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query-laysum | 1111 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a neurological disorder affecting both children and adults. Epileptic seizures are the result of excessive and abnormal cortical cell electrical activity in the brain. In response to criticism that epilepsy care for children has little impact on long-term outcomes, healthcare professionals and administrators have developed various service models and strategies to address perceived inadequacies.\nThis is an updated version of a Cochrane Review previously published in 2018.\nObjectives\nTo assess the effects of any specialised or dedicated intervention for epilepsy versus usual care in children and adolescents with epilepsy and their families.\nSearch methods\nWe searched the following databases on 14 January 2020: the Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 13 January 2020), PsycINFO (1887 to 14 January 2020), CINAHL Plus (1937 to 14 January 2020), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Register of Studies (CRS Web) includes the Cochrane Epilepsy Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL). We also contacted experts in the field seeking information on unpublished and ongoing studies and checked the websites of epilepsy organisations and the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials recruiting children and adolescents with epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 1. Seizure frequency and severity; 2. Appropriateness and volume of medication prescribed (including evidence of drug toxicity); 3. Participants' reported knowledge of information and advice received from professionals; 4. Participants' reports of health and quality of life; 5. Objective measures of general health status; 6. Objective measures of social or psychological functioning (including the number of days spent on sick leave/absence from school or work, and employment status); and 7. Costs of care or treatment. The results of the data extraction and quality assessment for each study were presented in structured tables and as a narrative summary. All summary statistics were extracted for each outcome.\nMain results\nWe included nine studies of eight interventions in the review, reporting on seven distinct self-management programmes for educating or counselling children with epilepsy and their parents, and one new model of care. Based largely on self-reported outcomes, each programme showed some benefits for the well-being of children with epilepsy; however, all of the included studies had methodological flaws. No single programme was evaluated with different study samples, and in no instance was the same outcome measured and reported in the same way across studies, precluding any possible meta-analysis, even if the interventions were considered sufficiently similar to include in meta-analysis.\nWe chose the outcomes for which data might be important for decisions about the interventions as per guidance in the Cochrane Handbook for Systematic Reviews of Interventions. We found moderate certainty evidence that one of the educational interventions reduced seizure frequency. There was low certainty evidence that two other educational interventions reduced seizure severity, seizure control, and seizure cure rates. The evidence for all other outcomes (drug adherence, knowledge, self-efficacy and self-perception of epilepsy on quality of life) was mixed.\nAuthors' conclusions\nWhilst each of the programmes evaluated in this review showed some benefit to children with epilepsy, their impact was extremely variable. No programme showed benefits across the full range of outcomes, and all studies had methodological problems. There is currently insufficient evidence in favour of any single programme. Further evidence from randomised controlled trials using validated measures and considering clinical meaningfulness as well as statistical significance of results is required.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included evidence published up to January 2020."
}
]
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query-laysum | 1112 | [
{
"role": "user",
"content": "Abstract: Background\nInflammatory bowel disease affects approximately seven million people globally. Iron deficiency anaemia can occur as a common systemic manifestation, with a prevalence of up to 90%, which can significantly affect quality of life, both during periods of active disease or in remission. It is important that iron deficiency anaemia is treated effectively and not be assumed to be a normal finding of inflammatory bowel disease. The various routes of iron administration, doses and preparations present varying advantages and disadvantages, and a significant proportion of people experience adverse effects with current therapies. Currently, no consensus has been reached amongst physicians as to which treatment path is most beneficial.\nObjectives\nThe primary objective was to evaluate the efficacy and safety of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two other databases on 21st November 2019. We also contacted experts in the field and searched references of trials for any additional trials.\nSelection criteria\nRandomised controlled trials investigating the effectiveness and safety of iron administration interventions compared to other iron administration interventions or placebo in the treatment of iron deficiency anaemia in inflammatory bowel disease. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors.\nData collection and analysis\nTwo review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology.\nMain results\nWe included 11 studies (1670 randomised participants) that met the inclusion criteria. The studies compared intravenous iron sucrose vs oral iron sulphate (2 studies); oral iron sulphate vs oral iron hydroxide polymaltose complex (1 study); oral iron fumarate vs intravenous iron sucrose (1 study); intravenous ferric carboxymaltose vs intravenous iron sucrose (1 study); erythropoietin injection + intravenous iron sucrose vs intravenous iron sucrose + injection placebo (1 study); oral ferric maltol vs oral placebo (1 study); oral ferric maltol vs intravenous ferric carboxymaltose (1 study); intravenous ferric carboxymaltose vs oral iron sulphate (1 study); intravenous iron isomaltoside vs oral iron sulphate (1 study); erythropoietin injection vs oral placebo (1 study).\nAll studies compared participants with CD and UC together, as well as considering a range of disease activity states. The primary outcome of number of responders, when defined, was stated to be an increase in haemoglobin of 20 g/L in all but two studies in which an increase in 10g/L was used.\nIn one study comparing intravenous ferric carboxymaltose and intravenous iron sucrose, moderate-certainty evidence was found that intravenous ferric carboxymaltose was probably superior to intravenous iron sucrose, although there were responders in both groups (150/244 versus 118/239, RR 1.25, 95% CI 1.06 to 1.46, number needed to treat for an additional beneficial outcome (NNTB) = 9).\nIn one study comparing oral ferric maltol to placebo, there was low-certainty evidence of superiority of the iron (36/64 versus 0/64, RR 73.00, 95% CI 4.58 to 1164.36).\nThere were no other direct comparisons that found any difference in the primary outcomes, although certainty was low and very low for all outcomes, due to imprecision from sparse data and risk of bias varying between moderate and high risk.\nThe reporting of secondary outcomes was inconsistent. The most common was the occurrence of serious adverse events or those requiring withdrawal of therapy. In no comparisons was there a difference seen between any of the intervention agents being studied, although the certainty was very low for all comparisons made, due to risk of bias and significant imprecision due to the low numbers of events.\nTime to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes were reported in any of the studies.\nAn analysis of all intravenous iron preparations to all oral iron preparations showed that intravenous administration may lead to more responders (368/554 versus 205/373, RR 1.17, 95% CI 1.05 to 1.31, NNTB = 11, low-certainty due to risk of bias and inconsistency). Withdrawals due to adverse events may be greater in oral iron preparations vs intravenous (15/554 versus 31/373, RR 0.39, 95% CI 0.20 to 0.74, low-certainty due to risk of bias, inconsistency and imprecision).\nAuthors' conclusions\nIntravenous ferric carboxymaltose probably leads to more people having resolution of IDA (iron deficiency anaemia) than intravenous iron sucrose. Oral ferric maltol may lead to more people having resolution of IDA than placebo.\nWe are unable to draw conclusions on which of the other treatments is most effective in IDA with IBD (inflammatory bowel disease) due to low numbers of studies in each comparison area and clinical heterogeneity within the studies. Therefore, there are no other conclusions regarding the treatments that can be made and certainty of all findings are low or very low. Overall, intravenous iron delivery probably leads to greater response in patients compared with oral iron, with a NNTB (number needed to treat) of 11.\nWhilst no serious adverse events were specifically elicited with any of the treatments studied, the numbers of reported events were low and the certainty of these findings very low for all comparisons, so no conclusions can be drawn. There may be more withdrawals due to such events when oral is compared with intravenous iron delivery.\nOther outcomes were poorly reported and once again no conclusions can be made as to the impact of IDA on any of these outcomes.\nGiven the widespread use of many of these treatments in practice and the only guideline that exists recommending the use of intravenous iron in favour of oral iron, research to investigate this key issue is clearly needed. Considering the current ongoing trials identified in this review, these are more focussed on the impact in specific patient groups (young people) or on other symptoms (such as fatigue). Therefore, there is a need for studies to be performed to fill this evidence gap.\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 searched for randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) comparing any treatment with another or dummy treatment. We found 11 RCTs looking at 1670 participants. The trials looked at adult participants, with none considering children.\n1) Intravenous iron in the form of ferric carboxymaltose probably leads to more people having an improvement in iron deficiency anaemia than intravenous iron sucrose (one extra person would improve for every 9 treated and five out of 10 people would improve with either therapy).\n2) Oral iron as ferric maltol may lead to more people having resolution of iron deficiency than dummy treatment.\n3) It is unclear whether there is any difference between any of the other treatments studied for treating iron deficiency anaemia.\n4) It is unclear whether any therapy leads to a difference in adverse events (minor or serious) when compared to any other therapy."
}
]
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query-laysum | 1113 | [
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of women of reproductive age suffer from endometriosis, a costly chronic disease causing pelvic pain and subfertility. Laparoscopy is the gold standard diagnostic test for endometriosis, but is expensive and carries surgical risks. Currently, there are no non-invasive tests available in clinical practice to accurately diagnose endometriosis. This review assessed the diagnostic accuracy of combinations of different non-invasive testing modalities for endometriosis and provided a summary of all the reviews in the non-invasive tests for endometriosis series.\nObjectives\nTo estimate the diagnostic accuracy of any combination of non-invasive tests for the diagnosis of pelvic endometriosis (peritoneal and/or ovarian or deep infiltrating) compared to surgical diagnosis as a reference standard. The combined tests were evaluated as replacement tests for diagnostic surgery and triage tests to assist decision-making to undertake diagnostic surgery for endometriosis.\nSearch methods\nWe did not restrict the searches to particular study designs, language or publication dates. We searched CENTRAL to July 2015, MEDLINE and EMBASE to May 2015, as well as the following databases to April 2015: CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP, ClinicalTrials.gov, DARE and PubMed.\nSelection criteria\nWe considered published, peer-reviewed, randomised controlled or cross-sectional studies of any size, including prospectively collected samples from any population of women of reproductive age suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE). We included studies comparing the diagnostic test accuracy of a combination of several testing modalities with the findings of surgical visualisation of endometriotic lesions.\nData collection and analysis\nThree review authors independently collected and performed a quality assessment of the data from each study by using the QUADAS-2 tool. For each test, the data were classified as positive or negative for the surgical detection of endometriosis and sensitivity and specificity estimates were calculated. The bivariate model was planned to obtain pooled estimates of sensitivity and specificity whenever sufficient data were available. The predetermined criteria for a clinically useful test to replace diagnostic surgery were a sensitivity of 0.94 and a specificity of 0.79 to detect endometriosis. We set the criteria for triage tests at a sensitivity of 0.95 and above and a specificity of 0.50 and above, which 'rules out' the diagnosis with high accuracy if there is a negative test result (SnOUT test), or a sensitivity of 0.50 and above and a specificity of 0.95 and above, which 'rules in' the diagnosis with high accuracy if there is a positive result (SpIN test).\nMain results\nEleven eligible studies included 1339 participants. All the studies were of poor methodological quality. Seven studies evaluated pelvic endometriosis, one study considered DIE and/or ovarian endometrioma, two studies differentiated endometrioma from other ovarian cysts and one study addressed mapping DIE at specific anatomical sites. Fifteen different diagnostic combinations were assessed, including blood, urinary or endometrial biomarkers, transvaginal ultrasound (TVUS) and clinical history or examination. We did not pool estimates of sensitivity and specificity, as each study analysed independent combinations of the non-invasive tests.\nTests that met the criteria for a replacement test were: a combination of serum IL-6 (cut-off >15.4 pg/ml) and endometrial PGP 9.5 for pelvic endometriosis (sensitivity 1.00 (95% confidence interval (CI) 0.91 to 1.00), specificity 0.93 (95% CI, 0.80, 0.98) and the combination of vaginal examination and transvaginal ultrasound (TVUS) for rectal endometriosis (sensitivity 0.96 (95% CI 0.86 to 0.99), specificity 0.98 (95% CI 0.94 to 1.00)). Tests that met the criteria for SpIN triage tests for pelvic endometriosis were: 1. a multiplication of urine vitamin-D-binding protein (VDBP) and serum CA-125 (cut-off >2755) (sensitivity 0.74 (95% CI 0.60 to 0.84), specificity 0.97 (95% CI 0.86 to 1.00)) and 2. a combination of history (length of menses), serum CA-125 (cut-off >35 U/ml) and endometrial leukocytes (sensitivity 0.61 (95% CI 0.54 to 0.69), specificity 0.95 (95% CI 0.91 to 0.98)). For endometrioma, the following combinations qualified as SpIN test: 1. TVUS and either serum CA-125 (cut-off ≥25 U/ml) or CA 19.9 (cut-off ≥12 U/ml) (sensitivity 0.79 (95% CI 0.64 to 0.91), specificity 0.97 (95% CI 0.91 to 1.00)); 2. TVUS and serum CA 19.9 (cut-off ≥12 U/ml) (sensitivity 0.54 (95% CI 0.37 to 0.70), specificity 0.97 (95% CI 0.91 to 1.0)); 3-4. TVUS and serum CA-125 (cut-off ≥20 U/ml or cut-off ≥25 U/ml) (sensitivity 0.69 (95% CI 0.49 to 0.85), specificity 0.96 (95% CI 0.88 to 0.99)); 5. TVUS and serum CA-125 (cut-off ≥35 U/ml) (sensitivity 0.52 (95% CI 0.33 to 0.71), specificity 0.97 (95% CI 0.90 to 1.00)). A combination of vaginal examination and TVUS reached the threshold for a SpIN test for obliterated pouch of Douglas (sensitivity 0.87 (95% CI 0.69 to 0.96), specificity 0.98 (95% CI 0.95 to 1.00)), vaginal wall endometriosis (sensitivity 0.82 (95% CI 0.60 to 0.95), specificity 0.99 (95% CI 0.97 to 1.0)) and rectovaginal septum endometriosis (sensitivity 0.88 (95% CI 0.47 to 1.00), specificity 0.99 (95% CI 0.96 to 1.00)).\nAll the tests were evaluated in individual studies and displayed wide CIs. Due to the heterogeneity and high risk of bias of the included studies, the clinical utility of the studied combination diagnostic tests for endometriosis remains unclear.\nAuthors' conclusions\nNone of the biomarkers evaluated in this review could be evaluated in a meaningful way and there was insufficient or poor-quality evidence. Laparoscopy remains the gold standard for the diagnosis of endometriosis and using any non-invasive tests should only be undertaken in a research setting.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence included in this review is current to April 2015. We included 11 studies on combinations of several testing methods involving 1339 participants. All studies evaluated women of reproductive age who were undertaking diagnostic surgery to investigate symptoms of endometriosis or for other indications. Fifteen combinations of different blood, endometrial and urinary biomarkers were studied, incorporating ultrasound, clinical history and examination. Each combination of tests was assessed in small individual studies."
}
]
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query-laysum | 1114 | [
{
"role": "user",
"content": "Abstract: Background\nMacular hole (MH) is a full-thickness defect in the central portion of the retina that causes loss of central vision. According to the usual definition, a large MH has a diameter greater than 400 µm at the narrowest point. For closure of MH, there is evidence that pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling achieves better anatomical outcomes than standard PPV. PPV with ILM peeling is currently the standard of care for MH management; however, the failure rate of this technique is higher for large MHs than for smaller MHs. Some studies have shown that the inverted ILM flap technique is superior to conventional ILM peeling for the management of large MHs.\nObjectives\nTo evaluate the clinical effectiveness and safety of pars plana vitrectomy with the inverted internal limiting membrane flap technique versus pars plana vitrectomy with conventional internal limiting membrane peeling for treating large macular holes, including idiopathic, traumatic, and myopic macular holes.\nSearch methods\nThe Cochrane Eyes and Vision Information Specialist searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registries on 12 December 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) that evaluated PPV with ILM peeling versus PPV with inverted ILM flap for treatment of large MHs (with a basal diameter greater than 400 µm at the narrowest point measured by optical coherence tomography) of any type (idiopathic, traumatic, or myopic).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and assessed the certainty of the body of evidence using GRADE.\nMain results\nWe included four RCTs (285 eyes of 275 participants; range per study 24 to 91 eyes). Most participants were women (63%), and of older age (range of means 59.4 to 66 years). Three RCTs were single-center trials, and the same surgeon performed all surgeries in two RCTs (the third single-center RCT did not report the number of surgeons). One RCT was a multicenter trial (three sites), and four surgeons performed all surgeries. Two RCTs took place in India, one in Poland, and one in Mexico. Maximum follow-up ranged from three months (2 RCTs) to 12 months (1 RCT). No RCTs reported conflicts of interest or disclosed financial support. All four RCTs enrolled people with large idiopathic MHs and compared conventional PPV with ILM peeling versus PPV with inverted ILM flap techniques. Variations in technique across the four RCTs were minimal. There was some heterogeneity in interventions: in two RCTs, all participants underwent combined cataract-PPV surgery, whereas in one RCT, some participants underwent cataract surgery after PPV (the fourth RCT did not mention cataract surgery). The critical outcomes for this review were mean best-corrected visual acuity (BCVA) and MH closure rates. All four RCTs provided data for meta-analyses of both critical outcomes. We assessed the risk of bias for both outcomes using the Cochrane risk of bias tool (RoB 2); there were some concerns for risk of bias associated with lack of masking of outcome assessors and selective reporting of outcomes in all RCTs.\nAll RCTs reported postoperative BCVA values; only one RCT reported the change in BCVA from baseline. Based on evidence from the four RCTs, it is unclear if the inverted ILM flap technique compared with ILM peeling reduces (improves) postoperative BCVA measured on a logarithm of the minimum angle of resolution (logMAR) chart at one month (mean difference [MD] −0.08 logMAR, 95% confidence interval [CI] −0.20 to 0.05; P = 0.23, I2 = 65%; 4 studies, 254 eyes; very low-certainty evidence), but it may improve BCVA at three months or more (MD −0.17 logMAR, 95% CI −0.23 to −0.10; P < 0.001, I2 = 0%; 4 studies, 276 eyes; low-certainty evidence). PPV with an inverted ILM flap compared to PPV with ILM peeling probably increases the proportion of eyes achieving MH closure (risk ratio [RR] 1.10, 95% CI 1.02 to 1.18; P = 0.01, I2 = 0%; 4 studies, 276 eyes; moderate-certainty evidence) and type 1 MH closure (RR 1.31, 95% CI 1.03 to 1.66; P = 0.03, I² = 69%; 4 studies, 276 eyes; moderate-certainty evidence). One study reported that none of the 38 participants experienced postoperative retinal detachment.\nAuthors' conclusions\nWe found low-certainty evidence from four small RCTs that PPV with the inverted ILM flap technique is superior to PPV with ILM peeling with respect to BCVA gains at three or more months after surgery. We also found moderate-certainty evidence that the inverted ILM flap technique achieves more overall and type 1 MH closures. There is a need for high-quality multicenter RCTs to ascertain whether the inverted ILM flap technique is superior to ILM peeling with regard to anatomical and functional outcomes. Investigators should use the standard logMAR charts when measuring BCVA to facilitate comparison across trials.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In three of the four studies, the people measuring the results of the surgery may have known which treatment each study participant had received, and this knowledge may have influenced their assessments. The studies reported the results at different time points after surgery, which may have affected the assessment of vision. There were some differences in the surgeries across the studies; for example, in two studies, all people had cataract surgery combined with PPV."
}
]
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query-laysum | 1115 | [
{
"role": "user",
"content": "Abstract: Background\nNeurocysticercosis is a parasitic infection of the central nervous system by the larval stage of the pork tapeworm and is a common cause of seizures and epilepsy in endemic areas. Anthelmintics (albendazole or praziquantel) may be given alongside supportive treatment (antiepileptics/analgesia) with the aim of killing these larvae (cysticerci), with or without corticosteroid treatment. However, there are potential adverse effects of these drugs, and the cysticerci may eventually die without directed anthelminthic treatment.\nObjectives\nTo assess the effects of anthelmintics on people with neurocysticercosis.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, the WHO ICTRP, and ClinicalTrials.gov, up to 21 October 2020.\nSelection criteria\nRandomized controlled trials comparing anthelmintics and supportive treatment (+/- corticosteroids) with supportive treatment alone (+/- corticosteroids) for people with neurocysticercosis.\nData collection and analysis\nTwo review authors independently screened the title and abstract of all articles identified by the search. We obtained full-text articles to confirm the eligibility of all studies that passed screening. One review author extracted data, which a second review author checked. Two review authors assessed the risk of bias of each trial and performed GRADE assessments. In cases of disagreement at consensus discussion stage between review authors, we consulted a third review author. We calculated risk ratios (RR) for dichotomous variables, with 95% confidence intervals (CIs) for pooled data from studies with similar interventions and outcomes.\nMain results\nWe included 16 studies in the review. Only two studies investigated praziquantel and did not report data in a format that could contribute to meta-analysis. Most results in this review are therefore applicable to albendazole versus placebo or no anthelmintic.\nThe aggregate analysis across all participants with neurocysticercosis did not demonstrate a difference between groups in seizure recurrence, but heterogeneity was marked (RR 0.94, 95% CI 0.78 to 1.14; 10 trials, 1054 participants; I2 = 67%; low-certainty evidence). When stratified by participants with a single cyst or multiple cysts, pooled analysis suggests that albendazole probably improves seizure recurrence for participants with a single cyst (RR 0.61, 95% CI 0.4 to 0.91; 5 trials, 396 participants; moderate-certainty evidence). All studies contributing to this analysis recruited participants with non-viable, intraparenchymal cysts only, and most participants were children. We are uncertain whether or not albendazole reduces seizure recurrence in participants with multiple cysts, as the certainty of the evidence is very low, although the direction of effect is towards albendazole causing harm (RR 2.05, 95% CI 1.28 to 3.31; 2 trials, 321 participants; very low-certainty evidence). This analysis included a large study containing a highly heterogeneous population that received an assessment of unclear risk for multiple 'Risk of bias' domains.\nRegarding radiological outcomes, albendazole probably slightly improves the complete radiological clearance of lesions (RR 1.22, 95% CI 1.07 to 1.39; 13 trials, 1324 participants; moderate-certainty evidence) and the evolution of cysts (RR 1.27, 95% CI 1.10 to 1.47; 6 trials, 434 participants; moderate-certainty evidence).\nMore adverse events appeared to be observed in participants treated with either albendazole or praziquantel compared to those receiving placebo or no anthelmintic. The most commonly reported side effects were headache, abdominal pain, and nausea/vomiting.\nAuthors' conclusions\nFor participants with a single cyst, there was less seizure recurrence in the albendazole group compared to the placebo/no anthelmintic group. The studies contributing to this evidence only recruited participants with a non-viable intraparenchymal cyst. We are uncertain whether albendazole reduces seizure recurrence for participants with multiple cysts. We also found that albendazole probably increases radiological clearance and evolution of lesions. There were very few studies reporting praziquantel outcomes, and these findings apply to albendazole only.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Neurocysticercosis is an infection of the brain with the pork tapeworm Taenia solium, which is caused by eating food or drinking water contaminated with the eggs of the worm. The eggs can travel from the gut to the brain, forming cysts in the brain that can cause various symptoms, the most common of which is seizures/epilepsy. Neurocysticercosis is found mainly in areas where people keep pigs and have poor sanitation facilities, and is a common cause of seizures in areas where it is prevalent.\nPeople with neurocysticercosis may have single or multiple cysts, and their symptoms depend on the position and numbers of these cysts within the brain. Each cyst goes through the natural process of being alive and dormant (viable), degrading (non-viable), and then it resolves or calcifies. This process can take many years. The number, type, and position of the cysts can be seen on brain imaging (lesions).\nTwo anthelmintics (drugs to treat worm infections), albendazole and praziquantel, are often used to treat neurocysticercosis. However, it is uncertain whether they reduce or stop seizures and other symptoms, or make them worse. In theory, the body's immune response to cysts dying as a result of treatment could cause more swelling and damage to the brain."
}
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query-laysum | 1116 | [
{
"role": "user",
"content": "Abstract: Background\nThe hepatitis C virus (HCV) infection affects about 2% of the world's population and can cause chronic liver infection and persistent long-term sequelae such as cirrhosis and liver cancer.\nThe prevalence of HCV infection among people on haemodialysis is often higher than the general population. The virus is easily transmitted parenterally, and blood transfusions have previously played a significant role in transmission; however, erythropoietin therapy has reduced the need for transfusions, and coupled with improved screening of donated blood, has significantly decreased transmission by transfusion. Although control of hospital-acquired infection has improved with the advent of biosafety measures, stopping HCV transmission in haemodialysis units remains challenging.\nIsolating people infected with HCV involves physical separation from others to limit direct or indirect transmission and includes a number of strategies during dialysis. The evidence for isolating people infected with HCV during haemodialysis is sparse with some inconsistencies.\nObjectives\nTo evaluate the benefits and harms of isolation of HCV-infected patients during haemodialysis on the transmission of HCV to other patients.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 26 November 2015 through contact with the Information Specialist using search terms relevant to this review. We also searched the Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to 2015), Web of Science Conference Proceedings Citation Index-Science (CPCI-S, 1990 to 2015), ProQuest Dissertations & Theses Database (1990 to 2015), and Open Grey (1990 to 2015).\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and cluster RCTs evaluating the clinical benefits and harms of isolating HCV-infected patients during haemodialysis on the transmission of HCV to other patients. We considered incidence of dialysis-acquired HCV infection, all-cause mortality, and adverse effects associated with isolation as the primary outcomes.\nData collection and analysis\nSummary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) and 95% CI for continuous outcomes.\nMain results\nOnly one study, which included 12 centres was identified: four centres used dedicated haemodialysis machines for HCV-infected patients and eight centres used non-dedicated machines. The total number of patients enrolled was 593. One centre was excluded after randomisation. Random sequence generation was not described and allocation concealment was not performed. Participants and personnel were not blinded and blinding of outcome assessors was not reported. Only 74.5% of the patients were followed for 9 months; and 47.3% were followed for an additional 9 months. The authors only reported one outcome, measuring the difference in the incidence of HCV in both groups. The authors did not consider the exposure time, to determine the adjusted rate of seroconversion risk/patient-year.\n\nThe study reported that the incidence of HCV infection during the first follow-up period (9 months) was 1.6% in the dedicated group, and 4.7% in the non-dedicated one (446 patients analysed out of 593 randomised; RR 0.34, 95% CI 0.11 to 1.07). During the second follow-up period (18 months) the incidence was 1.3% in the dedicated group and 5.8% in the control (281 patients analysed out of 593 randomised; RR 0.22, 95% CI 0.05 to 1.02). Therefore, we found no differences in terms of the number of participants developing HCV infection when comparing the dedicated group with the usual care. Moreover, the evidence was of very low quality, which means that we have very little confidence in the effect estimate.\nAuthors' conclusions\nThe benefits and harms of isolation of HCV-infected patients during haemodialysis on the transmission of HCV to other patients are uncertain. Evidence from one short-duration cluster-randomised study with a high risk of bias did not find differences in terms of the number of participants developing HCV infection when comparing the use of dedicated haemodialysis machines for HCV infected patients with the use of non-dedicated machines.\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": "This one study included 12 centres (593 patients). Four centres assigned HCV-infected patients to a dedicated haemodialysis machine and eight centres did not. This study reported the incidence of HCV in haemodialysis patients decreased with the use of dedicated machines; however it was not possible to determine the benefits and harms associated with isolation, cost, or mortality from the disease."
}
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query-laysum | 1117 | [
{
"role": "user",
"content": "Abstract: Background\nWe performed a systematic review, a standard meta-analysis and network meta-analysis (NMA), which updates the 2009 Cochrane Overview, 'Biologics for rheumatoid arthritis (RA)'. This review is focused on biologic monotherapy in people with RA in whom treatment with traditional disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) had failed (MTX/other DMARD-experienced).\nObjectives\nTo assess the benefits and harms of biologic monotherapy (includes anti-tumor necrosis factor (TNF) (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) or non-TNF (abatacept, anakinra, rituximab, tocilizumab)) or tofacitinib monotherapy (oral small molecule) versus comparator (placebo or MTX/other DMARDs) in adults with RA who were MTX/other DMARD-experienced.\nMethods\nWe searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2015, Issue 6, June), MEDLINE (via OVID 1946 to June 2015), and Embase (via OVID 1947 to June 2015). Article selection, data extraction and risk of bias and GRADE assessments were done in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparisons (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We calculated absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB).\nMain results\nThis update includes 40 new RCTs for a total of 46 RCTs, of which 41 studies with 14,049 participants provided data. The comparator was placebo in 16 RCTs (4,532 patients), MTX or other DMARD in 13 RCTs (5,602 patients), and another biologic in 12 RCTs (3,915 patients).\nMonotherapy versus placebo\nBased on moderate-quality direct evidence, biologic monotherapy (without concurrent MTX/other DMARDs) was associated with a clinically meaningful and statistically significant improvement in American College of Rheumatology score (ACR50) and physical function, as measured by the Health Assessment Questionnaire (HAQ) versus placebo. RR was 4.68 for ACR50 (95% CI, 2.93 to 7.48); absolute benefit RD 23% (95% CI, 18% to 29%); and NNTB = 5 (95% CI, 3 to 8). The mean difference (MD) was -0.32 for HAQ (95% CI, -0.42 to -0.23; a negative sign represents greater HAQ improvement); absolute benefit of -10.7% (95% CI, -14% to -7.7%); and NNTB = 4 (95% CI, 3 to 5). Direct and NMA estimates for TNF biologic, non-TNF biologic or tofacitinib monotherapy showed similar results for ACR50 , downgraded to moderate-quality evidence. Direct and NMA estimates for TNF biologic, anakinra or tofacitinib monotherapy showed a similar results for HAQ versus placebo with mostly moderate quality evidence.\nBased on moderate-quality direct evidence, biologic monotherapy was associated with a clinically meaningful and statistically significant greater proportion of disease remission versus placebo with RR 1.12 (95% CI 1.03 to 1.22); absolute benefit 10% (95% CI, 3% to 17%; NNTB = 10 (95% CI, 8 to 21)).\nBased on low-quality direct evidence, results for biologic monotherapy for withdrawals due to adverse events and serious adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase. The direct estimate for TNF monotherapy for withdrawals due to adverse events showed a clinically meaningful and statistically significant result with RR 2.02 (95% CI, 1.08 to 3.78), absolute benefit RD 3% (95% CI,1% to 4%), based on moderate-quality evidence. The NMA estimates for TNF biologic, non-TNF biologic, anakinra, or tofacitinib monotherapy for withdrawals due to adverse events and for serious adverse events were all inconclusive and downgraded to low-quality evidence.\nMonotherapy versus active comparator (MTX/other DMARDs)\nBased on direct evidence of moderate quality, biologic monotherapy (without concurrent MTX/other DMARDs) was associated with a clinically meaningful and statistically significant improvement in ACR50 and HAQ scores versus MTX/other DMARDs with a RR of 1.54 (95% CI, 1.14 to 2.08); absolute benefit 13% (95% CI, 2% to 23%), NNTB = 7 (95% CI, 4 to 26) and a mean difference in HAQ of -0.27 (95% CI, -0.40 to -0.14); absolute benefit of -9% (95% CI, -13.3% to -4.7%), NNTB = 2 (95% CI, 2 to 4). Direct and NMA estimates for TNF monotherapy and NMA estimate for non-TNF biologic monotherapy for ACR50 showed similar results, based on moderate-quality evidence. Direct and NMA estimates for non-TNF biologic monotherapy, but not TNF monotherapy, showed similar HAQ improvements , based on mostly moderate-quality evidence.\nThere were no statistically significant or clinically meaningful differences for direct estimates of biologic monotherapy versus active comparator for RA disease remission. NMA estimates showed a statistically significant and clinically meaningful difference versus active comparator for TNF monotherapy (absolute improvement 7% (95% CI, 2% to 14%)) and non-TNF monotherapy (absolute improvement 19% (95% CrI, 7% to 36%)), both downgraded to moderate quality.\nBased on moderate-quality direct evidence from a single study, radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologic monotherapy versus active comparator, MD -4.34 (95% CI, -7.56 to -1.12), though the absolute reduction was small, -0.97% (95% CI, -1.69% to -0.25%). We are not sure of the clinical relevance of this reduction.\nDirect and NMA evidence (downgraded to low quality), showed inconclusive results for withdrawals due to adverse events, serious adverse events and cancer, with wide confidence intervals encompassing the null effect and evidence of an important increase.\nAuthors' conclusions\nBased mostly on RCTs of six to 12-month duration in people with RA who had previously experienced and failed treatment with MTX/other DMARDs, biologic monotherapy improved ACR50, function and RA remission rates compared to placebo or MTX/other DMARDs.\nRadiographic progression was reduced versus active comparator, although the clinical significance was unclear.\nResults were inconclusive for whether biologic monotherapy was associated with an increased risk of withdrawals due to adverse events, serious adverse events or cancer, versus placebo (no data on cancer) or MTX/other DMARDs.\n\nGiven the provided abstract, please respond to the following query: \"Cancer\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The same number of people (1 out of 1000) who took biologic monotherapy compared to those on MTX/other DMARDs had cancer. However, we are cautious about this estimate as there were few events of cancer."
}
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query-laysum | 1118 | [
{
"role": "user",
"content": "Abstract: Background\nDamage caused by lung overdistension (volutrauma) has been implicated in the development of bronchopulmonary dysplasia (BPD). Modern neonatal ventilation modes can target a set tidal volume as an alternative to traditional pressure-limited ventilation (PLV) using a fixed inflation pressure. Volume-targeted ventilation (VTV) aims to produce a more stable tidal volume in order to reduce lung damage and stabilise the partial pressure of carbon dioxide (pCO2).\nObjectives\nTo determine whether VTV compared with PLV leads to reduced rates of death and death or BPD in newborn infants and to determine whether use of VTV affected outcomes including air leak, cranial ultrasound findings and neurodevelopment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 12), MEDLINE via PubMed (1966 to 13 January 2017), Embase (1980 to 13 January 2017) and CINAHL (1982 to 13 January 2017). We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We contacted the principal investigators of studies to obtain supplementary information.\nSelection criteria\nRandomised and quasi-randomised trials comparing VTV versus PLV in infants of less than 44 weeks' postmenstrual age and reporting clinically relevant outcomes.\nData collection and analysis\nWe assessed risk of bias for each trial using Cochrane methodology. We evaluated quality of evidence for each outcome using GRADE criteria. We tabulated mortality, rates of BPD, short-term clinical outcomes and long-term developmental outcomes.\nStatistics: for categorical outcomes, we calculated typical estimates for risk ratios (RR), risk differences (RD) and number needed to treat for an additional beneficial outcome (NNTB). For continuous variables, we calculated typical estimates for mean differences (MD). We used 95% confidence intervals (CI) and assumed a fixed-effect model for meta-analysis.\nMain results\nTwenty randomised trials met our inclusion criteria; 16 parallel trials (977 infants) and four cross-over trials (88 infants). No studies were blinded and the quality of evidence for outcomes assessed varied from moderate to low.\nWe found no difference in the primary outcome, death before hospital discharge, between VTV modes versus PLV modes (typical RR 0.75, 95% CI 0.53 to 1.07; low quality evidence). However, there was moderate quality evidence that the use of VTV modes resulted in a reduction in the primary outcome, death or BPD at 36 weeks' gestation (typical RR 0.73, 95% CI 0.59 to 0.89; typical NNTB 8, 95% CI 5 to 20) and the following secondary outcomes: rates of pneumothorax (typical RR 0.52, 95% CI 0.31 to 0.87; typical NNTB 20, 95% CI 11 to 100), mean days of mechanical ventilation (MD -1.35 days, 95% CI -1.83 to -0.86), rates of hypocarbia (typical RR 0.49, 95% CI 0.33 to 0.72; typical NNTB 3, 95% CI 2 to 5), rates of grade 3 or 4 intraventricular haemorrhage (typical RR 0.53, 95% CI 0.37 to 0.77; typical NNTB 11, 95% CI 7 to 25) and the combined outcome of periventricular leukomalacia with or without grade 3 or 4 intraventricular haemorrhage (typical RR 0.47, 95% CI 0.27 to 0.80; typical NNTB 11, 95% CI 7 to 33). VTV modes were not associated with any increased adverse outcomes.\nAuthors' conclusions\nInfants ventilated using VTV modes had reduced rates of death or BPD, pneumothoraces, hypocarbia, severe cranial ultrasound pathologies and duration of ventilation compared with infants ventilated using PLV modes. Further studies are needed to identify whether VTV modes improve neurodevelopmental outcomes and to compare and refine VTV strategies.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Does ventilator therapy of infants using a strategy targeting inflation volume rather than inflation pressure lead to lower rates of death or lung damage (or both) among these infants?"
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query-laysum | 1119 | [
{
"role": "user",
"content": "Abstract: Background\nUterine leiomyomas, also referred to as myomas or fibroids, are benign tumours arising from the smooth muscle cells of the myometrium. They are the most common pelvic tumour in women. The estimated rate of leiomyosarcoma, found during surgery for presumed benign leiomyomas, is about 0.51 per 1000 procedures, or approximately 1 in 2000.\nTreatment options for symptomatic uterine leiomyomas include medical, surgical, and radiologically-guided interventions. Laparoscopic myomectomy is the gold standard surgical approach for women who want offspring, or otherwise wish to retain their uterus. A limitation of laparoscopy is the inability to remove large specimens from the abdominal cavity through the laparoscope. To overcome this challenge, the morcellation approach was developed, during which larger specimens are broken into smaller pieces in order to remove them from the abdominal cavity via the port site. However, intracorporeal power morcellation may lead to scattering of benign tissues, with the risk of spreading leiomyoma or endometriosis. In cases of unsuspected malignancy, power morcellation can cause unintentional dissemination of malignant cells, and lead to a poorer prognosis by upstaging the occult cancer.\nA strategy to optimise women's safety is to morcellate the specimens inside a bag. In-bag morcellation may avoid the dissemination of tissue fragments.\nObjectives\nTo evaluate the effectiveness and safety of protected in-bag extracorporeal manual morcellation during laparoscopic myomectomy compared to intra-abdominal uncontained power morcellation.\nSearch methods\nOn 1 July 2019, we searched; the Cochrane Gynaecology and Fertility Group Specialized Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, PubMed, Google Scholar, and two trials registers.\nWe reviewed the reference lists of all retrieved full-text articles, and contacted experts in the field for additional and ongoing trials.\nSelection criteria\nWe included all randomised controlled trials comparing in-bag extracorporeal manual morcellation versus intracorporeal uncontained power morcellation during laparoscopic myomectomy in premenopausal women.\nData collection and analysis\nWe followed standard Cochrane methods.\nTwo review authors independently reviewed the eligibility of trials, extracted data, and evaluated the risk of bias. Data were checked for accuracy.\nThe summary measures were reported as risk ratios (RR) or mean differences (MD) with 95% confidence interval (CI).\nThe outcomes of interest were a composite of intraoperative and postoperative complications, operative times, ease of morcellation, length of hospital stay, postoperative pain, conversion to laparotomy, and postoperative diagnosis of leiomyosarcoma. Results for the five main outcomes follow.\nMain results\nWe included two trials, enrolling 176 premenopausal women with fibroids, who underwent laparoscopic myomectomy.\nThe experimental group received in-bag manual morcellation, during which each enucleated myoma was placed into a specimen retrieval bag, and manually morcellated with scalpel or scissors. In the control group, intracorporeal uncontained power morcellation was used to reduce the size of the myomas.\nNo intraoperative complications, including accidental morcellation of the liver, conversion to laparotomy, endoscopic bag disruption, bowel injury, bleeding, accidental injury to any viscus or vessel, were reported in either group in either trial.\nWe found very low-quality evidence of inconclusive results for total operative time (MD 9.93 minutes, 95% CI -1.35 to 21.20; 2 studies, 176 participants; I² = 35%), and ease of morcellation (MD -0.73 points, 95% CI -1.64 to 0.18; 1 study, 104 participants). The morcellation operative time was a little longer for the in-bag manual morcellation group, however the quality of the evidence was very low (MD 2.59 minutes, 95% CI 0.45 to 4.72; 2 studies, 176 participants; I² = 0%). There were no postoperative diagnoses of leiomyosarcoma made in either group in either trial.\nWe are very uncertain of any of these results. We downgraded the quality of the evidence due to indirectness and imprecision, because of limited sites in high-income settings and countries, small sample sizes, wide confidence intervals, and few events.\nAuthors' conclusions\nThere are limited data on the effectiveness and safety of in-bag morcellation at the time of laparoscopic myomectomy compared to uncontained power morcellation. We were unable to determine the effects of in-bag morcellation on intraoperative complications as no events were reported in either group. We are uncertain if in-bag morcellation improves total operative time or ease of morcellation compared to control. Regarding morcellation operative time, the quality of the evidence was also very low and we cannot be certain of the effect of in-bag morcellation compared to uncontained morcellation. No cases of postoperative diagnosis of leiomyosarcoma occurred in either group. We found only two trials comparing in-bag extracorporeal manual morcellation to intracorporeal uncontained power morcellation at the time of laparoscopic myomectomy. Both trials had morcellation operative time as primary outcome and were not powered for uncommon outcomes such as intraoperative complications, and postoperative diagnosis of leiomyosarcoma.\nLarge, well-planned and executed trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"Study Characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included two randomised controlled trials, which enrolled 176 premenopausal women undergoing laparoscopic myomectomy; they were randomised to receive either in-bag manual morcellation (87 women) or uncontained power morcellation (89 women). The literature was searched to 1 July 2019."
}
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query-laysum | 1120 | [
{
"role": "user",
"content": "Abstract: Background\nPrevention of childhood obesity is an international public health priority given the significant impact of obesity on acute and chronic diseases, general health, development and well-being. The international evidence base for strategies to prevent obesity is very large and is accumulating rapidly. This is an update of a previous review.\nObjectives\nTo determine the effectiveness of a range of interventions that include diet or physical activity components, or both, designed to prevent obesity in children.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsychINFO and CINAHL in June 2015. We re-ran the search from June 2015 to January 2018 and included a search of trial registers.\nSelection criteria\nRandomised controlled trials (RCTs) of diet or physical activity interventions, or combined diet and physical activity interventions, for preventing overweight or obesity in children (0-17 years) that reported outcomes at a minimum of 12 weeks from baseline.\nData collection and analysis\nTwo authors independently extracted data, assessed risk-of-bias and evaluated overall certainty of the evidence using GRADE. We extracted data on adiposity outcomes, sociodemographic characteristics, adverse events, intervention process and costs. We meta-analysed data as guided by the Cochrane Handbook for Systematic Reviews of Interventions and presented separate meta-analyses by age group for child 0 to 5 years, 6 to 12 years, and 13 to 18 years for zBMI and BMI.\nMain results\nWe included 153 RCTs, mostly from the USA or Europe. Thirteen studies were based in upper-middle-income countries (UMIC: Brazil, Ecuador, Lebanon, Mexico, Thailand, Turkey, US-Mexico border), and one was based in a lower middle-income country (LMIC: Egypt). The majority (85) targeted children aged 6 to 12 years.\n\nChildren aged 0-5 years: There is moderate-certainty evidence from 16 RCTs (n = 6261) that diet combined with physical activity interventions, compared with control, reduced BMI (mean difference (MD) −0.07 kg/m2, 95% confidence interval (CI) −0.14 to −0.01), and had a similar effect (11 RCTs, n = 5536) on zBMI (MD −0.11, 95% CI −0.21 to 0.01). Neither diet (moderate-certainty evidence) nor physical activity interventions alone (high-certainty evidence) compared with control reduced BMI (physical activity alone: MD −0.22 kg/m2, 95% CI −0.44 to 0.01) or zBMI (diet alone: MD −0.14, 95% CI −0.32 to 0.04; physical activity alone: MD 0.01, 95% CI −0.10 to 0.13) in children aged 0-5 years.\n\nChildren aged 6 to 12 years: There is moderate-certainty evidence from 14 RCTs (n = 16,410) that physical activity interventions, compared with control, reduced BMI (MD −0.10 kg/m2, 95% CI −0.14 to −0.05). However, there is moderate-certainty evidence that they had little or no effect on zBMI (MD −0.02, 95% CI −0.06 to 0.02). There is low-certainty evidence from 20 RCTs (n = 24,043) that diet combined with physical activity interventions, compared with control, reduced zBMI (MD −0.05 kg/m2, 95% CI −0.10 to −0.01). There is high-certainty evidence that diet interventions, compared with control, had little impact on zBMI (MD −0.03, 95% CI −0.06 to 0.01) or BMI (−0.02 kg/m2, 95% CI −0.11 to 0.06).\nChildren aged 13 to 18 years: There is very low-certainty evidence that physical activity interventions, compared with control reduced BMI (MD −1.53 kg/m2, 95% CI −2.67 to −0.39; 4 RCTs; n = 720); and low-certainty evidence for a reduction in zBMI (MD -0.2, 95% CI −0.3 to -0.1; 1 RCT; n = 100). There is low-certainty evidence from eight RCTs (n = 16,583) that diet combined with physical activity interventions, compared with control, had no effect on BMI (MD −0.02 kg/m2, 95% CI −0.10 to 0.05); or zBMI (MD 0.01, 95% CI −0.05 to 0.07; 6 RCTs; n = 16,543). Evidence from two RCTs (low-certainty evidence; n = 294) found no effect of diet interventions on BMI.\n\nDirect comparisons of interventions: Two RCTs reported data directly comparing diet with either physical activity or diet combined with physical activity interventions for children aged 6 to 12 years and reported no differences.\n\nHeterogeneity was apparent in the results from all three age groups, which could not be entirely explained by setting or duration of the interventions. Where reported, interventions did not appear to result in adverse effects (16 RCTs) or increase health inequalities (gender: 30 RCTs; socioeconomic status: 18 RCTs), although relatively few studies examined these factors.\nRe-running the searches in January 2018 identified 315 records with potential relevance to this review, which will be synthesised in the next update.\nAuthors' conclusions\nInterventions that include diet combined with physical activity interventions can reduce the risk of obesity (zBMI and BMI) in young children aged 0 to 5 years. There is weaker evidence from a single study that dietary interventions may be beneficial.\nHowever, interventions that focus only on physical activity do not appear to be effective in children of this age. In contrast, interventions that only focus on physical activity can reduce the risk of obesity (BMI) in children aged 6 to 12 years, and adolescents aged 13 to 18 years. In these age groups, there is no evidence that interventions that only focus on diet are effective, and some evidence that diet combined with physical activity interventions may be effective. Importantly, this updated review also suggests that interventions to prevent childhood obesity do not appear to result in adverse effects or health inequalities.\nThe review will not be updated in its current form. To manage the growth in RCTs of child obesity prevention interventions, in future, this review will be split into three separate reviews based on child age.\n\nGiven the provided abstract, please respond to the following query: \"Searching for studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched many scientific databases to find studies that looked at ways of preventing obesity in children. We included studies aimed at all ages of children. We only included studies if the methods they were using were aimed at changing children's diet, or their level of physical activity, or both. We looked only for the studies that contained the best information to answer this question, ‘randomised controlled trials’ or RCTs."
}
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query-laysum | 1121 | [
{
"role": "user",
"content": "Abstract: Background\nSkin-sparing mastectomy (SSM) is a surgical technique that aims to maximize skin preservation, facilitate breast reconstruction, and improve cosmetic outcomes. Despite its use in clinical practice, the benefits and harms related to SSM are not well established.\nObjectives\nTo assess the effectiveness and safety of skin-sparing mastectomy for the treatment of breast cancer.\nSearch methods\nWe searched Cochrane Breast Cancer's Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov on 9 August 2019.\nSelection criteria\nRandomized controlled trials (RCTs), quasi-randomized or non-randomized studies (cohort and case-control) comparing SSM to conventional mastectomy for treating ductal carcinoma in situ (DCIS) or invasive breast cancer.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome was overall survival. Secondary outcomes were local recurrence free-survival, adverse events (including overall complications, breast reconstruction loss, skin necrosis, infection and hemorrhage), cosmetic results, and quality of life. We performed a descriptive analysis and meta-analysis of the data.\nMain results\nWe found no RCTs or quasi-RCTs. We included two prospective cohort studies and twelve retrospective cohort studies. These studies included 12,211 participants involving 12,283 surgeries (3183 SSM and 9100 conventional mastectomies). It was not possible to perform a meta-analysis for overall survival and local recurrence free-survival due to clinical heterogeneity across studies and a lack of data to calculate hazard ratios (HR).\nBased on one study, the evidence suggests that SSM may not reduce overall survival for participants with DCIS tumors (HR 0.41, 95% CI 0.17 to 1.02; P = 0.06; 399 participants; very low-certainty evidence) or for participants with invasive carcinoma (HR 0.81, 95% CI 0.48 to 1.38; P = 0.44; 907 participants; very low-certainty evidence). For local recurrence-free survival, meta-analysis was not possible, due to high risk of bias in nine of the ten studies that measured this outcome. Informal visual examination of effect sizes from nine studies suggested the size of the HR may be similar between groups. Based on one study that adjusted for confounders, SSM may not reduce local recurrence-free survival (HR 0.82, 95% CI 0.47 to 1.42; P = 0.48; 5690 participants; very low-certainty evidence).\nThe effect of SSM on overall complications is unclear (RR 1.55, 95% CI 0.97 to 2.46; P = 0.07, I2 = 88%; 4 studies, 677 participants; very low-certainty evidence). Skin-sparing mastectomy may not reduce the risk of breast reconstruction loss (RR 1.79, 95% CI 0.31 to 10.35; P = 0.52; 3 studies, 475 participants; very low-certainty evidence), skin necrosis (RR 1.15, 95% CI 0.62 to 2.12; P = 0.22, I2 = 33%; 4 studies, 677 participants; very low-certainty evidence), local infection (RR 2.04, 95% CI 0.03 to 142.71; P = 0.74, I2 = 88%; 2 studies, 371 participants; very low-certainty evidence), nor hemorrhage (RR 1.23, 95% CI 0.47 to 3.27; P = 0.67, I2 = 0%; 4 studies, 677 participants; very low-certainty evidence). We downgraded the certainty of the evidence due to the risk of bias, imprecision, and inconsistency among the studies. There were no data available on the following outcomes: systemic surgical complications, local complications, explantation of implant/expander, hematoma, seroma, rehospitalization, skin necrosis with revisional surgery, and capsular contracture of the implant.\nIt was not possible to perform a meta-analysis for cosmetic and quality of life outcomes due to a lack of data. One study performed an evaluation of aesthetic outcome after SSM: 77.7% of participants with immediate breast reconstruction had an overall aesthetic result of excellent or good versus 87% of participants with delayed breast reconstruction.\nAuthors' conclusions\nBased on very low-certainty evidence from observational studies, it was not possible to draw definitive conclusions on the effectiveness and safety of SSM for breast cancer treatment. The decision for this technique of breast surgery for treatment of DCIS or invasive breast cancer must be individualized and shared between the physician and the patient while considering the potential risks and benefits of available surgical options.\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"
},
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"role": "assistant",
"content": "We wanted to find out if SSM is as effective to treat breast cancer as conventional mastectomy and assess whether the surgical complication rates differed."
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query-laysum | 1122 | [
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"role": "user",
"content": "Abstract: Background\nCough is a frequent symptom presenting to doctors. The most common cause of childhood chronic (greater than fours weeks' duration) wet cough is protracted bacterial bronchitis (PBB) in some settings, although other more serious causes can also present this way. Timely and effective management of chronic wet or productive cough improves quality of life and clinical outcomes. Current international guidelines suggest a course of antibiotics is the first treatment of choice in the absence of signs or symptoms specific to an alternative diagnosis. This review sought to clarify the current evidence to support this recommendation.\nObjectives\nTo determine the efficacy of antibiotics in treating children with prolonged wet cough (excluding children with bronchiectasis or other known underlying respiratory illness) and to assess risk of harm due to adverse events.\nSearch methods\nWe undertook an updated search (from 2008 onwards) using the Cochrane Airways Group Specialised Register, Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trials registries, review articles and reference lists of relevant articles. The latest searches were performed in September 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing antibiotics with a placebo or a control group in children with chronic wet cough. We excluded cluster and cross-over trials.\nData collection and analysis\nWe used standard methods as recommended by Cochrane. We reviewed results of searches against predetermined criteria for inclusion. Two independent review authors selected, extracted and assessed the data for inclusion. We contacted authors of eligible studies for further information as needed. We analysed data as 'intention to treat.'\nMain results\nWe identified three studies as eligible for inclusion in the review. Two were in the previous review and one new study was included. We considered the older studies to be at high or unclear risk of bias whereas we judged the newly included study at low risk of bias. The studies varied in treatment duration (from 7 to 14 days) and the antibiotic used (two studies used amoxicillin/clavulanate acid and one used erythromycin).\nWe included 190 children (171 completed), mean ages ranged from 21 months to six years, in the meta-analyses. Analysis of all three trials (190 children) found that treatment with antibiotics reduced the proportion of children not cured at follow-up (primary outcome measure) (odds ratio (OR) 0.15, 95% confidence interval (CI) 0.07 to 0.31, using intention-to -treat analysis), which translated to a number needed to treat for an additional beneficial outcome (NNTB) of 3 (95% CI 2 to 4). We identified no significant heterogeneity (for both fixed-effect and random-effects model the I² statistic was 0%). Two older trials assessed progression of illness, defined by requirement for further antibiotics (125 children), which was significantly lower in the antibiotic group (OR 0.10, 95% CI 0.03 to 0.34; NNTB 4, 95% CI 3 to 5). All three trials (190 children) reported adverse events, which were not significantly increased in the antibiotic group compared to the control group (OR 1.88, 95% CI 0.62 to 5.69). We assessed the quality of evidence GRADE rating as moderate for all outcome measures, except adverse events which we assessed as low quality.\nAuthors' conclusions\nEvidence suggests antibiotics are efficacious for the treatment of children with chronic wet cough (greater than four weeks) with an NNTB of three. However, antibiotics have adverse effects and this review reported only uncertainty as to the risk of increased adverse effects when they were used in this setting. The inclusion of a more robust study strengthened the previous Cochrane review and its results.\n\nGiven the provided abstract, please respond to the following query: \"Reliability of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The reliability of the evidence was moderate when using antibiotics to cure cough and for illness progression, while it was only low for side effects of medicines."
