dataset
stringclasses 1
value | id
stringlengths 1
5
| messages
listlengths 2
2
|
|---|---|---|
query-laysum
|
23044
|
[
{
"role": "user",
"content": "Abstract: Background\nThe definition of sepsis has evolved over time, along with the clinical and scientific knowledge behind it. For years, sepsis was defined as a systemic inflammatory response syndrome (SIRS) in the presence of a documented or suspected infection. At present, sepsis is defined as a life-threatening organ dysfunction resulting from a dysregulated host response to infection. Even though sepsis is one of the leading causes of mortality in critically ill patients, and the World Health Organization (WHO) recognizes it as a healthcare priority, it still lacks an accurate diagnostic test. Determining the accuracy of interleukin-6 (IL-6) concentrations in plasma, which is proposed as a new biomarker for the diagnosis of sepsis, might be helpful to provide adequate and timely management of critically ill patients, and thus reduce the morbidity and mortality associated with this condition.\nObjectives\nTo determine the diagnostic accuracy of plasma interleukin-6 (IL-6) concentration for the diagnosis of bacterial sepsis in critically ill adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, LILACS, and Web of Science on 25 January 2019. We screened references in the included studies to identify additional studies. We did not apply any language restriction to the electronic searches.\nSelection criteria\nWe included diagnostic accuracy studies enrolling critically ill adults aged 18 years or older under suspicion of sepsis during their hospitalization, where IL-6 concentrations were evaluated by serological measurement.\nData collection and analysis\nTwo review authors independently screened the references to identify relevant studies and extracted data. We assessed the methodological quality of studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We estimated a summary receiver operating characteristic (SROC) curve by fitting a hierarchical summary ROC (HSROC) non-linear mixed model. We explored sources of heterogeneity using the HSROC model parameters. We conducted all analyses in the SAS statistical software package and R software.\nMain results\nWe included 23 studies (n = 4192) assessing the accuracy of IL-6 for the diagnosis of sepsis in critically ill adults. Twenty studies that were available as conference proceedings only are awaiting classification. The included participants were heterogeneous in terms of their distribution of age, gender, main diagnosis, setting, country, positivity threshold, sepsis criteria, year of publication, and origin of infection, among other factors. Prevalence of sepsis greatly varied across studies, ranging from 12% to 78%. We considered all studies to be at high risk of bias due to issues related to the index test domain in QUADAS-2. The SROC curve showed a great dispersion in individual studies accuracy estimates (21 studies, 3650 adult patients), therefore the considerable heterogeneity in the collected data prevented us from calculating formal accuracy estimates. Using a fixed prevalence of sepsis of 50% and a fixed specificity of 74%, we found a sensitivity of 66% (95% confidence interval 60 to 72). If we test a cohort 1000 adult patients under suspicion of sepsis with IL-6, we will find that 330 patients would receive appropriate and timely antibiotic therapy, while 130 patients would be wrongly considered to have sepsis. In addition, 370 out of 1000 patients would avoid unnecessary antibiotic therapy, and 170 patients would have been undiagnosed of sepsis. This numerical approach should be interpreted with caution due to the limitations described above.\nAuthors' conclusions\nOur evidence assessment of plasma interleukin-6 concentrations for the diagnosis of sepsis in critically ill adults reveals several limitations. High heterogeneity of collected evidence regarding the main diagnosis, setting, country, positivity threshold, sepsis criteria, year of publication, and the origin of infection, among other factors, along with the potential number of misclassifications, remain significant constraints for its implementation. The 20 conference proceedings assessed as studies awaiting classification may alter the conclusions of the review once they are fully published and evaluated. Further studies about the accuracy of interleukin-6 for the diagnosis of sepsis in adults that apply rigorous methodology for conducting diagnostic test accuracy studies are needed. The conclusions of the review will likely change once the 20 studies pending publication are fully published and included.\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": "Our assessment of the evidence reveals the complexity of the research topic, represented in the high variability of information reported by the studies. We found the characteristics of assessed patients to vary considerably between studies in terms of age, gender, setting, initial diagnosis, indicative value for sepsis, and source of infection, among other factors. This variability in the collected data prevented a formal numerical synthesis of the findings. Using the available data to perform an approximated estimation of the consequences, we found that 700 out of 1000 patients under suspicion of sepsis might be correctly classified, but 130 out of 1000 patients would be wrongly considered as having sepsis, while 170 out of 1000 patients might be incorrectly considered as not having sepsis. These errors would result in a serious increase in the risk of further morbidity and death due to delays of adequate treatment. This information should be interpreted with caution due to limitations in the collected data."
}
] |
query-laysum
|
23045
|
[
{
"role": "user",
"content": "Abstract: Background\nMedical treatment and detoxification from opiate disorders includes oral administration of opioid agonists. Dihydrocodeine (DHC) substitution treatment is typically low threshold and therefore has the capacity to reach wider groups of opiate users. Decisions to prescribe DHC to patients with less severe opiate disorders centre on its perceived safety, reduced toxicity, shorter half-life and more rapid onset of action, and potential retention of patients. This review set out to investigate the effects of DHC in comparison to other pharmaceutical opioids and placebos in the detoxification and substitution of individuals with opiate use disorders.\nObjectives\nTo investigate the effectiveness of DHC in reducing illicit opiate use and other health-related outcomes among adults compared to other drugs or placebos used for detoxification or substitution therapy.\nSearch methods\nIn February 2019 we searched Cochrane Drugs and Alcohol's Specialised Register, CENTRAL, PubMed, Embase and Web of Science. We also searched for ongoing and unpublished studies via ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and Trialsjournal.com. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nWe included randomised controlled trials that evaluated the effect of DHC for detoxification and maintenance substitution therapy for adolescent (aged 15 years and older) and adult illicit opiate users.\nThe primary outcomes were abstinence from illicit opiate use following detoxification or maintenance therapy measured by self-report or urinalysis. The secondary outcomes were treatment retention and other health and behaviour outcomes.\nData collection and analysis\nWe followed the standard methodological procedures that are outlined by Cochrane. This includes the GRADE approach to appraise the quality of evidence.\nMain results\nWe included three trials (in five articles) with 385 opiate-using participants that measured outcomes at different follow-up periods in this review. Two studies with 150 individuals compared DHC with buprenorphine for detoxification, and one study with 235 participants compared DHC to methadone for maintenance substitution therapy. We downgraded the quality of evidence mainly due to risk of bias and imprecision.\nFor the two studies that compared DHC to buprenorphine, we found low-quality evidence of no significant difference between DHC and buprenorphine for detoxification at six-month follow-up (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.25 to 1.39; P = 0.23) in the meta-analysis for the primary outcome of abstinence from illicit opiates. Similarly, low-quality evidence indicated no difference for treatment retention (RR 1.29, 95% CI 0.99 to 1.68; P = 0.06).\nIn the single trial that compared DHC to methadone for maintenance substitution therapy, the evidence was also of low quality, and there may be no difference in effects between DHC and methadone for reported abstinence from illicit opiates (mean difference (MD) −0.01, 95% CI −0.31 to 0.29). For treatment retention at six months' follow-up in this single trial, the RR calculated with an intention-to-treat analysis also indicated that there may be no difference between DHC and methadone (RR 1.04, 95% CI 0.94 to 1.16).\nThe studies that compared DHC to buprenorphine reported no serious adverse events, while the DHC versus methadone study reported one death due to methadone overdose.\nAuthors' conclusions\nWe found low-quality evidence that DHC may be no more effective than other commonly used pharmacological interventions in reducing illicit opiate use. It is therefore premature to make any conclusive statements about the effectiveness of DHC, and it is suggested that further high-quality studies are conducted, especially in low- to middle-income countries.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included three studies in this review with 385 participants in total with follow-up periods of different length. Two studies with 150 participants compared DHC to buprenorphine for detoxification (managing physical symptoms of withdrawal), while one study with 235 individuals compared DHC to methadone for maintenance substitution therapy (providing legal substance to reduce risk behaviour and other harm related to drug use over a longer period). All the studies took place in the UK.\nOur primary outcome was abstinence or no longer using illegal substances; our secondary outcomes were completing treatment, as well as health-related consequences of substance use, and other behaviours often linked to substance use such as illegal activity. We also assessed the safety of DHC."
}
] |
query-laysum
|
23046
|
[
{
"role": "user",
"content": "Abstract: Background\nMotor neuron disease (MND), which is also known as amyotrophic lateral sclerosis (ALS), causes a wide range of symptoms but the evidence base for the effectiveness of the symptomatic treatment therapies is limited.\nObjectives\nTo summarise the evidence from Cochrane Systematic Reviews of all symptomatic treatments for MND.\nMethods\nWe searched the Cochrane Database of Systematic Reviews (CDSR) on 15 November 2016 for systematic reviews of symptomatic treatments for MND. We assessed the methodological quality of the included reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the GRADE approach. We followed standard Cochrane study (review) selection and data extraction procedures. We reported findings narratively and in tables.\nMain results\nWe included nine Cochrane Systematic Reviews of interventions to treat symptoms in people with MND. Three were empty reviews with no included randomised controlled trials (RCTs); however, all three reported on non-RCT evidence and the remaining six included mostly one or two studies. We deemed all of the included reviews of high methodological quality.\nDrug therapy for pain\nThere is no RCT evidence in a Cochrane Systematic Review exploring the efficacy of drug therapy for pain in MND.\nTreatment for cramps\nThere is evidence (13 RCTs, N = 4012) that for the treatment of cramps in MND, compared to placebo:\n– memantine and tetrahydrocannabinol (THC) are probably ineffective (moderate-quality evidence);\n– vitamin E may have little or no effect (low-quality evidence); and\n– the effects of L-threonine, gabapentin, xaliproden, riluzole, and baclofen are uncertain as the evidence is either very low quality or the trial specified the outcome but did not report numerical data.\nThe review reported adverse effects of riluzole, but it is not clear whether other interventions had adverse effects.\nTreatment for spasticity\nIt is uncertain whether an endurance-based exercise programme improved spasticity or quality of life, measured at three months after the programme, as the quality of evidence is very low (1 RCT, comparison \"usual activities\", N = 25). The review did not evaluate other approaches, such as use of baclofen as no RCTs were available.\nMechanical ventilation for supporting respiratory function\nNon-invasive ventilation (NIV) probably improves median survival and quality of life in people with respiratory insufficiency and normal to moderately impaired bulbar function compared to standard care, and improves quality of life but not survival for people with poor bulbar function (1 RCT, N = 41, moderate-quality evidence; a second RCT did not provide data). The review did not evaluate other approaches such as tracheostomy-assisted ('invasive') ventilation, or assess timing of NIV initiation.\nTreatment for sialorrhoea\nA single session of botulinum toxin type B injections to parotid and submandibular glands probably improves sialorrhoea and quality of life at up to 4 weeks compared to placebo injections, but not at 8 or 12 weeks after the injections (moderate-quality evidence from 1 placebo-controlled RCT, N = 20). The review authors found no trials of other approaches.\nEnteral tube feeding for supporting nutrition\nThere is no RCT evidence in a Cochrane Systematic Review to support benefit or harms of enteral tube feeding in supporting nutrition in MND.\nRepetitive transcranial magnetic stimulation\nIt is uncertain whether repetitive transcranial magnetic stimulation (rTMS) improves disability or limitation in activity in MND in comparison with sham rTMS (3 RCTs, very low quality evidence, N = 50).\nTherapeutic exercise\nThere is evidence that exercise may improve disability in MND at three months after the exercise programme, but not quality of life, in comparison with \"usual activities\" or \"usual care\" including stretching (2 RCTs, low-quality evidence, N = 43).\nMultidisciplinary care\nThere is no RCT evidence in a Cochrane Systematic Review to demonstrate any benefit or harm for multidisciplinary care in MND.\nNone of the reviews, other than the review of treatment for cramps, reported that adverse events occurred. However, the trials were too small for reliable adverse event reporting.\nAuthors' conclusions\nThis overview has highlighted the lack of robust evidence in Cochrane Systematic Reviews on interventions to manage symptoms resulting from MND. It is important to recognise that clinical trials may fail to demonstrate efficacy of an intervention for reasons other than a true lack of efficacy, for example because of insufficient statistical power, the wrong choice of dose, insensitive outcome measures or inappropriate participant eligibility. The trials were mostly too small to reliably assess adverse effects of the treatments. The nature of MND makes it difficult to research clinically accepted or recommended practice, regardless of the level of evidence supporting the practice. It would not be ethical, for example, to design a placebo-controlled trial for treatment of pain in MND or to withhold multidisciplinary care where such care is available. It is therefore highly unlikely that there will ever be classically designed placebo-controlled RCTs in these areas.\nWe need more research with appropriate study designs, robust methodology, and of sufficient duration to address the changing needs—of people with MND and their caregivers—associated with MND disease progression and mortality. There is a significant gap in studies assessing the effectiveness of interventions for symptoms relating to MND, such as pseudobulbar emotional lability and cognitive and behavioural difficulties. Future studies should use appropriate outcome measures that are reliable, have internal and external validity, and are sensitive to change in what is being measured (such as quality of life).\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There are currently many treatments in clinical use for pain, but no robust information currently exists on their effectiveness in people with MND.\nThere is evidence that memantine and tetrahydrocannabinol are probably ineffective for cramps in ALS and that vitamin E may be ineffective. There is too little information from RCTs on the effects of other treatments studied, including L-threonine, gabapentin, xaliproden, riluzole, and baclofen. The review did not report adverse events other than for riluzole.\nIt is uncertain whether exercise improves muscle stiffness (spasticity). Exercise may improve disability; it may not improve quality of life. Other interventions for spasticity have not been studied in RCTs.\nNon-invasive mechanical ventilation probably improves survival and quality of life in ALS; it may not improve survival in people with poor bulbar function. The review did not assess when to start NIV.\nA single session of botulinum toxin injections into the salivary glands probably improves excessive saliva production and dribbling, and quality of life in the short term (over weeks but not months).\nAt present, there is no evidence available from controlled trials to indicate whether or not there is a benefit to tube feeding for supporting nutrition, nor is there any evidence to indicate whether multidisciplinary care is helpful or harmful. It is uncertain whether rTMS is of benefit for improving disability or activity limitation in MND. Lack of evidence on multidisciplinary care or other treatments, however, should not be interpreted as ineffectiveness.\nOnly the cramps review reported that adverse events occurred. The trials were mostly too small to reliably assess adverse events or rule out uncommon events.\nMore research is required to determine which treatments help to manage symptoms for those living with MND, using suitable types of studies and outcome measures.\nThis overview is up to date to November 2016."
}
] |
query-laysum
|
23047
|
[
{
"role": "user",
"content": "Abstract: Background\nGonadotropins are the most commonly used medications for controlled ovarian stimulation in in vitro fertilisation (IVF). However, they are expensive and invasive, and are associated with the risk of ovarian hyperstimulation syndrome (OHSS). Recent calls for more patient-friendly regimens have led to growing interest in the use of clomiphene citrate (CC) and aromatase inhibitors with or without gonadotropins to reduce the burden of hormonal injections. It is currently unknown whether regimens using CC or aromatase inhibitors such as letrozole (Ltz) are as effective as gonadotropins alone.\nObjectives\nTo determine the effectiveness and safety of regimens including oral induction medication (such as clomiphene citrate or letrozole) versus gonadotropin-only regimens for controlled ovarian stimulation in IVF or intracytoplasmic sperm injection (ICSI) treatment.\nSearch methods\nWe searched the following databases: Cochrane Gynaecology and Fertility Group Specialised Register (searched January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL CRSO), MEDLINE (1946 to January 2017), Embase (1980 to January 2017), and reference lists of relevant articles. We also searched trials registries ClinicalTrials.gov (clinicaltrials.gov/) and the World Health Organization International Clinical Trials Registry Platform (www.who.int/trialsearch/Default.aspx). We handsearched relevant conference proceedings.\nSelection criteria\nWe included randomized controlled trials (RCTs). The primary outcomes were live-birth rate (LBR) and OHSS.\nData collection and analysis\nThree review authors independently assessed trial eligibility and risk of bias. We calculated risk ratios (RR) and Peto odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We analyzed the general population of women undergoing IVF treatment and (as a separate analysis) women identified as poor responders. We assessed the overall quality of the evidence using the GRADE approach.\nMain results\nWe included 27 studies in the updated review. Most of the new trials in the updated review included poor responders and evaluated Ltz protocols. We could perform meta-analysis with data from 22 studies including a total of 3599 participants. The quality of the evidence for different comparisons ranged from low to moderate. The main limitations in the quality of the evidence were risk of bias associated with poor reporting of study methods, and imprecision.\nIn the general population of women undergoing IVF, it is unclear whether CC or Ltz used with or without gonadotropins compared to use of gonadotropins along with gonadotropin-releasing hormone (GnRH) agonists or antagonists resulted in a difference in live birth (RR 0.92, 95% CI 0.66 to 1.27, 4 RCTs, n = 493, I2 = 0%, low-quality evidence) or clinical pregnancy rate (RR 1.00, 95% CI 0.86 to 1.16, 12 RCTs, n = 1998, I2 = 3%, moderate-quality evidence). This means that for a typical clinic with 23% LBR using a GnRH agonist regimen, switching to CC or Ltz protocols would be expected to result in LBRs between 15% and 30%. Clomiphene citrate or Ltz protocols were associated with a reduction in the incidence of OHSS (Peto OR 0.21, 95% CI 0.11 to 0.41, 5 RCTs, n = 1067, I2 = 0%, low-quality evidence). This means that for a typical clinic with 6% prevalence of OHSS associated with a GnRH regimen, switching to CC or Ltz protocols would be expected to reduce the incidence to between 0.5% and 2.5%. We found evidence of an increase in cycle cancellation rate with the CC protocol compared to gonadotropins in GnRH protocols (RR 1.87, 95% CI 1.43 to 2.45, 9 RCTs, n = 1784, I2 = 61%, low-quality evidence). There was moderate quality evidence of a decrease in the mean number of ampoules used,) and mean number of oocytes collected with CC with or without gonadotropins compared to the gonadotropins in GnRH agonist protocols, though data were too heterogeneous to pool.\nSimilarly, in the poor-responder population, it is unclear whether there was any difference in rates of live birth (RR 1.16, 95% CI 0.49 to 2.79, 2 RCTs, n = 357, I2 = 38%, low-quality evidence) or clinical pregnancy (RR 0.85, 95% CI 0.64 to 1.12, 8 RCTs, n = 1462, I2 = 0%, low-quality evidence) following CC or Ltz with or without gonadotropin versus gonadotropin and GnRH protocol. This means that for a typical clinic with a 5% LBR in the poor responders using a GnRH protocol, switching to CC or Ltz protocols would be expected to yield LBRs between 2% to 14%. There was low quality evidence that the CC or Ltz protocols were associated with an increase in the cycle cancellation rate (RR 1.46, 95% CI 1.18 to 1.81, 10 RCTs, n = 1601, I2 = 64%) and moderate quality evidence of a decrease in the mean number of gonadotropin ampoules used and the mean number of oocytes collected, though data were too heterogeneous to pool. The adverse effects of these protocols were poorly reported. In addition, data on foetal abnormalities following use of CC or Ltz protocols are lacking.\nAuthors' conclusions\nWe found no conclusive evidence indicating that clomiphene citrate or letrozole with or without gonadotropins differed from gonadotropins in GnRH agonist or antagonist protocols with respect to their effects on live-birth or pregnancy rates, either in the general population of women undergoing IVF treatment or in women who were poor responders. Use of clomiphene or letrozole led to a reduction in the amount of gonadotropins required and the incidence of OHSS. However, use of clomiphene citrate or letrozole may be associated with a significant increase in the incidence of cycle cancellations, as well as reductions in the mean number of oocytes retrieved in both the general IVF population and the poor responders. Larger, high-quality randomized trials are needed to reach a firm conclusion before they are adopted into routine 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"
},
{
"role": "assistant",
"content": "We included 27 studies, of which 22 studies with a total of 3599 participants had data suitable for analysis. We studied the general IVF population and those women who had fewer eggs (poor responders) during IVF separately. This is an update of a previous Cochrane Review first published in 2012. The evidence is current to 10 January 2017."
}
] |
query-laysum
|
23048
|
[
{
"role": "user",
"content": "Abstract: Background\nArthroscopic knee surgery remains a common treatment for symptomatic knee osteoarthritis, including for degenerative meniscal tears, despite guidelines strongly recommending against its use. This Cochrane Review is an update of a non-Cochrane systematic review published in 2017.\nObjectives\nTo assess the benefits and harms of arthroscopic surgery, including debridement, partial menisectomy or both, compared with placebo surgery or non-surgical treatment in people with degenerative knee disease (osteoarthritis, degenerative meniscal tears, or both).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trials registers up to 16 April 2021, unrestricted by language.\nSelection criteria\nWe included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing arthroscopic surgery with placebo surgery or non-surgical interventions (e.g. exercise, injections, non-arthroscopic lavage/irrigation, drug therapy, and supplements and complementary therapies) in people with symptomatic degenerative knee disease (osteoarthritis or degenerative meniscal tears or both). Major outcomes were pain, function, participant-reported treatment success, knee-specific quality of life, serious adverse events, total adverse events and knee surgery (replacement or osteotomy).\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was arthroscopic surgery compared to placebo surgery for outcomes that measured benefits of surgery, but we combined data from all control groups to assess harms and knee surgery (replacement or osteotomy).\nMain results\nSixteen trials (2105 participants) met our inclusion criteria. The average age of participants ranged from 46 to 65 years, and 56% of participants were women. Four trials (380 participants) compared arthroscopic surgery to placebo surgery. For the remaining trials, arthroscopic surgery was compared to exercise (eight trials, 1371 participants), a single intra-articular glucocorticoid injection (one trial, 120 participants), non-arthroscopic lavage (one trial, 34 participants), non-steroidal anti-inflammatory drugs (one trial, 80 participants) and weekly hyaluronic acid injections for five weeks (one trial, 120 participants). The majority of trials without a placebo control were susceptible to bias: in particular, selection (56%), performance (75%), detection (75%), attrition (44%) and selective reporting (75%) biases. The placebo-controlled trials were less susceptible to bias and none were at risk of performance or detection bias. Here we limit reporting to the main comparison, arthroscopic surgery versus placebo surgery.\nHigh-certainty evidence indicates arthroscopic surgery leads to little or no difference in pain or function at three months after surgery, moderate-certainty evidence indicates there is probably little or no improvement in knee-specific quality of life three months after surgery, and low-certainty evidence indicates arthroscopic surgery may lead to little or no difference in participant-reported success at up to five years, compared with placebo surgery.\nMean post-operative pain in the placebo group was 40.1 points on a 0 to 100 scale (where lower score indicates less pain) compared to 35.5 points in the arthroscopic surgery group, a difference of 4.6 points better (95% confidence interval (CI) 0.02 better to 9 better; I2 = 0%; 4 trials, 309 participants). Mean post-operative function in the placebo group was 75.9 points on a 0 to 100 rating scale (where higher score indicates better function) compared to 76 points in the arthroscopic surgery group, a difference of 0.1 points better (95% CI 3.2 worse to 3.4 better; I2 = 0%; 3 trials, 302 participants).\nMean post-operative knee-specific health-related quality of life in the placebo group was 69.7 points on a 0 to 100 rating scale (where higher score indicates better quality of life) compared with 75.3 points in the arthroscopic surgery group, a difference of 5.6 points better (95% CI 0.36 better to 10.68 better; I2 = 0%; 2 trials, 188 participants). We downgraded this evidence to moderate certainty as the 95% confidence interval does not rule in or rule out a clinically important change.\nAfter surgery, 74 out of 100 people reported treatment success with placebo and 82 out of 100 people reported treatment success with arthroscopic surgery at up to five years (risk ratio (RR) 1.11, 95% CI 0.66 to 1.86; I2 = 53%; 3 trials, 189 participants). We downgraded this evidence to low certainty due to serious indirectness (diversity in definition and timing of outcome measurement) and serious imprecision (small number of events).\nWe are less certain if the risk of serious or total adverse events increased with arthroscopic surgery compared to placebo or non-surgical interventions. Serious adverse events were reported in 6 out of 100 people in the control groups and 8 out of 100 people in the arthroscopy groups from eight trials (RR 1.35, 95% CI 0.64 to 2.83; I2 = 47%; 8 trials, 1206 participants). Fifteen out of 100 people reported adverse events with control interventions, and 17 out of 100 people with surgery at up to five years (RR 1.15, 95% CI 0.78 to 1.70; I2 = 48%; 9 trials, 1326 participants). The certainty of the evidence was low, downgraded twice due to serious imprecision (small number of events) and possible reporting bias (incomplete reporting of outcome across studies). Serious adverse events included death, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and deep infection.\nSubsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34; I2 = 11%; 4 trials, 864 participants). The certainty of the evidence was low, downgraded twice due to the small number of events.\nAuthors' conclusions\nArthroscopic surgery provides little or no clinically important benefit in pain or function, probably does not provide clinically important benefits in knee-specific quality of life, and may not improve treatment success compared with a placebo procedure. It may lead to little or no difference, or a slight increase, in serious and total adverse events compared to control, but the evidence is of low certainty. Whether or not arthroscopic surgery results in slightly more subsequent knee surgery (replacement or osteotomy) compared to control remains unresolved.\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": "Degenerative knee disease (osteoarthritis in the knee which affects the joint lining and menisci) is the most common cause of knee pain, swelling and stiffness in the knee joint which leads to difficulty in walking. The cartilage in the knee joint is damaged, resulting in friction in the joint surfaces and formation of new bone in severe cases. Arthroscopic knee surgery removes damaged cartilage and loose tissue and smooths the knee joint surfaces."
}
] |
query-laysum
|
23049
|
[
{
"role": "user",
"content": "Abstract: Background\nResilience can be defined as the maintenance or quick recovery of mental health during or after periods of stressor exposure, which may result from a potentially traumatising event, challenging life circumstances, a critical life transition phase, or physical illness. Healthcare professionals, such as nurses, physicians, psychologists and social workers, are exposed to various work-related stressors (e.g. patient care, time pressure, administration) and are at increased risk of developing mental disorders. This population may benefit from resilience-promoting training programmes.\nObjectives\nTo assess the effects of interventions to foster resilience in healthcare professionals, that is, healthcare staff delivering direct medical care (e.g. nurses, physicians, hospital personnel) and allied healthcare staff (e.g. social workers, psychologists).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 11 other databases and three trial registries from 1990 to June 2019. We checked reference lists and contacted researchers in the field. We updated this search in four key databases in June 2020, but we have not yet incorporated these results.\nSelection criteria\nRandomised controlled trials (RCTs) in adults aged 18 years and older who are employed as healthcare professionals, comparing any form of psychological intervention to foster resilience, hardiness or post-traumatic growth versus no intervention, wait-list, usual care, active or attention control. Primary outcomes were resilience, anxiety, depression, stress or stress perception and well-being or quality of life. Secondary outcomes were resilience factors.\nData collection and analysis\nTwo review authors independently selected studies, extracted data, assessed risks of bias, and rated the certainty of the evidence using the GRADE approach (at post-test only).\nMain results\nWe included 44 RCTs (high-income countries: 36). Thirty-nine studies solely focused on healthcare professionals (6892 participants), including both healthcare staff delivering direct medical care and allied healthcare staff. Four studies investigated mixed samples (1000 participants) with healthcare professionals and participants working outside of the healthcare sector, and one study evaluated training for emergency personnel in general population volunteers (82 participants). The included studies were mainly conducted in a hospital setting and included physicians, nurses and different hospital personnel (37/44 studies).\nParticipants mainly included women (68%) from young to middle adulthood (mean age range: 27 to 52.4 years). Most studies investigated group interventions (30 studies) of high training intensity (18 studies; > 12 hours/sessions), that were delivered face-to-face (29 studies). Of the included studies, 19 compared a resilience training based on combined theoretical foundation (e.g. mindfulness and cognitive-behavioural therapy) versus unspecific comparators (e.g. wait-list). The studies were funded by different sources (e.g. hospitals, universities), or a combination of different sources. Fifteen studies did not specify the source of their funding, and one study received no funding support.\nRisk of bias was high or unclear for most studies in performance, detection, and attrition bias domains.\nAt post-intervention, very-low certainty evidence indicated that, compared to controls, healthcare professionals receiving resilience training may report higher levels of resilience (standardised mean difference (SMD) 0.45, 95% confidence interval (CI) 0.25 to 0.65; 12 studies, 690 participants), lower levels of depression (SMD −0.29, 95% CI −0.50 to −0.09; 14 studies, 788 participants), and lower levels of stress or stress perception (SMD −0.61, 95% CI −1.07 to −0.15; 17 studies, 997 participants). There was little or no evidence of any effect of resilience training on anxiety (SMD −0.06, 95% CI −0.35 to 0.23; 5 studies, 231 participants; very-low certainty evidence) or well-being or quality of life (SMD 0.14, 95% CI −0.01 to 0.30; 13 studies, 1494 participants; very-low certainty evidence). Effect sizes were small except for resilience and stress reduction (moderate). Data on adverse effects were available for three studies, with none reporting any adverse effects occurring during the study (very-low certainty evidence).\nAuthors' conclusions\nFor healthcare professionals, there is very-low certainty evidence that, compared to control, resilience training may result in higher levels of resilience, lower levels of depression, stress or stress perception, and higher levels of certain resilience factors at post-intervention.\nThe paucity of medium- or long-term data, heterogeneous interventions and restricted geographical distribution limit the generalisability of our results. Conclusions should therefore be drawn cautiously. The findings suggest positive effects of resilience training for healthcare professionals, but the evidence is very uncertain. There is a clear need for high-quality replications and improved study designs.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do psychological interventions designed to foster resilience improve resilience, mental health and other factors associated with resilience in healthcare professionals?"
}
] |
query-laysum
|
23050
|
[
{
"role": "user",
"content": "Abstract: Background\nEarly enteral feeding practices are potentially modifiable risk factors for necrotising enterocolitis (NEC) in very preterm or very low birth weight (VLBW) infants. Observational studies suggest that conservative feeding regimens, including slowly advancing enteral feed volumes, reduce the risk of NEC. However, it is unclear whether slow feed advancement may delay establishment of full enteral feeding, and if it could be associated with infectious morbidities secondary to prolonged exposure to parenteral nutrition.\nObjectives\nTo determine the effects of slow rates of enteral feed advancement on the risk of NEC, mortality, and other morbidities in very preterm or VLBW infants.\nSearch methods\nWe searched CENTRAL (2020, Issue 10), Ovid MEDLINE (1946 to October 2020), Embase via Ovid (1974 to October 2020), Maternity and Infant Care database (MIDIRS) (1971 to October 2020), CINAHL (1982 to October 2020), and clinical trials databases and reference lists of retrieved articles for eligible trials.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that assessed effects of slow (up to 24 mL/kg/d) versus faster rates of advancement of enteral feed volumes on the risk of NEC in very preterm or VLBW infants.\nData collection and analysis\nTwo review authors separately evaluated trial risk of bias, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of evidence. Outcomes of interest were NEC, all-cause mortality, feed intolerance, and invasive infection.\nMain results\nWe included 14 trials involving a total of 4033 infants (2804 infants participated in one large trial). None of the trials masked parents, caregivers, or investigators. Risk of bias was otherwise low. Most infants were stable very preterm or VLBW infants of birth weight appropriate for gestation. About one-third of all infants were extremely preterm or extremely low birth weight (ELBW), and about one-fifth were small for gestational age, growth-restricted, or compromised as indicated by absent or reversed end-diastolic flow velocity in the foetal umbilical artery. Trials typically defined slow advancement as daily increments of 15 to 24 mL/kg, and faster advancement as daily increments of 30 to 40 mL/kg.\nMeta-analyses showed that slow advancement of enteral feed volumes probably has little or no effect on the risk of NEC (RR 1.06, 95% confidence interval (CI) 0.83 to 1.37; RD 0.00, 95% CI −0.01 to 0.02; 14 trials, 4026 infants; moderate-certainty evidence) or all-cause mortality prior to hospital discharge (RR 1.13, 95% CI 0.91 to 1.39; RD 0.01, 95% CI −0.01 to 0.02; 13 trials, 3860 infants; moderate-certainty evidence). Meta-analyses suggested that slow advancement may slightly increase feed intolerance (RR 1.18, 95% CI 0.95 to 1.46; RD 0.05, 95% CI −0.02 to 0.12; 9 trials, 719 infants; low-certainty evidence) and may slightly increase the risk of invasive infection (RR 1.14, 95% CI 0.99 to 1.31; RD 0.02, 95% CI −0.00 to 0.05; 11 trials, 3583 infants; low-certainty evidence).\nAuthors' conclusions\nThe available trial data indicate that advancing enteral feed volumes slowly (daily increments up to 24 mL/kg) compared with faster rates probably does not reduce the risk of NEC, death, or feed intolerance in very preterm or VLBW infants. Advancing the volume of enteral feeds at a slow rate may slightly increase the risk of invasive infection.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Combined analysis of the included trials showed that slow advancement of enteral feed volumes probably does not affect the risk of necrotising enterocolitis or death (moderate-certainty evidence)."
}
] |
query-laysum
|
23051
|
[
{
"role": "user",
"content": "Abstract: Background\nThyroid nodules are very common in general medical practice, but rarely turn out to be a medullary thyroid carcinoma (MTC). Calcitonin is a sensitive tumour marker for the detection of MTC (basal calcitonin). Sometimes a stimulation test is used to improve specificity (stimulated calcitonin). Although the European Thyroid Association's guideline advocates calcitonin determination in people with thyroid nodules, the role of routine calcitonin testing in individuals with thyroid nodules is still questionable.\nObjectives\nThe objective of this review was to determine the diagnostic accuracy of basal and/or stimulated calcitonin as a triage or add-on test for detection of MTC in people with thyroid nodules.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and Web of Science from inception to June 2018.\nSelection criteria\nWe included all retrospective and prospective cohort studies in which all participants with thyroid nodules had undergone determination of basal calcitonin levels (and stimulated calcitonin, if performed).\nData collection and analysis\nTwo review authors independently scanned all retrieved records. We extracted data using a standard data extraction form. We assessed risk of bias and applicability using the QUADAS-2 tool. Using the hierarchical summary receiver operating characteristic (HSROC) model, we estimated summary curves across different thresholds and also obtained summary estimates of sensitivity and specificity at a common threshold when possible.\nMain results\nIn 16 studies, we identified 72,368 participants with nodular thyroid disease in whom routinely calcitonin testing was performed. All included studies performed the calcitonin test as a triage test. Median prevalence of MTC was 0.32%. Sensitivity in these studies ranged between 83% and 100% and specificity ranged between 94% and 100%.\nAn important limitation in 15 of the 16 studies (94%) was the absence of adequate reference standards and follow-up in calcitonin-negative participants. This resulted in a high risk of bias with regard to flow and timing in the methodological quality assessment.\nAt the median specificity of 96.6% from the included studies, the estimated sensitivity (95% confidence interval (CI)) from the summary curve was 99.7% ( 68.8% to 100%). For the median prevalence of MTC of 0.23%, the positive predictive value (PPV) for basal calcitonin testing at a threshold of 10 pg/mL was 7.7% (4.9% to 12.1%).\nSummary estimates of sensitivity and specificity for the threshold of 10 pg/mL of basal calcitonin testing was 100% (95% CI 99.7 to 100) and 97.2% (95% CI 95.9 to 98.6), respectively. For combined basal and stimulated calcitonin testing, sensitivity ranged between 82% and 100% with specificity between 99% and 100%. The median specificity was 99.8% with an estimated sensitivity of 98.8% (95% CI 65.8 to 100) .\nAuthors' conclusions\nBoth basal and combined basal and stimulated calcitonin testing have a high sensitivity and specificity. However, this may be an overestimation due to high risk of bias in the use and choice of reference standard The value of routine testing in patients with thyroid nodules remains questionable, due to the low prevalence, which results in a low PPV of basal calcitonin testing. Whether routine calcitonin testing improves prognosis in MTC patients remains unclear.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In total 72,638 people with thyroid nodular disease were enrolled in the analysed studies, of which 187 had medullary thyroid carcinoma. Our findings indicate that both basal and stimulated calcitonin testing are able to detect nearly all people with medullary thyroid carcinoma. However, because medullary thyroid carcinoma is very rare in persons with a thyroid nodule, there is large chance that calcitonin levels are false positives (i.e. the test indicates the disease, whereas in fact there is none).\nIn practice this means that for every 10,000 persons with thyroid nodular disease, 23 persons will have medullary thyroid carcinoma. Of these, none will be missed using a basal calcitonin threshold of 10 pg/mL, while 280 people will have a false-positive test result. This might lead to unnecessary surgery of the thyroid with the need for life-long thyroid hormone supplementation and risk of complications. With the use of a stimulation test the chance of a false-positive test result may be reduced, however due to lack of sufficient studies this could not be calculated."
}
] |
query-laysum
|
23052
|
[
{
"role": "user",
"content": "Abstract: Background\nFor people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group.\nObjectives\nTo compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke.\nSearch methods\nWe searched the Cochrane Stroke Group and Cochrane Oral Health Group trials registers, CENTRAL, MEDLINE, Embase, and six other databases in February 2019. We scanned reference lists from relevant papers and contacted authors and researchers in the field. We handsearched the reference lists of relevant articles and contacted other researchers. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles according to prespecified selection criteria, extracted data and assessed the methodological quality using the Cochrane 'Risk of bias' tool. We sought clarification from investigators when required. Where suitable statistical data were available, we combined the selected outcome data in pooled meta-analyses. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nFifteen RCTs (22 randomised comparisons) involving 3631 participants with data for 1546 people with stroke met the selection criteria.\nOHC interventions compared with usual care\nSeven trials (2865 participants, with data for 903 participants with stroke, 1028 healthcare providers, 94 informal carers) investigated OHC interventions compared with usual care.\nMulti-component OHC interventions showed no evidence of a difference in the mean score (DMS) of dental plaque one month after the intervention was delivered (DMS –0.66, 95% CI –1.40 to 0.09; 2 trials, 83 participants; I2 = 83%; P = 0.08; very low-quality evidence).\nStroke survivors had less plaque on their dentures when staff had access to the multi-component OHC intervention (DMS –1.31, 95% CI –1.96 to –0.66; 1 trial, 38 participants; P < 0.0001; low-quality evidence).\nThere was no evidence of a difference in gingivitis (DMS –0.60, 95% CI –1.66 to 0.45; 2 trials, 83 participants; I2 = 93%; P = 0.26: very low-quality evidence) or denture-induced stomatitis (DMS –0.33, 95% CI –0.92 to 0.26; 1 trial, 38 participants; P = 0.69; low-quality evidence) among participants receiving the multi-component OHC protocol compared with usual care one month after the intervention. There was no difference in the incidence of pneumonia in participants receiving a multi-component OHC intervention (99 participants; 5 incidents of pneumonia) compared with those receiving usual care (105 participants; 1 incident of pneumonia) (OR 4.17, CI 95% 0.82 to 21.11; 1 trial, 204 participants; P = 0.08; low-quality evidence).\nOHC training for stroke survivors and healthcare providers significantly improved their OHC knowledge at one month after training (SMD 0.70, 95% CI 0.06 to 1.35; 3 trials, 728 participants; I2 = 94%; P = 0.03; very low-quality evidence). Pooled data one month after training also showed evidence of a difference between stroke survivor and providers' oral health attitudes (SMD 0.28, 95% CI 0.01 to 0.54; 3 trials, 728 participants; I2 = 65%; P = 0.06; very low-quality evidence).\nOHC interventions compared with placebo\nThree trials (394 participants, with data for 271 participants with stroke) compared an OHC intervention with placebo. There were no data for primary outcomes. There was no evidence of a difference in the incidence of pneumonia in participants receiving an OHC intervention compared with placebo (OR 0.39, CI 95% 0.14 to 1.09; 2 trials, 242 participants; I2 = 42%; P = 0.07; low-quality evidence). However, decontamination gel reduced the incidence of pneumonia among the intervention group compared with placebo gel group (OR 0.20, 95% CI 0.05 to 0.84; 1 trial, 203 participants; P = 0.028). There was no difference in the incidence of pneumonia in participants treated with povidone-iodine compared with a placebo (OR 0.81, 95% CI 0.18 to 3.51; 1 trial, 39 participants; P = 0.77).\nOne OHC intervention compared with another OHC intervention\nTwelve trials (372 participants with stroke) compared one OHC intervention with another OHC intervention. There was no difference in dental plaque scores between those participants that received an enhanced multi-component OHC intervention compared with conventional OHC interventions at three months (MD –0.04, 95% CI –0.33 to 0.25; 1 trial, 61 participants; P = 0.78; low-quality evidence). There were no data for denture plaque.\nAuthors' conclusions\nWe found low- to very low-quality evidence suggesting that OHC interventions can improve the cleanliness of patient's dentures and stroke survivor and providers' knowledge and attitudes. There is limited low-quality evidence that selective decontamination gel may be more beneficial than placebo at reducing the incidence of pneumonia. Improvements in the cleanliness of a patient's own teeth was limited. We judged the quality of the evidence included within meta-analyses to be low or very low quality, and this limits our confidence in the results. We still lack high-quality evidence of the optimal approach to providing OHC to people after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the quality of the current evidence in this review to be low to very low. We lack high-quality evidence of the optimal approach to providing OHC to people after stroke. Additional well-conducted clinical trials are needed."
}
] |
query-laysum
|
23053
|
[
{
"role": "user",
"content": "Abstract: Background\nAbstracts of presentations at scientific meetings are usually available only in conference proceedings. If subsequent full publication of results reported in these abstracts is based on the magnitude or direction of the results, publication bias may result. Publication bias creates problems for those conducting systematic reviews or relying on the published literature for evidence about health and social care.\nObjectives\nTo systematically review reports of studies that have examined the proportion of meeting abstracts and other summaries that are subsequently published in full, the time between meeting presentation and full publication, and factors associated with full publication.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Library, Science Citation Index, reference lists, and author files. The most recent search was done in February 2016 for this substantial update to our earlier Cochrane Methodology Review (published in 2007).\nSelection criteria\nWe included reports of methodology research that examined the proportion of biomedical results initially presented as abstracts or in summary form that were subsequently published. Searches for full publications had to be at least two years after meeting presentation.\nData collection and analysis\nTwo review authors extracted data and assessed risk of bias. We calculated the proportion of abstracts published in full using a random-effects model. Dichotomous variables were analyzed using risk ratio (RR), with multivariable models taking into account various characteristics of the reports. We assessed time to publication using Kaplan-Meier survival analyses.\nMain results\nCombining data from 425 reports (307,028 abstracts) resulted in an overall full publication proportion of 37.3% (95% confidence interval (CI), 35.3% to 39.3%) with varying lengths of follow-up. This is significantly lower than that found in our 2007 review (44.5%. 95% CI, 43.9% to 45.1%). Using a survival analyses to estimate the proportion of abstracts that would be published in full by 10 years produced proportions of 46.4% for all studies; 68.7% for randomized and controlled trials and 44.9% for other studies. Three hundred and fifty-three reports were at high risk of bias on one or more items, but only 32 reports were considered at high risk of bias overall.\nForty-five reports (15,783 abstracts) with 'positive' results (defined as any 'significant' result) showed an association with full publication (RR = 1.31; 95% CI 1.23 to 1.40), as did 'positive' results defined as a result favoring the experimental treatment (RR =1.17; 95% CI 1.07 to 1.28) in 34 reports (8794 abstracts). Results emanating from randomized or controlled trials showed the same pattern for both definitions (RR = 1.21; 95% CI 1.10 to 1.32 (15 reports and 2616 abstracts) and RR = 1.17; 95% CI, 1.04 to 1.32 (13 reports and 2307 abstracts), respectively.\nOther factors associated with full publication include oral presentation (RR = 1.46; 95% CI 1.40 to 1.52; studied in 143 reports with 115,910 abstracts); acceptance for meeting presentation (RR = 1.65; 95% CI 1.48 to 1.85; 22 reports with 22,319 abstracts); randomized trial design (RR = 1.51; 95% CI 1.36 to 1.67; 47 reports with 28,928 abstracts); and basic research (RR = 0.78; 95% CI 0.74 to 0.82; 92 reports with 97,372 abstracts). Abstracts originating at an academic setting were associated with full publication (RR = 1.60; 95% CI 1.34 to 1.92; 34 reports with 16,913 abstracts), as were those considered to be of higher quality (RR = 1.46; 95% CI 1.23 to 1.73; 12 reports with 3364 abstracts), or having high impact (RR = 1.60; 95% CI 1.41 to 1.82; 11 reports with 6982 abstracts). Sensitivity analyses excluding reports that were abstracts themselves or classified as having a high risk of bias did not change these findings in any important way.\nIn considering the reports of the methodology research that we included in this review, we found that reports published in English or from a native English-speaking country found significantly higher proportions of studies published in full, but that there was no association with year of report publication. The findings correspond to a proportion of abstracts published in full of 31.9% for all reports, 40.5% for reports in English, 42.9% for reports from native English-speaking countries, and 52.2% for both these covariates combined.\nAuthors' conclusions\nMore than half of results from abstracts, and almost a third of randomized trial results initially presented as abstracts fail to be published in full and this problem does not appear to be decreasing over time. Publication bias is present in that 'positive' results were more frequently published than 'not positive' results. Reports of methodology research written in English showed that a higher proportion of abstracts had been published in full, as did those from native English-speaking countries, suggesting that studies from non-native English-speaking countries may be underrepresented in the scientific literature. After the considerable work involved in adding in the more than 300 additional studies found by the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change these overall conclusions in any important way.\n\nGiven the provided abstract, please respond to the following query: \"Search Date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our search updated our 2007 review and is current to February 2016. After the considerable work involved in including more than 300 additional studies from the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change our overall conclusions in any important way."
}
] |
query-laysum
|
23054
|
[
{
"role": "user",
"content": "Abstract: Background\nInsomnia is a major public health issue affecting between 6% to 10% of the adult population in Western countries. Eszopiclone is a hypnotic drug belonging to a newer group of hypnotic agents, known as new generation hypnotics, which was marketed as being just as effective as benzodiazepines for this condition, while being safer and having a lower risk for abuse and dependence. It is the aim of the review to integrate evidence from randomised controlled trials and to draw conclusions on eszopiclone's efficacy and safety profile, while taking methodological features and bias risks into consideration.\nObjectives\nTo assess the efficacy and safety of eszopiclone for the treatment of insomnia compared to placebo or active control.\nSearch methods\nWe searched the Cochrane Central Register of Controlled trials (CENTRAL), MEDLINE, Embase, PsycINFO, PSYNDEX and registry databases (WHO trials portal, ClinicalTrials.gov) with results incorporated from searches to 10 February 2016. To identify trials not registered in electronic databases, we contacted key informants and searched reference lists of identified studies. We ran an update search (21 February 2018) and have placed studies of interest in awaiting classification/ongoing studies. These will be incorporated into the next version of the review, as appropriate.\nSelection criteria\nParallel group randomised controlled trials (RCTs) comparing eszopiclone with either placebo or active control were included in the review. Participants were adults with insomnia, as diagnosed with a standardised diagnostic system, including primary insomnia and comorbid insomnia.\nData collection and analysis\nTwo authors independently extracted outcome data; one reviewer assessed trial quality and the second author cross-checked it.\nMain results\nA total of 14 RCTs, with 4732 participants, were included in this review covering short-term (≤ 4 weeks; 6 studies), medium-term (> 4 weeks ≤ 6 months; 6 studies) and long-term treatment (> 6 months; 2 studies) with eszopiclone. Most RCTs included in the review included participants aged between 18 and 64 years, three RCTs only included elderly participants (64 to 85 years) and one RCT included participants with a broader age range (35 to 85 years). Seven studies considered primary insomnia; the remaining studies considered secondary insomnia comorbid with depression (2), generalised anxiety (1), back pain (1), Parkinson's disease (1), rheumatoid arthritis (1) and menopausal transition (1).\nMeta-analytic integrations of participant-reported data on sleep efficacy outcomes demonstrated better results for eszopiclone compared to placebo: a 12-minute decrease of sleep onset latency (mean difference (MD) -11.94 min, 95% confidence interval (CI) -16.03 to -7.86; 9 studies, 2890 participants, moderate quality evidence), a 17-minute decrease of wake time after sleep onset (MD -17.02 min, 95% CI -24.89 to -9.15; 8 studies, 2295 participants, moderate quality evidence) and a 28-minute increase of total sleep time (MD 27.70 min, 95% CI 20.30 to 35.09; 10 studies, 2965 participants, moderate quality evidence). There were no significant changes from baseline to the first three nights after drug discontinuation for sleep onset latency (MD 17.00 min, 95% CI -4.29 to 38.29; 1 study, 291 participants, low quality evidence) and wake time after sleep onset (MD -6.71 min, 95% CI -21.25 to 7.83; 1 study, 291 participants, low quality evidence). Adverse events during treatment that were documented more frequently under eszopiclone compared to placebo included unpleasant taste (risk difference (RD) 0.18, 95% CI 0.14 to 0.21; 9 studies, 3787 participants), dry mouth (RD 0.04, 95% CI 0.02 to 0.06; 6 studies, 2802 participants), somnolence (RD 0.04, 95% CI 0.02 to 0.06; 8 studies, 3532 participants) and dizziness (RD 0.03, 95% CI 0.01 to 0.05; 7 studies, 2933 participants). According to the GRADE criteria, evidence was rated as being of moderate quality for sleep efficacy outcomes and adverse events and of low quality for rebound effects and next-day functioning.\nAuthors' conclusions\nEszopiclone appears to be an efficient drug with moderate effects on sleep onset and maintenance. There was no or little evidence of harm if taken as recommended. However, as certain patient subgroups were underrepresented in RCTs included in the review, findings might not have displayed the entire spectrum of possible adverse events. Further, increased caution is required in elderly individuals with cognitive and motor impairments and individuals who are at increased risk of using eszopiclone in a non-recommended way.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who are affected by insomnia, general practitioners, professionals working in health services, and addiction treatment and health policy makers."
