.\n•We do not know if dexamethasone affects the need for glaucoma surgery because the evidence is poor and imprecise.\n•There is insufficient evidence to show if triamcinolone causes more adverse effects.\nCompared to laser therapy:\n• Cataract progression and the need for pressure-lowering eye drops is probably greater with triamcinolone.\n• The evidence is too imprecise to show how triamcinolone affects the need for glaucoma surgery."
}
] |
query-laysum
|
8089
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with multiple sclerosis (MS) have complex symptoms and different types of needs. These demands include how to manage the burden of physical disability as well as how to organise daily life, restructure social roles in the family and at work, preserve personal identity and community roles, keep self-sufficiency in personal care, and how to be part of an integrated care network. Palliative care teams are trained to keep open full and competent lines of communication about symptoms and disease progression, advanced care planning, and end-of-life issues and wishes. Teams create a treatment plan for the total management of symptoms, supporting people and families on decision-making. Despite advances in research and the existence of many interventions to reduce disease activity or to slow the progression of MS, this condition remains a life-limiting disease with symptoms that impact negatively the lives of people with it and their families.\nObjectives\nTo assess the effects (benefits and harms) of palliative care interventions compared to usual care for people with any form of multiple sclerosis: relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), and progressive-relapsing MS (PRMS) We also aimed to compare the effects of different palliative care interventions.\nSearch methods\nOn 31 October 2018, we conducted a literature search in the specialised register of the Cochrane MS and Rare Diseases of the Central Nervous System Review Group, which contains trials from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Clinical trials.gov and the World Health Organization International Clinical Trials Registry Platform. We also searched PsycINFO, PEDro and Opengrey. We also handsearched relevant journals and screened the reference lists of published reviews. We contacted researchers in palliative care and multiple sclerosis.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster randomised trials were eligible for inclusion, as well as the first phase of cross-over trials. We included studies that compared palliative care interventions versus usual care. We also included studies that compared palliative care interventions versus another type of palliative interventions.\nData collection and analysis\nWe used standard Cochrane methodological procedures. We summarised key results and certainty of evidence in a 'Summary of Finding' table that reported outcomes at six or more months of post-intervention.\nMain results\nThree studies (146 participants) met our selection criteria. Two studies compared multidisciplinary, fast-track palliative care versus multidisciplinary standard care while on a waiting-list control, and one study compared a multidisciplinary palliative approach versus multidisciplinary standard care at different time points (12, 16, and 24 weeks). Two were RCTs with parallel design (total 94 participants) and one was a cross-over design (52 participants). The three studies assessed palliative care as a home-based intervention. One of the three studies included participants with 'neurodegenerative diseases', with MS people being a subset of the randomised population. We assessed the risk of bias of included studies using Cochrane's 'Risk of Bias' tool.\nWe found no evidence of differences between intervention and control groups in long-time follow-up (> six months post-intervention) for the following outcomes: mean change in health-related quality of life (SEIQoL - higher scores mean better quality of life; MD 4.80, 95% CI -12.32 to 21.92; participants = 62; studies = 1; very low-certainty evidence), serious adverse events (RR 0.97, 95% CI 0.44 to 2.12; participants = 76; studies = 1, 22 events, low-certainty evidence) and hospital admission (RR 0.78, 95% CI 0.24 to 2.52; participants = 76; studies = 1, 10 events, low-certainty evidence).\nThe three included studies did not assess the following outcomes at long term follow-up (> six months post intervention): fatigue, anxiety, depression, disability, cognitive function, relapse-free survival, and sustained progression-free survival.\nWe did not find any trial that compared different types of palliative care with each other.\nAuthors' conclusions\nBased on the findings of the RCTs included in this review, we are uncertain whether palliative care interventions are beneficial for people with MS. There is low- or very low-certainty evidence regarding the difference between palliative care interventions versus usual care for long-term health-related quality of life, adverse events, and hospital admission in patients with MS. For intermediate-term follow-up, we are also uncertain about the effects of palliative care for the outcomes: health-related quality of life (measured by different assessments: SEIQoL or MSIS), disability, anxiety, and depression.\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": "Multiple sclerosis (MS) is a chronic, disabling and progressive condition that affects around 2.3 million people worldwide. The many symptoms of MS create emotional, psychosocial and physical burdens for those affected. Palliative care is defined as the active and total care of pain and psychological, spiritual and social problems of people with a disease that does not respond to curative treatments. Palliative care includes the relief of pain and other stressor symptoms, the promotion of the concept of life and death as something natural, promoting respect for the natural course of death, the integration of psychological and spiritual aspects into patient care, and the preservation of an active life for as long as possible."
}
] |
query-laysum
|
8090
|
[
{
"role": "user",
"content": "Abstract: Background\nThe efficacy of decongestants, antihistamines and nasal irrigation in children with clinically diagnosed acute sinusitis has not been systematically evaluated.\nObjectives\nTo determine the efficacy of decongestants, antihistamines or nasal irrigation in improving symptoms of acute sinusitis in children.\nSearch methods\nWe searched CENTRAL (2014, Issue 5), MEDLINE (1950 to June week 1, 2014) and EMBASE (1950 to June 2014).\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs, which evaluated children younger than 18 years of age with acute sinusitis, defined as 10 to 30 days of rhinorrhea, congestion or daytime cough. We excluded trials of children with chronic sinusitis and allergic rhinitis.\nData collection and analysis\nTwo review authors independently assessed each study for inclusion.\nMain results\nOf the 662 studies identified through the electronic searches and handsearching, none met all the inclusion criteria.\nAuthors' conclusions\nThere is no evidence to determine whether the use of antihistamines, decongestants or nasal irrigation is efficacious in children with acute sinusitis. Further research is needed to determine whether these interventions are beneficial in the treatment of children with acute sinusitis.\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": "Not applicable."
}
] |
query-laysum
|
8091
|
[
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of obesity is increasing worldwide, yet nutritional management remains contentious. It has been suggested that low glycaemic index (GI) or low glycaemic load (GL) diets may stimulate greater weight loss than higher GI/GL diets or other weight reduction diets. The previous version of this review, published in 2007, found mainly short-term intervention studies. Since then, randomised controlled trials (RCTs) with longer-term follow-up have become available, warranting an update of this review.\nObjectives\nTo assess the effects of low glycaemic index or low glycaemic load diets on weight loss in people with overweight or obesity.\nSearch methods\nWe searched CENTRAL, MEDLINE, one other database, and two clinical trials registers from their inception to 25 May 2022. We did not apply any language restrictions.\nSelection criteria\nWe included RCTs with a minimum duration of eight weeks comparing low GI/GL diets to higher GI/GL diets or any other diets in people with overweight or obesity.\nData collection and analysis\nWe used standard Cochrane methods. We conducted two main comparisons: low GI/GL diets versus higher GI/GL diets and low GI/GL diets versus any other diet. Our main outcomes included change in body weight and body mass index, adverse events, health-related quality of life, and mortality. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nIn this updated review, we included 10 studies (1210 participants); nine were newly-identified studies. We included only one study from the previous version of this review, following a revision of inclusion criteria. We listed five studies as 'awaiting classification' and one study as 'ongoing'. Of the 10 included studies, seven compared low GI/GL diets (233 participants) with higher GI/GL diets (222 participants) and three studies compared low GI/GL diets (379 participants) with any other diet (376 participants). One study included children (50 participants); one study included adults aged over 65 years (24 participants); the remaining studies included adults (1136 participants). The duration of the interventions varied from eight weeks to 18 months. All trials had an unclear or high risk of bias across several domains.\nLow GI/GL diets versus higher GI/GL diets\nLow GI/GL diets probably result in little to no difference in change in body weight compared to higher GI/GL diets (mean difference (MD) -0.82 kg, 95% confidence interval (CI) -1.92 to 0.28; I2 = 52%; 7 studies, 403 participants; moderate-certainty evidence). Evidence from four studies reporting change in body mass index (BMI) indicated low GI/GL diets may result in little to no difference in change in BMI compared to higher GI/GL diets (MD -0.45 kg/m2, 95% CI -1.02 to 0.12; I2 = 22%; 186 participants; low-certainty evidence)at the end of the study periods. One study assessing participants' mood indicated that low GI/GL diets may improve mood compared to higher GI/GL diets, but the evidence is very uncertain (MD -3.5, 95% CI -9.33 to 2.33; 42 participants; very low-certainty evidence). Two studies assessing adverse events did not report any adverse events; we judged this outcome to have very low-certainty evidence. No studies reported on all-cause mortality.\nFor the secondary outcomes, low GI/GL diets may result in little to no difference in fat mass compared to higher GI/GL diets (MD -0.86 kg, 95% CI -1.52 to -0.20; I2 = 6%; 6 studies, 295 participants; low certainty-evidence). Similarly, low GI/GL diets may result in little to no difference in fasting blood glucose level compared to higher GI/GL diets (MD 0.12 mmol/L, 95% CI 0.03 to 0.21; I2 = 0%; 6 studies, 344 participants; low-certainty evidence).\nLow GI/GL diets versus any other diet\nLow GI/GL diets probably result in little to no difference in change in body weight compared to other diets (MD -1.24 kg, 95% CI -2.82 to 0.34; I2 = 70%; 3 studies, 723 participants; moderate-certainty evidence). The evidence suggests that low GI/GL diets probably result in little to no difference in change in BMI compared to other diets (MD -0.30 kg in favour of low GI/GL diets, 95% CI -0.59 to -0.01; I2 = 0%; 2 studies, 650 participants; moderate-certainty evidence). Two adverse events were reported in one study: one was not related to the intervention, and the other, an eating disorder, may have been related to the intervention. Another study reported 11 adverse events, including hypoglycaemia following an oral glucose tolerance test. The same study reported seven serious adverse events, including kidney stones and diverticulitis. We judged this outcome to have low-certainty evidence. No studies reported on health-related quality of life or all-cause mortality.\nFor the secondary outcomes, none of the studies reported on fat mass. Low GI/GL diets probably do not reduce fasting blood glucose level compared to other diets (MD 0.03 mmol/L, 95% CI -0.05 to 0.12; I2 = 0%; 3 studies, 732 participants; moderate-certainty evidence).\nAuthors' conclusions\nThe current evidence indicates there may be little to no difference for all main outcomes between low GI/GL diets versus higher GI/GL diets or any other diet. There is insufficient information to draw firm conclusions about the effect of low GI/GL diets on people with overweight or obesity. Most studies had a small sample size, with only a few participants in each comparison group. We rated the certainty of the evidence as moderate to very low. More well-designed and adequately-powered studies are needed. They should follow a standardised intervention protocol, adopt objective outcome measurement since blinding may be difficult to achieve, and make efforts to minimise loss to follow-up. Furthermore, studies in people from a wide range of ethnicities and with a wide range of dietary habits, as well as studies in low- and middle-income countries, are needed.\n\nGiven the provided abstract, please respond to the following query: \"What 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 evaluate the effects of following these diets in people with overweight or obesity. We checked the effects on weight, quality of life, side effects, and death."
}
] |
query-laysum
|
8092
|
[
{
"role": "user",
"content": "Abstract: Background\nCataract is the leading cause of blindness in the world and, as such, cataract surgery is one of the most commonly performed operations globally. Surgical techniques have changed dramatically over the past half century with associated improvements in outcomes and safety. Femtosecond lasers can be used to perform the key steps in cataract surgery, such as corneal incisions, lens capsulotomy and fragmentation. The potential advantage of femtosecond laser-assisted cataract surgery (FLACS) is greater precision and reproducibility of these steps compared to manual techniques. The disadvantages are the costs associated with FLACS technology.\nObjectives\nTo compare the effectiveness and safety of FLACS with standard ultrasound phacoemulsification cataract surgery (PCS) by gathering evidence from randomised controlled trials (RCTs).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 5); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov; the WHO ICTRP and the US Food and Drug Administration (FDA) website. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 10 May 2022.\nSelection criteria\nWe included RCTs where FLACS was compared to PCS.\nData collection and analysis\nThree review authors independently screened the search results, assessed risk of bias and extracted data using the standard methodological procedures expected by Cochrane. The primary outcome for this review was intraoperative complications in the operated eye, namely anterior capsule, and posterior capsule tears. The secondary outcomes included corrected distance visual acuity (CDVA), quality of vision (as measured by any validated patient-reported outcome measure (PROM)), postoperative cystoid macular oedema complications, endothelial cell loss and cost-effectiveness. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 42 RCTs conducted in Europe, North America, South America and Asia, which enrolled a total of 7298 eyes of 5831 adult participants. Overall, the studies were at unclear or high risk of bias. In 16 studies the authors reported financial links with the manufacturer of the laser platform evaluated in their studies. Thirteen of the studies were within-person (paired-eye) studies with one eye allocated to one procedure and the other eye allocated to the other procedure. These studies were reported ignoring the paired nature of the data.\nThere was low-certainty evidence of little or no difference in the odds of developing anterior capsular tears when comparing FLACS and PCS (Peto odds ratio (OR) 0.83, 95% confidence interval (CI) 0.40 to 1.72; 5835 eyes, 27 studies) There was one fewer anterior capsule tear per 1000 operations in the FLACS group compared with the PCS group (95% CI 4 fewer to 3 more).\nThere was low-certainty evidence of lower odds of developing posterior capsular tears with FLACS compared to PCS (Peto OR 0.50, 95% CI 0.25 to 1.00; 5767 eyes, 26 studies). There were four fewer posterior capsule tears per 1000 operations in the FLACS group compared with the PCS group (95% CI 6 fewer to same).\nThere was moderate-certainty evidence of a very small advantage for the FLACS arm with regard to CDVA at six months or more follow-up, (mean difference (MD) -0.01 logMAR, 95% CI -0.02 to 0.00; 1323 eyes, 7 studies). This difference is equivalent to 1 logMAR letter between groups and is not thought to be clinically important.\nFrom the three studies (1205 participants) reporting a variety of PROMs (Cat-PROMS, EQ-5D, EQ-SD-3L, Catquest9-SF and patient survey) up to three months following surgery, there was moderate-certainty evidence of little or no difference in the various parameters between the two treatment arms.\nThere was low-certainty evidence of little or no difference in the odds of developing cystoid macular oedema when comparing FLACS and PCS (Peto OR 0.84, 95% CI 0.56 to 1.28; 4441 eyes, 18 studies). There were three fewer cystoid macular oedema cases per 1000 operations in the FLACS group compared with the PCS group (95% CI 10 fewer to 6 more).\nIn one study the incremental cost-effectiveness ratio (ICER) (cost difference divided by quality-adjusted life year (QALY) difference) was GBP £167,620 when comparing FLACS to PCS. In another study, the ICER was EUR €10,703 saved per additional patient who had treatment success with PCS compared to FLACS. Duration ranged from three minutes in favour of FLACS to eight minutes in favour of PCS (I2 = 100%, 11 studies) (low-certainty evidence).\nThere was low-certainty evidence of little or no important difference in endothelial cell loss when comparing FLACS with PCS (MD 12 cells per mm2 in favour of FLACS, 95% CI -40 to 64; 1512 eyes, 10 studies).\nAuthors' conclusions\nThis review of 42 studies provides evidence that there is probably little or no difference between FLACS and PCS in terms of intraoperative and postoperative complications, postoperative visual acuity and quality of life. Evidence from two studies suggests that FLACS may be the less cost-effective option. Many of the included studies only investigated very specific outcome measures such as effective phacoemulsification time, endothelial cell count change or aqueous flare, rather than those directly related to patient outcomes. Standardised reporting of complications and visual and refractive outcomes for cataract surgery would facilitate future synthesis, and guidance on this has been recently published.\n\nGiven the provided abstract, please respond to the following query: \"What is cataract surgery?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cataract surgery is one of the most performed operations globally. During standard surgery, the surgeon opens the front of the lens capsule (the lens outer layer or ‘skin’), removes the cloudy lens material inside the capsule and places a clear artificial lens in the remaining capsular bag. The aim of femtosecond laser-assisted cataract surgery (FLACS) is to provide more precise control over the steps involved in cataract surgery. By being more precise, it is plausible that this could lead to better outcomes or higher safety for people undergoing cataract surgery."
}
] |
query-laysum
|
8093
|
[
{
"role": "user",
"content": "Abstract: Background\nUterine fibroids (also known as leiomyomas) are the most common benign pelvic tumours among women. They may be asymptomatic, or may be associated with pelvic symptoms such as bleeding and pain. Medical treatment of this condition is limited and gonadotropin-releasing hormone (GnRH) analogues are the most effective agents. Long-term treatment with such agents, however, is restricted due to their adverse effects. The addition of other medications during treatment with GnRH analogues, a strategy known as add-back therapy, may limit these side effects. There is concern, however, that add-back therapy may also limit the efficacy of the GnRH analogues and that it may not be able to completely prevent their adverse effects.\nObjectives\nTo assess the short-term (within 12 months) effectiveness and safety of add-back therapy for women using GnRH analogues for uterine fibroids associated with excessive uterine bleeding, pelvic pain, or urinary symptoms.\nSearch methods\nWe searched electronic databases including the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, CENTRAL, MEDLINE, PubMed, EMBASE, LILACS, CINAHL, PsycINFO; and electronic registries of ongoing trials including ClinicalTrials.gov, Current Controlled Trials, World Health Organization (WHO) International Clinical Trials Registry Platform. All searches were from database inception to 16 June 2014.\nSelection criteria\nRandomized controlled trials (RCTs) that included women with uterine fibroids experiencing irregular or intense uterine bleeding, cyclic or non-cyclic pelvic pain, or urinary symptoms, and that compared treatment with a GnRH analogue plus add-back therapy versus a GnRH analogue alone or combined with placebo were eligible for inclusion.\nData collection and analysis\nTwo authors independently reviewed the identified titles and abstracts for potentially eligible records. Two review authors reviewed eligible studies and independently extracted data. Two authors independently assessed the studies' risk of bias. They assessed the quality of the evidence using GRADE criteria.\nMain results\nFourteen RCTs were included in the review. Data were extracted from 12 studies (622 women). The primary outcome was quality of life (QoL).\nAdd-back therapy with medroxyprogesterone (MPA): no studies reported QoL or uterine bleeding. There was no evidence of effect in relation to bone mass (standardized mean difference (SMD) 0.38, 95% confidence interval (CI) -0.62 to 1.38, 1 study, 16 women, P = 0.45, low quality evidence) and MPA was associated with a larger uterine volume (mean difference (MD) 342.19 cm3, 95% CI 77.58 to 606.80, 2 studies, 32 women, I2 = 0%, low quality evidence).\nTibolone: this was associated with a higher QoL but the estimate was imprecise and the effect could be clinically insignificant, small or large (SMD 0.47, 95% CI 0.09 to 0.85, 1 study, 110 women, P = 0.02, low quality evidence). It was also associated with a decreased loss of bone mass, which could be insignificant, small or moderate (SMD 0.36, 95% CI 0.03 to 0.7, 3 studies, 160 women, I2 = 7%, moderate quality evidence). Tibolone may, however, have been associated with larger uterine volumes (MD 23.89 cm3, 95% CI= 8.13 to 39.66, 6 studies, 365 women, I2 = 0%, moderate quality evidence) and more uterine bleeding (results were not combined but three studies demonstrated greater bleeding with tibolone while two other studies demonstrated no bleeding in either group). Four studies (268 women; not pooled owing to extreme heterogeneity) reported a large benefit on vasomotor symptoms in the tibolone group.\nRaloxifene: there was no evidence of an effect on QoL (SMD 0.11, 95% CI -0.57 to 0.34, 1 study, 74 women, P = 0.62, low quality evidence), while there was a beneficial impact on bone mass (SMD 1.01, 95% CI 0.57 to 1.45, 1 study, 91 women, P < 0.00001, low quality evidence). There was no clear evidence of effect on uterine volume (MD 27.1 cm3, 95% CI -17.94 to 72.14, 1 study, 91 women, P = 0.24, low quality evidence), uterine bleeding or severity of vasomotor symptoms (MD 0.2 hot flushes/day, 95% CI -0.34 to 0.74, 1 study, 91 women, P = 0.46, low quality evidence).\nEstriol: no studies reported QoL, uterine size, uterine bleeding or vasomotor symptoms. Add-back with estriol may have led to decreased loss of bone mass, from results of a single study (SMD 3.93, 95% CI 1.7 to 6.16, 1 study, 12 women, P = 0.0005, low quality evidence).\nIpriflavone: no studies reported QoL, uterine size or uterine bleeding. Iproflavone was associated with decreased loss of bone mass in a single study (SMD 2.71, 95% CI 2.14 to 3.27, 1 study, 95 women, P < 0.00001, low quality evidence); there was no evidence of an effect on the rate of vasomotor symptoms (RR 0.67, 95% Cl 0.44 to 1.02, 1 study, 95 women, P = 0.06, low quality evidence).\nConjugated estrogens: no studies reported QoL, uterine size, uterine bleeding or vasomotor symptoms. One study suggested that adding conjugated estrogens to GnRH analogues resulted in a larger decrease in uterine volume in the placebo group (MD 105.2 cm3, 95% CI 27.65 to 182.75, 1 study, 27 women, P = 0.008, very low quality evidence).\nNine of 12 studies were at high risk of bias in at least one domain, most commonly lack of blinding. All studies followed participants for a maximum of six months. This short-term follow-up is usually insufficient to observe any significant effect of the treatment on bone health (such as the occurrence of fractures), limiting the findings.\nAuthors' conclusions\nThere was low or moderate quality evidence that tibolone, raloxifene, estriol and ipriflavone help to preserve bone density and that MPA and tibolone may reduce vasomotor symptoms. Larger uterine volume was an adverse effect associated with some add-back therapies (MPA, tibolone and conjugated estrogens). For other comparisons, outcomes of interest were not reported or study findings were inconclusive.\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": "Uterine fibroids may be shrunk with gonadotropin-releasing hormone (GnRH) analogues but commonly cause hot flushes. Combining GnRHa with other drugs may decrease hot flushes (a strategy known as add-back therapy) but cause other problems such as low bone mineral density. The efficacy and safety of this approach is controversial."
}
] |
query-laysum
|
8094
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough many people infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) experience no or mild symptoms, some individuals can develop severe illness and may die, particularly older people and those with underlying medical problems. Providing evidence-based interventions to prevent SARS-CoV-2 infection has become more urgent with the spread of more infectious SARS-CoV-2 variants of concern (VoC), and the potential psychological toll imposed by the coronavirus disease 2019 (COVID-19) pandemic.\nControlling exposures to occupational hazards is the fundamental method of protecting workers. When it comes to the transmission of viruses, such as SARS-CoV-2, workplaces should first consider control measures that can potentially have the most significant impact. According to the hierarchy of controls, one should first consider elimination (and substitution), then engineering controls, administrative controls, and lastly, personal protective equipment (PPE).\nObjectives\nTo assess the benefits and harms of interventions in non-healthcare-related workplaces to reduce the risk of SARS-CoV-2 infection relative to other interventions, or no intervention.\nSearch methods\nWe searched MEDLINE, Embase, Web of Science, Cochrane COVID-19 Study Register, the Canadian Centre for Occupational Health and Safety (CCOHS), Clinicaltrials.gov, and the International Clinical Trials Registry Platform to 14 September 2021. We will conduct an update of this review in six months.\nSelection criteria\nWe included randomised control trials (RCT) and planned to include non-randomised studies of interventions. We included adult workers, both those who come into close contact with clients or customers (e.g. public-facing employees, such as cashiers or taxi drivers), and those who do not, but who could be infected by co-workers. We excluded studies involving healthcare workers. We included any intervention to prevent or reduce workers' exposure to SARS-CoV-2 in the workplace, defining categories of intervention according to the hierarchy of hazard controls, i.e. elimination; engineering controls; administrative controls; personal protective equipment.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were incidence rate of SARS-CoV-2 infection (or other respiratory viruses), SARS-CoV-2-related mortality, adverse events, and absenteeism from work. Our secondary outcomes were all-cause mortality, quality of life, hospitalisation, and uptake, acceptability, or adherence to strategies. We used the Cochrane RoB 2 tool to assess the risk of bias, and GRADE methods to assess the certainty of evidence for each outcome.\nMain results\nElimination of exposure interventions\nWe included one study examining an intervention that focused on elimination of hazards. This study is an open-label, cluster-randomised, non-inferiority trial, conducted in England in 2021. The study compared standard 10-day self-isolation after contact with an infected person to a new strategy of daily rapid antigen testing and staying at work if the test is negative (test-based attendance). The trialists hypothesised that this would lead to a similar rate of infections, but lower COVID-related absence. Staff (N = 11,798) working at 76 schools were assigned to standard isolation, and staff (N = 12,229) at 86 schools to the test-based attendance strategy.\nThe results between test-based attendance and standard 10-day self-isolation were inconclusive for the rate of symptomatic PCR-positive SARS-COV-2 infection rate ratio ((RR) 1.28, 95% confidence interval (CI) 0.74 to 2.21; 1 study, very low-certainty evidence)).\nThe results between test-based attendance and standard 10-day self-isolation were inconclusive for the rate of any PCR-positive SARS-COV-2 infection (RR 1.35, 95% CI 0.82 to 2.21; 1 study, very low-certainty evidence).\nCOVID-related absenteeism rates were 3704 absence days in 566,502 days-at-risk (6.5 per 1000 days at risk) in the control group and 2932 per 539,805 days-at-risk (5.4 per 1000 days at risk) in the intervention group (RR 0.83; 95% CI 0.55 to 1.25). The certainty of the evidence was downgraded to low, due to imprecision.\nUptake of the intervention was 71 % in the intervention group, but not reported for the control intervention.\nThe trial did not measure other outcomes, SARS-CoV-2-related mortality, adverse events, all-cause mortality, quality of life, and hospitalisation.\nWe found one ongoing RCT about screening in schools, using elimination of hazard strategies.\nPersonal protective equipment\nWe found one ongoing non-randomised study on the effects of closed face shields to prevent COVID-19 transmission.\nOther intervention categories\nWe did not find studies in the other intervention categories.\nAuthors' conclusions\nWe are uncertain whether a test-based attendance policy affects rates of PCR-postive SARS-CoV-2 infection (any infection; symptomatic infection) compared to standard 10-day self-isolation amongst school and college staff. Test-based attendance policy may result in little to no difference in absence rates compared to standard 10-day self-isolation.\nAs a large part of the population is exposed in the case of a pandemic, an apparently small relative effect that would not be worthwhile from the individual perspective may still affect many people, and thus, become an important absolute effect from the enterprise or societal perspective.\nThe included study did not report on any other primary outcomes of our review, i.e. SARS-CoV-2-related mortality and adverse events. No completed studies were identified on any other interventions specified in this review, but two eligible studies are ongoing. More controlled studies are needed on testing and isolation strategies, and working from home, as these have important implications for work organisations.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We screened more than 13 thousand reports, and included one study, conducted in 162 secondary and post-secondary schools in England, from March to June 2021. The study enrolled more than 24 thousand workers. In the 86 schools in the control group (standard isolation), staff who were considered COVID-19 contacts through contact tracing were required to self-isolate at home for 10 days. In the 76 schools in the intervention group (test-based attendance), staff who were considered COVID-19 contacts through contact tracing were not required to isolate. Instead, they took a daily rapid test (lateral flow antigen test) for seven days. If the rapid test was negative, the staff member could go to work. If the rapid test was positive, the staff member would self-isolate. The researchers wanted to know if there was a difference in COVID-related absence between the two methods.\nWe are uncertain whether a strategy of test-based attendance changes COVID-19 infection rates (any infection; symptomatic infection) compared with routine isolation after contact with a person with COVID-19. COVID-related absence may be lower or similar in the test-based attendance group. However, we were uncertain about these findings, because the number of infections was very low among the participants. Mortality, adverse events, quality of life, and hospitalisation were not measured. Seventy-one per cent of the test-based attendance group followed the strategy; the researchers did not report on compliance for the standard isolation group.\nWe identified one ongoing study that also addressed the effects of screening in schools.\nAnother ongoing study is evaluating the effects of using a face shield to prevent COVID-19 transmission.\nWe did not find any studies that studied engineering or administrative controls."
}
] |
query-laysum
|
8095
|
[
{
"role": "user",
"content": "Abstract: Background\nAsthma is one of the most common reasons for hospital admission among children and constitutes a significant economic burden. Use of non-invasive positive pressure ventilation (NPPV) in the care of children with acute asthma has increased even though evidence supporting the intervention has been considered weak and clinical guidelines do not recommend the intervention. NPPV might be an effective intervention for acute asthma, but no systematic review has been conducted to assess the effects of NPPV as an add-on therapy to usual care in children with acute asthma.\nObjectives\nTo assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children with acute asthma.\nSearch methods\nWe identified trials from the Cochrane Airways Group Specialised Register (CAGR). The Register contains trial reports identified through systematic searches of bibliographic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED and PsycINFO, and by handsearching of respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov) and the WHO trials portal (www.who.int/ictrp/en/). We searched all databases from their inception to February 2016, with no restriction on language of publication.\nSelection criteria\nWe included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children (age < 18 years) hospitalised for an acute asthma attack.\nData collection and analysis\nTwo review authors independently screened titles and abstracts. We retrieved all relevant full-text study reports, independently screened the full text, identified trials for inclusion and identified and recorded reasons for exclusion of ineligible trials. We resolved disagreements through discussion or, if required, consulted a third review author. We recorded the selection process in sufficient detail to complete a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) flow diagram and 'Characteristics of excluded studies' table. We identified the risk of bias of included studies to reduce the risk of systematic error. We contacted relevant study authors when data were missing.\nMain results\nWe included two RCTs that randomised 20 participants to NPPV and 20 participants to control. We assessed both studies as having high risk of bias; both trials assessed effects of bilateral positive airway pressure (BiPAP). Neither trial used continuous positive airway pressure (CPAP). Controls received standard care. Investigators reported no deaths and no serious adverse events (Grades of Recommendation, Assessment, Development and Evaluation (GRADE): very low quality of evidence due to serious risk of bias and serious imprecision of results). Both trials showed a statistically significant reduction in symptom score. One trial did not report a standard deviation (SD), but by using an estimated SD, we found a statistically significantly reduced asthma symptom score (mean difference (MD) -2.50, 95% confidence interval (CI) -4.70 to -0.30, P = 0.03, 19 participants, GRADE: very low quality of evidence). In the other trial, NPPV was associated with a lower total symptom score (5.6 vs 1.9, 16 participants, very low quality of evidence) before cross-over, but investigators did not report an SD, nor could it be estimated from the first phase of the trial, before the cross-over. These gains could be clinically relevant, as a reduction of three or more points in symptom score is considered a clinically meaningful change. Researchers documented five dropouts (12.5%), four of which were due to intolerance to NPPV, and one to respiratory failure requiring intubation. Owing to insufficient reporting in the latter trial and use of different scoring systems, it was not possible to conduct a meta-analysis nor a Trial Sequential Analysis.\nAuthors' conclusions\nCurrent evidence does not permit confirmation or rejection of the effects of NPPV for acute asthma in children. Large RCTs with low risk of bias are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Asthma is known to cause acute exacerbations, in which characteristic changes in the lungs predispose to respiratory difficulties and in some cases respiratory failure. This condition constitutes a significant economic burden and a major health issue worldwide. Evidence supporting this intervention has been considered weak, and the intervention is not recommended in clinical guidelines. Nevertheless, use of NPPV in the care of children with acute asthma has increased, and NPPV might be an effective intervention for acute asthma. Until now, no systematic review has summed up all the evidence provided by randomised clinical trials."
}
] |
query-laysum
|
8096
|
[
{
"role": "user",
"content": "Abstract: Background\nPresent-centered therapy (PCT) is a non-trauma, manualized psychotherapy for adults with post-traumatic stress disorder (PTSD). PCT was originally designed as a treatment comparator in trials evaluating the effectiveness of trauma-focused cognitive-behavioral therapy (TF-CBT). Recent trials have indicated that PCT may be an effective treatment option for PTSD and that patients may drop out of PCT at lower rates relative to TF-CBT.\nObjectives\nTo assess the effects of PCT for adults with PTSD. Specifically, we sought to determine whether (1) PCT is more effective in alleviating symptoms relative to control conditions, (2) PCT results in similar alleviation of symptoms compared to TF-CBT, based on an a priori minimally important differences on a semi-structured interview of PTSD symptoms, and (3) PCT is associated with lower treatment dropout as compared to TF-CBT.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register, the Cochrane Library, Ovid MEDLINE, Embase, PsycINFO, PubMed, and PTSDpubs (previously called the Published International Literature on Traumatic Stress (PILOTS) database) (all years to 15 February 2019 search). We also searched the World Health Organization (WHO) trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished and ongoing trials. Reference lists of included studies and relevant systematic reviews were checked. Grey literature searches were also conducted to identify dissertations and theses, clinical guidelines, and regulatory agency reports.\nSelection criteria\nWe selected all randomized clinical trials (RCTs) that recruited adults diagnosed with PTSD to evaluate PCT compared to TF-CBT or a control condition. Both individual and group PCT modalities were included. The primary outcomes of interest included reduced PTSD severity as determined by a clinician-administered measure and treatment dropout rates.\nData collection and analysis\nWe complied with the Cochrane recommended standards for data screening and collection. Two review authors independently screened articles for inclusion and extracted relevant data from eligible studies, including the assessment of trial quality. Random-effects meta-analyses, subgroup analyses, and sensitivity analyses were conducted using mean differences (MD) and standardized mean differences (SMD) for continuous data or risk ratios (RR) and risk differences (RD) for dichotomous data. To conclude that PCT resulted in similar reductions in PTSD symptoms relative to TF-CBT, we required a MD of less than 10 points (to include the 95% confidence interval) on the Clinician-Administered PTSD Scale (CAPS). Five members of the review team convened to rate the quality of evidence across the primary outcomes. Any disagreements were resolved through discussion. Review authors who were investigators on any of the included trials were not involved in the qualitative or quantitative syntheses.\nMain results\nWe included 12 studies (n = 1837), of which, three compared PCT to a wait-list/minimal attention (WL/MA) group and 11 compared PCT to TF-CBT. PCT was more effective than WL/MA in reducing PTSD symptom severity (SMD -0.84, 95% CI -1.10 to -0.59; participants = 290; studies = 3; I² = 0%). We assessed the quality of this evidence as moderate. The results of the non-inferiority analysis comparing PCT to TF-CBT did not support PCT non-inferiority, with the 95% confidence interval surpassing the clinically meaningful cut-off (MD 6.83, 95% CI 1.90 to 11.76; 6 studies, n = 607; I² = 42%). We assessed this quality of evidence as low. CAPS differences between PCT and TF-CBT attenuated at 6-month (MD 1.59, 95% CI -0.46 to 3.63; participants = 906; studies = 6; I² = 0%) and 12-month (MD 1.22, 95% CI -2.17 to 4.61; participants = 485; studies = 3; I² = 0%) follow-up periods. To confirm the direction of the treatment effect using all eligible trials, we also evaluated PTSD SMD differences. These results were consistent with the primary MD outcomes, with meaningful effect size differences between PCT and TF-CBT at post-treatment (SMD 0.32, 95% CI 0.08 to 0.56; participants = 1129; studies = 9), but smaller effect size differences at six months (SMD 0.17, 95% CI 0.05 to 0.29; participants = 1339; studies = 9) and 12 months (SMD 0.17, 95% CI 0.03 to 0.31; participants = 728; studies = 5). PCT had approximately 14% lower treatment dropout rates compared to TF-CBT (RD -0.14, 95% CI -0.18 to -0.10; participants = 1542; studies = 10). We assessed the quality of this evidence as moderate. There was no evidence of meaningful differences on self-reported PTSD (MD 4.50, 95% CI 3.09 to 5.90; participants = 983; studies = 7) or depression symptoms (MD 1.78, 95% CI -0.23 to 3.78; participants = 705; studies = 5) post-treatment.\nAuthors' conclusions\nModerate-quality evidence indicates that PCT is more effective in reducing PTSD severity compared to control conditions. Low quality of evidence did not support PCT as a non-inferior treatment compared to TF-CBT on clinician-rated post-treatment PTSD severity. The treatment effect differences between PCT and TF-CBT may attenuate over time. PCT participants drop out of treatment at lower rates relative to TF-CBT participants. Of note, all of the included studies were primarily designed to test the effectiveness of TF-CBT which may bias results away from PCT non-inferiority.The current systematic review provides the most rigorous evaluation to date to determine whether PCT is comparably as effective as TF-CBT. Findings are generally consistent with current clinical practice guidelines that suggest that PCT may be offered as a treatment for PTSD when TF-CBT is not available.\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": "PTSD is a psychiatric disorder that can develop in individuals who are exposed to a traumatic event. Although most trauma survivors experience gradual diminishment of symptoms and recover from the trauma exposure, some will go on to develop PTSD and experience persistent symptoms that disrupt biological, psychological, and social functioning.\nTF-CBT is considered one of the most effective treatments for PTSD. Trauma-focused therapies require patients to think about and/or talk about their prior traumas, which may prevent some patients from accessing or engaging in these treatments. PCT is a non-trauma based treatment that incorporates common psychotherapeutic components, and which may appeal to patients reluctant to engage in trauma-focused treatments. Although originally developed to be a treatment comparator in TF-CBT trials, PCT has performed well in these trials and may be associated with lower treatment dropout rates. If PCT is deemed to be comparably as effective as TF-CBT and also has lower treatment dropout rates, then it may be a preferred treatment option for those who do not want to participate in trauma-focused treatments. This systematic review seeks to determine whether PCT is an effective treatment option compared to TF-CBT for adults with PTSD."
}
] |
query-laysum
|
8097
|
[
{
"role": "user",
"content": "Abstract: Background\nPharmacological treatments for tobacco dependence, such as nicotine replacement therapy (NRT), have been shown to be safe and effective interventions for smoking cessation. Higher levels of adherence to these medications increase the likelihood of sustained smoking cessation, but many smokers use them at a lower dose and for less time than is optimal. It is important to determine the effectiveness of interventions designed specifically to increase medication adherence. Such interventions may address motivation to use medication, such as influencing beliefs about the value of taking medications, or provide support to overcome problems with maintaining adherence.\nObjectives\nTo assess the effectiveness of interventions aiming to increase adherence to medications for smoking cessation on medication adherence and smoking abstinence compared with a control group typically receiving standard care.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register, and clinical trial registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform) to the 3 September 2018. We also conducted forward and backward citation searches.\nSelection criteria\nRandomised, cluster-randomised or quasi-randomised studies in which adults using active pharmacological treatment for smoking cessation were allocated to an intervention arm where there was a principal focus on increasing adherence to medications for tobacco dependence, or a control arm providing standard care. Dependent on setting, standard care may have comprised minimal support or varying degrees of behavioural support. Included studies used a measure that allowed assessment of the degree of medication adherence.\nData collection and analysis\nTwo authors independently screened studies for eligibility, extracted data for included studies and assessed risk of bias. For continuous outcome measures, we calculated effect sizes as standardised mean differences (SMDs). For dichotomous outcome measures, we calculated effect sizes as risk ratios (RRs). In meta-analyses for adherence outcomes, we combined dichotomous and continuous data using the generic inverse variance method and reported pooled effect sizes as SMDs; for abstinence outcomes, we reported and pooled dichotomous outcomes. We obtained pooled effect sizes with 95% confidence intervals (CIs) using random-effects models. We conducted subgroup analyses to assess whether the primary focus of the adherence treatment ('practicalities' versus 'perceptions' versus both), the delivery approach (participant versus clinician-centred) or the medication type were associated with effectiveness.\nMain results\nWe identified two new studies, giving a total of 10 studies, involving 3655 participants. The medication adherence interventions studied were all provided in addition to standard behavioural support.They typically provided further information on the rationale for, and emphasised the importance of, adherence to medication or supported the development of strategies to overcome problems with maintaining adherence (or both). Seven studies targeted adherence to NRT, two to bupropion and one to varenicline. Most studies were judged to be at high or unclear risk of bias, with four of these studies judged at high risk of attrition or detection bias. Only one study was judged to be at low risk of bias.\nMeta-analysis of all 10 included studies (12 comparisons) provided moderate-certainty evidence that adherence interventions led to small improvements in adherence (i.e. the mean amount of medication consumed; SMD 0.10, 95% CI 0.03 to 0.18; I² = 6%; n = 3655), limited by risk of bias. Subgroup analyses for the primary outcome identified no significant subgroup effects, with effect sizes for subgroups imprecisely estimated. However, there was a very weak indication that interventions focused on the 'practicalities' of adhering to treatment (i.e. capabilities, resources, levels of support or skills) may be effective (SMD 0.21, 95% CI 0.03 to 0.38; I² = 39%; n = 1752), whereas interventions focused on treatment 'perceptions' (i.e. beliefs, cognitions, concerns and preferences; SMD 0.10, 95% CI –0.03 to 0.24; I² = 0%; n = 839) or on both (SMD 0.04, 95% CI –0.08 to 0.16; I² = 0%; n = 1064), may not be effective. Participant-centred interventions may be effective (SMD 0.12, 95% CI 0.02 to 0.23; I² = 20%; n = 2791), whereas those that are clinician-centred may not (SMD 0.09, 95% CI –0.05 to 0.23; I² = 0%; n = 864).\nFive studies assessed short-term smoking abstinence (five comparisons), while an overlapping set of five studies (seven comparisons) assessed long-term smoking abstinence of six months or more. Meta-analyses resulted in low-certainty evidence that adherence interventions may slightly increase short-term smoking cessation rates (RR 1.08, 95% CI 0.96 to 1.21; I² = 0%; n = 1795) and long-term smoking cessation rates (RR 1.16, 95% CI 0.96 to 1.40; I² = 48%; n = 3593). In both cases, the evidence was limited by risk of bias and imprecision, with CIs encompassing minimal harm as well as moderate benefit, and a high likelihood that further evidence will change the estimate of the effect. There was no evidence that interventions to increase adherence to medication led to any adverse events. Studies did not report on factors plausibly associated with increases in adherence, such as self-efficacy, understanding of and attitudes toward treatment, and motivation and intentions to quit.\nAuthors' conclusions\nIn people who are stopping smoking and receiving behavioural support, there is moderate-certainty evidence that enhanced behavioural support focusing on adherence to smoking cessation medications can modestly improve adherence. There is only low-certainty evidence that this may slightly improve the likelihood of cessation in the shorter or longer-term. Interventions to increase adherence can aim to address the practicalities of taking medication, change perceptions about medication, such as reasons to take it or concerns about doing so, or both. However, there is currently insufficient evidence to confirm which approach is more effective. There is no evidence on whether such interventions are effective for people who are stopping smoking without standard behavioural support.\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": "Medicines designed to make it easier for people to stop smoking, such as nicotine replacement therapy (NRT), bupropion and varenicline, are safe and successfully help people to quit. However, people often do not follow the instructions that come with the medicines properly, which may mean that the medicines do not work as well as they could. This probably reduces a person's chances of giving up smoking for good. In this review, we looked at whether there are ways to help people to use stop-smoking medicines correctly, and whether this makes people more likely to quit smoking."
}
] |
query-laysum
|
8098
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-alcohol related fatty liver disease (commonly called non-alcoholic fatty liver disease (NAFLD)) is liver steatosis in the absence of significant alcohol consumption, use of hepatotoxic medication, or other disorders affecting the liver such as hepatitis C virus infection, Wilson's disease, and starvation. NAFLD embraces the full spectrum of disease from pure steatosis (i.e. uncomplicated fatty liver) to non-alcoholic steatohepatitis (NASH), via NASH-cirrhosis to cirrhosis. The optimal pharmacological treatment for people with NAFLD remains uncertain.\nObjectives\nTo assess the comparative benefits and harms of different pharmacological interventions in the treatment of NAFLD through a network meta-analysis and to generate rankings of the available pharmacological treatments according to their safety and efficacy. However, it was not possible to assess whether the potential effect modifiers were similar across different comparisons. Therefore, we did not perform the network meta-analysis, and instead, assessed the comparative benefits and harms of different interventions using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.com to August 2016.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with NAFLD. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various pharmacological interventions compared with each other or with placebo or no intervention.\nData collection and analysis\nWe calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models based on an available participant analysis with Review Manager. We assessed risk of bias according to the Cochrane risk of bias tool, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nWe identified 77 trials including 6287 participants that met the inclusion criteria of this review. Forty-one trials (3829 participants) provided information for one or more outcomes. Only one trial was at low risk of bias in all domains. All other trials were at high risk of bias in one or more domains. Overall, all the evidence was very low quality. Thirty-five trials included only participants with non-alcohol related steatohepatitis (NASH) (based on biopsy confirmation). Five trials included only participants with diabetes mellitus; 14 trials included only participants without diabetes mellitus. The follow-up in the trials ranged from one month to 24 months.\nWe present here only the comparisons of active intervention versus no intervention in which two or more trials reported at least one of the following outcomes: mortality at maximal follow-up, serious adverse events, and health-related quality of life, the outcomes that determine whether a treatment should be used.\nAntioxidants versus no intervention\nThere was no mortality in either group (87 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the trial which reported the proportion of people with serious adverse events (87 participants; 1 trial; very low quality evidence). There was no evidence of difference in the number of serious adverse events between antioxidants and no intervention (rate ratio 0.89, 95% CI 0.36 to 2.19; 254 participants; 2 trials; very low quality evidence). None of the trials reported health-related quality of life.\nBile acids versus no intervention\nThere was no evidence of difference in mortality at maximal follow-up (OR 5.11, 95% CI 0.24 to 107.34; 659 participants; 4 trials; very low quality evidence), proportion of people with serious adverse events (OR 1.56, 95% CI 0.84 to 2.88; 404 participants; 3 trials; very low quality evidence), or the number of serious adverse events (rate ratio 1.01, 95% CI 0.66 to 1.54; 404 participants; 3 trials; very low quality evidence) between bile acids and no intervention. None of the trials reported health-related quality of life.\nThiazolidinediones versus no intervention\nThere was no mortality in either group (74 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the two trials which reported the proportion of people with serious adverse events (194 participants; 2 trials; very low quality evidence). There was no evidence of difference in the number of serious adverse events between thiazolidinediones and no intervention (rate ratio 0.25, 95% CI 0.06 to 1.05; 357 participants; 3 trials; very low quality evidence). None of the trials reported health-related quality of life.\nSource of funding\nTwenty-six trials were partially- or fully-funded by pharmaceutical companies that would benefit, based on the results of the trial. Twelve trials did not receive any additional funding or were funded by parties with no vested interest in the results. The source of funding was not provided in 39 trials.\nAuthors' conclusions\nDue to the very low quality evidence, we are very uncertain about the effectiveness of pharmacological treatments for people with NAFLD including those with steatohepatitis. Further well-designed randomised clinical trials with sufficiently large sample sizes are necessary.\n\nGiven the provided abstract, please respond to the following query: \"Selection criteria and date of search\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included all randomised clinical trials (clinical studies where people are randomly put into one of two or more intervention groups) reported to August 2016."
}
] |
query-laysum
|
8099
|
[
{
"role": "user",
"content": "Abstract: Background\nNeuroblastoma is a rare malignant disease that primarily affects children. The tumours mainly develop in the adrenal medullary tissue, and an abdominal mass is the most common presentation. High-risk disease is characterised by metastasis and other primary tumour characteristics resulting in increased risk for an adverse outcome. The GD2 carbohydrate antigen is expressed on the cell surface of neuroblastoma tumour cells and is thus a promising target for anti-GD2 antibody-containing immunotherapy.\nObjectives\nTo assess the efficacy of anti-GD2 antibody-containing postconsolidation immunotherapy after high-dose chemotherapy (HDCT) and autologous haematopoietic stem cell transplantation (HSCT) compared to standard therapy after HDCT and autologous HSCT in people with high-risk neuroblastoma. Our primary outcomes were overall survival and treatment-related mortality. Our secondary outcomes were progression-free survival, event-free survival, early toxicity, late non-haematological toxicity, and health-related quality of life.\nSearch methods\nWe searched the electronic databases CENTRAL (2018, Issue 9), MEDLINE (PubMed), and Embase (Ovid) on 20 September 2018. We searched trial registries and conference proceedings on 28 October 2018. Further searches included reference lists of recent reviews and relevant articles as well as contacting experts in the field. There were no limits on publication year or language.\nSelection criteria\nRandomised controlled trials evaluating anti-GD2 antibody-containing immunotherapy after HDCT and autologous HSCT in people with high-risk neuroblastoma.\nData collection and analysis\nTwo review authors independently performed study selection, abstracted data on study and participant characteristics, and assessed risk of bias and GRADE. Any differences were resolved by discussion, with third-party arbitration unnecessary. We performed analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. We used the five GRADE considerations, that is study limitations, consistency of effect, imprecision, indirectness, and publication bias, to judge the quality of the evidence.\nMain results\nWe identified one randomised controlled trial that included 226 people with high-risk neuroblastoma who were pre-treated with autologous HSCT. The study randomised 113 participants to receive immunotherapy including isotretinoin, granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2, and ch14.18, a type of anti-GD2 antibody also known as dinutuximab. The study randomised another 113 participants to receive standard therapy including isotretinoin.\nThe results on overall survival favoured the dinutuximab-containing immunotherapy group (hazard ratio (HR) 0.50, 95% confidence interval (CI) 0.31 to 0.80; P = 0.004). The results on event-free survival also favoured the dinutuximab-containing immunotherapy group (HR 0.61, 95% CI 0.41 to 0.92; P = 0.020). Randomised data on adverse events were not reported separately. The study did not report progression-free survival, late non-haematological toxicity, and health-related quality of life as separate endpoints. We graded the quality of the evidence as moderate.\nAuthors' conclusions\nThe evidence base favours dinutuximab-containing immunotherapy compared to standard therapy concerning overall survival and event-free survival in people with high-risk neuroblastoma pre-treated with autologous HSCT. Randomised data on adverse events are lacking, therefore more research is needed before definitive conclusions can be made regarding this outcome.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results on overall survival and event-free survival favoured the dinutuximab-containing immunotherapy group. Other outcomes including those on adverse events were not adequately reported; more research is needed before definitive conclusions can be made regarding these outcomes."
}
] |
query-laysum
|
8100
|
[
{
"role": "user",
"content": "Abstract: Background\nAsthma is a chronic respiratory condition characterised by airways inflammation, constriction of airway smooth muscle and structural alteration of the airways that is at least partially reversible. Exacerbations of asthma can be life threatening and place a significant burden on healthcare services. Various guidelines have been published to inform management personnel in the acute setting; several include the use of a single bolus of intravenous magnesium sulfate (IV MgSO4) in cases that do not respond to first-line treatment. However, the effectiveness of this approach remains unclear, particularly in less severe cases.\nObjectives\nTo assess the safety and efficacy of IV MgSO4 in adults treated for acute asthma in the emergency department.\nSearch methods\nWe identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to 2 May 2014. We also searched www.ClinicalTrials.gov and reference lists of other reviews, and we contacted trial authors to ask for additional information.\nSelection criteria\nWe included randomised controlled trials (RCTs) of adults treated in the emergency department (ED) for exacerbations of asthma if they compared any dose of IV MgSO4 with placebo.\nData collection and analysis\nAll review authors screened titles and abstracts for inclusion, and at least two review authors independently extracted study characteristics, risk of bias and numerical data. Disagreements were resolved by consensus, and we contacted trial investigators to obtain missing information.\nWe analysed dichotomous data as odds ratios using study participants as the unit of analysis, and we analysed continuous data as mean differences or standardised mean differences using fixed-effect models. We rated all outcomes using GRADE and presented results in Summary of findings table 1.\nWe carried out subgroup analyses on the primary outcome for baseline severity of exacerbations and whether or not ipratropium bromide was given as a co-medication. Unpublished data and studies at high risk of bias for blinding were removed from the main analysis in sensitivity analyses.\nMain results\nFourteen studies met the inclusion criteria, randomly assigning 2313 people with acute asthma to the comparisons of interest in this review.\nMost studies were double-blinded trials comparing a single infusion of 1.2 g or 2 g IV MgSO4 over 15 to 30 minutes versus a matching placebo. Eleven were conducted at a single centre, and three were multi-centre trials. Participants in almost all of the studies had already been given at least oxygen, nebulised short-acting beta2-agonists and IV corticosteroids in the ED; in some studies, investigators also administered ipratropium bromide. Ten studies included only adults, and four included both adults and children; these were included because the mean age of participants was over 18 years.\nIntravenous MgSO4 reduced hospital admissions compared with placebo (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.60 to 0.92; I2 = 28%, P value 0.18; n = 972; high-quality evidence). In absolute terms, this odds ratio translates into a reduction of seven hospital admissions for every 100 adults treated with IV MgSO4 (95% CI two to 13 fewer). The test for subgroup differences revealed no statistical heterogeneity between the three severity subgroups (I2 = 0%, P value 0.73) or between the four studies that administered nebulised ipratropium bromide as a co-medication and those that did not (I2 = 0%, P value 0.82). Sensitivity analyses in which unpublished data and studies at high risk for blinding were removed from the primary analysis did not change conclusions.\nWithin the secondary outcomes, high- and moderate-quality evidence across three spirometric indices suggests some improvement in lung function with IV MgSO4. No difference was found between IV MgSO4and placebo for most of the non-spirometric secondary outcomes, all of which were rated as low or moderate quality (intensive care admissions, ED treatment duration, length of hospital stay, readmission, respiration rate, systolic blood pressure).\nAdverse events were inconsistently reported and were not meta-analysed. The most commonly cited adverse events in the IV MgSO4 groups were flushing, fatigue, nausea and headache and hypotension (low blood pressure).\nAuthors' conclusions\nThis review provides evidence that a single infusion of 1.2 g or 2 g IV MgSO4 over 15 to 30 minutes reduces hospital admissions and improves lung function in adults with acute asthma who have not responded sufficiently to oxygen, nebulised short-acting beta2-agonists and IV corticosteroids. Differences in the ways the trials were conducted made it difficult for the review authors to assess whether severity of the exacerbation or additional co-medications altered the treatment effect of IV MgSO4. Limited evidence was found for other measures of benefit and safety.\nStudies conducted in these populations should clearly define baseline severity parameters and systematically record adverse events. Studies recruiting participants with exacerbations of varying severity should consider subgrouping results on the basis of accepted severity classifications.\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": "This review showed that IV MgSO4reduces hospital admissions and improves lung function in adults with exacerbations of asthma when other first-line medications have not relieved the acute symptoms (i.e. oxygen, inhaled short-acting medications and IV steroids). Evidence for other measures of benefit and safety was limited.\nResearchers should clearly define the severity of the asthma condition among people in their studies while carefully recording adverse events.\nThis plain language summary is current as of May 2014."