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query-laysum | 1123 | [
{
"role": "user",
"content": "Abstract: Background\nLeg ulcers are open skin wounds that occur below the knee but above the foot. The majority of leg ulcers are venous in origin, occurring as a result of venous insufficiency, where the flow of blood through the veins is impaired; they commonly arise due to blood clots and varicose veins. Compression therapy, using bandages or stockings, is the primary treatment for venous leg ulcers. Wound cleansing can be used to remove surface contaminants, bacteria, dead tissue and excess wound fluid from the wound bed and surrounding skin, however, there is uncertainty regarding the effectiveness of cleansing and the best method or solution to use.\nObjectives\nTo assess the effects of wound cleansing, wound cleansing solutions and wound cleansing techniques for treating venous leg ulcers.\nSearch methods\nIn September 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe considered randomised controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or RCTs comparing different wound cleansing solutions, or different wound cleansing techniques.\nData collection and analysis\nWe screened studies for their appropriateness for inclusion, assessed their risk of bias using the Cochrane 'Risk of bias' tool, and used GRADE methodology to determine the certainty of evidence. Two review authors undertook these tasks independently, using predetermined criteria. We contacted study authors for missing data where possible.\nMain results\nWe included four studies with a total of 254 participants. All studies included comparisons between different types of cleansing solutions, and three of these reported our primary outcomes of complete wound healing or change in ulcer size over time, or both. Two studies reported the secondary outcome, pain. One study (27 participants), which compared polyhexamethylene biguanide (PHMB) solution with saline solution for cleansing venous leg ulcers, did not report any of the review's primary or secondary outcomes. We did not identify any studies that compared cleansing with no cleansing, or that explored comparisons between different cleansing techniques.\nOne study (61 participants) compared aqueous oxygen peroxide with sterile water. We are uncertain whether aqueous oxygen peroxide makes any difference to the number of wounds completely healed after 12 months of follow-up (risk ratio (RR) 1.88, 95% confidence interval (CI) 1.10 to 3.20). Similarly, we are uncertain whether aqueous oxygen peroxide makes any difference to change in ulcer size after eight weeks of follow-up (mean difference (MD) -1.38 cm2, 95% CI -4.35 to 1.59 cm2). Finally, we are uncertain whether aqueous oxygen peroxide makes any difference to pain reduction, assessed after eight weeks of follow-up using a 0 to 100 pain rating, (MD 3.80, 95% CI -10.83 to 18.43). The evidence for these outcomes is of very low certainty (we downgraded for study limitations and imprecision; for the pain outcome we also downgraded for indirectness).\nAnother study (40 participants) compared propyl betaine and polihexanide with a saline solution. The authors did not present the raw data in the study report so we were unable to conduct independent statistical analysis of the data. We are uncertain whether propyl betaine and polihexanide make any difference to the number of wounds completely healed, change in ulcer size over time, or wound pain reduction. The evidence is of very low certainty (we downgraded for study limitations and imprecision).\nThe final study (126 participants) compared octenidine dihydrochloride/phenoxyethanol (OHP) with Ringer's solution. We are uncertain whether OHP makes any difference to the number of wounds healed (RR 0.96, 95% CI 0.53 to 1.72) or to the change in ulcer size over time (we were unable to conduct independent statistical analysis of available data). The evidence is of very low certainty (we downgraded for study limitations and imprecision).\nNone of the studies reported patient preference, ease of use of the method of cleansing, cost or health-related quality of life. In one study comparing propyl betaine and polihexanide with saline solution the authors do not report any adverse events occurring. We are uncertain whether OHP makes any difference to the number of adverse events compared with Ringer's solution (RR 0.58, 95% CI 0.29 to 1.14). The evidence is of very low certainty (we downgraded for study limitations and imprecision).\nAuthors' conclusions\nThere is currently a lack of RCT evidence to guide decision making about the effectiveness of wound cleansing compared with no cleansing and the optimal approaches to cleansing of venous leg ulcers. From the four studies identified, there is insufficient evidence to demonstrate whether the use of PHMB solution compared with saline solution; aqueous oxygen peroxide compared with sterile water; propyl betaine and polihexanide compared with a saline solution; or OHP compared with Ringer's solution makes any difference in the treatment of venous leg ulcers. Evidence from three of the studies is of very low certainty, due to study limitations and imprecision. One study did not present data for the primary or secondary outcomes. Further well-designed studies that address important clinical, quality of life and economic outcomes may be important, based on the clinical and patient priority of this uncertainty.\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:\n- whether cleaning venous leg ulcers helps them to become smaller and heal;\n- whether some cleaning solutions, or methods of applying solutions, are more effective than others;\n- which cleaning solution people prefer and find easiest to use;\n- whether cleaning wounds has an impact on quality of life;\n- how much cleaning wounds costs; and\n- whether cleaning wounds is associated with adverse (unwanted) effects such as pain, infection or skin damage."
}
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query-laysum | 1124 | [
{
"role": "user",
"content": "Abstract: Background\nCataract formation or acceleration can occur after intraocular surgery, especially following vitrectomy, a surgical technique for removing the vitreous that is used in the treatment of many disorders that affect the posterior segment of the eye. The underlying problem that led to vitrectomy may limit the benefit from removal of the cataractous lens.\nObjectives\nTo evaluate the effectiveness and safety of surgery versus no surgery for postvitrectomy cataract with respect to visual acuity, quality of life, and other outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 5), MEDLINE Ovid (1946 to 17 May 2017), Embase.com (1947 to 17 May 2017), PubMed (1946 to 17 May 2017), Latin American and Caribbean Health Sciences Literature database (LILACS) (January 1982 to 17 May 2017), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com); last searched May 2013, ClinicalTrials.gov (www.clinicaltrials.gov); searched 17 May 2017, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 17 May 2017. We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs) and quasi-RCTs that had compared surgery versus no surgery to remove the lens from eyes of adults in which cataracts had developed following vitrectomy.\nData collection and analysis\nTwo review authors independently screened the search results according to the standard methodological procedures expected by Cochrane.\nMain results\nWe found no RCTs or quasi-RCTs that had compared surgery versus no surgery to remove the lens from eyes of adults in which cataracts had developed following vitrectomy.\nAuthors' conclusions\nThere is no evidence from RCTs or quasi-RCTs on which to base clinical recommendations for surgery for postvitrectomy cataract. There is a clear need for RCTs to address this evidence gap. Such trials should stratify participants by their age, the retinal disorder leading to vitrectomy, and the status of the underlying disease process in the contralateral eye. Outcomes assessed in such trials may include changes (both gains and losses) of visual acuity, quality of life, and adverse events such as posterior capsular rupture and retinal detachment. Both short-term (six-month) and long-term (one- or two-year) outcomes should be examined.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 17 May 2017."
}
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query-laysum | 1125 | [
{
"role": "user",
"content": "Abstract: Background\nIt is generally accepted that taxanes are among the most active chemotherapy agents in the management of metastatic breast cancer. This is an update of a Cochrane review first published in 2003.\nObjectives\nThe objective of this review was to compare taxane-containing chemotherapy regimens with regimens not containing a taxane in the management of women with metastatic breast cancer.\nSearch methods\nIn this review update, we searched the Cochrane Breast Cancer Group Specialised Register, MEDLINE, EMBASE, the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov on 14 February 2013 using keywords such as 'advanced breast cancer' and 'chemotherapy'. We searched reference lists of articles, contacted study authors, and did not apply any language restrictions.\nSelection criteria\nRandomised controlled trials comparing taxane-containing chemotherapy regimens to regimens without taxanes in women with metastatic breast cancer. We included published and unpublished studies.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We derived hazard ratios (HRs) for overall survival, time to progression, and time to treatment failure where possible, and used a fixed-effect model for meta-analysis. We represented objective tumour response rates and toxicity as risk ratios (RRs). We extracted quality of life data where present.\nMain results\nThis review included 28 studies. The updated analysis included 6871 randomised women, while the original review had 3643 women. Of the 28 included studies, we considered 19 studies to be at low risk of bias overall; however, some studies failed to report details on allocation concealment and methods of outcome assessment for those outcomes that are more likely to be influenced by a lack of blinding (for example tumour response rate). Studies varied in the taxane-containing chemotherapy backbone, and the comparator arms and were categorised into three groups: Regimen A plus taxane versus Regimen A (2 studies); Regimen A plus taxane versus Regimen B (14 studies); and single-agent taxane versus Regimen C (13 studies). Thirteen studies used paclitaxel, 14 studies used docetaxel, and 1 study allowed the investigator to decide on the type of taxane; the majority of studies delivered a taxane every 3 weeks. Twenty studies administered taxanes as first-line treatment, and 21 studies involved anthracycline naïve women in the metastatic setting. The combined HR for overall survival and time to progression favoured the taxane-containing regimens (HR 0.93, 95% confidence interval (CI) 0.88 to 0.99, P = 0.002, deaths = 4477; and HR 0.92, 95% CI 0.87 to 0.97, P = 0.002, estimated 5122 events, respectively) with moderate to substantial heterogeneity across trials. If the analyses were restricted to studies of first-line chemotherapy, this effect persisted for overall survival (HR 0.93, 95% CI 0.87 to 0.99, P = 0.03) but not for time to progression (HR 0.96, 95% CI 0.90 to 1.02, P = 0.22). Tumour response rates appeared to be better with taxane-containing chemotherapy in assessable women (RR 1.20, 95% CI 1.14 to 1.27, P < 0.00001) with substantial heterogeneity across studies. Taxanes were associated with an increased risk of neurotoxicity (RR 4.84, 95% CI 3.18 to 7.35, P < 0.00001, 24 studies) and hair loss (RR 2.37, 95% CI 1.45 to 3.87, P = 0.0006, 11 studies) but less nausea/vomiting compared to non-taxane-containing regimens (RR 0.62, 95% CI 0.46 to 0.83, P = 0.001, 26 studies). Leukopaenia and treatment-related death did not differ between the two groups (RR 1.07, 95% CI 0.97 to 1.17, P = 0.16, 28 studies; and RR 1.00, 95% CI 0.63 to 1.57, P = 0.99, 23 studies, respectively). For quality of life measures, none of the individual studies reported a difference in overall or any of quality of life subscales between taxane-containing and non-taxane chemotherapy regimens.\nAuthors' conclusions\nTaxane-containing regimens appear to improve overall survival, time to progression, and tumour response rate in women with metastatic breast cancer. Taxanes are also associated with an increased risk of neurotoxicity but less nausea and vomiting compared to non-taxane-containing regimens. The considerable heterogeneity encountered across studies probably reflects the varying efficacy of the comparator regimens used in these studies and indicates that taxane-containing regimens are more effective than some, but not all, non-taxane-containing regimens.\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 taxane-containing chemotherapy regimens in women with metastatic breast cancer. This is an update of a Cochrane review first published in 2003."
}
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query-laysum | 1126 | [
{
"role": "user",
"content": "Abstract: Background\nOvarian cancer is seventh most common cancer in women worldwide. Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their life time. The majority of tumours arise from surface of the ovary (epithelial). Two thirds of these women will present with advanced disease, requiring aggressive treatment, which includes debulking surgery (removal of as much disease as possible) and chemotherapy. However, most women (75%) with advanced epithelial ovarian cancer (EOC) will relapse following surgery and chemotherapy. Patients who relapse are treated with either platinum or non-platinum drugs and this is dependent on the platinum-sensitivity and platinum-free interval. These drug regimens are generally well-tolerated although there are potential severe side effects. New treatments that can be used to treat recurrence or prevent disease progression after first-line or subsequent chemotherapy are important, especially those with a low toxicity profile. Hormones such as luteinising hormone releasing hormone (LHRH) agonists have been used in the treatment of relapsed EOC. Some studies have shown objective remissions, while other studies have shown little or no benefit. Most small studies report a better side-effect profile for LHRH agonists when compared to standard chemotherapeutic agents used in EOC.\nObjectives\nTo compare the effectiveness and safety of luteinising hormone releasing hormone (LHRH) agonists with chemotherapeutic agents or placebo in relapsed epithelial ovarian cancer (EOC).\nSearch methods\nWe searched the Cochrane Gynaecological Cancer Group trials register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase up to January 2016. We also searched registers of clinical trials and abstracts of scientific meetings.\nSelection criteria\nRandomised controlled trials (RCTs) that compared LHRH agonists with chemotherapeutic agents or placebo in relapsed EOC.\nData collection and analysis\nTwo review authors independently assessed whether relevant studies met the inclusion criteria, retrieved data and assessed risk of bias.\nMain results\nTwo studies, including 97 women, met our inclusion criteria: one assessed LHRH agonist (leuprorelin) use in relapsed (platinum-resistant and platinum-refractory) EOC in comparison with a chemotherapeutic agent (treosulfan) (Du Bois 2002); the other examined LHRH agonist (decapeptyl) versus a placebo (Currie 1994). Since both studies had different control groups, a meta-analysis was not possible.\nThere may be little or no difference between treatment with leuprorelin or treosulfan in overall survival (OS) (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.58 to 1.67; verylow-quality evidence) or progression-free survival (PFS) at six and 12 months (risk ratio (RR) 0.61, 95% CI 0.22 to 1.68, and RR 0.65, 95% CI 0.12 to 3.66; verylow-quality evidence), respectively (Du Bois 2002). The duration of follow-up was 2.5 years and quality of life (QoL) was not reported in this study.\nAlopecia and fatigue were probably more common with treosulfan than leuprorelin (alopecia RR 0.32, 95% CI 0.12 to 0.91 (very low-quality evidence)). There may be little or no difference in other Grade 3/4 side effects: nausea and vomiting (RR 0.65, 95% CI 0.12 to 3.66 (very low-quality evidence)); neurotoxicity (RR 0.32, 95% CI 0.01 to 7.71 (very low-quality evidence)) and neutropenia (RR 0.97, 95% 0.06 to 14.97 (very low-quality evidence)),\nThe Currie 1994 study, which compared decapeptyl treatment with placebo, reported mean PFS of 16 weeks verus 11.2 weeks, respectively. No relative effects measures or P value at a particular time point were reported. Overall survival (OS) and QoL outcomes were not reported. In addition, adverse events were only mentioned for the decapeptyl group.\nAdverse events were incompletely reported (no adverse events in decapeptyl group, but not reported for the placebo group).\nAuthors' conclusions\nBased on this review of two small RCTs, there is not enough evidence to comment on the safety and effectiveness of LHRH agonists in the treatment of platinum-refractory and platinum-resistant (relapsed) EOC. Overall, the quality of evidence for all outcomes (including OS, PFS, QoL and adverse events) is very low.\n\nGiven the provided abstract, please respond to the following query: \"Main findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched electronic databases and other resources for randomised controlled trials (RCTs) comparing LHRH agonists with chemotherapy or placebo in women with relapsed EOC.Two RCTs were identified. Since the comparisons differed, they were reported separately. Available evidence did not show improvement in overall survival and progression-free survival at six and12 months with hormonal (LHRH) therapy. Also, major side effects (haematological and neurological) did not statistically differ between the two treatment groups, but were incompletely reported. Quality of life data were not reported in either study."
}
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query-laysum | 1127 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.\nObjectives\nTo assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, and EMBASE via Ovid, on 8 January 2018. We searched www.ClinicalTrials.gov. on 16 January 2018.\nSelection criteria\nRandomised controlled trials (RCTs) comparing RAS versus CLS or open surgery in women requiring surgery for gynaecological disease.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We examined different procedures in separate comparisons and for hysterectomy subgrouped data according to type of disease (non-malignant versus malignant). When more than one study contributed data, we pooled data using random-effects methods in RevMan 5.3.\nMain results\nWe included 12 RCTs involving 1016 women. Studies were at moderate to high overall risk of bias, and we downgraded evidence mainly due to concerns about risk of bias in the studies contributing data and imprecision of effect estimates. Procedures performed were hysterectomy (eight studies) and sacrocolpopexy (three studies). In addition, one trial examined surgical treatment for endometriosis, which included resection or hysterectomy. Among studies of women undergoing hysterectomy procedures, two studies involved malignant disease (endometrial cancer); the rest involved non-malignant disease.\n• RAS versus CLS (hysterectomy)\nLow-certainty evidence suggests there might be little or no difference in any complication rates between RAS and CLS (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.54 to 1.59; participants = 585; studies = 6; I² = 51%), intraoperative complication rates (RR 1.05, 95% CI 0.31 to 3.56; participants = 487; studies = 5; I² = 28%), postoperative complications (RR 0.82, 95% CI 0.42 to 1.59; participants = 533; studies = 5; I2 = 51%), and blood transfusions (RR 2.49, 95% CI 0.75 to 8.23; participants = 346; studies = 4; I2 = 0%)). There was no statistical difference between malignant and non-malignant disease subgroups with regard to complication rates. Survival outcomes for women with malignant disease were not reported.\nMean total operating time was longer on average in the RAS arm than in the CLS arm (mean difference (MD) 41.18 minutes, 95% CI -6.17 to 88.53; participants = 148; studies = 2; I² = 80%; very low-certainty evidence), and the mean length of hospital stay was slightly shorter with RAS than with CLS (MD -0.30 days, 95% CI -0.53 to -0.07; participants = 192; studies = 2; I² = 0%; very low-certainty evidence).\n• RAS versus CLS (sacrocolpopexy)\nVery low-certainty evidence suggests little or no difference in rates of any complications between women undergoing sacrocolpopexy by RAS or CLS (RR 0.95, 95% CI 0.21 to 4.24; participants = 186; studies = 3; I² = 78%), nor in intraoperative complications (RR 0.82, 95% CI 0.09 to 7.59; participants = 108; studies = 2; I² = 47%). Low-certainty evidence on postoperative complications suggests these might be higher with RAS (RR 3.54, 95% CI 1.31 to 9.56; studies = 1; participants = 68). Researchers did not report blood transfusions and deaths up to 30 days.\nLow-certainty evidence suggests that RAS might be associated with increased operating time (MD 40.53 min, 95% CI 12.06 to 68.99; participants = 186; studies = 3; I² = 73%). Very low-certainty evidence suggests little or no difference between the two techniques in terms of duration of stay (MD 0.26 days, 95% CI -0.15 to 0.67; participants = 108; studies = 2; I² = 0%).\n• RAS versus open abdominal surgery (hysterectomy)\nTwo studies of 20 and 96 participants with non-malignant disease and malignant disease, respectively, compared RAS with open surgery. For most outcomes only one study contributed data, with most evidence assessed as very low-certainty. Low-certainty evidence from the study among women with endometrial cancer suggests that lymph node yields may be lower with RAS (MD -8.00, 95% CI -14.97 to -1.03), operating time may be longer (233 minutes (range 166 to 320 minutes) compared with 187 minutes (range 109 to 300), hospital stays may be shorter (mean of 2 days [1 to 5] versus 5 days [4 to 9]; P<0.001), and overall costs may be less (MD -1568.00 US dollars, 95% CI -3100.75 to -35.25) than open surgery. Survival outcomes were not reported.\n• RAS versus CLS for endometriosis\nA single study with data for 73 women was included in this comparison; women with endometriosis underwent procedures ranging from relatively minor endometrial resection through hysterectomy; many of the women included in this study had undergone previous surgery for their condition. For most outcomes, event rates were low, and the sample size was insufficient to detect potential differences between groups.\nAuthors' conclusions\nEvidence on the effectiveness and safety of RAS compared with CLS for non-malignant disease (hysterectomy and sacrocolpopexy) is of low certainty but suggests that surgical complication rates might be comparable. Evidence on the effectiveness and safety of RAS compared with CLS or open surgery for malignant disease is more uncertain, particularly because survival data are lacking. RAS is an operator-dependent expensive technology; therefore evaluating the safety of this technology independently will present challenges.\n\nGiven the provided abstract, please respond to the following query: \"Findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 12 studies involving 1016 women requiring surgery for gynaecological disease. Studies were at moderate to high overall risk of bias. Operations performed were hysterectomy (eight studies) and sacrocolpopexy (three studies). In addition, one trial examined surgical treatment for endometriosis, which included resection or hysterectomy. We are uncertain as to whether RAS or conventional laparoscopic surgery (CLS) has lower overall complication rates because the evidence gathered was of low certainty. The time taken to carry out the operation varied considerably among studies reporting this outcome, so results are difficult to interpret, and although the evidence suggested slightly shorter hospital stays with RAS (one-third of a day), we considered the evidence to be very uncertain and studies to be at high risk of bias.\nFor sacrocolpopexy procedures, overall evidence shows no clear differences in rates of any complications with RAS compared with CLS, but the evidence was of low certainty. Only one study reported postoperative complications, which were higher in the RAS group (low-certainty evidence). RAS was associated with an average increase in operating time of 40.53 minutes in the RAS group (low-certainty evidence), but these results probably are not reliable, as there was a lot of variation between studies. We found very low-certainty evidence suggesting there was little or no difference between RAS and CLS in terms of duration of hospital stay for this procedure.\nTwo small studies looked at hysterectomy using RAS versus open abdominal surgery; however, most findings were assessed as being too uncertain to draw any conclusions. Similarly, a study with data for 73 women looked at RAS versus CLS for surgery for endometriosis; women with endometriosis underwent procedures ranging from relatively minor endometrial resection through hysterectomy; many of the women included in this study had undergone previous surgery for their condition, and the sample size was insufficient to show potential differences between surgical techniques."
}
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query-laysum | 1128 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review first published in 2011, and most recently updated in 2019.\nEpilepsy is a chronic and disabling neurological disorder, affecting approximately 1% of the population. Up to 30% of people with epilepsy have seizures that are resistant to currently available antiepileptic drugs and require treatment with multiple antiepileptic drugs in combination. Felbamate is a second-generation antiepileptic drug that can be used as add-on therapy to standard antiepileptic drugs.\nObjectives\nTo evaluate the efficacy and tolerability of felbamate versus placebo when used as an add-on treatment for people with drug-resistant focal-onset epilepsy.\nSearch methods\nFor the latest update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 13 July 2021) on 15 July 2021. There were no language or time restrictions. We reviewed the reference lists of retrieved studies to search for additional reports of relevant studies. We also contacted the manufacturers of felbamate and experts in the field for information about any unpublished or ongoing studies.\nSelection criteria\nWe searched for randomised placebo-controlled add-on studies of people of any age with drug-resistant focal seizures. The studies could be double-blind, single-blind or unblinded and could be of parallel-group or cross-over design.\nData collection and analysis\nTwo review authors independently selected studies for inclusion and extracted information. In the case of disagreements, a third review author arbitrated. Review authors assessed the following outcomes: 50% or greater reduction in seizure frequency; absolute or percentage reduction in seizure frequency; treatment withdrawal; adverse effects; quality of life.\nMain results\nWe included four randomised controlled trials, representing a total of 236 participants, in the review. Two trials had parallel-group design, the third had a two-period cross-over design, and the fourth had a three-period cross-over design. We judged all four studies to be at an unclear risk of bias overall. Bias arose from the incomplete reporting of methodological details, the incomplete and selective reporting of outcome data, and from participants having unstable drug regimens during experimental treatment in one trial. Due to significant methodological heterogeneity, clinical heterogeneity and differences in outcome measures, it was not possible to perform a meta-analysis of the extracted data.\nOnly one study reported the outcome of 50% or greater reduction in seizure frequency, whilst three studies reported percentage reduction in seizure frequency compared to placebo. One study claimed an average seizure reduction of 35.8% with add-on felbamate whilst another study claimed a more modest reduction of 4.2%. Both studies reported that seizure frequency increased with add-on placebo and that there was a significant difference in seizure reduction between felbamate and placebo (P = 0.0005 and P = 0.018, respectively). The third study reported a 14% reduction in seizure frequency with add-on felbamate but stated that the difference between treatments was not significant. There were conflicting results regarding treatment withdrawal. One study reported a higher treatment withdrawal for placebo-randomised participants, whereas the other three studies reported higher treatment withdrawal rates for felbamate-randomised participants. Notably, the treatment withdrawal rates for felbamate treatment groups across all four studies remained reasonably low (less than 10%), suggesting that felbamate may be well tolerated. Felbamate-randomised participants most commonly withdrew from treatment due to adverse effects. The adverse effects consistently reported by all four studies were headache, dizziness and nausea. All three adverse effects were reported by 23% to 40% of felbamate-treated participants versus 3% to 15% of placebo-treated participants.\nWe assessed the evidence for all outcomes using GRADE and rated the evidence as very low certainty, meaning that we have little confidence in the findings reported. We mainly downgraded evidence for imprecision due to the narrative synthesis conducted and the low number of events. We stress that the true effect of felbamate could likely be significantly different from that reported in this current review update.\nAuthors' conclusions\nIn view of the methodological deficiencies, the limited number of included studies and the differences in outcome measures, we have found no reliable evidence to support the use of felbamate as an add-on therapy in people with drug-resistant focal-onset epilepsy. A large-scale, randomised controlled trial conducted over a longer period of time is required to inform 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": "Up to 30% of people with epilepsy still suffer epileptic seizures despite trying multiple antiepileptic drugs, whether separately or in combination. These people are described as having drug-resistant epilepsy. Drug resistance is most common in people with focal epilepsy (epilepsy that initially begins in one area of the brain, but can progress to affect the whole brain). Felbamate is an antiepileptic drug that might be effective for people with drug-resistant focal epilepsy when used with other antiepileptic drugs."
}
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query-laysum | 1129 | [
{
"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM) is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss.\nSystemic antibiotics are a commonly used treatment option for CSOM, which act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM.\nObjectives\nTo assess the effects of systemic antibiotics for people with CSOM.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.\nSelection criteria\nWe included randomised controlled trials comparing systemic antibiotics (oral, injection) against placebo/no treatment or other systemic antibiotics with at least a one-week follow-up period, involving patients with chronic (at least two weeks) ear discharge of unknown cause or due to CSOM. Other treatments were allowed if both treatment and control arms also received it.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not, measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks); health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.\nMain results\nWe included 18 studies (2135 participants) with unclear or high risk of bias.\n1. Systemic antibiotics versus no treatment/placebo\nIt is very uncertain if there is a difference between systemic (intravenous) antibiotics and placebo in the resolution of ear discharge at between one and two weeks (risk ratio (RR) 8.47, 95% confidence interval (CI) 1.88 to 38.21; 33 participants; 1 study; very low-certainty evidence). The study did not report results for resolution of ear discharge after two weeks. Health-related quality of life was not reported. The evidence is very uncertain for hearing and serious (intracranial) complications. Ear pain and suspected ototoxicity were not reported.\n2. Systemic antibiotics versus no treatment/placebo (both study arms received topical antibiotics)\nSix studies were included of which five presented useable data. There may be little or no difference in the resolution of ear discharge at between one to two weeks for oral ciprofloxacin compared to placebo or no treatment when ciprofloxacin ear drops were used in both intervention arms (RR 1.02, 95% CI 0.93 to 1.12; 390 participants; low-certainty evidence). No results after two weeks were reported. Health-related quality of life was not reported. The evidence is very uncertain for ear pain, serious complications and suspected ototoxicity.\n3. Systemic antibiotics versus no treatment/placebo (both study arms received other background treatments)\nTwo studies used topical antibiotics plus steroids as background treatment in both arms. It is very uncertain if there is a difference in resolution of ear discharge between metronidazole and placebo at four weeks (RR 0.91, 95% CI 0.51 to 1.65; 40 participants; 1 study; very low-certainty evidence). This study did not report other outcomes. It is also very uncertain if resolution of ear discharge at six weeks was improved with co-trimoxazole compared to placebo (RR 1.54, 95% CI 1.09 to 2.16; 98 participants; 1 study; very low-certainty evidence). Resolution of ear discharge was not reported at other time points. From the narrative report there was no evidence of a difference between groups for health-related quality of life, hearing or serious complications (very low-certainty evidence).\nOne study (136 participants) used topical antiseptics as background treatment in both arms and found similar resolution of ear discharge between the amoxicillin and no treatment groups at three to four months (RR 1.03, 95% CI 0.75 to 1.41; 136 participants; 1 study; very low-certainty evidence). The narrative report indicated no evidence of differences in hearing or suspected ototoxicity (both very low-certainty evidence). No other outcomes were reported.\n4. Different types of systemic antibiotics\nThis is a summary of four comparisons, where different antibiotics were compared to each other. Eight studies compared different types of systemic antibiotics against each other: quinolones against beta-lactams (four studies), lincosamides against nitroimidazoles (one study) and comparisons of different types of beta-lactams (three studies). It was not possible to conclude if there was one class or type of systemic antibiotic that was better in terms of resolution of ear discharge. The studies did not report adverse events well.\nAuthors' conclusions\nThere was a limited amount of evidence available to examine whether systemic antibiotics are effective in achieving resolution of ear discharge for people with CSOM. When used alone (with or without aural toileting), we are very uncertain if systemic antibiotics are more effective than placebo or no treatment. When added to an effective intervention such as topical antibiotics, there seems to be little or no difference in resolution of ear discharge (low-certainty evidence). Data were only available for certain classes of antibiotics and it is very uncertain whether one class of systemic antibiotic may be more effective than another. Adverse effects of systemic antibiotics were poorly reported in the studies included. As we found very sparse evidence for their efficacy, the possibility of adverse events may detract from their use for CSOM.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic suppurative otitis media (CSOM), also known as chronic otitis media (COM), is an inflammation and infection of the middle ear that lasts for two weeks or more. People with CSOM usually experience recurrent or persistent discharge – fluid that leaks out from a hole or tear in the eardrum – and hearing loss.\nCSOM can be treated with antibiotics (medicines that fight bacterial infections) taken orally or given as an injection (i.e. systemic treatment in which the whole body is treated). Systemic antibiotics can be used:\n- alone;\n- in combination with antibiotics in the form of drops, sprays, ointments or creams (topical, i.e. localised surface treatment); or\n- in combination with other treatments such as steroids (anti-inflammation medicines) or antiseptics (substances that stop or slow down the growth of micro-organisms).\nTo find out how effective systemic antibiotics are for treating CSOM, and whether they lead to side effects, we reviewed the evidence from research studies."
}
]
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query-laysum | 1130 | [
{
"role": "user",
"content": "Abstract: Background\nEndophthalmitis is a sight-threatening emergency that requires prompt diagnosis and treatment. The condition is characterised by purulent inflammation of the intraocular fluids caused by an infective agent. In exogenous endophthalmitis, the infective agent is foreign and typically introduced into the eye through intraocular surgery or open globe trauma.\nObjectives\nTo assess the potential role of combined pars plana vitrectomy and intravitreal antibiotics in the acute management of exogenous endophthalmitis, versus the standard of care, defined as vitreous tap and intravitreal antibiotics.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 5); Ovid MEDLINE; Ovid Embase; the International Standard Randomised Controlled Trial Number registry; ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. There were no restrictions to language or year of publication. The date of the search was 5 May 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared pars plana vitrectomy and intravitreal injection of antibiotics versus intravitreal injection of antibiotics alone, for the immediate management of exogenous endophthalmitis.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two review authors independently screened search results and extracted data. We considered the following outcomes: visual acuity improvement and change in visual acuity at three and six months; additional surgical procedures, including vitrectomy and cataract surgery, at any time during follow-up; quality of life and adverse effects. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe identified a single RCT that met our inclusion criteria. The included RCT enrolled a total of 420 participants with clinical evidence of endophthalmitis, within six weeks of cataract surgery or secondary intraocular lens implantation. Participants were randomly assigned according to a 2 x 2 factorial design to either treatment with vitrectomy (VIT) or vitreous tap biopsy (TAP) and to treatment with or without systemic antibiotics. Twenty-four participants did not have a final follow-up: 12 died, five withdrew consent to be followed up, and seven were not willing to return for the visit.\nThe study did not report visual acuity according to the review's predefined outcomes. At three months, 41% of all participants achieved 20/40 or better visual acuity and 69% had 20/100 or better acuity. The study authors reported that there was no statistically significant difference in visual acuity between treatment groups (very low-certainty evidence). There was low-certainty evidence of a similar requirement for additional surgical procedures (risk ratio RR 0.90, 95% confidence interval 0.66 to 1.21). Adverse effects included: VIT group: dislocated intraocular lens (n = 2), macular infarction (n = 1). TAP group: expulsive haemorrhage (n = 1). Quality of life and mean change in visual acuity were not reported.\nAuthors' conclusions\nWe identified a single RCT (published 27 years ago) for the role of early vitrectomy in exogenous endophthalmitis, which suggests that there may be no difference between groups (VIT vs TAP) for visual acuity at three or nine months' follow-up.\nWe are of the opinion that there is a clear need for more randomised studies comparing the role of primary vitrectomy in exogenous endophthalmitis. Moreover, since the original RCT study, there have been incremental changes in the surgical techniques with which vitrectomy is performed. Such advances are likely to influence the outcome of early vitrectomy in exogenous endophthalmitis.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We conducted a systematic review of studies of people with endophthalmitis who had undergone vitrectomy for the treatment of endophthalmitis following surgery or an eye injury."
}
]
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query-laysum | 1131 | [
{
"role": "user",
"content": "Abstract: Background\nMelanoma has one of the fastest rising incidence rates of any cancer. It accounts for a small percentage of skin cancer cases but is responsible for the majority of skin cancer deaths. History-taking and visual inspection of a suspicious lesion by a clinician is usually the first in a series of ‘tests’ to diagnose skin cancer. Establishing the accuracy of visual inspection alone is critical to understating the potential contribution of additional tests to assist in the diagnosis of melanoma.\nObjectives\nTo determine the diagnostic accuracy of visual inspection for the detection of cutaneous invasive melanoma and atypical intraepidermal melanocytic variants in adults with limited prior testing and in those referred for further evaluation of a suspicious lesion. Studies were separated according to whether the diagnosis was recorded face-to-face (in-person) or based on remote (image-based) assessment.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: CENTRAL; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nTest accuracy studies of any design that evaluated visual inspection in adults with lesions suspicious for melanoma, compared with a reference standard of either histological confirmation or clinical follow-up. We excluded studies reporting data for ‘clinical diagnosis’ where dermoscopy may or may not have been used.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic threshold were missing. We estimated summary sensitivities and specificities per algorithm and threshold using the bivariate hierarchical model. We investigated the impact of: in-person test interpretation; use of a purposely developed algorithm to assist diagnosis; and observer expertise.\nMain results\nWe included 49 publications reporting on a total of 51 study cohorts with 34,351 lesions (including 2499 cases), providing 134 datasets for visual inspection. Across almost all study quality domains, the majority of study reports provided insufficient information to allow us to judge the risk of bias, while in three of four domains that we assessed we scored concerns regarding applicability of study findings as 'high'. Selective participant recruitment, lack of detail regarding the threshold for deciding on a positive test result, and lack of detail on observer expertise were particularly problematic.\nAttempts to analyse studies by degree of prior testing were hampered by a lack of relevant information and by the restricted inclusion of lesions selected for biopsy or excision. Accuracy was generally much higher for in-person diagnosis compared to image-based evaluations (relative diagnostic odds ratio of 8.54, 95% CI 2.89 to 25.3, P < 0.001). Meta-analysis of in-person evaluations that could be clearly placed on the clinical pathway showed a general trade-off between sensitivity and specificity, with the highest sensitivity (92.4%, 95% CI 26.2% to 99.8%) and lowest specificity (79.7%, 95% CI 73.7% to 84.7%) observed in participants with limited prior testing (n = 3 datasets). Summary sensitivities were lower for those referred for specialist assessment but with much higher specificities (e.g. sensitivity 76.7%, 95% CI 61.7% to 87.1%) and specificity 95.7%, 95% CI 89.7% to 98.3%) for lesions selected for excision, n = 8 datasets). These differences may be related to differences in the spectrum of included lesions, differences in the definition of a positive test result, or to variations in observer expertise. We did not find clear evidence that accuracy is improved by the use of any algorithm to assist diagnosis in all settings. Attempts to examine the effect of observer expertise in melanoma diagnosis were hindered due to poor reporting.\nAuthors' conclusions\nVisual inspection is a fundamental component of the assessment of a suspicious skin lesion; however, the evidence suggests that melanomas will be missed if visual inspection is used on its own. The evidence to support its accuracy in the range of settings in which it is used is flawed and very poorly reported. Although published algorithms do not appear to improve accuracy, there is insufficient evidence to suggest that the ‘no algorithm’ approach should be preferred in all settings. Despite the volume of research evaluating visual inspection, further prospective evaluation of the potential added value of using established algorithms according to the prior testing or diagnostic difficulty of lesions may be warranted.\n\nGiven the provided abstract, please respond to the following query: \"Why is it important to know the diagnostic accuracy of visual examination of skin lesions suspected to be melanomas?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Not recognising a melanoma when it is present (a false-negative test result) delays surgery to remove it (excision), risking cancer spreading to other organs in the body and possibly death. Diagnosing a skin lesion (a mole or area of skin with an unusual appearance in comparison with the surrounding skin) as a melanoma when it is not (a false-positive result) may result in unnecessary surgery, further investigations, and patient anxiety. Visual inspection of suspicious skin lesions by a clinician using the naked eye is usually the first of a series of ‘tests’ to diagnose melanoma. Knowing the diagnostic accuracy of visual inspection alone is important to decide whether additional tests, such as a biopsy (removing a part of the lesion for examination under a microscope) are needed to improve accuracy to an acceptable level."
}
]
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query-laysum | 1132 | [
{
"role": "user",
"content": "Abstract: Background\nMost patients with oesophageal and gastro-oesophageal carcinoma are diagnosed at an advanced stage and require palliative intervention. Although there are many kinds of interventions, the optimal one for the palliation of dysphagia remains unclear. This review updates the previous version published in 2009.\nObjectives\nThe aim of this review was to systematically analyse and summarise the efficacy of different interventions used in the palliation of dysphagia in primary oesophageal and gastro-oesophageal carcinoma.\nSearch methods\nTo find new studies for this updated review, in January 2014 we searched, according to the Cochrane Upper Gastrointestinal and Pancreatic Diseases model, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE and CINAHL; and major conference proceedings (up to January 2014).\nSelection criteria\nOnly randomised controlled trials (RCTs) were included in which patients with inoperable or unresectable primary oesophageal cancer underwent palliative treatment. Different interventions like rigid plastic intubation, self-expanding metallic stent (SEMS) insertion, brachytherapy, external beam radiotherapy, chemotherapy, oesophageal bypass surgery, chemical and thermal ablation therapy, either head-to-head or in combination, were included. The primary outcome was dysphagia improvement. Secondary outcomes included recurrent dysphagia, technical success, procedure related mortality, 30-day mortality, adverse effects and quality of life.\nData collection and analysis\nData collection and analysis were performed in accordance with the methods of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Review Group.\nMain results\nWe included 3684 patients from 53 studies. SEMS insertion was safer and more effective than plastic tube insertion. Thermal and chemical ablative therapy provided comparable dysphagia palliation but had an increased requirement for re-interventions and for adverse effects. Anti-reflux stents provided comparable dysphagia palliation to conventional metal stents. Some anti-reflux stents might have reduced gastro-oesophageal reflux and complications. Newly-designed double-layered nitinol (Niti-S) stents were preferable due to longer survival time and fewer complications compared to simple Niti-S stents. Brachytherapy might be a suitable alternative to SEMS in providing a survival advantage and possibly a better quality of life, and might provide better results when combined with argon plasma coagulation or external beam radiation therapy.\nAuthors' conclusions\nSelf-expanding metal stent insertion is safe, effective and quicker in palliating dysphagia compared to other modalities. However, high-dose intraluminal brachytherapy is a suitable alternative and might provide additional survival benefit with a better quality of life. Some anti-reflux stents and newly-designed stents lead to longer survival and fewer complications compared to conventional stents. Combinations of brachytherapy with self-expanding metal stent insertion or radiotherapy are preferable due to the reduced requirement for re-interventions. Rigid plastic tube insertion, dilatation alone or in combination with other modalities, and chemotherapy alone are not recommended for palliation of dysphagia due to a high incidence of delayed complications and recurrent dysphagia.\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": "For most patients with unresectable or inoperable oesophageal cancer, providing clinical benefit with palliative treatment is highly desirable. However, the optimal palliative technique for dysphagia improvement and better quality of life is not established."
}
]
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query-laysum | 1133 | [
{
"role": "user",
"content": "Abstract: Background\nVery preterm infants often require respiratory support and are therefore exposed to an increased risk of bronchopulmonary dysplasia (chronic lung disease) and later neurodevelopmental disability. Caffeine is widely used to prevent and treat apnea (temporal cessation of breathing) associated with prematurity and facilitate extubation. Though widely recognized dosage regimes have been used for decades, higher doses have been suggested to further improve neonatal outcomes. However, observational studies suggest that higher doses may be associated with harm.\nObjectives\nTo determine the effects of higher versus standard doses of caffeine on mortality and major neurodevelopmental disability in preterm infants with (or at risk of) apnea, or peri-extubation.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and clinicaltrials.gov in May 2022. The reference lists of relevant articles were also checked to identify additional studies.\nSelection criteria\nWe included randomized (RCTs), quasi-RCTs and cluster-RCTs, comparing high-dose to standard-dose strategies in preterm infants. High-dose strategies were defined as a high-loading dose (more than 20 mg of caffeine citrate/kg) or a high-maintenance dose (more than 10 mg of caffeine citrate/kg/day). Standard-dose strategies were defined as a standard-loading dose (20 mg or less of caffeine citrate/kg) or a standard-maintenance dose (10 mg or less of caffeine citrate/kg/day). We specified three additional comparisons according to the indication for commencing caffeine: 1) prevention trials, i.e. preterm infants born at less than 34 weeks' gestation, who are at risk for apnea; 2) treatment trials, i.e. preterm infants born at less than 37 weeks' gestation, with signs of apnea; 3) extubation trials: preterm infants born at less than 34 weeks' gestation, prior to planned extubation.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data.\nMain results\nWe included seven trials enrolling 894 very preterm infants (reported in Comparison 1, i.e. any indication).\nTwo studies included infants for apnea prevention (Comparison 2), four studies for apnea treatment (Comparison 3) and two for extubation management (Comparison 4); in one study, indication for caffeine administration was both apnea treatment and extubation management (reported in Comparison 1, Comparison 3 and Comparison 4).\nIn the high-dose groups, loading and maintenance caffeine doses ranged from 30 mg/kg to 80 mg/kg, and 12 mg/kg to 30 mg/kg, respectively; in the standard-dose groups, loading and maintenance caffeine doses ranged from 6 mg/kg to 25 mg/kg, and 3 mg/kg to 10 mg/kg, respectively.\nTwo studies had three study groups: infants were randomized in three different doses (two of them matched our definition of high dose and one matched our definition of standard dose); high-dose caffeine and standard-dose caffeine were compared to theophylline administration (the latter is included in a separate review).\nSix of the seven included studies compared high-loading and high-maintenance dose to standard-loading and standard-maintenance dose, whereas in one study standard-loading dose and high-maintenance dose was compared to standard-loading dose and standard-maintenance dose.\nHigh-dose caffeine strategies (administration for any indication) may have little or no effect on mortality prior to hospital discharge (risk ratio (RR) 0.86, 95% confidence of interval (CI) 0.53 to 1.38; risk difference (RD) -0.01, 95% CI -0.05 to 0.03; I² for RR and RD = 0%; 5 studies, 723 participants; low-certainty evidence). Only one study enrolling 74 infants reported major neurodevelopmental disability in children aged three to five years (RR 0.79, 95% CI 0.51 to 1.24; RD -0.15, 95% CI -0.42 to 0.13; 46 participants; very low-certainty evidence). No studies reported the outcome mortality or major neurodevelopmental disability in children aged 18 to 24 months and 3 to 5 years. Five studies reported bronchopulmonary dysplasia at 36 weeks' postmenstrual age (RR 0.75, 95% CI 0.60 to 0.94; RD -0.08, 95% CI -0.15 to -0.02; number needed to benefit (NNTB) = 13; I² for RR and RD = 0%; 723 participants; moderate-certainty evidence). High-dose caffeine strategies may have little or no effect on side effects (RR 1.66, 95% CI 0.86 to 3.23; RD 0.03, 95% CI -0.01 to 0.07; I² for RR and RD = 0%; 5 studies, 593 participants; low-certainty evidence). The evidence is very uncertain for duration of hospital stay (data reported in three studies could not be pooled in meta-analysis because outcomes were expressed as medians and interquartile ranges) and seizures (RR 1.42, 95% CI 0.79 to 2.53; RD 0.14, 95% CI -0.09 to 0.36; 1 study, 74 participants; very low-certainty evidence).\nWe identified three ongoing trials conducted in China, Egypt, and New Zealand.\nAuthors' conclusions\nHigh-dose caffeine strategies in preterm infants may have little or no effect on reducing mortality prior to hospital discharge or side effects. We are very uncertain whether high-dose caffeine strategies improves major neurodevelopmental disability, duration of hospital stay or seizures. No studies reported the outcome mortality or major neurodevelopmental disability in children aged 18 to 24 months and 3 to 5 years. High-dose caffeine strategies probably reduce the rate of bronchopulmonary dysplasia.\nRecently completed and future trials should report long-term neurodevelopmental outcome of children exposed to different caffeine dosing strategies in the neonatal period. Data from extremely preterm infants are needed, as this population is exposed to the highest risk for mortality and morbidity. However, caution is required when administering high doses in the first hours of life, when the risk for intracranial bleeding is highest. Observational studies might provide useful information regarding potential harms of the highest doses.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date to May 2022."
}
]
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query-laysum | 1134 | [
{
"role": "user",
"content": "Abstract: Background\nAn unprecedented number of people around the world are experiencing forced displacement due to natural or man-made events. More than 50% of refugees worldwide are children or adolescents. In addition to the challenges of settling in a new country, many have witnessed or experienced traumatic events. Therefore, refugee children and adolescents are at risk of developing mental health problems such as post-traumatic stress disorder, and require appropriate and effective support within communities.\nObjectives\nTo assess the effectiveness and acceptability of community-based interventions (RCTs only) in comparison with controls (no treatment, waiting list, alternative treatment) for preventing and treating mental health problems (major depression, anxiety, post-traumatic stress disorder, psychological distress) and improving mental health in refugee children and adolescents in high-income countries.\nSearch methods\nDatabases searches included the Cochrane Common Mental Disorders Controlled Trials Register (all available years), CENTRAL/CDSR (2021, Issue 2), Ovid MEDLINE, Embase, six other databases, and two trials registries to 21 February 2021. We checked reference lists of included study reports.\nSelection criteria\nStudies of any design were eligible as long as they included child or adolescent refugees and evaluated a community-based mental health intervention in a high-income country. At a second stage, we selected randomised controlled trials.\nData collection and analysis\nFor randomised controlled trials, we extracted data relating to the study and participant characteristics, and outcome data relating to the results of the trial. For studies using other evaluation methods, we extracted data relating to the study and participant characteristics. W derived evidence on the efficacy and availability of interventions from the randomised controlled trials only. Data were synthesised narratively.\nMain results\nWe screened 5005 records and sought full-text manuscripts of 62 relevant records. Three randomised controlled trials were included in this review. Key concerns in the risk of bias assessments included a lack of clarity about the randomisation process, potential for bias is outcome measurement, and risk of bias in the selection of results.\nPrimary outcomes\nThere was no evidence of an effect of community-based interventions when compared with a waiting list for symptoms of post-traumatic stress (mean difference (MD) −1.46, 95% confidence interval (CI) −6.78 to 3.86: 1 study; low-certainty evidence), symptoms of depression (MD 0.26, 95% CI −2.15 to 2.67: 1 study; low-certainty evidence), and psychological distress (MD −10.5, 95% CI −47.94 to 26.94; 1 study; very low-certainty evidence).\nThere were no data on adverse events.\nSecondary outcomes\nThree trials reported on short-term changes in child behaviour, using different measures, and found no evidence of an effect of the intervention versus a waiting list (low to very low certainty).\nNone of the trials reported on quality of life or well-being, participation and functioning, or participant satisfaction.\nAuthors' conclusions\nThere is insufficient evidence to determine the efficacy and acceptability of community-based mental health interventions for refugee children and adolescents.\n\nGiven the provided abstract, please respond to the following query: \"What were the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There were important limitations relating to the quality of the included trials. There was no evidence on the acceptability of interventions. Data on effectiveness, relating to symptoms of mental health problems, psychological distress, and behaviour, showed no evidence of a difference in effectiveness between the intervention group and the waiting list control group (where the intervention was not delivered until after participants in the intervention group had completed the treatment) for any of the three studies."
}
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query-laysum | 1135 | [
{
"role": "user",
"content": "Abstract: Background\nEtanercept is a soluble tumour necrosis factor alpha-receptor disease-modifying anti-rheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).\nObjectives\nThe purpose of this review was to update the previous Cochrane systematic review published in 2003 assessing the benefits and harms of etanercept for the treatment of RA. In addition, we also evaluated the benefits and harms of etanercept plus DMARD compared with DMARD monotherapy in those people with RA who are partial responders to methotrexate (MTX) or any other traditional DMARD.\nSearch methods\nFive electronic databases were searched from 1966 to February 2003 with no language restriction. The search was updated to January 2012. Attempts were made to identify other studies by contact with experts, searching reference lists and searching trial registers.\nSelection criteria\nAll controlled trials (minimum 24 weeks' duration) comparing four possible combinations: 1) etanercept (10 mg or 25 mg twice weekly) plus a traditional DMARD (either MTX or sulphasalazine) versus a DMARD, 2) etanercept plus DMARD versus etanercept alone, 3) etanercept alone versus a DMARD or 4) etanercept versus placebo.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of the trials.\nMain results\nThree trials were included in the original version of the review. An additional six trials, giving a total of 2842 participants, were added to the 2012 update of the review. The trials were generally of moderate to low risk of bias, the majority funded by pharmaceutical companies. Follow-up ranged from six months to 36 months.\nBenefit\nAt six to 36 months the American College of Rheumatology (ACR) 50 response rate was statistically significantly improved with etanercept plus DMARD treatment when compared with a DMARD in those people who had an inadequate response to any traditional DMARD (risk ratio (RR) 2.0; 95% confidence interval (CI) 1.3 to 2.9, absolute treatment benefit (ATB) 38%; 95% CI 13% to 59%) and in those people who were partial responders to MTX (RR 11.7; 95% CI 1.7 to 82.5, ATB 36%). Similar results were observed when pooling data from all participants (responders or not) (ACR 50 response rates at 24 months: RR 1.9; 95% CI 1.3 to 2.8, ATB 29%; 36 months: RR 1.6; 95% CI 1.3 to 1.9, ATB 24%). Statistically significant improvement in physical function and a higher proportion of disease remission were observed in combination-treated participants compared with DMARDs alone ((mean difference (MD) -0.36; 95% CI -0.43 to -0.28 in a 0-3 scale) and (RR 1.92; 95% CI 1.60 to 2.31), respectively) in those people who had an inadequate response to any traditional DMARD. All changes in radiographic scores were statistically significantly less with combination treatment (etanercept plus DMARD) compared with MTX alone for all participants (responders or not) (Total Sharp Score (TSS) (scale = 0 to 448): MD -2.2, 95% CI -3.0 to -1.4; Erosion Score (ES) (scale = 0 to 280): MD -1.6; 95% CI -2.4 to -0.9; Joint Space Narrowing Score (JSNS) (scale = 0 to 168): MD -0.7; 95% CI -1.1 to -0.2), and with combination treatment compared with etanercept alone (TSS: MD -1.1; 95% CI -1.8 to -0.5; ES: MD -0.7; 95% CI -1.1 to -0.2; JSNS: MD -0.5, 95% CI -0.7 to -0.2). The estimate of irreversible physical disability over 10 years given the radiographic findings was 0.45 out of 3.0.\nWhen etanercept monotherapy was compared with DMARD monotherapy, there was generally no evidence of a difference in ACR50 response rates when etanercept 10 mg or 25 mg was used; at six months etanercept 25 mg was significantly more likely to achieve ACR50 than DMARD monotherapy but this difference was not found at 12, 24 or 36 months. TSS and ES radiographic scores were statistically significantly improved with etanercept 25 mg monotherapy compared with DMARD (TSS: MD -0.7; 95% CI -1.4 to 0.1; ES: MD -0.7; 95% CI -1.0 to -0.3) but there was no evidence of a statistically significant difference between etanercept 10 mg monotherapy and MTX.\nHarms\nThere was no evidence of statistically significant differences in infections or serious infections between etanercept plus DMARD and DMARD alone at any point in time. Infection rates were higher in people receiving etanercept monotherapy compared with DMARD; however, there were no differences regarding serious infections. For those participants who had an inadequate response to DMARDs, the rate of total withdrawals was lower for the etanercept plus DMARD group compared with DMARD alone (RR 0.53; 95% CI 0.36 to 0.77, ATB 18%). No other statistically significant differences were observed in any of the assessed comparisons.\nAuthors' conclusions\nEtanercept 25 mg administered subcutaneously twice weekly together with MTX was more efficacious than either etanercept or MTX monotherapy for ACR50 and it slowed joint radiographic progression after up to three years of treatment for all participants (responders or not). There was no evidence of a difference in the rates of infections between groups.\n\nGiven the provided abstract, please respond to the following query: \"Disease activity\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "22 more people out of 100 were considered to have low disease activity of their rheumatoid arthritis from six months to three years on etanercept with DMARDs (22% absolute improvement).\n46 people out of 100 on etanercept plus DMARDs were considered to have low disease activity of their rheumatoid arthritis.\n24 people out of 100 on DMARDs alone were considered to have low disease activity of their rheumatoid arthritis."
}
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query-laysum | 1136 | [
{
"role": "user",
"content": "Abstract: Background\nInflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies.\nObjectives\nTo assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator.\nSearch methods\nA systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies.\nSelection criteria\nRandomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included.\nData collection and analysis\nTwo authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used.\nMain results\nWe included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy).\nElectroacupuncture\nFatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group.\nCognitive behavioural therapy (CBT) and solution-focused therapy\nCompared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants).\nPhysical activity advice\nOne 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group.\nPharmacological interventions\nCompared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence).\nFerric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence)\nAuthors' conclusions\nThe effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence suggests electroacupuncture may result in a large reduction in fatigue compared to control and sham electroacupuncture, however, the overall certainty of the evidence is low due to sparse data. No adverse events were reported, except for one adverse event in the sham acupuncture group.\nWe are very uncertain about the effect of cognitive behavioural therapy and solution-focused therapy on fatigue, as the quality of the evidence is very low.\nOne small study found that physical activity advice plus omega 3 and physical activity advice plus placebo may reduce fatigue compared to no physical activity advice plus omega 3. Adverse events were similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group. Adverse events were mainly mild gastrointestinal events like diarrhoea and bloating\nCompared with placebo, the drug alimumab 40 mg, administered every other week, may reduce fatigue in patients with moderately-to-severely active Crohn's disease, who are already known to respond to adalimumab treatment, but the evidence is very uncertain. People taking adalimumab 40 mg weekly were less like to experience serious adverse events or withdraw from the trial due to adverse events, compared to people taking placebo.\nThe evidence suggests ferric maltol results in a slight increase in fatigue in participants with Crohn's disease and ulcerative colitis, in remission or with mild-to-moderate disease activity. Following 12 weeks of ferric maltol treatment, less fatigue was reported in the placebo group compared to the treatment group, however, the quality of evidence is low."