}
] |
query-laysum
|
23055
|
[
{
"role": "user",
"content": "Abstract: Background\nBreastfeeding is important, however not all infants can feed at the breast and methods of expressing milk need evaluation.\nObjectives\nTo assess acceptability, effectiveness, safety, effect on milk composition, contamination and costs of methods of milk expression.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (21 March 2016), handsearched relevant journals and conference proceedings, and contacted experts in the field to seek additional published or unpublished studies. We also examined reference lists of all relevant retrieved papers.\nSelection criteria\nRandomised and quasi-randomised trials comparing methods at any time after birth.\nData collection and analysis\nThree review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nThis updated review includes 41 trials involving 2293 participants, with 22 trials involving 1339 participants contributing data for analysis. Twenty-six of the trials referred to mothers of infants in neonatal units (n = 1547) and 14 to mothers of healthy infants at home (n = 730), with one trial containing mothers of both neonatal and healthy older infants (n = 16). Eleven trials compared one or more types of pump versus hand expression and 14 studies compared one type of pump versus another type of pump, with three of these studies comparing both hand expression and pump types. Twenty studies compared a specific protocol or adjunct behaviour including sequential versus simultaneous pumping protocols, pumping frequency, provision of an education and support intervention, relaxation, breast massage, combining hand expression with pumping and a breast cleansing protocol.\nDue to heterogeneity in participants, interventions, and outcomes measured or reported, we were unable to pool findings for most of the specified outcomes. It was not possible therefore to produce a 'Summary of findings' table in this update. Most of the included results were derived from single studies. Trials took place in 14 countries under a variety of circumstances and were published from 1982 to 2015. Sixteen of the 30 trials that evaluated pumps or products had support from the manufacturers. The risk of bias of the included studies was variable.\nPrimary outcomes\nOnly one of the 17 studies examining maternal satisfaction/acceptability with the method or adjunct behaviour provided data suitable for analysis. In this study, self-efficacy was assessed by asking mothers if they agreed or disagreed with the following statement: ‘I don't want anyone to see me (hand expressing/pumping)’. The study found that mothers who were using the electric pump were more likely to agree with the statement compared to mothers hand expressing, (mean difference (MD) 0.70, 95% confidence interval (CI) 0.15 to 1.25; P = 0.01, participants = 68). Mothers who were hand expressing reported that the instructions for expression were clearer compared to the electric pump, (MD -0.40, 95% CI -0.75 to -0.05; P = 0.02, participants = 68). Descriptive reporting of satisfaction in the other studies varied in the measures used, did not indicate a clear preference for one pump type, although there was satisfaction with some relaxation and support interventions.\nWe found no clinically significant differences between methods related to contamination of the milk that compared any type of pump to hand expression (risk ratio (RR) 1.13, 95% CI 0.79 to 1.61; P = 0.51, participants = 28), manual pump compared to hand expression, (MD 0.20, 95% CI -0.18 to 0.58; P = 0.30, participants = 142) a large electric pump compared to hand expression (MD 0.10, 95% CI -0.29 to 0.49; P = 0.61, participants = 123), or a large electric pump compared to a manual pump (MD -0.10, 95% CI -0.46 to 0.26; P = 0.59, participants = 141).\nThe level of maternal breast or nipple pain or damage was similar in comparisons of a large electric pump to hand expression (MD 0.02, 95% CI -0.67 to 0.71; P = 0.96, participants = 68). A study comparing a manual and large electric pump, reported sore nipples in 7% for both groups and engorgement in 4% using a manual pump versus 6% using an electric pump; and in one study no nipple damage was reported in the hand-expression group, and one case of nipple damage in each of the manual pump and the large electric pump groups.\nOne study examined adverse effects on infants, however as the infants did not all receive their mothers' expressed milk, we have not included the results.\nSecondary outcomes\nThe quantity of expressed milk obtained was increased, in some studies by a clinically significant amount, in interventions involving relaxation, music, warmth, massage, initiation of pumping, increased frequency of pumping and suitable breast shield size. Support programmes and simultaneous compared to sequential pumping did not show a difference in milk obtained. No pump consistently increased the milk volume obtained significantly.\nIn relation to nutrient quality, hand expression or a large electric pump were found to provide higher protein than a manual pump, and hand expression provided higher sodium and lower potassium compared to a large electric pump or a manual pump. Fat content was higher with breast massage when pumping; no evidence of difference was found for energy content between methods.\nNo consistent effect was found related to prolactin change or effect on oxytocin release with pump type or method. Economic aspects were not reported.\nAuthors' conclusions\nThe most suitable method for milk expression may depend on the time since birth, purpose of expression and the individual mother and infant. Low-cost interventions including initiation of milk expression sooner after birth when not feeding at the breast, relaxation, massage, warming the breasts, hand expression and lower cost pumps may be as effective, or more effective, than large electric pumps for some outcomes. Variation in nutrient content across methods may be relevant to some infants. Small sample sizes, large standard deviations, and the diversity of the interventions argue caution in applying these results beyond the specific method tested in the specific settings. Independently funded research is needed for more trials on hand expression, relaxation and other techniques that do not have a commercial potential.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The available evidence indicates that effective measures include starting to express milk soon after birth if the infant is unable to feed at the breast, relaxation, breast massage, warming of the breasts, hand expression, and use of low cost pumps.These may be as effective, or more effective, than large more costly electric pumps for some outcomes. The most suitable method for milk expression may depend on the time since birth, purpose of expression and the individual mother and infant. Publications on breast milk pumping should not be taken to imply that use of a pump is a routine part of breastfeeding, rather, practitioners need to be able to justify the use of a pump for an individual mother prior to making a recommendation on its use."
}
] |
query-laysum
|
23056
|
[
{
"role": "user",
"content": "Abstract: Background\nRoutine outcome monitoring of common mental health disorders (CMHDs), using patient reported outcome measures (PROMs), has been promoted across primary care, psychological therapy and multidisciplinary mental health care settings, but is likely to be costly, given the high prevalence of CMHDs. There has been no systematic review of the use of PROMs in routine outcome monitoring of CMHDs across these three settings.\nObjectives\nTo assess the effects of routine measurement and feedback of the results of PROMs during the management of CMHDs in 1) improving the outcome of CMHDs; and 2) in changing the management of CMHDs.\nSearch methods\nWe searched the Cochrane Depression Anxiety and Neurosis group specialised controlled trials register (CCDANCTR-Studies and CCDANCTR-References), the Oxford University PROMS Bibliography (2002-5), Ovid PsycINFO, Web of Science, The Cochrane Library, and International trial registries, initially to 30 May 2014, and updated to 18 May 2015.\nSelection criteria\nWe selected cluster and individually randomised controlled trials (RCTs) including participants with CMHDs aged 18 years and over, in which the results of PROMs were fed back to treating clinicians, or both clinicians and patients. We excluded RCTs in child and adolescent treatment settings, and those in which more than 10% of participants had diagnoses of eating disorders, psychoses, substance use disorders, learning disorders or dementia.\nData collection and analysis\nAt least two authors independently identified eligible trials, assessed trial quality, and extracted data. We conducted meta-analysis across studies, pooling outcome measures which were sufficiently similar to each other to justify pooling.\nMain results\nWe included 17 studies involving 8787 participants: nine in multidisciplinary mental health care, six in psychological therapy settings, and two in primary care. Pooling of outcome data to provide a summary estimate of effect across studies was possible only for those studies using the compound Outcome Questionnaire (OQ-45) or Outcome Rating System (ORS) PROMs, which were all conducted in multidisciplinary mental health care or psychological therapy settings, because both primary care studies identified used single symptom outcome measures, which were not directly comparable to the OQ-45 or ORS.\nMeta-analysis of 12 studies including 3696 participants using these PROMs found no evidence of a difference in outcome in terms of symptoms, between feedback and no-feedback groups (standardised mean difference (SMD) -0.07, 95% confidence interval (CI) -0.16 to 0.01; P value = 0.10). The evidence for this comparison was graded as low quality however, as all included studies were considered at high risk of bias, in most cases due to inadequate blinding of assessors and significant attrition at follow-up.\nQuality of life was reported in only two studies, social functioning in one, and costs in none. Information on adverse events (thoughts of self-harm or suicide) was collected in one study, but differences between arms were not reported.\nIt was not possible to pool data on changes in drug treatment or referrals as only two studies reported these. Meta-analysis of seven studies including 2608 participants found no evidence of a difference in management of CMHDs between feedback and no-feedback groups, in terms of the number of treatment sessions received (mean difference (MD) -0.02 sessions, 95% CI -0.42 to 0.39; P value = 0.93). However, the evidence for this comparison was also graded as low quality.\nAuthors' conclusions\nWe found insufficient evidence to support the use of routine outcome monitoring using PROMs in the treatment of CMHDs, in terms of improving patient outcomes or in improving management. The findings are subject to considerable uncertainty however, due to the high risk of bias in the large majority of trials meeting the inclusion criteria, which means further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate. More research of better quality is therefore required, particularly in primary care where most CMHDs are treated.\nFuture research should address issues of blinding of assessors and attrition, and measure a range of relevant symptom outcomes, as well as possible harmful effects of monitoring, health-related quality of life, social functioning, and costs. Studies should include people treated with drugs as well as psychological therapies, and should follow them up for longer than six months.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One in six people suffer from a common mental health disorder (CMHD), including depression and anxiety disorders. Patient reported outcome measures (PROMs) are questionnaires on patients' symptoms, functioning, and relationships. Using PROMs to monitor the progress of people with CMHDs might improve treatment outcomes, and change the management of CMHDs."
}
] |
query-laysum
|
23057
|
[
{
"role": "user",
"content": "Abstract: Background\nBeta thalassaemia is a common inherited blood disorder. The need for frequent blood transfusions in this condition poses a difficult problem to healthcare systems. The most common cause of morbidity and mortality is cardiac dysfunction from iron overload. The use of iron chelation therapy has reduced the severity of systemic iron overload but specific, non-toxic treatment is required for removal of iron from the myocardium.\nObjectives\nTo assess the effects of calcium channel blockers combined with standard iron chelation therapy in people with transfusion-dependent beta thalassaemia on the amount of iron deposited in the myocardium, on parameters of heart function, and on the incidence of severe heart failure or arrhythmias and related morbidity and mortality.\nSearch methods\nWe searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched ongoing trials databases, and the reference lists of relevant articles and reviews.\nDate of last search: 24 February 2018.\nSelection criteria\nWe included randomised controlled trials of calcium channel blockers combined with standard chelation therapy compared with standard chelation therapy alone or combined with placebo in people with transfusion-dependent beta thalassaemia.\nData collection and analysis\nTwo authors independently applied the inclusion criteria for the selection of trials. Two authors assessed the risk of bias of trials and extracted data and a third author verified these assessments. The authors used the GRADE system to assess the quality of the evidence.\nMain results\nTwo randomised controlled trials (n = 74) were included in the review; there were 35 participants in the amlodipine arms and 39 in the control arms. The mean age of participants was 24.4 years with a standard deviation of 8.5 years. There was comparable participation from both genders. Overall, the risk of bias in included trials was low. The quality of the evidence ranged across outcomes from low to high, but the evidence for most outcomes was judged to be low quality.\nCardiac iron assessment, as measured by heart T2*, did not significantly improve in the amlodipine groups compared to the control groups at six or 12 months (low-quality evidence). However, myocardial iron concentration decreased significantly in the amlodipine groups compared to the control groups at both six months, mean difference -0.23 mg/g (95% confidence interval -0.07 to -0.39), and 12 months, mean difference -0.25 mg/g (95% confidence interval -0.44 to -0.05) (low-quality evidence). There were no significant differences between treatment and control groups in serum ferritin (low-quality evidence), liver T2* (low-quality evidence), liver iron content (low-quality evidence) and left ventricular ejection fraction (low-quality evidence). There were no serious adverse events reported in either trial; however, one trial (n = 59) reported mild adverse events, with no statistically significant difference between groups (low-quality evidence).\nAuthors' conclusions\nThe available evidence does not clearly suggest that the use of calcium channel blockers is associated with a reduction in myocardial iron in people with transfusion-dependent beta thalassaemia, although a potential for this was seen. There is a need for more long-term, multicentre trials to assess the efficacy and safety of calcium channel blockers for myocardial iron overload, especially in younger children. Future trials should be designed to compare commonly used iron chelation drugs with the addition of calcium channel blockers to investigate the potential interplay of these treatments. In addition, the role of baseline myocardial iron content in affecting the response to calcium channel blockers should be investigated. An analysis of the cost-effectiveness of the treatment is also required.\n\nGiven the provided abstract, please respond to the following query: \"Trial characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included two trials (74 participants) in the review, an earlier pilot study and the later larger study. Participants had beta thalassaemia, significant iron overload, and were receiving standard chelation treatment; they had an average age of 24 years. They were randomly selected to be treated for 12 months with either amlodipine (a calcium channel blocker) in addition to their chelation drugs or with chelation drugs alone (in the earlier trial) or with chelation drugs together with a placebo (dummy drug with no active medication) in the later trial."
}
] |
query-laysum
|
23058
|
[
{
"role": "user",
"content": "Abstract: Background\nPrevention of cognitive impairment and dementia is an important public health goal. Epidemiological evidence shows a relationship between cognitive impairment and Type 2 diabetes mellitus. The risk of dementia increases with duration of disease. This updated systematic review investigated the effect on cognitive function of the type of treatment and level of metabolic control in people with Type 2 diabetes.\nObjectives\nTo assess the effects of different strategies for managing Type 2 diabetes mellitus on cognitive function and the incidence of dementia.\nSearch methods\nWe searched ALOIS (the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG)), the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL and LILACS on 15 October 2016. ALOIS contains records from all major health care databases, (CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS), as well as from many trials' registers and grey literature sources.\nSelection criteria\nWe included randomised controlled trials (RCTs) which compared two or more different treatments for Type 2 diabetes mellitus and in which cognitive function was measured at baseline and after treatment.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of the included RCTs. We pooled data for comparable trials and estimated the effects of treatment by using risk ratios (RRs) and mean differences (MDs), according to the nature of the outcome. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe identified seven eligible studies but only four provided data we could include in efficacy analyses. Two of these studies compared intensive versus standard glycaemic control and two compared different pharmacological treatments. All studies were at unclear risk of bias in at least two domains and one large study was at high risk of performance and detection bias.\n(a) Two studies with 13,934 participants at high cardiovascular risk provided efficacy data on intensive versus standard glycaemic control. A third study with 1791 participants provided additional data on hypoglycaemic episodes and mortality. There is probably no difference between treatment groups in the number of participants who decline by at least 3 points on the Mini–Mental State Examination (MMSE) over five years (RR 0.98, 95% CI 0.88 to 1.08; 1 study; n = 11,140; moderate-quality evidence); and there may also be little or no difference in the incidence of dementia (RR 1.27, 95% CI 0.87 to 1.85; 1 study; n = 11,140; low-quality evidence). From another study, there was probably little or no difference in MMSE score after 40 months (MD −0.01, 95% CI −0.18 to 0.16; 1 study; n = 2794; moderate quality evidence). Participants exposed to the intensive glycaemic control strategy probably experience more episodes of severe hypoglycaemia than those who have standard treatment (RR 2.18, 95% CI 1.52 to 3.14; 2 studies; n = 12,827; moderate-quality evidence). The evidence from these trials suggests that the intensity of glycaemic control may have little or no effect on all-cause mortality (RR 0.99, 95% CI 0.87 to 1.13; 3 studies; n = 15,888; low-quality evidence).\n(b) One study with 156 participants compared glibenclamide (glyburide) with repaglinide. There may be a small advantage of glibenclamide on global cognitive function measured with the MMSE after 12 months (MD −0.90, 95% CI −1.68 to −0.12; low-quality evidence). No data were reported on the incidence of dementia, hypoglycaemic events or all-cause mortality.\n(c) One study with 145 participants compared rosiglitazone plus metformin to glibenclamide (glyburide) plus metformin over 24 weeks. It reported only on cognitive subdomains and not on global cognitive function, incidence of MCI or dementia, hypoglycaemic events or all causes of mortality.\nAuthors' conclusions\nWe found no good evidence that any specific treatment or treatment strategy for Type 2 diabetes can prevent or delay cognitive impairment. The best available evidence related to the comparison of intensive with standard glycaemic control strategies. Here there was moderate-quality evidence that the strategies do not differ in their effect on global cognitive functioning over 40 to 60 months.\n\nGiven the provided abstract, please respond to the following query: \"What we did\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases for clinical trials in which participants had been assigned at random to different treatments for Type 2 diabetes and in which cognition had been measured at the beginning and end of the trial. We were only interested in treatments for Type 2 diabetes which are recommended by international clinical practice guidelines (CPGs). We analysed data from the studies we found, looking for effects on dementia and cognition, death rates and the side effect of hypoglycaemia, which is when blood glucose levels fall too low and which can be a result of treatment."
}
] |
query-laysum
|
23059
|
[
{
"role": "user",
"content": "Abstract: Background\nWeight loss, malnutrition and dehydration are common problems for people with dementia. Environmental modifications such as, change of routine, context or ambience at mealtimes, or behavioural modifications, such as education or training of people with dementia or caregivers, may be considered to try to improve food and fluid intake and nutritional status of people with dementia.\nObjectives\nPrimary: To assess the effects of environmental or behavioural modifications on food and fluid intake and nutritional status in people with dementia. Secondary: To assess the effects of environmental or behavioural modifications in connection with nutrition on mealtime behaviour, cognitive and functional outcomes and quality of life, in specific settings (i.e. home care, residential care and nursing home care) for different stages of dementia. To assess the adverse consequences or effects of the included interventions.\nSearch methods\nWe searched the Specialized Register of Cochrane Dementia and Cognitive Improvement (ALOIS), MEDLINE, Eembase, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 17 January 2018. We scanned reference lists of other reviews and of included articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating interventions designed to modify the mealtime environment of people with dementia, to modify the mealtime behaviour of people with dementia or their caregivers, or both, with the intention of improving food and fluid intake. We included people with any common dementia subtype.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed the risk of bias of included trials. We assessed the quality of evidence for each outcome using the GRADE approach.\nMain results\nWe included nine studies, investigating 1502 people. Three studies explicitly investigated participants with Alzheimer's disease; six did not specify the type of dementia. Five studies provided clear measures to identify the severity of dementia at baseline, and overall very mild to severe stages were covered. The interventions and outcome measures were diverse. The overall quality of evidence was mainly low to very low.\nOne study implemented environmental as well as behavioural modifications by providing additional food items between meals and personal encouragement to consume them. The control group received no intervention. Differences between groups were very small and the quality of the evidence from this study was very low, so we are very uncertain of any effect of this intervention.\nThe remaining eight studies implemented behavioural modifications.\nThree studies provided nutritional education and nutrition promotion programmes. Control groups did not receive these programmes. After 12 months, the intervention group showed slightly higher protein intake per day (mean difference (MD) 0.11 g/kg, 95% confidence interval (CI) -0.01 to 0.23; n = 78, 1 study; low-quality evidence), but there was no clear evidence of a difference in nutritional status assessed with body mass index (BMI) (MD -0.26 kg/m² favouring control, 95% CI -0.70 to 0.19; n = 734, 2 studies; moderate-quality evidence), body weight (MD -1.60 kg favouring control, 95% CI -3.47 to 0.27; n = 656, 1 study; moderate-quality evidence), or score on Mini Nutritional Assessment (MNA) (MD -0.10 favouring control, 95% CI -0.67 to 0.47; n = 656, 1 study; low-quality evidence). After six months, the intervention group in one study had slightly lower BMI (MD -1.79 kg/m² favouring control, 95% CI -1.28 to -2.30; n = 52, 1 study; moderate-quality evidence) and body weight (MD -8.11 kg favouring control, 95% CI -2.06 to -12.56; n = 52, 1 study; moderate-quality evidence). This type of intervention may have a small positive effect on food intake, but little or no effect, or a negative effect, on nutritional status.\nTwo studies compared self-feeding skills training programmes. In one study, the control group received no training and in the other study the control group received a different self-feeding skills training programme. For both comparisons the quality of the evidence was very low and we are very uncertain whether these interventions have any effect.\nOne study investigated general training of nurses to impart knowledge on how to feed people with dementia and improve attitudes towards people with dementia. Again, the quality of the evidence was very low so that we cannot be certain of any effect.\nTwo studies investigated vocal or tactile positive feedback provided by caregivers while feeding participants. After three weeks, the intervention group showed an increase in calories consumed per meal (MD 200 kcal, 95% CI 119.81 to 280.19; n = 42, 1 study; low-quality evidence) and protein consumed per meal (MD 15g, 95% CI 7.74 to 22.26; n = 42, 1 study; low-quality evidence). This intervention may increase the intake of food and liquids slightly; nutritional status was not assessed.\nAuthors' conclusions\nDue to the quantity and quality of the evidence currently available, we cannot identify any specific environmental or behavioural modifications for improving food and fluid intake in people with dementia.\n\nGiven the provided abstract, please respond to the following query: \"What we wanted to know\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Weight loss, malnutrition and dehydration are common problems for people with dementia and can occur at any stage of the illness. People with dementia often develop psychological symptoms or behaviours which cause them to eat or drink less. In the later stages of the illness, they become dependent on others to help them eat or drink. We wanted to investigate how to keep people with dementia eating and drinking as well as possible. We looked for studies which changed the way food and drink are presented to people with dementia, and for studies which attempted to change the behaviour of people with dementia or of those helping them to eat. We called these environmental and behavioural modifications respectively, though some interventions include aspects of both. We were mainly interested in the effect on how much people with dementia ate and drank and on measures of how well-nourished they were (e.g. body weight or body mass index (BMI)), but we also looked for effects on eating behaviour, symptoms of dementia and quality of life."
}
] |
query-laysum
|
23060
|
[
{
"role": "user",
"content": "Abstract: Background\nThe subclavian arteries are two major arteries of the upper chest, below the collar bone, which come from the arch of the aorta. Endovascular treatment for stenosis of the subclavian arteries includes angioplasty alone, and with stenting. There is insufficient evidence to guide the use of stents following angioplasty for subclavian artery stenosis. This is the second update of a review first published in 2011.\nObjectives\nThe aim of this review was to determine whether stenting was more effective than angioplasty alone for stenosis of the subclavian artery.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 2 February 2021.\nSelection criteria\nWe searched for randomised controlled trials of endovascular treatment of subclavian artery lesions that compared angioplasty alone and stent implantation.\nData collection and analysis\nTwo review authors independently evaluated studies to assess eligibility. Discrepancies were resolved by discussion. If there was no agreement, we asked a third review author to assess the study for inclusion. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions, and assess the certainty of the evidence using a GRADE approach.\nMain results\nTo date, we have not identified any completed or ongoing randomised controlled trials that compare percutaneous transluminal angioplasty and stenting for subclavian artery stenosis.\nAuthors' conclusions\nThere is currently insufficient evidence to determine whether stenting is more effective than angioplasty alone for stenosis of the subclavian artery.\n\nGiven the provided abstract, please respond to the following query: \"Key message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We could not find any randomised controlled trials in the medical literature that compared the effectiveness and safety of implanting a stent (a small tube that acts like a scaffold to help keep a blood vessel open) with angioplasty (surgical procedure to unblock a blood vessel) alone for the treatment of subclavian artery stenosis (narrowing or blockage of a blood vessel). There is currently insufficient evidence to determine whether stenting is more effective than angioplasty alone."
}
] |
query-laysum
|
23061
|
[
{
"role": "user",
"content": "Abstract: Background\nThe accessibility of health services is an important factor that affects the health outcomes of populations. A mobile clinic provides a wide range of services but in most countries the main focus is on health services for women and children. It is anticipated that improvement of the accessibility of health services via mobile clinics will improve women's and children's health.\nObjectives\nTo evaluate the impact of mobile clinic services on women's and children's health.\nSearch methods\nFor related systematic reviews, we searched the Database of Abstracts of Reviews of Effectiveness (DARE), CRD; Health Technology Assessment Database (HTA), CRD; NHS Economic Evaluation Database (NHS EED), CRD (searched 20 February 2014).\nFor primary studies, we searched ISI Web of Science, for studies that have cited the included studies in this review (searched 18 January 2016); WHO ICTRP, and ClinicalTrials.gov (searched 23 May 2016); Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library.www.cochranelibrary.com (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 7 April 2015); MEDLINE, OvidSP (searched 7 April 2015); Embase, OvidSP (searched 7 April 2015); CINAHL, EbscoHost (searched 7 April 2015); Global Health, OvidSP (searched 8 April 2015); POPLINE, K4Health (searched 8 April 2015); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (searched 8 April 2015); Global Health Library, WHO (searched 8 April 2015); PAHO, VHL (searched 8 April 2015); WHOLIS, WHO (searched 8 April 2015); LILACS, VHL (searched 9 April 2015).\nSelection criteria\nWe included individual- and cluster-randomised controlled trials (RCTs) and non-RCTs. We included controlled before-and-after (CBA) studies provided they had at least two intervention sites and two control sites. Also, we included interrupted time series (ITS) studies if there was a clearly defined point in time when the intervention occurred and at least three data points before and three after the intervention. We defined the intervention of a mobile clinic as a clinic vehicle with a healthcare provider (with or without a nurse) and a driver that visited areas on a regular basis. The participants were women (18 years or older) and children (under the age of 18 years) in low-, middle-, and high-income countries.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of studies identified by the search strategy, extracted data from the included studies using a specially-designed data extraction form based on the Cochrane EPOC Group data collection checklist, and assessed full-text articles for eligibility. All authors performed analyses, 'Risk of bias' assessments, and assessed the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nTwo cluster-RCTs met the inclusion criteria of this review. Both studies were conducted in the USA.\nOne study tested whether offering onsite mobile mammography combined with health education was more effective at increasing breast cancer screening rates than offering health education only, including reminders to attend a static clinic for mammography. Women in the group offered mobile mammography and health education may be more likely to undergo mammography within three months of the intervention than those in the comparison group (55% versus 40%; odds ratio (OR) 1.83, 95% CI 1.22 to 2.74; low certainty evidence).\nA cost-effectiveness analysis of mammography at mobile versus static units found that the total cost per patient screened may be higher for mobile units than for static units. The incremental costs per patient screened for a mobile over a stationary unit were USD 61 and USD 45 for a mobile full digital unit and a mobile film unit respectively.\nThe second study compared asthma outcomes for children aged two to six years who received asthma care from a mobile asthma clinic and children who received standard asthma care from the usual (static) primary provider. Children who receive asthma care from a mobile asthma clinic may experience little or no difference in symptom-free days, urgent care use and caregiver-reported medication use compared to children who receive care from their usual primary care provider. All of the evidence was of low certainty.\nAuthors' conclusions\nThe paucity of evidence and the restricted range of contexts from which evidence is available make it difficult to draw conclusions on the impacts of mobile clinics on women's and children's health compared to static clinics. Further rigorous studies are needed in low-, middle-, and high-income countries to evaluate the impacts of mobile clinics on women's and children's health.\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 review authors included two studies, which were from the USA.\nIn the first study, women were either offered health education and mammography screening in mobile clinics or health education only including reminders to attend a permanent clinic that offered mammography screening. The study showed that:\n· women offered mammography in mobile clinics may be more likely to undergo mammography (low certainty evidence);\n· the cost of screening per woman may be higher for mobile clinics than for permanent clinics (low certainty evidence).\nThis study did not assess the effect of the mobile clinics on women’s health and well-being, their access to services or their satisfaction with these services.\nIn the second study, children were offered asthma care either at mobile clinics or at their usual primary care provider. This study showed that mobile clinics:\n· may make little or no difference to the children’s asthma symptom-free days or their use of urgent care and medication (low certainty evidence);\n· may make little or no difference to the quality of life of the children’s caregivers (low certainty evidence).\nThe study did not assess the effect of the mobile clinics on children’s access to services or their satisfaction with these services, or on the cost and cost-effectiveness of using the mobile clinics."
}
] |
query-laysum
|
23062
|
[
{
"role": "user",
"content": "Abstract: Background\nBreast cancer is one of the most common cancers among women. Surgical removal of the cancer is the mainstay of treatment; however, tumour handling during surgery can cause microscopic dissemination of tumour cells and disease recurrence. The body's hormonal response to surgery (stress response) and general anaesthesia may suppress immunity, promoting tumour dissemination. Paravertebral anaesthesia numbs the site of surgery, provides good analgesia, and blunts the stress response, minimising the need for general anaesthesia.\nObjectives\nTo assess the effects of paravertebral anaesthesia with or without sedation compared to general anaesthesia in women undergoing breast cancer surgery, with important outcomes of quality of recovery, postoperative pain at rest, and mortality.\nSearch methods\nOn 6 April 2020, we searched the Specialised Register of the Cochrane Breast Cancer Group (CBCG); CENTRAL (latest issue), in the Cochrane Library; MEDLINE (via OvidSP); Embase (via OvidSP); the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal; and ClinicalTrials.gov for all prospectively registered and ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) conducted in adult women undergoing breast cancer surgery in which paravertebral anaesthesia with or without sedation was compared to general anaesthesia. We did not include studies in which paravertebral anaesthesia was given as an adjunct to general anaesthesia and then this was compared to use of general anaesthesia.\nData collection and analysis\nTwo review authors independently extracted details of trial methods and outcome data from eligible trials. When data could be pooled, analyses were performed on an intention-to-treat basis, and the random-effects model was used if there was heterogeneity. When data could not be pooled, the synthesis without meta-analysis (SWiM) approach was applied. The GRADE approach was used to assess the certainty of evidence for each outcome.\nMain results\nNine studies (614 participants) were included in the review. All were RCTs of parallel design, wherein female patients aged > 18 years underwent breast cancer surgery under paravertebral anaesthesia or general anaesthesia.\nNone of the studies assessed quality of recovery in the first three postoperative days using a validated questionnaire; most assessed factors affecting quality of recovery such as postoperative analgesic use, postoperative nausea and vomiting (PONV), hospital stay, ambulation, and patient satisfaction.\nParavertebral anaesthesia may reduce the 24-hour postoperative analgesic requirement (odds ratio (OR) 0.07, 95% confidence interval (CI) 0.01 to 0.34; 5 studies, 305 participants; low-certainty evidence) compared to general anaesthesia. Heterogeneity (I² = 70%) was attributed to the fixed dose of opioids and non-steroidal analgesics administered postoperatively in one study (70 participants), masking a difference in analgesic requirements between groups.\nParavertebral anaesthesia probably reduces the incidence of PONV (OR 0.16, 95% CI 0.08 to 0.30; 6 studies, 324 participants; moderate-certainty evidence), probably results in a shorter hospital stay (mean difference (MD) -79.39 minutes, 95% CI -107.38 to -51.40; 3 studies, 174 participants; moderate-certainty evidence), and probably reduces time to ambulation compared to general anaesthesia (SWiM analysis): percentages indicate vote counting based on direction of effect (100%, 95% CI 51.01% to 100%; P = 0.125; 4 studies, 375 participants; moderate-certainty evidence).\nParavertebral anaesthesia probably results in higher patient satisfaction (MD 5.52 points, 95% CI 1.30 to 9.75; 3 studies, 129 participants; moderate-certainty evidence) on a 0 to 100 scale 24 hours postoperatively compared to general anaesthesia.\nPostoperative pain at rest and on movement was assessed at 2, 6, and 24 postoperative hours on a 0 to 10 visual analogue scale (VAS). Four studies (224 participants) found that paravertebral anaesthesia as compared to general anaesthesia probably reduced pain at 2 postoperative hours (MD -2.95, 95% CI -3.37 to -2.54; moderate-certainty evidence). Five studies (324 participants) found that paravertebral anaesthesia may reduce pain at rest at 6 hours postoperatively (MD -1.54, 95% CI -3.20 to 0.11; low-certainty evidence). Five studies (278 participants) found that paravertebral anaesthesia may reduce pain at rest at 24 hours postoperatively (MD -1.19, 95% CI -2.27 to -0.10; low-certainty evidence). Differences in the methods of two studies (119 participants) and addition of clonidine to the local anaesthetic in two studies (109 participants), respectively, contributed to the heterogeneity (I² = 96%) observed for these two outcomes.\nTwo studies (130 participants) found that paravertebral anaesthesia may reduce pain on movement at 6 hours (MD-2.57, 95% CI -3.97 to -1.17) and at 24 hours (MD -2.12, 95% CI -4.80 to 0.55; low-certainty evidence). Heterogeneity (I² = 96%) was observed for both outcomes and could be due to methodological differences between studies.\nNone of the studies reported mortality related to the anaesthetic technique. Eight studies (574 participants) evaluated adverse outcomes with paravertebral anaesthesia: epidural spread (0.7%), minor bleeding (1.4%), pleural puncture not associated with pneumothorax (0.3%), and Horner's syndrome (7.1%). These complications were self-limiting and resolved without treatment.\nNo data are available on disease-free survival, chronic pain, and quality of life.\nBlinding of personnel or participants was not possible in any study, as a regional anaesthetic technique was compared to general anaesthesia. Risk of bias was judged to be serious, as seven studies had concerns of selection bias and three of detection bias.\nAuthors' conclusions\nModerate-certainty evidence shows that paravertebral anaesthesia probably reduces PONV, hospital stay, postoperative pain (at 2 hours), and time to ambulation and results in greater patient satisfaction on the first postoperative day compared to general anaesthesia. Paravertebral anaesthesia may also reduce postoperative analgesic use and postoperative pain at 6 and 24 hours at rest and on movement based on low-certainty evidence. However, RCTs using validated questionnaires are needed to confirm these results. Adverse events observed with paravertebral anaesthesia are rare.\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 randomised controlled trials in which participants in one group received paravertebral anaesthesia with or without sedation and participants in the other group received general anaesthesia during breast cancer surgery. We did not include studies in which paravertebral anaesthesia was administered in addition to general anaesthesia and then this was compared to the use of general anaesthesia."
}
] |
query-laysum
|
23063
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an uncommon progressive or relapsing paralysing disease caused by inflammation of the peripheral nerves. If the hypothesis that it is due to autoimmunity is correct, removal of autoantibodies in the blood by plasma exchange should be beneficial.\nObjectives\nTo assess the effects of plasma exchange for treating CIDP.\nSearch methods\nOn 30 June 2015, we searched the Cochrane Neuromuscular Disease Group Specialized Register, the Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL Plus, and LILACS. We also scrutinised the bibliographies of the trials, contacted the trial authors and other disease experts, and searched trials registries for ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs in participants of any age comparing plasma exchange with sham treatment or no treatment.\nData collection and analysis\nTwo review authors independently selected the trials, extracted the data, and assessed risk of bias. Where possible the review authors combined data according to the methods of the Cochrane Neuromuscular Disease Review Group.\nMain results\nPrimary outcome measure: one cross-over trial including 18 participants showed after four weeks, 2 (95% confidence interval (CI) 0.9 to 3.1) points more improvement on an 11-point disability scale with plasma exchange (10 exchanges over four weeks) than with sham exchange. Rapid deterioration after plasma exchange occurred in eight of 12 who had improved.\nSecondary outcome measures: when we combined the results of this cross-over trial and a trial with 29 participants treated in a parallel-group design, there were 31 points (95% CI 18 to 45) more improvement on an impairment scale (maximum score 280) after plasma exchange (six exchanges over three weeks) than after sham exchange. There were significant improvements in both trials in an electrophysiological measure, the proximally evoked compound muscle action potential, after three or four weeks. Non-randomised evidence indicates that plasma exchange induces adverse events in 3% to 17% of procedures. These events are sometimes serious. Both trials had a low risk of bias. A trial that showed no significant difference in the benefit between plasma exchange and intravenous immunoglobulin is included in the Cochrane review of intravenous immunoglobulin for this condition.\nAuthors' conclusions\nModerate- to high-quality evidence from two small trials shows that plasma exchange provides significant short-term improvement in disability, clinical impairment, and motor nerve conduction velocity in CIDP but rapid deterioration may occur afterwards. Adverse events related to difficulty with venous access, use of citrate, and haemodynamic changes are not uncommon. We need more research to identify agents that will prolong the beneficial action of plasma exchange.\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 cross-over trial showed on average two points more improvement on an 11-point disability scale with plasma exchange than sham exchange. This was unlikely to have occurred by chance. The parallel-group trial did not report this outcome. When we combined the results of both trials, plasma exchange produced significantly more improvement in severity of disease signs measured by neurologists than sham exchange. The results reported were short term. In practice, people with CIDP receive repeated courses or combinations of plasma exchange with additional agents. Another Cochrane review includes a trial showing similar improvement after plasma exchange to that after intravenous infusion of immunoglobulin (the antibody portion of blood). According to non-randomised evidence, plasma exchange causes adverse events in 3% to 17% of procedures. These are sometimes serious."
}
] |
query-laysum
|
23064
|
[
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is a chronic inflammatory condition that occurs during the reproductive years. It is characterised by endometrium-like tissue developing outside the uterine cavity. This endometriotic tissue development is dependent on oestrogen produced primarily by the ovaries and partially by the endometriotic tissue itself, therefore traditional management has focused on ovarian suppression. In this review we considered the role of modulation of the immune system as an alternative approach. This is an update of a Cochrane Review previously published in 2012.\nObjectives\nTo determine the effectiveness and safety of pentoxifylline in the management of endometriosis.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, and AMED on 16 December 2020, together with reference checking and contact with study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing pentoxifylline with placebo or no treatment, other medical treatment, or surgery in women with endometriosis. The primary outcomes were live birth rate and overall pain (as measured by a visual analogue scale (VAS) of pain, other validated scales, or dichotomous outcomes) per woman randomised. Secondary outcomes included clinical pregnancy rate, miscarriage rate, rate of recurrence, and adverse events resulting from the pentoxifylline intervention.\nData collection and analysis\nTwo review authors independently assessed studies against the inclusion criteria, extracted data, and assessed risk of bias, consulting a third review author where required. We contacted study authors as needed. 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 presented with 95% CIs. We used the I2 statistic to evaluate heterogeneity amongst studies. We employed the GRADE approach to assess the quality of the evidence.\nMain results\nWe included five parallel-design RCTs involving a total of 415 women. We included one additional RCT in this update. Three studies did not specify details relating to allocation concealment, and two studies were not blinded. There were also considerable loss to follow-up, with four studies not conducting intention-to-treat analysis. We judged the quality of the evidence as very low.\nPentoxifylline versus placebo\nNo trials reported on our primary outcomes of live birth rate and overall pain. We are uncertain as to whether pentoxifylline treatment affects clinical pregnancy rate when compared to placebo (RR 1.38, 95% CI 0.91 to 2.10; 3 RCTs, n = 285; I2 = 0%; very low-quality evidence). The evidence suggests that if the clinical pregnancy rate with placebo is estimated to be 20%, then the rate with pentoxifylline is estimated as between 18% and 43%. We are also uncertain as to whether pentoxifylline affects the recurrence rate of endometriosis (RR 0.84, 95% CI 0.30 to 2.36; 1 RCT, n = 121; very low-quality evidence) or miscarriage rate (Peto OR 1.99, 95% CI 0.20 to 19.37; 2 RCTs, n = 164; I2 = 0%; very low-quality evidence). No trials reported on the effect of pentoxifylline on improvement of endometriosis-related symptoms other than pain or adverse events.\nPentoxifylline versus no treatment\nNo trials reported on live birth rate. We are uncertain as to whether pentoxifylline treatment affects overall pain when compared to no treatment at one month (MD −0.36, 95% CI −2.12 to 1.40; 1 RCT, n = 34; very low-quality evidence), two months (MD −1.25, 95% CI −2.67 to 0.17; 1 RCT, n = 34; very low-quality evidence), or three months (MD −1.60, 95% CI −3.32 to 0.12; 1 RCT, n = 34; very low-quality evidence). No trials reported on adverse events caused by pentoxifylline or any of our other secondary outcomes.\nPentoxifylline versus other medical therapies\nOne study (n = 83) compared pentoxifylline to the combined oral contraceptive pill after laparoscopic surgery to treat endometriosis, but could not be included in the meta-analysis as it was unclear if the data were presented as +/- standard deviation and what the duration of treatment was. No trials reported on adverse events caused by pentoxifylline or any of our other secondary outcomes.\nPentoxifylline versus conservative surgical treatment\nNo study reported on this comparison.\nAuthors' conclusions\nNo studies reported on our primary outcome of live birth rate. Due to the very limited evidence, we are uncertain of the effects of pentoxifylline on clinical pregnancy rate, miscarriage rate, or overall pain.\nThere is currently insufficient evidence to support the use of pentoxifylline in the management of women with endometriosis with respect to subfertility and pain relief outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The overall quality of evidence was very low. The main limitations in the evidence were lack of intention-to-treat analysis (an assessment of all people taking part in a trial, based on the group to which they had initially (and randomly) been allocated to, regardless of whether or not they dropped out, fully adhered to the treatment, or switched to an alternative treatment); lack of blinding (the process where both women participating in the trial and research staff are kept unaware of the treatment used); and imprecision (random error and small size of some studies)."
}
] |
query-laysum
|
23065
|
[
{
"role": "user",
"content": "Abstract: Background\nLong-term physical conditions affect 10% to 12% of children and adolescents worldwide; these individuals are at greater risk of developing psychological problems, particularly anxiety and depression. Access to face-to-face treatment for such problems is often limited, and available interventions usually have not been tested with this population. As technology improves, e-health interventions (delivered via digital means, such as computers and smart phones and ranging from simple text-based programmes through to multimedia and interactive programmes, serious games, virtual reality and biofeedback programmes) offer a potential solution to address the psychological needs of this group of young people.\nObjectives\nTo assess the effectiveness of e-health interventions in comparison with attention placebos, psychological placebos, treatment as usual, waiting-list controls, or non-psychological treatments for treating anxiety and depression in children and adolescents with long-term physical conditions.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Group's Controlled Trials Register (CCMDTR to May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2017), Web of Science (1900 - 18 August 2016, updated 31 August 2017) and Ovid MEDLINE, Embase, PsycINFO (cross-search 2016 to 18 Aug 2017). We hand-searched relevant conference proceedings, reference lists of included articles, and the grey literature to May 2016. We also searched international trial registries to identify unpublished or ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-randomised trials, and cross-over trials of e-health interventions for treating any type of long-term physical condition in children and adolescents (aged 0 to 18 years), and that measured changes in symptoms or diagnoses of anxiety, depression, or subthreshold depression. We defined long-term physical conditions as those that were more than three-months' duration. We assessed symptoms of anxiety and depression using patient- or clinician-administered validated rating scales based on DSM III, IV or 5 (American Psychological Association 2013), or ICD 9 or 10 criteria (World Health Organization 1992). Formal depressive and anxiety disorders were diagnosed using structured clinical interviews. Attention placebo, treatment as usual, waiting list, psychological placebo, and other non-psychological therapies were eligible comparators.\nData collection and analysis\nTwo review authors independently reviewed titles, abstracts, and full-text articles; discrepancies were resolved through discussion or addressed by a third author. When available, we used odds ratio (OR) to compare dichotomous data and standardised mean differences (SMD) to analyse continuous data, both with 95% confidence intervals (CI). We undertook meta-analysis when treatments, participants, and the underlying clinical question were adequately similar. Otherwise, we undertook a narrative analysis.\nMain results\nWe included five trials of three interventions (Breathe Easier Online, Web-MAP, and multimodal cognitive behavioural therapy (CBT)), which included 463 participants aged 10 to 18 years. Each trial contributed to at least one meta-analysis. Trials involved children and adolescents with long-term physical conditions, such as chronic headache (migraine, tension headache, and others), chronic pain conditions (abdominal, musculoskeletal, and others), chronic respiratory illness (asthma, cystic fibrosis, and others), and symptoms of anxiety or depression. Participants were recruited from community settings and hospital clinics in high income countries.\nFor the primary outcome of change in depression symptoms versus any control, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.06, 95% CI -0.35 to 0.23; five RCTs, 441 participants). For the primary outcome of change in anxiety symptoms versus any comparator, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.07, 95% CI -0.29 to 0.14; two RCTs, 324 participants). For the primary outcome of treatment acceptability, there was very low-quality evidence that e-health interventions were less acceptable than any comparator (SMD 0.46, 95% CI 0.23 to 0.69; two RCTs, 304 participants).\nFor the secondary outcome of quality of life, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.83, 95% CI -1.53 to -0.12; one RCT, 34 participants). For the secondary outcome of functioning, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.08, 95% CI -0.33 to 0.18; three RCTs, 368 participants). For the secondary outcome of status of long-term physical condition, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD 0.06, 95% CI -0.12 to 0.24; five RCTs, 463 participants).\nThe risk of selection bias was considered low in most trials. However, the risk of bias due to inadequate blinding of participants or outcome assessors was considered unclear or high in all trials. Only one study had a published protocol; two trials had incomplete outcome data. All trials were conducted by the intervention developers, introducing another possible bias. No adverse effects were reported by any authors.\nAuthors' conclusions\nAt present, the field of e-health interventions for the treatment of anxiety or depression in children and adolescents with long-term physical conditions is limited to five low quality trials. The very low-quality of the evidence means the effects of e-health interventions are uncertain at this time, especially in children aged under 10 years.\nAlthough it is too early to recommend e-health interventions for this clinical population, given their growing number, and the global improvement in access to technology, there appears to be room for the development and evaluation of acceptable and effective technologically-based treatments to suit children and adolescents with long-term physical conditions.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review will be of interest to parents, children and adolescents, mental healthcare providers, service commissioners, and professionals caring for children with long-term physical conditions."
}
] |
query-laysum
|
23066
|
[
{
"role": "user",
"content": "Abstract: Background\nPain on propofol injection is an untoward effect and this condition can reduce patient satisfaction. Intravenous lidocaine injection has been commonly used to attenuate pain on propofol injection. Although many studies have reported that lidocaine was effective in reducing the incidence and severity of pain, nevertheless, no systematic review focusing on lidocaine for preventing high-intensity pain has been published.\nObjectives\nThe objective of this review was to determine the efficacy and adverse effects of lidocaine in preventing high-intensity pain on propofol injection.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), Ovid MEDLINE (1950 To October 2014), Ovid Embase (1988 to October 2014), LILACS (1992 to October 2014) and searched reference lists of articles.\nWe reran the search in November 2015. We found 11 potential studies of interest, those studies were added to the list of ‘Studies awaiting classification' and will be fully incorporated into the formal review findings when we update the review.\nSelection criteria\nWe included randomized controlled trials (RCTs) using intravenous lidocaine injection as an intervention to decrease pain on propofol injection in adults. We excluded studies without a placebo or control group.\nData collection and analysis\nWe collected selected studies with relevant criteria. We identified risk of bias in five domains according to the following criteria: random sequence generation, allocation concealment, adequacy of blinding, completeness of outcome data and selective reporting. We performed meta-analysis by direct comparisons of intervention versus control. We estimated the summary odds ratios (ORs) and 95% confidence intervals using the random-effects Mantel-Haenszel method in RevMan 5.3. We used the I2 statistic to assess statistical heterogeneity. We assessed overall quality of evidence using the GRADE approach.\nMain results\nWe included 85 studies, 82 of which (10,350 participants) were eligible for quantitative analysis in the review. All participants, aged 13 years to 89 years, were American Society of Anesthesiologists (ASA) I-III patients undergoing elective surgery. Each study was conducted in a single centre in high- , middle- and low-income countries worldwide. According to the risk of bias assessment, all except five studies were identified as being of satisfactory methodological quality, allowing 82 studies to be combined in the meta-analysis. Five of the 82 studies were assessed as high risk of bias: one for participant and personnel blinding, one for incomplete outcome data, and three for other potential sources of bias.\nThe overall incidence of pain and high-intensity pain following propofol injection in the control group were 63.7% (95% CI 60% to 67.9%) and 37.9% (95% CI 33.4% to 43.1%), respectively while those in the lidocaine group were 30.2% (95% CI 26.7% to 33.7%) and 11.8% (95% CI 9.7% to 13.8%). Both lidocaine admixture and pretreatment were effective in reducing pain on propofol injection (lidocaine admixture OR 0.19, 95% CI 0.15 to 0.25, 31 studies, 4927 participants, high-quality evidence; lidocaine pretreatment OR 0.13, 95% CI 0.10 to 0.18, 41 RCTs, 3918 participants, high-quality evidence). Similarly, lidocaine administration could considerably decrease the incidence of pain when premixed with the propofol (OR 0.19, 95% CI 0.15 to 0.24, 36 studies, 5628 participants, high-quality evidence) or pretreated prior to propofol injection (OR 0.14, 95% CI 0.11 to 0.18, 50 studies, 4722 participants, high-quality evidence). Adverse effects of lidocaine administration were rare. Thrombophlebitis was reported in only two studies (OR not estimated, low-quality evidence). No studies reported patient satisfaction.\nAuthors' conclusions\nOverall, the quality of the evidence was high. Currently available data from RCTs are sufficient to confirm that both lidocaine admixture and pretreatment were effective in reducing pain on propofol injection. Furthermore, there were no significant differences of effect between the two techniques.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is intravenous, (directly into a vein), lidocaine injection effective in reducing the pain caused by the injection of propofol, given to induce anaesthesia in adults undergoing general anaesthesia?"
}
] |
query-laysum
|
23067
|
[
{
"role": "user",
"content": "Abstract: Background\nDepressive illness is common in old age. Prevalence in the community of case level depression is around 15% and milder forms of depression are more common. It causes significant distress and disability. The number of people over the age of 60 years is expected to double by 2050 and so interventions for this often long-term and recurrent condition are increasingly important. The causes of late-life depression differ from depression in younger adults and so it is appropriate to study it separately.\nThis is an update of a Cochrane review first published in 2012.\nObjectives\nTo examine the efficacy of antidepressants and psychological therapies in preventing the relapse and recurrence of depression in older people.\nSearch methods\nWe performed a search of the Cochrane Common Mental Disorders Group's specialised register (the CCMDCTR) to 13 July 2015. The CCMDCTR includes relevant randomised controlled trials (RCTs) from the following bibliographic databases: The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We also conducted a cited reference search on 13 July 2015 of the Web of Science for citations of primary reports of included studies.\nSelection criteria\nBoth review authors independently selected studies. We included RCTs involving people aged 60 years and over successfully treated for an episode of depression and randomised to receive continuation and maintenance treatment with antidepressants, psychological therapies, or a combination.\nData collection and analysis\nTwo review authors independently extracted data. The primary outcome for benefit was recurrence rate of depression (reaching a cut-off on any depression rating scale) at 12 months and the primary outcome for harm was drop-outs at 12 months. Secondary outcomes included relapse/recurrence rates at other time points, global impression of change, social functioning, and deaths. We performed meta-analysis using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CI).\nMain results\nThis update identified no further trials. Seven studies from the previous review met the inclusion criteria (803 participants). Six compared antidepressant medication with placebo; two involved psychological therapies. There was marked heterogeneity between the studies.\nComparing antidepressants with placebo on the primary outcome for benefit, there was a statistically significant difference favouring antidepressants in reducing recurrence compared with placebo at 12 months with a GRADE rating of low for quality of evidence (three RCTs, n = 247, RR 0.67, 95% CI 0.54 to 0.82; number needed to treat for an additional beneficial outcome (NNTB) 5). Comparing antidepressants with placebo on the primary outcome for harms, there was no difference in drop-out rates at 12 months' follow-up, with a GRADE rating of low.\nThere was no significant difference between psychological treatment and antidepressant in recurrence rates at 12 months (one RCT, n = 53) or between combination treatment and antidepressant alone at 12 months.\nAuthors' conclusions\nThis updated Cochrane review supports the findings of the original 2012 review. The long-term benefits and harm of continuing antidepressant medication in the prevention of recurrence of depression in older people are not clear and no firm treatment recommendations can be made on the basis of this review. Continuing antidepressant medication for 12 months appears to be helpful with no increased harms; however, this was based on only three small studies, relatively few participants, use of a range of antidepressant classes, and clinically heterogeneous populations. Comparisons at other time points did not reach statistical significance.\nData on psychological therapies and combined treatments were too limited to draw any conclusions on benefits and harms.\nThe quality of the evidence used in reaching these conclusions was low and the review does not, therefore, offer clear guidance to clinicians and patients on best practice and matching interventions to particular patient characteristics.\nOf note, we identified no new studies that evaluated pharmacological or psychological interventions in the continuation and maintenance treatment of depression in older people. We are aware of studies conducted since the previous review that included both older people and adults under the age of 65 years, but these fall outside of the remit of this review. We believe that there remains a need for studies solely recruiting older people, particularly the 'older old' with comorbid medical problems. However, these studies are likely to be challenging to conduct and may not, so far, have been prioritised by funders.\n\nGiven the provided abstract, please respond to the following query: \"Which studies does the review include?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases to find all relevant studies completed up to 13 July 2015. The studies had to compare antidepressant treatment, psychological treatment, or a combination of the two, with placebo or the other treatments for preventing recurrence of depression in people aged 60 years and over. We included seven studies, involving 803 people.\nSix studies compared antidepressant medicine with placebo. Only two of the studies involved psychological treatments. The studies varied in how they were conducted, numbers of participants, and types of participants."