}
] |
query-laysum
|
8101
|
[
{
"role": "user",
"content": "Abstract: Background\nPhysical exercise training might improve muscle and cardiorespiratory function in spinal muscular atrophy (SMA). Optimization of aerobic capacity or other resources in residual muscle tissue through exercise may counteract the muscle deterioration that occurs secondary to motor neuron loss and inactivity in SMA. There is currently no evidence synthesis available on physical exercise training in people with SMA type 3.\nObjectives\nTo assess the effects of physical exercise training on functional performance in people with SMA type 3, and to identify any adverse effects.\nSearch methods\nOn 8 May 2018, we searched the Cochrane Neuromuscular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, AMED, and LILACS. On 25 April 2018 we searched NHSEED, DARE, and ClinicalTrials.gov and WHO ICTRP for ongoing trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) or quasi-RCTs lasting at least 12 weeks that compared physical exercise training (strength training, aerobic exercise training, or both) to placebo, standard or usual care, or another type of non-physical intervention for SMA type 3. Participants were adults and children from the age of five years with a diagnosis of SMA type 3 (Kugelberg-Welander syndrome), confirmed by genetic analysis.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included one RCT that studied the effects of a six-month, home-based, combined muscle strength and recumbent cycle ergometry training program versus usual care in 14 ambulatory people with SMA. The age range of the participants was between 10 years and 48 years. The study was evaluator-blinded, but personnel and participants could not be blinded to the intervention, which placed the results at a high risk of bias. Participants performed strength training as prescribed, but 50% of the participants did not achieve the intended aerobic exercise training regimen. The trial used change in walking distance on the six-minute walk test as a measure of function; a minimal detectable change is 24.0 m. The change from baseline to six months' follow-up in the training group (9.4 m) was not detectably different from the change in the usual care group (-0.14 m) (mean difference (MD) 9.54 m, 95% confidence interval (CI) -83.04 to 102.12; N = 12). Cardiopulmonary exercise capacity, assessed by the change from baseline to six months' follow-up in peak oxygen uptake (VO2max) was similar in the training group (-0.12 mL/kg/min) and the usual care group (-1.34 mL/kg/min) (MD 1.22 mL/kg/min, 95% CI -2.16 to 4.6; N = 12). A clinically meaningful increase in VO2max is 3.5 mL/kg/min.\nThe trial assessed function on the Hammersmith Functional Motor Scale - Expanded (HFMSE), which has a range of possible scores from 0 to 66, with an increase of 3 or more points indicating clinically meaningful improvement. The HFMSE score in the training group increased by 2 points from baseline to six months' follow-up, with no change in the usual care group (MD 2.00, 95% CI -2.06 to 6.06; N = 12). The training group showed a slight improvement in muscle strength, expressed as the manual muscle testing (MMT) total score, which ranges from 28 (weakest) to 280 (strongest). The change from baseline in MMT total score was 6.8 in the training group compared to -5.14 in the usual care group (MD 11.94, 95% CI -3.44 to 27.32; N = 12).\nThe trial stated that training had no statistically significant effects on fatigue and quality of life. The certainty of evidence for all outcomes was very low because of study limitations and imprecision. The study did not assess the effects of physical exercise training on physical activity levels. No study-related serious adverse events or adverse events leading to withdrawal occurred, but we cannot draw wider conclusions from this very low-certainty evidence.\nAuthors' conclusions\nIt is uncertain whether combined strength and aerobic exercise training is beneficial or harmful in people with SMA type 3, as the quality of evidence is very low. We need well-designed and adequately powered studies using protocols that meet international standards for the development of training interventions, in order to improve our understanding of the exercise response in people with SMA type 3 and eventually develop exercise guidelines for this condition.\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": "The included study was supported by the United States Department of Defense and the SMA Foundation."
}
] |
query-laysum
|
8102
|
[
{
"role": "user",
"content": "Abstract: Background\nPharmacological treatments for tobacco dependence, such as nicotine replacement therapy (NRT), have been shown to be safe and effective interventions for smoking cessation. Higher levels of adherence to these medications increase the likelihood of sustained smoking cessation, but many smokers use them at a lower dose and for less time than is optimal. It is important to determine the effectiveness of interventions designed specifically to increase medication adherence. Such interventions may address motivation to use medication, such as influencing beliefs about the value of taking medications, or provide support to overcome problems with maintaining adherence.\nObjectives\nTo assess the effectiveness of interventions aiming to increase adherence to medications for smoking cessation on medication adherence and smoking abstinence compared with a control group typically receiving standard care.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register, and clinical trial registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform) to the 3 September 2018. We also conducted forward and backward citation searches.\nSelection criteria\nRandomised, cluster-randomised or quasi-randomised studies in which adults using active pharmacological treatment for smoking cessation were allocated to an intervention arm where there was a principal focus on increasing adherence to medications for tobacco dependence, or a control arm providing standard care. Dependent on setting, standard care may have comprised minimal support or varying degrees of behavioural support. Included studies used a measure that allowed assessment of the degree of medication adherence.\nData collection and analysis\nTwo authors independently screened studies for eligibility, extracted data for included studies and assessed risk of bias. For continuous outcome measures, we calculated effect sizes as standardised mean differences (SMDs). For dichotomous outcome measures, we calculated effect sizes as risk ratios (RRs). In meta-analyses for adherence outcomes, we combined dichotomous and continuous data using the generic inverse variance method and reported pooled effect sizes as SMDs; for abstinence outcomes, we reported and pooled dichotomous outcomes. We obtained pooled effect sizes with 95% confidence intervals (CIs) using random-effects models. We conducted subgroup analyses to assess whether the primary focus of the adherence treatment ('practicalities' versus 'perceptions' versus both), the delivery approach (participant versus clinician-centred) or the medication type were associated with effectiveness.\nMain results\nWe identified two new studies, giving a total of 10 studies, involving 3655 participants. The medication adherence interventions studied were all provided in addition to standard behavioural support.They typically provided further information on the rationale for, and emphasised the importance of, adherence to medication or supported the development of strategies to overcome problems with maintaining adherence (or both). Seven studies targeted adherence to NRT, two to bupropion and one to varenicline. Most studies were judged to be at high or unclear risk of bias, with four of these studies judged at high risk of attrition or detection bias. Only one study was judged to be at low risk of bias.\nMeta-analysis of all 10 included studies (12 comparisons) provided moderate-certainty evidence that adherence interventions led to small improvements in adherence (i.e. the mean amount of medication consumed; SMD 0.10, 95% CI 0.03 to 0.18; I² = 6%; n = 3655), limited by risk of bias. Subgroup analyses for the primary outcome identified no significant subgroup effects, with effect sizes for subgroups imprecisely estimated. However, there was a very weak indication that interventions focused on the 'practicalities' of adhering to treatment (i.e. capabilities, resources, levels of support or skills) may be effective (SMD 0.21, 95% CI 0.03 to 0.38; I² = 39%; n = 1752), whereas interventions focused on treatment 'perceptions' (i.e. beliefs, cognitions, concerns and preferences; SMD 0.10, 95% CI –0.03 to 0.24; I² = 0%; n = 839) or on both (SMD 0.04, 95% CI –0.08 to 0.16; I² = 0%; n = 1064), may not be effective. Participant-centred interventions may be effective (SMD 0.12, 95% CI 0.02 to 0.23; I² = 20%; n = 2791), whereas those that are clinician-centred may not (SMD 0.09, 95% CI –0.05 to 0.23; I² = 0%; n = 864).\nFive studies assessed short-term smoking abstinence (five comparisons), while an overlapping set of five studies (seven comparisons) assessed long-term smoking abstinence of six months or more. Meta-analyses resulted in low-certainty evidence that adherence interventions may slightly increase short-term smoking cessation rates (RR 1.08, 95% CI 0.96 to 1.21; I² = 0%; n = 1795) and long-term smoking cessation rates (RR 1.16, 95% CI 0.96 to 1.40; I² = 48%; n = 3593). In both cases, the evidence was limited by risk of bias and imprecision, with CIs encompassing minimal harm as well as moderate benefit, and a high likelihood that further evidence will change the estimate of the effect. There was no evidence that interventions to increase adherence to medication led to any adverse events. Studies did not report on factors plausibly associated with increases in adherence, such as self-efficacy, understanding of and attitudes toward treatment, and motivation and intentions to quit.\nAuthors' conclusions\nIn people who are stopping smoking and receiving behavioural support, there is moderate-certainty evidence that enhanced behavioural support focusing on adherence to smoking cessation medications can modestly improve adherence. There is only low-certainty evidence that this may slightly improve the likelihood of cessation in the shorter or longer-term. Interventions to increase adherence can aim to address the practicalities of taking medication, change perceptions about medication, such as reasons to take it or concerns about doing so, or both. However, there is currently insufficient evidence to confirm which approach is more effective. There is no evidence on whether such interventions are effective for people who are stopping smoking without standard behavioural support.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies up to September 2018, and we found 10 studies, including 3655 people. All of these people were smokers, over 18 years of age. Studies tested different ways of helping people use their stop-smoking medicines properly. Typically this meant providing additional information about the medicine or helping people to overcome problems they had with taking the medicine. One study delivered support by telephone, and the rest provided at least some face-to-face support. All included studies measured the amount that people used their medicines and all but one measured how many people quit smoking."
}
] |
query-laysum
|
8103
|
[
{
"role": "user",
"content": "Abstract: Background\nPsoriatic arthritis is an inflammatory disease associated with joint damage, impaired function, pain, and reduced quality of life. Methotrexate is a disease-modifying anti-rheumatic drug (DMARD) commonly prescribed to alleviate symptoms, attenuate disease activity, and prevent progression of disease.\nObjectives\nTo assess the benefits and harms of methotrexate for psoriatic arthritis in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the WHO International Clinical Trials Registry Platform, and www.clinicaltrials.gov for relevant records. We searched all databases from inception to 29 January 2018. We handsearched included articles for additional records and contacted study authors for additional unpublished data. We applied no language restrictions.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs that compared methotrexate versus placebo, or versus another DMARD, for adults with psoriatic arthritis. We reported on the following major outcomes: disease response (measured by psoriatic arthritis response criteria (PsARC)), function (measured by the Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ)), health-related quality of life, disease activity (measured by disease activity score (28 joints) with erythrocyte sedimentation rate (DAS28-ESR)), radiographic progression, serious adverse events, and withdrawals due to adverse events.\nData collection and analysis\nTwo review authors independently reviewed search results, assessed risk of bias, extracted trial data, and assessed the quality of evidence using the GRADE approach. We undertook meta-analysis only when this was meaningful.\nMain results\nWe included in this review eight RCTs conducted in an outpatient setting, in Italy, the United Kingdom, the United States of America, China, Russia, and Bangladesh. Five studies compared methotrexate versus placebo, and four studies compared methotrexate versus other DMARDs. The average age of participants varied across studies (26 to 52 years), as did the average duration of psoriatic arthritis (one to nine years). Doses of methotrexate varied from 7.5 mg to 25 mg orally per week, but most studies administered approximately 15 mg or less orally per week. Risk of bias was generally unclear or high across most domains for all studies. We considered only one study to have low risk of selection and detection bias. The main study informing results of the primary comparison (methotrexate vs placebo up to six months) was at low risk of bias for all domains except attrition bias and reporting bias.\nWe restricted reporting of results to the comparison of methotrexate versus placebo for up to six months. Low-quality evidence (downgraded due to bias and imprecision) from a single study (221 participants; methotrexate dose 15 mg orally or less per week) informed results for disease response, function, and disease activity. Disease response, measured by the proportion who responded to treatment according to PsARC (response indicates improvement), was 41/109 in the methotrexate group and 24/112 in the placebo group (risk ratio (RR) 1.76, 95% confidence interval (CI) 1.14 to 2.70). This equates to an absolute difference of 16% more responders with methotrexate (4% more to 28% more), and a number needed to treat for an additional beneficial outcome (NNTB) of 6 (95% CI 5 to 25). Mean function, measured by the HAQ (scale 0 to 3; 0 meaning no functional impairment; minimum clinically important difference 0.22), was 1.0 points with placebo and 0.3 points better (95% 0.51 better to 0.09 better) with methotrexate; absolute improvement was 10% (3% better to 17% better), and relative improvement 30% (9% better to 51% better). Mean disease activity as measured by the DAS28-ESR (scale of 0 to 10; lower score means lower disease activity; minimum clinically important difference unknown) was 3.8 points in the methotrexate group and 4.06 points in the placebo group; mean difference was -0.26 points (95% CI -0.65 to 0.13); absolute improvement was 3% (7% better to 1% worse), and relative improvement 6% (16% better to 3% worse).\nLow-quality evidence (downgraded due to risk of bias and imprecision) from three studies (n = 293) informed our results for serious adverse events and withdrawals due to adverse events. Due to low event rates, we are uncertain if methotrexate results show increased risk of serious adverse events or withdrawals due to adverse events compared to placebo. Results show 1/141 serious adverse events in the methotrexate group and 4/152 in the placebo group: RR 0.26 (95% CI 0.03 to 2.26); absolute difference was 2% fewer events with methotrexate (5% fewer to 1% more). In all, 9/141 withdrawals in the methotrexate group were due to adverse events and 7/152 in the placebo group: RR 1.32 (95% CI 0.51 to 3.42); absolute difference was 1% more withdrawals (4% fewer to 6% more).\nOne study measured health-related quality of life but did not report these results. No study measured radiographic progression.\nAuthors' conclusions\nLow-quality evidence suggests that low-dose (15 mg or less) oral methotrexate might be slightly more effective than placebo when taken for six months; however we are uncertain if it is more harmful. Effects of methotrexate on health-related quality of life, radiographic progression, enthesitis, dactylitis, and fatigue; its benefits beyond six months; and effects of higher-dose methotrexate have not been measured or reported in a randomised placebo-controlled trial.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included eight studies published between 1964 and 2014. All studies involved people from rheumatology clinics. Studies were conducted in Italy, United Kingdom, United States of America, China, Russia, and Bangladesh. Five studies compared methotrexate against placebo (345 people), and four studies compared methotrexate against another DMARD (leflunomide (61 people), ciclosporin A (35 people), gold (30 people), and sulfasalazine (24 people)). The average age of people included in these studies varied from 26 to 52 years. The average duration of psoriatic arthritis ranged from one to nine years. The dose of methotrexate consisted of 7.5 mg to 25 mg orally, but for most studies, 15 mg was given orally per week. In most western countries, a dose of 15 mg to 20 mg orally per week is normally used in routine practice."
}
] |
query-laysum
|
8104
|
[
{
"role": "user",
"content": "Abstract: Background\nDysphagia (swallowing problems), which is common after stroke, is associated with increased risk of death or dependency, occurrence of pneumonia, poor quality of life, and longer hospital stay. Treatments provided to improve dysphagia are aimed at accelerating recovery of swallowing function and reducing these risks. This is an update of the review first published in 1999 and updated in 2012.\nObjectives\nTo assess the effects of swallowing therapy on death or dependency among stroke survivors with dysphagia within six months of stroke onset.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (26 June 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 6) in the Cochrane Library (searched 26 June 2018), MEDLINE (26 June 2018), Embase (26 June 2018), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (26 June 2018), Web of Science Core Collection (26 June 2018), SpeechBITE (28 June 2016), ClinicalTrials.Gov (26 June 2018), and the World Health Organization International Clinical Trials Registry Platform (26 June 2018). We also searched Google Scholar (7 June 2018) and the reference lists of relevant trials and review articles.\nSelection criteria\nWe sought to include randomised controlled trials (RCTs) of interventions for people with dysphagia and recent stroke (within six months).\nData collection and analysis\nTwo review authors independently applied the inclusion criteria, extracted data, assessed risk of bias, used the GRADE approach to assess the quality of evidence, and resolved disagreements through discussion with the third review author (PB). We used random-effects models to calculate odds ratios (ORs), mean differences (MDs), and standardised mean differences (SMDs), and provided 95% confidence intervals (CIs) for each.\nThe primary outcome was functional outcome, defined as death or dependency (or death or disability), at the end of the trial. Secondary outcomes were case fatality at the end of the trial, length of inpatient stay, proportion of participants with dysphagia at the end of the trial, swallowing ability, penetration aspiration score, or pneumonia, pharyngeal transit time, institutionalisation, and nutrition.\nMain results\nWe added 27 new studies (1777 participants) to this update to include a total of 41 trials (2660 participants).\nWe assessed the efficacy of swallowing therapy overall and in subgroups by type of intervention: acupuncture (11 studies), behavioural interventions (nine studies), drug therapy (three studies), neuromuscular electrical stimulation (NMES; six studies), pharyngeal electrical stimulation (PES; four studies), physical stimulation (three studies), transcranial direct current stimulation (tDCS; two studies), and transcranial magnetic stimulation (TMS; nine studies).\nSwallowing therapy had no effect on the primary outcome (death or dependency/disability at the end of the trial) based on data from one trial (two data sets) (OR 1.05, 95% CI 0.63 to 1.75; 306 participants; 2 studies; I² = 0%; P = 0.86; moderate-quality evidence). Swallowing therapy had no effect on case fatality at the end of the trial (OR 1.00, 95% CI 0.66 to 1.52; 766 participants; 14 studies; I² = 6%; P = 0.99; moderate-quality evidence). Swallowing therapy probably reduced length of inpatient stay (MD -2.9, 95% CI -5.65 to -0.15; 577 participants; 8 studies; I² = 11%; P = 0.04; moderate-quality evidence). Researchers found no evidence of a subgroup effect based on testing for subgroup differences (P = 0.54). Swallowing therapy may have reduced the proportion of participants with dysphagia at the end of the trial (OR 0.42, 95% CI 0.32 to 0.55; 1487 participants; 23 studies; I² = 0%; P = 0.00001; low-quality evidence). Trial results show no evidence of a subgroup effect based on testing for subgroup differences (P = 0.91). Swallowing therapy may improve swallowing ability (SMD -0.66, 95% CI -1.01 to -0.32; 1173 participants; 26 studies; I² = 86%; P = 0.0002; very low-quality evidence). We found no evidence of a subgroup effect based on testing for subgroup differences (P = 0.09). We noted moderate to substantial heterogeneity between trials for these interventions. Swallowing therapy did not reduce the penetration aspiration score (i.e. it did not reduce radiological aspiration) (SMD -0.37, 95% CI -0.74 to -0.00; 303 participants; 11 studies; I² = 46%; P = 0.05; low-quality evidence). Swallowing therapy may reduce the incidence of chest infection or pneumonia (OR 0.36, 95% CI 0.16 to 0.78; 618 participants; 9 studies; I² = 59%; P = 0.009; very low-quality evidence).\nAuthors' conclusions\nModerate- and low-quality evidence suggests that swallowing therapy did not have a significant effect on the outcomes of death or dependency/disability, case fatality at the end of the trial, or penetration aspiration score. However, swallowing therapy may have reduced length of hospital stay, dysphagia, and chest infections, and may have improved swallowing ability. However, these results are based on evidence of variable quality, involving a variety of interventions. Further high-quality trials are needed to test whether specific interventions are effective.\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": ""
}
] |
query-laysum
|
8105
|
[
{
"role": "user",
"content": "Abstract: Background\nMeningitis is inflammation of the meninges, the layers that protect the brain and spinal cord. Acute meningitis is an emergent disease that develops over the course of hours to several days. Delay in treatment can lead to serious outcomes.\nInflammation of the meninges is assessed by analysing cerebrospinal fluid. Identifying the pathogen in cerebrospinal fluid is another way to diagnose meningitis. Cerebrospinal fluid is collected by doing a lumbar puncture, which is an invasive test, and can be avoided if a physical examination excludes the diagnosis of meningitis. However, most physical examinations, such as nuchal rigidity, Kernig's test, and Brudzinski's test, are not sufficiently sensitive to exclude meningitis completely.\nJolt accentuation of headache is a new and less well-recognised physical examination, which assesses meningeal irritation. It is judged as positive if the headache is exacerbated by rotating the head horizontally two or three times per second. A 1991 observational study initially reported high sensitivity of this examination to predict pleocytosis. Pleocytosis, an abnormally high cerebrospinal fluid sample white cell count, is an accepted indicator of nervous system infection or inflammation. Jolt accentuation of headache may therefore accurately rule out meningitis without the use of lumbar puncture. However, more recent cross-sectional studies have reported variable diagnostic accuracy.\nObjectives\nTo estimate the diagnostic accuracy of jolt accentuation of headache for detecting acute meningitis in emergency settings. Secondary objectives: to investigate the sources of heterogeneity, including study population, patient condition, and types of meningitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), and Embase (Elsevier) to 27 April 2020. We searched ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and Ichushi-Web Version 5.0 to 28 April 2020.\nSelection criteria\nWe included cross-sectional studies that assessed the diagnostic accuracy of jolt accentuation of headache for people with suspected meningitis in emergency settings. We included participants of any age and any severity of illness. Meningitis should be diagnosed with any reference standard, such as cerebrospinal fluid pleocytosis, proof of causative agents, or autopsy.\nData collection and analysis\nTwo review authors independently collated study data. We assessed methodological quality of studies using QUADAS-2 criteria. We used a bivariate random-effects model to determine summary estimates of sensitivity and specificity where meta-analysis was possible. We performed sensitivity analyses to validate the robustness of outcomes. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included nine studies (1161 participants). Five studies included only adults. Four studies included both adults and children; however, the proportion was not reported in three of these studies. The youngest child reported in the studies was aged 13 years. There was no study including only children.\nThe reference standard was pleocytosis in eight studies, and the combination of pleocytosis and increased protein in the cerebrospinal fluid in one study. Two studies also used smear or positive culture of cerebrospinal fluid.\nRisk of bias and concern about applicability was high in the participant selection domain for all included studies and the consciousness subgroup.\nOverall, pooled sensitivity was 65.3% (95% confidence interval (CI) 37.3 to 85.6), and pooled specificity was 70.4% (95% CI 47.7 to 86.1) (very low-certainty evidence). We established the possibility of heterogeneity from visual inspection of forest plots. However, we were unable to conduct further analysis for study population, types of meningitis, and participants' condition, other than disturbance of consciousness (a secondary outcome).\nAmongst participants whose consciousness was undisturbed (8 studies, 921 participants), pooled sensitivity and specificity were 75.2% (95% CI 54.3 to 88.6) and 60.8% (95% CI 43.4 to 75.9), respectively (very low-certainty evidence).\nAuthors' conclusions\nJolt accentuation for headache may exclude diagnoses of meningitis in emergency settings, but high-quality evidence to support use of this test is lacking. Even where jolt accentuation of headache is negative, there is still the possibility of acute meningitis. This review identified the possibility of heterogeneity. However, factors that contribute to heterogeneity are incompletely understood, and should be considered in future research.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 27 April 2020."
}
] |
query-laysum
|
8106
|
[
{
"role": "user",
"content": "Abstract: Background\nPelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse.\nThis is an update of a Cochrane Review first published in 2003 and last published in 2013.\nObjectives\nTo assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.\nData collection and analysis\nTwo review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.\nMain results\nWe included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms.\nGenerally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials.\nPessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty).\nPessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls.\nPessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).\nAuthors' conclusions\nWe are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms.\nThe review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 28 January 2020."
}
] |
query-laysum
|
8107
|
[
{
"role": "user",
"content": "Abstract: Background\nHeart transplantation is considered to be the gold standard treatment for selected patients with end-stage heart disease when medical therapy has been unable to halt progression of the underlying pathology. Evidence suggests that aerobic exercise training may be effective in reversing the pathophysiological consequences associated with cardiac denervation and prevent immunosuppression-induced adverse effects in heart transplant recipients.\nObjectives\nTo determine the effectiveness and safety of exercise-based rehabilitation on the mortality, hospital admissions, adverse events, exercise capacity, health-related quality of life, return to work and costs for people after heart transplantation.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO) and Web of Science Core Collection (Thomson Reuters) to June 2016. We also searched two clinical trials registers and handsearched the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of parallel group, cross-over or cluster design, which compared exercise-based interventions with (i) no exercise control (ii) a different dose of exercise training (e.g. low- versus high-intensity exercise training); or (iii) an active intervention (i.e. education, psychological intervention). The study population comprised adults aged 18 years or over who had received a heart transplant.\nData collection and analysis\nTwo review authors independently screened all identified references for inclusion based on pre-specified inclusion criteria. Disagreements were resolved by consensus or by involving a third person. Two review authors extracted outcome data from the included trials and assessed their risk of bias. One review author extracted study characteristics from included studies and a second author checked them against the trial report for accuracy.\nMain results\nWe included 10 RCTs that involved a total of 300 participants whose mean age was 54.4 years. Women accounted for fewer than 25% of all study participants. Nine trials which randomised 284 participants to receive exercise-based rehabilitation (151 participants) or no exercise (133 participants) were included in the main analysis. One cross-over RCT compared high-intensity interval training with continued moderate-intensity training in 16 participants. We reported findings for all trials at their longest follow-up (median 12 weeks).\nExercise-based cardiac rehabilitation increased exercise capacity (VO2peak) compared with no exercise control (MD 2.49 mL/kg/min, 95% CI 1.63 to 3.36; N = 284; studies = 9; moderate quality evidence). There was evidence from one trial that high-intensity interval exercise training was more effective in improving exercise capacity than continuous moderate-intensity exercise (MD 2.30 mL/kg/min, 95% CI 0.59 to 4.01; N = 16; 1 study). Four studies reported health-related quality of life (HRQoL) measured using SF-36, Profile of Quality of Life in the Chronically Ill (PLC) and the World Health Organization Quality Of Life (WHOQoL) - BREF. Due to the variation in HRQoL outcomes and methods of reporting we were unable to meta-analyse results across studies, but there was no evidence of a difference between exercise-based cardiac rehabilitation and control in 18 of 21 HRQoL domains reported, or between high and moderate intensity exercise in any of the 10 HRQoL domains reported. One adverse event was reported by one study.\nExercise-based cardiac rehabilitation improves exercise capacity, but exercise was found to have no impact on health-related quality of life in the short-term (median 12 weeks follow-up), in heart transplant recipients whose health is stable.\nThere was no evidence of statistical heterogeneity across trials for exercise capacity and no evidence of small study bias. The overall risk of bias in included studies was judged as low or unclear; more than 50% of included studies were assessed at unclear risk of bias with respect to allocation concealment, blinding of outcome assessors and declaration of conflicts of interest. Evidence quality was assessed as moderate according to GRADE criteria.\nAuthors' conclusions\nWe found moderate quality evidence suggesting that exercise-based cardiac rehabilitation improves exercise capacity, and that exercise has no impact on health-related quality of life in the short-term (median 12 weeks follow-up), in heart transplant recipients. Cardiac rehabilitation appears to be safe in this population, but long-term follow-up data are incomplete and further good quality and adequately-powered trials are needed to demonstrate the longer-term benefits of exercise on safety and impact on both clinical and patient-related outcomes, such as health-related quality of life, and healthcare costs.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for randomised controlled trials (experiments that randomly allocate participants to one of two or more treatment groups) looking at the effectiveness of exercise-based rehabilitation programmes compared with no exercise, or a different type or intensity of exercise, in people aged 18 years or over, who were heart transplant recipients."
}
] |
query-laysum
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8108
|
[
{
"role": "user",
"content": "Abstract: Background\nChildhood and adolescent mental health problems are a serious and growing concern worldwide. Research suggests that psychotherapy can have a significant and positive impact on children and adolescents with mental health problems, such as anxiety disorders, depression and conduct disorders. Client feedback tools serve as a method of monitoring clients' progress and providing feedback from clients to therapists during the therapeutic process. These tools may help to enhance clinicians' decision-making by allowing them to adapt their treatment plans as the therapy progresses, resulting in a reduction of treatment failures. Research has shown that client feedback tools have a positive effect on adults' psychotherapy. This review addresses whether feedback tools in child and adolescent therapy could help therapists to better treat their young clients.\nObjectives\nTo assess the effects of client feedback in psychological therapy on child and adolescent mental health outcomes.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR, Studies and References), the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (1946-), Embase (1974-) and PsycINFO (1967-) to 3 April 2018. We did not apply any restriction on date, language or publication status to the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared client feedback to no client feedback in psychological therapies for children and adolescents.\nData collection and analysis\nTwo review authors independently assessed references for inclusion eligibility and extracted outcome, risk of bias and study characteristics data into customised forms. We contacted study authors to obtain missing data. We analysed dichotomous data using risk ratios (RRs) and calculated their 95% confidence intervals (CIs). For continuous data, we calculated mean differences (MDs), or standardised mean differences (SMDs) if different scales were used to measure the same outcome. We used a random-effects model for all analyses.\nMain results\nWe included six published RCTs, conducted in the USA (5 RCTs) and Israel (1 RCT), with 1097 children and adolescents (11 to 18 years old), in the review.\nWe are very uncertain about the effect of client feedback on improvement of symptoms, as reported by youth in the short term because we considered evidence to be of very low-certainty due to high risk of bias and very serious inconsistency in the effect estimates from the different studies. Similarly, we are very uncertain about the effect of client feedback on treatment acceptability, due to high risk of bias, imprecision in the results, and indirectness of measuring the outcome (RR 1.08, 95% CI 0.73 to 1.61; 2 studies, 237 participants; very low-certainty).\nOverall, most studies reported and carried out randomisation and allocation concealment adequately. None of the studies were blinded or attempted to blind participants and personnel and were at high risk of performance bias, and only one study had blind outcome assessors. All of the studies were at high or unclear risk of attrition bias mainly due to poor, non-transparent reporting of participants' flow through the studies.\nAuthors' conclusions\nDue to the paucity of high-quality data and considerable inconsistency in results from different studies, there is currently insufficient evidence to reach any firm conclusions regarding the role of client feedback in psychological therapies for children and adolescents with mental health problems, and further research on this important topic is needed.\nFuture studies should avoid risks of performance, detection and attrition biases, as seen in the studies included in this review. Studies from countries other than the USA are needed, as well as studies including children younger than 10 years.\n\nGiven the provided abstract, please respond to the following query: \"What should happen next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It cannot be ruled out that client feedback has positive effects on psychotherapy outcomes in children and adolescents. High-quality studies are needed to provide sufficient evidence. Future studies should also include younger children, and should take place in countries other than the USA."
}
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query-laysum
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8109
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[
{
"role": "user",
"content": "Abstract: Background\nMedications licensed for the treatment of dementia have limited efficacy against cognitive impairment or against the distressed behaviours (behavioural and psychological symptoms, or behaviour that challenges) which are also often the most distressing aspect of the disorder for caregivers. Complementary therapies, including aromatherapy, are attractive to patients, practitioners and families, because they are perceived as being unlikely to cause adverse effects. Therefore there is interest in whether aromatherapy might offer a safe means of alleviating distressed behaviours in dementia.\nObjectives\nTo assess the efficacy and safety of aromatherapy for people with dementia.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 5 May 2020 using the terms: aromatherapy, lemon, lavender, rose, aroma, alternative therapies, complementary therapies, essential oils. In addition, we searched MEDLINE, Embase, PsycINFO (all via Ovid SP), Web of Science Core Collection (via Thompson Web of Science), LILACS (via BIREME), CENTRAL (via the Cochrane Library), ClinicalTrials.gov and the World Health Organization (WHO) trials portal (ICTRP) on 5 May 2020.\nSelection criteria\nWe included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.\nData collection and analysis\nTwo reviewers independently selected studies for inclusion, extracted data and assessed risk of bias in included studies, involving other authors to reach consensus decisions where necessary. We did not perform any meta-analyses because of heterogeneity between studies, but presented a narrative synthesis of results from the included trials. Because of the heterogeneity of analysis methods and inadequate or absent reporting of data from some trials, we used statistical significance (P ≤ or > 0.5) as a summary metric when synthesising results across studies. As far as possible, we used GRADE methods to assess our confidence in the results of the trials, downgrading for risk of bias and imprecision.\nMain results\nWe included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were lavender (eight studies); lemon balm (four studies); lavender and lemon balm, lavender and orange, and cedar extracts (one study each). For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66), reducing our confidence in the results. Our primary outcomes were agitation, overall behavioural and psychological symptoms, and adverse effects. Ten trials assessed agitation using various scales. Among the five trials for which our confidence in the results was moderate or low, four trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other five trials either reported no useable data or our confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and we had moderate or low confidence in the results of five of them. Of these, four reported significant benefit from aromatherapy and one reported no significant effect. Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. We did not find evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. Our confidence in the results of these studies was low.\nAuthors' conclusions\nWe have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.\n\nGiven the provided abstract, please respond to the following query: \"Background to the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Medication prescribed for the treatment of dementia is not always effective at relieving symptoms of the condition such as problems with thinking, behaviour, mood, and sleep. Natural therapies, including aromatherapy (the use of fragrant essential oils from plants), are attractive options for treating these distressing symptoms of dementia as they are often thought to have a low risk of side effects."
}
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query-laysum
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8110
|
[
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic disease of the gut. About 75% of people with CD undergo surgery at least once in their lifetime to induce remission. However, as there is no known cure for the disease, patients usually experience a recurrence even after surgery. Different interventions are routinely used in maintaining postsurgical remission. There is currently no consensus on which treatment is the most effective.\nObjectives\nTo assess the effects and harms of interventions for the maintenance of surgically induced remission in Crohn's disease and rank the treatments in order of effectiveness.\nSearch methods\nWe searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, and Embase from inception to 15 January 2019. We also searched reference lists of relevant articles, abstracts from major gastroenterology meetings, ClinicalTrials.gov, and the WHO ICTRP. There was no restriction on language, date, or publication status.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) that compared different interventions used for maintaining surgically induced remission in people with CD who were in postsurgical remission. Participants had to have received maintenance treatment for at least three months. We excluded studies assessing enteral diet, diet manipulation, herbal medicine, and nutritional supplementation.\nData collection and analysis\nTwo review authors independently selected relevant studies, extracted data, and assessed the risk of bias. Any disagreements were resolved by discussion or by arbitration of a third review author when necessary. We conducted a network meta-analysis (NMA) using a Bayesian approach through Markov Chain Monte Carlo (MCMC) simulation. For the pairwise comparisons carried out in Review Manager 5, we calculated risk ratios (RR) with their corresponding 95% confidence intervals (95% CI). For the NMA, we presented hazard ratios (HR) with corresponding 95% credible intervals (95% CrI) and reported ranking probabilities for each intervention. For the NMA, we focused on three main outcomes: clinical relapse, endoscopic relapse, and withdrawals due to adverse events. Data were insufficient to assess time to relapse and histologic relapse. Adverse events and serious adverse events were not sufficiently or objectively reported to permit an NMA. We used CINeMA (Confidence in Network Meta-Analysis) methods to evaluate our confidence in the findings within networks, and GRADE for entire networks.\nMain results\nWe included 35 RCTs (3249 participants) in the review. The average age of study participants ranged between 33.6 and 38.8 years. Risk of bias was high in 18 studies, low in four studies, and unclear in 13 studies. Of the 35 included RCTs, 26 studies (2581 participants; 9 interventions) were considered eligible for inclusion in the NMA. The interventions studied included 5-aminosalicylic acid (5-ASA), adalimumab, antibiotics, budesonide, infliximab, probiotics, purine analogues, sulfasalazine, and a combination of sulfasalazine and prednisolone. This resulted in 30 direct contrasts, which informed 102 mixed-treatment contrasts.\nThe evidence for the clinical relapse network (21 studies; 2245 participants) and endoscopic relapse (12 studies; 1128 participants) were of low certainty while the evidence for withdrawal due to adverse events (15 studies; 1498 participants) was of very low certainty. This assessment was due to high risk of bias in most of the studies, inconsistency, and imprecision across networks. We mainly judged individual contrasts as of low or very low certainty, except 5-ASA versus placebo, the evidence for which was judged as of moderate certainty.\nWe ranked the treatments based on effectiveness and the certainty of the evidence. For clinical relapse, the five most highly ranked treatments were adalimumab, infliximab, budesonide, 5-ASA, and purine analogues. We found some evidence that adalimumab (HR 0.11, 95% Crl 0.02 to 0.33; low-certainty evidence) and 5-ASA may reduce the probability of clinical relapse compared to placebo (HR 0.69, 95% Crl 0.53 to 0.87; moderate-certainty evidence). However, budesonide may not be effective in preventing clinical relapse (HR 0.66, 95% CrI 0.27 to 1.34; low-certainty evidence). We are less confident about the effectiveness of infliximab (HR 0.36, 95% CrI 0.02 to 1.74; very low-certainty evidence) and purine analogues (HR 0.75, 95% CrI 0.55 to 1.00; low-certainty evidence). It was unclear whether the other interventions reduced the probability of a clinical relapse, as the certainty of the evidence was very low.\nDue to high risk of bias and limited data across the network, we are uncertain about the effectiveness of interventions for preventing endoscopic relapse. Whilst there might be some evidence of prevention of endoscopic relapse with adalimumab (HR 0.10, 95% CrI 0.01 to 0.32; low-certainty evidence), no other intervention studied appeared to be effective.\nDue to high risk of bias and limited data across the network, we are uncertain about the effectiveness of interventions for preventing withdrawal due to adverse events. Withdrawal due to adverse events appeared to be least likely with sulfasalazine (HR 1.96, 95% Crl 0.00 to 8.90; very low-certainty evidence) and most likely with antibiotics (HR 53.92, 95% Crl 0.43 to 259.80; very low-certainty evidence). When considering the network as a whole, two adverse events leading to study withdrawal (i.e. pancreatitis and leukopenia) occurred in more than 1% of participants treated with an intervention. Pancreatitis occurred in 2.8% (11/399) of purine analogue participants compared to 0.17% (2/1210) of all other groups studied. Leukopenia occurred in 2.5% (10/399) of purine analogue participants compared to 0.08% (1/1210) of all other groups studied.\nAuthors' conclusions\nDue to low-certainty evidence in the networks, we are unable to draw conclusions on which treatment is most effective for preventing clinical relapse and endoscopic relapse. Evidence on the safety of the interventions was inconclusive, however cases of pancreatitis and leukopenia from purine analogues were evident in the studies. Larger trials are needed to further understand the effect of the interventions on endoscopic relapse.\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": "We uncertain about which treatments are most effective in preventing postoperative relapse in Crohn's disease. Alhough there is limited research on the harms (side effects) of these treatments, there were reported instances of pancreatitis and leukopenia in participants who received purine analogues."
}
] |
query-laysum
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8111
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[
{
"role": "user",
"content": "Abstract: Background\nThis is the second substantive update of this review. It was originally published in 1998 and was previously updated in 2009. Elevated blood pressure (known as 'hypertension') increases with age - most rapidly over age 60. Systolic hypertension is more strongly associated with cardiovascular disease than is diastolic hypertension, and it occurs more commonly in older people. It is important to know the benefits and harms of antihypertensive treatment for hypertension in this age group, as well as separately for people 60 to 79 years old and people 80 years or older.\nObjectives\nPrimary objective\n• To quantify the effects of antihypertensive drug treatment as compared with placebo or no treatment on all-cause mortality in people 60 years and older with mild to moderate systolic or diastolic hypertension\nSecondary objectives\n• To quantify the effects of antihypertensive drug treatment as compared with placebo or no treatment on cardiovascular-specific morbidity and mortality in people 60 years and older with mild to moderate systolic or diastolic hypertension\n• To quantify the rate of withdrawal due to adverse effects of antihypertensive drug treatment as compared with placebo or no treatment in people 60 years and older with mild to moderate systolic or diastolic hypertension\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to 24 November 2017: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We contacted authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nRandomised controlled trials of at least one year's duration comparing antihypertensive drug therapy versus placebo or no treatment and providing morbidity and mortality data for adult patients (≥ 60 years old) with hypertension defined as blood pressure greater than 140/90 mmHg.\nData collection and analysis\nOutcomes assessed were all-cause mortality; cardiovascular morbidity and mortality; cerebrovascular morbidity and mortality; coronary heart disease morbidity and mortality; and withdrawal due to adverse effects. We modified the definition of cardiovascular mortality and morbidity to exclude transient ischaemic attacks when possible.\nMain results\nThis update includes one additional trial (MRC-TMH 1985). Sixteen trials (N = 26,795) in healthy ambulatory adults 60 years or older (mean age 73.4 years) from western industrialised countries with moderate to severe systolic and/or diastolic hypertension (average 182/95 mmHg) met the inclusion criteria. Most of these trials evaluated first-line thiazide diuretic therapy for a mean treatment duration of 3.8 years.\nAntihypertensive drug treatment reduced all-cause mortality (high-certainty evidence; 11% with control vs 10.0% with treatment; risk ratio (RR) 0.91, 95% confidence interval (CI) 0.85 to 0.97; cardiovascular morbidity and mortality (moderate-certainty evidence; 13.6% with control vs 9.8% with treatment; RR 0.72, 95% CI 0.68 to 0.77; cerebrovascular mortality and morbidity (moderate-certainty evidence; 5.2% with control vs 3.4% with treatment; RR 0.66, 95% CI 0.59 to 0.74; and coronary heart disease mortality and morbidity (moderate-certainty evidence; 4.8% with control vs 3.7% with treatment; RR 0.78, 95% CI 0.69 to 0.88. Withdrawals due to adverse effects were increased with treatment (low-certainty evidence; 5.4% with control vs 15.7% with treatment; RR 2.91, 95% CI 2.56 to 3.30. In the three trials restricted to persons with isolated systolic hypertension, reported benefits were similar.\nThis comprehensive systematic review provides additional evidence that the reduction in mortality observed was due mostly to reduction in the 60- to 79-year-old patient subgroup (high-certainty evidence; RR 0.86, 95% CI 0.79 to 0.95). Although cardiovascular mortality and morbidity was significantly reduced in both subgroups 60 to 79 years old (moderate-certainty evidence; RR 0.71, 95% CI 0.65 to 0.77) and 80 years or older (moderate-certainty evidence; RR 0.75, 95% CI 0.65 to 0.87), the magnitude of absolute risk reduction was probably higher among 60- to 79-year-old patients (3.8% vs 2.9%). The reduction in cardiovascular mortality and morbidity was primarily due to a reduction in cerebrovascular mortality and morbidity.\nAuthors' conclusions\nTreating healthy adults 60 years or older with moderate to severe systolic and/or diastolic hypertension with antihypertensive drug therapy reduced all-cause mortality, cardiovascular mortality and morbidity, cerebrovascular mortality and morbidity, and coronary heart disease mortality and morbidity. Most evidence of benefit pertains to a primary prevention population using a thiazide as first-line treatment.\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": "We searched the available medical literature to find all trials that compared drug treatment versus placebo or no treatment to examine this question. Data included in this review are up-to-date as of November 2017."
}
] |
query-laysum
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8112
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[
{
"role": "user",
"content": "Abstract: Background\nFetal growth restriction (FGR) is a condition of poor growth of the fetus in utero. One of the causes of FGR is placental insufficiency. Severe early-onset FGR at < 32 weeks of gestation occurs in an estimated 0.4% of pregnancies. This extreme phenotype is associated with a high risk of fetal death, neonatal mortality, and neonatal morbidity. Currently, there is no causal treatment, and management is focused on indicated preterm birth to prevent fetal death. Interest has risen in interventions that aim to improve placental function by administration of pharmacological agents affecting the nitric oxide pathway causing vasodilatation.\nObjectives\nThe objective of this systematic review and aggregate data meta-analysis is to assess the beneficial and harmful effects of interventions affecting the nitric oxide pathway compared with placebo, no therapy, or different drugs affecting this pathway against each other, in pregnant women with severe early-onset FGR.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (16 July 2022), and reference lists of retrieved studies.\nSelection criteria\nWe considered all randomised controlled comparisons of interventions affecting the nitric oxide pathway compared with placebo, no therapy, or another drug affecting this pathway in pregnant women with severe early-onset FGR of placental origin, for inclusion in this review.\nData collection and analysis\nWe used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis.\nMain results\nWe included a total of eight studies (679 women) in this review, all of which contributed to the data and analysis. The identified studies report on five different comparisons: sildenafil compared with placebo or no therapy, tadalafil compared with placebo or no therapy, L-arginine compared with placebo or no therapy, nitroglycerin compared with placebo or no therapy and sildenafil compared with nitroglycerin.\nThe risk of bias of included studies was judged as low or unclear. In two studies the intervention was not blinded. The certainty of evidence for our primary outcomes was judged as moderate for the intervention sildenafil and low for tadalafil and nitroglycerine (due to low number of participants and low number of events). For the intervention L-arginine, our primary outcomes were not reported.\nSildenafil citrate compared to placebo or no therapy (5 studies, 516 women)\nFive studies (Canada, Australia and New Zealand, the Netherlands, the UK and Brazil) involving 516 pregnant women with FGR were included. We assessed the certainty of the evidence as moderate.\nCompared with placebo or no therapy, sildenafil probably has little or no effect on all-cause mortality (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.80 to 1.27, 5 studies, 516 women); may reduce fetal mortality (RR 0.82, 95% CI 0.60 to 1.12, 5 studies, 516 women), and increase neonatal mortality (RR 1.45, 95% CI 0.90 to 2.33, 5 studies, 397 women), although the results are uncertain for fetal and neonatal mortality as 95% confidence intervals are wide crossing the line of no effect.\nTadalafil compared with placebo or no therapy (1 study, 87 women)\nOne study (Japan) involving 87 pregnant women with FGR was included. We assessed the certainty of the evidence as low.\nCompared with placebo or no therapy, tadalafil may have little or no effect on all-cause mortality (risk ratio 0.20, 95% CI 0.02 to 1.60, one study, 87 women); fetal mortality (RR 0.11, 95% CI 0.01 to 1.96, one study, 87 women); and neonatal mortality (RR 0.89, 95% CI 0.06 to 13.70, one study, 83 women).\nL-Arginine compared with placebo or no therapy (1 study, 43 women)\nOne study (France) involving 43 pregnant women with FGR was included. This study did not assess our primary outcomes.\nNitroglycerin compared to placebo or no therapy (1 studies, 23 women)\nOne study (Brazil) involving 23 pregnant women with FGR was included. We assessed the certainty of the evidence as low. The effect on the primary outcomes is not estimable due to no events in women participating in both groups.\nSildenafil citrate compared to nitroglycerin (1 study, 23 women)\nOne study (Brazil) involving 23 pregnant women with FGR was included. We assessed the certainty of the evidence as low.\nThe effect on the primary outcomes is not estimable due to no events in women participating in both groups.\nAuthors' conclusions\nInterventions affecting the nitric oxide pathway probably do not seem to influence all-cause (fetal and neonatal) mortality in pregnant women carrying a baby with FGR, although more evidence is needed. The certainty of this evidence is moderate for sildenafil and low for tadalafil and nitroglycerin.\nFor sildenafil a fair amount of data are available from randomised clinical trials, but with low numbers of participants. Therefore, the certainty of evidence is moderate. For the other interventions investigated in this review there are insufficient data, meaning we do not know whether these interventions improve perinatal and maternal outcomes in pregnant women with FGR.\n\nGiven the provided abstract, please respond to the following query: \"Nitroglycerin compared with placebo or no therapy (1 study, 23 women)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study (Brazil) involving 43 pregnant women with fetal growth restriction.\nThe effect on the primary outcomes is not estimable since no fetal or neonatal mortality occurred in the women participating in both intervention groups."
}
] |
query-laysum
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8113
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[
{
"role": "user",
"content": "Abstract: Background\nAnnually, infections contribute to approximately 25% of the 2.8 million neonatal deaths worldwide. Over 95% of sepsis-related neonatal deaths occur in low- and middle-income countries. Hand hygiene is an inexpensive and cost-effective method of preventing infection in neonates, making it an affordable and practicable intervention in low- and middle-income country settings. Therefore, hand hygiene practices may hold strong prospects for reducing the occurrence of infection and infection-related neonatal death.\nObjectives\nTo determine the effectiveness of different hand hygiene agents for preventing neonatal infection in both community and health facility settings.\nSearch methods\nSearches were conducted without date or language limits in December 2022 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulated Index to Nursing and Allied Health Literature (CINAHL), clinicaltrials.gov and International Clinical Trials Registry Platform (ICTRP) trial registries. The reference lists of retrieved studies or related systematic reviews were screened for studies not identified by the searches.\nSelection criteria\nWe included randomized controlled trials (RCTs), cross-over trials, and cluster trials that included pregnant women, mothers, other caregivers, and healthcare workers who received interventions within either the community setting or in health facility settings, and the neonates in the neonatal care units or community settings.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and the GRADE approach to assess the certainty of evidence. Primary outcomes were incidence of suspected infection (author-defined in study) within the first 28 days of life, bacteriologically confirmed infection within the first 28 days of life, all-cause mortality within the first seven days of life (early neonatal death), and all-cause mortality from the 8th to the 28th day of life (late neonatal death).\nMain results\nOur review included six studies: two RCTs, one cluster-RCT, and three cross-over trials. Three studies involved 3281 neonates; the remaining three did not specify the actual number of neonates included in their study. Three studies involved 279 nurses working in neonatal intensive care units (NICUs). The number of nurses included was not specified by one study. A cluster-RCT included 103 pregnant women of over 34 weeks gestation from 10 villages in a community setting (sources of data: 103 mother-neonate pairs) and another community-based study included 258 married pregnant women at 32 to 34 weeks of gestation (the trial reported adverse events on 258 mothers and 246 neonates). Studies examined the effectiveness of different hand hygiene practices for the incidence of suspected infection (author-defined in study) within the first 28 days of life. Three studies were rated as having low risk for allocation bias, two studies were rated as unclear risk, and one was rated as having high risk. One study was rated as having a low risk of bias for allocation concealment, one study was rated as unclear risk, and four werw rated as having high risk. Two studies were rated as having low risk for performance bias and two were rated as having low risk for attrition bias.\nOne class of agent versus another class of agent: 2% chlorhexidine gluconate (CHG) compared to alcohol hand sanitiser (61% alcohol and emollients)\nFor this comparison, no study assessed the effect of the intervention on the incidence of suspected infection within the first 28 days of life. Two percent chlorhexidine gluconate (CHG) probably reduces the risk of all infection in neonates compared to 61% alcohol hand sanitiser in regard to the incidence of all bacteriologically confirmed infection within the first 28 days of life (RR 0.79, 95% confidence interval (CI) 0.66 to 0.93; 2932 participants, 1 study; moderate-certainty evidence), number needed to treat for an additional beneficial outcome (NNTB): 385.\nThe adverse outcome was reported as mean self-reported skin change and mean observer-reported skin change. There may be little to no difference between the effects of 2% CHG on nurses’ skin compared to alcohol hand sanitiser, based on very low-certainty evidence for mean self-reported skin change (mean difference (MD) -0.80, 95% CI -1.59 to 0.01; 119 participants, 1 study) and on mean observer reported skin change (MD -0.19, CI -0.35 to -0.03; 119 participants, 1 study), respectively.\nWe identified no study that reported on all-cause mortality and other outcomes for this comparison.\nNone of the included studies assessed all-cause mortality within the first seven days of life nor the duration of hospital stay.\nOne class of agent versus two or more other classes of agent: CHG compared to plain liquid soap + hand sanitiser\nWe identified no studies that reported on our primary and secondary outcomes for this comparison except for author-defined adverse events. We are very uncertain whether plain soap plus hand sanitiser is better than CHG for nurses’ skin based on very low-certainty evidence (MD -1.87, 95% CI -3.74 to -0.00; 16 participants, 1 study; very low-certainty evidence).\nOne agent versus standard care: alcohol-based handrub (hand sanitiser) versus usual care\nThe evidence is very uncertain whether alcohol-based handrub is better than 'usual care' in the prevention of suspected infections, as reported by mothers (RR 0.98, CI 0.69 to 1.39; 103 participants, 1 study, very low-certainty evidence). We are uncertain whether alcohol-based hand sanitiser is better than 'usual care' in reducing the occurrence of early and late neonatal mortality (RR 0.29, 95% CI 0.01 to 7.00; 103 participants, 1 study; very low-certainty evidence) and (RR 0.29, CI 0.01 to 7.00; 103 participants, 1 study; very low-certainty evidence), respectively. We identified no studies that reported on other outcomes for this comparison.\nAuthors' conclusions\nWe found a paucity of data that would allow us to reach meaningful conclusions pertaining to the superiority of one form of antiseptic hand hygiene agent over another for the prevention of neonatal infection. Also, the sparse available data were of moderate- to very low-certainty. We are uncertain as to the superiority of one hand hygiene agent over another because this review included very few studies with very serious study limitations.\n\nGiven the provided abstract, please respond to the following query: \"Why is hand hygiene important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Every year, about 500,000 newborn babies die as a result of an infection caused by bacteria. Most of these deaths occur in poor countries. The hands of mothers and other caregivers harbour a lot of germs that are acquired during contact secretions and diaper changes; they have been linked to infections in newborns. These infections may be prevented when caregivers of these babies practice good hand hygiene."