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query-laysum | 1137 | [
{
"role": "user",
"content": "Abstract: Background\nThe functional and clinical basis on which to choose whether or not to retain the posterior cruciate ligament during total knee arthroplasty surgery remained unclear after a Cochrane systematic review and meta-analysis in 2005, which contained eight clinical trials. Several new trials have been conducted since then. Hence, an update of the review was performed.\nObjectives\nOur aim was to assess the benefits and harms of retention compared to sacrifice of the posterior cruciate ligament in total knee arthroplasty in patients with osteoarthritis of the knee.\nSearch methods\nAn extensive search was conducted in CENTRAL, MEDLINE (PubMed), EMBASE, Web of Science, CINAHL, Academic Search Premier, Current Contents Connect and Science Direct. All databases were searched, without any limitations, up to 6 December 2012. References of the articles were checked and citation tracking was performed.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing retention with sacrifice of the posterior cruciate ligament in primary total knee arthroplasty in patients with osteoarthritis of the knee.\nData collection and analysis\nData were collected with a pre-developed form. Risk of bias was assessed independently by two authors (WV, LB). The level of evidence was graded using the GRADE approach. Meta-analysis was performed by pooling the results of the selected studies, when possible. Subgroup analyses were performed for posterior cruciate ligament retention versus sacrifice using the same total knee arthroplasty design, and for studies using a posterior cruciate ligament retaining or posterior stabilised design, and when sufficient studies were available subgroup analyses were performed for the same brand.\nMain results\nSeventeen randomised controlled trials (with 1810 patients and 2206 knees) were found, described in 18 articles. Ten of these were new studies compared to the previous Cochrane Review. One study from the original Cochrane review was excluded. Most new studies compared a posterior cruciate ligament retaining design with a posterior stabilised design, in which the posterior cruciate ligament is sacrificed (a posterior stabilised design has an insert with a central post which can engage on a femoral cam during flexion).\nThe quality of evidence (graded with the GRADE approach) and the risk of bias were highly variable, ranging from moderate to low quality evidence and with unclear or low risk of bias for most domains, respectively.\nThe performance outcome 'range of motion' was 2.4 ° higher in favour of posterior cruciate ligament sacrifice (118.3 ° versus 115.9 °; 95% confidence interval (CI) of the difference 0.13 to 4.67; P = 0.04), however the results were heterogeneous. On the item 'knee pain' as experienced by patients, meta-analysis could be performed on the Knee Society knee pain score; this score was 48.3 in both groups, yielding no difference between the groups. Implant survival rate could not be meta-analysed adequately since randomised controlled trials lack the longer term follow-up in order to evaluate implant survival. A total of four revisions in the cruciate-retention and four revisions in the cruciate-sacrifice group were found. The well-validated Western Ontario and McMaster Universities osteoarthritis index (WOMAC) total score was not statistically significantly different between the groups (16.6 points for cruciate-retention versus 15.0 points for cruciate-sacrifice). One study reported a patient satisfaction grade (7.7 points for cruciate-retention versus 7.9 points for cruciate-sacrifice on a scale from 0 to 10, 10 being completely satisfied) which did not differ statistically significantly. Complications were distributed equally between both groups. Only one study reported several re-operations other than revision surgery; that is patella luxations, surgical manipulation because of impaired flexion.\nThe mean functional Knee Society Score was 2.3 points higher (81.2 versus 79.0 points; 95% CI of the difference 0.37 to 4.26; P = 0.02) in the posterior cruciate ligament sacrificing group. Results from the outcome Knee Society functional score were homogeneous. All other outcome measures (extension angle, knee pain, adverse effects, clinical questionnaire scores, Knee Society clinical scores, radiological rollback, radiolucencies, femorotibial angle and tibial slope) showed no statistically significant differences between the groups. In the subgroup analyses that allowed pooling of the results of the different studies, no homogeneous statistically significant differences were identified.\nAuthors' conclusions\nThe methodological quality and the quality of reporting of the studies were highly variable. With respect to range of motion, pain, clinical, and radiological outcomes, no clinically relevant differences were found between total knee arthroplasty with retention or sacrifice of the posterior cruciate ligament. Two statistically significant differences were found; range of motion was 2.4 ° higher in the posterior cruciate ligament sacrificing group, however results were heterogeneous; and the mean functional Knee Society Score was 2.3 points higher in the posterior cruciate ligament sacrificing group. These differences are clinically not relevant.\n\nGiven the provided abstract, please respond to the following query: \"Range of motion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "(range of motion is the distance your knee can move from being bent to being fully extended. A lower range of motion is worse; you can’t bend or stretch your knee fully)\n- People who had their posterior cruciate ligament preserved had 2 ° less range of motion compared to those who had it removed. This may be a result of chance \n- People who had their posterior cruciate ligament removed had a range of motion of 118 ° of a possible 0 ° to 140 °\n- People who had their posterior cruciate ligament preserved had a range of motion of 116 ° of a possible 0 ° to 140 °"
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query-laysum | 1138 | [
{
"role": "user",
"content": "Abstract: Background\nInfluenza is an infectious virus affecting both humans and animals. In humans, symptoms present as fever, cough, sore throat, runny nose, headache, muscle and joint pain, and malaise. The epidemiological profile of influenza is influenced by multiple factors, including transmissibility of the virus and the susceptibility of the population. Annually, influenza is estimated to infect 5% to 10% of adults, with higher rates in winter seasons in countries with seasonal variation. Exercise could be an intervention to enhance immune response and limit influenza incidence and its related complications.\nObjectives\nTo assess the efficacy and safety of short and long-term exercise prior to influenza vaccination in enhancing influenza prevention in adults.\nSearch methods\nWe searched CENTRAL (2015, Issue 11), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to 3 November 2015), Embase (1974 to 3 November 2015), CINAHL (1981 to 3 November 2015), LILACS (Latin American and Caribbean Health Sciences, 1982 to 3 November 2015), PEDro (1980 to 3 November 2015), SPORTDiscus (1985 to 3 November 2015), the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov (November 2015).\nSelection criteria\nRandomised controlled trials (RCTs) of short- and long-term exercise prior to influenza vaccination for the general adult population were eligible for inclusion.\nData collection and analysis\nTwo review authors independently extracted and checked data from the included trials using a standard form. We used the random-effects model due to differences in the type, duration, intensity and frequency of exercise in the analysis.\nMain results\nWe included six trials published between 2007 and 2014 that randomised 599 adult participants. Study size ranged from 46 to 158 participants. Participants were aged between 18 years and 80 years; we could not derive gender proportions, as participants' sex was not reported in all studies. One study was available in abstract form only.\nWe did not find a significant difference in outcomes between people who exercised and those who did not exercise before receiving influenza vaccination.\nPre-vaccination exercises included endurance activities such as walking or using a treadmill, and resistance activities included biceps curls and lateral raises. Five of the studies provided one session of exercise between 25 and 50 minutes. In five studies, exercise was undertaken on the same day as the vaccination. One study provided exercise over a period of eight weeks before vaccination, with one 2½ hour supervised session, plus daily home exercise practice of 45 minutes. Exercise intensity ranged from 55% to 85% of maximal heart rate. Control group participants undertook a range of activities, including quiet rest, sitting, reading, meditation or unspecified activity.\nOne study reported numbers of people who contracted influenza; no significant difference was reported between exercise and no-exercise participants. None of the included studies reported complications related to influenza illness. Only one study, which we assessed as providing low-quality evidence, reported numbers of people who experienced adverse events. This study reported no significant difference in outcomes between people who exercised and those who did not. No studies reported numbers of working days or days lost related to influenza illness. Only two studies reported participant-centred outcomes.\nOverall, study quality was unclear; we assessed five of the six included studies to have at least four unclear 'Risk of bias' domains (allocation concealment, blinding of outcome assessment, selective reporting and other bias). Insufficient reporting in four studies about selective reporting did not provide enough information to enable judgement; only two studies were included in trials registers.\nAuthors' conclusions\nFrom the available evidence, we found that exercising before influenza vaccination is neither beneficial nor harmful. However, study data were limited and of low quality. Small sample sizes, study design limitations, exercise types, and focus on biochemical rather than participant-centred outcomes strongly influenced our findings.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We looked at six studies that involved 599 people aged between 18 and 80 years that assessed exercise before flu vaccination. Exercises included walking or using a treadmill (endurance) and biceps curls and lateral raises (resistance) activities that ranged from 25 to 50 minutes per session. People in five studies did one session of exercise on the day of vaccination; in one study people exercised eight weeks before vaccination. Exercise was supervised in three studies. People not undertaking exercise (control group) were assessed after periods of quiet rest."
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query-laysum | 1139 | [
{
"role": "user",
"content": "Abstract: Background\nHalitosis or bad breath is a symptom in which a noticeably unpleasant breath odour is present due to an underlying oral or systemic disease. 50% to 60% of the world population has experienced this problem which can lead to social stigma and loss of self-confidence. Multiple interventions have been tried to control halitosis ranging from mouthwashes and toothpastes to lasers. This new Cochrane Review incorporates Cochrane Reviews previously published on tongue scraping and mouthrinses for halitosis.\nObjectives\nThe objectives of this review were to assess the effects of various interventions used to control halitosis due to oral diseases only. We excluded studies including patients with halitosis secondary to systemic disease and halitosis-masking interventions.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 8 April 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 3) in the Cochrane Library (searched 8 April 2019), MEDLINE Ovid (1946 to 8 April 2019), and Embase Ovid (1980 to 8 April 2019). We also searched LILACS BIREME (1982 to 19 April 2019), the National Database of Indian Medical Journals (1985 to 19 April 2019), OpenGrey (1992 to 19 April 2019), and CINAHL EBSCO (1937 to 19 April 2019). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (8 April 2019), the World Health Organization International Clinical Trials Registry Platform (8 April 2019), the ISRCTN Registry (19 April 2019), the Clinical Trials Registry - India (19 April 2019), were searched for ongoing trials. We also searched the cross-references of included studies and systematic reviews published on the topic. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) which involved adults over the age of 16, and any intervention for managing halitosis compared to another or placebo, or no intervention. The active interventions or controls were administered over a minimum of one week and with no upper time limit. We excluded quasi-randomised trials, trials comparing the results for less than one week follow-up, and studies including advanced periodontitis.\nData collection and analysis\nTwo pairs of review authors independently selected trials, extracted data, and assessed risk of bias. We estimated mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 44 trials in the review with 1809 participants comparing an intervention with a placebo or a control. The age of participants ranged from 17 to 77 years. Most of the trials reported on short-term follow-up (ranging from one week to four weeks). Only one trial reported long-term follow-up (three months).\nThree studies were at low overall risk of bias, 16 at high overall risk of bias, and the remaining 25 at unclear overall risk of bias.\nWe compared different types of interventions which were categorised as mechanical debridement, chewing gums, systemic deodorising agents, topical agents, toothpastes, mouthrinse/mouthwash, tablets, and combination methods.\nMechanical debridement: for mechanical tongue cleaning versus no tongue cleaning, the evidence was very uncertain for the outcome dentist-reported organoleptic test (OLT) scores (MD -0.20, 95% CI -0.34 to -0.07; 2 trials, 46 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nChewing gums: for 0.6% eucalyptus chewing gum versus placebo chewing gum, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.10, 95% CI -0.31 to 0.11; 1 trial, 65 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nSystemic deodorising agents: for 1000 mg champignon versus placebo, the evidence was very uncertain for the outcome patient-reported visual analogue scale (VAS) scores (MD -1.07, 95% CI -14.51 to 12.37; 1 trial, 40 participants; very low-certainty evidence). No data were reported for dentist-reported OLT score or adverse events.\nTopical agents: for hinokitiol gel versus placebo gel, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.27, 95% CI -1.26 to 0.72; 1 trial, 18 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nToothpastes: for 0.3% triclosan toothpaste versus control toothpaste, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -3.48, 95% CI -3.77 to -3.19; 1 trial, 81 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nMouthrinse/mouthwash: for mouthwash containing chlorhexidine and zinc acetate versus placebo mouthwash, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.20, 95% CI -0.58 to 0.18; 1 trial, 44 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nTablets: no data were reported on key outcomes for this comparison.\nCombination methods: for brushing plus cetylpyridium mouthwash versus brushing, the evidence was uncertain for the outcome dentist-reported OLT scores (MD -0.48, 95% CI -0.72 to -0.24; 1 trial, 70 participants; low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nAuthors' conclusions\nWe found low- to very low-certainty evidence to support the effectiveness of interventions for managing halitosis compared to placebo or control for the OLT and patient-reported outcomes tested. We were unable to draw any conclusions regarding the superiority of any intervention or concentration. Well-planned RCTs need to be conducted by standardising the interventions and concentrations.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "With this Cochrane Review we tried to find out the best way to control bad breath, also called halitosis, due to a disease within the mouth in adults."
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query-laysum | 1140 | [
{
"role": "user",
"content": "Abstract: Background\nPain during dental treatment, which is a common fear of patients, can be controlled successfully by local anaesthetic. Several different local anaesthetic formulations and techniques are available to dentists.\nObjectives\nOur primary objectives were to compare the success of anaesthesia, the speed of onset and duration of anaesthesia, and systemic and local adverse effects amongst different local anaesthetic formulations for dental anaesthesia. We define success of anaesthesia as absence of pain during a dental procedure, or a negative response to electric pulp testing or other simulated scenario tests. We define dental anaesthesia as anaesthesia given at the time of any dental intervention.\nOur secondary objective was to report on patients' experience of the procedures carried out.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2018, Issue 1), MEDLINE (OVID SP), Embase, CINAHL PLUS, WEB OF SCIENCE, and other resources up to 31 January 2018. Other resources included trial registries, handsearched journals, conference proceedings, bibliographies/reference lists, and unpublished research.\nSelection criteria\nWe included randomized controlled trials (RCTs) testing different formulations of local anaesthetic used for clinical procedures or simulated scenarios. Studies could apply a parallel or cross-over design.\nData collection and analysis\nWe used standard Cochrane methodological approaches for data collection and analysis.\nMain results\nWe included 123 studies (19,223 participants) in the review. We pooled data from 68 studies (6615 participants) for meta-analysis, yielding 23 comparisons of local anaesthetic and 57 outcomes with 14 different formulations. Only 10 outcomes from eight comparisons involved clinical testing.\nWe assessed the included studies as having low risk of bias in most domains. Seventy-three studies had at least one domain with unclear risk of bias. Fifteen studies had at least one domain with high risk of bias due to inadequate sequence generation, allocation concealment, masking of local anaesthetic cartridges for administrators or outcome assessors, or participant dropout or exclusion.\nWe reported results for the eight most important comparisons.\nSuccess of anaesthesia\nWhen the success of anaesthesia in posterior teeth with irreversible pulpitis requiring root canal treatment is tested, 4% articaine, 1:100,000 epinephrine, may be superior to 2% lidocaine, 1:100,000 epinephrine (31% with 2% lidocaine vs 49% with 4% articaine; risk ratio (RR) 1.60, 95% confidence interval (CI) 1.10 to 2.32; 4 parallel studies; 203 participants; low-quality evidence).\nWhen the success of anaesthesia for teeth/dental tissues requiring surgical procedures and surgical procedures/periodontal treatment, respectively, was tested, 3% prilocaine, 0.03 IU felypressin (66% with 3% prilocaine vs 76% with 2% lidocaine; RR 0.86, 95% CI 0.79 to 0.95; 2 parallel studies; 907 participants; moderate-quality evidence), and 4% prilocaine plain (71% with 4% prilocaine vs 83% with 2% lidocaine; RR 0.86, 95% CI 0.75 to 0.99; 2 parallel studies; 228 participants; low-quality evidence) were inferior to 2% lidocaine, 1:100,000 epinephrine.\nComparative effects of 4% articaine, 1:100,000 epinephrine and 4% articaine, 1:200,000 epinephrine on success of anaesthesia for teeth/dental tissues requiring surgical procedures are uncertain (RR 0.85, 95% CI 0.71 to 1.02; 3 parallel studies; 930 participants; very low-quality evidence).\nComparative effects of 0.5% bupivacaine, 1:200,000 epinephrine and both 4% articaine, 1:200,000 epinephrine (odds ratio (OR) 0.87, 95% CI 0.27 to 2.83; 2 cross-over studies; 37 participants; low-quality evidence) and 2% lidocaine, 1:100,000 epinephrine (OR 0.58, 95% CI 0.07 to 5.12; 2 cross-over studies; 31 participants; low-quality evidence) on success of anaesthesia for teeth requiring extraction are uncertain.\nComparative effects of 2% mepivacaine, 1:100,000 epinephrine and both 4% articaine, 1:100,000 epinephrine (OR 3.82, 95% CI 0.61 to 23.82; 1 parallel and 1 cross-over study; 110 participants; low-quality evidence) and 2% lidocaine, 1:100,000 epinephrine (RR 1.16, 95% CI 0.25 to 5.45; 2 parallel studies; 68 participants; low-quality evidence) on success of anaesthesia for teeth requiring extraction and teeth with irreversible pulpitis requiring endodontic access and instrumentation, respectively, are uncertain.\nFor remaining outcomes, assessing success of dental local anaesthesia via meta-analyses was not possible.\nOnset and duration of anaesthesia\nFor comparisons assessing onset and duration, no clinical studies met our outcome definitions.\nAdverse effects (continuous pain measured on 170-mm Heft-Parker visual analogue scale (VAS))\nDifferences in post-injection pain between 4% articaine, 1:100,000 epinephrine and 2% lidocaine, 1:100,000 epinephrine are small, as measured on a VAS (mean difference (MD) 4.74 mm, 95% CI -1.98 to 11.46 mm; 3 cross-over studies; 314 interventions; moderate-quality evidence). Lidocaine probably resulted in slightly less post-injection pain than articaine (MD 6.41 mm, 95% CI 1.01 to 11.80 mm; 3 cross-over studies; 309 interventions; moderate-quality evidence) on the same VAS.\nFor remaining comparisons assessing local and systemic adverse effects, meta-analyses were not possible. Other adverse effects were rare and minor.\nPatients' experience\nPatients' experience of procedures was not assessed owing to lack of data.\nAuthors' conclusions\nFor success (absence of pain), low-quality evidence suggests that 4% articaine, 1:100,000 epinephrine was superior to 2% lidocaine, 1:100,000 epinephrine for root treating of posterior teeth with irreversible pulpitis, and 2% lidocaine, 1:100,000 epinephrine was superior to 4% prilocaine plain when surgical procedures/periodontal treatment was provided. Moderate-quality evidence shows that 2% lidocaine, 1:100,000 epinephrine was superior to 3% prilocaine, 0.03 IU felypressin when surgical procedures were performed.\nAdverse events were rare. Moderate-quality evidence shows no difference in pain on injection when 4% articaine, 1:100,000 epinephrine and 2% lidocaine, 1:100,000 epinephrine were compared, although lidocaine resulted in slightly less pain following injection.\nMany outcomes tested our primary objectives in simulated scenarios, although clinical alternatives may not be possible.\nFurther studies are needed to increase the strength of the evidence. These studies should be clearly reported, have low risk of bias with adequate sample size, and provide data in a format that will allow meta-analysis. Once assessed, results of the 34 ‘Studies awaiting classification (full text unavailable)’ may alter the conclusions of the review.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "From comparisons of local anaesthetics in this review, all appeared effective and safe with little difference between them. Available evidence ranged from moderate to very low in quality. Some studies fell short, in terms of quality, owing to small numbers of participants, unclear reporting of study methods, and reporting of data in a format that was not easy to combine with other data. Further research is required to clarify the effectiveness and safety of one local anaesthetic over another."
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query-laysum | 1141 | [
{
"role": "user",
"content": "Abstract: Background\nMedical abortion became an alternative method of pregnancy termination following the development of prostaglandins and antiprogesterone in the 1970s and 1980s. Recently, synthesis inhibitors of oestrogen (such as letrozole) have also been used to enhance efficacy. The most widely researched drugs are prostaglandins (such as misoprostol, which has a strong uterotonic effect), mifepristone, mifepristone with prostaglandins, and letrozole with prostaglandins. More evidence is needed to identify the best dosage, regimen, and route of administration to optimise patient outcomes. This is an update of a review last published in 2011.\nObjectives\nTo compare the effectiveness and side effects of different medical methods for first trimester abortion.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Global Health, and LILACs on 28 February 2021. We also searched Clinicaltrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform, and reference lists of retrieved papers.\nSelection criteria\nWe considered randomised controlled trials (RCTs) that compared different medical methods for abortion before the 12th week of gestation. The primary outcome is failure to achieve complete abortion. Secondary outcomes are mortality, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the method.\nData collection and analysis\nTwo review authors independently selected and evaluated studies for inclusion, and assessed the risk of bias. We processed data using Review Manager 5 software. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 99 studies in the review (58 from the original review and 41 new studies).\n1. Combined regimen mifepristone/prostaglandin\nMifepristone dose: high-dose (600 mg) compared to low-dose (200 mg) mifepristone probably has similar effectiveness in achieving complete abortion (RR 1.07, 95% CI 0.87 to 1.33; I2 = 0%; 4 RCTs, 3494 women; moderate-certainty evidence).\nProstaglandin dose: 800 µg misoprostol probably reduces abortion failure compared to 400 µg (RR 0.63, 95% CI 0.51 to 0.78; I2= 0%; 3 RCTs, 4424 women; moderate-certainty evidence).\nProstaglandin timing: misoprostol administered on day one probably achieves more success on complete abortion than on day three (RR 1.94, 95% CI 1.05 to 3.58; 1489 women; 1 RCT; moderate-certainty evidence).\nAdministration strategy: there may be no difference in failure of complete abortion with self-administration at home compared with hospital administration (RR 1.63, 95% CI 0.68 to 3.94; I2 = 84%; 2263 women; 4 RCTs; low-certainty evidence), but failure may be higher when administered by nurses in hospital compared to by doctors in hospital (RR 2.69, 95% CI 1.39 to 5.22; I2 = 66%; 3 RCTs, 3056 women; low-certainty evidence).\nAdministration route: oral misoprostol probably leads to more failures than the vaginal route (RR 2.38, 95% CI 1.46 to 3.87; I2 = 39%; 3 RCTs, 1704 women; moderate-certainty evidence) and may be associated with more frequent side effects such as nausea (RR 1.14, 95% CI 1.03 to 1.26; I2 = 0%; 2 RCTs, 1380 women; low-certainty evidence) and diarrhoea (RR 1.80 95% CI 1.49 to 2.17; I2 = 0%; 2 RCTs, 1379 women). Compared with the vaginal route, complete abortion failure is probably lower with sublingual (RR 0.68, 95% CI 0.22 to 2.11; I2 = 59%; 2 RCTs, 3229 women; moderate-certainty evidence) and may be lower with buccal administration (RR 0.71, 95% CI 0.34 to 1.46; I2 = 0%; 2 RCTs, 479 women; low-certainty evidence), but sublingual or buccal routes may lead to more side effects. Women may experience more vomiting with sublingual compared to buccal administration (RR 1.33, 95% CI 1.01 to 1.77; low-certainty evidence).\n2. Mifepristone alone versus combined regimen\nThe efficacy of mifepristone alone in achieving complete abortion compared to combined mifepristone/prostaglandin up to 12 weeks is unclear (RR of failure 3.25, 95% CI 0.81 to 13.09; I2 = 83%; 3 RCTs, 273 women; very low-certainty evidence).\n3. Prostaglandin alone versus combined regimen\nNineteen studies compared prostaglandin alone to a combined regimen (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate). Compared to any of the combination regimens, misoprostol alone may increase the risk for failure to achieve complete abortion (RR of failure 2.39, 95% CI 1.89 to 3.02; I2 = 64%; 18 RCTs, 3471 women; low-certainty evidence), and with more diarrhoea.\n4. Prostaglandin alone (route of administration)\nOral misoprostol alone may lead to more failures in complete abortion than the vaginal route (RR 3.68, 95% CI 1.56 to 8.71, 2 RCTs, 216 women; low-certainty evidence). Failure to achieve complete abortion may be slightly reduced with sublingual compared with vaginal (RR 0.69, 95% CI 0.37 to 1.28; I2 = 87%; 5 RCTs, 2705 women; low-certainty evidence) and oral administration (RR 0.58, 95% CI 0.11 to 2.99; I2 = 66%; 2 RCTs, 173 women). Failure to achieve complete abortion may be similar or slightly higher with sublingual administration compared to buccal administration (RR 1.11, 95% CI 0.71 to 1.74; 1 study, 401 women).\nAuthors' conclusions\nSafe and effective medical abortion methods are available. Combined regimens (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate) may be more effective than single agents (prostaglandin alone or mifepristone alone). In the combined regimen, the dose of mifepristone can probably be lowered to 200 mg without significantly decreasing effectiveness. Vaginal misoprostol is probably more effective than oral administration, and may have fewer side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all studies were conducted in settings with good access to emergency services, which may limit the generalisability of these results.\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": "This is a update of a review last published in 2011. The evidence is up to date to February 2021."
}
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query-laysum | 1142 | [
{
"role": "user",
"content": "Abstract: Background\nPostural drainage is used primarily in infants with cystic fibrosis from diagnosis up to the moment when they are mature enough to actively participate in self-administered treatments. However, there is a risk of gastroesophageal reflux associated with this technique.\nThis is an update of a review published in 2015.\nObjectives\nTo compare the effects of standard postural drainage (15º to 45º head-down tilt) with modified postural drainage (15º to 30º head-up tilt) with regard to gastroesophageal reflux in infants and young children up to six years old with cystic fibrosis in terms of safety and efficacy.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register. We also searched the reference lists of relevant articles and reviews. Additional searches were conducted on ClinicalTrials.gov and on the WHO International Clinical Trials Registry Platform for any planned, ongoing and unpublished studies.\nThe date of the most recent literature searches: 19 June 2017.\nSelection criteria\nWe included randomised controlled studies that compared two postural drainage regimens (standard and modified postural drainage) with regard to gastroesophageal reflux in infants and young children (up to and including six years old) with cystic fibrosis.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently identified studies for inclusion, extracted outcome data and assessed risk of bias. We resolved disagreements by consensus or by involving a third review author. We contacted study authors to obtain missing or additional information. The quality of the evidence was assessed using GRADE.\nMain results\nTwo studies, involving a total of 40 participants, were eligible for inclusion in the review. We included no new studies in the 2018 update. The included studies were different in terms of the age of participants, the angle of tilt, the reported outcomes, the number of sessions and the study duration. The following outcomes were measured: appearance or exacerbation of gastroesophageal reflux episodes; percentage of peripheral oxygen saturation; number of exacerbations of upper respiratory tract symptoms; number of days on antibiotics for acute exacerbations; chest X-ray scores; and pulmonary function tests. One study reported that postural drainage with a 20° head-down position did not appear to exacerbate gastroesophageal reflux. However, the majority of the reflux episodes in this study reached the upper oesophagus (moderate-quality evidence). The second included study reported that modified postural drainage (30° head-up tilt) was associated with fewer number of gastroesophageal reflux episodes and fewer respiratory complications than standard postural drainage (30° head-down tilt) (moderate-quality evidence). The included studies had an overall low risk of bias. One included study was funded by the Sydney Children’s Hospital Foundation and the other by the Royal Children’s Hospital Research Foundation and Physiotherapy Research Foundation of Australia. Data were not able to be pooled by meta-analysis due to differences in the statistical presentation of the data.\nAuthors' conclusions\nThe limited evidence regarding the comparison between the two regimens of postural drainage is still weak due to the small number of included studies, the small number of participants assessed, the inability to perform any meta-analyses and some methodological issues with the studies. However, it may be inferred that the use of a postural regimen with a 30° head-up tilt is associated with a lower number of gastroesophageal reflux episodes and fewer respiratory complications in the long term. The 20° head-down postural drainage position was not found to be significantly different from the 20° head-up tilt modified position. Nevertheless, the fact that the majority of reflux episodes reached the upper oesophagus should make physiotherapists carefully consider their treatment strategy. We do not envisage that there will be any new trials undertaken that will affect the conclusions of this review; therefore, we do not plan to update this review.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
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query-laysum | 1143 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the review published on the Cochrane Library in 2016, Issue 8. Having cancer may result in extensive emotional, physical and social suffering. Music interventions have been used to alleviate symptoms and treatment side effects in people with cancer. This review includes music interventions defined as music therapy offered by trained music therapists, as well as music medicine, which was defined as listening to pre-recorded music offered by medical staff.\nObjectives\nTo assess and compare the effects of music therapy and music medicine interventions for psychological and physical outcomes in people with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 3) in the Cochrane Library, MEDLINE via Ovid, Embase via Ovid, CINAHL, PsycINFO, LILACS, Science Citation Index, CancerLit, CAIRSS, Proquest Digital Dissertations, ClinicalTrials.gov, Current Controlled Trials, the RILM Abstracts of Music Literature, http://www.wfmt.info/Musictherapyworld/ and the National Research Register. We searched all databases, except for the last two, from their inception to April 2020; the other two are no longer functional, so we searched them until their termination date. We handsearched music therapy journals, reviewed reference lists and contacted experts. There was no language restriction.\nSelection criteria\nWe included all randomized and quasi-randomized controlled trials of music interventions for improving psychological and physical outcomes in adults and pediatric patients with cancer. We excluded patients undergoing biopsy and aspiration for diagnostic purposes.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the risk of bias. Where possible, we presented results in meta-analyses using mean differences and standardized mean differences. We used post-test scores. In cases of significant baseline difference, we used change scores. We conducted separate meta-analyses for studies with adult participants and those with pediatric participants. Primary outcomes of interest included psychological outcomes and physical symptoms and secondary outcomes included physiological responses, physical functioning, anesthetic and analgesic intake, length of hospitalization, social and spiritual support, communication, and quality of life (QoL) . We used GRADE to assess the certainty of the evidence.\nMain results\nWe identified 29 new trials for inclusion in this update. In total, the evidence of this review rests on 81 trials with a total of 5576 participants. Of the 81 trials, 74 trials included adult (N = 5306) and seven trials included pediatric (N = 270) oncology patients. We categorized 38 trials as music therapy trials and 43 as music medicine trials. The interventions were compared to standard care.\nPsychological outcomes\nThe results suggest that music interventions may have a large anxiety-reducing effect in adults with cancer, with a reported average anxiety reduction of 7.73 units (17 studies, 1381 participants; 95% confidence interval (CI) -10.02 to -5.44; very low-certainty evidence) on the Spielberger State Anxiety Inventory scale (range 20 to 80; lower values reflect lower anxiety). Results also suggested a moderately strong, positive impact of music interventions on depression in adults (12 studies, 1021 participants; standardized mean difference (SMD): −0.41, 95% CI −0.67 to −0.15; very low-certainty evidence). We found no support for an effect of music interventions on mood (SMD 0.47, 95% CI −0.02 to 0.97; 5 studies, 236 participants; very low-certainty evidence). Music interventions may increase hope in adults with cancer, with a reported average increase of 3.19 units (95% CI 0.12 to 6.25) on the Herth Hope Index (range 12 to 48; higher scores reflect greater hope), but this finding was based on only two studies (N = 53 participants; very low-certainty evidence).\nPhysical outcomes\nWe found a moderate pain-reducing effect of music interventions (SMD −0.67, 95% CI −1.07 to −0.26; 12 studies, 632 adult participants; very low-certainty evidence). In addition, music interventions had a small treatment effect on fatigue (SMD −0.28, 95% CI −0.46 to −0.10; 10 studies, 498 adult participants; low-certainty evidence).\nThe results suggest a large effect of music interventions on adult participants' QoL, but the results were highly inconsistent across studies, and the pooled effect size was accompanied by a large confidence interval (SMD 0.88, 95% CI −0.31 to 2.08; 7 studies, 573 participants; evidence is very uncertain). Removal of studies that used improper randomization methods resulted in a moderate effect size that was less heterogeneous (SMD 0.47, 95% CI 0.06 to 0.88, P = 0.02, I2 = 56%).\nA small number of trials included pediatric oncology participants. The findings suggest that music interventions may reduce anxiety but this finding was based on only two studies (SMD −0.94, 95% CI −1.9 to 0.03; very low-certainty evidence). Due to the small number of studies, we could not draw conclusions regarding the effects of music interventions on mood, depression, QoL, fatigue or pain in pediatric participants with cancer.\nThe majority of studies included in this review update presented a high risk of bias, and therefore the overall certainty of the evidence is low. For several outcomes (i.e. anxiety, depression, pain, fatigue, and QoL) the beneficial treatment effects were consistent across studies for music therapy interventions delivered by music therapists. In contrast, music medicine interventions resulted in inconsistent treatment effects across studies for these outcomes.\nAuthors' conclusions\nThis systematic review indicates that music interventions compared to standard care may have beneficial effects on anxiety, depression, hope, pain, and fatigue in adults with cancer. The results of two trials suggest that music interventions may have a beneficial effect on anxiety in children with cancer. Too few trials with pediatric participants were included to draw conclusions about the treatment benefits of music for other outcomes. For several outcomes, music therapy interventions delivered by a trained music therapist led to consistent results across studies and this was not the case for music medicine interventions. Moreover, evidence of effect was found for music therapy interventions for QoL and fatigue but not for music medicine interventions. Most trials were at high risk of bias and low or very low certainty of evidence; therefore, these results need to be interpreted with caution.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is an update of a previous Cochrane review from 2016, which included 52 studies. For this review update, we searched for additional trials studying the effect of music interventions on psychological and physical outcomes in people with cancer. We searched for studies up to April 2020."
}
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query-laysum | 1144 | [
{
"role": "user",
"content": "Abstract: Background\nGlaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for glaucoma aims to reduce intraocular pressure (IOP) to slow or prevent further vision loss. IOP can be lowered with medications, laser, or incisional surgery. Trabeculectomy is a surgical approach which lowers IOP by shunting aqueous humor to a subconjunctival bleb. Device-modified trabeculectomy techniques are intended to improve the durability and safety of this bleb-forming surgery. Trabeculectomy-modifying devices include the Ex-PRESS, the XEN Gel Stent, the PreserFlo MicroShunt, as well as antifibrotic materials such as Ologen, amniotic membrane, expanded polytetrafluoroethylene (ePTFE) membrane, Gelfilm and others. However, the comparative effectiveness and safety of these devices are uncertain.\nObjectives\nTo evaluate the benefits and harms of different devices as adjuncts to trabeculectomy on IOP control in eyes with glaucoma compared to standard trabeculectomy.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was August 2021.\nSelection criteria\nWe included randomized controlled trials in participants with glaucoma comparing device-modified trabeculectomy techniques with standard trabeculectomy. We included studies that used antimetabolites in either or both treatment groups.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. change in IOP and 2. mean postoperative IOP at one year. Our secondary outcomes were 3. mean change in IOP from baseline, 4. mean postoperative IOP at any time point, 5. mean best-corrected visual acuity (BCVA), 6. visual field change, 7. quality of life, 8. proportion of participants who are drop-free at one year, 9. mean number of IOP lowering medications at one year, and 10. proportion of participants with complications.\nMain results\nEight studies met our inclusion criteria, of which seven were full-length journal articles and one was a conference abstract. The eight studies included 961 participants with glaucoma, and compared two types of devices implanted during trabeculectomy versus standard trabeculectomy. Seven studies (462 eyes, 434 participants) used the Ex-PRESS, and one study (527 eyes, 527 participants) used the PreserFlo MicroShunt. No studies using the XEN Gel Stent implantation met our criteria. The studies were conducted in North America, Europe, and Africa. Planned follow-up periods ranged from six months to five years. The studies were reported poorly, which limited our ability to judge risk of bias for many domains. None of the studies explicitly masked outcome assessment. We rated seven studies at high risk of detection bias.\nLow-certainty of evidence from five studies showed that using the Ex-PRESS plus trabeculectomy compared with standard trabeculectomy may be associated with a slightly lower IOP at one year (mean difference (MD) −1.76 mmHg, 95% confidence interval (CI) −2.81 to −0.70; 213 eyes). Moderate-certainty of evidence from one study showed that using the PreserFlo MicroShunt may be associated with a slightly higher IOP than standard trabeculectomy at one year (MD 3.20 mmHg, 95% CI 2.29 to 4.11). Participants who received standard trabeculectomy may have a higher risk of hypotony compared with those who received device-modified trabeculectomy, but the evidence is uncertain (RR 0.73, 95% CI 0.46 to 1.17; I² = 38%; P = 0.14). In the subgroup of participants who received the PreserFlo MicroShunt, there was a lower risk of developing hypotony or shallow anterior chamber compared with those receiving standard trabeculectomy (RR 0.44, 95% CI 0.25 to 0.79; 526 eyes). Device-modified trabeculectomy may lead to less subsequent cataract surgery within one year (RR 0.46, 95% CI 0.27 to 0.80; I² = 0%).\nAuthors' conclusions\nUse of an Ex-PRESS plus trabeculectomy may produce greater IOP reduction at one-year follow-up than standard trabeculectomy; however, due to potential biases and imprecision in effect estimates, the certainty of evidence is low. PreserFlo MicroShunt may be inferior to standard trabeculectomy in lowering IOP. However, PreserFlo MicroShunt may prevent postoperative hypotony and bleb leakage. Overall, device-modified trabeculectomy appears associated with a lower risk of cataract surgery within five years compared with standard trabeculectomy. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).\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 effectiveness and safety of using devices modifying a standard surgery (trabeculectomy) for the treatment of glaucoma."
}
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query-laysum | 1145 | [
{
"role": "user",
"content": "Abstract: Background\nSince the mid-1970s, short-term psychodynamic psychotherapies (STPP) for a broad range of psychological and somatic disorders have been developed and studied. Early published meta-analyses of STPP, using different methods and samples, have yielded conflicting results, although some meta-analyses have consistently supported an empirical basis for STPP. This is an update of a review that was last updated in 2006.\nObjectives\nTo evaluate the efficacy of STPP for adults with common mental disorders compared with wait-list controls, treatments as usual and minimal contact controls in randomised controlled trials (RCTs). To specify the differential effects of STPP for people with different disorders (e.g. depressive disorders, anxiety disorders, somatoform disorders, mixed disorders and personality disorder) and treatment characteristics (e.g. manualised versus non-manualised therapies).\nSearch methods\nThe Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR) was searched to February 2014, this register includes relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974-), MEDLINE (1950-) and PsycINFO (1967-). We also conducted searches on CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, DARE and Biological Abstracts (all years to July 2012) and all relevant studies (identified to 2012) were fully incorporated in this review update. We checked references from papers retrieved. We contacted a large group of psychodynamic researchers in an attempt to find new studies.\nSelection criteria\nWe included all RCTs of adults with common mental disorders, in which a brief psychodynamic therapy lasting 40 or fewer hours in total was provided in individual format.\nData collection and analysis\nEight review authors working in pairs evaluated studies. We selected studies only if pairs of review authors agreed that the studies met inclusion criteria. We consulted a third review author if two review authors could not reach consensus. Two review authors collected data and entered it into Review Manager software. Two review authors assessed and scored risk of bias. We assessed publication bias using a funnel plot. Two review authors conducted and reviewed subgroup analyses.\nMain results\nWe included 33 studies of STPP involving 2173 randomised participants with common mental disorders. Studies were of diverse conditions in which problems with emotional regulation were purported to play a causative role albeit through a range of symptom presentations. These studies evaluated STPP for this review's primary outcomes (general, somatic, anxiety and depressive symptom reduction), as well as interpersonal problems and social adjustment. Except for somatic measures in the short-term, all outcome categories suggested significantly greater improvement in the treatment versus the control groups in the short-term and medium-term. Effect sizes increased in long-term follow-up, but some of these effects did not reach statistical significance. A relatively small number of studies (N < 20) contributed data for the outcome categories. There was also significant heterogeneity between studies in most categories, possibly due to observed differences between manualised versus non-manualised treatments, short versus longer treatments, studies with observer-rated versus self report outcomes, and studies employing different treatment models.\nAuthors' conclusions\nThere has been further study of STPP and it continues to show promise, with modest to large gains for a wide variety of people. However, given the limited data, loss of significance in some measures at long-term follow-up and heterogeneity between studies, these findings should be interpreted with caution. Furthermore, variability in treatment delivery and treatment quality may limit the reliability of estimates of effect for STPP. Larger studies of higher quality and with specific diagnoses are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Common mental disorders include anxiety disorders, depressive disorders, stress-related physical conditions, certain behaviour disorders and personality disorders. People with these disorders tend to have problems handling difficult emotions and often respond with physical and psychic symptoms or avoidant behavioural patterns. Such patterns and emotional responses are theoretically treatable by short-term psychodynamic psychotherapies (STPP) because these therapies aim to improve long- and short-term problems with emotion processing, behaviour and communication/relationships with others. STPP is thought to work by making people aware of emotions, thoughts and problems with communication/relationships that are related to past and recent trauma. This in turn helps to correct problems with emotions and relationships with others.\nThis review sought to find out whether STPP is more effective than wait-list control (where people receive therapy after a delay during which people in the 'active' group receive the therapy), treatment as usual and minimal treatment (partial treatments not expected to provide a robust effect)."
}
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query-laysum | 1146 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) (commonly referred to as chronic bronchitis and emphysema) is a chronic lung condition characterised by the inflammation of airways and irreversible destruction of pulmonary tissue leading to progressively worsening dyspnoea. It is a leading international cause of disability and death in adults. Evidence suggests that there is an increased prevalence of anxiety disorders in people with COPD. The severity of anxiety has been shown to correlate with the severity of COPD, however anxiety can occur with all stages of COPD severity. Coexisting anxiety and COPD contribute to poor health outcomes in terms of exercise tolerance, quality of life and COPD exacerbations. The evidence for treatment of anxiety disorders in this population is limited, with a paucity of evidence to support the efficacy of medication-only treatments. It is therefore important to evaluate psychological therapies for the alleviation of these symptoms in people with COPD.\nObjectives\nTo assess the effects of psychological therapies for the treatment of anxiety disorders in people with chronic obstructive pulmonary disease.\nSearch methods\nWe searched the specialised registers of two Cochrane Review Groups: Cochrane Common Mental Disorders (CCMD) and Cochrane Airways (CAG) (to 14 August 2015). The specialised registers include reports of relevant randomised controlled trials from The Cochrane Library, MEDLINE, Embase, and PsycINFO. We carried out complementary searches on PsycINFO and CENTRAL to ensure no studies had been missed. We applied no date or language restrictions.\nSelection criteria\nWe considered all randomised controlled trials (RCTs), cluster-randomised trials and cross-over trials of psychological therapies for people (aged over 40 years) with COPD and coexisting anxiety disorders (as confirmed by recognised diagnostic criteria or a validated measurement scale), where this was compared with either no intervention or education only. We included studies in which the psychological therapy was delivered in combination with another intervention (co-intervention) only if there was a comparison group that received the co-intervention alone.\nData collection and analysis\nTwo review authors independently screened citations to identify studies for inclusion and extracted data into a pilot-tested standardised template. We resolved any conflicts that arose through discussion. We contacted authors of included studies to obtain missing or raw data. We performed meta-analyses using the fixed-effect model and, if we found substantial heterogeneity, we reanalysed the data using the random-effects model.\nMain results\nWe identified three prospective RCTs for inclusion in this review (319 participants available to assess the primary outcome of anxiety). The studies included people from the outpatient setting, with the majority of participants being male. All three studies assessed psychological therapy (cognitive behavioural therapy) plus co-intervention versus co-intervention alone. We assessed the quality of evidence contributing to all outcomes as low due to small sample sizes and substantial heterogeneity in the analyses. Two of the three studies had prespecified protocols available for comparison between prespecified methodology and outcomes reported within the final publications.\nWe observed some evidence of improvement in anxiety over 3 to 12 months, as measured by the Beck Anxiety Inventory (range from 0 to 63 points), with psychological therapies performing better than the co-intervention comparator arm (mean difference (MD) -4.41 points, 95% confidence interval (CI) -8.28 to -0.53; P = 0.03). There was however, substantial heterogeneity between the studies (I2 = 62%), which limited the ability to draw reliable conclusions. No adverse events were reported.\nAuthors' conclusions\nWe found only low-quality evidence for the efficacy of psychological therapies among people with COPD with anxiety. Based on the small number of included studies identified and the low quality of the evidence, it is difficult to draw any meaningful and reliable conclusions. No adverse events or harms of psychotherapy intervention were reported.\nA limitation of this review is that all three included studies recruited participants with both anxiety and depression, not just anxiety, which may confound the results. We downgraded the quality of evidence in the 'Summary of findings' table primarily due to the small sample size of included trials. Larger RCTs evaluating psychological interventions with a minimum 12-month follow-up period are needed to assess long-term efficacy.\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": "Chronic obstructive pulmonary disease (COPD) is commonly referred to as emphysema and chronic bronchitis. People with COPD are more likely to have anxiety disorders compared with the general population. Symptoms of anxiety affect various aspects of daily life, including quality of life and the ability to perform physical activities. Psychological therapies are used as part of clinical practice to treat these symptoms, however, there is little evidence to support these techniques."
}
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query-laysum | 1147 | [
{
"role": "user",
"content": "Abstract: Background\nAdhesive capsulitis (also termed frozen shoulder) is a common condition characterised by spontaneous onset of pain, progressive restriction of movement of the shoulder and disability that restricts activities of daily living, work and leisure. Electrotherapy modalities, which aim to reduce pain and improve function via an increase in energy (electrical, sound, light, thermal) into the body, are often delivered as components of a physical therapy intervention. This review is one in a series of reviews which form an update of the Cochrane review 'Physiotherapy interventions for shoulder pain'.\nObjectives\nTo synthesise the available evidence regarding the benefits and harms of electrotherapy modalities, delivered alone or in combination with other interventions, for the treatment of adhesive capsulitis.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, CINAHL Plus and the ClinicalTrials.gov and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) clinical trials registries up to May 2014, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials to identify any other potentially relevant trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and controlled clinical trials using a quasi-randomised method of allocation that included adults with adhesive capsulitis and compared any electrotherapy modality to placebo, no treatment, a different electrotherapy modality, or any other intervention. The two main questions of the review focused on whether electrotherapy modalities are effective compared to placebo or no treatment, or if they are an effective adjunct to manual therapy or exercise (or both). The main outcomes of interest were participant-reported pain relief of 30% or greater, overall pain, function, global assessment of treatment success, active shoulder abduction, quality of life, and the number of participants experiencing any adverse event.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted the data, performed a risk of bias assessment, and assessed the quality of the body of evidence for the main outcomes using the GRADE approach.\nMain results\nNineteen trials (1249 participants) were included in the review. Four trials reported using an adequate method of allocation concealment and six trials blinded participants and personnel. Only two electrotherapy modalities (low-level laser therapy (LLLT) and pulsed electromagnetic field therapy (PEMF)) have been compared to placebo. No trial has compared an electrotherapy modality plus manual therapy and exercise to manual therapy and exercise alone. The two main questions of the review were investigated in nine trials.\nLow quality evidence from one trial (40 participants) indicated that LLLT for six days may result in improvement at six days. Eighty per cent (16/20) of participants reported treatment success with LLLT compared with 10% (2/20) of participants receiving placebo (risk ratio (RR) 8.00, 95% confidence interval (CI) 2.11 to 30.34; absolute risk difference 70%, 95% CI 48% to 92%). No participants in either group reported adverse events.\nWe were uncertain whether PEMF for two weeks improved pain or function more than placebo at two weeks because of the very low quality evidence from one trial (32 participants). Seventy-five per cent (15/20) of participants reported pain relief of 30% or more with PEMF compared with 0% (0/12) of participants receiving placebo (RR 19.19, 95% CI 1.25 to 294.21; absolute risk difference 75%, 95% CI 53% to 97%). Fifty-five per cent (11/20) of participants reported total recovery of joint function with PEMF compared with 0% (0/12) of participants receiving placebo (RR 14.24, 95% CI 0.91 to 221.75; absolute risk difference 55%, 95% CI 31 to 79).\nModerate quality evidence from one trial (63 participants) indicated that LLLT plus exercise for eight weeks probably results in greater improvement when measured at the fourth week of treatment, but a similar number of adverse events, compared with placebo plus exercise. The mean pain score at four weeks was 51 points with placebo plus exercise, while with LLLT plus exercise the mean pain score was 32 points on a 100 point scale (mean difference (MD) 19 points, 95% CI 15 to 23; absolute risk difference 19%, 95% CI 15% to 23%). The mean function impairment score was 48 points with placebo plus exercise, while with LLLT plus exercise the mean function impairment score was 36 points on a 100 point scale (MD 12 points, 95% CI 6 to 18; absolute risk difference 12%, 95% CI 6 to 18). Mean active abduction was 70 degrees with placebo plus exercise, while with LLLT plus exercise mean active abduction was 79 degrees (MD 9 degrees, 95% CI 2 to 16; absolute risk difference 5%, 95% CI 1% to 9%). No participants in either group reported adverse events. LLLT's benefits on function were maintained at four months.\nBased on very low quality evidence from six trials, we were uncertain whether therapeutic ultrasound, PEMF, continuous short wave diathermy, Iodex phonophoresis, a combination of Iodex iontophoresis with continuous short wave diathermy, or a combination of therapeutic ultrasound with transcutaneous electrical nerve stimulation (TENS) were effective adjuncts to exercise. Based on low or very low quality evidence from 12 trials, we were uncertain whether a diverse range of electrotherapy modalities (delivered alone or in combination with manual therapy, exercise, or other active interventions) were more or less effective than other active interventions (for example glucocorticoid injection).\nAuthors' conclusions\nBased upon low quality evidence from one trial, LLLT for six days may be more effective than placebo in terms of global treatment success at six days. Based upon moderate quality evidence from one trial, LLLT plus exercise for eight weeks may be more effective than exercise alone in terms of pain up to four weeks, and function up to four months. It is unclear whether PEMF is more or less effective than placebo, or whether other electrotherapy modalities are an effective adjunct to exercise. Further high quality randomised controlled trials are needed to establish the benefits and harms of physical therapy interventions (that comprise electrotherapy modalities, manual therapy and exercise, and are reflective of clinical practice) compared to interventions with evidence of benefit (for example glucocorticoid injection or arthrographic joint distension).\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": "Frozen shoulder is a common cause of shoulder pain and stiffness. The pain and stiffness can last up to two to three years before going away, and in the early stages it can be very painful.\nElectrotherapy modalities (also known as electrophysical agents) are types of physical therapy that aim to reduce pain and improve function via an increase in energy (electrical, sound, light, thermal) into the body. Examples include therapeutic ultrasound, low-level laser therapy (LLLT), interferential current, transcutaneous electrical nerve stimulation (TENS), and pulsed electromagnetic field therapy (PEMF). Electrotherapy modalities are delivered by various clinicians, including physiotherapists, chiropractors and osteopaths. In practice, patients with frozen shoulder seldom receive a single electrotherapy modality in isolation from other components of physical therapy treatment (for example manual therapy, exercise)."
}
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query-laysum | 1148 | [
{
"role": "user",
"content": "Abstract: Background\nDry eye syndrome is a disorder of the tear film that is associated with symptoms of ocular discomfort. Punctal occlusion is a mechanical treatment that blocks the tear drainage system in order to aid in the preservation of natural tears on the ocular surface.\nObjectives\nTo assess the effects of punctal plugs versus no punctal plugs, different types of punctal plugs, and other interventions for managing dry eye.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), MEDLINE Ovid (1946 to 8 December 2016), Embase.com (1947 to 8 December 2016), PubMed (1948 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com; last searched 18 November 2012 - this resource is now archived), ClinicalTrials.gov (www.clinicaltrials.gov; searched 8 December 2016), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en; searched 8 December 2016). We did not use any date or language restrictions in the electronic searches for trials. We also searched the Science Citation Index-Expanded database and reference lists of included studies. The evidence was last updated on 8 December 2016\nSelection criteria\nWe included randomized and quasi-randomized controlled trials of collagen or silicone punctal plugs in symptomatic participants diagnosed with aqueous tear deficiency or dry eye syndrome.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study investigators for additional information when needed.\nMain results\nWe included 18 trials (711 participants, 1249 eyes) from Austria, Canada, China, Greece, Japan, Mexico, Netherlands, Turkey, the UK, and the USA in this review. We also identified one ongoing trial. Overall we judged these trials to be at unclear risk of bias because they were poorly reported. We assessed the evidence for eight comparisons.\nFive trials compared punctal plugs with no punctal plugs (control). Three of these trials employed a sham treatment and two trials observed the control group. Two trials did not report outcome data relevant to this review. There was very low-certainty evidence on symptomatic improvement. The three trials that reported this outcome used different scales to measure symptoms. In all three trials, there was little or no improvement in symptom scores with punctal plugs compared with no punctal plugs. Low-certainty evidence from one trial suggested less ocular surface staining in the punctal plug group compared with the no punctal plug group however this difference was small and possibly clinically unimportant (mean difference (MD) in fluorescein staining score -1.50 points, 95% CI -1.88 to -1.12; eyes = 61). Similarly there was a small difference in tear film stability with people in the punctal plug group having more stability (MD 1.93 seconds more, 95% CI 0.67 to 3.20; eyes = 28, low-certainty evidence). The number of artificial tear applications was lower in the punctal plug group compared with the no punctal plugs group in one trial (MD -2.70 applications, 95% CI -3.11 to -2.29; eyes = 61, low-certainty evidence). One trial with low-certainty evidence reported little or no difference between the groups in Schirmer scores, but did not report any quantitative data on aqueous tear production. Very low-certainty evidence on adverse events suggested that events occurred reasonably frequently in the punctal plug group and included epiphora, itching, tenderness and swelling of lids with mucous discharge, and plug displacement.\nOne trial compared punctal plugs with cyclosporine (20 eyes) and one trial compared punctal plugs with oral pilocarpine (55 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nFive trials compared punctal plugs with artificial tears. In one of the trials punctal plugs was combined with artificial tears and compared with artificial tears alone. There was very low-certainty evidence on symptomatic improvement. Low-certainty evidence of little or no improvement in ocular surface staining comparing punctal plugs with artificial tears (MD right eye 0.10 points higher, 0.56 lower to 0.76 higher, MD left eye 0.60 points higher, 0.10 to 1.10 higher) and low-certainty evidence of little or no difference in aqueous tear production (MD 0.00 mm/5 min, 0.33 lower to 0.33 higher)\nThree trials compared punctal plugs in the upper versus the lower puncta, and none of them reported the review outcomes at long-term follow-up. One trial with very low-certainty evidence reported no observed complications, but it was unclear which complications were collected.\nOne trial compared acrylic punctal plugs with silicone punctal plugs and the trial reported outcomes at approximately 11 weeks of follow-up (36 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nOne trial compared intracanalicular punctal plugs with silicone punctal plugs at three months follow-up (57 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nFinally, two trials with very low-certainty evidence compared collagen punctal plugs versus silicone punctal plugs (98 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.\nAuthors' conclusions\nAlthough the investigators of the individual trials concluded that punctal plugs are an effective means for treating dry eye signs and symptoms, the evidence in this systematic review suggests that improvements in symptoms and commonly tested dry eye signs are inconclusive. Despite the inclusion of 11 additional trials, the findings of this updated review are consistent with the previous review published in 2010. The type of punctal plug investigated, the type and severity of dry eye being treated, and heterogeneity in trial methodology confounds our ability to make decisive statements regarding the effectiveness of punctal plug use. Although punctal plugs are believed to be relatively safe, their use is commonly associated with epiphora and, less commonly, with inflammatory conditions such as dacryocystitis.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to determine whether punctal plugs, which are inserted into the tear ducts to block tear drainage, can treat dry eye syndrome. Cochrane review authors searched for all relevant studies and identified 18 clinical trials."