}
] |
query-laysum
|
23068
|
[
{
"role": "user",
"content": "Abstract: Background\nChemotherapy-induced neutropenia is a common adverse effect in children with cancer. Due to the high relative risk of infections and infectious complications, standard care for children with cancer and febrile neutropenia consists of routine hospitalization and parenteral administration of broad-spectrum antibiotics. However, there are less serious causes of febrile neutropenia; in a subgroup of these children, lengthy in-hospital treatment might be unnecessary. Various research groups have studied the adjustment of standard care to shorten in-hospital treatment for children with cancer and febrile neutropenia at low risk for bacterial infections. However, most of these studies were not done in a randomized matter.\nObjectives\nTo evaluate whether early discharge (mean/median of less than five days) from in-hospital treatment was not inferior to non-early discharge (mean/median of five days or more) and whether very early discharge (mean/median of less than 24 hours) was not inferior to early discharge, non-early discharge, or a combination of these, in children with cancer and febrile neutropenia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (2015, issue 11), MEDLINE/PubMed (from 1945 to December 2015), EMBASE/Ovid (from 1980 to December 2015), the reference lists of relevant articles and review articles, and various conference proceedings (dependent on availability from 2005 to 2010 to 2013 to 2015). We scanned the International Standard Randomised Controlled Trials Number (ISRCTN) Register, the National Institute of Health Register for ongoing trials, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 9 January 2016.\nSelection criteria\nWe included all randomized controlled trials and controlled clinical trials in which children with cancer and febrile neutropenia were divided in groups with different times of discharge.\nData collection and analysis\nWe used standard methods of Cochrane and its Childhood Cancer Group. Two independent review authors performed study selection, data extraction, and risk of bias assessment. We entered data extracted from the included studies into Review Manager 5 and undertook analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe included two randomized controlled trials assessing very early, early, non-early (or a combination of these) discharge in children with cancer and febrile neutropenia. We graded the evidence as low quality; we downgraded for risk of bias and imprecision. One study, Santolaya 2004, consisted of 149 randomized low-risk episodes and compared early discharge (mean/median of less than five days) to non-early discharge (mean/median of five days or more). This study found no clear evidence of difference in treatment failure (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.24 to 3.50, P value = 0.89 for rehospitalization or adjustment of antimicrobial treatment, or both; Fischer's exact P value = 0.477 for death) or duration of treatment (mean difference -0.3 days, 95% CI -1.22 to 0.62, P value = 0.52 for any antimicrobial treatment; mean difference -0.5 days, 95% CI -1.36 to 0.36, P value = 0.25 for intravenous antimicrobial treatment; mean difference 0.2 days, 95% CI -0.51 to 0.91, P value = 0.58 for oral antimicrobial treatment). Costs were lower in the early discharge group (mean difference USD -265, 95% CI USD -403.14 to USD -126.86, P value = 0.0002). The second included study, Brack 2012, consisted of 62 randomized low-risk episodes and compared very early discharge (mean/median of less than 24 hours) to early discharge (mean/median of less than five days). This study also found no clear evidence of difference in treatment failure (RR 0.54, 95% CI 0.15 to 1.89, P value = 0.34 for rehospitalization or adjustment of antimicrobial treatment (or both); Fischer's exact P value = 0.557 for death). Regarding duration of treatment, median duration of intravenous antimicrobial treatment was shorter in the very early discharge group (Wilcoxon's P value ≤ 0.001, stated in the study) and median duration of oral antimicrobial treatment was shorter in the early discharge group (Wilcoxon's P ≤ 0.001, stated in the study) as compared to one another. However, there was no clear evidence of difference in median duration of any antimicrobial treatment (Wilcoxon's P value = 0.34, stated in the study). Costs were not assessed in this study. Neither of the included studies assessed quality of life. Meta-analysis was not possible as the included studies assessed different discharge moments and used different risk stratification models.\nAuthors' conclusions\nVery limited data were available regarding the safety of early discharge compared to non-early discharge from in-hospital treatment in children with cancer and febrile neutropenia and a low risk for invasive infection. The absence of clear evidence of differences in both studies could be due to lack of power.\nEvidently, there are still profound gaps regarding very early and early discharge in children with cancer and febrile neutropenia. Future studies that assess this subject should have a large sample size and aim to establish uniform and objective criteria regarding the identification of a low-risk febrile neutropenic episode.\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": "Early discharge did not appear to be less safe than non-early discharge in children with cancer and fever during neutropenia with a low risk for bacterial infections; there was no clear evidence of difference in treatment failure between the two groups. Moreover, the treatment costs in the early discharge group were lower than in the non-early discharge group. Regarding very early discharge, this did not appear to be less safe than early discharge; there was no clear evidence of difference in treatment failure between the two groups. Duration of treatment differed between very early discharge and early discharge; duration of intravenous antibiotic treatment was shorter in the very early discharge group, and duration of oral antibiotic treatment was shorter in the early discharge group, as compared to one another. However, there was no clear evidence of difference in total treatment duration of any antibiotic treatment between these groups."
}
] |
query-laysum
|
23069
|
[
{
"role": "user",
"content": "Abstract: Background\nHyperimmune immunoglobulin (hIVIG) contains polyclonal antibodies, which can be prepared from large amounts of pooled convalescent plasma or prepared from animal sources through immunisation. They are being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). This review was previously part of a parent review addressing convalescent plasma and hIVIG for people with COVID-19 and was split to address hIVIG and convalescent plasma separately.\nObjectives\nTo assess the benefits and harms of hIVIG therapy for the treatment of people with COVID-19, and to maintain the currency of the evidence using a living systematic review approach.\nSearch methods\nTo identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Research Database, the Cochrane COVID-19 Study Register, the Epistemonikos COVID-19 L*OVE Platform and Medline and Embase from 1 January 2019 onwards. We carried out searches on 31 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated hIVIG for COVID-19, irrespective of disease severity, age, gender or ethnicity.\nWe excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies that evaluated standard immunoglobulin.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies, we used RoB 2. We rated the certainty of evidence, using the GRADE approach, for the following outcomes: all-cause mortality, improvement and worsening of clinical status (for individuals with moderate to severe disease), quality of life, adverse events, and serious adverse events.\nMain results\nWe included five RCTs with 947 participants, of whom 688 received hIVIG prepared from humans, 18 received heterologous swine glyco-humanised polyclonal antibody, and 241 received equine-derived processed and purified F(ab’)2 fragments. All participants were hospitalised with moderate-to-severe disease, most participants were not vaccinated (only 12 participants were vaccinated). The studies were conducted before or during the emergence of several SARS-CoV-2 variants of concern.\nThere are no data for people with COVID-19 with no symptoms (asymptomatic) or people with mild COVID-19. We identified a further 10 ongoing studies evaluating hIVIG.\nBenefits of hIVIG prepared from humans\nWe included data on one RCT (579 participants) that assessed the benefits and harms of hIVIG 0.4 g/kg compared to saline placebo. hIVIG may have little to no impact on all-cause mortality at 28 days (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.43 to 1.44; absolute effect 77 per 1000 with placebo versus 61 per 1000 (33 to 111) with hIVIG; low-certainty evidence). The evidence is very uncertain about the effect on worsening of clinical status at day 7 (RR 0.85, 95% CI 0.58 to 1.23; very low-certainty evidence). It probably has little to no impact on improvement of clinical status on day 28 (RR 1.02, 95% CI 0.97 to 1.08; moderate-certainty evidence). We did not identify any studies that reported quality-of-life outcomes, so we do not know if hIVIG has any impact on quality of life.\nHarms of hIVIG prepared from humans\nhIVIG may have little to no impact on adverse events at any grade on day 1 (RR 0.98, 95% CI 0.81 to 1.18; 431 per 1000; 1 study 579 participants; low-certainty evidence). Patients receiving hIVIG probably experience more adverse events at grade 3-4 severity than patients who receive placebo (RR 4.09, 95% CI 1.39 to 12.01; moderate-certainty evidence). hIVIG may have little to no impact on the composite outcome of serious adverse events or death up to day 28 (RR 0.72, 95% CI 0.45 to 1.14; moderate-certainty evidence).\nWe also identified additional results on the benefits and harms of other dose ranges of hIVIG, not included in the summary of findings table, but summarised in additional tables.\nBenefits of animal-derived polyclonal antibodies\nWe included data on one RCT (241 participants) to assess the benefits and harms of receptor-binding domain-specific polyclonal F(ab´)2 fragments of equine antibodies (EpAbs) compared to saline placebo. EpAbs may reduce all-cause mortality at 28 days (RR 0.60, 95% CI 0.26 to 1.37; absolute effect 114 per 1000 with placebo versus 68 per 1000 (30 to 156) ; low-certainty evidence). EpAbs may reduce worsening of clinical status up to day 28 (RR 0.67, 95% CI 0.38 to 1.18; absolute effect 203 per 1000 with placebo versus 136 per 1000 (77 to 240); low-certainty evidence). It may have some effect on improvement of clinical status on day 28 (RR 1.06, 95% CI 0.96 to 1.17; low-certainty evidence). We did not identify any studies that reported quality-of-life outcomes, so we do not know if EpAbs have any impact on quality of life.\nHarms of animal-derived polyclonal antibodies\nEpAbs may have little to no impact on the number of adverse events at any grade up to 28 days (RR 0.99, 95% CI 0.74 to 1.31; low-certainty evidence). Adverse events at grade 3-4 severity were not reported. Individuals receiving EpAbs may experience fewer serious adverse events than patients receiving placebo (RR 0.67, 95% CI 0.38 to 1.19; low-certainty evidence).\nWe also identified additional results on the benefits and harms of other animal-derived polyclonal antibody doses, not included in the summary of findings table, but summarised in additional tables.\nAuthors' conclusions\nWe included data from five RCTs that evaluated hIVIG compared to standard therapy, with participants with moderate-to-severe disease. As the studies evaluated different preparations (from humans or from various animals) and doses, we could not pool them. hIVIG prepared from humans may have little to no impact on mortality, and clinical improvement and worsening. hIVIG may increase grade 3-4 adverse events. Studies did not evaluate quality of life. RBD-specific polyclonal F(ab´)2 fragments of equine antibodies may reduce mortality and serious adverse events, and may reduce clinical worsening. However, the studies were conducted before or during the emergence of several SARS-CoV-2 variants of concern and prior to widespread vaccine rollout.\nAs no studies evaluated hIVIG for participants with asymptomatic infection or mild disease, benefits for these individuals remains uncertain.\nThis is a living systematic review. We search monthly for new evidence and update the review when we identify relevant new evidence.\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": "All studies compared hyperimmune immunoglobulin from human or animal sources with usual care or placebo. The studies included only hospitalised people with moderate to severe disease. No studies looked at people without COVID-19 symptoms or mild COVID-19. No studies reported on quality of life.\nWe are uncertain whether or not hyperimmune immunoglobulin prepared from humans affects risk of death from any cause up to 28 days after treatment. It may have little to no impact on improvement or worsening of symptoms up to 28 days after treatment. We are uncertain about a possible difference in unwanted or serious unwanted effects. The individual studies decided which events to classify as serious unwanted effects, but this usually means something that may cause hospitalisation or permanent harm.\nHyperimmune immunoglobulin from animals may reduce deaths up to 28 days after treatment, may reduce worsening of symptoms, may improve patients' condition and may reduce serious unwanted events."
}
] |
query-laysum
|
23070
|
[
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Aminoglycosides are sometimes administered directly into the middle ear to treat this condition. The aim of this treatment is to partially or completely destroy the balance function of the affected ear. The efficacy of this intervention in preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of intratympanic aminoglycosides versus placebo or no treatment in people with Ménière's disease.\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 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with a diagnosis of Ménière's disease comparing intratympanic aminoglycosides with either placebo or no treatment. We excluded studies with follow-up of less than three months, or 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) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included five RCTs with a total of 137 participants. All studies compared the use of gentamicin to either placebo or no treatment. Due to the very small numbers of participants in these trials, and concerns over the conduct and reporting of some studies, we considered all the evidence in this review to be very low-certainty.\nImprovement in vertigo\nThis outcome was assessed by only two studies, and they used different time periods for reporting. Improvement in vertigo was reported by more participants who received gentamicin at both 6 to ≤ 12 months (16/16 participants who received gentamicin, compared to 0/16 participants with no intervention; risk ratio (RR) 33.00, 95% confidence interval (CI) 2.15 to 507; 1 study; 32 participants; very low-certainty evidence) and at > 12 months follow-up (12/12 participants receiving gentamicin, compared to 6/10 participants receiving placebo; RR 1.63, 95% CI 0.98 to 2.69; 1 study; 22 participants; very low-certainty evidence). However, we were unable to conduct any meta-analysis for this outcome, the certainty of the evidence was very low and we cannot draw any meaningful conclusions from the results.\nChange in vertigo\nAgain, two studies assessed this outcome, but used different methods of measuring vertigo and assessed the outcome at different time points. We were therefore unable to carry out any meta-analysis or draw any meaningful conclusions from the results. Global scores of vertigo were lower for those who received gentamicin at both 6 to ≤ 12 months (mean difference (MD) -1 point, 95% CI -1.68 to -0.32; 1 study; 26 participants; very low-certainty evidence; four-point scale; minimally clinically important difference presumed to be one point) and at > 12 months (MD -1.8 points, 95% CI -2.49 to -1.11; 1 study; 26 participants; very low-certainty evidence). Vertigo frequency was also lower at > 12 months for those who received gentamicin (0 attacks per year in participants receiving gentamicin compared to 11 attacks per year for those receiving placebo; 1 study; 22 participants; very low-certainty evidence).\nSerious adverse events\nNone of the included studies provided information on the total number of participants who experienced a serious adverse event. It is unclear whether this is because no adverse events occurred, or because they were not assessed or reported.\nAuthors' conclusions\nThe evidence for the use of intratympanic gentamicin in the treatment of Ménière's disease is very uncertain. This is primarily due to the fact that there are few published RCTs in this area, and all the studies we identified enrolled a very small number of participants. As the studies assessed different outcomes, using different methods, and reported at different time points, we were not able to pool the results to obtain more reliable estimates of the efficacy of this treatment. More people may report an improvement in vertigo following gentamicin treatment, and scores of vertigo symptoms may also improve. However, the limitations of the evidence mean that we cannot be sure of these effects. Although there is the potential for intratympanic gentamicin to cause harm (for example, hearing loss) we did not find any information about the risks of treatment in this review.\nConsensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analysis of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\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."
}
] |
query-laysum
|
23071
|
[
{
"role": "user",
"content": "Abstract: Background\nThe use of antidepressants in dementia accompanied by depressive symptoms is widespread, but their clinical efficacy is uncertain. This review updates an earlier version, first published in 2002.\nObjectives\nTo determine the efficacy and safety of any type of antidepressant for patients who have been diagnosed as having dementia of any type and depression as defined by recognised criteria.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group’s Specialised Register, on 16 August 2017. ALOIS contains information on trials retrieved from databases and from a number of trial registers and grey literature sources.\nSelection criteria\nWe included all relevant double-blind, randomised trials comparing any antidepressant drug with placebo, for patients diagnosed as having dementia and depression.\nData collection and analysis\nTwo review authors selected studies for inclusion and extracted data independently. We assessed risk of bias in the included studies using the Cochrane 'Risk of bias' tool. Where clinically appropriate, we pooled data for treatment periods up to three months and from three to nine months. We used GRADE methods to assess the overall quality of the evidence.\nMain results\nWe included ten studies with a total of 1592 patients. Eight included studies reported sufficiently detailed results to enter into analyses related to antidepressant efficacy. We split one study which included two different antidepressants and therefore had nine groups of patients treated with antidepressants compared with nine groups receiving placebo treatment. Information needed to make 'Risk of bias' judgements was often missing.\nWe found high-quality evidence of little or no difference in scores on depression symptom rating scales between the antidepressant and placebo treated groups after 6 to 13 weeks (standardised mean difference (SMD) -0.10, 95% confidence interval (CI) -0.26 to 0.06; 614 participants; 8 studies). There was probably also little or no difference between groups after six to nine months (mean difference (MD) 0.59 point, 95% CI -1.12 to 2.3, 357 participants; 2 studies; moderate-quality evidence). The evidence on response rates at 12 weeks was of low quality, and imprecision in the result meant we were uncertain of any effect of antidepressants (antidepressant: 49.1%, placebo: 37.7%; odds ratio (OR) 1.71, 95% CI 0.80 to 3.67; 116 participants; 3 studies). However, the remission rate was probably higher in the antidepressant group than the placebo group (antidepressant: 40%, placebo: 21.7%; OR 2.57, 95% CI 1.44 to 4.59; 240 participants; 4 studies; moderate-quality evidence). The largest of these studies continued for another 12 weeks, but because of imprecision of the result we could not be sure of any effect of antidepressants on remission rates after 24 weeks. There was evidence of no effect of antidepressants on performance of activities of daily living at weeks 6 to 13 (SMD -0.05, 95% CI -0.36 to 0.25; 173 participants; 4 studies; high-quality evidence) and probably also little or no effect on cognition (MD 0.33 point on the Mini-Mental State Examination, 95% CI -1.31 to 1.96; 194 participants; 6 studies; moderate-quality evidence).\nParticipants on antidepressants were probably more likely to drop out of treatment than those on placebo over 6 to 13 weeks (OR 1.51, 95% CI 1.07 to 2.14; 836 participants; 9 studies). The meta-analysis of the number of participants suffering at least one adverse event showed a significant difference in favour of placebo (antidepressant: 49.2%, placebo: 38.4%; OR 1.55, 95% CI 1.21 to 1.98, 1073 participants; 3 studies), as did the analyses for participants suffering one event of dry mouth (antidepressant: 19.6%, placebo: 13.3%; OR 1.80, 95% CI 1.23 to 2.63, 1044 participants; 5 studies), and one event of dizziness (antidepressant: 19.2%, placebo: 12.5%; OR 2.00, 95% CI 1.34 to 2.98, 1044 participants; 5 studies). Heterogeneity in the way adverse events were reported in studies presented a major difficulty for meta-analysis, but there was some evidence that antidepressant treatment causes more adverse effects than placebo treatment does.\nAuthors' conclusions\nThe available evidence is of variable quality and does not provide strong support for the efficacy of antidepressants for treating depression in dementia, especially beyond 12 weeks. On the only measure of efficacy for which we had high-quality evidence (depression rating scale scores), antidepressants showed little or no effect. The evidence on remission rates favoured antidepressants but was of moderate quality, so future research may find a different result. There was insufficient evidence to draw conclusions about individual antidepressant drugs or about subtypes of dementia or depression. There is some evidence that antidepressant treatment may cause adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of antidepressants on depression in people with dementia."
}
] |
query-laysum
|
23072
|
[
{
"role": "user",
"content": "Abstract: Background\nHemophilia A and B are inherited coagulation disorders characterized by a reduced or absent level of factor VIII or factor IX respectively. The severe form is characterized by a factor level less than 0.01 international units (IU) per milliliter. The development of inhibitors in hemophilia is the main complication of treatment, because the presence of these antibodies, reduces or even nullifies the efficacy of replacement therapy, making it very difficult to control the bleeding. People with inhibitors continue to have significantly higher risks of morbidity and mortality, with considerable treatment costs. Given the wide 'off-label' use of rituximab for treating people with hemophilia and inhibitors, its efficacy and safety need to be evaluated. This is an update of a previously published Cochrane Review.\nObjectives\nTo assess the efficacy and safety of rituximab for treating inhibitors in people with inherited severe hemophilia A or B.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, complied from electronic database searches and handsearching of journals and conference abstract books. We searched the reference lists of relevant articles and reviews and also searched for ongoing or unpublished studies. We also undertook further searches of other bibliographic databases and trial registries.\nDate of last search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register: 19 March 2020.\nSelection criteria\nRandomized controlled trials and controlled clinical trials investigating the efficacy and safety of rituximab for treating inhibitors in people with hemophilia.\nData collection and analysis\nNo randomized controlled trials matching the selection criteria were eligible for inclusion.\nMain results\nNo randomized controlled trials on rituximab for treating inhibitors in people with hemophilia were identified.\nAuthors' conclusions\nWe were unable to identify any relevant trials on the efficacy and safety of rituximab for treating inhibitors in people with hemophilia. The research evidence available is from case reports and case series. Randomized controlled trials are needed to evaluate the efficacy and safety of rituximab for this condition. However, prior to the publication of any possible future randomized controlled trials, meta-analysis of case reports and case series may provide some evidence.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We did not find any randomized controlled trials assessing rituximab in people with severe hemophilia. Well-designed controlled trials are needed to assess the benefits and risks of using rituximab in people with hemophilia. Until controlled trials are published, only limited and low-level evidence, based on individual cases, can guide physicians in making clinical decisions."
}
] |
query-laysum
|
23073
|
[
{
"role": "user",
"content": "Abstract: Background\nIt is becoming increasingly common to publish information about the quality and performance of healthcare organisations and individual professionals. However, we do not know how this information is used, or the extent to which such reporting leads to quality improvement by changing the behaviour of healthcare consumers, providers, and purchasers.\nObjectives\nTo estimate the effects of public release of performance data, from any source, on changing the healthcare utilisation behaviour of healthcare consumers, providers (professionals and organisations), and purchasers of care. In addition, we sought to estimate the effects on healthcare provider performance, patient outcomes, and staff morale.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trials registers on 26 June 2017. We checked reference lists of all included studies to identify additional studies.\nSelection criteria\nWe searched for randomised or non-randomised trials, interrupted time series, and controlled before-after studies of the effects of publicly releasing data regarding any aspect of the performance of healthcare organisations or professionals. Each study had to report at least one main outcome related to selecting or changing care.\nData collection and analysis\nTwo review authors independently screened studies for eligibility and extracted data. For each study, we extracted data about the target groups (healthcare consumers, healthcare providers, and healthcare purchasers), performance data, main outcomes (choice of healthcare provider, and improvement by means of changes in care), and other outcomes (awareness, attitude, knowledge of performance data, and costs). Given the substantial degree of clinical and methodological heterogeneity between the studies, we presented the findings for each policy in a structured format, but did not undertake a meta-analysis.\nMain results\nWe included 12 studies that analysed data from more than 7570 providers (e.g. professionals and organisations), and a further 3,333,386 clinical encounters (e.g. patient referrals, prescriptions). We included four cluster-randomised trials, one cluster-non-randomised trial, six interrupted time series studies, and one controlled before-after study. Eight studies were undertaken in the USA, and one each in Canada, Korea, China, and The Netherlands. Four studies examined the effect of public release of performance data on consumer healthcare choices, and four on improving quality.\nThere was low-certainty evidence that public release of performance data may make little or no difference to long-term healthcare utilisation by healthcare consumers (3 studies; 18,294 insurance plan beneficiaries), or providers (4 studies; 3,000,000 births, and 67 healthcare providers), or to provider performance (1 study; 82 providers). However, there was also low-certainty evidence to suggest that public release of performance data may slightly improve some patient outcomes (5 studies, 315,092 hospitalisations, and 7502 providers). There was low-certainty evidence from a single study to suggest that public release of performance data may have differential effects on disadvantaged populations. There was no evidence about effects on healthcare utilisation decisions by purchasers, or adverse effects.\nAuthors' conclusions\nThe existing evidence base is inadequate to directly inform policy and practice. Further studies should consider whether public release of performance data can improve patient outcomes, as well as healthcare processes.\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": "Public release of performance data may lead to little or no difference in healthcare choices (made by either consumers or providers), or provider performance. However, it may slightly improve outcomes for patients."
}
] |
query-laysum
|
23074
|
[
{
"role": "user",
"content": "Abstract: Background\nAn estimated 60% of pharmacological randomised trials use placebo control interventions to blind (i.e. mask) participants. However, standard placebos do not control for perceptible non-therapeutic effects (i.e. side effects) of the experimental drug, which may unblind participants. Trials rarely use active placebo controls, which contain pharmacological compounds designed to mimic the non-therapeutic experimental drug effects in order to reduce the risk of unblinding. A relevant improvement in the estimated effects of active placebo compared with standard placebo would imply that trials with standard placebo may overestimate experimental drug effects.\nObjectives\nWe aimed to estimate the difference in drug effects when an experimental drug is compared with an active placebo versus a standard placebo control intervention, and to explore causes for heterogeneity. In the context of a randomised trial, this difference in drug effects can be estimated by directly comparing the effect difference between the active placebo and standard placebo intervention.\nSearch methods\nWe searched PubMed, CENTRAL, Embase, two other databases, and two trial registries up to October 2020. We also searched reference lists and citations and contacted trial authors.\nSelection criteria\nWe included randomised trials that compared an active placebo versus a standard placebo intervention. We considered trials both with and without a matching experimental drug arm.\nData collection and analysis\nWe extracted data, assessed risk of bias, scored active placebos for adequacy and risk of unintended therapeutic effect, and categorised active placebos as unpleasant, neutral, or pleasant. We requested individual participant data from the authors of four cross-over trials published after 1990 and one unpublished trial registered after 1990. Our primary inverse-variance, random-effects meta-analysis used standardised mean differences (SMDs) of active versus standard placebo for participant-reported outcomes at earliest post-treatment assessment. A negative SMD favoured the active placebo. We stratified analyses by trial type (clinical or preclinical) and supplemented with sensitivity and subgroup analyses and meta-regression. In secondary analyses, we investigated observer-reported outcomes, harms, attrition, and co-intervention outcomes.\nMain results\nWe included 21 trials (1462 participants). We obtained individual participant data from four trials. Our primary analysis of participant-reported outcomes at earliest post-treatment assessment resulted in a pooled SMD of −0.08 (95% confidence interval (CI) −0.20 to 0.04; I2 = 31%; 14 trials), with no clear difference between clinical and preclinical trials. Individual participant data contributed 43% of the weight of this analysis. Two of seven sensitivity analyses found more pronounced and statistically significant differences; for example, in the five trials with low overall risk of bias, the pooled SMD was −0.24 (95% CI −0.34 to −0.13). The pooled SMD of observer-reported outcomes was similar to the primary analysis. The pooled odds ratio (OR) for harms was 3.08 (95% CI 1.56 to 6.07), and for attrition, 1.22 (95% CI 0.74 to 2.03). Co-intervention data were limited. Meta-regression found no statistically significant association with adequacy of the active placebo or risk of unintended therapeutic effect.\nAuthors' conclusions\nWe did not find a statistically significant difference between active and standard placebo control interventions in our primary analysis, but the result was imprecise and the CI compatible with a difference ranging from important to irrelevant. Furthermore, the result was not robust, because two sensitivity analyses produced a more pronounced and statistically significant difference. We suggest that trialists and users of information from trials carefully consider the type of placebo control intervention in trials with high risk of unblinding, such as those with pronounced non-therapeutic effects and participant-reported outcomes.\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": "1. We found no clear difference in effect between active and standard placebos, but we are very uncertain about the results.\n2. We suggest that researchers carefully consider the type of placebo when investigating medicines with clear side effects."
}
] |
query-laysum
|
23075
|
[
{
"role": "user",
"content": "Abstract: Background\nIatrogenic injury of the inferior alveolar or lingual nerve or both is a known complication of oral and maxillofacial surgery procedures. Injury to these two branches of the mandibular division of the trigeminal nerve may result in altered sensation associated with the ipsilateral lower lip or tongue or both and may include anaesthesia, paraesthesia, dysaesthesia, hyperalgesia, allodynia, hypoaesthesia and hyperaesthesia. Injury to the lingual nerve may also affect taste perception on the affected side of the tongue. The vast majority (approximately 90%) of these injuries are temporary in nature and resolve within eight weeks. However, if the injury persists beyond six months it is deemed to be permanent. Surgical, medical and psychological techniques have been used as a treatment for such injuries, though at present there is no consensus on the preferred intervention, or the timing of the intervention.\nObjectives\nTo evaluate the effects of different interventions and timings of interventions to treat iatrogenic injury of the inferior alveolar or lingual nerves.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group's Trial Register (to 9 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE via OVID (1946 to 9 October 2013) and EMBASE via OVID (1980 to 9 October 2013). No language restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) involving interventions to treat patients with neurosensory defect of the inferior alveolar or lingual nerve or both as a sequela of iatrogenic injury.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration. We performed data extraction and assessment of the risk of bias independently and in duplicate. We contacted authors to clarify the inclusion criteria of the studies.\nMain results\nTwo studies assessed as at high risk of bias, reporting data from 26 analysed participants were included in this review. The age range of participants was from 17 to 55 years. Both trials investigated the effectiveness of low-level laser treatment compared to placebo laser therapy on inferior alveolar sensory deficit as a result of iatrogenic injury.\nPatient-reported altered sensation was partially reported in one study and fully reported in another. Following treatment with laser therapy, there was some evidence of an improvement in the subjective assessment of neurosensory deficit in the lip and chin areas compared to placebo, though the estimates were imprecise: a difference in mean change in neurosensory deficit of the chin of 8.40 cm (95% confidence interval (CI) 3.67 to 13.13) and a difference in mean change in neurosensory deficit of the lip of 21.79 cm (95% CI 5.29 to 38.29). The overall quality of the evidence for this outcome was very low; the outcome data were fully reported in one small study of 13 patients, with differential drop-out in the control group, and patients suffered only partial loss of sensation. No studies reported on the effects of the intervention on the remaining primary outcomes of pain, difficulty eating or speaking or taste. No studies reported on quality of life or adverse events.\nThe overall quality of the evidence was very low as a result of limitations in the conduct and reporting of the studies, indirectness of the evidence and the imprecision of the results.\nAuthors' conclusions\nThere is clearly a need for randomised controlled clinical trials to investigate the effectiveness of surgical, medical and psychological interventions for iatrogenic inferior alveolar and lingual nerve injuries. Primary outcomes of this research should include: patient-focused morbidity measures including altered sensation and pain, pain, quantitative sensory testing and the effects of delayed treatment.\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 overall quality of the evidence is very low as a result of limitations in the conduct and reporting of the two included studies and the low number of participants, and evidence from participants with only partial sensory loss."
}
] |
query-laysum
|
23076
|
[
{
"role": "user",
"content": "Abstract: Background\nHealthcare professionals are important contributors to healthcare quality and patient safety, but their performance does not always follow recommended clinical practice. There are many approaches to influencing practice among healthcare professionals. These approaches include audit and feedback, reminders, educational materials, educational outreach visits, educational meetings or conferences, use of local opinion leaders, financial incentives, and organisational interventions. In this review, we evaluated the effectiveness of patient-mediated interventions. These interventions are aimed at changing the performance of healthcare professionals through interactions with patients, or through information provided by or to patients. Examples of patient-mediated interventions include 1) patient-reported health information, 2) patient information, 3) patient education, 4) patient feedback about clinical practice, 5) patient decision aids, 6) patients, or patient representatives, being members of a committee or board, and 7) patient-led training or education of healthcare professionals.\nObjectives\nTo assess the effectiveness of patient-mediated interventions on healthcare professionals' performance (adherence to clinical practice guidelines or recommendations for clinical practice).\nSearch methods\nWe searched MEDLINE, Ovid in March 2018, Cochrane Central Register of Controlled Trials (CENTRAL) in March 2017, and ClinicalTrials.gov and the International Clinical Trials Registry (ICTRP) in September 2017, and OpenGrey, the Grey Literature Report and Google Scholar in October 2017. We also screened the reference lists of included studies and conducted cited reference searches for all included studies in October 2017.\nSelection criteria\nRandomised studies comparing patient-mediated interventions to either usual care or other interventions to improve professional practice.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We calculated the risk ratio (RR) for dichotomous outcomes using Mantel-Haenszel statistics and the random-effects model. For continuous outcomes, we calculated the mean difference (MD) using inverse variance statistics. Two review authors independently assessed the certainty of the evidence (GRADE).\nMain results\nWe included 25 studies with a total of 12,268 patients. The number of healthcare professionals included in the studies ranged from 12 to 167 where this was reported. The included studies evaluated four types of patient-mediated interventions: 1) patient-reported health information interventions (for instance information obtained from patients about patients' own health, concerns or needs before a clinical encounter), 2) patient information interventions (for instance, where patients are informed about, or reminded to attend recommended care), 3) patient education interventions (intended to increase patients' knowledge about their condition and options of care, for instance), and 4) patient decision aids (where the patient is provided with information about treatment options including risks and benefits). For each type of patient-mediated intervention a separate meta-analysis was produced.\nPatient-reported health information interventions probably improve healthcare professionals' adherence to recommended clinical practice (moderate-certainty evidence). We found that for every 100 patients consulted or treated, 26 (95% CI 23 to 30) are in accordance with recommended clinical practice compared to 17 per 100 in the comparison group (no intervention or usual care). We are uncertain about the effect of patient-reported health information interventions on desirable patient health outcomes and patient satisfaction (very low-certainty evidence). Undesirable patient health outcomes and adverse events were not reported in the included studies and resource use was poorly reported.\nPatient information interventions may improve healthcare professionals' adherence to recommended clinical practice (low-certainty evidence). We found that for every 100 patients consulted or treated, 32 (95% CI 24 to 42) are in accordance with recommended clinical practice compared to 20 per 100 in the comparison group (no intervention or usual care). Patient information interventions may have little or no effect on desirable patient health outcomes and patient satisfaction (low-certainty evidence). We are uncertain about the effect of patient information interventions on undesirable patient health outcomes because the certainty of the evidence is very low. Adverse events and resource use were not reported in the included studies.\nPatient education interventions probably improve healthcare professionals' adherence to recommended clinical practice (moderate-certainty evidence). We found that for every 100 patients consulted or treated, 46 (95% CI 39 to 54) are in accordance with recommended clinical practice compared to 35 per 100 in the comparison group (no intervention or usual care). Patient education interventions may slightly increase the number of patients with desirable health outcomes (low-certainty evidence). Undesirable patient health outcomes, patient satisfaction, adverse events and resource use were not reported in the included studies.\nPatient decision aid interventions may have little or no effect on healthcare professionals' adherence to recommended clinical practice (low-certainty evidence). We found that for every 100 patients consulted or treated, 32 (95% CI 24 to 43) are in accordance with recommended clinical practice compared to 37 per 100 in the comparison group (usual care). Patient health outcomes, patient satisfaction, adverse events and resource use were not reported in the included studies.\nAuthors' conclusions\nWe found that two types of patient-mediated interventions, patient-reported health information and patient education, probably improve professional practice by increasing healthcare professionals' adherence to recommended clinical practice (moderate-certainty evidence). We consider the effect to be small to moderate. Other patient-mediated interventions, such as patient information may also improve professional practice (low-certainty evidence). Patient decision aids may make little or no difference to the number of healthcare professionals' adhering to recommended clinical practice (low-certainty evidence).\nThe impact of these interventions on patient health and satisfaction, adverse events and resource use, is more uncertain mostly due to very low certainty evidence or lack of evidence.\n\nGiven the provided abstract, please respond to the following query: \"Patient decision aid strategies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In the one study that assessed effect of patient decision aids, patients were given a decision aid consisting of a booklet, personal worksheet, and audiotape to make decisions about their medical management. The review shows that these strategies:\n- may have little or no effect on the extent to which healthcare professionals follow recommended clinical practice (low-certainty evidence)\nWe are uncertain about the effect of these strategies on patient health, patient satisfaction and resource use because these outcomes were not measured in the studies or because the certainty of the evidence is very low."
}
] |
query-laysum
|
23077
|
[
{
"role": "user",
"content": "Abstract: Background\nPulmonary hypertension (PH) comprises a group of complex and heterogenous conditions, characterised by elevated pulmonary artery pressure, and which left untreated leads to right-heart failure and death. PH includes World Health Organisation (WHO) Group 1 pulmonary arterial hypertension (PAH); Group 2 consists of PH due to left-heart disease (PH-LHD); Group 3 comprises PH as a result of lung diseases or hypoxia, or both; Group 4 includes PH due to chronic thromboembolic occlusion of pulmonary vasculature (CTEPH), and Group 5 consists of cases of PH due to unclear and/or multifactorial mechanisms including haematological, systemic, or metabolic disorders. Phosphodiesterase type 5 (PDE5) inhibitors increase vasodilation and inhibit proliferation.\nObjectives\nTo determine the efficacy of PDE5 inhibitors for pulmonary hypertension in adults and children.\nSearch methods\nWe performed searches of CENTRAL, MEDLINE, Embase, CINAHL, and Web of Science up to 26 September 2018. We handsearched review articles, clinical trial registries, and reference lists of retrieved articles.\nSelection criteria\nWe included randomised controlled trials that compared any PDE5 inhibitor versus placebo, or any other PAH disease-specific therapies, for at least 12 weeks. We include separate analyses for each PH group.\nData collection and analysis\nWe imported studies identified by the search into a reference manager database. We retrieved the full-text versions of relevant studies, and two review authors independently extracted data. Primary outcomes were: change in WHO functional class, six-minute walk distance (6MWD), and mortality. Secondary outcomes were haemodynamic parameters, quality of life/health status, dyspnoea, clinical worsening (hospitalisation/intervention), and adverse events. When appropriate, we performed meta-analyses and subgroup analyses by severity of lung function, connective tissue disease diagnosis, and radiological pattern of fibrosis. We assessed the evidence using the GRADE approach and created 'Summary of findings' tables.\nMain results\nWe included 36 studies with 2999 participants (with pulmonary hypertension from all causes) in the final review. Trials were conducted for 14 weeks on average, with some as long as 12 months. Two trials specifically included children.\nNineteen trials included group 1 PAH participants. PAH participants treated with PDE5 inhibitors were more likely to improve their WHO functional class (odds ratio (OR) 8.59, 95% confidence interval (CI) 3.95 to 18.72; 4 trials, 282 participants), to walk 48 metres further in 6MWD (95% CI 40 to 56; 8 trials, 880 participants), and were 22% less likely to die over a mean duration of 14 weeks (95% CI 0.07 to 0.68; 8 trials, 1119 participants) compared to placebo (high-certainty evidence). The number needed to treat to prevent one additional death was 32 participants. There was an increased risk of adverse events with PDE5 inhibitors, especially headache (OR 1.97, 95% CI 1.33 to 2.92; 5 trials, 848 participants), gastrointestinal upset (OR 1.63, 95% CI 1.07 to 2.48; 5 trials, 848 participants), flushing (OR 4.12, 95% CI 1.83 to 9.26; 3 trials, 748 participants), and muscle aches and joint pains (OR 2.52, 95% CI 1.59 to 3.99; 4 trials, 792 participants).\nData comparing PDE5 inhibitors to placebo whilst on other PAH-specific therapy were limited by the small number of included trials. Those PAH participants on PDE5 inhibitors plus combination therapy walked 19.66 metres further in six minutes (95% CI 9 to 30; 4 trials, 509 participants) compared to placebo (moderate-certainty evidence). There were limited trials comparing PDE5 inhibitors directly with other PAH-specific therapy (endothelin receptor antagonists (ERAs)). Those on PDE5 inhibitors walked 49 metres further than on ERAs (95% CI 4 to 95; 2 trials, 36 participants) (low-certainty evidence). There was no evidence of a difference in WHO functional class or mortality across both treatments.\nFive trials compared PDE5 inhibitors to placebo in PH secondary to left-heart disease (PH-LHD). The quality of data were low due to imprecision and inconsistency across trials. In those with PH-LHD there were reduced odds of an improvement in WHO functional class using PDE5 inhibitors compared to placebo (OR 0.53, 95% CI 0.32 to 0.87; 3 trials, 285 participants), and those using PDE5 inhibitors walked 34 metres further compared to placebo (95% CI 23 to 46; 3 trials, 284 participants). There was no evidence of a difference in mortality. Five trials compared PDE5 inhibitors to placebo in PH secondary to lung disease/hypoxia, mostly in COPD. Data were of low quality due to imprecision of effect and inconsistency across trials. There was a small improvement of 27 metres in 6MWD using PDE5 inhibitors compared to placebo in those with PH due to lung disease. There was no evidence of worsening hypoxia using PDE5 inhibitors, although data were limited. Three studies compared PDE5 inhibitors to placebo or other PAH-specific therapy in chronic thromboembolic disease. There was no significant difference in any outcomes. Data quality was low due to imprecision of effect and heterogeneity across trials.\nAuthors' conclusions\nPDE5 inhibitors appear to have clear beneficial effects in group 1 PAH. Sildenafil, tadalafil and vardenafil are all efficacious in this clinical setting, and clinicians should consider the side-effect profile for each individual when choosing which PDE5 inhibitor to prescribe.\nWhile there appears to be some benefit for the use of PDE5 inhibitors in PH-left-heart disease, it is not clear based on the mostly small, short-term studies, which type of left-heart disease stands to benefit. These data suggest possible harm in valvular heart disease. There is no clear benefit for PDE5 inhibitors in pulmonary hypertension secondary to lung disease or chronic thromboembolic disease. Further research is required into the mechanisms of pulmonary hypertension secondary to left-heart disease, and cautious consideration of which subset of these patients may benefit from PDE5 inhibitors. Future trials in PH-LHD should be sufficiently powered, with long-term follow-up, and should include invasive haemodynamic data, WHO functional class, six-minute walk distance, and clinical worsening.\n\nGiven the provided abstract, please respond to the following query: \"Why the review is important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Approximately three people in every 1000 have pulmonary hypertension, due to different causes. This can lead to reduced exercise capacity, reduced quality of life, increased hospitalisations, and early death. A group of drugs called PDE5 inhibitors may improve blood circulation in the right heart and lungs. We wanted to make sure that if these drugs are being used, there is evidence of benefit and little or no harm."
}
] |
query-laysum
|
23078
|
[
{
"role": "user",
"content": "Abstract: Background\nImproved understanding and treatment of cystic fibrosis (CF) has led to longer life expectancy, which is accompanied by an increasingly complex regimen of treatments. Suboptimal adherence to the treatment plan, in the context of respiratory disease, has been found to be associated with poorer health outcomes. With digital technology being more accessible, it can be used to monitor adherence to inhaled therapies via chipped nebulisers, mobile phone apps and web-based platforms. This technology can allow monitoring of adherence as well as clinical outcomes, and allow feedback to both the person with CF and their healthcare team.\nObjectives\nTo assess the effects of using digital technology to monitor adherence to inhaled therapies and health status in adults and children with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.\nDate of last search: 28 October 2021.\nWe also searched Embase and three clinical trial registries and checked references of included studies.\nDate of last search: 9 November 2021.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) looking at the effects of a digital technology for monitoring adherence of children and adults with CF to inhaled therapies.\nData collection and analysis\nTwo review authors screened the search results for studies eligible for inclusion in the review and extracted their data. We used Risk of Bias 2 for assessing study quality. We assessed the overall certainty of the evidence using GRADE.\nMain results\nWe included two studies in our review, with 628 participants aged five to 41 years. There was one study each for two different comparisons.\nNebuliser target inhalation mode versus standard inhalation mode\nThe included parallel study was carried out over 10 weeks after a run-in period of four to six weeks. The study compared the effects of a digitally enhanced inhalation mode (target inhalation mode) for nebulised antibiotics compared to standard mode in children attending a regional CF clinic in the United Kingdom. The study's primary outcome was the time taken to complete the inhaled treatment, but investigators also reported on adherence to therapy. The results showed that there may be an improvement in adherence with the target inhalation mode when this intervention is used (mean difference (MD) 24.0%, 95% confidence interval (CI) 2.95 to 45.05; low-certainty evidence). The target inhalation mode may make little or no difference to forced expiratory volume in one second (FEV1) % predicted (MD 1.00 % predicted, 95% CI -9.37 to 11.37; low-certainty evidence). The study did not report on treatment burden, quality of life (QoL) or pulmonary exacerbations.\neNebuliser with digital support versus eNebuliser without support\nOne large multicentre RCT monitored adherence via data-tracking nebulisers. The intervention group also receiving access to an online web-based platform, CFHealthHub, which offered tailored, flexible support from the study interventionist as well as access to their adherence data, educational and problem-solving information throughout the 12-month trial period. We graded all evidence as moderate certainty. Compared to usual care, the digital intervention probably improves adherence to inhaled therapy (MD 18%, 95% CI 12.90 to 23.10); probably leads to slightly reduced treatment burden (MD 5.1, 95% CI 1.79 to 8.41); and may lead to slightly improved FEV1 % predicted (MD 3.70, 95% CI -0.23 to 7.63). There is probably little or no difference in the incidence of pulmonary exacerbations or QoL between the two groups.\nAuthors' conclusions\nDigital monitoring plus tailored support via an online platform probably improves adherence to inhaled therapies and reduces treatment burden (but without a corresponding change in QoL) in the medium term (low- and moderate-certainty evidence). In a shorter time frame, technological enhancement of inhaling antibiotics may improve adherence to treatment (low-certainty evidence). There may be little or no effect on lung function with either intervention, and online monitoring probably makes no difference to pulmonary exacerbations.\nFuture research should assess the effect of digital technology on adherence in both children and adults. Consideration of adherence to the total treatment regimen is also important, as an improvement in adherence to inhaled therapies could come at the cost of adherence to other parts of the treatment regimen.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found two studies using different digital technologies. We could not combine their results and analysed them separately. Both studies put the people taking part into one of two groups at random, with equal chances of being in either group.\nOne small study compared two breathing modes of a digital nebuliser in 20 children aged 5 to 16 years (the nebuliser delivered an antibiotic as an inhaled mist). One mode encouraged children to take longer, deeper breaths via an adapted mouthpiece; the other mode consisted of the usual breathing pattern. The study lasted for 10 weeks.\nThe larger study involved 608 people aged 16 years and older. It compared a data-tracking nebuliser paired with a web-based platform called CFHealthHub to the same nebuliser used without the web-based platform. CFHealthHub gave participants access to their adherence data and individual support from study investigators, who collected data for 12 months."
}
] |
query-laysum
|
23079
|
[
{
"role": "user",
"content": "Abstract: Background\nSubfertility is a condition found in up to 15% of couples of reproductive age. Gamete micromanipulation, such as intracytoplasmic sperm injection (ICSI), is very useful for treating couples with compromised sperm parameters. An alternative method of sperm selection has been described; the spermatozoa are selected under high magnification (over 6000x) and used for ICSI. This technique, named intracytoplasmic morphologically selected sperm injection (IMSI), has a theoretical potential to improve reproductive outcomes among couples undergoing assisted reproduction techniques (ART). However, our previous version of this Cochrane Review was unable to find evidence that supported this possible beneficial effect. This is an update of Teixeira 2013.\nObjectives\nTo identify, appraise, and summarise the available evidence regarding efficacy and safety of IMSI compared to ICSI in couples undergoing ART.\nSearch methods\nWe searched for randomised controlled trials (RCTs) in these electronic databases: the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, and in these trial registers: ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We also handsearched the reference lists of included studies and similar reviews. We performed the last electronic search on 18 November 2019.\nSelection criteria\nWe only considered RCTs that compared ICSI and IMSI; we did not include quasi-randomised trials. We considered studies that permitted the inclusion of the same participant more than once (cross-over or per cycle trials) only if data regarding the first treatment of each participant were available.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, and assessment of the risk of bias and quality of the evidence; we solved disagreements by consulting a third review author. We corresponded with study investigators to resolve any queries, as required.\nMain results\nThe updated search retrieved 535 records; we included 13 parallel-designed RCTs comparing IMSI and ICSI (four studies were added since the previous version), comprising 2775 couples (IMSI = 1256; ICSI = 1519).\nWe are uncertain if IMSI improves live birth rates (risk ratio (RR) 1.11, 95% confidence interval (CI) 0.89 to 1.39; 5 studies, 929 couples; I² = 1%), miscarriage rates per couple (RR 1.07, 95% CI 0.78 to 1.48; 10 studies, 2297 couples; I² = 0%, very-low quality evidence), and miscarriage rate per pregnancy (RR 0.90, 95% CI 0.68 to 1.20; 10 studies, 783 couples; I² = 0%, very-low quality evidence). We are uncertain if IMSI improves clinical pregnancy rates (RR 1.23, 95% CI 1.11 to 1.37; 13 studies, 2775 couples; I² = 47%, very-low quality evidence). None of the included studies reported congenital abnormalities. We judged the evidence for all outcomes to be of very low-quality. We downgraded the quality of the evidence due to limitations of the included studies (risk of bias), inconsistency of results, and a strong indication of publication bias.\nAuthors' conclusions\nThe current evidence from randomised controlled trials does not support or refute the clinical use of intracytoplasmic sperm injection (intracytoplasmic morphologically selected sperm injection (IMSI). We are very uncertain of the chances of having a live birth and of the risk of having a miscarriage. We found very low-quality evidence that IMSI may increase chances of a clinical pregnancy, which means that we are still very uncertain about any real difference.\nWe did not find any trials reporting on the risk of congenital abnormalities. Well-designed and sufficiently powered trials are still required.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We downgraded the quality of the evidence because of limitations in the included studies (risk of bias), inconsistency of the observed effect across studies, and high risk of publication bias. There was no evidence concerning congenital abnormalities. We conclude that the current evidence is very limited for suggesting using IMSI instead of ICSI in clinical practice."
}
] |
query-laysum
|
23080
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic respiratory conditions are major causes of mortality and morbidity. Children with chronic health conditions have increased morbidity associated with their physical, emotional, and general well-being. Acute respiratory exacerbations (AREs) are common in children with chronic respiratory disease, often requiring admission to hospital. Reducing the frequency of AREs and recurrent hospitalisations is therefore an important goal in the individual and public health management of chronic respiratory illnesses in children. Discharge planning is used to decide what a person needs for transition from one level of care to another and is usually considered in the context of discharge from hospital to the home. Discharge planning from hospital for ongoing management of an illness has historically been referral to a general practitioner or allied health professional or self management by the individual and their family with limited communication between the hospital and patient once discharged. Effective discharge planning can decrease the risk of recurrent AREs requiring medical care. An individual caseworker-assigned discharge plan may further decrease exacerbations.\nObjectives\nTo evaluate the efficacy of individual caseworker-assigned discharge plans, as compared to non-caseworker-assigned plans, in preventing hospitalisation for AREs in children with chronic lung diseases such as asthma and bronchiectasis.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of Trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trials registries, and reference lists of articles. The latest searches were undertaken in November 2017.\nSelection criteria\nAll randomised controlled trials comparing individual caseworker-assigned discharge planning compared to traditional discharge-planning approaches (including self management), and their effectiveness in reducing the subsequent need for emergency care for AREs (hospital admissions, emergency department visits, and/or unscheduled general practitioner visits) in children hospitalised with an acute exacerbation of chronic respiratory disease. We excluded studies that included children with cystic fibrosis.\nData collection and analysis\nWe used standard Cochrane Review methodological approaches. Relevant studies were independently selected in duplicate. Two review authors independently assessed trial quality and extracted data. We contacted the authors of one study for further information.\nMain results\nWe included four studies involving a total of 773 randomised participants aged between 14 months and 16 years. All four studies involved children with asthma, with the case-planning undertaken by a trained nurse educator. However, the discharge planning/education differed among the studies. We could include data from only two studies (361 children) in the meta-analysis. Two further studies enrolled children in both inpatient and outpatient settings, and one of these studies also included children with acute wheezing illness (no previous asthma diagnosis); the data specific to this review could not be obtained. For the primary outcome of exacerbations requiring hospitalisation, those in the intervention group were significantly less likely to be rehospitalised (odds ratio (OR) 0.29, 95% confidence interval (CI) 0.16 to 0.50) compared to controls. This equates to 189 (95% CI 124 to 236) fewer admissions per 1000 children. No adverse events were reported in any study. In the context of substantial statistical heterogeneity between the two studies, there were no statistically significant effects on emergency department (OR 0.37, 95% CI 0.04 to 3.05) or general practitioner (OR 0.87, 95% CI 0.22 to 3.44) presentations. There were no data on cost-effectiveness, length of stay of subsequent hospitalisations, or adherence to medications. One study reported quality of life, with no significant differences observed between the intervention and control groups.\nWe considered three of the studies to have an unclear risk of bias, primarily due to inadequate description of the blinding of participants and investigators. The fourth study was assessed as at high risk of bias as a single unblinded investigator was used. Using the GRADE system, we assessed the quality of the evidence as moderate for the outcome of hospitalisation and low for the outcomes of emergency department visits and general practitioner consultations.\nAuthors' conclusions\nCurrent evidence suggests that individual caseworker-assigned discharge plans, as compared to non-caseworker-assigned plans, may be beneficial in preventing hospital readmissions for acute exacerbations in children with asthma. There was no clear indication that the intervention reduces emergency department and general practitioner attendances for asthma, and there is an absence of data for children with other chronic respiratory conditions. Given the potential benefit and cost savings to the healthcare sector and families if hospitalisations and outpatient attendances can be reduced, there is a need for further randomised controlled trials encompassing different chronic respiratory illnesses, ethnicity, socio-economic settings, and cost-effectiveness, as well as defining the essential components of a complex intervention.\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 considered the quality of the evidence to be moderate for the outcome of hospital readmissions and low for the outcomes of future emergency department visits and general practitioner consultations for asthma flare-ups."