}
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8114
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[
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"role": "user",
"content": "Abstract: Background\nStudies suggest that a diet rich in omega-3 essential fatty acids may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. This is an updated version of a previously published review.\nObjectives\nTo determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality and to identify any adverse events associated with supplementation.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of last search: 01 April 2020.\nWe also searched online study registries and contacted authors. Date of last search: 12 February 2020.\nSelection criteria\nRandomised controlled trials in people with cystic fibrosis comparing omega-3 fatty acid supplements with placebo.\nData collection and analysis\nTwo authors independently selected studies for inclusion, extracted data and assessed the risk of bias of the studies. The quality of the evidence was assessed using GRADE.\nMain results\nThe searches identified 23 studies; five studies with 106 participants (children and adults) were included; duration of studies and interventions differed. Two studies compared omega-3 fatty acids to olive oil for six weeks; one study compared omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends) for three months; one study compared a liquid dietary supplement containing omega-3 fatty acids to one without for six months; and one study compared omega-3 fatty acids to a placebo for 12 months. Three studies had a low risk of bias for randomisation, but the risk was unclear in the remaining two studies; all studies had an unclear risk of bias for allocation concealment. Three of the studies adequately blinded participants; the risk of bias for selective reporting was high in one study and unclear for four studies.\nTwo studies reported the number of respiratory exacerbations. At three months, one study (43 participants) reported no change in antibiotic usage. At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome.\nWith regards to adverse events, one six-week study (12 participants) reported no difference in diarrhoea between omega-3 or placebo capsules; the very low-quality evidence means we are unsure if supplementation has any effect on this outcome. Additionally, one study reported an increase in steatorrhoea requiring participants to increase their daily dose of pancreatic enzymes, but three studies had already increased pancreatic enzyme dose at study begin so as to reduce the incidence of steatorrhoea. One study (43 participants) reported stomach pains at three months (treatment or control group not specified). One six-week study (19 participants) reported three asthma exacerbations leading to exclusion of participants since corticosteroid treatment could affect affect essential fatty acid metabolism.\nFour studies reported lung function. One six-week study (19 participants) reported an increase in forced expiratory volume in one second (FEV1) (L) and forced vital capacity (FVC) (L), but the very low-quality evidence means we are unsure if supplementation has any effect on lung function. The remaining studies did not report any difference in lung function at three months (unit of measurement not specified) or at six months and one year (FEV1 % predicted and FVC % predicted).\nNo deaths were reported in any of the five studies. Four studies reported clinical variables. One study reported an increase in Schwachman score and weight alongside a reduction in sputum volume with supplementation compared to placebo at three months (data not analysable). However, three studies reported no differences in either weight at six weeks, in body mass index (BMI) standard deviation (SD) score at six months (very low-quality evidence) or BMI Z score at 12 months.\nThree studies reported biochemical markers of fatty acid status. One study showed an increase from baseline in both EPA and DHA content of serum phospholipids in the omega-3 group compared to placebo at three months and also a significant decrease in n-6/n-3 ratio in the supplement group compared to placebo; since the quality of the evidence is very low we are not certain that these changes are due to supplementation. One six-month cross-over study showed a higher EPA content of the neutrophil membrane in the supplement group compared to the placebo group, but, no difference in DHA membrane concentration. Furthermore, the leukotriene B4 to leukotriene B5 ratio was lower at six months in the omega-3 group compared to placebo. A one-year study reported a greater increase in the essential fatty acid profile and a decrease in AA levels in the treatment arm compared to placebo.\nAuthors' conclusions\nThis review found that regular omega-3 supplements may provide some limited benefits for people with cystic fibrosis with relatively few adverse effects: however, the quality of the evidence across all outcomes was very low. The current evidence is insufficient to draw firm conclusions or recommend routine use of these supplements in people with cystic fibrosis. A large, long-term, multicentre, randomised controlled study is needed to determine any significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes when providing omega-3 supplementation or olive oil placebo capsules. More research is required to determine the exact dose of pancreatic enzyme required.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We judged the quality of the evidence to be very low due to very low participant numbers, low event rates, limited reporting and poor study design. There was no consistency with regards to the time points when results were reported or the measurements used for the same outcome in different studies."
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query-laysum
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8115
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[
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is a disabling psychotic disorder characterised by positive symptoms of delusions, hallucinations, disorganised speech and behaviour; and negative symptoms such as affective flattening and lack of motivation. Cognitive behavioural therapy (CBT) is a psychological intervention that aims to change the way in which a person interprets and evaluates their experiences, helping them to identify and link feelings and patterns of thinking that underpin distress. CBT models targeting symptoms of psychosis (CBTp) have been developed for many mental health conditions including schizophrenia. CBTp has been suggested as a useful add-on therapy to medication for people with schizophrenia. While CBT for people with schizophrenia was mainly developed as an individual treatment, it is expensive and a group approach may be more cost-effective. Group CBTp can be defined as a group intervention targeting psychotic symptoms, based on the cognitive behavioural model. In group CBTp, people work collaboratively on coping with distressing hallucinations, analysing evidence for their delusions, and developing problem-solving and social skills. However, the evidence for effectiveness is far from conclusive.\nObjectives\nTo investigate efficacy and acceptability of group CBT applied to psychosis compared with standard care or other psychosocial interventions, for people with schizophrenia or schizoaffective disorder.\nSearch methods\nOn 10 February 2021, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on CENTRAL, MEDLINE, Embase, four other databases and two trials registries. We handsearched the reference lists of relevant papers and previous systematic reviews and contacted experts in the field for supplemental data.\nSelection criteria\nWe selected randomised controlled trials allocating adults with schizophrenia to receive either group CBT for schizophrenia, compared with standard care, or any other psychosocial intervention (group or individual).\nData collection and analysis\nWe complied with Cochrane recommended standard of conduct for data screening and collection. Where possible, we calculated risk ratio (RR) and 95% confidence interval (CI) for binary data and mean difference (MD) and 95% CI for continuous data. We used 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\nThe review includes 24 studies (1900 participants). All studies compared group CBTp with treatments that a person with schizophrenia would normally receive in a standard mental health service (standard care) or any other psychosocial intervention (group or individual). None of the studies compared group CBTp with individual CBTp. Overall risk of bias within the trials was moderate to low.\nWe found no studies reporting data for our primary outcome of clinically important change. With regard to numbers of participants leaving the study early, group CBTp has little or no effect compared to standard care or other psychosocial interventions (RR 1.22, 95% CI 0.94 to 1.59; studies = 13, participants = 1267; I2 = 9%; low-certainty evidence). Group CBTp may have some advantage over standard care or other psychosocial interventions for overall mental state at the end of treatment for endpoint scores on the Positive and Negative Syndrome Scale (PANSS) total (MD –3.73, 95% CI –4.63 to –2.83; studies = 12, participants = 1036; I2 = 5%; low-certainty evidence). Group CBTp seems to have little or no effect on PANSS positive symptoms (MD –0.45, 95% CI –1.30 to 0.40; studies =8, participants = 539; I2 = 0%) and on PANSS negative symptoms scores at the end of treatment (MD –0.73, 95% CI –1.68 to 0.21; studies = 9, participants = 768; I2 = 65%). Group CBTp seems to have an advantage over standard care or other psychosocial interventions on global functioning measured by Global Assessment of Functioning (GAF; MD –3.61, 95% CI –6.37 to –0.84; studies = 5, participants = 254; I2 = 0%; moderate-certainty evidence), Personal and Social Performance Scale (PSP; MD 3.30, 95% CI 2.00 to 4.60; studies = 1, participants = 100), and Social Disability Screening Schedule (SDSS; MD –1.27, 95% CI –2.46 to –0.08; studies = 1, participants = 116). Service use data were equivocal with no real differences between treatment groups for number of participants hospitalised (RR 0.78, 95% CI 0.38 to 1.60; studies = 3, participants = 235; I2 = 34%). There was no clear difference between group CBTp and standard care or other psychosocial interventions endpoint scores on depression and quality of life outcomes, except for quality of life measured by World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF) Psychological domain subscale (MD –4.64, 95% CI –9.04 to –0.24; studies = 2, participants = 132; I2 = 77%). The studies did not report relapse or adverse effects.\nAuthors' conclusions\nGroup CBTp appears to be no better or worse than standard care or other psychosocial interventions for people with schizophrenia in terms of leaving the study early, service use and general quality of life. Group CBTp seems to be more effective than standard care or other psychosocial interventions on overall mental state and global functioning scores. These results may not be widely applicable as each study had a low sample size. Therefore, no firm conclusions concerning the efficacy of group CBTp for people with schizophrenia can currently be made. More high-quality research, reporting useable and relevant data 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"
},
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"role": "assistant",
"content": "Group CBTp seems to be better than standard care or other psychosocial interventions on total symptoms of schizophrenia and global functioning."
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query-laysum
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8116
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[
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"role": "user",
"content": "Abstract: Background\nAnaemia is a condition where the number of red blood cells (and consequently their oxygen-carrying capacity) is insufficient to meet the body's physiological needs. Fortification of wheat flour is deemed a useful strategy to reduce anaemia in populations.\nObjectives\nTo determine the benefits and harms of wheat flour fortification with iron alone or with other vitamins and minerals on anaemia, iron status and health-related outcomes in populations over two years of age.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, 21 other databases and two trials registers up to 21 July 2020, together with contacting key organisations to identify additional studies.\nSelection criteria\nWe included cluster- or individually-randomised controlled trials (RCTs) carried out among the general population from any country, aged two years and above. The interventions were fortification of wheat flour with iron alone or in combination with other micronutrients. We included trials comparing any type of food item prepared from flour fortified with iron of any variety of wheat\nData collection and analysis\nTwo review authors independently screened the search results and assessed the eligibility of studies for inclusion, extracted data from included studies and assessed risks of bias. We followed Cochrane methods in this review.\nMain results\nOur search identified 3538 records, after removing duplicates. We included 10 trials, involving 3319 participants, carried out in Bangladesh, Brazil, India, Kuwait, Philippines, South Africa and Sri Lanka. We identified two ongoing studies and one study is awaiting classification. The duration of interventions varied from 3 to 24 months. One study was carried out among adult women and one trial among both children and nonpregnant women. Most of the included trials were assessed as low or unclear risk of bias for key elements of selection, performance or reporting bias.\nThree trials used 41 mg to 60 mg iron/kg flour, three trials used less than 40 mg iron/kg and three trials used more than 60 mg iron/kg flour. One trial used various iron levels based on type of iron used: 80 mg/kg for electrolytic and reduced iron and 40 mg/kg for ferrous fumarate.\nAll included studies contributed data for the meta-analyses.\nIron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added\nIron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added may reduce by 27% the risk of anaemia in populations (risk ratio (RR) 0.73, 95% confidence interval (CI) 0.55 to 0.97; 5 studies, 2315 participants; low-certainty evidence).\nIt is uncertain whether iron-fortified wheat flour with or without other micronutrients reduces iron deficiency (RR 0.46, 95% CI 0.20 to 1.04; 3 studies, 748 participants; very low-certainty evidence) or increases haemoglobin concentrations (in g/L) (mean difference MD 2.75, 95% CI 0.71 to 4.80; 8 studies, 2831 participants; very low-certainty evidence).\nNo trials reported data on adverse effects in children (including constipation, nausea, vomiting, heartburn or diarrhoea), except for risk of infection or inflammation at the individual level. The intervention probably makes little or no difference to the risk of Infection or inflammation at individual level as measured by C-reactive protein (CRP) (mean difference (MD) 0.04, 95% CI −0.02 to 0.11; 2 studies, 558 participants; moderate-certainty evidence).\nIron-fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added)\nIt is unclear whether wheat flour fortified with iron, in combination with other micronutrients decreases anaemia (RR 0.77, 95% CI 0.41 to 1.46; 2 studies, 317 participants; very low-certainty evidence). The intervention probably reduces the risk of iron deficiency (RR 0.73, 95% CI 0.54 to 0.99; 3 studies, 382 participants; moderate-certainty evidence) and it is unclear whether it increases average haemoglobin concentrations (MD 2.53, 95% CI −0.39 to 5.45; 4 studies, 532 participants; very low-certainty evidence).\nNo trials reported data on adverse effects in children.\nNine out of 10 trials reported sources of funding, with most having multiple sources. Funding source does not appear to have distorted the results in any of the assessed trials.\nAuthors' conclusions\nFortification of wheat flour with iron (in comparison to unfortified flour, or where both groups received the same other micronutrients) may reduce anaemia in the general population above two years of age, but its effects on other outcomes are uncertain.\nIron-fortified wheat flour in combination with other micronutrients, in comparison with unfortified flour, probably reduces iron deficiency, but its effects on other outcomes are uncertain.\nNone of the included trials reported data on adverse side effects except for risk of infection or inflammation at the individual level. The effects of this intervention on other health outcomes are unclear. Future studies at low risk of bias should aim to measure all important outcomes, and to further investigate which variants of fortification, including the role of other micronutrients as well as types of iron fortification, are more effective, and for whom.\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 10 studies in 3319 people (aged 2 years and older). The studies lasted from 3 months to 24 months, and took place in Bangladesh, Brazil, India, Kuwait, the Philippines, Sri Lanka and South Africa.\nThe studies looked at the effects of:\n· wheat flour containing added iron (with or without other minerals and vitamins) compared with wheat flour without added iron (but with the same other minerals and vitamins);\n· wheat flour containing added iron and other minerals and vitamins compared with wheat flour without any added minerals or vitamins.\nThe wheat flours used in the studies contained different amounts of iron: from under 40 mg/kg to over 60 mg/kg.\nWe were interested in:\n· how many people had anaemia (defined by low haemoglobin levels);\n· how many people had low levels of iron in their blood (iron deficiency; tested using a biomarker);\n· haemoglobin concentrations in people's blood;\n· how many children had diarrhoea or respiratory infections;\n· how many children died (of any cause);\n· signs of infection or inflammation (the body's response to injury) in children (by testing a biomarker in the blood); and\n· any unwanted effects.\nMost studies had multiple sources of funding; some were partly funded by companies involved in the food, chemical or pharmaceutical industries."
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query-laysum
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8117
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[
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"role": "user",
"content": "Abstract: Background\nAssisted reproduction techniques (ART), such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), can help subfertile couples to create a family. It is necessary to induce multiple follicles, which is achieved by follicle stimulating hormone (FSH) injections. Current treatment regimens prescribe daily injections of FSH (urinary FSH either with or without luteinizing hormone (LH) injections or recombinant FSH (rFSH)).\nRecombinant DNA technologies have produced a new recombinant molecule which is a long-acting FSH, named corifollitropin alfa (Elonva) or FSH-CTP. A single dose of long-acting FSH is able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week. The optimal dose of long-acting FSH is still being determined. A single injection of long-acting FSH can replace seven daily FSH injections during the first week of controlled ovarian stimulation (COS) and can make assisted reproduction more patient friendly.\nObjectives\nTo compare the effectiveness of long-acting FSH versus daily FSH in terms of pregnancy and safety outcomes in women undergoing IVF or ICSI treatment cycles.\nSearch methods\nWe searched the following electronic databases, trial registers and websites from inception to June 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialized Register, MEDLINE, EMBASE, PsycINFO, CINAHL, electronic trial registers for ongoing and registered trials, citation indexes, conference abstracts in the ISI Web of Knowledge, LILACS, Clinical Study Results (for clinical trial results of marketed pharmaceuticals), PubMed and OpenSIGLE. We also carried out handsearches.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing long-acting FSH versus daily FSH in women who were part of a couple with subfertility and undertaking IVF or ICSI treatment cycles with a GnRH antagonist or agonist protocol.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction and assessment of risk of bias. We contacted trial authors in cases of missing data. We calculated risk ratios for each outcome, and our primary outcomes were live birth rate and ovarian hyperstimulation syndrome (OHSS) rate. Our secondary outcomes were ongoing pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, any other adverse event (including ectopic pregnancy, congenital malformations, drug side effects and infection) and patient satisfaction with the treatment. Trials reported all outcomes, except patient satisfaction with the treatment.\nMain results\nWe included six RCTs with a total of 3753 participants and we graded the quality of the included studies as moderate. All studies included women with an indication for COS as part of an IVF/ICSI cycle with age ranging from 18 to 41 years. A comparison of long-acting FSH versus daily FSH did not show evidence of difference in effect on overall live birth rate (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.07; 2363 participants, five studies; I² statistic = 44%) or OHSS (RR 1.00, 95% CI 0.74 to 1.37; 3753 participants, six studies; I² statistic = 0%). We compared subgroups by dose of long-acting FSH. There was evidence of a reduced live birth rate in women who received lower doses (60 to 120 μg) of long-acting FSH compared to daily FSH (RR 0.70, 95% CI 0.52 to 0.93; 645 participants, three studies; I² statistic = 0%). There was no evidence a difference between the groups in live births in the medium dose (150 to 180 μg) subgroup (RR 1.03, 95% CI 0.90 to 1.18; 1685 participants, four studies; I² statistic = 6%). There was no evidence of a difference between the groups in the clinical pregnancy rate (any dose), ongoing pregnancy rate (any dose), multiple pregnancy rate (any dose), miscarriage rate (low or medium dose), ectopic pregnancy rate (any dose), congenital malformation rate, congenital malformation rate; major or minor (low or medium dose).\nAuthors' conclusions\nThe use of a medium dose (150 to 180 μg) of long-acting FSH is a safe treatment option and equally effective compared to daily FSH in women with unexplained subfertility. There was evidence of reduced live birth rate in women receiving a low dose (60 to 120 μg) of long-acting FSH compared to daily FSH. Further research is needed to determine whether long-acting FSH is safe and effective for use in hyper- or poor responders and in women with all causes of subfertility.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included six randomised controlled trials comparing weekly versus daily FSH in 3753 women undertaking controlled ovarian stimulation as part of an IVF/ICSI cycle. Their age ranged from 18 to 41 years. The studies used different dosages of weekly FSH ranging from 60 to 240 μg. Five studies reported live birth rate and all six studies reported OHSS rate (our primary outcomes). The evidence is current to June 2015."
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query-laysum
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8118
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[
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"role": "user",
"content": "Abstract: Background\nTobacco smoking is the leading preventable cause of death and disease worldwide. Stopping smoking can reduce this harm and many people would like to stop. There are a number of medicines licenced to help people quit globally, and e-cigarettes are used for this purpose in many countries. Typically treatments work by reducing cravings to smoke, thus aiding initial abstinence and preventing relapse. More information on comparative effects of these treatments is needed to inform treatment decisions and policies.\nObjectives\nTo investigate the comparative benefits, harms and tolerability of different smoking cessation pharmacotherapies and e-cigarettes, when used to help people stop smoking tobacco.\nSearch methods\nWe identified studies from recent updates of Cochrane Reviews investigating our interventions of interest. We updated the searches for each review using the Cochrane Tobacco Addiction Group (TAG) specialised register to 29 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs and factorial RCTs, which measured smoking cessation at six months or longer, recruited adults who smoked combustible cigarettes at enrolment (excluding pregnant people) and randomised them to approved pharmacotherapies and technologies used for smoking cessation worldwide (varenicline, cytisine, nortriptyline, bupropion, nicotine replacement therapy (NRT) and e-cigarettes) versus no pharmacological intervention, placebo (control) or another approved pharmacotherapy. Studies providing co-interventions (e.g. behavioural support) were eligible if the co-intervention was provided equally to study arms.\nData collection and analysis\nWe followed standard Cochrane methods for screening, data extraction and risk of bias (RoB) assessment (using the RoB 1 tool). Primary outcome measures were smoking cessation at six months or longer, and the number of people reporting serious adverse events (SAEs). We also measured withdrawals due to treatment. We used Bayesian component network meta-analyses (cNMA) to examine intervention type, delivery mode, dose, duration, timing in relation to quit day and tapering of nicotine dose, using odds ratios (OR) and 95% credibility intervals (CrIs). We calculated an effect estimate for combination NRT using an additive model. We evaluated the influence of population and study characteristics, provision of behavioural support and control arm rates using meta-regression. We evaluated certainty using GRADE.\nMain results\nOf our 332 eligible RCTs, 319 (835 study arms, 157,179 participants) provided sufficient data to be included in our cNMA. Of these, we judged 51 to be at low risk of bias overall, 104 at high risk and 164 at unclear risk, and 118 reported pharmaceutical or e-cigarette/tobacco industry funding. Removing studies at high risk of bias did not change our interpretation of the results.\nBenefits\nWe found high-certainty evidence that nicotine e-cigarettes (OR 2.37, 95% CrI 1.73 to 3.24; 16 RCTs, 3828 participants), varenicline (OR 2.33, 95% CrI 2.02 to 2.68; 67 RCTs, 16,430 participants) and cytisine (OR 2.21, 95% CrI 1.66 to 2.97; 7 RCTs, 3848 participants) were associated with higher quit rates than control. In absolute terms, this might lead to an additional eight (95% CrI 4 to 13), eight (95% CrI 6 to 10) and seven additional quitters per 100 (95% CrI 4 to 12), respectively. These interventions appeared to be more effective than the other interventions apart from combination NRT (patch and a fast-acting form of NRT), which had a lower point estimate (calculated additive effect) but overlapping 95% CrIs (OR 1.93, 95% CrI 1.61 to 2.34). There was also high-certainty evidence that nicotine patch alone (OR 1.37, 95% CrI 1.20 to 1.56; 105 RCTs, 37,319 participants), fast-acting NRT alone (OR 1.41, 95% CrI 1.29 to 1.55; 120 RCTs, 31,756 participants) and bupropion (OR 1.43, 95% CrI 1.26 to 1.62; 71 RCTs, 14,759 participants) were more effective than control, resulting in two (95% CrI 1 to 3), three (95% CrI 2 to 3) and three (95% CrI 2 to 4) additional quitters per 100 respectively.\nNortriptyline is probably associated with higher quit rates than control (OR 1.35, 95% CrI 1.02 to 1.81; 10 RCTs, 1290 participants; moderate-certainty evidence), resulting in two (CrI 0 to 5) additional quitters per 100. Non-nicotine/placebo e-cigarettes (OR 1.16, 95% CrI 0.74 to 1.80; 8 RCTs, 1094 participants; low-certainty evidence), equating to one additional quitter (95% CrI -2 to 5), had point estimates favouring the intervention over control, but CrIs encompassed the potential for no difference and harm. There was low-certainty evidence that tapering the dose of NRT prior to stopping treatment may improve effectiveness; however, 95% CrIs also incorporated the null (OR 1.14, 95% CrI 1.00 to 1.29; 111 RCTs, 33,156 participants). This might lead to an additional one quitter per 100 (95% CrI 0 to 2).\nHarms\nThere were insufficient data to include nortriptyline and non-nicotine EC in the final SAE model. Overall rates of SAEs for the remaining treatments were low (average 3%). Low-certainty evidence did not show a clear difference in the number of people reporting SAEs for nicotine e-cigarettes, varenicline, cytisine or NRT when compared to no pharmacotherapy/e-cigarettes or placebo. Bupropion may slightly increase rates of SAEs, although the CrI also incorporated no difference (moderate certainty). In absolute terms bupropion may cause one more person in 100 to experience an SAE (95% CrI 0 to 2).\nAuthors' conclusions\nThe most effective interventions were nicotine e-cigarettes, varenicline and cytisine (all high certainty), as well as combination NRT (additive effect, certainty not rated). There was also high-certainty evidence for the effectiveness of nicotine patch, fast-acting NRT and bupropion. Less certain evidence of benefit was present for nortriptyline (moderate certainty), non-nicotine e-cigarettes and tapering of nicotine dose (both low certainty).\nThere was moderate-certainty evidence that bupropion may slightly increase the frequency of SAEs, although there was also the possibility of no increased risk. There was no clear evidence that any other tested interventions increased SAEs. Overall, SAE data were sparse with very low numbers of SAEs, and so further evidence may change our interpretation and certainty.\nFuture studies should report SAEs to strengthen certainty in this outcome. More head-to-head comparisons of the most effective interventions are needed, as are tests of combinations of these. Future work should unify data from behavioural and pharmacological interventions to inform approaches to combined support for smoking cessation.\n\nGiven the provided abstract, please respond to the following query: \"How confident are we in our results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are confident that e-cigarettes, cytisine, varenicline, nicotine replacement therapy and bupropion help people stop smoking. We do not expect more evidence will change these results. However, more evidence on how these treatments compare to one another, particularly in relation to harms, would be useful. Due to the nature of our analyses we were not able to judge our confidence in the evidence for combination nicotine replacement therapy (two types used together). We are moderately confident that nortriptyline also helps people to stop smoking, but are less confident in our results for non-nicotine e-cigarettes and for potential harms of most of the treatments. We still need more evidence on potential harms and hope more studies will report on these in future; however, nicotine replacement therapy has been used since the 1980s with no evidence of serious harms."
}
] |
query-laysum
|
8119
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic inflammatory joint diseases (IJDs) affect 1% to 2% of the population in developed countries. IJDs include rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and other forms of spondyloarthritis (SpA). Tobacco smoking is considered a significant environmental risk factor for developing IJDs. There are indications that smoking exacerbates the symptoms and worsens disease outcomes.\nObjectives\nThe objective of this review was to investigate the evidence for effects of smoking cessation interventions on smoking cessation and disease activity in smokers with IJD.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library; PubMed/MEDLINE; Embase; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and three trials registers to October 2018.\nSelection criteria\nWe included randomised controlled trials testing any form of smoking cessation intervention for adult daily smokers with a diagnosis of IJD, and measuring smoking cessation at least six months after baseline.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included two studies with 57 smokers with a diagnosis of rheumatoid arthritis (RA). We identified no studies including other IJDs. One pilot study compared a smoking cessation intervention specifically for people with RA with a less intensive, generic smoking cessation intervention. People included in the study had a mean age of 56.5 years and a disease duration of 7.7 years (mean). The second study tested effects of an eight-week cognitive-behavioural patient education intervention on cardiovascular disease (CVD) risk for people with RA and compared this with information on CVD risk only. The intervention encouraged participants to address multiple behaviours impacting CVD risk, including smoking cessation, but did not target smoking cessation alone. People included in the study had a mean age of 62.2 years (intervention group) and 60.8 years (control group), and disease duration of 11.6 years (intervention group) and 14.1 years (control group). It was not appropriate to perform a meta-analysis of abstinence data from the two studies due to clinical heterogeneity between interventions. Neither of the studies individually provided evidence to show benefit of the interventions tested. Only one study reported on adverse effects. These effects were non-serious, and numbers were comparable between trial arms. Neither of the studies assessed or reported disease activity or any of the predefined secondary outcomes. We assessed the overall certainty of evidence as very low due to indirectness, imprecision, and high risk of detection bias based on GRADE.\nAuthors' conclusions\nWe found very little research investigating the efficacy of smoking cessation intervention specifically in people with IJD. Included studies are limited by imprecision, risk of bias, and indirectness. Neither of the included studies investigated whether smoking cessation intervention reduced disease activity among people with IJD. High-quality, adequately powered studies are warranted. In particular, researchers should ensure that they measure disease markers and quality of life, in addition to long-term smoking cessation.\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": "Neither of the two included studies found that the more intensive, specialist interventions aimed at people with rheumatoid arthritis helped more people with rheumatoid arthritis to quit smoking than the less intensive, generic interventions. Only one of the studies reported on the safety of the stop smoking programme used. Very few side effects related to use of nicotine replacement therapy were reported, and none of these were serious. As a result, we do not know whether helping people with inflammatory arthritis improves their disease."
}
] |
query-laysum
|
8120
|
[
{
"role": "user",
"content": "Abstract: Background\nCurrent and expected problems such as ageing, increased prevalence of chronic conditions and multi-morbidity, increased emphasis on healthy lifestyle and prevention, and substitution for care from hospitals by care provided in the community encourage countries worldwide to develop new models of primary care delivery. Owing to the fact that many tasks do not necessarily require the knowledge and skills of a doctor, interest in using nurses to expand the capacity of the primary care workforce is increasing. Substitution of nurses for doctors is one strategy used to improve access, efficiency, and quality of care. This is the first update of the Cochrane review published in 2005.\nObjectives\nOur aim was to investigate the impact of nurses working as substitutes for primary care doctors on:\n• patient outcomes;\n• processes of care; and\n• utilisation, including volume and cost.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of the Cochrane Library (www.cochranelibrary.com), as well as MEDLINE, Ovid, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and EbscoHost (searched 20.01.2015). We searched for grey literature in the Grey Literature Report and OpenGrey (21.02.2017), and we searched the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov trial registries (21.02.2017). We did a cited reference search for relevant studies (searched 27.01 2015) and checked reference lists of all included studies. We reran slightly revised strategies, limited to publication years between 2015 and 2017, for CENTRAL, MEDLINE, and CINAHL, in March 2017, and we have added one trial to ‘Studies awaiting classification’.\nSelection criteria\nRandomised trials evaluating the outcomes of nurses working as substitutes for doctors. The review is limited to primary healthcare services that provide first contact and ongoing care for patients with all types of health problems, excluding mental health problems. Studies which evaluated nurses supplementing the work of primary care doctors were excluded.\nData collection and analysis\nTwo review authors independently carried out data extraction and assessment of risk of bias of included studies. When feasible, we combined study results and determined an overall estimate of the effect. We evaluated other outcomes by completing a structured synthesis.\nMain results\nFor this review, we identified 18 randomised trials evaluating the impact of nurses working as substitutes for doctors. One study was conducted in a middle-income country, and all other studies in high-income countries. The nursing level was often unclear or varied between and even within studies. The studies looked at nurses involved in first contact care (including urgent care), ongoing care for physical complaints, and follow-up of patients with a particular chronic conditions such as diabetes. In many of the studies, nurses could get additional support or advice from a doctor. Nurse-doctor substitution for preventive services and health education in primary care has been less well studied.\nStudy findings suggest that care delivered by nurses, compared to care delivered by doctors, probably generates similar or better health outcomes for a broad range of patient conditions (low- or moderate-certainty evidence):\n• Nurse-led primary care may lead to slightly fewer deaths among certain groups of patients, compared to doctor-led care. However, the results vary and it is possible that nurse-led primary care makes little or no difference to the number of deaths (low-certainty evidence).\n• Blood pressure outcomes are probably slightly improved in nurse-led primary care. Other clinical or health status outcomes are probably similar (moderate-certainty evidence).\n• Patient satisfaction is probably slightly higher in nurse-led primary care (moderate-certainty evidence). Quality of life may be slightly higher (low-certainty evidence).\nWe are uncertain of the effects of nurse-led care on process of care because the certainty of this evidence was assessed as very low.\nThe effect of nurse-led care on utilisation of care is mixed and depends on the type of outcome. Consultations are probably longer in nurse-led primary care (moderate-certainty evidence), and numbers of attended return visits are slightly higher for nurses than for doctors (high-certainty evidence). We found little or no difference between nurses and doctors in the number of prescriptions and attendance at accident and emergency units (high-certainty evidence). There may be little or no difference in the number of tests and investigations, hospital referrals and hospital admissions between nurses and doctors (low-certainty evidence).\nWe are uncertain of the effects of nurse-led care on the costs of care because the certainty of this evidence was assessed as very low.\nAuthors' conclusions\nThis review shows that for some ongoing and urgent physical complaints and for chronic conditions, trained nurses, such as nurse practitioners, practice nurses, and registered nurses, probably provide equal or possibly even better quality of care compared to primary care doctors, and probably achieve equal or better health outcomes for patients. Nurses probably achieve higher levels of patient satisfaction, compared to primary care doctors. Furthermore, consultation length is probably longer when nurses deliver care and the frequency of attended return visits is probably slightly higher for nurses, compared to doctors. Other utilisation outcomes are probably the same. The effects of nurse-led care on process of care and the costs of care are uncertain, and we also cannot ascertain what level of nursing education leads to the best outcomes when nurses are substituted for doctors.\n\nGiven the provided abstract, please respond to the following query: \"What are the key messages of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Delivery of primary healthcare services by nurses instead of doctors probably leads to similar or better patient health and higher patient satisfaction. Nurses probably also have longer consultations with patients. Using nurses instead of doctors makes little or no difference in the numbers of prescriptions and tests ordered. However, the impacts on the amount of information offered to patients, on the extent to which guidelines are followed and on healthcare costs are uncertain."
}
] |
query-laysum
|
8121
|
[
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of a review of tramadol for neuropathic pain, published in 2006; updating was to bring the review in line with current standards. Neuropathic pain, which is caused by a lesion or disease affecting the somatosensory system, may be central or peripheral in origin. Peripheral neuropathic pain often includes symptoms such as burning or shooting sensations, abnormal sensitivity to normally painless stimuli, or an increased sensitivity to normally painful stimuli. Neuropathic pain is a common symptom in many diseases of the peripheral nervous system.\nObjectives\nTo assess the analgesic efficacy of tramadol compared with placebo or other active interventions for chronic neuropathic pain in adults, and the adverse events associated with its use in clinical trials.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase for randomised controlled trials from inception to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trial registries.\nSelection criteria\nWe included randomised, double-blind trials of two weeks' duration or longer, comparing tramadol (any route of administration) with placebo or another active treatment for neuropathic pain, with subjective pain assessment by the participant.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)), or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC). Where pooled analysis was possible, we used dichotomous data to calculate risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH), using standard methods. We assessed the quality of the evidence using GRADE and created 'Summary of findings' tables.\nMain results\nWe identified six randomised, double-blind studies involving 438 participants with suitably characterised neuropathic pain. In each, tramadol was started at a dose of about 100 mg daily and increased over one to two weeks to a maximum of 400 mg daily or the maximum tolerated dose, and then maintained for the remainder of the study. Participants had experienced moderate or severe neuropathic pain for at least three months due to cancer, cancer treatment, postherpetic neuralgia, peripheral diabetic neuropathy, spinal cord injury, or polyneuropathy. The mean age was 50 to 67 years with approximately equal numbers of men and women. Exclusions were typically people with other significant comorbidity or pain from other causes. Study duration for treatments was four to six weeks, and two studies had a cross-over design.\nNot all studies reported all the outcomes of interest, and there were limited data for pain outcomes. At least 50% pain intensity reduction was reported in three studies (265 participants, 110 events). Using a random-effects analysis, 70/132 (53%) had at least 50% pain relief with tramadol, and 40/133 (30%) with placebo; the risk ratio (RR) was 2.2 (95% confidence interval (CI) 1.02 to 4.6). The NNT calculated from these data was 4.4 (95% CI 2.9 to 8.8). We downgraded the evidence for this outcome by two levels to low quality because of the small size of studies and of the pooled data set, because there were only 110 actual events, the analysis included different types of neuropathic pain, the studies all had at least one high risk of potential bias, and because of the limited duration of the studies.\nParticipants experienced more adverse events with tramadol than placebo. Report of any adverse event was higher with tramadol (58%) than placebo (34%) (4 studies, 266 participants, 123 events; RR 1.6 (95% CI 1.2 to 2.1); NNH 4.2 (95% CI 2.8 to 8.3)). Adverse event withdrawal was higher with tramadol (16%) than placebo (3%) (6 studies, 485 participants, 45 events; RR 4.1 (95% CI 2.0 to 8.4); NNH 8.2 (95% CI 5.8 to 14)). Only four serious adverse events were reported, without obvious attribution to treatment, and no deaths were reported. We downgraded the evidence for this outcome by two or three levels to low or very low quality because of small study size, because there were few actual events, and because of the limited duration of the studies.\nAuthors' conclusions\nThere is only modest information about the use of tramadol in neuropathic pain, coming from small, largely inadequate studies with potential risk of bias. That bias would normally increase the apparent benefits of tramadol. The evidence of benefit from tramadol was of low or very low quality, meaning that it does not provide a reliable indication of the likely effect, and the likelihood is very high that the effect will be substantially different from the estimate in this systematic review.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three small studies reported that pain was reduced by half or better in some people. Pain reduction by half or better was experienced by 5 in 10 with tramadol and 3 in 10 with placebo. Side effects were experienced by 6 in 10 with tramadol and 3 in 10 with placebo, and 2 in 10 with tramadol and almost no-one with placebo stopped taking the medicine because of side effects."
}
] |
query-laysum
|
8122
|
[
{
"role": "user",
"content": "Abstract: Background\nAnophthalmia is the absence of one or both eyes, and it can be congenital (i.e. a birth defect) or acquired later in life. There are two main types of orbital implant: integrated, whereby the implant receives a blood supply from the body that allows for the integration of the prosthesis within the tissue; and non-integrated, where the implant remains separate. Despite the remarkable progress in anophthalmic socket reconstruction and in the development of various types of implants, there are still uncertainties about the real roles of integrated (hydroxyapatite (HA), porous polyethylene (PP), composites) and non-integrated (polymethylmethacrylate (PMMA)/acrylic and silicone) orbital implants in anophthalmic socket treatment.\nObjectives\nTo assess the effects of integrated versus non-integrated orbital implants for treating anophthalmic sockets.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2016), Embase (January 1980 to August 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to August 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 did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 8 August 2016.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs of integrated and non-integrated orbital implants for treating anophthalmic sockets.\nData collection and analysis\nTwo authors independently selected relevant trials, assessed methodological quality and extracted data.\nMain results\nWe included three studies with a total of 284 participants (250 included in analysis). The studies were conducted in India, Iran and the Netherlands. The three studies were clinically heterogenous, comparing different materials and using different surgical techniques. None of the included studies used a peg (i.e. a fixing pin used to connect the implant to the prosthesis). In general the trials were poorly reported, and we judged them to be at unclear risk of bias.\nOne trial compared HA using traditional enucleation versus alloplastic implantation using evisceration (N = 100). This trial was probably not masked. The second trial compared PP with scleral cap enucleation versus PMMA with either myoconjunctival or traditional enucleation (N = 150). Although participants were not masked, outcome assessors were. The last trial compared HA and acrylic using the enucleation technique (N = 34) but did not report comparative effectiveness data.\nIn the trial comparing HA versus alloplastic implantation, there was no evidence of any difference between the two groups with respect to the proportion of successful procedures at one year (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.95 to 1.09, N = 100, low-certainty evidence). People receiving HA had slightly worse horizontal implant mobility compared to the alloplastic group (mean difference (MD) −3.35 mm, 95% CI −4.08 to −2.62, very low-certainty evidence) and slightly worse vertical implant motility (MD −2.76 mm, 95% CI −3.45 to −2.07, very low-certainty evidence). As different techniques were used – enucleation versus evisceration – it is not clear whether these differences in implant motility can be attributed solely to the type of material. Investigators did not report adverse events.\nIn the trial comparing PP versus PMMA, there was no evidence of any difference between the two groups with respect to the proportion of successful procedures at one year (RR 0.92, 95% CI 0.84 to 1.01, N = 150, low-certainty evidence). There was very low-certainty evidence of a difference in horizontal implant motility depending on whether PP was compared to PMMA with traditional enucleation (MD 1.96 mm, 95% CI 1.01 to 2.91) or PMMA with myoconjunctival enucleation (−0.57 mm, 95% CI −1.63 to 0.49). Similarly, for vertical implant motility, there was very low-certainty evidence of a difference in the comparison of PP to PMMA traditional (MD 3.12 mm 95% CI 2.36 to 3.88) but no evidence of a difference when comparing PP to PMMA myoconjunctival (MD −0.20 mm 95% CI −1.28 to 0.88). Four people in the PP group (total N = 50) experienced adverse events (i.e. exposures) compared to 6/100 in the PMMA groups (RR 17.82, 95% CI 0.98 to 324.67, N = 150, very low-certainty evidence).\nNone of the studies reported socket sphere size, cosmetic effect or quality of life measures.\nAuthors' conclusions\nCurrent very low-certainty evidence from three small published randomised controlled trials did not provide sufficient evidence to assess the effect of integrated and non-integrated material orbital implants for treating anophthalmic sockets. This review underlines the need to conduct further well-designed trials in this field.\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": "The type of material used for the orbital implant may not affect the success of the surgery (low-certainty evidence). The review authors judged the evidence on prosthesis movement and adverse effects as providing very little certainty about the true effects. There was no information on quality of life."
}
] |
query-laysum
|
8123
|
[
{
"role": "user",
"content": "Abstract: Background\nEtanercept is a soluble tumour necrosis factor alpha-receptor disease-modifying anti-rheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).\nObjectives\nThe purpose of this review was to update the previous Cochrane systematic review published in 2003 assessing the benefits and harms of etanercept for the treatment of RA. In addition, we also evaluated the benefits and harms of etanercept plus DMARD compared with DMARD monotherapy in those people with RA who are partial responders to methotrexate (MTX) or any other traditional DMARD.\nSearch methods\nFive electronic databases were searched from 1966 to February 2003 with no language restriction. The search was updated to January 2012. Attempts were made to identify other studies by contact with experts, searching reference lists and searching trial registers.\nSelection criteria\nAll controlled trials (minimum 24 weeks' duration) comparing four possible combinations: 1) etanercept (10 mg or 25 mg twice weekly) plus a traditional DMARD (either MTX or sulphasalazine) versus a DMARD, 2) etanercept plus DMARD versus etanercept alone, 3) etanercept alone versus a DMARD or 4) etanercept versus placebo.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of the trials.\nMain results\nThree trials were included in the original version of the review. An additional six trials, giving a total of 2842 participants, were added to the 2012 update of the review. The trials were generally of moderate to low risk of bias, the majority funded by pharmaceutical companies. Follow-up ranged from six months to 36 months.\nBenefit\nAt six to 36 months the American College of Rheumatology (ACR) 50 response rate was statistically significantly improved with etanercept plus DMARD treatment when compared with a DMARD in those people who had an inadequate response to any traditional DMARD (risk ratio (RR) 2.0; 95% confidence interval (CI) 1.3 to 2.9, absolute treatment benefit (ATB) 38%; 95% CI 13% to 59%) and in those people who were partial responders to MTX (RR 11.7; 95% CI 1.7 to 82.5, ATB 36%). Similar results were observed when pooling data from all participants (responders or not) (ACR 50 response rates at 24 months: RR 1.9; 95% CI 1.3 to 2.8, ATB 29%; 36 months: RR 1.6; 95% CI 1.3 to 1.9, ATB 24%). Statistically significant improvement in physical function and a higher proportion of disease remission were observed in combination-treated participants compared with DMARDs alone ((mean difference (MD) -0.36; 95% CI -0.43 to -0.28 in a 0-3 scale) and (RR 1.92; 95% CI 1.60 to 2.31), respectively) in those people who had an inadequate response to any traditional DMARD. All changes in radiographic scores were statistically significantly less with combination treatment (etanercept plus DMARD) compared with MTX alone for all participants (responders or not) (Total Sharp Score (TSS) (scale = 0 to 448): MD -2.2, 95% CI -3.0 to -1.4; Erosion Score (ES) (scale = 0 to 280): MD -1.6; 95% CI -2.4 to -0.9; Joint Space Narrowing Score (JSNS) (scale = 0 to 168): MD -0.7; 95% CI -1.1 to -0.2), and with combination treatment compared with etanercept alone (TSS: MD -1.1; 95% CI -1.8 to -0.5; ES: MD -0.7; 95% CI -1.1 to -0.2; JSNS: MD -0.5, 95% CI -0.7 to -0.2). The estimate of irreversible physical disability over 10 years given the radiographic findings was 0.45 out of 3.0.\nWhen etanercept monotherapy was compared with DMARD monotherapy, there was generally no evidence of a difference in ACR50 response rates when etanercept 10 mg or 25 mg was used; at six months etanercept 25 mg was significantly more likely to achieve ACR50 than DMARD monotherapy but this difference was not found at 12, 24 or 36 months. TSS and ES radiographic scores were statistically significantly improved with etanercept 25 mg monotherapy compared with DMARD (TSS: MD -0.7; 95% CI -1.4 to 0.1; ES: MD -0.7; 95% CI -1.0 to -0.3) but there was no evidence of a statistically significant difference between etanercept 10 mg monotherapy and MTX.\nHarms\nThere was no evidence of statistically significant differences in infections or serious infections between etanercept plus DMARD and DMARD alone at any point in time. Infection rates were higher in people receiving etanercept monotherapy compared with DMARD; however, there were no differences regarding serious infections. For those participants who had an inadequate response to DMARDs, the rate of total withdrawals was lower for the etanercept plus DMARD group compared with DMARD alone (RR 0.53; 95% CI 0.36 to 0.77, ATB 18%). No other statistically significant differences were observed in any of the assessed comparisons.\nAuthors' conclusions\nEtanercept 25 mg administered subcutaneously twice weekly together with MTX was more efficacious than either etanercept or MTX monotherapy for ACR50 and it slowed joint radiographic progression after up to three years of treatment for all participants (responders or not). There was no evidence of a difference in the rates of infections between groups.\n\nGiven the provided abstract, please respond to the following query: \"What happens to people with rheumatoid arthritis who take etanercept plus traditional DMARDs (methotrexate or sulphasalazine) after they have NOT improved with traditional DMARDs alone\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
8124
|
[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease is a genetic disorder involving a defect in the red blood cells due to its sickled hemoglobin. The main therapeutic interventions include preventive and supportive measures. Hematopoietic stem cell transplantations are carried out with the aim of replacing the defective cells and their progenitors (hematopoietic (i.e. blood forming) stem cells) in order to correct the disorder. This is an update of a previously published review.\nObjectives\nTo determine whether stem cell transplantation can improve survival and prevent symptoms and complications associated with sickle cell disease. To examine the risks of stem cell transplantation against the potential long-term gain for people with sickle cell disease.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Group's Haemoglobinopathies Trials Register complied from electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (updated each new issue of the Cochrane Library) and quarterly searches of MEDLINE. We also searched trial registries for ongoing trials up to April 2020.\nDate of the most recent search of the Group's Haemoglobinopathies Trials Register: 09 December 2019.\nSelection criteria\nRandomized controlled and quasi-randomized trials that compared any method of stem cell transplantation with either each other or with any of the preventive or supportive interventions (e.g. periodic blood transfusion, use of hydroxyurea, antibiotics, pain relievers, supplemental oxygen) in people with sickle cell disease irrespective of the type of sickle cell disease, gender and setting.\nData collection and analysis\nNo trials were eligible for inclusion in the review.\nMain results\nWe identified 12 potentially-eligible trials by the searches; we excluded 11 of these and the remaining trial is an ongoing trial that may be eligible for inclusion in a future version of the review.\nAuthors' conclusions\nReports on the use of hematopoietic stem cell transplantation improving survival and preventing symptoms and complications associated with sickle cell disease are currently limited to observational and other less robust studies. We did not find any eligible randomized controlled trials assessing the benefit or risk of hematopoietic stem cell transplantations. However, there is an ongoing quasi-randomized trial comparing hematopoietic stem cell transplantation with standard care, Thus, this systematic review identifies the need for a multicentre randomized controlled trial assessing the benefits and possible risks of hematopoietic stem cell transplantations comparing sickle status and severity of disease in people with sickle cell disease.\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": "Sickle cell disease is a genetic disorder mainly characterized by the presence of deformed, sickle-shaped red blood cells in the blood stream. These cells deprive tissues of blood and oxygen resulting in periodic and recurrent painful attacks. Complications include acute chest syndrome and stroke. Although sickle cell disease is responsive to preventive and supportive measures such as the use of prophylactic antibodies and periodic blood transfusion, these do not provide a cure. The use of hematopoietic (blood forming) stem cell transplantation involves replacing the deformed red blood cells and its stem cells with stem cells from a healthy donor thereby producing normal red blood cells. These stem cells can be derived from either the bone marrow or blood (umbilical cord blood or peripheral blood) of a healthy individual. This is an update of a previously published review."
}
] |
query-laysum
|
8125
|
[
{
"role": "user",
"content": "Abstract: Background\nRheumatoid arthritis is a systemic auto-immune disorder that causes widespread and persistent inflammation of the synovial lining of joints and tendon sheaths. Presently, there is no cure for rheumatoid arthritis and treatment focuses on managing symptoms such as pain, stiffness and mobility, with the aim of achieving stable remission and improving mobility. Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID) used for treatment of people with rheumatoid arthritis.\nObjectives\nTo assess the benefits and harms of celecoxib in people with rheumatoid arthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trials registers (ClinicalTrials.gov and the World Health Organization trials portal) to May 18, 2017. We also searched the reference and citation lists of included studies.\nSelection criteria\nWe included prospective randomized controlled trials (RCTs) that compared oral celecoxib (200 mg and 400 mg daily) versus no intervention, placebo or a traditional NSAID (tNSAID) in people with confirmed rheumatoid arthritis, of any age and either sex. We excluded studies with fewer than 50 participants in each arm or had durations of fewer than four weeks treatment.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included eight RCTs with durations of 4 to 24 weeks, published between 1998 and 2014 that involved a total of 3988 adults (mean age = 54 years), most of whom were women (73%). Participants had rheumatoid arthritis for an average of 9.2 years. All studies were assessed at high or unclear risk of bias in at least one domain. Overall, evidence was assessed as moderate-to-low quality. Five studies were funded by pharmaceutical companies.\nCelecoxib versus placebo\nWe included two studies (N = 873) in which participants received 200 mg daily or 400 mg daily or placebo. Participants who received celecoxib showed significant clinical improvement compared with those receiving placebo (15% absolute improvement; 95% CI 7% to 25%; RR 1.53, 95% CI 1.25 to 1.86; number needed to treat to benefit (NNTB) = 7, 95% CI 5 to 13; 2 studies, 873 participants; moderate to low quality evidence).\nParticipants who received celecoxib reported less pain than placebo-treated people (11% absolute improvement; 95% CI 8% to 14%; NNTB = 4, 95% CI 3 to 6; 1 study, 706 participants) but results were inconclusive for improvement in physical function (MD -0.10, 95% CI 0.29 to 0.10; 1 study, 706 participants).\nIn the celecoxib group, 15/293 participants developed ulcers, compared with 4/99 in the placebo group (Peto OR 1.26, 95% CI 0.44 to 3.63; 1 study, 392 participants; low quality evidence). Nine (of 475) participants in the celecoxib group developed short-term serious adverse events, compared with five (of 231) in the placebo group (Peto OR 0.87 (0.28 to 2.69; 1 study, 706 participants; low quality evidence).\nThere were fewer withdrawals among people who received celecoxib (163/475) compared with placebo (130/231) (22% absolute change; 95% CI 16% to 27%; RR 0.61, 95% CI 0.52 to 0.72; 1 study, 706 participants).\nCardiovascular events (myocardial infarction, stroke) were not reported. However, regulatory agencies warn of increased cardiovascular event risk associated with celecoxib.\nCelecoxib versus tNSAIDs\nSeven studies (N = 2930) compared celecoxib and tNSAIDs (amtolmetin guacyl, diclofenac, ibuprofen, meloxicam, nabumetone, naproxen, pelubiprofen); one study included comparisons of both placebo and tNSAIDs (N = 1149).\nThere was a small improvement, which may not be clinically significant, in numbers of participants achieving ACR20 criteria response in the celecoxib group compared to tNSAIDs (4% absolute improvement; 95% CI 0% less improvement to 8% more improvement; RR 1.10, 95% CI 0.99 to 1.23; 4 studies, 1981 participants). There was a lack of evidence of difference between participants in the celecoxib and tNSAID groups in terms of pain or physical function. Results were assessed at moderate-to-low quality evidence (downgraded due to risk of bias and inconsistency).\nPeople who received celecoxib had a lower incidence of gastroduodenal ulcers ≥ 3 mm (34/870) compared with those who received tNSAIDs (116/698). This corresponded to 12% absolute change (95% CI 11% to 13%; RR 0.22, 95% CI 0.15 to 0.32; 5 studies, 1568 participants; moderate quality evidence). There were 7% fewer withdrawals among people who received celecoxib (95% CI 4% to 9%; RR 0.73, 95% CI 0.62 to 0.86; 6 studies, 2639 participants).\nResults were inconclusive for short-term serious adverse events and cardiovascular events (low quality evidence). There were 17/918 serious adverse events in people taking celecoxib compared to 42/1236 among people who received placebo (Peto OR 0.71; 95% CI 0.39 to 1.28; 5 studies, 2154 participants). Cardiovascular events were reported in both celecoxib and placebo groups in one study (149 participants).\nAuthors' conclusions\nCelecoxib may improve clinical symptoms, alleviate pain and contribute to little or no difference in physical function compared with placebo. Celecoxib was associated with fewer numbers of participant withdrawals. Results for incidence of gastroduodenal ulcers (≥ 3 mm) and short-term serious adverse events were uncertain; however, there were few reported events for either.\nCelecoxib may slightly improve clinical symptoms compared with tNSAIDs. Results for reduced pain and improved physical function were uncertain. Particpants taking celecoxib had lower incidence of gastroduodenal ulcers (≥ 3 mm) and there were fewer withdrawals from trials. Results for cardiovascular events and short-term serious adverse events were also uncertain.\nUncertainty about the rate of cardiovascular events between celecoxib and tNSAIDs could be due to risk of bias; another factor is that these were small, short-term trials. It has been reported previously that both celecoxib and tNSAIDs increase cardiovascular event rates. Our confidence in results about harms is therefore low. Larger head-to-head clinical trials comparing celecoxib to other tNSAIDs is needed to better inform clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included eight studies published between 1998 and 2014 that involved 3988 adults (average age 54 years), most of whom were women (73%). Participants had rheumatoid arthritis for an average of 9.2 years.\nStudies compared celecoxib with another treatment; 1786 participants received celecoxib and 2202 received either placebo or a traditional NSAID (tNSAID).\nFive studies were supported or funded by the pharmaceutical industry."