}
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query-laysum | 1150 | [
{
"role": "user",
"content": "Abstract: Background\nInfective endocarditis is a severe infection arising in the lining of the chambers of the heart. It can be caused by fungi, but most often is caused by bacteria. Many dental procedures cause bacteraemia, which could lead to bacterial endocarditis in a small proportion of people. The incidence of bacterial endocarditis is low, but it has a high mortality rate.\nGuidelines in many countries have recommended that antibiotics be administered to people at high risk of endocarditis prior to invasive dental procedures. However, guidance by the National Institute for Health and Care Excellence (NICE) in England and Wales states that antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures. This is an update of a review that we first conducted in 2004 and last updated in 2013.\nObjectives\nPrimary objective\nTo determine whether prophylactic antibiotic administration, compared to no antibiotic administration or placebo, before invasive dental procedures in people at risk or at high risk of bacterial endocarditis, influences mortality, serious illness or the incidence of endocarditis.\nSecondary objectives\nTo determine whether the effect of dental antibiotic prophylaxis differs in people with different cardiac conditions predisposing them to increased risk of endocarditis, and in people undergoing different high risk dental procedures.\nHarms\nHad we foundno evidence from randomised controlled trials or cohort studies on whether prophylactic antibiotics affected mortality or serious illness, and we had found evidence from these or case-control studies suggesting that prophylaxis with antibiotics reduced the incidence of endocarditis, then we would also have assessed whether the harms of prophylaxis with single antibiotic doses, such as with penicillin (amoxicillin 2 g or 3 g) before invasive dental procedures, compared with no antibiotic or placebo, equalled the benefits in prevention of endocarditis in people at high risk of this disease.\nSearch methods\nAn information specialist searched four bibliographic databases up to 10 May 2021 and used additional search methods to identify published, unpublished and ongoing studies\nSelection criteria\nDue to the low incidence of bacterial endocarditis, we anticipated that few if any trials would be located. For this reason, we included cohort and case-control studies with suitably matched control or comparison groups. The intervention was antibiotic prophylaxis, compared to no antibiotic prophylaxis or placebo, before a dental procedure in people with an increased risk of bacterial endocarditis. Cohort studies would need to follow at-risk individuals and assess outcomes following any invasive dental procedures, grouping participants according to whether or not they had received prophylaxis. Case-control studies would need to match people who had developed endocarditis after undergoing an invasive dental procedure (and who were known to be at increased risk before undergoing the procedure) with those at similar risk who had not developed endocarditis.\nOur outcomes of interest were mortality or serious adverse events requiring hospital admission; development of endocarditis following any dental procedure in a defined time period; development of endocarditis due to other non-dental causes; any recorded adverse effects of the antibiotics; and the cost of antibiotic provision compared to that of caring for patients who developed endocarditis.\nData collection and analysis\nTwo review authors independently screened search records, selected studies for inclusion, assessed the risk of bias in the included study and extracted data from the included study. As an author team, we judged the certainty of the evidence identified for the main comparison and key outcomes using GRADE criteria. We presented the main results in a summary of findings table.\nMain results\nOur new search did not find any new studies for inclusion since the last version of the review in 2013.\nNo randomised controlled trials (RCTs), controlled clinical trials (CCTs) or cohort studies were included in the previous versions of the review, but one case-control study met the inclusion criteria. The trial authors collected information on 48 people who had contracted bacterial endocarditis over a specific two-year period and had undergone a medical or dental procedure with an indication for prophylaxis within the past 180 days. These people were matched to a similar group of people who had not contracted bacterial endocarditis. All study participants had undergone an invasive medical or dental procedure. The two groups were compared to establish whether those who had received preventive antibiotics (penicillin) were less likely to have developed endocarditis. The authors found no significant effect of penicillin prophylaxis on the incidence of endocarditis. No data on other outcomes were reported.\nThe level of certainty we have about the evidence is very low.\nAuthors' conclusions\nThere remains no clear evidence about whether antibiotic prophylaxis is effective or ineffective against bacterial endocarditis in at-risk people who are about to undergo an invasive dental procedure. We cannot determine whether the potential harms and costs of antibiotic administration outweigh any beneficial effect. Ethically, practitioners should discuss the potential benefits and harms of antibiotic prophylaxis with their patients before a decision is made about administration.\n\nGiven the provided abstract, please respond to the following query: \"Limitations of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is based on one study that has some limitations in its design. For example, the participants who received antibiotics may have been in worse general health than those who did not. We are not confident about the evidence we found. We can only conclude that we do not know the effects of antibiotic prophylaxis for the prevention of bacterial endocarditis."
}
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query-laysum | 1151 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related cataract is the principal cause of blindness and visual impairment in the world. Phacoemulsification is the main surgical procedure used to treat cataract. The comparative effectiveness and safety of different-sized incisions for phacoemulsification has not been determined.\nObjectives\nThe aim of this systematic review was to assess the effectiveness and safety of smaller versus larger incisions for phacoemulsification in age-related cataract. The primary outcome of this review was surgically induced astigmatism at three months after surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 10), MEDLINE Ovid (1946 to 28 October 2016), Embase Ovid (1947 to 28 October 2016), PubMed (1948 to 28 October 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 28 October 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com; last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov; searched 28 October 2016), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp; searched 28 October 2016). We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing different-sized incisions in people with age-related cataract undergoing phacoemulsification.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 26 RCTs with a total of 2737 participants (3120 eyes). These trials were conducted in Bosnia and Herzegovina, China, France, India, Italy, Korea, Spain, Switzerland, and Turkey. Half of the 26 trials were conducted in China. We judged all trials as mostly at unclear to low risk of bias. The included RCTs compared four different-sized incisions:<= 1.5 mm, 1.8 mm, 2.2 mm, and approximately 3.0 mm. These incisions were performed using three different techniques: coaxial and biaxial microincision phacoemulsification (C-MICS and B-MICS) and standard phacoemulsification. Not all studies provided data in a form that could be included in this review. Five studies had three arms.\nFifteen trials compared C-MICS (2.2 mm) with standard phacoemulsification (about 3.0 mm). Very low-certainty evidence suggested less surgically induced astigmatism in the C-MICS group at three months compared with standard phacoemulsification (mean difference (MD) -0.19 diopters (D), 95% confidence interval (CI) -0.30 to -0.09; 996 eyes; 8 RCTs). There was low-certainty evidence that both groups achieved similar best-corrected visual acuity (MD 0.00 logMAR, 95% CI -0.02 to 0.02; 242 eyes; 3 RCTs). There was low-certainty evidence of little or no difference in endothelial cell loss and central corneal thickness comparing C-MICS with standard phacoemulsification (MD -7.23 cells/mm2, 95% CI -78.66 to 64.20; 596 eyes; 4 RCTs) and (MD -0.68 μm, 95% CI -3.26 to 1.90; 487 eyes; 5 RCTs).\nNine trials compared C-MICS (1.8 mm) with standard phacoemulsification (about 3.0 mm). Very low-certainty evidence suggested less astigmatism at three months in the C-MICS group compared with standard phacoemulsification group (MD -0.23 D, 95% CI -0.34 to -0.13; 561 eyes; 5 RCTs). Low-certainty evidence suggested little or no difference in best-corrected visual acuity, endothelial cell loss, and central corneal thickness in the two groups at three months (MD -0.02 logMAR, 95% CI -0.03 to -0.00; 192 eyes; 3 RCTs), (MD 7.56 cells/mm2, 95% CI -67.65 to 82.77; 380 eyes; 5 RCTs), and (MD -1.52 μm, 95% CI -6.29 to 3.25; 245 eyes; 3 RCTs).\nSix studies compared C-MICS (1.8 mm) with C-MICS (2.2 mm). There was low-certainty evidence that astigmatism, visual acuity, and central corneal thickness were similar in the two groups at three months (MD 0.04 D, 95% CI -0.09 to 0.16; 259 eyes; 3 RCTs), (MD 0.01 logMAR, 95% CI -0.01 to 0.04; 200 eyes; 3 RCTs), and (MD 0.45 μm, 95% CI -2.70 to 3.60; 100 eyes; 1 RCT). Very low-certainty evidence suggested higher endothelial cell loss in the 1.8 mm group (MD 213.00 cells/mm2, 95% CI 11.15 to 414.85; 70 eyes; 1 RCT).\nFour studies compared B-MICS (<= 1.5 mm) with standard phacoemulsification (about 3.0 mm). Astigmatism was similar in the two groups at three months (MD -0.01 D, 95% CI -0.03 to 0.01; 368 eyes; 2 RCTs; moderate-certainty evidence). There was low-certainty evidence on visual acuity, suggesting little or no difference between the two groups (MD -0.02 logMAR, 95% CI -0.04 to -0.00; 464 eyes; 3 RCTs). Low-certainty evidence on endothelial cell loss and central corneal thickness also suggested little or no difference between the two groups (MD 55.83 cells/mm2, 95% CI -34.93 to 146.59; 280 eyes; 1 RCT) and (MD 0.10 μm, 95% CI -14.04 to 14.24; 90 eyes; 1 RCT).\nNone of the trials reported on quality of life. One trial reported that no participants experienced endophthalmitis or posterior capsule rupture; they also reported little or no difference between incision groups regarding corneal edema (risk ratio 1.02, 95% CI 0.40 to 2.63; 362 eyes).\nAuthors' conclusions\nPhacoemulsification with smaller incisions was not consistently associated with less surgically induced astigmatism compared with phacoemulsification with larger incisions. Coaxial microincision phacoemulsification may be associated with less astigmatism than standard phacoemulsification, but the difference was small, in the order of 0.2 D, and the evidence was uncertain. Safety outcomes and quality of life were not adequately reported; these should be addressed in future studies.\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 searched for studies that compared different-sized incisions for cataract surgery in people with age-related cataract. This review includes 26 studies from Europe and Asia.\nWe found the following results.\n• Some, but not all, surgical techniques using smaller incisions were associated with less astigmatism, however the differences were small and the evidence was uncertain (low- and very low-certainty evidence).\n• In general, there may be little or no difference in visual acuity based on whether a smaller or larger incision is made (low-certainty evidence).\n• There were no consistent effects on other signs such as thickness of the cornea (front of the eye) and number of cells in the front of the eye (low- and very low-certainty evidence).\n• Adverse effects were not reported by most of the included studies.\n• None of the studies reported on the quality of life of participants."
}
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query-laysum | 1152 | [
{
"role": "user",
"content": "Abstract: Background\nUnintentional injuries are the leading cause of death in children aged four to 18 years and are a major cause of ill health. The school setting offers the opportunity to deliver preventive interventions to a large number of children and has been used to address a range of public health problems. However, the effectiveness of the school setting for the prevention of different injury mechanisms in school-aged children is not well understood.\nObjectives\nTo assess the effects of school-based educational programmes for the prevention of injuries in children and evaluate their impact on improving children's safety skills, behaviour and practices, and knowledge, and assess their cost-effectiveness.\nSearch methods\nWe ran searches on the following electronic databases to 26 June 2015: PsycINFO, British Education Index (BEI), Education Resources Information Center (ERIC), Applied Social Sciences Index and Abstracts (ASSIA), International Bibliography of the Social Sciences (IBSS), Sociological Abstracts; Latin America and the Caribbean database (LILACS), together with several sources of grey literature. The Cochrane Injuries Information Specialist ran searches, to August 2013, on the Groups Specialised Register (SR-INJ), the Cochrane Central Register of Controlled Trials (CENTRAL) and other Cochrane Library databases, Ovid MEDLINE, Embase, CINAHL and the ISI Web of Science. In keeping with Cochrane standards, along with Cochrane Injuries' Information Specialist we ran an update search prior to publication (September and October 2016). We have screened the results and placed any relevant studies in the Characteristics of studies awaiting classification section of this review.These will be incorporated in the next version of this review, as appropriate.\nSelection criteria\nWe included randomised controlled trials (RCTs), non-randomised controlled trials (non-RCTs), and controlled before-and-after (CBA) studies that evaluated school-based educational programmes aimed at preventing a range of injury mechanisms. The primary outcome was self-reported or medically attended unintentional (or unspecified intent) injuries and secondary outcomes were observed safety skills, observed behaviour, self-reported behaviour and safety practices, safety knowledge, and health economic outcomes. The control groups received no intervention, a delayed injury-prevention intervention or alternative school-based curricular activities. We included studies that aimed interventions at primary or secondary prevention of injuries from more than one injury mechanism and were delivered, in part or in full, in schools catering for children aged four to 18 years.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors identified relevant trials from title and abstracts of studies identified in searches and two review authors extracted data from the included studies and assessed risk of bias. We grouped different types of interventions according to the outcome assessed and the injury mechanism targeted. Where data permitted, we performed random-effects meta-analyses to provide a summary of results across studies.\nMain results\nThe review included 27 studies reported in 30 articles. The studies had 73,557 participants with 12 studies from the US; four from China; two from each of Australia, Canada, the Netherlands and the UK; and one from each of Israel, Greece and Brazil. Thirteen studies were RCTs, six were non-RCTs and eight were CBAs. Of the included studies, 18 provided some element of the intervention in children aged four to 11 years, 17 studies included children aged 11 to 14 years and nine studies included children aged 14 to 18 years.\nThe overall quality of the results was poor, with the all studies assessed as being at high or unclear risks of bias across multiple domains, and varied interventions and data collection methods employed. Interventions comprised information-giving, peer education or were multi-component.\nSeven studies reported the primary outcome of injury occurrence and only three of these were similar enough to combine in a meta-analysis, with a pooled incidence rate ratio of 0.73 (95% confidence interval (CI) 0.49 to 1.08; 2073 children) and substantial statistical heterogeneity (I2 = 63%). However, this body of evidence was low certainty, due to concerns over this heterogeneity (inconsistency) and imprecision. This heterogeneity may be explained by the non-RCT study design of one of the studies, as a sensitivity analysis with this study removed found stronger evidence of an effect and no heterogeneity (I2 = 0%).\nTwo studies report an improvement in safety skills in the intervention group. Likewise, the four studies measuring observed safety behaviour reported an improvement in the intervention group relative to the control. Thirteen out of 19 studies describing self-reported behaviour and safety practices showed improvements, and of the 21 studies assessing changes in safety knowledge, 19 reported an improvement in at least one question domain in the intervention compared to the control group. However, we were unable to pool data for our secondary outcomes, so our conclusions were limited, as they were drawn from highly diverse single studies and the body of evidence was low (safety skills) or very low (behaviour, safety knowledge) certainty. Only one study reported intervention costs but did not undertake a full economic evaluation (very low certainty evidence).\nAuthors' conclusions\nThere is insufficient evidence to determine whether school-based educational programmes can prevent unintentional injuries. More high-quality studies are needed to evaluate the impact of educational programmes on injury occurrence. There is some weak evidence that such programmes improve safety skills, behaviour/practices and knowledge, although the evidence was of low or very low quality certainty. We found insufficient economic studies to assess cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to June 2015. It includes the results from 27 studies of 73,557 children. It included boys and girls aged four to 18. The studies compared injury prevention education with either the usual curriculum or an alternative programme unrelated to injuries. The studies we included were aimed at preventing a range of injuries. We excluded programmes that focused on just one cause of injury. The review measured the effects of the educational programmes on the occurrence of injuries in children, their safety skills, behaviour and knowledge. The review also looked at whether school-based approaches are good value for money."
}
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query-laysum | 1153 | [
{
"role": "user",
"content": "Abstract: Background\nTransient tachypnea of the newborn is characterized by tachypnea and signs of respiratory distress. Transient tachypnea typically appears within the first two hours of life in term and late preterm newborns. Although transient tachypnea of the newborn is usually a self limited condition, it is associated with wheezing syndromes in late childhood. The rationale for the use of epinephrine (adrenaline) for transient tachypnea of the newborn is based on studies showing that β-agonists can accelerate the rate of alveolar fluid clearance.\nObjectives\nTo assess whether epinephrine compared to placebo, no treatment or any other drugs (excluding salbutamol) is effective and safe in the treatment of transient tachypnea of the newborn in infants born at 34 weeks' gestational age or more.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 3), MEDLINE (1996 to March 2016), EMBASE (1980 to March 2016) and CINAHL (1982 to March 2016). We applied no language restrictions. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015.\nSelection criteria\nRandomized controlled trials, quasi-randomized controlled trials and cluster trials comparing epinephrine versus placebo or no treatment or any other drugs administered to infants born at 34 weeks' gestational age or more and less than three days of age with transient tachypnea of the newborn.\nData collection and analysis\nFor the included trial, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy (hours), need for continuous positive airway pressure and need for mechanical ventilation, duration of mechanical ventilation, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review were duration of oxygen therapy (hours), need for continuous positive airway pressure and need for mechanical ventilation.\nMain results\nOne trial, which included 20 infants, met the inclusion criteria of this review. Study authors administered three doses of nebulized 2.25% racemic epinephrine or placebo. We found no differences between the two group in the duration of supplemental oxygen therapy (mean difference (MD) -6.60, 95% confidence interval (CI) -54.80 to 41.60 hours) and need for mechanical ventilation (risk ratio (RR) 0.67, 95% CI 0.08 to 5.88; risk difference (RD) -0.07, 95% CI -0.46 to 0.32). Among secondary outcomes, we found no differences in terms of initiation of oral feeding. The quality of the evidence was limited due to the imprecision of the estimates.\nAuthors' conclusions\nAt present there is insufficient evidence to determine the efficacy and safety of epinephrine in the management of transient tachypnea of the newborn.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Epinephrine did not reduce the duration of treatment with oxygen, the need for respiratory support or any other relevant measurements in newborns with transient tachypnea."
}
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query-laysum | 1154 | [
{
"role": "user",
"content": "Abstract: Background\nSystemic antimicrobials can be used as an adjunct to mechanical debridement (scaling and root planing (SRP)) as a non-surgical treatment approach to manage periodontitis. A range of antibiotics with different dosage and combinations are documented in the literature. The review follows the previous classification of periodontitis as all included studies used this classification.\nObjectives\nTo assess the effects of systemic antimicrobials as an adjunct to SRP for the non-surgical treatment of patients with periodontitis.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases to 9 March 2020: Cochrane Oral Health's Trials Register, CENTRAL, MEDLINE, and Embase. The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) which involved individuals with clinically diagnosed untreated periodontitis. Trials compared SRP with systemic antibiotics versus SRP alone/placebo, or with other systemic antibiotics.\nData collection and analysis\nWe selected trials, extracted data, and assessed risk of bias in duplicate. We estimated mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 45 trials conducted worldwide involving 2664 adult participants. 14 studies were at low, 8 at high, and the remaining 23 at unclear overall risk of bias. Seven trials did not contribute data to the analysis. We assessed the certainty of the evidence for the 10 comparisons which reported long-term follow-up (≥ 1 year). None of the studies reported data on antimicrobial resistance and patient-reported quality of life changes.\nAmoxicillin + metronidazole + SRP versus SRP in chronic/aggressive periodontitis: the evidence for percentage of closed pockets (MD -16.20%, 95% CI -25.87 to -6.53; 1 study, 44 participants); clinical attachment level (CAL) (MD -0.47 mm, 95% CI -0.90 to -0.05; 2 studies, 389 participants); probing pocket depth (PD) (MD -0.30 mm, 95% CI -0.42 to -0.18; 2 studies, 389 participants); and percentage of bleeding on probing (BOP) (MD -8.06%, 95% CI -14.26 to -1.85; 2 studies, 389 participants) was of very low certainty. Only the results for closed pockets and BOP showed a minimally important clinical difference (MICD) favouring amoxicillin + metronidazole + SRP.\nMetronidazole + SRP versus SRP in chronic/aggressive periodontitis: the evidence for percentage of closed pockets (MD -12.20%, 95% CI -29.23 to 4.83; 1 study, 22 participants); CAL (MD -1.12 mm, 95% CI -2.24 to 0; 3 studies, 71 participants); PD (MD -1.11 mm, 95% CI -2.84 to 0.61; 2 studies, 47 participants); and percentage of BOP (MD -6.90%, 95% CI -22.10 to 8.30; 1 study, 22 participants) was of very low certainty. Only the results for CAL and PD showed an MICD favouring the MTZ + SRP group.\nAzithromycin + SRP versus SRP for chronic/aggressive periodontitis: we found no evidence of a difference in percentage of closed pockets (MD 2.50%, 95% CI -10.19 to 15.19; 1 study, 40 participants); CAL (MD -0.59 mm, 95% CI -1.27 to 0.08; 2 studies, 110 participants); PD (MD -0.77 mm, 95% CI -2.33 to 0.79; 2 studies, 110 participants); and percentage of BOP (MD -1.28%, 95% CI -4.32 to 1.76; 2 studies, 110 participants) (very low-certainty evidence for all outcomes).\nAmoxicillin + clavulanate + SRP versus SRP for chronic periodontitis: the evidence from 1 study, 21 participants for CAL (MD 0.10 mm, 95% CI -0.51 to 0.71); PD (MD 0.10 mm, 95% CI -0.17 to 0.37); and BOP (MD 0%, 95% CI -0.09 to 0.09) was of very low certainty and did not show a difference between the groups.\nDoxycycline + SRP versus SRP in aggressive periodontitis: the evidence from 1 study, 22 participants for CAL (MD -0.80 mm, 95% CI -1.49 to -0.11); and PD (MD -1.00 mm, 95% CI -1.78 to -0.22) was of very low certainty, with the doxycycline + SRP group showing an MICD in PD only.\nTetracycline + SRP versus SRP for aggressive periodontitis: we found very low-certainty evidence of a difference in long-term improvement in CAL for the tetracycline group (MD -2.30 mm, 95% CI -2.50 to -2.10; 1 study, 26 participants).\nClindamycin + SRP versus SRP in aggressive periodontitis: we found very low-certainty evidence from 1 study, 21 participants of a difference in long-term improvement in CAL (MD -1.70 mm, 95% CI -2.40 to -1.00); and PD (MD -1.80 mm, 95% CI -2.47 to -1.13) favouring clindamycin + SRP.\nDoxycycline + SRP versus metronidazole + SRP for aggressive periodontitis: there was very low-certainty evidence from 1 study, 27 participants of a difference in long-term CAL (MD 1.10 mm, 95% CI 0.36 to 1.84); and PD (MD 1.00 mm, 95% CI 0.30 to 1.70) favouring metronidazole + SRP.\nClindamycin + SRP versus metronidazole + SRP for aggressive periodontitis: the evidence from 1 study, 26 participants for CAL (MD 0.20 mm, 95% CI -0.55 to 0.95); and PD (MD 0.20 mm, 95% CI -0.38 to 0.78) was of very low certainty and did not show a difference between the groups.\nClindamycin + SRP versus doxycycline + SRP for aggressive periodontitis: the evidence from 1 study, 23 participants for CAL (MD -0.90 mm, 95% CI -1.62 to -0.18); and PD (MD -0.80 mm, 95% CI -1.58 to -0.02) was of very low certainty and did not show a difference between the groups.\nMost trials testing amoxicillin, metronidazole, and azithromycin reported adverse events such as nausea, vomiting, diarrhoea, mild gastrointestinal disturbances, and metallic taste. No serious adverse events were reported.\nAuthors' conclusions\nThere is very low-certainty evidence (for long-term follow-up) to inform clinicians and patients if adjunctive systemic antimicrobials are of any help for the non-surgical treatment of periodontitis. There is insufficient evidence to decide whether some antibiotics are better than others when used alongside SRP. None of the trials reported serious adverse events but patients should be made aware of the common adverse events related to these drugs.\nWell-planned RCTs need to be conducted clearly defining the minimally important clinical difference for the outcomes closed pockets, CAL, PD, and BOP.\n\nGiven the provided abstract, please respond to the following query: \"How did we identify and evaluate the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "First, we searched for randomized controlled studies (clinical studies where people are randomly put into one of two or more treatment groups), because these studies provide the most robust evidence about the effects of a treatment. We then compared the results, and summarized the evidence from all the studies. Finally, we rated our confidence in the evidence, based on factors such as study methods and sizes, and the consistency of findings across studies."
}
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query-laysum | 1155 | [
{
"role": "user",
"content": "Abstract: Background\nGlutamergic system dysfunction has been implicated in the pathophysiology of bipolar depression. This is an update of the 2015 Cochrane Review for the use of glutamate receptor modulators for depression in bipolar disorder.\nObjectives\n1. To assess the effects of ketamine and other glutamate receptor modulators in alleviating the acute symptoms of depression in people with bipolar disorder.\n2. To review the acceptability of ketamine and other glutamate receptor modulators in people with bipolar disorder who are experiencing depressive symptoms.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase and PsycINFO all years to July 2020. We did not apply any restrictions to date, language or publication status.\nSelection criteria\nRCTs comparing ketamine or other glutamate receptor modulators with other active psychotropic drugs or saline placebo in adults with bipolar depression.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed trial quality and extracted data. Primary outcomes were response rate and adverse events. Secondary outcomes included remission rate, depression severity change scores, suicidality, cognition, quality of life, and dropout rate. The GRADE framework was used to assess the certainty of the evidence.\nMain results\nTen studies (647 participants) were included in this review (an additional five studies compared to the 2015 review). There were no additional studies added to the comparisons identified in the 2015 Cochrane review on ketamine, memantine and cytidine versus placebo. However, three new comparisons were found: ketamine versus midazolam, N-acetylcysteine versus placebo, and riluzole versus placebo. The glutamate receptor modulators studied were ketamine (three trials), memantine (two), cytidine (one), N-acetylcysteine (three), and riluzole (one). Eight of these studies were placebo-controlled and two-armed. In seven trials the glutamate receptor modulators had been used as add-on drugs to mood stabilisers. Only one trial compared ketamine with an active comparator, midazolam. The treatment period ranged from a single intravenous administration (all ketamine studies), to repeated administration for riluzole, memantine, cytidine, and N-acetylcysteine (with a follow-up of eight weeks, 8 to 12 weeks, 12 weeks, and 16 to 20 weeks, respectively). Six of the studies included sites in the USA, one in Taiwan, one in Denmark, one in Australia, and in one study the location was unclear. All participants had a primary diagnosis of bipolar disorder and were experiencing an acute bipolar depressive episode, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition (IV) or fourth edition text revision (IV-TR).\nAmong all glutamate receptor modulators included in this review, only ketamine appeared to be more efficacious than placebo 24 hours after infusion for response rate (odds ratio (OR) 11.61, 95% confidence interval (CI) 1.25 to 107.74; P = 0.03; participants = 33; studies = 2; I² = 0%, low-certainty evidence). Ketamine seemed to be more effective in reducing depression rating scale scores (MD -11.81, 95% CI -20.01 to -3.61; P = 0.005; participants = 32; studies = 2; I2 = 0%, very low-certainty evidence). There was no evidence of ketamine's efficacy in producing remission over placebo at 24 hours (OR 5.16, 95% CI 0.51 to 52.30; P = 0.72; participants = 33; studies = 2; I2 = 0%, very low-certainty evidence).\nEvidence on response, remission or depression rating scale scores between ketamine and midazolam was uncertain at 24 hours due to very low-certainty evidence (OR 3.20, 95% CI 0.23 to 45.19). In the one trial assessing ketamine and midazolam, there were no dropouts due to adverse effects or for any reason (very low-certainty evidence).\nPlacebo may have been more effective than N-acetylcysteine in reducing depression rating scale scores at three months, although this was based on very low-certainty evidence (MD 1.28, 95% CI 0.24 to 2.31; participants = 58; studies = 2). Very uncertain evidence found no difference in response at three months (OR 0.82, 95% CI 0.32 to 2.14; participants = 69; studies = 2; very low-certainty evidence). No data were available for remission or acceptability.\nExtremely limited data were available for riluzole vs placebo, finding only very-low certainty evidence of no difference in dropout rates (OR 2.00, 95% CI 0.31 to 12.84; P = 0.46; participants = 19; studies = 1; I2 = 0%).\nAuthors' conclusions\nIt is difficult to draw reliable conclusions from this review due to the certainty of the evidence being low to very low, and the relatively small amount of data usable for analysis in bipolar disorder, which is considerably less than the information available for unipolar depression. Nevertheless, we found uncertain evidence in favour of a single intravenous dose of ketamine (as add-on therapy to mood stabilisers) over placebo in terms of response rate up to 24 hours, however ketamine did not show any better efficacy for remission in bipolar depression. Even though ketamine has the potential to have a rapid and transient antidepressant effect, the efficacy of a single intravenous dose may be limited. We did not find conclusive evidence on adverse events with ketamine, and there was insufficient evidence to draw meaningful conclusions for the remaining glutamate receptor modulators.\nHowever, ketamine's psychotomimetic effects (such as delusions or delirium) may have compromised study blinding in some studies, and so we cannot rule out the potential bias introduced by inadequate blinding procedures. To draw more robust conclusions, further methodologically sound RCTs (with adequate blinding) are needed to explore different modes of administration of ketamine, and to study different methods of sustaining antidepressant response, such as repeated administrations.\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 medical databases to find all relevant studies completed up to 30 July 2020. These studies had to be randomised controlled trials (where people in the study are randomly assigned to receive either the drug being tested or a different drug or placebo to compare the results). To be included in the review, studies had to compare ketamine or other glutamate receptor modulators with placebo or other medicines in adults with bipolar depression. We included 10 studies (647 participants). The studies investigated five different glutamate receptor modulator drugs: ketamine (three trials), memantine (two trials), cytidine (one trial), N-acetylcysteine (three trials), and riluzole (one trial). Nine studies compared glutamate receptor modulators with placebo, and one study compared ketamine with another drug. Most of the trials in the review included participants who were also receiving another medication (either lithium, valproate, or lamotrigine). We rated the certainty of the evidence 'very low' to 'low' across different comparisons, meaning that we cannot be confident that the results are a close representation of the truth."
}
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query-laysum | 1156 | [
{
"role": "user",
"content": "Abstract: Background\nWomen who carry a pathogenic mutation in either a BRCA1 DNA repair associated or BRCA2 DNA repair associated (BRCA1 or BRCA2) gene have a high lifetime risk of developing breast and tubo-ovarian cancer. To manage this risk women may choose to undergo risk-reducing surgery to remove breast tissue, ovaries, and fallopian tubes. Surgery should increase survival, but can impact women's lives adversely at the psychological and psychosexual levels. Interventions to facilitate psychological adjustment and improve quality of life post risk-reducing surgery are needed.\nObjectives\nTo examine psychosocial interventions in female BRCA carriers who have undergone risk-reducing surgery and to evaluate the effectiveness of such interventions on psychological adjustment and quality of life.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and Embase via Ovid, CINAHL, PsycINFO, Web of Science up to April 2019 and Scopus up to January 2018. We also handsearched abstracts of scientific meetings and other relevant publications.\nSelection criteria\nWe included randomised controlled trials (RCT), non-randomised studies (NRS), prospective and retrospective cohort studies and interventional studies using baseline and postintervention analyses in female BRCA carriers who have undergone risk-reducing surgery.\nData collection and analysis\nTwo review authors independently assessed eligibility studies for inclusion in the review. We used standard methodological procedures expected by Cochrane.\nMain results\nWe screened 4956 records from the searches, selecting 34 unique studies for full-text scrutiny, of which two met the inclusion criteria: one RCT and one NRS. The included studies assessed 113 female BRCA carriers who had risk-reducing surgery, but there was attrition, and outcome data were not available for all participants at final study assessments. We assessed the RCT as at a high risk of bias whilst the NRS did not have a control group. Our GRADE assessment of the studies was very low-certainty due to the paucity of data and methodological shortcomings of the studies. The primary outcome of quality of life was only measured in the RCT and that was specific to the menopause. Both studies reported on psychological distress and sexual function. Neither study measured body image, perhaps because this is most often associated with risk-reducing mastectomy rather than oophorectomy.\nThe RCT (66 participants recruited with 48 followed to 12 months) assessed the short- and long-term effects of an eight-week mindfulness-based stress reduction (MBSR) training programme on quality of life, sexual functioning, and sexual distress in female BRCA carriers (n = 34) in a specialised family cancer clinic in the Netherlands compared to female BRCA carriers (n = 32) who received usual care. Measurements on the Menopause-Specific Quality of Life Questionnaire (MENQOL) showed some improvement at 3 and 12 months compared to the usual care group. At 3 months the mean MENQOL scores were 3.5 (95% confidence interval (CI) 3.0 to 3.9) and 3.8 (95% CI 3.3 to 4.2) for the MBSR and usual care groups respectively, whilst at 12 months the corresponding values were 3.6 (95% CI 3.1 to 4.0) and 3.9 (95% CI 3.5 to 4.4) (1 study; 48 participants followed up at 12 months). However, these results should be interpreted with caution due to the very low-certainty of the evidence, where a lower score is better. Other outcome measures on the Female Sexual Function Index and the Female Sexual Distress Scale showed no significant differences between the two groups. Our GRADE assessment of the evidence was very low-certainty due to the lack of blinding of participants and personnel, attrition bias and self-selection (as only one-third of eligible women chose to participate in the study) and serious imprecision due to the small sample size and wide 95% CI.\nThe NRS comprised 37 female BRCA carriers selected from three Boston-area hospitals who had undergone a novel sexual health intervention following risk-reducing salpingo-oophorectomy (RRSO) without a history of tubo-ovarian cancer. The intervention consisted of targeted sexual-health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies, followed by two sessions of tailored telephone counselling. This was a single-arm study without a control group. Our GRADE assessment of the evidence was very low-certainty, and as there was no comparison group in the included study, we could not estimate a relative effect. The study reported change in psychosexual adjustment from baseline to postintervention (median 2.3 months) using measures of Female Sexual Function Index (n = 34), which yielded change with a mean of 3.91, standard deviation (SD) 9.12, P = 0.018 (1 study, 34 participants; very low-certainty evidence). The Brief Symptom Inventory, Global Severity Index yielded a mean change of 3.92, SD 5.94, P < 0.001. The Sexual Self-Efficacy Scale yielded change with a mean of 12.14, SD 20.56, P < 0.001. The Sexual Knowledge Scale reported mean change of 1.08, SD 1.50, P < 0.001 (n = 36). Participant satisfaction was measured by questionnaire, and 100% participants reported that they enjoyed taking part in the psychoeducation group and felt \"certain\" or \"very certain\" that they had learned new skills to help them cope with the sexual side effects of RRSO.\nAuthors' conclusions\nThe effect of psychosocial interventions on quality of life and emotional well-being in female BRCA carriers who undergo risk-reducing surgery is uncertain given the very low methodological quality in the two studies included in the review. The absence of such interventions highlights the need for partnership between researchers and clinicians in this specific area to take forward the patient-reported outcomes and develop interventions to address the psychosocial issues related to risk-reducing surgery in female BRCA carriers, particularly in this new era of genomics, where testing may become more mainstream and many more women are identified as gene carriers.\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": "Women who test positive for a fault (mutation) on one of the BRCA genes (BRCA1 DNA repair associated or BRCA2 DNA repair associated (BRCA1 or BRCA2)) are more at risk of developing breast and tubo-ovarian cancer (cancer of the fallopian tubes or ovaries). A significant number of female BRCA carriers will choose to have surgery to remove their breast tissue and fallopian tubes and ovaries in order to reduce their risk of developing breast cancer and tubo-ovarian cancer. This type of surgery can be life-changing, and women may experience negative physical and emotional changes as a result. These changes can affect the function and appearance of their bodies, which in turn can have a negative psychological effect on women and their relationships."
}
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query-laysum | 1157 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with venous thromboembolism (VTE) generally are treated for five days with intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin (LMWH), followed by three months of vitamin K antagonists (VKAs). Treatment with VKAs requires regular laboratory measurements and carries risk of bleeding; some patients have contraindications to such treatment. Treatment with LMWH has been proposed to minimise the risk of bleeding complications. This is the second update of a review first published in 2001.\nObjectives\nThe purpose of this review was to evaluate the efficacy and safety of long term treatment (three months) with LMWH versus long term treatment (three months) with VKAs for symptomatic VTE.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Specialised Register (last searched November 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 10), The Cochrane Vascular Information Specialistalso searched clinical trials registries for ongoing studies.\nSelection criteria\nRandomised controlled trials comparing LMWH versus VKA for long treatment (three months) of symptomatic VTE. Two review authors independently evaluated trials for inclusion and methodological quality.\nData collection and analysis\nReview authors independently extracted data and assessed risk of bias. We resolved disagreements by discussion and performed meta-analysis using fixed-effect models with Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs). Outcomes of interest were recurrent VTE, major bleeding, and mortality. We used GRADE to assess the overall quality of evidence supporting these outcomes.\nMain results\nSixteen trials, with a combined total of 3299 participants fulfilled our inclusion criteria. According to GRADE, the quality of evidence was moderate for recurrent VTE, low for major bleeding, and moderate for mortality. We downgraded the quality of the evidence for imprecision (recurrent VTE, mortality) and for risk of bias and inconsistency (major bleeding).\nWe found no clear differences in recurrent VTE between LMWH and VKA (Peto OR 0.83, 95% confidence interval (CI) 0.60 to 1.15; P = 0.27; 3299 participants; 16 studies; moderate-quality evidence). We found less bleeding with LMWH than with VKA (Peto OR 0.51, 95% CI 0.32 to 0.80; P = 0.004; 3299 participants; 16 studies; low-quality evidence). However, when comparing only high-quality studies for bleeding, we observed no clear differences between LMWH and VKA (Peto OR 0.62, 95% CI 0.36 to 1.07; P = 0.08; 1872 participants; seven studies). We found no clear differences between LMWH and VKA in terms of mortality (Peto OR 1.08, 95% CI 0.75 to 1.56; P = 0.68; 3299 participants; 16 studies; moderate-quality evidence).\nAuthors' conclusions\nModerate-quality evidence shows no clear differences between LMWH and VKA in preventing symptomatic VTE and death after an episode of symptomatic DVT. Low-quality evidence suggests fewer cases of major bleeding with LMWH than with VKA. However, comparison of only high-quality studies for bleeding shows no clear differences between LMWH and VKA. LMWH may represent an alternative for some patients, for example, those residing in geographically inaccessible areas, those who are unable or reluctant to visit the thrombosis service regularly, and those with contraindications to VKA.\n\nGiven the provided abstract, please respond to the following query: \"Purpose of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To assess the benefits and harms of long term treatment (three months) of venous thromboembolism with LMWH compared with long term treatment with VKAs."
}
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query-laysum | 1158 | [
{
"role": "user",
"content": "Abstract: Background\nNeurosyphilis is an infection of the central nervous system, caused by Treponema pallidum, a spirochete capable of infecting almost any organ or tissue in the body causing neurological complications due to the infection. This disease is a tertiary manifestation of syphilis. The first-line treatment for neurosyphilis is aqueous crystalline penicillin. However, in cases such as penicillin allergy, other regimes of antibiotic therapy can be used.\nObjectives\nTo assess the clinical effectiveness and safety of antibiotic therapy for adults with neurosyphilis.\nSearch methods\nWe searched the Cochrane Library, CENTRAL, MEDLINE, Embase, LILACS, World Health Organization International Clinical Trials Registry Platform and Opengrey up to April 2019. We also searched proceedings of eight congresses to a maximum of 10 years, and we contacted trial authors for additional information.\nSelection criteria\nWe included randomised clinical trials that included men and women, regardless of age, with definitive diagnoses of neurosyphilis, including HIV-seropositive patients. We compared any antibiotic regime (concentration, dose, frequency, duration), compared to any other antibiotic regime for the treatment for neurosyphilis in adults.\nData collection and analysis\nTwo review authors independently selected eligible trials, extracted data, and evaluated risk of bias. We resolved disagreements by involving a third review author. For dichotomous data (serological cure, clinical cure, adverse events), we presented results as summary risk ratios (RR) with 95% confidence intervals (CI). We assessed the quality of evidence using the GRADE approach.\nMain results\nWe identified one trial, with 36 participants diagnosed with syphilis and HIV. The participants were mainly men, with a median age of 34 years. This trial, funded by a pharmaceutical company, compared ceftriaxone in 18 participants (2 g daily for 10 days), with penicillin G, also in 18 participants (4 million/Units (MU)/intravenous (IV) every 4 hours for 10 days). The trial reported incomplete and inconclusive results. Three of 18 (16%) participants receiving ceftriaxone versus 2 of 18 (11%) receiving penicillin G achieved serological cure (RR 1.50; 95% CI: 0.28 to 7.93; 1 trial, 36 participants very low-quality evidence); and 8 of 18 (44%) participants receiving ceftriaxone versus 2 of 18 (18%) participants receiving penicillin G achieved clinical cure (RR 4.00; 95% CI: 0.98 to 16.30; 1 trial, 36 participants very low-quality evidence). Although more participants who received ceftriaxone achieved serological and clinical cure compared to those who received penicillin G, the evidence from this trial was insufficient to determine whether there was a difference between treatment with ceftriaxone or penicillin G.\nIn this trial, the authors reported what would usually be adverse events as symptoms and signs in the follow-up of participants. Furthermore, this trial did not evaluate recurrence of neurosyphilis, time to recovery nor quality of life. We judged risk of bias in this clinical trial to be unclear for random sequence generation, allocation, and blinding of participants, and high for incomplete outcome data, potential conflicts of interest (funding bias), and other bias, due to the lack of a sample size calculation. We rated the quality of evidence as very low.\nAuthors' conclusions\nDue to low quality and insufficient evidence, it was not possible to determine whether there was a difference between treatment with ceftriaxone or Penicillin G. Also, the benefits to people without HIV and neurosyphilis are unknown, as is the ceftriaxone safety profile.Therefore, these results should be interpreted with caution. This conclusion does not mean that antibiotics should not be used for treating this clinical entity. This Cochrane Review has identified the need of adequately powered trials, which should be planned according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) recommendations, conducted and reported as recommended by the CONSORT statement. Furthermore, the outcomes should be based on patients' perspectives taking into account Patient-Centered Outcomes Research Institute (PCORI) recommendations.\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": "Syphilis is a condition caused by a micro-organism called Treponema pallidum. At any stage of syphilis an individual can acquire neurosyphilis, which is an infection of the central nervous system (brain and spinal cord). The infection can be spread throughout the central nervous system, causing complications in the brain and spine. It may occur during early or late syphilis and it can have severe consequences for patients. Research has shown that people who are also infected with HIV are more likely to get neurosyphilis. Antibiotics are used to treat neurosyphilis. The first option is aqueous crystalline penicillin. However, in some cases, such as penicillin allergy, other antibiotics can be used."
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query-laysum | 1159 | [
{
"role": "user",
"content": "Abstract: Background\nAccess to the femoral vessels is necessary for a wide range of vascular procedures, including treatment of thromboembolic disease, arterial grafts (i.e. bifemoral aortic bypass or infrainguinal bypass), endovascular repair of abdominal aortic aneurysm (EVAR), thoracic endovascular aneurysm repair (TEVAR) and transcatheter aortic valve implantation (TAVI). The surgical technique used to access the femoral artery may be a factor in the occurrence of postoperative complications; this will be the focus of our review. We will compare the transverse surgical technique—a cut made parallel to the groin crease—versus the vertical groin incision surgical technique—classic technique: a surgical cut made across the groin crease—to access the femoral artery, in an attempt to determine which technique has the lower rate of complications, is safer and is more effective.\nObjectives\nTo evaluate the efficacy and safety of transverse groin incision compared with vertical groin incision for accessing the femoral artery in endovascular surgical procedures and open surgery.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases, and the World Health Organization (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to 17 February 2020. The review authors searched the IBECS database to 26 March 2020 and reference lists of relevant studies/papers.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized trials (qRCTs) that compare transverse and vertical groin incision, during either endovascular or open surgery procedures.\nData collection and analysis\nTwo review authors (MVCRC, FCN) independently selected the studies, assessed risk of bias, extracted data, performed data analysis and graded the certainty of evidence according to GRADE.\nMain results\nWe included one RCT and one qRCT in this review. These two studies had a combined total of 237 participants (283 groins). Infection of the surgical wound was the only outcome that was similar in both studies, and that could therefore be submitted to a combined analysis.\nMeta-analysis of the two studies showed low-certainty evidence that transverse groin incision resulted in a lower risk of surgical wound infection in the 10- to 28-day period following surgery (risk ratio [RR] 0.25, 95% confidence interval [CI] 0.08 to 0.76; 2 studies; 283 groin incisions). There was low heterogeneity between the studies. We downgraded the certainty of the evidence for surgical wound infection by one level due to serious limitations in the design (there was a high risk of bias in critical domains). The confidence interval for surgical wound infection is relatively wide, further indicating that the certainty of the effect estimate is low. This is likely due to the small number of studies and participants. We observed no evidence of a difference between the two surgical techniques for the other evaluated primary outcome 'lymphatic complications': lymphocele (RR 0.46, 95% CI 0.20 to 1.02; 1 study; 116 groins); and lymphorrhea (RR 2.77, 95% CI 0.92 to 8.34; 1 study; 116 groins). We downgraded the certainty of evidence for lymphatic complications by one level due to serious limitations in the design (there was a high risk of bias in critical domains); and by two further levels because of imprecision (small number of participants and only one study included).\nHigh-quality studies are needed to enable a comparison of the two surgical techniques with respect to other outcomes, such as infection of the vascular graft (endoprosthesis/prosthesis), prolonged hospitalization, reoperative surgery, death, neurological deficit (e.g. paresthesia), amputation, graft patency, and postoperative pain.\nAuthors' conclusions\nIn this systematic review, we found low-certainty evidence that performing transverse groin incision to access the femoral artery resulted in fewer surgical wound infections compared with performing vertical groin incision. We observed no evidence of a difference between the two surgical techniques for the other evaluated outcomes (lymphocele and lymphorrhea). Other outcomes were not evaluated in these studies.\nLimitations of this systematic review are, however, the 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.\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": "Evidence of low certainty suggests that surgical wound infection in the 28-day period post surgery occurs less frequently in transverse incisions than in vertical incisions to access the femoral artery. Evidence of very-low certainty indicated that there was no evidence of a difference between the two surgical techniques relating to the lymphatic complications' outcome for access to the femoral artery in the 28-day period post surgery."
}
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query-laysum | 1160 | [
{
"role": "user",
"content": "Abstract: Background\nAmbient air pollution is associated with a large burden of disease in both high-income countries (HICs) and low- and middle-income countries (LMICs). To date, no systematic review has assessed the effectiveness of interventions aiming to reduce ambient air pollution.\nObjectives\nTo assess the effectiveness of interventions to reduce ambient particulate matter air pollution in reducing pollutant concentrations and improving associated health outcomes.\nSearch methods\nWe searched a range of electronic databases with diverse focuses, including health and biomedical research (CENTRAL, Cochrane Public Health Group Specialised Register, MEDLINE, Embase, PsycINFO), multidisciplinary research (Scopus, Science Citation Index), social sciences (Social Science Citation Index), urban planning and environment (Greenfile), and LMICs (Global Health Library regional indexes, WHOLIS). Additionally, we searched grey literature databases, multiple online trial registries, references of included studies and the contents of relevant journals in an attempt to identify unpublished and ongoing studies, and studies not identified by our search strategy. The final search date for all databases was 31 August 2016.\nSelection criteria\nEligible for inclusion were randomized and cluster randomized controlled trials, as well as several non-randomized study designs, including controlled interrupted time-series studies (cITS-EPOC), interrupted time-series studies adhering to EPOC standards (ITS-EPOC), interrupted time-series studies not adhering to EPOC standards (ITS), controlled before-after studies adhering to EPOC standards (CBA-EPOC), and controlled before-after studies not adhering to EPOC standards (CBA); these were classified as main studies. Additionally, we included uncontrolled before-after studies (UBA) as supporting studies. We included studies that evaluated interventions to reduce ambient air pollution from industrial, residential, vehicular and multiple sources, with respect to their effect on mortality, morbidity and several air pollutant concentrations. We did not restrict studies based on the population, setting or comparison.\nData collection and analysis\nAfter a calibration exercise among the author team, two authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted data extraction, risk of bias assessment and evidence synthesis only for main studies; we mapped supporting studies with regard to the types of intervention and setting. To assess risk of bias, we used the Graphic Appraisal Tool for Epidemiological studies (GATE) for correlation studies, as modified and employed by the Centre for Public Health Excellence at the UK National Institute for Health and Care Excellence (NICE). For each intervention category, i.e. those targeting industrial, residential, vehicular and multiple sources, we synthesized evidence narratively, as well as graphically using harvest plots.\nMain results\nWe included 42 main studies assessing 38 unique interventions. These were heterogeneous with respect to setting; interventions were implemented in countries across the world, but most (79%) were implemented in HICs, with the remaining scattered across LMICs. Most interventions (76%) were implemented in urban or community settings.\nWe identified a heterogeneous mix of interventions, including those aiming to address industrial (n = 5), residential (n = 7), vehicular (n = 22), and multiple sources (n = 4). Some specific interventions, such as low emission zones and stove exchanges, were assessed by several studies, whereas others, such as a wood burning ban, were only assessed by a single study.\nMost studies assessing health and air quality outcomes used routine monitoring data. Studies assessing health outcomes mostly investigated effects in the general population, while few studies assessed specific subgroups such as infants, children and the elderly. No identified studies assessed unintended or adverse effects.\nThe judgements regarding the risk of bias of studies were mixed. Regarding health outcomes, we appraised eight studies (47%) as having no substantial risk of bias concerns, five studies (29%) as having some risk of bias concerns, and four studies (24%) as having serious risk of bias concerns. Regarding air quality outcomes, we judged 11 studies (31%) as having no substantial risk of bias concerns, 16 studies (46%) as having some risk of bias concerns, and eight studies (23%) as having serious risk of bias concerns.\nThe evidence base, comprising non-randomized studies only, was of low or very low certainty for all intervention categories and primary outcomes. The narrative and graphical synthesis showed that evidence for effectiveness was mixed across the four intervention categories. For interventions targeting industrial, residential and multiple sources, a similar pattern emerged for both health and air quality outcomes, with essentially all studies observing either no clear association in either direction or a significant association favouring the intervention. The evidence base for interventions targeting vehicular sources was more heterogeneous, as a small number of studies did observe a significant association favouring the control. Overall, however, the evidence suggests that the assessed interventions do not worsen air quality or health.\nAuthors' conclusions\nGiven the heterogeneity across interventions, outcomes, and methods, it was difficult to derive overall conclusions regarding the effectiveness of interventions in terms of improved air quality or health. Most included studies observed either no significant association in either direction or an association favouring the intervention, with little evidence that the assessed interventions might be harmful. The evidence base highlights the challenges related to establishing a causal relationship between specific air pollution interventions and outcomes. In light of these challenges, the results on effectiveness should be interpreted with caution; it is important to emphasize that lack of evidence of an association is not equivalent to evidence of no association.\nWe identified limited evidence for several world regions, notably Africa, the Middle East, Eastern Europe, Central Asia and Southeast Asia; decision-makers should prioritize the development and implementation of interventions in these settings. In the future, as new policies are introduced, decision-makers should consider a built-in evaluation component, which could facilitate more systematic and comprehensive evaluations. These could assess effectiveness, but also aspects of feasibility, fidelity and acceptability.\nThe production of higher quality and more uniform evidence would be helpful in informing decisions. Researchers should strive to sufficiently account for confounding, assess the impact of methodological decisions through the conduct and communication of sensitivity analyses, and improve the reporting of methods, and other aspects of the study, most importantly the description of the intervention and the context in which it is implemented.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 42 studies evaluating a broad range of measures to reduce air pollution in different countries around the world, although most were from high-income countries. Most aimed to reduce air pollution from cars and other vehicles. However, we also identified measures addressing heating and cooking, industry, or a combination of different sources.\nWe wanted to know whether these measures led to a reduction in the overall number of deaths, and in the number of deaths from cardiovascular and respiratory causes. We also investigated whether the measures led to fewer people going to hospitals for cardiovascular and respiratory problems. We also examined whether there were any changes in outdoor air quality, looking at different pollutants, such as particulate matter, fine particulate matter and other criteria pollutants.\nStudies were very diverse with respect to the policies or programmes they assessed, the settings and contexts in which they were implemented, and the methods used to evaluate them.\nThe evidence we identified was of low and very low certainty, which means we cannot be very confident in the overall findings. Questions around certainty arose because of how studies were designed, conducted and analyzed. While some studies applied rigorous methods, others did not.\nOverall, we observed mixed results across studies. Many studies observed no clear changes in health or air quality associated with the measures, while others did observe clear improvements. We identified very few studies that reported worsened health or air quality associated with the measures."
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query-laysum | 1161 | [
{
"role": "user",
"content": "Abstract: Background\nMany people with chronic disease have more than one chronic condition, which is referred to as multimorbidity. The term comorbidity is also used but this is now taken to mean that there is a defined index condition with other linked conditions, for example diabetes and cardiovascular disease. It is also used when there are combinations of defined conditions that commonly co-exist, for example diabetes and depression. While this is not a new phenomenon, there is greater recognition of its impact and the importance of improving outcomes for individuals affected. Research in the area to date has focused mainly on descriptive epidemiology and impact assessment. There has been limited exploration of the effectiveness of interventions to improve outcomes for people with multimorbidity.\nObjectives\nTo determine the effectiveness of health-service or patient-oriented interventions designed to improve outcomes in people with multimorbidity in primary care and community settings. Multimorbidity was defined as two or more chronic conditions in the same individual.\nSearch methods\nWe searched MEDLINE, EMBASE, CINAHL and seven other databases to 28 September 2015. We also searched grey literature and consulted experts in the field for completed or ongoing studies.\nSelection criteria\nTwo review authors independently screened and selected studies for inclusion. We considered randomised controlled trials (RCTs), non-randomised clinical trials (NRCTs), controlled before-after studies (CBAs), and interrupted time series analyses (ITS) evaluating interventions to improve outcomes for people with multimorbidity in primary care and community settings. Multimorbidity was defined as two or more chronic conditions in the same individual. This includes studies where participants can have combinations of any condition or have combinations of pre-specified common conditions (comorbidity), for example, hypertension and cardiovascular disease. The comparison was usual care as delivered in that setting.\nData collection and analysis\nTwo review authors independently extracted data from the included studies, evaluated study quality, and judged the certainty of the evidence using the GRADE approach. We conducted a meta-analysis of the results where possible and carried out a narrative synthesis for the remainder of the results. We present the results in a 'Summary of findings' table and tabular format to show effect sizes across all outcome types.\nMain results\nWe identified 17 RCTs examining a range of complex interventions for people with multimorbidity. Nine studies focused on defined comorbid conditions with an emphasis on depression, diabetes and cardiovascular disease. The remaining studies focused on multimorbidity, generally in older people. In 11 studies, the predominant intervention element was a change to the organisation of care delivery, usually through case management or enhanced multidisciplinary team work. In six studies, the interventions were predominantly patient-oriented, for example, educational or self-management support-type interventions delivered directly to participants. Overall our confidence in the results regarding the effectiveness of interventions ranged from low to high certainty. There was little or no difference in clinical outcomes (based on moderate certainty evidence). Mental health outcomes improved (based on high certainty evidence) and there were modest reductions in mean depression scores for the comorbidity studies that targeted participants with depression (standardized mean difference (SMD) −0.41, 95% confidence interval (CI) −0.63 to −0.2). There was probably a small improvement in patient-reported outcomes (moderate certainty evidence). The intervention may make little or no difference to health service use (low certainty evidence), may slightly improve medication adherence (low certainty evidence), probably slightly improves patient-related health behaviours (moderate certainty evidence), and probably improves provider behaviour in terms of prescribing behaviour and quality of care (moderate certainty evidence). Cost data were limited.\nAuthors' conclusions\nThis review identifies the emerging evidence to support policy for the management of people with multimorbidity and common comorbidities in primary care and community settings. There are remaining uncertainties about the effectiveness of interventions for people with multimorbidity in general due to the relatively small number of RCTs conducted in this area to date, with mixed findings overall. It is possible that the findings may change with the inclusion of large ongoing well-organised trials in future updates. The results suggest an improvement in health outcomes if interventions can be targeted at risk factors such as depression in people with co-morbidity.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review aimed to identify and summarise the existing evidence on the effectiveness of interventions to improve clinical and mental health outcomes and patient-reported outcomes including health-related quality of life for people with multimorbidity in primary care and community settings."
