dataset
stringclasses 1
value | id
stringlengths 1
5
| messages
listlengths 2
2
|
|---|---|---|
query-laysum
|
21733
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is the most common bacterial infection among young children in the United States. There are limitations and concerns over its treatment with antibiotics and surgery and so effective preventative measures are attractive. A potential preventative measure is xylitol, a natural sugar substitute that reduces the risk of dental decay. Xylitol can reduce the adherence of Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) to nasopharyngeal cells in vitro. This is an update of a review first published in 2011.\nObjectives\nTo assess the efficacy and safety of xylitol to prevent AOM in children aged up to 12 years.\nSearch methods\nWe searched CENTRAL (to Issue 12, 2015), MEDLINE (1950 to January 2016), Embase (1974 to January 2016), CINAHL (1981 to January 2016), LILACS (1982 to January 2016), Web of Science (2011 to January 2016) and International Pharmaceutical Abstracts (2000 to January 2016).\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs of children aged 12 years or younger where xylitol supplementation was compared with placebo or no treatment to prevent AOM.\nData collection and analysis\nTwo review authors independently selected trials from search results, assessed and rated study quality and extracted relevant data for inclusion in the review. We contacted trial authors to request missing data. We noted data on any adverse events of xylitol. We extracted data on relevant outcomes and estimated the effect size by calculating risk ratio (RR), risk difference (RD) and associated 95% confidence intervals (CI).\nMain results\nWe identified five clinical trials that involved 3405 children for inclusion. For this 2016 update, we identified one new trial for inclusion. This trial was systematically reviewed but due to several sources of heterogeneity, was not included in the meta-analysis. The remaining four trials were of adequate methodological quality. In three RCTs that involved a total of 1826 healthy Finnish children attending daycare, there is moderate quality evidence that xylitol (in any form) can reduce the risk of AOM from 30% to around 22% compared with the control group (RR 0.75, 95% CI 0.65 to 0.88). Among the reasons for dropouts, there were no significant differences in abdominal discomfort and rash between the xylitol and the control groups. Xylitol was not effective in reducing AOM among healthy children during a respiratory infection (RR 1.13, 95% CI 0.83 to 1.53; moderate quality evidence) or among otitis-prone healthy children (RR 0.90, 95% CI 0.67 to 1.21; low-quality evidence).\nAuthors' conclusions\nThere is moderate quality evidence showing that the prophylactic administration of xylitol among healthy children attending daycare centres can reduce the occurrence of AOM. There is inconclusive evidence with regard to the efficacy of xylitol in preventing AOM among children with respiratory infection, or among otitis-prone children. The meta-analysis was limited because data came from a small number of studies, and most were from the same research group.\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": "All five trials received governmental funding; and the Finnish study investigators have a US patent for the use of xylitol to treat respiratory infections."
}
] |
query-laysum
|
21734
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD; including chronic bronchitis and emphysema) is a chronic respiratory condition characterised by shortness of breath, cough and recurrent exacerbations. Long-term antibiotic use may reduce both bacterial load and inflammation in the airways. Studies have shown a reduction of exacerbations with antibiotics in comparison to placebo in people with COPD, but there are concerns about antibiotic resistance and safety.\nObjectives\nTo compare the safety and efficacy of different classes of antibiotics (continuous, intermittent or pulsed) for prophylaxis of exacerbations in patients with COPD.\nSearch methods\nWe searched the Cochrane Airways Group Trials Register and bibliographies of relevant studies. The latest literature search was conducted on 6 February 2019.\nSelection criteria\nRandomised controlled trials (RCTs) were selected that compared one prophylactic antibiotic with another in patients with COPD.\nData collection and analysis\nWe used the standard Cochrane methods. Two independent review authors selected trials for inclusion, extracted data and assessed risk of bias. Discrepancies were resolved by involving a third review author.\nMain results\nWe included two RCTs, both published in 2015 involving a total of 391 participants with treatment duration of 12 to 13 weeks. One RCT compared a quinolone (moxifloxacin pulsed, for 5 days every 4 weeks), with a tetracycline (doxycycline continuous) or a macrolide (azithromycin intermittent).\nThe second RCT compared a tetracycline (doxycycline continuous) plus a macrolide (roxithromycin continuous), with roxithromycin (continuous) alone.\nThe trials recruited participants with a mean age of 68 years, with moderate-severity COPD. Both trials included participants who had between two and five exacerbations in the previous one to two years. In one trial, 17% of patients had previously been using inhaled corticosteroids. In the other study, all patients were positive for Chlamydophila pneumoniae (C pneumoniae).\nOverall, we judged the evidence presented to be of very low-certainty, mainly due to imprecision, but we also had concerns about indirectness and methodological quality of the included studies. The primary outcome measures for this review included exacerbations, quality of life, drug resistance and serious adverse events.\nMacrolide + tetracycline versus macrolide\nThere was no clear difference between treatments in improvement in quality of life as assessed by the Chronic Respiratory Questionnaire (CRQ). The CRQ scale ranges from 0 to 10 and higher scores on the scale indicate better quality of life. CRQ sub-scales for dyspnoea (mean difference (MD) 0.58, 95% confidence interval (CI) -0.84 to 2.00; 187 participants; very low-certainty evidence), fatigue (MD 0.02, 95% CI -1.08 to 1.12; 187 participants; very low-certainty evidence), emotional function (MD -0.37, 95% CI -1.74 to 1.00; 187 participants; very low-certainty evidence), or mastery (MD -0.79, 95% CI -1.86 to 0.28; 187 participants; very low-certainty evidence) at 12 weeks. For serious adverse events, it was uncertain if there was a difference between combined roxithromycin and doxycycline versus roxithromycin alone at 48 weeks follow-up after active treatment of 12 weeks (odds ratio (OR) 1.00, 95% CI 0.52 to 1.93; 198 participants; very low-certainty evidence). There were five deaths reported in the combined treatment arm, versus three in the single treatment arm at 48 weeks follow-up after active treatment of 12 weeks (OR 1.63, 95% CI 0.38 to 7.02; 198 participants; very low-certainty evidence).\nQuinolone versus tetracycline\nThere was no clear difference between moxifloxacin and doxycycline for the number of participants experiencing one or more exacerbations (OR 0.44, 95% CI 0.14 to 1.38; 50 participants, very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes.\nQuinolone versus macrolide\nThere was no clear difference between moxifloxacin and azithromycin for the number of participants experiencing one or more exacerbations (OR 1.00, 95% CI 0.32 to 3.10; 50 participants; very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes.\nMarcolide versus tetracycline\nThere was no clear difference between azithromycin and doxycycline for the number of participants experiencing one or more exacerbations (OR 0.44, 95% CI 0.14 to 1.38; 50 participants; very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes.\nWe did not find head-to-head evidence for impact of antibiotics on drug resistance.\nAuthors' conclusions\nIt is not clear from the evidence included in this review whether there is a difference in efficacy or safety between different classes or regimens of prophylactic antibiotic, given for 12 to 13 weeks to people with COPD. Whilst no head-to-head comparisons of antibiotic resistance were identified, concerns about this continue. The sample size in this review is small and both included studies are of short duration. Thus, there is considerable uncertainty in effects observed and the effects of different prophylactic antibiotics requires further research.\n\nGiven the provided abstract, please respond to the following query: \"Why did we do this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to know whether one preventative antibiotic was better than another preventative antibiotic in reducing exacerbations, and improving quality of life for people with COPD."
}
] |
query-laysum
|
21735
|
[
{
"role": "user",
"content": "Abstract: Background\nMigraine and cluster headaches are severe and disabling. Migraine affects up to 18% of women, while cluster headaches are much less common (0.2% of the population). A number of acute and prophylactic therapies are available. Hyperbaric oxygen therapy (HBOT) is the therapeutic administration of 100% oxygen at environmental pressures greater than one atmosphere, while normobaric oxygen therapy (NBOT) is oxygen administered at one atmosphere. This is an updated version of the original Cochrane review published in Issue 3, 2008 under the title 'Normobaric and hyperbaric oxygen for migraine and cluster headache'.\nObjectives\nTo examine the efficacy and safety of normobaric oxygen therapy (NBOT) and hyperbaric oxygen therapy (HBOT) in the treatment and prevention of migraine and cluster headache.\nSearch methods\nWe updated searches of the following databases up to 15 June 2015: CENTRAL (the Cochrane Library), MEDLINE, EMBASE, and CINAHL. For the original review we searched the following databases up to May 2008: CENTRAL, MEDLINE, EMBASE, CINAHL, DORCTIHM, and reference lists from relevant articles. We handsearched relevant journals and contacted researchers to identify trials.\nSelection criteria\nRandomised controlled trials comparing HBOT or NBOT with one another, other active therapies, placebo (sham) interventions, or no treatment in participants with migraine or cluster headache.\nData collection and analysis\nThree review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.\nMain results\nIn this update, we included 11 trials with 209 participants. Five trials (103 participants) compared HBOT versus sham therapy for acute migraine, three trials compared NBOT to sham therapy or ergotamine tartrate for cluster headache (145 participants), two trials evaluated HBOT for cluster headache (29 participants), and one trial (56 participants) compared NBOT to sham for a mixed group of headache. The risk of bias varied considerably across these trials but in general trial quality was poor to moderate. One trial may not have been truly randomised and two included studies were reported as abstracts only. Seven trials did not indicate allocation concealment or randomisation method. Notably, 10 of the 11 trials used a sham comparator therapy and masked the outcome assessor to allocation.\nWe pooled data from three trials, which suggested that HBOT was effective in relieving migraine headaches compared to sham therapy (risk ratio (RR) 6.21, 95% CI 2.41 to 16.00; 58 participants, three trials). The quality of evidence was low, having been downgraded for small crossover studies with incomplete reporting. There was no evidence that HBOT could prevent migraine episodes, reduce the incidence of nausea and vomiting, or reduce the requirement for rescue medication. There was no evidence that HBOT was effective for the termination of cluster headache (RR 11.38, 95% CI 0.77 to 167.85; P = 0.08) (one trial), but this trial had low power.\nNBOT was effective in terminating cluster headache compared to sham in a single small study (RR 7.88, 95% CI 1.13 to 54.66), but not superior to ergotamine administration in another small trial (RR 1.17, 95% CI 0.94 to 1.46; P = 0.16). A third trial reported a statistically significant difference in the proportion of attacks successfully treated with oxygen (117 of 150 attacks were successfully treated with NBOT (78%) versus 30 of 148 attacks treated with NBOT (20%)). The proportion of responders was consistent across these three trials, and suggested more than 75% of headaches were likely to respond to NBOT.\nNo serious adverse events during HBOT or NBOT were reported.\nAuthors' conclusions\nSince the last version of this review, two new included studies have provided additional information to change the conclusions. There was some evidence that HBOT was effective for the termination of acute migraine in an unselected population, and some evidence that NBOT was similarly effective in cluster headache. Given the cost and poor availability of HBOT, more research should be done on patients unresponsive to standard therapy. NBOT is cheap, safe, and easy to apply, so will probably continue to be used despite the limited evidence in this review.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Migraine and cluster headaches are severe and disabling. Hyperbaric oxygen therapy (HBOT, that is the breathing of pure oxygen at pressures greater than one atmosphere in a pressurised chamber) and normal pressure oxygen therapy (NBOT) can be delivered via a mask at home or in a clinic. These treatments may help to end acute attacks and prevent future attacks."
}
] |
query-laysum
|
21736
|
[
{
"role": "user",
"content": "Abstract: Background\nCataract surgery is practiced widely, and substantial resources are committed to an increasing cataract surgical rate in low- and middle-income countries. With the current volume of cataract surgery and future increases, it is critical to optimize the safety and cost-effectiveness of this procedure. Most cataracts are performed on older individuals with correspondingly high systemic and ocular comorbidities. It is likely that routine preoperative medical testing will detect medical conditions, but it is questionable whether these conditions should preclude individuals from cataract surgery or change their perioperative management.\nObjectives\n1. To investigate the evidence for reductions in adverse events through preoperative medical testing\n2. To estimate the average cost of performing routine medical testing\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 6); Ovid MEDLINE; Embase.com; PubMed; LILACS BIREME, the metaRegister of Controlled Trials (mRCT) (last searched 5 January 2012); ClinicalTrials.gov and the WHO ICTRP. The date of the search was 29 June 2018, with the exception of mRCT which is no longer in service. We searched the references of reports from included studies for additional relevant studies without restrictions regarding language or date of publication.\nSelection criteria\nWe included randomized clinical trials in which routine preoperative medical testing was compared to no preoperative or selective preoperative testing prior to age-related cataract surgery.\nData collection and analysis\nTwo review authors independently assessed abstracts to identify possible trials for inclusion. For each included study, two review authors independently documented study characteristics, extracted data, and assessed risk of bias.\nMain results\nWe identified three randomized clinical trials that compared routine preoperative medical testing versus selective or no preoperative testing for 21,531 cataract surgeries. The largest trial, in which 19,557 surgeries were randomized, was conducted in Canada and the USA. Another study was conducted in Brazil and the third in Italy. Although the studies had some issues with respect to performance and detection bias due to lack of masking (high risk for one study, unclear for two studies), we assessed the studies as at overall low risk of bias.\nThe three randomized clinical trials included in this review reported results for 21,531 total cataract surgeries with 707 total surgery-associated medical adverse events, including 61 hospitalizations and three deaths. Of the 707 medical adverse events reported, 353 occurred in the pre-testing group and 354 occurred in the no-testing group (odds ratio (OR) 1.00, 95% confidence interval (CI) 0.86 to 1.16; high-certainty evidence). Most events were cardiovascular and occurred during the intraoperative period. Routine preoperative medical testing did not reduce the risk of intraoperative (OR 0.99, 95% CI 0.71 to 1.38) or postoperative ocular adverse events (OR 1.11, 95% CI 0.74 to 1.67) when compared to selective or no testing (2 studies; 2281 cataract surgeries; moderate-certainty evidence). One study evaluated cost savings, estimating the costs to be 2.55 times higher in those with preoperative medical testing compared to those without preoperative medical testing (1 study; 1005 cataract surgeries; moderate-certainty evidence). There was no difference in cancellation of surgery between those with preoperative medical testing and those with selective or no preoperative testing, reported by two studies with 20,582 cataract surgeries (OR 0.97, 95% CI 0.78 to 1.21; high-certainty evidence). No study reported outcomes related to clinical management changes (other than cancellation) or quality of life scores.\nAuthors' conclusions\nThis review has shown that routine preoperative testing does not increase the safety of cataract surgery. Alternatives to routine preoperative medical testing have been proposed, including self administered health questionnaires, which could substitute for health provider histories and physical examinations. Such avenues may lead to cost-effective means of identifying those at increased risk of medical adverse events due to cataract surgery. However, despite the rare occurrence, adverse medical events precipitated by cataract surgery remain a concern because of the large number of elderly patients with multiple medical comorbidities who have cataract surgery in various settings. The studies summarized in this review should assist recommendations for the standard of care of cataract surgery, at least in low- and middle-income settings. Unfortunately, in these settings, medical history questionnaires may be useless to screen for risk because few people have ever been to a physician, let alone been diagnosed with any chronic disease.\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 included three studies in this review. One study was from Canada and the USA, another from Brazil, and the third from Italy. These studies compared routine preoperative medical testing versus selective or no testing. Study participants were followed from one week to two months after surgery.\nThe review shows the following.\n• Preoperative medical testing did not reduce the risk of medical adverse events during or after cataract surgery when compared to selective or no testing (high-certainty evidence). The three studies reported results for 21,531 total cataract surgeries with 707 total surgery-associated medical adverse events, including 61 hospitalizations and three deaths. Of the 707 medical adverse events reported, 353 occurred in the pre-testing group and 354 occurred in the no-testing group.\n• No clear difference was observed for the occurrence of eye-related adverse events during or after surgery (moderate-certainty evidence).\n• One study evaluated cost, estimating the cost to be 2.55 times higher in those who had routine preoperative medical testing compared to those who had selective preoperative testing (moderate-certainty evidence).\n• There was no difference in the cancellation of surgery between those with routine preoperative medical testing and those with no or selective preoperative testing (high-certainty evidence).\n• No study reported changes in surgical management (other than cancellation of surgery) or quality of life measures (evidence gaps)."
}
] |
query-laysum
|
21737
|
[
{
"role": "user",
"content": "Abstract: Background\nHaematological malignancies are malignant neoplasms of the myeloid or lymphatic cell lines including leukaemia, lymphoma and myeloma. In order to manage physical and psychological aspects of the disease and its treatment, complementary therapies like yoga are coming increasingly into focus. However, the effectiveness of yoga practice for people suffering from haematological malignancies remains unclear.\nObjectives\nTo assess the effects of yoga practice in addition to standard cancer treatment for people with haematological malignancies.\nSearch methods\nOur search strategy included the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950 to 4th February 2014), databases of ongoing trials (controlled-trials.com; clinicaltrials.gov), conference proceedings of the American Society of Clinical Oncology, the American Society of Hematology, the European Haematology Association, the European Congress for Integrative Medicine, and Global Advances in Health and Medicine. We handsearched references of these studies from identified trials and relevant review articles. Two review authors independently screened the search results.\nSelection criteria\nWe included randomised controlled trials (RCTs) of yoga in addition to standard care for haematological malignancies compared with standard care only. We did not restrict this to any specific style of yoga.\nData collection and analysis\nTwo review authors independently extracted data for eligible studies and assessed the risk of bias according to predefined criteria. We evaluated distress, fatigue, anxiety, depression and quality of sleep. Further outcomes we planned to assess were health-related quality of life (HRQoL), overall survival (OS) and adverse events (AE), but data on these were not available.\nMain results\nOur search strategies led to 149 potentially relevant references, but only a single small study met our inclusion criteria. The included study was published as a full text article and investigated the feasibility and effect of Tibetan Yoga additional to standard care (N = 20; 1 person dropped out before attending any classes and no data were collected) compared to standard care only (N = 19). The study included people with all stages of Hodgkin and non-Hodgkin's lymphoma, with and without current cancer treatment. The mean age was 51 years.\nWe judged the overall risk of bias as high as we found a high risk for performance, detection and attrition bias. Additionally, potential outcome reporting bias could not be completely ruled out. Following the recommendations of GRADE, we judged the overall quality of the body of evidence for all predefined outcomes as 'very low', due to the methodical limitations and the very small sample size.\nThe influence of yoga on HRQoL and OS was not reported. There is no evidence that yoga in addition to standard care compared with standard care only can improve distress in people with haematological malignancies (mean difference (MD) -0.30, 95% confidence interval (CI) -5.55 to 4.95; P = 0.91). Similarly, there is no evidence of a difference between either group for fatigue (MD 0.00, 95% CI -0.94 to 0.94; P = 1.00), anxiety (MD 0.30, 95% CI -5.01 to 5.61; P = 0.91) or depression (MD -0.70, 95% CI -3.21 to 1.81; P = 0.58).\nThere is very low quality evidence that yoga improves the overall quality of sleep (MD -2.30, 95% CI -3.78 to -0.82; P = 0.002). The yoga groups' total score for the Pittsburgh Sleep Quality Index (PSQI) was 5.8 (± 2.3 SD) and better than the total score (8.1 (± 2.4 SD)) of the control group. A PSQI total score of 0 to 5 indicates good sleep whereas PSQI total score 6 to 21 points towards significant sleep disturbances. The occurrence of AEs was not reported.\nAuthors' conclusions\nThe currently available data provide little information about the effectiveness of yoga interventions for people suffering from haematological malignancies. The finding that yoga may be beneficial for the patients' quality of sleep is based on a very small body of evidence. Therefore, the role of yoga as an additional therapy for haematological malignancies remains unclear. Further high-quality randomised controlled trials with larger numbers of participants are needed to make a definitive statement.\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": "There are not enough data to say how effective yoga is in the management of haematological malignancies. Therefore, the role of yoga for haematological malignancies remains unclear. Further large, high-quality randomised controlled trials are needed.\nThe evidence is up-to-date as of 4 February 2014."
}
] |
query-laysum
|
21738
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with schizophrenia often experience symptoms which fail to fully respond to antipsychotic medication. Transcranial magnetic stimulation (TMS) has been proposed as a new treatment for people with schizophrenia, especially those who experience persistent auditory hallucinations.\nObjectives\nTo estimate the effects of TMS alone, compared with sham TMS or with 'standard management' and any other comparison interventions in reducing psychotic symptoms associated with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (June 2006, June 2008, April 2013). This register is compiled by methodical searches of MEDLINE, EMBASE, BIOSIS, CINAHL, Dissertation abstracts, LILACS, PSYNDEX, PsycINFO, RUSSMED, and Sociofile, and is supplemented with handsearching of relevant journals and numerous conference proceedings.\nSelection criteria\nWe included all randomised controlled trials recruiting at least five participants and comparing TMS with sham TMS or any other treatment for people with schizophrenia.\nData collection and analysis\nWe extracted data independently. For dichotomous data we calculated relative risks (RRs) and their 95% confidence intervals (CIs). For continuous data, we calculated mean differences (MD) and 95% CI. We used a fixed-effect model. We assessed overall quality of the evidence using the GRADE approach.\nMain results\nWe included 41 studies with 1473 participants in the review. We found significant differences in favour of temporoparietal TMS compared to sham TMS for global state measured on the CGI scale (7 RCTs, n = 224, MD -0.5, 95% CI -0.76 to -0.23, very low-quality evidence) and positive symptoms measured on the PANSS scale (5 RCTs, n = 127, MD -6.09, 95% CI -10.95 to -1.22, very low-quality evidence). Participants experienced significantly more headaches in the temporoparietal TMS group (10 RCTs, n = 392, RR 2.65, 95% CI 1.56 to 4.50, very low-quality evidence). However, no more participants left the study early from the TMS group than from the sham group (very low-quality evidence). Cognitive state was assessed using 39 different measures, and all were equivocal (very low-quality evidence).\nWe included only two trials which compared temporoparietal TMS with standard treatment. In both trials the participants received first- and second-generation antipsychotic medication in both treatment groups, therefore TMS was used an adjunctive therapy to medication. We found no significant differences in the number of participants that showed clinical improvement in global state (1 RCT, n = 100, RR 1.19, 95% CI 0.91 to 1.57) or left the study early (2 RCTs, n = 140, RR 0.33, 95% CI 0.08 to 1.46) (both very low-quality evidence). No studies reported on global state score, mental state, cognitive state and adverse effects.\nFor prefrontal TMS compared to sham TMS, global state was measured on three different scales, all of which presented equivocal results (very low quality evidence). We could not pool data for mental state on the PANSS scale due to high heterogeneity. Cognitive state was assessed using 19 different measures, with 15/19 being equivocal (very low-quality evidence). Prefrontal TMS caused more headaches (6 RCTs, n = 164, RR 2.77, 95% CI 1.22 to 6.26, very low-quality evidence) but there was no difference in the number of participants leaving the study early (very low-quality evidence). No studies reported data for clinical improvement.\nWe found a significant difference in favour of prefrontal theta burst stimulation TMS compared to sham TMS for mental state on the PANNS scale (3 RCTs, n = 108, MD -5.71, 95% CI -9.32 to -2.10, very low evidence). We found no difference for clinical improvement, cognitive state, number of headaches, and leaving the study early (very low-quality evidence).\nNone of the included studies reported satisfaction with care.\nAuthors' conclusions\nBased on this review, there is insufficient evidence to support or refute the use of TMS to treat symptoms of schizophrenia. Although some evidence suggests that TMS, and in particular temporoparietal TMS, may improve certain symptoms (such as auditory hallucinations and positive symptoms of schizophrenia) compared to sham TMS, the results were not robust enough to be unequivocal across the assessment measures used. There was insufficient evidence to suggest any added benefit with TMS used as an adjunctive therapy to antipsychotic medication.\nThe overall quality of evidence was graded as very low due to risk of bias, and this was accompanied by an imprecision in estimates due to the relatively small number of participants in the studies. Thus, consideration is required in improving the quality of trial processes, as well as the quality of reporting of ongoing and future TMS trials, so as to facilitate accurate future judgements in assessing risk of bias. Differences in TMS techniques in relation to stimulation intensity, stimulation length, brain areas stimulated and variations in the design of sham TMS all contributed to the heterogeneity of study findings and limited the interpretation and applicability of the results. In addition, the trials assessed their outcomes with a variety of scales, and usable data were limited. Therefore, to better evaluate the treatment effects of TMS in people with schizophrenia, we favour the use of standardised treatment protocols and outcome measures.\n\nGiven the provided abstract, please respond to the following query: \"Review Question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is transcranial magnetic stimulation (TMS) useful in treating people with schizophrenia?"
}
] |
query-laysum
|
21739
|
[
{
"role": "user",
"content": "Abstract: Background\nMagnetic seizure therapy (MST) is a potential alternative to electroconvulsive therapy (ECT). Reports to date on use of MST for patients with treatment-resistant depression (TRD) are limited.\nObjectives\nTo evaluate the effects of MST in comparison with sham-MST, antidepressant, and other forms of electric or magnetic treatment for adults with TRD.\nSearch methods\nIn March 2020, we searched a wide range of international electronic sources for published, unpublished, and ongoing studies. We handsearched the reference lists of all included studies and relevant systematic reviews and conference proceedings of the Annual Meeting of the American College of Neuropsychopharmacology (ACNP), the Annual Scientific Convention and Meeting, and the Annual Meeting of the European College of Neuropsychopharmacology (ECNP) to identify additional studies.\nSelection criteria\nAll randomised clinical trials (RCTs) focused on MST for adults with TRD.\nData collection and analysis\nTwo review authors extracted data independently. For binary outcomes, we calculated risk ratios (RRs) and 95% confidence intervals (CIs). For continuous data, we estimated mean differences (MDs) between groups and 95% CIs. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using the GRADE approach. Our main outcomes of interest were symptom severity, cognitive function, suicide, quality of life, social functioning, dropout for any reason, serious adverse events, and adverse events that led to discontinuation of treatment.\nMain results\nWe included three studies (65 participants) comparing MST with ECT. Two studies reported depressive symptoms with the Hamilton Rating Scale for Depression (HAMD). However, in one study, the data were skewed and there was an imbalance in baseline characteristics. Analysis of these two studies showed no clear differences in depressive symptoms between treatment groups (MD 0.71, 95% CI -2.23 to 3.65; 2 studies, 40 participants; very low-certainty evidence). Two studies investigated multiple domains of cognitive function. However most of the outcomes were not measured by validated neuropsychological tests, and many of the data suffered from unbalanced baseline and skewed distribution. Analysis of immediate memory performance measured by the Wechsler Memory Scale showed no clear differences between treatment groups (MD 0.40, 95% CI -4.16 to 4.96; 1 study, 20 participants; very low-certainty evidence). Analysis of delayed memory performance measured by the Wechsler Memory Scale also showed no clear differences between treatment groups (MD 2.57, 95% CI -2.39 to 7.53; 1 study, 20 participants; very low-certainty evidence). Only one study reported quality of life, but the data were skewed and baseline data were unbalanced across groups. Analysis of quality of life showed no clear differences between treatment groups (MD 14.86, 95% CI -42.26 to 71.98; 1 study, 20 participants; very low-certainty evidence). Only one study reported dropout and adverse events that led to discontinuation of treatment. Analysis of reported data showed no clear differences between treatment groups for this outcome (RR 1.38, 95% CI 0.28 to 6.91; 1 study, 25 participants; very low-certainty evidence). Adverse events occurred in only two participants who received ECT (worsening of preexisting coronary heart disease and a cognitive adverse effect). None of the included studies reported outcomes on suicide and social functioning. No RCTs comparing MST with other treatments were identified.\nAuthors' conclusions\nEvidence regarding effects of MST on patients with TRD is currently insufficient. Our analyses of available data did not reveal clearly different effects between MST and ECT. We are uncertain about these findings because of risk of bias and imprecision of estimates. Large, long, well-designed, and well-reported trials are needed to further examine the effects of MST.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included three studies involving 65 participants. These studies compared MST and ECT with up to 12 treatment sessions in six weeks. Existing evidence did not reveal differences in effectiveness or tolerance between MST and ECT.\nHowever, we are not sure how reliable study results are. All findings are based on only a few studies with a small number of participants. Participants knew which treatment they received. Studies were conducted in a different way from their protocols. Some key information was not reported, such as how participants were allocated to different treatments and whether there were participant dropouts from these studies. All studies were conducted by a single research team in Germany and were funded in part by the manufacturer of an MST device."
}
] |
query-laysum
|
21740
|
[
{
"role": "user",
"content": "Abstract: Background\nIdentification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth.\nObjectives\nTo assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017).\nSelection criteria\nWe planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.\nParticipants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.\nThis review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:\n* review of maternal and family history, and current pregnancy and birth history;\n* clinical history of present illness;\n* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);\n* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);\n* umbilical cord examination;\n* placental examination including histopathology (microscopic examination of placental tissue); and\n* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).\nWe planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).\nWe also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol.\nData collection and analysis\nTwo review authors assessed trial eligibility independently.\nMain results\nWe excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review.\nAuthors' conclusions\nThere is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.\nFuture RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence on 15 May 2017. We did not find any trials for inclusion in this review. We excluded five trials because they were not randomised controlled trials."
}
] |
query-laysum
|
21741
|
[
{
"role": "user",
"content": "Abstract: Background\nFew strategies are effective for the treatment of acute ischaemic stroke. Buflomedil is a vasoactive agent that has been used for peripheral arterial diseases. Research studies have suggested that buflomedil may have beneficial effects in people with cerebral vascular diseases, including acute ischaemic stroke, however it has not been approved for treating stroke in clinical practice.\nObjectives\nTo assess the efficacy and safety of buflomedil for the treatment of acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (September 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 4), MEDLINE (1950 to February 2014), EMBASE (1980 to February 2014), ProQuest Dissertations and Theses Database (July 2014), Web of Science (including Conference Proceedings Citation Index Science (CPCI-S)) (July 2014), and four Chinese databases (February 2014). We also searched five ongoing trials registers and reference lists of the included trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated the efficacy of buflomedil in people with acute ischaemic stroke. The primary outcome of this review was long-term death or disability/dependence. Other outcomes included short-term death, short-term disability, neurological deficits, and adverse events. We included trials comparing buflomedil versus a placebo control, trials comparing buflomedil plus usual medical care versus usual medical care alone, or those comparing buflomedil plus another intervention versus that intervention alone. We excluded trials comparing buflomedil alone with other potentially active intervention(s).\nData collection and analysis\nTwo review authors independently scrutinised citations, selected studies, extracted data and assessed risk of bias in the included trials. We reported risk ratios (RRs) for dichotomous data and standardised mean differences (SMDs) for continuous data. We performed meta-analysis, using a random-effects model, for death and improvement of neurological deficits. Data for disability/dependence and adverse events were not suitable for meta-analysis thus we reported these narratively. We performed subgroup analyses for time of recruitment since stroke, delivery route, daily dose, and treatment duration.\nMain results\nWe included 26 trials (2756 participants), all conducted in China. All participants were inpatients within the first few days after stroke onset (mean age 58 to 75 years and male proportion 45% to 80%). Most trials delivered buflomedil intravenously, with a daily dose of 200 mg for 14 days. The study quality was generally poor and many trials were poorly reported.\nOnly one trial reported long-term death and disability, where stroke survivors in the buflomedil group had a lower risk of suffering 'death or disability' than those in the control group (200 participants, RR 0.71, 95% confidence interval (CI) 0.53 to 0.94). All 26 trials assessed outcomes by the end of treatment (eight trials with 1056 participants reported death, one trial with 85 participants reported disability, and 26 trials with 2756 participants reported neurological deficits), but there was no robust evidence for any of these short-term outcomes. Seventeen trials (1899 participants) investigated the presence of adverse events during the treatment, of which six trials (853 participants) reported \"no significant adverse event in any participants\" and the other 11 trials (1046 participants) reported a total of 38 adverse events in the buflomedil group and two events in the control group. In general, for each of these outcomes the quality of evidence was low according to the GRADE principles.\nAuthors' conclusions\nThere is insufficient evidence on the efficacy or safety of buflomedil to support its use for the treatment of acute ischaemic stroke. Given these uncertainties, the data support the rationale for an adequately powered RCT of buflomedil in people with acute ischaemic stroke.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence was generally low. There were not enough data and most trials had poor study design or incomplete reporting of relevant information. To provide evidence for the use of buflomedil as a routine treatment for acute ischaemic stroke, high quality randomised trials are needed."
}
] |
query-laysum
|
21742
|
[
{
"role": "user",
"content": "Abstract: Background\nExercise has a number of health benefits and has been recommended as a treatment for primary dysmenorrhoea (period pain), but the evidence for its effectiveness on primary dysmenorrhoea is unclear. This review examined the available evidence supporting the use of exercise to treat primary dysmenorrhoea.\nObjectives\nTo evaluate the effectiveness and safety of exercise for women with primary dysmenorrhoea.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, AMED and CINAHL (from inception to July 2019). We searched two clinical trial databases (inception to March 2019) and handsearched reference lists and previous systematic reviews.\nSelection criteria\nWe included studies if they randomised women with moderate-to-severe primary dysmenorrhoea to receive exercise versus no treatment, attention control, non-steroidal anti-inflammatory drugs (NSAIDs) or the oral contraceptive pill. Cross-over studies and cluster-randomised trials were not eligible for inclusion.\nData collection and analysis\nTwo review authors independently selected the studies, assessed eligible studies for risk of bias, and extracted data from each study. We contacted study authors for missing information. We assessed the quality of the evidence using GRADE. Our primary outcomes were menstrual pain intensity and adverse events. Secondary outcomes included overall menstrual symptoms, usage of rescue analgesic medication, restriction of daily life activities, absence from work or school and quality of life.\nMain results\nWe included a total of 12 trials with 854 women in the review, with 10 trials and 754 women in the meta-analysis. Nine of the 10 studies compared exercise with no treatment, and one study compared exercise with NSAIDs. No studies compared exercise with attention control or with the oral contraceptive pill. Studies used low-intensity exercise (stretching, core strengthening or yoga) or high-intensity exercise (Zumba or aerobic training); none of the included studies used resistance training.\n\nExercise versus no treatment\nExercise may have a large effect on reducing menstrual pain intensity compared to no exercise (standard mean difference (SMD) -1.86, 95% confidence interval (CI) -2.06 to -1.66; 9 randomised controlled trials (RCTs), n = 632; I2= 91%; low-quality evidence). This SMD corresponds to a 25 mm reduction on a 100 mm visual analogue scale (VAS) and is likely to be clinically significant. We are uncertain if there is any difference in adverse event rates between exercise and no treatment.\nWe are uncertain if exercise reduces overall menstrual symptoms (as measured by the Moos Menstrual Distress Questionnaire (MMDQ)), such as back pain or fatigue compared to no treatment (mean difference (MD) -33.16, 95% CI -40.45 to -25.87; 1 RCT, n = 120; very low-quality evidence), or improves mental quality of life (MD 4.40, 95% CI 1.59 to 7.21; 1 RCT, n = 55; very low-quality evidence) or physical quality of life (as measured by the 12-Item Short Form Health Survey (SF-12)) compared to no exercise (MD 3.40, 95% CI -1.68 to 8.48; 1 RCT, n = 55; very low-quality evidence) when compared to no treatment. No studies reported on any changes in restriction of daily life activities or on absence from work or school.\nExercise versus NSAIDs\nWe are uncertain if exercise, when compared with mefenamic acid, reduced menstrual pain intensity (MD -7.40, 95% CI -8.36 to -6.44; 1 RCT, n = 122; very low-quality evidence), use of rescue analgesic medication (risk ratio (RR) 1.77, 95% CI 1.21 to 2.60; 1 RCT, n = 122; very low-quality evidence) or absence from work or school (RR 1.00, 95% CI 0.49 to 2.03; 1 RCT, n = 122; very low-quality evidence). None of the included studies reported on adverse events, overall menstrual symptoms, restriction of daily life activities or quality of life.\nAuthors' conclusions\nThe current low-quality evidence suggests that exercise, performed for about 45 to 60 minutes each time, three times per week or more, regardless of intensity, may provide a clinically significant reduction in menstrual pain intensity of around 25 mm on a 100 mm VAS. All studies used exercise regularly throughout the month, with some studies asking women not to exercise during menstruation. Given the overall health benefits of exercise, and the relatively low risk of side effects reported in the general population, women may consider using exercise, either alone or in conjunction with other modalities, such as NSAIDs, to manage menstrual pain. It is unclear if the benefits of exercise persist after regular exercise has stopped or if they are similar in women over the age of 25. Further research is required, using validated outcome measures, adequate blinding and suitable comparator groups reflecting current best practice or accounting for the extra attention given during exercise.\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": "We wanted to know whether using exercise was better than receiving no treatment, a treatment that gives you some attention but is not exercise, or currently recommended pharmaceutical medications for primary dysmenorrhoea, such as the oral contraceptive pill or non-steroidal anti-inflammatory drugs (NSAIDs)."
}
] |
query-laysum
|
21743
|
[
{
"role": "user",
"content": "Abstract: Background\nA permanent upper (maxillary) canine tooth that grows into the roof of the mouth and frequently does not appear (erupt) is called a palatally displaced canine (PDC). The reported prevalence of PDC in the population varies between 1% and 3%. Management of the unerupted PDC can be lengthy, involving surgery to uncover the tooth and prolonged orthodontic (brace) treatment to straighten it; therefore, various procedures have been suggested to encourage a PDC to erupt without the need for surgical intervention.\nObjectives\nTo assess the efficacy, safety and cost-effectiveness of any interceptive procedure to promote the eruption of a PDC compared to no treatment or other interceptive procedures in young people aged 9 to 14 years old.\nSearch methods\nAn information specialist searched four bibliographic databases up to 3 February 2021 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCT) involving at least 80% of children aged between 9 and 14 years, who were diagnosed with an upper PDC and undergoing an intervention to enable the successful eruption of the unerupted PDC, which was compared with an untreated control group or another intervention.\nData collection and analysis\nTwo review authors, independently and in duplicate, examined titles, keywords, abstracts, full articles, extracted data and assessed risk of bias using the Cochrane Risk of Bias 1 tool (RoB1). The primary outcome was summarised with risk ratios (RR) and 95% confidence intervals (CI). We reported an intention-to-treat (ITT) analysis when data were available and a modified intention-to-treat (mITT) analysis if not. We also undertook several sensitivity analyses. We used summary of findings tables to present the main findings and our assessment of the certainty of the evidence.\nMain results\nWe included four studies, involving 199 randomised participants (164 analysed), 108 girls and 91 boys, 82 of whom were diagnosed with unilateral PDC and 117 with bilateral PDC. The participants were aged between 8 and 13 years at recruitment. The certainty of the evidence was very low and future research may change our conclusions.\nOne study (randomised 67 participants, 89 teeth) found that extracting the primary canine may increase the proportion of PDCs that successfully erupt into the mouth at 12 months compared with no extraction (RR 2.87, 95% CI 0.90 to 9.23; 45 participants, 45 PDCs analysed; very low-certainty evidence), but the CI included the possibility of no difference; therefore the evidence was uncertain. There was no evidence that extraction of the primary canine reduced the number of young people with a PDC referred for surgery at 12 months (RR 0.61 (95% CI 0.29 to 1.28).\nThree studies (randomised 132 participants, 227 teeth) found no difference in the proportion of successfully erupted PDCs at 18 months with a double primary tooth extraction compared with extraction of a single primary canine (RR 0.68, 95% CI 0.35 to 1.31; 119 participants analysed, 203 PDCs; mITT; very low-certainty evidence). Two of these studies found no difference in the proportions referred for surgical exposure between the single and the double primary extraction groups data at 48 months (RR 0.31, 95% CI 0.06 to 1.45).\nThere are some descriptive data suggesting that the more severe the displacement of the PDC towards the midline, the lower the proportion of successfully erupted PDCs with or without intervention.\nAuthors' conclusions\nThe evidence that extraction of the primary canine in a young person aged between 9 and 14 years diagnosed with a PDC may increase the proportion of erupted PDCs, without surgical intervention, is very uncertain. There is no evidence that double extraction of primary teeth increases the proportion of erupted PDC compared with a single primary tooth extraction at 18 months or the proportion referred for surgery by 48 months. Because we have only low to very low certainty in these findings, future research is necessary to help us know for sure the best way to deal with upper permanent teeth that are not erupting as expected.\n\nGiven the provided abstract, please respond to the following query: \"What is the health problem?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Upper permanent canine teeth (commonly known as eye teeth or fang teeth) are positioned in the upper jaw, one on the right and one on the left. In around 1% to 3% of children, they may not erupt (appear from behind the gum and into the mouth) into their correct position. The permanent canine tooth or teeth may grow towards the palate (roof of the mouth) and remain unerupted (buried under the gum). This is known as a palatally displaced canine (PDC). If the permanent canine tooth remains displaced and unerupted, it can damage or change the position of neighbouring teeth, and occasionally it can lead to a cyst."
}
] |
query-laysum
|
21744
|
[
{
"role": "user",
"content": "Abstract: Background\nNeck pain is common, disabling and costly. The effectiveness of electrotherapy as a physiotherapeutic option remains unclear. This is an update of a Cochrane review first published in 2005 and previously updated in 2009.\nObjectives\nThis systematic review assessed the short, intermediate and long-term effects of electrotherapy on pain, function, disability, patient satisfaction, global perceived effect, and quality of life in adults with neck pain with and without radiculopathy or cervicogenic headache.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL, without language restrictions, from their beginning to August 2012; handsearched relevant conference proceedings; and consulted content experts.\nSelection criteria\nRandomized controlled trials (RCTs), in any language, investigating the effects of electrotherapy used primarily as unimodal treatment for neck pain. Quasi-RCTs and controlled clinical trials were excluded.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. We were unable to statistically pool any of the results, but we assessed the quality of the evidence using an adapted GRADE approach.\nMain results\nTwenty small trials (1239 people with neck pain) containing 38 comparisons were included. Analysis was limited by trials of varied quality, heterogeneous treatment subtypes and conflicting results. The main findings for reduction of neck pain by treatment with electrotherapeutic modalities were as follows.\nVery low quality evidence determined that pulsed electromagnetic field therapy (PEMF) and repetitive magnetic stimulation (rMS) were more effective than placebo, while transcutaneous electrical nerve stimulation (TENS) showed inconsistent results.\nVery low quality evidence determined that PEMF, rMS and TENS were more effective than placebo.\nLow quality evidence (1 trial, 52 participants) determined that permanent magnets (necklace) were no more effective than placebo (standardized mean difference (SMD) 0.27, 95% CI -0.27 to 0.82, random-effects model).\nVery low quality evidence showed that modulated galvanic current, iontophoresis and electric muscle stimulation (EMS) were not more effective than placebo.\nThere were four trials that reported on other outcomes such as function and global perceived effects, but none of the effects were of clinical importance. When TENS, iontophoresis and PEMF were compared to another treatment, very low quality evidence prevented us from suggesting any recommendations. No adverse side effects were reported in any of the included studies.\nAuthors' conclusions\nWe cannot make any definite statements on the efficacy and clinical usefulness of electrotherapy modalities for neck pain. Since the evidence is of low or very low quality, we are uncertain about the estimate of the effect. Further research is very likely to change both the estimate of effect and our confidence in the results. Current evidence for PEMF, rMS, and TENS shows that these modalities might be more effective than placebo. When compared to other interventions the quality of evidence was very low thus preventing further recommendations.\nFunding bias should be considered, especially in PEMF studies. Galvanic current, iontophoresis, EMS, and a static magnetic field did not reduce pain or disability. Future trials on these interventions should have larger patient samples, include more precise standardization, and detail treatment characteristics.\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": "About 70% of the trials were poorly conducted studies. The trials were very small, with a range of 16 to 336 participants. The data were sparse and imprecise, which suggests that results cannot be generalized to the broader population and contributes to the reduction in the quality of the evidence. Therefore, further research is very likely to change the results and our confidence in the results."