}
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query-laysum
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8126
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[
{
"role": "user",
"content": "Abstract: Background\nNasal continuous positive airway pressure (NCPAP) is a strategy to maintain positive airway pressure throughout the respiratory cycle through the application of a bias flow of respiratory gas to an apparatus attached to the nose. Early treatment with NCPAP is associated with decreased risk of mechanical ventilation exposure and might reduce chronic lung disease. Nasal intermittent positive pressure ventilation (NIPPV) is a form of noninvasive ventilation delivered through the same nasal interface during which patients are exposed to short inflations, along with background end-expiratory pressure.\nObjectives\nTo examine the risks and benefits of early (within the first six hours after birth) NIPPV versus early NCPAP for preterm infants at risk of or with respiratory distress syndrome (RDS).\nPrimary endpoints are respiratory failure and the need for intubated ventilatory support during the first week of life. Secondary endpoints include the incidence of mortality, chronic lung disease (CLD) (oxygen therapy at 36 weeks' postmenstrual age), pneumothorax, duration of respiratory support, duration of oxygen therapy, and intraventricular hemorrhage (IVH).\nSearch methods\nSearches were conducted in January 2023 in CENTRAL, MEDLINE, Embase, Web of Science, and Dissertation Abstracts. The reference lists of related systematic reviews and of studies selected for inclusion were also searched.\nSelection criteria\nWe considered all randomized and quasi-randomized controlled trials. Eligible studies compared NIPPV versus NCPAP treatment, starting within six hours after birth in preterm infants (< 37 weeks' gestational age (GA)).\nData collection and analysis\nWe collected and analyzed data using the recommendations of the Cochrane Neonatal Review Group.\nMain results\nWe included 17 trials, enrolling 1958 infants in this review. NIPPV likely reduces the rate of respiratory failure (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.54 to 0.78; risk difference (RD) -0.08, 95% CI -0.12 to -0.05; 17 RCTs, 1958 infants; moderate-certainty evidence) and needing endotracheal tube ventilation (RR 0.67, 95% CI 0.56 to 0.81; RD -0.07, 95% CI -0.11 to -0.04; 16 RCTs; 1848 infants; moderate-certainty evidence) amongst infants treated with early NIPPV compared with early NCPAP.\nThe meta-analysis demonstrated that NIPPV may reduce the risk of developing CLD compared to CPAP (RR 0.70, 95% CI 0.52 to 0.92; 12 RCTs, 1284 infants; low-certainty evidence) slightly. NIPPV may result in little to no difference in mortality (RR 0.82, 95% CI 0.62 to 1.10; 17 RCTs; 1958 infants; I2 of 0%; low-certainty evidence), the incidence of pneumothorax (RR 0.92, 95% CI 0.60 to 1.41; 16 RCTs; 1674 infants; I2 of 0%; low-certainty evidence), and rates of severe IVH (RR 0.98, 95% CI 0.53 to 1.79; 8 RCTs; 977 infants; I2 of 0%; low-certainty evidence).\nAuthors' conclusions\nWhen applied within six hours after birth, NIPPV likely reduces the risk of respiratory failure and the need for intubation and endotracheal tube ventilation in very preterm infants (GA 28 weeks and above) with respiratory distress syndrome or at risk for RDS. It may also decrease the rate of CLD slightly. However, most trials enrolled infants with a gestational age of approximately 28 to 32 weeks with an overall mean gestational age of around 30 weeks. As such, the results of this review may not apply to extremely preterm infants that are most at risk of needing mechanical ventilation or developing CLD. Additional studies are needed to confirm these results and to assess the safety of NIPPV compared with NCPAP alone in a larger patient population.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Does NIPPV confer greater short-term and long-term benefits without harm to preterm infants with or at risk of respiratory distress compared with NCPAP?"
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query-laysum
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8127
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[
{
"role": "user",
"content": "Abstract: Background\nAlthough highly effective in the treatment of obstructive sleep apnoea (OSA), continuous positive airway pressure (CPAP) is not universally accepted by users. Educational, supportive and behavioural interventions may help people with OSA initiate and maintain regular and continued use of CPAP.\nObjectives\nTo assess the effectiveness of educational, supportive, behavioural, or mixed (combination of two or more intervention types) strategies that aim to encourage adults who have been prescribed CPAP to use their devices.\nSearch methods\nSearches were conducted on the Cochrane Airways Group Specialised Register of trials. Searches are current to 29 April 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) that assessed intervention(s) designed to inform participants about CPAP/OSA, to support them in using CPAP, or to modify their behaviour to increase use of CPAP devices.\nData collection and analysis\nWe assessed studies to determine their suitability for inclusion in the review. Data were extracted independently and were entered into RevMan for analysis. 'Risk of bias' assessments were performed, using the updated 'Risk of bias 2' tool, for the primary outcome, CPAP usage. Study-level 'Risk of bias' assessments were performed using the original 'Risk of bias' tool. GRADE assessment was performed using GRADEpro.\nMain results\nForty-one studies (9005 participants) are included in this review; 16 of these studies are newly identified with updated searches. Baseline Epworth Sleepiness Scale (ESS) scores indicate that most participants suffered from excessive daytime sleepiness. The majority of recruited participants had not used CPAP previously. When examining risk of bias for the primary outcome of hourly machine usage/night, 58.3% studies have high overall risk (24/41 studies), 39.0% have some concerns (16/41 studies), and 2.4% have low overall risk (1/41 studies).\nWe are uncertain whether educational interventions improve device usage, as the certainty of evidence was assessed as very low. We were unable to perform meta-analyses for number of withdrawals and symptom scores due to high study heterogeneity.\nSupportive interventions probably increase device usage by 0.70 hours/night (95% confidence interval (CI) 0.36 to 1.05, N = 1426, 13 studies, moderate-certainty evidence), and low-certainty evidence indicates that the number of participants who used their devices ≥ 4 hours/night may increase from 601 to 717 per 1000 (odds ratio (OR), 1.68, 95% CI 1.08 to 2.60, N = 376, 2 studies). However, the number of withdrawals may also increase from 136 to 167 per 1000 (OR 1.27, 95% CI 0.97 to 1.66, N = 1702, 11 studies, low-certainty evidence). Participants may experience small improvements in symptoms (ESS score -0.32 points, 95% CI -1.19 to 0.56, N = 470, 5 studies, low-certainty evidence), and we are uncertain whether quality of life improves with supportive interventions, as the certainty of evidence was assessed as very low.\nWhen compared with usual care, behavioural interventions produce a clinically-meaningful increase in device usage by 1.31 hours/night (95% CI 0.95 to 1.66, N = 578, 8 studies, high-certainty evidence), probably increase the number of participants who used their machines ≥ 4 hours/night from 371 to 501 per 1000 (OR 1.70, 95% CI 1.20 to 2.41, N = 549, 6 studies, high-certainty evidence), and reduce the number of study withdrawals from 146 to 101 per 1000 (OR 0.66, 95% CI 0.44 to 0.98, N = 939, 10 studies, high-certainty evidence). Behavioural interventions may reduce symptoms (ESS score -2.42 points, 95% CI -4.27 to -0.57, N = 272, 5 studies, low-certainty evidence), but probably have no effect on quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ), standardised mean difference (SMD) 0.00, 0.95% CI -0.26 to 0.26, N = 228, 3 studies, moderate-certainty evidence). We are uncertain whether behavioural interventions improve apnoea hypopnoea index (AHI), as the certainty of evidence was assessed as very low.\nWe are uncertain if mixed interventions improve device usage, increase the number of participants using their machines ≥ 4 hours/night, reduce study withdrawals, improve quality of life, or reduce anxiety symptoms, as the certainty of evidence for these outcomes was assessed to be very low. Symptom scores via the ESS could not be measured due to considerable heterogeneity between studies.\nAuthors' conclusions\nIn CPAP-naïve people with OSA, high-certainty evidence indicates that behavioural interventions yield a clinically-significant increase in hourly device usage when compared with usual care. Moderate certainty evidence shows that supportive interventions increase usage modestly. Very low-certainty evidence shows that educational and mixed interventions may modestly increase CPAP usage. The impact of improved CPAP usage on daytime sleepiness, quality of life, and mood and anxiety scores remains unclear since these outcomes were not assessed in the majority of included studies. Studies addressing the choice of interventions that best match individual patient needs and therefore result in the most successful and cost-effective therapy are needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We already know that CPAP treats OSA effectively in most people by improving symptoms resulting from OSA. However many people do not use their CPAP machine as much as is recommended. We wanted to look at interventions designed to educate and motivate people with OSA to use their CPAP machines more."
}
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query-laysum
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8128
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[
{
"role": "user",
"content": "Abstract: Background\nAsthma is a respiratory disease characterised by variable airflow limitation and the presence of respiratory symptoms including wheeze, chest tightness, cough and/or dyspnoea. Exercise training is beneficial for people with asthma; however, the response to conventional models of pulmonary rehabilitation is less clear.\nObjectives\nTo evaluate, in adults with asthma, the effectiveness of pulmonary rehabilitation compared to usual care on exercise performance, asthma control, and quality of life (co-primary outcomes), incidence of severe asthma exacerbations/hospitalisations, mental health, muscle strength, physical activity levels, inflammatory biomarkers, and adverse events.\nSearch methods\nWe identified studies from the Cochrane Airways Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform, from their inception to May 2021, as well as the reference lists of all primary studies and review articles.\nSelection criteria\nWe included randomised controlled trials in which pulmonary rehabilitation was compared to usual care in adults with asthma. Pulmonary rehabilitation must have included a minimum of four weeks (or eight sessions) aerobic training and education or self-management. Co-interventions were permitted; however, exercise training alone was not.\nData collection and analysis\nFollowing the use of Cochrane's Screen4Me workflow, two review authors independently screened and selected trials for inclusion, extracted study characteristics and outcome data, and assessed risk of bias using the Cochrane risk of bias tool. We contacted study authors to retrieve missing data. We calculated between-group effects via mean differences (MD) or standardised mean differences (SMD) using a random-effects model. We evaluated the certainty of evidence using GRADE methodology.\nMain results\nWe included 10 studies involving 894 participants (range 24 to 412 participants (n = 2 studies involving n > 100, one contributing to meta-analysis), mean age range 27 to 54 years). We identified one ongoing study and three studies awaiting classification. One study was synthesised narratively, and another involved participants specifically with asthma-COPD overlap. Most programmes were outpatient-based, lasting from three to four weeks (inpatient) or eight to 12 weeks (outpatient). Education or self-management components included breathing retraining and relaxation, nutritional advice and psychological counselling. One programme was specifically tailored for people with severe asthma.\nPulmonary rehabilitation compared to usual care may increase maximal oxygen uptake (VO2 max) after programme completion, but the evidence is very uncertain for data derived using mL/kg/min (MD between groups of 3.63 mL/kg/min, 95% confidence interval (CI) 1.48 to 5.77; 3 studies; n = 129) and uncertain for data derived from % predicted VO2 max (MD 14.88%, 95% CI 9.66 to 20.1%; 2 studies; n = 60). The evidence is very uncertain about the effects of pulmonary rehabilitation compared to usual care on incremental shuttle walk test distance (MD between groups 74.0 metres, 95% CI 26.4 to 121.4; 1 study; n = 30). Pulmonary rehabilitation may have little to no effect on VO2 max at longer-term follow up (9 to 12 months), but the evidence is very uncertain (MD −0.69 mL/kg/min, 95% CI −4.79 to 3.42; I2 = 49%; 3 studies; n = 66).\nPulmonary rehabilitation likely improves functional exercise capacity as measured by 6-minute walk distance, with MD between groups after programme completion of 79.8 metres (95% CI 66.5 to 93.1; 5 studies; n = 529; moderate certainty evidence). This magnitude of mean change exceeds the minimally clinically important difference (MCID) threshold for people with chronic respiratory disease. The evidence is very uncertain about the longer-term effects one year after pulmonary rehabilitation for this outcome (MD 52.29 metres, 95% CI 0.7 to 103.88; 2 studies; n = 42).\nPulmonary rehabilitation may result in a small improvement in asthma control compared to usual care as measured by Asthma Control Questionnaire (ACQ), with an MD between groups of −0.46 (95% CI −0.76 to −0.17; 2 studies; n = 93; low certainty evidence); however, data derived from the Asthma Control Test were very uncertain (MD between groups 3.34, 95% CI −2.32 to 9.01; 2 studies; n = 442). The ACQ finding approximates the MCID of 0.5 points. Pulmonary rehabilitation results in little to no difference in asthma control as measured by ACQ at nine to 12 months follow-up (MD 0.09, 95% CI −0.35 to 0.53; 2 studies; n = 48; low certainty evidence).\nPulmonary rehabilitation likely results in a large improvement in quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ) total score (MD −18.51, 95% CI −20.77 to −16.25; 2 studies; n = 440; moderate certainty evidence), with this magnitude of change exceeding the MCID. However, pulmonary rehabilitation may have little to no effect on Asthma Quality of Life Questionnaire (AQLQ) total scores, with the evidence being very uncertain (MD 0.87, 95% CI −0.13 to 1.86; 2 studies; n = 442). Longer-term follow-up data suggested improvements in quality of life may occur as measured by SGRQ (MD −13.4, 95% CI −15.93 to −10.88; 2 studies; n = 430) but not AQLQ (MD 0.58, 95% CI −0.23 to 1.38; 2 studies; n = 435); however, the evidence is very uncertain.\nOne study reported no difference between groups in the proportion of participants who experienced an asthma exacerbation during the intervention period. Data from one study suggest adverse events attributable to the intervention are rare.\nOverall risk of bias was most commonly impacted by performance bias attributed to a lack of participant blinding to knowledge of the intervention. This is inherently challenging to overcome in rehabilitation studies.\nAuthors' conclusions\nModerate certainty evidence shows that pulmonary rehabilitation is probably associated with clinically meaningful improvements in functional exercise capacity and quality of life upon programme completion in adults with asthma. The certainty of evidence relating to maximal exercise capacity was very low to low. Pulmonary rehabilitation appears to confer minimal effect on asthma control, although the certainty of evidence is very low to low. Unclear reporting of study methods and small sample sizes limits our certainty in the overall body of evidence, whilst heterogenous study designs and interventions likely contribute to inconsistent findings across clinical outcomes and studies. There remains considerable scope for future research.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared pulmonary rehabilitation to usual care in adults with asthma. Treatment must have lasted at least four weeks (or eight or more sessions) and must have included aerobic exercises (such as walking or cycling) and education or self-management.\nWe compared and summarised findings across all eligible studies and rated our confidence in the evidence based on factors such as study methods and size."
}
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query-laysum
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8129
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[
{
"role": "user",
"content": "Abstract: Background\nAdults spend a majority of their time outside the workplace being sedentary. Large amounts of sedentary behaviour increase the risk of type 2 diabetes, cardiovascular disease, and both all-cause and cardiovascular disease mortality.\nObjectives\nPrimary\n• To assess effects on sedentary time of non-occupational interventions for reducing sedentary behaviour in adults under 60 years of age\nSecondary\n• To describe other health effects and adverse events or unintended consequences of these interventions\n• To determine whether specific components of interventions are associated with changes in sedentary behaviour\n• To identify if there are any differential effects of interventions based on health inequalities (e.g. age, sex, income, employment)\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Cochrane Database of Systematic Reviews, CINAHL, PsycINFO, SportDiscus, and ClinicalTrials.gov on 14 April 2020. We checked references of included studies, conducted forward citation searching, and contacted authors in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster RCTs of interventions outside the workplace for community-dwelling adults aged 18 to 59 years. We included studies only when the intervention had a specific aim or component to change sedentary behaviour.\nData collection and analysis\nTwo review authors independently screened titles/abstracts and full-text articles for study eligibility. Two review authors independently extracted data and assessed risk of bias. We contacted trial authors for additional information or data when required. We examined the following primary outcomes: device-measured sedentary time, self-report sitting time, self-report TV viewing time, and breaks in sedentary time.\nMain results\nWe included 13 trials involving 1770 participants, all undertaken in high-income countries. Ten were RCTs and three were cluster RCTs. The mean age of study participants ranged from 20 to 41 years. A majority of participants were female. All interventions were delivered at the individual level. Intervention components included personal monitoring devices, information or education, counselling, and prompts to reduce sedentary behaviour. We judged no study to be at low risk of bias across all domains. Seven studies were at high risk of bias for blinding of outcome assessment due to use of self-report outcomes measures.\nPrimary outcomes\nInterventions outside the workplace probably show little or no difference in device-measured sedentary time in the short term (mean difference (MD) -8.36 min/d, 95% confidence interval (CI) -27.12 to 10.40; 4 studies; I² = 0%; moderate-certainty evidence). We are uncertain whether interventions reduce device-measured sedentary time in the medium term (MD -51.37 min/d, 95% CI -126.34 to 23.59; 3 studies; I² = 84%; very low-certainty evidence)\nWe are uncertain whether interventions outside the workplace reduce self-report sitting time in the short term (MD -64.12 min/d, 95% CI -260.91 to 132.67; I² = 86%; very low-certainty evidence).\nInterventions outside the workplace may show little or no difference in self-report TV viewing time in the medium term (MD -12.45 min/d, 95% CI -50.40 to 25.49; 2 studies; I² = 86%; low-certainty evidence) or in the long term (MD 0.30 min/d, 95% CI -0.63 to 1.23; 2 studies; I² = 0%; low-certainty evidence).\nIt was not possible to pool the five studies that reported breaks in sedentary time given the variation in definitions used.\nSecondary outcomes\nInterventions outside the workplace probably have little or no difference on body mass index in the medium term (MD -0.25 kg/m², 95% CI -0.48 to -0.01; 3 studies; I² = 0%; moderate-certainty evidence). Interventions may have little or no difference in waist circumference in the medium term (MD -2.04 cm, 95% CI -9.06 to 4.98; 2 studies; I² = 65%; low-certainty evidence).\nInterventions probably have little or no difference on glucose in the short term (MD -0.18 mmol/L, 95% CI -0.30 to -0.06; 2 studies; I² = 0%; moderate-certainty evidence) and medium term (MD -0.08 mmol/L, 95% CI -0.21 to 0.05; 2 studies, I² = 0%; moderate-certainty evidence)\nInterventions outside the workplace may have little or no difference in device-measured MVPA in the short term (MD 1.99 min/d, 95% CI -4.27 to 8.25; 4 studies; I² = 23%; low-certainty evidence). We are uncertain whether interventions improve device-measured MVPA in the medium term (MD 6.59 min/d, 95% CI -7.35 to 20.53; 3 studies; I² = 70%; very low-certainty evidence).\nWe are uncertain whether interventions outside the workplace improve self-reported light-intensity PA in the short-term (MD 156.32 min/d, 95% CI 34.34 to 278.31; 2 studies; I² = 79%; very low-certainty evidence).\nInterventions may have little or no difference on step count in the short-term (MD 226.90 steps/day, 95% CI -519.78 to 973.59; 3 studies; I² = 0%; low-certainty evidence)\nNo data on adverse events or symptoms were reported in the included studies.\nAuthors' conclusions\nInterventions outside the workplace to reduce sedentary behaviour probably lead to little or no difference in device-measured sedentary time in the short term, and we are uncertain if they reduce device-measured sedentary time in the medium term. We are uncertain whether interventions outside the workplace reduce self-reported sitting time in the short term. Interventions outside the workplace may result in little or no difference in self-report TV viewing time in the medium or long term. The certainty of evidence is moderate to very low, mainly due to concerns about risk of bias, inconsistent findings, and imprecise results. Future studies should be of longer duration; should recruit participants from varying age, socioeconomic, or ethnic groups; and should gather quality of life, cost-effectiveness, and adverse event data. We strongly recommend that standard methods of data preparation and analysis are adopted to allow comparison of the effects of interventions to reduce sedentary behaviour.\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": "Adults spend most of their time outside of their workplace being sedentary, for example, sitting while watching TV or using a computer, or travelling to and from work in a car. Prolonged sedentary behaviour has been linked with increased risk of several diseases and premature death. We do not yet know if interventions to reduce sedentary behaviour outside the workplace are effective. This review will tell us whether there is evidence that these interventions reduce sedentary behaviour."
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query-laysum
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8130
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[
{
"role": "user",
"content": "Abstract: Background\nBronchiectasis is a chronic respiratory disease characterised by abnormal and irreversible dilatation and distortion of the smaller airways. Bacterial colonisation of the damaged airways leads to chronic cough and sputum production, often with breathlessness and further structural damage to the airways. Long-term macrolide antibiotic therapy may suppress bacterial infection and reduce inflammation, leading to fewer exacerbations, fewer symptoms, improved lung function, and improved quality of life. Further evidence is required on the efficacy of macrolides in terms of specific bacterial eradication and the extent of antibiotic resistance.\nObjectives\nTo determine the impact of macrolide antibiotics in the treatment of adults and children with bronchiectasis.\nSearch methods\nWe identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted all searches on 18 January 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) of at least four weeks' duration that compared macrolide antibiotics with placebo or no intervention for the long-term management of stable bronchiectasis in adults or children with a diagnosis of bronchiectasis by bronchography, plain film chest radiograph, or high-resolution computed tomography. We excluded studies in which participants had received continuous or high-dose antibiotics immediately before enrolment or before a diagnosis of cystic fibrosis, sarcoidosis, or allergic bronchopulmonary aspergillosis. Our primary outcomes were exacerbation, hospitalisation, and serious adverse events.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of 103 records. We independently screened the full text of 40 study reports and included 15 trials from 30 reports. Two review authors independently extracted outcome data and assessed risk of bias for each study. We analysed dichotomous data as odds ratios (ORs) and continuous data as mean differences (MDs) or standardised mean differences (SMDs). We used standard methodological procedures as expected by Cochrane.\nMain results\nWe included 14 parallel-group RCTs and one cross-over RCT with interventions lasting from 8 weeks to 24 months. Of 11 adult studies with 690 participants, six used azithromycin, four roxithromycin, and one erythromycin. Four studies with 190 children used either azithromycin, clarithromycin, erythromycin, or roxithromycin.\nWe included nine adult studies in our comparison between macrolides and placebo and two in our comparison with no intervention. We included one study with children in our comparison between macrolides and placebo and one in our comparison with no intervention.\nIn adults, macrolides reduced exacerbation frequency to a greater extent than placebo (OR 0.34, 95% confidence interval (CI) 0.22 to 0.54; 341 participants; three studies; I2 = 65%; moderate-quality evidence). This translates to a number needed to treat for an additional beneficial outcome of 4 (95% CI 3 to 8). Data show no differences in exacerbation frequency between use of macrolides (OR 0.31, 95% CI 0.08 to 1.15; 43 participants; one study; moderate-quality evidence) and no intervention. Macrolides were also associated with a significantly better quality of life compared with placebo (MD -8.90, 95% CI -13.13 to -4.67; 68 participants; one study; moderate-quality evidence). We found no evidence of a reduction in hospitalisations (OR 0.56, 95% CI 0.19 to 1.62; 151 participants; two studies; I2 = 0%; low-quality evidence), in the number of participants with serious adverse events, including pneumonia, respiratory and non-respiratory infections, haemoptysis, and gastroenteritis (OR 0.49, 95% CI 0.20 to 1.23; 326 participants; three studies; I2 = 0%; low-quality evidence), or in the number experiencing adverse events (OR 0.83, 95% CI 0.51 to 1.35; 435 participants; five studies; I2 = 28%) in adults with macrolides compared with placebo.\nIn children, exacerbation frequency was reduced more with macrolides than with placebo (IRR 0.50, 95% CI 0.35 to 0.71; 89 children; one study; low-quality evidence). However there was no significant difference in this age group with regard to: hospitalisations (OR 0.28, 95% CI 0.07 to 1.11; 89 children; one study; low-quality evidence), serious adverse events, defined within the study as exacerbations of bronchiectasis or investigations related to bronchiectasis (OR 0.43, 95% CI 0.17 to 1.05; 89 children; one study; low-quality evidence), or adverse events (OR 0.78, 95% CI 0.33 to 1.83; 89 children; one study), in those receiving macrolides compared to placebo. The same study reported an increase in macrolide-resistant bacteria (OR 7.13, 95% CI 2.13 to 23.79; 89 children; one study), an increase in resistance to Streptococcus pneumoniae (OR 13.20, 95% CI 1.61 to 108.19; 89 children; one study), and an increase in resistance to Staphylococcus aureus (OR 4.16, 95% CI 1.06 to 16.32; 89 children; one study) with macrolides compared with placebo. Quality of life was not reported in the studies with children.\nAuthors' conclusions\nLong-term macrolide therapy may reduce the frequency of exacerbations and improve quality of life, although supporting evidence is derived mainly from studies of azithromycin, rather than other macrolides, and predominantly among adults rather than children. However, macrolides should be used with caution, as limited data indicate an associated increase in microbial resistance. Macrolides are associated with increased risk of cardiovascular death and other serious adverse events in other populations, and available data cannot exclude a similar risk among patients with bronchiectasis.\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": "The studies on azithromycin reported improved quality of life in adults. We do not have sufficient evidence from other macrolides to make a robust judgement on their use, and we similarly have insufficient evidence from children to draw clear conclusions.\nAlthough we found only a few trials, they do show a possible increase in antibiotic resistance. Antibiotic resistance is seen when an antibiotic becomes less effective at killing the bacteria causing the chest infection.\nWe know that macrolides are associated with higher risk of cardiovascular death and other serious adverse events when they are used to treat other conditions. The data in our review suggest it is possible that people with bronchiectasis are at risk for these adverse effects when taking macrolides."
}
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query-laysum
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8131
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[
{
"role": "user",
"content": "Abstract: Background\nPeople with abdominal aortic aneurysm who receive endovascular aneurysm repair (EVAR) need lifetime surveillance to detect potential endoleaks. Endoleak is defined as persistent blood flow within the aneurysm sac following EVAR. Computed tomography (CT) angiography is considered the reference standard for endoleak surveillance. Colour duplex ultrasound (CDUS) and contrast-enhanced CDUS (CE-CDUS) are less invasive but considered less accurate than CT.\nObjectives\nTo determine the diagnostic accuracy of colour duplex ultrasound (CDUS) and contrast-enhanced-colour duplex ultrasound (CE-CDUS) in terms of sensitivity and specificity for endoleak detection after endoluminal abdominal aortic aneurysm repair (EVAR).\nSearch methods\nWe searched MEDLINE, Embase, LILACS, ISI Conference Proceedings, Zetoc, and trial registries in June 2016 without language restrictions and without use of filters to maximize sensitivity.\nSelection criteria\nAny cross-sectional diagnostic study evaluating participants who received EVAR by both ultrasound (with or without contrast) and CT scan assessed at regular intervals.\nData collection and analysis\nTwo pairs of review authors independently extracted data and assessed quality of included studies using the QUADAS 1 tool. A third review author resolved discrepancies. The unit of analysis was number of participants for the primary analysis and number of scans performed for the secondary analysis. We carried out a meta-analysis to estimate sensitivity and specificity of CDUS or CE-CDUS using a bivariate model. We analysed each index test separately. As potential sources of heterogeneity, we explored year of publication, characteristics of included participants (age and gender), direction of the study (retrospective, prospective), country of origin, number of CDUS operators, and ultrasound manufacturer.\nMain results\nWe identified 42 primary studies with 4220 participants. Twenty studies provided accuracy data based on the number of individual participants (seven of which provided data with and without the use of contrast). Sixteen of these studies evaluated the accuracy of CDUS. These studies were generally of moderate to low quality: only three studies fulfilled all the QUADAS items; in six (40%) of the studies, the delay between the tests was unclear or longer than four weeks; in eight (50%), the blinding of either the index test or the reference standard was not clearly reported or was not performed; and in two studies (12%), the interpretation of the reference standard was not clearly reported. Eleven studies evaluated the accuracy of CE-CDUS. These studies were of better quality than the CDUS studies: five (45%) studies fulfilled all the QUADAS items; four (36%) did not report clearly the blinding interpretation of the reference standard; and two (18%) did not clearly report the delay between the two tests.\nBased on the bivariate model, the summary estimates for CDUS were 0.82 (95% confidence interval (CI) 0.66 to 0.91) for sensitivity and 0.93 (95% CI 0.87 to 0.96) for specificity whereas for CE-CDUS the estimates were 0.94 (95% CI 0.85 to 0.98) for sensitivity and 0.95 (95% CI 0.90 to 0.98) for specificity. Regression analysis showed that CE-CDUS was superior to CDUS in terms of sensitivity (LR Chi2 = 5.08, 1 degree of freedom (df); P = 0.0242 for model improvement).\nSeven studies provided estimates before and after administration of contrast. Sensitivity before contrast was 0.67 (95% CI 0.47 to 0.83) and after contrast was 0.97 (95% CI 0.92 to 0.99). The improvement in sensitivity with of contrast use was statistically significant (LR Chi2 = 13.47, 1 df; P = 0.0002 for model improvement).\nRegression testing showed evidence of statistically significant effect bias related to year of publication and study quality within individual participants based CDUS studies. Sensitivity estimates were higher in the studies published before 2006 than the estimates obtained from studies published in 2006 or later (P < 0.001); and studies judged as low/unclear quality provided higher estimates in sensitivity. When regression testing was applied to the individual based CE-CDUS studies, none of the items, namely direction of the study design, quality, and age, were identified as a source of heterogeneity.\nTwenty-two studies provided accuracy data based on number of scans performed (of which four provided data with and without the use of contrast). Analysis of the studies that provided scan based data showed similar results. Summary estimates for CDUS (18 studies) showed 0.72 (95% CI 0.55 to 0.85) for sensitivity and 0.95 (95% CI 0.90 to 0.96) for specificity whereas summary estimates for CE-CDUS (eight studies) were 0.91 (95% CI 0.68 to 0.98) for sensitivity and 0.89 (95% CI 0.71 to 0.96) for specificity.\nAuthors' conclusions\nThis review demonstrates that both ultrasound modalities (with or without contrast) showed high specificity. For ruling in endoleaks, CE-CDUS appears superior to CDUS. In an endoleak surveillance programme CE-CDUS can be introduced as a routine diagnostic modality followed by CT scan only when the ultrasound is positive to establish the type of endoleak and the subsequent therapeutic management.\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": "An abdominal aortic aneurysm (AAA) is a localised swelling or widening of a major vessel that carries blood to the abdomen (tummy), pelvis, and legs. People with AAA are at risk from sudden death due to AAA rupture (bursting). Once detected, intervention (treatment) is recommended once the AAA is bigger than about 5 cm in diameter. Most repairs are now performed using a new vessel lining inside the aneurysm guided by x-ray control (endovascular aneurysm repair or EVAR).\nOnce the new lining is in place, the seals at either end may leak or vessel branches arising from the aneurysm wall may bleed backwards into the AAA sac. These are collectively referred to as endoleaks. Endoleaks are common after EVAR, developing in about 40% of people during monitoring (follow-up). Endoleaks can be associated with late aneurysm rupture and, therefore, detection and monitoring is essential. Ultrasound (uses high-frequency sound waves), computed tomography (uses x-rays), and magnetic resonance scans (uses strong magnetic fields and radio waves) have all been used to detect and monitor endoleaks. Sometimes, dye (contrast) is injected into a vein to improve the accuracy of ultrasound (contrast-enhanced ultrasound)."
}
] |
query-laysum
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8132
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[
{
"role": "user",
"content": "Abstract: Background\nAdjuvant aromatase inhibitors (AI) improve survival compared to tamoxifen in postmenopausal women with hormone receptor-positive stage I to III breast cancer. In approximately half of these women, AI are associated with aromatase inhibitor-induced musculoskeletal symptoms (AIMSS), often described as symmetrical pain and soreness in the joints, musculoskeletal pain and joint stiffness. AIMSS may have significant and prolonged impact on women's quality of life. AIMSS reduces adherence to AI therapy in up to a half of women, potentially compromising breast cancer outcomes. Differing systemic therapies have been investigated for the prevention and treatment of AIMSS, but the effectiveness of these therapies remains unclear.\nObjectives\nTo assess the effects of systemic therapies on the prevention or management of AIMSS in women with stage I to III hormone receptor-positive breast cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to September 2020 and the Cochrane Breast Cancer Group (CBCG) Specialised Register to March 2021.\nSelection criteria\nWe included all randomised controlled trials that compared systemic therapies to a comparator arm. Systemic therapy interventions included all pharmacological therapies, dietary supplements, and complementary and alternative medicines (CAM). All comparator arms were allowed including placebo or standard of care (or both) with analgesia alone. Published and non-peer-reviewed studies were eligible.\nData collection and analysis\nTwo review authors independently screened studies, extracted data, and assessed risk of bias and certainty of the evidence using the GRADE approach. Outcomes assessed were pain, stiffness, grip strength, safety data, discontinuation of AI, health-related quality of life (HRQoL), breast cancer-specific quality of life (BCS-QoL), incidence of AIMSS, breast cancer-specific survival (BCSS) and overall survival (OS). For continuous outcomes, we used vote-counting by reporting how many studies reported a clinically significant benefit within the confidence intervals (CI) of the mean difference (MD) between treatment arms, as determined by the minimal clinically importance difference (MCID) for that outcome scale. For dichotomous outcomes, we reported outcomes as a risk ratio (RR) with 95% CI.\nMain results\nWe included 17 studies with 2034 randomised participants. Four studies assessed systemic therapies for the prevention of AIMSS and 13 studies investigated treatment of AIMSS. Due to the variation in systemic therapy studies, including pharmacological, and CAM, or unavailable data, meta-analysis was limited, and only two trials were combined for meta-analysis. The certainty of evidence for all outcomes was either low or very low certainty.\nPrevention studies\nThe evidence is very uncertain about the effect of systemic therapies on pain (from baseline to the end of the intervention; 2 studies, 183 women). The two studies, investigating vitamin D and omega-3 fatty acids, showed a treatment effect with 95% CIs that did not include an MCID for pain. Systemic therapies may have little to no effect on grip strength (RR 1.08, 95% CI 0.37 to 3.17; 1 study, 137 women) or on women continuing to take their AI (RR 0.16, 95% 0.01 to 2.99; 1 study, 147 women). The evidence suggests little to no effect on HRQoL and BCS-QoL from baseline to the end of intervention (the same single study; 44 women, both quality of life outcomes showed a treatment effect with 95% CIs that did include an MCID).\nThe evidence is very uncertain for outcomes assessing incidence of AIMSS (RR 0.82, 95% CI 0.63 to 1.06; 2 studies, 240 women) and the safety of systemic therapies (4 studies, 344 women; very low-certainty evidence). One study had a US Food and Drug Administration alert issued for the intervention (cyclo-oxygenase-2 inhibitor) during the study, but there were no serious adverse events in this or any study.\nThere were no data on stiffness, BCSS or OS.\nTreatment studies\nThe evidence is very uncertain about the effect of systemic therapies on pain from baseline to the end of intervention in the treatment of AIMSS (10 studies, 1099 women). Four studies showed an MCID in pain scores which fell within the 95% CI of the measured effect (vitamin D, bionic tiger bone, Yi Shen Jian Gu granules, calcitonin). Six studies showed a treatment effect with 95% CI that did not include an MCID (vitamin D, testosterone, omega-3 fatty acids, duloxetine, emu oil, cat's claw).\nThe evidence was very uncertain for the outcomes of change in stiffness (4 studies, 295 women), HRQoL (3 studies, 208 women) and BCS-QoL (2 studies, 147 women) from baseline to the end of intervention. The evidence suggests systemic therapies may have little to no effect on grip strength (1 study, 107 women). The evidence is very uncertain about the safety of systemic therapies (10 studies, 1250 women). There were no grade four/five adverse events reported in any of the studies. The study of duloxetine reported more all-grade adverse events in this treatment group than comparator group.\nThere were no data on the incidence of AIMSS, the number of women continuing to take AI, BCCS or OS from the treatment studies.\nAuthors' conclusions\nAIMSS are chronic and complex symptoms with a significant impact on women with early breast cancer taking AI. To date, evidence for safe and effective systemic therapies for prevention or treatment of AIMSS has been minimal. Although this review identified 17 studies with 2034 randomised participants, the review was challenging due to the heterogeneous systemic therapy interventions and study methodologies, and the unavailability of certain trial data. Meta-analysis was thus limited and findings of the review were inconclusive. Further research is recommended into systemic therapy for AIMSS, including high-quality adequately powered RCT, comprehensive descriptions of the intervention/placebo, and robust definitions of the condition and the outcomes being studied.\n\nGiven the provided abstract, please respond to the following query: \"AIMSS treatment studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It is unclear whether any of these studies found a positive or negative effect on pain, stiffness and quality of life of women because of the very low-quality evidence. Systemic therapies likely result in little to no change on grip strength in women with AIMSS (low-quality evidence). None of the studies looked at the number of women continuing to take aromatase inhibitors or who developed AIMSS, or their survival."
}
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query-laysum
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8133
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[
{
"role": "user",
"content": "Abstract: Background\nTobacco smoking is the leading preventable cause of death worldwide, which makes it essential to stimulate smoking cessation. The financial cost of smoking cessation treatment can act as a barrier to those seeking support. We hypothesised that provision of financial assistance for people trying to quit smoking, or reimbursement of their care providers, could lead to an increased rate of successful quit attempts. This is an update of the original 2005 review.\nObjectives\nThe primary objective of this review was to assess the impact of reducing the costs for tobacco smokers or healthcare providers for using or providing smoking cessation treatment through healthcare financing interventions on abstinence from smoking. The secondary objectives were to examine the effects of different levels of financial support on the use or prescription of smoking cessation treatment, or both, and on the number of smokers making a quit attempt (quitting smoking for at least 24 hours). We also assessed the cost effectiveness of different financial interventions, and analysed the costs per additional quitter, or per quality-adjusted life year (QALY) gained.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register in September 2016.\nSelection criteria\nWe considered randomised controlled trials (RCTs), controlled trials and interrupted time series studies involving financial benefit interventions to smokers or their healthcare providers, or both.\nData collection and analysis\nTwo reviewers independently extracted data and assessed the quality of the included studies. We calculated risk ratios (RR) for individual studies on an intention-to-treat basis and performed meta-analysis using a random-effects model.\nMain results\nIn the current update, we have added six new relevant studies, resulting in a total of 17 studies included in this review involving financial interventions directed at smokers or healthcare providers, or both.\nFull financial interventions directed at smokers had a favourable effect on abstinence at six months or longer when compared to no intervention (RR 1.77, 95% CI 1.37 to 2.28, I² = 33%, 9333 participants). There was no evidence that full coverage interventions increased smoking abstinence compared to partial coverage interventions (RR 1.02, 95% CI 0.71 to 1.48, I² = 64%, 5914 participants), but partial coverage interventions were more effective in increasing abstinence than no intervention (RR 1.27 95% CI 1.02 to 1.59, I² = 21%, 7108 participants). The economic evaluation showed costs per additional quitter ranging from USD 97 to USD 7646 for the comparison of full coverage with partial or no coverage.\nThere was no clear evidence of an effect on smoking cessation when we pooled two trials of financial incentives directed at healthcare providers (RR 1.16, CI 0.98 to 1.37, I² = 0%, 2311 participants).\nFull financial interventions increased the number of participants making a quit attempt when compared to no interventions (RR 1.11, 95% CI 1.04 to 1.17, I² = 15%, 9065 participants). There was insufficient evidence to show whether partial financial interventions increased quit attempts compared to no interventions (RR 1.13, 95% CI 0.98 to 1.31, I² = 88%, 6944 participants).\nFull financial interventions increased the use of smoking cessation treatment compared to no interventions with regard to various pharmacological and behavioural treatments: nicotine replacement therapy (NRT): RR 1.79, 95% CI 1.54 to 2.09, I² = 35%, 9455 participants; bupropion: RR 3.22, 95% CI 1.41 to 7.34, I² = 71%, 6321 participants; behavioural therapy: RR 1.77, 95% CI 1.19 to 2.65, I² = 75%, 9215 participants.\nThere was evidence that partial coverage compared to no coverage reported a small positive effect on the use of bupropion (RR 1.15, 95% CI 1.03 to 1.29, I² = 0%, 6765 participants). Interventions directed at healthcare providers increased the use of behavioural therapy (RR 1.69, 95% CI 1.01 to 2.86, I² = 85%, 25820 participants), but not the use of NRT and/or bupropion (RR 0.94, 95% CI 0.76 to 1.18, I² = 6%, 2311 participants).\nWe assessed the quality of the evidence for the main outcome, abstinence from smoking, as moderate. In most studies participants were not blinded to the different study arms and researchers were not blinded to the allocated interventions. Furthermore, there was not always sufficient information on attrition rates. We detected some imprecision but we judged this to be of minor consequence on the outcomes of this study.\nAuthors' conclusions\nFull financial interventions directed at smokers when compared to no financial interventions increase the proportion of smokers who attempt to quit, use smoking cessation treatments, and succeed in quitting. There was no clear and consistent evidence of an effect on smoking cessation from financial incentives directed at healthcare providers. We are only moderately confident in the effect estimate because there was some risk of bias due to a lack of blinding in participants and researchers, and insufficient information on attrition rates.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We concluded that financial interventions directed at smokers increase the proportion of smokers who attempt to quit, use smoking cessation treatments, and succeed in quitting. We did not detect a clear effect on smoking cessation from financial incentives directed at healthcare providers. This review has some limitations that affect how confident we can be in the conclusions. The included studies varied substantially in quality and in methods and design, which makes it difficult to compare results."
}
] |
query-laysum
|
8134
|
[
{
"role": "user",
"content": "Abstract: Background\nCroup is an acute viral respiratory infection with upper airway mucosal inflammation that may cause respiratory distress. Most cases are mild. Moderate to severe croup may require treatment with corticosteroids (the benefits of which are often delayed) and nebulised epinephrine (adrenaline) (the benefits of which may be short-lived and which can cause dose-related adverse effects including tachycardia, arrhythmias, and hypertension). Rarely, croup results in respiratory failure necessitating emergency intubation and ventilation.\nA mixture of helium and oxygen (heliox) may prevent morbidity and mortality in ventilated neonates by reducing the viscosity of the inhaled air. It is currently used during emergency transport of children with severe croup. Anecdotal evidence suggests that it relieves respiratory distress.\nThis review updates versions published in 2010, 2013, and 2018.\nObjectives\nTo examine the effect of heliox compared to oxygen or other active interventions, placebo, or no treatment on relieving signs and symptoms in children with croup as determined by a croup score and rates of admission and intubation.\nSearch methods\nWe searched CENTRAL, which includes the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE, Embase, CINAHL, Web of Science, and LILACS, on 15 April 2021. We also searched the World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch/) and ClinicalTrials.gov (clinicaltrials.gov) on 15 April 2021. We contacted the British Oxygen Company, a leading supplier of heliox.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs comparing the effect of heliox in comparison with placebo, no treatment, or any active intervention(s) in children with croup.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Data that could not be pooled for statistical analysis were reported descriptively.\nMain results\nWe included 3 RCTs involving a total of 91 children aged between 6 months and 4 years. Study duration was from 7 to 16 months, and all studies were conducted in emergency departments. Two studies were conducted in the USA and one in Spain. Heliox was administered as a mixture of 70% heliox and 30% oxygen. Risk of bias was low in two studies and high in one study because of its open-label design. We did not identify any new trials for this 2021 update.\nOne study of 15 children with mild croup compared heliox with 30% humidified oxygen administered for 20 minutes. There may be no difference in croup score changes between groups at 20 minutes (mean difference (MD) −0.83, 95% confidence interval (CI) −2.36 to 0.70) (Westley croup score, scale range 0 to 16). The mean croup score at 20 minutes postintervention may not differ between groups (MD −0.57, 95% CI −1.46 to 0.32). There may be no difference between groups in mean respiratory rate (MD 6.40, 95% CI −1.38 to 14.18) and mean heart rate (MD 14.50, 95% CI −8.49 to 37.49) at 20 minutes. The evidence for all outcomes in this comparison was of low certainty, downgraded for serious imprecision. All children were discharged, but information on hospitalisation, intubation, or re-presenting to emergency departments was not reported.\nIn another study, 47 children with moderate croup received one dose of oral dexamethasone (0.3 mg/kg) with either heliox for 60 minutes or no treatment. Heliox may slightly improve Taussig croup scores (scale range 0 to 15) at 60 minutes postintervention (MD −1.10, 95% CI −1.96 to −0.24), but there may be no difference between groups at 120 minutes (MD −0.70, 95% CI −1.56 to 0.16). Children treated with heliox may have lower mean Taussig croup scores at 60 minutes (MD −1.11, 95% CI −2.05 to -0.17) but not at 120 minutes (MD −0.71, 95% CI −1.72 to 0.30). Children treated with heliox may have lower mean respiratory rates at 60 minutes (MD −4.94, 95% CI −9.66 to −0.22), but there may be no difference at 120 minutes (MD −3.17, 95% CI −7.83 to 1.49). There may be a difference in hospitalisation rates between groups (odds ratio 0.46, 95% CI 0.04 to 5.41). We assessed the evidence for all outcomes in this comparison as of low certainty, downgraded due to imprecision and high risk of bias related to an open-label design. Information on heart rate and intubation was not reported.\nIn the third study, 29 children with moderate to severe croup all received continuous cool mist and intramuscular dexamethasone (0.6 mg/kg). They were then randomised to receive either heliox (given as a mixture of 70% helium and 30% oxygen) plus one to two doses of nebulised saline or 100% oxygen plus nebulised epinephrine (adrenaline), with gas therapy administered continuously for three hours. Heliox may slightly improve croup scores at 90 minutes postintervention, but may result in little or no difference overall using repeated-measures analysis. We assessed the evidence for all outcomes in this comparison as of low certainty, downgraded due to high risk of bias related to inadequate reporting. Information on hospitalisation or re-presenting to the emergency department was not reported.\nThe included studies did not report on adverse events, intensive care admissions, or parental anxiety.\nWe could not pool the available data because each comparison included data from only one study.\nAuthors' conclusions\nGiven the very limited available evidence, uncertainty remains regarding the effectiveness and safety of heliox. Heliox may not be more effective than 30% humidified oxygen for children with mild croup, but may be beneficial in the short term for children with moderate croup treated with dexamethasone. The effect of heliox may be similar to 100% oxygen given with one or two doses of adrenaline. Adverse events were not reported, and it is unclear if these were monitored in the included studies. Adequately powered RCTs comparing heliox with standard treatments are needed to further assess the role of heliox in the treatment of children with moderate to severe croup.\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": "15 April 2021."
}
] |
query-laysum
|
8135
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[
{
"role": "user",
"content": "Abstract: Background\nUveitis is the most common extra-articular manifestation of juvenile idiopathic arthritis (JIA) and a potentially sight-threatening condition characterized by intraocular inflammation. Current treatment for JIA-associated uveitis (JIA-U) is largely based on physician experience, observational evidence and consensus guidelines, resulting in considerable variations in practice.\nObjectives\nTo evaluate the effectiveness and safety of tumor necrosis factor (TNF) inhibitors used for treatment of JIA-U.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We last searched the electronic databases on 3 February 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing TNF inhibitors with placebo in participants with a diagnosis of JIA and uveitis who were aged 2 to 18 years old.\nData collection and analysis\nWe used standard Cochrane methodology and graded the certainty of the body of evidence for seven outcomes using the GRADE classification.\nMain results\nWe included three RCTs with 134 participants.\nOne study conducted in the USA randomized participants to etanercept or placebo (N = 12). Two studies, one conducted in the UK (N = 90) and one in France (N = 32), randomized participants to adalimumab or placebo. All studies were at low risk of bias. Initial pooled estimates suggested that TNF-inhibitors may result in little to no difference on treatment success defined as 0 to trace cells on Standardization of Uveitis Nomenclature (SUN)-grading; or two-step decrease in activity based on SUN grading (estimated risk ratio (RR) 0.66; 95% confidence interval (CI) 0.21 to 2.10; 2 studies; 43 participants; low-certainty evidence) or treatment failure defined as a two-step increase in activity based on SUN grading (RR 0.31; 95% CI 0.01 to 7.15; 1 study; 31 participants; low-certainty evidence). Further analysis using the individual trial definitions of treatment response and failure suggested a positive treatment effect of TNF inhibitors; a RR of treatment success of 2.60 (95% CI 1.30 to 5.20; 3 studies; 124 participants; low-certainty evidence), and RR of treatment failure of 0.23 (95% CI 0.11 to 0.50; 3 studies; 133 participants). Almost all the evidence was on adalimumab and the evidence on etanercept was very limited. For secondary outcomes, one study suggests that adalimumab may have little to no effect on risk of recurrence after induction of remission at three months (RR 2.50, 95% CI 0.31 to 20.45; 90 participants; very low-certainty evidence) and visual acuity, but the evidence is very uncertain; mean difference in longitudinal logMAR score change over six months was -0.01 (95% CI –0.06 to 0.03) and -0.02 (95% CI –0.07 to 0.03) using the best and worst logMAR measurement, respectively (low-certainty evidence). Low-certainty evidence from one study suggested that adalimumab treatment results in reduction of topical steroid doses at six months (hazard ratio 3.58; 95% CI 1.24 to 10.32; 74 participants who took one or more topical steroid per day at baseline). Adverse events, including injection site reactions and infections, were more common in the TNF inhibitor group. Serious adverse events were uncommon.\nAuthors' conclusions\nAdalimumab appears to increase the likelihood of treatment success and decrease the likelihood of treatment failure when compared with placebo. The evidence was less conclusive about a positive treatment effect with etanercept. Adverse events from JIA-U trials are in keeping with the known side effect profile of TNF inhibitors. Standard validated JIA-U outcome measures are required to homogenize assessment and to allow for comparison and analysis of multiple datasets.\n\nGiven the provided abstract, please respond to the following query: \"What is juvenile idiopathic arthritis-associated uveitis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic condition in childhood and causes inflammation of the joints (arthritis). Some people with JIA also develop inflammation of the eye, known as uveitis. If not adequately detected and treated, uveitis can lead to permanent eye damage, visual impairment, or blindness."
}
] |
query-laysum
|
8136
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane Review last published in 2017. Survivors of stroke due to intracerebral haemorrhage (ICH) are at risk of major adverse cardiovascular events (MACE). Antithrombotic (antiplatelet or anticoagulant) treatments may lower the risk of ischaemic MACE after ICH, but they may increase the risk of bleeding.\nObjectives\nTo determine the overall effectiveness and safety of antithrombotic drugs on MACE and its components for people with ICH.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (5 October 2021). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL: the Cochrane Library 2021, Issue 10), MEDLINE Ovid (from 1948 to October 2021) and Embase Ovid (from 1980 to October 2021). The online registries of clinical trials searched were the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (5 October 2021). We screened the reference lists of included randomised controlled trials (RCTs) for additional, potentially relevant RCTs.\nSelection criteria\nWe selected RCTs in which participants with ICH of any age were allocated to a class of antithrombotic treatment as intervention or comparator.\nData collection and analysis\nIn accordance with standard methodological procedures recommended by Cochrane, two review authors assessed each selected RCT for its risk of bias and extracted data independently. The primary outcome was a composite of MACE, and secondary outcomes included death, individual components of the MACE composite, ICH growth, functional status and cognitive status. We estimated effects using the frequency of outcomes that occurred during the entire duration of follow-up and calculated a risk ratio (RR) for each RCT. We grouped RCTs separately for analysis according to 1) the class(es) of antithrombotic treatment used for the intervention and comparator, and 2) the duration of antithrombotic treatment use (short term versus long term). We pooled the intention-to-treat populations of RCTs using a fixed-effect model for meta-analysis, but used a random-effects model if RCTs differed substantially in their design or there was considerable heterogeneity (I2 ≥ 75%) in their results. We applied GRADE to assess the certainty of the evidence.\nMain results\nWe identified seven new completed RCTs for this update, resulting in the inclusion of a total of nine RCTs based in secondary care, comprising 1491 participants (average age ranged from 61 to 79 years and the proportion of men ranged from 44% to 67%). The proportion of included RCTs at low risk of bias, by category was: random sequence generation (67%), allocation concealment (67%), performance (22%), detection (78%), attrition (89%), and reporting (78%).\nFor starting versus avoiding short-term prophylactic dose anticoagulation after ICH, no RCT reported MACE. The evidence is very uncertain about the effect of starting short-term prophylactic dose anticoagulation on death (RR 1.00, 95% CI 0.59 to 1.70, P = 1.00; 3 RCTs; very low-certainty evidence), venous thromboembolism (RR 0.84, 95% CI 0.51 to 1.37, P = 0.49; 4 RCTs; very low-certainty evidence), ICH (RR 0.24, 95% CI 0.04 to 1.38, P = 0.11; 2 RCTs; very low-certainty evidence), and independent functional status (RR 2.03, 95% CI 0.78 to 5.25, P = 0.15; 1 RCT; very low-certainty evidence) over 90 days.\nFor starting versus avoiding long-term therapeutic dose oral anticoagulation for atrial fibrillation after ICH, starting long-term therapeutic dose oral anticoagulation probably reduces MACE (RR 0.61, 95% CI 0.40 to 0.94, P = 0.02; 3 RCTs; moderate-certainty evidence) and probably reduces all major occlusive vascular events (RR 0.27, 95% CI 0.14 to 0.53, P = 0.0002; 3 RCTs; moderate-certainty evidence), but probably results in little to no difference in death (RR 1.05, 95% CI 0.62 to 1.78, P = 0.86; 3 RCTs; moderate-certainty evidence), probably increases intracranial haemorrhage (RR 2.43, 95% CI 0.88 to 6.73, P = 0.09; 3 RCTs; moderate-certainty evidence), and may result in little to no difference in independent functional status (RR 0.98, 95% CI 0.78 to 1.24, P = 0.87; 2 RCTs; low-certainty evidence) over one to three years.\nFor starting versus avoiding long-term antiplatelet therapy after ICH, the evidence is uncertain about the effects of starting long-term antiplatelet therapy on MACE (RR 0.89, 95% CI 0.64 to 1.22, P = 0.46; 1 RCT; moderate-certainty evidence), death (RR 1.08, 95% CI 0.76 to 1.53, P = 0.66; 1 RCT; moderate-certainty evidence), all major occlusive vascular events (RR 1.03, 95% CI 0.68 to 1.55, P = 0.90; 1 RCT; moderate-certainty evidence), ICH (RR 0.52, 95% CI 0.27 to 1.03, P = 0.06; 1 RCT; moderate-certainty evidence) and independent functional status (RR 0.95, 95% CI 0.77 to 1.18, P = 0.67; 1 RCT; moderate-certainty evidence) over a median follow-up of two years.\nFor adults within 180 days of non-cardioembolic ischaemic stroke or transient ischaemic attack and a clinical history of prior ICH, there was no evidence of an effect of long-term cilostazol compared to aspirin on MACE (RR 1.33, 95% CI 0.74 to 2.40, P = 0.34; subgroup of 1 RCT; low-certainty evidence), death (RR 1.65, 95% CI 0.55 to 4.91, P = 0.37; subgroup of 1 RCT; low-certainty evidence), or ICH (RR 1.29, 95% CI 0.35 to 4.69, P = 0.70; subgroup of 1 RCT; low-certainty evidence) over a median follow-up of 1.8 years; all major occlusive vascular events and functional status were not reported.\nAuthors' conclusions\nWe did not identify beneficial or hazardous effects of short-term prophylactic dose parenteral anticoagulation and long-term oral antiplatelet therapy after ICH on important outcomes. Although there was a significant reduction in MACE and all major occlusive vascular events after long-term treatment with therapeutic dose oral anticoagulation for atrial fibrillation after ICH, the pooled estimates were imprecise, the certainty of evidence was only moderate, and effects on other important outcomes were uncertain. Large RCTs with a low risk of bias are required to resolve the ongoing dilemmas about antithrombotic treatment after ICH.\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 updated our extensive searches for randomised controlled trials, which are the fairest tests of treatment, in October 2021. We found nine trials, which included 1491 people with a brain haemorrhage in the past. Four trials studied short-term use of injected blood thinning drugs (known as 'anticoagulants') in immobile brain haemorrhage survivors. Three trials studied long-term use of oral anticoagulants in brain haemorrhage survivors with an irregular heart beat (known as 'atrial fibrillation'). One trial studied long-term use of oral blood thinning drugs (known as 'antiplatelet drugs') after brain haemorrhage, and another trial compared two different types of antiplatelet drug."