}
] |
query-laysum
|
23081
|
[
{
"role": "user",
"content": "Abstract: Background\nUpper endoscopy is the definitive treatment for upper gastrointestinal haemorrhage (UGIH). However, up to 13% of people who undergo upper endoscopy will have incomplete visualisation of the gastric mucosa at presentation. Erythromycin acts as a motilin receptor agonist in the upper gastrointestinal (GI) tract and increases gastric emptying, which may lead to better quality of visualisation and improved treatment effectiveness. However, there is uncertainty about the benefits and harms of erythromycin in UGIH.\nObjectives\nTo evaluate the benefits and harms of erythromycin before endoscopy in adults with acute upper gastrointestinal haemorrhage, compared with any other treatment or no treatment/placebo.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 15 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated erythromycin before endoscopy compared to any other treatment or no treatment/placebo before endoscopy in adults with acute UGIH.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. UGIH-related mortality and 2. serious adverse events. Our secondary outcomes were 1. all-cause mortality, 2. visualisation of gastric mucosa, 3. non-serious adverse events, 4. rebleeding, 5. blood transfusion, and 5. rescue invasive intervention. We used GRADE criteria to assess the certainty of the evidence for each outcome.\nMain results\nWe included 11 RCTs with 878 participants. The mean age ranged from 53.13 years to 64.5 years, and most participants were men (72.3%). One RCT included only non-variceal haemorrhage, one included only variceal haemorrhage, and eight included both aetiologies. We defined short-term outcomes as those occurring within one week of initial endoscopy.\nErythromycin versus placebo\nThree RCTs (255 participants) compared erythromycin with placebo. There were no UGIH-related deaths. The evidence is very uncertain about the short-term effects of erythromycin compared with placebo on serious adverse events (risk difference (RD) −0.01, 95% confidence interval (CI) −0.04 to 0.02; 3 studies, 255 participants; very low certainty), all-cause mortality (RD 0.00, 95% CI −0.03 to 0.03; 3 studies, 255 participants; very low certainty), non-serious adverse events (RD 0.01, 95% CI −0.03 to 0.05; 3 studies, 255 participants; very low certainty), and rebleeding (risk ratio (RR) 0.63, 95% CI 0.13 to 2.90; 2 studies, 195 participants; very low certainty). Erythromycin may improve gastric mucosa visualisation (mean difference (MD) 3.63 points on 16-point ordinal scale, 95% CI 2.20 to 5.05; higher MD means better visualisation; 2 studies, 195 participants; low certainty). Erythromycin may also result in a slight reduction in blood transfusion (MD −0.44 standard units of blood, 95% CI −0.86 to −0.01; 3 studies, 255 participants; low certainty).\nErythromycin plus nasogastric tube lavage versus no intervention/placebo plus nasogastric tube lavage\nSix RCTs (408 participants) compared erythromycin plus nasogastric tube lavage with no intervention/placebo plus nasogastric tube lavage. There were no UGIH-related deaths and no serious adverse events. The evidence is very uncertain about the short-term effects of erythromycin plus nasogastric tube lavage compared with no intervention/placebo plus nasogastric tube lavage on all-cause mortality (RD −0.02, 95% CI −0.08 to 0.03; 3 studies, 238 participants; very low certainty), visualisation of the gastric mucosa (standardised mean difference (SMD) 0.48 points on 10-point ordinal scale, 95% CI 0.10 to 0.85; higher SMD means better visualisation; 3 studies, 170 participants; very low certainty), non-serious adverse events (RD 0.00, 95% CI −0.05 to 0.05; 6 studies, 408 participants; very low certainty), rebleeding (RR 1.13, 95% CI 0.63 to 2.02; 1 study, 169 participants; very low certainty), and blood transfusion (MD −1.85 standard units of blood, 95% CI −4.34 to 0.64; 3 studies, 180 participants; very low certainty).\nErythromycin versus nasogastric tube lavage\nFour RCTs (287 participants) compared erythromycin with nasogastric tube lavage. There were no UGIH-related deaths and no serious adverse events. The evidence is very uncertain about the short-term effects of erythromycin compared with nasogastric tube lavage on all-cause mortality (RD 0.02, 95% CI −0.05 to 0.08; 3 studies, 213 participants; very low certainty), visualisation of the gastric mucosa (RR 1.19, 95% CI 0.79 to 1.79; 2 studies, 198 participants; very low certainty), non-serious adverse events (RD −0.10, 95% CI −0.34 to 0.13; 3 studies, 213 participants; very low certainty), rebleeding (RR 0.77, 95% CI 0.40 to 1.49; 1 study, 169 participants; very low certainty), and blood transfusion (median 2 standard units of blood, interquartile range 0 to 4 in both groups; 1 study, 169 participants; very low certainty).\nErythromycin plus nasogastric tube lavage versus metoclopramide plus nasogastric tube lavage\nOne RCT (30 participants) compared erythromycin plus nasogastric tube lavage with metoclopramide plus nasogastric tube lavage. The evidence is very uncertain about the effects of erythromycin plus nasogastric tube lavage on all the reported outcomes (serious adverse events, visualisation of gastric mucosa, non-serious adverse events, and blood transfusion).\nAuthors' conclusions\nWe are unsure if erythromycin before endoscopy in people with UGIH has any clinical benefits or harms. However, erythromycin compared with placebo may improve gastric mucosa visualisation and result in a slight reduction in blood transfusion.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included findings from 11 studies involving 878 adults with upper gastrointestinal bleeding. Most participants were men, and the average ages ranged from 53 years to 64 years. The studies were conducted in several different countries. They compared erythromycin with placebo, lavage of the stomach with a nasogastric tube (injecting and sucking out water or saline through a tube inserted through the nose and with the tip placed inside the stomach), and metoclopramide (a medicine that speeds up the emptying of the stomach)."
}
] |
query-laysum
|
23082
|
[
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) recommends mass drug administration (MDA), giving a drug at regular intervals to a whole population, as part of the strategy for several disease control programmes in low- and middle-income countries. MDA is currently WHO policy for areas endemic with lymphatic filariasis, which is a parasitic disease that can result in swollen limbs and disability. The success depends on communities adhering to the drugs given, and this will be influenced by the perception of the drug, the programme, and those delivering it.\nObjectives\nTo synthesize qualitative research evidence about community experience with, and understanding and perception of, MDA programmes for lymphatic filariasis.\nTo explore whether programme design and delivery influence the community experience identified in the analysis.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and seven other databases up to 8 April 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies.\nSelection criteria\nThis review synthesized qualitative research and mixed-methods studies when it was possible to extract qualitative data. Eligible studies explored community experiences, perceptions, or attitudes towards MDA programmes for lymphatic filariasis in any country, conducted between 2000 and 2019.\nData collection and analysis\nWe extracted data on study design including: authors, aims, participants, methods, and qualitative data collection methods. We also described programme delivery factors including: country, urban or rural setting, endemicity, drug regimen, rounds of MDA received at the time of the study, who delivered the drugs, how the drugs were delivered, use of health education, and sensitization and adherence monitoring.\nWe conducted a thematic analysis and developed codes inductively using ATLAS.ti software. We examined codes for underlying ideas, connections, and interpretations and, from this, generated analytical themes. We assessed the confidence in the findings using the GRADE-CERQual approach, and produced a conceptual model to display our findings.\nMain results\nFrom 902 results identified in the search, 29 studies met our inclusion criteria. The studies covered a broad range of countries in Africa, South-East Asia, and South America, and explored the views and experiences of community members and community drug distributors in low-income countries endemic for lymphatic filariasis. Four themes emerged.\nPeople weigh up benefits and harms before participating. People understand the potential benefits in terms of relief of suffering, stigma, and avoiding costs (high confidence); however, these theoretical benefits do not always mesh with their experiences (high confidence). In particular, adverse effects are frightening and unwelcome (high confidence); and these effects are amplified through rumour and social media (moderate confidence).\nMany people are suspicious of MDA programmes. When people lack a scientific explanation for the programme and their experiences of it, they often develop social explanations instead. These are largely shaped on the historical backdrop and level of trust people have in relevant authority figures (high confidence), although some have unwavering faith in their government and, by extension, the programme (moderate confidence).\nProgrammes expect compliance, and this can become coercive and blaming. Health workers and community members stigmatize non-compliance, which can become coercive (moderate confidence), so communities may appear to comply publicly, but privately reject treatment (moderate confidence).\nCommunity distributors are often not respected or valued. They have little authority (moderate confidence), and the behaviour of some distributors damages the MDA programme's reputation (high confidence). Communities want information about programmes to help make decisions about participation, but drug distributors are not sufficiently informed, or skilled in this communication (high confidence).\nWe intended to assess whether programme designs influenced communities' perceptions of the programme and decision to adhere but were unable to do so as few studies adequately reported the design and implementation of the local programme.\nWe have moderate to high confidence in the evidence contributing to the review themes and subthemes.\nAuthors' conclusions\nAdherence with MDA for filariasis is influenced by individual direct experience of benefit and harm; social influences in the community; political influences and their relationship to government; and historical influences. Fear of adverse effects was frequently described and this appears to be particularly important for communities. When views were negative, we were surprised by the strength of feeling expressed. Enthusiasm for these schemes as a strategy in global policy needs debate in the light of these findings.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this synthesis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this synthesis of qualitative research, we aimed to explore people's views on MDA programmes for treating lymphatic filariasis in low- and middle-income countries."
}
] |
query-laysum
|
23083
|
[
{
"role": "user",
"content": "Abstract: Background\nSince December 2019, the world has struggled with the COVID-19 pandemic. Even after the introduction of various vaccines, this disease still takes a considerable toll. In order to improve the optimal allocation of resources and communication of prognosis, healthcare providers and patients need an accurate understanding of factors (such as obesity) that are associated with a higher risk of adverse outcomes from the COVID-19 infection.\nObjectives\nTo evaluate obesity as an independent prognostic factor for COVID-19 severity and mortality among adult patients in whom infection with the COVID-19 virus is confirmed.\nSearch methods\nMEDLINE, Embase, two COVID-19 reference collections, and four Chinese biomedical databases were searched up to April 2021.\nSelection criteria\nWe included case-control, case-series, prospective and retrospective cohort studies, and secondary analyses of randomised controlled trials if they evaluated associations between obesity and COVID-19 adverse outcomes including mortality, mechanical ventilation, intensive care unit (ICU) admission, hospitalisation, severe COVID, and COVID pneumonia. Given our interest in ascertaining the independent association between obesity and these outcomes, we selected studies that adjusted for at least one factor other than obesity. Studies were evaluated for inclusion by two independent reviewers working in duplicate.\nData collection and analysis\nUsing standardised data extraction forms, we extracted relevant information from the included studies. When appropriate, we pooled the estimates of association across studies with the use of random-effects meta-analyses. The Quality in Prognostic Studies (QUIPS) tool provided the platform for assessing the risk of bias across each included study. In our main comparison, we conducted meta-analyses for each obesity class separately. We also meta-analysed unclassified obesity and obesity as a continuous variable (5 kg/m2 increase in BMI (body mass index)). We used the GRADE framework to rate our certainty in the importance of the association observed between obesity and each outcome. As obesity is closely associated with other comorbidities, we decided to prespecify the minimum adjustment set of variables including age, sex, diabetes, hypertension, and cardiovascular disease for subgroup analysis.\nMain results\nWe identified 171 studies, 149 of which were included in meta-analyses. As compared to 'normal' BMI (18.5 to 24.9 kg/m2) or patients without obesity, those with obesity classes I (BMI 30 to 35 kg/m2), and II (BMI 35 to 40 kg/m2) were not at increased odds for mortality (Class I: odds ratio [OR] 1.04, 95% confidence interval [CI] 0.94 to 1.16, high certainty (15 studies, 335,209 participants); Class II: OR 1.16, 95% CI 0.99 to 1.36, high certainty (11 studies, 317,925 participants)). However, those with class III obesity (BMI 40 kg/m2 and above) may be at increased odds for mortality (Class III: OR 1.67, 95% CI 1.39 to 2.00, low certainty, (19 studies, 354,967 participants)) compared to normal BMI or patients without obesity. For mechanical ventilation, we observed increasing odds with higher classes of obesity in comparison to normal BMI or patients without obesity (class I: OR 1.38, 95% CI 1.20 to 1.59, 10 studies, 187,895 participants, moderate certainty; class II: OR 1.67, 95% CI 1.42 to 1.96, 6 studies, 171,149 participants, high certainty; class III: OR 2.17, 95% CI 1.59 to 2.97, 12 studies, 174,520 participants, high certainty). However, we did not observe a dose-response relationship across increasing obesity classifications for ICU admission and hospitalisation.\nAuthors' conclusions\nOur findings suggest that obesity is an important independent prognostic factor in the setting of COVID-19. Consideration of obesity may inform the optimal management and allocation of limited resources in the care of COVID-19 patients.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to April 2021."
}
] |
query-laysum
|
23084
|
[
{
"role": "user",
"content": "Abstract: Background\nIn the absence of bleeding, plasma is commonly transfused to people prophylactically to prevent bleeding. In this context, it is transfused before operative or invasive procedures (such as liver biopsy or chest drainage tube insertion) in those considered at increased risk of bleeding, typically defined by abnormalities of laboratory tests of coagulation. As plasma contains procoagulant factors, plasma transfusion may reduce perioperative bleeding risk. This outcome has clinical importance given that perioperative bleeding and blood transfusion have been associated with increased morbidity and mortality. Plasma is expensive, and some countries have experienced issues with blood product shortages, donor pool reliability, and incomplete screening for transmissible infections. Thus, although the benefit of prophylactic plasma transfusion has not been well established, plasma transfusion does carry potentially life-threatening risks.\nObjectives\nTo determine the clinical effectiveness and safety of prophylactic plasma transfusion for people with coagulation test abnormalities (in the absence of inherited bleeding disorders or use of anticoagulant medication) requiring non-cardiac surgery or invasive procedures.\nSearch methods\nWe searched for randomised controlled trials (RCTs), without language or publication status restrictions in: Cochrane Central Register of Controlled Trials (CENTRAL; 2017 Issue 7); Ovid MEDLINE (from 1946); Ovid Embase (from 1974); Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOHost) (from 1937); PubMed (e-publications and in-process citations ahead of print only); Transfusion Evidence Library (from 1950); Latin American Caribbean Health Sciences Literature (LILACS) (from 1982); Web of Science: Conference Proceedings Citation Index-Science (CPCI-S) (Thomson Reuters, from 1990); ClinicalTrials.gov; and World Health Organization (WHO) International Clinical Trials Registry Search Platform (ICTRP) to 28 January 2019.\nSelection criteria\nWe included RCTs comparing: prophylactic plasma transfusion to placebo, intravenous fluid, or no intervention; prophylactic plasma transfusion to alternative pro-haemostatic agents; or different haemostatic thresholds for prophylactic plasma transfusion. We included participants of any age, and we excluded trials incorporating individuals with previous active bleeding, with inherited bleeding disorders, or taking anticoagulant medication before enrolment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included five trials in this review, all were conducted in high-income countries. Three additional trials are ongoing.\nOne trial compared fresh frozen plasma (FFP) transfusion with no transfusion given. One trial compared FFP or platelet transfusion or both with neither FFP nor platelet transfusion given. One trial compared FFP transfusion with administration of alternative pro-haemostatic agents (factors II, IX, and X followed by VII). One trial compared the use of different transfusion triggers using the international normalised ratio measurement. One trial compared the use of a thromboelastographic-guided transfusion trigger using standard laboratory measurements of coagulation.\nFour trials enrolled only adults, whereas the fifth trial did not specify participant age. Four trials included only minor procedures that could be performed by the bedside. Only one trial included some participants undergoing major surgical operations. Two trials included only participants in intensive care. Two trials included only participants with liver disease.\nThree trials did not recruit sufficient participants to meet their pre-calculated sample size. Overall, the quality of evidence was low to very low across different outcomes according to GRADE methodology, due to risk of bias, indirectness, and imprecision.\nOne trial was stopped after recruiting two participants, therefore this review's findings are based on the remaining four trials (234 participants).\nWhen plasma transfusion was compared with no transfusion given, we are very uncertain whether there was a difference in 30-day mortality (1 trial comparing FFP or platelet transfusion or both with neither FFP nor platelet transfusion, 72 participants; risk ratio (RR) 0.38, 95% confidence interval (CI) 0.13 to 1.10; very low-quality evidence).\nWe are very uncertain whether there was a difference in major bleeding within 24 hours (1 trial comparing FFP transfusion vs no transfusion, 76 participants; RR 0.33, 95% CI 0.01 to 7.93; very low-quality evidence; 1 trial comparing FFP or platelet transfusion or both with neither FFP nor platelet transfusion, 72 participants; RR 1.59, 95% CI 0.28 to 8.93; very low-quality evidence).\nWe are very uncertain whether there was a difference in the number of blood product transfusions per person (1 trial, 76 participants; study authors reported no difference; very low-quality evidence) or in the number of people requiring transfusion (1 trial comparing FFP or platelet transfusion or both with neither FFP nor platelet transfusion, 72 participants; study authors reported no blood transfusion given; very low-quality evidence) or in the risk of transfusion-related adverse events (acute lung injury) (1 trial, 76 participants; study authors reported no difference; very low-quality evidence).\nWhen plasma transfusion was compared with other pro-haemostatic agents, we are very uncertain whether there was a difference in major bleeding (1 trial; 21 participants; no events; very low-quality evidence) or in transfusion-related adverse events (febrile or allergic reactions) (1 trial, 21 participants; RR 9.82, 95% CI 0.59 to 162.24; very low-quality evidence).\nWhen different triggers for FFP transfusion were compared, the number of people requiring transfusion may have been reduced (for overall blood products) when a thromboelastographic-guided transfusion trigger was compared with standard laboratory tests (1 trial, 60 participants; RR 0.18, 95% CI 0.08 to 0.39; low-quality evidence). We are very uncertain whether there was a difference in major bleeding (1 trial, 60 participants; RR 0.33, 95% CI 0.01 to 7.87; very low-quality evidence) or in transfusion-related adverse events (allergic reactions) (1 trial; 60 participants; RR 0.33, 95% CI 0.01 to 7.87; very low-quality evidence).\nOnly one trial reported 30-day mortality. No trials reported procedure-related harmful events (excluding bleeding) or quality of life.\nAuthors' conclusions\nReview findings show uncertainty for the utility and safety of prophylactic FFP use. This is due to predominantly very low-quality evidence that is available for its use over a range of clinically important outcomes, together with lack of confidence in the wider applicability of study findings, given the paucity or absence of study data in settings such as major body cavity surgery, extensive soft tissue surgery, orthopaedic surgery, or neurosurgery. Therefore, from the limited RCT evidence, we can neither support nor oppose the use of prophylactic FFP in clinical practice.\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": "Human plasma is obtained from blood donors. It contains many factors that help blood to clot. Although plasma may be transfused to people based on blood tests suggesting that their blood may not clot adequately, these tests have limitations. A person's blood may clot adequately despite abnormal test results. Abnormal test results also do not clearly predict those people who will go on to bleed. Furthermore, plasma transfusion corrects abnormal blood tests to varying degrees.\nPlasma is also expensive, and some countries have issues with blood product shortages, donor reliability, and incomplete screening for infections that could be transmitted through blood product transfusion. Given the potential for life-threatening complications from plasma transfusion, its use in this setting carries risk of harm without clear evidence of benefit."
}
] |
query-laysum
|
23085
|
[
{
"role": "user",
"content": "Abstract: Background\nChagas disease-related cardiomyopathy is a major cause of morbidity and mortality in Latin America. Despite the substantial burden to the healthcare system, there is uncertainty regarding the efficacy and safety of pharmacological interventions for treating heart failure in people with Chagas disease. This is an update of a Cochrane review published in 2012.\nObjectives\nTo assess the clinical benefits and harms of current pharmacological interventions for treating heart failure in people with Chagas cardiomyopathy.\nSearch methods\nWe updated the searches in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 1), MEDLINE (Ovid; 1946 to to February Week 1 2016), EMBASE (Ovid; 1947 to 2016 Week 07), LILACS (1982 to 15 February 2016), and Web of Science (Thomson Reuters; 1970 to 15 February 2016). We checked the reference lists of included papers. We applied no language restrictions.\nSelection criteria\nWe included randomised clinical trials (RCTs) that assessed the effects of pharmacological interventions to treat heart failure in adult patients (18 years or older) with symptomatic heart failure (New York Heart Association classes II to IV), regardless of the left ventricular ejection fraction stage (reduced or preserved), with Chagas cardiomyopathy. We did not apply limits to the length of follow-up. Primary outcomes were all-cause mortality, cardiovascular mortality at 30 days, time-to-heart decompensation, disease-free period (at 30, 60, and 90 days), and adverse events.\nData collection and analysis\nTwo authors independently performed study selection, 'Risk of bias' assessment and data extraction. We estimated relative risk (RR) and 95% confidence intervals (CIs) for dichotomous outcomes. We measured statistical heterogeneity using the I² statistic. We used a fixed-effect model to synthesize the findings. We contacted authors for additional data. We developed 'Summary of findings' (SoF) tables and used GRADE methodology to assess the quality of the evidence.\nMain results\nIn this update, we identified one new trial. Therefore, this version includes three trials (108 participants). Two trials compared carvedilol against placebo and another assessed rosuvastatin versus placebo. All trials had a high risk of bias.\nMeta-analysis of two trials showed a lower proportion of all-cause mortality in the carvedilol groups compared with the placebo groups (RR 0.69; 95% CI 0.12 to 3.88, I² = 0%; 69 participants; very low-quality evidence). Neither of the trials reported on cardiovascular mortality, time-to-heart decompensation, or disease-free periods.\nOne trial (30 participants) found no difference in hospital readmissions (RR 1.00; 95% CI 0.31 to 3.28; very low-quality of evidence) or reported adverse events (RR 0.92; 95% CI 0.67 to 1.27; very low-quality of evidence) between the carvedilol and placebo groups.\nThere was very low-quality evidence from two trials of inconclusive effects on quality of life (QoL) between the carvedilol and placebo groups. One trial (30 participants) assessed QoL with the Minnesota Living With Heart Failure Questionnaire (21 items; item scores range from 0 to 5; a lower MLHFQ score is better). The MD was -14.74; 95% CI -24.75 to -4.73. The other trial (39 participants) measured QoL with the Medical Outcomes Study 36-item short-form health survey (SF-36; item scores range from 0 to 100; higher SF-36 score is better). Data were not provided.\nOne trial (39 participants) assessed the effect of rosuvastatin versus placebo. The trial did not report on any primary outcomes or adverse events. There was very low-quality evidence of uncertain effects on QoL (no data were provided).\nAuthors' conclusions\nThis first update of our review found very low-quality evidence for the effects of either carvedilol or rosuvastatin, compared with placebo, for treating heart failure in people with Chagas disease. The three included trials were underpowered and had a high risk of bias. There were no conclusive data to support or reject the use of either carvedilol or rosuvastatin for treating Chagas cardiomyopathy. Unless randomised clinical trials provide evidence of a treatment effect, and the trade-off between potential benefits and harms is established, policy-makers, clinicians, and academics should be cautious when recommending or administering either carvedilol or rosuvastatin to treat heart failure in people with Chagas disease. The efficacy and safety of other pharmacological interventions for treating heart failure in people with Chagas disease remains unknown.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our confidence in the results of this review is very low because the included trials had a high risk of bias and were small. which generated imprecise results."
}
] |
query-laysum
|
23086
|
[
{
"role": "user",
"content": "Abstract: Background\nAs many as one in six couples will encounter problems with fertility, defined as failure to achieve a clinical pregnancy after regular intercourse for 12 months. Increasingly, couples are turning to assisted reproductive technology (ART) for help with conceiving and ultimately giving birth to a healthy live baby of their own. Fertility treatments are complex, and each ART cycle consists of several steps. If one of these steps is incorrectly applied, the stakes are high as conception may not occur. With this in mind, it is important that each step of the ART cycle is supported by good evidence from well-designed studies.\nObjectives\nTo summarise the evidence from Cochrane systematic reviews on procedures and treatment options available to couples with subfertility undergoing assisted reproductive technology (ART) procedures.\nMethods\nPublished Cochrane systematic reviews of couples undergoing ART procedures (in vitro fertilisation or intracytoplasmic sperm injection) were eligible for inclusion in the overview. We also identified Cochrane reviews in preparation, for future inclusion.\nThe primary outcome of the overview was live birth or the composite outcome live birth or ongoing pregnancy, as reported by the included reviews. Our secondary outcomes were clinical pregnancy, multiple pregnancy, miscarriage, and ovarian hyperstimulation syndrome. We excluded studies of intrauterine insemination and ovulation induction.\nWe undertook selection of systematic reviews, data extraction, and quality assessment in duplicate. We assessed review quality by using the AMSTAR tool. We organised reviews by their relevance to specific stages in the ART cycle. We summarised their findings in the text and reported data for each outcome in 'Additional tables'.\nMain results\nWe included 68 systematic reviews published in the Cochrane Library up to May 2018. All were of high quality. These reviews identified 38 interventions that were effective (n = 23) or promising (n = 15), and they identified 19 interventions that were ineffective (n = 2) or possibly ineffective (n = 17). For 15 interventions, review authors were unable to draw conclusions owing to lack of evidence.\nWe identified an additional 11 protocols and four titles for future inclusion in this overview.\nAuthors' conclusions\nThis overview provides the most up-to-date evidence on ART cycles from systematic reviews of randomised controlled trials. Fertility treatments are costly, and the stakes are high. Using the best available evidence to optimise outcomes is best practice. Evidence from this overview could be used to develop clinical practice guidelines and protocols that can be applied in daily clinical practice to improve live birth rates and reduce rates of multiple pregnancy, cycle cancellation, and ovarian hyperstimulation syndrome.\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": "All included reviews were of high quality. The quality of the evidence for specific comparisons ranged from very low to high."
}
] |
query-laysum
|
23087
|
[
{
"role": "user",
"content": "Abstract: Background\nCerebral palsy (CP) is a heterogeneous group of non-progressive disorders of posture or movement, caused by a lesion of the developing brain. Osteoporosis is common in children with cerebral palsy, particularly in children with reduced gross motor function, and leads to an increased risk of fractures. Gross motor function in children with CP can be categorised using a tool called the Gross Motor Function Classification System (GMFCS). Bisphosphonate increases bone mineral density (BMD) and reduces fracture rates. Bisphosphonate is used widely in the treatment of adult osteoporosis. However, the use of bisphosphonate in children with CP remains controversial, due to a paucity of evidence and a lack of recent trials examining the efficacy and safety of bisphosphonate use in this population.\nObjectives\nTo examine the efficacy and safety of bisphosphonate therapy in the treatment of low BMD or secondary osteoporosis (or both) in children with cerebral palsy (GMFCS Levels III to V) who are under 18 years of age.\nSearch methods\nIn September 2020, we searched CENTRAL, MEDLINE, Embase, six other databases, and two trial registers for relevant studies. We also searched the reference lists of relevant systematic reviews, trials, and case studies identified by the search, and contacted the authors of relevant studies in an attempt to identify unpublished literature.\nSelection criteria\nAll relevant randomised controlled trials (RCTs), and quasi-RCTs, comparing at least one bisphosphonate (given at any dose, orally or intravenously) with placebo or no drug, for the treatment of low BMD or osteoporosis in children up to 18 years old, with cerebral palsy (GMFCS Levels III to V).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We were unable to conduct any meta-analyses due to insufficient data, and therefore provide a narrative assessment of the results.\nMain results\nWe found two relevant RCTs (34 participants). Both studies included participants with non-ambulatory CP or CP and osteoporosis. Participants in both studies were similar in severity of CP, age distribution, and sex distribution. The two trials used different bisphosphonate medications and different intervention durations, but further comparison of the interventions was not possible due to a lack of published data from one trial.\nOne trial received funding and support from research, academic, and hospital foundations, with pharmaceutical companies providing components of the calcium and vitamin supplement; the other trial did not report sources of funding. We judged one study at an overall high risk of bias; the other as overall unclear risk of bias.\nPrimary outcome. Compared to placebo or no treatment, both studies provided very low certainty evidence of improved BMD at least four months post-intervention in children treated with bisphosphonate. Only one study (12 participants) provided sufficient detail to assess a measure of the effect, and reported an improvement at six months post-intervention in lumbar spine z-score (mean difference (MD) 18%, 95% confidence interval (CI) 6.57 to 29.43; very low certainty evidence).\nSecondary outcomes. Very low certainty evidence from one study found that bisphosphonate reduced serum N-telopeptides (NTX) more than placebo; the other study reported that both bisphosphonate plus alfacalcidol and alfacalcidol alone reduced NTX, but did not compare groups.\nOne study reported inconclusive results between groups for serum bone-specific alkaline phosphatase (BAP). The other study reported that both bisphosphonate plus alfacalcidol and alfacalcidol alone reduced BAP, but did not compare groups.\nNeither study reported data for the effect of bisphosphonate treatment on changes in volumetric BMD in the distal radius or tibia, changes in fracture frequency, bone pain, or quality of life. One study reported that two participants had febrile events noted during their first dosing schedule, but no further adverse events were reported in either relevant study.\nAuthors' conclusions\nBased on the available evidence, there is very low certainty evidence that bisphosphonate treatment may improve bone health in children with cerebral palsy. We could only include one study with 14 participants in the assessment of the effect size; therefore, the precision of the effect estimate is low. We could only evaluate one planned primary outcome, as there was insufficient detail reported in the relevant studies.\nFurther research from RCTs on the effect and safety of bisphosphonate to improve bone health in children with cerebral palsy is required. These studies should clarify the optimal standard treatment regarding weight-bearing exercises, vitamin D and calcium supplementation, and should include fracture frequency as a primary outcome.\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": "First, what is the effect of bisphosphonate treatment compared to placebo (dummy pill) or no treatment on different measures of bone strength in children up to 18 years with CP? Measures include blood markers of bone health, fracture frequency, bone pain, and quality of life.\nSecond, are there any negative side effects?"
}
] |
query-laysum
|
23088
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-malignant dust-related respiratory diseases, such as asbestosis and silicosis, are similar to other chronic respiratory diseases and may be characterised by breathlessness, reduced exercise capacity and reduced health-related quality of life. Some non-malignant dust-related respiratory diseases are a global health issue and very few treatment options, including pharmacological, are available. Therefore, examining the role of exercise training is particularly important to determine whether exercise training is an effective treatment option in non-malignant dust-related respiratory diseases.\nObjectives\nTo assess the effects of exercise training for people with non-malignant dust-related respiratory diseases compared with control, placebo or another non-exercise intervention on exercise capacity, health-related quality of life and levels of physical activity.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, EMBASE, CINAHL, PEDro and AMED (all searched from inception until February 2015), national and international clinical trial registries, reference lists of relevant papers and we contacted experts in the field for identification of suitable studies.\nSelection criteria\nWe included only randomised controlled trials (RCTs) that compared exercise training of at least four weeks duration with no exercise training, placebo or another non-exercise intervention.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently assessed study eligibility and risk of bias, and extracted data. We employed the GRADE approach to assess the overall quality of evidence for each outcome and to interpret findings. We synthesized study results using a random-effects model based on the assessment of heterogeneity. We conducted subgroup analyses on participants with dust-related interstitial lung diseases (ILDs) and participants with asbestos related pleural disease (ARPD).\nMain results\nTwo RCTs including a combined total of 40 participants (35 from one study and five from a second study) met the inclusion criteria. Twenty-one participants were randomised to the exercise training group and 19 participants were randomised to the control group. The included studies evaluated the effects of exercise training compared to a control group of no exercise training in people with dust-related ILDs and ARPD. The exercise training programme in both studies was in an outpatient setting for an eight-week period. The risk of bias was low in both studies. There were no reported adverse events of exercise training. Following exercise training, six-minute walk distance (6MWD) increased with a mean difference (MD) of 53.81 metres (m) (95% CI 34.36 to 73.26 m). Improvements were also seen in the domains of health-related quality of life: Chronic Respiratory Disease Questionnaire (CRQ) Dyspnoea domain (MD 2.58, 95% CI 0.72 to 4.44); CRQ Fatigue domain (MD 1.00, 95% CI 0.11 to 1.89); CRQ Emotional Function domain (MD 2.61, 95% CI 0.74 to 4.49); and CRQ Mastery domain (MD 1.51, 95% CI 0.29 to 2.72). Improvements in exercise capacity and health-related quality of life were also evident six months following the intervention period: 6MWD (MD 52.68 m, 95% CI 27.43 to 77.93 m); CRQ Dyspnoea domain (MD 3.03, 95% CI 1.41 to 4.66); CRQ Emotional Function domain (MD 5.57, 95% CI 2.34 to 8.81); and CRQ Mastery domain (MD 2.66, 95% CI 1.08 to 4.23). Exercise training did not result in improvements in the Modified Medical Research Council (MMRC) dyspnoea scale immediately following exercise training or six months following exercise training. The improvements following exercise training were similar in a subgroup of participants with dust-related ILDs and in a subgroup of participants with ARPD compared to the control group, with no statistically significant differences in treatment effects between the subgroups.\nAuthors' conclusions\nThe evidence examining exercise training in people with non-malignant dust-related respiratory diseases is of very low quality. This is due to imprecision in the results from the small number of trials and the small number of participants, the indirectness of evidence due to a paucity of information on disease severity and the data from one study being from a subgroup of participants, and inconsistency from high heterogeneity in some results. Therefore, although the review findings indicate that an exercise training programme is effective in improving exercise capacity and health-related quality of life in the short-term and at six months follow-up, we remain unsure of these findings due to the very low quality evidence. Larger, high quality trials are needed to determine the strength of these findings.\n\nGiven the provided abstract, please respond to the following query: \"Research question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Exposure to harmful dusts or particles (such as asbestos), which may occur at work or outside of the work setting, can lead to respiratory diseases. These are called dust-related respiratory diseases and include diseases such as asbestosis. People with dust-related respiratory diseases may experience decreases in exercise capacity and quality of life. Therefore the research question for this review was: does exercise training improve exercise capacity and quality of life in people with dust-related respiratory diseases?"
}
] |
query-laysum
|
23089
|
[
{
"role": "user",
"content": "Abstract: Background\nInfants born preterm are at increased risk of early hypernatraemia (above-normal blood sodium levels) and late hyponatraemia (below-normal blood sodium levels). There are concerns that imbalances of sodium intake may impact neonatal morbidities, growth and developmental outcomes.\nObjectives\nTo determine the effects of higher versus lower sodium supplementation in preterm infants.\nSearch methods\nWe searched CENTRAL in February 2023; and MEDLINE, Embase and trials registries in March and April 2022. We checked reference lists of included studies and systematic reviews where subject matter related to the intervention or population examined in this review. We compared early (< 7 days following birth), late (≥ 7 days following birth), and early and late sodium supplementation, separately.\nSelection criteria\nWe included randomised, quasi-randomised or cluster-randomised controlled trials that compared nutritional supplementation that included higher versus lower sodium supplementation in parenteral or enteral intake, or both. Eligible participants were preterm infants born before 37 weeks' gestational age or with a birth weight less than 2500 grams, or both. We excluded studies that had prespecified differential water intakes between groups.\nData collection and analysis\nTwo review authors independently assessed eligibility and risk of bias, and extracted data. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included nine studies in total. However, we were unable to extract data from one study (20 infants); some studies contributed to more than one comparison. Eight studies (241 infants) were available for quantitative meta-analysis. Four studies (103 infants) compared early higher versus lower sodium intake, and four studies (138 infants) compared late higher versus lower sodium intake. Two studies (103 infants) compared intermediate sodium supplementation (≥ 3 mmol/kg/day to < 5 mmol/kg/day) versus no supplementation, and two studies (52 infants) compared higher sodium supplementation (≥ 5 mmol/kg/day) versus no supplementation. We assessed only two studies (63 infants) as low risk of bias.\nEarly (less than seven days following birth) higher versus lower sodium intake\nEarly higher versus lower sodium intake may not affect mortality (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.38 to 2.72; I2 = 0%; 3 studies, 83 infants; low-certainty evidence). Neurodevelopmental follow-up was not reported. Early higher versus lower sodium intake may lead to a similar incidence of hyponatraemia < 130 mmol/L (RR 0.68, 95% CI 0.40 to 1.13; I2 = 0%; 3 studies, 83 infants; low-certainty evidence) but an increased incidence of hypernatraemia ≥ 150 mmol/L (RR 1.62, 95% CI 1.00 to 2.65; I2 = 0%; 4 studies, 103 infants; risk difference (RD) 0.17, 95% CI 0.01 to 0.34; number needed to treat for an additional harmful outcome 6, 95% CI 3 to 100; low-certainty evidence). Postnatal growth failure was not reported. The evidence is uncertain for an effect on necrotising enterocolitis (RR 4.60, 95% CI 0.23 to 90.84; 1 study, 46 infants; very low-certainty evidence). Chronic lung disease at 36 weeks was not reported.\nLate (seven days or more following birth) higher versus lower sodium intake\nLate higher versus lower sodium intake may not affect mortality (RR 0.13, 95% CI 0.01 to 2.20; 1 study, 49 infants; very low-certainty evidence). Neurodevelopmental follow-up was not reported. Late higher versus lower sodium intake may reduce the incidence of hyponatraemia < 130 mmol/L (RR 0.13, 95% CI 0.03 to 0.50; I2 = 0%; 2 studies, 69 infants; RD −0.42, 95% CI −0.59 to −0.24; number needed to treat for an additional beneficial outcome 2, 95% CI 2 to 4; low-certainty evidence). The evidence is uncertain for an effect on hypernatraemia ≥ 150 mmol/L (RR 7.88, 95% CI 0.43 to 144.81; I2 = 0%; 2 studies, 69 infants; very low-certainty evidence). A single small study reported that later higher versus lower sodium intake may reduce the incidence of postnatal growth failure (RR 0.25, 95% CI 0.09 to 0.69; 1 study; 29 infants; low-certainty evidence). The evidence is uncertain for an effect on necrotising enterocolitis (RR 0.07, 95% CI 0.00 to 1.25; 1 study, 49 infants; very low-certainty evidence) and chronic lung disease (RR 2.03, 95% CI 0.80 to 5.20; 1 study, 49 infants; very low-certainty evidence).\nEarly and late (day 1 to 28 after birth) higher versus lower sodium intake for preterm infants\nEarly and late higher versus lower sodium intake may not have an effect on hypernatraemia ≥ 150 mmol/L (RR 2.50, 95% CI 0.63 to 10.00; 1 study, 20 infants; very low-certainty evidence). No other outcomes were reported.\nAuthors' conclusions\nEarly (< 7 days following birth) higher sodium supplementation may result in an increased incidence of hypernatraemia and may result in a similar incidence of hyponatraemia compared to lower supplementation. We are uncertain if there are any effects on mortality or neonatal morbidity. Growth and longer-term development outcomes were largely unreported in trials of early sodium supplementation.\nLate (≥ 7 days following birth) higher sodium supplementation may reduce the incidence of hyponatraemia. We are uncertain if late higher intake affects the incidence of hypernatraemia compared to lower supplementation. Late higher sodium intake may reduce postnatal growth failure. We are uncertain if late higher sodium intake affects mortality, other neonatal morbidities or longer-term development.\nWe are uncertain if early and late higher versus lower sodium supplementation affects outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What is high sodium?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Babies born very preterm (before 32 weeks' gestation) are at increased risk of high blood sodium (salt) levels (150 mmol/L or higher) in the first days (early hypernatraemia). Much of this is due to high water losses through the skin."
}
] |
query-laysum
|
23090
|
[
{
"role": "user",
"content": "Abstract: Background\nPulmonary embolism (PE) is a potentially life-threatening condition in which a clot can migrate from the deep veins, most commonly in the leg, to the lungs. Conventional treatment of PE used unfractionated heparin (UFH), low molecular weight heparin (LMWH), fondaparinux, and vitamin K antagonists (VKAs). Recently, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors. DOACs have characteristics that may be favourable to conventional treatment, including oral administration, a predictable effect, no need for frequent monitoring or re-dosing, and few known drug interactions. This review reports the efficacy and safety of these drugs in the long-term treatment of PE (minimum duration of three months). This is an update of a Cochrane Review first published in 2015.\nObjectives\nTo assess the efficacy and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of PE.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials registers to 2 March 2022. We checked the reference lists of relevant articles for additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which people with a PE confirmed by standard imaging techniques were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with a conventional anticoagulant or compared with each other for the long-term treatment of PE (minimum duration three months).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent PE, recurrent venous thromboembolism (VTE), and deep vein thrombosis (DVT). Secondary outcomes were all-cause mortality, major bleeding, and health-related quality of life. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified five additional RCTs with 1484 participants for this update. Together with the previously included trials, we have included ten RCTs with a total of 13,073 participants. Two studies investigated an oral DTI (dabigatran) and eight studies investigated oral factor Xa inhibitors (three rivaroxaban, three apixaban, and two edoxaban). The studies were of good methodological quality overall.\nMeta-analysis showed no clear difference in the efficacy and safety of oral DTI compared with conventional anticoagulation in preventing recurrent PE (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.50 to 2.04; 2 studies, 1602 participants; moderate-certainty evidence), recurrent VTE (OR 0.93, 95% CI 0.52 to 1.66; 2 studies, 1602 participants; moderate-certainty evidence), DVT (OR 0.79, 95% CI 0.29 to 2.13; 2 studies, 1602 participants; moderate-certainty evidence), and major bleeding (OR 0.50, 95% CI 0.15 to 1.68; 2 studies, 1527 participants; moderate-certainty evidence). We downgraded the certainty of evidence by one level for imprecision due to the low number of events.\nThere was also no clear difference between the oral factor Xa inhibitors and conventional anticoagulation in the prevention of recurrent PE (OR 0.92, 95% CI 0.66 to 1.29; 3 studies, 8186 participants; moderate-certainty evidence), recurrent VTE (OR 0.83, 95% CI 0.66 to 1.03; 8 studies, 11,416 participants; moderate-certainty evidence), DVT (OR 0.77, 95% CI 0.48 to 1.25; 2 studies, 8151 participants; moderate-certainty evidence), all-cause mortality (OR 1.16, 95% CI 0.79 to 1.70; 1 study, 4817 participants; moderate-certainty evidence) and major bleeding (OR 0.71, 95% CI 0.36 to 1.41; 8 studies, 11,447 participants; low-certainty evidence); the heterogeneity for major bleeding was significant (I2 = 79%). We downgraded the certainty of the evidence to moderate and low because of imprecision due to the low number of events and inconsistency due to clinical heterogeneity. None of the included studies measured health-related quality of life.\nAuthors' conclusions\nAvailable evidence shows there is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent PE, recurrent VTE, DVT, all-cause mortality, and major bleeding. The certainty of evidence was moderate or low. Future large clinical trials are required to identify if individual drugs differ in effectiveness and bleeding risk, and to explore effect differences in subgroups, including people with cancer and obesity.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "After searching for relevant studies, we included 10 studies with a combined total of 13,073 participants. Studies compared oral DTIs and factor Xa inhibitors with conventional anticoagulation. We combined the data from the studies and found that there was no clear difference in the incidence of:\n- recurrent pulmonary embolism;\n- recurrent deep vein thrombosis (DVT: when a blood clot forms, usually in a deep vein of the leg or pelvis);\n- recurrent venous thromboembolism (when DVT and pulmonary embolism occur together);\n- death; \n- major bleeding\nThis review showed that there was no clear difference between the direct oral anticoagulants and conventional treatment in preventing recurrent PE, recurrent VTE, DVT, mortality, and major bleeding. No study measured health-related quality of life."
}
] |
query-laysum
|
23091
|
[
{
"role": "user",
"content": "Abstract: Background\nMoxibustion, a common treatment in traditional Chinese medicine, involves burning herbal preparations containing Artemisia vulgaris on or above the skin at acupuncture points. Its intended effect is to enhance body function, and it could reduce the side effects of chemotherapy or radiotherapy and improve quality of life (QoL) in people with cancer.\nObjectives\nTo assess the effects of moxibustion for alleviating side effects associated with chemotherapy, radiotherapy or both in people with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE via Ovid, Embase via Ovid and AMED (Allied and Complementary Medicine Database) from their inception to February 2018. We also searched databases in China including the Chinese BioMedical Literature Database (CBM), Chinese Medical Current Contents (CMCC), TCMonline, Chinese Dissertation Database (CDDB), China Medical Academic Conference (CMAC) and Index to Chinese Periodical Literature from inception to August 2017. Registries for clinical trials and other resources were also searched.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing moxibustion treatment, including moxa cone and moxa stick, versus sham, no treatment or conventional treatment.\nData collection and analysis\nTwo review authors (HWZ and FC) independently extracted data on study design, participants, treatment and control intervention, and outcome measures, and they also assessed risk of bias in the included studies. We performed meta-analyses, expressing dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean differences (MD), with 95% confidence intervals (CI).\nMain results\nWe included 29 RCTs involving 2569 participants. Five RCTs compared moxibustion versus no treatment, 15 compared moxibustion plus conventional treatment versus conventional treatment, one compared moxibustion versus sham moxibustion, and eight compared moxibustion versus conventional medicine. The overall risk of bias was high in 18 studies and unclear in 11 studies. Studies measured outcomes in various ways, and we could rarely pool data.\nMoxibustion versus no treatment: low-certainty evidence from single small studies suggested that moxibustion was associated with higher white blood cell counts (MD 1.77 × 109/L; 95% CI 0.76 to 2.78; 80 participants, low-certainty evidence) and higher serum haemoglobin concentrations (MD 1.33 g/L; 95% CI 0.59 to 2.07; 66 participants, low-certainty evidence) in people with cancer, during or after chemotherapy/radiotherapy, compared with no treatment. There was no evidence of an effect on leukopenia (RR 0.50, 95% CI 0.10 to 2.56; 72 participants, low-certainty evidence) between study groups. The effects on immune function (CD3, CD4, and CD8 counts) were inconsistent.\nMoxibustion versus sham moxibustion: low-certainty evidence from one study (50 participants) suggested that moxibustion improved QoL (measured as the score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)) compared with sham treatment (MD 14.88 points; 95% CI 4.83 to 24.93). Low-certainty evidence from this study also showed reductions in symptom scores for nausea and vomiting (MD −38.57 points, 95% CI −48.67 to −28.47) and diarrhoea (MD −13.81, 95% CI −27.52 to −0.10), and higher mean white blood cell count (MD 1.72 × 109/L, 95% CI 0.97 to 2.47), serum haemoglobin (MD 2.06 g/L, 95% CI 1.26 to 2.86) and platelets (MD 210.79 × 109/L, 95% CI 167.02 to 254.56) when compared with sham moxibustion.\nMoxibustion versus conventional medicines: low-certainty evidence from one study (90 participants) suggested that moxibustion improved WBC count eight days after treatment ended compared with conventional medicines (MD 0.40 × 109/L; 95% CI 0.15 to 0.65). Low-certainty evidence from two studies (235 participants) suggested moxibustion improved serum haemoglobin concentrations compared with conventional medicines (MD 10.28 g/L; 95% CI 4.51 to 16.05).\nMoxibustion plus conventional treatment versus conventional treatment alone: low-certainty evidence showed that moxibustion plus conventional treatment was associated with lower incidence and severity of leukopenia (WHO grade 3 to 4) (RR 0.14, 95% CI 0.01 to 2.64; 1 study, 56 participants), higher QoL scores on the EORTC QLQ-C30 (MD 8.85 points, 95% CI 4.25 to 13.46; 3 studies, 134 participants, I² = 26%), lower symptom scores for nausea and vomiting (RR 0.43, 95% CI 0.25 to 0.74; 7 studies, 801participants; I² = 19%), higher white blood cell counts (data not pooled due to heterogeneity), higher serum haemoglobin (MD 3.97 g/L, 95% CI 1.40 to 6.53; 2 studies, 142 participants, I² = 0%). There was no difference in platelet counts between the two groups (MD 13.48 × 109/L; 95% CI −16.00 to 42.95; 2 studies, 142 participants; I² = 34%).\nMost included studies did not report related adverse events, such as burning or allergic reactions.\nAuthors' conclusions\nLimited, low-certainty evidence suggests that moxibustion treatment may help to reduce the haematological and gastrointestinal toxicities of chemotherapy or radiotherapy, improving QoL in people with cancer; however, the evidence is not conclusive, and we cannot rule out benefits or risks with this treatment. High-quality studies that report adverse effects are needed.\n\nGiven the provided abstract, please respond to the following query: \"What are the conclusions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is presently no good evidence to support or oppose the use of moxibustion in people receiving treatment for cancer. High-quality studies are needed, which should include reporting of adverse effects."
}
] |
query-laysum
|
23092
|
[
{
"role": "user",
"content": "Abstract: Background\nAnxiety frequently coexists with depression and adding benzodiazepines to antidepressant treatment is common practice to treat people with major depression. However, more evidence is needed to determine whether this combined treatment is more effective and not any more harmful than antidepressants alone. It has been suggested that benzodiazepines may lose their efficacy with long-term administration and their chronic use carries risks of dependence.\nThis is the 2019 updated version of a Cochrane Review first published in 2001, and previously updated in 2005. This update follows a new protocol to conform with the most recent Cochrane methodology guidelines, with the inclusion of 'Summary of findings' tables and GRADE evaluations for quality of evidence.\nObjectives\nTo assess the effects of combining antidepressants with benzodiazepines compared with antidepressants alone for major depression in adults.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Group's Controlled Trials Register (CCMDCTR), the Cochrane Central Register of Controlled Trials, MEDLINE, Embase and PsycINFO to May 2019. We searched the World Health Organization (WHO) trials portal and ClinicalTrials.gov to identify any additional unpublished or ongoing studies.\nSelection criteria\nAll randomised controlled trials that compared combined antidepressant plus benzodiazepine treatment with antidepressants alone for adults with major depression. We excluded studies administering psychosocial therapies targeted at depression and anxiety disorders concurrently. Antidepressants had to be prescribed, on average, at or above the minimum effective dose as presented by Hansen 2009 or according to the North American or European regulations. The combination therapy had to last at least four weeks.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias in the included studies, according to the criteria of the Cochrane Handbook for Systematic Reviews of Interventions. We entered data into Review Manager 5. We used intention-to-treat data. We combined continuous outcome variables of depressive and anxiety severity using standardised mean differences (SMD) with 95% confidence intervals (CIs). For dichotomous efficacy outcomes, we calculated the risk ratio (RR) with 95% CI. Regarding the primary outcome of acceptability, only overall dropout rates were available for all studies.\nMain results\nWe identified 10 studies published between 1978 to 2002 involving 731 participants. Six studies used tricyclic antidepressants (TCAs), two studies used selective serotonin reuptake inhibitors (SSRIs), one study used another heterocyclic antidepressant and one study used TCA or heterocyclic antidepressant.\nCombined therapy of benzodiazepines plus antidepressants was more effective than antidepressants alone for depressive severity in the early phase (four weeks) (SMD –0.25, 95% CI –0.46 to –0.03; 10 studies, 598 participants; moderate-quality evidence), but there was no difference between treatments in the acute phase (five to 12 weeks) (SMD –0.18, 95% CI –0.40 to 0.03; 7 studies, 347 participants; low-quality evidence) or in the continuous phase (more than 12 weeks) (SMD –0.21, 95% CI –0.76 to 0.35; 1 study, 50 participants; low-quality evidence). For acceptability of treatment, there was no difference in the dropouts due to any reason between combined therapy and antidepressants alone (RR 0.76, 95% CI 0.54 to 1.07; 10 studies, 731 participants; moderate-quality evidence).\nFor response in depression, combined therapy was more effective than antidepressants alone in the early phase (RR 1.34, 95% CI 1.13 to 1.58; 10 studies, 731 participants), but there was no evidence of a difference in the acute phase (RR 1.12, 95% CI 0.93 to 1.35; 7 studies, 383 participants) or in the continuous phase (RR 0.97, 95% CI 0.73 to 1.29; 1 study, 52 participants). For remission in depression, combined therapy was more effective than antidepressants alone in the early phase (RR 1.39, 95% CI 1.03 to 1.90, 10 studies, 731 participants), but there was no evidence of a difference in the acute phase (RR 1.27, 95% CI 0.99 to 1.63; 7 studies, 383 participants) or in the continuous phase (RR 1.31, 95% CI 0.80 to 2.16; 1 study, 52 participants). There was no evidence of a difference between combined therapy and antidepressants alone for anxiety severity in the early phase (SMD –0.76, 95% CI –1.67 to 0.14; 3 studies, 129 participants) or in the acute phase (SMD –0.48, 95% CI –1.06 to 0.10; 3 studies, 129 participants). No studies measured severity of insomnia. In terms of adverse effects, the dropout rates due to adverse events were lower for combined therapy than for antidepressants alone (RR 0.54, 95% CI 0.32 to 0.90; 10 studies, 731 participants; moderate-quality evidence). However, participants in the combined therapy group reported at least one adverse effect more often than participants who received antidepressants alone (RR 1.12, 95% CI 1.01 to 1.23; 7 studies, 510 participants; moderate-quality evidence).\nMost domains of risk of bias in the majority of the included studies were unclear. Random sequence generation, allocation concealment, blinding and selective outcome reporting were problematic due to insufficient details reported in most of the included studies and lack of availability of the study protocols. The greatest limitation in the quality of evidence was issues with attrition.\nAuthors' conclusions\nCombined antidepressant plus benzodiazepine therapy was more effective than antidepressants alone in improving depression severity, response in depression and remission in depression in the early phase. However, these effects were not maintained in the acute or the continuous phase. Combined therapy resulted in fewer dropouts due to adverse events than antidepressants alone, but combined therapy was associated with a greater proportion of participants reporting at least one adverse effect.\nThe moderate quality evidence of benefits of adding a benzodiazepine to an antidepressant in the early phase must be balanced judiciously against possible harms and consideration given to other alternative treatment strategies when antidepressant monotherapy may be considered inadequate. We need long-term, pragmatic randomised controlled trials to compare combination therapy against the monotherapy of antidepressant in major depression.\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": "Due to the potential for people to become dependent on benzodiazepines, new longer-term studies need to compare what happens when the combined treatment involves withdrawing the benzodiazepine after a short period (for example, one month)."