}
] |
query-laysum
|
21745
|
[
{
"role": "user",
"content": "Abstract: Background\nShivering after general anaesthesia is common. It is unpleasant but can also have adverse physiological effects. Alpha-2 (α-2) adrenergic agonist receptors, which can lead to reduced sympathetic activity and central regulation of vasoconstrictor tone, are a group of drugs that have been used to try to prevent postoperative shivering.\nObjectives\nTo assess the following: the effects of α-2 agonists on the prevention of shivering and subsequent complications after general anaesthesia in people undergoing surgery; the effects of α-2 agonists on the risk of inadvertent perioperative hypothermia; and whether any adverse effects are associated with these interventions.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE on 13 June 2014. Our search terms were relevant to the review question and limited to studies that assessed shivering or hypothermia. We also carried out searches of clinical trials registers, and forward and backward citation tracking.\nSelection criteria\nWe considered all randomized controlled trials, quasi-randomized studies, and cluster-randomized studies with adult participants undergoing surgery with general anaesthesia in which an α-2 agonist was compared with another α-2 agonist or a placebo for the prevention of shivering.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data, consulting a third review author in the case of disagreements. We used standard Cochrane methodological procedures, including an assessment of risk of bias and use of GRADEpro software to interpret findings.\nMain results\nWe included 20 studies with 1401 surgical participants comparing an α-2 agonist against a control. Thirteen studies compared clonidine with a control, whilst seven compared dexmedetomidine with a control. The doses, methods, and time of administration varied between studies: three studies gave the drug orally or as an intravenous bolus preoperatively and nine intraoperatively; one study gave the drug as an infusion starting preoperatively and seven started at varying points from anaesthetic induction to the end of surgery. Whilst all the studies were described as randomized, many provided insufficient detail on methods used. We had anticipated that attempts would be made to reduce performance bias by blinding of personnel and participants, however this was detailed in only six of the papers. Similarly, in some studies detail was lacking on methods to reduce the risk of detection bias. We therefore downgraded the quality of evidence in our 'Summary of findings' table by one level for risk of bias using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.\nAll 20 included studies presented outcome data for postoperative shivering, and in meta-analysis α-2 agonists were shown to significantly reduce the risk of shivering (Mantel-Haenszel risk ratio 0.28, 95% confidence interval 0.18 to 0.43, P value < 0.0001). We found significant evidence of heterogeneity (I2 = 80%) for this result that was not explained by sensitivity or subgroup analysis; we therefore downgraded the inconsistency of the evidence by one level. Although we did not feel that there were concerns with imprecision or indirectness of the data, we downgraded the quality of the evidence for the risk of publication bias following visual analysis of a funnel plot. Using GRADEpro, we rated the overall quality of the data for shivering as very low. Only one study reported the incidence of core hypothermia, whilst 12 studies measured core temperature. However, as the results for core temperature were reported in different styles, pooling the results was inappropriate. We found no studies with participant-reported outcomes such as experience of shivering or participant satisfaction. We found limited data for the outcomes of length of stay in the postanaesthetic care unit (three studies, 200 participants) and the following adverse effects: sedation (nine studies, 875 participants), bradycardia (eight studies, 716 participants), and hypotension (seven studies, 688 participants). Unpooled analysis suggested that sedation and bradycardia were significantly more common with dexmedetomidine than placebo, with all seven dexmedetomidine studies and none of the clonidine studies reporting statistically significantly higher levels of sedation as an adverse effect.\nAuthors' conclusions\nThere is evidence that clonidine and dexmedetomidine can reduce postoperative shivering, but patients given dexmedetomidine may be more sedated. However, our assessment of the quality of this evidence is very low.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We felt that the quality of the evidence was low and that some authors did not make enough of an effort to reduce the risk of bias in the methods, which could affect their results. For example, not all authors masked the anaesthetist or surgeon to which drug was given to each participant. This, along with some unexplained differences between studies and some concern about whether we could have missed some relevant results that had not been published, led us to assess the quality of the evidence for shivering as very low. We used GRADEpro software to assess evidence quality."
}
] |
query-laysum
|
21746
|
[
{
"role": "user",
"content": "Abstract: Background\nStrontium ranelate is a new treatment for osteoporosis therefore, its benefits and harms need to be known.\nObjectives\nTo determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis.\nSearch methods\nWe searched MEDLINE (1996-March 2005), EMBASE (1996-week 9 2005), the Cochrane Library (1996-Issue 1 2005), reference lists of relevant articles and conference proceedings from the last two years. Additional data was sought from authors.\nSelection criteria\nWe included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate to placebo and reporting fracture incidence, bone mineral density (BMD) or adverse events in postmenopausal women. Treatment population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T-score < -2.5 SD.\nData collection and analysis\nTwo reviewers independently determined study eligibility, assessed study validity, graded the evidence and extracted relevant data. Disagreements were resolved by consensus. RCTs were grouped by dose and treatment duration. Where possible, meta-analysis was conducted using the random effects model.\nMain results\nFour trials met the inclusion criteria. Three had losses to follow-up > 20% and only one provided an adequate description of allocation concealment. Three included a treatment population (0.5 to 2 g/day of strontium ranelate) and one a prevention population (0.125, 0.5 and 1 g/day). A 37% reduction in vertebral fractures (RR 0.63, 95% CI 0.56, 0.71), and a 14% reduction in non-vertebral fractures with the upper boundary of the confidence interval approaching one (RR 0.86, 95% CI 0.75, 0.98), were demonstrated over three years with 2 g of strontium ranelate daily in a treatment population. An increase in BMD was shown at all sites after two to three years of treatment in both populations. Lower doses of strontium ranelate were superior to placebo and the highest dose demonstrated the greatest reduction in vertebral fractures and increase in BMD. An increased risk of diarrhea with 2 g of strontium ranelate daily was found; however, adverse events did not affect the risk of discontinuing treatment nor did it increase the risk of serious side effects, gastritis or death. Additional data suggests that the risk of vascular and nervous system side-effects is increased with taking 2 g of strontium ranelate daily over three to four years.\nAuthors' conclusions\nThere is silver level evidence (www.cochranemsk.org) to support the efficacy of strontium ranelate for the reduction of fractures (vertebral and to a lesser extent, non-vertebral) in postmenopausal osteoporotic women and an increase in BMD in postmenopausal women with/without osteoporosis. Diarrhea may occur, however, adverse events leading to study withdrawal were not significantly increased. Potential vascular and neurological side-effects need to be further explored.\n\nGiven the provided abstract, please respond to the following query: \"Benefits of strontium ranelate\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In women after menopause who have osteoporosis:\n- strontium ranelate decreases spine fractures:\n13 out of 100 women had spine fractures taking strontium ranelate\n21 out of 100 women had spine fractures taking a placebo\n- strontium ranelate may decrease fractures that are not in the spine:\n10 out of 100 women had non-spine fractures taking strontium ranelate\n12 out of 100 women had non-spine fractures taking a placebo\n- strontium ranelate increases bone mineral density\n1 in 3 women had an increase in spine and hip bone mineral density taking strontium ranelate"
}
] |
query-laysum
|
21747
|
[
{
"role": "user",
"content": "Abstract: Background\nRebleeding is an important cause of death and disability in people with aneurysmal subarachnoid haemorrhage. Rebleeding is probably related to the dissolution of the blood clot at the site of the aneurysm rupture by natural fibrinolytic activity. This review is an update of previously published Cochrane Reviews.\nObjectives\nTo assess the effects of antifibrinolytic treatment in people with aneurysmal subarachnoid haemorrhage.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2022), CENTRAL (in the Cochrane Library 2021, Issue 1), MEDLINE (December 2012 to May 2022), and Embase (December 2012 to May 2022). In an effort to identify further published, unpublished, and ongoing studies, we searched reference lists and trial registers, performed forward tracking of relevant references, and contacted drug companies (the latter in previous versions of this review).\nSelection criteria\nRandomised trials comparing oral or intravenous antifibrinolytic drugs (tranexamic acid, epsilon amino-caproic acid, or an equivalent) with control in people with subarachnoid haemorrhage of suspected or proven aneurysmal cause.\nData collection and analysis\nTwo review authors (MRG & WJD) independently selected trials for inclusion, and extracted the data for the current update. In total, three review authors (MIB & MRG in the previous update; MRG & WJD in the current update) assessed risk of bias. For the primary outcome, we dichotomised the outcome scales into good and poor outcome, with poor outcome defined as death, vegetative state, or (moderate) severe disability, assessed with either the Glasgow Outcome Scale or the Modified Rankin Scale. We assessed death from any cause, rates of rebleeding, delayed cerebral ischaemia, and hydrocephalus per treatment group. We expressed effects as risk ratios (RR) with 95% confidence intervals (CI). We used random-effects models for all analyses. We assessed the quality of the evidence with GRADE.\nMain results\nWe included one new trial in this update, for a total of 11 included trials involving 2717 participants. The risk of bias was low in six studies. Five studies were open label, and we rated them at high risk of performance bias. We also rated one of these studies at high risk for attrition and reporting bias.\nFive trials reported on poor outcome (death, vegetative state, or (moderate) severe disability), with a pooled risk ratio (RR) of 1.03 (95% confidence interval (CI) 0.94 to 1.13; P = 0.53; 5 trials, 2359 participants; high-quality evidence), which showed no difference between groups. All trials reported on death from all causes, which showed no difference between groups, with a pooled RR of 1.02 (95% CI 0.90 to 1.16; P = 0.77; 11 trials, 2717 participants; high-quality evidence). In trials that combined short-term antifibrinolytic treatment (< 72 hours) with preventative measures for delayed cerebral ischaemia, the RR for poor outcome was 0.98 (95% CI 0.81 to 1.18; P = 0.83; 2 trials, 1318 participants; high-quality evidence).\nAntifibrinolytic treatment reduced the risk of rebleeding, reported at the end of follow-up (RR 0.65, 95% CI 0.47 to 0.91; P = 0.01; 11 trials, 2717 participants; absolute risk reduction 7%, 95% CI 3 to 12%; moderate-quality evidence), but there was heterogeneity (I² = 59%) between the trials. The pooled RR for delayed cerebral ischaemia was 1.27 (95% CI 1.00 to 1.62; P = 0.05; 7 trials, 2484 participants; moderate-quality evidence). However, this effect was less extreme after the implementation of ischaemia preventative measures and < 72 hours of treatment (RR 1.10, 95% CI 0.83 to 1.46; P = 0.49; 2 trials, 1318 participants; high-quality evidence). Antifibrinolytic treatment showed no effect on the reported rate of hydrocephalus (RR 1.09, 95% CI 0.99 to 1.20; P = 0.09; 6 trials, 1992 participants; high-quality evidence).\nAuthors' conclusions\nThe current evidence does not support the routine use of antifibrinolytic drugs in the treatment of people with aneurysmal subarachnoid haemorrhage. More specifically, early administration with concomitant treatment strategies to prevent delayed cerebral ischaemia does not improve clinical outcome. There is sufficient evidence from multiple randomised controlled trials to incorporate this conclusion in treatment guidelines.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We assessed the evidence for the outcomes as moderate- to high-quality, which means we are very, or moderately confident in the results."
}
] |
query-laysum
|
21748
|
[
{
"role": "user",
"content": "Abstract: Background\nThis an update of a Cochrane Review.\nParaquat is a widely used herbicide, but is also a lethal poison. In some low- and middle-income countries (LMICs) paraquat is commonly available and inexpensive, making poisoning prevention difficult. Most of the people poisoned by paraquat have taken it as a means of self-poisoning.\nStandard treatment for paraquat poisoning prevents further absorption and reduces the load of paraquat in the blood through haemoperfusion or haemodialysis. The effectiveness of standard treatments is extremely limited.\nThe immune system plays an important role in exacerbating paraquat-induced lung fibrosis. Immunosuppressive treatment using glucocorticoid and cyclophosphamide in combination has been developed and studied as an intervention for paraquat poisoning.\nObjectives\nTo assess the effects of glucocorticoid with cyclophosphamide for moderate to severe oral paraquat poisoning.\nSearch methods\nThe most recent searches were run in September 2020. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Injuries Trials Register), Ovid MEDLINE(R), Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily and Ovid OLDMEDLINE, Embase Classic + Embase (Ovid), ISI WOS (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), and trials registries. We also searched the following three resources: China National Knowledge Infrastructure database (CNKI 数据库); Wanfang Data (万方数据库); and VIP (维普数据库) on 12 November 2020. We examined the reference lists of included studies and review papers.\nSelection criteria\nWe included randomised controlled trials (RCTs). For this update, in accordance with Cochrane Injuries' Group policy (2015), we included only prospectively registered RCTs for trials published after 2010. We included trials which assessed the effects of glucocorticoid with cyclophosphamide delivered in combination. Eligible comparators were standard care (with or without a placebo), or any other therapy in addition to standard care. Outcomes of interest included mortality and infections.\nData collection and analysis\nWe calculated the mortality risk ratio (RR) and 95% confidence interval (CI). Where possible, we summarised data for all-cause mortality at relevant time periods (from hospital discharge to three months after discharge) in meta-analysis, using a fixed-effect model. We conducted sensitivity analyses based on factors including whether participants were assessed at baseline for plasma paraquat levels. We also reported data on infections within one week after initiation of treatment.\nMain results\nWe included four trials with a total of 463 participants. The included studies were conducted in Taiwan (Republic of China), Iran, and Sri Lanka. Most participants were male. The mean age of participants was 28 years.\nWe judged two of the four included studies, including the largest and most recently conducted study (n = 299), to be at low risk of bias for key domains including sequence generation. We assessed one study to be at high risk of selection bias and another at unclear risk, since allocation concealment was either not mentioned in the trial report or explicitly not undertaken. We assessed three of the four studies to be at unclear risk of selective reporting, as no protocols could be identified. An important source of heterogeneity amongst the included studies was the method of assessment of participants' baseline severity using analysis of plasma levels (two studies employed this method, whilst the other two did not).\nNo studies assessed the outcome of mortality at 30 days following ingestion of paraquat.\nLow-certainty evidence from two studies indicates that glucocorticoids with cyclophosphamide in addition to standard care may slightly reduce the risk of death in hospital compared to standard care alone ((RR 0.82, 95% CI 0.68 to 0.99; participants = 322); results come from sensitivity analysis excluding studies not assessing plasma at baseline). However, we have limited confidence in this finding as heterogeneity was high (I2 = 77%) and studies varied in terms of size and comparators. A single large study provided data showing that there may be little or no effect of treatment at three months post discharge from hospital (RR 0.98, 95% CI 0.85 to 1.13; 1 study, 293 participants; low-certainty evidence); however, analysis of long-term results amongst participants whose injuries arose from self-poisoning must be interpreted with caution.\nWe remain uncertain of the effect of glucocorticoids with cyclophosphamide on infection within one week after initiation of the treatment; this outcome was assessed by two small studies only (31 participants, very low-certainty evidence) that considered leukopenia as a proxy or risk factor for infection. Neither study reported infections in any participants.\nAuthors' conclusions\nLow-certainly evidence suggests that glucocorticoids with cyclophosphamide in addition to standard care may slightly reduce mortality in hospitalised people with oral paraquat poisoning. However, we have limited confidence in this finding because of substantial heterogeneity and concerns about imprecision. Glucocorticoids with cyclophosphamide in addition to standard care may have little or no effect on mortality at three months after hospital discharge. We are uncertain whether glucocorticoid with cyclophosphamide puts patients at an increased risk of infection due to the limited evidence available for this outcome. Future research should be prospectively registered and CONSORT-compliant. Investigators should attempt to ensure an adequate sample size, screen participants for inclusion rigorously, and seek long-term follow-up of participants. Investigators may wish to research the effects of glucocorticoid in combination with other treatments.\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": "- Steroids given with cyclophosphamide (an anti-cancer medicine) are unlikely to reduce the risk of death after paraquat poisoning in the short term, or at three months after hospital discharge.\n- We are uncertain whether these medicines increase the risk of infection.\n- Future studies need to be larger, measure the level of paraquat poisoning of patients accurately, and monitor patients in the long term. Research into steroids combined with other treatments could be useful."
}
] |
query-laysum
|
21749
|
[
{
"role": "user",
"content": "Abstract: Background\nEczema is a common skin condition. Although topical corticosteroids have been a first-line treatment for eczema for decades, there are uncertainties over their optimal use.\nObjectives\nTo establish the effectiveness and safety of different ways of using topical corticosteroids for treating eczema.\nSearch methods\nWe searched databases to January 2021 (Cochrane Skin Specialised Register; CENTRAL; MEDLINE; Embase; GREAT) and five clinical trials registers. We checked bibliographies from included trials to identify further trials.\nSelection criteria\nRandomised controlled trials in adults and children with eczema that compared at least two strategies of topical corticosteroid use. We excluded placebo comparisons, other than for trials that evaluated proactive versus reactive treatment.\nData collection and analysis\nWe used standard Cochrane methods, with GRADE certainty of evidence for key findings. Primary outcomes were changes in clinician-reported signs and relevant local adverse events. Secondary outcomes were patient-reported symptoms and relevant systemic adverse events. For local adverse events, we prioritised abnormal skin thinning as a key area of concern for healthcare professionals and patients.\nMain results\nWe included 104 trials (8443 participants). Most trials were conducted in high-income countries (81/104), most likely in outpatient or other hospital settings. We judged only one trial to be low risk of bias across all domains. Fifty-five trials had high risk of bias in at least one domain, mostly due to lack of blinding or missing outcome data.\nStronger-potency versus weaker-potency topical corticosteroids\nSixty-three trials compared different potencies of topical corticosteroids: 12 moderate versus mild, 22 potent versus mild, 25 potent versus moderate, and 6 very potent versus potent. Trials were usually in children with moderate or severe eczema, where specified, lasting one to five weeks. The most reported outcome was Investigator Global Assessment (IGA) of clinician-reported signs of eczema.\nWe pooled four trials that compared moderate- versus mild-potency topical corticosteroids (420 participants). Moderate-potency topical corticosteroids probably result in more participants achieving treatment success, defined as cleared or marked improvement on IGA (52% versus 34%; odds ratio (OR) 2.07, 95% confidence interval (CI) 1.41 to 3.04; moderate-certainty evidence). We pooled nine trials that compared potent versus mild-potency topical corticosteroids (392 participants). Potent topical corticosteroids probably result in a large increase in number achieving treatment success (70% versus 39%; OR 3.71, 95% CI 2.04 to 6.72; moderate-certainty evidence). We pooled 15 trials that compared potent versus moderate-potency topical corticosteroids (1053 participants). There was insufficient evidence of a benefit of potent topical corticosteroids compared to moderate topical corticosteroids (OR 1.33, 95% CI 0.93 to 1.89; moderate-certainty evidence). We pooled three trials that compared very potent versus potent topical corticosteroids (216 participants). The evidence is uncertain with a wide confidence interval (OR 0.53, 95% CI 0.13 to 2.09; low-certainty evidence).\nTwice daily or more versus once daily application\nWe pooled 15 of 25 trials in this comparison (1821 participants, all reported IGA). The trials usually assessed adults and children with moderate or severe eczema, where specified, using potent topical corticosteroids, lasting two to six weeks.\nApplying potent topical corticosteroids only once a day probably does not decrease the number achieving treatment success compared to twice daily application (OR 0.97, 95% CI 0.68 to 1.38; 15 trials, 1821 participants; moderate-certainty evidence).\nLocal adverse events\nWithin the trials that tested 'treating eczema flare-up' strategies, we identified only 26 cases of abnormal skin thinning from 2266 participants (1% across 22 trials). Most cases were from the use of higher-potency topical corticosteroids (16 with very potent, 6 with potent, 2 with moderate and 2 with mild). We assessed this evidence as low certainty, except for very potent versus potent topical corticosteroids, which was very low-certainty evidence.\nLonger versus shorter-term duration of application for induction of remission\nNo trials were identified.\nTwice weekly application (weekend, or ‘proactive therapy') to prevent relapse (flare-ups) versus no topical corticosteroids/reactive application\nNine trials assessed this comparison, generally lasting 16 to 20 weeks. We pooled seven trials that compared weekend (proactive) topical corticosteroids therapy versus no topical corticosteroids (1179 participants, children and adults with a range of eczema severities, though mainly moderate or severe).\nWeekend (proactive) therapy probably results in a large decrease in likelihood of a relapse from 58% to 25% (risk ratio (RR) 0.43, 95% CI 0.32 to 0.57; 7 trials, 1149 participants; moderate-certainty evidence).\nLocal adverse events\nWe did not identify any cases of abnormal skin thinning in seven trials that assessed skin thinning (1050 participants) at the end of treatment. We assessed this evidence as low certainty.\nOther comparisons\nOther comparisons included newer versus older preparations of topical corticosteroids (15 trials), cream versus ointment (7 trials), topical corticosteroids with wet wrap versus no wet wrap (6 trials), number of days per week applied (4 trials), different concentrations of the same topical corticosteroids (2 trials), time of day applied (2 trials), topical corticosteroids alternating with topical calcineurin inhibitors versus topical corticosteroids alone (1 trial), application to wet versus dry skin (1 trial) and application before versus after emollient (1 trial). No trials compared branded versus generic topical corticosteroids and time between application of emollient and topical corticosteroids.\nAuthors' conclusions\nPotent and moderate topical corticosteroids are probably more effective than mild topical corticosteroids, primarily in moderate or severe eczema; however, there is uncertain evidence to support any advantage of very potent over potent topical corticosteroids. Effectiveness is similar between once daily and twice daily (or more) frequent use of potent topical corticosteroids to treat eczema flare-ups, and topical corticosteroids weekend (proactive) therapy is probably better than no topical corticosteroids/reactive use to prevent eczema relapse (flare-ups). Adverse events were not well reported and came largely from low- or very low-certainty, short-term trials. In trials that reported abnormal skin thinning, frequency was low overall and increased with increasing potency. We found no trials on the optimum duration of treatment of a flare, branded versus generic topical corticosteroids, and time to leave between application of topical corticosteroids and emollient. There is a need for longer-term trials, in people with mild eczema.\n\nGiven the provided abstract, please respond to the following query: \"- Other comparisons.\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We also looked at newer versus older steroid cream preparations, cream versus ointment, steroid cream used with wet wrap, daily versus less frequent application, different strengths of the same steroid cream, time of day applied, steroid cream alternating with topical calcineurin inhibitors (e.g. Protopic and Elidel) versus steroid cream alone, application to wet versus dry skin, and before versus after emollients. No studies compared branded versus generic steroid cream or time between application of emollient and steroid cream."
}
] |
query-laysum
|
21750
|
[
{
"role": "user",
"content": "Abstract: Background\nPitavastatin is the newest statin on the market, and the dose-related magnitude of effect of pitavastatin on blood lipids is not known.\nObjectives\nPrimary objective\nTo quantify the effects of various doses of pitavastatin on the surrogate markers: LDL cholesterol, total cholesterol, HDL cholesterol and triglycerides in participants with and without cardiovascular disease.\nTo compare the effect of pitavastatin on surrogate markers with other statins.\nSecondary objectives\nTo quantify the effect of various doses of pitavastatin on withdrawals due to adverse effects.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for trials up to March 2019: the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 2, 2019), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions.\nSelection criteria\nRCT and controlled before-and-after studies evaluating the dose response of different fixed doses of pitavastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without cardiovascular disease.\nData collection and analysis\nTwo review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered data from RCT and controlled before-and-after studies into Review Manager 5 as continuous and generic inverse variance data, respectively. Withdrawals due to adverse effects (WDAE) information was collected from the RCTs. We assessed all included trials using the Cochrane 'Risk of bias' tool under the categories of allocation (selection bias), blinding (performance bias and detection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), and other potential sources of bias.\nMain results\nForty-seven studies (five RCTs and 42 before-and-after studies) evaluated the dose-related efficacy of pitavastatin in 5436 participants. The participants were of any age with and without cardiovascular disease, and pitavastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 1 mg to 16 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and triglycerides. There was no dose-related effect of pitavastatin on blood HDL cholesterol, which was increased by 4% on average by pitavastatin. Pitavastatin 1 mg/day to 16 mg/day reduced LDL cholesterol by 33.3% to 54.7%, total cholesterol by 23.3% to 39.0% and triglycerides by 13.0% to 28.1%. For every two-fold dose increase, there was a 5.35% (95% CI 3.32 to 7.38) decrease in blood LDL cholesterol, a 3.93% (95% CI 2.35 to 5.50) decrease in blood total cholesterol and a 3.76% (95% CI 1.03 to 6.48) decrease in blood triglycerides. The certainty of evidence for these effects was judged to be high. When compared to other statins for its effect to reduce LDL cholesterol, pitavastatin is about 6-fold more potent than atorvastatin, 1.7-fold more potent than rosuvastatin, 77-fold more potent than fluvastatin and 3.3-fold less potent than cerivastatin. For the placebo group, there were no participants who withdrew due to an adverse effect per 109 subjects and for all doses of pitavastatin, there were three participants who withdrew due to an adverse effect per 262 subjects.\nAuthors' conclusions\nPitavastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, pitavastatin is about 6-fold more potent than atorvastatin, 1.7-fold more potent than rosuvastatin, 77-fold more potent than fluvastatin and 3.3-fold less potent than cerivastatin. There were not enough data to determine risk of withdrawal due to adverse effects due to pitavastatin.\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": "There is a high level of trust around the effects of pitavastatin on total cholesterol, LDL cholesterol and triglycerides."
}
] |
query-laysum
|
21751
|
[
{
"role": "user",
"content": "Abstract: Background\nAutism spectrum disorders (ASD) include autistic disorder, Asperger's disorder and pervasive developmental disorder - not otherwise specified (PDD-NOS). Antipsychotics have been used as a medication intervention for irritability related to ASD. Aripiprazole, a third-generation, atypical antipsychotic, is a relatively new drug that has a unique mechanism of action different from that of other antipsychotics. This review updates a previous Cochrane review on the safety and efficacy of aripiprazole for individuals with ASD, published in 2011 (Ching 2011).\nObjectives\nTo assess the safety and efficacy of aripiprazole as medication treatment for individuals with ASD.\nSearch methods\nIn October 2015, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and seven other databases as well as two trial registers. We searched for records published in 1990 or later, as this was the year aripiprazole became available.\nSelection criteria\nRandomised controlled trials (RCTs) of aripiprazole (administered orally and at any dosage) versus placebo for treatment of individuals with a diagnosis of ASD.\nData collection and analysis\nTwo review authors independently collected, evaluated and analysed data. We performed meta-analysis for primary and secondary outcomes, when possible. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to rate the overall quality of the evidence.\nMain results\nWe included three trials in this review. Two were included in the previous published review, and the results of one, placebo-controlled discontinuation study were added to this review. Although we searched for studies across age groups, we found only studies conducted in children and youth. Included trials had low risk of bias across most domains. High risk of bias was seen in only one trial with incomplete outcome data. We judged the overall quality of the evidence for most outcomes to be moderate.\nTwo RCTs with similar methods evaluated use of aripiprazole for a duration of eight weeks in 316 children/adolescents with ASD. Meta-analysis of study results revealed a mean improvement of -6.17 points on the Aberrant Behavior Checklist (ABC) - Irritability subscale (95% confidence intervals (CIs) -9.07 to -3.26, two studies, 308 children/adolescents, moderate-quality evidence), -7.93 points on the ABC - Hyperactivity subscale (95% CI -10.98 to -4.88, two studies, 308 children/adolescents, moderate-quality evidence) and -2.66 points on the ABC - Stereotypy subscale (95% CI -3.55 to -1.77, two studies, 308 children/adolescents, moderate-quality evidence) in children/adolescents taking aripiprazole relative to children/adolescents taking placebo. In terms of side effects, children/adolescents taking aripiprazole had a greater increase in weight, with a mean increase of 1.13 kg relative to placebo (95% CI 0.71 to 1.54, two studies, 308 children/adolescents, moderate-quality evidence), and had a higher risk ratio (RR) for sedation (RR 4.28, 95% CI 1.58 to 11.60, two studies, 313 children/adolescents, moderate-quality evidence) and tremor (RR 10.26, 95% CI 1.37 to 76.63, two studies, 313 children/adolescents, moderate-quality evidence). A randomised, placebo-controlled discontinuation study found that 35% of children/adolescents randomised to continue intervention with aripiprazole relapsed with respect to their symptoms of irritability, compared with 52% of children/adolescents randomised to placebo, for a hazard ratio of 0.57 (95% CI 0.28 to 1.12, 85 children/adolescents, low-quality evidence).\nAll three included trials were supported by Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical Company, Ltd. (Tokyo, Japan), with editorial support provided by Ogilvy Healthworld Medical Education and Bristol-Myers Squibb.\nAuthors' conclusions\nEvidence from two RCTs suggests that aripiprazole can be effective as a short-term medication intervention for some behavioural aspects of ASD in children/adolescents. After a short-term medication intervention with aripiprazole, children/adolescents showed less irritability and hyperactivity and fewer stereotypies (repetitive, purposeless actions). However, notable side effects, such as weight gain, sedation, drooling and tremor, must be considered. One long-term, placebo discontinuation study found that relapse rates did not differ between children/adolescents randomised to continue aripiprazole versus children/adolescents randomised to receive placebo, suggesting that re-evaluation of aripiprazole use after a period of stabilisation in irritability symptoms is warranted. Studies included in this review used criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (APA 2000) for ASD diagnosis; however, the diagnostic criteria for ASD changed significantly with release of the fifth edition of the DSM (DSM-5) in 2013 (APA 2013).\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do children and adults with ASD benefit from treatment with aripiprazole, compared with other children and adults with ASD who receive a drug with no active ingredient (placebo)?"
}
] |
query-laysum
|
21752
|
[
{
"role": "user",
"content": "Abstract: Background\nIntimate partner violence (IPV) includes any violence (physical, sexual or psychological/emotional) by a current or former partner. This review reflects the current understanding of IPV as a profoundly gendered issue, perpetrated most often by men against women. IPV may result in substantial physical and mental health impacts for survivors. Women affected by IPV are more likely to have contact with healthcare providers (HCPs) (e.g. nurses, doctors, midwives), even though women often do not disclose the violence. Training HCPs on IPV, including how to respond to survivors of IPV, is an important intervention to improve HCPs' knowledge, attitudes and practice, and subsequently the care and health outcomes for IPV survivors.\nObjectives\nTo assess the effectiveness of training programmes that seek to improve HCPs' identification of and response to IPV against women, compared to no intervention, wait-list, placebo or training as usual.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and seven other databases up to June 2020. We also searched two clinical trials registries and relevant websites. In addition, we contacted primary authors of included studies to ask if they knew of any relevant studies not identified in the search. We evaluated the reference lists of all included studies and systematic reviews for inclusion. We applied no restrictions by search dates or language.\nSelection criteria\nAll randomised and quasi-randomised controlled trials comparing IPV training or educational programmes for HCPs compared with no training, wait-list, training as usual, placebo, or a sub-component of the intervention.\nData collection and analysis\nWe used standard methodological procedures outlined by Cochrane. Two review authors independently assessed studies for eligibility, undertook data extraction and assessed risks of bias. Where possible, we synthesised the effects of IPV training in a meta-analysis. Other analyses were synthesised in a narrative manner. We assessed evidence certainty using the GRADE approach.\nMain results\nWe included 19 trials involving 1662 participants. Three-quarters of all studies were conducted in the USA, with single studies from Australia, Iran, Mexico, Turkey and the Netherlands. Twelve trials compared IPV training versus no training, and seven trials compared the effects of IPV training to training as usual or a sub-component of the intervention in the comparison group, or both.\nStudy participants included 618 medical staff/students, 460 nurses/students, 348 dentists/students, 161 counsellors or psychologists/students, 70 midwives and 5 social workers. Studies were heterogeneous and varied across training content delivered, pedagogy and time to follow-up (immediately post training to 24 months). The risk of bias assessment highlighted unclear reporting across many areas of bias. The GRADE assessment of the studies found that the certainty of the evidence for the primary outcomes was low to very low, with studies often reporting on perceived or self-reported outcomes rather than actual HCPs' practices or outcomes for women. Eleven of the 19 included studies received some form of research grant funding to complete the research.\nWithin 12 months post-intervention, the evidence suggests that compared to no intervention, wait-list or placebo, IPV training:\n· may improve HCPs' attitudes towards IPV survivors (standardised mean difference (SMD) 0.71, 95% CI 0.39 to 1.03; 8 studies, 641 participants; low-certainty evidence);\n· may have a large effect on HCPs' self-perceived readiness to respond to IPV survivors, although the evidence was uncertain (SMD 2.44, 95% CI 1.51 to 3.37; 6 studies, 487 participants; very low-certainty evidence);\n· may have a large effect on HCPs' knowledge of IPV, although the evidence was uncertain (SMD 6.56, 95% CI 2.49 to 10.63; 3 studies, 239 participants; very low-certainty evidence);\n· may make little to no difference to HCPs' referral practices of women to support agencies, although this is based on only one study (with 49 clinics) assessed to be very low certainty;\n· has an uncertain effect on HCPs' response behaviours (based on two studies of very low certainty), with one trial (with 27 participants) reporting that trained HCPs were more likely to successfully provide advice on safety planning during their interactions with standardised patients, and the other study (with 49 clinics) reporting no clear impact on safety planning practices;\n· may improve identification of IPV at six months post-training (RR 4.54, 95% CI 2.5 to 8.09) as in one study (with 54 participants), although three studies (with 48 participants) reported little to no effects of training on identification or documentation of IPV, or both.\nNo studies assessed the impact of training HCPs on the mental health of women survivors of IPV compared to no intervention, wait-list or placebo.\nWhen IPV training was compared to training as usual or a sub-component of the intervention, or both, no clear effects were seen on HCPs' attitudes/beliefs, safety planning, and referral to services or mental health outcomes for women. Inconsistent results were seen for HCPs' readiness to respond (improvements in two out of three studies) and HCPs' IPV knowledge (improved in two out of four studies). One study found that IPV training improved HCPs' validation responses.\nNo adverse IPV-related events were reported in any of the studies identified in this review.\nAuthors' conclusions\nOverall, IPV training for HCPs may be effective for outcomes that are precursors to behaviour change. There is some, albeit weak evidence that IPV training may improve HCPs' attitudes towards IPV. Training may also improve IPV knowledge and HCPs' self-perceived readiness to respond to those affected by IPV, although we are not certain about this evidence. Although supportive evidence is weak and inconsistent, training may improve HCPs' actual responses, including the use of safety planning, identification and documentation of IPV in women's case histories. The sustained effect of training on these outcomes beyond 12 months is undetermined. Our confidence in these findings is reduced by the substantial level of heterogeneity across studies and the unclear risk of bias around randomisation and blinding of participants, as well as high risk of bias from attrition in many studies. Further research is needed that overcomes these limitations, as well as assesses the impacts of IPV training on HCPs' behavioral outcomes and the well-being of women survivors of IPV.\n\nGiven the provided abstract, please respond to the following query: \"Up-to-dateness of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to June 2020."
}
] |
query-laysum
|
21753
|
[
{
"role": "user",
"content": "Abstract: Background\nParkinson’s disease (PD) is a neurodegenerative disorder that is best managed by a combination of medication and regular physiotherapy. In this context, virtual reality (VR) technology is proposed as a new rehabilitation tool with a possible added value over traditional physiotherapy approaches. It potentially optimises motor learning in a safe environment, and by replicating real-life scenarios could help improve functional activities of daily living.\nObjectives\nThe objective of this review was to summarise the current best evidence for the effectiveness of VR interventions for the rehabilitation of people with PD in comparison with 1) active interventions, and 2) passive interventions. Our primary goal was to determine the effect of VR training on gait and balance. Secondary goals included examining the effects of VR on global motor function, activities of daily living, quality of life, cognitive function, exercise adherence, and the occurrence of adverse events.\nSearch methods\nWe identified relevant articles through electronic searches of the Cochrane Movement Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, Embase, CINAHL, the Physiotherapy Evidence Database (PEDro), online trials registers, and by handsearching reference lists. We carried out all searches up until 26 November 2016.\nSelection criteria\nWe searched for randomised and quasi-randomised controlled trials of VR exercise interventions in people with PD. We included only trials where motor rehabilitation was the primary goal.\nData collection and analysis\nTwo review authors independently searched for trials that corresponded to the predefined inclusion criteria. We independently extracted and assessed all data for methodological quality. A third review author was responsible for conflict resolution when required.\nMain results\nWe included 8 trials involving 263 people with PD in the review. Risk of bias was unclear or high for all but one of the included studies. Study sample sizes were small, and there was a large amount of heterogeneity between trials with regard to study design and the outcome measures used. As a result, we graded the quality of the evidence as low or very low. Most of the studies intended to improve motor function using commercially available devices, which were compared with physiotherapy. The interventions lasted for between 4 and 12 weeks.\nIn comparison to physiotherapy, VR may lead to a moderate improvement in step and stride length (standardised mean difference (SMD) 0.69, 95% confidence interval (CI) 0.30 to 1.08; 3 studies; 106 participants; low-quality evidence). VR and physiotherapy interventions may have similar effects on gait (SMD 0.20, 95% CI -0.14 to 0.55; 4 studies; 129 participants; low-quality evidence), balance (SMD 0.34, 95% CI -0.04 to 0.71; 5 studies; 155 participants; low-quality evidence), and quality of life (mean difference 3.73 units, 95% CI -2.16 to 9.61; 4 studies; 106 participants). VR interventions did not lead to any reported adverse events, and exercise adherence did not differ between VR and other intervention arms.\nThe evidence available comparing VR exercise with a passive control was more limited. The evidence for the main outcomes of interest was of very low quality due to the very small sample sizes of the two studies available for this comparison.\nAuthors' conclusions\nWe found low-quality evidence of a positive effect of short-term VR exercise on step and stride length. VR and physiotherapy may have similar effects on gait, balance, and quality of life. The evidence available comparing VR with passive control interventions was more limited. Additional high-quality, large-scale studies are needed to confirm these findings.\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 general, the quality of the evidence was low or very low. This was the result of small sample sizes and a large amount of heterogeneity between trials with regard to study design and outcome measures used."
}
] |
query-laysum
|
21754
|
[
{
"role": "user",
"content": "Abstract: Background\nBotulism is an acute paralytic illness caused by a neurotoxin produced by Clostridium botulinum. Supportive care, including intensive care, is key, but the role of other medical treatments is unclear. This is an update of a review first published in 2011.\nObjectives\nTo assess the effects of medical treatments on mortality, duration of hospitalization, mechanical ventilation, tube or parenteral feeding, and risk of adverse events in botulism.\nSearch methods\nWe searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, and Embase on 23 January 2018. We reviewed bibliographies and contacted authors and experts. We searched two clinical trials registers, WHO ICTRP and clinicaltrials.gov, on 21 February 2019.\nSelection criteria\nRandomized controlled trials (RCTs) and quasi-RCTs examining the medical treatment of any of the four major types of botulism (infant intestinal botulism, food-borne botulism, wound botulism, and adult intestinal toxemia). Potential medical treatments included equine serum trivalent botulism antitoxin, human-derived botulinum immune globulin intravenous (BIG-IV), plasma exchange, 3,4-diaminopyridine, and guanidine.\nData collection and analysis\nWe followed standard Cochrane methodology.\nOur primary outcome was in-hospital death from any cause occurring within four weeks from randomization or the beginning of treatment. Secondary outcomes were death from any cause occurring within 12 weeks, duration of hospitalization, duration of mechanical ventilation, duration of tube or parenteral feeding, and proportion of participants with adverse events or complications of treatment.\nMain results\nA single RCT met the inclusion criteria. Our 2018 search update identified no additional trials. The included trial evaluated BIG-IV for the treatment of infant botulism and included 59 treatment participants and 63 control participants. The control group received a control immune globulin that did not have an effect on botulinum toxin. Participants were followed during the length of their hospitalization to measure the outcomes of interest. There was some violation of intention-to-treat principles, and possibly some between-treatment group imbalances among participants admitted to the intensive care unit and mechanically ventilated, but otherwise the risk of bias was low. There were no deaths in either group, making any treatment effect on mortality inestimable. There was a benefit in the treatment group on mean duration of hospitalization (BIG-IV: 2.60 weeks, 95% confidence interval (CI) 1.95 to 3.25; control: 5.70 weeks, 95% CI 4.40 to 7.00; mean difference (MD) -3.10 weeks, 95% CI -4.52 to -1.68; moderate-certainty evidence); mechanical ventilation (BIG-IV: 1.80 weeks, 95% CI 1.20 to 2.40; control: 4.40 weeks, 95% CI 3.00 to 5.80; MD -2.60 weeks, 95% CI -4.06 to -1.14; low-certainty evidence); and tube or parenteral feeding (BIG-IV: 3.60 weeks, 95% CI 1.70 to 5.50; control: 10.00 weeks, 95% CI 6.85 to 13.15; MD -6.40 weeks, 95% CI -10.00 to -2.80; moderate-certainty evidence), but not on proportion of participants with adverse events or complications (BIG-IV: 63.08%; control: 68.75%; risk ratio 0.92, 95% CI 0.72 to 1.18; absolute risk reduction 0.06, 95% CI 0.22 to -0.11; moderate-certainty evidence).\nAuthors' conclusions\nWe found low- and moderate-certainty evidence supporting the use of BIG-IV in infant intestinal botulism. A single RCT demonstrated that BIG-IV probably decreases the duration of hospitalization; may decrease the duration of mechanical ventilation; and probably decreases the duration of tube or parenteral feeding. Adverse events were probably no more frequent with immune globulin than with placebo. Our search did not reveal any evidence examining the use of other medical treatments including serum trivalent botulism antitoxin.\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": "Our searches of the medical literature revealed one relevant study, which was in infant botulism. The treatment was a single dose of a medicine made from human immune proteins (human-derived botulinum immune globulin intravenous, or BIG-IV). Fifty-nine infants received BIG-IV, and 63 infants received a placebo (inactive treatment). Each study participant was followed up for the duration of their hospitalization. This study was sponsored by the California Department of Health Services."