}
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query-laysum
|
8137
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[
{
"role": "user",
"content": "Abstract: Background\nDecreased concentration of nitric oxide has been proposed as one of the possible cellular mechanisms of necrotising enterocolitis (NEC). Arginine can act as a substrate for production of nitric oxide in the tissues, and arginine supplementation may help to prevent NEC.\nObjectives\nTo examine the effect of arginine supplementation (administered by any route) on the incidence of NEC in preterm neonates. To conduct subgroup analyses based on the dose of arginine and the gestational age of participants (≤ 32 weeks, > 32 weeks).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4), MEDLINE via PubMed (from 1966 to 12 May 2016), Embase (from 1980 to 12 May 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982 to 12 May 2016). We also searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised controlled trials of arginine supplementation (administered orally or parenterally for at least seven days, in addition to what an infant may be receiving from an enteral or parenteral source) compared with placebo or no treatment.\nData collection and analysis\nWe assessed the methodological quality of trials by using information obtained from study reports and through personal communication with study authors. We extracted data on relevant outcomes and estimated and reported the effect size as risk ratio (RR), risk difference (RD) and mean difference (MD), as appropriate. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence.\nMain results\nWe identified three eligible studies that included a total of 285 neonates (140 received arginine) from three countries. We assessed the overall methodological quality of the included studies as good. We noted a statistically significant reduction in risk of development of NEC (any stage) among preterm neonates in the arginine group compared with the placebo group (RR 0.38, 95% confidence interval (CI) 0.23 to 0.64; I2 = 27%) (RD -0.19, 95% CI -0.28 to -0.10; I2 = 0%) and rated the quality of evidence as moderate. The number needed to treat for an additional beneficial outcome (NNTB) as required to prevent the development of NEC (any stage) was 6 (95% CI 4 to 10). Study results showed a statistically significant reduction in risk of development of NEC stage 1 (RR 0.37, 95% CI 0.15 to 0.90; I2 = 52%) (RD -0.07, 95% CI -0.14 to -0.01; I2 = 0%) and NEC stage 3 (RR 0.13, 95% CI 0.02 to 1.03; I2 = 0%) (RD -0.05, 95% CI -0.09 to -0.01; I2 = 89%) in the arginine group compared with the control group; the quality of evidence was moderate.\nArginine supplementation was associated with a significant reduction in death related to NEC (RR 0.18, 95% CI 0.03 to 1.00; I2 = 0%) (RD -0.05, 95% CI -0.09 to -0.01; I2 = 87%). Results showed clinical heterogeneity in mortality rates. Mortality due to any cause was not significantly different between arginine and control or no treatment groups (RR 0.77, 95% CI 0.41 to 1.45; I2 = 42%) (RD -0.03, 95% CI -0.10 to 0.04; I2 = 79%). Investigators noted no significant side effects directly attributable to arginine, including hypotension or alterations in glucose homeostasis. Follow-up data from one trial revealed no statistically significant differences in adverse outcomes (cerebral palsy, cognitive delay, bilateral blindness or hearing loss requiring hearing aids) at 36 months. Limitations of the present findings include a relatively small overall sample size.\nAuthors' conclusions\nAdministration of arginine to preterm infants may prevent development of NEC. Because information was provided by three small trials that included 285 participants, the data are insufficient at present to support a practice recommendation. A multi-centre randomised controlled study that is focused on the incidence of NEC, particularly at more severe stages (2 and 3), is needed.\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": "Necrotising enterocolitis (NEC) is a condition in which inflammation damages an infant's gastrointestinal (GI) tract. The rate of NEC ranges from 4% to 22% in very low birth weight infants. Necrotising enterocolitis may be caused by an infant's immaturity, lack of blood flow to the GI tract and surface (mucosa) breakdown resulting from infection or feeding with formula. To protect the GI tract, the body makes a natural substance - nitric oxide - from the amino acid arginine. Plasma arginine concentrations are reported to be low in very low birth weight infants and preterm infants who develop NEC. Adding extra arginine to the feeding solution may prevent NEC."
}
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query-laysum
|
8138
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[
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers (also known as pressure sores, decubitus ulcers or bedsores) are localised injuries to the skin or underlying tissue, or both. Pressure ulcers are a disabling consequence of immobility. Electrical stimulation (ES) is widely used for the treatment of pressure ulcers. However, it is not clear whether ES is effective.\nObjectives\nTo determine the effects (benefits and harms) of electrical stimulation (ES) for treating pressure ulcers.\nSearch methods\nIn July 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. We did not impose any restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included published and unpublished randomised controlled trials (RCTs) comparing ES (plus standard care) with sham/no ES (plus standard care) for treating pressure ulcers.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, and assessed risk of bias. We assessed the certainty of evidence using GRADE.\nMain results\nWe included 20 studies with 913 participants. The mean age of participants ranged from 26 to 83 years; 50% were male. ES was administered for a median (interquartile range (IQR)) duration of five (4 to 8) hours per week. The chronicity of the pressure ulcers was variable, ranging from a mean of four days to more than 12 months. Most of the pressure ulcers were on the sacral and coccygeal region (30%), and most were stage III (45%). Half the studies were at risk of performance and detection bias, and 25% were at risk of attrition and selective reporting bias. Overall, the GRADE assessment of the certainty of evidence for outcomes was moderate to very low. Nineteen studies were conducted in four different settings, including rehabilitation and geriatric hospitals, medical centres, a residential care centre, and a community-based centre.\nES probably increases the proportion of pressure ulcers healed compared with no ES (risk ratio (RR) 1.99, 95% confidence interval (CI) 1.39 to 2.85; I2 = 0%; 11 studies, 501 participants (512 pressure ulcers)). We downgraded the evidence to moderate certainty due to risk of bias.\nIt is uncertain whether ES decreases pressure ulcer severity on a composite measure compared with no ES (mean difference (MD) -2.43, 95% CI -6.14 to 1.28; 1 study, 15 participants (15 pressure ulcers) and whether ES decreases the surface area of pressure ulcers when compared with no ES (12 studies; 494 participants (505 pressure ulcers)). Data for the surface area of pressure ulcers were not pooled because there was considerable statistical heterogeneity between studies (I2 = 96%) but the point estimates for the MD of each study ranged from -0.90 cm2 to 10.37 cm2. We downgraded the evidence to very low certainty due to risk of bias, inconsistency and imprecision.\nIt is uncertain whether ES decreases the time to complete healing of pressure ulcers compared with no ES (hazard ratio (HR) 1.06, 95% CI 0.47 to 2.41; I2 = 0%; 2 studies, 55 participants (55 pressure ulcers)). We downgraded the evidence to very low certainty due to risk of bias, indirectness and imprecision.\nES may be associated with an excess of, or difference in, adverse events (13 studies; 586 participants (602 pressure ulcers)). Data for adverse events were not pooled but the types of reported adverse events included skin redness, itchy skin, dizziness and delusions, deterioration of the pressure ulcer, limb amputation, and occasionally death. We downgraded the evidence to low certainty due to risk of selection and attrition bias and imprecision.\nES probably increases the rate of pressure ulcer healing compared with no ES (MD 4.59% per week, 95% CI 3.49 to 5.69; I2 = 25%; 12 studies, 561 participants (613 pressure ulcers)). We downgraded the evidence to moderate certainty due to risk of bias. We did not find any studies that looked at quality of life, depression, or consumers' perception of treatment effectiveness.\nAuthors' conclusions\nES probably increases the proportion of pressure ulcers healed and the rate of pressure ulcer healing (moderate certainty evidence), but its effect on time to complete healing is uncertain compared with no ES (very low certainty evidence). It is also uncertain whether ES decreases the surface area of pressure ulcers. The evidence to date is insufficient to support the widespread use of ES for pressure ulcers outside of research. Future research needs to focus on large-scale trials to determine the effect of ES on all key outcomes.\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": "This review includes the results of 20 randomised controlled trials dating from 1985 to 2018 and involving 913 participants. The average age of participants ranged from 26 to 83 years; 50% were male. Participants had their pressure ulcers for at least four days and in some cases for more than 12 months. The majority of pressure ulcers (60%) were serious and on or adjacent to the buttocks (62%). Studies were conducted in four different settings, including rehabilitation and geriatric hospitals, medical centres, a residential care centre, and a community-based centre. ES was administered for an average of five hours per week. Studies compared ES plus usual care (e.g. wound dressing, pressure relief, regular turning, nutritional advice and supplements) to no ES (but with usual care). Eight studies out of 20 were funded by a device manufacturer with a vested interest in the results of the studies.\nEleven studies that compared ES with no ES indicated that ES probably improves the proportion of pressure ulcers healed (moderate certainty evidence based on 501 participants (512 pressure ulcers)). It is uncertain whether ES decreases pressure ulcer severity on a composite measure (based on 1 study with 15 participants (15 pressure ulcers)). The effect of ES on pressure ulcer area was not estimable because different studies showed very different results. It is uncertain whether ES decreases the surface area of pressure ulcers (very low certainty evidence based on 494 participants (505 pressure ulcers)). We cannot be certain whether ES has an effect on time to complete healing (very low certainty evidence based on 55 participants (55 pressure ulcers)). The common complications related to ES were skin redness and discomfort (low certainty evidence based on 586 participants (602 pressure ulcers)). Twelve studies also indicated that ES probably increases the rate of pressure ulcer healing (moderate certainty evidence based on 561 participants (613 pressure ulcers)). No studies reported results for quality of life or depression."
}
] |
query-laysum
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8139
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[
{
"role": "user",
"content": "Abstract: Background\nProstaglandin E1 (PGE1) is used to keep the ductus arteriosus patent and can be life-saving in neonates with ductal-dependent cardiac lesions. PGE1 is used to promote mixing of pulmonary and systemic blood flow or improve pulmonary or systemic circulations, prior to balloon atrial septostomy or surgery. PGE1 therapy may cause several short-term and long-term adverse effects. The efficacy and safety of PGE1 in neonates with ductal-dependent cardiac lesions has not been systematically reviewed.\nObjectives\nTo determine the efficacy and safety of both short-term (< 120 hours) and long-term (≥120 hours) PGE1 therapy in maintaining patency of the ductus arteriosus and decreasing mortality in ductal-dependent cardiac lesions.\nSearch methods\nWe searched the literature in October 2017, using the search strategy recommended by Cochrane Neonatal. We searched electronic databases (CENTRAL (in the Cochrane Library), MEDLINE, CINAHL, Embase); abstracts of the Pediatric Academic Societies; websites for registered trials at www.clinicaltrials.gov and www.controlled-trials.com; and in the reference list of identified articles.\nSelection criteria\nRandomized or quasi-randomized trials using PGE1 at any dose or duration to maintain ductal patency in term or late preterm (≥ 34 weeks' gestation) infants with ductal-dependent cardiac lesions and which reported effectiveness and safety in the short term or long term.\nData collection and analysis\nWe followed the standard Cochrane methods for conducting a systematic review. Two review authors (SA and MP) independently assessed the titles and abstracts of studies identified by the search strategy to determine eligibility for inclusion. We obtained the full-text version if eligibility could not be done reliably by title and abstract. We resolved any differences by discussion. We designed electronic forms for trial inclusion/exclusion, data extraction, and for requesting additional published information from authors of the original reports.\nMain results\nOur search did not identify any completed or ongoing trials that met our inclusion criteria.\nAuthors' conclusions\nThere is insufficient evidence from randomized controlled trials to determine the safety and efficacy of PGE1 in neonates with ductal-dependent cardiac lesions. Evidence from observational trials have informed clinical practice on the use of PGE, which is now considered the standard of care for ductal-dependent cardiac lesions. It is unlikely that randomized controlled studies will be performed for this indication but comparative efficacy of newer formulations of PGE1, different doses of PGE1 and studies comparing PGE with PDA stents or other measures to keep the ductus open may be ethical and necessary.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Ductus arteriosus is a blood vessel connection between the large blood vessel supplying blood to the lungs (pulmonary artery) and to the large blood vessel supplying blood to the body (aorta). Normally the ductus is open before birth and closes within the first day after birth. However, certain heart conditions where there is a block to the blood flow to the lungs or the body, or a condition where the blood vessels supplying the lungs and body are switched (transposition of great arteries), an open ductus is necessary for survival. Prostaglandin E1 (PGE1) is a substance produced by the ductus that keeps it open. External PGE1 is used to keep the ductus arteriosus open in neonates who have heart lesions that depend on an open ductus for survival. PGE1, though lifesaving, is not without risks. There are no systematic reviews to assess PGE1's effectiveness or safety."
}
] |
query-laysum
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8140
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[
{
"role": "user",
"content": "Abstract: Background\nBurn injuries are an important health problem. They occur frequently in the head and neck region. The face is the area central to a person's identity that provides our most expressive means of communication. Topical interventions are currently the cornerstone of treatment of burns to the face.\nObjectives\nTo assess the effects of topical interventions on wound healing in people with facial burns of any depth.\nSearch methods\nIn December 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nRandomised controlled trials (RCTs) that evaluated the effects of topical treatment for facial burns were eligible for inclusion in this review.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, risk of bias assessment and GRADE assessment of the certainty of the evidence.\nMain results\nIn this first update, we included 12 RCTs, comprising 507 participants.\nMost trials included adults admitted to specialised burn centres after recent burn injuries.\nTopical agents included antimicrobial agents (silver sulphadiazine (SSD), Aquacel-Ag, cerium-sulphadiazine, gentamicin cream, mafenide acetate cream, bacitracin), non-antimicrobial agents (Moist Exposed Burn Ointment (MEBO), saline-soaked dressings, skin substitutes (including bioengineered skin substitute (TransCyte), allograft, and xenograft (porcine Xenoderm), and miscellaneous treatments (growth hormone therapy, recombinant human granulocyte-macrophage colony-stimulating factor hydrogel (rhGMCS)), enzymatic debridement, and cream with Helix Aspersa extract).\nAlmost all the evidence included in this review was assessed as low or very low-certainty, often because of high risk of bias due to unclear randomisation procedures (i.e. sequence generation and allocation concealment); lack of blinding of participants, providers and sometimes outcome assessors; and imprecision resulting from few participants, low event rates or both, often in single studies.\nTopical antimicrobial agents versus topical non-antimicrobial agents\nThere is moderate-certainty evidence that there is probably little or no difference between antimicrobial agents and non-antimicrobial agents (SSD and MEBO) in time to complete wound healing (hazard ratio (HR) 0.84 (95% confidence interval (CI) 0.78 to 1.85, 1 study, 39 participants). Topical antimicrobial agents may make little or no difference to the proportion of wounds completely healed compared with topical non-antimicrobial agents (comparison SSD and MEBO, risk ratio (RR) 0.94, 95% CI 0.68 to 1.29; 1 study, 39 participants; low-certainty evidence). We are uncertain whether there is a difference in wound infection (comparison topical antimicrobial agent (Aquacel-Ag) and MEBO; RR 0.38, 95% CI 0.12 to 1.21; 1 study, 40 participants; very low-certainty evidence). No trials reported change in wound surface area over time or partial wound healing. There is low-certainty evidence for the secondary outcomes scar quality and patient satisfaction. Two studies assessed pain but it was incompletely reported.\nTopical antimicrobial agents versus other topical antimicrobial agents\nIt is uncertain whether topical antimicrobial agents make any difference in effects as the evidence is low to very low-certainty. For primary outcomes, there is low-certainty evidence for time to partial (i.e. greater than 90%) wound healing (comparison SSD versus cerium SSD: mean difference (MD) –7.10 days, 95% CI –16.43 to 2.23; 1 study, 142 participants). There is very low-certainty evidence regarding whether topical antimicrobial agents make a difference to wound infection (RR 0.73, 95% CI 0.46 to 1.17; 1 study, 15 participants). There is low to very low-certainty evidence for the proportion of facial burns requiring surgery, pain, scar quality, adverse effects and length of hospital stay.\nSkin substitutes versus topical antimicrobial agents\nThere is low-certainty evidence that a skin substitute may slightly reduce time to partial (i.e. greater than 90%) wound healing, compared with a non-specified antibacterial agent (MD –6.00 days, 95% CI –8.69 to –3.31; 1 study, 34 participants).\nWe are uncertain whether skin substitutes in general make any other difference in effects as the evidence is very low certainty. Outcomes included wound infection, pain, scar quality, adverse effects of treatment and length of hospital stay.\nSingle studies showed contrasting low-certainty evidence. A bioengineered skin substitute may slightly reduce procedural pain (MD –4.00, 95% CI –5.05 to –2.95; 34 participants) and background pain (MD –2.00, 95% CI –3.05 to –0.95; 34 participants) compared with an unspecified antimicrobial agent. In contrast, a biological dressing (porcine Xenoderm) might slightly increase pain in superficial burns (MD 1.20, 95% CI 0.65 to 1.75; 15 participants (30 wounds)) as well as deep partial thickness burns (MD 3.00, 95% CI 2.34 to 3.66; 10 participants (20 wounds)), compared with antimicrobial agents (Physiotulle Ag (Coloplast)).\nMiscellaneous treatments versus miscellaneous treatments\nSingle studies show low to very low-certainty effects of interventions. Low-certainty evidence shows that MEBO may slightly reduce time to complete wound healing compared with saline soaked dressing (MD –1.7 days, 95% CI –3.32 to –0.08; 40 participants). In addition, a cream containing Helix Aspersa may slightly increase the proportion of wounds completely healed at 14 days compared with MEBO (RR 4.77, 95% CI 1.87 to 12.15; 43 participants). We are uncertain whether any miscellaneous treatment in the included studies makes a difference in effects for the outcomes wound infection, scar quality, pain and patient satisfaction as the evidence is low to very low-certainty.\nAuthors' conclusions\nThere is mainly low to very low-certainty evidence on the effects of any topical intervention on wound healing in people with facial burns. The number of RCTs in burn care is growing, but the body of evidence is still hampered due to an insufficient number of studies that follow appropriate evidence-based standards of conducting and reporting RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Burn injuries are an important health problem, and a major global cause of disability and disfigurement in both adults and children. Women and children in low-income countries are at particular risk. Burns pose particular problems when they occur on the head or neck. The face is central to a person's identity and plays a vital role in communication. Other basic functions such as hearing, smell and breathing may become affected as a direct result of a facial burn. Topical treatments such as (non) antimicrobial creams and skin substitutes, are most commonly used to treat facial burns. We wanted to compare the effectiveness of these treatments to evaluate their benefits and harms."
}
] |
query-laysum
|
8141
|
[
{
"role": "user",
"content": "Abstract: Background\nMalignant pleural effusion (MPE) is a common problem for people with cancer and usually associated with considerable breathlessness. A number of treatment options are available to manage the uncontrolled accumulation of pleural fluid, including administration of a pleurodesis agent (via a chest tube or thoracoscopy) or placement of an indwelling pleural catheter (IPC). This is an update of a review published in Issue 5, 2016, which replaced the original, published in 2004.\nObjectives\nTo ascertain the optimal management strategy for adults with malignant pleural effusion in terms of pleurodesis success and to quantify differences in patient-reported outcomes and adverse effects between interventions.\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and three other databases to June 2019. We screened reference lists from other relevant publications and searched trial registries.\nSelection criteria\nWe included randomised controlled trials of intrapleural interventions for adults with symptomatic MPE, comparing types of sclerosant, mode of administration and IPC use.\nData collection and analysis\nTwo review authors independently extracted data on study design, characteristics, outcome measures, potential effect modifiers and risk of bias.\nThe primary outcome was pleurodesis failure rate. Secondary outcomes were adverse events, patient-reported breathlessness control, quality of life, cost, mortality, survival, duration of inpatient stay and patient acceptability.\nWe performed network meta-analyses of primary outcome data and secondary outcomes with enough data. We also performed pair-wise meta-analyses of direct comparison data. If we deemed interventions not jointly randomisable, or we found insufficient available data, we reported results by narrative synthesis. For the primary outcome, we performed sensitivity analyses to explore potential causes of heterogeneity and to evaluate pleurodesis agents administered via a chest tube only.\nWe assessed the certainty of the evidence using GRADE.\nMain results\nWe identified 80 randomised trials (18 new), including 5507 participants. We found all except three studies at high or unclear risk of bias for at least one domain. Due to the nature of the interventions, most studies were unblinded.\nPleurodesis failure rate\nWe included 55 studies of 21 interventions in the primary network meta-analysis. We estimated the rank of each intervention's effectiveness. Talc slurry (ranked 6, 95% credible interval (Cr-I) 3 to 10) is an effective pleurodesis agent (moderate certainty for comparison with placebo) and may result in fewer pleurodesis failures than bleomycin and doxycycline (bleomycin versus talc slurry: odds ratio (OR) 2.24, 95% Cr-I 1.10 to 4.68; low certainty; ranked 11, 95% Cr-I 7 to 15; doxycycline versus talc slurry: OR 2.51, 95% Cr-I 0.81 to 8.40; low certainty; ranked 12, 95% Cr-I 5 to 18).\nThere is little evidence of a difference between the pleurodesis failure rate of talc poudrage and talc slurry (OR 0.50, 95% Cr-I 0.21 to 1.02; moderate certainty). Evidence for any difference was further reduced when restricting analysis to studies at low risk of bias (defined as maximum one high risk domain in the risk of bias assessment) (pleurodesis failure talc poudrage versus talc slurry: OR 0.78, 95% Cr-I 0.16 to 2.08).\nIPCs without daily drainage are probably less effective at obtaining a definitive pleurodesis (cessation of pleural fluid drainage facilitating IPC removal) than talc slurry (OR 7.60, 95% Cr-I 2.96 to 20.47; rank = 18/21, 95% Cr-I 13 to 21; moderate certainty). Daily IPC drainage or instillation of talc slurry via IPC are likely to reduce pleurodesis failure rates.\nAdverse effects\nAdverse effects were inconsistently reported. We performed network meta-analyses for the risk of procedure-related fever and pain.\nThe evidence for risk of developing fever was of low certainty, but suggested there may be little difference between interventions relative to talc slurry (talc poudrage: OR 0.89, 95% Cr-I 0.11 to 6.67; bleomycin: OR 2.33, 95% Cr-I 0.45 to 12.50; IPCs: OR 0.41, 95% Cr-I 0.00 to 50.00; doxycycline: OR 0.85, 95% Cr-I 0.05 to 14.29).\nEvidence also suggested there may be little difference between interventions in the risk of developing procedure-related pain, relative to talc slurry (talc poudrage: OR 1.26, 95% Cr-I 0.45 to 6.04; very-low certainty; bleomycin: OR 2.85, 95% Cr-I 0.78 to 11.53; low certainty; IPCs: OR 1.30, 95% Cr-I 0.29 to 5.87; low certainty; doxycycline: OR 3.35, 95% Cr-I 0.64 to 19.72; low certainty).\nPatient-reported control of breathlessness\nPair-wise meta-analysis suggests there is likely no difference in breathlessness control, relative to talc slurry, of talc poudrage ((mean difference (MD) 4.00 mm, 95% CI –6.26 to 14.26) on a 100 mm visual analogue scale for breathlessness; studies = 1; participants = 184; moderate certainty) and IPCs without daily drainage (MD –6.12 mm, 95% CI –16.32 to 4.08; studies = 2; participants = 160; low certainty).\nOverall mortality\nThere may be little difference between interventions when compared to talc slurry (bleomycin and IPC without daily drainage; low certainty) but evidence is uncertain for talc poudrage and doxycycline.\nPatient acceptability\nPair-wise meta-analysis demonstrated that IPCs probably result in a reduced risk of requiring a repeat invasive pleural intervention (OR 0.25, 95% Cr-I 0.13 to 0.48; moderate certainty) relative to talc slurry. There is likely little difference in the risk of repeat invasive pleural intervention with talc poudrage relative to talc slurry (OR 0.96, 95% CI 0.59 to 1.56; moderate certainty).\nAuthors' conclusions\nBased on the available evidence, talc poudrage and talc slurry are effective methods for achieving a pleurodesis, with lower failure rates than a number of other commonly used interventions.\nIPCs provide an alternative approach; whilst associated with inferior definitive pleurodesis rates, comparable control of breathlessness can probably be achieved, with a lower risk of requiring repeat invasive pleural intervention.\nLocal availability, global experience of agents and adverse events (which may not be identified in randomised trials) and patient preference must be considered when selecting an intervention.\nFurther research is required to delineate the roles of different treatments according to patient characteristics, such as presence of trapped lung. Greater attention to patient-centred outcomes, including breathlessness, quality of life and patient preference is essential to inform clinical decision-making. Careful consideration to minimise the risk of bias and standardise outcome measures is essential for future trial design.\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": "From our searches in June 2019, we found 80 studies (18 new) involving 5507 participants (2079 new).\nIn the network meta-analysis, we found that giving talc through a chest tube after draining the fluid (talc slurry) resulted in fewer pleurodesis failures than other commonly used methods, such as the medicines doxycycline or bleomycin through a chest tube (low certainty). Using a thoracoscopy procedure to remove the fluid and blow talc into the chest (talc poudrage) is likely to be as effective as talc slurry (moderate certainty).\nWe had a low level of certainty that the risk of having a fever is similar between treatments. There may be little difference between treatments in the chance of having pain (low certainty for bleomycin, IPCs and doxycycline; very-low certainty for talc poudrage).\nUsing an IPC, which allows intermittent drainage of fluid at home, may relieve breathlessness as much as a talc slurry procedure (low certainty).\nThere may be little difference in the risk of death between treatments when compared to talc slurry (low certainty for bleomycin and IPC without daily drainage; very low certainty for talc poudrage and doxycycline).\nThe chance of needing another invasive procedure to remove fluid was lower after having an IPC than after talc slurry pleurodesis (moderate certainty)."
}
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query-laysum
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8142
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[
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a chronic respiratory condition characterised by shortness of breath, cough and recurrent exacerbations. People with COPD often live with one or more co-existing long-term health conditions (comorbidities). People with more severe COPD often have a higher number of comorbidities, putting them at greater risk of morbidity and mortality.\nObjectives\nTo assess the effectiveness of any single intervention for COPD adapted or tailored to their comorbidity(s) compared to any other intervention for people with COPD and one or more common comorbidities (quantitative data, RCTs) in terms of the following outcomes: Quality of life, exacerbations, functional status, all-cause and respiratory-related hospital admissions, mortality, pain, and depression and anxiety.\nTo assess the effectiveness of an adapted or tailored single COPD intervention (simple or complex) that is aimed at changing the management of people with COPD and one or more common comorbidities (quantitative data, RCTs) compared to usual care in terms of the following outcomes: Quality of life, exacerbations, functional status, all-cause and respiratory-related hospital admissions, mortality, pain, and depression and anxiety.\nTo identify emerging themes that describe the views and experiences of patients, carers and healthcare professionals when receiving or providing care to manage multimorbidities (qualitative data).\nSearch methods\nWe searched multiple databases including the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, and CINAHL, to identify relevant randomised and qualitative studies. We also searched trial registries and conducted citation searches. The latest search was conducted in January 2021.\nSelection criteria\nEligible randomised controlled trials (RCTs) compared a) any single intervention for COPD adapted or tailored to their comorbidity(s) compared to any other intervention, or b) any adapted or tailored single COPD intervention (simple or complex) that is aimed at changing the management of people with COPD and one or more comorbidities, compared to usual care. We included qualitative studies or mixed-methods studies to identify themes.\nData collection and analysis\nWe used standard Cochrane methods for analysis of the RCTs. We used Cochrane's risk of bias tool for the RCTs and the CASP checklist for the qualitative studies. We planned to use the Mixed Methods Appraisal tool (MMAT) to assess the risk of bias in mixed-methods studies, but we found none. We used GRADE and CERQual to assess the quality of the quantitative and qualitative evidence respectively. The primary outcome measures for this review were quality of life and exacerbations.\nMain results\nQuantitative studies\nWe included seven studies (1197 participants) in the quantitative analyses, with interventions including telemonitoring, pulmonary rehabilitation, treatment optimisation, water-based exercise training and case management. Interventions were either compared with usual care or with an active comparator (such as land-based exercise training). Duration of trials ranged from 4 to 52 weeks. Mean age of participants ranged from 64 to 72 years and COPD severity ranged from mild to very severe. Trials included either people with COPD and a specific comorbidity (including cardiovascular disease, metabolic syndrome, lung cancer, head or neck cancer, and musculoskeletal conditions), or with one or more comorbidities of any type.\nOverall, we judged the evidence presented to be of moderate to very low certainty (GRADE), mainly due to the methodological quality of included trials and imprecision of effect estimates.\nIntervention versus usual care\nQuality of life as measured by the St George's Respiratory Questionnaire (SGRQ) total score may improve with tailored pulmonary rehabilitation compared to usual care at 52 weeks (mean difference (MD) −10.85, 95% confidence interval (CI) −12.66 to −9.04; 1 study, 70 participants; low-certainty evidence). Tailored pulmonary rehabilitation is likely to improve COPD assessment test (CAT) scores compared with usual care at 52 weeks (MD −8.02, 95% CI −9.44 to −6.60; 1 study, 70 participants, moderate-certainty evidence) and with a multicomponent telehealth intervention at 52 weeks (MD −6.90, 95% CI −9.56 to −4.24; moderate-certainty evidence). Evidence is uncertain about effects of pharmacotherapy optimisation or telemonitoring interventions on CAT improvement compared with usual care.\nThere may be little to no difference in the number of people experiencing exacerbations, or mean exacerbations with case management compared with usual care (OR 1.09, 95% CI 0.75 to 1.57; 1 study, 470 participants; very low-certainty evidence).\nFor secondary outcomes, six-minute walk distance (6MWD) may improve with pulmonary rehabilitation, water-based exercise or multicomponent interventions at 38 to 52 weeks (low-certainty evidence). A multicomponent intervention may result in fewer people being admitted to hospital at 17 weeks, although there may be little to no difference in a telemonitoring intervention. There may be little to no difference between intervention and usual care for mortality.\nIntervention versus active comparator\nWe included one study comparing water-based and land-based exercise (30 participants). We found no evidence for quality of life or exacerbations.\nThere may be little to no difference between water- and land-based exercise for 6MWD (MD 5 metres, 95% CI −22 to 32; 38 participants; very low-certainty evidence).\nQualitative studies\nOne nested qualitative study (21 participants) explored perceptions and experiences of people with COPD and long-term conditions, and of researchers and health professionals who were involved in an RCT of telemonitoring equipment.\nSeveral themes were identified, including health status, beliefs and concerns, reliability of equipment, self-efficacy, perceived ease of use, factors affecting usefulness and perceived usefulness, attitudes and intention, self-management and changes in healthcare use. We judged the qualitative evidence presented as of very low certainty overall.\nAuthors' conclusions\nOwing to a paucity of eligible trials, as well as diversity in the intervention type, comorbidities and the outcome measures reported, we were unable to provide a robust synthesis of data. Pulmonary rehabilitation or multicomponent interventions may improve quality of life and functional status (6MWD), but the evidence is too limited to draw a robust conclusion. The key take-home message from this review is the lack of data from RCTs on treatments for people living with COPD and comorbidities.\nGiven the variation in number and type of comorbidity(s) an individual may have, and severity of COPD, larger studies reporting individual patient data are required to determine these effects.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the information\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall there were very few studies and most studies were small. This means the results are based on a small amount of information. Trials with different interventions and different or more people may give a different result."
}
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query-laysum
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8143
|
[
{
"role": "user",
"content": "Abstract: Background\nExcessive alcohol use contributes significantly to physical and psychological illness, injury and death, and a wide array of social harm in all age groups. A proven strategy for reducing excessive alcohol consumption levels is to offer a brief conversation-based intervention in primary care settings, but more recent technological innovations have enabled people to interact directly via computer, mobile device or smartphone with digital interventions designed to address problem alcohol consumption.\nObjectives\nTo assess the effectiveness and cost-effectiveness of digital interventions for reducing hazardous and harmful alcohol consumption, alcohol-related problems, or both, in people living in the community, specifically: (i) Are digital interventions more effective and cost-effective than no intervention (or minimal input) controls? (ii) Are digital interventions at least equally effective as face-to-face brief alcohol interventions? (iii) What are the effective component behaviour change techniques (BCTs) of such interventions and their mechanisms of action? (iv) What theories or models have been used in the development and/or evaluation of the intervention? Secondary objectives were (i) to assess whether outcomes differ between trials where the digital intervention targets participants attending health, social care, education or other community-based settings and those where it is offered remotely via the internet or mobile phone platforms; (ii) to specify interventions according to their mode of delivery (e.g. functionality features) and assess the impact of mode of delivery on outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, PsycINFO, CINAHL, ERIC, HTA and Web of Knowledge databases; ClinicalTrials.com and WHO ICTRP trials registers and relevant websites to April 2017. We also checked the reference lists of included trials and relevant systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated the effectiveness of digital interventions compared with no intervention or with face-to-face interventions for reducing hazardous or harmful alcohol consumption in people living in the community and reported a measure of alcohol consumption.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included 57 studies which randomised a total of 34,390 participants. The main sources of bias were from attrition and participant blinding (36% and 21% of studies respectively, high risk of bias). Forty one studies (42 comparisons, 19,241 participants) provided data for the primary meta-analysis, which demonstrated that participants using a digital intervention drank approximately 23 g alcohol weekly (95% CI 15 to 30) (about 3 UK units) less than participants who received no or minimal interventions at end of follow up (moderate-quality evidence).\nFifteen studies (16 comparisons, 10,862 participants) demonstrated that participants who engaged with digital interventions had less than one drinking day per month fewer than no intervention controls (moderate-quality evidence), 15 studies (3587 participants) showed about one binge drinking session less per month in the intervention group compared to no intervention controls (moderate-quality evidence), and in 15 studies (9791 participants) intervention participants drank one unit per occasion less than no intervention control participants (moderate-quality evidence).\nOnly five small studies (390 participants) compared digital and face-to-face interventions. There was no difference in alcohol consumption at end of follow up (MD 0.52 g/week, 95% CI -24.59 to 25.63; low-quality evidence). Thus, digital alcohol interventions produced broadly similar outcomes in these studies. No studies reported whether any adverse effects resulted from the interventions.\nA median of nine BCTs were used in experimental arms (range = 1 to 22). 'B' is an estimate of effect (MD in quantity of drinking, expressed in g/week) per unit increase in the BCT, and is a way to report whether individual BCTs are linked to the effect of the intervention. The BCTs of goal setting (B -43.94, 95% CI -78.59 to -9.30), problem solving (B -48.03, 95% CI -77.79 to -18.27), information about antecedents (B -74.20, 95% CI -117.72 to -30.68), behaviour substitution (B -123.71, 95% CI -184.63 to -62.80) and credible source (B -39.89, 95% CI -72.66 to -7.11) were significantly associated with reduced alcohol consumption in unadjusted models. In a multivariable model that included BCTs with B > 23 in the unadjusted model, the BCTs of behaviour substitution (B -95.12, 95% CI -162.90 to -27.34), problem solving (B -45.92, 95% CI -90.97 to -0.87), and credible source (B -32.09, 95% CI -60.64 to -3.55) were associated with reduced alcohol consumption.\nThe most frequently mentioned theories or models in the included studies were Motivational Interviewing Theory (7/20), Transtheoretical Model (6/20) and Social Norms Theory (6/20). Over half of the interventions (n = 21, 51%) made no mention of theory. Only two studies used theory to select participants or tailor the intervention. There was no evidence of an association between reporting theory use and intervention effectiveness.\nAuthors' conclusions\nThere is moderate-quality evidence that digital interventions may lower alcohol consumption, with an average reduction of up to three (UK) standard drinks per week compared to control participants. Substantial heterogeneity and risk of performance and publication bias may mean the reduction was lower. Low-quality evidence from fewer studies suggested there may be little or no difference in impact on alcohol consumption between digital and face-to-face interventions.\nThe BCTs of behaviour substitution, problem solving and credible source were associated with the effectiveness of digital interventions to reduce alcohol consumption and warrant further investigation in an experimental context.\nReporting of theory use was very limited and often unclear when present. Over half of the interventions made no reference to any theories. Limited reporting of theory use was unrelated to heterogeneity in intervention effectiveness.\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 aimed to find out if personalised advice to reduce heavy drinking provided using a computer or mobile device is better than nothing or printed information. We also compared advice provided using a computer or mobile device to advice given in a face-to-face conversation. The main outcome was how much alcohol people drank."
}
] |
query-laysum
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8144
|
[
{
"role": "user",
"content": "Abstract: Background\nAscites is the accumulation of fluid within the abdominal cavity. Most women with advanced ovarian cancer and some women with advanced endometrial cancer need repeated drainage for ascites. Guidelines to advise those involved in the drainage of ascites are usually produced locally and are generally not evidence-based. Managing drains that improve the efficacy and quality of the procedure is key in making recommendations that could improve the quality of life (QoL) for women at this critical period of their lives.\nObjectives\nTo evaluate the effectiveness and adverse events of different interventions for the management of malignant ascites drainage in the palliative care of women with gynaecological cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase to 4 November 2019. We checked clinical trial registries, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of women with malignant ascites with gynaecological cancer. If studies also included women with non-gynaecological cancer, we planned to extract data specifically for women with gynaecological cancers or request the data from trial authors. If this was not possible, we planned to include the study only if at least 50% of participants were diagnosed with gynaecological cancer.\nData collection and analysis\nTwo review authors independently selected studies, extracted data, evaluated the quality of the included studies, compared results, and assessed the certainty of the evidence using Cochrane methodology.\nMain results\nIn the original 2010 review, we identified no relevant studies. This updated review included one RCT involving 245 participants that compared abdominal paracentesis and intraperitoneal infusion of catumaxomab versus abdominal paracentesis alone. The study was at high risk of bias in almost all domains. The data were not suitable for analysis. The median time to the first deterioration of QoL ranged from 19 to 26 days in participants receiving paracentesis alone compared to 47 to 49 days among participants receiving paracentesis with catumaxomab infusion (very low-certainty evidence). Adverse events were only reported among participants receiving catumaxomab infusion. The most common severe adverse events were abdominal pain and lymphopenia (157 participants; very low-certainty evidence). There were no data on the improvement of symptoms, satisfaction of participants and caregivers, and cost-effectiveness.\nAuthors' conclusions\nCurrently, there is insufficient evidence to recommend the most appropriate management of drainage for malignant ascites among women with gynaecological cancer, as there was only very low-certainty evidence from one small RCT at overall high risk of bias.\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": "Malignant ascites is the build-up of fluid within the abdominal cavity caused by underlying cancer. Women with advanced ovarian cancer and some women with advanced uterine cancer (also known as womb cancer) often need drainage for malignant ascites to alleviate discomfort. Guidelines to advise healthcare professionals involved in the drainage of ascites are usually produced locally and are generally based on clinicians' experience."
}
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query-laysum
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8145
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[
{
"role": "user",
"content": "Abstract: Background\nSerious illness is often characterised by physical/psychological problems, family support needs, and high healthcare resource use. Hospital-based specialist palliative care (HSPC) has developed to assist in better meeting the needs of patients and their families and potentially reducing hospital care expenditure. There is a need for clarity on the effectiveness and optimal models of HSPC, given that most people still die in hospital and also to allocate scarce resources judiciously.\nObjectives\nTo assess the effectiveness and cost-effectiveness of HSPC compared to usual care for adults with advanced illness (hereafter patients) and their unpaid caregivers/families.\nSearch methods\nWe searched CENTRAL, CDSR, DARE and HTA database via the Cochrane Library; MEDLINE; Embase; CINAHL; PsycINFO; CareSearch; National Health Service Economic Evaluation Database (NHS EED) and two trial registers to August 2019, together with checking of reference lists and relevant systematic reviews, citation searching and contact with experts to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating the impact of HSPC on outcomes for patients or their unpaid caregivers/families, or both. HSPC was defined as specialist palliative care delivered by a palliative care team that is based in a hospital providing holistic care, co-ordination by a multidisciplinary team, and collaboration between HSPC providers and generalists. HSPC was provided to patients while they were admitted as inpatients to acute care hospitals, outpatients or patients receiving care from hospital outreach teams at home. The comparator was usual care, defined as inpatient or outpatient hospital care without specialist palliative care input at the point of entry into the study, community care or hospice care provided outside of the hospital setting.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We assessed risk of bias and extracted data. To account for use of different scales across studies, we calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for continuous data. We used an inverse variance random-effects model. For binary data, we calculated odds ratio (ORs) with 95% CIs. We assessed the evidence using GRADE and created a 'Summary of findings' table.\nOur primary outcomes were patient health-related quality of life (HRQoL) and symptom burden (a collection of two or more symptoms). Key secondary outcomes were pain, depression, satisfaction with care, achieving preferred place of death, mortality/survival, unpaid caregiver burden, and cost-effectiveness. Qualitative data was analysed where available.\nMain results\nWe identified 42 RCTs involving 7779 participants (6678 patients and 1101 caregivers/family members). Twenty-one studies were with cancer populations, 14 were with non-cancer populations (of which six were with heart failure patients), and seven with mixed cancer and non-cancer populations (mixed diagnoses).\nHSPC was offered in different ways and included the following models: ward-based, inpatient consult, outpatient, hospital-at-home or hospital outreach, and service provision across multiple settings which included hospital. For our main analyses, we pooled data from studies reporting adjusted endpoint values. Forty studies had a high risk of bias in at least one domain.\nCompared with usual care, HSPC improved patient HRQoL with a small effect size of 0.26 SMD over usual care (95% CI 0.15 to 0.37; I2 = 3%, 10 studies, 1344 participants, low-quality evidence, higher scores indicate better patient HRQoL). HSPC also improved other person-centred outcomes. It reduced patient symptom burden with a small effect size of -0.26 SMD over usual care (95% CI -0.41 to -0.12; I2 = 0%, 6 studies, 761 participants, very low-quality evidence, lower scores indicate lower symptom burden). HSPC improved patient satisfaction with care with a small effect size of 0.36 SMD over usual care (95% CI 0.41 to 0.57; I2 = 0%, 2 studies, 337 participants, low-quality evidence, higher scores indicate better patient satisfaction with care). Using home death as a proxy measure for achieving patient's preferred place of death, patients were more likely to die at home with HSPC compared to usual care (OR 1.63, 95% CI 1.23 to 2.16; I2 = 0%, 7 studies, 861 participants, low-quality evidence). Data on pain (4 studies, 525 participants) showed no evidence of a difference between HSPC and usual care (SMD -0.16, 95% CI -0.33 to 0.01; I2 = 0%, very low-quality evidence). Eight studies (N = 1252 participants) reported on adverse events and very low-quality evidence did not demonstrate an effect of HSPC on serious harms. Two studies (170 participants) presented data on caregiver burden and both found no evidence of effect of HSPC (very low-quality evidence). We included 13 economic studies (2103 participants). Overall, the evidence on cost-effectiveness of HSPC compared to usual care was inconsistent among the four full economic studies. Other studies that used only partial economic analysis and those that presented more limited resource use and cost information also had inconsistent results (very low-quality evidence).\nQuality of the evidence\nThe quality of the evidence assessed using GRADE was very low to low, downgraded due to a high risk of bias, inconsistency and imprecision.\nAuthors' conclusions\nVery low- to low-quality evidence suggests that when compared to usual care, HSPC may offer small benefits for several person-centred outcomes including patient HRQoL, symptom burden and patient satisfaction with care, while also increasing the chances of patients dying in their preferred place (measured by home death). While we found no evidence that HSPC causes serious harms, the evidence was insufficient to draw strong conclusions. Although these are only small effect sizes, they may be clinically relevant at an advanced stage of disease with limited prognosis, and are person-centred outcomes important to many patients and families. More well conducted studies are needed to study populations with non-malignant diseases and mixed diagnoses, ward-based models of HSPC, 24 hours access (out-of-hours care) as part of HSPC, pain, achieving patient preferred place of care, patient satisfaction with care, caregiver outcomes (satisfaction with care, burden, depression, anxiety, grief, quality of life), and cost-effectiveness of HSPC. In addition, research is needed to provide validated person-centred outcomes to be used across studies and populations.\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": "When compared with usual care, HSPC may slightly improve a patient’s quality of life, symptom burden and their satisfaction with care. It may also increase their chances of dying at home. However, future research is likely to change these findings, since they are based on low-certainty evidence. We need further studies to evaluate the effect of HSPC on other outcomes, such as pain, caregivers’ burden, unwanted events and cost-effectiveness."
}
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query-laysum
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8146
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[
{
"role": "user",
"content": "Abstract: Background\nDrugs with combined alpha and beta blocking activity are commonly prescribed to treat hypertension. However, the blood pressure (BP) lowering efficacy of this class of beta blockers has not been systematically reviewed and quantified.\nObjectives\nTo quantify the dose-related effects of various types of dual alpha and beta adrenergic receptor blockers (dual receptor blockers) on systolic and diastolic blood pressure versus placebo in patients with primary hypertension.\nSearch methods\nWe searched the Cochrane Hypertension Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and ClinicalTrials.gov for randomized controlled trials up to October 2014. The WHO International Clinical Trials Registry Platform (ICTRP) is searched for inclusion in the Group's Specialised Register.\nSelection criteria\nRandomized double blind placebo controlled parallel or cross-over trials. Studies contained a beta blocker monotherapy arm with a fixed dose. Patients enrolled in the studies had primary hypertension at baseline. Duration of the studies was from three to 12 weeks. Drugs in this class of beta blockers are carvedilol, dilevalol and labetalol.\nData collection and analysis\nTwo review authors (GW and AL) confirmed the inclusion of studies and extracted the data independently. RevMan 5.3 was used to synthesize data.\nMain results\nWe included eight studies examining the blood pressure lowering efficacy of carvedilol and labetalol in 1493 hypertensive patients. Five of the included studies were parallel design; three were cross-over design. The two largest included studies were unpublished carvedilol studies. The estimates of BP lowering effect (systolic BP/diastolic BP millimeters of mercury; SPB/DBP mm Hg) were -4 mm Hg (95% confidence intervals (CI) -6 to -2)/-3 mm Hg (95% CI -4 to -2) for carvedilol (>1000 subjects) and -10 mm Hg (95% CI -14 to -7)/-7 mm Hg (95% CI -9 to -5) for labetalol (110 subjects). The effect of labetalol is likely to be exaggerated due to high risk of bias. Carvedilol, within the recommended dose range, did not show a significant dose response effect for SBP or DBP. Carvedilol had little or no effect on pulse pressure (-1 mm Hg) and did not change BP variability. Overall, once and twice the starting dose of carvedilol and labetalol lowered BP by -6 mm Hg (95% CI -7 to -4) /-4 mm Hg (95% CI -4 to -3) (low quality evidence) and lowered heart rate by five beats per minute (95% CI -6 to -4) (low quality evidence). Five studies (N = 1412) reported withdrawal due to adverse effects; the risk ratio was 0.88 (95% CI 0.54 to 1.42) (moderate quality evidence).\nAuthors' conclusions\nThis review provides low quality evidence that in patients with mild to moderate hypertension, dual receptor blockers lowered trough BP by an average of -6/-4 mm Hg and reduced heart rate by five beats per minute. Due to the larger sample size from the two unpublished studies, carvedilol provided a better estimate of BP lowering effect than labetalol. The BP lowering estimate from combining carvedilol once and twice the starting doses is -4/-3 mm Hg. Doses higher than the recommended starting dose did not provide additional BP reduction. Higher doses of dual receptor blockers caused more bradycardia than lower doses. Based on indirect comparison with other classes of drugs, the blood pressure lowering effect of dual alpha- and beta-receptor blockers is less than non-selective, beta1 selective and partial agonist beta blockers, as well as thiazides and drugs inhibiting the renin angiotensin system. Dual blockers also had little or no effect on reducing pulse pressure, which is similar to the other beta-blocker classes, but less than the average reduction of pulse pressure seen with thiazides and drugs inhibiting the renin angiotensin system. Patients taking dual receptor blockers were not more likely to withdraw from the study compared to patients taking placebo.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "On average, dual receptor blockers lowered systolic BP by six points, diastolic BP by four points and heart rate by five beats per minute in patients with mild to moderate high blood pressure. There were more data on the effects of carvedilol. On average, carvedilol lowered systolic BP by four points and diastolic BP by three points. Higher doses of dual receptor blockers caused more slowing of heart rate but not more lowering of BP. The BP lowering effect of dual receptor blockers was less than other classes of BP lowering drugs. Patients taking dual receptor blockers were not more likely to withdraw from the study compared to patients taking placebo."
}
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query-laysum
|
8147
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[
{
"role": "user",
"content": "Abstract: Background\nIn response to the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the impact of coronavirus disease 2019 (COVID-19), governments have implemented a variety of measures to control the spread of the virus and the associated disease. Among these, have been measures to control the pandemic in primary and secondary school settings.\nObjectives\nTo assess the effectiveness of measures implemented in the school setting to safely reopen schools, or keep schools open, or both, during the COVID-19 pandemic, with particular focus on the different types of measures implemented in school settings and the outcomes used to measure their impacts on transmission-related outcomes, healthcare utilisation outcomes, other health outcomes as well as societal, economic, and ecological outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Educational Resources Information Center, as well as COVID-19-specific databases, including the Cochrane COVID-19 Study Register and the WHO COVID-19 Global literature on coronavirus disease (indexing preprints) on 9 December 2020. We conducted backward-citation searches with existing reviews.\nSelection criteria\nWe considered experimental (i.e. randomised controlled trials; RCTs), quasi-experimental, observational and modelling studies assessing the effects of measures implemented in the school setting to safely reopen schools, or keep schools open, or both, during the COVID-19 pandemic. Outcome categories were (i) transmission-related outcomes (e.g. number or proportion of cases); (ii) healthcare utilisation outcomes (e.g. number or proportion of hospitalisations); (iii) other health outcomes (e.g. physical, social and mental health); and (iv) societal, economic and ecological outcomes (e.g. costs, human resources and education). We considered studies that included any population at risk of becoming infected with SARS-CoV-2 and/or developing COVID-19 disease including students, teachers, other school staff, or members of the wider community.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full texts. One review author extracted data and critically appraised each study. One additional review author validated the extracted data. To critically appraise included studies, we used the ROBINS-I tool for quasi-experimental and observational studies, the QUADAS-2 tool for observational screening studies, and a bespoke tool for modelling studies. We synthesised findings narratively. Three review authors made an initial assessment of the certainty of evidence with GRADE, and several review authors discussed and agreed on the ratings.\nMain results\nWe included 38 unique studies in the analysis, comprising 33 modelling studies, three observational studies, one quasi-experimental and one experimental study with modelling components.\nMeasures fell into four broad categories: (i) measures reducing the opportunity for contacts; (ii) measures making contacts safer; (iii) surveillance and response measures; and (iv) multicomponent measures. As comparators, we encountered the operation of schools with no measures in place, less intense measures in place, single versus multicomponent measures in place, or closure of schools.\nAcross all intervention categories and all study designs, very low- to low-certainty evidence ratings limit our confidence in the findings. Concerns with the quality of modelling studies related to potentially inappropriate assumptions about the model structure and input parameters, and an inadequate assessment of model uncertainty. Concerns with risk of bias in observational studies related to deviations from intended interventions or missing data. Across all categories, few studies reported on implementation or described how measures were implemented. Where we describe effects as 'positive', the direction of the point estimate of the effect favours the intervention(s); 'negative' effects do not favour the intervention.\nWe found 23 modelling studies assessing measures reducing the opportunity for contacts (i.e. alternating attendance, reduced class size). Most of these studies assessed transmission and healthcare utilisation outcomes, and all of these studies showed a reduction in transmission (e.g. a reduction in the number or proportion of cases, reproduction number) and healthcare utilisation (i.e. fewer hospitalisations) and mixed or negative effects on societal, economic and ecological outcomes (i.e. fewer number of days spent in school).\nWe identified 11 modelling studies and two observational studies assessing measures making contacts safer (i.e. mask wearing, cleaning, handwashing, ventilation). Five studies assessed the impact of combined measures to make contacts safer. They assessed transmission-related, healthcare utilisation, other health, and societal, economic and ecological outcomes. Most of these studies showed a reduction in transmission, and a reduction in hospitalisations; however, studies showed mixed or negative effects on societal, economic and ecological outcomes (i.e. fewer number of days spent in school).\nWe identified 13 modelling studies and one observational study assessing surveillance and response measures , including testing and isolation, and symptomatic screening and isolation. Twelve studies focused on mass testing and isolation measures, while two looked specifically at symptom-based screening and isolation. Outcomes included transmission, healthcare utilisation, other health, and societal, economic and ecological outcomes. Most of these studies showed effects in favour of the intervention in terms of reductions in transmission and hospitalisations, however some showed mixed or negative effects on societal, economic and ecological outcomes (e.g. fewer number of days spent in school).\nWe found three studies that reported outcomes relating to multicomponent measures , where it was not possible to disaggregate the effects of each individual intervention, including one modelling, one observational and one quasi-experimental study. These studies employed interventions, such as physical distancing, modification of school activities, testing, and exemption of high-risk students, using measures such as hand hygiene and mask wearing. Most of these studies showed a reduction in transmission, however some showed mixed or no effects.\nAs the majority of studies included in the review were modelling studies, there was a lack of empirical, real-world data, which meant that there were very little data on the actual implementation of interventions.\nAuthors' conclusions\nOur review suggests that a broad range of measures implemented in the school setting can have positive impacts on the transmission of SARS-CoV-2, and on healthcare utilisation outcomes related to COVID-19. The certainty of the evidence for most intervention-outcome combinations is very low, and the true effects of these measures are likely to be substantially different from those reported here. Measures implemented in the school setting may limit the number or proportion of cases and deaths, and may delay the progression of the pandemic. However, they may also lead to negative unintended consequences, such as fewer days spent in school (beyond those intended by the intervention). Further, most studies assessed the effects of a combination of interventions, which could not be disentangled to estimate their specific effects. Studies assessing measures to reduce contacts and to make contacts safer consistently predicted positive effects on transmission and healthcare utilisation, but may reduce the number of days students spent at school. Studies assessing surveillance and response measures predicted reductions in hospitalisations and school days missed due to infection or quarantine, however, there was mixed evidence on resources needed for surveillance. Evidence on multicomponent measures was mixed, mostly due to comparators. The magnitude of effects depends on multiple factors. New studies published since the original search date might heavily influence the overall conclusions and interpretation of findings for this review.\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 December 2020."