}
] |
query-laysum
|
23093
|
[
{
"role": "user",
"content": "Abstract: Background\nThis review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.\nChronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Nasal saline irrigation is commonly used to improve patient symptoms.\nObjectives\nTo evaluate the effects of saline irrigation in patients with chronic rhinosinusitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 9); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 30 October 2015.\nSelection criteria\nRandomised controlled trials (RCTs) with a follow-up period of at least three months comparing saline delivered to the nose by any means (douche, irrigation, drops, spray or nebuliser) with (a) placebo, (b) no treatment or (c) other pharmacological interventions.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation and discomfort. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included two RCTs (116 adult participants). One compared large-volume (150 ml) hypertonic (2%) saline irrigation with usual treatment over a six-month period; the other compared 5 ml nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later.\nLarge-volume, hypertonic nasal saline versus usual care\nOne trial included 76 adult participants (52 intervention, 24 control) with or without polyps.Disease-specific HRQL was reported using the Rhinosinusitis Disability Index (RSDI; 0 to 100, 100 = best quality of life). At the end of three months of treatment, patients in the saline group were better than those in the placebo group (mean difference (MD) 6.3 points, 95% confidence interval (CI) 0.89 to 11.71) and at six months there was a greater effect (MD 13.5 points, 95% CI 9.63 to 17.37). We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up.\nPatient-reported disease severity was evaluated using a \"single-item sinus symptom severity assessment\" but the range of scores is not stated, making it impossible for us to determine the meaning of the data presented.\nNo adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including epistaxis.\nGeneral HRQL was measured using SF-12 (0 to 100, 100 = best quality of life). No difference was found after three months of treatment (low quality evidence) but at six months there was a small difference favouring the saline group, which may not be of clinical significance and has high uncertainty (MD 10.5 points, 95% CI 0.66 to 20.34) (very low quality evidence).\nLow-volume, nebulised saline versus intranasal corticosteroids\nOne trial included 40 adult participants with polyps. Our primary outcome of disease-specific HRQL was not reported. At the end of treatment (three months) the patients who had intranasal corticosteroids had less severe symptoms (MD -13.50, 95% CI -14.44 to -12.56); this corresponds to a large effect size. We assessed the evidence to be of very low quality.\nAuthors' conclusions\nThe two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there is no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids. There is some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution when compared with placebo, but the quality of the evidence is low for three months and very low for six months of treatment.\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 two randomised controlled trials with a total of 116 adult participants in this review. One compared large-volume (150 ml) hypertonic saline irrigation with usual treatment over a six-month period. The other compared 5 ml of nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Both of these studies had important limitations in their methodology and we considered them to have a high risk of bias."
}
] |
query-laysum
|
23094
|
[
{
"role": "user",
"content": "Abstract: Background\nMorbidity in patients with chronic heart failure is high, and this predisposes them to thrombotic complications, including stroke and thromboembolism, which in turn contribute to high mortality. Oral anticoagulants (e.g. warfarin) and antiplatelet agents (e.g. aspirin) are the principle oral antithrombotic agents. Many heart failure patients with sinus rhythm take aspirin because coronary artery disease is the leading cause of heart failure. Oral anticoagulants have become a standard in the management of heart failure with atrial fibrillation. However, a question remains regarding the appropriateness of oral anticoagulants in heart failure with sinus rhythm. This update of a review previously published in 2012 aims to address this question.\nObjectives\nTo assess the effects of oral anticoagulant therapy versus antiplatelet agents for all-cause mortality, non-fatal cardiovascular events and risk of major bleeding in adults with heart failure (either with reduced or preserved ejection fraction) who are in sinus rhythm.\nSearch methods\nWe updated the searches in September 2015 on CENTRAL (The Cochrane Library), MEDLINE and Embase. We searched reference lists of papers and abstracts from cardiology meetings and contacted study authors for further information. We did not apply any language restrictions. Additionally, we searched two clinical trials registers: ClinicalTrials.gov (www.ClinicalTrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal apps.who.int/trialsearch/) (searched in July 2016).\nSelection criteria\nWe included randomised controlled trials comparing antiplatelet therapy versus oral anticoagulation in adults with chronic heart failure in sinus rhythm. Treatment had to last at least one month. We compared orally administered antiplatelet agents (aspirin, ticlopidine, clopidogrel, prasugrel, ticagrelor, dipyridamole) versus anticoagulant agents (coumarins, warfarin, non-vitamin K oral anticoagulants).\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and assessed the risks and benefits of antithrombotic versus antiplatelet therapy using relative measures of effects, such as risk ratios (RR), accompanied with 95% confidence intervals (CI). The data extracted included data relating to the study design, patient characteristics, study eligibility, quality, and outcomes. We used GRADE criteria to assess the quality of the evidence.\nMain results\nThis update identified one additional study for inclusion, adding data for 2305 participants. This addition more than doubled the overall number of patients eligible for the review. In total, we included four randomised controlled trials (RCTs) with a total of 4187 eligible participants. All studies compared warfarin with aspirin. One RCT additionally compared warfarin with clopidogrel. All included RCTs studied patients with heart failure with reduced ejection fraction.\nAnalysis of all outcomes for warfarin versus aspirin was based on 3663 patients from four RCTs. All-cause mortality was similar for warfarin and aspirin (RR 1.00, 95% CI 0.89 to 1.13; 4 studies; 3663 participants; moderate quality evidence). Oral anticoagulation was associated with a reduction in non-fatal cardiovascular events, which included non-fatal stroke, myocardial infarction, pulmonary embolism, peripheral arterial embolism (RR 0.79, 95% CI 0.63 to 1.00; 4 studies; 3663 participants; moderate quality evidence). The rate of major bleeding events was twice as high in the warfarin groups (RR 2.00, 95% CI 1.44 to 2.78; 4 studies; 3663 participants; moderate quality evidence). We generally considered the risk of bias of the included studies to be low.\nAnalysis of warfarin versus clopidogrel was based on a single RCT (N = 1064). All-cause mortality was similar for warfarin and clopidogrel (RR 0.93, 95% CI 0.72 to 1.21; 1 study; 1064 participants; low quality evidence). There were similar rates of non-fatal cardiovascular events (RR 0.85, 95% CI 0.50 to 1.45; 1 study; 1064 participants; low quality evidence). The rate of major bleeding events was 2.5 times higher in the warfarin group (RR 2.47, 95% CI 1.24 to 4.91; 1 study; 1064 participants; low quality evidence). Risk of bias for this study can be summarised as low.\nAuthors' conclusions\nThere is evidence from RCTs to suggest that neither oral anticoagulation with warfarin or platelet inhibition with aspirin is better for mortality in systolic heart failure with sinus rhythm (high quality of the evidence for all-cause mortality and moderate quality of the evidence for non-fatal cardiovascular events and major bleeding events). Treatment with warfarin was associated with a 20% reduction in non-fatal cardiovascular events but a twofold higher risk of major bleeding complications (high quality of the evidence). We saw a similar pattern of results for the warfarin versus clopidogrel comparison (low quality of the evidence). At present, there are no data on the role of oral anticoagulation versus antiplatelet agents in heart failure with preserved ejection fraction with sinus rhythm. Also, there were no data from RCTs on the utility of non-vitamin K antagonist oral anticoagulants compared to antiplatelet agents in heart failure with sinus rhythm.\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": "Blood clots can be formed by clotting proteins (coagulation factors) and sticky blood cells (platelets). Oral anticoagulants such as warfarin are drugs that can prevent clot formation by blocking the clotting proteins. Other drugs, like aspirin, can also reduce clotting by blocking the platelets. Warfarin is better than aspirin in patients with heart failure who have abnormal heart rhythm (atrial fibrillation). Aspirin is known to be helpful in patients with heart failure with normal (sinus) rhythm, whose heart arteries are narrowed. This condition is a common cause of heart failure, so doctors often advise patients with a normal rhythm to take aspirin. Arguably, people with heart failure with a normal rhythm are at increased risk of clotting due to slower blood flow in the heart, similarly to people with an abnormal rhythm. Also, blood clots (thromboembolism) in the lungs, legs and brain (ischaemic stroke) lead to disability and death of patients with heart failure. Several studies have tried to find out whether all heart failure patients should receive oral anticoagulants, but the debate is still open."
}
] |
query-laysum
|
23095
|
[
{
"role": "user",
"content": "Abstract: Background\nSymptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.\nObjectives\nTo evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019.\nSelection criteria\nWe included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.\nData collection and analysis\nTwo review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.\nMain results\nWe included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency.\nSix studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events.\nThere was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups.\nOne study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).\nAuthors' conclusions\nThis review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In conclusion, we have found no clear difference in effect on patency, mortality or cardiovascular event rates when comparing atherectomy against balloon angioplasty with or without stenting. The limited evidence available does not support a significant advantage of atherectomy over conventional balloon angioplasty or stenting."
}
] |
query-laysum
|
23096
|
[
{
"role": "user",
"content": "Abstract: Background\nEarly discharge of stable preterm infants still requiring gavage feeds offers the benefits of uniting families sooner and reducing healthcare and family costs compared with discharge home when on full sucking feeds. Potential disadvantages of early discharge include increased care burden for the family and risk of complications related to gavage feeding.\nObjectives\nTo determine the effects of a policy of early discharge of stable preterm infants with home support of gavage feeding compared with a policy of discharge of such infants when they have reached full sucking feeds.\nWe planned subgroup analyses to determine whether safety and efficacy outcomes are altered by the type of support received (outpatient visits vs home support) or by the maturity of the infants discharged (gestational age ≤ 28 weeks at birth or birth weight ≤ 1000 grams).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group, together with searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to March 2015), EMBASE (1980 to March 2015) and MEDLINE (1950 to March 2015). We found no new trials.\nSelection criteria\nWe included all randomised and quasi-randomised trials among infants born at < 37 weeks and requiring no intravenous nutrition at the point of discharge. Trials were required to compare early discharge home with gavage feeds and healthcare support versus later discharge home when full sucking feeds were attained.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We conducted study authors for additional information. We performed data analysis in accordance with the standards of the Cochrane Neonatal Review Group.\nMain results\nWe included in the review data from one quasi-randomised trial with 88 infants from 75 families. Infants in the early discharge programme with home gavage feeding had a mean hospital stay that was 9.3 days shorter (mean difference (MD) -9.3, 95% confidence interval (CI) -18.49 to -0.11) than that of infants in the control group. Infants in the early discharge programme also had lower risk of clinical infection during the home gavage period compared with those in the control group spending corresponding time in hospital (risk ratio 0.35, 95% CI 0.17 to 0.69). No significant differences were noted between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage programme or from hospital, scores reflecting parental satisfaction or overall health service use.\nAuthors' conclusions\nExperimental evidence on the benefits and risks for preterm infants of early discharge from hospital with home gavage feeding compared with later discharge upon attainment of full sucking feeds is limited to the results of one small quasi-randomised controlled trial. High-quality trials with concealed allocation, complete follow-up of all randomly assigned infants and adequate sample size are needed before practice recommendations can be made.\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": "Data from one quasi-randomised trial with 88 infants from 75 families were included in the review."
}
] |
query-laysum
|
23097
|
[
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is an autoimmune, inflammatory, demyelinating disease of the central nervous system (CNS), which can occur in many parts of the CNS and result in a wide range of symptoms including sensory impairment, fatigue, walking or balance problems, visual impairment, vertigo and cognitive disabilities. At present, the most commonly used MS treatments are immunomodulating agents, but they have little effect on the disability. Experimental studies show that sodium (Na+) accumulation leads to intracellular calcium (Ca2+) release, and the increased calcium levels can activate nitric oxide synthase and harmful proteases and lipases. These factors contribute to axonal injury in people with MS. If partial blockade of voltage-gated sodium channels could result in neuroprotection, this would be of benefit for preventing disability progression in these people. Neuroprotection is emerging as a potentially important strategy for preventing disability progression in people with MS.\nObjectives\nTo assess the efficacy and safety of sodium channel blockers for neuroprotection in people with MS to prevent the occurrence of disability and alleviate the burden of the disease.\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register (27 August 2015) which, among other sources, contains references from the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue (8), MEDLINE (1966 to August 2015), EMBASE (1974 to August 2015), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1981 to August 2015), Latin American and Caribbean Health Science Information Database (LILACS) (1982 to August 2015), ClinicalTrials.gov (http://clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Portal (ICTRP) search portal (http://apps.who.int/trialsearch). In addition, we searched four Chinese databases, ongoing trials registers and relevant reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) that examined sodium channel blockers used alone or as an add-on to any approved treatments for MS.\nData collection and analysis\nTwo review authors independently selected trials, assessed trial quality and extracted the data.\nMain results\nOnly one study evaluating lamotrigine in secondary progressive MS was eligible. One hundred and twenty people were included, 61 randomly assigned to lamotrigine treatment and 59 to placebo treatment. The average age of participants in the two groups was 51.9 years and 50.1 years, respectively. The proportion of male participants was 27.5%. The period of follow-up was 2 years. No data were found on disability progression and people who experienced relapses. No significant differences were found for serious adverse events between the two groups. Treatment with lamotrigine was associated with more rashes (20% vs 5%, P value 0.03) and transient, dose-related deterioration of mobility (66% vs 34%, P value 0.001) than placebo. Furthermore, no significant difference between the two groups was found in the magnetic resonance imaging (MRI) measurements of cerebral atrophy, Expanded Disability Status Score changes, Multiple Sclerosis Functional Composite score changes. This study was judged to be at high risk of bias. This review will be updated when the three ongoing studies we identified are completed.\nAuthors' conclusions\nThe quality of evidence was judged to be very low due to the low number of available studies and included participants. There is a lack of evidence to address the review question on the efficacy of sodium channel blockers for people with MS. Assessment of the three ongoing trials might change this conclusion. Further high-quality large scale studies are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Multiple sclerosis (MS) is an autoimmune, inflammatory, demyelinating disease of the central nervous system. It can result in a wide range of symptoms including sensory impairment, fatigue, walking or balance problems, visual impairment, vertigo and cognitive disabilities. At present, the most commonly used MS treatments are immunomodulating agents, such as beta interferon, glatiramer acetate, natalizumab, fingolimod, teriflunomide and dimethyl fumarate. Although these agents have all been shown to reduce relapse frequency, they have little effect on the disability that characterises the progressive forms of the disease. Animal studies show the sodium (Na+) accumulation leads to intracellular calcium (Ca2+) release, and the increased calcium levels can activate the release of harmful elements. These elements contribute to axonal injury exacerbating the neurological disability. If partial blockade of voltage-gated sodium channels could result in neuroprotection in patients with MS, this would be of benefit in preventing the progression of disability in these patients. Neuroprotection is emerging as a potentially important strategy for preventing disability progression in MS."
}
] |
query-laysum
|
23098
|
[
{
"role": "user",
"content": "Abstract: Background\nIn primary care, general practitioners (GPs) unavoidably reach a clinical judgement about a patient as part of their encounter with patients, and so clinical judgement can be an important part of the diagnostic evaluation. Typically clinical decision making about what to do next for a patient incorporates clinical judgement about the diagnosis with severity of symptoms and patient factors, such as their ideas and expectations for treatment. When evaluating patients for dementia, many GPs report using their own judgement to evaluate cognition, using information that is immediately available at the point of care, to decide whether someone has or does not have dementia, rather than more formal tests.\nObjectives\nTo determine the diagnostic accuracy of GPs’ clinical judgement for diagnosing cognitive impairment and dementia in symptomatic people presenting to primary care. To investigate the heterogeneity of test accuracy in the included studies.\nSearch methods\nWe searched MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), Web of Science Core Collection (ISI Web of Science), and LILACs (BIREME) on 16 September 2021.\nSelection criteria\nWe selected cross-sectional and cohort studies from primary care where clinical judgement was determined by a GP either prospectively (after consulting with a patient who has presented to a specific encounter with the doctor) or retrospectively (based on knowledge of the patient and review of the medical notes, but not relating to a specific encounter with the patient). The target conditions were dementia and cognitive impairment (mild cognitive impairment and dementia) and we included studies with any appropriate reference standard such as the Diagnostic and Statistical Manual of Mental Disorders (DSM), International Classification of Diseases (ICD), aetiological definitions, or expert clinical diagnosis.\nData collection and analysis\nTwo review authors screened titles and abstracts for relevant articles and extracted data separately with differences resolved by consensus discussion. We used QUADAS-2 to evaluate the risk of bias and concerns about applicability in each study using anchoring statements. We performed meta-analysis using the bivariate method.\nMain results\nWe identified 18,202 potentially relevant articles, of which 12,427 remained after de-duplication. We assessed 57 full-text articles and extracted data on 11 studies (17 papers), of which 10 studies had quantitative data. We included eight studies in the meta-analysis for the target condition dementia and four studies for the target condition cognitive impairment. Most studies were at low risk of bias as assessed with the QUADAS-2 tool, except for the flow and timing domain where four studies were at high risk of bias, and the reference standard domain where two studies were at high risk of bias. Most studies had low concern about applicability to the review question in all QUADAS-2 domains.\nAverage age ranged from 73 years to 83 years (weighted average 77 years). The percentage of female participants in studies ranged from 47% to 100%. The percentage of people with a final diagnosis of dementia was between 2% and 56% across studies (a weighted average of 21%). For the target condition dementia, in individual studies sensitivity ranged from 34% to 91% and specificity ranged from 58% to 99%. In the meta-analysis for dementia as the target condition, in eight studies in which a total of 826 of 2790 participants had dementia, the summary diagnostic accuracy of clinical judgement of general practitioners was sensitivity 58% (95% confidence interval (CI) 43% to 72%), specificity 89% (95% CI 79% to 95%), positive likelihood ratio 5.3 (95% CI 2.4 to 8.2), and negative likelihood ratio 0.47 (95% CI 0.33 to 0.61).\nFor the target condition cognitive impairment, in individual studies sensitivity ranged from 58% to 97% and specificity ranged from 40% to 88%. The summary diagnostic accuracy of clinical judgement of general practitioners in four studies in which a total of 594 of 1497 participants had cognitive impairment was sensitivity 84% (95% CI 60% to 95%), specificity 73% (95% CI 50% to 88%), positive likelihood ratio 3.1 (95% CI 1.4 to 4.7), and negative likelihood ratio 0.23 (95% CI 0.06 to 0.40).\nIt was impossible to draw firm conclusions in the analysis of heterogeneity because there were small numbers of studies. For specificity we found the data were compatible with studies that used ICD-10, or applied retrospective judgement, had higher reported specificity compared to studies with DSM definitions or using prospective judgement. In contrast for sensitivity, we found studies that used a prospective index test may have had higher sensitivity than studies that used a retrospective index test.\nAuthors' conclusions\nClinical judgement of GPs is more specific than sensitive for the diagnosis of dementia. It would be necessary to use additional tests to confirm the diagnosis for either target condition, or to confirm the absence of the target conditions, but clinical judgement may inform the choice of further testing. Many people who a GP judges as having dementia will have the condition. People with false negative diagnoses are likely to have less severe disease and some could be identified by using more formal testing in people who GPs judge as not having dementia. Some false positives may require similar practical support to those with dementia, but some - such as some people with depression - may suffer delayed intervention for an alternative treatable pathology.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this review there were some technical problems with the design of the original studies, and there were differences between studies that made it difficult to compare them to each other. This means that it is difficult to be certain how applicable these findings are in clinical practice."
}
] |
query-laysum
|
23099
|
[
{
"role": "user",
"content": "Abstract: Background\nThe rising prevalence of autism spectrum disorder (ASD) has increased the need for evidence-based treatments to lessen the impact of symptoms. Presently, no therapies are available to effectively treat individuals with all of the symptoms of this disorder. It has been suggested that hyperbaric oxygen therapy may alleviate the biochemical dysfunction and clinical symptoms of ASD.\nObjectives\nTo determine whether treatment with hyperbaric oxygen:\n1. improves core symptoms of ASD, including social communication problems and stereotypical and repetitive behaviors;\n2. improves noncore symptoms of ASD, such as challenging behaviors;\n3. improves comorbid states, such as depression and anxiety; and\n4. causes adverse effects.\nSearch methods\nOn 10 December 2015, we searched CENTRAL, Ovid MEDLINE, Embase, and 15 other databases, four of which were Chinese language databases. We also searched multiple trial and research registers.\nSelection criteria\nWe selected randomized controlled trials (RCTs) and quasi-RCTs of any dose, duration, and frequency for hyperbaric oxygen therapy compared with no treatment or sham treatment for children and adults with ASD.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration, in that three review authors independently selected studies, assessed them for risk of bias, and extracted relevant data. We also assessed the quality of the evidence by using the GRADE approach.\nMain results\nWe included one trial with a total of 60 children with a diagnosis of ASD who randomly received hyperbaric oxygen therapy or a sham treatment. Using GRADE criteria, we rated the quality of the evidence as low because of the small sample size and wide confidence intervals (CIs). Other problems included selection bias and short duration or follow-up.\nOverall, study authors reported no improvement in social interaction and communication, behavioral problems, communication and linguistic abilities, or cognitive function. With regard to the safety of hyperbaric oxygen therapy (adverse events), they reported minor-grade ear barotrauma events. Investigators found significant differences between groups in total number of side effect events (Peto odds ratio (OR) 3.87, 95% CI 1.53 to 9.82) and in the number of children who experienced side effects (Peto OR 4.40, 95% CI 1.33 to 14.48).\nAuthors' conclusions\nTo date, there is no evidence that hyperbaric oxygen therapy improves core symptoms and associated symptoms of ASD. It is important to note that adverse effects (minor-grade ear barotrauma events) can occur. Given the absence of evidence of effectiveness and the limited biological plausibility and possible adverse effects, the need for future RCTs of hyperbaric oxygen therapy must be carefully considered.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched electronic databases and identified randomized controlled trials (in which participants are randomly allocated to one of two or more treatment groups) consisting of participants who received high-pressure oxygen therapy or room air or no treatment as a control.\nThe evidence is current up to December 2015."
}
] |
query-laysum
|
23100
|
[
{
"role": "user",
"content": "Abstract: Background\nDeep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately one in 1000 people. If left untreated, the clot can travel up to the lungs and cause a potentially life-threatening pulmonary embolism (PE). Previously, a DVT was treated with the anticoagulants heparin and vitamin K antagonists. However, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors, which have characteristics that may be favourable compared to conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or dose adjustment and few known drug interactions. DOACs are now commonly being used for treating DVT: recent guidelines recommended DOACs over conventional anticoagulants for both DVT and PE treatment. This Cochrane Review was first published in 2015. It was the first systematic review to measure the effectiveness and safety of these drugs in the treatment of DVT. This is an update of the 2015 review.\nObjectives\nTo assess the effectiveness and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of DVT.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which people with a DVT, confirmed by standard imaging techniques, were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with conventional anticoagulation or compared with each other for the treatment of DVT.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent venous thromboembolism (VTE), recurrent DVT and PE. Secondary outcomes included all-cause mortality, major bleeding, post-thrombotic syndrome (PTS) and quality of life (QoL). We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified 10 new studies with 2950 participants for this update. In total, we included 21 RCTs involving 30,895 participants. Three studies investigated oral DTIs (two dabigatran and one ximelagatran), 17 investigated oral factor Xa inhibitors (eight rivaroxaban, five apixaban and four edoxaban) and one three-arm trial investigated both a DTI (dabigatran) and factor Xa inhibitor (rivaroxaban). Overall, the studies were of good methodological quality.\nMeta-analysis comparing DTIs to conventional anticoagulation showed no clear difference in the rate of recurrent VTE (odds ratio (OR) 1.17, 95% confidence interval (CI) 0.83 to 1.65; 3 studies, 5994 participants; moderate-certainty evidence), recurrent DVT (OR 1.11, 95% CI 0.74 to 1.66; 3 studies, 5994 participants; moderate-certainty evidence), fatal PE (OR 1.32, 95% CI 0.29 to 6.02; 3 studies, 5994 participants; moderate-certainty evidence), non-fatal PE (OR 1.29, 95% CI 0.64 to 2.59; 3 studies, 5994 participants; moderate-certainty evidence) or all-cause mortality (OR 0.66, 95% CI 0.41 to 1.08; 1 study, 2489 participants; moderate-certainty evidence). DTIs reduced the rate of major bleeding (OR 0.58, 95% CI 0.38 to 0.89; 3 studies, 5994 participants; high-certainty evidence).\nFor oral factor Xa inhibitors compared with conventional anticoagulation, meta-analysis demonstrated no clear difference in recurrent VTE (OR 0.85, 95% CI 0.71 to 1.01; 13 studies, 17,505 participants; moderate-certainty evidence), recurrent DVT (OR 0.70, 95% CI 0.49 to 1.01; 9 studies, 16,439 participants; moderate-certainty evidence), fatal PE (OR 1.18, 95% CI 0.69 to 2.02; 6 studies, 15,082 participants; moderate-certainty evidence), non-fatal PE (OR 0.93, 95% CI 0.68 to 1.27; 7 studies, 15,166 participants; moderate-certainty evidence) or all-cause mortality (OR 0.87, 95% CI 0.67 to 1.14; 9 studies, 10,770 participants; moderate-certainty evidence). Meta-analysis showed a reduced rate of major bleeding with oral factor Xa inhibitors compared with conventional anticoagulation (OR 0.63, 95% CI 0.45 to 0.89; 17 studies, 18,066 participants; high-certainty evidence).\nAuthors' conclusions\nThe current review suggests that DOACs may be superior to conventional therapy in terms of safety (major bleeding), and are probably equivalent in terms of efficacy. There is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent VTE, recurrent DVT, pulmonary embolism and all-cause mortality. DOACs reduced the rate of major bleeding compared to conventional anticoagulation. The certainty of evidence was moderate or high.\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": "When treating people with a DVT, current evidence shows there is probably a similar effect between direct oral anticoagulants and conventional anticoagulants for preventing recurrent venous thromboembolism, recurrent DVT, pulmonary embolism and death. Direct oral anticoagulants reduced major bleeding compared to conventional anticoagulation."
}
] |
query-laysum
|
23101
|
[
{
"role": "user",
"content": "Abstract: Background\nThe question of what potential benefits and harms are associated with certain dietary regimes used in rheumatoid arthritis is an important one for many patients and health care providers.\nObjectives\nTo assess the effectiveness and safety of dietary interventions in the treatment of rheumatoid arthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library, issue 1 2008), MEDLINE, EMBASE, AMED, CINAHL and reference lists of relevant articles (up to January 2008), and contacted authors of included articles.\nSelection criteria\nRandomised controlled trials (RCTs) or controlled clinical trials (CCTs) where the effectiveness of dietary manipulation was evaluated. Dietary supplement studies (including fish oil supplements) were not included.\nData collection and analysis\nTwo authors independently selected trials for inclusion, assessed the internal validity of included trials and extracted data. Investigators were contacted to obtain missing information.\nMain results\nFourteen RCTs and one CCT, with a total of 837 patients, were included. Due to heterogeneity of interventions and outcomes, baseline imbalance and inadequate data reporting, no overall effects were calculated. A single trial with a moderate risk of bias found that fasting, followed by 13 months on a vegetarian diet, may reduce pain (mean difference (MD) on a 0 to 10 scale -1.89, 95% confidence interval (CI) -3.62 to -0.16), but not physical function or morning stiffness immediately after intervention. Another single trial with a moderate risk of bias found that a 12-week Cretan Mediterranean diet may reduce pain (MD on a 0 to 100 scale -14.00, 95% CI -23.6 to -4.37), but not physical function or morning stiffness immediately after intervention. Two trials compared a 4-week elemental diet with an ordinary diet and reported no significant differences in pain, function or stiffness. Due to inadequate data reporting, the effects of vegan and elimination diets are uncertain. When comparing any dietary manipulation with an ordinary diet we found a significantly higher total drop-out of 10% (risk difference (RD) 0.10, 95% CI 0.02 to 0.18), higher treatment-related drop-out of 5% (RD 0.05, 95% CI -0.03 to 0.14) and a significantly higher weight loss (weighted mean difference -3.23, 95% CI -4.79 to -1.67 kg) in the diet groups compared to the control groups.\nAuthors' conclusions\nThe effects of dietary manipulation, including vegetarian, Mediterranean, elemental and elimination diets, on rheumatoid arthritis are still uncertain due to the included studies being small, single trials with moderate to high risk of bias. Higher drop-out rates and weight loss in the groups with dietary manipulation indicate that potential adverse effects should not be ignored.\n\nGiven the provided abstract, please respond to the following query: \"What the research says\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It is uncertain whether diets improve pain, stiffness and the ability to move better.\nInstead, diets may be difficult to stick to, and people may lose weight on these diets even though they did not plan to.\n- people who follow special diets may lose 3 kg (6 ½ pounds) more than people who do not follow special diets, even though they did not plan to."
}
] |
query-laysum
|
23102
|
[
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a disease with an impaired immune response characterized by chronic, relapsing-remitting, and progressive inflammation mainly affecting the gastrointestinal tract. Certolizumab pegol (CZP) is a biological agent that regulates the impaired immune response by controlling tumour necrosis factor-α (TNFα). However, the efficacy and safety of long-term administration of CZP for people with CD with inflammation under control are not well understood.\nObjectives\nTo assess the efficacy and safety of CZP for maintenance of remission in people with CD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, and conference abstracts from inception to 23 March 2022. We contacted pharmaceutical companies involved with the production of CZP for further relevant information.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing CZP with placebo in adults with CD.\nData collection and analysis\nTwo review authors independently selected studies and extracted data. The main outcomes were failure to maintain clinical remission at week 26, failure to maintain clinical response at week 26, and serious adverse events. We planned to perform meta-analyses including all available studies if similar enough for pooling to be appropriate and calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences with 95% CIs for continuous outcomes. We analyzed the number needed to treat for an additional beneficial outcome (NNTB) and the number needed to treat for an additional harmful outcome (NNTH) to indicate the magnitude of treatment effects. The same two review authors independently evaluated the risk of bias by using the Cochrane RoB 2 tool and evaluated the certainty of evidence using the GRADE framework.\nMain results\nWe identified one study meeting our prespecified eligibility criteria. The included study enrolled 428 adults with CD who responded to induction therapy with CZP 400 mg at weeks 0, 2, and 4. The study evaluated long-term efficacy and safety of CZP administered subcutaneously every four weeks compared with placebo.\nThe proportion of participants who failed to maintain clinical remission at week 26 was 52.3% (113/216) in the CZP group compared to 71.7% (152/212) in the placebo group. Treatment of CZP probably results in a large reduction in failure to maintain clinical remission at week 26 (RR 0.73, 95% CI 0.63 to 0.85). The NNTB was 5 (95% CI 4 to 9). We judged this outcome at low risk of bias. Using the GRADE assessment, we judged the certainty of evidence as moderate due to the low number of events occurred.\nThe proportion of participants who failed to maintain clinical response at week 26 was 37.5% (81/216) in the CZP group compared to 64.2% (136/212) in the placebo group. Treatment of CZP probably results in a large reduction in failure to maintain clinical response at week 26 (RR 0.58, 95% CI 0.48 to 0.71). The NNTB was 4 (95% CI 3 to 5). We judged this outcome at low risk of bias. Using the GRADE assessment, we judged the certainty of evidence as moderate due to the low number of events occurred.\nThe proportion of participants who developed serious adverse events was 5.6% (12/216) in the CZP group compared to 6.6% (14/212) in the placebo group. Treatment of CZP may lead to no difference in serious adverse events compared to placebo when used as a remission maintenance treatment (RR 0.84, 95% CI 0.40 to 1.78). The NNTB was 95 (95% CI NNTH 19 to NNTB 25). We evaluated the risk of bias for this outcome as low. We evaluated the certainty of evidence as low due to the low number of events occurred and the CIs were not sufficiently narrow.\nAuthors' conclusions\nCZP probably results in a large reduction in failure to maintain clinical remission and response at week 26 in people with CD. The evidence suggests that CZP may lead to no difference in serious adverse events compared to placebo when used as a remission maintenance treatment. However, the current studies are limited to 26 weeks of follow-up and only included adults. Therefore, these conclusions cannot be used to guide longer term treatment or for treatment in children at present.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that CZP use likely contributed to better control of CD. Of 216 people with CD who were given CZP, 103 had control of the disease for 26 weeks. In contrast, of the 212 people with CD who were given a placebo, 60 had control of their disease. In addition, there were no obvious side effects of either CZP or placebo over the 26 weeks."
}
] |
query-laysum
|
23104
|
[
{
"role": "user",
"content": "Abstract: Background\nAnxiety disorders are a potentially disabling group of disorders that frequently co-occur with alcohol use disorders. Comorbid anxiety and alcohol use disorders are associated with poorer outcomes, and are difficult to treat with standard psychosocial interventions. In addition, improved understanding of the biological basis of the conditions has contributed to a growing interest in the use of medications for the treatment of people with both diagnoses.\nObjectives\nTo assess the effects of pharmacotherapy for treating anxiety in people with comorbid alcohol use disorders, specifically: to provide an estimate of the overall effects of medication in improving treatment response and reducing symptom severity in the treatment of anxiety disorders in people with comorbid alcohol use disorders; to determine whether specific medications are more effective and tolerable than other medications in the treatment of particular anxiety disorders; and to identify which factors (clinical, methodological) predict response to pharmacotherapy for anxiety disorders.\nSearch methods\nReview authors searched the specialized registers of The Cochrane Collaboration Depression, Anxiety and Neurosis Review Group (CCDANCTR, to January 2014) and the Cochrane Drugs and Alcohol Group (CDAG, to March 2013) for eligible trials. These registers contain reports of relevant randomized controlled trials (RCT) from: the Cochrane Central Register of Controlled Trials (CENTRAL, all years), MEDLINE (1950 to date), EMBASE (1974 to date) and PsycINFO (1967 to date). Review authors ran complementary searches on EMBASE, PubMed, PsycINFO and the Alcohol and Alcohol Problems Science Database (ETOH) (to August 2013). We located unpublished trials through the National Institutes of Health (NIH) RePORTER service and the World Health Organization (WHO) International Clinical Trials Registry Platform (to August 2013). We screened reference lists of retrieved articles for additional studies.\nSelection criteria\nAll true RCTs of pharmacotherapy for treating anxiety disorders with comorbid alcohol use disorders. Trials assessing drugs administered for the treatment of drinking behaviour, such as naltrexone, disulfiram and acamprosate were not eligible for inclusion in this systematic review.\nData collection and analysis\nA systematic review is a standardised evaluation of all research studies that address a particular clinical issue.\nTwo review authors independently assessed RCTs for inclusion in the review, collated trial data and assessed trial quality. We contacted investigators to obtain missing data. We calculated categorical and continuous treatment effect estimates and their 95% confidence intervals (CI) for treatment using a random-effects model with effect-size variability expressed using Chi2 and I2 heterogeneity statistics.\nMain results\nWe included five placebo-controlled pharmacotherapy RCTs (with 290 participants) in the review. Most of the trials provided little information on how randomization was performed or on whether both participants and study personnel were blinded to the intervention. Two of the three trials reporting superiority of medication compared with placebo on anxiety symptom outcomes were industry funded. We regarded one trial as being at high risk of bias due to selective reporting.\nStudy participants had Diagnostic and Statistical Manual (DSM) III- and DSM IV-diagnosed alcohol use disorders and post-traumatic stress disorder (two studies), social anxiety disorder (SAD; two studies) or generalized anxiety disorder (GAD; one study). Four trials assessed the efficacy of the selective serotonin re-uptake inhibitors (SSRIs: sertraline, paroxetine); one RCT investigated the efficacy of buspirone, a 5-hydroxytryptamine (5-HT) partial agonist. Treatment duration lasted between eight and 24 weeks. Overall, 70% of participants included in the review were male.\nThere was very low quality evidence for an effect of paroxetine on global clinical response to treatment, as assessed by the Clinical Global Impressions - Improvement scale (CGI-I). Global clinical response was observed in more than twice as many participants with paroxetine than with placebo (57.7% with paroxetine versus 25.8% with placebo; risk ratio (RR) 2.23, 95% CI 1.13 to 4.41; 2 trials, 57 participants). However, there was substantial uncertainty regarding the size of the effect of paroxetine due to the small number of studies providing data on clinically diverse patient samples. The second primary outcome measure was reduction of anxiety symptom severity. Although study investigators reported that buspirone (one trial) was superior to placebo in reducing the severity of anxiety symptoms over 12 weeks, no evidence of efficacy was observed for paroxetine (mean difference (MD) -14.70, 95% CI -33.00 to 3.60, 2 trials, 44 participants) and sertraline (one trial). Paroxetine appeared to be equally effective in reducing the severity of post-traumatic stress disorder (PTSD) symptoms as the tricyclic antidepressant desipramine in one RCT. The maximal reduction in anxiety disorder symptom severity was achieved after six weeks with paroxetine (two RCTs) and 12 weeks with buspirone (one RCT), with maintenance of medication efficacy extending to 16 with paroxetine and 24 weeks with buspirone. There was no evidence of an effect for any of the medications tested on abstinence from alcohol use or depression symptoms. There was very low quality evidence that paroxetine was well tolerated, based on drop-out due to treatment-emergent adverse effects. Nevertheless, levels of treatment discontinuation were high, with 43.1% of the participants in the studies withdrawing from medication treatment. Certain adverse effects, such as sexual problems, were commonly reported after treatment with paroxetine and sertraline.\nAuthors' conclusions\nThe evidence-base for the effectiveness of medication in treating anxiety disorders and comorbid alcohol use disorders is currently inconclusive. There was a small amount of evidence for the efficacy of medication, but this was limited and of very low quality. The majority of the data for the efficacy and tolerability of medication were for SSRIs; there were insufficient data to establish differences in treatment efficacy between medication classes or patient subgroups. There was a small amount of very low quality evidence that medication was well tolerated. There was no evidence that alcohol use was responsive to medication.\nLarge, rigorously conducted RCTs would help supplement the small evidence-base for the efficacy and tolerability of pharmacotherapy for anxiety and comorbid alcohol use disorders. Further research on patient subgroups who may benefit from pharmacological treatment, as well as novel pharmacological interventions, is warranted.\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": "We wanted to find out whether medication is effective in treating people with both anxiety disorders and alcohol use problems. For this reason, we systematically searched for randomized controlled trials (RCTs) of medication in treating people with both disorders. RCTs provide a more accurate measure of the effectiveness of medication by making sure that people in the study have an equal chance of being treated with medication or placebo."
}
] |
query-laysum
|
23105
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is the third update of this review, first published in July 2009. All major guidelines on treatment of hypertension recommend weight loss; anti-obesity drugs may be able to help in this respect.\nObjectives\nPrimary objectives:\nTo assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events)..\nSecondary objectives:\nTo assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on change from baseline in systolic and diastolic blood pressure, and on body weight reduction.\nSearch methods\nFor this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to March 2020: the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. The searches had no language restrictions. We contacted authors of relevant papers about further published and unpublished work.\nSelection criteria\nRandomised controlled trials of at least 24 weeks' duration in adults with hypertension that compared approved long-term weight-loss medications to placebo.\nData collection and analysis\nTwo review authors independently selected studies, assessed risks of bias, and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using a fixed-effect meta-analysis. When heterogeneity was present, we used the random-effects method and investigated the cause of the heterogeneity.\nMain results\nThis third update of the review added one new trial, investigating the combination of naltrexone/bupropion versus placebo. Two medications, which were included in the previous versions of this review (rimonabant and sibutramine) are no longer considered relevant for this update, since their marketing approval was withdrawn in 2010 and 2009, respectively. The number of included studies in this review update is therefore six (12,724 participants in total): four RCTs comparing orlistat to placebo, involving a total of 3132 participants with high blood pressure and a mean age of 46 to 55 years; one trial comparing phentermine/topiramate to placebo, involving 1305 participants with high blood pressure and a mean age of 53 years; and one trial comparing naltrexone/bupropion to placebo, involving 8283 participants with hypertension and a mean age of 62 years. We judged the risks of bias to be unclear for the trials investigating orlistat or naltrexone/bupropion. and low for the trial investigating phentermine/topiramate. Only the study of naltrexone/bupropion included cardiovascular mortality and morbidity as predefined outcomes.\nThere were no differences in the rates of all-cause or cardiovascular mortality, major cardiovascular events, or serious adverse events between naltrexone/bupropion and placebo. The incidence of overall adverse events was significantly higher in participants treated with naltrexone/bupropion. For orlistat, the incidence of gastrointestinal side effects was consistently higher compared to placebo. The most frequent side effects with phentermine/topiramate were dry mouth and paraesthesia. After six to 12 months, orlistat reduced systolic blood pressure compared to placebo by mean difference (MD) −2.6 mm Hg (95% confidence interval (CI) −3.8 to −1.4 mm Hg; 4 trials, 2058 participants) and diastolic blood pressure by MD −2.0 mm Hg (95% CI −2.7 to −1.2 mm Hg; 4 trials, 2058 participants). After 13 months of follow-up, phentermine/topiramate decreased systolic blood pressure compared to placebo by −2.0 to −4.2 mm Hg (1 trial, 1030 participants) (depending on drug dosage), and diastolic blood pressure by −1.3 to −1.9 mm Hg (1 trial, 1030 participants) (depending on drug dosage). There was no difference in the change in systolic or diastolic blood pressure between naltrexone/bupropion and placebo (1 trial, 8283 participants). We identified no relevant studies investigating liraglutide or lorcaserin in people with hypertension.\nAuthors' conclusions\nIn people with elevated blood pressure, orlistat, phentermine/topiramate and naltrexone/bupropion reduced body weight; the magnitude of the effect was greatest with phentermine/topiramate. In the same trials, orlistat and phentermine/topiramate, but not naltrexone/bupropion, reduced blood pressure. One RCT of naltrexone/bupropion versus placebo showed no differences in all-cause mortality or cardiovascular mortality or morbidity after two years. The European Medicines Agency refused marketing authorisation for phentermine/topiramate due to safety concerns, while for lorcaserin the application for European marketing authorisation was withdrawn due to a negative overall benefit/risk balance. In 2020 lorcaserin was also withdrawn from the US market. Two other medications (rimonabant and sibutramine) had already been withdrawn from the market in 2009 and 2010, respectively.\n\nGiven the provided abstract, please respond to the following query: \"Weight and hypertension\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hypertension treatment guidelines recommend keeping to a healthy weight and losing weight when needed. Some people may take medicines to help reduce their weight."
}
] |
query-laysum
|
23106
|
[
{
"role": "user",
"content": "Abstract: Background\nStanding up from a seated position is one of the most frequently performed functional tasks, is an essential pre-requisite to walking and is important for independent living and preventing falls. Following stroke, patients can experience a number of problems relating to the ability to sit-to-stand independently.\nObjectives\nTo review the evidence of effectiveness of interventions aimed at improving sit-to-stand ability after stroke. The primary objectives were to determine (1) the effect of interventions that alter the starting posture (including chair height, foot position, hand rests) on ability to sit-to-stand independently; and (2) the effect of rehabilitation interventions (such as repetitive practice and exercise programmes) on ability to sit-to-stand independently. The secondary objectives were to determine the effects of interventions aimed at improving ability to sit-to-stand on: (1) time taken to sit-to-stand; (2) symmetry of weight distribution during sit-to-stand; (3) peak vertical ground reaction forces during sit-to-stand; (4) lateral movement of centre of pressure during sit-to-stand; and (5) incidence of falls.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (June 2013), CENTRAL (2013, Issue 5), MEDLINE (1950 to June 2013), EMBASE (1980 to June 2013), CINAHL (1982 to June 2013), AMED (1985 to June 2013) and six additional databases. We also searched reference lists and trials registers and contacted experts.\nSelection criteria\nRandomised trials in adults after stroke where: the intervention aimed to affect the ability to sit-to-stand by altering the posture of the patient, or the design of the chair; stated that the aim of the intervention was to improve the ability to sit-to-stand; or the intervention involved exercises that included repeated practice of the movement of sit-to-stand (task-specific practice of rising to stand).\nThe primary outcome of interest was the ability to sit-to-stand independently. Secondary outcomes included time taken to sit-to-stand, measures of lateral symmetry during sit-to-stand, incidence of falls and general functional ability scores.\nData collection and analysis\nTwo review authors independently screened abstracts, extracted data and appraised trials. We undertook an assessment of methodological quality for random sequence generation, allocation concealment, blinding of outcome assessors and method of dealing with missing data.\nMain results\nThirteen studies (603 participants) met the inclusion criteria for this review, and data from 11 of these studies were included within meta-analyses. Twelve of the 13 included studies investigated rehabilitation interventions; one (nine participants) investigated the effect of altered starting posture for sit-to-stand. We judged only four studies to be at low risk of bias for all methodological parameters assessed. The majority of randomised controlled trials included participants who were already able to sit-to-stand or walk independently.\nOnly one study (48 participants), which we judged to be at high risk of bias, reported our primary outcome of interest, ability to sit-to-stand independently, and found that training increased the odds of achieving independent sit-to-stand compared with control (odds ratio (OR) 4.86, 95% confidence interval (CI) 1.43 to 16.50, very low quality evidence).\nInterventions or training for sit-to-stand improved the time taken to sit-to-stand and the lateral symmetry (weight distribution between the legs) during sit-to-stand (standardised mean difference (SMD) -0.34; 95% CI -0.62 to -0.06, seven studies, 335 participants; and SMD 0.85; 95% CI 0.38 to 1.33, five studies, 105 participants respectively, both moderate quality evidence). These improvements are maintained at long-term follow-up.\nFew trials assessing the effect of sit-to-stand training on peak vertical ground reaction force (one study, 54 participants) and functional ability (two studies, 196 participants) were identified, providing very low and low quality evidence respectively.\nThe effect of sit-to-stand training on number of falls was imprecise, demonstrating no benefit or harm (OR 0.75, 95% CI 0.46 to 1.22, five studies, 319 participants, low quality evidence). We judged the majority of studies that assessed falls to be at high risk of bias.\nAuthors' conclusions\nThis review has found insufficient evidence relating to our primary outcome of ability to sit-to-stand independently to reach any generalisable conclusions. This review has found moderate quality evidence that interventions to improve sit-to-stand may have a beneficial effect on time taken to sit-to-stand and lateral symmetry during sit-to-stand, in the population of people with stroke who were already able to sit-to-stand independently. There was insufficient evidence to reach conclusions relating to the effect of interventions to improve sit-to-stand on peak vertical ground reaction force, functional ability and falls. This review adds to a growing body of evidence that repetitive task-specific training is beneficial for outcomes in people receiving rehabilitation following stroke.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 13 studies up to June 2013. These studies included 603 participants who had had a stroke. Twelve of the studies investigated the effect of different types of training or exercise: six studies (276 participants) investigated repetitive sit-to-stand training, four studies (264 participants) investigated an exercise training programme that included sit-to-stand training, one study (12 participants) included a training programme (sitting training) aiming to improve sit-to-stand, and one study (42 participants) investigated feedback (information about the symmetry of weight taken through the feet) during sit-to-stand. One of the studies investigated the effect of starting posture for sit-to-stand: this study (nine participants) compared sit-to-stand with a cane and without a cane. This study measured people during three tests of rising to stand with a cane, and three tests of rising to stand without a cane; there was no training period."
}
] |
query-laysum
|
23107
|
[
{
"role": "user",
"content": "Abstract: Background\nEngagement in multiple risk behaviours can have adverse consequences for health during childhood, during adolescence, and later in life, yet little is known about the impact of different types of interventions that target multiple risk behaviours in children and young people, or the differential impact of universal versus targeted approaches. Findings from systematic reviews have been mixed, and effects of these interventions have not been quantitatively estimated.\nObjectives\nTo examine the effects of interventions implemented up to 18 years of age for the primary or secondary prevention of multiple risk behaviours among young people.\nSearch methods\nWe searched 11 databases (Australian Education Index; British Education Index; Campbell Library; Cumulative Index to Nursing and Allied Health Literature (CINAHL); Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; Embase; Education Resource Information Center (ERIC); International Bibliography of the Social Sciences; MEDLINE; PsycINFO; and Sociological Abstracts) on three occasions (2012, 2015, and 14 November 2016)). We conducted handsearches of reference lists, contacted experts in the field, conducted citation searches, and searched websites of relevant organisations.\nSelection criteria\nWe included randomised controlled trials (RCTs), including cluster RCTs, which aimed to address at least two risk behaviours. Participants were children and young people up to 18 years of age and/or parents, guardians, or carers, as long as the intervention aimed to address involvement in multiple risk behaviours among children and young people up to 18 years of age. However, studies could include outcome data on children > 18 years of age at the time of follow-up. Specifically,we included studies with outcomes collected from those eight to 25 years of age. Further, we included only studies with a combined intervention and follow-up period of six months or longer. We excluded interventions aimed at individuals with clinically diagnosed disorders along with clinical interventions. We categorised interventions according to whether they were conducted at the individual level; the family level; or the school level.\nData collection and analysis\nWe identified a total of 34,680 titles, screened 27,691 articles and assessed 424 full-text articles for eligibility. Two or more review authors independently assessed studies for inclusion in the review, extracted data, and assessed risk of bias.\nWe pooled data in meta-analyses using a random-effects (DerSimonian and Laird) model in RevMan 5.3. For each outcome, we included subgroups related to study type (individual, family, or school level, and universal or targeted approach) and examined effectiveness at up to 12 months' follow-up and over the longer term (> 12 months). We assessed the quality and certainty of evidence using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe included in the review a total of 70 eligible studies, of which a substantial proportion were universal school-based studies (n = 28; 40%). Most studies were conducted in the USA (n = 55; 79%). On average, studies aimed to prevent four of the primary behaviours. Behaviours that were most frequently addressed included alcohol use (n = 55), drug use (n = 53), and/or antisocial behaviour (n = 53), followed by tobacco use (n = 42). No studies aimed to prevent self-harm or gambling alongside other behaviours.\nEvidence suggests that for multiple risk behaviours, universal school-based interventions were beneficial in relation to tobacco use (odds ratio (OR) 0.77, 95% confidence interval (CI) 0.60 to 0.97; n = 9 studies; 15,354 participants) and alcohol use (OR 0.72, 95% CI 0.56 to 0.92; n = 8 studies; 8751 participants; both moderate-quality evidence) compared to a comparator, and that such interventions may be effective in preventing illicit drug use (OR 0.74, 95% CI 0.55 to 1.00; n = 5 studies; 11,058 participants; low-quality evidence) and engagement in any antisocial behaviour (OR 0.81, 95% CI 0.66 to 0.98; n = 13 studies; 20,756 participants; very low-quality evidence) at up to 12 months' follow-up, although there was evidence of moderate to substantial heterogeneity (I² = 49% to 69%). Moderate-quality evidence also showed that multiple risk behaviour universal school-based interventions improved the odds of physical activity (OR 1.32, 95% CI 1.16 to 1.50; I² = 0%; n = 4 studies; 6441 participants). We considered observed effects to be of public health importance when applied at the population level. Evidence was less certain for the effects of such multiple risk behaviour interventions for cannabis use (OR 0.79, 95% CI 0.62 to 1.01; P = 0.06; n = 5 studies; 4140 participants; I² = 0%; moderate-quality evidence), sexual risk behaviours (OR 0.83, 95% CI 0.61 to 1.12; P = 0.22; n = 6 studies; 12,633 participants; I² = 77%; low-quality evidence), and unhealthy diet (OR 0.82, 95% CI 0.64 to 1.06; P = 0.13; n = 3 studies; 6441 participants; I² = 49%; moderate-quality evidence). It is important to note that some evidence supported the positive effects of universal school-level interventions on three or more risk behaviours.\nFor most outcomes of individual- and family-level targeted and universal interventions, moderate- or low-quality evidence suggests little or no effect, although caution is warranted in interpretation because few of these studies were available for comparison (n ≤ 4 studies for each outcome).\nSeven studies reported adverse effects, which involved evidence suggestive of increased involvement in a risk behaviour among participants receiving the intervention compared to participants given control interventions.\nWe judged the quality of evidence to be moderate or low for most outcomes, primarily owing to concerns around selection, performance, and detection bias and heterogeneity between studies.\nAuthors' conclusions\nAvailable evidence is strongest for universal school-based interventions that target multiple- risk behaviours, demonstrating that they may be effective in preventing engagement in tobacco use, alcohol use, illicit drug use, and antisocial behaviour, and in improving physical activity among young people, but not in preventing other risk behaviours. Results of this review do not provide strong evidence of benefit for family- or individual-level interventions across the risk behaviours studied. However, poor reporting and concerns around the quality of evidence highlight the need for high-quality multiple- risk behaviour intervention studies to further strengthen the evidence base in this field.\n\nGiven the provided abstract, please respond to the following query: \"Search methods and selection of studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We carried out thorough searches of multiple scientific databases to identify studies that looked at ways of preventing or decreasing engagement in two or more risk behaviours, including tobacco use, alcohol use, illicit drug use, gambling, self-harm, sexual risk behaviour, antisocial behaviour, vehicle-risk behaviour, physical inactivity, and poor nutrition, among young people aged eight to 25 years. We divided these studies into groups (individual-level, family-level, and school-level studies) according to whether researchers worked with individuals, families, or children and young people in schools, respectively. We specifically looked at \"gold standard\" studies - randomised controlled trials that aimed to examine two or more behaviours of interest."