}
] |
query-laysum
|
21755
|
[
{
"role": "user",
"content": "Abstract: Background\nDelivery of pain-free dentistry is crucial for reducing fear and anxiety, completion of treatment, and increasing acceptance of future dental treatment in children. Local anaesthetic (LA) facilitates this pain-free approach but it remains challenging. A number of interventions to help children cope with delivery of LA have been described, with no consensus on the best method to increase its acceptance.\nObjectives\nTo evaluate the effects of methods for acceptance of LA in children and adolescents during dental treatment.\nSearch methods\nCochrane Oral Health's Information Specialist searched the Cochrane Oral Health's Trials Register (to 24 May 2019); the Cochrane Central Register of Controlled Trials (CENTRAL; 2019 Issue 4) in the Cochrane Library (searched 24 May 2019); MEDLINE Ovid (1946 to 24 of May 2019); Embase Ovid (1980 to 24 May 2019); and Web of Science (1900 to 24 May 2019). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and World Health Organization International Clinical Trials Registry Platform were also searched to 24 May 2019. There were no restrictions on language or date of publications.\nSelection criteria\nParallel randomised controlled trials (RCTs) of interventions used to increase acceptance of dental LA in children and adolescents under the age of 18 years.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We performed data extraction and assessment of risk of bias independently and in duplicate. We contacted authors for missing information. We assessed the certainty of the body of evidence using GRADE.\nMain results\nWe included 26 trials with 2435 randomised participants aged between 2 and 16 years. Studies were carried out between 2002 and 2019 in dental clinics in the UK, USA, the Netherlands, Iran, India, France, Egypt, Saudi Arabia, Syria, Mexico, and Korea. Studies included equipment interventions (using several LA delivery devices for injection or audiovisual aids used immediately prior to or during LA delivery or both) and dentist interventions (psychological behaviour interventions delivered in advance of LA (video modelling), or immediately prior to or during delivery of LA or both (hypnosis, counter-stimulation).\nWe judged one study to be at low risk and the rest at high risk of bias. Clinical heterogeneity of the included studies rendered it impossible to pool data into meta-analyses. None of the studies reported on our primary outcome of acceptance of LA. No studies reported on the following secondary outcomes: completion of dental treatment, successful LA/painless treatment, patient satisfaction, parent satisfaction, and adverse events.\nAudiovisual distraction compared to conventional treatment: the evidence was uncertain for the outcome pain-related behaviour during delivery of LA with a reduction in negative behaviour when 3D video glasses where used in the audiovisual distraction group (risk ratio (RR) 0.13, 95% confidence interval (CI) 0.03 to 0.50; 1 trial, 60 participants; very low-certainty evidence).\nThe wand versus conventional treatment: the evidence was uncertain regarding the effect of the wand on pain-related behaviour during delivery of LA. Four studies reported a benefit in using the wand while the remaining studies results suggested no difference between the two methods of delivering LA (six trials, 704 participants; very low-certainty evidence).\nCounter-stimulation/distraction versus conventional treatment: the evidence was uncertain for the outcome pain experience during delivery of LA with children experiencing less pain when counter-stimulation was used (RR 0.12, 95% CI 0.04 to 0.34; 1 trial, 134 participants; very low-certainty evidence).\nHypnosis versus conventional treatment: the evidence was uncertain for the outcome pain experience during delivery of LA with participants in the hypnosis group experiencing less pain (mean difference (MD) -1.79, 95% CI -3.01 to -0.57; 1 trial, 29 participants; very low-certainty evidence).\nOther comparisons considered included pre-cooling of the injection site, the wand versus Sleeper One, the use of a camouflage syringe, use of an electrical counter-stimulation device, and video modelling acclimatisation, and had a single study each. The findings from these other comparisons were insufficient to draw any affirmative conclusions about their effectiveness, and were considered to be very low-certainty evidence.\nAuthors' conclusions\nWe did not find sufficient evidence to draw firm conclusions as to the best interventions to increase acceptance of LA in children due to variation in methodology and nature/timing of outcome measures. We recommend further parallel RCTs, reported in line with the CONSORT Statement. Care should be taken when choosing outcome measures.\n\nGiven the provided abstract, please respond to the following query: \"Review questio\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "n\nWith this Cochrane Review we tried to find out the best way to get children to accept receiving an injection of local anaesthetic during dental treatment."
}
] |
query-laysum
|
21756
|
[
{
"role": "user",
"content": "Abstract: Background\nMycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma, a malignant, chronic disease initially affecting the skin. Several therapies are available, which may induce clinical remission for a time. This is an update of a Cochrane Review first published in 2012: we wanted to assess new trials, some of which investigated new interventions.\nObjectives\nTo assess the effects of interventions for MF in all stages of the disease.\nSearch methods\nWe updated our searches of the following databases to May 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched 2 trials registries for additional references. For adverse event outcomes, we undertook separate searches in MEDLINE in April, July and November 2017.\nSelection criteria\nRandomised controlled trials (RCTs) of local or systemic interventions for MF in adults with any stage of the disease compared with either another local or systemic intervention or with placebo.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcomes were improvement in health-related quality of life as defined by participants, and common adverse effects of the treatments. Key secondary outcomes were complete response (CR), defined as complete disappearance of all clinical evidence of disease, and objective response rate (ORR), defined as proportion of patients with a partial or complete response. We used GRADE to assess the certainty of evidence and considered comparisons of psoralen plus ultraviolet A (PUVA) light treatment as most important because this is first-line treatment for MF in most guidelines.\nMain results\nThis review includes 20 RCTs (1369 participants) covering a wide range of interventions. The following were assessed as either treatments or comparators: imiquimod, peldesine, hypericin, mechlorethamine, nitrogen mustard and intralesional injections of interferon-α (IFN-α) (topical applications); PUVA, extracorporeal photopheresis (ECP: photochemotherapy), and visible light (light applications); acitretin, bexarotene, lenalidomide, methotrexate and vorinostat (oral agents); brentuximab vedotin; denileukin diftitox; mogamulizumab; chemotherapy with cyclophosphamide, doxorubicin, etoposide, and vincristine; a combination of chemotherapy with electron beam radiation; subcutaneous injection of IFN-α; and intramuscular injections of active transfer factor (parenteral systemics).\nThirteen trials used an active comparator, five were placebo-controlled, and two compared an active operator to observation only. In 14 trials, participants had MF in clinical stages IA to IIB. All participants were treated in secondary and tertiary care settings, mainly in Europe, North America or Australia. Trials recruited both men and women, with more male participants overall. Trial duration varied from four weeks to 12 months, with one longer-term study lasting more than six years. We judged 16 trials as at high risk of bias in at least one domain, most commonly performance bias (blinding of participants and investigators), attrition bias and reporting bias.\nNone of our key comparisons measured quality of life, and the two studies that did presented no usable data. Eighteen studies reported common adverse effects of the treatments. Adverse effects ranged from mild symptoms to lethal complications depending upon the treatment type. More aggressive treatments like systemic chemotherapy generally resulted in more severe adverse effects.\nIn the included studies, CR rates ranged from 0% to 83% (median 31%), and ORR ranged from 0% to 88% (median 47%). Five trials assessed PUVA treatment, alone or combined, summarised below.\nThere may be little to no difference between intralesional IFN-α and PUVA compared with PUVA alone for 24 to 52 weeks in CR (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.87 to 1.31; 2 trials; 122 participants; low-certainty evidence). Common adverse events and ORR were not measured.\nOne small cross-over trial found once-monthly ECP for six months may be less effective than twice-weekly PUVA for three months, reporting CR in two of eight participants and ORR in six of eight participants after PUVA, compared with no CR or ORR after ECP (very low-certainty evidence). Some participants reported mild nausea after PUVA but no numerical data were given. One participant in the ECP group withdrew due to hypotension. However, we are unsure of the results due to very low-certainty evidence.\nOne trial comparing bexarotene plus PUVA versus PUVA alone for up to 16 weeks reported one case of photosensitivity in the bexarotene plus PUVA group compared to none in the PUVA-alone group (87 participants; low-certainty evidence). There may be little to no difference between bexarotene plus PUVA and PUVA alone in CR (RR 1.41, 95% CI 0.71 to 2.80) and ORR (RR 0.94, 95% CI 0.61 to 1.44) (93 participants; low-certainty evidence).\nOne trial comparing subcutaneous IFN-α injections combined with either acitretin or PUVA for up to 48 weeks or until CR indicated there may be little to no difference in the common IFN-α adverse effect of flu-like symptoms (RR 1.32, 95% CI 0.92 to 1.88; 82 participants). There may be lower CR with IFN-α and acitretin compared with IFN-α and PUVA (RR 0.54, 95% CI 0.35 to 0.84; 82 participants) (both outcomes: low-certainty evidence). This trial did not measure ORR.\nOne trial comparing PUVA maintenance treatment to no maintenance treatment, in participants who had already had CR, did report common adverse effects. However, the distribution was not evaluable. CR and OR were not assessable.\nThe range of treatment options meant that rare adverse effects consequently occurred in a variety of organs.\nAuthors' conclusions\nThere is a lack of high-certainty evidence to support decision making in the treatment of MF. Because of substantial heterogeneity in design, missing data, small sample sizes, and low methodological quality, the comparative safety and efficacy of these interventions cannot be reliably established on the basis of the included RCTs. PUVA is commonly recommended as first-line treatment for MF, and we did not find evidence to challenge this recommendation. There was an absence of evidence to support the use of intralesional IFN-α or bexarotene in people receiving PUVA and an absence of evidence to support the use of acitretin or ECP for treating MF.\nFuture trials should compare the safety and efficacy of treatments to PUVA, as the current standard of care, and should measure quality of life and common adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no evidence to challenge or support the standard treatment (PUVA). In the absence of a cure, treatment of MF should be based on disease stage, with a focus on limiting severe adverse effects."
}
] |
query-laysum
|
21757
|
[
{
"role": "user",
"content": "Abstract: Background\nIn areas where vitamin A deficiency (VAD) is a public health concern, the maternal dietary intake of vitamin A may be not sufficient to meet either the maternal nutritional requirements, or those of the breastfed infant, due the low retinol concentrations in breast milk.\nObjectives\nTo evaluate the effects of vitamin A supplementation for postpartum women on maternal and infant health.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (8 February 2016), LILACS (1982 to December 2015), Web of Science (1945 to December 2015), and the reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) or cluster-randomised trials that assessed the effects of vitamin A supplementation for postpartum women on maternal and infant health (morbidity, mortality and vitamin A nutritional status).\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias and checked for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nFourteen trials of mainly low or unclear risk of bias, enrolling 25,758 women and infant pairs were included. The supplementation schemes included high, single or double doses of vitamin A (200,000 to 400,000 internation units (IU)), or 7.8 mg daily beta-carotene compared with placebo, no treatment, other (iron); or higher (400,000 IU) versus lower dose (200,000 IU). In all trials, a considerable proportion of infants were at least partially breastfed until six months.\nSupplement (vitamin A as retinyl, water-miscible or beta-carotene) 200,000 to 400,000 IU versus control (placebo or no treatment)\nMaternal: We did not find evidence that vitamin A supplementation reduced maternal mortality at 12 months (hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.44 to 2.21; 8577 participants; 1 RCT, moderate-quality evidence). Effects were less certain at six months (risk ratio (RR) 0.50, 95% CI 0.09 to 2.71; 564 participants; 1 RCT; low-quality evidence). The effect on maternal morbidity (diarrhoea, respiratory infections, fever) was uncertain because the quality of evidence was very low (50 participants, 1 RCT). We found insufficient evidence that vitamin A increases abdominal pain (RR 1.28, 95% CI 0.95 to 1.73; 786 participants; 1 RCT; low-quality evidence). We found low-quality evidence that vitamin A supplementation increased breast milk retinol concentrations by 0.20 µmol/L at three to three and a half months (mean difference (MD) 0.20 µmol/L, 95% CI 0.08 to 0.31; 837 participants; 6 RCTs).\nInfant: We did not find evidence that vitamin A supplementation reduced infant mortality at two to 12 months (RR 1.08, 95% CI 0.77 to 1.52; 6090 participants; 5 RCTs; low-quality evidence). Effects on morbidity (gastroenteritis at three months) was uncertain (RR 6.03, 95% CI 0.30 to 121.82; 84 participants; 1 RCT; very low-quality evidence). There was low-quality evidence for the effect on infant adverse outcomes (bulging fontanelle at 24 to 48 hours) (RR 2.00, 95% CI 0.61 to 6.55; 444 participants; 1 RCT).\nSupplement (vitamin A as retinyl) 400,000 IU versus 200,000 IU\nThree studies (1312 participants) were included in this comparison. None of the studies assessed maternal mortality, maternal morbidity or infant mortality. Findings from one study showed that there may be little or no difference in infant morbidity between the doses (diarrhoea, respiratory illnesses, and febrile illnesses) (312 participants, data not pooled). No firm conclusion could be drawn on the impact on maternal and infant adverse outcomes (limited data available).The effect on breast milk retinol was also uncertain due to the small amount of information available.\nAuthors' conclusions\nThere was no evidence of benefit from different doses of vitamin A supplementation for postpartum women on maternal and infant mortality and morbidity, compared with other doses or placebo. Although maternal breast milk retinol concentrations improved with supplementation, this did not translate to health benefits for either women or infants. Few studies reported on maternal and infant mortality and morbidity. Future studies should include these important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Breastfeeding is expected to provide for the infant's needs in the early months of life. However, if the mother is undernourished herself, the infant may not receive all the nutrients they need. Vitamin A is important for immunity and helping the infant stay healthy, so if the mother does not have enough vitamin A intake in her diet, the infant may also not receive enough in the breast milk."
}
] |
query-laysum
|
21758
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-selective beta-blockers are recommended for the prevention of bleeding in people with cirrhosis, portal hypertension and gastroesophageal varices. Carvedilol is a non-selective beta-blocker with additional intrinsic alpha1-blocking effects, which may be superior to traditional, non-selective beta-blockers in reducing portal pressure and, therefore, in reducing the risk of upper gastrointestinal bleeding.\nObjectives\nTo assess the beneficial and harmful effects of carvedilol compared with traditional, non-selective beta-blockers for adults with cirrhosis and gastroesophageal varices.\nSearch methods\nWe combined searches in the Cochrane Hepato-Biliary's Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, and Science Citation Index with manual searches. The last search update was 08 May 2018.\nSelection criteria\nWe included randomised clinical trials comparing carvedilol versus traditional, non-selective beta-blockers, irrespective of publication status, blinding, or language. We included trials evaluating both primary and secondary prevention of upper gastrointestinal bleeding in adults with cirrhosis and verified gastroesophageal varices.\nData collection and analysis\nThree review authors (AZ, RJ and LH), independently extracted data. The primary outcome measures were mortality, upper gastrointestinal bleeding and serious adverse events. We undertook meta-analyses and presented results using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CIs), and I2 values as a marker of heterogeneity. We assessed bias control using the Cochrane Hepato-Biliary domains and the quality of the evidence with GRADE.\nMain results\nEleven trials fulfilled our inclusion criteria. One trial did not report clinical outcomes. We included the remaining 10 randomised clinical trials, involving 810 participants with cirrhosis and oesophageal varices, in our analyses. The intervention comparisons were carvedilol versus propranolol (nine trials), or nadolol (one trial). Six trials were of short duration (mean 6 (range 1 to 12) weeks), while four were of longer duration (13.5 (6 to 30) months). Three trials evaluated primary prevention; three evaluated secondary prevention; while four evaluated both primary and secondary prevention. We classified all trials as at 'high risk of bias'. We gathered mortality data from seven trials involving 507 participants; no events occurred in four of these. Sixteen of 254 participants receiving carvedilol and 19 of 253 participants receiving propranolol or nadolol died (RR 0.86, 95% CI 0.48 to 1.53; I2 = 0%, low-quality evidence). There appeared to be no differences between carvedilol versus traditional, non-selective beta-blockers and the risks of upper gastrointestinal bleeding (RR 0.77, 95% CI 0.43 to 1.37; 810 participants; 10 trials; I2 = 45%, very low-quality evidence) and serious adverse events (RR 0.97, 95% CI 0.67 to 1.42; 810 participants; 10 trials; I2 = 14%, low-quality evidence). Significantly more deaths, episodes of upper gastrointestinal bleeding and serious adverse events occurred in the long-term trials but there was not enough information to determine whether there were differences between carvedilol and traditional, non-selective beta-blockers, by trial duration. There was also insufficient information to detect differences in the effects of these interventions in trials evaluating primary or secondary prevention. There appeared to be no differences in the risk of non-serious adverse events between carvedilol versus its comparators (RR 0.55, 95% CI 0.23 to 1.29; 596 participants; 6 trials; I2 = 88%; very low-quality evidence). Use of carvedilol was associated with a greater reduction in hepatic venous pressure gradient than traditional, non-selective beta-blockers both in absolute (MD -1.75 mmHg, 95% CI -2.60 to -0.89; 368 participants; 6 trials; I2 = 0%; low-quality evidence) and percentage terms (MD -8.02%, 95% CI -11.49% to -4.55%; 368 participants; 6 trials; I2 = 0%; low-quality evidence). However, we did not observe a concomitant reduction in the number of participants who failed to achieve a sufficient haemodynamic response (RR 0.76, 95% CI 0.57 to 1.02; 368 participants; 6 trials; I2 = 42%; very low-quality evidence) or in clinical outcomes.\nAuthors' conclusions\nWe found no clear beneficial or harmful effects of carvedilol versus traditional, non-selective beta-blockers on mortality, upper gastrointestinal bleeding, serious or non-serious adverse events despite the fact that carvedilol was more effective at reducing the hepatic venous pressure gradient. However, the evidence was of low or very low quality, and hence the findings are uncertain. Additional evidence is required from adequately powered, long-term, double-blind, randomised clinical trials, which evaluate both clinical and haemodynamic outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our analyses found no differences in the effects of carvedilol on the rates of death, bleeding or serious and non-serious complications compared with traditional, non-selective beta-blockers. Carvedilol lowered the portal pressure more effectively than the traditional, non-selective beta-blockers, but did not increase the number of participants in whom the pressure was reduced enough to reduce the risk of bleeding."
}
] |
query-laysum
|
21759
|
[
{
"role": "user",
"content": "Abstract: Background\nA dacryocystorhinostomy (DCR) procedure aims to restore drainage of tears by bypassing a blockage in the nasolacrimal duct, through the creation of a bony ostium that allows communication between the lacrimal sac and the nasal cavity. It can be performed using endonasal or external approaches. The comparative success rates of these two approaches have not yet been established and this review aims to evaluate the relevant up-to-date research.\nObjectives\nThe primary aim of this review is to compare the success rates of endonasal DCR with that of external DCR. The secondary aim is to compare the complication rates between the two procedures.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2016, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to 22 August 2016), Embase (January 1980 to 22 August 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to 22 August 2016), Web of Science Conference Proceedings Citation Index- Science (CPCI-S) (January 1990 to 22 August 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 22 August 2016. We requested or examined relevant conference proceedings for appropriate trials.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing endonasal and external DCRs.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility and extracted data on reported outcomes. We attempted to contact investigators to clarify the methodological quality of the studies. We graded the certainty of the evidence using GRADE.\nMain results\nWe included two trials in this review. One trial from Finland compared laser-assisted endonasal DCR with external DCR, and one trial from India compared mechanical endonasal DCR (using punch forceps) with external DCR. The trials were poorly reported and it was difficult to judge the extent to which bias had been avoided.\nAnatomic success was defined as the demonstration of a patent lacrimal passage on syringing, or endoscopic visualisation of fluorescein dye at the nasal opening of the anastomoses after a period of at least six months following surgery. Subjective success was defined as the resolution of symptoms of watering following surgery after a period of at least six months. Both included trials used anatomic patency demonstrated by irrigation as a measure of anatomic success. Different effects were seen in these two trials (I2 = 76%). People receiving laser-assisted endonasal DCR were less likely to have a successful operation compared with external DCR (63% versus 91%; risk ratio (RR) 0.69, 95% confidence intervals (CI) 0.52 to 0.92; 64 participants). There was little or no difference in success comparing mechanical endonasal DCR and external DCR (90% in both groups; RR 1.00, CI 0.81 to 1.23; 40 participants). We judged this evidence on success to be very low-certainty, downgrading for risk of bias, imprecision and inconsistency. The trial from Finland also assessed subjective improvement in symptoms following surgery. Resolution of symptoms of watering in outdoor conditions was reported by 84% of the participants in the external DCR group and 59% of those in the laser-assisted endonasal DCR group (RR 0.70, CI 0.51 to 0.97; 64 participants, low-certainty evidence).\nThere were no cases of intraoperative bleeding in any participant in the trial that compared laser-assisted endonasal DCR to external DCR. This was in contrast to the trial comparing mechanical endonasal DCR to external DCR in which 45% of participants in both groups experienced intraoperative bleeding (RR 1.00, 95% CI 0.50 to 1.98; 40 participants). We judged this evidence on intraoperative bleeding to be very low-certainty, downgrading for risk of bias, imprecision and inconsistency.\nThere were only two cases of postoperative bleeding, both in the external DCR group (RR 0.33, 95% CI 0.04 to 3.10; participants = 104; studies = 2). There were only two cases of wound infection/gaping, again both in the external DCR group (RR 0.20, CI 0.01 to 3.92; participants = 40; studies = 1). We judged this evidence on complications to be very low-certainty, downgrading one level for risk of bias and two levels for imprecision due to the very low number of cases.\nAuthors' conclusions\nThere is uncertainty as to the relative effects of endonasal and external DCR. Differences in effect seen in the two trials included in this review may be due to variations in the endonasal technique, but may also be due to other differences between the trials. Future larger RCTs are required to further assess the success and complication rates of endonasal and external DCR. Different techniques of endonasal DCR should also be assessed, as the choice of endonasal technique can influence the outcome. Strict outcome criteria should be adopted to assess functional and anatomical outcomes with a minimal follow-up of six months.\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": "It is unclear whether or not endonasal dacryocystorhinostomy (DCR) is a better way of treating tear duct obstruction than external DCR (very low-certainty evidence), nor is it clear whether endonasal DCR reduces the chance of complications such as bleeding or wound infection (very low-certainty evidence)."
}
] |
query-laysum
|
21761
|
[
{
"role": "user",
"content": "Abstract: Background\nEngagement in multiple risk behaviours can have adverse consequences for health during childhood, during adolescence, and later in life, yet little is known about the impact of different types of interventions that target multiple risk behaviours in children and young people, or the differential impact of universal versus targeted approaches. Findings from systematic reviews have been mixed, and effects of these interventions have not been quantitatively estimated.\nObjectives\nTo examine the effects of interventions implemented up to 18 years of age for the primary or secondary prevention of multiple risk behaviours among young people.\nSearch methods\nWe searched 11 databases (Australian Education Index; British Education Index; Campbell Library; Cumulative Index to Nursing and Allied Health Literature (CINAHL); Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; Embase; Education Resource Information Center (ERIC); International Bibliography of the Social Sciences; MEDLINE; PsycINFO; and Sociological Abstracts) on three occasions (2012, 2015, and 14 November 2016)). We conducted handsearches of reference lists, contacted experts in the field, conducted citation searches, and searched websites of relevant organisations.\nSelection criteria\nWe included randomised controlled trials (RCTs), including cluster RCTs, which aimed to address at least two risk behaviours. Participants were children and young people up to 18 years of age and/or parents, guardians, or carers, as long as the intervention aimed to address involvement in multiple risk behaviours among children and young people up to 18 years of age. However, studies could include outcome data on children > 18 years of age at the time of follow-up. Specifically,we included studies with outcomes collected from those eight to 25 years of age. Further, we included only studies with a combined intervention and follow-up period of six months or longer. We excluded interventions aimed at individuals with clinically diagnosed disorders along with clinical interventions. We categorised interventions according to whether they were conducted at the individual level; the family level; or the school level.\nData collection and analysis\nWe identified a total of 34,680 titles, screened 27,691 articles and assessed 424 full-text articles for eligibility. Two or more review authors independently assessed studies for inclusion in the review, extracted data, and assessed risk of bias.\nWe pooled data in meta-analyses using a random-effects (DerSimonian and Laird) model in RevMan 5.3. For each outcome, we included subgroups related to study type (individual, family, or school level, and universal or targeted approach) and examined effectiveness at up to 12 months' follow-up and over the longer term (> 12 months). We assessed the quality and certainty of evidence using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe included in the review a total of 70 eligible studies, of which a substantial proportion were universal school-based studies (n = 28; 40%). Most studies were conducted in the USA (n = 55; 79%). On average, studies aimed to prevent four of the primary behaviours. Behaviours that were most frequently addressed included alcohol use (n = 55), drug use (n = 53), and/or antisocial behaviour (n = 53), followed by tobacco use (n = 42). No studies aimed to prevent self-harm or gambling alongside other behaviours.\nEvidence suggests that for multiple risk behaviours, universal school-based interventions were beneficial in relation to tobacco use (odds ratio (OR) 0.77, 95% confidence interval (CI) 0.60 to 0.97; n = 9 studies; 15,354 participants) and alcohol use (OR 0.72, 95% CI 0.56 to 0.92; n = 8 studies; 8751 participants; both moderate-quality evidence) compared to a comparator, and that such interventions may be effective in preventing illicit drug use (OR 0.74, 95% CI 0.55 to 1.00; n = 5 studies; 11,058 participants; low-quality evidence) and engagement in any antisocial behaviour (OR 0.81, 95% CI 0.66 to 0.98; n = 13 studies; 20,756 participants; very low-quality evidence) at up to 12 months' follow-up, although there was evidence of moderate to substantial heterogeneity (I² = 49% to 69%). Moderate-quality evidence also showed that multiple risk behaviour universal school-based interventions improved the odds of physical activity (OR 1.32, 95% CI 1.16 to 1.50; I² = 0%; n = 4 studies; 6441 participants). We considered observed effects to be of public health importance when applied at the population level. Evidence was less certain for the effects of such multiple risk behaviour interventions for cannabis use (OR 0.79, 95% CI 0.62 to 1.01; P = 0.06; n = 5 studies; 4140 participants; I² = 0%; moderate-quality evidence), sexual risk behaviours (OR 0.83, 95% CI 0.61 to 1.12; P = 0.22; n = 6 studies; 12,633 participants; I² = 77%; low-quality evidence), and unhealthy diet (OR 0.82, 95% CI 0.64 to 1.06; P = 0.13; n = 3 studies; 6441 participants; I² = 49%; moderate-quality evidence). It is important to note that some evidence supported the positive effects of universal school-level interventions on three or more risk behaviours.\nFor most outcomes of individual- and family-level targeted and universal interventions, moderate- or low-quality evidence suggests little or no effect, although caution is warranted in interpretation because few of these studies were available for comparison (n ≤ 4 studies for each outcome).\nSeven studies reported adverse effects, which involved evidence suggestive of increased involvement in a risk behaviour among participants receiving the intervention compared to participants given control interventions.\nWe judged the quality of evidence to be moderate or low for most outcomes, primarily owing to concerns around selection, performance, and detection bias and heterogeneity between studies.\nAuthors' conclusions\nAvailable evidence is strongest for universal school-based interventions that target multiple- risk behaviours, demonstrating that they may be effective in preventing engagement in tobacco use, alcohol use, illicit drug use, and antisocial behaviour, and in improving physical activity among young people, but not in preventing other risk behaviours. Results of this review do not provide strong evidence of benefit for family- or individual-level interventions across the risk behaviours studied. However, poor reporting and concerns around the quality of evidence highlight the need for high-quality multiple- risk behaviour intervention studies to further strengthen the evidence base in this field.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In total, 70 studies were eligible for inclusion in this review. Half included populations without any consideration for risk status, and half focused on higher-risk groups. Most were conducted in the USA or in high-income countries. On average, studies examined the effects of interventions on four behaviours, most commonly alcohol, tobacco use, drug use, and antisocial behaviour.\nWe found that for multiple risk behaviours, school-based studies for all young people are more beneficial than a comparator for preventing tobacco use, alcohol use, and physical inactivity, and that they may also be beneficial in relation to illicit drug use and antisocial behaviour. Findings were weaker for cannabis use, sexual risk behaviour, and unhealthy diet. Evidence suggests that certain school-based programmes could have a beneficial impact on more than one behaviour. In contrast, we did not find strong evidence of beneficial effects of interventions for families or individuals for the behaviours of interest, although caution must be applied in interpreting these findings because we identified fewer of these studies. Last, we found seven studies that reported increased levels of engagement in risk behaviours among those receiving the intervention compared to those given the control.\nOverall, reviewers judged the quality of the evidence to be moderate or low for most behaviours examined using standardised criteria, with one behaviour found to have very low quality evidence. In part, this was due to concerns around how some studies were conducted, which could have introduced bias."
}
] |
query-laysum
|
21762
|
[
{
"role": "user",
"content": "Abstract: Background\nMany studies have recently been conducted to assess the antidepressant efficacy of glutamate modification in mood disorders. This is an update of a review first published in 2015 focusing on the use of glutamate receptor modulators in unipolar depression.\nObjectives\nTo assess the effects - and review the acceptability and tolerability - of ketamine and other glutamate receptor modulators in alleviating the acute symptoms of depression in people with unipolar major depressive disorder.\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\nDouble- or single-blinded randomised controlled trials (RCTs) comparing ketamine, memantine, esketamine or other glutamate receptor modulators with placebo (pill or saline infusion), other active psychotropic drugs, or electroconvulsive therapy (ECT) in adults with unipolar major depression.\nData collection and analysis\nThree review authors independently identified studies, assessed trial quality and extracted data. The primary outcomes were response rate (50% reduction on a standardised rating scale) and adverse events. We decided a priori to measure the efficacy outcomes at different time points and run sensitivity/subgroup analyses. Risk of bias was assessed using the Cochrane tool, and certainty of the evidence was assessed using GRADE.\nMain results\nThirty-one new studies were identified for inclusion in this updated review. Overall, we included 64 studies (5299 participants) on ketamine (31 trials), esketamine (9), memantine (5), lanicemine (4), D-cycloserine (2), Org26576 (2), riluzole (2), atomoxetine (1), basimglurant (1), citicoline (1), CP-101,606 (1), decoglurant (1), MK-0657 (1), N-acetylcysteine (1), rapastinel (1), and sarcosine (1).\nForty-eight studies were placebo-controlled, and 48 were two-arm studies. The majority of trials defined an inclusion criterion for the severity of depressive symptoms at baseline: 29 at least moderate depression; 17 severe depression; and five mild-to-moderate depression. Nineteen studies recruited only patients with treatment-resistant depression, defined as inadequate response to at least two antidepressants.\nThe majority of studies investigating ketamine administered as a single dose, whilst all of the included esketamine studies used a multiple dose regimen (most frequently twice a week for four weeks). Most studies looking at ketamine used intravenous administration, whilst the majority of esketamine trials used intranasal routes.\nThe evidence suggests that ketamine may result in an increase in response and remission compared with placebo at 24 hours odds ratio (OR) 3.94, 95% confidence interval (CI) 1.54 to 10.10; n = 185, studies = 7, very low-certainty evidence). Ketamine may reduce depression rating scale scores over placebo at 24 hours, but the evidence is very uncertain (standardised mean difference (SMD) -0.87, 95% CI -1.26 to -0.48; n = 231, studies = 8, very low-certainty evidence). There was no difference in the number of participants assigned to ketamine or placebo who dropped out for any reason (OR 1.25, 95% CI 0.19 to 8.28; n = 201, studies = 6, very low-certainty evidence).\nWhen compared with midazolam, the evidence showed that ketamine increases remission rates at 24 hours (OR 2.21, 95% CI 0.67 to 7.32; n = 122,studies = 2, low-certainty evidence). The evidence is very uncertain about the response efficacy of ketamine at 24 hours in comparison with midazolam, and its ability to reduce depression rating scale scores at the same time point (OR 2.48, 95% CI 1.00 to 6.18; n = 296, studies = 4,very low-certainty evidence). There was no difference in the number of participants who dropped out of studies for any reason between ketamine and midazolam (OR 0.33, 95% CI 0.05 to 2.09; n = 72, studies = 1, low-certainty evidence).\nEsketamine treatment likely results in a large increase in participants achieving remission at 24 hours compared with placebo (OR 2.74, 95% CI 1.71 to 4.40; n = 894, studies = 5, moderate-certainty evidence). Esketamine probably results in decreases in depression rating scale scores at 24 hours compared with placebo (SMD -0.31, 95% CI -0.45 to -0.17; n = 824, studies = 4, moderate-certainty evidence). Our findings show that esketamine increased response rates, although this evidence is uncertain (OR 2.11, 95% CI 1.20 to 3.68; n = 1071, studies = 5, low-certainty evidence). There was no evidence that participants assigned to esketamine treatment dropped out of trials more frequently than those assigned to placebo for any reason (OR 1.58, 95% CI 0.92 to 2.73; n = 773, studies = 4,moderate-certainty evidence).\nWe found very little evidence for the remaining glutamate receptor modulators.\nWe rated the risk of bias as low or unclear for most domains, though lack of detail regarding masking of treatment in the studies reduced our certainty in the effect for all outcomes.\nAuthors' conclusions\nOur findings show that ketamine and esketamine may be more efficacious than placebo at 24 hours. How these findings translate into clinical practice, however, is not entirely clear. The evidence for use of the remaining glutamate receptor modulators is limited as very few trials were included in the meta-analyses for each comparison and the majority of comparisons included only one study.\nLong term non-inferiority RCTs comparing repeated ketamine and esketamine, and rigorous real-world monitoring are needed to establish comprehensive data on safety and efficacy.\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 (specifically randomised controlled trials) completed up to 30 July 2020. To be included in the review, studies had to compare ketamine or other glutamate receptor modulators with placebo, other medicines or electroconvulsive therapy (ECT) for depression in adults (aged 18 and over). The studies also had to be single-blind (the participant does not know which treatment they are receiving) or double-blind (neither the participant or researcher know which treatment the participant is receiving), to attempt to reduce bias. We included 64 studies in the review, involving a total of 5299 people. The studies investigated16 different glutamate receptor modulator medications. The majority of participants had treatment-resistant depression (depression which had not responded to two or more medications) at the start of the studies. Most studies were two-armed, where the glutamate receptor modulator was compared with one other intervention."
}
] |
query-laysum
|
21763
|
[
{
"role": "user",
"content": "Abstract: Background\nThere are a limited number of treatment options for people with corticosteroid-refractory ulcerative colitis. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that tacrolimus may be an effective treatment for ulcerative colitis.\nObjectives\nTo evaluate the efficacy and safety of tacrolimus for induction of remission in people with corticosteroid-refractory ulcerative colitis.\nSearch methods\nWe searched the Cochrane Gut group specialised register, CENTRAL, MEDLINE (PubMed), Embase, Clinicaltrials.gov and WHO ICTRP from inception to October 2021 to identify relevant randomised controlled trials (RCT).\nSelection criteria\nTwo review authors independently selected potentially relevant studies to determine eligibility based on the prespecified criteria.\nData collection and analysis\nTwo review authors independently extracted data and analysed them using Review Manager Web. The primary outcomes were induction of remission and clinical improvement, as defined by the studies and expressed as a percentage of the participants randomised (intention-to-treat analysis).\nMain results\nThis review included five RCTs with 347 participants who had active ulcerative colitis or ulcerative proctitis. The duration of intervention varied between two weeks and eight weeks.\nTacrolimus versus placebo\nTacrolimus (oral and rectal) may be superior in achieving clinical remission compared to placebo (oral and rectal) (14/87 participants with tacrolimus versus 1/61 participants with placebo; risk ratio (RR) 3.76, 95% confidence interval (CI) 1.03 to 13.73; 3 studies). These results are of low certainty due to imprecision and risk of bias.\nTacrolimus (oral and rectal) may be superior for clinical improvement compared to placebo (oral and rectal) (45/87 participants with tacrolimus versus 7/61 participants with placebo; RR 4.47, 95% CI 2.15 to 9.29; 3 studies). These results are of low certainty due to imprecision and risk of bias.\nThe evidence is very uncertain about the effects of tacrolimus (oral and rectal) on serious adverse events compared to placebo (oral and rectal) (2/87 participants with tacrolimus versus 0/61 participants with placebo; RR 2.44, 95% CI 0.12 to 48.77; 3 studies). These results are of very low certainty due to high imprecision and risk of bias.\nTacrolimus versus ciclosporin\nOne study compared oral tacrolimus to intravenous ciclosporin, with an intervention lasting two weeks and 113 randomised participants. The evidence is very uncertain about the effect of tacrolimus on achievement of clinical remission compared to ciclosporin (15/33 participants with tacrolimus versus 24/80 participants with ciclosporin; RR 1.52, 95% CI 0.92 to 2.50). The results are of very low certainty due to risk of bias and high imprecision.\nThe evidence is very uncertain about the effect of tacrolimus on clinical improvement compared to intravenous ciclosporin (23/33 participants with tacrolimus versus 62/80 participants with ciclosporin; RR 0.90, 95% CI 0.70 to 1.16). The results are of very low certainty due to risk of bias and imprecision.\nTacrolimus versus beclometasone\nOne study compared tacrolimus suppositories with beclometasone suppositories in an intervention lasting four weeks with 88 randomised participants. There may be little to no difference in achievement of clinical remission (16/44 participants with tacrolimus versus 15/44 participants with beclometasone; RR 1.07, 95% CI 0.60 to 1.88). The results are of low certainty due to high imprecision.\nThere may be little to no difference in clinical improvement when comparing tacrolimus suppositories to beclometasone suppositories (22/44 participants with tacrolimus versus 22/44 with beclometasone; RR 1.00, 95% CI 0.66 to 1.52). The results are of low certainty due to high imprecision.\nThere may be little to no difference in serious adverse events when comparing tacrolimus suppositories to beclometasone suppositories (1/44 participants with tacrolimus versus 0/44 with beclometasone; RR 3.00, 95% CI 0.13 to 71.70). These results are of low certainty due to high imprecision.\nThere may be little to no difference in total adverse events when comparing tacrolimus suppositories to beclometasone suppositories (21/44 participants with tacrolimus versus 14/44 participants with beclometasone; RR 1.50, 95% CI 0.88 to 2.55). These results are of low certainty due to high imprecision.\nNo secondary outcomes were reported for people requiring rescue medication or to undergo surgery.\nAuthors' conclusions\nThere is low-certainty evidence that tacrolimus may be superior to placebo for achievement of clinical remission and clinical improvement in corticosteroid-refractory colitis or corticosteroid-refractory proctitis. The evidence is very uncertain about the effect of tacrolimus compared to ciclosporin for achievement of clinical remission or clinical improvement. There may be no difference between tacrolimus and beclometasone for inducing clinical remission or clinical improvement.\nThe cohorts studied to date were small, with missing data sets, offered short follow-up and the clinical endpoints used were not in line with those suggested by regulatory bodies. Therefore, no clinical practice conclusions can be made.\nThis review highlights the need for further research that targets the relevant clinical questions, uses appropriate trial methodology and reports key findings in a systematic manner that facilitates future integration of findings with current evidence to better inform clinicians and patients. Future studies need to be adequately powered and of pertinent duration so as to capture the efficacy and effectiveness of tacrolimus in the medium to long term. Well-structured efficacy studies need to be followed up by long-term phase 4 extensions to provide key outputs and inform in a real-world setting.\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": "Tacrolimus may be better than placebo for stopping the symptoms or improving them.\nTacrolimus may be no different to beclometasone for stopping the symptoms or improving them.\nThere are few data comparing tacrolimus to ciclosporin.\nIt is difficult to tell if tacrolimus causes more or fewer side effects compared to placebo or the other two medicines because of the very limited data."
}
] |
query-laysum
|
21764
|
[
{
"role": "user",
"content": "Abstract: Background\nSince the mid-2000s, the field of metastatic renal cell carcinoma (mRCC) has experienced a paradigm shift from non-specific therapy with broad-acting cytokines to specific regimens, which directly target the cancer, the tumour microenvironment, or both.\nCurrent guidelines recommend targeted therapies with agents such as sunitinib, pazopanib or temsirolimus (for people with poor prognosis) as the standard of care for first-line treatment of people with mRCC and mention non-specific cytokines as an alternative option for selected patients.\nIn November 2015, nivolumab, a checkpoint inhibitor directed against programmed death-1 (PD-1), was approved as the first specific immunotherapeutic agent as second-line therapy in previously treated mRCC patients.\nObjectives\nTo assess the effects of immunotherapies either alone or in combination with standard targeted therapies for the treatment of metastatic renal cell carcinoma and their efficacy to maximize patient benefit.\nSearch methods\nWe searched the Cochrane Library, MEDLINE (Ovid), Embase (Ovid), ISI Web of Science and registers of ongoing clinical trials in November 2016 without language restrictions. We scanned reference lists and contacted experts in the field to obtain further information.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs with or without blinding involving people with mRCC.\nData collection and analysis\nWe collected and analyzed studies according to the published protocol. Summary statistics for the primary endpoints were risk ratios (RRs) and mean differences (MD) with their 95% confidence intervals (CIs). We rated the quality of evidence using GRADE methodology and summarized the quality and magnitude of relative and absolute effects for each primary outcome in our 'Summary of findings' tables.\nMain results\nWe identified eight studies with 4732 eligible participants and an additional 13 ongoing studies. We categorized studies into comparisons, all against standard therapy accordingly as first-line (five comparisons) or second-line therapy (one comparison) for mRCC.\nInterferon (IFN)-α monotherapy probably increases one-year overall mortality compared to standard targeted therapies with temsirolimus or sunitinib (RR 1.30, 95% CI 1.13 to 1.51; 2 studies; 1166 participants; moderate-quality evidence), may lead to similar quality of life (QoL) (e.g. MD -5.58 points, 95% CI -7.25 to -3.91 for Functional Assessment of Cancer - General (FACT-G); 1 study; 730 participants; low-quality evidence) and may slightly increase the incidence of adverse events (AEs) grade 3 or greater (RR 1.17, 95% CI 1.03 to 1.32; 1 study; 408 participants; low-quality evidence).\nThere is probably no difference between IFN-α plus temsirolimus and temsirolimus alone for one-year overall mortality (RR 1.13, 95% CI 0.95 to 1.34; 1 study; 419 participants; moderate-quality evidence), but the incidence of AEs of 3 or greater may be increased (RR 1.30, 95% CI 1.17 to 1.45; 1 study; 416 participants; low-quality evidence). There was no information on QoL.\nIFN-α alone may slightly increase one-year overall mortality compared to IFN-α plus bevacizumab (RR 1.17, 95% CI 1.00 to 1.36; 2 studies; 1381 participants; low-quality evidence). This effect is probably accompanied by a lower incidence of AEs of grade 3 or greater (RR 0.77, 95% CI 0.71 to 0.84; 2 studies; 1350 participants; moderate-quality evidence). QoL could not be evaluated due to insufficient data.\nTreatment with IFN-α plus bevacizumab or standard targeted therapy (sunitinib) may lead to similar one-year overall mortality (RR 0.37, 95% CI 0.13 to 1.08; 1 study; 83 participants; low-quality evidence) and AEs of grade 3 or greater (RR 1.18, 95% CI 0.85 to 1.62; 1 study; 82 participants; low-quality evidence). QoL could not be evaluated due to insufficient data.\nTreatment with vaccines (e.g. MVA-5T4 or IMA901) or standard therapy may lead to similar one-year overall mortality (RR 1.10, 95% CI 0.91 to 1.32; low-quality evidence) and AEs of grade 3 or greater (RR 1.16, 95% CI 0.97 to 1.39; 2 studies; 1065 participants; low-quality evidence). QoL could not be evaluated due to insufficient data.\nIn previously treated patients, targeted immunotherapy (nivolumab) probably reduces one-year overall mortality compared to standard targeted therapy with everolimus (RR 0.70, 95% CI 0.56 to 0.87; 1 study; 821 participants; moderate-quality evidence), probably improves QoL (e.g. RR 1.51, 95% CI 1.28 to 1.78 for clinically relevant improvement of the FACT-Kidney Symptom Index Disease Related Symptoms (FKSI-DRS); 1 study, 704 participants; moderate-quality evidence) and probably reduces the incidence of AEs grade 3 or greater (RR 0.51, 95% CI 0.40 to 0.65; 1 study; 803 participants; moderate-quality evidence).\nAuthors' conclusions\nEvidence of moderate quality demonstrates that IFN-α monotherapy increases mortality compared to standard targeted therapies alone, whereas there is no difference if IFN is combined with standard targeted therapies. Evidence of low quality demonstrates that QoL is worse with IFN alone and that severe AEs are increased with IFN alone or in combination. There is low-quality evidence that IFN-α alone increases mortality but moderate-quality evidence on decreased AEs compared to IFN-α plus bevacizumab. Low-quality evidence shows no difference for IFN-α plus bevacizumab compared to sunitinib with respect to mortality and severe AEs. Low-quality evidence demonstrates no difference of vaccine treatment compared to standard targeted therapies in mortality and AEs, whereas there is moderate-quality evidence that targeted immunotherapies reduce mortality and AEs and improve QoL.\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": "A systematic search up to the end of October 2016 identified eight studies that looked at four different types of immunotherapy in 4732 people. Studies were only included if patients were randomized to a form of immunotherapy included in this review or a standard form of targeted therapy. One study was funded by a public institution whereas all the others were supported by drug companies.\nThe study participants were generally representative of people with advanced kidney cancer. The majority of people had their kidney cancer removed before starting treatment. We compared studies of people who had previously received standard medicine (821 participants) to those of people who had not (3911 participants). All studies reported our main outcome of interest; the chance of longer survival including the survival for one year. We also focused on the frequency of severe treatment side effects, quality of life and the delay in disease worsening."