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query-laysum | 1162 | [
{
"role": "user",
"content": "Abstract: Background\nAnaemia is a condition where the number of red blood cells (and consequently their oxygen-carrying capacity) is insufficient to meet the body's physiological needs. Fortification of wheat flour is deemed a useful strategy to reduce anaemia in populations.\nObjectives\nTo determine the benefits and harms of wheat flour fortification with iron alone or with other vitamins and minerals on anaemia, iron status and health-related outcomes in populations over two years of age.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, 21 other databases and two trials registers up to 21 July 2020, together with contacting key organisations to identify additional studies.\nSelection criteria\nWe included cluster- or individually-randomised controlled trials (RCTs) carried out among the general population from any country, aged two years and above. The interventions were fortification of wheat flour with iron alone or in combination with other micronutrients. We included trials comparing any type of food item prepared from flour fortified with iron of any variety of wheat\nData collection and analysis\nTwo review authors independently screened the search results and assessed the eligibility of studies for inclusion, extracted data from included studies and assessed risks of bias. We followed Cochrane methods in this review.\nMain results\nOur search identified 3538 records, after removing duplicates. We included 10 trials, involving 3319 participants, carried out in Bangladesh, Brazil, India, Kuwait, Philippines, South Africa and Sri Lanka. We identified two ongoing studies and one study is awaiting classification. The duration of interventions varied from 3 to 24 months. One study was carried out among adult women and one trial among both children and nonpregnant women. Most of the included trials were assessed as low or unclear risk of bias for key elements of selection, performance or reporting bias.\nThree trials used 41 mg to 60 mg iron/kg flour, three trials used less than 40 mg iron/kg and three trials used more than 60 mg iron/kg flour. One trial used various iron levels based on type of iron used: 80 mg/kg for electrolytic and reduced iron and 40 mg/kg for ferrous fumarate.\nAll included studies contributed data for the meta-analyses.\nIron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added\nIron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added may reduce by 27% the risk of anaemia in populations (risk ratio (RR) 0.73, 95% confidence interval (CI) 0.55 to 0.97; 5 studies, 2315 participants; low-certainty evidence).\nIt is uncertain whether iron-fortified wheat flour with or without other micronutrients reduces iron deficiency (RR 0.46, 95% CI 0.20 to 1.04; 3 studies, 748 participants; very low-certainty evidence) or increases haemoglobin concentrations (in g/L) (mean difference MD 2.75, 95% CI 0.71 to 4.80; 8 studies, 2831 participants; very low-certainty evidence).\nNo trials reported data on adverse effects in children (including constipation, nausea, vomiting, heartburn or diarrhoea), except for risk of infection or inflammation at the individual level. The intervention probably makes little or no difference to the risk of Infection or inflammation at individual level as measured by C-reactive protein (CRP) (mean difference (MD) 0.04, 95% CI −0.02 to 0.11; 2 studies, 558 participants; moderate-certainty evidence).\nIron-fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added)\nIt is unclear whether wheat flour fortified with iron, in combination with other micronutrients decreases anaemia (RR 0.77, 95% CI 0.41 to 1.46; 2 studies, 317 participants; very low-certainty evidence). The intervention probably reduces the risk of iron deficiency (RR 0.73, 95% CI 0.54 to 0.99; 3 studies, 382 participants; moderate-certainty evidence) and it is unclear whether it increases average haemoglobin concentrations (MD 2.53, 95% CI −0.39 to 5.45; 4 studies, 532 participants; very low-certainty evidence).\nNo trials reported data on adverse effects in children.\nNine out of 10 trials reported sources of funding, with most having multiple sources. Funding source does not appear to have distorted the results in any of the assessed trials.\nAuthors' conclusions\nFortification of wheat flour with iron (in comparison to unfortified flour, or where both groups received the same other micronutrients) may reduce anaemia in the general population above two years of age, but its effects on other outcomes are uncertain.\nIron-fortified wheat flour in combination with other micronutrients, in comparison with unfortified flour, probably reduces iron deficiency, but its effects on other outcomes are uncertain.\nNone of the included trials reported data on adverse side effects except for risk of infection or inflammation at the individual level. The effects of this intervention on other health outcomes are unclear. Future studies at low risk of bias should aim to measure all important outcomes, and to further investigate which variants of fortification, including the role of other micronutrients as well as types of iron fortification, are more effective, and for whom.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": ""
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query-laysum | 1163 | [
{
"role": "user",
"content": "Abstract: Background\nPeripheral regional anaesthesia techniques are well established for postoperative pain treatment following knee surgery. The adductor canal block (ACB) is a new technique, which can be applied as a single shot or by catheter for continuous regional analgesia.\nObjectives\nTo compare the analgesic efficacy and adverse events of ACB versus other regional analgesic techniques or systemic analgesic treatment for adults undergoing knee surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase, five other databases, and one trial register on 19 September 2018; we checked references, searched citations, and contacted study authors to identify additional studies.\nSelection criteria\nWe included all randomized controlled trials (RCTs) comparing single or continuous ACB versus other regional analgesic techniques or systemic analgesic treatment. Inclusion was independent of the technique used (landmarks, peripheral nerve stimulator, or ultrasound) and the level of training of providers.\nData collection and analysis\nWe used Cochrane’s standard methodological procedures. Our primary outcomes were pain intensity at rest and during movement; rate of accidental falls; and rates of opioid-related adverse events. We used GRADE to assess the quality of evidence for primary outcomes.\nMain results\nWe included 25 RCTs (1688 participants) in this review (23 trials combined within meta-analyses). In 18 studies, participants underwent total knee arthroplasty (TKA), whereas seven trials investigated patients undergoing arthroscopic knee surgery. We identified 11 studies awaiting classification and 11 ongoing studies.\nWe investigated the following comparisons.\nACB versus sham treatment\nWe included eight trials for this comparison. We found no significant differences in postoperative pain intensity at rest (2 hours: standardized mean difference (SMD) -0.56, 95% confidence interval (CI) -1.20 to 0.07, 4 trials, 208 participants, low-quality evidence; 24 hours: SMD -0.49, 95% CI -1.05 to 0.07, 6 trials, 272 participants, low-quality evidence) or during movement (2 hours: SMD -0.59, 95% CI -1.5 to 0.33; 3 trials, 160 participants, very low-quality evidence; 24 hours: SMD 0.03, 95% CI -0.26 to 0.32, 4 trials, 184 participants, low-quality evidence). Furthermore, they noted no evidence of a difference in postoperative nausea between groups (24 hours: risk ratio (RR) 1.91, 95% CI 0.48 to 7.58, 3 trials, 121 participants, low-quality evidence). One trial reported that no accidental falls occurred 24 hours postoperatively (low-quality evidence).\nACB versus femoral nerve block\nWe included 15 RCTs for this comparison. We found no evidence of a difference in postoperative pain intensity at rest (2 hours: SMD -0.74, 95% CI -1.76 to 0.28, 5 trials, 298 participants, low-quality evidence; 24 hours: SMD 0.04, 95% CI -0.09 to 0.18, 12 trials, 868 participants, high-quality evidence) or during movement (2 hours: SMD -0.47, 95% CI -1.86 to 0.93, 2 trials, 88 participants, very low-quality evidence; 24 hours: SMD 0.56, 95% CI -0.00 to 1.12, 9 trials, 576 participants, very low-quality evidence). They noted no evidence of a difference in postoperative nausea (24 hours: RR 1.22, 95% CI 0.42 to 3.54, 2 trials, 138 participants, low-quality evidence) and no evidence that the rate of accidental falls during postoperative care was significantly different between groups (24 hours: RR 0.20, 95% CI 0.04 to 1.15, 3 trials, 172 participants, low-quality evidence).\nAuthors' conclusions\nWe are currently uncertain whether patients treated with ACB suffer from lower pain intensity at rest and during movement, fewer opioid-related adverse events, and fewer accidental falls during postoperative care compared to patients receiving sham treatment. The same holds true for the comparison of ACB versus femoral nerve block focusing on postoperative pain intensity. The overall evidence level was mostly low or very low, so further research might change the conclusion. The 11 studies awaiting classification and the 11 ongoing studies, once assessed, may alter the conclusions of this review.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We are uncertain whether patients treated with adductor canal block have lower pain intensity at rest or during movement (e.g. walking) compared with those who received only saline. It is unclear whether rates of adverse events after taking opioids (e.g. nausea) or after accidental falls during postoperative care are lower. It is also uncertain whether patients receiving adductor canal block show different postoperative pain intensity at rest and during movement compared to those treated with femoral nerve block. We noted no differences in adverse events after taking opioids and after accidental falls."
}
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query-laysum | 1164 | [
{
"role": "user",
"content": "Abstract: Background\nIn patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), mortality remains high. These patients require mechanical ventilation, which has been associated with ventilator-induced lung injury. High levels of positive end-expiratory pressure (PEEP) could reduce this condition and improve patient survival. This is an updated version of the review first published in 2013.\nObjectives\nTo assess the benefits and harms of high versus low levels of PEEP in adults with ALI and ARDS.\nSearch methods\nFor our previous review, we searched databases from inception until 2013. For this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, and the Web of Science from inception until May 2020. We also searched for ongoing trials (www.trialscentral.org; www.clinicaltrial.gov; www.controlled-trials.com), and we screened the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials that compared high versus low levels of PEEP in ALI and ARDS participants who were intubated and mechanically ventilated in intensive care for at least 24 hours.\nData collection and analysis\nTwo review authors assessed risk of bias and extracted data independently. We contacted investigators to identify additional published and unpublished studies. We used standard methodological procedures expected by Cochrane.\nMain results\nWe included four new studies (1343 participants) in this review update. In total, we included 10 studies (3851 participants). We found evidence of risk of bias in six studies, and the remaining studies fulfilled all criteria for low risk of bias. In eight studies (3703 participants), a comparison was made between high and low levels of PEEP, with the same tidal volume in both groups. In the remaining two studies (148 participants), the tidal volume was different between high- and low-level groups.\nIn the main analysis, we assessed mortality occurring before hospital discharge only in studies that compared high versus low PEEP, with the same tidal volume in both groups. Evidence suggests that high PEEP may result in little to no difference in mortality compared to low PEEP (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.90 to 1.04; I² = 15%; 7 studies, 3640 participants; moderate-certainty evidence).\nIn addition, high PEEP may result in little to no difference in barotrauma (RR 1.00, 95% CI 0.64 to 1.57; I² = 63%; 9 studies, 3791 participants; low-certainty evidence). High PEEP may improve oxygenation in patients up to the first and third days of mechanical ventilation (first day: mean difference (MD) 51.03, 95% CI 35.86 to 66.20; I² = 85%; 6 studies, 2594 participants; low-certainty evidence; third day: MD 50.32, 95% CI 34.92 to 65.72; I² = 83%; 6 studies, 2309 participants; low-certainty evidence) and probably improves oxygenation up to the seventh day (MD 28.52, 95% CI 20.82 to 36.21; I² = 0%; 5 studies, 1611 participants; moderate-certainty evidence). Evidence suggests that high PEEP results in little to no difference in the number of ventilator-free days (MD 0.45, 95% CI -2.02 to 2.92; I² = 81%; 3 studies, 1654 participants; low-certainty evidence). Available data were insufficient to pool the evidence for length of stay in the intensive care unit.\nAuthors' conclusions\nModerate-certainty evidence shows that high levels compared to low levels of PEEP do not reduce mortality before hospital discharge. Low-certainty evidence suggests that high levels of PEEP result in little to no difference in the risk of barotrauma. Low-certainty evidence also suggests that high levels of PEEP improve oxygenation up to the first and third days of mechanical ventilation, and moderate-certainty evidence indicates that high levels of PEEP improve oxygenation up to the seventh day of mechanical ventilation. As in our previous review, we found clinical heterogeneity - mainly within participant characteristics and methods of titrating PEEP - that does not allow us to draw definitive conclusions regarding the use of high levels of PEEP in patients with ALI and ARDS. Further studies should aim to determine the appropriate method of using high levels of PEEP and the advantages and disadvantages associated with high levels of PEEP in different ARDS and ALI patient populations.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Evidence is current to May 2020. This review has no funding sources. We included 10 studies with 3851 participants (6 from the previous review and 4 from our updated search of the literature). In eight studies (3703 participants), a comparison was made between high and low levels of PEEP, with the same amount of air delivered to the lungs and breathed out (exhaled) with each breath (tidal volume) in each group. The other two studies used different tidal volumes for the two groups and could not be included in all of the review results."
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query-laysum | 1165 | [
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"role": "user",
"content": "Abstract: Background\nLarviciding refers to the regular application of chemical or microbial insecticides to water bodies or water containers to kill the aquatic immature forms of the mosquito (the larvae and pupae).\nObjectives\nTo summarize research evidence evaluating whether larviciding with chemical or microbial insecticides prevents malaria transmission.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; Embase; CAB Abstracts; LILACS; the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); ClinicalTrials.gov; and the ISRCTN registry up to 6 June 2019.\nSelection criteria\nWe included cluster-randomized controlled trials (cRCTs), interrupted time series (ITS), randomized cross-over studies, non-randomized cross-over studies, and controlled before-and-after studies (CBAs) that compared larviciding with no larviciding.\nData collection and analysis\nWe independently assessed trials for eligibility and risk of bias, and extracted data. We assessed the certainty of evidence using the GRADE approach.\nMain results\nFour studies (one cRCT, two CBAs, and one non-randomized cross-over design) met the inclusion criteria. All used ground application of larvicides (people hand-delivering larvicides); one evaluated chemical and three evaluated microbial agents. Studies were carried out in The Gambia, Tanzania, Kenya, and Sri Lanka. Three studies were conducted in areas where mosquito aquatic habitats were less extensive (< 1 km²), and one where habitats were more extensive (> 1 km²; a cross-over study from The Gambia).\nFor aquatic habitats of less than 1 km², one cRCT randomized eight villages in Sri Lanka to evaluate chemical larviciding using insect growth regulator; and two CBA studies undertaken in Kenya and Tanzania evaluated microbial larvicides. In the cRCT, larviciding across all villages was associated with lower malaria incidence (rate ratio 0.24, 4649 participants, low-certainty evidence) and parasite prevalence (risk ratio (RR) 0.26, 5897 participants, low-certainty evidence) compared to no larviciding. The two CBA studies reported lower malaria prevalence during the intervention period (parasite prevalence RR 0.79, 95% confidence interval (CI) 0.71 to 0.89; 70,902 participants; low-certainty evidence). The Kenyan study also reported a reduction in the incidence of new malaria cases (RR 0.62, 95% CI 0.38 to 1.01; 720 participants; very low-certainty evidence).\nFor aquatic habitats of more than 1 km², the non-randomized cross-over trial using microbial larvicides did not detect an effect for malaria incidence (RR 1.58, 95% CI 0.94 to 2.65; 4226 participants), or parasite prevalence (RR 1.15, 95% CI 0.41 to 3.20; 3547 participants); both were very low-certainty evidence. The Gambia trial also reported the mean haemoglobin level, and there was no difference across the four comparisons (mean difference –0.13, 95% CI –0.40 to 0.13; 3586 participants).\nWe were unable to summarize or pool entomological outcomes due to unreported and missing data.\nAuthors' conclusions\nMost controlled studies on larviciding have been performed with microbial agents. Ground larviciding for non-extensive larval habitats may have an effect on malaria transmission, and we do not know if there is an effect in large-scale aquatic habitats. We found no studies using larviciding application techniques that could cover large aquatic habitats, such as aerial spraying using aircraft.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for relevant trials up to 6 June 2019."
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query-laysum | 1166 | [
{
"role": "user",
"content": "Abstract: Background\nSevere coronavirus disease 2019 (COVID-19) can cause thrombotic events that lead to severe complications or death. Antiplatelet agents, such as acetylsalicylic acid, have been shown to effectively reduce thrombotic events in other diseases: they could influence the course of COVID-19 in general.\nObjectives\nTo assess the efficacy and safety of antiplatelets given with standard care compared to no treatment or standard care (with/without placebo) for adults with COVID-19.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (which comprises MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO ICTRP, medRxiv, CENTRAL), Web of Science, WHO COVID-19 Global literature on coronavirus disease and the Epistemonikos COVID-19 L*OVE Platform to identify completed and ongoing studies without language restrictions to December 2022.\nSelection criteria\nWe followed standard Cochrane methodology. We included randomised controlled trials (RCTs) evaluating antiplatelet agents for the treatment of COVID-19 in adults with COVID-19, irrespective of disease severity, gender or ethnicity.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies, we used the Cochrane risk of bias tool (RoB 2) for RCTs. We rated the certainty of evidence using the GRADE approach for the outcomes.\nMain results\nAntiplatelets plus standard care versus standard care (with/without placebo)\nAdults with a confirmed diagnosis of moderate to severe COVID-19\nWe included four studies (17,541 participants) that recruited hospitalised people with a confirmed diagnosis of moderate to severe COVID-19. A total of 8964 participants were analysed in the antiplatelet arm (either with cyclooxygenase inhibitors or P2Y12 inhibitors) and 8577 participants in the control arm. Most people were older than 50 years and had comorbidities such as hypertension, lung disease or diabetes. The studies were conducted in high- to lower middle-income countries prior to wide-scale vaccination programmes.\nAntiplatelets compared to standard care:\n– probably result in little to no difference in 28-day mortality (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.85 to 1.05; 3 studies, 17,249 participants; moderate-certainty evidence). In absolute terms, this means that for every 177 deaths per 1000 people not receiving antiplatelets, there were 168 deaths per 1000 people who did receive the intervention (95% CI 151 to 186 per 1000 people);\n– probably result in little to no difference in worsening (new need for invasive mechanical ventilation or death up to day 28) (RR 0.95, 95% CI 0.90 to 1.01; 2 studies, 15,266 participants; moderate-certainty evidence);\n– probably result in little to no difference in improvement (participants discharged alive up to day 28) (RR 1.00, 95% CI 0.96 to 1.04; 2 studies, 15,454 participants; moderate-certainty evidence);\n– probably result in a slight reduction of thrombotic events at longest follow-up (RR 0.90, 95% CI 0.80 to 1.02; 4 studies, 17,518 participants; moderate-certainty evidence);\n– may result in a slight increase in serious adverse events at longest follow-up (Peto odds ratio (OR) 1.57, 95% CI 0.48 to 5.14; 1 study, 1815 participants; low-certainty evidence), but non-serious adverse events during study treatment were not reported;\n– probably increase the occurrence of major bleeding events at longest follow-up (Peto OR 1.68, 95% CI 1.29 to 2.19; 4 studies, 17,527 participants; moderate-certainty evidence).\nAdults with a confirmed diagnosis of asymptomatic SARS-CoV-2 infection or mild COVID-19\nWe included two RCTs allocating participants, of whom 4209 had confirmed mild COVID-19 and were not hospitalised. A total of 2109 participants were analysed in the antiplatelet arm (treated with acetylsalicylic acid) and 2100 participants in the control arm. No study included people with asymptomatic SARS-CoV-2 infection.\nAntiplatelets compared to standard care:\n– may result in little to no difference in all-cause mortality at day 45 (Peto OR 1.00, 95% CI 0.45 to 2.22; 2 studies, 4209 participants; low-certainty evidence);\n– may slightly decrease the incidence of new thrombotic events up to day 45 (Peto OR 0.37, 95% CI 0.09 to 1.46; 2 studies, 4209 participants; low-certainty evidence);\n– may make little or no difference to the incidence of serious adverse events up to day 45 (Peto OR 1.00, 95% CI 0.60 to 1.64; 1 study, 3881 participants; low-certainty evidence), but non-serious adverse events were not reported.\nThe evidence is very uncertain about the effect of antiplatelets on the following outcomes (compared to standard care plus placebo):\n– admission to hospital or death up to day 45 (Peto OR 0.79, 95% CI 0.57 to 1.10; 2 studies, 4209 participants; very low-certainty evidence);\n– major bleeding events up to longest follow-up (no event occurred in 328 participants; very low-certainty evidence).\nQuality of life and adverse events during study treatment were not reported.\nAuthors' conclusions\nIn people with confirmed or suspected COVID-19 and moderate to severe disease, we found moderate-certainty evidence that antiplatelets probably result in little to no difference in 28-day mortality, clinical worsening or improvement, but probably result in a slight reduction in thrombotic events. They probably increase the occurrence of major bleeding events. Low-certainty evidence suggests that antiplatelets may result in a slight increase in serious adverse events.\nIn people with confirmed COVID-19 and mild symptoms, we found low-certainty evidence that antiplatelets may result in little to no difference in 45-day mortality and serious adverse events, and may slightly reduce thrombotic events. The effects on the combined outcome admission to hospital or death up to day 45 and major bleeding events are very uncertain. Quality of life was not reported.\nIncluded studies were conducted in high- to lower middle-income settings using antiplatelets prior to vaccination roll-outs.\nWe identified a lack of evidence concerning quality of life assessments, adverse events and people with asymptomatic infection. The 14 ongoing and three completed, unpublished RCTs that we identified in trial registries address similar settings and research questions as in the current body of evidence. We expect to incorporate the findings of these studies in future versions of this review.\n\nGiven the provided abstract, please respond to the following query: \"What are antiplatelets?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Antiplatelets are a group of drugs which, in different ways, stop blood from changing to a gel-like substance called a clot, which we mean by the term 'thrombotic events'. They are taken mainly by mouth, usually by people who are at high risk of developing a clot (people who have already experienced or who tend to build up a clot).\nA clot could lead to a stroke, coronary heart disease, poor blood circulation in the legs, thromboses in the legs or clot obstruction ('embolism') in the lung circulation that could lead to shortness of breath, heart failure and death."
}
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query-laysum | 1167 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a previous Cochrane Review, last updated in 2014. Ovarian cancer is the eighth most common cancer and seventh most common cause of death due to cancer in women worldwide. Traditionally, most women who have been treated for cancer undergo long-term follow-up in secondary care. However, it has been suggested that the use of routine review may not be effective in improving survival, or health-related quality of life (HRQOL), or relieving anxiety. In addition, traditional follow-up may not be cost-effective.\nObjectives\nTo compare the potential effects of different strategies of follow-up in women with epithelial ovarian cancer, following completion of primary treatment.\nSearch methods\nFor this update, we searched the Cochrane Gynaecological Cancer Group Trials Register, CENTRAL 2022, Issue 11, MEDLINE, and Embase from August 2013 to November 2022. We also searched review articles and contacted experts in the field.\nSelection criteria\nAll randomised controlled trials (RCTs) that evaluated follow-up strategies for women with epithelial ovarian cancer following completion of primary treatment.\nData collection and analysis\nWe followed standard Cochrane methodology. Two review authors independently selected potentially relevant trials, extracted data, and assessed risk of bias. They compared results, and resolved disagreements by discussion. We assessed the certainty of evidence, using the GRADE approach, for the outcomes of interest: overall survival (OS), health-related quality of life (HRQOL), psychological effects, and cost analysis.\nMain results\nFor this update, we included one new RCT, including 112 women with ovarian, fallopian tube, or peritoneal cancer, who had completed primary treatment by surgery, with or without chemotherapy. This study reported the effect of individualised, i.e. individually tailored, nurse-led follow-up versus conventional medical follow-up on HRQOL, psychological outcomes, and cost-analysis.\nIndividualised follow-up improved HRQOL in one of the two scales, with a decrease in mean difference (MD) in the QLQ-C30 discomfort scale following 12 months of individualised treatment compared to 12 months of conventional treatment (MD -5.76 points, 95% confidence interval (CI) -10.92 to -0.60; 1 study, 112 participants; low-certainty evidence; minimal important difference 4 to 10 points). There may be little or no difference in the other HRQOL scale (QLQ-Ov28, MD -0.97 points, 95% CI -2.57 to 0.63; 1 study, 112 participants: low-certainty evidence); psychological outcome, measured with the hospital anxiety and depression scale (HADS; MD 0.10 point, 95% CI -0.81 to 1.02; 1 study, 112 participants: low-certainty evidence), or cost analysis (MD -GBP 695.00, 95% CI -1467.23 to 77.23; 1 study, 112 participants: moderate-certainty evidence).\nOur previous review included one RCT, with 529 women in a confirmed remission, with normal CA125 concentration and no radiological evidence of disease, after surgery and first-line chemotherapy for ovarian cancer. This study evaluated immediate treatment of ovarian cancer relapse following a rise of serum CA125 levels versus delaying treatment until symptoms developed for OS, and HRQOL.\nThere was little or no difference in OS between the immediate and delayed arms after a median follow-up of 56.9 months (unadjusted hazard ratio (HR) 0.98, 95% CI 0.80 to 1.20; 1 study, 529 participants; moderate-certainty evidence). Time from randomisation to first deterioration in global health score or death was shorter in the immediate treatment group than in the delayed treatment group (HR 0.71, 95% CI 0.58 to 0.88).\nAuthors' conclusions\nLimited evidence from one trial suggests that routine surveillance with CA125 in asymptomatic women and treatment at CA125-defined relapse does not seem to offer survival advantage when compared to treatment at symptomatic relapse. However, this study pre-dates the use of PARPi maintenance treatment and the increased use of secondary cytoreductive surgery, so the results may be limited in their applicability to current practice.\nLimited evidence from one trial suggests that individualised nurse-led follow-up may improve HRQOL in women with ovarian cancer following completion of primary treatment.\nLarge RCTs are needed to compare different types of follow-up, looking at survival, HRQOL, psychological effects, and cost as outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature for studies that evaluated different types of follow-up for women who had undergone treatment for ovarian cancer. We assessed their limitations, summarised their results, and assessed how certain we were in the evidence for: overall survival, health-related quality of life, psychological effects (for example, anxiety, depression), and cost-effectiveness."
}
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query-laysum | 1168 | [
{
"role": "user",
"content": "Abstract: Background\nThis review represents one from a family of three reviews focusing on interventions for drug-using offenders. Many people under the care of the criminal justice system have co-occurring mental health problems and drug misuse problems; it is important to identify the most effective treatments for this vulnerable population.\nObjectives\nTo assess the effectiveness of interventions for drug-using offenders with co-occurring mental health problems in reducing criminal activity or drug use, or both.\nThis review addresses the following questions.\n• Does any treatment for drug-using offenders with co-occurring mental health problems reduce drug use?\n• Does any treatment for drug-using offenders with co-occurring mental health problems reduce criminal activity?\n• Does the treatment setting (court, community, prison/secure establishment) affect intervention outcome(s)?\n• Does the type of treatment affect treatment outcome(s)?\nSearch methods\nWe searched 12 databases up to February 2019 and checked the reference lists of included studies. We contacted experts in the field for further information.\nSelection criteria\nWe included randomised controlled trials designed to prevent relapse of drug use and/or criminal activity among drug-using offenders with co-occurring mental health problems.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane .\nMain results\nWe included 13 studies with a total of 2606 participants. Interventions were delivered in prison (eight studies; 61%), in court (two studies; 15%), in the community (two studies; 15%), or at a medium secure hospital (one study; 8%). Main sources of bias were unclear risk of selection bias and high risk of detection bias.\nFour studies compared a therapeutic community intervention versus (1) treatment as usual (two studies; 266 participants), providing moderate-certainty evidence that participants who received the intervention were less likely to be involved in subsequent criminal activity (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.53 to 0.84) or returned to prison (RR 0.40, 95% CI 0.24 to 0.67); (2) a cognitive-behavioural therapy (one study; 314 participants), reporting no significant reduction in self-reported drug use (RR 0.78, 95% CI 0.46 to 1.32), re-arrest for any type of crime (RR 0.69, 95% CI 0.44 to 1.09), criminal activity (RR 0.74, 95% CI 0.52 to 1.05), or drug-related crime (RR 0.87, 95% CI 0.56 to 1.36), yielding low-certainty evidence; and (3) a waiting list control (one study; 478 participants), showing a significant reduction in return to prison for those people engaging in the therapeutic community (RR 0.60, 95% CI 0.46 to 0.79), providing moderate-certainty evidence.\nOne study (235 participants) compared a mental health treatment court with an assertive case management model versus treatment as usual, showing no significant reduction at 12 months' follow-up on an Addictive Severity Index (ASI) self-report of drug use (mean difference (MD) 0.00, 95% CI -0.03 to 0.03), conviction for a new crime (RR 1.05, 95% CI 0.90 to 1.22), or re-incarceration to jail (RR 0.79, 95% CI 0.62 to 1.01), providing low-certainty evidence.\nFour studies compared motivational interviewing/mindfulness and cognitive skills with relaxation therapy (one study), a waiting list control (one study), or treatment as usual (two studies). In comparison to relaxation training, one study reported narrative information on marijuana use at three-month follow-up assessment. Researchers reported a main effect < .007 with participants in the motivational interviewing group, showing fewer problems than participants in the relaxation training group, with moderate-certainty evidence. In comparison to a waiting list control, one study reported no significant reduction in self-reported drug use based on the ASI (MD -0.04, 95% CI -0.37 to 0.29) and on abstinence from drug use (RR 2.89, 95% CI 0.73 to 11.43), presenting low-certainty evidence at six months (31 participants). In comparison to treatment as usual, two studies (with 40 participants) found no significant reduction in frequency of marijuana use at three months post release (MD -1.05, 95% CI -2.39 to 0.29) nor time to first arrest (MD 0.87, 95% CI -0.12 to 1.86), along with a small reduction in frequency of re-arrest (MD -0.66, 95% CI -1.31 to -0.01) up to 36 months, yielding low-certainty evidence; the other study with 80 participants found no significant reduction in positive drug screens at 12 months (MD -0.7, 95% CI -3.5 to 2.1), providing very low-certainty evidence.\nTwo studies reported on the use of multi-systemic therapy involving juveniles and families versus treatment as usual and adolescent substance abuse therapy. In comparing treatment as usual, researchers found no significant reduction up to seven months in drug dependence on the Drug Use Disorders Identification Test (DUDIT) score (MD -0.22, 95% CI -2.51 to 2.07) nor in arrests (RR 0.97, 95% CI 0.70 to 1.36), providing low-certainty evidence (156 participants). In comparison to an adolescent substance abuse therapy, one study (112 participants) found significant reduction in re-arrests up to 24 months (MD 0.24, 95% CI 0.76 to 0.28), based on low-certainty evidence.\nOne study (38 participants) reported on the use of interpersonal psychotherapy in comparison to a psychoeducational intervention. Investigators found no significant reduction in self-reported drug use at three months (RR 0.67, 95% CI 0.30 to 1.50), providing very low-certainty evidence. The final study (29 participants) compared legal defence service and wrap-around social work services versus legal defence service only and found no significant reductions in the number of new offences committed at 12 months (RR 0.64, 95% CI 0.07 to 6.01), yielding very low-certainty evidence.\nAuthors' conclusions\nTherapeutic community interventions and mental health treatment courts may help people to reduce subsequent drug use and/or criminal activity. For other interventions such as interpersonal psychotherapy, multi-systemic therapy, legal defence wrap-around services, and motivational interviewing, the evidence is more uncertain. Studies showed a high degree of variation, warranting a degree of caution in interpreting the magnitude of effect and the direction of benefit for treatment outcomes.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "February 2019."
}
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query-laysum | 1169 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants and neonates with respiratory conditions commonly require intubation and conventional mechanical ventilation (CMV) to maintain airway patency and support their respiration. Whilst this therapy is often lifesaving, it simultaneously carries the risk of lung injury. The use of lung recruitment manoeuvres (LRMs) has been found to reduce the incidence of lung injury, and improve oxygenation and lung compliance in ventilated adults. However, evidence pertaining to their use in neonates is limited, and there is no consensus of opinion as to whether LRMs are appropriate or effective in this population.\nObjectives\nTo determine the effects of LRMs on mortality and respiratory outcomes in mechanically ventilated neonates, when compared to no recruitment (routine care).\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to 13 April 2020), and CINAHL via EBSCOhost (1989 to 13 April 2020). We also handsearched the reference lists of retrieved studies to source additional articles.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and randomised cross-over studies that compared the effect of LRMs to no recruitment (routine care) in mechanically ventilated neonates.\nData collection and analysis\nTwo review authors independently assessed trial eligibility, extracted data and evaluated risk of bias in the included studies. When studies were sufficiently similar, we performed a meta-analysis using mean difference (MD) for continuous data and risk ratio (RR) for dichotomous data, with their respective 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of the evidence for key (clinically important) outcomes.\nMain results\nWe included four studies (152 participants in total) in this review. Three of these studies, enrolling 56 participants, contributed data to our prespecified outcomes.\nTwo studies enrolling 44 participants on CMV for respiratory distress syndrome compared a stepwise LRM with positive end-expiratory pressure (PEEP) to routine care. Meta-analysis demonstrated no evidence of a difference between the LRM and routine care on mortality by hospital discharge (RR 1.00, 95% CI 0.17 to 5.77; low-certainty evidence), incidence of bronchopulmonary dysplasia (RR 0.25, 95% CI 0.03 to 2.07; low-certainty evidence), duration of supplemental oxygen (MD -7.52 days, 95% CI -20.83 to 5.78; very low-certainty evidence), and duration of ventilatory support (MD -3.59 days, 95% CI -12.97 to 5.79; very low-certainty evidence). The certainty of the evidence for these outcomes was downgraded due to risk of bias, imprecision, and inconsistency. Whilst these studies contributed data to four of our primary outcomes, we were unable to identify any studies that reported our other primary outcomes: duration of continuous positive airway pressure therapy, duration of neonatal intensive care unit stay, and duration of hospital stay.\nThe third study that contributed data to the review enrolled 12 participants on CMV for respiratory and non-respiratory causes, and compared two different LRMs applied after endotracheal tube suctioning to routine care. It was determined that both LRMs may slightly improve end-expiratory lung volume at 120 minutes' post-suctioning, when compared to routine care (incremental PEEP LRM versus routine care: MD -0.21, 95% CI -0.37 to -0.06; double PEEP LRM versus routine care: MD -0.18, 95% CI -0.35 to -0.02). It was also demonstrated that a double PEEP LRM may slightly reduce mean arterial pressure at 30 minutes' post-suctioning, when compared with routine care (MD -16.00, 95% CI -29.35 to -2.65).\nAuthors' conclusions\nThere is insufficient evidence to guide the use of LRMs in mechanically ventilated neonates. Well-designed randomised trials with larger sample sizes are needed to further evaluate the potential benefits and risks of LRM application in this population.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of the evidence for these results was low to very low as the included studies were small and vulnerable to bias from limitations in their methods. Evidence-based guidance for the use of LRMs in mechanically ventilated neonates continues to be limited. Our review should raise awareness of the lack of high-certainty evidence in this field and encourage further research. Additional research would be valuable given our findings of possible but uncertain benefit with LRMs in mechanically ventilated neonates."
}
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query-laysum | 1170 | [
{
"role": "user",
"content": "Abstract: Background\nAbdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. Therefore, it is critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft is introduced to the aneurysm in this way. This Cochrane Review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. However, the technique may be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the previous Cochrane Review published in 2017.\nObjectives\nTo evaluate the benefits and harms of totally percutaneous access compared to cut-down femoral artery access in people undergoing elective bifurcated abdominal endovascular aneurysm repair (EVAR).\nSearch methods\nWe used standard, extensive Cochrane search methods The latest search was 8 April 2022.\nSelection criteria\nWe included randomised controlled trials in people diagnosed with an AAA comparing totally percutaneous versus surgical cut-down access endovascular repair. We considered all device types. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for ruptured AAAs and those reporting aorto-uni-iliac repairs.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. short-term mortality, 2. failure of aneurysm exclusion and 3. wound infection. Secondary outcomes were 4. major complications (30-day or in-hospital); 5. medium- to long-term (6 and 12 months) complications and mortality; 6. bleeding complications and haematoma; and 7. operating time, duration of intensive treatment unit (ITU) stay and hospital stay. We used GRADE to assess the certainty of evidence for the seven most clinically relevant primary and secondary outcomes.\nMain results\nThree studies with 318 participants met the inclusion criteria, 189 undergoing the percutaneous technique and 129 treated by cut-down femoral artery access. One study had a small sample size and did not adequately report the method of randomisation, allocation concealment or preselected outcomes. The other two larger studies had few sources of bias and good methodology; although one study had a high risk of bias in selective reporting.\nWe observed no clear difference in short-term mortality between groups, with only one death occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.06 to 36.18; 2 studies, 181 participants; low-certainty evidence). One study reported failure of aneurysm exclusion. There was one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 1 study, 151 participants; moderate-certainty evidence). For wound infection, there was no clear difference between groups (RR 0.18, 95% CI 0.01 to 3.59; 3 studies, 318 participants; moderate-certainty evidence).\nThere was no clear difference between percutaneous and cut-down femoral artery access groups in major complications (RR 1.21, 95% CI 0.61 to 2.41; 3 studies, 318 participants; moderate-certainty evidence), bleeding complications (RR 1.02, 95% CI 0.29 to 3.64; 2 studies, 181 participants; moderate-certainty evidence) or haematoma (RR 0.88, 95% CI 0.13 to 6.05; 2 studies, 288 participants).\nOne study reported medium- to long-term complications at six months, with no clear differences between the percutaneous and cut-down femoral artery access groups (RR 0.82, 95% CI 0.25 to 2.65; 1 study, 135 participants; moderate-certainty evidence).\nWe detected differences in operating time, with the percutaneous approach being faster than cut-down femoral artery access (mean difference (MD) −21.13 minutes, 95% CI −41.74 to −0.53 minutes; 3 studies, 318 participants; low-certainty evidence). One study reported the duration of ITU stay and hospital stay, with no clear difference between groups.\nAuthors' conclusions\nSkin puncture may make little to no difference to short-term mortality. There is probably little or no difference in failure of aneurysm exclusion (failure to seal the aneurysms), wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications between the two groups. Compared with exposing the femoral artery, skin puncture may reduce the operating time slightly. We downgraded the certainty of the evidence to moderate and low as a result of imprecision due to the small number of participants, low event rates and wide CIs, and inconsistency due to clinical heterogeneity. As the number of included studies was limited, further research into this technique would be beneficial.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that included people with abdominal aortic aneurysms who were treated with minimally invasive repairs. These studies randomly selected participants to receive the minimally invasive repairs by skin puncture or exposing the femoral artery. We compared and summarised their results and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
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query-laysum | 1171 | [
{
"role": "user",
"content": "Abstract: Background\nZinc deficiency is prevalent in low- and middle-income countries, and is considered a significant risk factor for morbidity, mortality, and linear growth failure. The effectiveness of preventive zinc supplementation in reducing prevalence of zinc deficiency needs to be assessed.\nObjectives\nTo assess the effects of zinc supplementation for preventing mortality and morbidity, and for promoting growth, in children aged 6 months to 12 years.\nSearch methods\nA previous version of this review was published in 2014. In this update, we searched CENTRAL, MEDLINE, Embase, five other databases, and one trials register up to February 2022, together with reference checking and contact with study authors to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs) of preventive zinc supplementation in children aged 6 months to 12 years compared with no intervention, a placebo, or a waiting list control. We excluded hospitalized children and children with chronic diseases or conditions. We excluded food fortification or intake, sprinkles, and therapeutic interventions.\nData collection and analysis\nTwo review authors screened studies, extracted data, and assessed the risk of bias. We contacted study authors for missing information and used GRADE to assess the certainty of evidence. The primary outcomes of this review were all-cause mortality; and cause-specific mortality, due to all-cause diarrhea, lower respiratory tract infection (LRTI, including pneumonia), and malaria. We also collected information on a number of secondary outcomes, such as those related to diarrhea and LRTI morbidity, growth outcomes and serum levels of micronutrients, and adverse events.\nMain results\nWe included 16 new studies in this review, resulting in a total of 96 RCTs with 219,584 eligible participants. The included studies were conducted in 34 countries; 87 of them in low- or middle-income countries. Most of the children included in this review were under five years of age. The intervention was delivered most commonly in the form of syrup as zinc sulfate, and the most common dose was between 10 mg and 15 mg daily. The median duration of follow-up was 26 weeks. We did not consider that the evidence for the key analyses of morbidity and mortality outcomes was affected by risk of bias.\nHigh-certainty evidence showed little to no difference in all-cause mortality with preventive zinc supplementation compared to no zinc (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.84 to 1.03; 16 studies, 17 comparisons, 143,474 participants).\nModerate-certainty evidence showed that preventive zinc supplementation compared to no zinc likely results in little to no difference in mortality due to all-cause diarrhea (RR 0.95, 95% CI 0.69 to 1.31; 4 studies, 132,321 participants); but probably reduces mortality due to LRTI (RR 0.86, 95% CI 0.64 to 1.15; 3 studies, 132,063 participants) and mortality due to malaria (RR 0.90, 95% CI 0.77 to 1.06; 2 studies, 42,818 participants); however, the confidence intervals around the summary estimates for these outcomes were wide, and we could not rule out a possibility of increased risk of mortality.\nPreventive zinc supplementation likely reduces the incidence of all-cause diarrhea (RR 0.91, 95% CI 0.90 to 0.93; 39 studies, 19,468 participants; moderate-certainty evidence) but results in little to no difference in morbidity due to LRTI (RR 1.01, 95% CI 0.95 to 1.08; 19 studies, 10,555 participants; high-certainty evidence) compared to no zinc.\nThere was moderate-certainty evidence that preventive zinc supplementation likely leads to a slight increase in height (standardized mean difference (SMD) 0.12, 95% CI 0.09 to 0.14; 74 studies, 20,720 participants).\nZinc supplementation was associated with an increase in the number of participants with at least one vomiting episode (RR 1.29, 95% CI 1.14 to 1.46; 5 studies, 35,192 participants; high-certainty evidence). We report a number of other outcomes, including the effect of zinc supplementation on weight and serum markers such as zinc, hemoglobin, iron, copper, etc. We also performed a number of subgroup analyses and there was a consistent finding for a number of outcomes that co-supplementation of zinc with iron decreased the beneficial effect of zinc.\nAuthors' conclusions\nEven though we included 16 new studies in this update, the overall conclusions of the review remain unchanged. Zinc supplementation might help prevent episodes of diarrhea and improve growth slightly, particularly in children aged 6 months to 12 years of age. The benefits of preventive zinc supplementation may outweigh the harms in regions where the risk of zinc deficiency is relatively high.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review updates a previous version published in 2014. The evidence is current to February 2022."
}
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query-laysum | 1172 | [
{
"role": "user",
"content": "Abstract: Background\nAcute pulmonary embolism (PE) is a common cause of death, accounting for 50,000 to 200,000 deaths annually. It is the third most common cause of mortality among the cardiovascular diseases, after coronary artery disease and stroke. The advent of multi-detector computed tomographic pulmonary angiography (CTPA) has allowed better assessment of PE regarding visualisation of the peripheral pulmonary arteries, increasing its rate of diagnosis. More cases of peripheral PEs, such as isolated subsegmental PE (SSPE) and incidental PE, have thereby been identified. These two conditions are usually found in patients with few or none of the classic PE symptoms such as haemoptysis or pleuritic pain, acute dyspnoea or circulatory collapse. However, in patients with reduced cardiopulmonary reserve, classic PE symptoms can be found with isolated SSPEs. Incidental SSPE is found casually in asymptomatic patients, usually by diagnostic imaging performed for other reasons (for example routine CT for cancer staging in oncology patients). Traditionally, all PEs are anticoagulated in a similar manner independent of their location, or number and size of the thrombi. It has been suggested that many patients with SSPE may be treated without benefit, increasing adverse events by a possible unnecessary use of anticoagulants. Patients with isolated SSPE, or incidental PE, may have a more benign clinical presentation compared to those with proximal PEs. However, the clinical significance in patients, and their prognosis, needs to be studied to evaluate whether anticoagulation therapy is required. This is the second update of the Cochrane systematic review published in 2014.\nObjectives\nTo assess the effectiveness and safety of anticoagulation therapy versus control in patients with isolated subsegmental pulmonary embolism (SSPE) or incidental SSPE.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 26 November 2019. We also undertook reference checking to identify additional studies.\nSelection criteria\nWe included randomised controlled trials of anticoagulation therapy versus control in patients with SSPE or incidental SSPE.\nData collection and analysis\nTwo review authors inspected all citations identified to ensure reliable assessment. If relevant studies were identified, we planned for two review authors to independently extract data and to assess the methodological quality of identified trials using the criteria recommended in the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe did not identify any studies that met the inclusion criteria.\nAuthors' conclusions\nThere is no evidence from randomised controlled trials to assess the effectiveness and safety of anticoagulation therapy versus control in patients with isolated subsegmental pulmonary embolism (SSPE) or incidental SSPE. Well-conducted research is required before informed practice decisions can be made.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute pulmonary embolism (PE) is a common cause of death, accounting for 50,000 to 200,000 deaths annually. It is the third most common cause of mortality among the cardiovascular diseases, after coronary artery disease and stroke. The advent of multi-detector computed tomographic pulmonary angiography (CTPA) has allowed better assessment of PE regarding visualisation of the peripheral pulmonary arteries, increasing its rate of diagnosis. More cases of peripheral PEs, such as isolated subsegmental PE (SSPE) and incidental PE, have thereby been identified. These two conditions are usually found in patients with few or no classic symptoms such as coughing (including coughing up blood), chest or upper back pain, acute shortness of breath, or general or specific failure of the circulation that is either cardiac or peripheral in nature. However, in patients with an impaired cardiac and pulmonary condition the classic PE symptoms can be found with isolated SSPEs. Incidental SSPE is found casually in asymptomatic patients, usually by diagnostic imaging performed for other reasons (for example routine computed tomography (CT) for cancer staging in oncologic patients). Patients with isolated SSPE or incidental PE may have a more benign clinical presentation compared to those with proximal PEs. However, the clinical significance and prognosis in these patients has to be studied to evaluate whether anticoagulation therapy is required."
}
]
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query-laysum | 1173 | [
{
"role": "user",
"content": "Abstract: Background\nNon-steroidal antiandrogens and castration are the main therapy options for advanced stages of prostate cancer. However, debate regarding the value of these treatment options continues.\nObjectives\nTo assess the effects of non-steroidal antiandrogen monotherapy compared with luteinising hormone–releasing hormone agonists or surgical castration monotherapy for treating advanced stages of prostate cancer.\nSearch methods\nWe searched the Cochrane Prostatic Diseases and Urologic Cancers Group Specialized Register (PROSTATE), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science with Conference Proceedings, three trial registries and abstracts from three major conferences to 23 December 2013, together with reference lists, and contacted selected experts in the field and manufacturers.\nSelection criteria\nWe included randomised controlled trials comparing non-steroidal antiandrogen monotherapy with medical or surgical castration monotherapy for men in advanced stages of prostate cancer.\nData collection and analysis\nOne review author screened all titles and abstracts; only citations that were clearly irrelevant were excluded at this stage. Then, two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, assessed trial quality and extracted data. We contacted the study authors to request additional information. We used Review Manager 5 for data synthesis and used the fixed-effect model for heterogeneity less than 50%; we used the random-effects model for substantial or considerable heterogeneity.\nMain results\nEleven studies involving 3060 randomly assigned participants were included in this review. The quality of evidence is hampered by risk of bias. Use of non-steroidal antiandrogens decreased overall survival (hazard ratio (HR) 1.24, 95% confidence interval (CI) 1.05 to 1.48, six studies, 2712 participants) and increased clinical progression (one year: risk ratio (RR) 1.25, 95% CI 1.08 to 1.45, five studies, 2067 participants; 70 weeks: RR 1.26, 95% CI 1.08 to 1.45, six studies, 2373 participants; two years: RR 1.14, 95% CI 1.04 to 1.25, three studies, 1336 participants), as well as treatment failure (one year: RR 1.19, 95% CI 1.02 to 1.38, four studies, 1539 participants; 70 weeks: RR 1.27, 95% CI 1.05 to 1.52, five studies, 1845 participants; two years: RR 1.14, 95% CI 1.05 to 1.24, two studies, 808 participants), compared with medical or surgical castration. The quality of evidence for overall survival, clinical progression and treatment failure was rated as moderate according to GRADE. Predefined subgroup analyses showed that use of non-steroidal antiandrogens, compared with castration, was less favourable for overall survival, clinical progression (at one year, 70 weeks, two years) and treatment failure (at one year, 70 weeks, two years) in men with metastatic disease. Use of non-steroidal antiandrogens also increased the risk for treatment discontinuation due to adverse events (RR 1.82, 95% CI 1.13 to 2.94, eight studies, 1559 participants), including events such as breast pain (RR 22.97, 95% CI 14.79 to 35.67, eight studies, 2670 participants), gynaecomastia (RR 8.43, 95% CI 3.19 to 22.28, nine studies, 2774 participants) and asthenia (RR 1.77, 95% CI 1.36 to 2.31, five studies, 2073 participants). The risk of other adverse events, such as hot flashes (RR 0.23, 95% CI 0.19 to 0.27, nine studies, 2774 participants), haemorrhage (RR 0.07, 95% CI 0.01 to 0.54, two studies, 546 participants), nocturia (RR 0.38, 95% CI 0.20 to 0.69, one study, 480 participants), fatigue (RR 0.52, 95% CI 0.31 to 0.88, one study, 51 participants), loss of sexual interest (RR 0.50, 95% CI 0.30 to 0.83, one study, 51 participants) and urinary frequency (RR 0.22, 95% CI 0.11 to 0.47, one study, 480 participants) was decreased when non-steroidal antiandrogens were used. The quality of evidence for breast pain, gynaecomastia and hot flashes was rated as moderate according to GRADE. The effects of non-steroidal antiandrogens on cancer-specific survival and biochemical progression remained unclear.\nAuthors' conclusions\nCurrently available evidence suggests that use of non-steroidal antiandrogen monotherapy compared with medical or surgical castration monotherapy for advanced prostate cancer is less effective in terms of overall survival, clinical progression, treatment failure and treatment discontinuation due to adverse events. Evidence quality was rated as moderate according to GRADE. Further research is likely to have an important impact on results for patients with advanced but non-metastatic prostate cancer treated with non-steroidal antiandrogen monotherapy. However, we believe that research is likely not necessary on non-steroidal antiandrogen monotherapy for men with metastatic prostate cancer. Only high-quality, randomised controlled trials with long-term follow-up should be conducted. If further research is planned to investigate biochemical progression, studies with standardised follow-up schedules using measurements of prostate-specific antigen based on current guidelines should be conducted.\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": "Use of non-steroidal antiandrogens decreased overall survival and increased clinical progression and treatment failure. Subgroup analyses showed that non-steroidal antiandrogens, compared with castration, were less favourable for overall survival, for clinical progression and for treatment failure in men with metastatic disease. Participants receiving antiandrogens were also more likely to stop treatment as the result of side effects. The risk of suffering breast pain, enlargement of breast tissue or symptoms of physical weakness was also increased with non-steroidal antiandrogens. The risks of feeling intense heat with sweating and rapid heartbeat and of bleeding, the need to get up in the night to urinate, loss of sexual interest, extreme tiredness and the need to urinate more often than usual were increased with castration. No difference was noted for other side effects. The effect of non-steroidal antiandrogens on cancer-specific survival and biochemical progression remained unclear."
}
]
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query-laysum | 1174 | [
{
"role": "user",
"content": "Abstract: Background\nWhilst carrying out dental procedures under general anaesthesia (GA), practitioners routinely give local anaesthetics (LA) intraoperatively to children. Local anaesthetics are used to help manage postoperative pain and reduce bleeding and the physiological response to procedures. Studies of effectiveness of intraoperative LA to date have reported contradictory results.\nObjectives\nTo assess the effects of intraoperative local anaesthesia for reducing postoperative pain following general anaesthesia for dental treatment in children and young people aged 17 years or younger.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2013, Issue 12), MEDLINE via OVID (1946 to 02 January 2014), EMBASE via OVID (1980 to 02 January 2014) and Web of Science Conference Proceedings (1990 to 02 January 2014). We searched for ongoing trials in the US National Institutes of Health Register, the metaRegister of Controlled Trials (mRCT) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Clinical Trials Portal. We did not place any restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials in which local anaesthetic was given intraoperatively under general anaesthesia for dental treatment of children and young people aged 17 years or younger.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. We performed data extraction and assessment of risk of bias independently and in duplicate. We contacted authors to clarify omissions in trial reports. In the 'Summary of findings' tables, we elected to report the outcomes pain, distress, postoperative bleeding, and physiological parameters related to the general anaesthetic, as we considered these to be the outcomes of greatest importance to readers of the review.\nMain results\nWe included 14 trials in this review, with 1152 randomised participants. The studies were published between 1990 and 2009 and were conducted in the United Kingdom, Egypt, Saudi Arabia, and the United States. The age of participants ranged from 2 to 40 years. Three studies were at an overall high risk of bias, seven studies were at an unclear risk of bias, and we judged four studies to be at low risk of bias.\nThe clinical heterogeneity of the included studies precluded pooling of studies in terms of method of administration of LA (e.g., intraligamental injection, infiltration injection, or topical delivery) and variation in the use of supplementary analgesics and follow-up time.\nOf the seven studies where administration of LA was by infiltration injection, six studies (very low-quality body of evidence, 542 participants analysed, 1 study had overall high risk of bias, 4 studies had overall unclear risk of bias, 1 study had overall low risk of bias) measured postoperative pain. The results were equivocal. There was a decrease in bleeding and increase in soft tissue damage in the LA groups, but we did not judge this to be clinically significant.\nIn the 2 studies where administration of LA was by intraligamental injection, there was no difference in mean pain scores, and they did not report any soft tissue damage (very low-quality body of evidence, 115 participants analysed, 1 study had overall high risk of bias, 1 study had overall unclear risk of bias).\nOne 3-armed study (very low-quality body of evidence, 54 participants analysed, overall high risk of bias) compared the effects of intraligamental and infiltration LA injection with no treatment. There was no evidence of a mean difference in pain, distress, or postoperative anxiety among the three groups.\nFour studies (very low-quality body of evidence, 343 participants analysed, 2 studies had overall low risk of bias, 2 studies had overall unclear risk of bias) evaluated the effects of topical LA compared with no treatment or placebo. One study (overall unclear risk of bias) with a no-treatment comparator reported lower mean pain in the LA group; all other studies reported no difference in mean pain scores. Two studies reported on bleeding (overall unclear risk of bias): One study reported a clinically insignificant increase in bleeding with no treatment; the other reported no difference.\nNone of the studies reported on participant or child satisfaction.\nAuthors' conclusions\nIn this review, it was difficult to reach firm conclusions as to the benefit of using local anaesthetic for dental treatment under general anaesthesia. The information reported in the included studies was comprehensive and applicable to the review question, but ultimately it was not sufficient to address the objective of the review. We were unable to pool the included studies in a meta-analysis because of substantial variation in outcome measures, interventions, and treatment types. The use of supplementary analgesia further obscured the effect of local anaesthetics.\nBased on the literature review and the results of this review, we recommend further randomised controlled trials that minimise bias through adequate allocation concealment and blinding of participants and assessors, and assess the effect of intraoperative local anaesthetic on the volume and type of anaesthetic used and on the cardiovascular system in participants receiving supplementary analgesics as well. Researchers should give consideration to the impact of any changes on the health and well-being of the participant and report baseline measures of pain or distress, or both, and preoperative anxiety.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the 14 included studies was variable. We assessed three studies as being at overall risk of high bias, seven at unclear risk of bias, and four at low risk of bias."