}
] |
query-laysum
|
23108
|
[
{
"role": "user",
"content": "Abstract: Background\nCorticosteroids are routinely given to children undergoing cardiac surgery with cardiopulmonary bypass (CPB) in an attempt to ameliorate the inflammatory response. Their use is still controversial and the decision to administer the intervention can vary by centre and/or by individual doctors within that centre.\nObjectives\nThis review is designed to assess the benefits and harms of prophylactic corticosteroids in children between birth and 18 years of age undergoing cardiac surgery with CPB.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and Conference Proceedings Citation Index-Science in June 2020. We also searched four clinical trials registers and conducted backward and forward citation searching of relevant articles.\nSelection criteria\nWe included studies of prophylactic administration of corticosteroids, including single and multiple doses, and all types of corticosteroids administered via any route and at any time-point in the perioperative period. We excluded studies if steroids were administered therapeutically. We included individually randomised controlled trials (RCTs), with two or more groups (e.g. multi-drug or dose comparisons with a control group) but not ‘head-to-head' trials without a placebo or a group that did not receive corticosteroids. We included studies in children, from birth up to 18 years of age, including preterm infants, undergoing cardiac surgery with the use of CPB. We also excluded studies in patients undergoing heart or lung transplantation, or both; studies in patients already receiving corticosteroids; in patients with abnormalities of the hypothalamic-pituitary-adrenal axis; and in patients given steroids at the time of cardiac surgery for indications other than cardiac surgery.\nData collection and analysis\nWe used the Covidence systematic review manager to extract and manage data for the review. Two review authors independently assessed studies for inclusion, extracted data, and assessed risks of bias. We resolved disagreements by consensus or by consultation with a third review author. We assessed the certainty of evidence with GRADE.\nMain results\nWe found 3748 studies, of which 888 were duplicate records. Two studies had the same clinical trial registration number, but reported different populations and interventions. We therefore included them as separate studies. We screened titles and abstracts of 2868 records and reviewed full text reports for 84 studies to determine eligibility. We extracted data for 13 studies. Pooled analyses are based on eight studies. We reported the remaining five studies narratively due to zero events for both intervention and placebo in the outcomes of interest. Therefore, the final meta-analysis included eight studies with a combined population of 478 participants.\nThere was a low or unclear risk of bias across the domains. There was moderate certainty of evidence that corticosteroids do not change the risk of in-hospital mortality (five RCTs; 313 participants; risk ratio (RR) 0.83, 95% confidence interval (CI) 0.33 to 2.07) for children undergoing cardiac surgery with CPB. There was high certainty of evidence that corticosteroids reduce the duration of mechanical ventilation (six RCTs; 421 participants; mean difference (MD) 11.37 hours lower, 95% CI -20.29 to -2.45) after the surgery. There was high-certainty evidence that the intervention probably made little to no difference to the length of postoperative intensive care unit (ICU) stay (six RCTs; 421 participants; MD 0.28 days lower, 95% CI -0.79 to 0.24) and moderate-certainty evidence that the intervention probably made little to no difference to the length of the postoperative hospital stay (one RCT; 176 participants; mean length of stay 22 days; MD -0.70 days, 95% CI -2.62 to 1.22). There was moderate certainty of evidence for no effect of the intervention on all-cause mortality at the longest follow-up (five RCTs; 313 participants; RR 0.83, 95% CI 0.33 to 2.07) or cardiovascular mortality at the longest follow-up (three RCTs; 109 participants; RR 0.40, 95% CI 0.07 to 2.46). There was low certainty of evidence that corticosteroids probably make little to no difference to children separating from CPB (one RCT; 40 participants; RR 0.20, 95% CI 0.01 to 3.92). We were unable to report information regarding adverse events of the intervention due to the heterogeneity of reporting of outcomes.\nWe downgraded the certainty of evidence for several reasons, including imprecision due to small sample sizes, a single study providing data for an individual outcome, the inclusion of both appreciable benefit and harm in the confidence interval, and publication bias.\nAuthors' conclusions\nCorticosteroids probably do not change the risk of mortality for children having heart surgery using CPB at any time point. They probably reduce the duration of postoperative ventilation in this context, but have little or no effect on the total length of postoperative ICU stay or total postoperative hospital stay. There was inconsistency in the adverse event outcomes reported which, consequently, could not be pooled. It is therefore impossible to provide any implications and policy-makers will be unable to make any recommendations for practice without evidence about adverse effects. The review highlighted the need for well-conducted RCTs powered for clinical outcomes to confirm or refute the effect of corticosteroids versus placebo in children having cardiac surgery with CPB. A core outcome set for adverse event reporting in the paediatric major surgery and intensive care setting is required.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 13 studies that involved a total of 1087 children. The studies lasted for between 14 months and 30 months (duration was not reported for seven studies). Three corticosteroids were investigated: methylprednisolone (five studies), hydrocortisone (two studies) and dexamethasone (six studies). The studies compared these corticosteroids against a placebo (medicine that is exactly the same apart from it does not have the active medicine in it).\nThe evidence shows that:\n- corticosteroids probably make little or no difference to the number of children who die in hospital after surgery (five studies, 313 children (participating in the studies), moderate-certainty evidence);\n- corticosteroids probably make little or no difference to the number of children who die from any cause (five studies, 313 children, moderate-certainty evidence) or from heart and circulation problems specifically (three studies, 109 children, moderate-certainty evidence) at the longest follow-up time after surgery;\n- corticosteroids may make little or no difference to whether children are taken off the heart-lung machine after surgery (one study, 40 children, low-certainty evidence).\n- corticosteroids reduce the number of hours for which children need a breathing machine (six studies, 421 children, high-certainty evidence);\n- corticosteroids make little or no difference to the length of time children spend in the intensive care unit (six studies, 421 children, high-certainty evidence);\n- corticosteroids probably make little or no difference to the total length of time children spend in hospital after surgery (one study, 176 children, moderate-certainty evidence).\nIt is unclear whether corticosteroids are associated with non-fatal unwanted effects because the studies did not report on unwanted effects consistently."
}
] |
query-laysum
|
23109
|
[
{
"role": "user",
"content": "Abstract: Background\nReady-to-use lipid-based nutrient supplements (LNS) are a highly nutrient-dense supplement, which could be a good source of macro- and micronutrients for pregnant women who need to supplement their nutrient intake.\nObjectives\nTo assess the effects of LNS for maternal, birth and infant outcomes in pregnant women. Secondary objectives were to explore the most appropriate composition, frequency and duration of LNS administration.\nSearch methods\nIn May 2018, we searched CENTRAL, MEDLINE, Embase, 22 other databases and two trials registers for any published and ongoing studies. We also checked the reference lists of included studies and relevant reviews, and we contacted the authors of included studies and other experts in the field to identify any studies we may have missed, including any unpublished studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that compared LNS given in pregnancy to no intervention, placebo, iron folic acid (IFA), multiple micronutrients (MMN) or nutritional counselling.\nData collection and analysis\nWe used standard Cochrane procedures.\nMain results\nWe included four studies in 8018 pregnant women. All four studies took place in stable community settings in low- and middle-income countries: Bangladesh, Burkina Faso, Ghana and Malawi. None were in emergency settings. The oldest trial was published in 2009. Of the four included studies, one compared LNS to IFA, one compared LNS to MMN, and two compared LNS to both IFA and MMN.\nWe considered the included studies to be of medium to high quality, and we rated the quality of the evidence as moderate using the GRADE approach.\nLNS versus IFA\nMaternal outcomes: there was no difference between the LNS and IFA groups as regards maternal gestational weight gain per week (standard mean difference (SMD) 0.46, 95% confidence interval (CI) −0.44 to 1.36; 2 studies, 3539 participants). One study (536 participants) showed a two-fold increase in the prevalence of maternal anaemia in the LNS group compared to the IFA group, but no difference between the groups as regards adverse effects. There was no difference between the two groups for maternal mortality (risk ratio (RR) 0.53, 95% CI 0.12 to 2.41; 3 studies, 5628 participants).\nBirth and infant outcomes: there was no difference between the LNS and IFA groups for low birth weight (LBW) (RR 0.87, 95% CI 0.72 to 1.05; 3 studies, 4826 participants), though newborns in the LNS group had a slightly higher mean birth weight (mean difference (MD) 53.28 g, 95% CI 28.22 to 78.33; 3 studies, 5077 participants) and birth length (cm) (MD 0.24 cm, 95% CI 0.11 to 0.36; 3 studies, 4986 participants). There was a reduction in the proportion of infants who were small for gestational age (SGA) (RR 0.94, 95% CI 0.89 to 0.99; 3 studies, 4823 participants) and had newborn stunting (RR 0.82, 95% CI 0.71 to 0.94; 2 studies, 4166 participants) in the LNS group, but no difference between the LNS and IFA groups for preterm delivery (RR 0.94, 95% CI 0.80 to 1.11; 4 studies, 4924 participants), stillbirth (RR 1.14; 95% CI 0.52 to 2.48; 3 studies, 5575 participants) or neonatal death (RR 0.96, 95% CI 0.14 to 6.51). The current evidence for child developmental outcomes is not sufficient to draw any firm conclusions.\nLNS versus MMN\nMaternal outcomes: one study (662 participants) showed no difference between the LNS and MMN groups as regards gestational weight gain per week or adverse effects. Another study (557 participants) showed an increased risk of maternal anaemia in the LNS group compared to the MMN group.\nBirth and infant outcomes: there was no difference between the LNS and MMN groups for LBW (RR 0.92, 95% CI 0.74 to 1.14; 3 studies, 2404 participants), birth weight (MD 23.67 g, 95% CI −10.53 to 57.86; 3 studies, 2573 participants), birth length (MD 0.20 cm, 95% CI −0.02 to 0.42; 3 studies, 2567 participants), SGA (RR 0.95, 95% CI 0.84 to 1.07; 3 studies, 2393 participants), preterm delivery (RR 1.15, 95% CI 0.93 to 1.42; 3 studies, 2630 participants), head circumference z score (MD 0.10, 95% CI −0.01 to 0.21; 2 studies, 1549 participants) or neonatal death (RR 0.88, 95% CI 0.36 to 2.15; 1 study, 1175 participants).\nAuthors' conclusions\nFindings from this review suggest that LNS supplementation has a slight, positive effect on weight at birth, length at birth, SGA and newborn stunting compared to IFA. LNS and MMN were comparable for all maternal, birth and infant outcomes. Both IFA and MMN were better at reducing maternal anaemia when compared to LNS. We did not find any trials for LNS given to pregnant women in emergency settings.\nReaders should interpret the beneficial findings of the review with caution since the evidence comes from a small number of trials, with one-large scale study (conducted in community settings in Bangladesh) driving most of the impact. In addition, effect sizes are too small to propose any concrete recommendation for practice.\n\nGiven the provided abstract, please respond to the following query: \"Currentness of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to May 2018."
}
] |
query-laysum
|
23110
|
[
{
"role": "user",
"content": "Abstract: Background\nHypertension is a chronic condition associated with an increased risk of mortality and morbidity. Renin is the enzyme responsible for converting angiotensinogen to angiotensin I, which is then converted to angiotensin II. Renin inhibitors are a new class of drugs that decrease blood pressure (BP) by preventing the formation of both angiotensin I and angiotensin II.\nObjectives\nTo quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension.\nTo determine the change in BP variability, pulse pressure, and heart rate and to evaluate adverse events (mortality, non-fatal serious adverse events, total adverse events, withdrawal due to adverse effects and specific adverse events such as dry cough, diarrhoea and angioedema).\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to February 2017: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 2), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. There was no restriction by language or publication status. We also searched the European Medicines Agency (EMA) for clinical study reports, the Novartis Clinical Study Results Database, bibliographic citations from retrieved references, and contacted authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nWe included randomized, double-blinded, placebo-controlled studies evaluating BP lowering efficacy of fixed-dose monotherapy with renin inhibitor compared with placebo for a minimum duration of three to 12 weeks in adult patients with primary hypertension.\nData collection and analysis\nThis systematic review is a comprehensive update which includes four additional studies and extensive detail from nine clinical study reports (CSRs) of previously included studies obtained from EMA. The remaining three CSRs are not available.\nTwo review authors independently assessed study eligibility and extracted data. In all cases where there was a difference between the CSR and the published report, data from the CSR was used. Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence intervals (CIs) and continuous outcomes as mean difference (MD) with 95% CIs.\nMain results\n12 studies (mean duration of eight weeks) in 7439 mostly Caucasian patients (mean age 54 years) with mild-to-moderate uncomplicated hypertension were eligible for inclusion in the review. Aliskiren was the only renin inhibitor evaluated. All included studies were assessed to have high likelihood of attrition, reporting and funding bias.\nAliskiren has a dose-related systolic/diastolic blood pressure (SBP/DBP) lowering effect as compared with placebo MD with 95% CI: aliskiren 75 mg (MD -2.97, 95% CI -4.76 to -1.18)/(MD -2.05, 95% CI -3.13 to -0.96) mm Hg (moderate-quality evidence), aliskiren 150 mg (MD -5.95, 95% CI -6.85 to -5.06)/ (MD -3.16, 95% CI -3.74 to -2.58) mm Hg (moderate-quality evidence), aliskiren 300 mg (MD -7.88, 95% CI -8.94 to -6.82)/ (MD -4.49, 95% CI -5.17 to -3.82) mm Hg (moderate-quality evidence), aliskiren 600 mg (MD -11.35, 95% CI -14.43 to -8.27)/ (MD -5.86, 95% CI -7.73 to -3.99) mm Hg (low-quality evidence). There was a dose-dependent decrease in blood pressure for aliskiren 75 mg, 150 mg and 300 mg. The blood pressure lowering effect of aliskiren 600 mg was not different from 300 mg (MD -0.61, 95% CI -2.78 to 1.56)/(MD -0.68, 95% CI -2.03 to 0.67). Aliskiren had no effect on blood pressure variability. Due to very limited information available regarding change in heart rate and pulse pressure, it was not possible to meta-analyze these outcomes.\nMortality and non-fatal serious adverse events were not increased. This review found that in studies of eight week duration aliskiren may not increase withdrawal due to adverse events (low-quality evidence). Diarrhoea was increased in a dose-dependent manner (RR 7.00, 95% CI 2.48 to 19.72) with aliskiren 600 mg (low-quality evidence). The most frequent adverse events reported were headache, nasopharyngitis, diarrhoea, dizziness and fatigue.\nAuthors' conclusions\nCompared to placebo, aliskiren lowered BP and this effect is dose-dependent. This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). There is no difference in mortality, nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy. Diarrhoea was considerably increased with aliskiren 600 mg.\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": "High blood pressure or hypertension can lead to heart attacks and stroke. A new class of drugs called renin inhibitors is indicated for the treatment of hypertension. Aliskiren is the only drug of the renin inhibitor class that has been studied and approved for treatment of hypertension at this time."
}
] |
query-laysum
|
23111
|
[
{
"role": "user",
"content": "Abstract: Background\nLamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a newly recognised type of epiretinal membrane termed ‘epiretinal proliferation’. There may be a rationale to recommend surgery for individuals with LMHs, particularly those with functional or anatomical deterioration, or poor baseline vision causing significant disability, to stabilise the LMH and prevent further visual deterioration; however, there is currently no evidence-based consensus.\nObjectives\nTo assess the effect of surgical interventions on post-operative visual and anatomical outcomes in people with a confirmed LMH.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, Scopus SciVerse, ISRCTN registry, US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched reference lists of included trials to identify other eligible trials which our search strategy may have missed. The date of the search was 20 July 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) involving participants with a confirmed LMH diagnosis which reported one or more surgical intervention(s), alone or in combination, in at least one arm of the RCT.\nData collection and analysis\nWe used standard methods as expected by Cochrane. Two study authors independently extracted data and assessed the risk of bias for included trials. Trial authors were contacted for further information and clarification.\nMain results\nA single RCT was eligible for inclusion. Thirty-six participants were randomised in a 2:1 ratio; 24 were allocated to undergo surgery (pars plana vitrectomy, peeling of the epiretial proliferation followed by fovea-sparing removal of the internal limiting membrane) and 12 (10 following two participant dropouts) to observation.\nOverall, the certainty of the evidence was low for all outcomes due to selection and detection bias, and the low number of participants enrolled in the study which may affect the accuracy of results and reliability of conclusions.\nAt six-month follow-up, change in vision was better in the surgery group (-0.27 logMAR improvement) than observation (0.02 worsening) (mean difference (MD): -0.29 logMAR, 95% confidence intervals (CI): -0.33 to -0.25). Central retinal thickness increased in the surgery group over 6 months 126 μm increase) compared with observation group (decrease by 11μm) (MD: 137 μm, 95% CI: 125.87 μm to 148.13 μm). Finally, at six-month follow-up, retinal sensitivity was better in the surgery group (3.03 dB increase) compared with the observation group (0.06 dB decrease) (MD: 3.09 dB, 95% CI: 2.07 to 4.11 dB).\nVision-related quality of life and metamorphopsia were not reported. No adverse outcomes or complications were reported in the study, however, authors could not provide information on whether any individuals developed deterioration in vision of 0.2 logMAR or worse.\nAuthors' conclusions\nThe included single trial demonstrated improvements in visual and anatomical outcome measures for participants with a LMH who underwent surgery compared with observation only. Therefore, we can conclude that participants who undergo surgery may achieve superior post-operative best corrected visual acuity and anatomical outcomes compared with observation only. However, the results of a single and small RCT provides limited evidence to support or refute surgery as an effective management option for LMHs. Future RCTs with a larger number of participants and with fewer methodological limitations and biases are necessary to inform future clinical practice.\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": "It remains unclear whether surgery is effective for people with lamellar macular holes. Further research is required."
}
] |
query-laysum
|
23112
|
[
{
"role": "user",
"content": "Abstract: Background\nThe use of opioids in the long-term management of chronic low-back pain (CLBP) has increased dramatically. Despite this trend, the benefits and risks of these medications remain unclear. This review is an update of a Cochrane review first published in 2007.\nObjectives\nTo determine the efficacy of opioids in adults with CLBP.\nSearch methods\nWe electronically searched the Cochrane Back Review Group's Specialized Register, CENTRAL, CINAHL and PsycINFO, MEDLINE, and EMBASE from January 2006 to October 2012. We checked the reference lists of these trials and other relevant systematic reviews for potential trials for inclusion.\nSelection criteria\nWe included randomized controlled trials (RCTs) that assessed the use of opioids (as monotherapy or in combination with other therapies) in adults with CLBP that were at least four weeks in duration. We included trials that compared non-injectable opioids to placebo or other treatments. We excluded trials that compared different opioids only.\nData collection and analysis\nTwo authors independently assessed the risk of bias and extracted data onto a pre-designed form. We pooled results using Review Manager (RevMan) 5.2. We reported on pain and function outcomes using standardized mean difference (SMD) or risk ratios with 95% confidence intervals (95% CI). We used absolute risk difference (RD) with 95% CI to report adverse effects.\nMain results\nWe included 15 trials (5540 participants). Tramadol was examined in five trials (1378 participants); it was found to be better than placebo for pain (SMD -0.55, 95% CI -0.66 to -0.44; low quality evidence) and function (SMD -0.18, 95% CI -0.29 to -0.07; moderate quality evidence). Transdermal buprenorphine (two trials, 653 participants) may make little difference for pain (SMD -2.47, 95%CI -2.69 to -2.25; very low quality evidence), but no difference compared to placebo for function (SMD -0.14, 95%CI -0.53 to 0.25; very low quality evidence). Strong opioids (morphine, hydromorphone, oxycodone, oxymorphone, and tapentadol), examined in six trials (1887 participants), were better than placebo for pain (SMD -0.43, 95%CI -0.52 to -0.33; moderate quality evidence) and function (SMD -0.26, 95% CI -0.37 to -0.15; moderate quality evidence). One trial (1583 participants) demonstrated that tramadol may make little difference compared to celecoxib (RR 0.82, 95% CI 0.76 to 0.90; very low quality evidence) for pain relief. Two trials (272 participants) found no difference between opioids and antidepressants for either pain (SMD 0.21, 95% CI -0.03 to 0.45; very low quality evidence), or function (SMD -0.11, 95% -0.63 to 0.42; very low quality evidence). The included trials in this review had high drop-out rates, were of short duration, and had limited interpretability of functional improvement. They did not report any serious adverse effects, risks (addiction or overdose), or complications (sleep apnea, opioid-induced hyperalgesia, hypogonadism). In general, the effect sizes were medium for pain and small for function.\nAuthors' conclusions\nThere is some evidence (very low to moderate quality) for short-term efficacy (for both pain and function) of opioids to treat CLBP compared to placebo. The very few trials that compared opioids to non-steroidal anti-inflammatory drugs (NSAIDs) or antidepressants did not show any differences regarding pain and function. The initiation of a trial of opioids for long-term management should be done with extreme caution, especially after a comprehensive assessment of potential risks. There are no placebo-RCTs supporting the effectiveness and safety of long-term opioid therapy for treatment of CLBP.\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 trials, both published and unpublished, up to October 2012. We included fifteen trials which included 5540 participants and compared opioids against a placebo (fake medication) or other drugs that have been used for LBP. Most people included in the trials were aged 40 to 50 years and all reported at least moderate pain across the low-back area. The trials included a slightly higher proportion of women. Most of the trials followed the patients during three months and were supported by the pharmaceutical industry."
}
] |
query-laysum
|
23113
|
[
{
"role": "user",
"content": "Abstract: Background\nNitric oxide (NO) is a major endogenous regulator of vascular tone. Inhaled nitric oxide (iNO) gas has been investigated as treatment for persistent pulmonary hypertension of the newborn.\nObjectives\nTo determine whether treatment of hypoxaemic term and near-term newborn infants with iNO improves oxygenation and reduces rate of death and use of extracorporeal membrane oxygenation (ECMO), or affects long-term neurodevelopmental outcomes.\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 1), MEDLINE via PubMed (1966 to January 2016), Embase (1980 to January 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to January 2016). We searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We contacted the principal investigators of studies published as abstracts to ascertain the necessary information.\nSelection criteria\nRandomised studies of iNO in term and near-term infants with hypoxic respiratory failure, with clinically relevant outcomes, including death, use of ECMO and oxygenation.\nData collection and analysis\nWe analysed trial reports to assess methodological quality using the criteria of the Cochrane Neonatal Review Group. We tabulated mortality, oxygenation, short-term clinical outcomes (particularly use of ECMO) and long-term developmental outcomes.\nStatistics: For categorical outcomes, we calculated typical estimates for risk ratios and risk differences. For continuous variables, we calculated typical estimates for weighted mean differences. We used 95% confidence intervals and assumed a fixed-effect model for meta-analysis.\nMain results\nWe found 17 eligible randomised controlled studies that included term and near-term infants with hypoxia.\nTen trials compared iNO versus control (placebo or standard care without iNO) in infants with moderate or severe severity of illness scores (Ninos 1996; Roberts 1996; Wessel 1996; Davidson 1997; Ninos 1997; Mercier 1998; Christou 2000; Clark 2000; INNOVO 2007; Liu 2008). Mercier 1998 compared iNO versus control but allowed back-up treatment with iNO for infants who continued to satisfy the same criteria for severity of illness after two hours. This trial enrolled both preterm and term infants but reported most results separately for the two groups. Ninos 1997 studied only infants with congenital diaphragmatic hernia.\nOne trial compared iNO versus high-frequency ventilation (Kinsella 1997).\nSix trials enrolled infants with moderate severity of illness scores (oxygenation index (OI) or alveolar-arterial oxygen difference (A-aDO2)) and randomised them to immediate iNO treatment or iNO treatment only after deterioration to more severe criteria (Barefield 1996; Day 1996; Sadiq 1998; Cornfield 1999; Konduri 2004; Gonzalez 2010).\nInhaled nitric oxide appears to have improved outcomes in hypoxaemic term and near-term infants by reducing the incidence of the combined endpoint of death or use of ECMO (high-quality evidence). This reduction was due to a reduction in use of ECMO (with number needed to treat for an additional beneficial outcome (NNTB) of 5.3); mortality was not affected. Oxygenation was improved in approximately 50% of infants receiving iNO. The OI was decreased by a (weighted) mean of 15.1 within 30 to 60 minutes after the start of therapy, and partial pressure of arterial oxygen (PaO2) was increased by a mean of 53 mmHg. Whether infants had clear echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) did not appear to affect response to iNO. Outcomes of infants with diaphragmatic hernia were not improved; outcomes were slightly, but not significantly, worse with iNO (moderate-quality evidence).\nInfants who received iNO at less severe criteria did not have better clinical outcomes than those who were enrolled but received treatment only if their condition deteriorated. Fewer of the babies who received iNO early satisfied late treatment criteria, showing that earlier iNO reduced progression of the disease but did not further decrease mortality nor the need for ECMO (moderate-quality evidence). Incidence of disability, incidence of deafness and infant development scores were all similar between tested survivors who received iNO and those who did not.\nAuthors' conclusions\nInhaled nitric oxide is effective at an initial concentration of 20 ppm for term and near-term infants with hypoxic respiratory failure who do not have a diaphragmatic hernia.\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": "Inhaled nitric oxide is safe and can help some full-term babies with respiratory failure who have not responded to other methods of support. Inhaled nitric oxide increases levels of oxygen in babies' blood, and babies are more likely to survive without needing ECMO, a highly invasive therapy with many complications. Unfortunately, benefits of iNO are not clear in babies whose respiratory failure is due to a diaphragmatic hernia. Inhaled nitric oxide has shown no short-term or long-term adverse effects. No signs suggest that iNO given earlier is more beneficial or results in more babies treated, and the number who die or who need ECMO is not significantly reduced."
}
] |
query-laysum
|
23114
|
[
{
"role": "user",
"content": "Abstract: Background\nRetinitis pigmentosa (RP) comprises a group of hereditary eye diseases characterized by progressive degeneration of retinal photoreceptors. It results in severe visual loss that may lead to blindness. Symptoms may become manifest during childhood or adulthood which include poor night vision (nyctalopia) and constriction of peripheral vision (visual field loss). Visual field loss is progressive and affects central vision later in the disease course. The worldwide prevalence of RP is approximately 1 in 4000, with 100,000 individuals affected in the USA. At this time, there is no proven therapy for RP.\nObjectives\nThe objective of this review was to synthesize the best available evidence regarding the effectiveness and safety of vitamin A and fish oils (docosahexaenoic acid (DHA)) in preventing the progression of RP.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2020, Issue 2); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and OpenGrey. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 7 February 2020.\nSelection criteria\nWe included randomized controlled trials that enrolled participants of any age diagnosed with any degree of severity or type of RP, and evaluated the effectiveness of vitamin A, fish oils (DHA), or both compared to placebo, vitamins (other than vitamin A), or no therapy, as a treatment for RP. We excluded cluster-randomized trials and cross-over trials.\nData collection and analysis\nWe prespecified the following outcomes: mean change from baseline visual field, mean change from baseline electroretinogram (ERG) amplitudes, and anatomic changes as measured by optical coherence tomography (OCT), at one-year follow-up, and mean change in visual acuity, at five-year follow-up. Two review authors independently extracted data and evaluated risk of bias for all included trials. We also contacted study investigators for further information when necessary.\nMain results\nIn addition to three trials from the previous version of this review, we included a total of four trials with 944 participants aged 4 to 55 years. Two trials included only participants with X-linked RP and the other two included participants with RP of all forms of genetic predisposition. Two trials evaluated the effect of DHA alone; one trial evaluated vitamin A alone; and one trial evaluated DHA and vitamin A versus vitamin A alone. Two trials recruited participants from the USA, and the other two recruited from the USA and Canada. All trials were at low risk of bias for most domains. We did not perform meta-analysis due to clinical heterogeneity.\nFour trials assessed visual field sensitivity. Investigators found no evidence of a difference in mean values between the groups. However, one trial found that the annual rate of change of visual field sensitivity over four years favored the DHA group in foveal (−0.02 ± 0.55 (standard error (SE)) dB versus −0.47 ± 0.03 dB, P = 0.039), macular (−0.42 ± 0.05 dB versus −0.85 ± 0.03 dB, P = 0.031), peripheral (−0.39 ± 0.02 versus −0.86 ± 0.02 dB, P < 0.001), and total visual field sensitivity (−0.39 ± 0.02 versus −0.86 ± 0.02 dB, P < 0.001). The certainty of the evidence was very low.\nThe four trials evaluated visual acuity (LogMAR scale) at a follow-up of four to six years. In one trial (208 participants), investigators found no evidence of a difference between the two groups, as both groups lost 0.7 letters of the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity per year. In another trial (41 participants), DHA showed no evidence of effect on visual acuity (mean difference −0.01 logMAR units (95% confidence interval −0.14 to 0.12; one letter difference between the two groups; very low-certainty evidence). In the third trial (60 participants), annual change in mean number of letters correct was −0.8 (DHA) and 1.4 letters (placebo), with no evidence of between-group difference. In the fourth trial (572 participants), which evaluated (vitamin A + vitamin E trace) compared with (vitamin A trace + vitamin E trace), decline in ETDRS visual acuity was 1.1 versus 0.9 letters per year, respectively.\nAll four trials reported electroretinography (ERG). Investigators of two trials found no evidence of a difference between the DHA and placebo group in yearly rates of change in 31 Hz cone ERG amplitude (mean ± SE) (−0.028 ± 0.001 log μV versus −0.022 ± 0.002 log μV; P = 0.30); rod ERG amplitude (mean ± SE) (−0.010 ± 0.001 log μV versus −0.023 ± 0.001 log μV; P = 0.27); and maximal ERG amplitude (mean ± SE) (−0.042 ± 0.001 log μV versus −0.036 ± 0.001 log μV; P = 0.65). In another trial, a slight difference (6.1% versus 7.1%) in decline of ERG per year favored vitamin A (P = 0.01). The certainty of the evidence was very low.\nOne trial (51 participants) that assessed optical coherence tomography found no evidence of a difference in ellipsoid zone constriction (P = 0.87) over two years, with very low-certainty evidence. The other three trials did not report this outcome.\nOnly one trial reported adverse events, which found that 27/60 participants experienced 42 treatment-related emergent adverse events (22 in DHA group, 20 in placebo group). The certainty of evidence was very low. The rest of the trials reported no adverse events, and no study reported any evidence of benefit of vitamin supplementation on the progression of visual acuity loss.\nAuthors' conclusions\nBased on the results of four studies, it is uncertain if there is a benefit of treatment with vitamin A or DHA, or both for people with RP. Future trials should also take into account the changes observed in ERG amplitudes and other outcome measures from trials included in this review.\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": "We found four studies that were conducted in the USA and Canada, including a total of 944 participants between the ages of 4 and 55 years. The participants were given vitamin A or fish oil, or both because of their inherited eye disorder and were followed for four years. People who were given vitamin A or fish oil, or both, were compared with those who were not given vitamin A or fish oil. Participants in the vitamin A and/or fish oil group were given different doses of vitamin A or fish oil for differing lengths of time. Participants in the no-vitamin A and/or fish oil group were given pills that did not include vitamin A or fish oil (placebo pills); other treatments thought to prevent progression of vision loss such as multivitamins with or without traces of vitamin A; or no treatment at all.\nThe review shows that whether vitamin A or fish oil, or both, makes any difference in delaying the progression of visual loss is uncertain."
}
] |
query-laysum
|
23115
|
[
{
"role": "user",
"content": "Abstract: Background\nLow vision in childhood is a significant barrier to learning and development, particularly for reading and education. Optical low vision aids may be used to maximise the child's functional vision. The World Health Organization (WHO) has previously highlighted the importance of the use of low vision aids in managing children with visual impairment across the world.\nObjectives\nTo assess the effect of optical low vision aids on reading in children and young people with low vision.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to January 2015), EMBASE (January 1980 to January 2015), the Health Technology Assessment Programme (HTA) (www.hta.ac.uk/), 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 January 2015.\nWe also used manual searching to check the references listed in retrieved articles. Manufacturers of low vision aids were contacted to request any information about studies or research regarding their products.\nSelection criteria\nWe planned to include randomised controlled trials (RCTs) and quasi-RCTs where any optical low vision aid was compared to standard refractive correction in children and young people aged between 5 and 16 years of age with low vision as defined by the WHO. We planned to include within-person design studies where the order of presentation of devices was randomised.\nData collection and analysis\nTwo authors independently reviewed the search results for eligibility .\nMain results\nNo studies met the inclusion criteria for this review.\nAuthors' conclusions\nThere is a lack of good quality evidence regarding the use of optical low vision aids in children and young people. As such, no implications for practice can be drawn. We believe future research should include functional outcome measures such as reading speed, accuracy and comprehension, as well as the effect of low vision aids on quality of life, in order to truly assess and compare the effect of these devices on a child's life and development.\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": "Low vision in children and teenagers not only affects reading, learning and education but is also thought to have a significant effect on a child's general development. Magnifying reading aids can assist a child or teenager to make the best use of the vision they have.\nWe reviewed the current evidence on the use of magnifying reading aids in children between the ages of 5 and 16 years of age with low vision, when compared to the use of glasses alone. We included magnifying aids such as hand- or stand-held magnifying glasses, telescopes or binoculars but we excluded electronic reading aids which will be the subject of a separate review."
}
] |
query-laysum
|
23116
|
[
{
"role": "user",
"content": "Abstract: Background\nContinuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD).\nObjectives\nTo assess benefits and harms of CERA compared with other epoetins (darbepoetin alfa and epoetin alfa or beta) or placebo/no treatment or CERA with differing strategy of administration for anaemia in individuals with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 13 June 2017 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) of at least three months' duration, comparing CERA with a different ESA (darbepoetin alfa or epoetin alfa or beta) or placebo or standard care or versus CERA with different strategies for administration in people with any stage of CKD.\nData collection and analysis\nData were extracted by two independent investigators. We summarised patient-centred outcomes (all-cause and cardiovascular mortality, major adverse cardiovascular events, red cell blood transfusion, iron therapy, cancer, hypertension, seizures, dialysis vascular access thrombosis, drug injection-related events, hyperkalaemia and health-related quality of life and haemoglobin levels) using random effects meta-analysis. Treatment estimates were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean differences or standardized mean difference with 95% CI for continuous outcomes.\nMain results\nWe included 27 studies involving 5410 adults with CKD. Seven studies (1273 participants) involved people not requiring dialysis, 19 studies (4209 participants) involved people treated with dialysis and one study (71 participants) evaluated treatment in recipients of a kidney transplant. Treatment was given for 24 weeks on average. No data were available for children with CKD. Studies were generally at high or unclear risk of bias from allocation concealment and blinding of outcomes. Only two studies masked participants and investigators to treatment allocation. One study compared CERA with placebo, nine studies CERA with epoetin alfa or beta, nine studies CERA with darbepoetin alfa, and two studies compared CERA with epoetin alfa or beta and darbepoetin alfa. Three studies assessed the effects of differing frequencies of CERA administration and five assessed differing CERA doses.\nThere was low certainty evidence that CERA had little or no effects on mortality (RR 1.07, 95% CI 0.73 to 1.57; RR 1.11, 95% CI 0.75 to 1.65), major adverse cardiovascular events (RR 5.09, 95% CI 0.25 to 105.23; RR 5.56, 95% CI 0.99 to 31.30), hypertension (RR 1.01, 95% CI 0.75 to 1.37; RR 1.00, 95% CI 0.79 to 1.28), need for blood transfusion (RR 1.02, 95% CI 0.72 to 1.46; RR 0.94, 95% CI 0.55 to 1.61), or additional iron therapy (RR 1.03, 95% CI 0.91 to 1.15; RR 0.99, 95% CI 0.95 to 1.03) compared to epoetin alfa/beta or darbepoetin alfa respectively. There was insufficient evidence to compare the effect of CERA to placebo on clinical outcomes. Only one low quality study reported that CERA compared to placebo might lead to little or no difference in the risk of major cardiovascular events (RR 2.97, 95% CI 0.31 to 28.18) and hypertension ((RR 0.73, 95% CI 0.35 to 1.52). There was low certainty evidence that different doses (higher versus lower) or frequency (twice versus once monthly) of CERA administration had little or no different effect on all-cause mortality (RR 3.95, 95% CI 0.17 to 91.61; RR 0.97, 95% CI 0.56 to 1.66), hypertension (RR 0.45, 95% CI 0.08 to 2.52; RR 0.85, 95% CI 0.60 to 1.21), and blood cell transfusions (RR 4.16, 95% CI 0.89 to 19.53; RR 0.91, 95% CI 0.51 to 1.62). No studies reported comparative treatment effects of different ESAs on health-related quality of life.\nAuthors' conclusions\nThere is low certainty evidence that CERA has little or no effects on patient-centred outcomes compared with placebo, epoetin alfa or beta or darbepoetin alfa for adults with CKD. The effects of CERA among children who have CKD have not studied in RCTs.\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": "This review looked at whether CERA has different complication rates and benefits from correcting anaemia (improved quality of life) than other anaemia treatments."
}
] |
query-laysum
|
23117
|
[
{
"role": "user",
"content": "Abstract: Background\nCOVID-19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them.\nIf the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose.\nObjectives\nTo assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection.\nSearch methods\nInformation Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.\nSelection criteria\nThis is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.\nWe sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe found no completed studies to include in this review.\nAuthors' conclusions\nWe identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.\n\nGiven the provided abstract, please respond to the following query: \"How did we search for evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our team of researchers searched the medical literature for studies that compared the effects of patients or healthcare workers self-administering any antimicrobial mouthwash or nasal spray against using no treatment, water or a salt solution."
}
] |
query-laysum
|
23118
|
[
{
"role": "user",
"content": "Abstract: Background\nAllogeneic haematopoietic stem cell transplantation (allo-HSCT) is an established treatment option for many malignant and non-malignant disorders. In the past two decades, peripheral blood stem cells replaced bone marrow as stem cell source due to faster engraftment and practicability. Previous meta-analyses analysed patients treated from 1990 to 2002 and demonstrated no impact of the stem cell source on overall survival, but a greater risk for graft-versus-host disease (GvHD) in peripheral blood transplants. As transplant indications and conditioning regimens continue to change, whether the choice of the stem cell source has an impact on transplant outcomes remains to be determined.\nObjectives\nTo assess the effect of bone marrow versus peripheral blood stem cell transplantation in adult patients with haematological malignancies with regard to overall survival, incidence of relapse and non-relapse mortality, disease-free survival, transplant-related mortality, incidence of GvHD and time to engraftment.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE (from 1948 to February 2014), trial registries and conference proceedings. The search was conducted in October 2011 and was last updated in February 2014. We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing bone marrow and peripheral blood allogeneic stem cell transplantation in adults with haematological malignancies.\nData collection and analysis\nTwo review authors screened abstracts and extracted and analysed data independently. We contacted study authors for additional information. We used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included nine RCTs that met the pre-defined selection criteria, involving a total of 1521 participants. Quality of data reporting was heterogeneous among the studies. Overall, the risk of bias in the included studies was low.\nFor the primary outcome overall survival, our analysis demonstrated comparable results between bone marrow transplantation (BMT) and peripheral blood stem cell transplantation (PBSCT) (six studies, 1330 participants; hazard ratio (HR) 1.07; 95% CI 0.91 to 1.25; P value = 0.43; high-quality evidence).\nDisease-free survival (six studies, 1225 participants; HR 1.04; 95% CI 0.89 to 1.21; P value = 0.6; moderate-quality of evidence) and non-relapse or transplant-related mortality (three studies, 758 participants; HR 0.98; 95% CI 0.76 to 1.28; P = 0.91; high-quality evidence) were also comparable between transplantation arms.\nIn the related-donor setting, data from two of eight studies with 211 participants (21%) indicated a higher relapse incidence in participants transplanted with bone marrow stem cells rather than peripheral blood stem cells (HR 2.73; 95% CI 1.47 to 5.08; P value = 0.001). There was no clear evidence of a difference in relapse incidence between transplantation groups in unrelated donors (HR 1.07; 95% CI 0.78 to 1.47; P value = 0.66). The difference between the donor-related and -unrelated subgroups (P-value = 0.008) was considered to be statistically significant.\nBMT was associated with lower rates of overall and extensive chronic GvHD than PBSCT (overall chronic GvHD: four studies, 1121 participants; HR 0.72; 95% CI 0.61 to 0.85; P value = 0.0001, extensive chronic GvHD: four studies, 765 participants; HR 0.69; 95% CI 0.54 to 0.9; P value = 0.006; moderate-quality evidence for both outcomes). The incidence of acute GvHD grades II to IV was not lower (six studies, 1330 participants; HR 1.03; 95% CI 0.89 to 1.21; P value = 0.67; moderate-quality evidence), but there was a trend for a lower incidence of grades III and IV acute GvHD with BMT than with PBSCT (three studies, 925 participants; HR 0.75; 95% CI 0.55 to 1.02; P value = 0.07; moderate-quality evidence).\nTimes to neutrophil and platelet engraftment were longer with BMT than with PBSCT (neutrophil: five studies, 662 participants; HR 1.96; 95% CI 1.64 to 2.35; P value < 0.00001; platelet: four studies, 333 participants; HR 2.17; 95% CI 1.69 to 2.78; P value < 0.00001).\nAuthors' conclusions\nThis systematic review found high-quality evidence that overall survival following allo-HSCT using the current clinical standard stem cell source - peripheral blood stem cells - was similar to that following allo-HSCT using bone marrow stem cells in adults with haematological malignancies. We found moderate-quality evidence that PBSCT was associated with faster engraftment of neutrophils and platelets, but a higher risk of GvHD (in terms of more overall and extensive chronic GvHD). There was an imprecise effect on relapse and on severe (grades III to IV) acute GvHD. Quality of life, which is severely affected by GvHD, was not evaluated.\nAgainst the background of transplantation practices that have clearly changed over the past 10 to 15 years, our aim was to provide current data on the best stem cell source for allo-HSCT, by including the results of recently conducted trials. Our review includes participants recruited up to 2009, a proportion of whom were older, had received reduced-intensity conditioning regimens or had been transplanted with stem cells from unrelated donors. However, only one, large, study included relatively recently treated participants. Nevertheless, our findings are comparable to those of previous meta-analyses suggesting that our results hold true for today's practice.\n\nGiven the provided abstract, please respond to the following query: \"Results of this meta-analysis\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this systemic review we included nine randomised controlled trials involving 1521 participants. Key inclusion criteria were adults undergoing stem cell transplantation for a blood cancer using either bone marrow stem cells or peripheral stem cells as a stem cell source. Participants were treated between 1994 and 2009. The evidence is current to February 2014.\nIn summary, we found overall and disease-free survival to be comparable for both PBSCT and BMT. Recipients of bone marrow stem cells from related donors were more likely to relapse than recipients of peripheral blood stem cells from related donors, but this difference was not seen in the recipients of bone marrow stem cells from unrelated donors. The incidence of acute GvHD following PBSCT and BMT was comparable; however, there was a tendency to more severe GvHD with PBSCT. PBSCT was associated with higher rates of chronic GvHD. The time to engraftment was significantly shorter with PBSCT than with BMT. The quality of the evidence was considered moderate to high."
}
] |
query-laysum
|
23119
|
[
{
"role": "user",
"content": "Abstract: Background\nLower urinary tract symptoms caused by benign prostatic obstruction (LUTS/BPO) represents one of the most common clinical complaints in men. Physical activity might represent a viable first-line intervention for treating LUTS/BPO.\nObjectives\nTo assess the effects of physical activity for lower urinary tract symptoms caused by benign prostatic obstruction (LUTS/BPO).\nSearch methods\nWe performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase, Web of Science, LILACS, ClinicalTrials.gov, and WHO ICTRP); checked the reference lists of retrieved articles; and handsearched abstract proceedings of conferences with no restrictions on the language of publication or publication status from database inception to 6 November 2018.\nSelection criteria\nWe included published and unpublished randomised controlled and controlled clinical trials that included men diagnosed with LUTS/BPO. We excluded studies in which medical history suggested non-BPO causes of LUTS or prior invasive therapies to physical activity or that used electrical stimulation.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed the risk of bias of included studies. We assessed primary outcomes (symptom score for LUTS; response rate, defined as 20% improvement in symptom score; withdrawal due to adverse events) and secondary outcomes (change of medication use; need for an invasive procedure; postvoid residual urine). We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included six studies that randomised 652 men over 40 years old with moderate or severe LUTS. The four different comparisons were as follows:\nPhysical activity versus watchful waiting\nTwo RCTs randomised 119 participants. The interventions included tai chi and pelvic floor exercise. The evidence was overall of very low quality, and we are uncertain about the effects of physical activity on symptom score for LUTS (mean difference (MD) -8.1, 95% confidence interval (CI) -13.2 to -3.1); response rate (risk ratio (RR) 1.80, 95% CI 0.81 to 4.02; 286 more men per 1000, 95% CI 68 fewer to 1079 more); and withdrawal due to adverse events (RR 1.00, 95% CI 0.59 to 1.69; 0 fewer men per 1000, 95% CI 205 fewer to 345 more).\nPhysical activity as part of self-management programme versus watchful waiting\nTwo RCTs randomised 362 participants. Pelvic floor exercise was one of multiple intervention components. The evidence was of very low quality, and we are uncertain about the effects of physical activity for symptom score for LUTS (MD -6.2, 95% CI -9.9 to -2.5); response rate (RR 2.36, 95% CI 1.32 to 4.21; 424 more men per 1000, 95% CI 100 more to 1000 more); and withdrawal due to adverse events (risk difference 0.00, 95% CI -0.05 to 0.06; 65 fewer men per 1000, 95% CI 65 fewer to 65 fewer).\nPhysical activity as part of weight reduction programme versus watchful waiting\nOne RCT randomised 130 participants. An unclear type of intense exercise was one of multiple intervention components. The evidence was of very low quality, and we are uncertain about the effects for symptom score for LUTS (MD -1.1, 95% CI -3.5 to 1.3); response rate (RR 1.20, 95% CI 0.74 to 1.94; 67 more men per 1000, 95% CI 87 fewer to 313 more); and withdrawal due to adverse events (RR 1.63, 95% CI 1.03 to 2.57; 184 more men per 1000, 95% CI 9 more to 459 more).\nPhysical activity versus alpha-blockers\nOne RCT randomised 41 participants to pelvic floor exercise or alpha-blockers. The evidence was of very low quality, and we are uncertain about the effects for symptom score for LUTS (MD 2.8, 95% CI -0.9 to 6.4) and response rate (RR 0.80, 95% CI 0.55 to 1.15; 167 fewer men per 1000, 95% CI 375 fewer to 125 more). The evidence was of low quality for withdrawal due to adverse events; the effects for this outcome may be similar between interventions (RR 0.86, 95% CI 0.06 to 12.89; 7 fewer men per 1000, 95% CI 49 fewer to 626 more).\nAuthors' conclusions\nWe rated the quality of the evidence for most of the effects of physical activity for LUTS/BPO as very low. We are therefore uncertain whether physical activity affects symptom scores for LUTS, response rate, and withdrawal due to adverse events. Our confidence in the estimates was lowered due to study limitations, inconsistency, indirectness, and imprecision. Additional high-quality research is necessary.\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 six studies, comprising 652 men altogether, that studied four different comparisons. The studies compared different forms of physical activity, alone or as part of a self-management programme, to watchful waiting (no specific intervention) or to alpha-blocker treatment.\nBased on very low-quality evidence for the outcomes of symptom score for lower urinary tract symptoms, and stopping the treatment because of unwanted effects, we are uncertain whether physical activity interventions are helpful in men with lower urinary tract symptoms due to benign prostatic obstruction."
}
] |
query-laysum
|
23120
|
[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is a life-limiting genetic condition affecting various organ systems including the gastrointestinal tract, endocrine system and especially the respiratory tract. Pulmonary exacerbations in CF result in increased symptoms, an acceleration in the rate of lung decline and an increased need for treatment. Early detection of infections or clinical worsening provides an opportunity for proactive treatment that may affect clinical outcomes.\nObjectives\nTo evaluate whether digital technology can effectively predict pulmonary exacerbations to allow earlier intervention and improved health outcomes without increasing the burden of treatment in people with CF.\nSearch methods\nWe used standard, extensive Cochrane search methods. We searched the Cochrane Cystic Fibrosis Trials Register and the reference lists of relevant articles and reviews on 13 October 2022. We searched Embase and the clinical trial registries on 3 January 2023.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs in people with CF looking at whether digital technology can effectively predict pulmonary exacerbations to allow earlier intervention and improved health outcomes without increasing the burden of treatment.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. pulmonary exacerbations and 2. quality of life (QoL). Our secondary outcomes were 3. lung function, 4. hospitalisations, 5. intravenous (IV) antibiotics, 6. microbiology, 7. cost-effectiveness and 8. adverse events. We used GRADE to assess certainty of evidence.\nMain results\nWe included three studies (415 participants) in people with CF aged 15 to 41 years over a 12-month period. One was a multicentre RCT, whilst two were single-centre RCTs.\nThe three studies were mostly similar in their risk of bias, having low or unclear risk of selection bias but a high risk of detection bias, due to the unblinded design of these studies. The studies used a variety of digital technologies to monitor symptoms such as a digital symptom diary either with or without home spirometry monitoring. As the trials only included adults and older children, we are not certain that the results would apply to younger children.\nOne of our primary outcomes was to assess time to detection of pulmonary exacerbation and number of pulmonary exacerbations identified between the intervention and routine care groups. We were largely unable to pool results in a meta-analysis due to the variety of methodologies and ways of reporting data. Two studies noted a shorter time to detection of exacerbations in the intervention group and one of these also reported that the intervention group had a shorter time to first exacerbation (hazard ratio for time to first exacerbation 1.45, 95% confidence interval (CI) 1.09 to 1.93), whilst a further study reported a shorter time to detection of exacerbations in the intervention group requiring oral or IV antibiotics compared to the control group (median: 70 (interquartile range (IQR) 123) days with intervention versus 141 (IQR 140) days with control; P = 0.02). However, all three studies were concordant in finding no probable effect on spirometry in the intervention groups when compared with their routine care groups over a 12-month period.\nWe found that there is probably no difference between groups with regard to QoL scores across most domains except for Weight and Body Image, which favoured the usual care group. There is also probably no difference in the number of days of additional IV antibiotics needed or newly detected pathogens.\nNo studies reported serious adverse events directly linked to the intervention and one study reported their smartphone application was generally well received.\nAuthors' conclusions\nPulmonary exacerbations are universally accepted to be detrimental to progression of CF-related lung disease, therefore, it is intuitive that early detection and intervention would help to improve outcomes. Digital technology provides an opportunity to detect physiological and symptomatic changes to identify exacerbations early.\nOur review found that digital technologies based on recording physiological change (spirometry) and symptoms probably allow earlier identification of exacerbations as a group. However, this may not reduce the number of exacerbations warranting IV antibiotics and there is probably no effect on lung function. This may be partly due to inconsistent definitions of pulmonary exacerbations and discrepancy in the management strategies for pulmonary exacerbations. Overall, the intervention may make little or no difference to QoL scores.\nThe adherence to and uptake of digital technologies, especially those which include physiological measurements, are not well sustained and the costs of these need to be balanced against the clinical efficacy.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found three studies with 415 people with CF aged 15 to 41 years. All the treatment groups used a technology to track their breathing problems, two studies also asked their treatment groups to do regular breathing tests with special devices. All studies followed people in their groups for one year."