}
] |
query-laysum
|
21765
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-infectious intermediate, posterior, and panuveitis (NIIPPU) represent a heterogenous collection of autoimmune and inflammatory disorders isolated to or concentrated in the posterior structures of the eye. Because NIIPPU is typically a chronic condition, people with NIIPPU frequently require treatment with steroid-sparing immunosuppressive therapy. Methotrexate, mycophenolate, cyclosporine, azathioprine, and tacrolimus are non-biologic, disease-modifying antirheumatic drugs (DMARDs) which have been used to treat people with NIIPPU.\nObjectives\nTo compare the effectiveness and safety of selected DMARDs (methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, and azathioprine) in the treatment of NIIPPU in adults.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, the Latin American and Caribbean Health Sciences database, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform, most recently on 16 April 2021.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing selected DMARDs (methotrexate, mycophenolate, tacrolimus, cyclosporine, and azathioprine) with placebo, standard of care (topical steroids, with or without oral steroids), or with each other.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 11 RCTs with a total of 601 participants in this review.\nDMARDs versus control\nTwo studies compared an experimental DMARD (cyclosporine A or enteric-coated mycophenolate [EC-MPS]) plus oral steroid with steroid monotherapy. We did not pool these results into a meta-analysis because the dose of cyclosporine used was much higher than that used in current clinical practice. The evidence is very uncertain about whether EC-MPS plus low-dose oral steroid results in a higher proportion of participants achieving control of inflammation over steroid monotherapy (risk ratio [RR] 2.81, 95% confidence interval [CI] 1.10 to 7.17; 1 study, 41 participants; very low-certainty evidence). The change in best-corrected visual acuity (BCVA) was reported separately for right and left eyes. The evidence for improvement (lower logarithm of the minimum angle of resolution (logMAR) indicates better vision) between the groups is very uncertain (mean difference [MD] -0.03 and -0.10, 95% CI -0.96 to 0.90 and -0.27 to 0.07 for right and left, respectively; 1 study, 82 eyes; very low-certainty evidence). No data were available for the following outcomes: proportion of participants achieving a 2-line improvement in visual acuity, with confirmed macular edema, or achieving steroid-sparing control. The evidence for the proportion of participants requiring cessation of medication in the DMARD versus control group is very uncertain (RR 2.61, 95% CI 0.11 to 60.51; 1 study, 41 participants; very low-certainty evidence).\nMethotrexate versus mycophenolate\nWe were able to combine two studies into a meta-analysis comparing methotrexate versus mycophenolate mofetil. Methotrexate probably results in a slight increase in the proportion of participants achieving control of inflammation, including steroid-sparing control, compared to mycophenolate at six months (RR 1.23, 95% CI 1.01 to 1.50; 2 studies, 261 participants; moderate-certainty evidence). Change in BCVA was reported per eye and the treatments likely result in little to no difference in change in vision (MD 0.01 logMAR higher [worse] for methotrexate versus mycophenolate; 2 studies, 490 eyes; moderate-certainty evidence). No data were available for the proportion of participants achieving a 2-line improvement in visual acuity. The evidence is very uncertain regarding the proportion of participants with confirmed macular edema between methotrexate versus mycophenolate (RR 0.49, 95% CI 0.19 to 1.30; 2 studies, 35 eyes; very low-certainty). Methotrexate versus mycophenolate may result in little to no difference in the proportion of participants requiring cessation of medication (RR 0.99, 95% CI 0.43 to 2.27; 2 studies, 296 participants; low-certainty evidence).\nSteroids with or without azathioprine versus cyclosporine A\nFour studies compared steroids with or without azathioprine (oral steroids, intravenous [IV] steroids, or azathioprine) to cyclosporine A. We excluded two studies from the meta-analysis because the participants were treated with 8 mg to 15 mg/kg/day of cyclosporine A, a significantly higher dose than is utilized today because of concerns for nephrotoxicity.\nThe remaining two studies were conducted in all Vogt-Koyanagi-Harada disease (VKH) populations and compared cyclosporine A to azathioprine or IV pulse-dose steroids. The evidence is very uncertain for whether the steroids with or without azathioprine or cyclosporine A influenced the proportion of participants achieving control of inflammation (RR 0.84, 95% CI 0.70 to 1.02; 2 studies, 112 participants; very low-certainty evidence), achieving steroid-sparing control (RR 0.64, 95% CI 0.33 to 1.25; 1 study, 21 participants; very low-certainty evidence), or requiring cessation of medication (RR 0.85, 95% 0.21 to 3.45; 2 studies, 91 participants; very low-certainty evidence). The evidence is uncertain for improvement in BCVA (MD 0.04 logMAR lower [better] with the steroids with or without azathioprine versus cyclosporine A; 2 studies, 91 eyes; very low-certainty evidence). There were no data available (with current cyclosporine A dosing) for the proportion of participants achieving a 2-line improvement in visual acuity or with confirmed macular edema.\nStudies not included in synthesis\nWe were unable to include three studies in any of the comparisons (in addition to the aforementioned studies excluded based on historic doses of cyclosporine A). One was a dose-response study comparing cyclosporine A to cyclosporine G, a formulation which was never licensed and is not clinically available. We excluded another study from meta-analysis because it compared cyclosporine A and tacrolimus, considered to be of the same class (calcineurin inhibitors). We were unable to combine the third study, which examined tacrolimus monotherapy versus tacrolimus plus oral steroid, with any group.\nAuthors' conclusions\nThere is a paucity of data regarding which DMARD is most effective or safe in NIIPPU. Studies in general were small, heterogenous in terms of their design and outcome measures, and often did not compare different classes of DMARD with each other. Methotrexate is probably slightly more efficacious than mycophenolate in achieving control of inflammation, including steroid-sparing control (moderate-certainty evidence), although there was insufficient evidence to prefer one medication over the other in the VKH subgroup (very low-certainty evidence). Methotrexate may result in little to no difference in safety outcomes compared to mycophenolate.\n\nGiven the provided abstract, please respond to the following query: \"Key message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that the medication methotrexate may be slightly more effective than mycophenolate. Otherwise, there was no strong evidence to suggest one medication is more effective or safe than the others."
}
] |
query-laysum
|
21766
|
[
{
"role": "user",
"content": "Abstract: Background\nEssential tremor (ET) is one of the most common movement disorders. The management is primarily based on pharmacological agents and in clinical practice propranolol and primidone are considered the first-line therapy. However, these treatments can be ineffective in 25% to 55% of people and are frequently associated with serious adverse events (AEs). For these reasons, it is worthwhile evaluating other treatments for ET. Topiramate has been suggested as a potentially useful agent for the treatment of ET but there is uncertainty about its efficacy and safety.\nObjectives\nTo assess the efficacy and safety of topiramate in the treatment of ET.\nSearch methods\nWe carried out a systematic search without language restrictions to identify all relevant trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (January 1966 to January 2017), Embase (January 1988 to January 2017), National Institute for Health and Care Excellence (1999 to January 2017), ClinicalTrials.gov (1997 to January 2017) and World Health Organization International Clinical Trials Registry Platform (ICTRP; 2004 to January 2017). We searched BIOSIS Citation Index (2000 to January 2017) for conference proceedings. We handsearched grey literature and the reference lists of identified studies and reviews.\nSelection criteria\nWe included all randomised controlled trials (RCTs) of topiramate versus placebo/open control or any other treatments. We included studies in which the diagnosis of ET was made according to accepted and validated diagnostic criteria. We excluded studies conducted in people presenting with secondary forms of tremor or reporting only neurophysiological parameters to assess outcomes.\nData collection and analysis\nTwo review authors independently collected and extracted data using a data collection form. We assessed the risk of bias and the quality of evidence. We used a fixed-effect meta-analysis for data synthesis.\nMain results\nThis review included three trials comparing topiramate to placebo (309 participants). They were all at high overall risk of bias. The quality of evidence ranged from very low to low. Compared to placebo, participants treated with topiramate showed a significant improvement in functional disability and an increased risk of withdrawal (risk ratio (RR) 1.78, 95% confidence interval (CI) 1.23 to 2.60). There were more AEs for topiramate-treated participants, particularly paraesthesia, weight loss, appetite decrease and memory difficulty.\nAuthors' conclusions\nThis systematic review highlighted the presence of limited data and very low to low quality evidence to support the apparent efficacy and the occurrence of treatment-limiting AEs in people with ET treated with topiramate. Further research to assess topiramate efficacy and safety on ET is needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The authors of this review tried to assess the effectiveness and safety of topiramate in people with essential tremor."
}
] |
query-laysum
|
21767
|
[
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of opiate use among pregnant women can range from 1% to 2% to as high as 21%. Just in the United States alone, among pregnant women with hospital delivery, a fourfold increase in opioid use is reported from 1999 to 2014 (Haight 2018). Heroin crosses the placenta, and pregnant, opiate-dependent women experience a six-fold increase in maternal obstetric complications such as low birth weight, toxaemia, third trimester bleeding, malpresentation, puerperal morbidity, fetal distress and meconium aspiration. Neonatal complications include narcotic withdrawal, postnatal growth deficiency, microcephaly, neuro-behavioural problems, increased neonatal mortality and a 74-fold increase in sudden infant death syndrome. This is an updated version of the original Cochrane Review first published in 2008 and last updated in 2013.\nObjectives\nTo assess the effectiveness of any maintenance treatment alone or in combination with a psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions alone for child health status, neonatal mortality, retaining pregnant women in treatment, and reducing the use of substances.\nSearch methods\nWe updated our searches of the following databases to February 2020: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science. We also searched two trials registers and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nRandomised controlled trials which assessed the efficacy of any pharmacological maintenance treatment for opiate-dependent pregnant women.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nWe found four trials with 271 pregnant women. Three compared methadone with buprenorphine and one methadone with oral slow-release morphine. Three out of four studies had adequate allocation concealment and were double-blind. The major flaw in the included studies was attrition bias: three out of four had a high dropout rate (30% to 40%), and this was unbalanced between groups.\nMethadone versus buprenorphine:\nThere was probably no evidence of a difference in the dropout rate from treatment (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.37 to 1.20, three studies, 223 participants, moderate-quality evidence). There may be no evidence of a difference in the use of primary substances between methadone and buprenorphine (RR 1.81, 95% CI 0.70 to 4.68, two studies, 151 participants, low-quality evidence). Birth weight may be higher in the buprenorphine group in the two trials that reported data MD;-530.00 g, 95%CI -662.78 to -397.22 (one study, 19 particpants) and MD: -215.00 g, 95%CI -238.93 to -191.07 (one study, 131 participants) although the results could not be pooled due to very high heterogeneity (very low-quality of evidence). The third study reported that there was no evidence of a difference. We found there may be no evidence of a difference in the APGAR score (MD: 0.00, 95% CI -0.03 to 0.03, two studies,163 participants, low-quality evidence). Many measures were used in the studies to assess neonatal abstinence syndrome. The number of newborns treated for neonatal abstinence syndrome, which is the most critical outcome, may not differ between groups (RR 1.19, 95% CI 0.87 to1.63, three studies, 166 participants, low-quality evidence).\nOnly one study which compared methadone with buprenorphine reported side effects. We found there may be no evidence of a difference in the number of mothers with serious adverse events (AEs) (RR 1.69, 95% CI 0.75 to 3.83, 175 participants, low-quality evidence) and we found there may be no difference in the numbers of newborns with serious AEs (RR 4.77, 95% CI 0.59, 38.49,131 participants, low-quality evidence).\nMethadone versus slow-release morphine:\nThere were no dropouts in either treatment group. Oral slow-release morphine may be superior to methadone for abstinence from heroin use during pregnancy (RR 2.40, 95% CI 1.00 to 5.77, one study, 48 participants, low-quality evidence).\nIn the comparison between methadone and slow-release morphine, no side effects were reported for the mother. In contrast, one child in the methadone group had central apnoea, and one child in the morphine group had obstructive apnoea (low-quality evidence).\nAuthors' conclusions\nMethadone and buprenorphine may be similar in efficacy and safety for the treatment of opioid-dependent pregnant women and their babies. There is not enough evidence to make conclusions for the comparison between methadone and slow-release morphine. Overall, the body of evidence is too small to make firm conclusions about the equivalence of the treatments compared. There is still a need for randomised controlled trials of adequate sample size comparing different maintenance treatments.\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": "This review summarised research studies comparing different types of pharmacologic maintenance treatments for pregnant women with opioid dependence"
}
] |
query-laysum
|
21768
|
[
{
"role": "user",
"content": "Abstract: Background\nColorectal resection through a midline laparotomy is a commonly performed surgical procedure to treat various bowel conditions. The typical postoperative hospital stay after this operation is 6 to 10 days. The main factors hindering early recovery and discharge are thought to include postoperative pain and delayed return of bowel function.\nContinuous infusion of a local anaesthetic into tissues surrounding the surgical incision via a multi-lumen indwelling wound catheter placed by the surgeon prior to wound closure may reduce postoperative pain, opioid consumption, the time to return of bowel function, and the length of hospital stay.\nObjectives\nTo evaluate the efficacy and adverse events of continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults.\nSearch methods\nWe searched the CENTRAL, MEDLINE and Embase databases to January 2019 to identify trials relevant to this review. We also searched reference lists of relevant trials and reviews for eligible trials. Additionally, we searched two clinical trials registers for ongoing trials.\nSelection criteria\nWe considered randomised controlled trials (including non-standard designs) or quasi-randomised controlled trials comparing continuous wound infusion of a local anaesthetic versus a placebo or a sham after midline laparotomy for colorectal resection in adults. We did not compare continuous local anaesthetic wound infusion to other techniques, such as transverse abdominis plane block or thoracic epidural analgesia. We allowed non-randomised analgesic co-interventions carried out equally in the intervention and control groups.\nData collection and analysis\nTwo review authors independently identified trials for inclusion and assessed their quality using the Cochrane 'Risk of bias' tool. We extracted data using standardised forms, including pain at rest and on movement (10-point scale), opioid consumption via a patient-controlled analgesia (PCA) system (mg morphine equivalent), postoperative opioid-related adverse events, the time to rescue analgesia, the time to first flatus and to first bowel movement, the time to ambulation, the length of hospital stay, serious postoperative adverse events, and patient satisfaction. We quantitatively synthesised the data by meta-analysis. We summarised and graded the certainty of the evidence for critical outcomes using the GRADEpro tool and created a 'Summary of findings' table.\nMain results\nThis review included six randomised controlled trials that enrolled a total of 564 adults undergoing elective midline laparotomy for colorectal resection comparing continuous wound infusion of a local anaesthetic to a normal saline placebo. Due to 23 post-randomisation exclusions, a total of 541 participants contributed data to the analysis of at least one outcome (local anaesthetic 268; control 273). Most participants were aged 55 to 65 years, with normal body mass index and low to moderate anaesthetic risk (American Society of Anesthesiologists class I-III). Random sequence generation, allocation concealment, and blinding were appropriately carried out in most trials. However, we had to downgrade the certainty of the evidence for most outcomes due to serious study limitations (risk of bias), inconsistency, indirectness, imprecision and reporting bias.\nPrimary outcomes\nOn postoperative day 1, pain at rest (mean difference (MD) −0.59 (from 3.1), 95% confidence interval (CI) −1.12 to −0.07; 5 studies, 511 participants; high-certainty evidence), pain on movement (MD −1.1 (from 6.1), 95% CI −2.3 to −0.01; 3 studies, 407 participants; low-certainty evidence) and opioid consumption via PCA (MD −12 mg (from 41 mg), 95% CI −20 to −4; 6 studies, 528 participants; moderate-certainty evidence) were reduced in the local anaesthetic group compared to the control group.\nSecondary outcomes\nThere was a reduction in the time to first bowel movement (MD −0.67 from 4.4 days, 95% CI −1.17 to −0.17; 4 studies, 197 participants; moderate-certainty evidence) and the length of hospital stay (MD −1.2 from 7.4 days, 95% CI −2.0 to −0.3; 4 studies, 456 participants; high-certainty evidence) in the local anaesthetic group compared to the control group.\nThere was no evidence of a difference in any serious postoperative adverse events until hospital discharge (RR 1.04, 95% CI 0.68 to 1.58; 6 studies, 541 participants; low-certainty evidence) between the two study groups.\nAuthors' conclusions\nAfter elective midline laparotomy for colorectal resection, continuous wound infusion of a local anaesthetic compared to a normal saline placebo reduces postoperative pain at rest and the length of hospital stay, on the basis of high-certainty evidence. This means we are very confident that the effect estimates for these outcomes lie close to the true effects. There is moderate-certainty evidence to indicate that the intervention probably reduces opioid consumption via PCA and the time to first bowel movement. This means we are moderately confident that effect estimates for these outcomes are likely to be close to the true effects, but there is a possibility that they are substantially different. The intervention may reduce postoperative pain on movement, however, this conclusion is based on low-certainty evidence. This means our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. There is low-certainty evidence to indicate that the intervention may have little or no effect on the rates of any serious postoperative adverse events until hospital discharge. High-quality randomised controlled trials to evaluate the intervention with a focus on important clinical and patient-centred outcomes 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 searched for clinical trials to January 2019 looking at the benefits and harms of continuous injection of a local anaesthetic after surgery to remove the bowel through a vertical cut in the abdomen. We looked for trials comparing local anaesthetic to an inactive substance (placebo) such as salty water (normal saline). We found six clinical trials including 541 participants. Most participants were aged 55 to 65 years, of varying health status from fit and healthy to having a severe systemic disease (a disease that affects the whole body)."
}
] |
query-laysum
|
21769
|
[
{
"role": "user",
"content": "Abstract: Background\nHand eczema is an inflammation of the skin of the hands that tends to run a chronic, relapsing course. This common condition is often associated with itch, social stigma, and impairment in employment. Many different interventions of unknown effectiveness are used to treat hand eczema.\nObjectives\nTo assess the effects of topical and systemic interventions for hand eczema in adults and children.\nSearch methods\nWe searched the following up to April 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, GREAT, and four trials registries. We checked the reference lists of included studies for further references to relevant trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared interventions for hand eczema, regardless of hand eczema type and other affected sites, versus no treatment, placebo, vehicle, or active treatments.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcomes were participant- and investigator-rated good/excellent control of symptoms, and adverse events.\nMain results\nWe included 60 RCTs, conducted in secondary care (5469 participants with mild to severe chronic hand eczema). Most participants were over 18 years old. The duration of treatment was short, generally up to four months. Only 24 studies included a follow-up period. Clinical heterogeneity in treatments and outcome measures was evident. Few studies performed head-to-head comparisons of different interventions. Risk of bias varied considerably, with only five studies at low risk in all domains. Twenty-two studies were industry-funded.\nEighteen trials studied topical corticosteroids or calcineurin inhibitors; 10 studies, phototherapy; three studies, systemic immunosuppressives; and five studies, oral retinoids. Most studies compared an active intervention against no treatment, variants of the same medication, or placebo (or vehicle). Below, we present results from the main comparisons.\nCorticosteroid creams/ointments: when assessed 15 days after the start of treatment, clobetasol propionate 0.05% foam probably improves participant-rated control of symptoms compared to vehicle (risk ratio (RR) 2.32, 95% confidence interval (CI) 1.38 to 3.91; number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 8; 1 study, 125 participants); the effect of clobetasol compared to vehicle for investigator-rated improvement is less clear (RR 1.43, 95% CI 0.86 to 2.40). More participants had at least one adverse event with clobetasol (11/62 versus 5/63; RR 2.24, 95% CI 0.82 to 6.06), including application site burning/pruritus. This evidence was rated as moderate certainty.\nWhen assessed 36 weeks after the start of treatment, mometasone furoate cream used thrice weekly may slightly improve investigator-rated symptom control compared to twice weekly (RR 1.23, 95% CI 0.94 to 1.61; 1 study, 72 participants) after remission is reached. Participant-rated symptoms were not measured. Some mild atrophy was reported in both groups (RR 1.76, 95% CI 0.45 to 6.83; 5/35 versus 3/37). This evidence was rated as low certainty.\nIrradiation with ultraviolet (UV) light: local combination ultraviolet light therapy (PUVA) may lead to improvement in investigator-rated symptom control when compared to local narrow-band UVB after 12 weeks of treatment (RR 0.50, 95% CI 0.22 to 1.16; 1 study, 60 participants). However, the 95% CI indicates that PUVA might make little or no difference. Participant-rated symptoms were not measured. Adverse events (mainly erythema) were reported by 9/30 participants in the narrow-band UVB group versus none in the PUVA group. This evidence was rated as moderate certainty.\nTopical calcineurin inhibitors: tacrolimus 0.1% over two weeks probably improves investigator-rated symptom control measured after three weeks compared to vehicle (14/14 tacrolimus versus 0/14 vehicle; 1 study). Participant-rated symptoms were not measured. Four of 14 people in the tacrolimus group versus zero in the vehicle group had well-tolerated application site burning/itching.\nA within-participant study in 16 participants compared 0.1% tacrolimus to 0.1% mometasone furoate but did not measure investigator- or participant-rated symptoms. Both treatments were well tolerated when assessed at two weeks during four weeks of treatment.\nEvidence from these studies was rated as moderate certainty.\nOral interventions: oral cyclosporin 3 mg/kg/d probably slightly improves investigator-rated (RR 1.88, 95% CI 0.88 to 3.99; 1 study, 34 participants) or participant-rated (RR 1.25, 95% CI 0.69 to 2.27) control of symptoms compared to topical betamethasone dipropionate 0.05% after six weeks of treatment. The risk of adverse events such as dizziness was similar between groups (up to 36 weeks; RR 1.22, 95% CI 0.80 to 1.86, n = 55; 15/27 betamethasone versus 19/28 cyclosporin). The evidence was rated as moderate certainty.\nAlitretinoin 10 mg improves investigator-rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210). Similar results were found for participant-rated symptom control: alitretinoin 10 mg RR 1.73 (95% CI 1.25 to 2.40) and 30 mg RR 2.75 (95% CI 2.18 to 3.48). Evidence was rated as high certainty. The number of adverse events (including headache) probably did not differ between alitretinoin 10 mg and placebo (RR 1.01, 95% CI 0.66 to 1.55; 1 study, n = 158; moderate-certainty evidence), but the risk of headache increased with alitretinoin 30 mg (RR 3.43, 95% CI 2.45 to 4.81; 2 studies, n = 1210; high-certainty evidence). Outcomes were assessed between 48 and 72 weeks.\nAuthors' conclusions\nMost findings were from single studies with low precision, so they should be interpreted with caution. Topical corticosteroids and UV phototherapy were two of the major standard treatments, but evidence is insufficient to support one specific treatment over another. The effect of topical calcineurin inhibitors is not certain. Alitretinoin is more effective than placebo in controlling symptoms, but advantages over other treatments need evaluating.\nWell-designed and well-reported, long-term (more than three months), head-to-head studies comparing different treatments are needed. Consensus is required regarding the definition of hand eczema and its subtypes, and a standard severity scale should be established.\nThe main limitation was heterogeneity between studies. Small sample size impacted our ability to detect differences between treatments.\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": "Hand eczema is an inflammation of the skin of the hands that can be caused by contact allergens (i.e. substances that cause an allergic reaction) such as rubber chemicals, but other external factors (e.g. irritants such as water or detergents) and atopic predisposition are often important triggers. Hand eczema can cause a reduction in quality of life leading to many work-related problems. Various types of hand eczema exist, and different topical (creams, ointments, or lotions) and systemic treatments with unknown effectiveness can be used."
}
] |
query-laysum
|
21770
|
[
{
"role": "user",
"content": "Abstract: Background\nIndividuals with chronic obstructive pulmonary disease (COPD) or chronic bronchitis may experience recurrent exacerbations, which negatively impact prognosis and quality of life, and can impose a significant socioeconomic burden on the individual and wider society. Immunostimulants are a broad category of therapies that may theoretically enhance non-specific immunity against several respiratory insults, thereby reducing exacerbation risk and severity. However, evidence to date for their use in this population is limited.\nObjectives\nTo determine the efficacy of immunostimulants in preventing respiratory exacerbations in adults with chronic obstructive pulmonary disease, chronic bronchitis, or both.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest literature search was conducted on 25 January 2022.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs) that compared immunostimulant therapy, administered by any method and with the intention of preventing (rather than treating) exacerbations, with placebo for a minimum treatment duration of one month in adults with chronic bronchitis or COPD, or both. We excluded participants with other respiratory conditions.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were number of participants with no exacerbations during the study period and all-cause mortality, secondary outcomes were respiratory-related mortality, quality of life, number of participants requiring antibiotics, exacerbation duration, respiratory-related hospitalisation duration and adverse events/side effects. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nThis review included 36 studies involving 6192 participants. Studies were published between 1981 and 2015. Duration ranged from three to 14 months. The mean age of study participants varied between 35.2 and 82 years. Twelve studies examined participants with COPD only. Seventeen studies reported baseline lung function values; most indicated a moderate-to-severe degree of airflow limitation. Nineteen studies indicated inclusion of participants with a mean baseline exacerbation frequency of two or more in the preceding year. Immunostimulants investigated were OM-85, AM3, RU41740 (Biostim), Ismigen, Diribiotine CK, thymomodulin, pidotimod, D53 (Ribomunyl), Lantigen B, Symbioflor, and hyaluronan; routes of administration were oral, sublingual, and subcutaneous. The risk of bias of the included studies was mostly low or unclear.\nParticipants receiving immunostimulants for a mean duration of six months were slightly more likely to be free of exacerbations during that time (odds ratio (OR) 1.48, 95% confidence interval (CI) 1.15 to 1.90; 15 RCTs, 2961 participants; moderate-certainty evidence). The overall number needed to treat with immunostimulants for a mean of six months, to prevent one participant from experiencing an exacerbation, was 11 (95% CI 7 to 29). This outcome was associated with a moderate degree of unexplained heterogeneity (I2 = 53%). Type of immunostimulant, baseline lung function, baseline exacerbation frequency, treatment duration, and follow-up duration did not modify the effect size, although due to heterogeneity and limited study and participant numbers within some subgroups, the validity of the subgroup treatment effect estimates were uncertain.\nImmunostimulants probably result in little to no difference in all-cause mortality (OR 0.64, 95% CI 0.37 to 1.10; 5 RCTs, 1558 participants; moderate-certainty evidence) and respiratory-related mortality (OR 0.40, 95% CI 0.15 to 1.07; 2 RCTs, 735 participants; low-certainty evidence) compared to placebo; however, the effects were imprecise and data quality limited the certainty of these results.\nThere was a small improvement in health-related quality of life, as measured by the St George's Respiratory Questionnaire (SGRQ), with immunostimulant compared to placebo (mean difference −4.59, 95% CI −7.59 to −1.59; 2 RCTs, 617 participants; very-low certainty evidence). The effect estimate just met the minimum clinically important difference (MCID) score of 4 units; however, the CI width means the possibility of a non-meaningful difference cannot be excluded.\nThe pooled result from five studies indicated that immunostimulants likely reduce the number of participants requiring antibiotics over a mean duration of six months (OR 0.34, 95% CI 0.18 to 0.63; 542 participants; moderate-certainty evidence). This outcome had a low-to-moderate degree of heterogeneity (I2 = 38%), but the direction of effect was consistent across all studies.\nThere was no evidence of a difference in the odds of experiencing an adverse event with immunostimulant compared to placebo, over a mean duration of six months (OR 1.01, 95% CI 0.84 to 1.21; 20 RCTs, 3780 participants; high-certainty evidence). The CI limits for the associated risk ratio (RR) did not cross thresholds for appreciable harm or benefit (RR 1.02, 95% CI 0.92 to 1.13). An additional seven studies reported no events rates in either study arm.\nMeta-analyses were not performed for the outcomes of exacerbation duration and respiratory-related hospitalisation duration, due to high levels of heterogeneity across the included studies (exacerbation duration: I2 = 92%; respiratory-related hospitalisation duration: I2 = 83%). Results from an effect direction plot and binomial probability test for exacerbation duration indicated that a significant proportion of studies (94% (95% CI 73% to 99%); P = 0.0002) favoured intervention, possibly indicating that immunostimulants are efficacious in reducing the mean exacerbation duration compared to placebo. However, the degree of uncertainty associated with this estimate remained high due to data quality and heterogeneity. Three studies reported mean duration of respiratory-related hospitalisation, two of which demonstrated a direction of effect that favoured immunostimulant over placebo.\nAuthors' conclusions\nIn participants with chronic bronchitis or COPD, we are moderately confident that treatment with immunostimulants is associated with a small reduction in the likelihood of having an exacerbation and a moderate reduction in the requirement for antibiotics. Low numbers of events limit interpretation of the effect of immunostimulants on all-cause and respiratory-related mortality. We are uncertain whether immunostimulants improve quality of life, and whether they are associated with a reduction in exacerbation and respiratory-related hospitalisation durations, although immunostimulants were generally associated with a positive effect direction in the studies that examined these outcomes. Immunostimulants appear to be safe and well-tolerated, and are not associated with an increased risk of adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What are chronic obstructive pulmonary disease and chronic bronchitis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic obstructive pulmonary disease (COPD) and chronic bronchitis are common conditions that permanently affect the airways of the lungs. They are mainly caused by exposure to cigarette smoke or other air pollutants. People with COPD or chronic bronchitis may develop persistent symptoms of breathlessness, cough, and phlegm production, and are prone to flare-ups (exacerbations) of these symptoms. Flare-ups can be debilitating, worsen lung function over time, and cause further exacerbations. Several standard treatments exist to help prevent flare-ups, which are recommended in almost all people who have a diagnosis of COPD. These mainly include quitting smoking, participating in exercise programmes, obtaining vaccinations to prevent infection, and using specific medications through an inhaler device."
}
] |
query-laysum
|
21771
|
[
{
"role": "user",
"content": "Abstract: Background\nThe role of vitamin D supplementation as a treatment for COVID-19 has been a subject of considerable discussion. A thorough understanding of the current evidence regarding the effectiveness and safety of vitamin D supplementation for COVID-19 based on randomised controlled trials is required.\nObjectives\nTo assess whether vitamin D supplementation is effective and safe for the treatment of COVID-19 in comparison to an active comparator, placebo, or standard of care alone, and to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, Web of Science and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 11 March 2021.\nSelection criteria\nWe followed standard Cochrane methodology. We included randomised controlled trials (RCTs) evaluating vitamin D supplementation for people with COVID-19, irrespective of disease severity, age, gender or ethnicity.\nWe excluded studies investigating preventive effects, or studies including populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)).\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 following prioritised outcome categories: individuals with moderate or severe COVID-19: all-cause mortality, clinical status, quality of life, adverse events, serious adverse events, and for individuals with asymptomatic or mild disease: all-cause mortality, development of severe clinical COVID-19 symptoms, quality of life, adverse events, serious adverse events.\nMain results\nWe identified three RCTs with 356 participants, of whom 183 received vitamin D. In accordance with the World Health Organization (WHO) clinical progression scale, two studies investigated participants with moderate or severe disease, and one study individuals with mild or asymptomatic disease. The control groups consisted of placebo treatment or standard of care alone.\nEffectiveness of vitamin D supplementation for people with COVID-19 and moderate to severe disease\nWe included two studies with 313 participants. Due to substantial clinical and methodological diversity of both studies, we were not able to pool data. Vitamin D status was unknown in one study, whereas the other study reported data for vitamin D deficient participants. One study administered multiple doses of oral calcifediol at days 1, 3 and 7, whereas the other study gave a single high dose of oral cholecalciferol at baseline. We assessed one study with low risk of bias for effectiveness outcomes, and the other with some concerns about randomisation and selective reporting.\nAll-cause mortality at hospital discharge (313 participants)\nWe found two studies reporting data for this outcome. One study reported no deaths when treated with vitamin D out of 50 participants, compared to two deaths out of 26 participants in the control group (Risk ratio (RR) 0.11, 95% confidence interval (CI) 0.01 to 2.13). The other study reported nine deaths out of 119 individuals in the vitamin D group, whereas six participants out of 118 died in the placebo group (RR 1.49, 95% CI 0.55 to 4.04]. We are very uncertain whether vitamin D has an effect on all-cause mortality at hospital discharge (very low-certainty evidence).\nClinical status assessed by the need for invasive mechanical ventilation (237 participants)\nWe found one study reporting data for this outcome. Nine out of 119 participants needed invasive mechanical ventilation when treated with vitamin D, compared to 17 out of 118 participants in the placebo group (RR 0.52, 95% CI 0.24 to 1.13). Vitamin D supplementation may decrease need for invasive mechanical ventilation, but the evidence is uncertain (low-certainty evidence).\nQuality of life\nWe did not find data for quality of life.\nSafety of vitamin D supplementation for people with COVID-19 and moderate to severe disease\nWe did not include data from one study, because assessment of serious adverse events was not described and we are concerned that data might have been inconsistently measured. This study reported vomiting in one out of 119 participants immediately after vitamin D intake (RR 2.98, 95% CI 0.12 to 72.30). We are very uncertain whether vitamin D supplementation is associated with higher risk for adverse events (very low-certainty).\nEffectiveness and safety of vitamin D supplementation for people with COVID-19 and asymptomatic or mild disease\nWe found one study including 40 individuals, which did not report our prioritised outcomes, but instead data for viral clearance, inflammatory markers, and vitamin D serum levels. The authors reported no events of hypercalcaemia, but recording and assessment of further adverse events remains unclear. Authors administered oral cholecalciferol in daily doses for at least 14 days, and continued with weekly doses if vitamin D blood levels were > 50 ng/mL.\nAuthors' conclusions\nThere is currently insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment of COVID-19. The evidence for the effectiveness of vitamin D supplementation for the treatment of COVID-19 is very uncertain. Moreover, we found only limited safety information, and were concerned about consistency in measurement and recording of these outcomes.\nThere was substantial clinical and methodological heterogeneity of included studies, mainly because of different supplementation strategies, formulations, vitamin D status of participants, and reported outcomes.\nThere is an urgent need for well-designed and adequately powered randomised controlled trials (RCTs) with an appropriate randomisation procedure, comparability of study arms and preferably double-blinding. We identified 21 ongoing and three completed studies without published results, which indicates that these needs will be addressed and that our findings are subject to change in the future. Due to the living approach of this work, we will update the review periodically.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found three studies with 356 participants. One study took place in Brazil, and the other two in Spain. Two studies had participants with severe COVID-19 and one had participants with mild COVID-19 or with no symptoms. All the participants tested positive for COVID-19 with a laboratory test called ‘PCR’, which is currently the most accurate test available.\nThe studies gave their participants different doses of vitamin D. They used different timings from each other, from one large dose in one study to several smaller doses over 14 days in another study. Only two studies said that their participants were vitamin D-deficient. The other study did not say anything about their participants’ vitamin D status."
}
] |
query-laysum
|
21772
|
[
{
"role": "user",
"content": "Abstract: Background\nThe hypertensive disorders of pregnancy include pre-eclampsia, gestational hypertension, chronic hypertension, and undefined hypertension. Pre-eclampsia is considerably more prevalent in low-income than in high-income countries. One possible explanation for this discrepancy is dietary differences, particularly calcium deficiency. Calcium supplementation in the second half of pregnancy reduces the serious consequences of pre-eclampsia, but has limited effect on the overall risk of pre-eclampsia. It is important to establish whether calcium supplementation before, and in early pregnancy (before 20 weeks' gestation) has added benefit. Such evidence could count towards justification of population-level interventions to improve dietary calcium intake, including fortification of staple foods with calcium, especially in contexts where dietary calcium intake is known to be inadequate. This is an update of a review first published in 2017.\nObjectives\nTo determine the effect of calcium supplementation, given before or early in pregnancy and for at least the first half of pregnancy, on pre-eclampsia and other hypertensive disorders, maternal morbidity and mortality, and fetal and neonatal outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Trials Register (31 July 2018), PubMed (13 July 2018), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP; 31 July 2018), and reference lists of retrieved studies.\nSelection criteria\nEligible studies were randomised controlled trials (RCT) of calcium supplementation, including women not yet pregnant, or women in early pregnancy. Cluster-RCTs, quasi-RCTs, and trials published as abstracts were eligible, but we did not identify any.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. They assessed the quality of the evidence for key outcomes using the GRADE approach.\nMain results\nCalcium versus placebo\nWe included one study (1355 women), which took place across multiple hospital sites in Argentina, South Africa, and Zimbabwe. Most analyses were conducted only on 633 women from this group who were known to have conceived, or on 579 who reached 20 weeks' gestation; the trial was at moderate risk of bias due to high attrition rates pre-conception. Non-pregnant women with previous pre-eclampsia received either calcium 500 mg daily or placebo, from enrolment until 20 weeks' gestation. All participants received calcium 1.5 g daily from 20 weeks until birth.\nPrimary outcomes: calcium supplementation commencing before conception may make little or no difference to the risk of pre-eclampsia (69/296 versus 82/283, risk ratio (RR) 0.80, 95% confidence interval (CI) 0.61 to 1.06; low-quality evidence). For pre-eclampsia or pregnancy loss or stillbirth (or both) at any gestational age, calcium may slightly reduce the risk of this composite outcome, however the 95% CI met the line of no effect (RR 0.82, 95% CI 0.66 to 1.00; low-quality evidence). Supplementation may make little or no difference to the severe maternal morbidity and mortality index (RR 0.93, 95% CI 0.68 to 1.26; low-quality evidence), pregnancy loss or stillbirth at any gestational age (RR 0.83, 95% CI 0.61 to 1,14; low-quality evidence), or caesarean section (RR 1.11, 95% CI 0.96 to 1,28; low-quality evidence).\nCalcium supplementation may make little or no difference to the following secondary outcomes: birthweight < 2500 g (RR 1.00, 95% CI 0.76 to 1.30; low-quality evidence), preterm birth < 37 weeks (RR 0.90, 95% CI 0.74 to 1.10), early preterm birth < 32 weeks (RR 0.79, 95% CI 0.56 to 1.12), and pregnancy loss, stillbirth or neonatal death before discharge (RR 0.82, 95% CI 0.61 to 1.10; low-quality evidence), no conception, gestational hypertension, gestational proteinuria, severe gestational hypertension, severe pre-eclampsia, severe pre-eclamptic complications index. There was no clear evidence on whether or not calcium might make a difference to perinatal death, or neonatal intensive care unit admission for > 24h, or both (RR 1.11, 95% CI 0.77 to 1.60; low-quality evidence).\nIt is unclear what impact calcium supplementation has on Apgar score < 7 at five minutes (RR 0.43, 95% CI 0.15 to 1.21; very low-quality evidence), stillbirth, early onset pre-eclampsia, eclampsia, placental abruption, intensive care unit admission > 24 hours, maternal death, hospital stay > 7 days from birth, and pregnancy loss before 20 weeks' gestation.\nAuthors' conclusions\nThe single included study suggested that calcium supplementation before and early in pregnancy may reduce the risk of women experiencing the composite outcome pre-eclampsia or pregnancy loss at any gestational age, but the results are inconclusive for all other outcomes for women and babies. Therefore, current evidence neither supports nor refutes the routine use of calcium supplementation before conception and in early pregnancy.\nTo determine the overall benefit of calcium supplementation commenced before or in early pregnancy, the effects found in the study of calcium supplementation limited to the first half of pregnancy need to be added to the known benefits of calcium supplementation in the second half of pregnancy.\nFurther research is needed to confirm whether initiating calcium supplementation pre- or in early pregnancy is associated with a reduction in adverse pregnancy outcomes for mother and baby. Research could also address the acceptability of the intervention to women, which was not covered by this review update.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature in July 2018 and found one relevant clinical trial. This trial included 1355 women who had previously had pre-eclampsia, who lived in Argentina, South Africa, and Zimbabwe.\nThe trial compared pregnant women who had daily calcium with women who had placebo (a dummy tablet) until 20 weeks of pregnancy, when all women switched to having daily calcium until birth. We had some concerns about the evidence from this trial, because nearly a quarter of the women who were enrolled were lost to follow-up, and we do not know whether they went on to become pregnant. Overall, while the results suggested that some women may benefit from calcium supplements, the findings included the possibility that the calcium didn't make a difference. Calcium may have helped some pregnant women avoid either losing the pregnancy or developing blood pressure problems, but we need more studies to be really confident that this effect was due to calcium. Calcium may have made little or no difference to whether pregnant women had other serious health conditions during pregnancy, such as: maternal admission to intensive care, blood pressure problems (pre-eclampsia, severe pre-eclampsia, eclampsia), placental separation from the uterus (placental abruption), or death. For babies, calcium may have had little or no impact on whether they were of low birthweight, of poor condition at birth, or required intensive care. The results did not clearly indicate the impact of calcium on whether babies died either before or after the birth, or needed to be admitted to neonatal intensive care for more than 24 hours."