}
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query-laysum
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8148
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[
{
"role": "user",
"content": "Abstract: Background\nAffordable, feasible and efficacious interventions to reduce neonatal infections and improve neonatal survival are needed. Chlorhexidine, a broad spectrum topical antiseptic agent, is active against aerobic and anaerobic organisms and reduces neonatal bacterial colonisation and may reduce infection.\nObjectives\nTo evaluate the efficacy of neonatal skin or cord care with chlorhexidine versus routine care or no treatment for prevention of infections in late preterm or term newborn infants in hospital and community settings.\nSearch methods\nWe searched CENTRAL, latest issue of The Cochrane Library, MEDLINE (1966 to November 2013), EMBASE (1980 to November 2013), and CINAHL (1982 to November 2013). Ongoing trials were detected by searching the following databases: www.clinicaltrials.gov and www.controlled-trials.com.\nSelection criteria\nCluster and individual patient randomised controlled trials of chlorhexidine use (for skin care, or cord care, or both) in term or late preterm neonates in hospital and community settings were eligible for inclusion. Three authors independently screened and selected studies for inclusion.\nData collection and analysis\nTwo review authors independently extracted data, and assessed study risk of bias. The quality of evidence for each outcome was assessed using GRADE. We calculated pooled risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs), and presented results using GRADE 'Summary of findings' tables.\nMain results\nWe included 12 trials in this review. There were seven hospital-based and five community-based studies. In four studies maternal vaginal wash with chlorhexidine was done in addition to neonatal skin and cord care.\nNewborn skin or cord cleansing with chlorhexidine compared to usual care in hospitals\nLow-quality evidence from one trial showed that chlorhexidine cord cleansing compared to dry cord care may lead to no difference in neonatal mortality (RR 0.11, 95% CI 0.01 to 2.04). Moderate-quality evidence from two trials showed that chlorhexidine cord cleansing compared to dry cord care probably reduces the risk of omphalitis/infections (RR 0.48, 95% CI 0.28 to 0.84).\nLow-quality evidence from two trials showed that chlorhexidine skin cleansing compared to dry cord care may lead to no difference in omphalitis/infections (RR 0.88, 95% CI 0.56 to 1.39). None of the studies in this comparison reported effects of the treatments on neonatal mortality.\nNewborn skin or cord cleansing with chlorhexidine compared to usual care in the community\nHigh-quality evidence from three trials showed that chlorhexidine cord cleansing compared to dry cord care reduces neonatal mortality (RR 0.81, 95% CI 0.71 to 0.92) and omphalitis/infections (RR 0.48, 95% CI 0.40 to 0.57).\nHigh-quality evidence from one trial showed no difference between chlorhexidine skin cleansing and usual skin care on neonatal mortality (RR 1.03, 95% CI 0.87 to 1.23). None of the studies in this comparison reported effects of the treatments on omphalitis/infections.\nMaternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention (sterile saline solution) in hospitals\nModerate-quality evidence from one trial showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on neonatal mortality (RR 0.98, 95% CI 0.67 to 1.42). High-quality evidence from two trials showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on the risk of infections (RR 0.93, 95% CI 0.82 to 1.16).\nFindings from one trial showed that maternal vaginal cleansing in addition to total body cleansing results in increased risk of hypothermia (RR 1.33, 95% CI 1.19 to 1.49).\nMaternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention (sterile saline solution) in the community\nLow-quality evidence from one trial showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on neonatal mortality (RR 0.20, 95% CI 0.01 to 4.03). Moderate-quality evidence from one trial showed that maternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention probably reduces the risk of neonatal infections (RR 0.69, 95% CI 0.49 to 0.95). These studies did not report effect on omphalitis.\nAuthors' conclusions\nThere is some uncertainty as to the effect of chlorhexidine applied to the umbilical cords of newborns in hospital settings on neonatal mortality. The quality of evidence for the effects on infection are moderate for cord application and low for application to skin. There is high-quality evidence that chlorhexidine skin or cord care in the community setting results in a 50% reduction in the incidence of omphalitis and a 12% reduction in neonatal mortality. Maternal vaginal chlorhexidine compared to usual care probably leads to no difference in neonatal mortality in hospital settings. Maternal vaginal chlorhexidine compared to usual care results in no difference in the risk of infections in hospital settings. The uncertainty over the effect of maternal vaginal chlorhexidine on mortality outcomes reflects small sample sizes and low event rates in the community settings.\n\nGiven the provided abstract, please respond to the following query: \"Newborn skin or cord cleansing with chlorhexidine compared to usual care in the community\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chlorhexidine cord cleansing compared to dry cord care reduces neonatal mortality and omphalitis or infections. There was no difference between chlorhexidine skin cleansing and usual skin care on neonatal mortality (none of the studies in this comparison reported effects of the treatments on omphalitis or infections)."
}
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query-laysum
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8149
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[
{
"role": "user",
"content": "Abstract: Background\nSeptic arthritis is an acute infection of the joints characterised by erosive disruption of the articular space. It is the most common non-degenerative articular disease in developing countries. The most vulnerable population for septic arthritis includes infants and preschoolers, especially boys. Septic arthritis disproportionately affects populations of low socioeconomic status. Systemic corticosteroids and antibiotic therapy may be beneficial for treatment of septic arthritis. Even if the joint infection is eradicated by antibiotic treatment, the inflammatory process may produce residual joint damage and sequelae.\nObjectives\nTo determine the benefits and harms of corticosteroids as adjunctive therapy in children with a diagnosis of septic arthritis.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, Latin American Caribbean Health Sciences Literature (LILACS), the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/), ClinicalTrials.gov (www.ClinicalTrials.gov), and Google Scholar. We searched all databases from their inception to 17 April 2018, with no restrictions on language of publication.\nSelection criteria\nWe included randomised controlled trials (RCTs) with patients from two months to 18 years of age with a diagnosis of septic arthritis who were receiving corticosteroids in addition to antibiotic therapy or as an adjuvant to other therapies such as surgical drainage, intra-articular puncture, arthroscopic irrigation, or debridement.\nData collection and analysis\nTwo review authors independently assessed eligibility, data extraction, and evaluation of risk of bias. We considered as major outcomes the presence of pain, activities of daily living, normal physical joint function, days of antibiotic treatment, length of hospital stay, and numbers of total and serious adverse events. We used standard methodological procedures expected by Cochrane. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created a 'Summary of findings' table.\nMain results\nWe included two RCTs involving a total of 149 children between three months and 18 years of age who were receiving antibiotics for septic arthritis. The most commonly affected joints were hips and knees. These studies were performed in Costa Rica and Israel. In both studies, dexamethasone administered intravenously (ranging from 0.15 to 0.2 mg/kg/dose every six to eight hours) during four days was the corticosteroid, and the comparator was placebo. Trials excluded patients with any degree of immunodeficiency or immunosuppression. The longest follow-up was one year. Trials did not report activities of daily living nor length of hospital stay. Both studies used adequate processes for randomisation, allocation concealment, and blinding, and review authors judged them to have low risk of selection and performance bias. Losses to follow-up were substantive in both studies, and we judged them to have high risk of attrition bias and of selective outcome reporting. We graded all outcomes as low quality due to concerns about study limitations and imprecision.\nThe risk ratio (RR) for absence of pain at 12 months of follow-up was 1.33, favouring corticosteroids (95% confidence interval (CI) 1.03 to 1.72; P = 0.03; number needed to treat for an additional beneficial outcome (NNTB) = 13, 95% CI 6 to 139; absolute risk difference 24%, 95% CI 5% to 43%).\nThe RR for normal function of the affected joint at 12 months of follow-up was 1.32, favouring corticosteroids (95% CI 1.12 to 1.57; P = 0.001; NNTB = 13, 95% CI 7 to 33; absolute risk difference 24%, 95% CI 11% to 37%).\nWe found a reduction in the number of days of intravenous antibiotic treatment favouring corticosteroids (mean difference (MD) -2.77, 95% CI -4.16 to -1.39) based on two trials with 149 participants.\nResearchers did not report length of hospital stay. One trial (49 participants) reported that treatment with dexamethasone was associated with a shorter duration of IV antibiotic treatment, leading to a shorter hospital stay, and although duration of hospitalisation was a primary outcome of the study, study authors did not provide data on the duration of hospitalisation. We downgraded the quality by one level for concerns about study limitations (high risk of attrition bias and selective reporting), and by another level for imprecision.\nIn one trial of 49 participants, researchers followed 29 children for 12 months, and parents reported that no children demonstrated adverse effects of the intervention.\nAuthors' conclusions\nEvidence for corticosteroids as adjunctive therapy in children with a diagnosis of septic arthritis is of low quality and is derived from the findings of two trials (N = 149). Corticosteroids may increase the proportion of patients without pain and the proportion of patients with normal function of the affected joint at 12 months, and may also reduce the number of days of antibiotic treatment. However, we cannot draw strong conclusions based upon these trial results. Additional randomised clinical trials in children with relevant outcomes are needed.\n\nGiven the provided abstract, please respond to the following query: \"Length of hospital stay\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "1. We are uncertain whether corticosteroids had an effect on the length of hospital stay because the evidence was of very low quality"
}
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query-laysum
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8150
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[
{
"role": "user",
"content": "Abstract: Background\nProliferative diabetic retinopathy (PDR) is an advanced complication of diabetic retinopathy that can cause blindness. It consists of the presence of new vessels in the retina and vitreous haemorrhage. Although panretinal photocoagulation (PRP) is the treatment of choice for PDR, it has secondary effects that can affect vision. Anti-vascular endothelial growth factor (anti-VEGF), which produces an inhibition of vascular proliferation, could improve the vision of people with PDR.\nObjectives\nTo assess the effectiveness and safety of anti-VEGFs for PDR and summarise any relevant economic evaluations of their use.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov, and the WHO ICTRP. We did not use any date or language restrictions. We last searched the electronic databases on 1 June 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing anti-VEGFs to another active treatment, sham treatment, or no treatment for people with PDR. We also included studies that assessed the combination of anti-VEGFs with other treatments. We excluded studies that used anti-VEGFs in people undergoing vitrectomy.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data, and assessed the risk of bias (RoB) for all included trials. We calculated the risk ratio (RR) or the mean difference (MD), and 95% confidence intervals (CI). We used GRADE to assess the certainty of evidence.\nMain results\nWe included 15 new studies in this update, bringing the total to 23 RCTs with 1755 participants (2334 eyes). Forty-five per cent of participants were women and 55% were men, with a mean age of 56 years (range 48 to 77 years). The mean glycosylated haemoglobin (Hb1Ac) was 8.45% for the PRP group and 8.25% for people receiving anti-VEGFs alone or in combination. Twelve studies included people with PDR, and participants in 11 studies had high-risk PDR (HRPDR).\nTwelve studies were of bevacizumab, seven of ranibizumab, one of conbercept, two of pegaptanib, and one of aflibercept. The mean number of participants per RCT was 76 (ranging from 15 to 305). Most studies had an unclear or high RoB, mainly in the blinding of interventions and outcome assessors. A few studies had selective reporting and attrition bias.\nNo study reported loss or gain of 3 or more lines of visual acuity (VA) at 12 months. Anti-VEGFs ± PRP probably increase VA compared with PRP alone (mean difference (MD) -0.08 logMAR, 95% CI -0.12 to -0.04; I2 = 28%; 10 RCTS, 1172 eyes; moderate-certainty evidence). Anti-VEGFs ± PRP may increase regression of new vessels (MD -4.14 mm2, 95% CI -6.84 to -1.43; I2 = 75%; 4 RCTS, 189 eyes; low-certainty evidence) and probably increase a complete regression of new vessels (RR 1.63, 95% CI 1.19 to 2.24; I2 = 46%; 5 RCTS, 405 eyes; moderate-certainty evidence). Anti-VEGFs ± PRP probably reduce vitreous haemorrhage (RR 0.72, 95% CI 0.57 to 0.90; I2 = 0%; 6 RCTS, 1008 eyes; moderate-certainty evidence). Anti-VEGFs ± PRP may reduce the need for vitrectomy compared with eyes that received PRP alone (RR 0.67, 95% CI 0.49 to 0.93; I2 = 43%; 8 RCTs, 1248 eyes; low-certainty evidence). Anti-VEGFs ± PRP may result in little to no difference in the quality of life compared with PRP alone (MD 0.62, 95% CI -3.99 to 5.23; I2 = 0%; 2 RCTs, 382 participants; low-certainty evidence). We do not know if anti-VEGFs ± PRP compared with PRP alone had an impact on adverse events (very low-certainty evidence). We did not find differences in visual acuity in subgroup analyses comparing the type of anti-VEGFs, the severity of the disease (PDR versus HRPDR), time to follow-up (< 12 months versus 12 or more months), and treatment with anti-VEGFs + PRP versus anti-VEGFs alone.\nThe main reasons for downgrading the certainty of evidence included a high RoB, imprecision, and inconsistency of effect estimates.\nAuthors' conclusions\nAnti-VEGFs ± PRP compared with PRP alone probably increase visual acuity, but the degree of improvement is not clinically meaningful. Regarding secondary outcomes, anti-VEGFs ± PRP produce a regression of new vessels, reduce vitreous haemorrhage, and may reduce the need for vitrectomy compared with eyes that received PRP alone. We do not know if anti-VEGFs ± PRP have an impact on the incidence of adverse events and they may have little or no effect on patients' quality of life. Carefully designed and conducted clinical trials are required, assessing the optimal schedule of anti-VEGFs alone compared with PRP, and with a longer follow-up.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for randomised controlled trials (RCTs) comparing anti-VEGFs (combined or not with laser) to another active treatment, sham treatment, or no treatment for people with PDR. We also included studies that assessed the combination of anti-VEGFs with other treatments. We excluded studies in people undergoing vitrectomy or treatment to remove some or all of the gel that fills the space between the lens and the retina."
}
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query-laysum
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8151
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[
{
"role": "user",
"content": "Abstract: Background\nRosacea is a common chronic skin condition affecting the face, characterised by flushing, redness, pimples, pustules and dilated blood vessels. The eyes are often involved and thickening of the skin with enlargement (phymas), especially of the nose, can occur in some people. A range of treatment options are available but it is unclear which are most effective.\nObjectives\nTo assess the efficacy and safety of treatments for rosacea.\nSearch methods\nWe updated our searches, to July 2014, of: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2014, Issue 6), MEDLINE (from 1946), EMBASE (from 1974) and Science Citation Index (from 1988). We searched five trials registers and checked reference lists for further relevant studies.\nSelection criteria\nRandomised controlled trials in people with moderate to severe rosacea.\nData collection and analysis\nStudy selection, data extraction, risk of bias assessment and analyses were carried out independently by two authors.\nMain results\nWe included 106 studies, comprising 13,631 participants. Sample sizes of 30-100 and study duration of two to three months were most common. More women than men were included, mean age of 48.6 years, and the majority had papulopustular rosacea, followed by erythematotelangiectatic rosacea.\nA wide range of comparisons (67) were evaluated. Topical interventions: metronidazole, azelaic acid, ivermectin, brimonidine or other topical treatments. Systemic interventions: oral antibiotics, combinations with topical treatments or other systemic treatments, i.e. isotretinoin. Several studies evaluated laser or light-based treatment.\nThe majority of studies (57/106) were assessed as 'unclear risk of bias', 37 'high risk ' and 12 'low risk'. Twenty-two studies provided no usable or retrievable data i.e. none of our outcomes were addressed, no separate data reported for rosacea or limited data in abstracts.\nEleven studies assessed our primary outcome 'change in quality of life', 52 studies participant-assessed changes in rosacea severity and almost all studies addressed adverse events, although often only limited data were provided. In most comparisons there were no statistically significant differences in number of adverse events, most were mild and transient. Physician assessments including investigators' global assessments, lesion counts and erythema were evaluated in three-quarters of the studies, but time needed for improvement and duration of remission were incompletely or not reported.\nThe quality of the body of evidence was rated moderate to high for most outcomes, but for some outcomes low to very low.\nData for several outcomes could only be pooled for topical metronidazole and azelaic acid. Both were shown to be more effective than placebo in papulopustular rosacea (moderate quality evidence for metronidazole and high for azelaic acid). Pooled data from physician assessments in three trials demonstrated that metronidazole was more effective compared to placebo (risk ratio (RR) 1.98, 95% confidence interval (CI) 1.29 to 3.02). Four trials provided data on participants' assessments, illustrating that azelaic acid was more effective than placebo (RR 1.46, 95% CI 1.30 to 1.63). The results from three studies were contradictory on which of these two treatments was most effective.\nTwo studies showed a statistically significant and clinically important improvement in favour of topical ivermectin when compared to placebo (high quality evidence). Participants' assessments in these studies showed a RR of 1.78 (95% CI 1.50 to 2.11) and RR of 1.92 (95% CI 1.59 to 2.32),which were supported by physicians' assessments. Topical ivermectin appeared to be slightly more effective than topical metronidazole for papulopustular rosacea, based on one study, for improving quality of life and participant and physician assessed outcomes (high quality evidence for these outcomes).\nTopical brimonidine in two studies was more effective than vehicle in reducing erythema in rosacea at all time points over 12 hours (high quality evidence). At three hours the participants' assessments had a RR of 2.21 (95% CI 1.52 to 3.22) and RR of 2.00 (95% CI 1.33 to 3.01) in favour of brimonidine. Physicians' assessments confirmed these data. There was no rebound or worsening of erythema after treatment cessation.\nTopical clindamycin phosphate combined with tretinoin was not considered to be effective compared to placebo (moderate quality evidence).\nTopical ciclosporin ophthalmic emulsion demonstrated effectiveness and improved quality of life for people with ocular rosacea (low quality evidence).\nOf the comparisons assessing oral treatments for papulopustular rosacea there was moderate quality evidence that tetracycline was effective but this was based on two old studies of short duration. Physician-based assessments in two trials indicated that doxycycline appeared to be significantly more effective than placebo (RR 1.59, 95% CI 1.02 to 2.47 and RR 2.37, 95% CI 1.12 to 4.99) (high quality evidence). There was no statistically significant difference in effectiveness between 100 mg and 40 mg doxycycline, but there was evidence of fewer adverse effects with the lower dose (RR 0.25, 95% CI 0.11 to 0.54) (low quality evidence). There was very low quality evidence from one study (assessed at high risk of bias) that doxycycline 100 mg was as effective as azithromycin. Low dose minocycline (45 mg) was effective for papulopustular rosacea (low quality evidence).\nOral tetracycline was compared with topical metronidazole in four studies and showed no statistically significant difference between the two treatments for any outcome (low to moderate quality evidence).\nLow dose isotretinoin was considered by both the participants (RR 1.23, 95% CI 1.05 to 1.43) and physicians (RR 1.18, 95% CI 1.03 to 1.36) to be slightly more effective than doxycycline 50-100 mg (high quality evidence).\nPulsed dye laser was more effective than yttrium-aluminium-garnet (Nd:YAG) laser based on one study, and it appeared to be as effective as intense pulsed light therapy (both low quality evidence).\nAuthors' conclusions\nThere was high quality evidence to support the effectiveness of topical azelaic acid, topical ivermectin, brimonidine, doxycycline and isotretinoin for rosacea. Moderate quality evidence was available for topical metronidazole and oral tetracycline. There was low quality evidence for low dose minocycline, laser and intense pulsed light therapy and ciclosporin ophthalmic emulsion for ocular rosacea. Time needed to response and response duration should be addressed more completely, with more rigorous reporting of adverse events. Further studies on treatment of ocular rosacea are warranted.\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": "Rosacea is a common skin condition causing flushing, redness, red pimples and pustules on the face, and should not be confused with acne. Dilated blood vessels may appear near the surface of the skin (telangiectasia). It can also cause inflammation of the eyes or eyelids, or both (ocular rosacea). Some people can develop a thickening of the skin, especially of the nose (rhinophyma). Although the cause of rosacea remains unclear, a wide variety of treatments are available for this persistent (chronic) and recurring and often distressing disease. These include medications applied directly to the skin (topical), oral medications and light-based therapies. We wanted to discover how people assessed their treatments: if the treatments changed their quality of life, if they saw changes in their condition and if there were side effects. From the doctors, we wanted to discover whether treatments changed the severity of rosacea, as well as how long it took before symptoms reduced and reappeared."
}
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query-laysum
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8152
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[
{
"role": "user",
"content": "Abstract: Background\nGastric cancer is the third most common cause of cancer-related mortality in the world. Currently there are two surgical options for potentially curable patients (i.e. people with non-metastatic gastric cancer), laparoscopic and open gastrectomy. However, it is not clear whether one of these options is superior.\nObjectives\nTo assess the benefits and harms of laparoscopic gastrectomy or laparoscopy-assisted gastrectomy versus open gastrectomy for people with gastric cancer. In particular, we planned to investigate the effects by patient groups, such as cancer stage, anaesthetic risk, and body mass index (BMI), and by intervention methods, such as method of anastomosis, type of gastrectomy and laparoscopic or laparoscopically-assisted gastrectomy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index, ClinicalTrials.gov and the WHO ICTRP (World Health Organization International Clinical Trials Registry Platform) until September 2015. We also screened reference lists from included trials.\nSelection criteria\nTwo review authors independently selected references for further assessment by going through all titles and abstracts. Further selection was based on review of full text articles for selected references.\nData collection and analysis\nTwo review authors independently extracted study data. We calculated the risk ratio (RR) with 95% confidence interval (CI) for binary outcomes, the mean difference (MD) or the standardised mean difference (SMD) with 95% CI for continuous outcomes and the hazard ratio (HR) for time-to-event outcomes. We performed meta-analyses where it was meaningful.\nMain results\nIn total, 2794 participants were randomised in 13 trials included in this review. All the trials were at unclear or high risk of bias. One trial (which included 53 participants) did not contribute any data to this review. A total of 213 participants were excluded in the remaining trials after randomisation, leaving a total of 2528 randomised participants for analysis, with 1288 undergoing laparoscopic gastrectomy and 1240 undergoing open gastrectomy. All the participants were suitable for major surgery.\nThere was no difference in the proportion of participants who died within thirty days of treatment between laparoscopic gastrectomy (7/1188: adjusted proportion = 0.6% (based on meta-analysis)) and open gastrectomy (4/1447: 0.3%) (RR 1.60, 95% CI 0.50 to 5.10; risk difference 0.00, 95% CI -0.01 to 0.01; participants = 2335; studies = 11; I2 = 0%; low quality evidence). There were no events in either group for short-term recurrence (participants = 103; studies = 3), proportion requiring blood transfusion (participants = 66; studies = 2), and proportion with positive margins at histopathology (participants = 28; studies = 1). None of the trials reported health-related quality of life, time to return to normal activity or time to return to work. The differences in long-term mortality (HR 0.94, 95% CI 0.70 to 1.25; participants = 195; studies = 3; I2 = 0%; very low quality evidence), serious adverse events within three months (laparoscopic gastrectomy (7/216: adjusted proportion = 3.6%) versus open gastrectomy (13/216: 6%) (RR 0.60, 95% CI 0.27 to 1.34; participants = 432; studies = 8; I2 = 0%; very low quality evidence), long-term recurrence (HR 0.95, 95% CI 0.70 to 1.30; participants = 162; studies = 4; very low quality evidence), adverse events within three months (laparoscopic gastrectomy (204/268: adjusted proportion = 16.1%) versus open gastrectomy (253/1222: 20.7%) (RR 0.78, 95% CI 0.60 to 1.01; participants = 2490; studies = 11; I2 = 38%; very low quality evidence), quantity of perioperative blood transfused (SMD 0.05, 95% CI -0.27 to 0.38; participants = 143; studies = 2; I2 = 0%; very low quality evidence), length of hospital stay (MD -1.82 days, 95% CI -3.72 to 0.07; participants = 319; studies = 6; I2 = 83%; very low quality evidence), and number of lymph nodes harvested (MD -0.63, 95% CI -1.51 to 0.25; participants = 472; studies = 9; I2 = 40%; very low quality evidence) were imprecise. There was no alteration in the interpretation of the results in any of the subgroups.\nAuthors' conclusions\nBased on low quality evidence, there is no difference in short-term mortality between laparoscopic and open gastrectomy. Based on very low quality evidence, there is no evidence for any differences in short-term or long-term outcomes between laparoscopic and open gastrectomy. However, the data are sparse, and the confidence intervals were wide, suggesting that significant benefits or harms of laparoscopic gastrectomy cannot be ruled out. Several trials are currently being conducted and interim results of these trials have been included in this review. These trials need to perform intention-to-treat analysis to ensure that the results are reliable and report the results according to the CONSORT Statement.\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 evidence was very low for all outcomes, apart from short-term mortality, which was low. As a result, there is a lot of uncertainty regarding the results."
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query-laysum
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8153
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[
{
"role": "user",
"content": "Abstract: Background\nDespite considerable improvement in outcomes for preterm infants, rates of bronchopulmonary dysplasia (BPD) remain high, affecting an estimated 33% of very low birthweight infants, with corresponding long-term respiratory and neurosensory issues. Systemic corticosteroids can address the inflammation underlying BPD, but the optimal regimen for prevention of this disease, balancing of the benefits with the potentially meaningful risks of systemic corticosteroids, continues to be a medical quandary.\nNumerous studies have shown that systemic corticosteroids, particularly dexamethasone and hydrocortisone, effectively treat or prevent BPD. However, concerning short and long-term side effects have been reported and the optimal approach to corticosteroid treatment remains unclear.\nObjectives\nTo determine whether differences in efficacy and safety exist between high-dose dexamethasone, moderate-dose dexamethasone, low-dose dexamethasone, hydrocortisone, and placebo in the prevention of BPD, death, the composite outcome of death or BPD, and other relevant morbidities, in preterm infants through a network meta-analysis, generating both pairwise comparisons between all treatments and rankings of the treatments.\nSearch methods\nWe searched the Cochrane Library for all systematic reviews of systemic corticosteroids for the prevention of BPD and searched for completed and ongoing studies in the following databases in January 2023: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and clinical trial databases.\nSelection criteria\nWe included randomized controlled trials (RCTs) in preterm infants (< 37 weeks’ gestation) at risk for BPD that evaluated systemic corticosteroids (high-dose [≥ 4 mg/kg cumulative dose] dexamethasone, moderate-dose [≥ 2 to < 4 mg/kg] dexamethasone, low-dose [< 2 mg/kg] dexamethasone, or hydrocortisone) versus control or another systemic corticosteroid.\nData collection and analysis\nOur main information sources were the systematic reviews, with reference to the original manuscript only for data not included in these reviews. Teams of two paired review authors independently performed data extraction, with disagreements resolved by discussion. Data were entered into Review Manager 5 and exported to R software for network meta-analysis (NMA). NMA was performed using a frequentist model with random-effects. Two separate networks were constructed, one for early (< seven days) initiation of treatment and one for late (≥ seven days) treatment initiation, to reflect the different patient populations evaluated. We assessed the certainty of evidence derived from the NMA for our primary outcomes using principles of the GRADE framework modified for application to NMA.\nMain results\nWe included 59 studies, involving 6441 infants, in our analyses.\nOnly six of the included studies provided direct comparisons between any of the treatment (dexamethasone or hydrocortisone) groups, forcing network comparisons between treatments to rely heavily on indirect evidence through comparisons with placebo/no treatment groups. Thirty-one studies evaluated early corticosteroid treatment, 27 evaluated late corticosteroid treatment, and one study evaluated both early and late corticosteroid treatments.\nEarly treatment (prior to seven days after birth):\nBenefits:NMA for early treatment showed only moderate-dose dexamethasone to decrease the risk of BPD at 36 weeks' postmenstrual age (PMA) compared with control (RR 0.56, 95% CI 0.39 to 0.80; moderate-certainty evidence), although the other dexamethasone dosing regimens may have similar effects compared with control (high-dose dexamethasone, RR 0.71, 95% CI 0.50 to 1.01; low-certainty evidence; low-dose dexamethasone, RR 0.83, 95% CI 0.67 to 1.03; low-certainty evidence). Other early treatment regimens may have little or no effect on the risk of death at 36 weeks' PMA. Only moderate-dose dexamethasone decreased the composite outcome of death or BPD at 36 weeks' PMA compared with control (RR 0.77, 95% CI 0.60 to 0.98; moderate-certainty evidence).\nHarms: Low-dose dexamethasone increased the risk for cerebral palsy (RR 1.92, 95% CI 1.12 to 3.28; moderate-certainty evidence) compared with control. Hydrocortisone may decrease the risk of major neurosensory disability versus low-dose dexamethasone (RR 0.65, 95% CI 0.41 to 1.01; low-certainty evidence).\nLate treatment (at seven days or later after birth):\nBenefits: NMA for late treatment showed high-dose dexamethasone to decrease the risk of BPD both versus hydrocortisone (RR 0.66, 95% CI 0.51 to 0.85; low-certainty evidence) and versus control (RR 0.72, CI 0.59 to 0.87; moderate-certainty evidence). The late treatment regimens evaluated may have little or no effect on the risk of death at 36 weeks' PMA. High-dose dexamethasone decreased risk for the composite outcome of death or BPD compared with all other treatments (control, RR 0.69, 95% CI 0.59 to 0.80, high-certainty evidence; hydrocortisone, RR 0.69, 95% CI 0.58 to 0.84, low-certainty evidence; low-dose dexamethasone, RR 0.73, 95% CI 0.60 to 0.88, low-certainty evidence; moderate-dose dexamethasone, RR 0.76, 95% CI 0.62 to 0.93, low-certainty evidence).\nHarms: No effect was observed for the outcomes of major neurosensory disability or cerebral palsy.\nThe evidence for the primary outcomes was of overall low certainty, with notable deductions for imprecision and heterogeneity across the networks.\nAuthors' conclusions\nWhile early treatment with moderate-dose dexamethasone or late treatment with high-dose dexamethasone may lead to the best effects for survival without BPD, the certainty of the evidence is low. There is insufficient evidence to guide this therapy with regard to plausible adverse long-term outcomes. Further RCTs with direct comparisons between systemic corticosteroid treatments are needed to determine the optimal treatment approach, and these studies should be adequately powered to evaluate survival without major neurosensory disability.\n\nGiven the provided abstract, please respond to the following query: \"How can BPD be prevented?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Anti-inflammatory drugs known as corticosteroids can decrease the development of BPD through their anti-inflammatory properties, but they also have their own potential risks. The optimal corticosteroid treatment plan to balance these benefits and risks is unknown, including which type of corticosteroid (options include dexamethasone and hydrocortisone), what dose of corticosteroid, and at what age to start treatment."
}
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query-laysum
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8154
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[
{
"role": "user",
"content": "Abstract: Background\nRisky consumption of alcohol is a global problem. More than 3.3 million deaths annually are associated with risky use of alcohol, and global alcohol consumption continues to increase. People who have high alcohol consumption often require planned and emergency surgical procedures.\nRisky drinking is associated with increased postoperative complications such as infections, cardiopulmonary complications, and bleeding episodes. Alcohol causes disorders of the liver, pancreas, and nervous system. Stopping consumption of alcohol can normalize these organ systems to some degree and may reduce the occurrence of complications after surgery.\nThis review was first published in 2012 and was updated in 2018.\nObjectives\nTo assess the effects of perioperative alcohol cessation interventions on rates of postoperative complications and alcohol consumption.\nSearch methods\nWe searched the following databases up until 21 September 2018: Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; CINAHL via EBSCOhost; and two trials registers. We scanned the reference lists and citations of included trials and any identified relevant systematic reviews for further references to additional trials. When necessary, we contacted trial authors to ask for additional information.\nSelection criteria\nWe included all randomized controlled trials (RCTs) that evaluated the effects of perioperative alcohol cessation interventions on postoperative complications and alcohol consumption. We included participants with risky consumption of alcohol who were undergoing all types of elective or acute surgical procedures under general or regional anaesthesia or sedation, who were offered a perioperative alcohol cessation intervention or no intervention.\nWe defined 'risky drinking' as alcohol consumption equivalent to more than 3 alcoholic units (AU)/d or 21 AU/week (with 1 AU containing 12 grams of ethanol) with or without symptoms of alcohol abuse or dependency. This corresponds to the amount of alcohol associated with increased postoperative complication rates in most clinical studies.\nData collection and analysis\nWe used guidance provided in the Cochrane Handbook for Systematic Reviews of Interventions. We presented main outcomes as dichotomous variables in a meta-analysis. When data were available, we conducted subgroup and sensitivity analyses to explore the risk of bias. Primary outcome measures were postoperative complications and in-hospital and 30-day mortality. Secondary outcomes were successful quitting at the end of the programme, postoperative alcohol use, and length of hospital stay. We assessed the quality of evidence using the GRADE approach.\nMain results\nWe included in this updated review one new study (70 participants), resulting in a total of three RCTs (140 participants who drank 3 to 40 AU/d). All three studies were of moderate to good quality. All studies evaluated the effects of intensive alcohol cessation interventions, including pharmacological strategies for alcohol withdrawal symptoms, patient education, and relapse prophylaxis. We identified one ongoing study.\nOverall, 53 of the 122 participants from three studies who underwent surgery developed any type of postoperative complication that required treatment. Of 61 participants in the intervention groups, 20 had complications, compared with 33 of 61 participants in the control groups (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.40 to 0.96). Results show differences between the three clinical studies regarding outcome measurement and intensity of the interventions. However, all alcohol cessation programmes were intensive and included pharmacological therapy. The overall quality of evidence for this outcome is moderate.\nIn-hospital and 30-day postoperative mortality rates were low in the three studies. Researchers reported one death among 61 participants in the intervention groups, and three deaths among 61 participants in the control groups (RR 0.47, 95% CI 0.07 to 2.96). The quality of evidence for this outcome is low.\nInvestigators describe more successful quitters at the end of the intervention programme than among controls. Forty-one out of 70 participants in the intervention groups successfully quit drinking compared with only five out of 70 participants in the control groups (RR 8.22, 95% CI 1.67 to 40.44). The quality of evidence for this outcome is moderate.\nAll three studies reported postoperative alcohol consumption (grams of alcohol/week) at the end of the programme as median and range values; therefore it was not possible to estimate the mean and the standard deviation (SD). We performed no meta-analysis. All three studies reported length of stay, and none of these studies described a significant difference in length of stay. Data were insufficient for review authors to perform a meta-analysis. No studies reported on the prevalence of participants without risky drinking in the longer term.\nAuthors' conclusions\nThis systematic review assessed the efficacy of perioperative alcohol cessation interventions for postoperative complications and alcohol consumption. All three studies showed a significant reduction in the number of participants who quit drinking alcohol during the intervention period. Intensive alcohol cessation interventions offered for four to eight weeks to participants undergoing all types of surgical procedures to achieve complete alcohol cessation before surgery probably reduced the number of postoperative complications. Data were insufficient for review authors to assess their effects on postoperative mortality. No studies reported an effect on length of stay, and no studies addressed the prevalence of risky drinking in the longer term.\nIncluded studies were few and reported small sample sizes; therefore one should be careful about drawing firm conclusions based on these study results. All three studies were conducted in Denmark, and most participants were men. The included participants may represent a selective group, as they could have been more motivated and/or more interested in participating in clinical research or otherwise different, and effects may have been overestimated for both intervention and control groups in these studies. Trial results indicate that these studies are difficult to perform, that strong research competencies are necessary for future studies, and that further evaluation of perioperative alcohol cessation interventions in high-quality randomized controlled trials is needed. Once published and assessed, the one 'ongoing' study identified may alter the conclusions of this review.\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 assessed the evidence from randomized controlled trials to determine whether not drinking alcohol during the perioperative period reduces postoperative complications for people with risky alcohol consumption. These programmes supported participants in quitting drinking or in reducing their alcohol consumption before, during, and after surgery. 'Risky drinking' was defined as alcohol consumption equivalent to more than 3 alcoholic units (three small glasses of wine) per day or 21 units per week - with or without alcohol abuse or dependency. Most clinical studies report that consuming this amount of alcohol increases postoperative complication rates."
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query-laysum
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8155
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[
{
"role": "user",
"content": "Abstract: Background\nInfertility is a condition affecting 10% to 15% of couples of reproductive age. It is generally defined as \"the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse\". The treatment of infertility may involve manipulation of gametes or of the embryos themselves. These techniques are together known as assisted reproductive technology (ART). Practitioners are constantly seeking alternative or adjunct treatments, or both, in the hope that they may improve the outcome of assisted reproductive techniques. This Cochrane review focusses on the adjunct use of synthetic versions of two naturally-produced hormones, dehydroepiandrosterone (DHEA) and testosterone (T), in assisted reproduction.\nDHEA and its derivative testosterone are steroid hormones proposed to increase conception rates by positively affecting follicular response to gonadotrophin stimulation, leading to greater oocyte yields and, in turn, increased chance of pregnancy.\nObjectives\nTo assess the effectiveness and safety of DHEA and testosterone as pre- or co-treatments in subfertile women undergoing assisted reproduction.\nSearch methods\nWe searched the following electronic databases, trial registers and websites up to 12 March 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, MEDLINE, EMBASE, PsycINFO, CINAHL, electronic trial registers for ongoing and registered trials, citation indexes, conference abstracts in the Web of Science, PubMed and OpenSIGLE. We also carried out handsearches. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing DHEA or testosterone as an adjunct treatment to any other active intervention, placebo, or no treatment in women undergoing assisted reproduction.\nData collection and analysis\nTwo review authors independently selected studies, extracted relevant data and assessed them for risk of bias. We pooled studies using fixed-effect models. We calculated odds ratios (ORs) for each dichotomous outcome. Analyses were stratified by type of treatment. There were no data for the intended groupings by dose, mode of delivery or after one/more than one cycle.\nWe assessed the overall quality of the evidence for the main findings using the GRADE working group methods.\nMain results\nWe included 17 RCTs with a total of 1496 participants. Apart from two trials, the trial participants were women identified as 'poor responders' to standard IVF protocols. The included trials compared either testosterone or DHEA treatment with placebo or no treatment.\nWhen DHEA was compared with placebo or no treatment, pre-treatment with DHEA was associated with higher rates of live birth or ongoing pregnancy (OR 1.88, 95% CI 1.30 to 2.71; eight RCTs, N = 878, I² statistic = 27%, moderate quality evidence). This suggests that in women with a 12% chance of live birth/ongoing pregnancy with placebo or no treatment, the live birth/ongoing pregnancy rate in women using DHEA will be between 15% and 26%. However, in a sensitivity analysis removing trials at high risk of performance bias, the effect size was reduced and no longer reached significance (OR 1.50, 95% CI 0.88 to 2.56; five RCTs, N = 306, I² statistic = 43%). There was no evidence of a difference in miscarriage rates (OR 0.58, 95% CI 0.29 to 1.17; eight RCTs, N = 950, I² statistic = 0%, moderate quality evidence). Multiple pregnancy data were available for five trials, with one multiple pregnancy in the DHEA group of one trial (OR 3.23, 95% CI 0.13 to 81.01; five RCTs, N = 267, very low quality evidence).\nWhen testosterone was compared with placebo or no treatment we found that pre-treatment with testosterone was associated with higher live birth rates (OR 2.60, 95% CI 1.30 to 5.20; four RCTs, N = 345, I² statistic = 0%, moderate evidence). This suggests that in women with an 8% chance of live birth with placebo or no treatment, the live birth rate in women using testosterone will be between 10% and 32%. On removal of studies at high risk of performance bias in a sensitivity analysis, the remaining study showed no evidence of a difference between the groups (OR 2.00, 95% CI 0.17 to 23.49; one RCT, N = 53). There was no evidence of a difference in miscarriage rates (OR 2.04, 95% CI 0.58 to 7.13; four RCTs, N = 345, I² = 0%, low quality evidence). Multiple pregnancy data were available for three trials, with four events in the testosterone group and one in the placebo/no treatment group (OR 3.09, 95% CI 0.48 to 19.98; three RCTs, N = 292, very low quality evidence).\nOne study compared testosterone with estradiol and reported no evidence of a difference in live birth rates (OR 2.06, 95% CI 0.43 to 9.87; one RCT, N = 46, very low quality evidence) or miscarriage rates (OR 0.70, 95% CI 0.11 to 4.64; one RCT, N = 46, very low quality evidence).\nThe quality of the evidence was moderate, the main limitations being lack of blinding in the included trials, inadequate reporting of study methods, and low event and sample sizes in some trials.\nAuthors' conclusions\nIn women identified as poor responders undergoing ART, pre-treatment with DHEA or testosterone may be associated with improved live birth rates. The overall quality of the evidence is moderate. There is insufficient evidence to draw any conclusions about the safety of either androgen. Definitive conclusions regarding the clinical role of either androgen awaits evidence from further well-designed 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": "The quality of the trials was moderate, and the main limitations were lack of blinding, inadequate reporting of study methods and small sample sizes in some included trials."
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query-laysum
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8156
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[
{
"role": "user",
"content": "Abstract: Background\nDespite major advances in medical technology, the incidence of preterm birth remains high. The use of antenatal corticosteroid administered transplacentally, by intramuscular injection to women at risk of preterm birth, has reduced the incidence of respiratory distress syndrome and increased the survival rates of preterm infants. However, this intervention also comes with its own risks and side effects. Animal studies and early studies in pregnant women at risk of preterm birth have reported the use of an alternative route of administration, by direct intramuscular injection of corticosteroid into the fetus under ultrasound guidance, in an attempt to minimise the side-effect profile. Direct fetal corticosteroid administration may have benefits over maternal administration in terms of safety and efficacy.\nObjectives\nTo assess if different routes of corticosteroid administration (maternal versus direct fetal) have effects on health outcomes for women and their babies.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (25 October 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 October 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials comparing maternal with direct fetal routes of antenatal corticosteroid administration in women at risk of preterm birth.\nData collection and analysis\nThe two review authors independently assessed study eligibility. In future updates of this review, at least two review authors will extract data and assess the risks of bias in included studies. We will also assess the quality of the evidence using the GRADE approach.\nMain results\nWe did not identify any eligible randomised controlled trials to include in this review.\nAuthors' conclusions\nThe available clinical studies carried out so far on animals and human have shown that direct intramuscular injection of corticosteroid into the fetus under ultrasound guidance is feasible, but data on health outcomes are lacking. Uncertainty therefore persists as to which method could provide better efficacy and safety. Randomised controlled trials are required focusing on the benefits and harms of transplacental versus direct fetal corticosteroid treatment. Until the uncertainties have been addressed, it is advisable to stay with the current standard of antenatal transplacental maternally-administered corticosteroid treatment.\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"
},
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"role": "assistant",
"content": "Babies born preterm (before 37 weeks of pregnancy) are at risk of dying, having bleeding into their brain and problems with their breathing because their lungs are not fully developed. Corticosteroid treatment given to the mother before early birth has been shown to be effective in preventing these problems and has become standard care in many countries. The common method of giving corticosteroid is by injecting into the mother's muscles. The corticosteroid treatment then transfers across the placenta (known as transplacental transfer) to the fetus. This treatment has its own risks, such as reducing fetal growth and brain development as well as increasing the baby's risks of diseases such as diabetes and high blood pressure. Injecting corticosteroid directly into the fetus is feasible with ultrasound guidance."
}
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query-laysum
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8157
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[
{
"role": "user",
"content": "Abstract: Background\nThere may be an association between periodontitis and cardiovascular disease (CVD); however, the evidence so far has been uncertain about whether periodontal therapy can help prevent CVD in people diagnosed with chronic periodontitis. This is the third update of a review originally published in 2014, and most recently updated in 2019. Although there is a new multidimensional staging and grading system for periodontitis, we have retained the label 'chronic periodontitis' in this version of the review since available studies are based on the previous classification system.\nObjectives\nTo investigate the effects of periodontal therapy for primary or secondary prevention of CVD in people with chronic periodontitis.\nSearch methods\nAn information specialist searched five bibliographic databases up to 17 November 2021 and additional search methods were used to identify published, unpublished, and ongoing studies.\nWe also searched the Chinese BioMedical Literature Database, the China National Knowledge Infrastructure, the VIP database, and Sciencepaper Online to March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared active periodontal therapy to no periodontal treatment or a different periodontal treatment. We included studies of participants with a diagnosis of chronic periodontitis, either with CVD (secondary prevention studies) or without CVD (primary prevention studies).\nData collection and analysis\nTwo review authors carried out the study identification, data extraction, and 'Risk of bias' assessment independently and in duplicate. They resolved any discrepancies by discussion, or with a third review author. We adopted a formal pilot-tested data extraction form, and used the Cochrane tool to assess the risk of bias in the studies. We used GRADE criteria to assess the certainty of the evidence.\nMain results\nThere are no new completed RCTs on this topic since we published our last update in 2019.\nWe included two RCTs in the review. One study focused on the primary prevention of CVD, and the other addressed secondary prevention. We evaluated both as being at high risk of bias. Our primary outcomes of interest were death (all-cause and CVD-related) and all cardiovascular events, measured at one-year follow-up or longer.\nFor primary prevention of CVD in participants with periodontitis and metabolic syndrome, one study (165 participants) provided very low-certainty evidence. There was only one death in the study; we were unable to determine whether scaling and root planning plus amoxicillin and metronidazole could reduce incidence of all-cause death (Peto odds ratio (OR) 7.48, 95% confidence interval (CI) 0.15 to 376.98), or all CVD-related death (Peto OR 7.48, 95% CI 0.15 to 376.98). We could not exclude the possibility that scaling and root planning plus amoxicillin and metronidazole could increase cardiovascular events (Peto OR 7.77, 95% CI 1.07 to 56.1) compared with supragingival scaling measured at 12-month follow-up.\nFor secondary prevention of CVD, one pilot study randomised 303 participants to receive scaling and root planning plus oral hygiene instruction (periodontal treatment) or oral hygiene instruction plus a copy of radiographs and recommendation to follow-up with a dentist (community care). As cardiovascular events had been measured for different time periods of between 6 and 25 months, and only 37 participants were available with at least one-year follow-up, we did not consider the data to be sufficiently robust for inclusion in this review. The study did not evaluate all-cause death and all CVD-related death. We are unable to draw any conclusions about the effects of periodontal therapy on secondary prevention of CVD.\nAuthors' conclusions\nFor primary prevention of cardiovascular disease (CVD) in people diagnosed with periodontitis and metabolic syndrome, very low-certainty evidence was inconclusive about the effects of scaling and root planning plus antibiotics compared to supragingival scaling. There is no reliable evidence available regarding secondary prevention of CVD in people diagnosed with chronic periodontitis and CVD. Further trials are needed to reach conclusions about whether treatment for periodontal disease can help prevent occurrence or recurrence of CVD.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the main electronic databases for scientific research studies known as 'randomised controlled trials', up to November 2021. In this type of study, participants are assigned in a random way to an experimental or control group. People in the experimental group receive the treatment being tested, and people in the control group usually receive either no treatment, placebo (fake treatment), another type of treatment, or routine care.\nWe found two studies to include in our review. One study assessed 165 participants who did not have cardiovascular diseases, but had metabolic syndrome (a combination of risk factors for cardiovascular disease, such as obesity, high blood pressure, and high blood sugar). The other study started off with 303 participants who had cardiovascular diseases, but after a year, only 37 participants were assessed and so we thought the results were not be reliable enough to be used. Both studies had problems with their design and we judged them to be at high risk of bias."
}
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query-laysum
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8158
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[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is an inherited progressive life-limiting disease characterised by the build-up of abnormally thick, sticky mucus affecting mostly the lungs, pancreas, and digestive system. Airway clearance techniques (ACTs), traditionally referred to as chest physiotherapy, are recommended as part of a complex treatment programme for people with CF. The aim of an ACTs is to enhance mucociliary clearance and remove viscous secretions from the airways within the lung to prevent distal airway obstruction. This reduces the infective burden and associated inflammatory effects on the airway epithelia.\nThere are a number of recognised ACTs, none of which have shown superiority in improving short-term outcomes related to mucus transport. This systematic review, which has been updated regularly since it was first published in 2000, considers the efficacy of ACTs compared to not performing any ACT in adults and children with CF. It is important to continue to review this evidence, particularly the long-term outcomes, given the recent introduction of highly effective modulator therapies and the improved health outcomes and potential changes to CF management associated with these drugs.\nObjectives\nTo determine the effectiveness and acceptability of airway clearance techniques compared to no airway clearance techniques or cough alone in people with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings, to 17 October 2022. We searched ongoing trials registers (Clinicaltrials.gov and the WHO International Clinical Trials Registry Platform) to 7 November 2022.\nSelection criteria\nWe included randomised or quasi-randomised studies that compared airway clearance techniques (chest physiotherapy) with no airway clearance techniques or spontaneous cough alone in people with CF.\nData collection and analysis\nBoth review authors independently assessed study eligibility, extracted data, and assessed the risk of bias of the included studies. We used GRADE methodology to assess the certainty of the evidence.\nMain results\nWe included 11 cross-over studies (153 participants) and one parallel study (41 participants). There were differences between studies in how the interventions were delivered, with several intervention groups combining more than one ACT. One study used autogenic drainage; five used conventional chest physiotherapy; nine used positive expiratory pressure (PEP), with one study varying the water pressure between arms; three studies used oscillating PEP; two used exercise; and two used high-frequency chest wall oscillation (HFCWO). Of the 12 included studies, 10 were single-treatment studies, and two delivered the intervention over two consecutive days (once daily in one study, twice daily in the second). This substantial heterogeneity in the treatment interventions precluded pooling of data for meta-analysis. Blinding of participants, caregivers, and clinicians is impossible in airway clearance studies; we therefore judged all studies at unclear risk of performance bias. Lack of information in eight studies made assessment of risk of bias unclear for most other domains.\nWe rated the certainty of evidence as low or very low due to the short-term cross-over trial design, small numbers of participants, and uncertain risk of bias across most or all domains.\nSix studies (84 participants) reported no effect on pulmonary function variables following intervention; but one study (14 participants) reported an improvement in pulmonary function following the intervention in some of the treatment groups. Two studies reported lung clearance index: one (41 participants) found a variable response to treatment with HFCWO, whilst another (15 participants) found no effect on lung clearance index with PEP therapy (low-certainty evidence). Five studies (55 participants) reported that ACTs, including coughing, increased radioactive tracer clearance compared to control, while a further study (eight participants) reported no improvement in radioactive tracer clearance when comparing PEP to control, although coughing was discouraged during the PEP intervention. We rated the certainty of evidence on the effect of ACTs on radioactive tracer clearance as very low.\nFour studies (46 participants) investigated the weight of mucus cleared from the lungs and reported greater secretions during chest physiotherapy compared to a control. One study (18 participants) reported no differences in sputum weight (very low-certainty evidence).\nAuthors' conclusions\nThe evidence from this review shows that ACTs may have short-term effects on increasing mucus transport in people with CF. All included studies had short-term follow-up; consequently, we were unable to draw any conclusions on the long-term effects of ACTs compared to no ACTs in people with CF.\nThe evidence in this review represents the use of airway clearance techniques in a CF population before widespread use of cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Further research is needed to determine the effectiveness and acceptability of airway clearance in those treated with highly effective CFTR modulators.\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 lungs of people with cystic fibrosis produce excess mucus. This leads to repeated infection and tissue damage in the lungs. It is important to clear the mucus using medicines and airway clearance techniques (physiotherapy). There are different airway clearance techniques for clearing mucus, some of which may include the use of mechanical devices. Daily physiotherapy takes a lot of time and trouble, so it is important to know if it works. We searched for studies where the people taking part had equal chances of being in the group using airway clearance techniques or the group with no airway clearance techniques. This is an update of a previously published review."