}
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query-laysum | 1175 | [
{
"role": "user",
"content": "Abstract: Background\nHypoglycaemia is a common occurrence in people with diabetes but can also result from an imbalance in glucose homeostasis in the absence of diabetes. The best enteral route for glucose administration for suspected hypoglycaemia in a first aid situation is unknown.\nObjectives\nTo assess the effects of first aid glucose administration by any route appropriate for use by first-aid providers (buccal, sublingual, oral, rectal) for symptomatic hypoglycaemia.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL as well as grey literature (records identified in the WHO ICTRP Search Portal, ClinicalTrials.gov and the EU Clinical Trials Register) up to July 2018. We searched reference lists of included studies retrieved by the above searches.\nSelection criteria\nWe included studies involving adults and children with documented or suspected hypoglycaemia as well as healthy volunteers, in which glucose was administered by any enteral route appropriate for use by first-aid providers.\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, extracted data and evaluated trials for overall certainty of the evidence using the GRADE instrument. We used the Cochrane 'Risk of bias' tool to assess the risk of bias in the randomised controlled trials (RCTs), and the 'risk of bias In non-randomised studies of interventions' (ROBINS-I) tool, in addition to the Cochrane Handbook for Systematic Reviews of Interventions recommendations on cross-over studies, for the non-RCTs. We reported continuous outcomes as mean differences (MD) with 95% confidence intervals (CIs) and dichotomous outcomes as risk ratios (RR) with 95% CIs. All data on glucose concentrations were converted to mg/dL. We contacted authors of included studies to obtain missing data.\nMain results\nFrom 6394 references, we included four studies evaluating 77 participants, including two RCTs, studying children and adults with hypoglycaemia, respectively, and two non-RCTs with healthy volunteers. The studies included three different routes of glucose administration (sublingual, buccal and a combination of oral and buccal administration). All studies had a high risk of bias in one or more 'Risk of bias' domain.\nGlucose administration by the sublingual route, in the form of table sugar under the tongue, resulted in a higher blood glucose concentration after 20 minutes compared with the oral route in the very specific setting of children with hypoglycaemia and symptoms of concomitant malaria or respiratory tract infection (MD 17 mg/dL, 95% CI 4.4 to 29.6; P = 0.008; 1 study; 42 participants; very low-quality evidence). Resolution of hypoglycaemia at 80 minutes may favour sublingual administration (RR 2.10, 95% CI 1.24 to 3.54; P = 0.006; 1 study; 42 participants; very low-certainty evidence), but no substantial difference could be demonstrated at 20 minutes (RR 1.26, 95% CI 0.91 to 1.74; P = 0.16; 1 study; 42 participants; very low-certainty evidence). A decrease in the time to resolution of hypoglycaemia was found in favour of sublingual administration (MD -51.5 min, 95% CI -58 to -45; P < 0.001; 1 study; 42 participants; very low-certainty evidence). No adverse events were reported in either group. No data were available for resolution of symptoms and time to resolution of symptoms, and treatment delay.\nGlucose administered by the buccal route in one study resulted in a lower plasma glucose concentration after 20 minutes compared with oral administration (MD -14.4 mg/dL, 95% CI -17.5 to -11.4 for an imputed within-participants correlation coefficient of 0.9; P < 0.001; 1 trial; 16 participants; very low-quality evidence). In another study there were fewer participants with increased blood glucose at 20 minutes favouring oral glucose (RR 0.07, 95% CI 0.00 to 0.98; P = 0.05; 1 study; 7 participants; very low-certainty evidence). No data were available for resolution of symptoms and time to resolution of symptoms, resolution of hypoglycaemia and time to resolution of hypoglycaemia, adverse events, and treatment delay.\nFor the combined oral and buccal mucosal route (in the form of a dextrose gel) the MD was -15.3 mg/dL, 95%CI -33.6 to 3; P = 0.09; 1 study; 18 participants; very low-quality evidence . No improvement was identified for either route in the resolution of symptoms at 20 minutes or less following glucose administration (RR 0.36, 95% CI 0.12 to 1.14; P = 0.08; 1 study; 18 participants; very low-certainty evidence). No data were available for time to resolution of symptoms, resolution of hypoglycaemia and time to resolution of hypoglycaemia, adverse events, and treatment delay.\nAuthors' conclusions\nWhen providing first aid to individuals with hypoglycaemia, oral glucose administration results in a higher blood glucose concentrations after 20 minutes when compared with buccal administration of glucose. A difference in plasma glucose concentration could not be demonstrated, when administering a dextrose gel, defined as “a combined oral and buccal mucosal route” compared to oral administration of a glucose tablet or solution. In the specific population of children with concomitant malaria and respiratory illness, sublingual sugar results in a higher blood glucose concentration after 20 minutes when compared with oral administration.These results need to be interpreted cautiously because our confidence in the body of evidence is very low due to the low number of participants and studies as well as methodological deficiencies in the included studies.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hypoglycaemia, or having low blood sugar levels, is a common occurrence in people with diabetes but may also occur in other persons due to an imbalance in blood sugar regulation. Symptoms of mild or moderate hypoglycaemia are for example, shakiness, dizziness, sweating or nervousness, First aid for this condition is usually self-administered but is often provided by family or friends, and glucose tablets compared with dietary forms of sugar such as juice, candies or dried fruit strips have shown to result in a better resolution of symptoms. Glucose can be given orally (swallowed), but also inside the cheek against the buccal mucosa (‘buccal administration’), under the tongue (‘sublingual administration’) or via the rectal route. In the latter three ways of treatment, the glucose is not being swallowed as with the oral route."
}
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query-laysum | 1176 | [
{
"role": "user",
"content": "Abstract: Background\nPeripheral arterial disease (PAD), caused by narrowing of the arteries in the limbs, is increasing in incidence and prevalence as our population is ageing and as diabetes is becoming more prevalent. PAD can cause pain in the limbs while walking, known as intermittent claudication, or can be more severe and cause pain while at rest, ulceration, and ultimately gangrene and limb loss. This more severe stage of PAD is known as 'critical limb ischaemia'. Treatments for PAD include medications that help to reduce the increased risk of cardiovascular events and help improve blood flow, as well as endovascular or surgical repair or bypass of the blocked arteries. However, many people are unresponsive to medications and are not suited to surgical or endovascular treatment, leaving amputation as the last option. Gene therapy is a novel approach in which genetic material encoding for proteins that may help increase revascularisation is injected into the affected limbs of patients. This type of treatment has been shown to be safe, but its efficacy, especially regarding ulcer healing, effects on quality of life, and other symptomatic outcomes remain unknown.\nObjectives\nTo assess the effects of gene therapy for symptomatic peripheral arterial disease.\nSearch methods\nThe Cochrane Vascular Information Specialist searched Cochrane CENTRAL, the Cochrane Vascular Specialised Register, MEDLINE Ovid, Embase Ovid, CINAHL, and AMED, along with trials registries (all searched 27 November 2017). We also checked reference lists of included studies and systematic reviews for further studies.\nSelection criteria\nWe included randomised and quasi-randomised studies that evaluated gene therapy versus no gene therapy in people with PAD. We excluded studies that evaluated direct growth hormone treatment or cell-based treatments.\nData collection and analysis\nTwo review authors independently selected studies, performed quality assessment, and extracted data from the included studies. We collected pertinent information on each study, as well as data for the outcomes of amputation-free survival, ulcer healing, quality of life, amputation, all-cause mortality, ankle brachial index, symptom scores, and claudication distance.\nMain results\nWe included in this review a total of 17 studies with 1988 participants (evidence current until November 2017). Three studies limited their inclusion to people with intermittent claudication, 12 limited inclusion to people with varying levels of critical limb ischaemia, and two included people with either condition. Study investigators evaluated many different types of gene therapies, using different protocols. Most studies evaluated growth factor-encoding gene therapy, with six studies using vascular endothelial growth factor (VEGF)-encoding genes, four using hepatocyte growth factor (HGF)-encoding genes, and three using fibroblast growth factor (FGF)-encoded genes. Two studies evaluated hypoxia-inducible factor 1-alpha (HIF-1α) gene therapy, one study used a developmental endothelial locus-1 gene therapy, and the final study evaluated a stromal cell-derived factor-1 (SDF-1) gene therapy. Most studies reported outcomes after 12 months of follow-up, but follow-up ranged from three months to two years.\nOverall risk of bias varied between studies, with many studies not providing sufficient detail for adequate determination of low risk of bias for many domains. Two studies did not utilise a placebo control, leading to risk of performance bias. Several studies reported in previous protocols or in their Methods sections that they would report on certain outcomes for which no data were then reported, increasing risk of reporting bias. All included studies reported sponsorships from corporate entities that led to unclear risk of other bias. The overall quality of evidence ranged from moderate to very low, generally as the result of heterogeneity and imprecision, with few or no studies reporting on outcomes.\nEvidence suggests no clear differences for the outcomes of amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving this treatment (all moderate-quality evidence). Low-quality evidence suggests improvement in complete ulcer healing with gene therapy (odds ratio (OR) 2.16, 95% confidence interval (CI) 1.02 to 4.59; P = 0.04). We could not combine data on quality of life and can draw no conclusions at this time regarding this outcome (very low-quality evidence). We included one study in the meta-analysis for ankle brachial index, which showed no clear differences between treatments, but we can draw no overall association (low-quality evidence). We combined in a meta-analysis pain symptom scores as assessed by visual analogue scales from two studies and found no clear differences between treatment groups (very low-quality evidence). We carried out extensive subgroup analyses by PAD classification, dosage schedule, vector type, and gene used but identified no substantial differences.\nAuthors' conclusions\nModerate-quality evidence shows no clear differences in amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving gene therapy. Some evidence suggests that gene therapy may lead to improved complete ulcer healing, but this outcome needs to be explored with improved reporting of the measure, such as decreased ulcer area in cm², and better description of ulcer types and healing. Further standardised data that are amenable to meta-analysis are needed to evaluate other outcomes such as quality of life, ankle brachial index, symptom scores, and claudication distance.\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 17 studies that had a total of 1988 participants (evidence current until November 2017). These studies used various types of gene therapy as well as different dosages, some providing single treatments and some repeated treatments. Most of the studies included people with critical limb ischaemia; three studies included people with intermittent claudication."
}
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query-laysum | 1177 | [
{
"role": "user",
"content": "Abstract: Background\nOnchocerciasis, also known as \"river blindness,\" is a parasitic disease that is caused by infection from the filarial nematode (roundworm), Onchocerca volvulus. Nematodes are transmitted from person to person by blackflies of the Simulium genus, which usually breed in fast flowing streams and rivers. The disease is the second leading infectious cause of blindness in endemic areas.\nIvermectin (a microfilaricide) is widely distributed to endemic populations for prevention and treatment of onchocerciasis. Doxycycline, an antibiotic, targets Wolbachia organisms that are crucial to the survival of adult onchocerca (macrofilaricide). Combined treatment with both drugs is believed to cause direct microfilarial death by ivermectin and indirect macrofilarial death by doxycycline. Long-term reduction in the numbers of microfilaria in the skin and eyes and in the numbers of adult worms in the body has the potential to reduce the transmission and occurrence of onchocercal eye disease.\nObjectives\nThe primary aim of this review was to assess the effectiveness of doxycycline plus ivermectin versus ivermectin alone for prevention and treatment of onchocerciasis. The secondary aim was to assess the effectiveness of doxycycline plus ivermectin versus ivermectin alone for prevention and treatment of onchocercal ocular lesions in communities co-endemic for onchocerciasis and Loa loa (loiasis) infection.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 7, 2015), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2015), EMBASE (January 1980 to July 2015), PubMed (1948 to July 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to July 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 1 July 2014), 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 search for trials. We last searched the electronic databases on 15 July 2015.\nSelection criteria\nWe included randomized controlled trials (RCTs) that had compared doxycycline plus ivermectin versus ivermectin alone. Participants with or without one or more characteristic signs of ocular onchocerciasis resided in communities where onchocerciasis was endemic.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and extracted data. We used standard methodological procedures as expected by Cochrane.\nMain results\nWe identified three RCTs including a total of 466 participants with a diagnosis of onchocerciasis. All trials compared doxycycline plus ivermectin versus ivermectin alone. One study investigated improvement in visual impairment at six-month follow-up; the other two studies measured microfilarial loads in skin snips to assess sustained effects of treatment at follow-up of 21 months or longer. The studies were conducted at various centers across three countries (Cameroon, Ghana, and Liberia). We judged all studies to be at overall high risk of bias because of inadequate randomization and lack of masking (one study), missing data (two studies), and selective outcome reporting (three studies).\nOnly one study measured visual outcomes. This study reported uncertainty about the difference in the proportion of participants with improvement in visual impairment at six-month follow-up for doxycycline plus ivermectin compared with ivermectin alone (risk ratio (RR) 1.06, 95% confidence interval (95% CI) 0.80 to 1.39; 240 participants; very low-quality evidence). No participant in either group showed improvement in optic atrophy, chorioretinitis, or sclerosing keratitis at six-month follow-up. More participants in the doxycycline plus ivermectin group than in the ivermectin alone group showed improvement in iridocyclitis (RR 1.24, 95% CI 0.69 to 2.22) and punctate keratitis (RR 1.43, 95% CI 1.02 to 2.00) at six-month follow-up; however, we graded these results as very low quality.\nTwo studies reported that a six-week course of doxycycline may result in Wolbachia depletion and macrofilaricidal and sterilizing activities in female Onchocerca worms; however, no analysis was possible because data were missing and incomplete (graded evidence as very low quality). Adverse events were reported in 16 of 135 (12%) participants in one of these studies and included itching, headaches, body pains, and vertigo; no difference between treatment groups was reported for any adverse event. The second study reported that one (1.3%) participant in the doxycycline plus ivermectin group had bloody diarrhea after treatment was initiated.\nAuthors' conclusions\nAvailable evidence on the effectiveness of doxycycline plus ivermectin compared with ivermectin alone in preventing and treating onchocerciasis is unclear. Limited evidence of very low quality from two studies indicates that a six-week course of doxycycline followed by ivermectin may result in more frequent macrofilaricidal and microfilaricidal activity and sterilization of female adult Onchocerca compared with ivermectin alone; however, effects on vision-related outcomes are uncertain. Future studies should consider the effectiveness of treatments in preventing visual acuity and visual field loss and their effects on anterior and posterior segment lesions, particularly chorioretinitis. These studies should report outcomes in a uniform and consistent manner at follow-up of three years or longer to allow detection of meaningful changes in vision-related outcomes.\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": "As of 15 July 2015, we identified three randomized controlled trials. A total of 466 people with RB participated in the three trials. The trials were conducted in Cameroon, Ghana, and Liberia. In the Cameroon and Ghana trials, people with RB took doxycycline or placebo (sugar pills) for four weeks or six weeks. One dose of ivermectin was then given four or six months later. People were then followed for two to three years. In the trial from Liberia, people with RB were divided into two groups. One group was given doxycycline for 6 weeks followed by a single dose of ivermectin. The other group was given ivermectin alone. Both Liberian groups were followed up for six months."
}
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query-laysum | 1178 | [
{
"role": "user",
"content": "Abstract: Background\nPoor outcomes after breech birth might be the result of underlying conditions causing breech presentation or due to factors associated with the delivery.\nObjectives\nTo assess the effects of planned caesarean section for singleton breech presentation at term on measures of pregnancy outcome.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015).\nSelection criteria\nRandomised trials comparing planned caesarean section for singleton breech presentation at term with planned vaginal birth.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nThree trials (2396 participants) were included in the review. Caesarean delivery occurred in 550/1227 (45%) of those women allocated to a vaginal delivery protocol and 1060/1169 (91%) of those women allocated to planned caesarean section (average risk ratio (RR) random-effects, 1.88, 95% confidence interval (CI) 1.60 to 2.20; three studies, 2396 women, evidence graded low quality). Perinatal or neonatal death (excluding fatal anomalies) or severe neonatal morbidity was reduced with a policy of planned caesarean section in settings with a low national perinatal mortality rate (RR 0.07, 95% CI 0.02 to 0.29, one study, 1025 women, evidence graded moderate quality), but not in settings with a high national perinatal mortality rate (RR 0.66, 95% CI 0.35 to 1.24, one study, 1053 women, evidence graded low quality). The difference between subgroups was significant (Test for subgroup differences: Chi² = 8.01, df = 1 (P = 0.005), I² = 87.5%). Due to this significant heterogeneity, a random-effects analysis was performed. The average overall effect was not statistically significant (RR 0.23, 95% CI 0.02 to 2.44, one study, 2078 infants). Perinatal or neonatal death (excluding fatal anomalies) was reduced with planned caesarean section (RR 0.29, 95% CI 0.10 to 0.86, three studies, 2388 women). The proportional reductions were similar for countries with low and high national perinatal mortality rates.\nThe numbers studied were too small to satisfactorily address reductions in birth trauma and brachial plexus injury with planned caesarean section. Neither of these outcomes reached statistical significance (birth trauma: RR 0.42, 95% CI 0.16 to 1.10, one study, 2062 infants (20 events),evidence graded low quality; brachial plexus injury: RR 0.35, 95% CI 0.08 to 1.47, three studies, 2375 infants (nine events)).\nPlanned caesarean section was associated with modestly increased short-term maternal morbidity (RR 1.29, 95% CI 1.03 to 1.61, three studies, 2396 women,low quality evidence). At three months after delivery, women allocated to the planned caesarean section group reported less urinary incontinence (RR 0.62, 95% CI 0.41 to 0.93, one study, 1595 women); no difference in 'any pain' (RR 1.09, 95% CI 0.93 to 1.29, one study, 1593 women,low quality evidence); more abdominal pain (RR 1.89, 95% CI 1.29 to 2.79, one study, 1593 women); and less perineal pain (RR 0.32, 95% CI 0.18 to 0.58, one study, 1593 women).\nAt two years, there were no differences in the combined outcome 'death or neurodevelopmental delay' (RR 1.09, 95% CI 0.52 to 2.30, one study, 920 children,evidence graded low quality); more infants who had been allocated to planned caesarean delivery had medical problems at two years (RR 1.41, 95% CI 1.05 to 1.89, one study, 843 children). Maternal outcomes at two years were also similar. In countries with low perinatal mortality rates, the protocol of planned caesarean section was associated with lower healthcare costs, expressed in 2002 Canadian dollars (mean difference -$877.00, 95% CI -894.89 to -859.11, one study, 1027 women).\nAll of the trials included in this review had design limitations, and the GRADE level of evidence was mostly low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in two studies. Two of the three trials had serious design limitations, however these studies contributed to fewer outcomes than the large multi-centre trial with lower risk of bias.\nAuthors' conclusions\nPlanned caesarean section compared with planned vaginal birth reduced perinatal or neonatal death as well as the composite outcome death or serious neonatal morbidity, at the expense of somewhat increased maternal morbidity. In a subset with 2-year follow up, infant medical problems were increased following planned caesarean section and no difference in long-term neurodevelopmental delay or the outcome \"death or neurodevelopmental delay\" was found, though the numbers were too small to exclude the possibility of an important difference in either direction.\nThe benefits need to be weighed against factors such as the mother's preference for vaginal birth and risks such as future pregnancy complications in the woman's specific healthcare setting. The option of external cephalic version is dealt with in separate reviews. The data from this review cannot be generalised to settings where caesarean section is not readily available, or to methods of breech delivery that differ materially from the clinical delivery protocols used in the trials reviewed. The review will help to inform individualised decision-making regarding breech delivery. Research on strategies to improve the safety of breech delivery and to further investigate the possible association of caesarean section with infant medical problems is needed.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 3 studies involving 2396 women. (We included studies up to March 2015.) The quality of the studies and therefore the strength of the evidence was mainly low. In the short term, births with a planned caesarean were safer for babies than vaginal births. Fewer babies died or were seriously hurt when they were born by caesarean. However, children who were born by caesarean had more health problems at age two, though the numbers were too small to be certain. Caesareans caused some short-term problems for mothers such as more abdominal pain. They also had some benefits, such as less urinary incontinence and less perineal pain in one study. The studies did not look at effects on future pregnancies, when having had a previous caesarean may cause complications. The studies only looked at single births (not twins or triplets) and did not study premature babies."
}
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query-laysum | 1179 | [
{
"role": "user",
"content": "Abstract: Background\nPost-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. The current standard care for the prevention of PTS following DVT is elastic compression stockings. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the prevention of PTS. This is the second update of the review first published in 2013.\nObjectives\nTo determine the effectiveness and safety of rutosides for prevention of post-thrombotic syndrome (PTS) in patients with deep vein thrombosis (DVT), compared to placebo, no intervention, or reference medication.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 21 August 2018.\nSelection criteria\nWe planned to include trials of rutosides versus any alternative (placebo, no intervention, or reference medication) in the prevention of PTS in patients with DVT.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and intended to extract information from the trials.\nMain results\nNo studies were identified comparing rutosides versus any alternative in the prevention of PTS.\nAuthors' conclusions\nAs there were no studies identified in this review there is currently insufficient evidence to determine the effectiveness and safety of rutosides for prevention of PTS in patients with DVT. Some studies suggest that rutosides may provide short-term relief of PTS symptoms. However, there is nothing published on their use as a preventative therapy for PTS. High quality randomised controlled trials of rutoside versus any alternative are required to build the evidence base in this area.\n\nGiven the provided abstract, please respond to the following query: \"Key results and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We did not find any trials of rutosides versus an alternative therapy for the prevention of PTS that were suitable for inclusion. We therefore have no evidence to support the use of rutosides in the prevention of PTS and high quality randomised controlled trials are required."
}
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query-laysum | 1180 | [
{
"role": "user",
"content": "Abstract: Background\nThe Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes practice recommendations for the care of newborn infants in the delivery room (DR). ILCOR recommends that all infants who are gasping, apnoeic, or bradycardic (heart rate < 100 per minute) should be given positive pressure ventilation (PPV) with a manual ventilation device (T-piece, self-inflating bag, or flow-inflating bag) via an interface. The most commonly used interface is a face mask that encircles the infant’s nose and mouth. However, gas leak and airway obstruction are common during face mask PPV. Nasal interfaces (single and binasal prongs (long or short), or nasal masks) and laryngeal mask airways (LMAs) may also be used to deliver PPV to newborns in the DR, and may be more effective than face masks.\nObjectives\nTo determine whether newborn infants receiving PPV in the delivery room with a nasal interface compared to a face mask, laryngeal mask airway (LMA), or another type of nasal interface have reduced mortality and morbidity. To assess whether safety and efficacy of the nasal interface differs according to gestational age or ventilation device.\nSearch methods\nSearches were conducted in September 2022 in CENTRAL, MEDLINE, Embase, Epistemonikos, and two trial registries. We searched conference abstracts and checked the reference lists of included trials and related systematic reviews identified through the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCT's that compared the use of nasal interfaces to other interfaces (face masks, LMAs, or one nasal interface to another) to deliver PPV to newborn infants in the DR.\nData collection and analysis\nEach review author independently evaluated the search results against the selection criteria, screened retrieved records, extracted data, and appraised the risk of bias. If they were study authors, they did not participate in the selection, risk of bias assessment, or data extraction related to the study. In such instances, the study was independently assessed by other review authors. We contacted trial investigators to obtain additional information. We completed data analysis according to the standards of Cochrane Neonatal, using risk ratio (RR) and 95% confidence Intervals (CI) to measure the effect of the different interfaces. We used fixed-effect models and the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included five trials, in which 1406 infants participated. They were conducted in 13 neonatal centres across Europe and Australia. Each of these trials compared a nasal interface to a face mask for the delivery of respiratory support to newborn infants in the DR. Potential sources of bias were a lack of blinding to treatment allocation of the caregivers and investigators in all trials.\nThe evidence suggests that resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on reducing death before discharge (typical risk ratio (RR) 0.72, 95% CI 0.47 to 1.13; 3 studies, 1124 infants; low-certainty evidence).\nResuscitation with a nasal interface may reduce the rate of intubation in the DR, but the evidence is very uncertain (RR 0.68, 95% CI 0.54 to 0.85; 5 studies, 1406 infants; very low-certainty evidence). The evidence is very uncertain for the rate of intubation within 24 hours of birth (RR 0.97, 95% CI 0.85 to 1.09; 3 studies, 749 infants; very low-certainty evidence), endotracheal intubation outside the DR during hospitalisation (RR 1.15, 95% CI 0.93 to 1.42; 1 study, 144 infants; very low-certainty evidence) and cranial ultrasound abnormalities (intraventricular haemorrhage (IVH) grade ≥ 3, or periventricular leukomalacia; RR 0.94, 95% CI 0.55 to 1.61; 3 studies, 749 infants; very low-certainty evidence). Resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on the incidence of air leaks (RR 1.09, 95% CI 0.85 to 1.09; 2 studies, 507 infants; low-certainty evidence), or the need for supplemental oxygen at 36 weeks' corrected gestational age (RR 1.06, 95% CI 0.8 to 1.40; 2 studies, 507 infants; low-certainty evidence).\nWe identified one ongoing study, which compares a nasal mask to a face mask to deliver PPV to infants in the DR. We did not identify any completed trials that compared nasal interfaces to LMAs or one nasal interface to another.\nAuthors' conclusions\nNasal interfaces were found to offer comparable efficacy to face masks (low- to very low-certainty evidence), supporting resuscitation guidelines that state that nasal interfaces are a comparable alternative to face masks for providing respiratory support in the DR.\nResuscitation with a nasal interface may reduce the rate of intubation in the DR when compared with a face mask. However, the evidence is very uncertain. This uncertainty is attributed to the use of a new ventilation system in the nasal interface group in two of the five trials. As such, it is not possible to differentiate separate, specific effects related to the ventilation device or to the interface in these studies.\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 five studies that involved 1406 babies whose breathing was supported with a nasal interface compared to a face mask in the delivery room. The studies were conducted in high-income countries across Europe and Australia; the largest study included 617 babies and the smallest included 36 babies.\nWe found that giving breathing support with a nasal interface in the delivery room may have little to no effect on the rate of death before discharge, compared to a face mask. It may reduce the number of newborn babies who are intubated in the delivery room, but the evidence is very uncertain. The evidence is very uncertain about the effect of giving breathing support with a nasal interface on the rate of intubation within 24 hours of birth; the rate of intubation during hospitalisation, once they leave the delivery room; or bleeding inside the brain. Using a nasal interface may have little to no effect on the rate of lung complications (e.g. chronic lung disease, or air leaks).\nDespite this uncertainty, our results suggest that nasal interfaces and face masks are likely to be equally effective at giving breathing support in the delivery room.\nWe found one ongoing study comparing a nasal mask to a face mask to give breathing support to babies in the delivery room.\nWe did not find any studies that compared nasal interfaces to laryngeal mask airways or one type of nasal interface to another."
}
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query-laysum | 1181 | [
{
"role": "user",
"content": "Abstract: Background\nChronic spontaneous urticaria (CSU) is characterised by the development of crops of red, itchy, raised weals or hives with no identifiable external cause.\nObjectives\nTo assess the effects of H1-antihistamines for CSU.\nSearch methods\nWe searched the following databases up to June 2014: Cochrane Skin Group Specialised Register, CENTRAL (2014, Issue 5), MEDLINE (from 1946), EMBASE (from 1974) and PsycINFO (from 1806). We searched five trials registers and checked articles for references to relevant randomised controlled trials.\nSelection criteria\nWe included randomised controlled trials of H1-antihistamines for CSU. Interventions included single therapy or a combination of H1-antihistamines compared with no treatment (placebo) or another active pharmacological compound at any dose.\nData collection and analysis\nWe used standard methodological procedures as expected by The Cochrane Collaboration.\nOur primary outcome measures were proportion of participants with complete suppression of urticaria: 'good or excellent' response, 50% or greater improvement in quality of life measures, and adverse events. We present risk ratios (RR) with 95% confidence intervals (CIs).\nMain results\nWe identified 73 studies (9759 participants); 34 studies provided data for 23 comparisons. The duration of the intervention was up to two weeks (short-term) or longer than two weeks and up to three months (intermediate-term).\nCetirizine 10 mg once daily in the short term and in the intermediate term led to complete suppression of urticaria by more participants than was seen with placebo (RR 2.72, 95% CI 1.51 to 4.91). For this same outcome, comparison of desloratadine versus placebo in the intermediate term (5 mg) (RR 37.00, 95% CI 2.31 to 593.70) and in the short term (20 mg) (RR 15.97, 95% CI 1.04 to 245.04) favoured desloratadine, but no differences were seen between 5 mg and 10 mg for short-term treatment.\nLevocetirizine 20 mg per day (short-term) was more effective for complete suppression of urticaria compared with placebo (RR 20.87, 95% CI 1.37 to 317.60), and at 5 mg was effective in the intermediate term (RR 52.88, 95% CI 3.31 to 843.81) but not in the short term, nor was 10 mg effective in the short term.\nRupatadine at 10 mg and 20 mg in the intermediate term achieved a 'good or excellent response' compared with placebo (RR 1.35, 95% CI 1.03 to 1.77).\nLoratadine (10 mg) versus placebo (RR 1.86, 95% CI 0.91 to 3.79) and loratadine (10 mg) versus cetirizine (10 mg) (RR 1.05, 95% CI 0.76 to 1.43) over short-term and intermediate-term treatment showed no significant difference for 'good or excellent response' or for complete suppression of urticaria, respectively.\nLoratadine (10 mg) versus desloratadine (5 mg) (intermediate-term) showed no statistically significant difference for complete suppression of urticaria (RR 0.91, 95% CI 0.78 to 1.06) or for 'good or excellent response' (RR 1.04, 95% CI 0.64 to 1.71). For loratadine (10 mg) versus mizolastine (10 mg) (intermediate-term), no statistically significant difference was seen for complete suppression of urticaria (RR 0.86, 95% CI 0.64 to 1.16) or for 'good or excellent response' (RR 0.88, 95% CI 0.55 to 1.42).\nLoratadine (10 mg) versus emedastine (2 mg) (intermediate-term) showed no statistically significant difference for complete suppression (RR 1.04, 95% CI 0.78 to 1.39) or for 'good or excellent response' (RR 1.09, 95% CI 0.96 to 1.24); the quality of the evidence was moderate for this comparison.\nNo difference in short-term treatment was noted between loratadine (10 mg) and hydroxyzine (25 mg) in terms of complete suppression (RR 1.00, 95% CI 0.32 to 3.10).\nWhen desloratadine (5 to 20 mg) was compared with levocetirizine (5 to 20 mg), levocetirizine appeared to be the more effective (P value < 0.02).\nIn a comparison of fexofenadine versus cetirizine, more participants in the cetirizine group showed complete suppression of urticaria (P value < 0.001).\nAdverse events leading to withdrawals were not significantly different in the following comparisons: cetirizine versus placebo at 10 mg and 20 mg (RR 3.00, 95% CI 0.68 to 13.22); desloratadine 5 mg versus placebo (RR 1.46, 95% CI 0.42 to 5.10); loratadine 10 mg versus mizolastine 10 mg (RR 0.38, 95% CI 0.04 to 3.60); loratadine 10 mg versus emedastine 2 mg (RR 1.09, 95% CI 0.07 to 17.14); cetirizine 10 mg versus hydroxyzine 25 mg (RR 0.78, 95% CI 0.25 to 2.45); and hydroxyzine 25 mg versus placebo (RR 3.64, 95% CI 0.77 to 17.23), all intermediate term.\nNo difference was seen between loratadine 10 mg versus mizolastine 10 mg in the proportion of participants with at least 50% improvement in quality of life (RR 3.21, 95% CI 0.32 to 32.33).\nAuthors' conclusions\nAlthough the results of our review indicate that at standard doses of treatment, several antihistamines are effective when compared with placebo, all results were gathered from a few studies or, in some cases, from single-study estimates. The quality of the evidence was affected by the small number of studies in each comparison and the small sample size for many of the outcomes, prompting us to downgrade the quality of evidence for imprecision (unless stated for each comparison, the quality of the evidence was low).\nNo single H1-antihistamine stands out as most effective. Cetirizine at 10 mg once daily in the short term and in the intermediate term was found to be effective in completely suppressing urticaria. Evidence is limited for desloratadine given at 5 mg once daily in the intermediate term and at 20 mg in the short term. Levocetirizine at 5 mg in the intermediate but not short term was effective for complete suppression. Levocetirizine 20 mg was effective in the short term, but 10 mg was not. No difference in rates of withdrawal due to adverse events was noted between active and placebo groups. Evidence for improvement in quality of life was insufficient.\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": "Chronic spontaneous urticaria (CSU) is a condition characterised by a rash of red itchy raised weals or hives, which appear for no identifiable reason. Other names include chronic idiopathic or chronic ordinary urticaria. 'Spontaneous' differentiates this type of urticaria from 'inducible' or 'physical' urticaria, for which there are specific triggers such as cold or pressure. 'Chronic' indicates that the condition has continued for at least six weeks. Hives may be intensely itchy, and the appearance may be unsightly and distressing to sufferers. In some cases, hives can be accompanied by deeper swelling, known as angio-oedema, which is most common around the eyes and mouth.\nAntihistamine drugs, specifically H1 antihistamines, are the mainstay of treatment for urticaria, although they control the condition rather than cure it. Many antihistamines are available to buy without a prescription, including brand names such as Clarityn, Piriton, Zirtek, Benadryl and Phenergan (brand names may differ by country)."
}
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query-laysum | 1182 | [
{
"role": "user",
"content": "Abstract: Background\nChlorpromazine, a widely available and inexpensive antipsychotic drug, is considered the benchmark treatment for schizophrenia worldwide. Metiapine, a dibenzothiazepine derivative, has been reported to have potent antipsychotic characteristics. However, no evidence currently exists on the effectiveness of chlorpromazine in treatment of people with schizophrenia compared to metiapine, a newer antipsychotic.\nObjectives\nTo compare the effect of chlorpromazine versus metiapine for the treatment of people with schizophrenia\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials in November 2015 and 2016.\nSelection criteria\nAll randomised controlled trials (RCTs) focusing on chlorpromazine versus metiapine for adults with schizophrenia. We included trials meeting our selection criteria and reporting useable data.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference between groups and its 95% CI. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE.\nMain results\nWe included three studies randomising 161 people with schizophrenia. Data were available for only two of our seven prestated main outcomes. Clinically important improvement in global state was measured using the Clinical Global Impression (CGI). There was no clear difference between chlorpromazine and metiapine groups (2 RCTs, n = 120, RR 1.11, 95% CI 0.84 to 1.47, very low quality evidence) and numbers of participants with parkinsonism at eight weeks were similar (2 RCTs, n = 70, RR 0.97, 95% CI 0.46 to 2.03, very low quality evidence). There were no useable data available for the other key outcomes of clinically important improvement in mental state, readmission due to relapse, satisfaction with treatment, aggressive or violent behaviour, or cost of care.\nAuthors' conclusions\nChlorpromazine has been the mainstay treatment for schizophrenia for decades, yet available evidence comparing this drug to metiapine fails to provide high-quality trial based data. However, the need to determine whether metiapine is more or less effective than chlorpromazine seems to be lacking in clinical relevance and future research on this comparison seems unlikely.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We cannot draw firm conclusions from the data provided. The number of studies and number of participants in each study is small, all studies are also short term. Therefore, we rated the reported evidence as very low quality. However, metiapine is not a highly prescribed or used antipsychotic medicine, so although our evidence is poor, it probably will remain the best available evidence as it is unlikely new trials comparing metiapine with chlorpromazine will be conducted in the future."
}
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query-laysum | 1183 | [
{
"role": "user",
"content": "Abstract: Background\nChorioamnionitis is a leading cause of perinatal morbidity and mortality. Amnioinfusion aims at reducing the adverse effects of chorioamnionitis by dilution of the infective organisms or by an anti-microbial effect of the fluid infused.\nObjectives\nThe objective of this review was to determine the effect of amnioinfusion on clinical and sub-clinical chorioamnionitis, fetal well-being, fetal heart rate characteristics and perinatal and maternal morbidity and mortality.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 July 2016), PubMed, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 July 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised clinical trials (RCTs) of amnioinfusion (treatment group) versus no amnioinfusion in women with chorioamnionitis.\nWe would have also considered trials comparing amnioinfusion with sham amnioinfusion; different types or volumes of amnioinfusion fluid but none were identified.\nCluster-RCTs and quasi-RCTs were eligible for inclusion but none were identified. We identified one study published in abstract form but it did not contain any numerical data and has therefore been excluded. Studies using a cross-over design are not an appropriate study design and thus were not eligible for inclusion in this review.\nData collection and analysis\nTwo review authors independently assessed potential studies for inclusion and assessed trial quality. Both review authors independently extracted data and data were checked for accuracy.\nMain results\nWe included one small trial (with data from 34 participants) comparing transcervical amnioinfusion with no amnioinfusion. The trial was considered to be at a high risk of bias overall, due to small numbers, inconsistency in the reporting and lack of information on blinding. Meta-analysis was not possible. Transcervical amnioinfusion was with room temperature saline at 10 mL per minute for 60 minutes, then 3 mL per minute until delivery versus no amnioinfusion. All women received intrauterine pressure catheter, acetaminophen and antibiotics (ampicillin or, if receiving Group B beta streptococcal prophylaxis, penicillin and gentamycin). We did not identify any trials that used transabdominal amnioinfusion.\nCompared to no amnioinfusion, transcervical amnioinfusion had no clear effect on the incidence of postpartum endometritis (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.29 to 7.87; absolute risk 176/1000 (95% CI 34 to 96) versus 118/1000;low-quality evidence). Nor was there a clear effect in the incidence of neonatal infection (RR 3.00, 95% CI 0.13 to 68.84; absolute risk 0/1000 (95% CI 0 to 0) versus 0/1000; low-quality evidence). The outcome of perinatal death or severe morbidity (such as neonatal encephalopathy, intraventricular haemorrhage, admission to intensive/high care) was not reported in the included trial.\nIn terms of this review's secondary outcomes, the rate of caesarean section was the same in both groups (RR 1.00, 95% CI 0.35 to 2.83; absolute risk 294/1000 (95% CI 103 to 832) versus 294/1000; low-quality evidence). There was no clear difference in the duration of maternal antibiotic treatment between the amnioinfusion and no amnioinfusion control group (mean difference (MD) 16 hours, 95% CI -1.75 to 33.75); nor in the duration of hospitalisation (MD 3.00 hours, 95% CI -15.49 to 21.49). The study did not report any information about how many babies had a low Apgar score at five minutes after birth.\nWomen in the amnioinfusion group had a lower temperature at delivery compared to women in the control group (MD -0.38°C, 95% CI -0.74 to -0.02) but this outcome was not pre-specified in the protocol for this review.\nThe majority of this review's secondary outcomes were not reported in the included study.\nAuthors' conclusions\nThere is insufficient evidence to fully evaluate the effectiveness of using transcervical amnioinfusion for chorioamnionitis and to assess the safety of this intervention or women’s satisfaction. We did not identify any trials that used transabdominal amnioinfusion. The evidence in this review can neither support nor refute the use of transcervical amnioinfusion outside of clinical trials. We included one small study that reported on a limited number of outcomes of interest in this review. The numbers included in this review are too small for meaningful assessment of substantive outcomes, where reported. For those outcomes we assessed using GRADE (postpartum endometritis, neonatal infection, and caesarean section), we downgraded the quality of the evidence to low - with downgrading decisions based on small numbers and a lack of information on blinding. The included study did not report on this review's other primary outcome (perinatal death or severe morbidity).\nThe reduction in pyrexia, though not a pre-specified outcome of this review, may be of relevance in terms of benefits to the fetus of reduced exposure to heat. We postulate that the temperature reduction found may be a direct cooling effect of amnioinfusion with room temperature fluid, rather than reduction of infection. Larger trials are needed to confirm and extend the findings of the trial reviewed here. These should be randomised controlled trials; participants, women with chorioamnionitis; interventions, amnioinfusion; comparisons, no amnioinfusion; outcomes, maternal and perinatal outcomes including neurodevelopmental measures.\nFurther research is justified to determine possible benefits or risks of amnioinfusion for chorioamnionitis, and to investigate possible benefits of reducing temperature in fetuses considered at risk of neurological damage. Research should include randomised trials to examine transcervical or transabdominal amnioinfusion compared with no infusion for chorioamnionitis and examine outcomes listed in the methods of this review.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Chrioamnionitis is an infection of the fluid and sac surrounding the baby in the womb. This is usually managed with antibiotics and by delivering the baby. An additional method suggested is to infuse a salt solution into the womb either via a needle through the mother's abdomen (transabdominal) or a catheter via the mother's vagina (transcervical). The theory is that this may have a beneficial flushing or diluting effect on the infecting organisms."
}
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query-laysum | 1184 | [
{
"role": "user",
"content": "Abstract: Background\nMost cancer survivors receive follow-up care after completion of treatment with the primary aim of detecting recurrence. Traditional follow-up consisting of fixed visits to a cancer specialist for examinations and tests are expensive and may be burdensome for the patient. Follow-up strategies involving non-specialist care providers, different intensity of procedures, or addition of survivorship care packages have been developed and tested, however their effectiveness remains unclear.\nObjectives\nThe objective of this review is to compare the effect of different follow-up strategies in adult cancer survivors, following completion of primary cancer treatment, on the primary outcomes of overall survival and time to detection of recurrence. Secondary outcomes are health-related quality of life, anxiety (including fear of recurrence), depression and cost.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries on 11 December 2018 together with reference checking, citation searching and contact with study authors to identify additional studies.\nSelection criteria\nWe included all randomised trials comparing different follow-up strategies for adult cancer survivors following completion of curatively-intended primary cancer treatment, which included at least one of the outcomes listed above. We compared the effectiveness of: 1) non-specialist-led follow-up (i.e. general practitioner (GP)-led, nurse-led, patient-initiated or shared care) versus specialist-led follow-up; 2) less intensive versus more intensive follow-up (based on clinical visits, examinations and diagnostic procedures) and 3) follow-up integrating additional care components relevant for detection of recurrence (e.g. patient symptom education or monitoring, or survivorship care plans) versus usual care.\nData collection and analysis\nWe used the standard methodological guidelines by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC). We assessed the certainty of the evidence using the GRADE approach. For each comparison, we present synthesised findings for overall survival and time to detection of recurrence as hazard ratios (HR) and for health-related quality of life, anxiety and depression as mean differences (MD), with 95% confidence intervals (CI). When meta-analysis was not possible, we reported the results from individual studies. For survival and recurrence, we used meta-regression analysis where possible to investigate whether the effects varied with regards to cancer site, publication year and study quality.\nMain results\nWe included 53 trials involving 20,832 participants across 12 cancer sites and 15 countries, mainly in Europe, North America and Australia. All the studies were carried out in either a hospital or general practice setting. Seventeen studies compared non-specialist-led follow-up with specialist-led follow-up, 24 studies compared intensity of follow-up and 12 studies compared patient symptom education or monitoring, or survivorship care plans with usual care. Risk of bias was generally low or unclear in most of the studies, with a higher risk of bias in the smaller trials.\nNon-specialist-led follow-up compared with specialist-led follow-up\nIt is uncertain how this strategy affects overall survival (HR 1.21, 95% CI 0.68 to 2.15; 2 studies; 603 participants), time to detection of recurrence (4 studies, 1691 participants) or cost (8 studies, 1756 participants) because the certainty of the evidence is very low.\nNon-specialist- versus specialist-led follow up may make little or no difference to health-related quality of life at 12 months (MD 1.06, 95% CI −1.83 to 3.95; 4 studies; 605 participants; low-certainty evidence); and probably makes little or no difference to anxiety at 12 months (MD −0.03, 95% CI −0.73 to 0.67; 5 studies; 1266 participants; moderate-certainty evidence). We are more certain that it has little or no effect on depression at 12 months (MD 0.03, 95% CI −0.35 to 0.42; 5 studies; 1266 participants; high-certainty evidence).\nLess intensive follow-up compared with more intensive follow-up\nLess intensive versus more intensive follow-up may make little or no difference to overall survival (HR 1.05, 95% CI 0.96 to 1.14; 13 studies; 10,726 participants; low-certainty evidence) and probably increases time to detection of recurrence (HR 0.85, 95% CI 0.79 to 0.92; 12 studies; 11,276 participants; moderate-certainty evidence). Meta-regression analysis showed little or no difference in the intervention effects by cancer site, publication year or study quality.\nIt is uncertain whether this strategy has an effect on health-related quality of life (3 studies, 2742 participants), anxiety (1 study, 180 participants) or cost (6 studies, 1412 participants) because the certainty of evidence is very low. None of the studies reported on depression.\nFollow-up strategies integrating additional patient symptom education or monitoring, or survivorship care plans compared with usual care:\nNone of the studies reported on overall survival or time to detection of recurrence.\nIt is uncertain whether this strategy makes a difference to health-related quality of life (12 studies, 2846 participants), anxiety (1 study, 470 participants), depression (8 studies, 2351 participants) or cost (1 studies, 408 participants), as the certainty of evidence is very low.\nAuthors' conclusions\nEvidence regarding the effectiveness of the different follow-up strategies varies substantially. Less intensive follow-up may make little or no difference to overall survival but probably delays detection of recurrence. However, as we did not analyse the two outcomes together, we cannot make direct conclusions about the effect of interventions on survival after detection of recurrence. The effects of non-specialist-led follow-up on survival and detection of recurrence, and how intensity of follow-up affects health-related quality of life, anxiety and depression, are uncertain. There was little evidence for the effects of follow-up integrating additional patient symptom education/monitoring and survivorship care plans.\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": "Non-specialist-led follow-up, such as follow-up provided by a general practitioner (GP) or nurse, makes little or no difference to health-related quality of life, anxiety or depression, when compared to specialist-led follow-up. We cannot be sure about its effects on overall survival and detection of a cancer returning after treatment (recurrence).\nLess intensive follow-up, such as follow-up with fewer examinations or tests, may make little or no difference to overall survival but probably delays detection of recurrence when compared to more intensive follow-up. However, other types of studies are needed before we can be certain about the effects of early detection of recurrence on survival. We also cannot be sure about its effect on health-related quality of life, anxiety and depression.\nThere was little evidence for the final type of follow-up, which integrated additional components relevant for detection of recurrence, such as patient symptom education or monitoring, or survivorship care plans."
}
]
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query-laysum | 1185 | [
{
"role": "user",
"content": "Abstract: Background\nRespiratory viruses are the leading cause of lower respiratory tract infection (LRTI) and hospitalisation in infants and young children. Respiratory syncytial virus (RSV) is the main infectious agent in this population. Palivizumab is administered intramuscularly every month during five months in the first RSV season to prevent serious RSV LRTI in children. Given its high cost, it is essential to know if palivizumab continues to be effective in preventing severe RSV disease in children.\nObjectives\nTo assess the effects of palivizumab for preventing severe RSV infection in children.\nSearch methods\nWe searched CENTRAL, MEDLINE, three other databases and two trials registers to 14 October 2021, together with reference checking, citation searching and contact with study authors to identify additional studies. We searched Embase to October 2020, as we did not have access to this database for 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs), including cluster-RCTs, comparing palivizumab given at a dose of 15 mg/kg once a month (maximum five doses) with placebo, no intervention or standard care in children 0 to 24 months of age from both genders, regardless of RSV infection history.\nData collection and analysis\nWe used Cochrane’s Screen4Me workflow to help assess the search results. Two review authors screened studies for selection, assessed risk of bias and extracted data. We used standard Cochrane methods. We used GRADE to assess the certainty of the evidence. The primary outcomes were hospitalisation due to RSV infection, all-cause mortality and adverse events. Secondary outcomes were hospitalisation due to respiratory-related illness, length of hospital stay, RSV infection, number of wheezing days, days of supplemental oxygen, intensive care unit length of stay and mechanical ventilation days.\nMain results\nWe included five studies with a total of 3343 participants. All studies were parallel RCTs, assessing the effects of 15 mg/kg of palivizumab every month up to five months compared to placebo or no intervention in an outpatient setting, although one study also included hospitalised infants. Most of the included studies were conducted in children with a high risk of RSV infection due to comorbidities like bronchopulmonary dysplasia and congenital heart disease. The risk of bias of outcomes across all studies was similar and predominately low.\nPalivizumab reduces hospitalisation due to RSV infection at two years' follow-up (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.30 to 0.64; 5 studies, 3343 participants; high certainty evidence). Based on 98 hospitalisations per 1000 participants in the placebo group, this corresponds to 43 (29 to 62) per 1000 participants in the palivizumab group. Palivizumab probably results in little to no difference in mortality at two years' follow-up (RR 0.69, 95% CI 0.42 to 1.15; 5 studies, 3343 participants; moderate certainty evidence). Based on 23 deaths per 1000 participants in the placebo group, this corresponds to 16 (10 to 27) per 1000 participants in the palivizumab group. Palivizumab probably results in little to no difference in adverse events at 150 days' follow-up (RR 1.09, 95% CI 0.85 to 1.39; 3 studies, 2831 participants; moderate certainty evidence). Based on 84 cases per 1000 participants in the placebo group, this corresponds to 91 (71 to 117) per 1000 participants in the palivizumab group. Palivizumab probably results in a slight reduction in hospitalisation due to respiratory-related illness at two years' follow-up (RR 0.78, 95% CI 0.62 to 0.97; 5 studies, 3343 participants; moderate certainty evidence). Palivizumab may result in a large reduction in RSV infection at two years' follow-up (RR 0.33, 95% CI 0.20 to 0.55; 3 studies, 554 participants; low certainty evidence). Based on 195 cases of RSV infection per 1000 participants in the placebo group, this corresponds to 64 (39 to 107) per 1000 participants in the palivizumab group. Palivizumab also reduces the number of wheezing days at one year's follow-up (RR 0.39, 95% CI 0.35 to 0.44; 1 study, 429 participants; high certainty evidence).\nAuthors' conclusions\nThe available evidence suggests that prophylaxis with palivizumab reduces hospitalisation due to RSV infection and results in little to no difference in mortality or adverse events. Moreover, palivizumab results in a slight reduction in hospitalisation due to respiratory-related illness and may result in a large reduction in RSV infections. Palivizumab also reduces the number of wheezing days. These results may be applicable to children with a high risk of RSV infection due to comorbidities.\nFurther research is needed to establish the effect of palivizumab on children with other comorbidities known as risk factors for severe RSV disease (e.g. immune deficiencies) and other social determinants of the disease, including children living in low- and middle-income countries, tropical regions, children lacking breastfeeding, living in poverty, or members of families in overcrowded situations.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most studies did not specify their funding sources. One study was funded by Abbott Laboratories and by the Netherlands Organisation for Health Research and Development."
}
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query-laysum | 1186 | [
{
"role": "user",
"content": "Abstract: Background\nExercise programmes are often recommended for managing ankylosing spondylitis (AS), to reduce pain and improve or maintain functional capacity.\nObjectives\nTo assess the benefits and harms of exercise programmes for people with AS.\nSearch methods\nWe searched CENTRAL, the Cochrane Library, MEDLINE Ovid, EMBASE Ovid, CINAHL EBSCO, PEDro, Scopus, and two trials registers to December 2018. We searched reference lists of identified systematic reviews and included studies, handsearched recent relevant conference proceedings, and contacted experts in the field.\nSelection criteria\nWe included reports of randomised controlled trials (RCT) of adults with AS that compared exercise therapy programmes with an inactive control (no intervention, waiting list) or usual care.\nData collection and analysis\nWe used standard Cochrane methodology.\nMain results\nWe included 14 RCTs with 1579 participants with AS. Most participants were male (70%), the median age was 45 years (range 39 to 47), and the mean symptom duration was nine years. The most frequently used exercises were those designed to help improve strength, flexibility, stretching, and breathing. Most exercise programmes were delivered along with drug therapy or a biological agent. We judged most of the studies at unclear or high risk of bias for several domains. All 14 studies provided data obtained immediately upon completion of the exercise programme. The median exercise programme duration was 12 weeks (interquartile range (IQR) 8 to 16). Three studies (146 participants) provided data for medium-term follow-up (< 24 weeks after completion of the exercise programmes), and one (63 participants) for long-term follow-up (> 24 weeks after completion of the exercise programmes). Nine studies compared exercise programmes to no intervention; five studies compared them to usual care (including physiotherapy, medication, or self-management).\nExercise programmes versus no intervention\nAll data were obtained immediately upon completion of the exercise programme.\nFor physical function, measured by a self-reporting questionnaire (the Bath Ankylosing Spondylitis Functional Index (BASFI) scale, 0 to 10; lower is better), moderate-quality evidence showed a no important clinically meaningful improvement with exercise programmes (mean difference (MD) -1.3, 95% confidence interval (CI) -1.7 to -0.9; 7 studies, 312 participants; absolute reduction 13%, 95% CI 17% to 9%).\nFor pain, measured on a visual analogue scale (VAS, 0 to 10, lower is better), low-quality evidence showed an important clinically meaningful reduction of pain with exercise (MD -2.1, 95% CI -3.6 to -0.6; 6 studies, 288 participants; absolute reduction 21%, 95% CI 36% to 6%).\nFor patient global assessment of disease activity, measured by a self-reporting questionnaire (the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scale, 0 to 10, lower is better), moderate-quality evidence showed no important clinically meaningful reduction with exercise (MD -0.9, 95% CI -1.3 to -0.5; 6 studies, 262 participants; absolute reduction 9%, 95% CI 13% to 5%).\nFor spinal mobility, measured by a self-reporting questionnaire (the Bath Ankylosing Spondylitis Metrology Index (BASMI) scale, 0 to 10, lower is better), very low-quality evidence showed an improvement with exercise (MD -0.7 95%, -1.3 to -0.1; 5 studies, 232 participants) with no important clinical meaningful benefit (absolute reduction 7%, 95% CI 13% to 1%).\nFor fatigue, measured on a VAS (0 to 10, lower is better), very low-quality evidence showed a no important clinically meaningful reduction with exercise (MD -1.4, 95% CI -2.7 to -0.1; 2 studies, 72 participants; absolute reduction 14%, 95% CI 27% to 1%).\nExercise programmes versus usual care\nAll data were obtained immediately upon completion of the exercise programme.\nFor physical function, measured by the BASFI scale, moderate-quality evidence showed an improvement with exercise (MD -0.4, 95% CI -0.6 to -0.2; 5 studies, 1068 participants). There was no important clinical meaningful benefit (absolute reduction 4%, 95% CI 6% to 2%).\nFor pain, measured on a VAS (0 to 10, lower is better), moderate-quality evidence showed a reduction of pain with exercise (MD -0.5, 95% CI -0.9 to -0.1; 2 studies, 911 participants; absolute reduction 5%, 95% CI 9% to 1%). No important clinical meaningful benefit was found.\nFor patient global assessment of disease activity, measured by the BASDAI scale, low-quality evidence showed a reduction with exercise (MD -0.7, 95% CI -1.3 to -0.1; 5 studies, 1068 participants), but it was not clinically important (absolute reduction 7%, 95% CI 13% to 1%) with important clinical meaningful benefit\nFor spinal mobility, measured by the BASMI scale, very low-quality evidence found a no important clinically meaningful improvement with exercise (MD -1.2, 95% CI -2.8 to 0.5; 2 studies, 85 participants; absolute reduction 12%, 95% CI 5% less to 28% more). There was no important clinical meaningful benefit.\nNone of the studies measured fatigue.\nAdverse effects\nWe found very low-quality evidence of the effect of exercise versus either no intervention, or usual care. We are uncertain of the potential for harm of exercises, due to low event rates, and a limited number of studies reporting events.\nAuthors' conclusions\nWe found moderate- to low-quality evidence that exercise programmes probably slightly improve function, may reduce pain, and probably slightly reduce global patient assessment of disease activity, when compared with no intervention, and measured upon completion of the programme. We found moderate- to low-quality evidence that exercise programmes probably have little or no effect on improving function or reducing pain, when compared with usual care, and may have little or no effect on reducing patient assessment of disease activity, when measured upon completion of the programmes. We are uncertain whether exercise programmes improve spinal mobility, reduce fatigue, or induce adverse effects.\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": "All data were obtained immediately upon completion of the exercise programme."