}
] |
query-laysum
|
21773
|
[
{
"role": "user",
"content": "Abstract: Background\nUlcerative colitis (UC) is a chronic inflammation of the colon characterised by periods of relapse and remission. It starts in the rectum and can extend throughout the colon. UC and Crohn’s disease (CD) are the most common inflammatory bowel diseases (IBDs). However, UC tends to be more common than CD. It has no known cure but can be managed with medication and surgery. However, studies have shown that abdominal pain persists in up to one-third of people with UC in remission. Abdominal pain could be a symptom of relapse of the disease due to adverse effects of medication, surgical complications and strictures or adhesions secondary to UC.\nObjectives\nTo assess the efficacy and safety of interventions for managing abdominal pain in people with ulcerative colitis.\nSearch methods\nWe searched CENTRAL, MEDLINE and five other databases and clinical trials registries on 28 April 2021. We contacted authors of relevant studies and ongoing or unpublished trials that may be relevant to the review. We also searched references of trials and systematic reviews for any additional trials.\nSelection criteria\nAll published, unpublished and ongoing randomised trials that compared interventions for the management of abdominal pain with other active interventions or standard therapy, placebo or no therapy were included. People with both active and inactive disease were included. We excluded studies that did not report on any abdominal pain outcomes.\nData collection and analysis\nTwo review authors independently conducted data extraction and 'Risk of bias' assessments. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs), respectively, with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology.\nMain results\nWe included five studies (360 randomised participants). Studies considered mainly participants in an inactive state of the disease.\nNo conclusions could be drawn about the efficacy of any of the interventions on pain frequency, pain intensity, and treatment success. The certainty of the evidence was very low for all comparisons because of imprecision due to sparse data, and risk of bias.\nOne study compared a low FODMAPs diet (n=13) to a sham diet (n=13). The evidence is very uncertain about the effect of this treatment on pain frequency (MD -4.00, 95% CI -20.61 to 12.61) and intensity (MD -9.00, 95% CI -20.07 to 2.07). Treatment success was not reported.\nOne study compared relaxation training (n=20) to wait-list (n=20). The evidence is very uncertain about the effect of this treatment on pain frequency at end of intervention (MD 2.60, 95% CI 1.14 to 4.06) and 6-month follow-up (MD 3.30, 95% CI 1.64 to 4.96). Similarly, the evidence is very uncertain about the effect of this treatment on pain intensity at end of intervention (MD -1.70, 95% CI -2.92 to -0.48) and 6-month follow-up (MD -2.30, 95% CI -3.70 to -0.90). Treatment success was not reported.\nOne study compared yoga (n=30) to no intervention (n=30). The study defined treatment success as the presence or absence of pain; however, the data they provided was unclear. Pain frequency and intensity were not reported.\nOne study compared a kefir diet (Lactobacillus bacteria, n=15) to no intervention (n=15). The evidence is very uncertain about the effect of this treatment on pain intensity (MD -0.17, 95% CI -0.91 to 0.57). Pain frequency and treatment success were not reported.\nOne study compared a stellate ganglion block treatment (n=90) to sulfasalazine treatment (n=30). The study defined treatment success as \"stomachache\"; however, the data they provided was unclear. Pain frequency and intensity were not reported.\nTwo studies reported withdrawals due to adverse events. One study reported withdrawals due to adverse events as zero. Two studies did not report this outcome. We cannot draw any conclusions about the effects of any of the interventions on withdrawals due to adverse events because of the very limited evidence.\nThe reporting of secondary outcomes was inconsistent.\nAdverse events tended to be very low or zero. However, we can make no clear judgements about adverse events for any of the interventions, due to the low number of events.\nAnxiety was measured and reported at end of intervention in only one study (yoga versus no intervention), and depression was not measured in any of the studies. We can therefore draw no meaningful conclusions about these outcomes.\nAuthors' conclusions\nWe found very low-certainty evidence on the efficacy and safety of interventions for the management of abdominal pain in ulcerative colitis. Pervasive issues with very serious imprecision from small samples size and high risk of bias have led to very low-certainty outcomes, precluding conclusions.\nWhile few adverse events and no serious adverse events were reported, the certainty of these findings was again very low for all comparisons, so no conclusions can be drawn.\nThere is a need for further research. We have identified eight ongoing studies in this review, so an update will be warranted. It is key that future research addresses the issues leading to reduced certainty of outcomes, specifically sample size and reporting that leads to high risk of bias. It is also important that if researchers are considering pain as a critical outcome, they should report clearly if participants were pain-free at baseline; in that case, data would be best presented as separate subgroups throughout their research.\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": "People with ulcerative colitis commonly suffer pain, whether their disease is active on inactive.\nSeveral types of therapies have tried to reduce pain in ulcerative colitis, including diets, psychological therapies, drugs, exercise therapies and brain therapies.\nThere is currently no agreement amongst clinicians as to which therapy is better."
}
] |
query-laysum
|
21774
|
[
{
"role": "user",
"content": "Abstract: Background\nSpecific allergen immunotherapy (SIT) is a treatment that may improve disease severity in people with atopic eczema (AE) by inducing immune tolerance to the relevant allergen. A high quality systematic review has not previously assessed the efficacy and safety of this treatment.\nObjectives\nTo assess the effects of specific allergen immunotherapy (SIT), including subcutaneous, sublingual, intradermal, and oral routes, compared with placebo or a standard treatment in people with atopic eczema.\nSearch methods\nWe searched the following databases up to July 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 7, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), Web of Science™ (from 2005), the Global Resource of EczemA Trials (GREAT database), and five trials databases. We searched abstracts from recent European and North American allergy meetings and checked the references of included studies and review articles for further references to relevant trials.\nSelection criteria\nRandomised controlled trials (RCTs) of specific allergen immunotherapy that used standardised allergen extracts in people with AE.\nData collection and analysis\nTwo authors independently undertook study selection, data extraction (including adverse effects), assessment of risk of bias, and analyses. We used standard methodological procedures expected by Cochrane.\nMain results\nWe identified 12 RCTs for inclusion in this review; the total number of participants was 733. The interventions included SIT in children and adults allergic to either house dust mite (10 trials), grass pollen, or other inhalant allergens (two trials). They were administered subcutaneously (six trials), sublingually (four trials), orally, or intradermally (two trials). Overall, the risk of bias was moderate, with high loss to follow up and lack of blinding as the main methodological concern.\nOur primary outcomes were 'Participant- or parent-reported global assessment of disease severity at the end of treatment'; 'Participant- or parent-reported specific symptoms of eczema, by subjective measures'; and 'Adverse events, such as acute episodes of asthma or anaphylaxis'. SCORing Atopic Dermatitis (SCORAD) is a means of measuring the effect of atopic dermatitis by area (A); intensity (B); and subjective measures (C), such as itch and sleeplessness, which we used.\nFor 'Participant- or parent-reported global assessment of disease severity at the end of treatment', one trial (20 participants) found improvement in 7/9 participants (78%) treated with the SIT compared with 3/11 (27%) treated with the placebo (risk ratio (RR) 2.85, 95% confidence interval (CI) 1.02 to 7.96; P = 0.04). Another study (24 participants) found no difference: global disease severity improved in 8/13 participants (62%) treated with the SIT compared with 9/11 (81%) treated with the placebo (RR 0.75, 95% CI 0.45 to 1.26; P = 0.38). We did not perform meta-analysis because of high heterogeneity between these two studies. The quality of the evidence was low.\nFor 'Participant- or parent-reported specific symptoms of eczema, by subjective measures', two trials (184 participants) did not find that the SIT improved SCORAD part C (mean difference (MD) -0.74, 95% CI -1.98 to 0.50) or sleep disturbance (MD -0.49, 95% CI -1.03 to 0.06) more than placebo. For SCORAD part C itch severity, these two trials (184 participants) did not find that the SIT improved itch (MD -0.24, 95% CI -1.00 to 0.52). One other non-blinded study (60 participants) found that the SIT reduced itch compared with no treatment (MD -4.20, 95% CI -3.69 to -4.71) and reduced the participants' overall symptoms (P < 0.01), but we could not pool these three studies due to high heterogeneity. The quality of the evidence was very low.\nSeven trials reported systemic adverse reactions: 18/282 participants (6.4%) treated with the SIT had a systemic reaction compared with 15/210 (7.1%) with no treatment (RR 0.78, 95% CI 0.41 to 1.49; the quality of the evidence was moderate). The same seven trials reported local adverse reactions: 90/280 participants (32.1%) treated with the SIT had a local reaction compared with 44/204 (21.6%) in the no treatment group (RR 1.27, 95% CI 0.89 to 1.81). As these had the same study limitations, we deemed the quality of the evidence to also be moderate.\nOf our secondary outcomes, there was a significant improvement in 'Investigator- or physician-rated global assessment of disease severity at the end of treatment' (six trials, 262 participants; RR 1.48, 95% CI 1.16 to 1.88). None of the studies reported our secondary outcome 'Parent- or participant-rated eczema severity assessed using a published scale', but two studies (n = 184), which have been mentioned above, used SCORAD part C, which we included as our primary outcome 'Participant- or parent-reported specific symptoms of eczema, by subjective measures'.\nOur findings were generally inconclusive because of the small number of studies. We were unable to determine by subgroup analyses a particular type of allergen or a particular age or level of disease severity where allergen immunotherapy was more successful. We were also unable to determine whether sublingual immunotherapy was associated with more local adverse reactions compared with subcutaneous immunotherapy.\nAuthors' conclusions\nOverall, the quality of the evidence was low. The low quality was mainly due to the differing results between studies, lack of blinding in some studies, and relatively few studies reporting participant-centred outcome measures. We found limited evidence that SIT may be an effective treatment for people with AE. The treatments used in these trials were not associated with an increased risk of local or systemic reactions. Future studies should use high quality allergen formulations with a proven track record in other allergic conditions and should include participant-reported outcome measures.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is specific allergen immunotherapy an effective treatment for people with atopic eczema?"
}
] |
query-laysum
|
21775
|
[
{
"role": "user",
"content": "Abstract: Background\nAcupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library.\nObjectives\nTo investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials.\nSelection criteria\nWe included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache.\nData collection and analysis\nTwo review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nTwelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.\nAcupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.\nAcupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).\nAcupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.\nOverall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes.\nAuthors' conclusions\nThe available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall the quality of the evidence was moderate."
}
] |
query-laysum
|
21776
|
[
{
"role": "user",
"content": "Abstract: Background\nEczema is a common chronic skin condition. Probiotics have been proposed as an effective treatment for eczema; their use is increasing, as numerous clinical trials are under way. This is an update of a Cochrane Review first published in 2008, which suggested that probiotics may not be an effective treatment for eczema but identified areas in which evidence was lacking.\nObjectives\nTo assess the effects of probiotics for treating patients of all ages with eczema.\nSearch methods\nWe updated our searches of the following databases to January 2017: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, the Global Resource of Eczema Trials (GREAT) database, MEDLINE, Embase, PsycINFO, the Allied and Complementary Medicine Database (AMED), and Latin American Caribbean Health Sciences Literature (LILACS). We searched five trials registers and checked the reference lists of included studies and relevant reviews for further references to relevant randomised controlled trials (RCTs). We also handsearched a number of conference proceedings. We updated the searches of the main databases in January 2018 and of trials registries in March 2018, but we have not yet incorporated these results into the review.\nSelection criteria\nRandomised controlled trials of probiotics (live orally ingested micro-organisms) compared with no treatment, placebo, or other active intervention with no probiotics for the treatment of eczema diagnosed by a doctor.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane. We recorded adverse events from the included studies and from a separate adverse events search conducted for the first review. We formally assessed reporting bias by preparing funnel plots, and we performed trial sequential analysis for the first primary outcome - eczema symptoms at the end of active treatment.\nWe used GRADE to assess the quality of the evidence for each outcome (in italic font).\nMain results\nWe included 39 randomised controlled trials involving 2599 randomised participants. We included participants of either gender, aged from the first year of life through to 55 years (only six studies assessed adults), who had mild to severe eczema. Trials were undertaken in primary and secondary healthcare settings, mainly in Europe or Asia. Duration of treatment ranged from four weeks to six months, and duration of follow-up after end of treatment ranged from zero to 36 months. We selected no standard dose: researchers used a variety of doses and concentrations of probiotics. The probiotics used were bacteria of the Lactobacillus and Bifidobacteria species, which were taken alone or combined with other probiotics, and were given with or without prebiotics. Comparators were no treatment, placebo, and other treatments with no probiotics.\nFor all results described in this abstract, the comparator was no probiotics. Active treatment ranged from six weeks to three months for all of the following results, apart from the investigator-rated eczema severity outcome, for which the upper limit of active treatment was 16 weeks. With regard to score, the higher the score, the more severe were the symptoms. All key results reported in this abstract were measured at the end of active treatment, except for adverse events, which were measured during the active treatment period.\nProbiotics probably make little or no difference in participant- or parent-rated symptoms of eczema (13 trials; 754 participants): symptom severity on a scale from 0 to 20 was 0.44 points lower after probiotic treatment (95% confidence interval (CI) -1.22 to 0.33; moderate-quality evidence). Trial sequential analysis shows that target sample sizes of 258 and 456, which are necessary to demonstrate a minimum mean difference of -2 and -1.5, respectively, with 90% power, have been exceeded, suggesting that further trials with similar probiotic strains for this outcome at the end of active treatment may be futile.\nWe found no evidence suggesting that probiotics make a difference in QoL for patients with eczema (six studies; 552 participants; standardised mean difference (SMD) 0.03, 95% CI -0.36 to 0.42; low-quality evidence) when measured by the participant or the parent using validated disease-specific QoL instruments.\nProbiotics may slightly reduce investigator-rated eczema severity scores (24 trials; 1596 participants). On a scale of 0 to 103 for total Severity Scoring of Atopic Dermatitis (SCORAD), a score combining investigator-rated eczema severity score and participant scoring for eczema symptoms of itch and sleep loss was 3.91 points lower after probiotic treatment than after no probiotic treatment (95% CI -5.86 to -1.96; low-quality evidence). The minimum clinically important difference for SCORAD has been estimated to be 8.7 points.\nWe noted significant to extreme levels of unexplainable heterogeneity between the results of individual studies. We judged most studies to be at unclear risk of bias; six studies had high attrition bias, and nine were at low risk of bias overall.\nWe found no evidence to show that probiotics make a difference in the risk of adverse events during active treatment (risk ratio (RR) 1.54, 95% CI 0.90 to 2.63; seven trials; 402 participants; low-quality evidence). Studies in our review that reported adverse effects described gastrointestinal symptoms.\nAuthors' conclusions\nEvidence suggests that, compared with no probiotic, currently available probiotic strains probably make little or no difference in improving patient-rated eczema symptoms. Probiotics may make little or no difference in QoL for people with eczema nor in investigator-rated eczema severity score (combined with participant scoring for eczema symptoms of itch and sleep loss); for the latter, the observed effect was small and of uncertain clinical significance. Therefore, use of probiotics for the treatment of eczema is currently not evidence-based. This update found no evidence of increased adverse effects with probiotic use during studies, but a separate adverse events search from the first review revealed that probiotic treatment carries a small risk of adverse events.\nResults show significant, unexplainable heterogeneity between individual trial results. Only a small number of studies measured some outcomes.\nFuture studies should better measure QoL scores and adverse events, and should report on new probiotics. Researchers should also consider studying subgroups of patients (e.g. patients with atopy or food allergies, adults) and standardising doses/concentrations of probiotics given.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eczema is an itchy, non-contagious, inflamed skin condition that affects between 5% and 20% of people at some time in their life. People with eczema have different bacteria in their gut compared to people without eczema, and sometimes they have inflammation in their gut. It has been suggested that eczema symptoms may be treated by changing the mix of gut bacteria or by reducing inflammation in the gut. Probiotics, which are live micro-organisms taken by mouth, such as the Lactobacillus bacteria found in unpasteurised milk and yoghurt, might achieve this.\nThis is an update of a previous Cochrane Review published in 2008; this update is important because more trials have been done since publication of the first review, and because use of probiotics is increasing and new treatments for eczema are needed."
}
] |
query-laysum
|
21777
|
[
{
"role": "user",
"content": "Abstract: Background\nManaged withdrawal is a necessary step prior to drug-free treatment or as the endpoint of long-term substitution treatment.\nObjectives\nTo assess the effects of opioid antagonists plus minimal sedation for opioid withdrawal. Comparators were placebo as well as more established approaches to detoxification, such as tapered doses of methadone, adrenergic agonists, buprenorphine and symptomatic medications.\nSearch methods\nWe updated our searches of the following databases to December 2016: CENTRAL, MEDLINE, Embase, PsycINFO and Web of Science. We also searched two trials registers and checked the reference lists of included studies for further references to relevant studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled clinical trials along with prospective controlled cohort studies comparing opioid antagonists plus minimal sedation versus other approaches or different opioid antagonist regimens for withdrawal in opioid-dependent participants.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nTen studies (6 randomised controlled trials and 4 prospective cohort studies, involving 955 participants) met the inclusion criteria for the review. We considered 7 of the 10 studies to be at high risk of bias in at least one of the domains we assessed.\nNine studies compared an opioid antagonist-adrenergic agonist combination versus a treatment regimen based primarily on an alpha2-adrenergic agonist (clonidine or lofexidine). Other comparisons (placebo, tapered doses of methadone, buprenorphine) made by included studies were too diverse for any meaningful analysis. This review therefore focuses on the nine studies comparing an opioid antagonist (naltrexone or naloxone) plus clonidine or lofexidine versus treatment primarily based on clonidine or lofexidine.\nFive studies took place in an inpatient setting, two studies were in outpatients with day care, two used day care only for the first day of opioid antagonist administration, and one study described the setting as outpatient without indicating the level of care provided.\nThe included studies were heterogeneous in terms of the type of opioid antagonist treatment regimen, the comparator, the outcome measures assessed, and the means of assessing outcomes. As a result, the validity of any estimates of overall effect is doubtful, therefore we did not calculate pooled results for any of the analyses.\nThe quality of the evidence for treatment with an opioid antagonist-adrenergic agonist combination versus an alpha2-adrenergic agonist is very low. Two studies reported data on peak withdrawal severity, and four studies reported data on the average severity over the period of withdrawal. Peak withdrawal induced by opioid antagonists in combination with an adrenergic agonist appears to be more severe than withdrawal managed with clonidine or lofexidine alone, but the average severity over the withdrawal period is less. In some situations antagonist-induced withdrawal may be associated with significantly higher rates of treatment completion compared to withdrawal managed with adrenergic agonists. However, this result was not consistent across studies, and the extent of any benefit is highly uncertain.\nWe could not extract any data on the occurrence of adverse events, but two studies reported delirium or confusion following the first dose of naltrexone. Delirium may be more likely with higher initial doses and with naltrexone rather than naloxone (which has a shorter half-life), but we could not confirm this from the available evidence.\nInsufficient data were available to make any conclusions on the best duration of treatment.\nAuthors' conclusions\nUsing opioid antagonists plus alpha2-adrenergic agonists is a feasible approach for managing opioid withdrawal. However, it is unclear whether this approach reduces the duration of withdrawal or facilitates transfer to naltrexone treatment to a greater extent than withdrawal managed primarily with an adrenergic agonist.\nA high level of monitoring and support is desirable for several hours following administration of opioid antagonists because of the possibility of vomiting, diarrhoea and delirium.\nUsing opioid antagonists to induce and accelerate opioid withdrawal is not currently an active area of research or clinical practice, and the research community should give greater priority to investigating approaches, such as those based on buprenorphine, that facilitate the transition to sustained-release preparations of naltrexone.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence on the effects of opioid antagonists (naltrexone, naloxone) plus minimal sedation for managing withdrawal in people who are dependent on opioid drugs (for example, heroin or pharmaceutical opiates)."
}
] |
query-laysum
|
21778
|
[
{
"role": "user",
"content": "Abstract: Background\nAnkylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. Disease progression may result in loss of mobility and function. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. However, its efficacy remains unclear. This is an update of a Cochrane review first published in 2005.\nObjectives\nTo evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS).\nSearch methods\nWe searched for relevant randomized and quasi-randomized trials in any language, using the following sources: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 11); MEDLINE (2003 to 28 November 2013); EMBASE (2003 to 27 November 2013); CINAHL (2003 to 28 November 2013); Ovid MEDLINE data, World Health Organization International Clinical Trials Registry Platform (28 November 2013); and the reference sections of retrieved articles.\nSelection criteria\nWe evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS.\nData collection and analysis\nTwo review authors independently reviewed unblinded trial reports according to the selection criteria. Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. The same authors independently assessed the risk of bias of included trials and entered the data extracted from the included trials. We combined results using mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data.\nWe restructured outcome measures for this update based on recommendations from the editorial group. Major outcomes included: pain, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), radiographic progression, total number of withdrawals due to adverse events, and serious adverse events.\nMain results\nWe did not add any new studies to this review following the updated search. In the original review, we included 11 studies in the analysis, involving 895 participants in total. All included studies compared sulfasalazine with placebo. We judged most of the studies as low risk of bias or unclear risk of bias in five domains (random sequence generation, allocation concealment, blinding of outcome assessment, selective reporting, and other sources of bias). However, for incomplete outcome data, we only judged one trial at low risk of bias.\nNone of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Different parameters were used to assess pain. The pooled MD for back pain measured on a 0 to 100 mm visual analogue scale was -2.96 (95% confidence interval (CI) -6.33 to 0.41; absolute risk difference 3%, 95% CI 1% to 6%; 6 trials). Compared to placebo, a significantly higher rate of withdrawals due to adverse effects (RR 1.50, 95% CI 1.04 to 2.15; absolute risk difference 4%, 95% CI 0.4% to 8.8%; 11 trials) was found in the sulfasalazine group. A serious adverse reaction was reported in one patient taking sulfasalazine (Peto odds ratio 7.50, 95% CI 0.15 to 378.16).\nAuthors' conclusions\nThere is not enough evidence to support any benefit of sulfasalazine in reducing pain, disease activity, radiographic progression, or improving physical function and spinal mobility in the treatment of AS. A statistically significant benefit in reducing the erythrocyte sedimentation rate and easing spinal stiffness was mentioned in the previous version. However, the effect size was very small and not clinically meaningful. More withdrawals because of side effects occurred with sulfasalazine. Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS.\n\nGiven the provided abstract, please respond to the following query: \"Serious adverse events\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Only one person out of 469 stopped taking sulfasalazine for serious adverse events."
}
] |
query-laysum
|
21779
|
[
{
"role": "user",
"content": "Abstract: Background\nMobile health (mHealth), refers to healthcare practices supported by mobile devices, such as mobile phones and tablets. Within primary care, health workers often use mobile devices to register clients, track their health, and make decisions about care, as well as to communicate with clients and other health workers. An understanding of how health workers relate to, and experience mHealth, can help in its implementation.\nObjectives\nTo synthesise qualitative research evidence on health workers' perceptions and experiences of using mHealth technologies to deliver primary healthcare services, and to develop hypotheses about why some technologies are more effective than others.\nSearch methods\nWe searched MEDLINE, Embase, CINAHL, Science Citation Index and Social Sciences Citation Index in January 2018. We searched Global Health in December 2015. We screened the reference lists of included studies and key references and searched seven sources for grey literature (16 February to 5 March 2018). We re-ran the search strategies in February 2020. We screened these records and any studies that we identified as potentially relevant are awaiting classification.\nSelection criteria\nWe included studies that used qualitative data collection and analysis methods. We included studies of mHealth programmes that were part of primary healthcare services. These services could be implemented in public or private primary healthcare facilities, community and workplace, or the homes of clients. We included all categories of health workers, as well as those persons who supported the delivery and management of the mHealth programmes. We excluded participants identified as technical staff who developed and maintained the mHealth technology, without otherwise being involved in the programme delivery. We included studies conducted in any country.\nData collection and analysis\nWe assessed abstracts, titles and full-text papers according to the inclusion criteria. We found 53 studies that met the inclusion criteria and sampled 43 of these for our analysis. For the 43 sampled studies, we extracted information, such as country, health worker category, and the mHealth technology. We used a thematic analysis process. We used GRADE-CERQual to assess our confidence in the findings.\nMain results\nMost of the 43 included sample studies were from low- or middle-income countries. In many of the studies, the mobile devices had decision support software loaded onto them, which showed the steps the health workers had to follow when they provided health care. Other uses included in-person and/or text message communication, and recording clients' health information. Almost half of the studies looked at health workers' use of mobile devices for mother, child, and newborn health.\nWe have moderate or high confidence in the following findings.\nmHealth changed how health workers worked with each other : health workers appreciated being more connected to colleagues, and thought that this improved co-ordination and quality of care. However, some described problems when senior colleagues did not respond or responded in anger. Some preferred face-to-face connection with colleagues. Some believed that mHealth improved their reporting, while others compared it to \"big brother watching\".\nmHealth changed how health workers delivered care : health workers appreciated how mHealth let them take on new tasks, work flexibly, and reach clients in difficult-to-reach areas. They appreciated mHealth when it improved feedback, speed and workflow, but not when it was slow or time consuming. Some health workers found decision support software useful; others thought it threatened their clinical skills. Most health workers saw mHealth as better than paper, but some preferred paper. Some health workers saw mHealth as creating more work.\nmHealth led to new forms of engagement and relationships with clients and communities : health workers felt that communicating with clients by mobile phone improved care and their relationships with clients, but felt that some clients needed face-to-face contact. Health workers were aware of the importance of protecting confidential client information when using mobile devices. Some health workers did not mind being contacted by clients outside working hours, while others wanted boundaries. Health workers described how some community members trusted health workers that used mHealth while others were sceptical. Health workers pointed to problems when clients needed to own their own phones.\nHealth workers' use and perceptions of mHealth could be influenced by factors tied to costs, the health worker, the technology, the health system and society, poor network access, and poor access to electricity : some health workers did not mind covering extra costs. Others complained that phone credit was not delivered on time. Health workers who were accustomed to using mobile phones were sometimes more positive towards mHealth. Others with less experience, were sometimes embarrassed about making mistakes in front of clients or worried about job security. Health workers wanted training, technical support, user-friendly devices, and systems that were integrated into existing electronic health systems. The main challenges health workers experienced were poor network connections, access to electricity, and the cost of recharging phones. Other problems included damaged phones. Factors outside the health system also influenced how health workers experienced mHealth, including language, gender, and poverty issues. Health workers felt that their commitment to clients helped them cope with these challenges.\nAuthors' conclusions\nOur findings propose a nuanced view about mHealth programmes. The complexities of healthcare delivery and human interactions defy simplistic conclusions on how health workers will perceive and experience their use of mHealth. Perceptions reflect the interplay between the technology, contexts, and human attributes. Detailed descriptions of the programme, implementation processes and contexts, alongside effectiveness studies, will help to unravel this interplay to formulate hypotheses regarding the effectiveness of mHealth.\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 of qualitative research was to explore how health workers view and experience the use of mobile phones and tablets when delivering primary healthcare services. To answer this, we analysed 43 studies about health workers' views and experiences of mobile health (mHealth) programmes."
}
] |
query-laysum
|
21780
|
[
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents, characterised by age-inappropriate levels of inattention, hyperactivity, and impulsivity, and is associated with long-term social, academic, and mental health problems. The stimulant medications methylphenidate and amphetamine are the most frequently used treatments for ADHD, but these are not always effective and can be associated with side effects. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. Research has shown that children and adolescents with ADHD have significantly lower plasma and blood concentrations of PUFA and, in particular, lower levels of omega-3 PUFA. These findings suggest that PUFA supplementation may reduce the attention and behaviour problems associated with ADHD. This review is an update of a previously published Cochrane Review. Overall, there was little evidence that PUFA supplementation improved symptoms of ADHD in children and adolescents.\nObjectives\nTo compare the efficacy of PUFA to other forms of treatment or placebo in treating the symptoms of ADHD in children and adolescents.\nSearch methods\nWe searched 13 databases and two trials registers up to October 2021. We also checked the reference lists of relevant studies and reviews for additional references.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials that compared PUFA with placebo or PUFA plus alternative therapy (medication, behavioural therapy, or psychotherapy) with the same alternative therapy alone in children and adolescents (aged 18 years and under) diagnosed with ADHD.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was severity or improvement of ADHD symptoms. Our secondary outcomes were severity or incidence of behavioural problems; quality of life; severity or incidence of depressive symptoms; severity or incidence of anxiety symptoms; side effects; loss to follow-up; and cost. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included 37 trials with more than 2374 participants, of which 24 trials were new to this update. Five trials (seven reports) used a cross-over design, while the remaining 32 trials (52 reports) used a parallel design. Seven trials were conducted in Iran, four each in the USA and Israel, and two each in Australia, Canada, New Zealand, Sweden, and the UK. Single studies were conducted in Brazil, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Singapore, Spain, Sri Lanka, and Taiwan. Of the 36 trials that compared a PUFA to placebo, 19 used an omega-3 PUFA, six used a combined omega-3/omega-6 supplement, and two used an omega-6 PUFA. The nine remaining trials were included in the comparison of PUFA to placebo, but also had the same co-intervention in the PUFA and placebo groups. Of these, four trials compared a combination of omega-3 PUFA plus methylphenidate to methylphenidate. One trial each compared omega-3 PUFA plus atomoxetine to atomoxetine; omega-3 PUFA plus physical training to physical training; and an omega-3 or omega-6 supplement plus methylphenidate to methylphenidate; and two trials compared omega-3 PUFA plus dietary supplement to dietary supplement. Supplements were given for a period of between two weeks and six months.\nAlthough we found low-certainty evidence that PUFA compared to placebo may improve ADHD symptoms in the medium term (risk ratio (RR) 1.95, 95% confidence interval (CI) 1.47 to 2.60; 3 studies, 191 participants), there was high-certainty evidence that PUFA had no effect on parent-rated total ADHD symptoms compared to placebo in the medium term (standardised mean difference (SMD) −0.08, 95% CI −0.24 to 0.07; 16 studies, 1166 participants). There was also high-certainty evidence that parent-rated inattention (medium-term: SMD −0.01, 95% CI −0.20 to 0.17; 12 studies, 960 participants) and hyperactivity/impulsivity (medium-term: SMD 0.09, 95% CI −0.04 to 0.23; 10 studies, 869 participants) scores were no different compared to placebo.\nThere was moderate-certainty evidence that overall side effects likely did not differ between PUFA and placebo groups (RR 1.02, 95% CI 0.69 to 1.52; 8 studies, 591 participants). There was also moderate-certainty evidence that medium-term loss to follow-up was likely similar between groups (RR 1.03, 95% CI 0.77 to 1.37; 13 studies, 1121 participants).\nAuthors' conclusions\nAlthough we found low-certainty evidence that children and adolescents receiving PUFA may be more likely to improve compared to those receiving placebo, there was high-certainty evidence that PUFA had no effect on total parent-rated ADHD symptoms. There was also high-certainty evidence that inattention and hyperactivity/impulsivity did not differ between PUFA and placebo groups.\nWe found moderate-certainty evidence that overall side effects likely did not differ between PUFA and placebo groups. There was also moderate-certainty evidence that follow-up was similar between groups.\nIt is important that future research addresses the current weaknesses in this area, which include small sample sizes, variability of selection criteria, variability of the type and dosage of supplementation, and short follow-up times.\n\nGiven the provided abstract, please respond to the following query: \"What is ADHD?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Attention deficit hyperactivity disorder (ADHD) is a common problem in children and adolescents. Those affected may struggle to concentrate, feel restless, or act on impulse. As a result of these difficulties, ADHD can cause long-term social, academic, and mental health problems. Medicines are the most frequently used treatments for ADHD, but they are not always effective and can cause unwanted side effects."
}
] |
query-laysum
|
21781
|
[
{
"role": "user",
"content": "Abstract: Background\nProper sedation for neonates undergoing uncomfortable procedures may reduce stress and avoid complications. Midazolam is a short-acting benzodiazepine that is used increasingly in neonatal intensive care units (NICUs). However, its effectiveness as a sedative in neonates has not been systematically evaluated.\nObjectives\nPrimary objecive\nTo assess the effectiveness of intravenous midazolam infusion for sedation, as evaluated by behavioural and/or physiological measurements of sedation levels, in critically ill neonates in the NICU.\nSecondary objectives\nTo assess effects of intravenous midazolam infusion for sedation on complications including the following.\n1. Incidence of intraventricular haemorrhage (IVH)/periventricular leukomalacia (PVL).\n2. Mortality.\n3. Occurrence of adverse effects associated with the use of midazolam (hypotension, neurological abnormalities).\n4. Days of ventilation.\n5. Days of supplemental oxygen.\n6. Incidence of pneumothorax.\n7. Length of NICU stay (days).\n8. Long-term neurodevelopmental outcomes.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), MEDLINE via PubMed (1966 to 16 June 2016), Embase (1980 to 16 June 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 16 June 2016). We searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe selected for review randomised and quasi-randomised controlled trials of intravenous midazolam infusion for sedation in infants aged 28 days or younger.\nData collection and analysis\nWe abstracted data regarding the primary outcome of level of sedation. We assessed secondary outcomes such as intraventricular haemorrhage, periventricular leukomalacia, death, length of NICU stay and adverse effects associated with midazolam. When appropriate, we performed meta-analyses using risk ratios (RRs) and risk differences (RDs), and if the RD was statistically significant, we calculated the number needed to treat for an additional beneficial outcome (NNTB) or an additional harmful outcome (NNTH), along with their 95% confidence intervals (95% CIs) for categorical variables, and weighted mean differences (WMDs) for continuous variables. We assessed heterogeneity by performing the I-squared (I2) test.\nMain results\nWe included in the review three trials enrolling 148 neonates. We identified no new trials for this update. Using different sedation scales, each study showed a statistically significantly higher sedation level in the midazolam group compared with the placebo group. However, none of the sedation scales used have been validated in preterm infants; therefore, we could not ascertain the effectiveness of midazolam in this population. Duration of NICU stay was significantly longer in the midazolam group than in the placebo group (WMD 5.4 days, 95% CI 0.40 to 10.5; I2 = 0%; two studies, 89 infants). One study (43 infants) reported significantly lower Premature Infant Pain Profile (PIPP) scores during midazolam infusion than during dextrose (placebo) infusion (MD -3.80, 95% CI -5.93 to -1.67). Another study (46 infants) observed a higher incidence of adverse neurological events at 28 days' postnatal age (death, grade III or IV IVH or PVL) in the midazolam group compared with the morphine group (RR 7.64, 95% CI 1.02 to 57.21; RD 0.28, 95% CI 0.07 to 0.49; NNTH 4, 95% CI 2 to 14) (tests for heterogeneity not applicable). We considered these trials to be of moderate quality according to GRADE assessment based on the following outcomes: mortality during hospital stay, length of NICU stay, adequacy of analgesia according to PIPP scores and poor neurological outcomes by 28 days' postnatal age.\nAuthors' conclusions\nData are insufficient to promote the use of intravenous midazolam infusion as a sedative for neonates undergoing intensive care. This review raises concerns about the safety of midazolam in neonates. Further research on the effectiveness and safety of midazolam in neonates is needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We assessed the quality of the evidence on the outcomes of mortality during hospital stay, length of stay in the NICU, pain, and neurological outcomes at 28 days of life and found the evidence to be of moderate quality, as there was not enough evidence available. Therefore, we conclude there is not enough evidence to support the use of midazolam as a sedative for babies undergoing intensive care. Additional research is needed to address the safety and effectiveness of midazolam in this population."
}
] |
query-laysum
|
21782
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is evidence that the process of transition from paediatric (child) to adult health services is often associated with deterioration in the health of adolescents with chronic conditions.Transitional care is the term used to describe services that seek to bridge this care gap. It has been defined as ‘the purposeful, planned movement of adolescents and young adults with chronic physical and medical conditions from child-centred to adult-oriented health care systems’. In order to develop appropriate services for adolescents, evidence of what works and what factors act as barriers and facilitators of effective interventions is needed.\nObjectives\nTo evaluate the effectiveness of interventions designed to improve the transition of care for adolescents from paediatric to adult health services.\nSearch methods\nWe searched The Cochrane Central Register of Controlled Trials 2015, Issue 1, (including the Cochrane Effective Practice and Organisation of Care Group Specialised Register), MEDLINE, EMBASE, PsycINFO, and Web of Knowledge to 19 June 2015. We also searched reference lists of included studies and relevant reviews, and contacted experts and study authors for additional studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs), controlled before- and after-studies (CBAs), and interrupted time-series studies (ITSs) that evaluated the effectiveness of any intervention (care model or clinical pathway), that aimed to improve the transition of care for adolescents from paediatric to adult health services. We considered adolescents with any chronic condition that required ongoing clinical care, who were leaving paediatric services and going on to receive services in adult healthcare units, and their families. Participating providers included all health professionals responsible for the care of young people.\nData collection and analysis\nTwo review authors independently extracted data from included papers, assessed the risk of bias of each study, and assessed the certainty of the evidence for the main comparisons using GRADE. Discrepancies were resolved by discussion. Authors were contacted for missing data. We reported the findings of the studies as pre- and post-intervention means and calculated the unadjusted absolute change from baseline with 95% confidence intervals (CI).\nMain results\nWe included four RCTs (N = 238 participants) that explored: a two-day workshop-based transition preparation training for adolescents with spina bifida; a nurse-led, one-on-one, teaching session with the additional support of a ‘health passport’ for adolescents with heart disease; a web- and SMS-based educational intervention for adolescents with a range of different conditions; and a structured comprehensive transition programme with a transition co-ordinator for adolescents with type 1 diabetes.\nOne study evaluating a one-on-one nurse-led intervention, and one evaluating a technology-based intervention suggested that these interventions may lead to slight improvements in transitional readiness and chronic disease self-management measured at six- to eight-month follow-ups (low certainty evidence). Results with the TRAQ self-management tool were: MD 0.20; 95% CI -0.16 to 0.56 and MD 0.43; 95% CI; -0.09 to 0.95; with the TRAQ self-advocacy tool: MD 0.37; 95% CI -0.06 to 0.80; and with the PAM tool were: MD 10; 95% CI 2.96 to 17.04. In contrast, transition-preparation training delivered via a two-day workshop for patients with spina bifida may lead to little or no difference in measures of self-care practice and general health behaviours when measured using the DSCPI-90©.\nTwo studies evaluated the use of health services. One study evaluated a technology-based intervention and another a comprehensive transition programme; these interventions may lead to slightly more young people taking positive steps to initiate contact with health professionals themselves (Relative risk (RR): 4.87; 95% CI 0.24 to 98.12 and RR 1.50; 95% CI 0.32 to 6.94, respectively; low certainty evidence.\nYoung people’s knowledge of their disease may slightly improve with a nurse-led, one-on-one intervention to prepare young people for transition to an adult congenital heart programme (MD 14; 95% CI 2.67 to 25.33; one study; low certainty evidence).\nDisease-specific outcome measures were reported in two studies, both of which led to little or no difference in outcomes (low certainty evidence). One study found little or no difference between intervention and control groups. A second study found that follow-up HbA1c in young people with type 1 diabetes mellitus increased by 1.2% for each percentage increase in baseline HbA1c, independent of treatment group (1.2%; 95% CI 0.4 to 1.9; P = 0.01).\nTransition interventions may lead to little or no difference in well-being or quality of life as measured with the PARS III or PedsQ (two studies; low certainty evidence). Both the technology-based intervention and the two-day workshop for young people with spina bifida found little or no difference between intervention and control groups (MD 1.29; 95% CI -4.49 to 7.07). One study did not report the data.\nFour telephone support calls from a transition co-ordinator may lead to little or no difference in rates of transfer from paediatric to adult diabetes services (one study; low certainty evidence). At 12-month follow-up, there was little or no difference between groups of young people receiving usual care or a telephone support (RR 0.80; 95% CI 0.59 to 1.08)). They may slightly reduce the risk of disease-related hospital admissions at 12-month follow-up (RR 0.29; 95% CI 0.03 to 2.40).\nAuthors' conclusions\nThe available evidence (four small studies; N = 238), covers a limited range of interventions developed to facilitate transition in a limited number of clinical conditions, with only four to 12 months follow-up. These follow-up periods may not be long enough for any changes to become apparent as transition is a lengthy process. There was evidence of improvement in patients' knowledge of their condition in one study, and improvements in self-efficacy and confidence in another, but since few studies were eligible for this review, and the overall certainty of the body of this evidence is low, no firm conclusions can be drawn about the effectiveness of the evaluated interventions. Further research is very likely to have an important impact on our confidence in the intervention effect and likely could change our conclusions. There is considerable scope for the rigorous evaluation of other models of transitional care, reporting on clinical outcomes with longer term follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the literature up to 19 June 2015 and found four studies (N = 238 participants) for this review. The studies evaluated four different types of educational interventions, all targeting adolescents with different clinical conditions. All sought to improve knowledge and self-management skills of adolescents in preparation for transition to adult care."
}
] |
query-laysum
|
21783
|
[
{
"role": "user",
"content": "Abstract: Background\nFocal abnormalities most commonly acquired within the uterine cavity include endometrial polyps (arising from the endometrium) and submucous fibroids (arising from the myometrium). These benign abnormalities can cause several problems, including abnormal uterine bleeding (AUB) and subfertility. Two-dimensional saline infusion sonography (2D SIS) is a minimally invasive test that can be used to diagnose these pathologies, but it is less accurate than hysteroscopy, which is a more invasive procedure by which an endoscope allows direct visualisation of the uterine cavity. Three-dimensional (3D) SIS appears to enhance sonographic visualisation within the uterine cavity, thereby offering a potentially more accurate minimally invasive diagnostic test.\nObjectives\nPrimary objectives\n• To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test.\n• To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. In this case, any abnormality on either modality was regarded as a positive result (‘OR’ approach).\nSecondary objectives\n• To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.\n• To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PubMed, Cochrane Gynaecology and Fertility Group (CGF) Specialised Register and CGFG Diagnostic Test Accuracy (DTA) Specialised Register, clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Screening reference lists of appropriate studies was also performed. We screened for eligibility all studies identified from inception until March 2016. We performed searches with no date or language restrictions.\nSelection criteria\nThe population of interest consisted of premenopausal women with AUB or subfertility and postmenopausal women with AUB. Diagnostic test accuracy studies, randomised controlled trials (RCTs) and prospective cohort studies were eligible for inclusion if they evaluated the accuracy of both 2D SIS and 3D SIS for the diagnosis of acquired intracavitary abnormalities with hysteroscopy used as the reference standard. In light of the lack of data for 3D SIS, we also included studies that evaluated the accuracy of 3D SIS alone.\nData collection and analysis\nTwo review authors read all potentially eligible references after performing a first screening by title and abstract (LLN and FJRH). They independently extracted data to construct 2×2 tables from eligible studies and assessed studies for methodological quality using the QUADAS-2 tool (revised tool for quality assessment of diagnostic accuracy studies). To describe and visually present results, we produced in RevMan forest plots showing pairs of sensitivity and specificity together with 95% confidence intervals from each study, as well as raw receiver operating characteristic (ROC) plots. We displayed paired analyses in an ROC plot by linking sensitivity-specificity pairs from each study by using a dashed line. To compare 3D SIS versus 2D SIS, we restricted analyses to studies that provided 2×2 tables for both tests and used the bivariate meta-analysis of sensitivity and specificity.\nMain results\nThirteen studies (1053 women) reported the accuracy of 3D SIS for focal uterine abnormalities; 11 of these (846 women) were suitable for meta-analysis, and eight reported accuracy according to the type of focal abnormality. The design of the included studies seems applicable. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, we considered the overall quality of the evidence as low. The summary estimate (11 studies reporting absence or presence of abnormality at 3D SIS) for sensitivity was 94.5% (95% confidence interval (CI) 90.6% to 96.9%) and for specificity 99.4% (95% CI 96.2% to 99.9%). Meta-analysis of the eight studies (N = 716) directly comparing 2D SIS versus 3D SIS showed summary sensitivity of 96.9% (95% CI 91.9% to 98.8%) and summary specificity of 99.5% (95% CI 96.1% to 100%) for 3D SIS. For 2D SIS, summary sensitivity was 90.9% (95% CI 81.2% to 95.8%) and summary specificity was 96.3% (95% CI 86.1% to 99.1%). The difference in accuracy between 2D SIS and 3D SIS was non-significant (P values of 0.07 for sensitivity and 0.10 for specificity).\nAuthors' conclusions\nLow-quality evidence suggests that 3D SIS may be very accurate in detecting intracavitary abnormalities. Meta-analysis revealed no statistically significant differences between 2D SIS and 3D SIS. Summary sensitivity and summary specificity are higher for 3D SIS, but margins of improvement are limited because 2D SIS is already very accurate. When the technology and appropriate expertise are available, 3D SIS offers an alternative to 2D SIS. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding.\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": "Review authors searched for studies published from inception until March 2016 and found 13 studies (in total 1053 women), eight of which directly compared 3D SIS versus 2D SIS. Data included all women reporting abnormal menstrual bleeding or difficulty getting pregnant. The number of patients in these studies varied from 23 to 180 women."