}
] |
query-laysum
|
23121
|
[
{
"role": "user",
"content": "Abstract: Background\nLung cancer is the most commonly diagnosed cancer and the leading cause of cancer death in both sexes worldwide. Approximately 50% of those diagnosed with lung cancer will have locally advanced or metastatic disease and will be treated in a palliative setting. Platinum-based combination chemotherapy has benefits in terms of survival and symptom control when compared with best supportive care.\nObjectives\nTo assess the effectiveness and safety of carboplatin-based chemotherapy when compared with cisplatin-based chemotherapy, both in combination with a third-generation drug, in people with advanced non-small cell lung cancer (NSCLC). To compare quality of life in people with advanced NSCLC receiving chemotherapy with cisplatin and carboplatin combined with a third-generation drug.\nSearch methods\nWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 13 January 2019), MEDLINE (via PubMed) (1966 to 13 January 2019), and Embase (via Ovid) (1974 to 13 January 2019). In addition, we handsearched the proceedings of the American Society of Clinical Oncology Meetings (January 1990 to September 2018) and reference lists from relevant resources.\nSelection criteria\nRandomised clinical trials (RCTs) comparing regimens with carboplatin or cisplatin combined with a third-generation drug in people with locally advanced or metastatic NSCLC. We accepted any regimen and number of cycles that included these drugs, since there is no widely accepted standard regimen.\nData collection and analysis\nTwo review authors independently assessed the search results, and a third review author resolved any disagreements. The primary outcomes were overall survival and health-related quality of life. The secondary outcomes were one-year survival rate, objective response rate and toxicity.\nMain results\nIn this updated review, we located one additional RCT, for a total of 11 included RCTs (5088 participants, 4046 of whom were available for meta-analysis). There was no difference in overall survival (hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.82 to 1.20; 10 RCTs; 2515 participants; high-quality evidence); one-year survival rate (risk ratio (RR) 0.98, 95% CI 0.89 to 1.08; I2 = 17%; 4004 participants; all 11 RCTs; high-quality evidence); or response rate (RR 0.89, 95% CI 0.79 to 1.00; I2 = 12%; all 11 RCTs; 4020 participants; high-quality evidence). A subgroup analysis comparing carboplatin with different doses of cisplatin found an overall survival benefit in favour of carboplatin-based regimens when compared to cisplatin at lower doses (40 to 80 mg/m2) (HR 1.15, 95% CI 1.03 to 1.28; 6 RCTs; 2508 participants), although there was no overall survival benefit when carboplatin-based chemotherapy was compared to cisplatin at higher doses (80 to 100 mg/m2) (HR 0.93, 95% CI 0.83 to 1.04; I2 = 0%; 4 RCTs; 1823 participants). Carboplatin caused more thrombocytopenia (RR 2.46, 95% CI 1.49 to 4.04; I2 = 68%; 10 RCTs; 3670 participants) and was associated with more neurotoxicity (RR 1.42, 95% CI 0.91 to 2.23; I2 = 0%, 5 RCTs; 1489 participants), although we believe this last finding is probably related to a confounding factor (higher dose of paclitaxel in the carboplatin-containing treatment arm of a large study included in the analysis). There was no statistically significant difference in renal toxicity (RR 0.52, 95% CI 0.19 to 1.45; I2 = 3%; 3 RCTs; 1272 participants); alopecia (RR 1.11, 95% CI 0.73 to 1.68; I2 = 0%; 2 RCTs; 300 participants); anaemia (RR 1.37, 95% CI 0.79 to 2.38; I2 = 77%; 10 RCTs; 3857 participants); and neutropenia (RR 1.18, 95% CI 0.85 to 1.63; I2 = 94%; 10 RCTs; 3857 participants) between cisplatin-based chemotherapy and carboplatin-based chemotherapy regimens. Two RCTs performed a health-related quality of life analysis; however, as they used different methods of measurement we were unable to perform a meta-analysis. One RCT reported comparative health-related quality of life data between cisplatin and carboplatin-containing arms but found no significant differences in global indices of quality of life, including global health status or functional scales.\nIn this Cochrane review, we found that the quality of evidence was high for overall survival, one-year survival rate and response rate but moderate quality evidence for the other outcomes measured.\nAuthors' conclusions\nAdvanced NSCL patients treated with carboplatin or cisplatin doublet with third-generation chemotherapy drugs showed equivalent overall survival, one-year survival, and response rate. Regarding adverse events, carboplatin caused more thrombocytopenia, and cisplatin caused more nausea/vomiting. Therefore, in this palliative therapeutic intent, the choice of the platin compound should take into account the expected toxicity profile, patient's comorbidities and preferences.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is carboplatin more effective and less toxic than cisplatin in the treatment of people with advanced non-small cell lung cancer?"
}
] |
query-laysum
|
23123
|
[
{
"role": "user",
"content": "Abstract: Background\nInadvertent perioperative hypothermia occurs because of interference with normal temperature regulation by anaesthetic drugs and exposure of skin for prolonged periods. A number of different interventions have been proposed to maintain body temperature by reducing heat loss. Thermal insulation, such as extra layers of insulating material or reflective blankets, should reduce heat loss through convection and radiation and potentially help avoid hypothermia.\nObjectives\nTo assess the effects of pre- or intraoperative thermal insulation, or both, in preventing perioperative hypothermia and its complications during surgery in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 2), MEDLINE, OvidSP (1956 to 4 February 2014), EMBASE, OvidSP (1982 to 4 February 2014), ISI Web of Science (1950 to 4 February 2014), and CINAHL, EBSCOhost (1980 to 4 February 2014), and reference lists of articles. We also searched Current Controlled Trials and ClinicalTrials.gov.\nSelection criteria\nRandomized controlled trials of thermal insulation compared to standard care or other interventions aiming to maintain normothermia.\nData collection and analysis\nTwo authors extracted data and assessed risk of bias for each included study, with a third author checking details. We contacted some authors to ask for additional details. We only collected adverse events if reported in the trials.\nMain results\nWe included 22 trials, with 16 trials providing data for some analyses. The trials varied widely in the type of patients and operations, the timing and measurement of temperature, and particularly in the types of co-interventions used. The risk of bias was largely unclear, but with a high risk of performance bias in most studies and a low risk of attrition bias. The largest comparison of extra insulation versus standard care had five trials with 353 patients at the end of surgery and showed a weighted mean difference (WMD) of 0.12 ºC (95% CI -0.07 to 0.31; low quality evidence). Comparing extra insulation with forced air warming at the end of surgery gave a WMD of -0.67 ºC (95% CI -0.95 to -0.39; very low quality evidence) indicating a higher temperature with forced air warming. Major cardiovascular outcomes were not reported and so were not analysed. There were no clear effects on bleeding, shivering or length of stay in post-anaesthetic care for either comparison. No other adverse effects were reported.\nAuthors' conclusions\nThere is no clear benefit of extra thermal insulation compared with standard care. Forced air warming does seem to maintain core temperature better than extra thermal insulation, by between 0.5 ºC and 1 ºC, but the clinical importance of this difference is unclear.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People can get cold during operations, particularly because of the drugs used as anaesthetics. This can sometimes cause potentially dangerous heart problems. The cold can also make people shiver and feel uncomfortable after an operation. Ways have therefore been developed to try to keep people warm during an operation. One way is to use reflective blankets or clothing as extra insulation."
}
] |
query-laysum
|
23124
|
[
{
"role": "user",
"content": "Abstract: Background\nInsufficient consumption of fruits and vegetables in childhood increases the risk of future non-communicable diseases, including cardiovascular disease. Testing the effects of interventions to increase consumption of fruit and vegetables, including those focused on specific child-feeding strategies or broader multicomponent interventions targeting the home or childcare environment is required to assess the potential to reduce this disease burden.\nObjectives\nTo assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two clinical trials registries to identify eligible trials on 25 January 2020. We searched Proquest Dissertations and Theses in November 2019. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included trials to identify further potentially relevant trials.\nSelection criteria\nWe included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risks of bias of included trials; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures. We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures.\nMain results\nWe included 80 trials with 218 trial arms and 12,965 participants. Fifty trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Fifteen trials examined the impact of parent nutrition education only in increasing child fruit and vegetable intake. Fourteen trials examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. Two trials examined the effect of a nutrition education intervention delivered to children in increasing child fruit and vegetable intake. One trial examined the impact of a child-focused mindfulness intervention in increasing vegetable intake.\nWe judged 23 of the 80 included trials as free from high risks of bias across all domains. Performance, detection and attrition bias were the most common domains judged at high risk of bias for the remaining trials.\nThere is low-quality evidence that child-feeding practices versus no intervention may have a small positive effect on child vegetable consumption, equivalent to an increase of 5.30 grams as-desired consumption of vegetables (SMD 0.50, 95% CI 0.29 to 0.71; 19 trials, 2140 participants; mean post-intervention follow-up = 8.3 weeks). Multicomponent interventions versus no intervention has a small effect on child consumption of fruit and vegetables (SMD 0.32, 95% CI 0.09 to 0.55; 9 trials, 2961 participants; moderate-quality evidence; mean post-intervention follow-up = 5.4 weeks), equivalent to an increase of 0.34 cups of fruit and vegetables a day. It is uncertain whether there are any short-term differences in child consumption of fruit and vegetables in meta-analyses of trials examining parent nutrition education versus no intervention (SMD 0.13, 95% CI −0.02 to 0.28; 11 trials, 3050 participants; very low-quality evidence; mean post-intervention follow-up = 13.2 weeks). We were unable to pool child nutrition education interventions in meta-analysis; both trials reported a positive intervention effect on child consumption of fruit and vegetables (low-quality evidence).\nVery few trials reported long-term effectiveness (6 trials), cost effectiveness (1 trial) or unintended adverse consequences of interventions (2 trials), limiting our ability to assess these outcomes. Trials reported receiving governmental or charitable funds, except for four trials reporting industry funding.\nAuthors' conclusions\nDespite identifying 80 eligible trials of various intervention approaches, the evidence for how to increase children's fruit and vegetable consumption remains limited in terms of quality of evidence and magnitude of effect. Of the types of interventions identified, there was moderate-quality evidence that multicomponent interventions probably lead to, and low-quality evidence that child-feeding practice may lead to, only small increases in fruit and vegetable consumption in children aged five years and under. It is uncertain whether parent nutrition education or child nutrition education interventions alone are effective in increasing fruit and vegetable consumption in children aged five years and under. Our confidence in effect estimates for all intervention approaches, with the exception of multicomponent interventions, is limited on the basis of the very low to low-quality evidence. Long-term follow-up of at least 12 months is required and future research should adopt more rigorous methods to advance the field.\nThis is a living systematic review. Living systematic reviews offer a new approach to review updating, in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.\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": "Not eating enough fruit and vegetables is a considerable health burden in developed countries. Eating adequate amounts of fruit and vegetables is associated with a reduced risk of future non-communicable diseases (such as heart and circulatory disease). Early childhood represents a critical period for the establishment of dietary habits that track into adulthood. Interventions to increase consumption of fruit and vegetables in early childhood may therefore be an effective strategy to reduce this disease burden."
}
] |
query-laysum
|
23125
|
[
{
"role": "user",
"content": "Abstract: Background\nAdvanced renal cell carcinoma has been resistant to drug therapy of different types and new types of drug therapy are needed. Targeted agents inhibit known molecular pathways and have been tested in renal cancer for just over a decade.\nObjectives\n1) To provide a systematic and regularly updated review of randomized studies testing targeted agents in advanced renal cell cancer. \n2) To identify the type and degree of clinical benefit of targeted agents over the prevailing standard of care.\nSearch methods\nPeriod of search: January 2000 to June 2010. \n1) Electronic search of CENTRAL, MEDLINE and EMBASE databases. \n2) Hand search of international cancer meeting abstracts.\nSelection criteria\nRandomized, controlled studies, including a targeted agent in patients with advanced renal cell cancer reporting any pre-specified cancer outcome by allocation.\nData collection and analysis\nThe majority of the standardized search and data extraction was conducted independently by two investigators with subsequent resolution of differences. Handsearching, quality of life and toxicity data extraction, most of the initial analysis, and risk of bias assessment, was carried out by one investigator and verified by additional authors as required. Twenty-five fully eligible studies tested thirteen different targeted agents in a total of 7484 patients with mostly Stage IV disease; 61% had not received prior systemic treatment. The majority of patients were good performance status (ECOG (Eastern Cooperative Oncology Group) 0 to 1). Most comparisons were each examined in only a single study. Risk of bias was considered low for studies that were placebo-controlled, had a primary outcome of overall survival, or that evaluated progression by independent radiologic reviewers unaware of the intervention allocation.\nMain results\nMost progress has been made in patients with advanced renal cancer of the clear cell subtype, a condition with a clearly defined molecular pathology promoting angiogenesis. In systemically untreated patients, two approaches to angiogenesis inhibition have demonstrated benefit. Compared with interferon-alfa monotherapy, oral sunitinib improved multiple outcomes including overall survival (18% risk reduction for death; median survival improved from 21.8 to 26.4 months, P = 0.049) without correction for crossover) in patients with mostly good or moderate prognosis. In the same setting, two studies have shown that the addition of biweekly intravenous bevacizumab to interferon-alfa also improved the chance of major remission and prolonged progression-free survival. These two bevacizumab plus interferon studies each observed improved overall survival approaching statistical significance (each study observed a 14% risk reduction for death). Additional anti-angiogenesis agents, such as pazopanib and tivozanib, are in earlier stages of evaluation. \nAfter progression of clear cell disease on prior cytokine therapy, oral sorafenib results in a better quality of life than placebo. In patients with clear cell disease with progression on or within 6 months of first-line targeted therapy with sunitinib or sorafenib, the targeted oral mTOR (mammalian target of rapamycin) inhibitor everolimus resulted in prolonged disease-free survival without detriment to quality of life. Remissions were very infrequent and no improvement in overall survival was observed in this study where the majority of placebo-assigned patients received everolimus at disease progression. \nIn untreated patients with unselected renal cancer histology and poor prognostic features, weekly intravenous temsirolimus, an mTOR inhibitor, improved outcomes compared with interferon-alfa (median overall survival improved from 7.3 to 10.9 months, P = 0.008). Of particular interest, an exploratory analysis observed a marked reduction in hazard for death in the non-clear cell subgroup. \nCombinations of targeted agents are being evaluated, but toxicity is problematic.\nAuthors' conclusions\nSeveral agents with specified molecular targets have demonstrated clinically useful benefits over interferon-alfa, and also after either prior cytokine or initial anti-angiogenesis therapy. More research is required to fully establish the role of targeted agents in this condition.\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": ""
}
] |
query-laysum
|
23126
|
[
{
"role": "user",
"content": "Abstract: Background\nMajor depressive disorder (MDD), or depression, is a syndrome characterised by a number of behavioural, cognitive and emotional features. It is most commonly associated with a sad or depressed mood, a reduced capacity to feel pleasure, feelings of hopelessness, loss of energy, altered sleep patterns, weight fluctuations, difficulty in concentrating and suicidal ideation. There is a need for more effective and better tolerated antidepressants to combat this condition. Agomelatine was recently added to the list of available antidepressant drugs; it is a novel antidepressant that works on melatonergic (MT1 and MT2), 5-HT 2B and 5-HT2C receptors. Because the mechanism of action is claimed to be novel, it may provide a useful, alternative pharmacological strategy to existing antidepressant drugs.\nObjectives\nThe objective of this review was 1) to determine the efficacy of agomelatine in alleviating acute symptoms of major depressive disorder in comparison with other antidepressants, 2) to review the acceptability of agomelatine in comparison with other antidepressant drugs, and, 3) to investigate the adverse effects of agomelatine, including the general prevalence of side effects in adults.\nSearch methods\nWe searched the Cochrane Collaboration's Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to 31 July 2013. The CCDANCTR includes relevant randomised controlled trials from the following bibliographic databases: CENTRAL (the Cochrane Central Register of Controlled Trials) (all years), EMBASE (1974 onwards), MEDLINE (1950 onwards) and PsycINFO (1967 onwards). We checked reference lists of relevant studies together with reviews and regulatory agency reports. No restrictions on date, language or publication status were applied to the search. Servier Laboratories (developers of agomelatine) and other experts in the field were contacted for supplemental data.\nSelection criteria\nRandomised controlled trials allocating adult participants with major depression to agomelatine versus any other antidepressive agent.\nData collection and analysis\nTwo review authors independently extracted data and a double-entry procedure was employed. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability.\nMain results\nA total of 13 studies (4495 participants) were included in this review. Agomelatine was compared to selective serotonin reuptake inhibitors (SSRIs), namely paroxetine, fluoxetine, sertraline, escitalopram, and to the serotonin–norepinephrine reuptake inhibitor (SNRI), venlafaxine. Participants were followed up for six to 12 weeks. Agomelatine did not show any advantage or disadvantage over the other antidepressants for our primary outcome, response to treatment (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.95 to 1.08, P value 0.75 compared to SSRIs, and RR 1.06; 95% CI 0.98 to 1.16, P value 0.16 compared to venlafaxine). Also, agomelatine showed no advantage or disadvantage over other antidepressants for remission (RR 0.83; 95% CI 0.68 to 1.01, P value 0.07 compared to SSRIs, and RR 1.08; 95% CI 0.94 to 1.24, P value 0.73 compared to venlafaxine). Overall, agomelatine appeared to be better tolerated than venlafaxine in terms of lower rates of drop outs (RR 0.40; 95% CI 0.24 to 0.67, P value 0.0005), and showed the same level of tolerability as SSRIs (RR 0.95; 95% CI 0.83 to 1.09, P value 0.44). Agomelatine induced a lower rate of dizziness than venlafaxine (RR 0.19, 95% CI 0.06 to 0.64, P value 0.007).\nWith regard to the quality of the body of evidence, there was a moderate risk of bias for all outcomes, due to the number of included unpublished studies. There was some heterogeneity, particularly between published and unpublished studies. The included studies were conducted in inpatient and outpatient settings, thus limiting the generalisability of the results to primary care settings. With regard to precision, the efficacy outcomes were precise, but the tolerability outcomes were mostly imprecise. Publication bias was variable and depended on the outcome of the trial. Our review included unpublished studies, and we think that this reduced the impact of publication bias. The overall methodological quality of the studies was not very good. Almost all of the studies were sponsored by the pharmaceutical company that manufactures agomelatine (Servier), and some of these were unpublished. Attempts to contact the pharmaceutical company Servier for additional information on all unpublished studies were unsuccessful.\nAuthors' conclusions\nAgomelatine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. Agomelatine was better tolerated than paroxetine and venlafaxine in terms of overall side effects, and fewer participants treated with agomelatine dropped out of the trials due to side effects compared to sertraline and venlafaxine, but data were limited because the number of included studies was small. We found evidence that compared agomelatine with only a small number of other active antidepressive agents, and there were only a few trials for each comparison, which limits the generalisability of the results. Moreover, the overall methodological quality of the studies was low, and, therefore, no firm conclusions can be drawn concerning the efficacy and tolerability of agomelatine.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Major depression is a serious illness that can cause significant distress both to sufferers and their families. Major depression affects people's work, relationships and self-esteem. It also affects people physically, changing their sleep patterns, concentration and appetite. The symptoms of major depression can lead people to feel hopeless and even suicidal. Antidepressant medications are an effective treatment option for major depression, but many have unpleasant side-effects.\nThis review is important because it compares a new antidepressant, called agomelatine, with some other antidepressants used to treat major depression. Agomelatine works in a different way to existing antidepressants, it affects the hormone melatonin in the brain, and stimulates release of the brain chemicals dopamine and norepinephrine."
}
] |
query-laysum
|
23127
|
[
{
"role": "user",
"content": "Abstract: Background\nDelirium is a common mental disorder, which is distressing and has serious adverse outcomes in hospitalised patients. Prevention of delirium is desirable from the perspective of patients and carers, and healthcare providers. It is currently unclear, however, whether interventions for preventing delirium are effective.\nObjectives\nTo assess the effectiveness of interventions for preventing delirium in hospitalised non-Intensive Care Unit (ICU) patients.\nSearch methods\nWe searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group’s Specialized Register on 4 December 2015 for all randomised studies on preventing delirium. We also searched MEDLINE (Ovid SP), EMBASE (Ovid SP), PsycINFO (Ovid SP), Central (The Cochrane Library), CINAHL (EBSCOhost), LILACS (BIREME), Web of Science core collection (ISI Web of Science), ClinicalTrials.gov and the WHO meta register of trials, ICTRP.\nSelection criteria\nWe included randomised controlled trials (RCTs) of single and multi- component non-pharmacological and pharmacological interventions for preventing delirium in hospitalised non-ICU patients.\nData collection and analysis\nTwo review authors examined titles and abstracts of citations identified by the search for eligibility and extracted data independently, with any disagreements settled by consensus. The primary outcome was incidence of delirium; secondary outcomes included duration and severity of delirium, institutional care at discharge, quality of life and healthcare costs. We used risk ratios (RRs) as measures of treatment effect for dichotomous outcomes; and between group mean differences and standard deviations for continuous outcomes.\nMain results\nWe included 39 trials that recruited 16,082 participants, assessing 22 different interventions or comparisons. Fourteen trials were placebo-controlled, 15 evaluated a delirium prevention intervention against usual care, and 10 compared two different interventions. Thirty-two studies were conducted in patients undergoing surgery, the majority in orthopaedic settings. Seven studies were conducted in general medical or geriatric medicine settings.\nWe found multi-component interventions reduced the incidence of delirium compared to usual care (RR 0.69, 95% CI 0.59 to 0.81; seven studies; 1950 participants; moderate-quality evidence). Effect sizes were similar in medical (RR 0.63, 95% CI 0.43 to 0.92; four studies; 1365 participants) and surgical settings (RR 0.71, 95% CI 0.59 to 0.85; three studies; 585 participants). In the subgroup of patients with pre-existing dementia, the effect of multi-component interventions remains uncertain (RR 0.90, 95% CI 0.59 to 1.36; one study, 50 participants; low-quality evidence).\nThere is no clear evidence that cholinesterase inhibitors are effective in preventing delirium compared to placebo (RR 0.68, 95% CI, 0.17 to 2.62; two studies, 113 participants; very low-quality evidence).\nThree trials provide no clear evidence of an effect of antipsychotic medications as a group on the incidence of delirium (RR 0.73, 95% CI, 0.33 to 1.59; 916 participants; very low-quality evidence). In a pre-planned subgroup analysis there was no evidence for effectiveness of a typical antipsychotic (haloperidol) (RR 1.05, 95% CI 0.69 to 1.60; two studies; 516 participants, low-quality evidence). However, delirium incidence was lower (RR 0.36, 95% CI 0.24 to 0.52; one study; 400 participants, moderate-quality evidence) for patients treated with an atypical antipsychotic (olanzapine) compared to placebo (moderate-quality evidence).\nThere is no clear evidence that melatonin or melatonin agonists reduce delirium incidence compared to placebo (RR 0.41, 95% CI 0.09 to 1.89; three studies, 529 participants; low-quality evidence).\nThere is moderate-quality evidence that Bispectral Index (BIS)-guided anaesthesia reduces the incidence of delirium compared to BIS-blinded anaesthesia or clinical judgement (RR 0.71, 95% CI 0.60 to 0.85; two studies; 2057 participants).\nIt is not possible to generate robust evidence statements for a range of additional pharmacological and anaesthetic interventions due to small numbers of trials, of variable methodological quality.\nAuthors' conclusions\nThere is strong evidence supporting multi-component interventions to prevent delirium in hospitalised patients. There is no clear evidence that cholinesterase inhibitors, antipsychotic medication or melatonin reduce the incidence of delirium. Using the Bispectral Index to monitor and control depth of anaesthesia reduces the incidence of postoperative delirium. The role of drugs and other anaesthetic techniques to prevent delirium remains uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found strong evidence that multi-component interventions can prevent delirium in both medical and surgical settings and less robust evidence that they reduce the severity of delirium. Evidence about their effect on the duration of delirium is inconclusive.\nThere is evidence that monitoring the depth of anaesthesia can reduce the occurrence of delirium after general anaesthetic.\nWe found no clear evidence that a range of medications or other anaesthetic techniques or procedures are effective in preventing delirium."
}
] |
query-laysum
|
23128
|
[
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for adults with fibromyalgia. We defined flexibility exercise training programs as those involving movements of a joint or a series of joints, through complete range of motion, thus targeting major muscle-tendon units. This review is one of a series of reviews updating the first review published in 2002.\nObjectives\nTo evaluate the benefits and harms of flexibility exercise training in adults with fibromyalgia.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database), Thesis and Dissertation Abstracts, AMED (Allied and Complementary Medicine Database), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov up to December 2017, unrestricted by language, and we reviewed the reference lists of retrieved trials to identify potentially relevant trials.\nSelection criteria\nWe included randomized trials (RCTs) including adults diagnosed with fibromyalgia based on published criteria. Major outcomes were health-related quality of life (HRQoL), pain intensity, stiffness, fatigue, physical function, trial withdrawals, and adverse events.\nData collection and analysis\nTwo review authors independently selected articles for inclusion, extracted data, performed 'Risk of bias' assessments, and assessed the certainty of the body of evidence for major outcomes using the GRADE approach. All discrepancies were rechecked, and consensus was achieved by discussion.\nMain results\nWe included 12 RCTs (743 people). Among these RCTs, flexibility exercise training was compared to an untreated control group, land-based aerobic training, resistance training, or other interventions (i.e. Tai Chi, Pilates, aquatic biodanza, friction massage, medications). Studies were at risk of selection, performance, and detection bias (due to lack of adequate randomization and allocation concealment, lack of participant or personnel blinding, and lack of blinding for self-reported outcomes). With the exception of withdrawals and adverse events, major outcomes were self-reported and were expressed on a 0-to-100 scale (lower values are best, negative mean differences (MDs) indicate improvement). We prioritized the findings of flexibility exercise training compared to land-based aerobic training and present them fully here.\nVery low-certainty evidence showed that compared with land-based aerobic training, flexibility exercise training (five trials with 266 participants) provides no clinically important benefits with regard to HRQoL, pain intensity, fatigue, stiffness, and physical function. Low-certainty evidence showed no difference between these groups for withdrawals at completion of the intervention (8 to 20 weeks).\nMean HRQoL assessed on the Fibromyalgia Impact Questionnaire (FIQ) Total scale (0 to 100, higher scores indicating worse HRQoL) was 46 mm and 42 mm in the flexibility and aerobic groups, respectively (2 studies, 193 participants); absolute change was 4% worse (6% better to 14% worse), and relative change was 7.5% worse (10.5% better to 25.5% worse) in the flexibility group. Mean pain was 57 mm and 52 mm in the flexibility and aerobic groups, respectively (5 studies, 266 participants); absolute change was 5% worse (1% better to 11% worse), and relative change was 6.7% worse (2% better to 15.4% worse). Mean fatigue was 67 mm and 71 mm in the aerobic and flexibility groups, respectively (2 studies, 75 participants); absolute change was 4% better (13% better to 5% worse), and relative change was 6% better (19.4% better to 7.4% worse). Mean physical function was 23 points and 17 points in the flexibility and aerobic groups, respectively (1 study, 60 participants); absolute change was 6% worse (4% better to 16% worse), and relative change was 14% worse (9.1% better to 37.1% worse). We found very low-certainty evidence of an effect for stiffness. Mean stiffness was 49 mm to 79 mm in the flexibility and aerobic groups, respectively (1 study, 15 participants); absolute change was 30% better (8% better to 51% better), and relative change was 39% better (10% better to 68% better). We found no evidence of an effect in all-cause withdrawal between the flexibility and aerobic groups (5 studies, 301 participants). Absolute change was 1% fewer withdrawals in the flexibility group (8% fewer to 21% more), and relative change in the flexibility group compared to the aerobic training intervention group was 3% fewer (39% fewer to 55% more). It is uncertain whether flexibility leads to long-term effects (36 weeks after a 12-week intervention), as the evidence was of low certainty and was derived from a single trial.\nVery low-certainty evidence indicates uncertainty in the risk of adverse events for flexibility exercise training. One adverse effect was described among the 132 participants allocated to flexibility training. One participant had tendinitis of the Achilles tendon (McCain 1988), but it is unclear if the tendinitis was a pre-existing condition.\nAuthors' conclusions\nWhen compared with aerobic training, it is uncertain whether flexibility improves outcomes such as HRQoL, pain intensity, fatigue, stiffness, and physical function, as the certainty of the evidence is very low. Flexibility exercise training may lead to little or no difference for all-cause withdrawals. It is also uncertain whether flexibility exercise training has long-term effects due to the very low certainty of the evidence. We downgraded the evidence owing to the small number of trials and participants across trials, as well as due to issues related to unclear and high risk of bias (selection, performance, and detection biases). While flexibility exercise training appears to be well tolerated (similar withdrawal rates across groups), evidence on adverse events was scarce, therefore its safety is uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Health-related quality of life\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who received flexibility exercise training were 4% worse (ranging from 6% better to 14% worse).\n• People who had flexibility training rated their quality of life as 46 points.\n• People who had aerobic training rated their quality of life as 42 points."
}
] |
query-laysum
|
23129
|
[
{
"role": "user",
"content": "Abstract: Background\nThe development of severe coronavirus disease 2019 (COVID-19) and poor clinical outcomes are associated with hyperinflammation and a complex dysregulation of the immune response. Colchicine is an anti-inflammatory medicine and is thought to improve disease outcomes in COVID-19 through a wide range of anti-inflammatory mechanisms. Patients and healthcare systems need more and better treatment options for COVID-19 and a thorough understanding of the current body of evidence.\nObjectives\nTo assess the effectiveness and safety of Colchicine as a treatment option for COVID-19 in comparison to an active comparator, placebo, or standard care alone in any setting, and to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (comprising CENTRAL, MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv), Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index), and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 21 May 2021.\nSelection criteria\nWe included randomised controlled trials evaluating colchicine for the treatment of people with COVID-19, irrespective of disease severity, age, sex, or ethnicity.\nWe excluded studies investigating the prophylactic effects of colchicine for people without severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but at high risk of SARS-CoV-2 exposure.\nData collection and analysis\nWe followed standard Cochrane methodology. We used the Cochrane risk of bias tool (ROB 2) to assess bias in included studies and GRADE to rate the certainty of evidence for the following prioritised outcome categories considering people with moderate or severe COVID-19: all-cause mortality, worsening and improvement of clinical status, quality of life, adverse events, and serious adverse events and for people with asymptomatic infection or mild disease: all-cause mortality, admission to hospital or death, symptom resolution, duration to symptom resolution, quality of life, adverse events, serious adverse events.\nMain results\nWe included three RCTs with 11,525 hospitalised participants (8002 male) and one RCT with 4488 (2067 male) non-hospitalised participants. Mean age of people treated in hospital was about 64 years, and was 55 years in the study with non-hospitalised participants. Further, we identified 17 ongoing studies and 11 studies completed or terminated, but without published results.\nColchicine plus standard care versus standard care (plus/minus placebo)\nTreatment of hospitalised people with moderate to severe COVID-19\nAll-cause mortality: colchicine plus standard care probably results in little to no difference in all-cause mortality up to 28 days compared to standard care alone (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93 to 1.08; 2 RCTs, 11,445 participants; moderate-certainty evidence).\nWorsening of clinical status: colchicine plus standard care probably results in little to no difference in worsening of clinical status assessed as new need for invasive mechanical ventilation or death compared to standard care alone (RR 1.02, 95% CI 0.96 to 1.09; 2 RCTs, 10,916 participants; moderate-certainty evidence).\nImprovement of clinical status: colchicine plus standard care probably results in little to no difference in improvement of clinical status, assessed as number of participants discharged alive up to day 28 without clinical deterioration or death compared to standard care alone (RR 0.99, 95% CI 0.96 to 1.01; 1 RCT, 11,340 participants; moderate-certainty evidence).\nQuality of life, including fatigue and neurological status: we identified no studies reporting this outcome.\nAdverse events: the evidence is very uncertain about the effect of colchicine on adverse events compared to placebo (RR 1.00, 95% CI 0.56 to 1.78; 1 RCT, 72 participants; very low-certainty evidence).\nSerious adverse events: the evidence is very uncertain about the effect of colchicine plus standard care on serious adverse events compared to standard care alone (0 events observed in 1 RCT of 105 participants; very low-certainty evidence).\nTreatment of non-hospitalised people with asymptomatic SARS-CoV-2 infection or mild COVID-19\nAll-cause mortality: the evidence is uncertain about the effect of colchicine on all-cause mortality at 28 days (Peto odds ratio (OR) 0.57, 95% CI 0.20 to 1.62; 1 RCT, 4488 participants; low-certainty evidence).\nAdmission to hospital or death within 28 days: colchicine probably slightly reduces the need for hospitalisation or death within 28 days compared to placebo (RR 0.80, 95% CI 0.62 to 1.03; 1 RCT, 4488 participants; moderate-certainty evidence).\nSymptom resolution: we identified no studies reporting this outcome.\nQuality of life, including fatigue and neurological status: we identified no studies reporting this outcome.\nAdverse events: the evidence is uncertain about the effect of colchicine on adverse events compared to placebo . Results are from one RCT reporting treatment-related events only in 4412 participants (low-certainty evidence).\nSerious adverse events: colchicine probably slightly reduces serious adverse events (RR 0.78, 95% CI 0.61 to 1.00; 1 RCT, 4412 participants; moderate-certainty evidence).\nColchicine versus another active treatment (e.g. corticosteroids, anti-viral drugs, monoclonal antibodies)\nNo studies evaluated this comparison.\nDifferent formulations, doses, or schedules of colchicine\nNo studies assessed this.\nAuthors' conclusions\nBased on the current evidence, in people hospitalised with moderate to severe COVID-19 the use of colchicine probably has little to no influence on mortality or clinical progression in comparison to placebo or standard care alone. We do not know whether colchicine increases the risk of (serious) adverse events.\nWe are uncertain about the evidence of the effect of colchicine on all-cause mortality for people with asymptomatic infection or mild disease. However, colchicine probably results in a slight reduction of hospital admissions or deaths within 28 days, and the rate of serious adverse events compared with placebo.\nNone of the studies reported data on quality of life or compared the benefits and harms of colchicine versus other drugs, or different dosages of colchicine.\nWe identified 17 ongoing and 11 completed but not published RCTs, which we expect to incorporate in future versions of this review as their results become available.\nEditorial note: due to the living approach of this work, we monitor newly published results of RCTs on colchicine on a weekly basis and will update the review when the evidence or our certainty in the evidence changes.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
23130
|
[
{
"role": "user",
"content": "Abstract: Background\nChildbirth is a complex life event that can be associated with both positive and negative psychological responses. When giving birth is experienced as particularly traumatic this can have a negative impact on a woman’s postnatal emotional well-being. There has been an increasing focus on women's psychological trauma symptoms following childbirth, including the relatively rare phenomenon of post-traumatic stress disorder (PTSD), and the benefit of debriefing interventions to prevent this. In this review we examined the evidence for debriefing as a preventative intervention for psychological trauma following childbirth.\nObjectives\nTo assess the effects of debriefing interventions compared with standard postnatal care for the prevention of psychological trauma in women following childbirth.\nSearch methods\nThe trials registers of the Cochrane Depression, Anxiety and Neurosis Group (CCDANCTR-References and CCDANCTR-Studies) and the Cochrane Pregnancy and Childbirth Group were searched up to 4 March 2015. These registers include relevant randomised controlled trials from the following bibliographic databases: the Cochrane Library (all years to date), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). Additional searches were conducted in CENTRAL, MEDLINE, EMBASE, PsycINFO, and Maternity and Infant Care. The reference lists of all included studies were checked for additional published reports and citations of unpublished research. Experts in the field were contacted.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised trials comparing postnatal debriefing interventions with standard postnatal care for the prevention of psychological trauma of women following childbirth. The intervention consisted of at least one debriefing intervention session, which had the purpose of allowing women to describe their experience and to normalise their emotional reaction to that experience.\nData collection and analysis\nThree authors independently assessed trial quality and extracted data. Meta-analysis was conducted where there were more than two trials examining the same outcomes.\nMain results\nWe included seven trials (eight articles) from three countries (UK, Australia and Sweden) that fulfilled the inclusion criteria. The number of women contributing data to each outcome varied from 102 to 1745. Methodological quality was variable and most of the studies were of low quality. The quality of evidence for the prevalence of psychological trauma (primary outcome) and the prevalence of depression symptoms was rated low or very low, based on few studies (ranging from a single study to three studies) with high risk of bias in main domains such as performance bias, random sequence generation, allocation concealment and incomplete outcome data. The quality of evidence for the remaining outcomes (that is prevalence of anxiety, prevalence of fear of childbirth, prevalence of general psychological morbidity, health service utilization and attrition from treatment) was not assessed as data were not available.\nAmong women who had a high level of obstetric intervention during labour and birth, we found no difference between standard postnatal care with debriefing and standard postnatal care without debriefing on psychological trauma symptoms within three months postpartum (RR 0.61; 95% CI 0.28 to 1.31; n = 425) or at three to six months postpartum (RR 0.62; 95% CI 0.27 to 1.42; n = 246). The results were based on two trials, respectively. Among women who experienced a distressing or traumatic birth, there was no evidence of an effect of psychological debriefing on the prevention of PTSD (measured by the MINI-PTSD) at four to six weeks postpartum (RR 1.15; 95% CI 0.66 to 2.01; n = 102) or at six months (RR 0.35; 95% CI 0.10 to 1.23; n = 103). The results were based on one small trial. One trial involving low-risk women who delivered healthy infants at or near term reported no significant difference between the intervention group and the control group in the proportion of women who met the diagnostic criteria for psychological trauma during the year following childbirth (RR 1.06; 95% CI 0.88 to 1.28; n = 1745). We did not find any information about attrition rates.\nAuthors' conclusions\nWe did not find any high quality evidence to inform practice, with substantial heterogeneity being found between the studies conducted to date. There is little or no evidence to support either a positive or adverse effect of psychological debriefing for the prevention of psychological trauma in women following childbirth. There is no evidence to support routine debriefing for women who perceive giving birth as psychologically traumatic.\nFuture research should provide greater detail of the outcome measures used, and with scales for measuring psychological trauma validated against clinical diagnostic interviews. High rates of obstetric intervention in some birth settings may mean that women require improved emotional care from health professionals to reduce the risk of childbirth being experienced as traumatic. As all included trials excluded women unable to communicate in the native language of the study setting, there is no information on the response of these women to psychological debriefing. No included studies were conducted in low or middle-income countries.\n\nGiven the provided abstract, please respond to the following query: \"Which studies were included in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched databases to find all studies (specifically randomised controlled trials) published before 4 March 2015 that investigated debriefing for the prevention of psychological trauma in women following childbirth. We included seven studies with a total of 3596 women. The studies were published between 1998 and 2005 and all were conducted in high-income countries (UK, Australia and Sweden)."
}
] |
query-laysum
|
23131
|
[
{
"role": "user",
"content": "Abstract: Background\nDown's syndrome occurs when a person has three copies of chromosome 21, or the specific area of chromosome 21 implicated in causing Down's syndrome, rather than two. It is the commonest congenital cause of mental disability and also leads to numerous metabolic and structural problems. It can be life-threatening, or lead to considerable ill health, although some individuals have only mild problems and can lead relatively normal lives. Having a baby with Down's syndrome is likely to have a significant impact on family life. The risk of a Down's syndrome affected pregnancy increases with advancing maternal age.\nNoninvasive screening based on biochemical analysis of maternal serum or urine, or fetal ultrasound measurements, allows estimates of the risk of a pregnancy being affected and provides information to guide decisions about definitive testing. Before agreeing to screening tests, parents need to be fully informed about the risks, benefits and possible consequences of such a test. This includes subsequent choices for further tests they may face, and the implications of both false positive and false negative screening tests (i.e. invasive diagnostic testing, and the possibility that a miscarried fetus may be chromosomally normal). The decisions that may be faced by expectant parents inevitably engender a high level of anxiety at all stages of the screening process, and the outcomes of screening can be associated with considerable physical and psychological morbidity. No screening test can predict the severity of problems a person with Down's syndrome will have.\nObjectives\nTo estimate and compare the accuracy of first and second trimester urine markers for the detection of Down's syndrome.\nSearch methods\nWe carried out a sensitive and comprehensive literature search of MEDLINE (1980 to 25 August 2011), EMBASE (1980 to 25 August 2011), BIOSIS via EDINA (1985 to 25 August 2011), CINAHL via OVID (1982 to 25 August 2011), The Database of Abstracts of Reviews of Effectiveness (The Cochrane Library 2011, Issue 7), MEDION (25 August 2011), The Database of Systematic Reviews and Meta-Analyses in Laboratory Medicine (25 August 2011), The National Research Register (archived 2007), Health Services Research Projects in Progress database (25 August 2011). We studied reference lists and published review articles.\nSelection criteria\nStudies evaluating tests of maternal urine in women up to 24 weeks of gestation for Down's syndrome, compared with a reference standard, either chromosomal verification or macroscopic postnatal inspection.\nData collection and analysis\nWe extracted data as test positive or test negative results for Down's and non-Down's pregnancies allowing estimation of detection rates (sensitivity) and false positive rates (1-specificity). We performed quality assessment according to QUADAS (Quality Assessment of Diagnostic Accuracy Studies) criteria. We used hierarchical summary ROC (receiver operating characteristic) meta-analytical methods to analyse test performance and compare test accuracy. We performed analysis of studies allowing direct comparison between tests. We investigated the impact of maternal age on test performance in subgroup analyses.\nMain results\nWe included 19 studies involving 18,013 pregnancies (including 527 with Down's syndrome). Studies were generally of high quality, although differential verification was common with invasive testing of only high-risk pregnancies. Twenty-four test combinations were evaluated formed from combinations of the following seven different markers with and without maternal age: AFP (alpha-fetoprotein), ITA (invasive trophoblast antigen), ß-core fragment, free ßhCG (beta human chorionic gonadotrophin), total hCG, oestriol, gonadotropin peptide and various marker ratios. The strategies evaluated included three double tests and seven single tests in combination with maternal age, and one triple test, two double tests and 11 single tests without maternal age. Twelve of the 19 studies only evaluated the performance of a single test strategy while the remaining seven evaluated at least two test strategies. Two marker combinations were evaluated in more than four studies; second trimester ß-core fragment (six studies), and second trimester ß-core fragment with maternal age (five studies).\nIn direct test comparisons, for a 5% false positive rate (FPR), the diagnostic accuracy of the double marker second trimester ß-core fragment and oestriol with maternal age test combination was significantly better (ratio of diagnostic odds ratio (RDOR): 2.2 (95% confidence interval (CI) 1.1 to 4.5), P = 0.02) (summary sensitivity of 73% (CI 57 to 85) at a cut-point of 5% FPR) than that of the single marker test strategy of second trimester ß-core fragment and maternal age (summary sensitivity of 56% (CI 45 to 66) at a cut-point of 5% FPR), but was not significantly better (RDOR: 1.5 (0.8 to 2.8), P = 0.21) than that of the second trimester ß-core fragment to oestriol ratio and maternal age test strategy (summary sensitivity of 71% (CI 51 to 86) at a cut-point of 5% FPR).\nAuthors' conclusions\nTests involving second trimester ß-core fragment and oestriol with maternal age are significantly more sensitive than the single marker second trimester ß-core fragment and maternal age, however, there were few studies. There is a paucity of evidence available to support the use of urine testing for Down's syndrome screening in clinical practice where alternatives are available.\n\nGiven the provided abstract, please respond to the following query: \"Other important information to consider\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The urine tests themselves have no adverse effects for the woman. However, some women who have a ‘high risk’ screening test result, and are given amniocentesis or CVS have a risk of miscarrying a baby unaffected by Down’s. Parents will need to weigh up this risk when deciding whether or not to have an amniocentesis or CVS following a ‘high risk’ screening test result."
}
] |
query-laysum
|
23132
|
[
{
"role": "user",
"content": "Abstract: Background\nTrigger finger is a disease of the tendons of the hand leading to triggering (locking) of affected fingers, dysfunction and pain. Available treatments include local injection with corticosteroids, surgery, or splinting.\nObjectives\nTo summarize the evidence on the efficacy and safety of corticosteroid injections for trigger finger in adults using the following endpoints: treatment success, frequency of triggering or locking, functional status of the affected fingers, and severity of pain of the fingers.\nSearch methods\nThe databases CENTRAL, DARE, MEDLINE (1966 to November 2007), EMBASE (1956 to November 2007), CINAHL (1982 to November 2007), AMED (1985 to November 2007) and PEDro (a physiotherapy evidence database) were searched.\nSelection criteria\nWe selected randomized and controlled clinical trials evaluating efficacy and safety of corticosteroid injections for trigger finger in adults.\nData collection and analysis\nThe databases were searched for titles of eligible studies. After screening abstracts of these studies, full text articles of studies which fulfilled the selection criteria were obtained. Data were extracted using a predefined electronic form. The methodological quality of included trials was assessed by using items from the checklist developed by Jadad and the Delphi list. We planned to extract data regarding information on the primary outcome measures: treatment success, frequency of triggering or locking, and functional impairment of fingers, severity of the trigger finger; and the secondary outcome measures: proportion of patients with side effects, types of side effects, and patient satisfaction with injection.\nMain results\nTwo randomized controlled studies were found that involved 63 participants: 34 were allocated to corticosteroids and lidocaine, and 29 were allocated to lidocaine alone. Corticosteroid injection with lidocaine was more effective than lidocaine alone on treatment success at four weeks (relative risk 3.15, 95% CI 1.34 to 7.40). The number needed to treat to benefit was 3. No adverse events or side effects were reported.\nAuthors' conclusions\nThe effectiveness of local corticosteroid injections was studied in only two small randomized controlled trials of poor methodological quality. Both studies showed better short-term effects of corticosteroid injection combined with lidocaine compared to lidocaine alone on the treatment success outcome. In one study the effects of corticosteroid injections lasted up to four months. No adverse effects were observed. The available evidence for the effectiveness of intra-tendon sheath corticosteroid injection for trigger finger can be graded as a silver level evidence for superiority of corticosteroid injections combined with lidocaine over injections with lidocaine alone.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens after a corticosteroid injection\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "37 out of 100 people benefited from corticosteroid injection combined with a painkiller; compared to 17 out of 100 people who benefited following injection with a painkiller only."
}
] |
query-laysum
|
23133
|
[
{
"role": "user",
"content": "Abstract: Background\nHepatocellular carcinoma (primary liver cancer) is classified in many ways. The Barcelona Clinic Liver Cancer (BCLC) group staging classifies the cancer based on patient's life expectancy. People with very early- or early-stage hepatocellular carcinoma have single tumour or three tumours of maximum diameter of 3 cm or less, Child-Pugh status A to B, and performance status 0 (fully functional). Management of hepatocellular carcinoma is uncertain.\nObjectives\nTo assess the comparative benefits and harms of different interventions used in the treatment of early or very early hepatocellular carcinoma through a network meta-analysis and to generate rankings of the available interventions 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 benefits and harms of different interventions versus each other or versus sham or no intervention using standard Cochrane methodology.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, and trials registers to September 2016 to identify randomised clinical trials (RCTs) on hepatocellular carcinoma.\nSelection criteria\nWe included only RCTs, irrespective of language, blinding, or publication status, in participants with very early- or early-stage hepatocellular carcinoma, irrespective of the presence of cirrhosis, portal hypertension, aetiology of hepatocellular carcinoma, size and number of the tumours, and future remnant liver volume. We excluded trials including participants who were previously liver transplanted. We considered interventions compared with each other, sham, or no intervention.\nData collection and analysis\nWe calculated the odds ratio, mean difference, rate ratio, or hazard ratio with 95% confidence intervals using both fixed-effect and random-effects models based on available-participant analysis with Review Manager 5. We assessed the risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis using Stata, and the quality of the evidence using GRADE.\nMain results\nEighteen trials met the inclusion criteria for this review. Four trials (593 participants; 574 participants included for one or more analyses) compared surgery versus radiofrequency ablation in people with early hepatocellular carcinoma, eligible to undergo surgery. Fourteen trials (2533 participants; 2494 participants included for various analyses) compared different non-surgical interventions in people with early hepatocellular carcinoma, not eligible to undergo surgery. Overall, the quality of evidence was low or very low for all outcomes for both comparisons.\nSurgery versus radiofrequency ablation\nThe majority of participants had cirrhotic livers, and the hepatocellular carcinoma was of viral aetiology. The trials did not report the participants' portal hypertension status or whether they received adjuvant antiviral treatment or adjuvant immunotherapy. The average follow-up ranged from 29 months to 42 months (3 trials).\nThere was no evidence of a difference in all-cause mortality at maximal follow-up for surgery versus radiofrequency ablation (hazard ratio 0.80, 95% confidence interval (CI) 0.60 to 1.08; 574 participants; 4 trials; I2 = 68). Cancer-related mortality was lower in the surgery group (20/115 (17.4%)) than in the radiofrequency ablation group (43/115 (37.4%)) (odds ratio 0.35, 95% CI 0.19 to 0.65; 230 participants; 1 trial). Serious adverse events (number of participants) was higher in the surgery group (14/60 (23.3%)) than in the radiofrequency ablation group (1/60 (1.7%)) (odds ratio 17.96, 95% CI 2.28 to 141.60; 120 participants; 1 trial). The number of serious adverse events was higher in the surgery group (adjusted rate 11.3 events per 100 participants) than in the radiofrequency ablation group (3/186 (1.6 events per 100 participants)) (rate ratio 7.02, 95% CI 2.29 to 21.46; 391 participants; 2 trials; I2 = 0%). None of the trials reported health-related quality of life. One trial was funded by a party with vested interests; three trials were funded by parties without any vested.\nNon-surgical interventions\nThe majority of participants had cirrhotic livers, and the hepatocellular carcinoma was of viral aetiology. Most trials did not report the portal hypertension status of the participants, and none of the trials reported whether the participants received adjuvant antiviral treatment or adjuvant immunotherapy. The average follow-up ranged from 6 months to 37 months (11 trials). Trial participants, who were not eligible for surgery, were treated with radiofrequency ablation, laser ablation, microwave ablation, percutaneous acetic acid injection, percutaneous alcohol injection, a combination of radiofrequency ablation with systemic chemotherapy, a combination of radiofrequency ablation with percutaneous alcohol injection, a combination of transarterial chemoembolisation with percutaneous alcohol injection, or a combination of transarterial chemoembolisation with radiofrequency ablation.\nThe mortality at maximal follow-up was higher in the percutaneous acetic acid injection (hazard ratio 1.77, 95% CI 1.12 to 2.79; 125 participants; 1 trial) and percutaneous alcohol injection (hazard ratio 1.49, 95% CI 1.18 to 1.88; 882 participants; 5 trials; I2 = 57%) groups compared with the radiofrequency ablation group. There was no evidence of a difference in all-cause mortality at maximal follow-up for any of the other comparisons. The proportion of people with cancer-related mortality at maximal follow-up was higher in the percutaneous alcohol injection group (adjusted proportion 16.8%) compared with the radiofrequency ablation group (20/232 (8.6%)) (odds ratio 2.18, 95% CI 1.22 to 3.89; 458 participants; 3 trials; I2 = 0%). There was no evidence of a difference in any of the comparisons that reported serious adverse events (number of participants or number of events). None of the trials reported health-related quality of life. Five trials were funded by parties without any vested interest; the source of funding was not available in the remaining trials.\nAuthors' conclusions\nThe evidence was of low or very low quality. There was no evidence of a difference in all-cause mortality at maximal follow-up between surgery and radiofrequency ablation in people eligible for surgery. All-cause mortality at maximal follow-up was higher with percutaneous acetic acid injection and percutaneous alcohol injection than with radiofrequency ablation in people not eligible for surgery. There was no evidence of a difference in all-cause mortality at maximal follow-up for the other comparisons. High-quality RCTs designed to assess clinically important differences in all-cause mortality and health-related quality of life, and having an adequate follow-up period (approximately five years) are needed.\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": "Surgery versus radiofrequency ablation\nThe majority of participants had cirrhotic livers, and the hepatocellular carcinoma was of viral cause. The trials did not report the participants' portal hypertension status or whether they received adjuvant antiviral treatment or adjuvant immunotherapy. Three trials reported average follow-up (range 29 months to 42 months). One trial was funded by a party with vested interests; three trials were funded by parties without any vested..\nIn people eligible for surgery, there was no evidence of a difference in death between radiofrequency ablation and surgery; although there were fewer deaths due to cancer in the surgery group. There were more serious complications in the the surgery group than in the radiofrequency ablation group. None of the trials reported health-related quality of life.\nNon-surgical interventions\nThe majority of participants had cirrhotic livers, and the hepatocellular carcinoma was of viral cause. Most trials did not report the portal hypertension status of the participants, and none reported whether the participants received adjuvant antiviral treatment or adjuvant immunotherapy. Eleven trials reported average follow-up (range 6 months to 37 months). Trial participants, who were not eligible for surgery, were treated with radiofrequency ablation, laser ablation (cancer destruction using laser), microwave ablation (cancer destruction using microwaves), percutaneous acetic acid injection (cancer destruction using vinegar), percutaneous alcohol injection (cancer destruction using alcohol), a combination of radiofrequency ablation with systemic chemotherapy, a combination of radiofrequency ablation with percutaneous alcohol injection, a combination of transarterial chemoembolisation (blocking the artery supplying the cancer with beads containing chemotherapy drugs) with percutaneous alcohol injection, or a combination of transarterial chemoembolisation with radiofrequency ablation. Five trials were funded by parties without any vested interest; the source of funding was not available in the remaining trials.\nIn people not eligible for surgery, the percentage of people who died during the follow-up period was higher in the percutaneous acetic acid injection and percutaneous alcohol injection groups than in the radiofrequency ablation group. There was no evidence of any difference in the percentage of people who died between any of the remaining comparisons. The percentage of people who died because of cancer was also higher in the percutaneous alcohol injection group than in the radiofrequency ablation group. There was no evidence of any difference in the percentage of people who died because of cancer between any of the remaining comparisons. None of the trials reported health-related quality of life at any time point."