}
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query-laysum | 1187 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with diabetes mellitus (DM) sometimes present with acute or subacute, progressive, asymmetrical pain and weakness of the proximal lower limb muscles. The various names for the condition include diabetic amyotrophy, diabetic lumbosacral radiculoplexus neuropathies, diabetic femoral neuropathy or Bruns-Garland syndrome. Some studies suggest that diabetic amyotrophy may be an immune-mediated inflammatory microvasculitis causing ischaemic damage of the nerves. Immunotherapies would therefore be expected to be beneficial. This is the second update of a review first published in 2009.\nObjectives\nTo review the evidence from randomised trials for the efficacy of any form of immunotherapy in the treatment of diabetic amyotrophy.\nSearch methods\nOn 5 September 2016 we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE and Embase. We also contacted authors of relevant publications and other experts to obtain additional references, unpublished trials, and ongoing trials.\nSelection criteria\nWe intended to include all randomised and quasi-randomised trials of any immunotherapy in participants with the condition fulfilling all the following: diabetes mellitus as defined by internationally recognised criteria; acute or subacute onset of pain and lower motor neuron weakness involving predominantly the proximal muscles of the lower limbs; weakness that is not confined to one nerve or nerve root distribution; and exclusion of other causes of lumbosacral radiculopathies and plexopathy.\nData collection and analysis\nTwo authors independently examined all references retrieved by the search to select those meeting the inclusion criteria.\nMain results\nWe found only one completed placebo-controlled trial (N = 75) using intravenous methylprednisolone in diabetic amyotrophy (Dyck 2006). The results have not been fully published and were not available for analysis. The risk of bias was unclear because there was too little information to make a judgement, but we considered the trial at high risk of selective reporting. The published abstract did not report adverse events. We found no additional trials when the searches were updated in September 2016.\nAuthors' conclusions\nThere is presently no evidence from randomised trials to support a positive or negative effect of any immunotherapy in the treatment in diabetic amyotrophy.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found only one completed trial, which included 75 people who received methylprednisolone or a placebo. However the results have not been fully published and were not available for further scrutiny. The published abstract did not report adverse events. There is presently no evidence from any trial to show whether immunotherapies may benefit people with this condition.\nWe await results from trials to show whether corticosteroids, immunoglobulin or other treatments that act on the immune system have an effect in the treatment of diabetic amyotrophy.\nSearches are up to date to September 2016."
}
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query-laysum | 1188 | [
{
"role": "user",
"content": "Abstract: Background\nFebrile seizures occurring in a child older than one month during an episode of fever affect 2-4% of children in Great Britain and the United States and recur in 30%. Rapid-acting antiepileptics and antipyretics given during subsequent fever episodes have been used to avoid the adverse effects of continuous antiepileptic drugs.\nThis is an updated version of a Cochrane Review previously published in 2017.\nObjectives\nTo evaluate primarily the effectiveness and safety of antiepileptic and antipyretic drugs used prophylactically to treat children with febrile seizures; and also to evaluate any other drug intervention where there is a sound biological rationale for its use.\nSearch methods\nFor the latest update we searched the following databases on 3 February 2020: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 31 January 2020). CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including the Cochrane Epilepsy Group. We imposed no language restrictions and contacted researchers to identify continuing or unpublished studies.\nSelection criteria\nTrials using randomised or quasi-randomised participant allocation that compared the use of antiepileptics, antipyretics or recognised Central Nervous System active agents with each other, placebo, or no treatment.\nData collection and analysis\nFor the original review, two review authors independently applied predefined criteria to select trials for inclusion and extracted the predefined relevant data, recording methods for randomisation, blinding, and exclusions. For the 2016 update, a third review author checked all original inclusions, data analyses, and updated the search. For the 2020 update, one review author updated the search and performed the data analysis following a peer-review process with the original review authors. We assessed seizure recurrence at 6, 12, 18, 24, 36, 48 months, and where data were available at age 5 to 6 years along with recorded adverse effects. We evaluated the presence of publication bias using funnel plots.\nMain results\nWe included 42 articles describing 32 randomised trials, with 4431 randomised participants used in the analysis of this review. We analysed 15 interventions of continuous or intermittent prophylaxis and their control treatments. Methodological quality was moderate to poor in most studies. We found no significant benefit for intermittent phenobarbital, phenytoin, valproate, pyridoxine, ibuprofen, or zinc sulfate versus placebo or no treatment; nor for diclofenac versus placebo followed by ibuprofen, paracetamol, or placebo; nor for continuous phenobarbital versus diazepam, intermittent rectal diazepam versus intermittent valproate, or oral diazepam versus clobazam.\nThere was a significant reduction of recurrent febrile seizures with intermittent diazepam versus placebo or no treatment at six months (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.48 to 0.85; 6 studies, 1151 participants; moderate-certainty evidence), 12 months (RR 0.69, 95% CI 0.56 to 0.84; 8 studies, 1416 participants; moderate-certainty evidence), 18 months (RR 0.37, 95% CI 0.23 to 0.60; 1 study, 289 participants; low-certainty evidence), 24 months (RR 0.73, 95% CI 0.56 to 0.95; 4 studies, 739 participants; high-certainty evidence), 36 months (RR 0.58, 95% CI 0.40 to 0.85; 1 study, 139 participants; low-certainty evidence), 48 months (RR 0.36, 95% CI 0.15 to 0.89; 1 study, 110 participants; moderate-certainty evidence), with no benefit at 60 to 72 months (RR 0.08, 95% CI 0.00 to 1.31; 1 study, 60 participants; very low-certainty evidence).\nPhenobarbital versus placebo or no treatment reduced seizures at six months (RR 0.59, 95% CI 0.42 to 0.83; 6 studies, 833 participants; moderate-certainty evidence), 12 months (RR 0.54, 95% CI 0.42 to 0.70; 7 studies, 807 participants; low-certainty evidence), and 24 months (RR 0.69, 95% CI 0.53 to 0.89; 3 studies, 533 participants; moderate-certainty evidence), but not at 18 months (RR 0.77, 95% CI 0.56 to 1.05; 2 studies, 264 participants) or 60 to 72 months follow-up (RR 1.50, 95% CI 0.61 to 3.69; 1 study, 60 participants; very low-certainty evidence).\nIntermittent clobazam compared to placebo at six months resulted in a RR of 0.36 (95% CI 0.20 to 0.64; 1 study, 60 participants; low-certainty evidence), an effect found against an extremely high (83.3%) recurrence rate in the controls, a result that needs replication.\nWhen compared to intermittent diazepam, intermittent oral melatonin did not significantly reduce seizures at six months (RR 0.45, 95% CI 0.18 to 1.15; 1 study, 60 participants; very-low certainty evidence).\nWhen compared to placebo, intermittent oral levetiracetam significantly reduced recurrent seizures at 12 months (RR 0.27, 95% CI 0.15 to 0.52; 1 study, 115 participants; very low-certainty evidence).\nThe recording of adverse effects was variable. Two studies reported lower comprehension scores in phenobarbital-treated children. Adverse effects were recorded in up to 30% of children in the phenobarbital-treated groups and 36% in benzodiazepine-treated groups. We found evidence of publication bias in the meta-analyses of comparisons for phenobarbital versus placebo (seven studies) at 12 months but not at six months (six studies); and valproate versus placebo (four studies) at 12 months. There were too few studies to identify publication bias for the other comparisons.\nThe methodological quality of most of the included studies was low or very low. Methods of randomisation and allocation concealment often did not meet current standards, and 'treatment versus no treatment' was more commonly seen than 'treatment versus placebo', leading to obvious risks of bias.\nAuthors' conclusions\nWe found reduced recurrence rates for intermittent diazepam and continuous phenobarbital, with adverse effects in up to 30% of children. The apparent benefit for clobazam treatment in one trial needs to be replicated. Levetiracetam also shows benefit with a good safety profile; however, further study is required. Given the benign nature of recurrent febrile seizures, and the high prevalence of adverse effects of these drugs, parents and families should be supported with adequate contact details of medical services and information on recurrence, first aid management, and, most importantly, the benign nature of the phenomenon.\n\nGiven the provided abstract, please respond to the following query: \"Methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 32 studies with a total of 4431 children in the review. Children who had had at least one febrile seizure were assigned to one of two or more treatment groups. The studies recorded any further seizures at various time intervals between six months and up to six years of age in each group. Unwanted medication effects were also noted."
}
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query-laysum | 1189 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical excision by removal of the head of the pancreas to decompress the obstructed ducts is one of the treatment options for people with symptomatic chronic pancreatitis. Surgical excision of the head of the pancreas can be performed by excision of the duodenum along with the head of the pancreas (pancreaticoduodenectomy (PD)) or without excision of the duodenum (duodenum-preserving pancreatic head resection (DPPHR)). There is currently no consensus on the method of pancreatic head resection in people with chronic pancreatitis.\nObjectives\nTo assess the benefits and harms of duodenum-preserving pancreatic head resection versus pancreaticoduodenectomy in people with chronic pancreatitis for whom pancreatic resection is considered the main treatment option.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and trials registers to June 2015 to identify randomised trials. We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered only randomised controlled trials (RCT) performed in people with chronic pancreatitis undergoing pancreatic head resection, irrespective of language, blinding, or publication status, for inclusion in the review.\nData collection and analysis\nTwo review authors independently identified trials and extracted data. We calculated the risk ratio (RR), mean difference (MD), rate ratio (RaR), or hazard ratio (HR) with 95% confidence intervals (CI) based on an available-case analysis.\nMain results\nFive trials including 292 participants met the inclusion criteria for the review. After exclusion of 23 participants mainly due to pancreatic cancer or because participants did not receive the planned treatment, a total of 269 participants (with symptomatic chronic pancreatitis involving the head of pancreas and requiring surgery) were randomly assigned to receive DPPHR (135 participants) or PD (134 participants). The trials did not report the American Society of Anesthesiologists (ASA) status of the participants. All the trials were single-centre trials and included people with and without obstructive jaundice and people with and without duodenal stenosis but did not report data separately for those with and without jaundice or those with and without duodenal stenosis. The surgical procedures compared in the five trials included DPPHR (Beger or Frey procedures, or wide local excision of the head of the pancreas) and PD (pylorus-preserving pancreaticoduodenectomy or Whipple procedure). The participants were followed up for various periods of time ranging from one to 15 years. The trials were at unclear or high risk of bias. The overall quality of evidence was low or very low.\nThe differences in short-term mortality (up to 90 days after surgery) (RR 2.89, 95% CI 0.31 to 26.87; 369 participants; 5 studies; DPPHR: 2/135 (1.5%) versus PD: 0/134 (0%); very low quality evidence) or long-term mortality (maximal follow-up) (HR 0.65, 95% CI 0.31 to 1.34; 229 participants; 4 studies; very low quality evidence), medium-term (three months to five years) (only a narrative summary was possible; 229 participants; 4 studies; very low quality evidence), or long-term quality of life (more than five years) (MD 8.45, 95% CI -0.27 to 17.18; 101 participants; 2 studies; low quality evidence), proportion of people with adverse events (RR 0.55, 95% CI 0.22 to 1.35; 226 participants; 4 studies; DPPHR: 23/113 (adjusted proportion 20%) versus PD: 41/113 (36.3%); very low quality evidence), number of people with adverse events (RaR 0.95, 95% CI 0.43 to 2.12; 43 participants; 1 study; DPPHR: 12/22 (54.3 events per 100 participants) versus PD: 12/21 (57.1 events per 100 participants); very low quality evidence), proportion of people employed (maximal follow-up) (RR 1.54, 95% CI 1.00 to 2.37; 189 participants; 4 studies; DPPHR: 65/98 (adjusted proportion 69.4%) versus PD: 41/91 (45.1%); low quality evidence), incidence proportion of diabetes mellitus (maximum follow-up) (RR 0.78, 95% CI 0.50 to 1.22; 269 participants; 5 studies; DPPHR: 25/135 (adjusted proportion 18.6%) versus PD: 32/134 (23.9%); very low quality evidence), and prevalence proportion of pancreatic exocrine insufficiency (maximum follow-up) (RR 0.83, 95% CI 0.68 to 1.02; 189 participants; 4 studies; DPPHR: 62/98 (adjusted proportion 62.0%) versus PD: 68/91 (74.7%); very low quality evidence) were imprecise. The length of hospital stay appeared to be lower with DPPHR compared to PD and ranged between a reduction of one day and five days in the trials (208 participants; 4 studies; low quality evidence). None of the trials reported short-term quality of life (four weeks to three months), clinically significant pancreatic fistulas, serious adverse events, time to return to normal activity, time to return to work, and pain scores using a visual analogue scale.\nAuthors' conclusions\nLow quality evidence suggested that DPPHR may result in shorter hospital stay than PD. Based on low or very low quality evidence, there is currently no evidence of any difference in the mortality, adverse events, or quality of life between DPPHR and PD. However, the results were imprecise and further RCTs are required on this topic. Future RCTs comparing DPPHR with PD should report the severity as well as the incidence of postoperative complications and their impact on patient recovery. In such trials, participant and observer blinding should be performed and the analysis should be performed on an intention-to-treat basis to decrease the bias. In addition to the short-term benefits and harms such as mortality, surgery-related complications, quality of life, length of hospital stay, return to normal activity, and return to work, future trials should consider linkage of trial participants to health databases, social databases, and mortality registers to obtain the long-term benefits and harms of the different treatments.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence was low or very low. As a result, further studies are required on this topic. Such studies should report the severity of postoperative complications and their impact on patient recovery and should include all the trial participants in the results. In addition to the short-term benefits and harms such as mortality, surgery-related complications, quality of life, length of hospital stay, return to normal activity, and return to work, future trials should consider linkage of trial participants to health databases, social databases, and mortality registers to obtain the long-term benefits and harms of the different treatments."
}
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query-laysum | 1190 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is an important consequence of stroke that influences recovery yet often is not detected, or is inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and previously updated in 2008.\nObjectives\nThe primary objective is to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation, or combinations of these interventions reduce the incidence of diagnosable depression after stroke. Secondary objectives are to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation or combinations of these interventions reduce levels of depressive symptoms and dependency, and improve physical functioning after stroke. We also aim to determine the safety of, and adherence to, the interventions.\nSearch methods\nWe searched the Specialised Register of Cochrane Stroke and the Cochrane Depression Anxiety and Neurosis (last searched August 2018). In addition, we searched the following databases; Cochrane Central Register of Controlled Trials, CENTRAL (the Cochrane Library, 2018, Issue 8), MEDLINE (1966 to August 2018), Embase (1980 to August 2018), PsycINFO (1967 to August 2018), CINAHL (1982 to August 2018) and three Web of Science indexes (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); to August 2018 and ClinicalTrials.gov; to August 2018), conference proceedings; we also contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) one of various forms of psychological therapy with usual care and/or attention control; 3) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; 4) a pharmacological intervention and one of various forms of psychological therapy with a pharmacological intervention and usual care and/or attention control; 5) non-invasive brain stimulation and pharmacological intervention with a pharmacological intervention and sham stimulation or usual care; 6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; 7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; 8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and 9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of preventing depression after stroke.\nData collection and analysis\nReview authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data and risk ratio (RR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic and assessed the certainty of evidence using GRADE.\nMain results\nWe included 19 RCTs (21 interventions), with 1771 participants in the review. Data were available for 12 pharmacological trials (14 interventions) and seven psychological trials. There were no trials of non-invasive brain stimulation compared with sham stimulation or usual care, a combination of pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy, or a combination of non-invasive brain stimulation and a pharmacological intervention with a pharmacological intervention and sham stimulation or usual care to prevent depression after stroke. Treatment effects were observed on the primary outcome of meeting the study criteria for depression at the end of treatment: there is very low-certainty evidence from eight trials (nine interventions) that pharmacological interventions decrease the number of people meeting the study criteria for depression (RR 0.50, 95% CI 0.37 to 0.68; 734 participants) compared to placebo. There is very low-certainty evidence from two trials that psychological interventions reduce the proportion of people meeting the study criteria for depression (RR 0.68, 95% CI 0.49 to 0.94, 607 participants) compared to usual care and/or attention control.\nEight trials (nine interventions) found no difference in death and other adverse events between pharmacological intervention and placebo groups (RR 1.25, 95% CI 0.32 to 4.91; 496 participants) based on very low-certainty evidence. Five trials found no difference in psychological intervention and usual care and/or attention control groups for death and other adverse events (RR 1.18, 95% CI 0.73 to 1.91; 975 participants) based on very low-certainty evidence.\nAuthors' conclusions\nThe available evidence suggests that pharmacological interventions and psychological therapy may prevent depression and improve mood after stroke. However, there is very low certainty in these conclusions because of the very low-certainty evidence. More trials are required before reliable recommendations can be made about the routine use of such treatments after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The role of interventions for preventing depression after stroke is unclear. Depression is a common and important complication of stroke that is often missed or poorly managed. Little is known about whether prevention strategies started early after stroke will reduce the risk of depression and improve recovery for those not depressed at assessment."
}
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query-laysum | 1191 | [
{
"role": "user",
"content": "Abstract: Background\nRespiratory support is a central component of the management of critically ill children. It can be delivered invasively via an endotracheal tube or non-invasively via face mask, nasal mask, nasal cannula or oxygen hood/tent. Invasive ventilation can be damaging to the lungs, and the tendency to use non-invasive forms is growing. However, non-invasive delivery is often poorly tolerated by children. High-flow nasal cannula (HFNC) oxygen delivery is a relatively new therapy that shows the potential to reduce the need for intubation and be better tolerated by children than other non-invasive forms of support. HFNC therapy differs from other non-invasive forms of treatment in that it delivers heated, humidified and blended air/oxygen via nasal cannula at rates > 2 L/kg/min. This allows the user to deliver high concentrations of oxygen and to potentially deliver continuous distending pressure; this treatment often is better tolerated by the child.\nObjectives\nTo determine whether HFNC therapy is more effective than other forms of non-invasive therapy in paediatric patients who require respiratory support.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 4); MEDLINE via PubMed (January 1966 to April 2013); EMBASE (January 1980 to April 2013); CINAHL (1982 to April 2013); and LILACS (1982 to April 2013). Abstracts from conference proceedings, theses and dissertations and bibliographical references to relevant studies were also searched. We applied no restriction on language.\nSelection criteria\nWe planned to included randomized controlled trials (RCTs) and quas-randomized trials comparing HFNC therapy with other forms of non-invasive respiratory support for children. Non-invasive support encompassed cot, hood or tent oxygen; low-flow nasal cannulae (flow rates ≤ 2 L/min); and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) delivered via facial or nasal mask/cannula. Treatment failure was defined by the need for additional respiratory support. We excluded children with a diagnosis of bronchiolitis.\nData collection and analysis\nTwo review authors independently assessed all studies for selection and data extraction. We used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nOur search yielded 922 records. A total of 109 relevant records were retrieved with reference to our search criteria. After duplicates and irrelevant studies were removed, 69 studies were further scrutinized. Of these, 11 studies involved children. No study matched our inclusion criteria.\nAuthors' conclusions\nBased on the results of this review, no evidence is available to allow determination of the safety or effectiveness of HFNC as a form of respiratory support in children.\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 studies on children from four weeks to 16 years of age. We searched for randomized controlled trials; however we excluded studies involving infants with bronchiolitis (a respiratory illness affecting infants that typically mimics a common cold) because children with this condition are included in another Cochrane review."
}
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query-laysum | 1192 | [
{
"role": "user",
"content": "Abstract: Background\nGuillain-Barré syndrome (GBS) is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin (IVIg) is beneficial in other autoimmune diseases. This is an update of a review first published in 2001 and previously updated in 2003, 2005, 2007, 2010 and 2012. Other Cochrane systematic reviews have shown that plasma exchange (PE) significantly hastens recovery in GBS compared with supportive treatment alone, and that corticosteroids alone are ineffective.\nObjectives\nWe had the following four objectives.\n1. To examine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the long-term morbidity from Guillain-Barré syndrome (GBS).\n2. To determine the most efficacious dose of IVIg in hastening recovery and reducing the long-term morbidity from GBS.\n3. To compare the efficacy of IVIg and plasma exchange (PE) or immunoabsorption in hastening recovery and reducing the long-term morbidity from GBS.\n4. To compare the efficacy of IVIg added to PE with PE alone in hastening recovery and reducing the long-term morbidity from GBS.\nSearch methods\nWe searched the Cochrane Neuromuscular Disease Group Specialized Register (2 December 2013), CENTRAL (2013, Issue 12 in The Cochrane Library), MEDLINE (January 1966 to November 2013) and EMBASE (January 1980 to November 2013). We checked the bibliographies in reports of the randomised trials and contacted the authors and other experts in the field to identify additional published or unpublished data.\nSelection criteria\nRandomised and quasi-randomised trials of IVIg compared with no treatment, placebo treatment, PE, or other immunomodulatory treatments in children and adults with GBS of all degrees of severity. We also included trials in which IVIg was added to another treatment.\nData collection and analysis\nTwo authors independently selected papers, extracted data and assessed quality. We collected data about adverse events from the included trials.\nMain results\nTwelve trials were found to be eligible for inclusion in this review. Seven trials with a variable risk of bias compared IVIg with PE in 623 severely affected participants. In five trials with 536 participants for whom the outcome was available, the mean difference (MD) of change in a seven-grade disability scale after four weeks was not significantly different between the two treatments: MD of 0.02 of a grade more improvement in the intravenous immunoglobulin than the plasma exchange group; 95% confidence interval (CI) 0.25 to -0.20. There were also no statistically significant differences in the other measures considered. Three studies including a total of 75 children suggested that IVIg significantly hastens recovery compared with supportive care. The primary outcome for this review, available for only one trial with 21 mildly affected children, showed significantly more improvement in disability grade after four weeks with IVIg than supportive treatment alone, MD 1.42, 95% CI 2.57 to 0.27.\nIn one trial involving 249 participants comparing PE followed by IVIg with PE alone, the mean grade improvement was 0.2 (95% CI -0.14 to 0.54) more in the combined treatment group than in the PE alone group; not clinically significantly different, but not excluding the possibility of significant extra benefit. Another trial with 34 participants comparing immunoabsorption followed by IVIg with immunoabsorption alone did not reveal significant extra benefit from the combined treatment.\nAdverse events were not significantly more frequent with either treatment, but IVIg is significantly much more likely to be completed than PE.\nOne trial in altogether 51 children showed no significant difference when the standard dose was given over two days rather than five days.\nAuthors' conclusions\nA previous Cochrane review has shown that PE hastens recovery compared with supportive treatment alone. There are no adequate comparisons of IVIg with placebo in adults, but this review provides moderate quality evidence that, in severe disease, IVIg started within two weeks from onset hastens recovery as much as PE. Adverse events were not significantly more frequent with either treatment but IVIg is significantly much more likely to be completed than PE. Also, according to moderate quality evidence, giving IVIg after PE did not confer significant extra benefit. In children, according to low quality evidence, IVIg probably hastens recovery compared with supportive care alone. More research is needed in mild disease and in patients whose treatment starts more than two weeks after onset. Dose-ranging studies are also needed and one is in progress.\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": "Five of the trials comparing IVIg and PE measured change in disability. IVIg and PE produced a similar amount of improvement in disability in the 536 trial participants. This evidence was of moderate quality. Harmful effects were no more frequent with PE or IVIg, but people were more likely to finish a course of IVIg.\nIn one trial involving 249 participants who received PE or PE followed by IVIg, there was slightly more improvement from PE and IVIg together. The effect was probably not large enough to be noticeable but the results do not rule out the possibility. This evidence was of moderate quality.\nThree studies in children suggested that IVIg speeds up recovery compared with supportive care. Only one used the disability scale. They provided low quality evidence.\nIn one small trial in children, the effect on disability appeared similar with a standard dose over two days rather than five days.\nGiving IVIg after immunoabsorption provided no extra benefit over immunoabsorption alone. No conclusions can be drawn from the trial comparing IVIg with immunoabsorption.\nThe risk of bias in the included studies was variable.\nMore research is needed to find the best dose of IVIg in adults and children, and one trial of giving a second dose to people who otherwise would be expected to do badly is in progress.\nThe evidence is current to December 2013."
}
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query-laysum | 1193 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin A deficiency is a major public health problem in low and middle income countries. Vitamin A supplementation in children six months of age and older has been found to be beneficial, but no effect of supplementation has been noted for children between one and five months of age. Supplementation during the neonatal period has been suggested to have an impact by increasing body stores in early infancy.\nObjectives\nTo evaluate the role of vitamin A supplementation for term neonates in low and middle income countries with respect to prevention of mortality and morbidity.\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 2), MEDLINE via PubMed (1966 to 13 March 2016), Embase (1980 to 13 March 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 13 March 2016). We also searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised controlled trials. Also trials with a factorial design.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted study data. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence.\nMain results\nWe included 12 trials (168,460 neonates) in this review, with only a few trials reporting disaggregated data for term infants. Therefore, we analysed data and presented estimates for term infants (when specified) and for all infants.\nData for term neonates from three studies did not show a statistically significant effect on the risk of infant mortality at six months in the vitamin A group compared with the control group (typical risk ratio (RR) 0.80; 95% confidence interval (CI) 0.54 to 1.18; I2 = 63%). Analysis of data for all infants from 11 studies revealed no evidence of a significant reduction in the risk of infant mortality at six months among neonates supplemented with vitamin A compared with control neonates (typical RR 0.98, 95% CI 0.89 to 1.07; I2 = 47%). We observed similar results for infant mortality at 12 months of age with no significant effect of vitamin A compared with control (typical RR 1.04, 95% CI 0.94 to 1.15; I2 = 47%). Limited data were available for the outcomes of cause-specific mortality and morbidity, vitamin A deficiency, anaemia and adverse events.\nAuthors' conclusions\nGiven the high burden of death among children younger than five years of age in low and middle income countries, and the fact that mortality in infancy is a major contributory cause, it is critical to obtain sound scientific evidence of the effect of vitamin A supplementation during the neonatal period on infant mortality and morbidity. Evidence provided in this review does not indicate a potential beneficial effect of vitamin A supplementation among neonates at birth in reducing mortality during the first six months or 12 months of life. Given this finding and the absence of a clear indication of the biological mechanism through which vitamin A could affect mortality, along with substantial conflicting findings from individual studies conducted in settings with potentially varying levels of maternal vitamin A deficiency and infant mortality, absence of follow-up studies assessing any long-term impact of a bulging fontanelle after supplementation and the finding of a potentially harmful effect among female infants, additional research is warranted before a decision can be reached regarding policy recommendations for this intervention.\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": "Analysis of data for all infants shows no significant reduction in infant deaths at six months of age with the intervention and similar findings for infant deaths at 12 months of age."
}
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query-laysum | 1194 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants often start milk feeds by gavage tube. As they mature, sucking feeds are gradually introduced. Women with preterm infants may not always be in hospital to breastfeed their baby and need an alternative approach to feeding. Most commonly, milk (expressed breast milk or formula) is given by bottle. Whether using bottles during establishment of breastfeeds is detrimental to breastfeeding success is a topic of ongoing debate.\nObjectives\nTo identify the effects of avoidance of bottle feeds during establishment of breastfeeding on the likelihood of successful breastfeeding, and to assess the safety of alternatives to bottle feeds.\nSearch methods\nA new search strategy was developed for this update. Searches were conducted without date or language limits in September 2021 in: MEDLINE, CENTRAL, and CINAHL. We also searched the ISRCTN trial registry and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs comparing avoidance of bottles with use of bottles for preterm infants where their mothers planned to breastfeed.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. When appropriate, we contacted study authors for additional information. We used the GRADE approach to assess the certainty of evidence. Outcomes included full breastfeeding and any breastfeeding on discharge home and at three and six months after discharge, as well as length of hospital stay and episodes of infant infection. We synthesised data using risk ratios (RR), risk differences (RD) and mean differences (MD), with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included seven trials with 1152 preterm infants in this updated review. There are three studies awaiting classification. Five included studies used a cup feeding strategy, one used a tube feeding strategy and one used a novel teat when supplements to breastfeeds were needed. We included the novel teat study in this review as the teat was designed to closely mimic the sucking action of breastfeeding. The trials were of small to moderate size, and two had high risk of attrition bias. Adherence with cup feeding was poor in one of the studies, indicating dissatisfaction with this method by staff or parents (or both); the remaining four cup feeding studies provided no such reports of dissatisfaction or low adherence.\nAvoiding bottles may increase the extent of full breastfeeding on discharge home (RR 1.47, 95% CI 1.19 to 1.80; 6 studies, 1074 infants; low-certainty evidence), and probably increases any breastfeeding (full and partial combined) on discharge (RR 1.11, 95% CI 1.06 to 1.16; studies, 1138 infants; moderate-certainty evidence). Avoiding bottles probably increases the occurrence of full breastfeeding three months after discharge (RR 1.56, 95% CI 1.37 to 1.78; 4 studies, 986 infants; moderate-certainty evidence), and may also increase full breastfeeding six months after discharge (RR 1.64, 95% CI 1.14 to 2.36; 3 studies, 887 infants; low-certainty evidence).\nAvoiding bottles may increase the occurrence of any breastfeeding (full and partial combined) three months after discharge (RR 1.31, 95% CI 1.01 to 1.71; 5 studies, 1063 infants; low-certainty evidence), and six months after discharge (RR 1.25, 95% CI 1.10 to 1.41; 3 studies, 886 infants; low-certainty evidence). The effects on breastfeeding outcomes were evident at all time points for the tube alone strategy and for all except any breastfeeding three months after discharge for cup feeding, but were not present for the novel teat. There were no other benefits or harms including for length of hospital stay (MD 2.25 days, 95% CI −3.36 to 7.86; 4 studies, 1004 infants; low-certainty evidence) or episodes of infection per infant (RR 0.70, 95% CI 0.35 to 1.42; 3 studies, 500 infants; low-certainty evidence).\nAuthors' conclusions\nAvoiding the use of bottles when preterm infants need supplementary feeds probably increases the extent of any breastfeeding at discharge, and may improve any and full breastfeeding (exclusive) up to six months postdischarge. Most of the evidence demonstrating benefit was for cup feeding. Only one study used a tube feeding strategy. We are uncertain whether a tube alone approach to supplementing breastfeeds improves breastfeeding outcomes; further studies of high certainty are needed to determine this.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "we have low to moderate confidence in these results."
}
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query-laysum | 1195 | [
{
"role": "user",
"content": "Abstract: Background\nCritically ill patients require regular body position changes to minimize the adverse effects of bed rest, inactivity and immobilization. However, uncertainty surrounds the effectiveness of lateral positioning for improving pulmonary gas exchange, aiding drainage of tracheobronchial secretions and preventing morbidity. In addition, it is unclear whether the perceived risk levied by respiratory and haemodynamic instability upon turning critically ill patients outweighs the respiratory benefits of side-to-side rotation. Thus, lack of certainty may contribute to variation in positioning practice and equivocal patient outcomes.\nObjectives\nTo evaluate effects of the lateral position compared with other body positions on patient outcomes (mortality, morbidity and clinical adverse events) in critically ill adult patients. (Clinical adverse events include hypoxaemia, hypotension, low oxygen delivery and global indicators of impaired tissue oxygenation.) We examined single use of the lateral position (i.e. on the right or left side) and repeat use of the lateral position (i.e. lateral positioning) within a positioning schedule.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5), MEDLINE (1950 to 23 May 2015), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 to 23 May 2015), the Allied and Complementary Medicine Database (AMED) (1984 to 23 May 2015), Latin American Caribbean Health Sciences Literature (LILACS) (1901 to 23 May 2015), Web of Science (1945 to 23 May 2015), Index to Theses in Great Britain and Ireland (1950 to 23 May 2015), Trove (2009 to 23 May 2015; previously Australasian Digital Theses Program (1997 to December 2008)) and Proquest Dissertations and Theses (2009 to 23 May 2015; previously Proquest Digital Dissertations (1980 to 23 May 2015)). We handsearched the reference lists of potentially relevant reports and two nursing journals.\nSelection criteria\nWe included randomized and quasi-randomized trials examining effects of lateral positioning in critically ill adults. We included manual or automated turns but limited eligibility to studies that included duration of body position of 10 minutes or longer. We examined each lateral position versus at least one comparator (opposite lateral position and/or another body position) for single therapy effects, and the lateral positioning schedule (repeated lateral turning) versus other positioning schedules for repetitive therapy effects.\nData collection and analysis\nWe pre-specified methods to be used for data collection, risk of bias assessment and analysis. Two independent review authors carried out each stage of selection and data extraction and settled differences in opinion by consensus, or by third party adjudication when disagreements remained unresolved. We planned analysis of pair-wise comparisons under composite time intervals with the aim of considering recommendations based on meta-analyses of studies with low risk of bias.\nMain results\nWe included 24 studies of critically ill adults. No study reported mortality as an outcome of interest. Two randomized controlled trials (RCTs) examined lateral positioning for pulmonary morbidity outcomes but provided insufficient information for meta-analysis. A total of 22 randomized trials examined effects of lateral positioning (four parallel-group and 18 cross-over designs) by measuring various continuous data outcomes commonly used to detect adverse cardiopulmonary events within critical care areas. However, parallel-group studies were not comparable, and cross-over studies provided limited data as the result of unit of analysis errors. Eight studies provided some data; most of these were single studies with small effects that were imprecise. We pooled partial pressure of arterial oxygen (PaO2) as a measure to detect hypoxaemia from two small studies of participants with unilateral lung disease (n = 19). The mean difference (MD) between lateral positions (bad lung down versus good lung down) was approximately 50 mmHg (MD -49.26 mmHg, 95% confidence interval (CI) -67.33 to -31.18; P value < 0.00001). Despite a lower mean PaO2 for bad lung down, hypoxaemia (mean PaO2 < 60 mmHg) was not consistently reported. Furthermore, pooled data had methodological shortcomings with unclear risk of bias. We had similar doubts regarding internal validity for other studies included in the review.\nAuthors' conclusions\nReview authors could provide no clinical practice recommendations based on the findings of included studies. Available research could not eliminate the uncertainty surrounding benefits and/or risks associated with lateral positioning of critically ill adult patients. Research gaps include the effectiveness of lateral positioning compared with semi recumbent positioning for mechanically ventilated patients, lateral positioning compared with prone positioning for acute respiratory distress syndrome (ARDS) and less frequent changes in body position. We recommend that future research be undertaken to address whether the routine practice of repositioning patients on their side benefits all, some or few critically ill patients.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 24 eligible studies. No studies reported on mortality. Two studies reported on pulmonary morbidity following cardiac surgery, but available data were insufficient for analysis. The other studies reported measures that we included to identify clinical adverse events. Most of these studies did not report results in a way that could be combined for review of evidence, and trial design was often dissimilar. We compared two studies of critically ill adults with unilateral lung disease (one 'bad lung' and one 'good lung'). Oxygen levels within the blood were lower for 'bad lung down' (side lying with the 'bad lung' lowermost). However, the sample was small, both studies were of poor quality and very low oxygen levels in the blood were not consistently found across studies. Therefore, results need to be viewed with caution."
}
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query-laysum | 1196 | [
{
"role": "user",
"content": "Abstract: Background\nParacetamol, either alone or in combination with codeine or dihydrocodeine, is commonly used to treat chronic neuropathic pain. This review sought evidence for efficacy and harm from randomised double-blind studies.\nObjectives\nTo assess the analgesic efficacy and adverse events of paracetamol with or without codeine or dihydrocodeine for chronic neuropathic pain in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to July 2016, together with reference lists of retrieved papers and reviews, and two online study registries.\nSelection criteria\nWe included randomised, double-blind studies of two weeks' duration or longer, comparing paracetamol, alone or in combination with codeine or dihydrocodeine, with placebo or another active treatment in chronic neuropathic pain.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE.\nMain results\nNo study satisfied the inclusion criteria. Effects of interventions were not assessed as there were no included studies. We have only very low quality evidence and have no reliable indication of the likely effect.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the suggestion that paracetamol alone, or in combination with codeine or dihydrocodeine, works in any neuropathic pain 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": "Neuropathic pain is pain coming from damaged nerves. It is different from pain messages that are carried along healthy nerves from damaged tissue (e.g. a fall or cut, or arthritic knee). Neuropathic pain is often treated by different medicines (drugs) to those used for pain from damaged tissue, which we often think of as painkillers. Medicines that are sometimes used to treat depression or epilepsy (fits) can be very effective in some people with neuropathic pain. But sometimes paracetamol is used to treat neuropathic pain, either by itself or with the opioid painkillers codeine or dihydrocodeine.\nParacetamol has been widely available for over 50 years. There is evidence it works as a painkiller in some short-lived pains, but it does not appear to work well for long lasting pains. We do not really know how it works. Paracetamol is commonly used combined with opioid drugs.\nOpioid painkillers are drugs like morphine. Morphine is derived from plants, but many opioids are also made in a laboratory rather than being extracted from plants. Codeine and dihydrocodeine are often combined with paracetamol."
}
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query-laysum | 1197 | [
{
"role": "user",
"content": "Abstract: Background\nProlonged treatment with benzodiazepines is common practice despite clinical recommendations of short-term use. Benzodiazepines are used by approximately 4% of the general population, with increased prevalence in psychiatric populations and the elderly. After long-term use it is often difficult to discontinue benzodiazepines due to psychological and physiological dependence. This review investigated if pharmacological interventions can facilitate benzodiazepine tapering.\nObjectives\nTo assess the benefits and harms of pharmacological interventions to facilitate discontinuation of chronic benzodiazepine use.\nSearch methods\nWe searched the following electronic databases up to October 2017: Cochrane Drugs and Alcohol Group's Specialised Register of Trials, CENTRAL, PubMed, Embase, CINAHL, and ISI Web of Science. We also searched ClinicalTrials.gov, the WHO ICTRP, and ISRCTN registry, and checked the reference lists of included studies for further references to relevant randomised controlled trials.\nSelection criteria\nWe included randomised controlled trials comparing pharmacological treatment versus placebo or no intervention or versus another pharmacological intervention in adults who had been treated with benzodiazepines for at least two months and/or fulfilled criteria for benzodiazepine dependence (any criteria).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 38 trials (involving 2543 participants), but we could only extract data from 35 trials with 2295 participants. Many different interventions were studied, and no single intervention was assessed in more than four trials. We extracted data on 18 different comparisons. The risk of bias was high in all trials but one. Trial Sequential Analysis showed imprecision for all comparisons.\nFor benzodiazepine discontinuation, we found a potential benefit of valproate at end of intervention (1 study, 27 participants; risk ratio (RR) 2.55, 95% confidence interval (CI) 1.08 to 6.03; very low-quality evidence) and of tricyclic antidepressants at longest follow-up (1 study, 47 participants; RR 2.20, 95% CI 1.27 to 3.82; low-quality evidence).\nWe found potentially positive effects on benzodiazepine withdrawal symptoms of pregabalin (1 study, 106 participants; mean difference (MD) -3.10 points, 95% CI -3.51 to -2.69; very low-quality evidence), captodiame (1 study, 81 participants; MD -1.00 points, 95% CI -1.13 to -0.87; very low-quality evidence), paroxetine (2 studies, 99 participants; MD -3.57 points, 95% CI -5.34 to -1.80; very low-quality evidence), tricyclic antidepressants (1 study, 38 participants; MD -19.78 points, 95% CI -20.25 to -19.31; very low-quality evidence), and flumazenil (3 studies, 58 participants; standardised mean difference -0.95, 95% CI -1.71 to -0.19; very low-quality evidence) at end of intervention. However, the positive effect of paroxetine on benzodiazepine withdrawal symptoms did not persist until longest follow-up (1 study, 54 participants; MD -0.13 points, 95% CI -4.03 to 3.77; very low-quality evidence).\nThe following pharmacological interventions reduced symptoms of anxiety at end of intervention: carbamazepine (1 study, 36 participants; MD -6.00 points, 95% CI -9.58 to -2.42; very low-quality evidence), pregabalin (1 study, 106 participants; MD -4.80 points, 95% CI -5.28 to -4.32; very low-quality evidence), captodiame (1 study, 81 participants; MD -5.70 points, 95% CI -6.05 to -5.35; very low-quality evidence), paroxetine (2 studies, 99 participants; MD -6.75 points, 95% CI -9.64 to -3.86; very low-quality evidence), and flumazenil (1 study, 18 participants; MD -1.30 points, 95% CI -2.28 to -0.32; very low-quality evidence).\nTwo pharmacological treatments seemed to reduce the proportion of participants that relapsed to benzodiazepine use: valproate (1 study, 27 participants; RR 0.31, 95% CI 0.11 to 0.90; very low-quality evidence) and cyamemazine (1 study, 124 participants; RR 0.33, 95% CI 0.14 to 0.78; very low-quality evidence). Alpidem decreased the proportion of participants with benzodiazepine discontinuation (1 study, 25 participants; RR 0.41, 95% CI 0.17 to 0.99; number needed to treat for an additional harmful outcome (NNTH) 2.3 participants; low-quality evidence) and increased the occurrence of withdrawal syndrome (1 study, 145 participants; RR 4.86, 95% CI 1.12 to 21.14; NNTH 5.9 participants; low-quality evidence). Likewise, magnesium aspartate decreased the proportion of participants discontinuing benzodiazepines (1 study, 144 participants; RR 0.80, 95% CI 0.66 to 0.96; NNTH 5.8; very low-quality evidence).\nGenerally, adverse events were insufficiently reported. Specifically, one of the flumazenil trials was discontinued due to severe panic reactions.\nAuthors' conclusions\nGiven the low or very low quality of the evidence for the reported outcomes, and the small number of trials identified with a limited number of participants for each comparison, it is not possible to draw firm conclusions regarding pharmacological interventions to facilitate benzodiazepine discontinuation in chronic benzodiazepine users. Due to poor reporting, adverse events could not be reliably assessed across trials. More randomised controlled trials are required with less risk of systematic errors ('bias') and of random errors ('play of chance') and better and full reporting of patient-centred and long-term clinical outcomes. Such trials ought to be conducted independently of industry involvement.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The quality of the evidence was generally low or very low due to the small number of trials including a limited number of participants for each comparison; dissimilar results across studies; poor study design; and pronounced financial involvement of the pharmaceutical industry. Randomised controlled trials are therefore needed without risk of bias and random significant results involving long-term assessments of participants conducted without involvement of industry."
}
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query-laysum | 1198 | [
{
"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antibiotics, the most common treatment for CSOM, act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM, such as antiseptics or ear cleaning (aural toileting).\nObjectives\nTo assess the effects of topical antibiotics (without steroids) for people with CSOM.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks.\nThe interventions were any single, or combination of, topical antibiotic agent(s) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure.\nThe two main comparisons were topical antibiotic compared to a) placebo or no intervention and b) another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B).\nWithin each comparison we separated studies where both groups of participants had received topical antibiotic a) alone or with aural toileting and b) on top of background treatment (such as systemic antibiotics).\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.\nMain results\nWe included 17 studies with a total of 2198 participants. Twelve studies reported the sample size in terms of participants (not ears); these had a total of 1797 participants. The remaining five studies reported both the number of participants and ears, representing 401 participants, or 510 ears.\nA: Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment)\nOne small study compared a topical antibiotic (ciprofloxacin) with placebo (saline). All participants received aural toilet. Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other. The study authors reported that \"no medical side-effects and worsening of audiological measurements related to this topical medication were detected\" (very low-certainty evidence).\nB: Topical antibiotics versus placebo or no treatment (with use of oral antibiotics in both arms)\nFour studies compared topical ciprofloxacin to no treatment (three studies; 190 participants) or topical ceftizoxime to no treatment (one study; 248 participants). In each study all participants received the same antibiotic systemically (oral ciprofloxacin, injected ceftizoxime). In at least one study all participants received aural toilet. Useable data were only available from the first three studies; ciprofloxacin was better than no treatment, resolution of discharge occurring in 88.2% versus 60% at one to two weeks (RR 1.47, 95% CI 1.20 to 1.80; 2 studies, 150 participants; low-certainty evidence). None of the studies reported ear pain or discomfort/local irritation.\nC: Comparisons of different topical antibiotics\nThe certainty of evidence for all outcomes in these comparisons is very low.\nQuinolones versus aminoglycosides\nSeven studies compared an aminoglycoside (gentamicin, neomycin or tobramycin) with ciprofloxacin (734 participants) or ofloxacin (214 participants). Whilst resolution of discharge at one to two weeks was higher in the quinolones group the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other (RR 1.95, 95% CI 0.88 to 4.29; 6 studies, 694 participants). One study measured ear pain and reported no difference between the groups.\nQuinolones versus aminoglycosides/polymyxin B combination ±gramicidin\nWe identified three studies but data on our primary outcome were only available in one study. Comparing ciprofloxacin to a neomycin/polymyxin B/gramicidin combination, for an unknown treatment duration (likely four weeks), ciprofloxacin was better (RR 1.12, 95% CI 1.03 to 1.22, 186 participants). A \"few\" patients experienced local irritation upon the first instillation of topical treatment (numbers/groups not stated).\nOthers\nOther studies examined topical gentamicin versus a trimethoprim/sulphacetamide/polymixin B combination (91 participants) and rifampicin versus chloramphenicol (160 participants). Limited data were available and the findings were very uncertain.\nAuthors' conclusions\nWe are uncertain about the effectiveness of topical antibiotics in improving resolution of ear discharge in patients with CSOM because of the limited amount of low-quality evidence available. However, amongst this uncertainty there is some evidence to suggest that the use of topical antibiotics may be effective when compared to placebo, or when used in addition to a systemic antibiotic. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 17 studies examining at least 2126 participants, but it was difficult to determine precisely how many participants were included as a number of studies did not clearly report the number. A number of different types of antibiotics and combinations of antibiotics were used.\nComparison of topical antibiotics to placebo or no treatment\nOne study compared topical antibiotics to a saline (salt water) ear wash. The topical antibiotics appeared to be more effective than the saline ear wash when assessed one to two weeks after treatment, but this study was too small to provide any certainty of the findings (very low-certainty evidence).\nComparison of topical antibiotics in addition to systemic (oral or injected) antibiotics\nFour studies compared treatment with topical antibiotic (ciprofloxacin) drops in addition to a systemic (oral or injected) antibiotic. Treatment marginally favoured the combined topical and oral antibiotics compared to oral antibiotics only for resolution of discharge at one to two weeks and two to four weeks. These studies were too small to provide any certainty of the findings (low-certainty evidence).\nComparisons of different topical antibiotics\nThere were 12 studies that examined the effectiveness of different types of antibiotics. The certainty of the evidence for all outcomes in these comparisons is very low. Two studies did not report the number of included participants, or reported only the number of ears treated, so the total number of participants could not be calculated. Due to the low certainty of evidence it is not known which type of topical antibiotic is the most effective."
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query-laysum | 1199 | [
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"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane review first published in The Cochrane Library in Issue 4, 2007 and previously updated in 2011.\nUnilateral peripheral vestibular dysfunction (UPVD) can occur as a result of disease, trauma or postoperatively. The dysfunction is characterised by complaints of dizziness, visual or gaze disturbances and balance impairment. Current management includes medication, physical manoeuvres and exercise regimes, the latter known collectively as vestibular rehabilitation.\nObjectives\nTo assess the effectiveness of vestibular rehabilitation in the adult, community-dwelling population of people with symptomatic unilateral peripheral vestibular dysfunction.\nSearch methods\nWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The most recent search was 18 January 2014.\nSelection criteria\nRandomised controlled trials of adults living in the community, diagnosed with symptomatic unilateral peripheral vestibular dysfunction. We sought comparisons of vestibular rehabilitation versus control (e.g. placebo), other treatment (non-vestibular rehabilitation, e.g. pharmacological) or another form of vestibular rehabilitation. Our primary outcome measure was change in the specified symptomatology (for example, proportion with dizziness resolved, frequency or severity of dizziness). Secondary outcomes were measures of function, quality of life and/or measure(s) of physiological status, where reproducibility has been confirmed and shown to be relevant or related to health status (for example, posturography), and adverse effects\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included 39 studies involving 2441 participants with unilateral peripheral vestibular disorders in the review. Trials addressed the effectiveness of vestibular rehabilitation against control/sham interventions, medical interventions or other forms of vestibular rehabilitation. Non-blinding of outcome assessors and selective reporting were threats that may have biased the results in 25% of studies, but otherwise there was a low risk of selection or attrition bias.\nIndividual and pooled analyses of the primary outcome, frequency of dizziness, showed a statistically significant effect in favour of vestibular rehabilitation over control or no intervention (odds ratio (OR) 2.67, 95% confidence interval (CI) 1.85 to 3.86; four studies, 565 participants). Secondary outcomes measures related to levels of activity or participation measured, for example, with the Dizziness Handicap Inventory, which also showed a strong trend towards significant differences between the groups (standardised mean difference (SMD) -0.83, 95% CI -1.02 to -0.64). The exception to this was when movement-based vestibular rehabilitation was compared to physical manoeuvres for benign paroxysmal positional vertigo (BPPV), where the latter was shown to be superior in cure rate in the short term (OR 0.19, 95% CI 0.07 to 0.49). There were no reported adverse effects.\nAuthors' conclusions\nThere is moderate to strong evidence that vestibular rehabilitation is a safe, effective management for unilateral peripheral vestibular dysfunction, based on a number of high-quality randomised controlled trials. There is moderate evidence that vestibular rehabilitation resolves symptoms and improves functioning in the medium term. However, there is evidence that for the specific diagnostic group of BPPV, physical (repositioning) manoeuvres are more effective in the short term than exercise-based vestibular rehabilitation; although a combination of the two is effective for longer-term functional recovery. There is insufficient evidence to discriminate between differing forms of vestibular rehabilitation.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with vestibular problems often experience dizziness and trouble with vision, balance or mobility. The vestibular disorders that are called unilateral and peripheral (UPVD) are those that affect one side of the vestibular system (unilateral) and only the portion of the system that is outside of the brain (peripheral - part of the inner ear). Examples of these disorders include benign paroxysmal positional vertigo (BPPV), vestibular neuritis, labyrinthitis, one-sided Ménière's disease or vestibular problems following surgical procedures such as labyrinthectomy or removal of an acoustic neuroma. Vestibular rehabilitation for these disorders is becoming increasingly used and involves various movement-based regimes. Components of vestibular rehabilitation may involve learning to bring on the symptoms to 'desensitise' the vestibular system, learning to co-ordinate eye and head movements, improving balance and walking skills, and learning about the condition and how to cope or become more active."