}
] |
query-laysum
|
21784
|
[
{
"role": "user",
"content": "Abstract: Background\nIn some low- and middle-income countries, separate vertical programmes deliver specific life-saving interventions but can fragment services. Strategies to integrate services aim to bring together inputs, organisation, and delivery of particular functions to increase efficiency and people's access. We examined the evidence on the effectiveness of integration strategies at the point of delivery (sometimes termed 'linkages'), including integrated delivery of tuberculosis (TB), HIV/AIDS and reproductive health programmes.\nObjectives\nTo assess the effects of strategies to integrate primary health care services on healthcare delivery and health status in low- and middle-income countries.\nSearch methods\nWe searched The Cochrane Central Register of Controlled Trials (CENTRAL) 2010, Issue 3, part of the The Cochrane Library.www.thecochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care Group Specialised Register (searched 15 September 2010); MEDLINE, Ovid (1950 to August Week 5 2010) (searched 10 September 2010); EMBASE, Ovid (1980 to 2010 Week 35) (searched 10 September 2010); CINAHL, EBSCO (1980 to present) (searched 20 September 2010); Sociological Abstracts, CSA Illumina (1952 to current) (searched 10 September 2010); Social Services Abstracts, CSA Illumina (1979 to current) (searched 10 September 2010); POPLINE (1970 to current) (searched 10 September 2010); International Bibliography of the Social Sciences, Webspirs (1951 to current) (searched 01 July 2008); HealthStar (1975 to September 2005), Cab Health (1972 to 1999), and reference lists of articles. We also searched the World Health Organization (WHOLIS) library database, handsearched relevant WHO publications, and contacted experts in the field.\nSelection criteria\nRandomised controlled trials, non-randomised controlled trials, controlled before and after studies, and interrupted time series analyses of integration strategies, including strengthening linkages, in primary health care services. Health services in high-income countries, private public partnerships, and hospital inpatient care were excluded as were programmes promoting the integrated management of childhood illnesses. The main outcomes were indicators of healthcare delivery, user views, and health status.\nData collection and analysis\nTwo authors independently extracted data and assessed the risk of bias. The statistical results of individual studies are reported and summarised.\nMain results\nFive randomised trials and four controlled before and after studies were included. The interventions were complex.\nFive studies added an additional component, or linked a new component, to an existing service, for example, adding family planning or HIV counselling and testing to routine services. The evidence from these studies indicated that adding on services probably increases service utilisation but probably does not improve health status outcomes, such as incident pregnancies.\nFour studies compared integrated services to single, special services. Based on the included studies, fully integrating sexually transmitted infection (STI) and family planning, and maternal and child health services into routine care as opposed to delivering them as special 'vertical' services may decrease utilisation, client knowledge of and satisfaction with the services and may not result in any difference in health outcomes, such as child survival. Integrating HIV prevention and control at facility and community level improved the effectiveness of certain services (STI treatment in males) but resulted in no difference in health seeking behaviour, STI incidence, or HIV incidence in the population.\nAuthors' conclusions\nThere is some evidence that 'adding on' services (or linkages) may improve the utilisation and outputs of healthcare delivery. However, there is no evidence to date that a fuller form of integration improves healthcare delivery or health status. Available evidence suggests that full integration probably decreases the knowledge and utilisation of specific services and may not result in any improvements in health status. More rigorous studies of different strategies to promote integration over a wider range of services and settings are needed. These studies should include economic evaluation and the views of clients as clients' views will influence the uptake of integration strategies at the point of delivery and the effectiveness on community health of these strategies.\n\nGiven the provided abstract, please respond to the following query: \"A summary of this review for policy-makers is available\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "here"
}
] |
query-laysum
|
21785
|
[
{
"role": "user",
"content": "Abstract: Background\nThe effective control of moisture and microbes is necessary for the success of restoration procedures. The rubber dam, as an isolation method, has been widely used in dental restorative treatments. The effects of rubber dam usage on the longevity and quality of dental restorations still require evidence-based discussion. This review compares the effects of rubber dam with other isolation methods in dental restorative treatments. This is an update of the Cochrane Review first published in 2016.\nObjectives\nTo assess the effects of rubber dam isolation compared with other types of isolation used for direct and indirect restorative treatments in dental patients.\nSearch methods\nCochrane Oral Health's Information specialist searched the following electronic databases: Cochrane Oral Health's Trials Register (searched 13 January 2021), Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 12) in the Cochrane Library (searched 13 January 2021), MEDLINE Ovid (1946 to 13 January 2021), Embase Ovid (1980 to 13 January 2021), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 13 January 2021), and SciELO BIREME Virtual Health Library (1998 to 13 January 2021). We also searched Chinese BioMedical Literature Database (CBM, in Chinese) (1978 to 13 January 2021), VIP database (in Chinese) (1989 to 13 January 2021), and China National Knowledge Infrastructure (CNKI, in Chinese) (1994 to 13 January 2021). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform, OpenGrey, and Sciencepaper Online (in Chinese) for ongoing trials. There were no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (including split-mouth trials) over one month in length assessing the effects of rubber dam compared with alternative isolation methods for dental restorative treatments.\nData collection and analysis\nTwo review authors independently screened the results of the electronic searches, extracted data, and assessed the risk of bias of the included studies. Disagreement was resolved by discussion. We strictly followed Cochrane's statistical guidelines and assessed the certainty of the evidence using GRADE.\nMain results\nWe included six studies conducted worldwide between 2010 and 2015 involving a total of 1342 participants (of which 233 participants were lost to follow-up). All the included studies were at high risk of bias.\nFive studies compared rubber dam with traditional cotton rolls isolation. One study was excluded from the analysis due to inconsistencies in the presented data. Of the four remaining trials, three reported survival rates of the restorations with a minimum follow-up of six months. Pooled results from two studies involving 192 participants indicated that the use of rubber dam isolation may increase the survival rates of direct composite restorations of non-carious cervical lesions (NCCLs) at six months (odds ratio (OR) 2.29, 95% confidence interval (CI) 1.05 to 4.99; low-certainty evidence). However, the use of rubber dam in NCCLs composite restorations may have little to no effect on the survival rates of the restorations compared to cotton rolls at 12 months (OR 1.38, 95% CI 0.45 to 4.28; 1 study, 30 participants; very low-certainty evidence) and at 18 months (OR 1.00, 95% CI 0.45 to 2.25; 1 study, 30 participants; very low-certainty evidence) but the evidence is very uncertain. At 24 months, the use of rubber dam may decrease the risk of failure of the restorations in children undergoing proximal atraumatic restorative treatment in primary molars but the evidence is very uncertain (hazard ratio (HR) 0.80, 95% CI 0.66 to 0.97; 1 study, 559 participants; very low-certainty evidence).\nNone of the included studies mentioned adverse effects or reported the direct cost of the treatment.\nAuthors' conclusions\nThis review found some low-certainty evidence that the use of rubber dam in dental direct restorative treatments may lead to a lower failure rate of the restorations compared with cotton roll usage after six months. At other time points, the evidence is very uncertain. Further high-quality research evaluating the effects of rubber dam usage on different types of restorative treatments is required.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found six studies that involved 1342 people in total (mostly children). Teeth needed repairing for a range of reasons, including caries (holes in teeth created by bacteria) and loss of hard tissue at the base of teeth. The studies compared rubber dams against:\n- cotton rolls (five studies); and\n- the Isolite system (a new method that combines plastic blocks, a shield for the tongue and cheek, and a tube that sucks up saliva and other mouth contents) (one study).\nRubber dam compared against cotton rolls\nThe evidence suggests that when a rubber dam is used rather than cotton rolls, tooth repairs may be more likely to remain in place and be in good condition after six months (2 studies). There is not enough robust evidence for us to determine if this is the case beyond six months.\nRubber dam compared against the Isolite system\nThe evidence is not robust enough for us to determine if using a rubber dam improves the success of tooth repairs when compared against the Isolite system.\nSide effects\nNo study investigated side effects."
}
] |
query-laysum
|
21786
|
[
{
"role": "user",
"content": "Abstract: Background\nOesophageal cancer is the seventh leading cause of cancer death worldwide. Traditional Chinese herbal medicine is sometimes used as an adjunct to radiotherapy or chemotherapy for this type of cancer. This review was first published in 2007 and updated in 2009; this 2016 update is the latest version of the review.\nObjectives\nTo assess the efficacy and possible adverse effects of the addition of Chinese herbal medicine to treatment with radiotherapy or chemotherapy for oesophageal cancer.\nSearch methods\nWe searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, the Cochrane Library, MEDLINE, EMBASE, Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database and the Chinese Cochrane Centre Controlled Trials Register up to 1 October, 2015. We also searched databases of ongoing trials, the Internet and reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the use of radiotherapy or chemotherapy with and without the addition of Chinese herbal medicine.\nData collection and analysis\nAt least two review authors independently extracted data and assessed trial quality.\nMain results\nWe tried to contact the 142 study authors by telephone, and finally included nine studies with 490 participants. All included studies were conducted in China, and allocated advanced oesophageal cancer patients to radiotherapy or chemotherapy groups, with and without additional Chinese herbal medicine. Quality of life, short-term therapeutic effects, TCM symptoms and adverse events caused by radiotherapy or chemotherapy were reported in these studies. Overall, we considered the trials to be at unclear or high risk of bias.\nThe quality of life measure was conducted before and after the intervention; our analysis showed a beneficial effect, both in number of participants experiencing an improvement (risk ratio (RR) 2.20, 95% confidence interval (CI) 1.42 to 3.39; 5 RCTs, 233 participants, change of performance status score ≥ 10) and number of participants experiencing a deterioration (RR 0.41, 95% CI 0.27 to 0.62; 6 RCTs, 287 participants, change of performance status score ≤ 10). We judged this to have low quality evidence, downgrading quality of evidence for risk of bias and imprecision, and upgrading quality of evidence for the large effect.\nFor short-term therapeutic effects, the results suggest that traditional Chinese medicine (TCM) has a positive impact on improvement (complete response + partial response) (RR 1.17, 95% CI 1.02 to 1.35; 8 RCTs, 450 participants), moderate quality evidence and downgrading for risk of bias. There was no significant difference for progressive disease (RR 0.73, 95% CI 0.52 to 1.01; 8 RCTs, 450 participants), low quality evidence and downgrading for risk of bias and imprecision. Three studies assessed this outcome after four weeks or three months' follow-up, the remaining studies gave no detailed information for this outcome. TCM symptoms, which was similar to short-term therapeutic effects evaluated with TCM clinical criteria, was diagnosed in two studies of 88 people at the end of the intervention. The results suggest that TCM has a positive impact on both total effectiveness (RR 1.84, 95% CI 1.20 to 2.81) and ineffectiveness (RR 0.22, 95% CI 0.05 to 0.93); we judged the studies to have very low quality evidence, downgrading for risk of bias and imprecision.\nNine studies reported a series of adverse events caused by radiotherapy or chemotherapy at the end of the intervention, including mucositis, radiation oesophagitis, arrest of bone marrow, gastrointestinal reactions, renal and hepatic impairment, white blood cell descent, neurotoxicity, cardiac toxicity and anaemia. For those containing multiple studies, we conducted a pooled analysis. As a result, TCM showed a significant effect on radiation oesophagitis (RR 0.66, 95% CI 0.47 to 0.94; 2 RCTs, 90 participants), gastrointestinal reactions (RR 0.54, 95% CI 0.36 to 0.81; 4 RCTs, 268 participants) and white blood cell descent (RR 0.60, 95% CI 0.44 to 0.83; 4 RCTs, 224 participants). The quality of evidence was low or very low, downgrading for risk of bias and imprecision.\nAuthors' conclusions\nWe currently find no evidence to determine whether TCM is an effective treatment for oesophageal cancer. The effect of TCM on short-term therapeutic effects is uncertain. TCM probably has positive effects on quality of life and on some adverse events caused by radiotherapy or chemotherapy in advanced oesophageal cancer patients undergoing radiotherapy or chemotherapy. The results of the review need to be interpreted cautiously owing to overall low quality evidence. Future trials should be large and correctly designed to detect important clinical effects and minimise risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the quality of evidence to be low to moderate due to risk of bias; the small number of people enrolled in these studies caused imprecision and inconsistent results. The nine included trials did not allow a subgroup analysis of different kinds of Chinese herbal medicine, the therapeutic purposes of which are different between each other; this might be another reason for imprecise results. High quality trials are required in the future."
}
] |
query-laysum
|
21787
|
[
{
"role": "user",
"content": "Abstract: Background\nThe early detection of oral cavity squamous cell carcinoma (OSCC) and oral potentially malignant disorders (OPMD), followed by appropriate treatment, may improve survival and reduce the risk for malignant transformation respectively. This is an update of a Cochrane Review first published in 2013.\nObjectives\nTo estimate the diagnostic test accuracy of conventional oral examination, vital rinsing, light-based detection, mouth self-examination, remote screening, and biomarkers, used singly or in combination, for the early detection of OPMD or OSCC in apparently healthy adults.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 20 October 2020), MEDLINE Ovid (1946 to 20 October 2020), and Embase Ovid (1980 to 20 October 2020). 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. No restrictions were placed on the language or date of publication when searching the electronic databases. We conducted citation searches, and screened reference lists of included studies for additional references.\nSelection criteria\nWe selected studies that reported the test accuracy of any of the aforementioned tests in detecting OPMD or OSCC during a screening procedure. Diagnosis of OPMD or OSCC was provided by specialist clinicians or pathologists, or alternatively through follow-up.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for relevance. Eligibility, data extraction, and quality assessment were carried out by at least two authors independently and in duplicate. Studies were assessed for methodological quality using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). We reported the sensitivity and specificity of the included studies. We provided judgement of the certainty of the evidence using a GRADE assessment.\nMain results\nWe included 18 studies, recruiting 72,202 participants, published between 1986 and 2019. These studies evaluated the diagnostic test accuracy of conventional oral examination (10 studies, none new to this update), mouth self-examination (four studies, two new to this update), and remote screening (three studies, all new to this update). One randomised controlled trial of test accuracy directly evaluated conventional oral examination plus vital rinsing versus conventional oral examination alone. There were no eligible studies evaluating light-based detection or blood or salivary sample analysis (which tests for the presence of biomarkers for OPMD and OSCC). Only one study of conventional oral examination was judged as at overall low risk of bias and overall low concern regarding applicability.\nGiven the clinical heterogeneity of the included studies in terms of the participants recruited, setting, prevalence of the target condition, the application of the index test and reference standard, and the flow and timing of the process, the data could not be pooled within the broader categories of index test. For conventional oral examination (10 studies, 25,568 participants), prevalence in the test accuracy sample ranged from 1% to 51%. For the seven studies with prevalence of 10% or lower, a prevalence more comparable to the general population, the sensitivity estimates were variable, and ranged from 0.50 (95% confidence interval (CI) 0.07 to 0.93) to 0.99 (95% CI 0.97 to 1.00); the specificity estimates were more consistent and ranged from 0.94 (95% CI 0.88 to 0.97) to 0.99 (95% CI 0.98 to 1.00). We judged the overall certainty of the evidence to be low, and downgraded for inconsistency and indirectness.\nEvidence for mouth self-examination and remote screening was more limited. We judged the overall certainty of the evidence for these index tests to be very low, and downgraded for imprecision, inconsistency, and indirectness. We judged the evidence for vital rinsing (toluidine blue) as an adjunct to conventional oral examination compared to conventional oral examination to be moderate, and downgraded for indirectness as the trial was undertaken in a high-risk population.\nAuthors' conclusions\nThere is a lack of high-certainty evidence to support the use of screening programmes for oral cavity cancer and OPMD in the general population. Frontline screeners such as general dentists, dental hygienists, other allied professionals, and community healthcare workers should remain vigilant for signs of OPMD and OSCC.\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 a lack of high-certainty evidence to support the use of screening tests for cancer of the mouth and conditions that may lead to mouth cancer in the general population.\n- General dental practitioners and healthcare professionals should be watchful for signs of oral potentially malignant disorders (OPMD) and malignancies whilst performing routine oral examinations in practice for other common oral lesions/conditions."
}
] |
query-laysum
|
21788
|
[
{
"role": "user",
"content": "Abstract: Background\nPoor diet and insufficient physical activity are major risk factors for non-communicable diseases. Developing healthy diet and physical activity behaviors early in life is important as these behaviors track between childhood and adulthood. Parents and other adult caregivers have important influences on children's health behaviors, but whether their involvement in children's nutrition and physical activity interventions contributes to intervention effectiveness is not known.\nObjectives\n• To assess effects of caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors, including those intended to prevent overweight and obesity\n• To describe intervention content and behavior change techniques employed, drawing from a behavior change technique taxonomy developed and advanced by Abraham, Michie, and colleagues (Abraham 2008; Michie 2011; Michie 2013; Michie 2015)\n• To identify content and techniques related to reported outcomes when such information was reported in included studies\nSearch methods\nIn January 2019, we searched CENTRAL, MEDLINE, Embase, 11 other databases, and three trials registers. We also searched the references lists of relevant reports and systematic reviews.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of interventions to improve children's dietary intake or physical activity behavior, or both, with children aged 2 to 18 years as active participants and at least one component involving caregivers versus the same interventions but without the caregiver component(s). We excluded interventions meant as treatment or targeting children with pre-existing conditions, as well as caregiver-child units residing in orphanages and school hostel environments.\nData collection and analysis\nWe used standard methodological procedures outlined by Cochrane.\nMain results\nWe included 23 trials with approximately 12,192 children in eligible intervention arms. With the exception of two studies, all were conducted in high-income countries, with more than half performed in North America. Most studies were school-based and involved the addition of healthy eating or physical education classes, or both, sometimes in tandem with other changes to the school environment. The specific intervention strategies used were not always reported completely. However, based on available reports, the behavior change techniques used most commonly in the child-only arm were \"shaping knowledge,\" \"comparison of behavior,\" \"feedback and monitoring,\" and \"repetition and substitution.\" In the child + caregiver arm, the strategies used most commonly included additional \"shaping knowledge\" or \"feedback and monitoring\" techniques, as well as \"social support\" and \"natural consequences.\"\nWe considered all trials to be at high risk of bias for at least one design factor. Seven trials did not contribute any data to analyses. The quality of reporting of intervention content varied between studies, and there was limited scope for meta-analysis. Both validated and non-validated instruments were used to measure outcomes of interest. Outcomes measured and reported differed between studies, with 16 studies contributing data to the meta-analyses. About three-quarters of studies reported their funding sources; no studies reported industry funding. We assessed the quality of evidence to be low or very low.\nDietary behavior change interventions with a caregiver component versus interventions without a caregiver component\nSeven studies compared dietary behavior change interventions with and without a caregiver component. At the end of the intervention, we did not detect a difference between intervention arms in children's percentage of total energy intake from saturated fat (mean difference [MD] −0.42%, 95% confidence interval [CI] −1.25 to 0.41, 1 study, n = 207; low-quality evidence) or from sodium intake (MD −0.12 g/d, 95% CI −0.36 to 0.12, 1 study, n = 207; low-quality evidence). No trial in this comparison reported data for children's combined fruit and vegetable intake, sugar-sweetened beverage (SSB) intake, or physical activity levels, nor for adverse effects of interventions.\nPhysical activity interventions with a caregiver component versus interventions without a caregiver component\nSix studies compared physical activity interventions with and without a caregiver component. At the end of the intervention, we did not detect a difference between intervention arms in children's total physical activity (MD 0.20 min/h, 95% CI −1.19 to 1.59, 1 study, n = 54; low-quality evidence) or moderate to vigorous physical activity (MVPA) (standard mean difference [SMD] 0.04, 95% CI −0.41 to 0.49, 2 studies, n = 80; moderate-quality evidence). No trial in this comparison reported data for percentage of children's total energy intake from saturated fat, sodium intake, fruit and vegetable intake, or SSB intake, nor for adverse effects of interventions.\nCombined dietary and physical activity interventions with a caregiver component versus interventions without a caregiver component\nTen studies compared dietary and physical activity interventions with and without a caregiver component. At the end of the intervention, we detected a small positive impact of a caregiver component on children's SSB intake (SMD −0.28, 95% CI −0.44 to −0.12, 3 studies, n = 651; moderate-quality evidence). We did not detect a difference between intervention arms in children's percentage of total energy intake from saturated fat (MD 0.06%, 95% CI −0.67 to 0.80, 2 studies, n = 216; very low-quality evidence), sodium intake (MD 35.94 mg/d, 95% CI −322.60 to 394.47, 2 studies, n = 315; very low-quality evidence), fruit and vegetable intake (MD 0.38 servings/d, 95% CI −0.51 to 1.27, 1 study, n = 134; very low-quality evidence), total physical activity (MD 1.81 min/d, 95% CI −15.18 to 18.80, 2 studies, n = 573; low-quality evidence), or MVPA (MD −0.05 min/d, 95% CI −18.57 to 18.47, 1 study, n = 622; very low-quality evidence). One trial indicated that no adverse events were reported by study participants but did not provide data.\nAuthors' conclusions\nCurrent evidence is insufficient to support the inclusion of caregiver involvement in interventions to improve children's dietary intake or physical activity behavior, or both. For most outcomes, the quality of the evidence is adversely impacted by the small number of studies with available data, limited effective sample sizes, risk of bias, and imprecision. To establish the value of caregiver involvement, additional studies measuring clinically important outcomes using valid and reliable measures, employing appropriate design and power, and following established reporting guidelines are needed, as is evidence on how such interventions might contribute to health equity.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does it make a difference if parents or other adult caregivers are involved in interventions to encourage children to eat healthier or be more physically active?"
}
] |
query-laysum
|
21789
|
[
{
"role": "user",
"content": "Abstract: Background\nAlveolar osteitis (dry socket) is a complication of dental extractions more often involving mandibular molar teeth. It is associated with severe pain developing 2 to 3 days postoperatively with or without halitosis, a socket that may be partially or totally devoid of a blood clot, and increased postoperative visits. This is an update of the Cochrane Review first published in 2012.\nObjectives\nTo assess the effects of local interventions used for the prevention and treatment of alveolar osteitis (dry socket) following tooth extraction.\nSearch methods\nAn Information Specialist searched four bibliographic databases up to 28 September 2021 and used additional search methods to identify published, unpublished, and ongoing studies.\nSelection criteria\nWe included randomised controlled trials of adults over 18 years of age who were having permanent teeth extracted or who had developed dry socket postextraction. We included studies with any type of local intervention used for the prevention or treatment of dry socket, compared to a different local intervention, placebo or no treatment. We excluded studies reporting on systemic use of antibiotics or the use of surgical techniques because these interventions are evaluated in separate Cochrane Reviews.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We followed Cochrane statistical guidelines and reported dichotomous outcomes as risk ratios (RR) and calculated 95% confidence intervals (CI) using random-effects models. For some of the split-mouth studies with sparse data, it was not possible to calculate RR so we calculated the exact odds ratio (OR) instead. We used GRADE to assess the certainty of the body of evidence.\nMain results\nWe included 49 trials with 6771 participants; 39 trials (with 6219 participants) investigated prevention of dry socket and 10 studies (with 552 participants) looked at the treatment of dry socket. 16 studies were at high risk of bias, 30 studies at unclear risk of bias, and 3 studies at low risk of bias.\nChlorhexidine in the prevention of dry socket\nWhen compared to placebo, rinsing with chlorhexidine mouthrinses (0.12% and 0.2% concentrations) both before and 24 hours after extraction(s) substantially reduced the risk of developing dry socket with an OR of 0.38 (95% CI 0.25 to 0.58; P < 0.00001; 6 trials, 1547 participants; moderate-certainty evidence). The prevalence of dry socket varies from 1% to 5% in routine dental extractions to upwards of 30% in surgically extracted third molars. The number of patients needed to be treated (NNT) with chlorhexidine rinse to prevent one patient having dry socket was 162 (95% CI 155 to 240), 33 (95% CI 27 to 49), and 7 (95% CI 5 to 10) for control prevalence of dry socket 0.01, 0.05, and 0.30 respectively.\nCompared to placebo, placing chlorhexidine gel intrasocket after extractions reduced the odds of developing a dry socket by 58% with an OR of 0.44 (95% CI 0.27 to 0.71; P = 0.0008; 7 trials, 753 participants; moderate-certainty evidence). The NNT with chlorhexidine gel (0.2%) to prevent one patient developing dry socket was 180 (95% CI 137 to 347), 37 (95% CI 28 to 72), and 7 (95% CI 5 to 15) for control prevalence of dry socket of 0.01, 0.05, and 0.30 respectively.\nCompared to chlorhexidine rinse (0.12%), placing chlorhexidine gel (0.2%) intrasocket after extractions was not superior in reducing the risk of dry socket (RR 0.74, 95% CI 0.46 to 1.20; P = 0.22; 2 trials, 383 participants; low-certainty evidence).\nThe present review found some evidence for the association of minor adverse reactions with use of 0.12%, 0.2% chlorhexidine mouthrinses (alteration in taste, staining of teeth, stomatitis) though most studies were not designed explicitly to detect the presence of hypersensitivity reactions to mouthwash as part of the study protocol. No adverse events were reported in relation to the use of 0.2% chlorhexidine gel placed directly into a socket.\nPlatelet rich plasma in the prevention of dry socket\nCompared to placebo, placing platelet rich plasma after extractions was not superior in reducing the risk of having a dry socket (RR 0.51, 95% CI 0.19 to 1.33; P = 0.17; 2 studies, 127 participants; very low-certainty evidence).\nA further 21 intrasocket interventions to prevent dry socket were each evaluated in single studies, and there is insufficient evidence to determine their effects.\nZinc oxide eugenol versus Alvogyl in the treatment of dry socket\nTwo studies, with 80 participants, showed that Alvogyl (old formulation) is more effective than zinc oxide eugenol at reducing pain at day 7 (mean difference (MD) -1.40, 95% CI -1.75 to -1.04; P < 0.00001; 2 studies, 80 participants; very low-certainty evidence)\nA further nine interventions for the treatment of dry socket were evaluated in single studies, providing insufficient evidence to determine their effects.\nAuthors' conclusions\nTooth extractions are generally undertaken by dentists for a variety of reasons, however, all but five studies included in the present review included participants undergoing extraction of third molars, most of which were undertaken by oral surgeons. There is moderate-certainty evidence that rinsing with chlorhexidine (0.12% and 0.2%) or placing chlorhexidine gel (0.2%) in the sockets of extracted teeth, probably results in a reduction in dry socket. There was insufficient evidence to determine the effects of the other 21 preventative interventions each evaluated in single studies. There was limited evidence of very low certainty that Alvogyl (old formulation) may reduce pain at day 7 in patients with dry socket when compared to zinc oxide eugenol.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared antiseptic rinses or intrasocket gels with a placebo (dummy) rinse or nothing and a placebo (dummy) intrasocket gel or nothing.\nTo find the best way to treat dry socket we searched for studies that compared different soothing agents with a placebo (dummy) with other soothing agents or with nothing.\nWe compared the results of the studies and summarised the findings. We made an assessment of our confidence in the evidence based on the design of the study and the number of patients recruited."
}
] |
query-laysum
|
21790
|
[
{
"role": "user",
"content": "Abstract: Background\nSupplemental oxygen is frequently administered to patients with acute respiratory distress syndrome (ARDS), including ARDS secondary to viral illness such as coronavirus disease 19 (COVID-19). An up-to-date understanding of how best to target this therapy (e.g. arterial partial pressure of oxygen (PaO2) or peripheral oxygen saturation (SpO2) aim) in these patients is urgently required.\nObjectives\nTo address how oxygen therapy should be targeted in adults with ARDS (particularly ARDS secondary to COVID-19 or other respiratory viruses) and requiring mechanical ventilation in an intensive care unit, and the impact oxygen therapy has on mortality, days ventilated, days of catecholamine use, requirement for renal replacement therapy, and quality of life.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, CENTRAL, MEDLINE, and Embase from inception to 15 May 2020 for ongoing or completed randomized controlled trials (RCTs).\nSelection criteria\nTwo review authors independently assessed all records in accordance with standard Cochrane methodology for study selection.\nWe included RCTs comparing supplemental oxygen administration (i.e. different target PaO2 or SpO2 ranges) in adults with ARDS and receiving mechanical ventilation in an intensive care setting. We excluded studies exploring oxygen administration in patients with different underlying diagnoses or those receiving non-invasive ventilation, high-flow nasal oxygen, or oxygen via facemask.\nData collection and analysis\nOne review author performed data extraction, which a second review author checked. We assessed risk of bias in included studies using the Cochrane 'Risk of bias' tool. We used the GRADE approach to judge the certainty of the evidence for the following outcomes; mortality at longest follow-up, days ventilated, days of catecholamine use, and requirement for renal replacement therapy.\nMain results\nWe identified one completed RCT evaluating oxygen targets in patients with ARDS receiving mechanical ventilation in an intensive care setting. The study randomized 205 mechanically ventilated patients with ARDS to either conservative (PaO2 55 to 70 mmHg, or SpO2 88% to 92%) or liberal (PaO2 90 to 105 mmHg, or SpO2≥ 96%) oxygen therapy for seven days.\nOverall risk of bias was high (due to lack of blinding, small numbers of participants, and the trial stopping prematurely), and we assessed the certainty of the evidence as very low. The available data suggested that mortality at 90 days may be higher in those participants receiving a lower oxygen target (odds ratio (OR) 1.83, 95% confidence interval (CI) 1.03 to 3.27). There was no evidence of a difference between the lower and higher target groups in mean number of days ventilated (14.0, 95% CI 10.0 to 18.0 versus 14.5, 95% CI 11.8 to 17.1); number of days of catecholamine use (8.0, 95% CI 5.5 to 10.5 versus 7.2, 95% CI 5.9 to 8.4); or participants receiving renal replacement therapy (13.7%, 95% CI 5.8% to 21.6% versus 12.0%, 95% CI 5.0% to 19.1%). Quality of life was not reported.\nAuthors' conclusions\nWe are very uncertain as to whether a higher or lower oxygen target is more beneficial in patients with ARDS and receiving mechanical ventilation in an intensive care setting. We identified only one RCT with a total of 205 participants exploring this question, and rated the risk of bias as high and the certainty of the findings as very low. Further well-conducted studies are urgently needed to increase the certainty of the findings reported here. This review should be updated when more evidence is available.\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 searched major medical databases up to 15 May 2020 for clinical trials studying oxygen use in adult patients with ARDS in intensive care units. We only searched for studies with the sickest patients, that is those who needed help with their breathing through a breathing tube that was connected to an artificial breathing machine. We did not restrict the search by language of publication.\nIn addition to extracting and analysing the data from any studies that met these criteria, we also assessed the risk of bias (fairness) and the certainty (confidence) of the findings."
}
] |
query-laysum
|
21791
|
[
{
"role": "user",
"content": "Abstract: Background\nMost ischaemic strokes are caused by blockage of a cerebral artery by a thrombus. Intravenous administration of recombinant tissue plasminogen activator given within 4.5 hours is now standard treatment for this condition. Percutaneous vascular interventions use an intra-arterial, mechanical approach for thrombus disruption or removal (thrombectomy). Recent randomised trials indicate that percutaneous vascular interventions are superior to usual care (usual care usually included intravenous thrombolysis). However, intravenous thrombolysis was usually given in both arms of the trial and there was a lack of direct comparison of percutaneous vascular interventions with intravenous thrombolysis.\nObjectives\nTo assess the effectiveness and safety of percutaneous vascular interventions compared with intravenous thrombolytic treatment for acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last search: August 2018). In addition, in September 2017, we searched the following electronic databases: CENTRAL, MEDLINE, Embase, and Science Citation Index; and Stroke Trials Registry, and US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) that directly compared a percutaneous vascular intervention with intravenous thrombolytic treatment in people with acute ischaemic stroke.\nData collection and analysis\nTwo review authors applied the inclusion criteria, extracted data, and assessed risk of bias. We obtained both published and unpublished data. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included four trials with 450 participants. Data on functional outcome and death at end of follow-up were available for 443 participants from three trials. Compared with intravenous thrombolytic therapy, percutaneous vascular intervention did not improve the proportion of participants with good functional outcome (modified Rankin Scale score 0 to 2, risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.25, P = 0.92). The quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). At the end of follow-up, there was a non-significant increase in the proportion of participants who died in the percutaneous vascular intervention group (RR 1.34, 95% CI 0.84 to 2.14, P = 0.21). The quality of evidence was low (wide confidence interval). There was no difference in the proportion of participants with symptomatic intracranial haemorrhages between the intervention and control groups (RR 0.99, 95% CI 0.50 to 1.95, P = 0.97). The quality of evidence was low (wide confidence interval). Data on vascular status (recanalisation rate) were only available for seven participants from one trial; we considered this inadequate for statistical analyses.\nAuthors' conclusions\nThe present review directly compared intravenous thrombolytic treatment with percutaneous vascular interventions for ischaemic stroke. We found no evidence from RCTs that percutaneous vascular interventions are superior to intravenous thrombolytic treatment with respect to functional outcome. Quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). New trials with adequate sample sizes are warranted because of the rapid development of new techniques and devices for such interventions.\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": "Most strokes are caused by a blockage of an artery in the brain by a blood clot. Prompt treatment with clot-dissolving drugs (thrombolysis) can restore blood flow and prevent brain damage. The development of treatments delivered through a tube into the artery (percutaneous vascular interventions) has led to new possibilities in the treatment of stroke. This approach gives direct access to the blood clot, which can be mechanically removed or dissolved. Despite widespread use of these treatments it is unclear whether they are more effective and safe than clot-dissolving drugs given by injection (intravenous thrombolysis)."
}
] |
query-laysum
|
21792
|
[
{
"role": "user",
"content": "Abstract: Background\nAs a consequence of their condition, people with sickle cell disease are at high risk of developing an acute infection of the pulmonary parenchyma called community-acquired pneumonia. Many different bacteria can cause this infection and antibiotic treatment is generally needed to resolve it. There is no standardized approach to antibiotic therapy and treatment is likely to vary from country to country. Thus, there is a need to identify the efficacy and safety of different antibiotic treatment approaches for people with sickle cell disease suffering from community-acquired pneumonia. This is an update of a previously published Cochrane Review.\nObjectives\nTo determine the efficacy and safety of the antibiotic treatment approaches (monotherapy or combined) for people with sickle cell disease suffering from community-acquired pneumonia.\nSearch methods\nWe searched The Group's Haemoglobinopathies Trials Register (01 September 2016), which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also searched LILACS (1982 to 01 September 2016), African Index Medicus (1982 to 20 October 2016) and WHO ICT Registry (20 October 2016).\nSelection criteria\nWe searched for published or unpublished randomized controlled trials.\nData collection and analysis\nWe intended to summarise data by standard Cochrane methodologies, but no eligible randomized controlled trials were identified.\nMain results\nWe were unable to find any randomized controlled trials on antibiotic treatment approaches for community-acquired pneumonia in people with sickle cell disease.\nAuthors' conclusions\nThe updated review was unable to identify randomized controlled trials on efficacy and safety of the antibiotic treatment approaches for people with sickle cell disease suffering from community-acquired pneumonia. Randomized controlled trials are needed to establish the optimum antibiotic treatment for this condition. The trials regarding this issue should be structured and reported according to the CONSORT statement for improving the quality of reporting of efficacy and improved reports of harms in clinical research. Triallists should consider including the following outcomes in new trials: number of days to become afebrile; mortality; onset of pain crisis or complications of sickle cell disease following community-acquired pneumonia; diagnosis; hospitalization (admission rate and length of hospital stay); respiratory failure rate; and number of participants receiving a blood transfusion.\nThere are no trials included in the review and we have not identified any relevant trials up to September 2016. We therefore do not plan to update this review until new trials are published.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sickle cell disease affects millions of people throughout the world. These people can catch pneumonia more easily due to sickle damage to the spleen. The germs causing pneumonia caught in the community vary across the world. They have different sensitivities and resistance levels which are affected by how antibiotics are prescribed in that area."
}
] |
query-laysum
|
21793
|
[
{
"role": "user",
"content": "Abstract: Background\nTophi develop in untreated or uncontrolled gout. This is an update of a Cochrane Review first published in 2014.\nObjectives\nTo assess the benefits and harms of non-surgical and surgical treatments for the management of tophi in gout.\nSearch methods\nWe updated the search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase databases to 28 August 2020.\nSelection criteria\nWe included all published randomised controlled trials (RCTs) or controlled clinical trials examining interventions for tophi in gout in adults.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included one trial in our original review. We added four more trials (1796 participants) in this update. One had three arms; pegloticase infusion every two weeks (biweekly), monthly pegloticase infusion (pegloticase infusion alternating with placebo infusion every two weeks) and placebo. Two studies looked at lesinurad 200 mg or 400 mg in combination with allopurinol. One trial studied lesinurad 200 mg or 400 mg in combination with febuxostat. One trial compared febuxostat 80 mg and 120 mg to allopurinol.\nTwo trials were at unclear risk of performance and detection bias due to lack of information on blinding of participants and personnel. All other trials were at low risk of bias.\nModerate-certainty evidence (downgraded for imprecision; one study; 79 participants) showed that biweekly pegloticase resolved tophi in 21/52 participants compared with 2/27 on placebo (risk ratio (RR) 5.45, 95% confidence interval (CI) 1.38 to 21.54; number needed to treat for a benefit (NNTB) 3, 95% CI 2 to 6). Similar proportions of participants receiving biweekly pegloticase (80/85) had an adverse event compared to placebo (41/43) (RR 0.99, 95% CI 0.91 to 1.07). However, more participants on biweekly pegloticase (15/85) withdrew due to an adverse event compared to placebo (1/43) (RR 7.59, 95% CI 1.04 to 55.55; number needed to treat for a harm (NNTH) 7, 95% CI 4 to 16).\nMore participants on monthly pegloticase (11/52) showed complete resolution of tophi compared with placebo (2/27) (RR 2.86, 95% CI 0.68 to 11.97; NNTB 8, 95% CI 4 to 91). Similar numbers of participants on monthly pegloticase (84/84) had an adverse event compared to placebo (41/43) (RR 1.05, 95% CI 0.98 to 1.14). More participants on monthly pegloticase (16/84) withdrew due to adverse events compared to placebo (1/43) (RR 8.19, 95% CI 1.12 to 59.71; NNTH 6, 95% CI 4 to 14). Infusion reaction was the most common reason for withdrawal.\nModerate-certainty evidence (2 studies; 103 participants; downgraded for imprecision) showed no clinically significant difference for complete resolution of target tophus in the lesinurad 200 mg plus allopurinol arm (11/53) compared to the placebo plus allopurinol arm (16/50) (RR 0.40, 95% CI 0.04 to 4.57), or in the lesinurad 400 mg plus allopurinol arm (12/48) compared to the placebo plus allopurinol arm (16/50) (RR 0.79, 95% CI 0.42 to 1.49).\nAn extension study examined lesinurad 200 mg or 400 mg in combination with febuxostat, or placebo (low-certainty evidence, downgraded for indirectness and imprecision). Participants on lesinurad in the original study continued (CONT) on the same dose. Lesinurad 400 mg plus febuxostat may be beneficial for tophi resolution; 43/65 in the lesinurad 400 mg CONT arm compared to 38/64 in the lesinurad 200 mg CONT arm had tophi resolution (RR 1.11, 95% CI 0.85 to 1.46). Lesinurad 400 mg plus febuxostat may result in no difference in adverse events; 57/65 in the lesinurad 400 mg CONT arm had an adverse event compared to 50/64 in lesinurad 200 mg CONT arm (RR 1.12, 95% CI 0.96 to 1.32). Lesinurad 400 mg plus febuxostat may result in no difference in withdrawals due to adverse events; 10/65 participants in the lesinurad 400 mg CONT arm withdrew due to an adverse event compared to 10/64 participants in the lesinurad 200 mg CONT arm (RR 0.98, 95% CI 0.44 to 2.20). Lesinurad 400 mg plus febuxostat may result in no difference in mean serum uric acid (sUA), which was 3 mg/dl in the lesinurad 400 mg CONT group compared to 3.9 mg/dl in the lesinurad 200 mg CONT group (mean difference -0.90, 95% CI -1.51 to -0.29).\nParticipants who were not on lesinurad in the original study were randomised (CROSS) to lesinurad 200 mg or 400 mg, both in combination with febuxostat. Low-certainty evidence downgraded for indirectness and imprecision showed that lesinurad 400 mg (CROSS) may result in tophi resolution (17/34) compared to lesinurad 200 mg (CROSS) (14/33) (RR 1.18, 95% CI 0.70 to 1.98). Lesinurad 400 mg in combination with febuxostat may result in no difference in adverse events (33/34 in the lesinurad 400 mg CROSS arm compared to 27/33 in the lesinurad 200 mg (CROSS); RR 1.19, 95% CI 1.00 to 1.41). Lesinurad 400 mg plus febuxostat may result in no difference in withdrawals due to adverse events, 5/34 in the lesinurad 400 mg CROSS arm withdrew compared to 2/33 in the lesinurad 200 mg CROSS arm (RR 2.43, 95% CI 0.51 to 11.64). Lesinurad 400 mg plus febuxostat results in no difference in sUA (4.2 mg/dl in lesinurad 400 mg CROSS) compared to lesinurad 200 mg (3.8 mg/dl in lesinurad 200 mg CROSS), mean difference 0.40 mg/dl, 95% CI -0.75 to 1.55.\nAuthors' conclusions\nModerate-certainty evidence showed that pegloticase is probably beneficial for resolution of tophi in gout. Although there was little difference in adverse events when compared to placebo, participants on pegloticase had more withdrawals due to adverse events. Lesinurad 400 mg plus febuxostat may be beneficial for tophi resolution compared with lesinurad 200 mg plus febuxostat; there was no difference in adverse events between these groups. We were unable to determine whether lesinurad plus febuxostat is more effective than placebo. Lesinurad (400 mg or 200 mg) plus allopurinol is probably not beneficial for tophi resolution, and there was no difference in adverse events between these groups. RCTs on interventions for managing tophi in gout are needed, and the lack of trial data is surprising given that allopurinol is a well-established treatment for gout.\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": "Moderate-certainty evidence indicated that pegloticase biweekly or monthly probably resolves one or more tophi. Moderate-certainty evidence showed that lesinurad (400 mg or 200 mg) in combination with allopurinol is probably not beneficial for resolution of tophi in gout. Low-certainty evidence indicated that lesinurad 400 mg compared to lesinurad 200 mg (both in combination with febuxostat) may resolve tophi and may result in no difference in adverse events or withdrawals due to adverse events. However, this study did not have a placebo arm."