}
] |
query-laysum
|
23134
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic pain following mesh-based inguinal hernia repair is frequently reported, and has a significant impact on quality of life. Whether mesh fixation with glue can reduce chronic pain without increasing the recurrence rate is still controversial.\nObjectives\nTo determine whether tissue adhesives can reduce postoperative complications, especially chronic pain, with no increase in recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair.\nSearch methods\nWe searched the following electronic databases with no language restrictions: the Cochrane Central Register of Controlled Trials (CENTRAL; issue 4, 2016) in the Cochrane Library (searched 11 May 2016), MEDLINE Ovid (1986 to 11 May 2016), Embase Ovid (1986 to 11 May 2016), Science Citation Index (Web of Science) (1986 to 11 May 2016), CBM (Chinese Biomedical Database), CNKI (China National Knowledge Infrastructure), VIP (a full-text database in China), Wanfang databases. We also checked reference lists of identified papers (included studies and relevant reviews).\nSelection criteria\nWe included all randomised and quasi-randomised controlled trials comparing glue versus sutures for mesh fixation in Lichtenstein hernia repair. Cluster-RCTs were also eligible.\nData collection and analysis\nTwo review authors extracted data and assessed the risk of bias independently. Dichotomous outcomes were expressed as odds ratio (OR) with 95% confidence intervals (CI). Continuous outcomes were expressed as mean differences (MD) with 95% CIs.\nMain results\nTwelve trials with a total of 1932 participants were included in this review. The overall postoperative chronic pain in the glue group was reduced by 37% (OR 0.63, 95% CI 0.44 to 0.91; 10 studies, 1418 participants, low-quality evidence) compared with the suture group. However, the results changed when we conducted subgroup analysis with regard to the type of mesh. Subgroup analysis of included studies using lightweight mesh showed the reduction of chronic pain was less profound and insignificant (OR 0.77, 95% CI 0.50 to 1.17). Subgroup analysis of included studies using heavyweight mesh resulted in a significant benefit from the fixation with glue (OR 0.38, 95% CI 0.17 to 0.82).\nHernia recurrence was similar between the two groups (OR 1.44, 95% CI 0.63 to 3.28; 12 studies, 1932 participants, low-quality evidence). Fixation with glue was superior to suture regarding duration of the operation (MD −3.13, 95% CI −4.48 to −1.78; 9 studies, 1790 participants, low-quality evidence); haematoma (OR 0.52, 95% CI 0.31 to 0.86; 10 studies, 1384 participants, moderate-quality evidence); and recovery time to daily activities (MD −1.26, 95% CI −1.89 to −0.63; 3 studies, 403 participants, low-quality evidence).\nWe also investigated adverse events. There were no significant differences between the two groups. For superficial wound infection pooled analyses showed OR 1.23, 95% CI 0.37 to 4.11; 7 studies, 763 participants (low-quality evidence); for mesh/deep infection OR 0.67, 95% CI 0.16 to 2.83; 8 studies, 1393 participants (low-quality evidence). Furthermore, we investigated seroma (a postoperative swelling caused by fluid) (OR 0.83, 95% CI 0.51 to 1.33); and persisting numbness (OR 0.81, 95% CI 0.57 to 1.14).\nFinally, six trials involving 1009 participants reported postoperative length of stay, resulting in non-significant difference between the two groups (MD −0.12, 95% CI: −0.35 to 0.10)\nDue to the lack of data, it was impossible to draw any distinction between synthetic glue and biological glue.\nEight out of 12 trials showed high risk of bias in at least one of the investigated domains. Two studies were quasi-randomised controlled trials and the allocation sequence of one trial was not concealed. Nearly half of the included trials either did not provide adequate information or had high risk of bias regarding blinding processes. The risk of bias for incomplete outcome data of all the included studies varied from low to high risk of bias. Two trials did not report on some important outcomes. One study was funded by the manufacturer producing the fibrin sealant. Therefore, according to the 'Summary of findings' tables, the quality of the evidence (GRADE) for the outcomes is moderate to low.\nAuthors' conclusions\nBased on the short-term results, glue may reduce postoperative chronic pain and not simultaneously increase the recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair. Glue may therefore be a sensible alternative to suture for mesh fixation in Lichtenstein repair. Larger trials with longer follow-up and high quality are warranted. The difference between synthetic glue and biological glue should also be assessed in the future.\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": "Glue fixation is superior to suture for the outcomes of chronic pain, duration of operation, haematoma and recovery time to daily activities.\nGlue fixation is not associated with an increased risk of infection, hernia recurrence, seroma (a collection of fluid that builds up under the surface of the skin after surgery), persisting numbness (loss of sensation or feeling), quality of life, and postoperative length of stay.\nWe do not know the role of glue fixation in people with recurrent hernia, femoral hernia or complicated hernia. Meanwhile no conclusions could be drawn on which type of glue should be used because of lack of trials."
}
] |
query-laysum
|
23135
|
[
{
"role": "user",
"content": "Abstract: Background\nDepression is common in the postnatal period and can lead to adverse effects on the infant and wider family, in addition to the morbidity for the mother. It is not clear whether antidepressants are effective for the prevention of postnatal depression and little is known about possible adverse effects for the mother and infant, particularly during breastfeeding. This is an update of a Cochrane Review last published in 2005.\nObjectives\nTo assess the effectiveness of antidepressant medication for the prevention of postnatal depression, in comparison with any other treatment, placebo or standard care.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR ‒ both Studies and References), CENTRAL (Wiley), MEDLINE (OVID), Embase (OVID), PsycINFO (OVID), on 13 February 2018. We also searched the World Health Organization (WHO) trials portal (ICTRP) and ClinicalTrials.gov on 13 February 2018 to identify any additional unpublished or ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) of initiation of antidepressants (alone or in combination with another treatment), compared with any other treatment, placebo or standard care for the prevention of postnatal depression among women who were either pregnant or had given birth in the previous six weeks and were not currently depressed at baseline.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We requested missing information from investigators wherever possible and sought data to allow intention-to-treat analyses.\nMain results\nTwo trials including a total of 81 participants fulfilled the inclusion criteria for this review. All participants in both studies had a history of postnatal depression and were not taking antidepressant medication at baseline. Both trials were conducted by the same research group. Risk of bias was low or unclear in most domains for both studies. We were unable to perform a meta-analysis due to the small number of studies.\nOne study compared nortriptyline with placebo and did not find any evidence that nortriptyline was effective in preventing postnatal depression. In this study, 23% (6/26) of women who took nortriptyline and 24% (6/25) of women who took placebo experienced postnatal depression (RR 0.96, 95% CI 0.36 to 2.59, very low quality evidence) in the first 17 weeks postpartum. One woman taking nortriptyline developed mania; and one side effect, constipation, was more common among women taking nortriptyline than those taking placebo.\nThe second study compared sertraline with placebo. In this study, 7% (1/14) of women who took sertraline developed postnatal depression in the first 17 weeks postpartum compared with 50% (4/8) of women who took placebo. It is uncertain whether sertraline reduces the risk of postnatal depression (RR 0.14, 95% CI 0.02 to 1.07, very low quality evidence). One woman taking sertraline had a hypomanic episode. Two side effects (dizziness and drowsiness) were more common among women taking sertraline than women taking placebo.\nConclusions are limited by the small number of studies, small sample sizes and incomplete outcome data due to study drop-out which may have led to bias in the results. We have assessed the certainty of the evidence as very low, based on the GRADE system. No data were available on secondary outcomes of interest including child development, the mother‒infant relationship, breastfeeding, maternal daily functioning, family relationships or maternal satisfaction.\nAuthors' conclusions\nDue to the limitations of the current evidence base, such as the low statistical power of the included studies, it is not possible to draw any clear conclusions about the effectiveness of antidepressants for the prevention of postnatal depression. It is striking that no new eligible trials have been completed in the period of over a decade since the last published version of this review. Larger trials are needed which include comparisons of antidepressant drugs with other prophylactic treatments (e.g. psychological interventions), and examine adverse effects for the fetus or infant. Future reviews in this area may benefit from broadening their focus to examine the effectiveness of antidepressants for the prevention of perinatal (i.e. antenatal or postnatal) depression, which could include studies comparing antidepressant discontinuation with continuation for the prevention of relapse of depression during pregnancy and the postnatal period.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified two small, relevant trials. All the women in these trials had a history of postnatal depression, but were not depressed or using antidepressants at the beginning of the studies. Both studies compared antidepressant medicine with placebo. Women started taking the medicine or placebo on the first day after giving birth.\nIn the larger study (56 women), the antidepressant given to women was nortriptyline, which is a tricyclic antidepressant. In the other study (25 women), the antidepressant used was sertraline which is a selective serotonin reuptake inhibitor (SSRI); these types of antidepressants work in different ways. The women and the researchers assessing the outcomes in both studies did not know which women were taking antidepressants and which placebo (i.e. both studies were 'double-blind'). Both studies were funded by the National Institute of Mental Health (NIMH), a US government organisation."
}
] |
query-laysum
|
23136
|
[
{
"role": "user",
"content": "Abstract: Background\nObservational evidence suggests a potential benefit with several anti-adhesion therapies in women undergoing operative hysteroscopy (e.g. insertion of an intrauterine device or balloon, hormonal treatment, barrier gels or human amniotic membrane grafting) for decreasing intrauterine adhesions (IUAs).\nObjectives\nTo assess the effectiveness of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy, following operative hysteroscopy for treatment of female subfertility.\nSearch methods\nWe searched the following databases from inception to June 2017: the Cochrane Gynaecology and Fertility Group Specialised Register; the Cochrane Central Register of Studies (CRSO); MEDLINE; Embase; CINAHL and other electronic sources of trials, including trial registers, sources of unpublished literature and reference lists. We handsearched the Journal of Minimally Invasive Gynecology, and we contacted experts in the field. We also searched reference lists of appropriate papers.\nSelection criteria\nRandomised controlled trials (RCTs) of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy following operative hysteroscopy in subfertile women. The primary outcome was live birth. Secondary outcomes were clinical pregnancy, miscarriage and IUAs present at second-look hysteroscopy, along with mean adhesion scores and severity of IUAs.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, extracted data and evaluated quality of evidence using the GRADE method.\nMain results\nThe overall quality of the evidence was low to very low. The main limitations were serious risk of bias related to blinding of participants and personnel, indirectness and imprecision. We identified 16 RCTs comparing a device versus no treatment (two studies; 90 women), hormonal treatment versus no treatment or placebo (two studies; 136 women), device combined with hormonal treatment versus no treatment (one study; 20 women), barrier gel versus no treatment (five studies; 464 women), device with graft versus device without graft (three studies; 190 women), one type of device versus another device (one study; 201 women), gel combined with hormonal treatment and antibiotics versus hormonal treatment with antibiotics (one study; 52 women) and device combined with gel versus device (one study; 120 women). The total number of participants was 1273, but data on 1133 women were available for analysis. Only two of 16 studies included 100% infertile women; in all other studies, the proportion was variable or unknown.\nNo study reported live birth, but some (five studies) reported outcomes that were used as surrogate outcomes for live birth (term delivery or ongoing pregnancy).\nAnti-adhesion therapy versus placebo or no treatment following operative hysteroscopy.\nThere was insufficient evidence to determine whether there was a difference between the use of a device or hormonal treatment compared to no treatment or placebo with respect to term delivery or ongoing pregnancy rates (odds ratio (OR) 0.94, 95% confidence interval (CI) 0.42 to 2.12; 107 women; 2 studies; I² = 0%; very-low-quality evidence).\nThere were fewer IUAs at second-look hysteroscopy using a device with or without hormonal treatment or hormonal treatment or barrier gels compared with no treatment or placebo (OR 0.35, 95% CI 0.21 to 0.60; 560 women; 8 studies; I² = 0%; low-quality evidence). The number needed to treat for an additional beneficial outcome (NNTB) was 9 (95% CI 5 to 17).\nComparisons of different anti-adhesion therapies following operative hysteroscopy\nIt was unclear whether there was a difference between the use of a device combined with graft versus device only for the outcome of ongoing pregnancy (OR 1.48, 95% CI 0.57 to 3.83; 180 women; 3 studies; I² = 0%; low-quality evidence). There were fewer IUAs at second-look hysteroscopy using a device with or without graft/gel or gel combined with hormonal treatment and antibiotics compared with using a device only or hormonal treatment combined with antibiotics, but the findings of this meta-analysis were affected by evidence quality (OR 0.55, 95% CI 0.36 to 0.83; 451 women; 5 studies; I² = 0%; low-quality evidence).\nAuthors' conclusions\nImplications for clinical practice\nThe quality of the evidence ranged from very low to low. The effectiveness of anti-adhesion treatment for improving key reproductive outcomes or for decreasing IUAs following operative hysteroscopy in subfertile women remains uncertain.\nImplications for research\nMore research is needed to assess the comparative safety and (cost-)effectiveness of different anti-adhesion treatments compared to no treatment or other interventions for improving key reproductive outcomes in subfertile women.\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 overall quality of the study evidence ranged from very low to low. There were limitations to the studies, for example, a serious risk of bias related to participants and investigators knowing what treatment was given.\nMore research is needed before anti-adhesion treatment can be offered in everyday clinical practice after surgery of the womb in women having difficulty becoming pregnant."
}
] |
query-laysum
|
23137
|
[
{
"role": "user",
"content": "Abstract: Background\nNephrolithiasis, or urinary stone disease, in children causes significant morbidity, and is increasing in prevalence in the North American population. Therefore, medical and dietary interventions (MDI) for recurrent urinary stones in children are poised to gain increasing importance in the clinical armamentarium.\nObjectives\nTo assess the effects of medical and dietary interventions (MDI) for the prevention of idiopathic urinary stones in children aged from one to 18 years.\nSearch methods\nWe searched multiple databases using search terms relevant to this review, including studies identified from the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 1), MEDLINE OvidSP (1946 to 14 February 2017), Embase OvidSP (1980 to 14 February 2017), International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. Additionally, we handsearched renal-related journals and the proceedings of major renal conferences, and reviewed weekly current awareness alerts for selected renal journals. The date of the last search was 14 February 2017. There were no language restrictions.\nSelection criteria\nRandomized controlled trials of at least one year of MDI versus control for prevention of recurrent idiopathic (non-syndromic) nephrolithiasis in children.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane. Titles and abstracts were identified by search criteria and then screened for relevance, and then data extraction and risk of bias assessment were carried out. We assessed the quality of evidence using GRADE.\nMain results\nThe search identified one study of 125 children (72 boys and 53 girls) with calcium-containing idiopathic nephrolithiasis and normal renal morphology following initial treatment with shockwave lithotripsy (SWL). Patients were randomized to oral potassium citrate 1 mEq/kg per day for 12 months versus no specific medication or preventive measure with results reported for a total of 96 patients (48 per group). This included children who were stone-free (n = 52) or had residual stone fragments (n = 44) following SWL.\nPrimary outcomes:\nMedical therapy may lower rates of stone recurrence with a risk ratio (RR) of 0.19 (95% confidence interval (CI) 0.06 to 0.60; low quality evidence). This corresponds to 270 fewer stone recurrences per 1000 (133 fewer to 313 fewer) children. We downgraded the quality of evidence by two levels for very serious study limitations related to unclear allocation concealment (selection bias) and a high risk of performance, detection and attrition bias. While the data for adverse events were incomplete, they reported that six of 48 (12.5%) children receiving potassium citrate left the trial because of adverse effects. This corresponds to a RR of 13.0 (95% CI 0.75 to 224.53; very low quality evidence); an absolute effect size estimate could not be generated. We downgraded the quality of evidence for study limitations and imprecision.\nWe found no information on retreatment rates.\nSecondary outcomes:\nWe found no evidence on serum electrolytes, 24-hour urine collection parameters or time to new stone formation.\nWe were unable to perform any preplanned secondary analyses.\nAuthors' conclusions\nOral potassium citrate supplementation may reduce recurrent calcium urinary stone formation in children following SWL; however, our confidence in this finding is limited. A substantial number of children stopped the medication due to adverse events. There is no trial evidence on retreatment rates. There is a critical need for additional well-designed trials in children with nephrolithiasis.\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 examined research published up to 14 February 2017. We looked for studies of boys and girls from age one to 18 years who sometime before had problems with kidney stones and who were assigned to a different diet or a medicine (or both) to stop the stones from coming back for at least 12 months. We were most interested in whether the stones returned, how many side effects there were and if children had to have more treatments for kidney stones."
}
] |
query-laysum
|
23138
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute limb ischaemia (ALI), the sudden and significant reduction of blood flow to the limb, is considered a vascular emergency. In the general population, the incidence is estimated as 14 per 100,000. Prognosis depends on the time it takes to diagnose the condition and begin appropriate treatment. Standard initial interventional treatments include conventional open surgery and endovascular interventions such as catheter-directed thrombolysis (CDT). Percutaneous interventions, such as percutaneous thrombectomy (PT, including mechanical thrombectomy or pharmomechanical thrombectomy) and ultrasound-accelerated thrombolysis (USAT), are also performed as alternative endovascular techniques. The proposed advantages of PT and USAT include reduced time to revascularisation and when combined with catheter-directed thrombolysis, a reduction in dose of thrombolytic agents and infusion time. The benefits of PT or USAT versus open surgery or thrombolysis alone are still uncertain. In this review, we compared PT or USAT against standard treatment for ALI, in an attempt to determine if any technique is comparatively safer and more effective.\nObjectives\nTo assess the safety and effectiveness of percutaneous thrombectomy or ultrasound-accelerated thrombolysis for the initial management of acute limb ischaemia in adults.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) International Clinical Trials Registry Platform, and ClinicalTrials.gov to 3 March 2021. We searched reference lists of relevant studies and papers.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared PT (any modality, including mechanical thrombectomy (aspiration, rheolysis, rotation) or pharmomechanical thrombectomy) or USAT with open surgery, thrombolysis alone, no treatment, or another PT modality for the treatment of ALI.\nData collection and analysis\nTwo review authors independently selected the studies, assessed risk of bias, extracted data, performed data analysis, and assessed the certainty of evidence according to GRADE. Outcomes of interest were primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects.\nMain results\nWe included one RCT in this review. This study had a total of 60 participants and compared USAT with standard treatment (CDT). The study included 32 participants in the CDT group and 28 participants in the USAT group.\nWe found no evidence of a difference between USAT and CDT alone for the following evaluated outcomes: amputation rate (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.17 to 7.59); major bleeding (RR 1.71, 95% CI 0.31 to 9.53); clinical success (RR 1.00, 95% CI 0.94 to 1.07); and adverse effects (RR 5.69, 95% CI 0.28 to 113.72). We rated the certainty of the evidence as very low for these outcomes. We downgraded the certainty of the evidence for amputation rate, major bleeding, clinical success, and adverse effects by two levels due to serious limitations in the design (there was a high risk of bias in critical domains) and by two further levels due to imprecision (a small number of participants and only one study included). The study authors reported 30-day patency, but did not report primary and secondary patency separately. The patency rate in the successfully lysed participants was 71% (15/21) in the USAT group and 82% (22/27) in the CDT group. The study authors did not directly report secondary patency, which is patency after secondary procedures, but they did report on secondary procedures. Secondary procedures were subdivided into embolectomy and bypass grafting. Embolectomy was performed on 14% (4/28) of participants in the USAT group versus 3% (1/32) of participants in the CDT group. Bypass grafting was performed on 4% (1/28) of participants in the USAT group versus 0% in the CDT group. As we did not have access to the specific participant data, it was not possible to assess these outcomes further.\nWe did not identify studies comparing the other planned interventions.\nAuthors' conclusions\nThere is insufficient evidence to assess the safety and effectiveness of USAT versus CDT alone for ALI for our evaluated outcomes: amputation rate, major bleeding, clinical success, and adverse effects. Primary and secondary patency were not reported separately. There was no RCT evidence for PT. Limitations of this systematic review derive from the single included study, small sample size, short clinical follow-up period, and high risk of bias in critical domains. For this reason, the applicability of the results is limited. There is a need for high-quality studies to compare PT or USAT against open surgery, thrombolysis alone, no treatment, or other PT modalities for ALI. Future trials should assess outcomes, such as primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found one study that involved 60 people with acute limb ischaemia. The study lasted 30 days and compared ultrasound-accelerated thrombolysis with catheter-directed thrombolysis. The study did not present the results in a way that could tell us whether ultrasound-accelerated thrombolysis, compared with catheter-directed thrombolysis, had an effect on blood flow, and it is unclear if these treatments have an effect on amputation, bleeding, and other risks. Thus, we are very uncertain about the results."
}
] |
query-laysum
|
23139
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is one of the most common diseases in early infancy and childhood. Antibiotic use for AOM varies from 56% in the Netherlands to 95% in the USA, Canada and Australia. This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 1997 and previously updated in 1999, 2005, 2009 and 2013.\nObjectives\nTo assess the effects of antibiotics for children with AOM.\nSearch methods\nWe searched CENTRAL (2015, Issue 3), MEDLINE (1966 to April week 3, 2015), OLDMEDLINE (1958 to 1965), EMBASE (January 1990 to April 2015), Current Contents (1966 to April 2015), CINAHL (2008 to April 2015) and LILACS (2008 to April 2015).\nSelection criteria\nRandomised controlled trials (RCTs) comparing 1) antimicrobial drugs with placebo and 2) immediate antibiotic treatment with expectant observation (including delayed antibiotic prescribing) in children with AOM.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data.\nMain results\nFor the review of antibiotics against placebo, 13 RCTs (3401 children and 3938 AOM episodes) from high-income countries were eligible and had generally low risk of bias. The combined results of the trials revealed that by 24 hours from the start of treatment, 60% of the children had recovered whether or not they had placebo or antibiotics. Pain was not reduced by antibiotics at 24 hours (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.78 to 1.01) but almost a third fewer had residual pain at two to three days (RR 0.70, 95% CI 0.57 to 0.86; number needed to treat for an additional beneficial outcome (NNTB) 20). A quarter fewer had pain at four to seven days (RR 0.76, 95% CI 0.63 to 0.91; NNTB 16) and two-thirds fewer had pain at 10 to 12 days (RR 0.33, 95% CI 0.17 to 0.66; NNTB 7) compared with placebo. Antibiotics did reduce the number of children with abnormal tympanometry findings at two to four weeks (RR 0.82, 95% CI 0.74 to 0.90; NNTB 11), at six to eight weeks (RR 0.88, 95% CI 0.78 to 1.00; NNTB 16) and the number of children with tympanic membrane perforations (RR 0.37, 95% CI 0.18 to 0.76; NNTB 33) and halved contralateral otitis episodes (RR 0.49, 95% CI 0.25 to 0.95; NNTB 11) compared with placebo. However, antibiotics neither reduced the number of children with abnormal tympanometry findings at three months (RR 0.97, 95% CI 0.76 to 1.24) nor the number of children with late AOM recurrences (RR 0.93, 95% CI 0.78 to 1.10) when compared with placebo. Severe complications were rare and did not differ between children treated with antibiotics and those treated with placebo. Adverse events (such as vomiting, diarrhoea or rash) occurred more often in children taking antibiotics (RR 1.38, 95% CI 1.19 to 1.59; number needed to treat for an additional harmful outcome (NNTH) 14). Funnel plots do not suggest publication bias. Individual patient data meta-analysis of a subset of included trials found antibiotics to be most beneficial in children aged less than two years with bilateral AOM, or with both AOM and otorrhoea.\nFor the review of immediate antibiotics against expectant observation, five trials (1149 children) from high-income countries were eligible and had low to moderate risk of bias. Four trials (1007 children) reported outcome data that could be used for this review. From these trials, data from 959 children could be extracted for the meta-analysis of pain at three to seven days. No difference in pain was detectable at three to seven days (RR 0.75, 95% CI 0.50 to 1.12). One trial (247 children) reported data on pain at 11 to 14 days. Immediate antibiotics were not associated with a reduction in the number of children with pain (RR 0.91, 95% CI 0.75 to 1.10) compared with expectant observation. Additionally, no differences in the number of children with abnormal tympanometry findings at four weeks, tympanic membrane perforations and AOM recurrence were observed between groups. No serious complications occurred in either the antibiotic or the expectant observation group. Immediate antibiotics were associated with a substantial increased risk of vomiting, diarrhoea or rash compared with expectant observation (RR 1.71, 95% CI 1.24 to 2.36; NNTH 9).\nResults from an individual patient data meta-analysis including data from six high-quality trials (1643 children) that were also included as individual trials in our review showed that antibiotics seem to be most beneficial in children younger than two years of age with bilateral AOM (NNTB 4) and in children with both AOM and otorrhoea (NNTB 3).\nAuthors' conclusions\nThis review reveals that antibiotics have no early effect on pain, a slight effect on pain in the days following and only a modest effect on the number of children with tympanic perforations, contralateral otitis episodes and abnormal tympanometry findings at two to four weeks and at six to eight weeks compared with placebo in children with AOM. In high-income countries, most cases of AOM spontaneously remit without complications. The benefits of antibiotics must be weighed against the possible harms: for every 14 children treated with antibiotics one child experienced an adverse event (such as vomiting, diarrhoea or rash) that would not have occurred if antibiotics were withheld. Therefore clinical management should emphasise advice about adequate analgesia and the limited role for antibiotics. Antibiotics are most useful in children under two years of age with bilateral AOM, or with both AOM and otorrhoea. For most other children with mild disease in high-income countries, an expectant observational approach seems justified.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence in this review is current to 26 April 2015.\nFor the review of antibiotics against placebo we included 13 trials (3401 children aged between two months and 15 years) from high-income countries with generally low risk of bias. Three trials were performed in a general practice (GP) setting, six in an outpatient hospital setting and four in both settings.\nFor the review of antibiotics against expectant observation, five trials (1149 children) from high-income countries were eligible with low to moderate risk of bias. Two trials were performed in a GP setting and three in an outpatient hospital setting. Four trials (1007 children) reported outcome data that could be used for this review."
}
] |
query-laysum
|
23140
|
[
{
"role": "user",
"content": "Abstract: Background\nFollowing traumatic brain injury (TBI) there is an increased prevalence of depression compared to the general population. It is unknown whether non-pharmacological interventions for depression are effective for people with TBI.\nObjectives\nTo investigate the effectiveness of non-pharmacological interventions for depression in adults and children with TBI at reducing the diagnosis and severity of symptoms of depression.\nSearch methods\nWe ran the most recent search on 11 February 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, MEDLINE (OvidSP), Embase (OvidSP), three other databases and clinical trials registers. Relevant conference proceedings and journals were handsearched, as were the reference lists of identified studies.\nSelection criteria\nRandomised controlled trials (RCTs) of non-pharmacological interventions for depression in adults and children who had a TBI.\nData collection and analysis\nTwo authors independently selected trials from the search results, then assessed risk of bias and extracted data from the included trials. The authors contacted trial investigators to obtain missing information. We rated the overall quality of the evidence of the primary outcomes using the GRADE approach.\nMain results\nSix studies met the inclusion criteria, with a total of 334 adult participants. We identified no studies that included children as participants. All studies were affected by high risk of bias due to a lack of blinding of participants and personnel; five studies were affected by high risk of bias for lack of blinding of outcome assessors. There was high or unclear risk of biases affecting some studies across all the Cochrane risk of bias measures.\nThree studies compared a psychological intervention (either cognitive behaviour therapy or mindfulness-based cognitive therapy) with a control intervention. Data regarding depression symptom outcome measures were combined in a meta-analysis, but did not find an effect in favour of treatment (SMD -0.14; 95% CI -0.47 to 0.19; Z = 0.83; P = 0.41). The other comparisons comprised of single studies of depression symptoms and compared; cognitive behaviour therapy versus supportive psychotherapy (SMD -0.09; 95% CI -0.65 to 0.48; Z = 0.30; P = 0.77); repetitive transcranial magnetic stimulation plus tricyclic antidepressant (rTMS + TCA) versus tricyclic antidepressant alone (SMD -0.84; 95% CI -1.36 to -0.32; Z = 3;19, P = 0.001); and a supervised exercise program versus exercise as usual (SMD -0.43; 95% CI -0.88 to 0.03; Z = 1.84; P = 0.07). There was very-low quality evidence, small effect sizes and wide variability of results, suggesting that no comparisons showed a reliable effect for any intervention.\nOnly one study mentioned minor, transient adverse events from repetitive transcranial magnetic stimulation.\nAuthors' conclusions\nThe review did not find compelling evidence in favour of any intervention. Future studies should focus on participants with a diagnosed TBI and include only participants who have a diagnosis of depression, or who record scores above a clinical cutoff on a depression measure. There is a need for additional RCTs that include a comparison between an intervention and a control that replicates the effect of the attention given to participants during an active treatment.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three studies compared a psychological therapy (cognitive behaviour therapy or mindfulness-based cognitive therapy) with a no-treatment control intervention. When the data for these studies were combined, there was no reliable effect in support of psychological therapy. One study compared cognitive behavioural therapy with another psychological intervention (supportive psychotherapy), and did not find an effect in favour of either intervention. One study compared a supervised exercise programme with exercise as usual, but did not find a effect in favour of either intervention. One study compared rTMS plus an antidepressant medication with the antidepressant medication alone. Because the quality of the evidence was very low, it was not possible to draw the conclusion that the addition of rTMS improved outcomes. Only one study, of rTMS, reported any harmful effects and these were relatively minor and resolved quickly."
}
] |
query-laysum
|
23141
|
[
{
"role": "user",
"content": "Abstract: Background\nMagnetic seizure therapy (MST) is a potential alternative to electroconvulsive therapy (ECT). Reports to date on use of MST for patients with treatment-resistant depression (TRD) are limited.\nObjectives\nTo evaluate the effects of MST in comparison with sham-MST, antidepressant, and other forms of electric or magnetic treatment for adults with TRD.\nSearch methods\nIn March 2020, we searched a wide range of international electronic sources for published, unpublished, and ongoing studies. We handsearched the reference lists of all included studies and relevant systematic reviews and conference proceedings of the Annual Meeting of the American College of Neuropsychopharmacology (ACNP), the Annual Scientific Convention and Meeting, and the Annual Meeting of the European College of Neuropsychopharmacology (ECNP) to identify additional studies.\nSelection criteria\nAll randomised clinical trials (RCTs) focused on MST for adults with TRD.\nData collection and analysis\nTwo review authors extracted data independently. For binary outcomes, we calculated risk ratios (RRs) and 95% confidence intervals (CIs). For continuous data, we estimated mean differences (MDs) between groups and 95% CIs. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using the GRADE approach. Our main outcomes of interest were symptom severity, cognitive function, suicide, quality of life, social functioning, dropout for any reason, serious adverse events, and adverse events that led to discontinuation of treatment.\nMain results\nWe included three studies (65 participants) comparing MST with ECT. Two studies reported depressive symptoms with the Hamilton Rating Scale for Depression (HAMD). However, in one study, the data were skewed and there was an imbalance in baseline characteristics. Analysis of these two studies showed no clear differences in depressive symptoms between treatment groups (MD 0.71, 95% CI -2.23 to 3.65; 2 studies, 40 participants; very low-certainty evidence). Two studies investigated multiple domains of cognitive function. However most of the outcomes were not measured by validated neuropsychological tests, and many of the data suffered from unbalanced baseline and skewed distribution. Analysis of immediate memory performance measured by the Wechsler Memory Scale showed no clear differences between treatment groups (MD 0.40, 95% CI -4.16 to 4.96; 1 study, 20 participants; very low-certainty evidence). Analysis of delayed memory performance measured by the Wechsler Memory Scale also showed no clear differences between treatment groups (MD 2.57, 95% CI -2.39 to 7.53; 1 study, 20 participants; very low-certainty evidence). Only one study reported quality of life, but the data were skewed and baseline data were unbalanced across groups. Analysis of quality of life showed no clear differences between treatment groups (MD 14.86, 95% CI -42.26 to 71.98; 1 study, 20 participants; very low-certainty evidence). Only one study reported dropout and adverse events that led to discontinuation of treatment. Analysis of reported data showed no clear differences between treatment groups for this outcome (RR 1.38, 95% CI 0.28 to 6.91; 1 study, 25 participants; very low-certainty evidence). Adverse events occurred in only two participants who received ECT (worsening of preexisting coronary heart disease and a cognitive adverse effect). None of the included studies reported outcomes on suicide and social functioning. No RCTs comparing MST with other treatments were identified.\nAuthors' conclusions\nEvidence regarding effects of MST on patients with TRD is currently insufficient. Our analyses of available data did not reveal clearly different effects between MST and ECT. We are uncertain about these findings because of risk of bias and imprecision of estimates. Large, long, well-designed, and well-reported trials are needed to further examine the effects of MST.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Evidence regarding effects of MST on patients with TRD is currently insufficient. Our analyses of available data did not reveal clearly different effects between MST and ECT. Our certainty in the evidence is very low. Large, long, well-designed, well-reported trials are needed to further examine the effects of MST."
}
] |
query-laysum
|
23142
|
[
{
"role": "user",
"content": "Abstract: Background\nSurgical site infection (SSI) rates vary from 1% to 5% in the month following surgery. Due to the large number of surgical procedures conducted annually, the costs of these SSIs can be considerable in financial and social terms. Many interventions are used with the aim of reducing the risk of SSI in people undergoing surgery. These interventions can be broadly delivered at three stages: preoperatively, intraoperatively and postoperatively. The intraoperative interventions are largely focused on decontamination of skin using soap and antiseptics; the use of barriers to prevent movement of micro-organisms into incisions; and optimising the patient's own bodily functions to promote best recovery. Both decontamination and barrier methods can be aimed at people undergoing surgery and operating staff. Other interventions focused on SSI prevention may be aimed at the surgical environment and include methods of theatre cleansing and approaches to managing theatre traffic.\nObjectives\nTo present an overview of Cochrane Reviews of the effectiveness and safety of interventions, delivered during the intraoperative period, aimed at preventing SSIs in all populations undergoing surgery in an operating theatre.\nMethods\nPublished Cochrane systematic reviews reporting the effectiveness of interventions delivered during the intraoperative period in terms of SSI prevention were eligible for inclusion in this overview. We also identified Cochrane protocols and title registrations for future inclusion into the overview. We searched the Cochrane Library on 01 July 2017. Two review authors independently screened search results and undertook data extraction and 'Risk of bias' and certainty assessment. We used the ROBIS (risk of bias in systematic reviews) tool to assess the quality of included reviews, and we used GRADE methods to assess the certainty of the evidence for each outcome. We summarised the characteristics of included reviews in the text and in additional tables.\nMain results\nWe included 32 Cochrane Reviews in this overview: we judged 30 reviews as being at low risk of bias and two at unclear risk of bias. Thirteen reviews had not been updated in the past three years. Two reviews had no relevant data to extract. We extracted data from 30 reviews with 349 included trials, totaling 73,053 participants. Interventions assessed included gloving, use of disposable face masks, patient oxygenation protocols, use of skin antiseptics for hand washing and patient skin preparation, vaginal preparation, microbial sealants, methods of surgical incision, antibiotic prophylaxis and methods of skin closure. Overall, the GRADE certainty of evidence for outcomes was low or very low. Of the 77 comparisons providing evidence for the outcome of SSI, seven provided high- or moderate-certainty evidence, 39 provided low-certainty evidence and 31 very low-certainty evidence. Of the nine comparisons that provided evidence for the outcome of mortality, five provided low-certainty evidence and four very low-certainty evidence.\nThere is high- or moderate-certainty evidence for the following outcomes for these intraoperative interventions. (1) Prophylactic intravenous antibiotics administered before caesarean incision reduce SSI risk compared with administration after cord clamping (10 trials, 5041 participants; risk ratio (RR) 0.59, 95% confidence interval (CI) 0.44 to 0.81; high-certainty evidence - assessed by review authors). (2) Preoperative antibiotics reduce SSI risk compared with placebo after breast cancer surgery (6 trials, 1708 participants; RR 0.74, 95% CI 0.56 to 0.98; high-certainty evidence - assessed by overview authors). (3) Antibiotic prophylaxis probably reduce SSI risk in caesarean sections compared with no antibiotics (82 relevant trials, 14,407 participants; RR 0.40, 95% CI 0.35 to 0.46; moderate-certainty evidence; downgraded once for risk of bias - assessed by review authors). (4) Antibiotic prophylaxis probably reduces SSI risk for hernia repair compared with placebo or no treatment (17 trials, 7843 participants; RR 0.67, 95% CI 0.54 to 0.84; moderate-certainty evidence; downgraded once for risk of bias - assessed by overview authors); (5) There is currently no clear difference in the risk of SSI between iodine-impregnated adhesive drapes compared with no adhesive drapes (2 trials, 1113 participants; RR 1.03, 95% CI 0.66 to 1.60; moderate-certainty evidence; downgraded once for imprecision - assessed by review authors); (6) There is currently no clear difference in SSI risk between short-term compared with long-term duration antibiotics in colorectal surgery (7 trials; 1484 participants; RR 1.05 95% CI 0.78 to 1.40; moderate-certainty evidence; downgraded once for imprecision - assessed by overview authors). There was only one comparison showing negative effects associated with the intervention: adhesive drapes increase the risk of SSI compared with no drapes (5 trials; 3082 participants; RR 1.23, 95% CI 1.02 to 1.48; high-certainty evidence - rated by review authors).\nAuthors' conclusions\nThis overview provides the most up-to-date evidence on use of intraoperative treatments for the prevention of SSIs from all currently published Cochrane Reviews. There is evidence that some interventions are useful in reducing SSI risk for people undergoing surgery, such as antibiotic prophylaxis for caesarean section and hernia repair, and also the timing of prophylactic intravenous antibiotics administered before caesarean incision. Also, there is evidence that adhesive drapes increase SSI risk. Evidence for the many other treatment choices is largely of low or very low certainty and no quality-of-life or cost-effectiveness data were reported. Future trials should elucidate the relative effects of some treatments. These studies should focus on increasing participant numbers, using robust methodology and being of sufficient duration to adequately assess SSI. Assessment of other outcomes such as mortality might also be investigated as part of non-experimental prospective follow-up of people with SSI of different severity, so the risk of death for different subgroups can be better understood.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this overview of reviews?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To identify and summarise all evidence from Cochrane Reviews on interventions to prevent surgical site infections (SSIs) that are delivered while surgery is taking place (during the intraoperative period)."
}
] |
query-laysum
|
23143
|
[
{
"role": "user",
"content": "Abstract: Background\nViral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review last published in 2020. We include results from studies from the current COVID-19 pandemic.\nObjectives\nTo assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses.\nSearch methods\nWe searched CENTRAL, PubMed, Embase, CINAHL, and two trials registers in October 2022, with backwards and forwards citation analysis on the new studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster-RCTs investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, glasses, and gargling) to prevent respiratory virus transmission.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 11 new RCTs and cluster-RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID-19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID-19 pandemic.\nMany studies were conducted during non-epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID-19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high-income countries; crowded inner city settings in low-income countries; and an immigrant neighbourhood in a high-income country. Adherence with interventions was low in many studies.\nThe risk of bias for the RCTs and cluster-RCTs was mostly high or unclear.\nMedical/surgical masks compared to no masks\nWe included 12 trials (10 cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza-like illness (ILI)/COVID-19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate-certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory-confirmed influenza/SARS-CoV-2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate-certainty evidence). Harms were rarely measured and poorly reported (very low-certainty evidence).\nN95/P2 respirators compared to medical/surgical masks\nWe pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). We are very uncertain on the effects of N95/P2 respirators compared with medical/surgical masks on the outcome of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779 participants; very low-certainty evidence). N95/P2 respirators compared with medical/surgical masks may be effective for ILI (RR 0.82, 95% CI 0.66 to 1.03; 5 trials, 8407 participants; low-certainty evidence). Evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirators compared to medical/surgical masks probably makes little or no difference for the objective and more precise outcome of laboratory-confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; 5 trials, 8407 participants; moderate-certainty evidence). Restricting pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies (very low-certainty evidence).\nOne previously reported ongoing RCT has now been published and observed that medical/surgical masks were non-inferior to N95 respirators in a large study of 1009 healthcare workers in four countries providing direct care to COVID-19 patients.\nHand hygiene compared to control\nNineteen trials compared hand hygiene interventions with controls with sufficient data to include in meta-analyses. Settings included schools, childcare centres and homes. Comparing hand hygiene interventions with controls (i.e. no intervention), there was a 14% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9 trials, 52,105 participants; moderate-certainty evidence), suggesting a probable benefit. In absolute terms this benefit would result in a reduction from 380 events per 1000 people to 327 per 1000 people (95% CI 308 to 342). When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.94, 95% CI 0.81 to 1.09; 11 trials, 34,503 participants; low-certainty evidence), and laboratory-confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials, 8332 participants; low-certainty evidence), suggest the intervention made little or no difference. We pooled 19 trials (71, 210 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. Pooled data showed that hand hygiene may be beneficial with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.83 to 0.94; low-certainty evidence), but with high heterogeneity. In absolute terms this benefit would result in a reduction from 200 events per 1000 people to 178 per 1000 people (95% CI 166 to 188). Few trials measured and reported harms (very low-certainty evidence).\nWe found no RCTs on gowns and gloves, face shields, or screening at entry ports.\nAuthors' conclusions\nThe high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions. There were additional RCTs during the pandemic related to physical interventions but a relative paucity given the importance of the question of masking and its relative effectiveness and the concomitant measures of mask adherence which would be highly relevant to the measurement of effectiveness, especially in the elderly and in young children.\nThere is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness, and although this effect was also present when ILI and laboratory-confirmed influenza were analysed separately, it was not found to be a significant difference for the latter two outcomes. Harms associated with physical interventions were under-investigated.\nThere is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk of ARIs.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out whether physical measures stop or slow the spread of respiratory viruses from well-controlled studies in which one intervention is compared to another, known as randomised controlled trials."
}
] |
query-laysum
|
23144
|
[
{
"role": "user",
"content": "Abstract: Background\nAspirin and heparin are widely used as preventive strategy to reduce the high risk of recurrent pregnancy loss in women with antiphospholipid antibodies (aPL).\nThis review supersedes a previous, out-of-date review that evaluated all potential therapies for preventing recurrent pregnancy loss in women with aPL. The current review focusses on a narrower scope because current clinical practice is restricted to using aspirin or heparins, or both for women with aPL in an attempt to reduce pregnancy complications.\nObjectives\nTo assess the effects of aspirin or heparin, or both for improving pregnancy outcomes in women with persistent (on two separate occasions) aPL, either lupus anticoagulant (LAC), anticardiolipin (aCL) or aβ2-glycoprotein-I antibodies (aβ2GPI) or a combination, and recurrent pregnancy loss (two or more, which do not have to be consecutive).\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (3 June 2019), and reference lists of retrieved studies. Where necessary, we attempted to contact trial authors.\nSelection criteria\nRandomised, cluster-randomised and quasi-randomised controlled trials that assess the effects of aspirin, heparin (either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH]), or a combination of aspirin and heparin compared with no treatment, placebo or another, on pregnancy outcomes in women with persistent aPL and recurrent pregnancy loss were eligible. All treatment regimens were considered.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion criteria and risk of bias. Two review authors independently extracted data and checked them for accuracy and the certainty of the evidence was assessed using the GRADE approach.\nMain results\nEleven studies (1672 women) met the inclusion criteria; nine randomised controlled trials and two quasi-RCTs. The studies were conducted in the USA, Canada, UK, China, New Zealand, Iraq and Egypt. One included trial involved 1015 women, all other included trials had considerably lower numbers of participants (i.e. 141 women or fewer).\nSome studies had high risk of selection and attrition bias, and many did not include sufficient information to judge the risk of reporting bias. Overall, the certainty of evidence is low to very low due to the small numbers of women in the studies and to the risk of bias.\nThe dose and type of heparin and aspirin varied among studies. One study compared aspirin alone with placebo; no studies compared heparin alone with placebo and there were no trials that had a no treatment comparator arm during pregnancy; five studies explored the efficacy of heparin (either UFH or LMWH) combined with aspirin compared with aspirin alone; one trial compared LMWH with aspirin; two trials compared the combination of LMWH plus aspirin with the combination of UFH plus aspirin; two studies evaluated the combination of different doses of heparin combined with aspirin. All trials used aspirin at a low dose.\nAspirin versus placebo\nWe are very uncertain if aspirin has any effect on live birth compared to placebo (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.71 to 1.25, 1 trial, 40 women, very low-certainty evidence).\nWe are very uncertain if aspirin has any effect on the risk of pre-eclampsia, pregnancy loss, preterm delivery of a live infant, intrauterine growth restriction or adverse events in the child, compared to placebo. We are very uncertain if aspirin has any effect on adverse events (bleeding) in the mother compared with placebo (RR 1.29, 95% CI 0.60 to 2.77, 1 study, 40 women). The certainty of evidence for these outcomes is very low because of imprecision, due to the low numbers of women involved and the wide 95% CIs, and also because of risk of bias.\nVenous thromboembolism and arterial thromboembolism were not reported in the included studies.\nHeparin plus aspirin versus aspirin alone\nHeparin plus aspirin may increase the number of live births (RR 1.27, 95% CI 1.09 to 1.49, 5 studies, 1295 women, low-certainty evidence).\nWe are uncertain if heparin plus aspirin has any effect on the risk of pre-eclampsia, preterm delivery of a live infant, or intrauterine growth restriction, compared with aspirin alone because of risk of bias and imprecision due to the low numbers of women involved and the wide 95% CIs. We are very uncertain if heparin plus aspirin has any effect on adverse events (bleeding) in the mother compared with aspirin alone (RR 1.65, 95% CI 0.19 to 14.03, 1 study, 31 women).\nNo women in either the heparin plus aspirin group or the aspirin alone group had heparin-induced thrombocytopenia, allergic reactions, or venous or arterial thromboembolism. Similarly, no infants had congenital malformations.\nHeparin plus aspirin may reduce the risk of pregnancy loss (RR 0.48, 95% CI 0.32 to 0.71, 5 studies, 1295 women, low-certainty evidence).\nWhen comparing LMWH plus aspirin versus aspirin alone the pooled RR for live birth was 1.20 (95% CI 1.04 to 1.38, 3 trials, 1155 women). In the comparison of UFH plus aspirin versus aspirin alone, the RR for live birth was 1.74 (95% CI 1.28 to 2.35, 2 trials, 140 women).\nAuthors' conclusions\nThe combination of heparin (UFH or LMWH) plus aspirin during the course of pregnancy may increase live birth rate in women with persistent aPL when compared with aspirin treatment alone. The observed beneficial effect of heparin was driven by one large study in which LMWH plus aspirin was compared with aspirin alone. Adverse events were frequently not, or not uniformly, reported in the included studies. More research is needed in this area in order to further evaluate potential risks and benefits of this treatment strategy, especially among women with aPL and recurrent pregnancy loss, to gain consensus on the ideal prevention for recurrent pregnancy loss, based on a risk profile.\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": "Antiphospholipid antibodies are associated with a higher risk of pregnancy complications, including the risk of pregnancy loss. Use of antithrombotic drugs during pregnancy may help prevent pregnancy loss for women who have had recurrent miscarriages. Aspirin is an anti-inflammatory drug that reduces platelet aggregation and blood clotting. Heparin is a potent anticoagulant that prevents blood clot formation. Aspirin and heparin may reduce the risk of miscarriage associated with antiphospholipid antibodies. Low-molecular-weight heparin is easier to use and causes less side effects for the mother than undivided or unfractionated heparin."
}
] |
query-laysum
|
23145
|
[
{
"role": "user",
"content": "Abstract: Background\nAcquired hearing loss is common and its incidence increases markedly with age. In most people, 'age-related' hearing loss is sensorineural (due to the loss of cochlear hair cells) and bilateral, affecting both ears to the same degree. Hearing loss categorised as mild, moderate or severe is primarily managed with hearing aids. People with bilateral hearing loss may be offered one aid, fitted to one specific ear, or two aids fitted to both ears. There is uncertainty about the relative benefits to people with hearing loss of these different strategies.\nObjectives\nTo assess the effects of bilateral versus unilateral hearing aids in adults with a bilateral hearing impairment.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Cochrane Register of Studies Online; PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 8 June 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the fitting of two versus one ear-level acoustic hearing aids in adults (over 18 years) with a bilateral hearing impairment, both ears being eligible for hearing aids.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were patient preference for bilateral or unilateral aids, hearing-specific health-related quality of life and adverse effects (pain or discomfort in the ear, initiation or exacerbation of middle or outer ear infection). Secondary outcomes included: usage of hearing aids (as measured by, for example, data logging or battery consumption), generic health-related quality of life, listening ability and audiometric benefit measured as binaural loudness summation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included four cross-over RCTs with a total of 209 participants, ranging in age from 23 to 85 and with a preponderance of men. All the studies allowed the use of hearing aids for a total period of at least eight weeks before questions on preference were asked. All studies recruited patients with bilateral hearing loss but there was considerable variation in the types and degree of sensorineural hearing loss that the participants were experiencing.\nThree of the studies were published before the mid-1990s whereas the fourth study was published in 2011. Therefore, only the most recent study used hearing aids incorporating technology comparable to that currently readily available in high-income settings. Of the four studies, two were conducted in the UK in National Health Service (NHS – public sector) patients: one recruited patients from primary care with hearing loss detected by a screening programme whereas the other recruited patients who had been referred by their primary care practitioner to an otolaryngology department for hearing aids. The other two studies were conducted in the United States: one study recruited only military personnel or veterans with noise-induced hearing loss whereas about half of the participants in the other study were veterans.\nOnly one primary outcome (patient preference) was reported in all studies. The percentage of patients who preferred bilateral hearing aids varied between studies: this was 54% (51 out of 94 participants), 39% (22 out of 56), 55% (16 out of 29) and 77% (23 out of 30), respectively. We have not combined the data from these four studies. The evidence for this outcome is of very low quality.\nThe other outcomes of interest were not reported in the included studies.\nAuthors' conclusions\nThis review identified only four studies comparing the use of one hearing aid with two. The studies were small and included participants of widely varying ages. There was also considerable variation in the types and degree of sensorineural hearing loss that the participants were experiencing.\nFor the most part, the types of hearing aid evaluated would now be regarded, in high-income settings, as 'old technology', with only one study looking at 'modern' digital aids. However, the relevance of this is uncertain, as this review did not evaluate the differences in outcomes between the different types of technology.\nWe were unable to pool data from the four studies and the very low quality of the evidence leads us to conclude that we do not know if people with hearing loss have a preference for one aid or two. Similarly, we do not know if hearing-specific health-related quality of life, or any of our other outcomes, are better with bilateral or unilateral aids.\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": "Should adult patients with bilateral (two-sided) hearing loss be fitted with one or two hearing aids?"
}
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.