}
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query-laysum | 1200 | [
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) has major short- and long-term implications for both the mother and her baby. GDM is defined as a carbohydrate intolerance resulting in hyperglycaemia or any degree of glucose intolerance with onset or first recognition during pregnancy from 24 weeks' gestation onwards and which resolves following the birth of the baby. Rates for GDM can be as high as 25% depending on the population and diagnostic criteria used, and overall rates are increasing globally. There is wide variation internationally in glycaemic treatment target recommendations for women with GDM that are based on consensus rather than high-quality trials.\nObjectives\nTo assess the effect of different intensities of glycaemic control in pregnant women with GDM on maternal and infant health outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (26 September 2022), and reference lists of the retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs, and quasi-RCTs. Trials were eligible for inclusion if women were diagnosed with GDM during pregnancy and the trial compared tighter and less-tight glycaemic targets during management. We defined tighter glycaemic targets as lower numerical glycaemic concentrations, and less-tight glycaemic targets as higher numerical glycaemic concentrations.\nData collection and analysis\nWe used standard Cochrane methods for carrying out data collection, assessing risk of bias, and analysing results. Two review authors independently assessed trial eligibility for inclusion, evaluated risk of bias, and extracted data for the four included studies. We assessed the certainty of evidence for selected outcomes using the GRADE approach. Primary maternal outcomes included hypertensive disorders of pregnancy and subsequent development of type 2 diabetes. Primary infant outcomes included perinatal mortality, large-for-gestational-age, composite of mortality or serious morbidity, and neurosensory disability.\nMain results\nThis was an update of a previous review completed in 2016. We included four RCTs (reporting on 1731 women) that compared a tighter glycaemic control with less-tight glycaemic control in women diagnosed with GDM. Three studies were parallel RCTs, and one study was a stepped-wedged cluster-RCT. The trials took place in Canada, New Zealand, Russia, and the USA. We judged the overall risk of bias to be unclear. Two trials were only published in abstract form. Tight glycaemic targets used in the trials ranged between ≤ 5.0 and 5.1 mmol/L for fasting plasma glucose and ≤ 6.7 and 7.4 mmol/L postprandial. Less-tight targets for glycaemic control used in the included trials ranged between < 5.3 and 5.8 mmol/L for fasting plasma glucose and < 7.8 and 8.0 mmol/L postprandial.\nFor the maternal outcomes, compared with less-tight glycaemic control, the evidence suggests a possible increase in hypertensive disorders of pregnancy with tighter glycaemic control (risk ratio (RR) 1.16, 95% confidence interval (CI) 0.80 to 1.69, 2 trials, 1491 women; low certainty evidence); however, the 95% CI is compatible with a wide range of effects that encompass both benefit and harm. Tighter glycaemic control likely results in little to no difference in caesarean section rates (RR 0.98, 95% CI 0.82 to 1.17, 3 studies, 1662 women; moderate certainty evidence) or induction of labour rates (RR 0.96, 95% CI 0.78 to 1.18, 1 study, 1096 women; moderate certainty evidence) compared with less-tight control. No data were reported for the outcomes of subsequent development of type 2 diabetes, perineal trauma, return to pre-pregnancy weight, and postnatal depression.\nFor the infant outcomes, it was difficult to determine if there was a difference in perinatal mortality (RR not estimable, 2 studies, 1499 infants; low certainty evidence), and there was likely no difference in being large-for-gestational-age (RR 0.96, 95% CI 0.72 to 1.29, 3 studies, 1556 infants; moderate certainty evidence). The evidence suggests a possible reduction in the composite of mortality or serious morbidity with tighter glycaemic control (RR 0.84, 95% CI 0.55 to 1.29, 3 trials, 1559 infants; low certainty evidence); however, the 95% CI is compatible with a wide range of effects that encompass both benefit and harm. There is probably little difference between groups in infant hypoglycaemia (RR 0.92, 95% CI 0.72 to 1.18, 3 studies, 1556 infants; moderate certainty evidence). Tighter glycaemic control may not reduce adiposity in infants of women with GDM compared with less-tight control (mean difference −0.62%, 95% CI −3.23 to 1.99, 1 study, 60 infants; low certainty evidence), but the wide CI suggests significant uncertainty. We found no data for the long-term outcomes of diabetes or neurosensory disability.\nWomen assigned to tighter glycaemic control experienced an increase in the use of pharmacological therapy compared with women assigned to less-tight glycaemic control (RR 1.37, 95% CI 1.17 to 1.59, 4 trials, 1718 women). Tighter glycaemic control reducedadherence with treatment compared with less-tight glycaemic control (RR 0.41, 95% CI 0.32 to 0.51, 1 trial, 395 women).\nOverall the certainty of evidence assessed using GRADE ranged from low to moderate, downgraded primarily due to risk of bias and imprecision.\nAuthors' conclusions\nThis review is based on four trials (1731 women) with an overall unclear risk of bias. The trials provided data on most primary outcomes and suggest that tighter glycaemic control may increase the risk of hypertensive disorders of pregnancy. The risk of birth of a large-for-gestational-age infant and perinatal mortality may be similar between groups, and tighter glycaemic targets may result in a possible reduction in composite of death or severe infant morbidity. However, the CIs for these outcomes are wide, suggesting both benefit and harm.\nThere remains limited evidence regarding the benefit of different glycaemic targets for women with GDM to minimise adverse effects on maternal and infant health. Glycaemic target recommendations from international professional organisations vary widely and are currently reliant on consensus given the lack of high-certainty evidence.\nFurther high-quality trials are needed, and these should assess both short- and long-term health outcomes for women and their babies; include women's experiences; and assess health services costs in order to confirm the current findings. Two trials are ongoing.\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"
},
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"role": "assistant",
"content": "This review found that there is not yet enough evidence from randomised trials to determine the best blood sugar range for improving health for pregnant women with GDM and their babies. The evidence currently points towards no increased benefit when using lower blood sugar targets. Two trials are ongoing. More high-quality studies are needed that compare different targets for blood sugar levels and assess both short- and long-term health outcomes for women and their babies to guide treatment. Studies should include women's experiences and assess health services costs."
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query-laysum | 1201 | [
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"role": "user",
"content": "Abstract: Background\nWhile most guidance recommends the use of insulin in women whose pregnancies are affected by pre-existing diabetes, oral anti-diabetic agents may be more acceptable to women. The effects of these oral anti-diabetic agents on maternal and infant health outcomes need to be established in pregnant women with pre-existing diabetes or impaired glucose tolerance, as well as in women with previous gestational diabetes mellitus preconceptionally or during a subsequent pregnancy. This review is an update of a review that was first published in 2010.\nObjectives\nTo investigate the effects of oral anti-diabetic agents in women with established diabetes, impaired glucose tolerance or previous gestational diabetes who are planning a pregnancy, or pregnant women with pre-existing diabetes, on maternal and infant health. The use of oral anti-diabetic agents for the management of gestational diabetes in a current pregnancy is evaluated in a separate Cochrane Review.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs assessing the effects of oral anti-diabetic agents in women with established diabetes, impaired glucose tolerance or previous gestational diabetes who were planning a pregnancy, or pregnant women with pre-existing diabetes. Cluster-RCTs were eligible for inclusion, but none were identified.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included RCTs. Review authors checked the data for accuracy, and assessed the quality of the evidence using the GRADE approach.\nMain results\nWe identified six RCTs (707 women), eligible for inclusion in this updated review, however, three RCTs had mixed populations (that is, they included pregnant women with gestational diabetes) and did not report data separately for the relevant subset of women for this review. Therefore we have only included outcome data from three RCTs; data were available for 241 women and their infants. The three RCTs all compared an oral anti-diabetic agent (metformin) with insulin. The women in the RCTs that contributed data had type 2 diabetes diagnosed before or during their pregnancy. Overall, the RCTs were judged to be at varying risk of bias. We assessed the quality of the evidence for selected important outcomes using GRADE; the evidence was low- or very low-quality, due to downgrading because of design limitations (risk of bias) and imprecise effect estimates (for many outcomes only one or two RCTs contributed data).\nFor our primary outcomes there was no clear difference between metformin and insulin groups for pre-eclampsia (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.33 to 1.20; RCTs = 2; participants = 227; very low-quality evidence) although in one RCT women receiving metformin were less likely to have pregnancy-induced hypertension (RR 0.58, 95% CI 0.37 to 0.91; RCTs = 1; participants = 206; low-quality evidence). Women receiving metformin were less likely to have a caesarean section compared with those receiving insulin (RR 0.73, 95% CI 0.61 to 0.88; RCTs = 3; participants = 241; low-quality evidence). In one RCT there was no clear difference between groups for large-for-gestational-age infants (RR 1.12, 95% CI 0.73 to 1.72; RCTs = 1; participants = 206; very low-quality evidence). There were no perinatal deaths in two RCTs (very low-quality evidence). Neonatal mortality or morbidity composite outcome and childhood/adulthood neurosensory disability were not reported.\nFor other secondary outcomes we assessed using GRADE, there were no clear differences between metformin and insulin groups for induction of labour (RR 1.42, 95% CI 0.62 to 3.28; RCTs = 2; participants = 35; very low-quality evidence), though infant hypoglycaemia was reduced in the metformin group (RR 0.34, 95% CI 0.18 to 0.62; RCTs = 3; infants = 241; very low-quality evidence). Perineal trauma, maternal postnatal depression and postnatal weight retention, and childhood/adulthood adiposity and diabetes were not reported.\nAuthors' conclusions\nThere are insufficient RCT data to evaluate the use of oral anti-diabetic agents in women with established diabetes, impaired glucose tolerance or previous gestational diabetes who are planning a pregnancy, or in pregnant women with pre-existing diabetes. Low to very low-quality evidence suggests possible reductions in pregnancy-induced hypertension, caesarean section birth and neonatal hypoglycaemia with metformin compared with insulin for women with type 2 diabetes diagnosed before or during their pregnancy, and no clear differences in pre-eclampsia, induction of labour and babies that are large-for-gestational age. Further high-quality RCTs that compare any combination of oral anti-diabetic agent, insulin and dietary and lifestyle advice for these women are needed. Future RCTs could be powered to evaluate effects on short- and long-term clinical outcomes; such RCTs could attempt to collect and report on the standard outcomes suggested in this review. We have identified three ongoing studies and four are awaiting classification. We will consider these when this review is updated.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Pre-existing diabetes and gestational diabetes can increase the risks of a number of poor outcomes for both mothers and their babies. For the mother, these include pregnancy-induced high blood pressure (pre-eclampsia) with additional fluid retention and protein in the urine; and giving birth by caesarean. For the infant, these can include preterm birth; as well as an increased risk of the presence of physical defects at birth such as heart defects, brain, spine, and spinal cord defects, Down syndrome; and spontaneous abortion. Other complications at birth include babies that are large for their gestational age, and obstructed labour (shoulder dystocia) caused by one of the shoulders becoming stuck in the birth canal once the baby's head has been born."
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query-laysum | 1202 | [
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"role": "user",
"content": "Abstract: Background\nTreatment for lower respiratory tract infections (LRTIs) includes administering complementary oxygen. The effectiveness of oxygen therapy and of different delivery methods remains uncertain.\nObjectives\nTo determine the effectiveness and safety of oxygen therapy and oxygen delivery methods in the treatment of LRTIs and to define the indications for oxygen therapy in children with LRTIs.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE, EMBASE and LILACS from March 2008 to October 2014.\nSelection criteria\nRandomised controlled trials (RCTs) or non-RCTs comparing oxygen versus no oxygen therapy or different methods of oxygen delivery in children with LRTI aged from three months to 15 years. To determine the indications for oxygen therapy, we included observational studies or diagnostic test accuracy studies.\nData collection and analysis\nThree review authors independently scanned the search results to identify studies for inclusion. Two authors independently performed the methodological assessment and the third author resolved any disagreements. We calculated risk ratios (RRs) and their 95% confidence intervals (CIs) for dichotomous outcomes and adverse events (AEs). We performed fixed-effect meta-analyses for the estimation of pooled effects whenever there was no heterogeneity between included RCTs. We summarised the results reported in the included observational studies for the clinical indicators of hypoxaemia.\nMain results\nIn this review update, we included four studies (479 participants) assessing the efficacy of non-invasive delivery methods for the treatment of LRTI in children and 14 observational studies assessing the clinical sign indicators of hypoxaemia in children with LRTIs.\nThree RCTs (399 participants) compared the effectiveness of nasal prongs or nasal cannula with nasopharyngeal catheter; one non-RCT (80 participants) compared head box, face mask, nasopharyngeal catheter and nasal cannula. The nasopharyngeal catheter was the control group. Treatment failure was defined as number of children failing to achieve adequate arterial oxygen saturation. All included studies had a high risk of bias because of allocation methods and lack of blinded outcome assessment.\nFor nasal prongs versus nasopharyngeal catheter, the pooled effect estimate for RCTs showed a worrying trend towards no difference between the groups (two RCTs; 239 participants; RR 0.93, 95% CI 0.36 to 2.38). Similar results were shown in the one non-RCT (RR 1.0, 95% CI 0.44 to 2.27). The overall quality of this evidence is very low. Nasal obstruction due to severe mucus production was different between treatment groups (three RCTs, 338 participants; RR 0.20, 95% CI 0.09 to 0.44; I2 statistic = 0%). The quality of this evidence is low.\nThe use of a face mask showed a statistically significant lower risk of failure to achieve arterial oxygen > 60 mmHg than the nasopharyngeal catheter (one non-RCT; 80 participants; odds ratio (OR) 0.20, 95% CI 0.05 to 0.88).\nThe use of a head box showed a non-statistically significant trend towards a reduced risk of treatment failure compared to the nasopharyngeal catheter (one non-RCT; OR 0.40, 95% CI 0.13 to 1.12). The quality of this evidence is very low.\nTo determine the presence of hypoxaemia in children presenting with LRTI, we assessed the sensitivity and specificity of nine clinical signs reported by the included observational studies and used this information to calculate likelihood ratios. The results showed that there is no single clinical sign or symptom that accurately identifies hypoxaemia.\nAuthors' conclusions\nIt appears that oxygen therapy given early in the course of pneumonia via nasal prongs at a flow rate of 1 to 2 L/min does not prevent children with severe pneumonia from developing hypoxaemia. However, the applicability of this evidence is limited as it comes from a small pilot trial.\nNasal prongs and nasopharyngeal catheter are similar in effectiveness when used for children with LRTI. Nasal prongs are associated with fewer nasal obstruction problems. The use of a face mask and head box has been poorly studied and it is not superior to a nasopharyngeal catheter in terms of effectiveness or safety in children with LRTI.\nStudies assessing the effectiveness of oxygen therapy and oxygen delivery methods in children with different baseline risks are needed.\nThere is no single clinical sign or symptom that accurately identifies hypoxaemia in children with LRTI. The summary of results presented here can help clinicians to identify children with more severe conditions.\nThis review is limited by the small number of trials assessing oxygen therapy and oxygen delivery methods as part of LRTI treatment. There is insufficient evidence to determine which non-invasive delivery methods should be used in children with LRTI and low levels of oxygen in their blood.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute LRTI is the most frequent cause for hospitalisation out of all respiratory infections and one of the leading causes of morbidity and mortality in children aged under five in low-income countries. Oxygen therapy plays an important part in treating severe LRTIs but we need to determine its effectiveness at preventing children from developing more severe disease. Oxygen can be delivered by non-invasive methods (nasal prongs, nasal cannula, nasopharyngeal catheter, face mask and head box) and we wanted to discover how effective these methods are as they have not been adequately evaluated."
}
]
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query-laysum | 1203 | [
{
"role": "user",
"content": "Abstract: Background\nImplant overdentures are one of the most common treatment options used to rehabilitate edentulous patients. Attachment systems are used to anchor the overdentures to implants. The plethora of attachment systems available dictates a need for clinicians to understand their prosthodontic and patient-related outcomes.\nObjectives\nTo compare different attachment systems for maxillary and mandibular implant overdentures by assessing prosthodontic success, prosthodontic maintenance, patient preference, patient satisfaction/quality of life and costs.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 24 January 2018); Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 12) in the Cochrane Library (searched 24 January 2018); MEDLINE Ovid (1946 to 24 January 2018); and Embase Ovid (1980 to 24 January 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials on 24 January 2018. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nAll randomised controlled trials (RCTs), including cross-over trials on maxillary or mandibular implant overdentures with different attachment systems with at least 1 year follow-up.\nData collection and analysis\nFour review authors extracted data independently and assessed risk of bias for each included trial. Several corresponding authors were subsequently contacted to obtain missing information. Fixed-effect meta-analysis was used to combine the outcomes with risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (95% CI). We used the GRADE approach to assess the quality of evidence and create 'Summary of findings' tables.\nMain results\nWe identified six RCTs with a total of 294 mandibular overdentures (including one cross-over trial). No trials on maxillary overdentures were eligible. Due to the poor reporting of the outcomes across the included trials, only limited analyses between mandibular overdenture attachment systems were possible.\nComparing ball and bar attachments, upon pooling the data regarding short-term prosthodontic success, we identified substantial heterogeneity (I2 = 97%) with inconsistency in the direction of effect, which was unexplained by clinical or methodological differences between the studies, and accordingly we did not perform meta-analyses for this outcome. Short-term re-treatment (repair of attachment system) was higher with ball attachments (RR 3.11, 95% CI 1.68 to 5.75; 130 participants; 2 studies; very low-quality evidence), and there was no difference between both attachment systems in short-term re-treatment (replacement of attachment system) (RR 1.18, 95% CI 0.38 to 3.71; 130 participants; 2 studies; very low-quality evidence). It is uncertain whether there is a difference in short-term prosthodontic success when ball attachments are compared with bar attachments.\nComparing ball and magnet attachments, there was no difference between them in medium-term prosthodontic success (RR 0.84, 95% CI 0.64 to 1.10; 69 participants; 1 study; very low-quality evidence), or in medium-term re-treatment (repair of attachment system) (RR 1.75, 95% CI 0.65 to 4.72; 69 participants; 1 study; very low-quality evidence). However, after 5 years, prosthodontic maintenance costs were higher when magnet attachments were used (MD -247.37 EUR, 95% CI -346.32 to -148.42; 69 participants; 1 study; very low-quality evidence). It is uncertain whether there is a difference in medium-term prosthodontic success when ball attachments are compared with magnet attachments.\nOne trial provided data for ball versus telescopic attachments and reported no difference in prosthodontic maintenance between the two systems in short-term patrix replacement (RR 6.00, 95% CI 0.86 to 41.96; 22 participants; 1 study; very low-quality evidence), matrix activation (RR 11.00, 95% CI 0.68 to 177.72; 22 participants; 1 study; very low-quality evidence), matrix replacement (RR 1.75, 95% CI 0.71 to 4.31; 22 participants; 1 study; very low-quality evidence), or in relining of the implant overdenture (RR 2.33, 95% CI 0.81 to 6.76; 22 participants; 1 study; very low-quality evidence). It is uncertain whether there is a difference in short-term prosthodontic maintenance when ball attachments are compared with telescopic attachments.\nIn the only cross-over trial included, patient preference between different attachment systems was assessed after only 3 months and not for the entire trial period of 10 years.\nAuthors' conclusions\nFor mandibular overdentures, there is insufficient evidence to determine the relative effectiveness of different attachment systems on prosthodontic success, prosthodontic maintenance, patient satisfaction, patient preference or costs. In the short term, there is some evidence that is insufficient to show a difference and where there was no evidence was reported. It was not possible to determine any preferred attachment system for mandibular overdentures.\nFor maxillary overdentures, there is no evidence (with no trials identified) to determine the relative effectiveness of different attachment systems on prosthodontic success, prosthodontic maintenance, patient satisfaction, patient preference or costs.\nFurther RCTs on edentulous cohorts must pay attention to trial design specifically using the same number of implants of the same implant system, but with different attachment systems clearly identified in control and test groups. Trials should also determine the longevity of different attachment systems and patient preferences. Trials on the current array of computer-aided designed/computer-assisted manufactured (CAD/CAM) bar attachment systems are encouraged.\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": "Authors from Cochrane Oral Health carried out this review and the evidence is up to date to 24 January 2018. A total of six trials on adults with complete tooth loss were included with a total of 294 lower jaw dentures (anchored by one or more implants). The review looked at different attachment systems on the same implant systems. The six trials did not each evaluate the same attachment systems. There were no eligible trials with upper jaw implant dentures."
}
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query-laysum | 1204 | [
{
"role": "user",
"content": "Abstract: Background\nPrimary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common causes of maternal mortality worldwide and causes significant physical and psychological morbidity.\nAn earlier Cochrane Review considering any treatments for the management of primary PPH, has been split into separate reviews. This review considers treatment with mechanical and surgical interventions.\nObjectives\nTo determine the effectiveness and safety of mechanical and surgical interventions used for the treatment of primary PPH.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 July 2019) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) of mechanical/surgical methods for the treatment of primary PPH compared with standard care or another mechanical/surgical method. Interventions could include uterine packing, intrauterine balloon insertion, artery ligation/embolism, or uterine compression (either with sutures or manually).\nWe included studies reported in abstract form if there was sufficient information to permit risk of bias assessment. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and risk of bias, independently extracted data and checked data for accuracy. We used GRADE to assess the certainty of the evidence.\nMain results\nWe included nine small trials (944 women) conducted in Pakistan, Turkey, Thailand, Egypt (four trials), Saudi Arabia, Benin and Mali. Overall, included trials were at an unclear risk of bias. Due to substantial differences between the studies, it was not possible to combine any trials in meta-analysis. Many of this review's important outcomes were not reported. GRADE assessments ranged from very low to low, with the majority of outcome results rated as very low certainty. Downgrading decisions were mainly based on study design limitations and imprecision; one study was also downgraded for indirectness.\nExternal uterine compression versus normal care (1 trial, 64 women)\nVery low-certainty evidence means that we are unclear about the effect on blood transfusion (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.66 to 8.23).\nUterine arterial embolisation versus surgical devascularisation plus B-Lynch (1 trial, 23 women)\nThe available evidence for hysterectomy to control bleeding (RR 0.73, 95% CI 0.15 to 3.57) is unclear due to very low-certainty evidence. The available evidence for intervention side effects is also unclear because the evidence was very low certainty (RR 1.09; 95% CI 0.08 to 15.41).\nIntrauterine Tamponade\nStudies included various methods of intrauterine tamponade: the commercial Bakri balloon, a fluid-filled condom-loaded latex catheter ('condom catheter'), an air-filled latex balloon-loaded catheter ('latex balloon catheter'), or traditional packing with gauze.\nBalloon tamponade versus normal care (2 trials, 356 women)\nOne study(116 women) used the condom catheter. This study found that it may increase blood loss of 1000 mL or more (RR 1.52, 95% CI 1.15 to 2.00; 113 women), very low-certainty evidence. For other outcomes the results are unclear and graded as very low-certainty evidence: mortality due to bleeding (RR 6.21, 95% CI 0.77 to 49.98); hysterectomy to control bleeding (RR 4.14, 95% CI 0.48 to 35.93); total blood transfusion (RR 1.49, 95% CI 0.88 to 2.51); and side effects. A second study of 240 women used the latex balloon catheter together with cervical cerclage. Very low-certainty evidence means we are unclear about the effect on hysterectomy (RR 0.14, 95% CI 0.01 to 2.74) and additional surgical interventions to control bleeding (RR 0.20, 95% CI 0.01 to 4.12).\nBakri balloon tamponade versus haemostatic square suturing of the uterus (1 trial, 13 women)\nIn this small trial there was no mortality due to bleeding, serious maternal morbidity or side effects of the intervention, and the results are unclear for blood transfusion (RR 0.57, 95% CI 0.14 to 2.36; very low certainty). Bakri balloon tamponade may reduce mean 'intraoperative' blood loss (mean difference (MD) -426 mL, 95% CI -631.28 to -220.72), very low-certainty evidence.\nComparison of intrauterine tamponade methods (3 trials, 328 women)\nOne study (66 women) compared the Bakri balloon and the condom catheter, but it was uncertain whether the Bakri balloon reduces the risk of hysterectomy to control bleeding due to very low-certainty evidence (RR 0.50, 95% CI 0.05 to 5.25). Very low-certainty evidence also means we are unclear about the results for the risk of blood transfusion (RR 0.97, 95% CI 0.88 to 1.06).\nA second study (50 women) compared Bakri balloon, with and without a traction stitch. Very low-certainty evidence means we are unclear about the results for hysterectomy to control bleeding (RR 0.20, 95% CI 0.01 to 3.97).\nA third study (212 women) compared the condom catheter to gauze packing and found that it may reduce fever (RR 0.47, 95% CI 0.38 to 0.59), but again the evidence was very low certainty.\nModified B-Lynch compression suture versus standard B-Lynch compression suture (1 trial, 160 women)\nLow-certainty evidence suggests that a modified B-Lynch compression suture may reduce the risk of hysterectomy to control bleeding (RR 0.33, 95% CI 0.11 to 0.99) and postoperative blood loss (MD -244.00 mL, 95% CI -295.25 to -192.75).\nAuthors' conclusions\nThere is currently insufficient evidence from RCTs to determine the relative effectiveness and safety of mechanical and surgical interventions for treating primary PPH. High-quality randomised trials are urgently needed, and new emergency consent pathways should facilitate recruitment.\nThe finding that intrauterine tamponade may increase total blood loss > 1000 mL suggests that introducing condom-balloon tamponade into low-resource settings on its own without multi-system quality improvement does not reduce PPH deaths or morbidity. The suggestion that modified B-Lynch suture may be superior to the original requires further research before the revised technique is adopted. In high-resource settings, uterine artery embolisation has become popular as the equipment and skills become more widely available. However, there is little randomised trial evidence regarding efficacy and this requires further research. We urge new trial authors to adopt PPH core outcomes to facilitate consistency between primary studies and subsequent meta-analysis.\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": "PPH is a common cause of maternal death and illness worldwide. Nearly 300,000 pregnant women die annually across the world with approximately 25% of those deaths caused by haemorrhage. It can also lead to the mother having significant long-term medical and psychological problems."
}
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query-laysum | 1205 | [
{
"role": "user",
"content": "Abstract: Background\nOpen fractures of the major long bones are complex limb-threatening injuries that are predisposed to deep infection. Treatment includes antibiotics and surgery to debride the wound, stabilise the fracture and reconstruct any soft tissue defect to enable infection-free bone repair. There is a need to assess the effect of timing and duration of antibiotic administration and timing and staging of surgical interventions to optimise outcomes.\nObjectives\nTo assess the effects (risks and benefits) of the timing of antibiotic administration, wound debridement and the stages of surgical interventions in managing people with open long bone fractures of the upper and lower limbs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trial registers in February 2021. We also searched conference proceedings and reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that recruited adults with open fractures of the major long bones, comparing: 1) timings of prophylactic antibiotic treatment, 2) duration of prophylactic antibiotic treatment, 3) timing of wound debridement following injury or 4) timing of the stages of reconstructive surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We aimed to collect data for the following outcomes: limb function, health-related quality of life (HRQoL), deep surgical site infection, delayed or non-union, adverse events (in the short- and long-term course of recovery), and resource-related outcomes.\nMain results\nWe included three RCTs of 613 randomised participants with 617 open fractures. Studies were conducted in medical and trauma centres in the USA and Kenya. Where reported, there was a higher proportion of men and a mean age of participants between 30 and 34 years old. Fractures were in the upper and lower limbs in one study, and were tibia fractures in two studies; where reported, these were the result of high-energy trauma such as road traffic accidents. No studies compared the timing of antibiotic treatment or wound debridement.\nDuration of prophylactic antibiotic treatment (1 study, 77 participants available for analysis)\nOne study compared antibiotic treatment for 24 hours with antibiotic treatment for five days. We are very uncertain about the effects of different durations of antibiotic treatment on superficial infections (risk ratio (RR) 1.19, 95% CI 0.49 to 2.87, favours 5 day treatment; 1 study, 77 participants); this was very low-certainty evidence derived from one small study with unclear and high risks of bias, and with an imprecise effect estimate. This study reported no other review outcomes.\nReconstructive surgery: timing of the stages of surgery (2 studies, 458 participants available for analysis)\nTwo studies compared the timing of wound closure, which was completed immediately or delayed. In one study, the mean time of delay was 5.9 days; in the other study, the time of delay was not reported. We are very uncertain about the effects of different timings of wound closure on deep infections (RR 0.82, 95% CI 0.37 to 1.80, favours immediate closure; 2 studies, 458 participants), delayed union or non-union (RR 1.13, 95% CI 0.83 to 1.55, favours delayed closure; 1 study, 387 participants), or superficial infections (RR 6.45, 95% CI 0.35 to 120.43, favours delayed closure; 1 study, 71 participants); this was very low-certainty evidence. We downgraded the certainty of the evidence for very serious risks of bias because both studies had unclear and high risks of bias. We also downgraded for serious imprecision because effect estimates were imprecise, including the possibility of benefits as well as harms, and very serious imprecision when the data were derived from single small study. These studies reported no other review outcomes.\nAuthors' conclusions\nWe could not determine the risks and benefits of different treatment protocols for open long bone fractures because the evidence was very uncertain for the two comparisons and we did not find any studies addressing the other possible comparisons. Well-designed randomised trials with adequate power are needed to guide surgical and antibiotic treatment of open fractures, particularly with regard to timing and duration of antibiotic administration and timing and staging of surgery.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain whether the different timings of treatments (antibiotics, wound cleaning and whether to do all the surgery in one operation or more) might affect how well people recover from open long bone fractures. We found very few studies, and they did not provide reliable evidence."
}
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query-laysum | 1206 | [
{
"role": "user",
"content": "Abstract: Background\nMarfan syndrome is a hereditary disorder affecting the connective tissue and is caused by a mutation of the fibrillin-1 (FBN1) gene. It affects multiple systems of the body, most notably the cardiovascular, ocular, skeletal, dural and pulmonary systems. Aortic root dilatation is the most frequent cardiovascular manifestation and its complications, including aortic regurgitation, dissection and rupture are the main cause of morbidity and mortality.\nObjectives\nTo assess the long-term efficacy and safety of beta-blocker therapy as compared to placebo, no treatment or surveillance only in people with Marfan syndrome.\nSearch methods\nWe searched the following databases on 28 June 2017; CENTRAL, MEDLINE, Embase, Science Citation Index Expanded and the Conference Proceeding Citation Index - Science in the Web of Science Core Collection. We also searched the Online Metabolic and Molecular Bases of Inherited Disease (OMMBID), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 30 June 2017. We did not impose any restriction on language of publication.\nSelection criteria\nAll randomised controlled trials (RCTs) of at least one year in duration assessing the effects of beta-blocker monotherapy compared with placebo, no treatment or surveillance only, in people of all ages with a confirmed diagnosis of Marfan syndrome were eligible for inclusion.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for inclusion, extracted data and assessed trial quality. Trial authors were contacted to obtain missing data. Dichotomous outcomes will be reported as relative risk and continuous outcomes as mean differences with 95% confidence intervals. We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nOne open-label, randomised, single-centre trial including 70 participants with Marfan syndrome (aged 12 to 50 years old) met the inclusion criteria. Participants were randomly assigned to propranolol (N = 32) or no treatment (N = 38) for an average duration of 9.3 years in the control group and 10.7 years in the treatment group. The initial dose of propranolol was 10 mg four times daily and the optimal dose was reached when the heart rate remained below 100 beats per minute during exercise or the systolic time interval increased by 30%. The mean (± standard error (SE)) optimal dose of propranolol was 212 ± 68 mg given in four divided doses daily.\nBeta-blocker therapy did not reduce the incidence of all-cause mortality (RR 0.24, 95% CI 0.01 to 4.75; participants = 70; low-quality evidence). Mortality attributed to Marfan syndrome was not reported. Non-fatal serious adverse events were also not reported. However, study authors report on pre-defined, non-fatal clinical endpoints, which include aortic dissection, aortic regurgitation, cardiovascular surgery and congestive heart failure. Their analysis showed no difference between the treatment and control groups in these outcomes (RR 0.79, 95% CI 0.37 to 1.69; participants = 70; low-quality evidence).\nBeta-blocker therapy did not reduce the incidence of aortic dissection (RR 0.59, 95% CI 0.12 to 3.03), aortic regurgitation (RR 1.19, 95% CI 0.18 to 7.96), congestive heart failure (RR 1.19, 95% CI 0.18 to 7.96) or cardiovascular surgery, (RR 0.59, 95% CI 0.12 to 3.03); participants = 70; low-quality evidence.\nThe study reports a reduced rate of aortic dilatation measured by M-mode echocardiography in the treatment group (aortic ratio mean slope: 0.084 (control) vs 0.023 (treatment), P < 0.001). The change in systolic and diastolic blood pressure, total adverse events and withdrawal due to adverse events were not reported in the treatment or control group at study end point.\nWe judged this study to be at high risk of selection (allocation concealment) bias, performance bias, detection bias, attrition bias and selective reporting bias. The overall quality of evidence was low. We do not know whether a statistically significant reduced rate of aortic dilatation translates into clinical benefit in terms of aortic dissection or mortality.\nAuthors' conclusions\nBased on only one, low-quality RCT comparing long-term propranolol to no treatment in people with Marfan syndrome, we could draw no definitive conclusions for clinical practice. High-quality, randomised trials are needed to evaluate the long-term efficacy of beta-blocker treatment in people with Marfan syndrome. Future trials should report on all clinically relevant end points and adverse events to evaluate benefit versus harm of therapy.\n\nGiven the provided abstract, please respond to the following query: \"Search Date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to June 2017."
}
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query-laysum | 1207 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative administration of non-steroidal anti-inflammatory drugs (NSAIDs) reduces patient opioid requirements and, in turn, may reduce the incidence and severity of opioid-induced adverse events (AEs).\nObjectives\nTo assess the analgesic efficacy and adverse effects of single-dose intravenous (IV) ibuprofen, compared with placebo or an active comparator, for moderate-to-severe postoperative pain in adults.\nSearch methods\nWe searched the following databases without language restrictions: CENTRAL, MEDLINE, Embase and LILACS on 10 June 2021. We checked clinical trials registers and reference lists of retrieved articles for additional studies.\nSelection criteria\nWe included randomized trials that compared a single postoperative dose of intravenous (IV) ibuprofen with placebo or another active treatment, for treating acute postoperative pain in adults following any surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for review inclusion, assessed risk of bias, and extracted data.\nOur primary outcome was the number of participants in each arm achieving at least 50% pain relief over a 4- and 6-hour period.\nOur secondary outcomes were time to, and number of participants using rescue medication; withdrawals due to lack of efficacy, adverse events (AEs), and for any other cause; and number of participants reporting or experiencing any AE, serious AEs (SAEs), and specific NSAID-related or opioid-related AEs.\nWe were not able to carry out any planned meta-analysis. We assessed the certainty of the evidence using GRADE.\nMain results\nOnly one study met our inclusion criteria, involving 201 total participants, mostly female (mean age 42 years), undergoing primary, unilateral, distal, first metatarsal bunionectomy (with osteotomy and internal fixation). Ibuprofen 300 mg, placebo or acetaminophen 1000 mg was administered intravenously to participants reporting moderate pain intensity the day after surgery. Since we identified only one study for inclusion, we did not perform any quantitative analyses. The study was at low risk of bias for most domains. We downgraded the certainty of the evidence due to serious study limitations, indirectness and imprecision.\nIbuprofen versus placebo\nFindings of the single study found that at both the 4-hour and 6-hour assessment period, the proportion of participants with at least 50% pain relief was 32% (24/76) for those assigned to ibuprofen and 22% (11/50) for those assigned to placebo. These findings produced a risk ratio (RR) of 1.44 (95% confidence interval (CI) 0.77 to 2.66 versus placebo for at least 50% of maximum pain relief over the 4-hour and 6-hour period (very low-certainty evidence).\nMedian time to rescue medication was 101 minutes for ibuprofen and 71 minutes for placebo (1 study, 126 participants; very low-certainty evidence). The number of participants using rescue medication was not reported within the included study.\nDuring the study (1 study, 126 participants), 58/76 (76%) of participants assigned to ibuprofen and 39/50 (78%) assigned to placebo reported or experienced any adverse event (AE), (RR 0.98, 95% CI 0.81 to 1.19; low-certainty evidence).\nNo serious AEs (SAEs) were experienced (1 study, 126 participants; very low-certainty evidence).\nIbuprofen versus active comparators\nIbuprofen (300 mg) was similar to the active comparator, IV acetaminophen (1000 mg) at 4 hours and 6 hours (1 study, 126 participants). For those assigned to active control (acetaminophen), the proportion of participants with at least 50% pain relief was 35% (26/75) at 4 hours and 31% (23/75) at 6 hours. At 4 hours, these findings produced a RR of 0.91 (95% CI 0.58 to 1.43; very low-certainty evidence) versus active comparator (acetaminophen). At 6 hours, these findings produced a RR of 1.03 (95% CI 0.64 to 1.66; very low-certainty evidence) versus active comparator (acetaminophen).\nMedian time to rescue medication was 101 minutes for ibuprofen and 125 minutes for the active comparator, acetaminophen (1 study, 151 participants; very low-certainty evidence). The number of participants using rescue medication was not reported within the included study.\nDuring the study, 58/76 (76%) of participants assigned to ibuprofen and 45/75 (60%) assigned to active control (acetaminophen) reported or experienced any AE, (RR 1.27, 95% CI 1.02 to 1.59; very low-certainty evidence).\nNo SAEs were experienced (1 study, 151 participants; very low-certainty evidence).\nAuthors' conclusions\nThere is insufficient evidence to support or refute the suggestion that IV ibuprofen is effective and safe for acute postoperative pain in adults.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- There is not enough evidence to determine whether intravenous (injection into a vein) ibuprofen is an effective treatment for adults with pain after surgery or if it can harm them.\n- It would be beneficial if future studies on this topic were well-designed with a large number of patients to determine if ibuprofen is an effective treatment for the management of pain after surgery.\n- More evidence is required to establish if ibuprofen causes serious unwanted effects."
}
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query-laysum | 1208 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is the third update of a previously published Cochrane Review. The original review, looking at all possible cardioprotective agents, was split and this part now focuses on dexrazoxane only.\nAnthracyclines are effective chemotherapeutic agents in the treatment of numerous malignancies. Unfortunately, their use is limited by a dose-dependent cardiotoxicity. In an effort to prevent or reduce this cardiotoxicity, different cardioprotective agents have been studied, including dexrazoxane.\nObjectives\nTo assess the efficacy of dexrazoxane to prevent or reduce cardiotoxicity and determine possible effects of dexrazoxane on antitumour efficacy, quality of life and toxicities other than cardiac damage in adults and children with cancer receiving anthracyclines when compared to placebo or no additional treatment.\nSearch methods\nWe searched CENTRAL, MEDLINE and Embase to May 2021. We also handsearched reference lists, the proceedings of relevant conferences and ongoing trials registers.\nSelection criteria\nRandomised controlled trials (RCTs) in which dexrazoxane was compared to no additional therapy or placebo in adults and children with cancer receiving anthracyclines.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, risk of bias and GRADE assessment of included studies. We analysed results in adults and children separately. We performed analyses according to the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nFor this update, we identified 548 unique records. We included three additional RCTs: two paediatric and one adult. Therefore, we included a total of 13 eligible RCTs (five paediatric and eight adult). The studies enrolled 1252 children with leukaemia, lymphoma or a solid tumour and 1269 participants, who were mostly diagnosed with breast cancer.\nIn adults, moderate-quality evidence showed that there was less clinical heart failure with the use of dexrazoxane (risk ratio (RR) 0.22, 95% confidence interval (CI) 0.11 to 0.43; 7 studies, 1221 adults). In children, we identified no difference in clinical heart failure risk between treatment groups (RR 0.20, 95% CI 0.01 to 4.19; 3 studies, 885 children; low-quality evidence). In three paediatric studies assessing cardiomyopathy/heart failure as the primary cause of death, none of the children had this outcome (1008 children, low-quality evidence). In the adult studies, different definitions for subclinical myocardial dysfunction and clinical heart failure combined were used, but pooled analyses were possible: there was a benefit in favour of the use of dexrazoxane (RR 0.37, 95% CI 0.24 to 0.56; 3 studies, 417 adults and RR 0.46, 95% CI 0.33 to 0.66; 2 studies, 534 adults, respectively, moderate-quality evidence). In the paediatric studies, definitions of subclinical myocardial dysfunction and clinical heart failure combined were incomparable, making pooling impossible. One paediatric study showed a benefit in favour of dexrazoxane (RR 0.33, 95% CI 0.13 to 0.85; 33 children; low-quality evidence), whereas another study showed no difference between treatment groups (Fischer exact P = 0.12; 537 children; very low-quality evidence).\nOverall survival (OS) was reported in adults and overall mortality in children. The meta-analyses of both outcomes showed no difference between treatment groups (hazard ratio (HR) 1.04, 95% 0.88 to 1.23; 4 studies; moderate-quality evidence; and HR 1.01, 95% CI 0.72 to 1.42; 3 studies, 1008 children; low-quality evidence, respectively). Progression-free survival (PFS) was only reported in adults. We subdivided PFS into three analyses based on the comparability of definitions, and identified a longer PFS in favour of dexrazoxane in one study (HR 0.62, 95% CI 0.43 to 0.90; 164 adults; low-quality evidence). There was no difference between treatment groups in the other two analyses (HR 0.95, 95% CI 0.64 to 1.40; 1 study; low-quality evidence; and HR 1.18, 95% CI 0.97 to 1.43; 2 studies; moderate-quality evidence, respectively). In adults, there was no difference in tumour response rate between treatment groups (RR 0.91, 95% CI 0.79 to 1.04; 6 studies, 956 adults; moderate-quality evidence). We subdivided tumour response rate in children into two analyses based on the comparability of definitions, and identified no difference between treatment groups (RR 1.01, 95% CI 0.95 to 1.07; 1 study, 206 children; very low-quality evidence; and RR 0.92, 95% CI 0.84 to 1.01; 1 study, 200 children; low-quality evidence, respectively). The occurrence of secondary malignant neoplasms (SMN) was only assessed in children. The available and worst-case analyses were identical and showed a difference in favour of the control group (RR 3.08, 95% CI 1.13 to 8.38; 3 studies, 1015 children; low-quality evidence). In the best-case analysis, the direction of effect was the same, but there was no difference between treatment groups (RR 2.51, 95% CI 0.96 to 6.53; 4 studies, 1220 children; low-quality evidence). For other adverse effects, results also varied. None of the studies evaluated quality of life.\nIf not reported, the number of participants for an analysis was unclear.\nAuthors' conclusions\nOur meta-analyses showed the efficacy of dexrazoxane in preventing or reducing cardiotoxicity in adults treated with anthracyclines. In children, there was a difference between treatment groups for one cardiac outcome (i.e. for one of the definitions used for clinical heart failure and subclinical myocardial dysfunction combined) in favour of dexrazoxane. In adults, no evidence of a negative effect on tumour response rate, OS and PFS was identified; and in children, no evidence of a negative effect on tumour response rate and overall mortality was identified. The results for adverse effects varied. In children, dexrazoxane may be associated with a higher risk of SMN; in adults this was not addressed. In adults, the quality of the evidence ranged between moderate and low; in children, it ranged between low and very low. Before definitive conclusions on the use of dexrazoxane can be made, especially in children, more high-quality research is needed.\nWe conclude that if the risk of cardiac damage is expected to be high, it might be justified to use dexrazoxane in children and adults with cancer who are treated with anthracyclines. However, clinicians and patients should weigh the cardioprotective effect of dexrazoxane against the possible risk of adverse effects, including SMN, for each individual.\nFor children, the International Late Effects of Childhood Cancer Guideline Harmonization Group has developed a clinical practice guideline.\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": "In children, we assessed the quality of the evidence as low for almost all evaluated outcomes and very low for two outcomes (one definition of clinical heart failure and subclinical myocardial dysfunction combined and one definition of tumour response rate); for the other definitions of these outcomes, we assessed the results as low quality. In adults, we assessed the quality of the evidence as moderate for almost all evaluated outcomes, and as low for two definitions of survival (for the other two definitions of survival as moderate).\nThe quality of the evidence was limited because of issues with the study design, the small numbers of participants in some studies, or for both reasons."
}
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query-laysum | 1209 | [
{
"role": "user",
"content": "Abstract: Background\nPatients with kidney failure require vascular access to receive maintenance haemodialysis (HD), which can be achieved by an arteriovenous fistula or a central venous catheter (CVC). CVC use is related to frequent complications such as venous stenosis and infection. Venous stenosis occurs mainly due to trauma caused by the entrance of the catheter into the venous lumen and repeated contact with the vein wall. A biofilm, a colony of irreversible adherent and self-sufficient micro-organisms embedded in a self-produced matrix of exopolysaccharides, is associated with the development of infections in patients with indwelling catheters. Despite its clinical relevance, the treatment of catheter-related bloodstream infections (CRBSIs) in patients receiving maintenance HD remains controversial, especially regarding catheter management. Antibiotic lock solutions may sterilise the catheter, treat the infection and prevent unnecessary catheter procedures. However, such treatment may also lead to antibiotic resistance or even clinical worsening in certain more virulent pathogens. Catheter removal and delayed replacement may remove the source of infection, improving infectious outcomes, but this approach may also increase vascular access stenosis, thrombosis or both, or even central vein access failure. Catheter guidewire exchange attempts to remove the source of infection while maintaining access to the same vein and, therefore, may improve clinical outcomes and preserve central veins for future access.\nObjectives\nTo assess the benefits and harms of different interventions for CRBSI treatment in patients receiving maintenance HD through a permanent CVC, such as systemic antibiotics alone or systemic antibiotics combined with either lock solutions or catheter guidewire exchange or catheter replacement.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 21 December 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs evaluating the management of CRBSI in permanent CVCs in people receiving maintenance HD.\nData collection and analysis\nTwo authors independently selected studies for inclusion, assessed their risk of bias, and performed data extraction. Results were expressed as risk ratios (RR) or hazard ratios (HR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with their 95% confidence intervals (CI). The certainty of the evidence was assessed using GRADE.\nMain results\nWe identified two RCTs and one quasi-RCT that enrolled 760 participants addressing the treatment of CRBSIs in people (children and adults) receiving maintenance HD through CVC. No two studies compared the same interventions. The quasi-RCT compared two different lock solutions (tissue plasminogen activator (TPA) and heparin) with concurrent systemic antibiotics. One RCT compared systemic antibiotics alone and in association with an ethanol lock solution, and the other compared systemic antibiotics with different catheter management strategies (guidewire exchange versus removal and replacement). The overall certainty of the evidence was downgraded due to the small number of participants, high risk of bias in many domains, especially randomisation, allocation, and other sources of bias, and missing outcome data. It is uncertain whether an ethanol lock solution used with concurrent systemic antibiotics improved CRBSI eradication compared to systemic antibiotics alone (RR 1.61, 95% CI 1.16 to 2.23) because the certainty of this evidence is very low. There were no reported differences between the effects of TPA and heparin lock solutions on cure rates (RR 0.92, 95% CI 0.74 to 1.15) or between catheter guidewire exchange versus catheter removal with delayed replacement, expressed as catheter infection-free survival (HR 0.88, 95% CI 0.43 to 1.79). To date, no results are available comparing other interventions.\nOutcomes such as venous stenosis and/or thrombosis, antibiotic resistance, death, and adverse events were not reported.\nAuthors' conclusions\nCurrently, there is no available high certainty evidence to support one treatment over another for CRBSIs. The benefit of using ethanol lock treatment in combination with systemic antibiotics compared to systemic antibiotics alone for CRBSIs in patients receiving maintenance HD remains uncertain due to the very low certainty of the evidence. Hence, further RCTs to identify the benefits and harms of CRBSI treatment options are needed. Future studies should unify CRBSI and cure definitions and improve methodological design.\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 enrolling 760 participants that compared various treatments for catheter-related bloodstream infections. No studies compared similar treatment strategies or had similar outcomes, and therefore we were unable to combine data in our meta-analyses. The comparisons included systemic antibiotics with two different lock solutions, systemic antibiotics alone versus systemic antibiotics plus an ethanol lock solution, and systemic antibiotics plus catheter removal versus systemic antibiotics plus catheter exchange.\nOne study reported a higher success rate for clearing infection with systemic antibiotics plus ethanol locking treatment than systemic antibiotics alone. The other studies reported no difference between their two treatment arms. Outcomes such as venous stenosis and/or thrombosis, antibiotic resistance, death, and adverse events were not reported."
}
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query-laysum | 1210 | [
{
"role": "user",
"content": "Abstract: Background\nProminent lower front teeth (termed reverse bite; under bite; Class III malocclusion) may be due to a combination of the jaw or tooth positions or both. The upper jaw (maxilla) can be too far back or the lower jaw (mandible) too far forward, or both. Prominent lower front teeth can also occur if the upper front teeth (incisors) are tipped back or the lower front teeth are tipped forwards, or both. Various treatment approaches have been described to correct prominent lower front teeth in children and adolescents.\nObjectives\nTo assess the effects of orthodontic treatment for prominent lower front teeth in children and adolescents.\nSearch methods\nWe searched the following databases: Cochrane Oral Health Group's Trials Register (to 7 January 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 12), MEDLINE via OVID (1946 to 7 January 2013), and EMBASE via OVID (1980 to 7 January 2013).\nSelection criteria\nRandomised controlled trials (RCTs) recruiting children or adolescents or both (aged 16 years or less) receiving any type of orthodontic treatment to correct prominent lower front teeth (Class III malocclusion). Orthodontic treatments were compared with control groups who received either no treatment, delayed treatment or a different active intervention.\nData collection and analysis\nScreening of references, identification of included and excluded studies, data extraction and assessment of the risk of bias of the included studies was performed independently and in duplicate by two review authors. The mean differences with 95% confidence intervals were calculated for continuous data. Meta-analysis was only undertaken when studies of similar comparisons reported comparable outcome measures. A fixed-effect model was used. The I2 statistic was used as a measure of statistical heterogeneity.\nMain results\nSeven RCTs with a total of 339 participants were included in this review. One study was assessed as at low risk of bias, three studies were at high risk of bias, and in the remaining three studies risk of bias was unclear. Four studies reported on the use of a facemask, two on the chin cup, one on the tandem traction bow appliance, and one on mandibular headgear. One study reported on both the chin cup and mandibular headgear appliances.\nOne study (n = 73, low quality evidence), comparing a facemask to no treatment, reported a mean difference (MD) in overjet of 4.10 mm (95% confidence interval (CI) 3.04 to 5.16; P value < 0.0001) favouring the facemask treatment. Two studies comparing facemasks to untreated control did not report the outcome of overjet. Three studies (n = 155, low quality evidence) reported ANB (an angular measurement relating the positions of the top and bottom jaws) differences immediately after treatment with a facemask when compared to an untreated control. The pooled data showed a statistically significant MD in ANB in favour of the facemask of 3.93 ° (95% CI 3.46 to 4.39; P value < 0.0001). There was significant heterogeneity between these studies (I2 = 82%). This is likely to have been caused by the different populations studied and the different ages at the time of treatment.\nOne study (n = 73, low quality evidence) reported outcomes of the use of the facemask compared to an untreated control at three years follow-up. This study showed that improvements in overjet and ANB were still present three years post-treatment. In this study, adverse effects were reported but due to the low prevalence of temporomandibular (TMJ) signs and symptoms no analysis was undertaken.\nTwo studies (n = 90, low quality evidence) compared the chin cup with an untreated control. Both studies found a statistically significant improvement in ANB, and one study also found an improvement in the Wits appraisal. Data from these two studies were not suitable for pooling.\nA single study of the tandem traction bow appliance compared to untreated control (n = 30, very low quality evidence) showed a statistically significant difference in both overjet and ANB favouring the intervention group.\nThe remaining two studies did not report the primary outcome of this review.\nAuthors' conclusions\nThere is some evidence that the use of a facemask to correct prominent lower front teeth in children is effective when compared to no treatment on a short-term basis. However, in view of the general poor quality of the included studies, these results should be viewed with caution. Further randomised controlled trials with long follow-up are required.\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 on which this review is based was found to be up to date as of 7 January 2013.\nA total of seven suitable studies were identified and included in this review; they included 339 children aged from five to 11 years. There were roughly equal numbers of girls and boys in each study and participants were from different ethnic groups depending on where the study was carried out. Studies included were conducted in Turkey, Egypt, China, the United States of America and the United Kingdom."
}
]
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query-laysum | 1211 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with unstable angina and non-ST elevation myocardial infarction (UA/NSTEMI) are managed with a combination of medical therapy, invasive angiography and revascularisation. Specifically, two approaches have evolved: either a 'routine invasive' strategy whereby all patients undergo coronary angiography shortly after admission and, if indicated, coronary revascularisation; or a 'selective invasive' (also referred to as 'conservative') strategy in which medical therapy alone is used initially, with a selection of patients for angiography based upon evidence of persistent myocardial ischaemia. Uncertainty exists as to which strategy provides the best outcomes for these patients. This Cochrane review is an update of a Cochrane review originally published in 2006, to provide a robust comparison of these two strategies in the early management of patients with UA/NSTEMI.\nObjectives\nTo determine the benefits and harms associated with the following.\n1. A routine invasive versus a conservative or 'selective invasive' strategy for the management of UA/NSTEMI in the stent era.\n2. A routine invasive strategy with and without glycoprotein IIb/IIIa receptor antagonists versus a conservative strategy for the management of UA/NSTEMI in the stent era.\nSearch methods\nWe searched the following databases and additional resources up to 25 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, MEDLINE and EMBASE, with no language restrictions.\nSelection criteria\nWe included prospective randomised controlled trials (RCTs) that compared invasive with conservative or 'selective invasive' strategies in participants with acute UA/NSTEMI.\nData collection and analysis\nTwo review authors screened the records and extracted data in duplicate. Using intention-to-treat analysis with random-effects models, we calculated summary estimates of the risk ratio (RR) with 95% confidence intervals (CIs) for the primary endpoints of all-cause death, fatal and non-fatal myocardial infarction (MI), combined all-cause death or non-fatal MI, refractory angina and re-hospitalisation. We performed further analysis of included studies based on whether glycoprotein IIb/IIIa receptor antagonists were used routinely. We assessed the heterogeneity of included trials using Pearson χ² (Chi² test) and variance (I² statistic) analysis. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and the GRADE profiler (GRADEPRO) was used to import data from Review Manager 5.3 (Review Manager) to create Summary of findings (SoF) tables.\nMain results\nEight RCTs with a total of 8915 participants (4545 invasive strategies, 4370 conservative strategies) were eligible for inclusion. We included three new studies and 1099 additional participants in this review update. In the all-study analysis, evidence did not show appreciable risk reductions in all-cause mortality (RR 0.87, 95% CI 0.64 to 1.18; eight studies, 8915 participants; low quality evidence) and death or non-fatal MI (RR 0.93, 95% CI 0.71 to 1.2; seven studies, 7715 participants; low quality evidence) with invasive strategies compared to conservative (selective invasive) strategies at six to 12 months follow-up. There was appreciable risk reduction in MI (RR 0.79, 95% CI 0.63 to 1.00; eight studies, 8915 participants; moderate quality evidence), refractory angina (RR 0.64, 95% CI 0.52 to 0.79; five studies, 8287 participants; moderate quality evidence) and re-hospitalisation (RR 0.77, 95% CI 0.63 to 0.94; six studies, 6921 participants; moderate quality evidence) with routine invasive strategies compared to conservative (selective invasive) strategies also at six to 12 months follow-up.\nEvidence also showed increased risks in bleeding (RR 1.73, 95% CI 1.30 to 2.31; six studies, 7584 participants; moderate quality evidence) and procedure-related MI (RR 1.87, 95% CI 1.47 to 2.37; five studies, 6380 participants; moderate quality evidence) with routine invasive strategies compared to conservative (selective invasive) strategies.\nThe low quality evidence were as a result of serious risk of bias and imprecision in the estimate of effect while moderate quality evidence was only due to serious risk of bias.\nAuthors' conclusions\nIn the all-study analysis, the evidence failed to show appreciable benefit with routine invasive strategies for unstable angina and non-ST elevation MI compared to conservative strategies in all-cause mortality and death or non-fatal MI at six to 12 months. There was evidence of risk reduction in MI, refractory angina and re-hospitalisation with routine invasive strategies compared to conservative (selective invasive) strategies at six to 12 months follow-up. However, routine invasive strategies were associated with a relatively high risk (almost double the risk) of procedure-related MI, and increased risk of bleeding complications. This systematic analysis of published RCTs supports the conclusion that, in patients with UA/NSTEMI, a selectively invasive (conservative) strategy based on clinical risk for recurrent events is the preferred management strategy.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The debate continues as to which strategy is better. The invasive strategy reduces the incidence of further chest pain or re-hospitalisation. Also, long-term follow-up from three studies suggests that it lowers the risk of a heart attack over the next three to five years. However, the invasive strategy also is associated with double the risk of heart attack during or soon after initial treatment, as well as an increased risk of bleeding. In summary, the published scientific research suggests that the invasive strategy may have particular benefit in those patients who are at high risk for recurrent events, and that patients at low risk for a recurrent event may even suffer harm from such an approach."
}
]
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