}
] |
query-laysum
|
21794
|
[
{
"role": "user",
"content": "Abstract: Background\nHypoxic-ischaemic encephalopathy (HIE) is a serious birth complication affecting term and late preterm newborns. Although therapeutic hypothermia (cooling) has been shown to be an effective therapy for neonatal HIE, many cooled infants have poor long-term neurodevelopmental outcomes. In animal models of neonatal encephalopathy, inhaled xenon combined with cooling has been shown to offer better neuroprotection than cooling alone.\nObjectives\nTo determine the effects of xenon as an adjuvant to therapeutic hypothermia on mortality and neurodevelopmental morbidity, and to ascertain clinically important side effects of xenon plus therapeutic hypothermia in newborn infants with HIE. To assess early predictors of adverse outcomes and potential side effects of xenon.\nSearch methods\nWe used the standard strategy of the Cochrane Neonatal Review Group to search the Cochrane Library (2017, Issue 8), MEDLINE (from 1966), Embase (from 1966), and PubMed (from 1966) for randomised controlled and quasi-randomised trials. We also searched conference proceedings and the reference lists of cited articles. We conducted our most recent search in August 2017.\nSelection criteria\nWe included all trials allocating term or late preterm encephalopathic newborns to cooling plus xenon or cooling alone, irrespective of timing (starting age and duration) and concentrations used for xenon administration.\nData collection and analysis\nTwo review authors independently assessed results of searches against predetermined criteria for inclusion, assessed risk of bias, and extracted data. We performed meta-analyses using risk ratios (RRs), risk differences (RDs), and number needed to treat for an additional beneficial outcome (NNTB) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MDs) for continuous data.\nMain results\nA single randomised controlled trial enrolling 92 participants was eligible for this review. Researchers have not reported long-term neurodevelopmental outcomes, including the primary outcome of this review - death or long-term major neurodevelopmental disability in infancy (18 months to three years of age). Cooling plus xenon was not associated with reduced mortality at latest follow-up, based upon low quality evidence. Investigators noted no substantial differences between groups for other secondary outcomes of this review, such as biomarkers of brain damage assessed with magnetic resonance imaging and occurrence of seizures during primary hospitalisation. Available data do not show an increased adverse event rate in the cooling plus xenon group compared with the cooling alone group.\nAuthors' conclusions\nCurrent evidence from one small randomised controlled pilot trial is inadequate to show whether cooling plus xenon is safe or effective in near-term and term newborns with HIE. Further trials reporting long-term neurodevelopmental outcomes are needed.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This trial enrolled 92 participants. Cooling plus xenon did not improve clinical outcomes before discharge from the hospital compared with cooling alone. Data on long-term development were not provided."
}
] |
query-laysum
|
21795
|
[
{
"role": "user",
"content": "Abstract: Background\nBacterial keratitis is a serious ocular infectious disease that can lead to severe visual disability. Risk factors for bacterial corneal infection include contact lens wear, ocular surface disease, corneal trauma, and previous ocular or eyelid surgery. Topical antibiotics constitute the mainstay of treatment in cases of bacterial keratitis, whereas the use of topical corticosteroids as an adjunctive therapy to antibiotics remains controversial. Topical corticosteroids are usually used to control inflammation using the smallest amount of the drug. Their use requires optimal timing, concomitant antibiotics, and careful follow-up.\nObjectives\nThe objective of the review was to assess the effectiveness and safety of corticosteroids as adjunctive therapy for bacterial keratitis. Secondary objectives included evaluation of health economic outcomes and quality of life outcomes.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2014), EMBASE (January 1980 to July 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to July 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 14 July 2014. We also searched the Science Citation Index to identify additional studies that had cited the only trial included in the original version of this review, reference lists of included trials, earlier reviews, and the American Academy of Ophthalmology guidelines. We also contacted experts to identify any unpublished and ongoing randomized trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that had evaluated adjunctive therapy with topical corticosteroids in people with bacterial keratitis who were being treated with antibiotics.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe found four RCTs that met the inclusion criteria of this review. The total number of included participants was 611 (612 eyes), ranging from 30 to 500 participants per trial. One trial was included in the previous version of the review, and we identified three additional trials through the updated searches in July 2014. One of the three smaller trials was a pilot study of the largest study: the Steroids for Corneal Ulcers Trial (SCUT). All trials compared the treatment of bacterial keratitis with topical corticosteroid and without topical corticosteroid and had follow-up periods ranging from two months to one year. These trials were conducted in the USA, Canada, India, and South Africa.\nAll trials reported data on visual acuity ranging from three weeks to one year, and none of them found any important difference between the corticosteroid group and the control group. The pilot study of the SCUT reported that time to re-epithelialization in the steroid group was 53% slower than the placebo group after adjusting for baseline epithelial defect size (hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.23 to 0.94). However, the SCUT did not find any important difference in time to re-epithelialization (HR 0.92; 95% CI 0.76 to 1.11). For adverse events, none of the three small trials found any important difference between the two treatment groups. The investigators of the largest trial reported that more patients in the control group developed intraocular pressure (IOP) elevation (risk ratio (RR) 0.20; 95% CI 0.04 to 0.90). One trial reported quality of life and concluded that there was no difference between the two groups (data not available). We did not find any reports regarding economic outcomes.\nAlthough the four trials were generally of good methodological design, all trials had considerable losses to follow-up (10% or more) in the final analyses. Further, three of the four trials were underpowered to detect treatment effect differences between groups and inconsistency in outcome measurements precluded meta-analyses for most outcomes relevant to this review.\nAuthors' conclusions\nThere is inadequate evidence as to the effectiveness and safety of adjunctive topical corticosteroids compared with no topical corticosteroids in improving visual acuity, infiltrate/scar size, or adverse events among participants with bacterial keratitis. Current evidence does not support a strong effect of corticosteroid, but may be due to insufficient power to detect a treatment effect.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "None of the four studies reported an important difference between topical corticosteroid therapy and placebo or control treatment for reduction in ulcer size, change in visual acuity, adverse events, or quality of life. One study reported that healing or cure time in the steroid group was slower than the placebo group (for every 100 people cured in the control group, only 47 were cured in the steroid group during the same time period), but the largest study did not report any difference (for every 100 people cured in the control group, 92 were cured in the steroid group during the same time interval). For adverse events, none of the studies found a difference between the two groups, except that one study reported that more eyes in the control group developed intraocular pressure (IOP) elevation. We did not find any information on economic outcomes."
}
] |
query-laysum
|
21796
|
[
{
"role": "user",
"content": "Abstract: Background\nDiabetic retinopathy is a complication of diabetes in which high blood sugar levels damage the blood vessels in the retina. Sometimes new blood vessels grow in the retina, and these can have harmful effects; this is known as proliferative diabetic retinopathy. Laser photocoagulation is an intervention that is commonly used to treat diabetic retinopathy, in which light energy is applied to the retina with the aim of stopping the growth and development of new blood vessels, and thereby preserving vision.\nObjectives\nTo assess the effects of laser photocoagulation for diabetic retinopathy compared to no treatment or deferred treatment.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2014), EMBASE (January 1980 to June 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 June 2014.\nSelection criteria\nWe included randomised controlled trials (RCTs) where people (or eyes) with diabetic retinopathy were randomly allocated to laser photocoagulation or no treatment or deferred treatment. We excluded trials of lasers that are no longer in routine use. Our primary outcome was the proportion of people who lost 15 or more letters (3 lines) of best-corrected visual acuity (BCVA) as measured on a logMAR chart at 12 months. We also looked at longer-term follow-up of the primary outcome at two to five years. Secondary outcomes included mean best corrected distance visual acuity, severe visual loss, mean near visual acuity, progression of diabetic retinopathy, quality of life, pain, loss of driving licence, vitreous haemorrhage and retinal detachment.\nData collection and analysis\nWe used standard methods as expected by the Cochrane Collaboration. Two review authors selected studies and extracted data.\nMain results\nWe identified a large number of trials of laser photocoagulation of diabetic retinopathy (n = 83) but only five of these studies were eligible for inclusion in the review, i.e. they compared laser photocoagulation with currently available lasers to no (or deferred) treatment. Three studies were conducted in the USA, one study in the UK and one study in Japan. A total of 4786 people (9503 eyes) were included in these studies. The majority of participants in four of these trials were people with proliferative diabetic retinopathy; one trial recruited mainly people with non-proliferative retinopathy. Four of the studies evaluated panretinal photocoagulation with argon laser and one study investigated selective photocoagulation of non-perfusion areas. Three studies compared laser treatment to no treatment and two studies compared laser treatment to deferred laser treatment. All studies were at risk of performance bias because the treatment and control were different and no study attempted to produce a sham treatment. Three studies were considered to be at risk of attrition bias.\nAt 12 months there was little difference between eyes that received laser photocoagulation and those allocated to no treatment (or deferred treatment), in terms of loss of 15 or more letters of visual acuity (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.89 to 1.11; 8926 eyes; 2 RCTs, low quality evidence). Longer term follow-up did not show a consistent pattern, but one study found a 20% reduction in risk of loss of 15 or more letters of visual acuity at five years with laser treatment. Treatment with laser reduced the risk of severe visual loss by over 50% at 12 months (RR 0.46, 95% CI 0.24 to 0.86; 9276 eyes; 4 RCTs, moderate quality evidence). There was a beneficial effect on progression of diabetic retinopathy with treated eyes experiencing a 50% reduction in risk of progression of diabetic retinopathy (RR 0.49, 95% CI 0.37 to 0.64; 8331 eyes; 4 RCTs, low quality evidence) and a similar reduction in risk of vitreous haemorrhage (RR 0.56, 95% CI 0.37 to 0.85; 224 eyes; 2 RCTs, low quality evidence).\nNone of the studies reported near visual acuity or patient-relevant outcomes such as quality of life, pain, loss of driving licence or adverse effects such as retinal detachment.\nWe did not plan any subgroup analyses, but there was a difference in baseline risk in participants with non-proliferative retinopathy compared to those with proliferative retinopathy. With the small number of included studies we could not do a formal subgroup analysis comparing effect in proliferative and non-proliferative retinopathy.\nAuthors' conclusions\nThis review provides evidence that laser photocoagulation is beneficial in treating proliferative diabetic retinopathy. We judged the evidence to be moderate or low, depending on the outcome. This is partly related to reporting of trials conducted many years ago, after which panretinal photocoagulation has become the mainstay of treatment of proliferative diabetic retinopathy.\nFuture Cochrane Reviews on variations in the laser treatment protocol are planned. Future research on laser photocoagulation should investigate the combination of laser photocoagulation with newer treatments such as anti-vascular endothelial growth factors (anti-VEGFs).\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": "Diabetic retinopathy (DR) is a common problem for people with diabetes and can lead to loss of vision. The back of the eye (retina) can develop problems because of diabetes, including the growth of harmful new blood vessels (proliferative DR, referred to here as 'PDR'). Laser photocoagulation is a commonly used treatment for DR in which the eye doctor uses a laser on the back of the eye to stop some of the harmful changes."
}
] |
query-laysum
|
21797
|
[
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a highly prevalent neurological condition characterised by repeated unprovoked seizures with various aetiologies. Although antiepileptic medications produce clinical improvement in many individuals, nearly a third of individuals have drug-resistant epilepsy that carries significant morbidity and mortality, and even individuals who have clinical improvement from antiepileptic medications often report iatrogenic symptoms. There remains a need for non-invasive and more effective therapies for this population. Transcranial magnetic stimulation (TMS) uses electromagnetic coils to excite or inhibit neurons, with repetitive pulses at low-frequency producing an inhibitory effect that could conceivably reduce cortical excitability associated with epilepsy.\nThis is an updated version of the original Cochrane Review published in 2016.\nObjectives\nTo assess the evidence for the use of TMS in individuals with drug-resistant epilepsy compared with other available treatments in reducing seizure frequency, improving quality of life, reducing epileptiform discharges, antiepileptic medication use, and side effects.\nSearch methods\nFor the latest update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid 1946 to 2 June 2020). CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Epilepsy.\nSelection criteria\nWe included randomised controlled trials that were double-blinded, single-blinded, or unblinded, and placebo controlled, no treatment, or active controlled, which used repetitive transcranial magnetic stimulation (rTMS) without restriction of frequency, coil, duration or intensity on participants with drug-resistant epilepsy.\nData collection and analysis\nWe extracted information from each trial including methodological data; participant demographics including baseline seizure frequency, type of epileptic drugs taken; intervention details and intervention groups for comparison; potential biases; and outcomes and time points, primarily change in seizure frequency or responder rates, as well as quality of life and epileptiform discharges, adverse effects, and changes in medication use.\nMain results\nThe original search revealed 274 records from the databases that after selection provided seven full-text relevant studies for inclusion. The latest search identified 179 new records from the databases that after evaluation against the inclusion and exclusion criteria provided one additional full-text relevant study. The eight included studies (241 participants) were all randomised trials; seven of the studies were blinded. Methodological and design information in the included studies was unclear, particularly relating to randomisation and allocation concealment methods. We were not able to combine the results of the trials in analysis due to differences in the studies' designs.\nFor the current update, two of the eight studies analysed showed a statistically significant reduction in seizure rate from baseline (72% and 78.9% reduction of seizures per week from the baseline rate, respectively), whilst the other six studies showed no statistically significant difference in seizure frequency following rTMS treatment compared with controls (low-certainty evidence). One study assessed quality of life and found that more participants showed improvement in quality of life scores with active treatments compared to the sham treatment, but this only involved seven participants (very low-certainty evidence).\nFour studies evaluated our secondary endpoint of mean number of epileptic discharges, three of which showed a statistically significant reduction in discharges after active rTMS treatment. Adverse effects were uncommon in the studies and typically involved headache, dizziness, and tinnitus; however increased seizure frequency did occur in a small number of individuals. The included trials reported no significant changes in medication use. Overall the risk of bias was either low or unclear, and the certainty of the evidence was low to very low.\nAuthors' conclusions\nOverall, we judged the certainty of evidence for the primary outcomes of this review to be low to very low. We found some evidence to suggest that rTMS is safe but some adverse events were experienced. The variability in technique and outcome reporting prevented meta-analysis, and the evidence for efficacy of rTMS for seizure reduction is still lacking, despite reasonable evidence that it is effective at reducing epileptiform discharges.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, we judged the certainty of the evidence for the main outcome of reduction in seizure frequency to be low due to unclear information in the published papers about study design and the unclear presentation of results. One included study commented on quality of life, but involved only seven participants.\nThe evidence is current to June 2020."
}
] |
query-laysum
|
21798
|
[
{
"role": "user",
"content": "Abstract: Background\nBipolar disorder is a chronic mental disorder with repetitive mania/hypomania as well as depressive episodes, which eventually results in marked impairment in overall functioning and health-related quality of life. A worldwide prevalence rate of 2.4% has been reported. The risk of suicide is higher in people with bipolar disorder than those with other mental disorders. Therefore, effective management of bipolar disorder in the maintenance period is warranted to minimize the risk of relapse or recurrence. Although lithium has been the standard treatment of bipolar disorder for many years, it is associated with adverse effects and teratogenicity. Lamotrigine is approved to be expected for prevention of recurrence for the maintenance treatment of bipolar disorder. In addition, lamotrigine is as effective as lithium. Therefore, we performed a systematic review to confirm the efficacy and safety of lamotrigine in the maintenance treatment of bipolar disorder.\nObjectives\nTo assess the efficacy and tolerability of lamotrigine in the maintenance treatment of bipolar disorder.\nSearch methods\nWe searched Ovid MEDLINE, Embase, PsycINFO, the Cochrane Common Mental Disorders Group's Specialized Register (CCMDCTR) and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to 21 May 2021. We also searched international trial registries and contacted experts in the field.\nSelection criteria\nWe included randomized controlled trials enrolling adults with bipolar disorder who were treated with lamotrigine, placebo or lithium.\nData collection and analysis\nTwo reviews authors independently checked the eligibility of studies and extracted data using a standardized form. Data extracted included study characteristics, participant characteristics, intervention details, settings, and outcome measures in the term of efficacy and tolerability. Study information were then entered into RevMan web.\nMain results\nWe included 11 studies with a total of 2314 participants in this review; 1146 were randomized to lamotrigine, 869 were randomized to placebo and, 299 to lithium.\nWe rated all studies as having an unclear risk of bias in at least one domain of Cochrane's tool for assessing risk of bias, with the most commonly observed weakness being selection bias (random sequence generation and allocation concealment). We judged five studies to be at a high risk of detection bias (blinding of outcome assessment). These potential biases pose as major threat to the validity of the included studies in this review.\nOutcomes of efficacy showed a possible advantage of lamotrigine over placebo. The estimated risk ratio (RR) for recurrence of manic symptom at one year as measured by the Young Mania Rating Scale (YMRS) was 0.67, (95% confidence interval (CI) 0.51 to 0.87; 3 studies, 663 participants; low-certainty evidence) in favor of lamotrigine. The RR of clinical worsening with the need for additional psychotropic treatment (RR 0.82, 95% CI 0.70 to 0.98; 4 studies, 756 participants) based on moderate-certainty evidence. The possible benefits of lamotrigine were also seen for the outcome of treatment withdrawal due to any reason at 6-12 months after treatment (RR 0.88, 95% CI 0.78 to 0.99; 4 studies, 700 participants; moderate-certainty evidence). Regarding tolerability, our analyses showed that the incidence rates of adverse effects were similar between the lamotrigine group and the placebo group (short-term effect: RR 1.07, 95% CI 0.81 to 1.42; 5 studies, 1138 participants; very low-certainty evidence; long-term effect: RR 0.97, 95% CI 0.77 to 1.23; 4 studies, 756 participants; moderate-certainty evidence).\nIn the comparison between lamotrigine and lithium, efficacy was similar between groups except for recurrence of mania episode at one year. Recurrence of manic symptoms was higher in the lamotrigine group than that of the lithium group (RR 2.13, 95% CI 1.32 to 3.44; 3 studies, 602 participants; moderate-certainty evidence). Analysis of adverse effects at 6-12 months showed that a lower proportion of participants experienced at least one adverse effect when treated with lamotrigine compared to lithium (RR 0.70, 95% CI 0.51 to 0.96; 4 studies, 691 participants; moderate-certainty evidence).\nAuthors' conclusions\nLow- to moderate-certainty evidence collectively suggests that lamotrigine may be superior to placebo as a treatment modality for bipolar disorder. In comparison to lithium, people with bipolar disorder seem to tolerate lamotrigine better in the long run; however, the demonstrated efficacy in the maintenance of bipolar disorder was similar between the two groups.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to May 2021. We included 11 studies in this review with a total 2314 participants. 1146 participants were assigned to lamotrigine, and 1168 participants were assigned to control intervention (869 received placebo and 299 received lithium).\nOur review identified the following.\nLamotrigine versus placebo\nBenefits: lamotrigine was found to be superior over placebo in the following outcomes.\n1) Reduced the rate of recurrence of manic symptoms\n2) Suppressed depressive symptoms\n3) Less need for additional therapeutic agents for the recurrence of all symptoms\n4) Reduction in the withdrawal rate due to any causes six months or more after the initiating of intervention\nHarms: adverse-event profile of lamotrigine was similar to that of placebo.\nLamotrigine versus lithium\nBenefits: lamotrigine was as effective as lithium, except for the recurrence of manic symptoms, for which the rate was higher in people who received lamotrigine than people treated with lithium.\nHarms: the rate of adverse events associated with lamotrigine was lower than that of lithium."
}
] |
query-laysum
|
21799
|
[
{
"role": "user",
"content": "Abstract: Background\nDepression is a highly prevalent mood disorder that is characterised by persistent low mood, diminished interest, and loss of pleasure. Music therapy may be helpful in modulating moods and emotions. An update of the 2008 Cochrane review was needed to improve knowledge on effects of music therapy for depression.\nObjectives\n1. To assess effects of music therapy for depression in people of any age compared with treatment as usual (TAU) and psychological, pharmacological, and/or other therapies.\n2. To compare effects of different forms of music therapy for people of any age with a diagnosis of depression.\nSearch methods\nWe searched the following databases: the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR; from inception to 6 May 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; to 17 June 2016); Thomson Reuters/Web of Science (to 21 June 2016); Ebsco/PsycInfo, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, and PubMed (to 5 July 2016); the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, the National Guideline Clearing House, and OpenGrey (to 6 September 2016); and the Digital Access to Research Theses (DART)-Europe E-theses Portal, Open Access Theses and Dissertations, and ProQuest Dissertations and Theses Database (to 7 September 2016). We checked reference lists of retrieved articles and relevant systematic reviews and contacted trialists and subject experts for additional information when needed. We updated this search in August 2017 and placed potentially relevant studies in the \"Awaiting classification\" section; we will incorporate these into the next version of this review as appropriate.\nSelection criteria\nAll randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing music therapy versus treatment as usual (TAU), psychological therapies, pharmacological therapies, other therapies, or different forms of music therapy for reducing depression.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated standardised mean difference (SMD) for continuous data and odds ratio (OR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic.\nMain results\nWe included in this review nine studies involving a total of 421 participants, 411 of whom were included in the meta-analysis examining short-term effects of music therapy for depression. Concerning primary outcomes, we found moderate-quality evidence of large effects favouring music therapy and TAU over TAU alone for both clinician-rated depressive symptoms (SMD -0.98, 95% CI -1.69 to -0.27, 3 RCTs, 1 CCT, n = 219) and patient-reported depressive symptoms (SMD -0.85, 95% CI -1.37 to -0.34, 3 RCTs, 1 CCT, n = 142). Music therapy was not associated with more or fewer adverse events than TAU. Regarding secondary outcomes, music therapy plus TAU was superior to TAU alone for anxiety and functioning. Music therapy and TAU was not more effective than TAU alone for improved quality of life (SMD 0.32, 95% CI -0.17 to 0.80, P = 0.20, n = 67, low-quality evidence). We found no significant discrepancies in the numbers of participants who left the study early (OR 0.49, 95% CI 0.14 to 1.70, P = 0.26, 5 RCTs, 1 CCT, n = 293, moderate-quality evidence). Findings of the present meta-analysis indicate that music therapy added to TAU provides short-term beneficial effects for people with depression if compared to TAU alone. Additionally, we are uncertain about the effects of music therapy versus psychological therapies on clinician-rated depression (SMD -0.78, 95% CI -2.36 to 0.81, 1 RCT, n = 11, very low-quality evidence), patient-reported depressive symptoms (SMD -1.28, 95% CI -3.75 to 1.02, 4 RCTs, n = 131, low-quality evidence), quality of life (SMD -1.31, 95% CI - 0.36 to 2.99, 1 RCT, n = 11, very low-quality evidence), and leaving the study early (OR 0.17, 95% CI 0.02 to 1.49, 4 RCTs, n = 157, moderate-quality evidence). We found no eligible evidence addressing adverse events, functioning, and anxiety. We do not know whether one form of music therapy is better than another for clinician-rated depressive symptoms (SMD -0.52, 95% CI -1.87 to 0.83, 1 RCT, n = 9, very low-quality evidence), patient-reported depressive symptoms (SMD -0.01, 95% CI -1.33 to 1.30, 1 RCT, n = 9, very low-quality evidence), quality of life (SMD -0.24, 95% CI -1.57 to 1.08, 1 RCT, n = 9, very low-quality evidence), or leaving the study early (OR 0.27, 95% CI 0.01 to 8.46, 1 RCT, n = 10). We found no eligible evidence addressing adverse events, functioning, or anxiety.\nAuthors' conclusions\nFindings of the present meta-analysis indicate that music therapy provides short-term beneficial effects for people with depression. Music therapy added to treatment as usual (TAU) seems to improve depressive symptoms compared with TAU alone. Additionally, music therapy plus TAU is not associated with more or fewer adverse events than TAU alone. Music therapy also shows efficacy in decreasing anxiety levels and improving functioning of depressed individuals.\nFuture trials based on adequate design and larger samples of children and adolescents are needed to consolidate our findings. Researchers should consider investigating mechanisms of music therapy for depression. It is important to clearly describe music therapy, TAU, the comparator condition, and the profession of the person who delivers the intervention, for reproducibility and comparison purposes.\n\nGiven the provided abstract, please respond to the following query: \"What does evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that music therapy plus treatment as usual is more effective than treatment as usual alone. Music therapy seems to reduce depressive symptoms and anxiety and helps to improve functioning (e.g. maintaining involvement in job, activities, and relationships). We are not sure whether music therapy is better than psychological therapy. We do not know whether one form of music therapy is better than another. The small numbers of identified studies and participants make it hard to be confident about these comparisons."
}
] |
query-laysum
|
21800
|
[
{
"role": "user",
"content": "Abstract: Background\nAbout one in five strokes occur during sleep (wake-up stroke). People with wake-up strokes have previously been considered to be ineligible for thrombolytic treatment because the time of stroke onset is unknown. However, recent studies suggest benefit from recanalisation therapies in selected patients.\nObjectives\nTo assess the effects of intravenous thrombolysis and endovascular thrombectomy versus control in people with acute ischaemic stroke presenting on awakening from sleep.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last search 24 of May 2021). In addition, we searched the following electronic databases in May 2021: Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 4 of 12, April 2021) in the Cochrane Library, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. We searched the Stroke Trials Registry (last search 7 December 2017, as the site is currently inactive). We also screened references lists of relevant trials, contacted trialists, and undertook forward tracking of relevant references.\nSelection criteria\nRandomised controlled trials (RCTs) of intravenous thrombolytic drugs or endovascular thrombectomy treatments in people with acute ischaemic stroke presenting upon awakening.\nData collection and analysis\nTwo review authors applied the inclusion criteria, extracted data, and assessed risk of bias and the certainty of the evidence using the GRADE approach. We obtained both published and unpublished data for participants with wake-up strokes. We excluded participants with strokes of unknown onset if the symptoms did not begin upon awakening.\nMain results\nWe included seven trials with a total of 980 participants, of which five trials with 775 participants investigated intravenous thrombolytic treatment and two trials with 205 participants investigated endovascular thrombectomy in large vessel occlusion in the anterior intracranial circulation. All trials used advanced imaging for selecting patients to treat.\nFor intravenous thrombolytic treatment, good functional outcome (defined as modified Rankin Scale score 0 to 2) at 90 days follow-up was observed in 66% of participants randomised to thrombolytic treatment and 58% of participants randomised to control (risk ratio (RR) 1.13, 95% confidence interval (CI) 1.01 to 1.26; P = 0.03; 763 participants, 5 RCTs; high-certainty evidence). Seven per cent of participants randomised to intravenous thrombolytic treatment and 10% of participants randomised to control had died at 90 days follow-up (RR 0.68, 95% CI 0.43 to 1.07; P = 0.09; 763 participants, 5 RCTs; high-certainty evidence). Symptomatic intracranial haemorrhage occurred in 3% of participants randomised to intravenous thrombolytic treatment and 1% of participants randomised to control (RR 3.47, 95% CI 0.98 to 12.26; P = 0.05; 754 participants, 4 RCTs; high-certainty evidence).\nFor endovascular thrombectomy of large vessel occlusion, good functional outcome at 90 days follow-up was observed in 46% of participants randomised to endovascular thrombectomy and 9% of participants randomised to control (RR 5.12, 95% CI 2.57 to 10.17; P < 0.001; 205 participants, 2 RCTs; high-certainty evidence). Twenty-two per cent of participants randomised to endovascular thrombectomy and 33% of participants randomised to control had died at 90 days follow-up (RR 0.68, 95% CI 0.43 to 1.07; P = 0.10; 205 participants, 2 RCTs; high-certainty evidence).\nAuthors' conclusions\nIn selected patients with acute ischaemic wake-up stroke, both intravenous thrombolytic treatment and endovascular thrombectomy of large vessel occlusion improved functional outcome without increasing the risk of death. However, a possible increased risk of symptomatic intracranial haemorrhage associated with thrombolytic treatment cannot be ruled out. The criteria used for selecting patients to treatment differed between the trials. All studies were relatively small, and six of the seven studies were terminated early. More studies are warranted in order to determine the optimal criteria for selecting patients for treatment.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for randomised controlled trials (a type of study in which people are randomly allocated to one of two or more treatment groups) until 24 May 2021."
}
] |
query-laysum
|
21801
|
[
{
"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: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was low quality evidence that LLLT for six days may improve global assessment of treatment success more than placebo, when measured at six days. Further research is likely to change the estimate.\nWe are very uncertain about whether PEMF for two weeks improves pain or function any more than placebo because of the very low quality evidence from one trial.\nThere was moderate quality evidence that LLLT plus exercise for eight weeks may improve pain, up to four weeks, and function, up to four months, more than placebo plus exercise. Further research may change the estimate.\nWe are very uncertain about whether therapeutic ultrasound, PEMF, Iodex phonophoresis, continuous short wave diathermy, a combination of Iodex iontophoresis with continuous short wave diathermy, or a combination of therapeutic ultrasound with transcutaneous electrical nerve stimulation (TENS) are effective adjuncts to exercise."
}
] |
query-laysum
|
21802
|
[
{
"role": "user",
"content": "Abstract: Background\nAn association has been hypothesized between periodontitis and hypertension. Periodontal therapy is believed to reduce systemic inflammatory mediators and increase endothelial function, thus having the potential to prevent and treat hypertension.\nObjectives\nTo assess the effect and safety of different periodontal treatment modalities on blood pressure (BP) in people with chronic periodontitis.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched for randomized controlled trials (RCTs) up to November 2020 in the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE, Embase, seven other databases, and two clinical trials registries. We contacted the authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nRCTs and quasi-RCTs aiming to detect the effect of periodontal treatment on BP were eligible. Participants should have been diagnosed with chronic periodontitis and hypertension (or no hypertension if the study explored the preventive effect of periodontal treatment). Participants in the intervention group should have undergone subgingival scaling and root planing (SRP) and any other type of periodontal treatments, compared with either no periodontal treatment or alternative periodontal treatment in the control group.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane for study identification, data extraction, and risk of bias assessment. We used a formal pilot-tested data extraction form for data extraction, and the Cochrane risk of bias tool for risk of bias assessment. We planned the meta-analysis, test for heterogeneity, sensitivity analysis, and subgroup analysis. We assessed the certainty of evidence using GRADE. The primary outcome was change in systolic BP (SBP) and diastolic BP (DBP).\nMain results\nWe included eight RCTs. Five had low risk of bias, one had unclear risk of bias, and two had high risk of bias.\nFour trials compared periodontal treatment with no treatment. We found no evidence of a difference in the short-term change of SBP and DBP for people diagnosed with periodontitis and other cardiovascular diseases except hypertension (very low-certainty evidence). We found no evidence of a difference in long-term changes in SBP (mean difference [MD] −2.25 mmHg, 95% confidence interval [CI] −9.41 to 4.92; P = 0.54; studies = 2, participants = 108; low-certainty evidence) and DBP (MD −2.55 mmHg, 95% CI −6.90 to 1.80; P = 0.25; studies = 2, participants = 103; low-certainty evidence). Concerning people diagnosed with periodontitis, in the short term, two studies of low certainty reported no changes in SBP (MD −0.14 mmHg, 95% CI −4.05 to 3.77; P = 0.94; participants = 294) and DBP (MD −0.15 mmHg, 95% CI −2.47 to 2.17; P = 0.90; participants = 294), and we found no evidence of a difference in SBP and DBP over a long period based on low certainty of evidence.\nThree studies compared intensive periodontal treatment with supra-gingival scaling. We found no evidence of a difference in changes in SBP and DBP for any length of time in people diagnosed with periodontitis (very low-certainty evidence).\nIn people diagnosed with periodontitis and hypertension, we found one study reporting a significant reduction in the short term in SBP (MD −11.20 mmHg, 95% CI −15.40 to −7.00; P < 0.001; participants = 101; moderate-certainty evidence) and DBP (MD −8.40 mmHg, 95% CI −12.19 to −4.61; P < 0.0001; participants = 101; moderate-certainty evidence).\nAuthors' conclusions\nWe found no evidence of a difference of an impact of periodontal treatments on BP in most comparisons assessed in this review, and given the low certainty of evidence and the lack of relevant studies we could not draw conclusions about the effect of periodontal treatment on BP in people with chronic periodontitis. We found only one study suggesting that periodontal treatment may reduce SBP and DBP over a short period in people with hypertension and chronic periodontitis, but the certainty of evidence was moderate.\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": "Periodontitis is a severe form of gingivitis (gum disease) caused by some specific bacteria that are also found in atherosclerotic plaque (a buildup of fat, cholesterol, calcium, and other substances in the blood vessels), with the latter exerting significant effects on hypertension (high blood pressure). Multiple studies have shown an association between periodontitis and hypertension. It is important to evaluate whether periodontal treatment can prevent or treat hypertension."
}
] |
query-laysum
|
21803
|
[
{
"role": "user",
"content": "Abstract: Background\nConcerns exist regarding antibiotic prescribing for respiratory tract infections (RTIs) owing to adverse reactions, cost and antibacterial resistance. One proposed strategy to reduce antibiotic prescribing is to provide prescriptions, but to advise delay in antibiotic use with the expectation that symptoms will resolve first. This is an update of a Cochrane Review originally published in 2007, and updated in 2010, 2013 and 2017.\nObjectives\nTo evaluate the effects on duration and/or severity of clinical outcomes (pain, malaise, fever, cough and rhinorrhoea), antibiotic use, antibiotic resistance and patient satisfaction of advising a delayed prescription of antibiotics in respiratory tract infections.\nSearch methods\nFrom May 2017 until 20 August 2022, this was a living systematic review with monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL and Web of Science. We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov on 20 August 2022. Due to the abundance of evidence supporting the review's key findings, it ceased being a living systematic review on 21 August 2022.\nSelection criteria\nRandomised controlled trials involving participants of all ages with an RTI, where delayed antibiotics were compared to immediate or no antibiotics. We defined a delayed antibiotic as advice to delay the filling of an antibiotic prescription by at least 48 hours. We considered all RTIs regardless of whether antibiotics were recommended or not.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nFor this 2022 update, we added one new trial enrolling 448 children (436 analysed) with uncomplicated acute RTIs. Overall, this review includes 12 studies with a total of 3968 participants, of which data from 3750 are available for analysis. These 12 studies involved acute RTIs including acute otitis media (three studies), streptococcal pharyngitis (three studies), cough (two studies), sore throat (one study), common cold (one study) and a variety of RTIs (two studies). Six studies involved only children, two only adults and four included both adults and children. Six studies were conducted in primary care, four in paediatric clinics and two in emergency departments.\nStudies were well reported and appeared to provide moderate-certainty evidence. Randomisation was not adequately described in two trials. Four trials blinded the outcome assessor, and three included blinding of participants and doctors. We conducted meta-analyses for pain, malaise, fever, adverse effects, antibiotic use and patient satisfaction.\nCough (four studies): we found no differences amongst delayed, immediate and no prescribed antibiotics for clinical outcomes in any of the four studies.\nSore throat (six studies): for the outcome of fever with sore throat, four of the six studies favoured immediate antibiotics, and two found no difference. For the outcome of pain related to sore throat, two studies favoured immediate antibiotics, and four found no difference. Two studies compared delayed antibiotics with no antibiotic for sore throat, and found no difference in clinical outcomes.\nAcute otitis media (four studies): two studies compared immediate with delayed antibiotics - one found no difference for fever, and the other favoured immediate antibiotics for pain and malaise severity on Day 3. Two studies compared delayed with no antibiotics: one found no difference for pain and fever severity on Day 3, and the other found no difference for the number of children with fever on Day 3.\nCommon cold (two studies): neither study found differences for clinical outcomes between delayed and immediate antibiotic groups. One study found delayed antibiotics were probably favoured over no antibiotics for pain, fever and cough duration (moderate-certainty evidence).\nAdverse effects: there were either no differences for adverse effects or results may have favoured delayed over immediate antibiotics with no significant differences in complication rates (low-certainty evidence).\nAntibiotic use: delayed antibiotics probably resulted in a reduction in antibiotic use compared to immediate antibiotics (odds ratio (OR) 0.03, 95% confidence interval (CI) 0.01 to 0.07; 8 studies, 2257 participants; moderate-certainty evidence). However, a delayed antibiotic was probably more likely to result in reported antibiotic use than no antibiotics (OR 2.52, 95% CI 1.69 to 3.75; 5 studies, 1529 participants; moderate-certainty evidence).\nPatient satisfaction: patient satisfaction probably favoured delayed over no antibiotics (OR 1.45, 1.08 to 1.96; 5 studies, 1523 participants; moderate-certainty evidence). There was probably no difference in patient satisfaction between delayed and immediate antibiotics (OR 0.77, 95% CI 0.45 to 1.29; 7 studies, 1927 participants; moderate-certainty evidence).\nNo studies evaluated antibiotic resistance. Reconsultation rates and use of alternative medicines were similar for delayed, immediate and no antibiotic strategies. In one of the four studies reporting use of alternative medicines, less paracetamol was used in the immediate group compared to the delayed group.\nAuthors' conclusions\nFor many clinical outcomes, there were no differences between prescribing strategies. Symptoms for acute otitis media and sore throat were modestly improved by immediate antibiotics compared with delayed antibiotics. There were no differences in complication rates. Delaying prescribing did not result in significantly different levels of patient satisfaction compared with immediate provision of antibiotics (86% versus 91%; moderate-certainty evidence). However, delay was favoured over no antibiotics (87% versus 82%). Delayed antibiotics achieved lower rates of antibiotic use compared to immediate antibiotics (30% versus 93%). The strategy of no antibiotics further reduced antibiotic use compared to delaying prescription for antibiotics (13% versus 27%).\nDelayed antibiotics for people with acute respiratory infection reduced antibiotic use compared to immediate antibiotics, but was not shown to be different to no antibiotics in terms of symptom control and disease complications. Where clinicians feel it is safe not to prescribe antibiotics immediately for people with RTIs, no antibiotics with advice to return if symptoms do not resolve is likely to result in the least antibiotic use while maintaining similar patient satisfaction and clinical outcomes to delayed antibiotics. Where clinicians are not confident in not prescribing antibiotics, delayed antibiotics may be an acceptable compromise in place of immediate prescribing to significantly reduce unnecessary antibiotic use for RTIs, while maintaining patient safety and satisfaction levels.\nFurther research into antibiotic prescribing strategies for RTIs may best be focused on identifying patient groups at high risk of disease complications, enhancing doctors' communication with patients to maintain satisfaction, ways of increasing doctors' confidence to not prescribe antibiotics for RTIs, and policy measures to reduce unnecessary antibiotic prescribing for RTIs.\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": "Two studies were funded by pharmaceutical companies, two studies did not describe the funding sources and the remaining eight studies were funded by state institutions or specialist colleges."
}
] |
query-laysum
|
21804
|
[
{
"role": "user",
"content": "Abstract: Background\nHepatitis B virus (HBV) infection, a liver disease caused by hepatitis B virus, may lead to serious complications such as cirrhosis and hepatocellular carcinoma. People with HBV infection may have co-infections including HIV and other hepatitis viruses (hepatitis C or D), and co-infection may increase the risk of all-cause mortality. Chronic HBV infection increases morbidity and psychological stress and is an economic burden on people with chronic hepatitis B and their families. Radix Sophorae flavescentis, an herbal medicine, is administered most often in combination with other drugs or herbs. It is believed that it decreases discomfort and prevents replication of the virus in people with chronic hepatitis B. However, the benefits and harms of Radix Sophorae flavescentis for patient-centred outcomes are not known, and its wide usage has never been established with rigorous review methodology.\nObjectives\nTo assess the benefits and harms of Radix Sophorae flavescentis versus placebo or no intervention in people with chronic hepatitis B.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, Conference Proceedings Citation Index - Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), Wanfang Data, and SinoMed. We also searched the World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp), ClinicalTrials.gov (www.clinicaltrials.gov/), and the Chinese Clinical Trial Registry for ongoing or unpublished trials. We conducted the last search in December 2018.\nSelection criteria\nWe included randomised clinical trials, irrespective of publication status, language, or blinding, comparing Radix Sophorae flavescentis versus no intervention or placebo in people with chronic hepatitis B. We excluded polyherbal blends containing Radix Sophorae flavescentis. We allowed co-interventions when the co-interventions were administered equally to all intervention groups.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. Review authors in pairs retrieved data from individual published reports and after correspondence with investigators. Our primary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. Our secondary outcomes were hepatitis B-related mortality, hepatitis B-related morbidity, and adverse events considered 'not to be serious'. We presented meta-analysed results as risk ratios (RRs) with 95% confidence intervals (CIs). We assessed risk of bias using domains with pre-defined definitions. We conducted Trial Sequential Analyses to control the risk of random errors. We used GRADE methodology to evaluate our certainty in the evidence (i.e. \"the extent of our confidence that the estimates of the effect are correct or are adequate to support a particular decision or recommendation\").\nMain results\nWe included 35 randomised clinical trials with 3556 participants. One trial compared Radix Sophorae flavescentis with placebo; the remaining 34 trials compared effects of Radix Sophorae flavescentis in addition to a co-intervention versus the same co-intervention. The included trials assessed heterogenous forms and ways of administering Radix Sophorae flavescentis (e.g. oral capsules, oral tablets, intravenous infusion, intramuscular injection, acupoint (a specifically chosen site of acupuncture) injection) with treatment duration of 1 to 24 months. Two of the trials included children up to 14 years old. Participants in two trials had cirrhosis in addition to chronic hepatitis B. All trials were assessed at high risk of bias, and certainty of the evidence for all outcomes was very low.\nOnly one of the 35 trials assessed mortality; no deaths occurred. Ten trials assessed serious adverse events; no serious adverse events occurred. None of the trials reported health-related quality of life, hepatitis B-related mortality, or morbidity. Adverse events considered 'not to be serious' was an outcome in 19 trials; nine of these trials had zero events in both groups. Radix Sophorae flavescentis versus placebo or no intervention showed no difference in effects on adverse events considered 'not to be serious' (RR 1.10, 95% CI 0.76 to 1.59; I² = 49%; 10 trials, 1050 participants). Radix Sophorae flavescentis showed a reduction in the proportion of participants with detectable HBV-DNA (RR 0.61, 95% CI 0.55 to 0.68; I² = 56%; 29 trials, 2914 participants) and in the proportion of participants with detectable HBeAg (hepatitis B e-antigen) (RR 0.71, 95% CI 0.66 to 0.76; I² = 19%; 20 trials, 2129 participants).\nSeven of the 35 randomised clinical trials received academic funding from government or hospital. Four trials received no funding. The remaining 24 trials provided no information on funding.\nAdditionally, 432 trials lacked the methodological information needed to ensure inclusion of these trials in our review.\nAuthors' conclusions\nThe included trials lacked data on health-related quality of life, hepatitis B-related mortality, and hepatitis B-related morbidity. The effects of Radix Sophorae flavescentis on all-cause mortality and on the proportion of participants with serious adverse events and adverse events considered 'not to be serious' remain unclear. We advise caution in interpreting results showing that Radix Sophorae flavescentis reduced the proportion of people with detectable HBV-DNA and detectable HBeAg because the trials reporting on these outcomes are at high risk of bias and both outcomes are non-validated surrogate outcomes. We were unable to obtain information on the design and conduct of a large number of trials; therefore, we were deterred from including them in our review. Undisclosed funding may influence trial results and may lead to poor trial design. Given the wide usage of Radix Sophorae flavescentis, we need large, unbiased, high-quality placebo-controlled randomised trials in which patient-centred outcomes are assessed.\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": "Only one of the 35 trials assessed mortality; no deaths occurred. Ten trials assessed serious adverse events; no serious adverse events occurred. None of the trials assessed health-related quality of life, and no trials followed people who died from hepatitis B or were at risk of dying because of hepatitis B. Adverse events considered 'not to be serious' was an outcome in 19 trials. We cannot say if Radix Sophorae flavescentis versus placebo or no intervention is better or worse regarding the occurrence of adverse events considered 'not to be serious'. Radix Sophorae flavescentis reduced the proportion of people with detectable HBV-DNA and also the proportion of people with detectable HBeAg. However, caution is needed to understand these beneficial findings, as these trials were at high risk of bias, and these outcomes have not yet been proven relevant to patients. The 432 trials identified could not be included in the review because of lack of information required for the conduct of this review. Accordingly, more information from properly designed randomised clinical trials is needed before one can determine the benefits or harms of Radix Sophorae flavescentis for people with chronic hepatitis B."