}
] |
query-laysum
|
8159
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople requiring long-term bladder draining with an indwelling catheter can experience catheter blockage. Regimens involving different solutions can be used to wash out catheters with the aim of preventing blockage. This is an update of a review published in 2010.\nObjectives\nTo determine if certain washout regimens are better than others in terms of effectiveness, acceptability, complications, quality of life and critically appraise and summarise economic evidence for the management of long-term indwelling urinary catheterisation in adults.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings to 23 May 2016. We also examined all reference lists of identified trials and contacted manufacturers and researchers in the field.\nSelection criteria\nAll randomised and quasi-randomised trials comparing catheter washout policies (e.g. washout versus no washout, different washout solutions, frequency, duration, volume, concentration, method of administration) in adults (aged 16 years and above) in any setting (i.e. hospital, nursing/residential home, community) with an indwelling urethral or suprapubic catheter for more than 28 days.\nData collection and analysis\nTwo review authors independently extracted data. Disagreements were resolved by discussion. Data were assessed and analysed as described in the Cochrane Handbook. If data in trials were not fully reported, clarification was sought from the study authors. For categorical outcomes, the numbers reporting an outcome were related to the numbers at risk in each group to derive a risk ratio (RR). For continuous outcomes, means and standard deviations were used to derive mean differences (MD).\nMain results\nWe included seven trials involving a total of 349 participants, 217 of whom completed the studies. Three were cross-over and four were parallel-group randomised controlled trials (RCTs). Of these, two trials were added for this update (one parallel-group RCT with 40 participants and one cross-over RCT with 67 participants). Analyses of three cross-over trials yielded suboptimal results because they were based on between-group differences rather than individual participants' differences for sequential interventions. Two parallel-group trials had limited clinical value: one combined results for suprapubic and urethral catheters and the other provided data for only four participants. Only one trial was free of significant methodological limitations, but there were difficulties with recruitment and maintaining participants in this study.\nThe included studies reported data on six of the nine primary and secondary outcome measures. None of the trials addressed: number of catheters used, washout acceptability measures (including patient satisfaction, patient discomfort, pain and ease of use), or health status/measures of psychological health; very limited data were collected for health economic outcomes. Trials assessed only three of the eight intervention comparisons identified. Two trials reported in more than one comparison group.\nFour trials compared washout (either saline or acidic solution) with no washout. We are uncertain if washout solutions (saline or acidic), compared to no washout solutions, has an important effect on the rate of symptomatic urinary tract infection or length of time each catheter was in situ because the results are imprecise.\nFour trials compared different types of washout solution; saline versus acidic solutions (2 trials); saline versus acidic solution versus antibiotic solution (1 trial); saline versus antimicrobial solution (1 trial). We are uncertain if type of washout solution has an important effect on the rate of symptomatic urinary tract infection or length of time each catheter was in situ because the results are imprecise.\nOne trial compared different compositions of acidic solution (stronger versus weaker solution). We are uncertain if different compositions of acidic solutions has an important effect on the rate of symptomatic urinary tract infection or length of time each catheter was in situ because only 14 participants (of 25 who were recruited) completed this 12 week, three arm trial.\nFour studies reported on possible harmful effects of washout use, such as blood in the washout solution, changes in blood pressure and bladder spasms.\nThere were very few small trials that met the review inclusion criteria. The high risk of bias of the included studies resulted in the evidence being graded as low or very low quality.\nAuthors' conclusions\nData from seven trials that compared different washout policies were limited, and generally, of poor methodological quality or were poorly reported. The evidence was not adequate to conclude if washouts were beneficial or harmful. Further rigorous, high quality trials that are adequately powered to detect benefits from washout being performed as opposed to no washout are needed. Trials comparing different washout solutions, washout volumes, and frequencies or timings are also needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to assess effectiveness of urinary catheter washout solutions. This is an update of a review previously published in 2010."
}
] |
query-laysum
|
8160
|
[
{
"role": "user",
"content": "Abstract: Background\nPatients with unicompartmental osteoarthritis of the knee can be treated with an osteotomy. The goal of an osteotomy is to unload the diseased compartment of the knee. This is the second update of the original review published in The Cochrane Library, Issue 1, 2005.\nObjectives\nTo assess the benefits and harms of an osteotomy for treating patients with knee osteoarthritis, including the following main outcomes scores: treatment failure, pain and function scores, health-related quality of life, serious adverse events, mortality and reoperation rate.\nSearch methods\nThe Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (Current Contents, HealthSTAR) were searched until November 2013 for this second update.\nSelection criteria\nRandomised and controlled clinical trials comparing an osteotomy with other treatments for patients with unicompartmental osteoarthritis of the knee.\nData collection and analysis\nTwo review authors independently selected trials, extracted data and assessed risk of bias using the domains recommended in the 'Risk of bias' tool of The Cochrane Collaboration. The quality of the results was analysed by performing overall grading of evidence by outcome using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\nEight new studies were included in this update, for a total of 21 included studies involving 1065 people.\nIn four studies, the randomised sequence was adequately generated and clearly described. In eight studies, allocation concealment was adequately generated and described. In four studies, the blinding procedures were sufficient. In six studies, incomplete outcome data were not adequately addressed. Furthermore, in 11 studies, the selective outcome reporting item was unclear because no study protocol was provided.\nFollow-up of studies comparing different osteotomy techniques was too short to measure treatment failure, which implicates revision to a knee arthroplasty.\nFour studies evaluated a closing wedge high tibial osteotomy (CW-HTO) with another high tibial osteotomy (aHTO). Based on these studies, the CW-HTO group had 1.8% (95% confidence interval (CI) -7.7% to 4.2%; low-quality evidence) more pain compared with the aHTO group; this finding was not statistically significant. Pooled function in the CW-HTO group was 0.5% (95% CI -3.8% to 2.8%; low-quality evidence) higher compared with the aHTO group; this finding was not statistically significant. No data on health-related quality of life and mortality were presented.\nSerious adverse events were reported in only four studies and were not significantly different (low-quality evidence) between groups. The reoperation rate were scored as early hardware removal because of pain and pin track infection due to the external fixator. Risk of reoperation was 2.6 (95% CI 1.5 to 4.5; low-quality evidence) times higher in the aHTO group compared with the CW-HTO group, and this finding was statistically significant.\nThe quality of evidence for most outcomes comparing different osteotomy techniques was downgraded to low because of the numbers of available studies, the numbers of participants and limitations in design.\nTwo studies compared high tibial osteotomy versus unicompartmental knee replacement. Treatment failure and pain and function scores were not different between groups after a mean follow-up of 7.5 years. The osteotomy group reported more adverse events when compared with the unicompartmental knee replacement group, but the difference was not statistically significant. No data on health-related quality of life and mortality were presented.\nNo study compared an osteotomy versus conservative treatment.\nTen included studies compared differences in perioperative or postoperative conditions after high tibial osteotomy. In most of these studies, no statistically significant differences in outcomes were noted between groups.\nAuthors' conclusions\nThe conclusion of this update did not change: Valgus high tibial osteotomy reduces pain and improves knee function in patients with medial compartmental osteoarthritis of the knee. However, this conclusion is based on within-group comparisons, not on non-operative controls. No evidence suggests differences between different osteotomy techniques. No evidence shows whether an osteotomy is more effective than alternative surgical treatment such as unicompartmental knee replacement or non-operative treatment. So far, the results of this updated review do not justify a conclusion on benefit of specific high tibial osteotomy technique for knee osteoarthritis.\n\nGiven the provided abstract, please respond to the following query: \"What is osteoarthritis of the knee, and what is an osteotomy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Osteoarthritis (OA) is a disease of the joints, such as the knee or the hip. When the joint loses cartilage, the bone grows to try to repair the damage. Instead of making things better, however, the bone grows abnormally and makes things worse. For example, the bone can become misshapen, and this can make the joint painful and unstable. This can affect physical function or ability to use the knee. Two main types of surgery are used to treat patients with osteoarthritis of the knee: knee replacement and osteotomy.\nOsteotomy is surgery in which the bones are cut and realigned. Osteotomy around the knee changes the alignment of the knee. Weight bearing will be shifted from the diseased part to a healthy part of the knee. By 'unloading' the damaged cartilage of the knee, osteotomy may decrease pain, improve function, slow knee deterioration and possibly delay the need for (partial or) total knee replacement surgery."
}
] |
query-laysum
|
8161
|
[
{
"role": "user",
"content": "Abstract: Background\nThere have been a number of studies with conflicting results which have examined the effect of anti-tuberculous therapy in Crohn's disease. A meta-analysis was performed to evaluate the use of anti-tuberculous therapy for the maintenance of remission in Crohn's disease.\nObjectives\nTo evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease.\nSearch methods\nWe searched MEDLINE, EMBASE, the Cochrane LIbrary, and the Cochrane IBD Group Specialized Register from inception to June 22, 2015.\nSelection criteria\nRandomized controlled trials (RCTs) of anti-tuberculous therapy compared to placebo or another active therapy in patients with quiescent Crohn's disease were considered for inclusion.\nData collection and analysis\nAt least two authors independently extracted data and assessed the quality of included studies using the Cochrane risk of bias tool. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for dichotomous outcomes.. The primary outcome was relapse. Secondary outcomes included adverse events, withdrawals due to adverse events and serious adverse events. All data were analyzed on an intention-to-treat basis. The overall quality of the evidence supporting the primary and secondary outcomes was evaluated using the GRADE criteria.\nMain results\nFour placebo-controlled RCTs including 206 participants were included. Three trials included an 8 to 16 week induction phase with tapering corticosteroids (prednisone, prednisolone or methylprednisolone) as induction therapy. Anti-tuberculous therapy included monotherapy with clofazimine, combination therapy with clofazimine, rifampin, ethambutol, and dapsone or combination therapy with clarithromycin, rifabutin and clofazimine. All of the studies were rated as unclear risk of bias for allocation concealment, three were rated as unclear risk of bias for random sequence generation and two were rated as unclear risk of bias for blinding or participants and personnel. There was a statistically significant difference in relapse rates favoring anti-tuberculous therapy over placebo. Thirty-nine per cent (44/112) of patients in the anti-tuberculous therapy group relapsed at 9 months to 2 years compared to 67% (63/94) of placebo patients (RR 0.58, 95% CI 0.45 to 0.75, I2 = 47%). A GRADE analysis indicates that the overall quality of the evidence supporting this outcome was very low due to unknown risk of bias and sparse data. Adverse events occurred more frequently in the anti-tuberculous therapy group (37/159) compared to the placebo group (14/163) with a pooled RR of 2.57 (95% CI 1.45 to 4.55; N=322; studies=4, I2=64%). A GRADE analysis indicates that the overall quality of the evidence supporting this outcome was very low due to unknown risk of bias, unexplained heterogeneity and sparse data. There was no difference in withdrawals due to adverse events. Nine per cent (14/159) of anti-tuberculous therapy patients withdrew due to adverse events compared to 7% (11/163) of placebo patients (RR 1.29, 95% CI 0.60 to 2.77, I2 = 0%). Common adverse events included increased skin pigmentation and rashes. No serious adverse events were reported in any of the included studies.\nAuthors' conclusions\nAnti-tuberculous therapy may provide a benefit over placebo for the prevention of relapse in participants with Crohn's disease in remission. However, this result is very uncertain due to unclear study quality and the small numbers of patients assessed. Further studies are needed to provide better quality evidence for the use of anti-tuberculous therapy for maintaining remission in people with quiescent Crohn's disease.\n\nGiven the provided abstract, please respond to the following query: \"What is anti-tuberculous therapy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Anti-tuberculous therapy generally consists of combinations of antibiotic and antibacterial type drugs."
}
] |
query-laysum
|
8162
|
[
{
"role": "user",
"content": "Abstract: Background\nApproximately 40% to 95% of people with cirrhosis have oesophageal varices. About 15% to 20% of oesophageal varices bleed in about one to three years. There are several different treatments to prevent bleeding, including: beta-blockers, endoscopic sclerotherapy, and variceal band ligation. However, there is uncertainty surrounding their individual and relative benefits and harms.\nObjectives\nTo compare the benefits and harms of different treatments for prevention of first variceal bleeding from oesophageal varices in adults with liver cirrhosis through a network meta-analysis and to generate rankings of the different treatments for prevention of first variceal bleeding from oesophageal varices according to their safety and efficacy.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and trials registers to December 2019 to identify randomised clinical trials in people with cirrhosis and oesophageal varices with no history of bleeding.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or status) in adults with cirrhosis and oesophageal varices with no history of bleeding. We excluded randomised clinical trials in which participants had previous bleeding from oesophageal varices and those who had previously undergone liver transplantation or previously received prophylactic treatment for oesophageal varices.\nData collection and analysis\nWe performed a network meta-analysis with OpenBUGS using Bayesian methods and calculated the differences in treatments using hazard ratios (HR), odds ratios (OR), and rate ratios with 95% credible intervals (CrI) based on an available-case analysis, according to National Institute for Health and Care Excellence Decision Support Unit guidance. We performed the direct comparisons from randomised clinical trials using the same codes and the same technical details.\nMain results\nWe included 66 randomised clinical trials (6653 participants) in the review. Sixty trials (6212 participants) provided data for one or more comparisons in the review. The trials that provided the information included people with cirrhosis due to varied aetiologies and those at high risk of bleeding from oesophageal varices. The follow-up in the trials that reported outcomes ranged from 6 months to 60 months. All but one of the trials were at high risk of bias. The interventions compared included beta-blockers, no active intervention, variceal band ligation, sclerotherapy, beta-blockers plus variceal band ligation, beta-blockers plus nitrates, nitrates, beta-blockers plus sclerotherapy, and portocaval shunt.\nOverall, 21.2% of participants who received non-selective beta-blockers ('beta-blockers') − the reference treatment (chosen because this was the most common treatment compared in the trials) − died during 8-month to 60-month follow-up.\nBased on low-certainty evidence, beta-blockers, variceal band ligation, sclerotherapy, and beta-blockers plus nitrates all had lower mortality versus no active intervention (beta-blockers: HR 0.49, 95% CrI 0.36 to 0.67; direct comparison HR: 0.59, 95% CrI 0.42 to 0.83; 10 trials, 1200 participants; variceal band ligation: HR 0.51, 95% CrI 0.35 to 0.74; direct comparison HR 0.49, 95% CrI 0.12 to 2.14; 3 trials, 355 participants; sclerotherapy: HR 0.66, 95% CrI 0.51 to 0.85; direct comparison HR 0.61, 95% CrI 0.41 to 0.90; 18 trials, 1666 participants; beta-blockers plus nitrates: HR 0.41, 95% CrI 0.20 to 0.85; no direct comparison). No trials reported health-related quality of life. Based on low-certainty evidence, variceal band ligation had a higher number of serious adverse events (number of events) than beta-blockers (rate ratio 10.49, 95% CrI 2.83 to 60.64; 1 trial, 168 participants).\nBased on low-certainty evidence, beta-blockers plus nitrates had a higher number of 'any adverse events (number of participants)' than beta-blockers alone (OR 3.41, 95% CrI 1.11 to 11.28; 1 trial, 57 participants). Based on low-certainty evidence, adverse events (number of events) were higher in sclerotherapy than in beta-blockers (rate ratio 2.49, 95% CrI 1.53 to 4.22; direct comparison rate ratio 2.47, 95% CrI 1.27 to 5.06; 2 trials, 90 participants), and in beta-blockers plus variceal band ligation than in beta-blockers (direct comparison rate ratio 1.72, 95% CrI 1.08 to 2.76; 1 trial, 140 participants).\nBased on low-certainty evidence, any variceal bleed was lower in beta-blockers plus variceal band ligation than in beta-blockers (direct comparison HR 0.21, 95% CrI 0.04 to 0.71; 1 trial, 173 participants). Based on low-certainty evidence, any variceal bleed was higher in nitrates than beta-blockers (direct comparison HR 6.40, 95% CrI 1.58 to 47.42; 1 trial, 52 participants).\nThe evidence indicates considerable uncertainty about the effect of the interventions in the remaining comparisons.\nAuthors' conclusions\nBased on low-certainty evidence, beta-blockers, variceal band ligation, sclerotherapy, and beta-blockers plus nitrates may decrease mortality compared to no intervention in people with high-risk oesophageal varices in people with cirrhosis and no previous history of bleeding. Based on low-certainty evidence, variceal band ligation may result in a higher number of serious adverse events than beta-blockers. The evidence indicates considerable uncertainty about the effect of beta-blockers versus variceal band ligation on variceal bleeding. The evidence also indicates considerable uncertainty about the effect of the interventions in most of the remaining comparisons.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this Cochrane Review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to find the best available treatment for prevention of first bleeding from oesophageal varices (enlarged veins in the food pipe (oesophagus)) in people with advanced liver scarring (liver cirrhosis, or late stage scarring of the liver with complications). People with cirrhosis and oesophageal varices are at significant risk of bleeding and death. Therefore, treatment is important, but the benefits and harms of different treatments available are currently unclear. The review authors collected and analysed 66 randomised clinical trials (clinical studies where people are randomly put into one of two or more treatment groups) with the aim of finding what the best treatment is. During analysis of data, we used standard Cochrane methods, which allow the comparison of only two treatments at a time. We also used advanced techniques that allow comparison of multiple treatments at the same time (referred to as 'network (or indirect) meta-analysis')."
}
] |
query-laysum
|
8163
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with cystic fibrosis are at an increased risk of fat-soluble vitamin deficiency, including vitamin E. Vitamin E deficiency can cause a host of conditions such as haemolytic anaemia, cerebellar ataxia and cognitive difficulties. Vitamin E supplementation is widely recommended for people with cystic fibrosis and aims to ameliorate this deficiency. This is an updated version of the review.\nObjectives\nTo determine the effects of any level of vitamin E supplementation on the frequency of vitamin E deficiency disorders in people with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Group's Cystic Fibrosis Trials Register and also searched international online trial registries for any ongoing clinical trials that were not identified during our register search.\nDate of last search of the Register: 11 August 2020.\nDate of last search of international online trial registries: 20 July 2020.\nSelection criteria\nRandomised controlled trials and quasi-randomised controlled trials comparing any preparation of vitamin E supplementation to placebo or no supplement, regardless of dosage or duration.\nData collection and analysis\nTwo authors extracted outcome data from each study (published information) and assessed the risk of bias of each included study. They assessed the quality of the evidence using GRADE.\nMain results\nFour studies with a total of 141 participants were included in the review, two of these were in children (aged six months to 14.5 years), and two did not specify participants’ age. All studies used different formulations and doses of vitamin E for various durations of treatment (10 days to six months). Two studies compared the supplementation of fat-soluble as well as water-soluble formulations to no supplementation in different arms of the same study. A third study compared a water-soluble formulation to a placebo; and in the fourth study a fat-soluble formulation of vitamin E was assessed against placebo.\nThere was limited detail about randomisation and blinding in the included studies which compromises the quality of the evidence base for the review. The heterogeneous mix of the formulations with differing biovailabilities among these studies also limits the generalisability of the data to the wider cystic fibrosis population.\nNone of the studies in either comparison report the review's primary outcomes of vitamin E total lipid ratio or the incidence of vitamin E-specific deficiency disorders, or the secondary outcomes lung function or quality of life.\nWater-soluble vitamin E\nWater-soluble vitamin E may improve serum vitamin E levels compared with control at six months, one study (45 participants), mean difference (MD) 19.74 umol/L (95% confidence interval (CI) 13.48 to 26.00) (low-quality evidence). Similar results were also seen at one month, two studies (32 participants), MD 17.66 umol/L (95% CI 10.59 to 24.74) and at three months, one study (45 participants), MD 11.61 umol/L (95% CI 4.77 to 18.45). Only one study (45 participants) reported weight (secondary outcome of growth and nutritional status) at one and six months, but showed no difference between treatment and control at either time point.\nFat-soluble vitamin E\nTwo studies (36 participants) reported higher levels of serum vitamin E at one month with fat-soluble vitamin E compared with control, MD 13.59 umol/L (95% CI 9.52 to 17.66); however, at three months one study (36 participants) showed no difference between treatment and control. No studies in this comparison reported on growth or nutritional status.\nAuthors' conclusions\nVitamin E supplementation may lead to an improvement in vitamin E levels in people with cystic fibrosis, although evidence we assessed was low quality. No data on other outcomes of interest were available to allow conclusions about any other benefits of this therapy.\nIn future, larger studies are needed, especially in people already being treated with enteric-coated pancreatic enzymes and supplemented with vitamin E, to look at more specific outcome measures such as vitamin E status, lung function and nutritional status. Future studies could also look at the optimal dose of vitamin E required to achieve maximal clinical effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to know what effects, if any, vitamin E supplementation (at any dose) has on how often people with cystic fibrosis have health problems due to vitamin E deficiency."
}
] |
query-laysum
|
8164
|
[
{
"role": "user",
"content": "Abstract: Background\nPartnering with consumers in the planning, delivery and evaluation of health services is an essential component of person-centred care. There are many ways to partner with consumers to improve health services, including formal group partnerships (such as committees, boards or steering groups). However, consumers' and health providers' views and experiences of formal group partnerships remain unclear.\nIn this qualitative evidence synthesis (QES), we focus specifically on formal group partnerships where health providers and consumers share decision-making about planning, delivering and/or evaluating health services. Formal group partnerships were selected because they are widely used throughout the world to improve person-centred care.\nFor the purposes of this QES, the term 'consumer' refers to a person who is a patient, carer or community member who brings their perspective to health service partnerships. 'Health provider' refers to a person with a health policy, management, administrative or clinical role who participates in formal partnerships in an advisory or representative capacity.\nThis QES was co-produced with a Stakeholder Panel of consumers and health providers. The QES was undertaken concurrently with a Cochrane intervention review entitled Effects of consumers and health providers working in partnership on health services planning, delivery and evaluation.\nObjectives\n1. To synthesise the views and experiences of consumers and health providers of formal partnership approaches that aimed to improve planning, delivery or evaluation of health services.\n2. To identify best practice principles for formal partnership approaches in health services by understanding consumers' and health providers' views and experiences.\nSearch methods\nWe searched MEDLINE, Embase, PsycINFO and CINAHL for studies published between January 2000 and October 2018. We also searched grey literature sources including websites of relevant research and policy organisations involved in promoting person-centred care.\nSelection criteria\nWe included qualitative studies that explored consumers' and health providers' perceptions and experiences of partnering in formal group formats to improve the planning, delivery or evaluation of health services.\nData collection and analysis\nFollowing completion of abstract and full-text screening, we used purposive sampling to select a sample of eligible studies that covered a range of pre-defined criteria, including rich data, range of countries and country income level, settings, participants, and types of partnership activities. A Framework Synthesis approach was used to synthesise the findings of the sample. We appraised the quality of each study using the CASP (Critical Appraisal Skill Program) tool. We assessed our confidence in the findings using the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach.\nThe Stakeholder Panel was involved in each stage of the review from development of the protocol to development of the best practice principles.\nMain results\nWe found 182 studies that were eligible for inclusion. From this group, we selected 33 studies to include in the final synthesis. These studies came from a wide range of countries including 28 from high-income countries and five from low- or middle-income countries (LMICs).\nEach of the studies included the experiences and views of consumers and/or health providers of partnering in formal group formats. The results were divided into the following categories.\nContextual factors influencing partnerships: government policy, policy implementation processes and funding, as well as the organisational context of the health service, could facilitate or impede partnering (moderate level of confidence).\nConsumer recruitment: consumer recruitment occurred in different ways and consumers managed the recruitment process in a minority of studies only (high level of confidence). Recruiting a range of consumers who were reflective of the clinic's demographic population was considered desirable, particularly by health providers (high level of confidence). Some health providers perceived that individual consumers' experiences were not generalisable to the broader population whereas consumers perceived it could be problematic to aim to represent a broad range of community views (high level of confidence).\nPartnership dynamics and processes: positive interpersonal dynamics between health providers and consumers facilitated partnerships (high level of confidence). However, formal meeting formats and lack of clarity about the consumer role could constrain consumers’ involvement (high level of confidence). Health providers’ professional status, technical knowledge and use of jargon were intimidating for some consumers (high level of confidence) and consumers could feel their experiential knowledge was not valued (moderate level of confidence). Consumers could also become frustrated when health providers dominated the meeting agenda (moderate level of confidence) and when they experienced token involvement, such as a lack of decision-making power (high level of confidence)\nPerceived impacts on partnership participants: partnering could affect health provider and consumer participants in both positive and negative ways (high level of confidence).\nPerceived impacts on health service planning, delivery and evaluation: partnering was perceived to improve the person-centredness of health service culture (high level of confidence), improve the built environment of the health service (high level of confidence), improve health service design and delivery e.g. facilitate 'out of hours' services or treatment closer to home (high level of confidence), enhance community ownership of health services, particularly in LMICs (moderate level of confidence), and improve consumer involvement in strategic decision-making, under certain conditions (moderate level of confidence). There was limited evidence suggesting partnering may improve health service evaluation (very low level of confidence).\nBest practice principles for formal partnering to promote person-centred care were developed from these findings. The principles were developed collaboratively with the Stakeholder Panel and included leadership and health service culture; diversity; equity; mutual respect; shared vision and regular communication; shared agendas and decision-making; influence and sustainability.\nAuthors' conclusions\nSuccessful formal group partnerships with consumers require health providers to continually reflect and address power imbalances that may constrain consumers' participation. Such imbalances may be particularly acute in recruitment procedures, meeting structure and content and decision-making processes. Formal group partnerships were perceived to improve the physical environment of health services, the person-centredness of health service culture and health service design and delivery. Implementing the best practice principles may help to address power imbalances, strengthen formal partnering, improve the experiences of consumers and health providers and positively affect partnership 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": "Most of the findings in this review are rated as \"high\" or \"moderate\" confidence, which means the evidence for the findings is strong. However, one finding that showed people perceived formal partnerships improved health service evaluation, was rated as \"very low\" confidence because it was based on weaker evidence."
}
] |
query-laysum
|
8165
|
[
{
"role": "user",
"content": "Abstract: Background\nUpper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Several treatments are used for upper gastrointestinal bleeding in people with liver diseases. One of them is vitamin K administration, but it is not known whether it benefits or harms people with acute or chronic liver disease and upper gastrointestinal bleeding. This is an update of this Cochrane review.\nObjectives\nTo assess the beneficial and harmful effects of vitamin K for people with acute or chronic liver disease and upper gastrointestinal bleeding.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), and LILACS (1982 to 25 February 2015). We sought additional randomised trials from two registries of clinical trials: the World Health Organization Clinical Trials Search Portal and the metaRegister of Controlled Trials. We looked through the reference lists of the retrieved publications and review articles.\nSelection criteria\nRandomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. We considered observational studies for assessment of harms only.\nData collection and analysis\n\\We aimed to summarise data from randomised clinical trials using Standard Cochrane methodology and assess them according to the GRADE approach.\nMain results\nWe found no randomised trials on vitamin K for upper gastrointestinal bleeding in people with liver diseases assessing benefits and harms of the intervention. We identified no quasi-randomised studies, historically controlled studies, or observational studies assessing harms.\nAuthors' conclusions\nThis updated review found no randomised clinical trials of vitamin K for upper gastrointestinal bleeding in people with liver diseases. The benefits and harms of vitamin K need to be tested in randomised clinical trials. Until randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute the use of vitamin K for upper gastrointestinal bleeding in people with liver diseases.\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 no evidence to recommend or refute the use of vitamin K for upper gastrointestinal bleeding in people with liver diseases."
}
] |
query-laysum
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8166
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[
{
"role": "user",
"content": "Abstract: Background\nStroke is a major cause of long-term disability in adults. Several systematic reviews have shown that a higher intensity of training can lead to better functional outcomes after stroke. Currently, the resources in inpatient settings are not always sufficient and innovative methods are necessary to meet these recommendations without increasing healthcare costs. A resource efficient method to augment intensity of training could be to involve caregivers in exercise training. A caregiver-mediated exercise programme has the potential to improve outcomes in terms of body function, activities, and participation in people with stroke. In addition, caregivers are more actively involved in the rehabilitation process, which may increase feelings of empowerment with reduced levels of caregiver burden and could facilitate the transition from rehabilitation facility (in hospital, rehabilitation centre, or nursing home) to home setting. As a consequence, length of stay might be reduced and early supported discharge could be enhanced.\nObjectives\nTo determine if caregiver-mediated exercises (CME) improve functional ability and health-related quality of life in people with stroke, and to determine the effect on caregiver burden.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (October 2015), CENTRAL (the Cochrane Library, 2015, Issue 10), MEDLINE (1946 to October 2015), Embase (1980 to December 2015), CINAHL (1982 to December 2015), SPORTDiscus (1985 to December 2015), three additional databases (two in October 2015, one in December 2015), and six additional trial registers (October 2015). We also screened reference lists of relevant publications and contacted authors in the field.\nSelection criteria\nRandomised controlled trials comparing CME to usual care, no intervention, or another intervention as long as it was not caregiver-mediated, aimed at improving motor function in people who have had a stroke.\nData collection and analysis\nTwo review authors independently selected trials. One review author extracted data, and assessed quality and risk of bias, and a second review author cross-checked these data and assessed quality. We determined the quality of the evidence using GRADE. The small number of included studies limited the pre-planned analyses.\nMain results\nWe included nine trials about CME, of which six trials with 333 patient-caregiver couples were included in the meta-analysis. The small number of studies, participants, and a variety of outcome measures rendered summarising and combining of data in meta-analysis difficult. In addition, in some studies, CME was the only intervention (CME-core), whereas in other studies, caregivers provided another, existing intervention, such as constraint-induced movement therapy. For trials in the latter category, it was difficult to separate the effects of CME from the effects of the other intervention.\nWe found no significant effect of CME on basic ADL when pooling all trial data post intervention (4 studies; standardised mean difference (SMD) 0.21, 95% confidence interval (CI) -0.02 to 0.44; P = 0.07; moderate-quality evidence) or at follow-up (2 studies; mean difference (MD) 2.69, 95% CI -8.18 to 13.55; P = 0.63; low-quality evidence). In addition, we found no significant effects of CME on extended ADL at post intervention (two studies; SMD 0.07, 95% CI -0.21 to 0.35; P = 0.64; low-quality evidence) or at follow-up (2 studies; SMD 0.11, 95% CI -0.17 to 0.39; P = 0.45; low-quality evidence).\nCaregiver burden did not increase at the end of the intervention (2 studies; SMD -0.04, 95% CI -0.45 to 0.37; P = 0.86; moderate-quality evidence) or at follow-up (1 study; MD 0.60, 95% CI -0.71 to 1.91; P = 0.37; very low-quality evidence).\nAt the end of intervention, CME significantly improved the secondary outcomes of standing balance (3 studies; SMD 0.53, 95% CI 0.19 to 0.87; P = 0.002; low-quality evidence) and quality of life (1 study; physical functioning: MD 12.40, 95% CI 1.67 to 23.13; P = 0.02; mobility: MD 18.20, 95% CI 7.54 to 28.86; P = 0.0008; general recovery: MD 15.10, 95% CI 8.44 to 21.76; P < 0.00001; very low-quality evidence). At follow-up, we found a significant effect in favour of CME for Six-Minute Walking Test distance (1 study; MD 109.50 m, 95% CI 17.12 to 201.88; P = 0.02; very low-quality evidence). We also found a significant effect in favour of the control group at the end of intervention, regarding performance time on the Wolf Motor Function test (2 studies; MD -1.72, 95% CI -2.23 to -1.21; P < 0.00001; low-quality evidence). We found no significant effects for the other secondary outcomes (i.e. patient: motor impairment, upper limb function, mood, fatigue, length of stay and adverse events; caregiver: mood and quality of life).\nIn contrast to the primary analysis, sensitivity analysis of CME-core showed a significant effect of CME on basic ADL post intervention (2 studies; MD 9.45, 95% CI 2.11 to 16.78; P = 0.01; moderate-quality evidence).\nThe methodological quality of the included trials and variability in interventions (e.g. content, timing, and duration), affected the validity and generalisability of these observed results.\nAuthors' conclusions\nThere is very low- to moderate-quality evidence that CME may be a valuable intervention to augment the pallet of therapeutic options for stroke rehabilitation. Included studies were small, heterogeneous, and some trials had an unclear or high risk of bias. Future high-quality research should determine whether CME interventions are (cost-)effective.\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": "Stroke is a major cause of acquired adult disability. Research has shown that more time spent on exercise therapy in the first weeks to months after stroke leads to better functioning. Due to lack of personnel and resources, in practice it is difficult to spend more time on exercise therapy in this period. One method to increase this exercise time, is to involve caregivers in performing exercise training together with a person with stroke. During this exercise training a therapist coaches patient and caregiver and an evaluation is planned on a regular basis."
}
] |
query-laysum
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8167
|
[
{
"role": "user",
"content": "Abstract: Background\nRestless legs syndrome (RLS) is defined as the spontaneous movement of the limbs (mainly legs) associated with unpleasant, sometimes painful sensation which is relieved by moving the affected limb. Prevalence of RLS among people on dialysis has been estimated between 6.6% and 80%. RLS symptoms contribute to impaired quality of life and people with RLS are shown to have increased cardiovascular morbidity and mortality.\nVarious pharmacological and non-pharmacological interventions have been used to treat primary RLS. However, the evidence for use of these interventions in people with chronic kidney disease (CKD) is not well established. The agents used in the treatment of primary RLS may be limited by the side effects in people with CKD due to increased comorbidity and altered drug pharmacokinetics.\nObjectives\nThe aim of this review was to critically look at the benefits, efficacy and safety of various treatment options used in the treatment of RLS in people with CKD and those undergoing renal replacement therapy (RRT). We aimed to define different group characteristics based on CKD stage to assess the applicability of a particular intervention to an individual patient.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 12 January 2016 through contact with the Information Specialist using search terms relevant to this review.\nSelection criteria\nRandomised controlled trials (RCT) and quasi-RCTs that assessed the efficacy of an intervention for RLS in adults with CKD were eligible for inclusion. Studies investigating idiopathic RLS or RLS secondary to other causes were excluded.\nData collection and analysis\nTwo authors independently assessed studies for eligibility and conducted risk of bias evaluation. 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.\nMain results\nWe included nine studies enrolling 220 dialysis participants. Seven studies were deemed to have moderate to high risk of bias. All studies were small in size and had a short follow-up period (two to six months). Studies evaluated the effects of six different interventions against placebo or standard treatment. The interventions studied included aerobic resistance exercise, gabapentin, ropinirole, levodopa, iron dextran, and vitamins C and E (individually and in combination).\nAerobic resistance exercise showed a significant reduction in severity of RLS compared to no exercise (2 studies, 48 participants: MD -7.56, 95% CI -14.20 to -0.93; I2 = 65%), and when compared to exercise with no resistance (1 study, 24 participants: MD -11.10, 95% CI -17.11 to -5.09), however there was no significant reduction when compared to ropinirole (1 study, 22 participants): MD -0.55, 95% CI -6.41 to 5.31). There were no significant differences between aerobic resistance exercise and either no exercise or ropinirole in the physical or mental component summary scores (using the SF-36 form). Improvement in sleep quality varied. There was no significant difference in subjective sleep quality between exercise and no exercise; however one study reported a significant improvement with ropinirole compared to resistance exercise (MD 3.71, 95% CI 0.89 to 6.53). Using the Epworth Sleepiness Scale there were no significant differences between resistance exercise and no exercise, ropinirole, or exercise with no resistance. Two studies reported there were no adverse events and one study did not mention if there were any adverse events. In one study, one patient in each group dropped out but the reason for dropout was not reported. Two studies reported no adverse events and one study did not report adverse events.\nGabapentin was associated with reduced RLS severity when compared to placebo or levodopa, and there was a significant improvement in sleep quality, latency and disturbance reported in one study when compared to levodopa. Three patients dropped out due to lethargy (2 patients), and drowsiness, syncope and fatigue (1 patient).\nBecause of a short duration of action, rebound and augmentation were noted with levodopa treatment even though it conferred some benefit in reducing the symptoms of RLS. Reported adverse events were severe vomiting, agitation after caffeine intake, headaches, dry mouth, and gastrointestinal symptoms.\nOne study (25 participants) reported iron dextran reduced the severity of RLS at weeks one and two, but not at week four. Vitamins C, E and C plus E (1 study, 60 participants) helped the symptoms of RLS with minimal side effects (nausea and dyspepsia) but more evidence is needed before any conclusions can be drawn.\nAuthors' conclusions\nGiven the small size of the studies and short follow-up, it can only be concluded that pharmacological interventions and intra-dialytic exercise programs have uncertain effects on RLS in haemodialysis patients. There have been no studies performed in non-dialysis CKD, peritoneal dialysis patients, or kidney transplant recipients. Further studies are warranted before any conclusions can be drawn. Aerobic resistance exercise and ropinirole may be suitable interventions for further evaluation.\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 small number of studies, small sample sizes and short duration of follow up make it difficult to draw any firm conclusions. The effects of aerobic exercise and other pharmacological agents on RLS are uncertain in haemodialysis patients. There is a need to perform high quality randomised studies to establish the best treatment for RLS in patients with CKD. Aerobic exercise and ropinirole may be suitable interventions for further evaluation."
}
] |
query-laysum
|
8168
|
[
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is known to have an impact on fertility and it is common for women affected by endometriosis to require fertility treatments, including in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI), to improve the chance of pregnancy. It has been postulated that long-term gonadotrophin-releasing hormone (GnRH) agonist therapy prior to IVF or ICSI can improve pregnancy outcomes. This systematic review supersedes the previous Cochrane Review on this topic (Sallam 2006).\nObjectives\nTo determine the effectiveness and safety of long-term gonadotrophin-releasing hormone (GnRH) agonist therapy (minimum 3 months) versus no pretreatment or other pretreatment modalities, such as long-term continuous combined oral contraception (COC) or surgical therapy of endometrioma, before standard in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) in women with endometriosis.\nSearch methods\nWe searched the following electronic databases from their inception to 8 January 2019: Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL via the Cochrane CENTRAL Register of Studies ONLINE (CRSO), MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL). We searched trial registries to identify unpublished and ongoing trials. We also searched DARE (Database of Abstracts of Reviews of Effects), Web of Knowledge, OpenGrey, Latin American and Caribbean Health Science Information Database (LILACS), PubMed, Google and reference lists from relevant papers for any other relevant trials.\nSelection criteria\nRandomised controlled trials (RCTs) involving women with surgically diagnosed endometriosis that compared use of any type of GnRH agonist for at least three months before an IVF/ICSI protocol to no pretreatment or other pretreatment modalities, specifically use of long-term continuous COC (minimum of 6 weeks) or surgical excision of endometrioma within six months prior to standard IVF/ICSI. The primary outcomes were live birth rate and complication rate per woman randomised.\nData collection and analysis\nTwo independent review authors assessed studies against the inclusion criteria, extracted data and assessed risk of bias. A third review author was consulted, if required. We contacted the study authors, as required. We analysed dichotomous outcomes using Mantel-Haenszel risk ratios (RRs), 95% confidence intervals (CIs) and a fixed-effect model. For small numbers of events, we used a Peto odds ratio (OR) with 95% CI instead. We analysed continuous outcomes using the mean difference (MD) between groups and presented with 95% CIs. We studied heterogeneity of the studies via the I2 statistic. We assessed the quality of evidence using GRADE criteria.\nMain results\nWe included eight parallel-design RCTs, involving a total of 640 participants. We did not assess any of the studies as being at low risk of bias across all domains, with the main limitation being lack of blinding. Using GRADE methodology, the quality of the evidence ranged from very low to low quality.\nLong-term GnRH agonist therapy versus no pretreatment\nWe are uncertain whether long-term GnRH agonist therapy affects the live birth rate (RR 0.48, 95% CI 0.26 to 0.87; 1 RCT, n = 147; I2 not calculable; very low-quality evidence) or the overall complication rate (Peto OR 1.23, 95% CI 0.37; to 4.14; 3 RCTs, n = 318; I2 = 73%; very low-quality evidence) compared to standard IVF/ICSI. Further, we are uncertain whether this intervention affects the clinical pregnancy rate (RR 1.13, 95% CI 0.91 to 1.41; 6 RCTs, n = 552, I2 = 66%; very low-quality evidence), multiple pregnancy rate (Peto OR 0.14, 95% CI 0.03 to 0.56; 2 RCTs, n = 208, I2 = 0%; very low-quality evidence), miscarriage rate (Peto OR 0.45, 95% CI 0.10 to 2.00; 2 RCTs, n = 208; I2 = 0%; very low-quality evidence), mean number of oocytes (MD 0.72, 95% CI 0.06 to 1.38; 4 RCTs, n = 385; I2 = 81%; very low-quality evidence) or mean number of embryos (MD -0.76, 95% CI -1.33 to -0.19; 2 RCTs, n = 267; I2 = 0%; very low-quality evidence).\nLong-term GnRH agonist therapy versus long-term continuous COC\nNo studies reported on this comparison.\nLong-term GnRH agonist therapy versus surgical therapy of endometrioma\nNo studies reported on this comparison.\nAuthors' conclusions\nThis review raises important questions regarding the merit of long-term GnRH agonist therapy compared to no pretreatment prior to standard IVF/ICSI in women with endometriosis. Contrary to previous findings, we are uncertain as to whether long-term GnRH agonist therapy impacts on the live birth rate or indeed the complication rate compared to standard IVF/ICSI. Further, we are uncertain whether this intervention impacts on the clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, mean number of oocytes and mean number of embryos. In light of the paucity and very low quality of existing data, particularly for the primary outcomes examined, further high-quality trials are required to definitively determine the impact of long-term GnRH agonist therapy on IVF/ICSI outcomes, not only compared to no pretreatment, but also compared to other proposed alternatives to endometriosis management.\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 quality. The main limitations in the evidence were lack of blinding (the process where the women participating in the trial, as well as the research staff, are not aware of the intervention used), inconsistency (differences between different studies) and imprecision (random error and small size of each study)."
}
] |
query-laysum
|
8169
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory distress syndrome (ARDS) represents the most severe course of COVID-19 (caused by the SARS-CoV-2 virus), usually resulting in a prolonged stay in an intensive care unit (ICU) and high mortality rates. Despite the fact that most affected individuals need invasive mechanical ventilation (IMV), evidence on specific ventilation strategies for ARDS caused by COVID-19 is scarce. Spontaneous breathing during IMV is part of a therapeutic concept comprising light levels of sedation and the avoidance of neuromuscular blocking agents (NMBA). This approach is potentially associated with both advantages (e.g. a preserved diaphragmatic motility and an optimised ventilation-perfusion ratio of the ventilated lung), as well as risks (e.g. a higher rate of ventilator-induced lung injury or a worsening of pulmonary oedema due to increases in transpulmonary pressure). As a consequence, spontaneous breathing in people with COVID-19-ARDS who are receiving IMV is subject to an ongoing debate amongst intensivists.\nObjectives\nTo assess the benefits and harms of early spontaneous breathing activity in invasively ventilated people with COVID-19 with ARDS compared to ventilation strategies that avoid spontaneous breathing.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (which includes CENTRAL, PubMed, Embase, Clinical Trials.gov WHO ICTRP, and medRxiv) and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies from their inception to 2 March 2022.\nSelection criteria\nEligible study designs comprised randomised controlled trials (RCTs) that evaluated spontaneous breathing in participants with COVID-19-related ARDS compared to ventilation strategies that avoided spontaneous breathing (e.g. using NMBA or deep sedation levels). Additionally, we considered controlled before-after studies, interrupted time series with comparison group, prospective cohort studies and retrospective cohort studies. For these non-RCT studies, we considered a minimum total number of 50 participants to be compared as necessary for inclusion. Prioritised outcomes were all-cause mortality, clinical improvement or worsening, quality of life, rate of (serious) adverse events and rate of pneumothorax. Additional outcomes were need for tracheostomy, duration of ICU length of stay and duration of hospitalisation.\nData collection and analysis\nWe followed the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions.\nTwo review authors independently screened all studies at the title/abstract and full-text screening stage. We also planned to conduct data extraction and risk of bias assessment in duplicate. We planned to conduct meta-analysis for each prioritised outcome, as well as subgroup analyses of mortality regarding severity of oxygenation impairment and duration of ARDS. In addition, we planned to perform sensitivity analyses for studies at high risk of bias, studies using NMBA in addition to deep sedation level to avoid spontaneous breathing and a comparison of preprints versus peer-reviewed articles. We planned to assess the certainty of evidence using the GRADE approach.\nMain results\nWe identified no eligible studies for this review.\nAuthors' conclusions\nWe found no direct evidence on whether early spontaneous breathing in SARS-CoV-2-induced ARDS is beneficial or detrimental to this particular group of patients. RCTs comparing early spontaneous breathing with ventilatory strategies not allowing for spontaneous breathing in SARS-CoV-2-induced ARDS are necessary to determine its value within the treatment of severely ill people with COVID-19. Additionally, studies should aim to clarify whether treatment effects differ between people with SARS-CoV-2-induced ARDS and people with non-SARS-CoV-2-induced ARDS.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared early spontaneous breathing during invasive mechanical ventilation with mandatory invasive ventilation and neuromuscular blockade in people with ARDS related to COVID-19. People could have been any age, sex or ethnicity."
}
] |
query-laysum
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8170
|
[
{
"role": "user",
"content": "Abstract: Background\nHigh blood pressure constitutes one of the leading causes of mortality and morbidity all over the world. At the same time, heavy drinking increases the risk for developing cardiovascular diseases, including cardiomyopathy, hypertension, atrial arrhythmias, or stroke. Several studies have already assessed specifically the relationship between alcohol intake and hypertension. However, the potential effect on blood pressure of alcohol intake reduction interventions is largely unknown.\nObjectives\nTo assess the effect of any intervention to reduce alcohol intake in terms of blood pressure decrease in hypertensive people with alcohol consumption compared to a control intervention or no intervention at all. To determine additional effects related to mortality, major cardiovascular events, serious adverse events, or quality of life.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to June 2020: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2020), MEDLINE Ovid (from 1946), MEDLINE Ovid Epub Ahead of Print, and MEDLINE Ovid In-Process, Embase Ovid (from 1974), ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. Trial authors were contacted when needed and no language restrictions were applied.\nSelection criteria\nWe included randomised controlled trials with minimum 12 weeks duration and including 50 or more subjects per group with quantitative measurement of alcohol consumption and/or biological measurement of the outcomes of interest.\nParticipants were adults (16 years of age or older) with systolic blood pressure (SBP) greater than 140 mmHg and diastolic blood pressure (DBP) greater than 90 mmHg, and SBP ≥ 130 or DBP ≥ 80 mmHg in participants with diabetes. We included any intervention implemented to reduce their alcohol intake.\nData collection and analysis\nTwo review authors independently assessed search results and extracted data using standard methodological procedures adopted by Cochrane.\nMain results\nA total of 1210 studies were screened. We included one randomised controlled trial involving a total of 269 participants with a two-year follow-up. Individual patient data for all participants were provided and used in this review.\nNo differences were found between the cognitive-behavioural intervention group and the control group for overall mortality (RR 0.72, 95% CI 0.16 to 3.17; low-certainty evidence), cardiovascular mortality (not estimable) and cardiovascular events (RR 0.80, 95% CI 0.36 to 1.79; very low-certainty evidence). There was no statistical difference in systolic blood pressure (SBP) reduction (Mean Difference (MD) -0.92 mmHg, 95% confidence interval (CI) -5.66 to 3.82 mmHg; very low-certainty evidence) or diastolic blood pressure (DBP) decrease (MD 0.98 mmHg, 95% CI -1.69 to 3.65 mmHg; low-certainty evidence) between the cognitive-behavioural intervention group and the control group. We also did not find any differences in the proportion of subjects with SBP < 140 mmHg and DBP < 90 mmHg (Risk Ratio (RR) 1.21, 95% CI 0.88 to 1.65; very low-certainty evidence).\nConcerning secondary outcomes, the alcohol intake was significantly reduced in the cognitive-behavioural intervention compared with the control group (MD 191.33 g, 95% CI 85.36 to 297.30 g). We found no differences between the active and control intervention in the proportion of subjects with lower-risk alcohol intake versus higher-risk and extreme drinkers at the end of the study (RR 1.04, 95% CI 0.68 to 1.60). There were no estimable results for the quality of life outcome.\nAuthors' conclusions\nAn intervention for decreasing alcohol intake consumption did not result in differences in systolic and diastolic blood pressure when compared with a control intervention, although there was a reduction in alcohol intake favouring the active intervention. No differences were found either for overall mortality, cardiovascular mortality or cardiovascular events. No data on serious adverse events or quality of life were available to assess. Adequate randomised controlled trials are needed to provide additional evidence on this specific question.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found only one relevant study to answer our question. The certainty of evidence from this single included study was evaluated as being low to very low. More long-term trials need to be conducted to assess the effect of reduction in alcohol intake on blood pressure."
}
] |
query-laysum
|
8171
|
[
{
"role": "user",
"content": "Abstract: Background\nA new Cochrane Review entitled 'Cognitive behavioural therapy for anxiety disorders in children and adolescents' was published on 16 November 2020 which supersedes this publication.\nCitation: James AC, Reardon T, Soler A, James G, Creswell C. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No.: CD013162. DOI: 10.1002/14651858.CD013162.pub2.\nA previous Cochrane review (James 2005) showed that cognitive behavioural therapy (CBT) was effective in treating childhood anxiety disorders; however, questions remain regarding (1) the relative efficacy of CBT versus non-CBT active treatments; (2) the relative efficacy of CBT versus medication and the combination of CBT and medication versus placebo; and (3) the long-term effects of CBT.\nObjectives\nTo examine (1) whether CBT is an effective treatment for childhood and adolescent anxiety disorders in comparison with (a) wait-list controls; (b) active non-CBT treatments (i.e. psychological placebo, bibliotherapy and treatment as usual (TAU)); and (c) medication and the combination of medication and CBT versus placebo; and (2) the long-term effects of CBT.\nSearch methods\nSearches for this review included the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Depression, Anxiety and Neurosis Group Register, which consists of relevant randomised controlled trials from the bibliographic databases－The Cochrane Library (1970 to July 2012), EMBASE, (1970 to July 2012) MEDLINE (1970 to July 2012) and PsycINFO (1970 to July 2012).\nSelection criteria\nAll randomised controlled trials (RCTs) of CBT versus waiting list, active control conditions, TAU or medication were reviewed. All participants must have met the criteria of the Diagnostic and Statistical Manual (DSM) or the International Classification of Diseases (ICD) for an anxiety diagnosis, excluding simple phobia, obsessive-compulsive disorder, post-traumatic stress disorder and elective mutism.\nData collection and analysis\nThe methodological quality of included trials was assessed by three reviewers independently. For the dichotomous outcome of remission of anxiety diagnosis, the odds ratio (OR) with 95% confidence interval (CI) based on the random-effects model, with pooling of data via the inverse variance method of weighting, was used. Significance was set at P < 0.05. Continuous data on each child’s anxiety symptoms were pooled using the standardised mean difference (SMD).\nMain results\nForty-one studies consisting of 1806 participants were included in the analyses. The studies involved children and adolescents with anxiety of mild to moderate severity in university and community clinics and school settings. For the primary outcome of remission of any anxiety diagnosis for CBT versus waiting list controls, intention-to-treat (ITT) analyses with 26 studies and 1350 participants showed an OR of 7.85 (95% CI 5.31 to 11.60, Z = 10.34, P < 0.0001), but with evidence of moderate heterogeneity (P = 0.05, I² = 30%). The number needed to treat (NNT) was 3.0 (95% CI 1.75 to 3.03). No difference in outcome was noted between individual, group and family/parental formats. ITT analyses revealed that CBT was no more effective than non-CBT active control treatments (six studies, 426 participants) or TAU in reducing anxiety diagnoses (two studies, 88 participants). The few controlled follow-up studies (n = 4) indicate that treatment gains in the remission of anxiety diagnosis are not statistically significant.\nAuthors' conclusions\nCognitive behavioural therapy is an effective treatment for childhood and adolescent anxiety disorders; however, the evidence suggesting that CBT is more effective than active controls or TAU or medication at follow-up, is limited and inconclusive.\n\nGiven the provided abstract, please respond to the following query: \"What questions does this review aim to answer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is an update of a previous Cochrane review from 2005, which showed that CBT is an effective treatment for children and young people with anxiety.\nThis update aims to answer the following questions:\n• Is CBT more effective than no therapy (waiting list)?\n• Is CBT more effective than other 'active' therapies such as self-help books aimed at children and young people?\n• Is CBT more effective than medication?\n• Does CBT help to reduce symptoms of anxiety for children and young people in the longer term?"
}
] |
query-laysum
|
8172
|
[
{
"role": "user",
"content": "Abstract: Background\nAsthma management guidelines recommend low-dose inhaled corticosteroids (ICS) as first-line therapy for adults and adolescents with persistent asthma. The addition of anti-leukotriene agents to ICS offers a therapeutic option in cases of suboptimal control with daily ICS.\nObjectives\nTo assess the efficacy and safety of anti-leukotriene agents added to ICS compared with the same dose, an increased dose or a tapering dose of ICS (in both arms) for adults and adolescents 12 years of age and older with persistent asthma. Also, to determine whether any characteristics of participants or treatments might affect the magnitude of response.\nSearch methods\nWe identified relevant studies from the Cochrane Airways Group Specialised Register of Trials, which is derived from systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, the Allied and Complementary Medicine Database (AMED), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the trial registries clinicaltrials.gov and ICTRP from inception to August 2016.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) of adults and adolescents 12 years of age and older on a maintenance dose of ICS for whom investigators added anti-leukotrienes to the ICS and compared treatment with the same dose, an increased dose or a tapering dose of ICS for at least four weeks.\nData collection and analysis\nWe used standard methods expected by Cochrane. The primary outcome was the number of participants with exacerbations requiring oral corticosteroids (except when both groups tapered the dose of ICS, in which case the primary outcome was the % reduction in ICS dose from baseline with maintained asthma control). Secondary outcomes included markers of exacerbation, lung function, asthma control, quality of life, withdrawals and adverse events.\nMain results\nWe included in the review 37 studies representing 6128 adult and adolescent participants (most with mild to moderate asthma). Investigators in these studies used three leukotriene receptor antagonists (LTRAs): montelukast (n = 24), zafirlukast (n = 11) and pranlukast (n = 2); studies lasted from four weeks to five years.\nAnti-leukotrienes and ICS versus same dose of ICS\nOf 16 eligible studies, 10 studies, representing 2364 adults and adolescents, contributed data. Anti-leukotriene agents given as adjunct therapy to ICS reduced by half the number of participants with exacerbations requiring oral corticosteroids (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.29 to 0.86; 815 participants; four studies; moderate quality); this is equivalent to a number needed to treat for additional beneficial outcome (NNTB) over six to 16 weeks of 22 (95% CI 16 to 75). Only one trial including 368 participants reported mortality and serious adverse events, but events were too infrequent for researchers to draw a conclusion. Four trials reported all adverse events, and the pooled result suggested little difference between groups (RR 1.06, 95% CI 0.92 to 1.22; 1024 participants; three studies; moderate quality). Investigators noted between-group differences favouring the addition of anti-leukotrienes for morning peak expiratory flow rate (PEFR), forced expiratory volume in one second (FEV1), asthma symptoms and night-time awakenings, but not for reduction in β2-agonist use or evening PEFR.\nAnti-leukotrienes and ICS versus higher dose of ICS\nOf 15 eligible studies, eight studies, representing 2008 adults and adolescents, contributed data. Results showed no statistically significant difference in the number of participants with exacerbations requiring oral corticosteroids (RR 0.90, 95% CI 0.58 to 1.39; 1779 participants; four studies; moderate quality) nor in all adverse events between groups (RR 0.96, 95% CI 0.89 to 1.03; 1899 participants; six studies; low quality). Three trials reported no deaths among 834 participants. Results showed no statistically significant differences in lung function tests including morning PEFR and FEV1 nor in asthma control measures including use of rescue β2-agonists or asthma symptom scores.\nAnti-leukotrienes and ICS versus tapering dose of ICS\nSeven studies, representing 1150 adults and adolescents, evaluated the combination of anti-leukotrienes and tapering-dose of ICS compared with tapering-dose of ICS alone and contributed data. Investigators observed no statistically significant difference in % change from baseline ICS dose (mean difference (MD) -3.05, 95% CI -8.13 to 2.03; 930 participants; four studies; moderate quality), number of participants with exacerbations requiring oral corticosteroids (RR 0.46, 95% CI 0.20 to 1.04; 542 participants; five studies; low quality) or all adverse events (RR 0.95, 95% CI 0.83 to 1.08; 1100 participants; six studies; moderate quality). Serious adverse events occurred more frequently among those taking anti-leukotrienes plus tapering ICS than in those taking tapering doses of ICS alone (RR 2.44, 95% CI 1.52 to 3.92; 621 participants; two studies; moderate quality), but deaths were too infrequent for researchers to draw any conclusions about mortality. Data showed no improvement in lung function nor in asthma control measures.\nAuthors' conclusions\nFor adolescents and adults with persistent asthma, with suboptimal asthma control with daily use of ICS, the addition of anti-leukotrienes is beneficial for reducing moderate and severe asthma exacerbations and for improving lung function and asthma control compared with the same dose of ICS. We cannot be certain that the addition of anti-leukotrienes is superior, inferior or equivalent to a higher dose of ICS. Scarce available evidence does not support anti-leukotrienes as an ICS sparing agent, and use of LTRAs was not associated with increased risk of withdrawals or adverse effects, with the exception of an increase in serious adverse events when the ICS dose was tapered. Information was insufficient for assessment of mortality.\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": "For adolescents and adults with asthma not controlled with daily low-dose ICS, adding anti-leukotriene agents to ICS reduced by half the number of patients with asthma exacerbations requiring an oral corticosteroid. Anti-leukotrienes and ICS also improved lung function and asthma control. However, we are not sure whether the combination of anti-leukotrienes and ICS is superior to higher-dose ICS. Limited available evidence does not support use of anti-leukotrienes as a way to decrease ICS dose. In general, addition of anti-leukotrienes to ICS therapy was not associated with increased side effects, if the dose of ICS was maintained."
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query-laysum
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8173
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[
{
"role": "user",
"content": "Abstract: Background\nAmong subfertile couples undergoing assisted reproductive technology (ART), pregnancy rates following frozen-thawed embryo transfer (FET) treatment cycles have historically been found to be lower than following embryo transfer undertaken two to five days following oocyte retrieval. Nevertheless, FET increases the cumulative pregnancy rate, reduces cost, is relatively simple to undertake and can be accomplished in a shorter time period than repeated in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles with fresh embryo transfer. FET is performed using different cycle regimens: spontaneous ovulatory (natural) cycles; cycles in which the endometrium is artificially prepared by oestrogen and progesterone hormones, commonly known as hormone therapy (HT) FET cycles; and cycles in which ovulation is induced by drugs (ovulation induction FET cycles). HT can be used with or without a gonadotrophin releasing hormone agonist (GnRHa). This is an update of a Cochrane review; the first version was published in 2008.\nObjectives\nTo compare the effectiveness and safety of natural cycle FET, HT cycle FET and ovulation induction cycle FET, and compare subtypes of these regimens.\nSearch methods\nOn 13 December 2016 we searched databases including Cochrane Gynaecology and Fertility's Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL. Other search sources were trials registers and reference lists of included studies.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing the various cycle regimens and different methods used to prepare the endometrium during FET.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Our primary outcomes were live birth rates and miscarriage.\nMain results\nWe included 18 RCTs comparing different cycle regimens for FET in 3815 women. The quality of the evidence was low or very low. The main limitations were failure to report important clinical outcomes, poor reporting of study methods and imprecision due to low event rates. We found no data specific to non-ovulatory women.\n1. Natural cycle FET comparisons\nNatural cycle FET versus HT FET\nNo study reported live birth rates, miscarriage or ongoing pregnancy.\nThere was no evidence of a difference in multiple pregnancy rates between women in natural cycles and those in HT FET cycle (odds ratio (OR) 2.48, 95% confidence interval (CI) 0.09 to 68.14, 1 RCT, n = 21, very low-quality evidence).\nNatural cycle FET versus HT plus GnRHa suppression\nThere was no evidence of a difference in rates of live birth (OR 0.77, 95% CI 0.39 to 1.53, 1 RCT, n = 159, low-quality evidence) or multiple pregnancy (OR 0.58, 95% CI 0.13 to 2.50, 1 RCT, n = 159, low-quality evidence) between women who had natural cycle FET and those who had HT FET cycles with GnRHa suppression. No study reported miscarriage or ongoing pregnancy.\nNatural cycle FET versus modified natural cycle FET (human chorionic gonadotrophin (HCG) trigger)\nThere was no evidence of a difference in rates of live birth (OR 0.55, 95% CI 0.16 to 1.93, 1 RCT, n = 60, very low-quality evidence) or miscarriage (OR 0.20, 95% CI 0.01 to 4.13, 1 RCT, n = 168, very low-quality evidence) between women in natural cycles and women in natural cycles with HCG trigger. However, very low-quality evidence suggested that women in natural cycles (without HCG trigger) may have higher ongoing pregnancy rates (OR 2.44, 95% CI 1.03 to 5.76, 1 RCT, n = 168). There were no data on multiple pregnancy.\n2. Modified natural cycle FET comparisons\nModified natural cycle FET (HCG trigger) versus HT FET\nThere was no evidence of a difference in rates of live birth (OR 1.34, 95% CI 0.88 to 2.05, 1 RCT, n = 959, low-quality evidence) or ongoing pregnancy (OR 1.21, 95% CI 0.80 to 1.83, 1 RCT, n = 959, low-quality evidence) between women in modified natural cycles and those who received HT. There were no data on miscarriage or multiple pregnancy.\nModified natural cycle FET (HCG trigger) versus HT plus GnRHa suppression\nThere was no evidence of a difference between the two groups in rates of live birth (OR 1.11, 95% CI 0.66 to 1.87, 1 RCT, n = 236, low-quality evidence) or miscarriage (OR 0.74, 95% CI 0.25 to 2.19, 1 RCT, n = 236, low-quality evidence) rates. There were no data on ongoing pregnancy or multiple pregnancy.\n3. HT FET comparisons\nHT FET versus HT plus GnRHa suppression\nHT alone was associated with a lower live birth rate than HT with GnRHa suppression (OR 0.10, 95% CI 0.04 to 0.30, 1 RCT, n = 75, low-quality evidence). There was no evidence of a difference between the groups in either miscarriage (OR 0.64, 95% CI 0.37 to 1.12, 6 RCTs, n = 991, I2 = 0%, low-quality evidence) or ongoing pregnancy (OR 1.72, 95% CI 0.61 to 4.85, 1 RCT, n = 106, very low-quality evidence).\nThere were no data on multiple pregnancy.\n4. Comparison of subtypes of ovulation induction FET\nHuman menopausal gonadotrophin(HMG) versus clomiphene plus HMG\nHMG alone was associated with a higher live birth rate than clomiphene combined with HMG (OR 2.49, 95% CI 1.07 to 5.80, 1 RCT, n = 209, very low-quality evidence). There was no evidence of a difference between the groups in either miscarriage (OR 1.33, 95% CI 0.35 to 5.09,1 RCT, n = 209, very low-quality evidence) or multiple pregnancy (OR 1.41, 95% CI 0.31 to 6.48, 1 RCT, n = 209, very low-quality evidence).\nThere were no data on ongoing pregnancy.\nAuthors' conclusions\nThis review did not find sufficient evidence to support the use of one cycle regimen in preference to another in preparation for FET in subfertile women with regular ovulatory cycles. The most common modalities for FET are natural cycle with or without HCG trigger or endometrial preparation with HT, with or without GnRHa suppression. We identified only four direct comparisons of these two modalities and there was insufficient evidence to support the use of either one in preference to the other.\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 subfertile women undergoing ART, eggs are collected from the ovaries and fertilised by sperm in a laboratory (in vitro fertilisation or IVF). Some or all embryos may be frozen, to be thawed and transferred to the womb at a later stage. This is called frozen-thawed embryo transfer (or FET).\nWomen with regular spontaneous periods (menstrual cycles) may be offered a range of cycle regimens to prepare the womb lining for FET. Alternatively, FET can be carried out after spontaneous ovulation (release of an egg) in a natural cycle. This is called natural cycle FET.\nWomen with irregular cycles are either not ovulating or are ovulating randomly. Therefore, natural cycle FET is not suitable for them. These women can be offered either ovulation induction with fertility drugs or hormone therapy (HT) to prepare them for FET.\nThe most common regimens for FET are natural cycle with or without HCG (human chorionic gonadrotophin) trigger, or endometrial preparation with HT with or without a gonadotrophin-releasing hormone agonist (GnRHa) to temporarily suppress ovarian function.\nWe conducted this review to find out if a particular FET regimen is more effective or safer than others. Our main outcomes were live birth rates and miscarriage rates per woman."
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query-laysum
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8174
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[
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"role": "user",
"content": "Abstract: Background\nZinc deficiency is a global nutritional problem, particularly in children and women residing in settings where diets are cereal based and monotonous. It has several negative health consequences. Fortification of staple foods with zinc may be an effective strategy for preventing zinc deficiency and improving zinc-related health outcomes.\nObjectives\nTo evaluate the beneficial and adverse effects of fortification of staple foods with zinc on health-related outcomes and biomarkers of zinc status in the general population.\nSearch methods\nWe searched the following databases in April 2015: Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3 of 12, 2015, the Cochrane Library), MEDLINE & MEDLINE In Process (OVID) (1950 to 8 April 2015), EMBASE (OVID) (1974 to 8 April 2015), CINAHL (1982 to April 2015), Web of Science (1900 to 9 April 2015), BIOSIS (1969 to 9 April 2015), POPLINE (1970 to April 2015), AGRICOLA, OpenGrey, BiblioMap, and Trials Register of Promoting Health Interventions (TRoPHI), besides regional databases (April 2015) and theses. We also searched clinical trial registries (17 March 2015) and contacted relevant organisations (May 2014) in order to identify ongoing and unpublished studies.\nSelection criteria\nWe included randomised controlled trials, randomised either at the level of the individual or cluster. We also included non-randomised trials at the level of the individual if there was a concurrent comparison group. We included non-randomised cluster trials and controlled before-after studies only if there were at least two intervention sites and two control sites. Interventions included fortification (central/industrial) of staple foods (cereal flours, edible fats, sugar, condiments, seasonings, milk and beverages) with zinc for a minimum period of two weeks. Participants were members of the general population who were over two years of age (including pregnant and lactating women) from any country.\nData collection and analysis\nTwo review authors independently assessed the eligibility of studies for inclusion, extracted data from included studies, and assessed the risk of bias of the included studies.\nMain results\nWe included eight trials (709 participants); seven were from middle-income countries of Asia, Africa, Europe, and Latin America where zinc deficiency is likely to be a public health problem. Four trials compared the effect of zinc-fortified staple foods with unfortified foods (comparison 1), and four compared zinc-fortified staple foods in combination with other nutrients/factors with the same foods containing other nutrients or factors without zinc (comparison 2). The interventions lasted between one and nine months. We categorised most trials as having unclear or high risk of bias for randomisation, but low risk of bias for blinding and attrition. None of the studies in comparison 1 reported data on zinc deficiency.\nFoods fortified with zinc increased the serum or plasma zinc levels in comparison to foods without added zinc (mean difference (MD) 2.12 µmol/L, 95% confidence interval (CI) 1.25 to 3.00 µmol/L; 3 studies; 158 participants; low-quality evidence). Participants consuming foods fortified with zinc versus participants consuming the same food without zinc had similar risk of underweight (average risk ratio 3.10, 95% CI 0.52 to 18.38; 2 studies; 397 participants; low-quality evidence) and stunting (risk ratio (RR) 0.88, 95% CI 0.36 to 2.13; 2 studies; 397 participants; low-quality evidence). A single trial of addition of zinc to iron in wheat flour did not find a reduction in proportion of zinc deficiency (RR 0.17, 95% CI 0.01 to 3.94; very low-quality evidence). We did not find a difference in serum or plasma zinc levels in participants consuming foods fortified with zinc plus other micronutrients when compared with participants consuming the same foods with micronutrients but no added zinc (MD 0.03 µmol/L, 95% CI -0.67 to 0.72 µmol/L; 4 studies; 250 participants; low-quality evidence). No trial in comparison 2 provided information about underweight or stunting.\nThere was no reported adverse effect of fortification of foods with zinc on indicators of iron or copper status.\nAuthors' conclusions\nFortification of foods with zinc may improve the serum zinc status of populations if zinc is the only micronutrient used for fortification. If zinc is added to food in combination with other micronutrients, it may make little or no difference to the serum zinc status. Effects of fortification of foods with zinc on other outcomes including zinc deficiency, children’s growth, cognition, work capacity of adults, or on haematological indicators are unknown. Given the small number of trials and participants in each trial, further investigation of these outcomes is required.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We evaluated the effects of fortification of staple foods with zinc on blood zinc levels and health-related outcomes in the general population above two years of age."
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query-laysum
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8175
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[
{
"role": "user",
"content": "Abstract: Background\nCoronary heart disease (CHD) is the most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people living with CHD may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an update of a Cochrane Review previously published in 2016.\nObjectives\nTo assess the clinical effectiveness and cost-effectiveness of exercise-based CR (exercise training alone or in combination with psychosocial or educational interventions) compared with 'no exercise' control, on mortality, morbidity and health-related quality of life (HRQoL) in people with CHD.\nSearch methods\nWe updated searches from the previous Cochrane Review, by searching CENTRAL, MEDLINE, Embase, and two other databases in September 2020. We also searched two clinical trials registers in June 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) of exercise-based interventions with at least six months’ follow-up, compared with 'no exercise' control. The study population comprised adult men and women who have had a myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), or have angina pectoris, or coronary artery disease.\nData collection and analysis\nWe screened all identified references, extracted data and assessed risk of bias according to Cochrane methods. We stratified meta-analysis by duration of follow-up: short-term (6 to 12 months); medium-term (> 12 to 36 months); and long-term ( > 3 years), and used meta-regression to explore potential treatment effect modifiers. We used GRADE for primary outcomes at 6 to 12 months (the most common follow-up time point).\nMain results\nThis review included 85 trials which randomised 23,430 people with CHD. This latest update identified 22 new trials (7795 participants). The population included predominantly post-MI and post-revascularisation patients, with a mean age ranging from 47 to 77 years.\nIn the last decade, the median percentage of women with CHD has increased from 11% to 17%, but females still account for a similarly small percentage of participants recruited overall ( < 15%). Twenty-one of the included trials were performed in low- and middle-income countries (LMICs). Overall trial reporting was poor, although there was evidence of an improvement in quality over the last decade. The median longest follow-up time was 12 months (range 6 months to 19 years).\nAt short-term follow-up (6 to 12 months), exercise-based CR likely results in a slight reduction in all-cause mortality (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.73 to 1.04; 25 trials; moderate certainty evidence), a large reduction in MI (RR 0.72, 95% CI 0.55 to 0.93; 22 trials; number needed to treat for an additional beneficial outcome (NNTB) 75, 95% CI 47 to 298; high certainty evidence), and a large reduction in all-cause hospitalisation (RR 0.58, 95% CI 0.43 to 0.77; 14 trials; NNTB 12, 95% CI 9 to 21; moderate certainty evidence). Exercise-based CR likely results in little to no difference in risk of cardiovascular mortality (RR 0.88, 95% CI 0.68 to 1.14; 15 trials; moderate certainty evidence), CABG (RR 0.99, 95% CI 0.78 to 1.27; 20 trials; high certainty evidence), and PCI (RR 0.86, 95% CI 0.63 to 1.19; 13 trials; moderate certainty evidence) up to 12 months' follow-up. We are uncertain about the effects of exercise-based CR on cardiovascular hospitalisation, with a wide confidence interval including considerable benefit as well as harm (RR 0.80, 95% CI 0.41 to 1.59; low certainty evidence). There was evidence of substantial heterogeneity across trials for cardiovascular hospitalisations (I2 = 53%), and of small study bias for all-cause hospitalisation, but not for all other outcomes.\nAt medium-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.90, 95% CI 0.80 to 1.02; 15 trials), MI (RR 1.07, 95% CI 0.91 to 1.27; 12 trials), PCI (RR 0.96, 95% CI 0.69 to 1.35; 6 trials), CABG (RR 0.97, 95% CI 0.77 to 1.23; 9 trials), and all-cause hospitalisation (RR 0.92, 95% CI 0.82 to 1.03; 9 trials), a large reduction in cardiovascular mortality was found (RR 0.77, 95% CI 0.63 to 0.93; 5 trials). Evidence is uncertain for difference in risk of cardiovascular hospitalisation (RR 0.92, 95% CI 0.76 to 1.12; 3 trials).\nAt long-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.91, 95% CI 0.75 to 1.10), exercise-based CR may result in a large reduction in cardiovascular mortality (RR 0.58, 95% CI 0.43 to 0.78; 8 trials) and MI (RR 0.67, 95% CI 0.50 to 0.90; 10 trials). Evidence is uncertain for CABG (RR 0.66, 95% CI 0.34 to 1.27; 4 trials), and PCI (RR 0.76, 95% CI 0.48 to 1.20; 3 trials).\nMeta-regression showed benefits in outcomes were independent of CHD case mix, type of CR, exercise dose, follow-up length, publication year, CR setting, study location, sample size or risk of bias.\nThere was evidence that exercise-based CR may slightly increase HRQoL across several subscales (SF-36 mental component, physical functioning, physical performance, general health, vitality, social functioning and mental health scores) up to 12 months' follow-up; however, these may not be clinically important differences. The eight trial-based economic evaluation studies showed exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years (QALYs).\nAuthors' conclusions\nThis updated Cochrane Review supports the conclusions of the previous version, that exercise-based CR provides important benefits to people with CHD, including reduced risk of MI, a likely small reduction in all-cause mortality, and a large reduction in all-cause hospitalisation, along with associated healthcare costs, and improved HRQoL up to 12 months' follow-up. Over longer-term follow-up, benefits may include reductions in cardiovascular mortality and MI. In the last decade, trials were more likely to include females, and be undertaken in LMICs, increasing the generalisability of findings. Well-designed, adequately-reported RCTs of CR in people with CHD more representative of usual clinical practice are still needed. Trials should explicitly report clinical outcomes, including mortality and hospital admissions, and include validated HRQoL outcome measures, especially over longer-term follow-up, and assess costs and cost-effectiveness.\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": "Coronary heart disease (CHD) is the single most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people live with CHD and may need support to manage their symptoms (such as angina, shortness of breath with physical activity, and fatigue) and reduce the chances of future problems, such as heart attacks. Exercise-based cardiac rehabilitation (exercise training alone or in combination with psychological or educational interventions) aims to improve the health and outcomes of people with CHD."
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query-laysum
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8176
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[
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"role": "user",
"content": "Abstract: Background\nRoot canal treatment (RoCT), or endodontic treatment, is a common procedure in dentistry. The main indications for RoCT are irreversible pulpitis and necrosis of the dental pulp caused by carious processes, coronal crack or fracture, or dental trauma. Successful RoCT is characterised by an absence of symptoms (i.e. pain) and clinical signs (i.e. swelling and sinus tract) in teeth without radiographic evidence of periodontal involvement (i.e. normal periodontal ligament). The success of RoCT depends on a number of variables related to the preoperative condition of the tooth, as well as the endodontic procedures. RoCT can be carried out with a single-visit approach, which involves root canal system obturation (filling and sealing) directly after instrumentation and irrigation, or with a multiple-visits approach, in which the treatment is completed in two or more sessions and obturation is performed in the last session. This review updates the previous versions published in 2007 and 2016.\nObjectives\nTo evaluate the benefits and harms of completion of root canal treatment (RoCT) in a single visit compared to RoCT over two or more visits, with or without medication, in people aged over 10 years.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 25 April 2022.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised controlled trials in people needing RoCT comparing completion of RoCT in a single visit compared to RoCT over two or more visits.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. tooth extraction and 2. radiological failure after at least one year (i.e. periapical radiolucency). Our secondary outcomes were 3. postoperative and postobturation pain; 4. swelling or flare-up; 5. analgesic use and 6. presence of sinus track or fistula after at least one month. We used GRADE to assess certainty of evidence for each outcome.\nWe excluded five studies that were included in the previous version of the review because they did not meet the current standard of care (i.e. rubber dam isolation and irrigation with sodium hypochlorite).\nMain results\nWe included 47 studies with 5805 participants and 5693 teeth analysed. We judged 10 studies at low risk of bias, 17 at high risk of bias and 20 at unclear risk of bias.\nOnly two studies reported data on tooth extraction. We found no evidence of a difference between treatment in one visit or treatment over multiple visits, but we had very low certainty about the findings (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.09 to 2.50; I2 = 0%; 2 studies, 402 teeth). We found no evidence of a difference between single-visit and multiple-visit treatment in terms of radiological failure (RR 0.93, 95% CI 0.81 to 1.07; I2 = 0%; 13 studies, 1505 teeth; moderate-certainty evidence).\nWe found evidence of a higher proportion of participants reporting pain within one week in single-visit groups compared to multiple visit groups (RR 1.55, 95% CI 1.14 to 2.09; I2 = 18%; 5 studies, 638 teeth; moderate-certainty evidence).\nWe found no evidence of a difference in the proportion of participants reporting pain until 72 hours postobturation (RR 0.97, 95% CI 0.81 to 1.16; I2 = 70%; 12 studies, 1329 teeth; low-certainty evidence), pain intensity until 72 hours postobturation (mean difference (MD) 0.26, 95% CI −4.76 to 5.29; I2 = 98%; 12 studies, 1258 teeth; low-certainty evidence) or pain at one week postobturation (RR 1.05, 95% CI 0.67 to 1.67; I2 = 61%; 9 studies, 1139 teeth; very low-certainty evidence). We found no evidence of a difference in swelling or flare-up incidence (RR 0.56 95% CI 0.16 to 1.92; I2 = 0%; 6 studies; 605 teeth; very low-certainty evidence), analgesic use (RR 1.25 95% CI 0.75 to 2.09; I2 = 36%; 6 studies, 540 teeth; very low-certainty evidence) or sinus tract or fistula presence (RR 1.00, 95% CI 0.24 to 4.28; I2 = 0%; 5 studies, 650 teeth; very low-certainty evidence).\nSubgroup analysis found no differences between single-visit and multiple-visit RoCT for considered outcomes other than proportion of participants reporting post-treatment pain within one week, which was higher in the single-visit groups for vital teeth (RR 2.16, 95% CI 1.39 to 3.36; I2 = 0%; 2 studies, 316 teeth), and when instrumentation was mechanical (RR 1.80, 95% CI 1.10 to 2.92; I2 = 56%; 2 studies, 278 teeth).\nAuthors' conclusions\nAs in the previous two versions of the review, there is currently no evidence to suggest that one treatment regimen (single-visit or multiple-visit RoCT) is more effective than the other. Neither regimen can prevent pain and other complications in the 12-month postoperative period. There was moderate-certainty evidence of higher proportion of participants reporting pain within one week in single-visit groups compared to multiple-visit groups. In contrast to the results of the last version of the review, there was no difference in analgesic use.\n\nGiven the provided abstract, please respond to the following query: \"What did the studies show?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Whether teeth are treated in a single visit or multiple visits may have no effect on the likelihood of tooth extraction (removal), but we are very uncertain about the results (evidence from two studies). Single-visit and multiple-visit treatments do not seem to have a different outcome when they are judged using x-rays taken one year after treatment (evidence from 13 studies).\nParticipants treated over multiple visits are probably less likely to experience pain in the first week after treatment starts than participants treated in a single visit (evidence from five studies).\nThere seems to be no difference between single- and multiple-visit treatment for other outcomes (whether or not there is pain after filling and the intensity of that pain, use of painkillers, swelling, and whether or not there is sinus tract), but we are uncertain about these results."
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query-laysum
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8177
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[
{
"role": "user",
"content": "Abstract: Background\nPeople with advanced ovarian or gastrointestinal cancer may develop malignant bowel obstruction (MBO). They are able to tolerate limited, if any, oral or enteral (via a tube directly into the gut) nutrition. Parenteral nutrition (PN) is the provision of macronutrients, micronutrients, electrolytes and fluid infused as an intravenous solution and provides a method for these people to receive nutrients. There are clinical and ethical arguments for and against the administration of PN to people receiving palliative care.\nObjectives\nTo assess the effectiveness of home parenteral nutrition (HPN) in improving survival and quality of life in people with inoperable MBO.\nSearch methods\nWe searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), MEDLINE (Ovid), Embase (Ovid), BNI, CINAHL, Web of Science and NHS Economic Evaluation and Health Technology Assessment up to January 2018, ClinicalTrials.gov (http://clinicaltrials.gov/) and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal (http://apps.who.int/trialsearch/). In addition, we handsearched included studies and used the ‘Similar articles’ feature on PubMed for included articles.\nSelection criteria\nWe included any studies with more than five participants investigating HPN in people over 16 years of age with inoperable MBO.\nData collection and analysis\nWe extracted the data and assessed risk of bias for each study. We entered data into Review Manager 5 and used GRADEpro to assess the quality of the evidence.\nMain results\nWe included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary.\nThe evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN.\nAuthors' conclusions\nWe are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.\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": "People with advanced cancer within the abdominal cavity can develop blockages of the bowel that cannot be treated surgically. This may cause nausea and vomiting and an inability to absorb enough nutrition via the gut. An alternative to conventional feeding when the gut does not work, is feeding through a vein, known as parenteral nutrition (PN). This is often used in hospital to support patients when return of gut function is expected. However, it can also be considered as part of palliative treatment in advanced cancer when return of gut function is unlikely."
}
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query-laysum
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8178
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[
{
"role": "user",
"content": "Abstract: Background\nVestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. These unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of interventions have been used, or proposed to be used, as prophylaxis for this condition, to help reduce the frequency of the attacks. Many of these interventions include dietary, lifestyle or behavioural changes, rather than medication.\nObjectives\nTo assess the benefits and harms of non-pharmacological treatments used for prophylaxis of vestibular migraine.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing dietary modifications, sleep improvement techniques, vitamin and mineral supplements, herbal supplements, talking therapies, mind-body interventions or vestibular rehabilitation with either placebo or no treatment. We excluded studies with a cross-over design, unless data from the first phase of the study could be identified.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 3 months, 3 to < 6 months, > 6 to 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included three studies in this review with a total of 319 participants. Each study addressed a different comparison and these are outlined below. We did not identify any evidence for the remaining comparisons of interest in this review.\nDietary interventions (probiotics) versus placebo\nWe identified one study with 218 participants (85% female). The use of a probiotic supplement was compared to a placebo and participants were followed up for two years. Some data were reported on the change in vertigo frequency and severity over the duration of the study. However, there were no data regarding improvement of vertigo or serious adverse events.\nCognitive behavioural therapy (CBT) versus no intervention\nOne study compared CBT to no treatment in 61 participants (72% female). Participants were followed up for eight weeks. Data were reported on the change in vertigo over the course of the study, but no information was reported on the proportion of people whose vertigo improved, or on the occurrence of serious adverse events.\nVestibular rehabilitation versus no intervention\nThe third study compared the use of vestibular rehabilitation to no treatment in a group of 40 participants (90% female) and participants were followed up for six months. Again, this study reported some data on change in the frequency of vertigo during the study, but no information on the proportion of participants who experienced an improvement in vertigo or the number who experienced serious adverse events.\nWe are unable to draw meaningful conclusions from the numerical results of these studies, as the data for each comparison of interest come from single, small studies and the certainty of the evidence was low or very low.\nAuthors' conclusions\nThere is a paucity of evidence for non-pharmacological interventions that may be used for prophylaxis of vestibular migraine. Only a limited number of interventions have been assessed by comparing them to no intervention or a placebo treatment, and the evidence from these studies is all of low or very low certainty. We are therefore unsure whether any of these interventions may be effective at reducing the symptoms of vestibular migraine and we are also unsure whether they have the potential to cause harm.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This evidence is up-to-date to September 2022."
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query-laysum
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8179
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update to the review published in the Cochrane Library (2012, Issue 4).\nIt is estimated that 20% to 40% of people with cancer will develop brain metastases during the course of their illness. The burden of brain metastases impacts quality and length of survival.\nObjectives\nTo assess the effectiveness and adverse effects of whole brain radiotherapy (WBRT) given alone or in combination with other therapies to adults with newly diagnosed multiple brain metastases.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase to May 2017 and the National Cancer Institute Physicians Data Query for ongoing trials.\nSelection criteria\nWe included phase III randomised controlled trials (RCTs) comparing WBRT versus other treatments for adults with newly diagnosed multiple brain metastases.\nData collection and analysis\nTwo review authors independently assessed trial quality and abstracted information in accordance with Cochrane methods.\nMain results\nWe added 10 RCTs to this updated review. The review now includes 54 published trials (45 fully published reports, four abstracts, and five subsets of data from previously published RCTs) involving 11,898 participants.\nLower biological WBRT doses versus control \nThe hazard ratio (HR) for overall survival (OS) with lower biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 1.21 (95% confidence interval (CI) 1.04 to 1.40; P = 0.01; moderate-certainty evidence) in favour of control. The HR for neurological function improvement (NFI) was 1.74 (95% CI 1.06 to 2.84; P = 0.03; moderate-certainty evidence) in favour of control fractionation.\nHigher biological WBRT doses versus control\nThe HR for OS with higher biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 0.97 (95% CI 0.83 to 1.12; P = 0.65; moderate-certainty evidence). The HR for NFI was 1.14 (95% CI 0.92 to 1.42; P = 0.23; moderate-certainty evidence).\nWBRT and radiosensitisers \nThe addition of radiosensitisers to WBRT did not confer additional benefit for OS (HR 1.05, 95% CI 0.99 to 1.12; P = 0.12; moderate-certainty evidence) or for brain tumour response rates (odds ratio (OR) 0.84, 95% CI 0.63 to 1.11; P = 0.22; high-certainty evidence).\nRadiosurgery and WBRT versus WBRT alone \nThe HR for OS with use of WBRT and radiosurgery boost as compared with WBRT alone for selected participants was 0.61 (95% CI 0.27 to 1.39; P = 0.24; moderate-certainty evidence). For overall brain control at one year, the HR was 0.39 (95% CI 0.25 to 0.60; P < 0.0001; high-certainty evidence) favouring the WBRT and radiosurgery boost group.\nRadiosurgery alone versus radiosurgery and WBRT\nThe HR for local brain control was 2.73 (95% CI 1.87 to 3.99; P < 0.00001; high-certainty evidence)favouring the addition of WBRT to radiosurgery. The HR for distant brain control was 2.34 (95% CI 1.73 to 3.18; P < 0.00001; high-certainty evidence) favouring WBRT and radiosurgery. The HR for OS was 1.00 (95% CI 0.80 to 1.25; P = 0.99; moderate-certainty evidence). Two trials reported worse neurocognitive outcomes and one trial reported worse quality of life outcomes when WBRT was added to radiosurgery.\nWe could not pool data from trials related to chemotherapy, optimal supportive care (OSC), molecular targeted agents, neurocognitive protective agents, and hippocampal sparing WBRT. However, one trial reported no differences in quality-adjusted life-years for selected participants with brain metastases from non-small-cell lung cancer randomised to OSC and WBRT versus OSC alone.\nAuthors' conclusions\nNone of the trials with altered higher biological WBRT dose-fractionation schemes reported benefit for OS, NFI, or symptom control compared with standard care. However, OS and NFI were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules.\nThe addition of WBRT to radiosurgery improved local and distant brain control in selected people with brain metastases, but data show worse neurocognitive outcomes and no differences in OS.\nSelected people with multiple brain metastases from non-small-cell lung cancer may show no difference in OS when OSC is given and WBRT is omitted.\nUse of radiosensitisers, chemotherapy, or molecular targeted agents in conjunction with WBRT remains experimental.\nFurther trials are needed to evaluate the use of neurocognitive protective agents and hippocampal sparing with WBRT. As well, future trials should examine homogeneous participants with brain metastases with focus on prognostic features and molecular markers.\n\nGiven the provided abstract, please respond to the following query: \"What are the conclusions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Altered higher biological WBRT dose-fractionation schemes, as reported in randomised trials, did not confer benefit for overall survival, neurological function, or symptom control compared with standard treatment (3000 cGy in 10 daily fractions, or 2000 cGy in 4 or 5 daily fractions). However, overall survival and neurological function were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules.\nThe addition of WBRT to radiosurgery improved local and distant brain control (i.e. absence of new intracranial lesions at the site or outside of treated lesions after treatment) among selected people with brain metastases, but investigators reported worse cognitive outcomes and no differences in overall survival.\nSelected people with multiple brain metastases from non-small-cell lung cancer may show no difference in overall survival when optimal supportive care is given and WBRT is omitted.\nUse of other treatments (radiosensitisers, chemotherapy, or molecular targeted agents) in conjunction with WBRT remains experimental.\nAdditional trials are needed to evaluate strategies to protect cognitive decline associated with WBRT. As well, future trials should examine people with brain metastases with focus on prognostic features and tumour characteristics."
}
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query-laysum
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8180
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[
{
"role": "user",
"content": "Abstract: Background\nSince the mid-1970s, short-term psychodynamic psychotherapies (STPP) for a broad range of psychological and somatic disorders have been developed and studied. Early published meta-analyses of STPP, using different methods and samples, have yielded conflicting results, although some meta-analyses have consistently supported an empirical basis for STPP. This is an update of a review that was last updated in 2006.\nObjectives\nTo evaluate the efficacy of STPP for adults with common mental disorders compared with wait-list controls, treatments as usual and minimal contact controls in randomised controlled trials (RCTs). To specify the differential effects of STPP for people with different disorders (e.g. depressive disorders, anxiety disorders, somatoform disorders, mixed disorders and personality disorder) and treatment characteristics (e.g. manualised versus non-manualised therapies).\nSearch methods\nThe Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR) was searched to February 2014, this register includes relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974-), MEDLINE (1950-) and PsycINFO (1967-). We also conducted searches on CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, DARE and Biological Abstracts (all years to July 2012) and all relevant studies (identified to 2012) were fully incorporated in this review update. We checked references from papers retrieved. We contacted a large group of psychodynamic researchers in an attempt to find new studies.\nSelection criteria\nWe included all RCTs of adults with common mental disorders, in which a brief psychodynamic therapy lasting 40 or fewer hours in total was provided in individual format.\nData collection and analysis\nEight review authors working in pairs evaluated studies. We selected studies only if pairs of review authors agreed that the studies met inclusion criteria. We consulted a third review author if two review authors could not reach consensus. Two review authors collected data and entered it into Review Manager software. Two review authors assessed and scored risk of bias. We assessed publication bias using a funnel plot. Two review authors conducted and reviewed subgroup analyses.\nMain results\nWe included 33 studies of STPP involving 2173 randomised participants with common mental disorders. Studies were of diverse conditions in which problems with emotional regulation were purported to play a causative role albeit through a range of symptom presentations. These studies evaluated STPP for this review's primary outcomes (general, somatic, anxiety and depressive symptom reduction), as well as interpersonal problems and social adjustment. Except for somatic measures in the short-term, all outcome categories suggested significantly greater improvement in the treatment versus the control groups in the short-term and medium-term. Effect sizes increased in long-term follow-up, but some of these effects did not reach statistical significance. A relatively small number of studies (N < 20) contributed data for the outcome categories. There was also significant heterogeneity between studies in most categories, possibly due to observed differences between manualised versus non-manualised treatments, short versus longer treatments, studies with observer-rated versus self report outcomes, and studies employing different treatment models.\nAuthors' conclusions\nThere has been further study of STPP and it continues to show promise, with modest to large gains for a wide variety of people. However, given the limited data, loss of significance in some measures at long-term follow-up and heterogeneity between studies, these findings should be interpreted with caution. Furthermore, variability in treatment delivery and treatment quality may limit the reliability of estimates of effect for STPP. Larger studies of higher quality and with specific diagnoses are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched scientific databases to find all published and unpublished studies of STPP compared with wait-list control, treatment as usual or minimal treatment up to July 2012. We searched for studies in adults over 17 years of age with common mental disorders being treated in an outpatient setting. We excluded people with psychotic disorders."
}
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query-laysum
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8181
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[
{
"role": "user",
"content": "Abstract: Background\nOral nirmatrelvir/ritonavir (Paxlovid®) aims to avoid severe COVID-19 in asymptomatic people or those with mild symptoms, thereby decreasing hospitalization and death. Due to its novelty, there are currently few published study results. It remains to be evaluated for which indications and patient populations the drug is suitable.\nObjectives\nTo assess the efficacy and safety of nirmatrelvir/ritonavir (Paxlovid®) plus standard of care compared to standard of care with or without placebo, or any other intervention for treating COVID-19 and for preventing SARS-CoV-2 infection.\nTo explore equity aspects in subgroup analyses.\nTo keep up to date with the evolving evidence base using a living systematic review (LSR) approach and make new relevant studies available to readers in-between publication of review updates.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, Scopus, and WHO COVID-19 Global literature on coronavirus disease database, identifying completed and ongoing studies without language restrictions and incorporating studies up to 11 July 2022.\nThis is a LSR. We conduct monthly update searches that are being made publicly available on the open science framework (OSF) platform.\nSelection criteria\nStudies were eligible if they were randomized controlled trials (RCTs) comparing nirmatrelvir/ritonavir plus standard of care with standard of care with or without placebo, or any other 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.\nWe screened all studies for research integrity. Studies were ineligible if they had been retracted, or if they were not prospectively registered including appropriate ethics approval.\nData collection and analysis\nWe followed standard Cochrane methodology and used the Cochrane risk of bias 2 tool. We rated the certainty of evidence using the GRADE approach for the following outcomes: 1. to treat outpatients with mild COVID-19; 2. to treat inpatients with moderate-to-severe COVID-19: mortality, clinical worsening or improvement, quality of life, (serious) adverse events, and viral clearance; 3. to prevent SARS-CoV-2 infection in post-exposure prophylaxis (PEP); and 4. pre-exposure prophylaxis (PrEP) scenarios: SARS-CoV-2 infection, development of COVID-19 symptoms, mortality, admission to hospital, quality of life, and (serious) adverse events.\nWe explored inequity by subgroup analysis for elderly people, socially-disadvantaged people with comorbidities, populations from LICs and LMICs, and people from different ethnic and racial backgrounds.\nMain results\nAs of 11 July 2022, we included one RCT with 2246 participants in outpatient settings with mild symptomatic COVID-19 comparing nirmatrelvir/ritonavir plus standard of care with standard of care plus placebo. Trial participants were unvaccinated, without previous confirmed SARS-CoV-2 infection, had a symptom onset of no more than five days before randomization, and were at high risk for progression to severe disease. Prohibited prior or concomitant therapies included medications highly dependent on CYP3A4 for clearance and CYP3A4 inducers.\nWe identified eight ongoing studies.\nNirmatrelvir/ritonavir for treating COVID-19 in outpatient settings with asymptomatic or mild disease\nFor the specific population of unvaccinated, high-risk patients nirmatrelvir/ritonavir plus standard of care compared to standard of care plus placebo may reduce all-cause mortality at 28 days (risk ratio (RR) 0.04, 95% confidence interval (CI) 0.00 to 0.68; 1 study, 2224 participants; estimated absolute effect: 11 deaths per 1000 people receiving placebo compared to 0 deaths per 1000 people receiving nirmatrelvir/ritonavir; low-certainty evidence, and admission to hospital or death within 28 days (RR 0.13, 95% CI 0.07 to 0.27; 1 study, 2224 participants; estimated absolute effect: 61 admissions or deaths per 1000 people receiving placebo compared to eight admissions or deaths per 1000 people receiving nirmatrelvir/ritonavir; low-certainty evidence).\nNirmatrelvir/ritonavir plus standard of care may reduce serious adverse events during the study period compared to standard of care plus placebo (RR 0.24, 95% CI 0.15 to 0.41; 1 study, 2224 participants; low-certainty evidence). Nirmatrelvir/ritonavir plus standard of care probably has little or no effect on treatment-emergent adverse events (RR 0.95, 95% CI 0.82 to 1.10; 1 study, 2224 participants; moderate-certainty evidence), and probably increases treatment-related adverse events such as dysgeusia and diarrhoea during the study period compared to standard of care plus placebo (RR 2.06, 95% CI 1.44 to 2.95; 1 study, 2224 participants; moderate-certainty evidence). Nirmatrelvir/ritonavir plus standard of care probably decreases discontinuation of study drug due to adverse events compared to standard of care plus placebo (RR 0.49, 95% CI 0.30 to 0.80; 1 study, 2224 participants; moderate-certainty evidence).\nNo study results were identified for improvement of clinical status, quality of life, and viral clearance.\nSubgroup analyses for equity\nMost study participants were younger than 65 years (87.1% of the : modified intention to treat (mITT1) population with 2085 participants), of white ethnicity (71.5%), and were from UMICs or HICs (92.1% of study centres). Data on comorbidities were insufficient.\nThe outcome ‘admission to hospital or death’ was investigated for equity: age (< 65 years versus ≥ 65 years) and ethnicity (Asian versus Black versus White versus others). There was no difference between subgroups of age. The effects favoured treatment with nirmatrelvir/ritonavir for the White ethnic group. Estimated effects in the other ethnic groups included the line of no effect (RR = 1). No subgroups were reported for comorbidity status and World Bank country classification by income level. No subgroups were reported for other outcomes.\nNirmatrelvir/ritonavir for treating COVID-19 in inpatient settings with moderate to severe disease\nNo studies available.\nNirmatrelvir/ritonavir for preventing SARS-CoV-2 infection (PrEP and PEP)\nNo studies available.\nAuthors' conclusions\nThere is low-certainty evidence that nirmatrelvir/ritonavir reduces the risk of all-cause mortality and hospital admission or death based on one trial investigating unvaccinated COVID-19 participants without previous infection that were at high risk and with symptom onset of no more than five days. There is low- to moderate-certainty evidence that nirmatrelvir/ritonavir is safe in people without prior or concomitant therapies including medications highly dependent on CYP3A4.\nRegarding equity aspects, except for ethnicity, no differences in effect size and direction were identified.\nNo evidence is available on nirmatrelvir/ritonavir to treat hospitalized people with COVID-19 and to prevent a SARS-CoV-2 infection.\nWe will continually update our search and make search results available on OSF.\n\nGiven the provided abstract, please respond to the following query: \"Treating outpatients with COVID-19\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "For the specific population of unvaccinated, high-risk patients, nirmatrelvir/ritonavir may;\n- lead to fewer deaths; and\n- improve patients' condition assessed by need for hospitalization or death within 28 days;\n- reduce serious unwanted events.\nFor the specific population of unvaccinated, high-risk patients, nirmatrelvir/ritonavir probably:\n- has little effect on any unwanted events;\n- increases any treatment-related unwanted events (mostly taste disturbance and diarrhoea);\n- probably decreases discontinuation of study drug due to unwanted events."
}
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query-laysum
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8182
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[
{
"role": "user",
"content": "Abstract: Background\nDepression is common in young people. It has a marked negative impact and is associated with self-harm and suicide. Preventing its onset would be an important advance in public health. This is an update of a Cochrane review that was last updated in 2011.\nObjectives\nTo determine whether evidence-based psychological interventions (including cognitive behavioural therapy (CBT), interpersonal therapy (IPT) and third wave CBT)) are effective in preventing the onset of depressive disorder in children and adolescents.\nSearch methods\nWe searched the specialised register of the Cochrane Common Mental Disorders Group (CCMDCTR to 11 September 2015), which includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We searched conference abstracts and reference lists of included trials and reviews, and contacted experts in the field.\nSelection criteria\nWe included randomised controlled trials of an evidence-based psychological prevention programme compared with any comparison control for young people aged 5 to 19 years, who did not currently meet diagnostic criteria for depression.\nData collection and analysis\nTwo authors independently assessed trials for inclusion and rated their risk of bias. We adjusted sample sizes to take account of cluster designs and multiple comparisons. We contacted trial authors for additional information where needed. We assessed the quality of evidence for the primary outcomes using GRADE.\nMain results\nWe included 83 trials in this review. The majority of trials (67) were carried out in school settings with eight in colleges or universities, four in clinical settings, three in the community and four in mixed settings. Twenty-nine trials were carried out in unselected populations and 53 in targeted populations.\nFor the primary outcome of depression diagnosis at medium-term follow-up (up to 12 months), there were 32 trials with 5965 participants and the risk of having a diagnosis of depression was reduced for participants receiving an intervention compared to those receiving no intervention (risk difference (RD) -0.03, 95% confidence interval (CI) -0.05 to -0.01; P value = 0.01). We rated this evidence as moderate quality according to the GRADE criteria. There were 70 trials (73 trial arms) with 13,829 participants that contributed to the analysis for the primary outcome of depression symptoms (self-rated) at the post-intervention time point, with results showing a small but statistically significant effect (standardised mean difference (SMD) -0.21, 95% CI -0.27 to -0.15; P value < 0.0001). This effect persisted to the short-term assessment point (up to three months) (SMD -0.31, 95% CI -0.45 to -0.17; P value < 0.0001; 16 studies; 1558 participants) and medium-term (4 to 12 months) assessment point (SMD -0.12, 95% CI -0.18 to -0.05; P value = 0.0002; 53 studies; 11,913 participants); however, the effect was no longer evident at the long-term follow-up. We rated this evidence as low to moderate quality according to the GRADE criteria.\nThe evidence from this review is unclear with regard to whether the type of population modified the overall effects; there was statistically significant moderation of the overall effect for depression symptoms (P value = 0.0002), but not for depressive disorder (P value = 0.08). For trials implemented in universal populations there was no effect for depression diagnosis (RD -0.01, 95% CI -0.03 to 0.01) and a small effect for depression symptoms (SMD -0.11, 95% CI -0.17 to -0.05). For trials implemented in targeted populations there was a statistically significantly beneficial effect of intervention (depression diagnosis RD -0.04, 95% CI -0.07 to -0.01; depression symptoms SMD -0.32, 95% CI -0.42 to -0.23). Of note were the lack of attention placebo-controlled trials in targeted populations (none for depression diagnosis and four for depression symptoms). Among trials implemented in universal populations a number used an attention placebo comparison in which the intervention consistently showed no effect.\nAuthors' conclusions\nOverall the results show small positive benefits of depression prevention, for both the primary outcomes of self-rated depressive symptoms post-intervention and depression diagnosis up to 12 months (but not beyond). Estimates of numbers needed to treat to benefit (NNTB = 11) compare well with other public health interventions. However, the evidence was of moderate to low quality using the GRADE framework and the results were heterogeneous. Prevention programmes delivered to universal populations showed a sobering lack of effect when compared with an attention placebo control. Interventions delivered to targeted populations, particularly those selected on the basis of depression symptoms, had larger effect sizes, but these seldom used an attention placebo comparison and there are practical difficulties inherent in the implementation of targeted programmes. We conclude that there is still not enough evidence to support the implementation of depression prevention programmes.\nFuture research should focus on current gaps in our knowledge. Given the relative lack of evidence for universal interventions compared with attention placebo controls and the poor results from well-conducted effectiveness trials of universal interventions, in our opinion any future such trials should test a depression prevention programme in an indicated targeted population using a credible attention placebo comparison group. Depressive disorder as the primary outcome should be measured over the longer term, as well as clinician-rated depression. Such a trial should consider scalability as well as the potential for the intervention to do harm.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found that, compared with any comparison group, psychological depression prevention programmes have small positive benefits on depression prevention. There were some problems with the way the trials were done and in particular the results showed that compared to an attention placebo comparison group (a control intervention that controls for non-specific factors like involvement in a trial and attention from researchers), these programmes had no effect. There is still not enough evidence to support the implementation of depression prevention programmes. However, based on the effects seen for targeted depression prevention programmes (albeit with inadequate control groups), we recommend that further research be undertaken to test the effectiveness of depression prevention programmes in populations of young people who already have some symptoms of depression. Such trials should compare the intervention to an attention placebo comparison group and measure whether depressive diagnosis is prevented in the long term. They also need to consider whether the approach is something that can be implemented in the real world. In addition, they should consider and measure whether the intervention produces harmful outcomes."
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query-laysum
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8183
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[
{
"role": "user",
"content": "Abstract: Background\nMother-infant separation post birth is common. In standard hospital care, newborn infants are held wrapped or dressed in their mother’s arms, placed in open cribs or under radiant warmers. Skin-to-skin contact (SSC) begins ideally at birth and should last continually until the end of the first breastfeeding. SSC involves placing the dried, naked baby prone on the mother's bare chest, often covered with a warm blanket. According to mammalian neuroscience, the intimate contact inherent in this place (habitat) evokes neuro-behaviors ensuring fulfillment of basic biological needs. This time frame immediately post birth may represent a 'sensitive period' for programming future physiology and behavior.\nObjectives\nTo assess the effects of immediate or early SSC for healthy newborn infants compared to standard contact on establishment and maintenance of breastfeeding and infant physiology.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (17 December 2015), made personal contact with trialists, consulted the bibliography on kangaroo mother care (KMC) maintained by Dr Susan Ludington, and reviewed reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials that compared immediate or early SSC with usual hospital care.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Quality of the evidence was assessed using the GRADE approach.\nMain results\nWe included 46 trials with 3850 women and their infants; 38 trials with 3472 women and infants contributed data to our analyses. Trials took place in 21 countries, and most recruited small samples (just 12 trials randomized more than 100 women). Eight trials included women who had SSC after cesarean birth. All infants recruited to trials were healthy, and the majority were full term. Six trials studied late preterm infants (greater than 35 weeks' gestation). No included trial met all criteria for good quality with respect to methodology and reporting; no trial was successfully blinded, and all analyses were imprecise due to small sample size. Many analyses had statistical heterogeneity due to considerable differences between SSC and standard care control groups.\nResults for women\nSSC women were more likely than women with standard contact to be breastfeeding at one to four months post birth, though there was some uncertainty in this estimate due to risks of bias in included trials (average risk ratio (RR) 1.24, 95% confidence interval (CI) 1.07 to 1.43; participants = 887; studies = 14; I² = 41%; GRADE: moderate quality). SSC women also breast fed their infants longer, though data were limited (mean difference (MD) 64 days, 95% CI 37.96 to 89.50; participants = 264; studies = six; GRADE:low quality); this result was from a sensitivity analysis excluding one trial contributing all of the heterogeneity in the primary analysis. SSC women were probably more likely to exclusively breast feed from hospital discharge to one month post birth and from six weeks to six months post birth, though both analyses had substantial heterogeneity (from discharge average RR 1.30, 95% CI 1.12 to 1.49; participants = 711; studies = six; I² = 44%; GRADE: moderate quality; from six weeks average RR 1.50, 95% CI 1.18 to 1.90; participants = 640; studies = seven; I² = 62%; GRADE: moderate quality).\nWomen in the SCC group had higher mean scores for breastfeeding effectiveness, with moderate heterogeneity (IBFAT (Infant Breastfeeding Assessment Tool) score MD 2.28, 95% CI 1.41 to 3.15; participants = 384; studies = four; I² = 41%). SSC infants were more likely to breast feed successfully during their first feed, with high heterogeneity (average RR 1.32, 95% CI 1.04 to 1.67; participants = 575; studies = five; I² = 85%).\nResults for infants\nSSC infants had higher SCRIP (stability of the cardio-respiratory system) scores overall, suggesting better stabilization on three physiological parameters. However, there were few infants, and the clinical significance of the test was unclear because trialists reported averages of multiple time points (standardized mean difference (SMD) 1.24, 95% CI 0.76 to 1.72; participants = 81; studies = two; GRADE low quality). SSC infants had higher blood glucose levels (MD 10.49, 95% CI 8.39 to 12.59; participants = 144; studies = three; GRADE: low quality), but similar temperature to infants in standard care (MD 0.30 degree Celcius (°C) 95% CI 0.13 °C to 0.47 °C; participants = 558; studies = six; I² = 88%; GRADE: low quality).\nWomen and infants after cesarean birth\nWomen practicing SSC after cesarean birth were probably more likely to breast feed one to four months post birth and to breast feed successfully (IBFAT score), but analyses were based on just two trials and few women. Evidence was insufficient to determine whether SSC could improve breastfeeding at other times after cesarean. Single trials contributed to infant respiratory rate, maternal pain and maternal state anxiety with no power to detect group differences.\nSubgroups\nWe found no differences for any outcome when we compared times of initiation (immediate less than 10 minutes post birth versus early 10 minutes or more post birth) or lengths of contact time (60 minutes or less contact versus more than 60 minutes contact).\nAuthors' conclusions\nEvidence supports the use of SSC to promote breastfeeding. Studies with larger sample sizes are necessary to confirm physiological benefit for infants during transition to extra-uterine life and to establish possible dose-response effects and optimal initiation time. Methodological quality of trials remains problematic, and small trials reporting different outcomes with different scales and limited data limit our confidence in the benefits of SSC for infants. Our review included only healthy infants, which limits the range of physiological parameters observed and makes their interpretation difficult.\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": "There are well-known benefits to breastfeeding for women and their babies. We wanted to know if immediate or early SSC could improve women's chances of successfully breastfeeding. Having early contact may also help keep babies warm and calm and improve other aspects of a baby's transition to life outside the womb."
}
] |
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