}
] |
query-laysum
|
21805
|
[
{
"role": "user",
"content": "Abstract: Background\nAsthma is a respiratory disease characterised by variable airflow limitation and the presence of respiratory symptoms including wheeze, chest tightness, cough and/or dyspnoea. Exercise training is beneficial for people with asthma; however, the response to conventional models of pulmonary rehabilitation is less clear.\nObjectives\nTo evaluate, in adults with asthma, the effectiveness of pulmonary rehabilitation compared to usual care on exercise performance, asthma control, and quality of life (co-primary outcomes), incidence of severe asthma exacerbations/hospitalisations, mental health, muscle strength, physical activity levels, inflammatory biomarkers, and adverse events.\nSearch methods\nWe identified studies from the Cochrane Airways Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform, from their inception to May 2021, as well as the reference lists of all primary studies and review articles.\nSelection criteria\nWe included randomised controlled trials in which pulmonary rehabilitation was compared to usual care in adults with asthma. Pulmonary rehabilitation must have included a minimum of four weeks (or eight sessions) aerobic training and education or self-management. Co-interventions were permitted; however, exercise training alone was not.\nData collection and analysis\nFollowing the use of Cochrane's Screen4Me workflow, two review authors independently screened and selected trials for inclusion, extracted study characteristics and outcome data, and assessed risk of bias using the Cochrane risk of bias tool. We contacted study authors to retrieve missing data. We calculated between-group effects via mean differences (MD) or standardised mean differences (SMD) using a random-effects model. We evaluated the certainty of evidence using GRADE methodology.\nMain results\nWe included 10 studies involving 894 participants (range 24 to 412 participants (n = 2 studies involving n > 100, one contributing to meta-analysis), mean age range 27 to 54 years). We identified one ongoing study and three studies awaiting classification. One study was synthesised narratively, and another involved participants specifically with asthma-COPD overlap. Most programmes were outpatient-based, lasting from three to four weeks (inpatient) or eight to 12 weeks (outpatient). Education or self-management components included breathing retraining and relaxation, nutritional advice and psychological counselling. One programme was specifically tailored for people with severe asthma.\nPulmonary rehabilitation compared to usual care may increase maximal oxygen uptake (VO2 max) after programme completion, but the evidence is very uncertain for data derived using mL/kg/min (MD between groups of 3.63 mL/kg/min, 95% confidence interval (CI) 1.48 to 5.77; 3 studies; n = 129) and uncertain for data derived from % predicted VO2 max (MD 14.88%, 95% CI 9.66 to 20.1%; 2 studies; n = 60). The evidence is very uncertain about the effects of pulmonary rehabilitation compared to usual care on incremental shuttle walk test distance (MD between groups 74.0 metres, 95% CI 26.4 to 121.4; 1 study; n = 30). Pulmonary rehabilitation may have little to no effect on VO2 max at longer-term follow up (9 to 12 months), but the evidence is very uncertain (MD −0.69 mL/kg/min, 95% CI −4.79 to 3.42; I2 = 49%; 3 studies; n = 66).\nPulmonary rehabilitation likely improves functional exercise capacity as measured by 6-minute walk distance, with MD between groups after programme completion of 79.8 metres (95% CI 66.5 to 93.1; 5 studies; n = 529; moderate certainty evidence). This magnitude of mean change exceeds the minimally clinically important difference (MCID) threshold for people with chronic respiratory disease. The evidence is very uncertain about the longer-term effects one year after pulmonary rehabilitation for this outcome (MD 52.29 metres, 95% CI 0.7 to 103.88; 2 studies; n = 42).\nPulmonary rehabilitation may result in a small improvement in asthma control compared to usual care as measured by Asthma Control Questionnaire (ACQ), with an MD between groups of −0.46 (95% CI −0.76 to −0.17; 2 studies; n = 93; low certainty evidence); however, data derived from the Asthma Control Test were very uncertain (MD between groups 3.34, 95% CI −2.32 to 9.01; 2 studies; n = 442). The ACQ finding approximates the MCID of 0.5 points. Pulmonary rehabilitation results in little to no difference in asthma control as measured by ACQ at nine to 12 months follow-up (MD 0.09, 95% CI −0.35 to 0.53; 2 studies; n = 48; low certainty evidence).\nPulmonary rehabilitation likely results in a large improvement in quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ) total score (MD −18.51, 95% CI −20.77 to −16.25; 2 studies; n = 440; moderate certainty evidence), with this magnitude of change exceeding the MCID. However, pulmonary rehabilitation may have little to no effect on Asthma Quality of Life Questionnaire (AQLQ) total scores, with the evidence being very uncertain (MD 0.87, 95% CI −0.13 to 1.86; 2 studies; n = 442). Longer-term follow-up data suggested improvements in quality of life may occur as measured by SGRQ (MD −13.4, 95% CI −15.93 to −10.88; 2 studies; n = 430) but not AQLQ (MD 0.58, 95% CI −0.23 to 1.38; 2 studies; n = 435); however, the evidence is very uncertain.\nOne study reported no difference between groups in the proportion of participants who experienced an asthma exacerbation during the intervention period. Data from one study suggest adverse events attributable to the intervention are rare.\nOverall risk of bias was most commonly impacted by performance bias attributed to a lack of participant blinding to knowledge of the intervention. This is inherently challenging to overcome in rehabilitation studies.\nAuthors' conclusions\nModerate certainty evidence shows that pulmonary rehabilitation is probably associated with clinically meaningful improvements in functional exercise capacity and quality of life upon programme completion in adults with asthma. The certainty of evidence relating to maximal exercise capacity was very low to low. Pulmonary rehabilitation appears to confer minimal effect on asthma control, although the certainty of evidence is very low to low. Unclear reporting of study methods and small sample sizes limits our certainty in the overall body of evidence, whilst heterogenous study designs and interventions likely contribute to inconsistent findings across clinical outcomes and studies. There remains considerable scope for future research.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- We found that people with asthma who take part in supervised programmes of exercise and education (known as pulmonary rehabilitation) are likely to get fitter (can walk further) and have better wellbeing immediately after completing these programmes compared to those who receive usual care. However, we are not certain if these benefits persist up to one year later.\n- Due to a lack of evidence, the effects of pulmonary rehabilitation on outcomes such as rates of asthma attacks or hospitalisations, anxiety and depression, or physical activity levels is unclear.\n- Larger, well-designed studies are needed to better estimate the true benefit of pulmonary rehabilitation for adults with asthma."
}
] |
query-laysum
|
21806
|
[
{
"role": "user",
"content": "Abstract: Background\nThis review was published originally in 1999 and was updated in 2001, 2002, 2009, 2017, and 2020. Updating was deemed necessary due to the high incidence of hip fractures, the large number of official societies providing recommendations on this condition, the possibility that perioperative peripheral nerve blocks (PNBs) may improve patient outcomes, and the major role that PNBs may play in reducing preoperative and postoperative opioid use for analgesia.\nObjectives\nTo compare PNBs used as preoperative analgesia, as postoperative analgesia, or as a supplement to general anaesthesia versus no nerve block (or sham block) for adults with hip fracture. Outcomes were pain on movement at 30 minutes after block placement, acute confusional state, myocardial infarction, chest infection, death, time to first mobilization, and costs of an analgesic regimen for single-injection blocks.\nWe undertook the update to look for new studies and to update the methods to reflect Cochrane standards.\nSearch methods\nFor the updated review, we searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; MEDLINE (Ovid SP, 1966 to November 2019); Embase (Ovid SP, 1974 to November 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO, 1982 to November 2019), as well as trial registers and reference lists of relevant articles.\nSelection criteria\nWe included randomized controlled trials (RCTs) assessing use of PNBs compared with no nerve block (or sham block) as part of the care provided for adults 16 years of age and older with hip fracture.\nData collection and analysis\nTwo review authors independently screened new trials for inclusion, assessed trial quality using the Cochrane Risk of Bias-2 tool, and extracted data. When appropriate, we pooled results of outcome measures. We rated the certainty of evidence using the GRADE approach.\nMain results\nWe included 49 trials (3061 participants; 1553 randomized to PNBs and 1508 to no nerve block (or sham block)). For this update, we added 18 new trials. Trials were published from 1981 to 2020. Trialists followed participants for periods ranging from 5 minutes to 12 months. The average age of participants ranged from 59 to 89 years. People with dementia were often excluded from the included trials. Additional analgesia was available for all participants.\nResults of 11 trials with 503 participants show that PNBs reduced pain on movement within 30 minutes of block placement (standardized mean difference (SMD) -1.05, 95% confidence interval (CI) -1.25 to -0.86; equivalent to -2.5 on a scale from 0 to 10; high-certainty evidence). Effect size was proportionate to the concentration of local anaesthetic used (P = 0.0003). Based on 13 trials with 1072 participants, PNBs reduce the risk of acute confusional state (risk ratio (RR) 0.67, 95% CI 0.50 to 0.90; number needed to treat for an additional beneficial outcome (NNTB) 12, 95% CI 7 to 47; high-certainty evidence). For myocardial infarction, there were no events in one trial with 31 participants (RR not estimable; low-certainty evidence). From three trials with 131 participants, PNBs probably reduce the risk for chest infection (RR 0.41, 95% CI 0.19 to 0.89; NNTB 7, 95% CI 5 to 72; moderate-certainty evidence). Based on 11 trials with 617 participants, the effects of PNBs on mortality within six months are uncertain due to very serious imprecision (RR 0.87, 95% CI 0.47 to 1.60; low-certainty evidence). From three trials with 208 participants, PNBs likely reduce time to first mobilization (mean difference (MD) -10.80 hours, 95% CI -12.83 to -8.77 hours; moderate-certainty evidence). One trial with 75 participants indicated there may be a small reduction in the cost of analgesic drugs with a single-injection PNB (MD -4.40 euros, 95% CI -4.84 to -3.96 euros; low-certainty evidence).\nWe identified 29 ongoing trials, of which 15 were first posted or at least were last updated after 1 January 2018.\nAuthors' conclusions\nPNBs reduce pain on movement within 30 minutes after block placement, risk of acute confusional state, and probably also reduce the risk of chest infection and time to first mobilization. There may be a small reduction in the cost of analgesic drugs for single-injection PNB. We did not find a difference for myocardial infarction and mortality, but the numbers of participants included for these two outcomes were insufficient. Although randomized clinical trials may not be the best way to establish risks associated with an intervention, our review confirms low risks of permanent injury associated with PNBs, as found by others.\nSome trials are ongoing, but it is unclear whether any further RCTs should be registered, given the benefits found. Good-quality non-randomized trials with appropriate sample size may help to clarify the potential effects of PNBs on myocardial infarction and mortality.\n\nGiven the provided abstract, please respond to the following query: \"What is a peripheral nerve block?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A peripheral nerve block (PNB) is an injection of local anaesthetic close to nerves to block pain signals to the brain. PNBs can be used alone or together with other pain relief medicines. They may be given as a single injection or continuously, using a catheter (drip)."
}
] |
query-laysum
|
21807
|
[
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of reproductive-aged women suffer from endometriosis, which is a costly, chronic disease that causes pelvic pain and subfertility. Laparoscopy is the gold standard diagnostic test for endometriosis, but it is expensive and carries surgical risks. Currently, there are no non-invasive tests available in clinical practice that accurately diagnose endometriosis. This is the first diagnostic test accuracy review of endometrial biomarkers for endometriosis that utilises Cochrane methodologies, providing an update on the rapidly expanding literature in this field.\nObjectives\nTo determine the diagnostic accuracy of the endometrial biomarkers for pelvic endometriosis, using a surgical diagnosis as the reference standard. We evaluated the tests as replacement tests for diagnostic surgery and as triage tests to inform decisions to undertake surgery for endometriosis.\nSearch methods\nWe did not restrict the searches to particular study designs, language or publication dates. To identify trials, we searched the following databases: CENTRAL (2015, July), MEDLINE (inception to May 2015), EMBASE (inception to May 2015), CINAHL (inception to April 2015), PsycINFO (inception to April 2015), Web of Science (inception to April 2015), LILACS (inception to April 2015), OAIster (inception to April 2015), TRIP (inception to April 2015) and ClinicalTrials.gov (inception to April 2015). We searched DARE and PubMed databases up to April 2015 to identify reviews and guidelines as sources of references to potentially relevant studies. We also performed searches for papers recently published and not yet indexed in the major databases. The search strategies incorporated words in the title, abstract, text words across the record and the medical subject headings (MeSH).\nSelection criteria\nWe considered published peer-reviewed, randomised controlled or cross-sectional studies of any size that included prospectively collected samples from any population of reproductive-aged women suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE).\nData collection and analysis\nTwo authors independently extracted data from each study and performed a quality assessment. For each endometrial diagnostic test, we classified the data as positive or negative for the surgical detection of endometriosis and calculated the estimates of sensitivity and specificity. We considered two or more tests evaluated in the same cohort as separate data sets. We used the bivariate model 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 was one with a sensitivity of 94% and a specificity of 79%. The criteria for triage tests were set at sensitivity at or above 95% and specificity at or above 50%, which in case of negative results rules out the diagnosis (SnOUT test) or sensitivity at or above 50% with specificity at or above 95%, which in case of positive result rules in the diagnosis (SpIN test).\nMain results\nWe included 54 studies involving 2729 participants, most of which were of poor methodological quality. The studies evaluated endometrial biomarkers either in specific phases of the menstrual cycle or outside of it, and the studies tested the biomarkers either in menstrual fluid, in whole endometrial tissue or in separate endometrial components. Twenty-seven studies evaluated the diagnostic performance of 22 endometrial biomarkers for endometriosis. These were angiogenesis and growth factors (PROK-1), cell-adhesion molecules (integrins α3β1, α4β1, β1 and α6), DNA-repair molecules (hTERT), endometrial and mitochondrial proteome, hormonal markers (CYP19, 17βHSD2, ER-α, ER-β), inflammatory markers (IL-1R2), myogenic markers (caldesmon, CALD-1), neural markers (PGP 9.5, VIP, CGRP, SP, NPY, NF) and tumour markers (CA-125). Most of these biomarkers were assessed in single studies, whilst only data for PGP 9.5 and CYP19 were available for meta-analysis. These two biomarkers demonstrated significant diversity for the diagnostic estimates between the studies; however, the data were too limited to reliably determine the sources of heterogeneity. The mean sensitivities and specificities of PGP 9.5 (7 studies, 361 women) were 0.96 (95% confidence interval (CI) 0.91 to 1.00) and 0.86 (95% CI 0.70 to 1.00), after excluding one outlier study, and for CYP19 (8 studies, 444 women), they were were 0.77 (95% CI 0.70 to 0.85) and 0.74 (95% CI 0.65 to 84), respectively. We could not statistically evaluate other biomarkers in a meaningful way. An additional 31 studies evaluated 77 biomarkers that showed no evidence of differences in expression levels between the groups of women with and without endometriosis.\nAuthors' conclusions\nWe could not statistically evaluate most of the biomarkers assessed in this review in a meaningful way. In view of the low quality of most of the included studies, the findings of this review should be interpreted with caution. Although PGP 9.5 met the criteria for a replacement test, it demonstrated considerable inter study heterogeneity in diagnostic estimates, the source of which could not be determined. Several endometrial biomarkers, such as endometrial proteome, 17βHSD2, IL-1R2, caldesmon and other neural markers (VIP, CGRP, SP, NPY and combination of VIP, PGP 9.5 and SP) showed promising evidence of diagnostic accuracy, but there was insufficient or poor quality evidence for any clinical recommendations. Laparoscopy remains the gold standard for the diagnosis of endometriosis, and using any non-invasive tests should only be undertaken in a research setting. We have also identified a number of biomarkers that demonstrated no diagnostic value for endometriosis. We recommend that researchers direct future studies towards biomarkers with high diagnostic potential in good quality diagnostic studies.\n\nGiven the provided abstract, please respond to the following query: \"Future research\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Further high quality research is necessary to accurately evaluate the diagnostic potential of the endometrial biomarkers for the diagnosis of endometriosis."
}
] |
query-laysum
|
21808
|
[
{
"role": "user",
"content": "Abstract: Background\nSmoking is a leading cause of disease and death worldwide. In people who smoke, quitting smoking can reverse much of the damage. Many people use behavioural interventions to help them quit smoking; these interventions can vary substantially in their content and effectiveness.\nObjectives\nTo summarise the evidence from Cochrane Reviews that assessed the effect of behavioural interventions designed to support smoking cessation attempts and to conduct a network meta-analysis to determine how modes of delivery; person delivering the intervention; and the nature, focus, and intensity of behavioural interventions for smoking cessation influence the likelihood of achieving abstinence six months after attempting to stop smoking; and whether the effects of behavioural interventions depend upon other characteristics, including population, setting, and the provision of pharmacotherapy.\nTo summarise the availability and principal findings of economic evaluations of behavioural interventions for smoking cessation, in terms of comparative costs and cost-effectiveness, in the form of a brief economic commentary.\nMethods\nThis work comprises two main elements. 1. We conducted a Cochrane Overview of reviews following standard Cochrane methods. We identified Cochrane Reviews of behavioural interventions (including all non-pharmacological interventions, e.g. counselling, exercise, hypnotherapy, self-help materials) for smoking cessation by searching the Cochrane Library in July 2020. We evaluated the methodological quality of reviews using AMSTAR 2 and synthesised data from the reviews narratively. 2. We used the included reviews to identify randomised controlled trials of behavioural interventions for smoking cessation compared with other behavioural interventions or no intervention for smoking cessation. To be included, studies had to include adult smokers and measure smoking abstinence at six months or longer. Screening, data extraction, and risk of bias assessment followed standard Cochrane methods. We synthesised data using Bayesian component network meta-analysis (CNMA), examining the effects of 38 different components compared to minimal intervention. Components included behavioural and motivational elements, intervention providers, delivery modes, nature, focus, and intensity of the behavioural intervention. We used component network meta-regression (CNMR) to evaluate the influence of population characteristics, provision of pharmacotherapy, and intervention intensity on the component effects. We evaluated certainty of the evidence using GRADE domains. We assumed an additive effect for individual components.\nMain results\nWe included 33 Cochrane Reviews, from which 312 randomised controlled trials, representing 250,563 participants and 845 distinct study arms, met the criteria for inclusion in our component network meta-analysis. This represented 437 different combinations of components. Of the 33 reviews, confidence in review findings was high in four reviews and moderate in nine reviews, as measured by the AMSTAR 2 critical appraisal tool. The remaining 20 reviews were low or critically low due to one or more critical weaknesses, most commonly inadequate investigation or discussion (or both) of the impact of publication bias. Of note, the critical weaknesses identified did not affect the searching, screening, or data extraction elements of the review process, which have direct bearing on our CNMA. Of the included studies, 125/312 were at low risk of bias overall, 50 were at high risk of bias, and the remainder were at unclear risk. Analyses from the contributing reviews and from our CNMA showed behavioural interventions for smoking cessation can increase quit rates, but effectiveness varies on characteristics of the support provided. There was high-certainty evidence of benefit for the provision of counselling (odds ratio (OR) 1.44, 95% credibility interval (CrI) 1.22 to 1.70, 194 studies, n = 72,273) and guaranteed financial incentives (OR 1.46, 95% CrI 1.15 to 1.85, 19 studies, n = 8877). Evidence of benefit remained when removing studies at high risk of bias. These findings were consistent with pair-wise meta-analyses from contributing reviews. There was moderate-certainty evidence of benefit for interventions delivered via text message (downgraded due to unexplained statistical heterogeneity in pair-wise comparison), and for the following components where point estimates suggested benefit but CrIs incorporated no clinically significant difference: individual tailoring; intervention content including motivational components; intervention content focused on how to quit. The remaining intervention components had low-to very low-certainty evidence, with the main issues being imprecision and risk of bias. There was no evidence to suggest an increase in harms in groups receiving behavioural support for smoking cessation. Intervention effects were not changed by adjusting for population characteristics, but data were limited. Increasing intensity of behavioural support, as measured through the number of contacts, duration of each contact, and programme length, had point estimates associated with modestly increased chances of quitting, but CrIs included no difference. The effect of behavioural support for smoking cessation appeared slightly less pronounced when people were already receiving smoking cessation pharmacotherapies.\nAuthors' conclusions\nBehavioural support for smoking cessation can increase quit rates at six months or longer, with no evidence that support increases harms. This is the case whether or not smoking cessation pharmacotherapy is also provided, but the effect is slightly more pronounced in the absence of pharmacotherapy. Evidence of benefit is strongest for the provision of any form of counselling, and guaranteed financial incentives. Evidence suggested possible benefit but the need of further studies to evaluate: individual tailoring; delivery via text message, email, and audio recording; delivery by lay health advisor; and intervention content with motivational components and a focus on how to quit. We identified 23 economic evaluations; evidence did not consistently suggest one type of behavioural intervention for smoking cessation was more cost-effective than another. Future reviews should fully consider publication bias. Tools to investigate publication bias and to evaluate certainty in CNMA are needed.\n\nGiven the provided abstract, please respond to the following query: \"Why we did this Cochrane Review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out:\n– which types of behavioural support work best to help people stop smoking;\n– the best ways to give behavioural support (including the best people to give it); and\n– what aspects of behavioural support help someone to stop smoking.\nWe also wanted to know if behavioural support can cause any unwanted effects."
}
] |
query-laysum
|
21809
|
[
{
"role": "user",
"content": "Abstract: Background\nVitamin D and related compounds have been used to prevent osteoporotic fractures in older people. This is the third update of a Cochrane review first published in 1996.\nObjectives\nTo determine the effects of vitamin D or related compounds, with or without calcium, for preventing fractures in post-menopausal women and older men.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to December 2012), the Cochrane Central Register of Controlled Trials (2012, Issue 12), MEDLINE (1966 to November Week 3 2012), EMBASE (1980 to 2012 Week 50), CINAHL (1982 to December 2012), BIOSIS (1985 to 3 January 2013), Current Controlled Trials (December 2012) and reference lists of articles.\nSelection criteria\nRandomised or quasi-randomised trials that compared vitamin D or related compounds, alone or with calcium, against placebo, no intervention or calcium alone, and that reported fracture outcomes in older people. The primary outcome was hip fracture.\nData collection and analysis\nTwo authors independently assessed trial risk of selection bias and aspects of methodological quality, and extracted data. Data were pooled, where possible, using the fixed-effect model, or the random-effects model when heterogeneity between studies appeared substantial.\nMain results\nWe included 53 trials with a total of 91,791 participants. Thirty-one trials, with sample sizes ranging from 70 to 36,282 participants, examined vitamin D (including 25-hydroxy vitamin D) with or without calcium in the prevention of fractures in community, nursing home or hospital inpatient populations. Twelve of these 31 trials had participants with a mean or median age of 80 years or over.\nAnother group of 22 smaller trials examined calcitriol or alfacalcidol (1-alphahydroxyvitamin D3), mostly with participants who had established osteoporosis. These trials were carried out in the setting of institutional referral clinics or hospitals.\nIn the assessment of risk of bias for random sequence generation, 21 trials (40%) were deemed to be at low risk, 28 trials (53%) at unclear risk and four trials at high risk (8%). For allocation concealment, 22 trials were at low risk (42%), 29 trials were at unclear risk (55%) and two trials were at high risk (4%).\nThere is high quality evidence that vitamin D alone, in the formats and doses tested, is unlikely to be effective in preventing hip fracture (11 trials, 27,693 participants; risk ratio (RR) 1.12, 95% confidence intervals (CI) 0.98 to 1.29) or any new fracture (15 trials, 28,271 participants; RR 1.03, 95% CI 0.96 to 1.11).\nThere is high quality evidence that vitamin D plus calcium results in a small reduction in hip fracture risk (nine trials, 49,853 participants; RR 0.84, 95% confidence interval (CI) 0.74 to 0.96; P value 0.01). In low-risk populations (residents in the community: with an estimated eight hip fractures per 1000 per year), this equates to one fewer hip fracture per 1000 older adults per year (95% CI 0 to 2). In high risk populations (residents in institutions: with an estimated 54 hip fractures per 1000 per year), this equates to nine fewer hip fractures per 1000 older adults per year (95% CI 2 to 14).\nThere is high quality evidence that vitamin D plus calcium is associated with a statistically significant reduction in incidence of new non-vertebral fractures. However, there is only moderate quality evidence of an absence of a statistically significant preventive effect on clinical vertebral fractures. There is high quality evidence that vitamin D plus calcium reduces the risk of any type of fracture (10 trials, 49,976 participants; RR 0.95, 95% CI 0.90 to 0.99).\nIn terms of the results for adverse effects: mortality was not adversely affected by either vitamin D or vitamin D plus calcium supplementation (29 trials, 71,032 participants, RR 0.97, 95% CI 0.93 to 1.01). Hypercalcaemia, which was usually mild (2.6 to 2.8 mmol/L), was more common in people receiving vitamin D or an analogue, with or without calcium (21 trials, 17,124 participants, RR 2.28, 95% CI 1.57 to 3.31), especially for calcitriol (four trials, 988 participants, RR 4.41, 95% CI 2.14 to 9.09), than in people receiving placebo or control. There was also a small increased risk of gastrointestinal symptoms (15 trials, 47,761 participants, RR 1.04, 95% CI 1.00 to 1.08), especially for calcium plus vitamin D (four trials, 40,524 participants, RR 1.05, 95% CI 1.01 to 1.09), and a significant increase in renal disease (11 trials, 46,548 participants, RR 1.16, 95% CI 1.02 to 1.33). Other systematic reviews have found an increased association of myocardial infarction with supplemental calcium; and evidence of increased myocardial infarction and stroke, but decreased cancer, with supplemental calcium plus vitamin D, without an overall effect on mortality.\nAuthors' conclusions\nVitamin D alone is unlikely to prevent fractures in the doses and formulations tested so far in older people. Supplements of vitamin D and calcium may prevent hip or any type of fracture. There was a small but significant increase in gastrointestinal symptoms and renal disease associated with vitamin D and calcium. This review found that there was no increased risk of death from taking calcium and vitamin D.\n\nGiven the provided abstract, please respond to the following query: \"Why do older people suffer bone fractures?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hip fractures and several other types of fractures are very common in post-menopausal women and older men due to age-related weakening of their bones (osteoporosis)."
}
] |
query-laysum
|
21810
|
[
{
"role": "user",
"content": "Abstract: Background\nPanic disorder is characterised by repeated, unexpected panic attacks, which represent a discrete period of fear or anxiety that has a rapid onset, reaches a peak within 10 minutes, and in which at least four of 13 characteristic symptoms are experienced, including racing heart, chest pain, sweating, shaking, dizziness, flushing, stomach churning, faintness and breathlessness. It is common in the general population with a lifetime prevalence of 1% to 4%. The treatment of panic disorder includes psychological and pharmacological interventions. Amongst pharmacological agents, the National Institute for Health and Care Excellence (NICE) and the British Association for Psychopharmacology consider antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs), as the first-line treatment for panic disorder, due to their more favourable adverse effect profile over monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs). Several classes of antidepressants have been studied and compared, but it is still unclear which antidepressants have a more or less favourable profile in terms of effectiveness and acceptability in the treatment of this condition.\nObjectives\nTo assess the effects of antidepressants for panic disorder in adults, specifically:\n1. to determine the efficacy of antidepressants in alleviating symptoms of panic disorder, with or without agoraphobia, in comparison to placebo;\n2. to review the acceptability of antidepressants in panic disorder, with or without agoraphobia, in comparison with placebo; and\n3. to investigate the adverse effects of antidepressants in panic disorder, with or without agoraphobia, including the general prevalence of adverse effects, compared to placebo.\nSearch methods\nWe searched the Cochrane Common Mental Disorders' (CCMD) Specialised Register, and CENTRAL, MEDLINE, EMBASE and PsycINFO up to May 2017. We handsearched reference lists of relevant papers and previous systematic reviews.\nSelection criteria\nAll double-blind, randomised, controlled trials (RCTs) allocating adults with panic disorder to antidepressants or placebo.\nData collection and analysis\nTwo review authors independently checked eligibility and extracted data using a standard form. We entered data into Review Manager 5 using a double-check procedure. Information extracted included study characteristics, participant characteristics, intervention details and settings. Primary outcomes included failure to respond, measured by a range of response scales, and treatment acceptability, measured by total number of dropouts for any reason. Secondary outcomes included failure to remit, panic symptom scales, frequency of panic attacks, agoraphobia, general anxiety, depression, social functioning, quality of life and patient satisfaction, measured by various scales as defined in individual studies. We used GRADE to assess the quality of the evidence for each outcome\nMain results\nForty-one unique RCTs including 9377 participants overall, of whom we included 8252 in the 49 placebo-controlled arms of interest (antidepressant as monotherapy and placebo alone) in this review. The majority of studies were of moderate to low quality due to inconsistency, imprecision and unclear risk of selection and performance bias.\nWe found low-quality evidence that revealed a benefit for antidepressants as a group in comparison with placebo in terms of efficacy measured as failure to respond (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.66 to 0.79; participants = 6500; studies = 30). The magnitude of effect corresponds to a number needed to treat for an additional beneficial outcome (NNTB) of 7 (95% CI 6 to 9): that means seven people would need to be treated with antidepressants in order for one to benefit. We observed the same finding when classes of antidepressants were compared with placebo.\nModerate-quality evidence suggested a benefit for antidepressants compared to placebo when looking at number of dropouts due to any cause (RR 0.88, 95% CI 0.81 to 0.97; participants = 7850; studies = 30). The magnitude of effect corresponds to a NNTB of 27 (95% CI 17 to 105); treating 27 people will result in one person fewer dropping out. Considering antidepressant classes, TCAs showed a benefit over placebo, while for SSRIs and serotonin-norepinephrine reuptake inhibitor (SNRIs) we observed no difference.\nWhen looking at dropouts due to adverse effects, which can be considered as a measure of tolerability, we found moderate-quality evidence showing that antidepressants as a whole are less well tolerated than placebo. In particular, TCAs and SSRIs produced more dropouts due to adverse effects in comparison with placebo, while the confidence interval for SNRI, noradrenergic reuptake inhibitors (NRI) and other antidepressants were wide and included the possibility of no difference.\nAuthors' conclusions\nThe identified studies comprehensively address the objectives of the present review.\nBased on these results, antidepressants may be more effective than placebo in treating panic disorder. Efficacy can be quantified as a NNTB of 7, implying that seven people need to be treated with antidepressants in order for one to benefit. Antidepressants may also have benefit in comparison with placebo in terms of number of dropouts, but a less favourable profile in terms of dropout due to adverse effects. However, the tolerability profile varied between different classes of antidepressants.\nThe choice of whether antidepressants should be prescribed in clinical practice cannot be made on the basis of this review.\nLimitations in results include funding of some studies by pharmaceutical companies, and only assessing short-term outcomes.\nData from the present review will be included in a network meta-analysis of psychopharmacological treatment in panic disorder, which will hopefully provide further useful information on this issue.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with panic disorder and general practitioners."
}
] |
query-laysum
|
21811
|
[
{
"role": "user",
"content": "Abstract: Background\nMany dental procedures produce aerosols (droplets, droplet nuclei and splatter) that harbour various pathogenic micro-organisms and may pose a risk for the spread of infections between dentist and patient. The COVID-19 pandemic has led to greater concern about this risk.\nObjectives\nTo assess the effectiveness of methods used during dental treatment procedures to minimize aerosol production and reduce or neutralize contamination in aerosols.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases on 17 September 2020: Cochrane Oral Health’s Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (in the Cochrane Library, 2020, Issue 8), MEDLINE Ovid (from 1946); Embase Ovid (from 1980); the WHO COVID-19 Global literature on coronavirus disease; the US National Institutes of Health Trials Registry (ClinicalTrials.gov); and the Cochrane COVID-19 Study Register. We placed no restrictions on the language or date of publication.\nSelection criteria\nWe included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on aerosol-generating procedures (AGPs) performed by dental healthcare providers that evaluated methods to reduce contaminated aerosols in dental clinics (excluding preprocedural mouthrinses). The primary outcomes were incidence of infection in dental staff or patients, and reduction in volume and level of contaminated aerosols in the operative environment. The secondary outcomes were cost, accessibility and feasibility.\nData collection and analysis\nTwo review authors screened search results, extracted data from the included studies, assessed the risk of bias in the studies, and judged the certainty of the available evidence. We used mean differences (MDs) and 95% confidence intervals (CIs) as the effect estimate for continuous outcomes, and random-effects meta-analysis to combine data. We assessed heterogeneity.\nMain results\nWe included 16 studies with 425 participants aged 5 to 69 years. Eight studies had high risk of bias; eight had unclear risk of bias. No studies measured infection. All studies measured bacterial contamination using the surrogate outcome of colony-forming units (CFU). Two studies measured contamination per volume of air sampled at different distances from the patient's mouth, and 14 studies sampled particles on agar plates at specific distances from the patient's mouth.\nThe results presented below should be interpreted with caution as the evidence is very low certainty due to heterogeneity, risk of bias, small sample sizes and wide confidence intervals. Moreover, we do not know the 'minimal clinically important difference' in CFU.\nHigh-volume evacuator\nUse of a high-volume evacuator (HVE) may reduce bacterial contamination in aerosols less than one foot (~ 30 cm) from a patient's mouth (MD −47.41, 95% CI −92.76 to −2.06; 3 split-mouth RCTs, 122 participants; very high heterogeneity I² = 95%), but not at longer distances (MD −1.00, −2.56 to 0.56; 1 RCT, 80 participants).\nOne split-mouth RCT (six participants) found that HVE may not be more effective than conventional dental suction (saliva ejector or low-volume evacuator) at 40 cm (MD CFU −2.30, 95% CI −5.32 to 0.72) or 150 cm (MD −2.20, 95% CI −14.01 to 9.61).\nDental isolation combination system\nOne RCT (50 participants) found that there may be no difference in CFU between a combination system (Isolite) and a saliva ejector (low-volume evacuator) during AGPs (MD −0.31, 95% CI −0.82 to 0.20) or after AGPs (MD −0.35, −0.99 to 0.29). However, an 'n of 1' design study showed that the combination system may reduce CFU compared with rubber dam plus HVE (MD −125.20, 95% CI −174.02 to −76.38) or HVE (MD −109.30, 95% CI −153.01 to −65.59).\nRubber dam\nOne split-mouth RCT (10 participants) receiving dental treatment, found that there may be a reduction in CFU with rubber dam at one-metre (MD −16.20, 95% CI −19.36 to −13.04) and two-metre distance (MD −11.70, 95% CI −15.82 to −7.58). One RCT of 47 dental students found use of rubber dam may make no difference in CFU at the forehead (MD 0.98, 95% CI −0.73 to 2.70) and occipital region of the operator (MD 0.77, 95% CI −0.46 to 2.00).\nOne split-mouth RCT (21 participants) found that rubber dam plus HVE may reduce CFU more than cotton roll plus HVE on the patient's chest (MD −251.00, 95% CI −267.95 to −234.05) and dental unit light (MD −12.70, 95% CI −12.85 to −12.55).\nAir cleaning systems\nOne split-mouth CCT (two participants) used a local stand-alone air cleaning system (ACS), which may reduce aerosol contamination during cavity preparation (MD −66.70 CFU, 95% CI −120.15 to −13.25 per cubic metre) or ultrasonic scaling (MD −32.40, 95% CI - 51.55 to −13.25).\nAnother CCT (50 participants) found that laminar flow in the dental clinic combined with a HEPA filter may reduce contamination approximately 76 cm from the floor (MD −483.56 CFU, 95% CI −550.02 to −417.10 per cubic feet per minute per patient) and 20 cm to 30 cm from the patient's mouth (MD −319.14 CFU, 95% CI - 385.60 to −252.68).\nDisinfectants ‒ antimicrobial coolants\nTwo RCTs evaluated use of antimicrobial coolants during ultrasonic scaling. Compared with distilled water, coolant containing chlorhexidine (CHX), cinnamon extract coolant or povidone iodine may reduce CFU: CHX (MD −124.00, 95% CI −135.78 to −112.22; 20 participants), povidone iodine (MD −656.45, 95% CI −672.74 to −640.16; 40 participants), cinnamon (MD −644.55, 95% CI −668.70 to −620.40; 40 participants). CHX coolant may reduce CFU more than povidone iodine (MD −59.30, 95% CI −64.16 to −54.44; 20 participants), but not more than cinnamon extract (MD −11.90, 95% CI −35.88 to 12.08; 40 participants).\nAuthors' conclusions\nWe found no studies that evaluated disease transmission via aerosols in a dental setting; and no evidence about viral contamination in aerosols.\nAll of the included studies measured bacterial contamination using colony-forming units. There appeared to be some benefit from the interventions evaluated but the available evidence is very low certainty so we are unable to draw reliable conclusions.\nWe did not find any studies on methods such as ventilation, ionization, ozonisation, UV light and fogging.\nStudies are needed that measure contamination in aerosols, size distribution of aerosols and infection transmission risk for respiratory diseases such as COVID-19 in dental patients and staff.\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 16 studies that involved a total of 425 people. Studies involved between one and 80 participants, who were aged between 5 and 69 years. Six studies were conducted in the USA, five in India, two in the UK and one each in Egypt, the Netherlands and the United Arab Emirates.\nThe studies evaluated one or more of the following devices:\n- high-volume evacuator (7 studies);\n- hands-free suction device (2 studies);\n- saliva ejector (1 study);\n- rubber dam (3 studies);\n- rubber dam with a high-volume evacuator (1 study); or\n- air cleaning system (1 study).\nNone of the studies evaluated the risk infectious disease transmission. Nor did they evaluate cost, acceptability or ease of implementation.\nAll 16 studies measured changes in the levels of bacterial contamination in aerosols, but we assessed the evidence as being of very low certainty. This means that we have very little confidence in the evidence, and that we expect further research to change the findings of our review. We therefore cannot deduce from this evidence whether there is an effect on levels of bacterial contamination. No studies investigated viral or fungal contamination."
}
] |
query-laysum
|
21812
|
[
{
"role": "user",
"content": "Abstract: Background\nManagement of the open abdomen is a considerable burden for patients and healthcare professionals. Various temporary abdominal closure techniques have been suggested for managing the open abdomen. In recent years, negative pressure wound therapy (NPWT) has been used in some centres for the treatment of non-trauma patients with an open abdomen; however, its effectiveness is uncertain.\nObjectives\nTo assess the effects of negative pressure wound therapy (NPWT) on primary fascial closure for managing the open abdomen in non-trauma patients in any care setting.\nSearch methods\nIn October 2021 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL EBSCO Plus. To identify additional studies, 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. There were no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared NPWT with any other type of temporary abdominal closure (e.g. Bogota bag, Wittmann patch) in non-trauma patients with open abdomen in any care setting. We also included RCTs that compared different types of NPWT systems for managing the open abdomen in non-trauma patients.\nData collection and analysis\nTwo review authors independently performed the study selection process, risk of bias assessment, data extraction, and GRADE assessment of the certainty of evidence.\nMain results\nWe included two studies, involving 74 adults with open abdomen associated with various conditions, predominantly severe peritonitis (N = 55). The mean age of the participants was 52.8 years; the mean proportion of women was 39.2%. Both RCTs were carried out in single centres and were at high risk of bias.\nNegative pressure wound therapy versus Bogota bag\nWe included one study (40 participants) comparing NPWT with Bogota bag. We are uncertain whether NPWT reduces time to primary fascial closure of the abdomen (NPWT: 16.9 days versus Bogota bag: 20.5 days (mean difference (MD) -3.60 days, 95% confidence interval (CI) -8.16 to 0.96); very low-certainty evidence) or adverse events (fistulae formation, NPWT: 10% versus Bogota: 5% (risk ratio (RR) 2.00, 95% CI 0.20 to 20.33); very low-certainty evidence) compared with the Bogota bag. We are also uncertain whether NPWT reduces all-cause mortality (NPWT: 25% versus Bogota bag: 35% (RR 0.71, 95% CI 0.27 to 1.88); very low-certainty evidence) or length of hospital stay compared with the Bogota bag (NPWT mean: 28.5 days versus Bogota bag mean: 27.4 days (MD 1.10 days, 95% CI -13.39 to 15.59); very low-certainty evidence). The study did not report the proportion of participants with successful primary fascial closure of the abdomen, participant health-related quality of life, reoperation rate, wound infection, or pain.\nNegative pressure wound therapy versus any other type of temporary abdominal closure\nThere were no randomised controlled trials comparing NPWT with any other type of temporary abdominal closure.\nComparison of different negative pressure wound therapy devices\nWe included one study (34 participants) comparing different types of NPWT systems (Suprasorb CNP system versus ABThera system). We are uncertain whether the Suprasorb CNP system increases the proportion of participants with successful primary fascial closure of the abdomen compared with the ABThera system (Suprasorb CNP system: 88.2% versus ABThera system: 70.6% (RR 0.80, 95% CI 0.56 to 1.14); very low-certainty evidence). We are also uncertain whether the Suprasorb CNP system reduces adverse events (fistulae formation, Suprasorb CNP system: 0% versus ABThera system: 23.5% (RR 0.11, 95% CI 0.01 to 1.92); very low-certainty evidence), all-cause mortality (Suprasorb CNP system: 5.9% versus ABThera system: 17.6% (RR 0.33, 95% CI 0.04 to 2.89); very low-certainty evidence), or reoperation rate compared with the ABThera system (Suprasorb CNP system: 100% versus ABThera system: 100% (RR 1.00, 95% CI 0.90 to 1.12); very low-certainty evidence). The study did not report the time to primary fascial closure of the abdomen, participant health-related quality of life, length of hospital stay, wound infection, or pain.\nAuthors' conclusions\nBased on the available trial data, we are uncertain whether NPWT has any benefit in primary fascial closure of the abdomen, adverse events (fistulae formation), all-cause mortality, or length of hospital stay compared with the Bogota bag. We are also uncertain whether the Suprasorb CNP system has any benefit in primary fascial closure of the abdomen, adverse events, all-cause mortality, or reoperation rate compared with the ABThera system. Further research evaluating these outcomes as well as participant health-related quality of life, wound infection, and pain outcomes is required. We will update this review when data from the large studies that are currently ongoing are available.\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 do not know if negative pressure wound therapy (NPWT, defined as pressure lower than a given reference pressure, generally causing suction) helps abdominal wounds to heal quicker or reduces potential harmful effects compared with using a Bogota bag (a sterilised fluid bag used for closing abdominal wounds).\n- We do not know if a Suprasorb CNP system (a type of NPWT) helps abdominal wounds to heal quicker or reduces potential harmful effects compared with using an ABThera system (another type of NPWT).\n- We do not know if NPWT increases the risk of bowel perforation. Future research should explore healing time, potential unwanted or harmful effects, all-cause mortality, length of hospital stay, health-related quality of life, reoperation rate, wound infection, and pain outcomes."
}
] |
query-laysum
|
21813
|
[
{
"role": "user",
"content": "Abstract: Background\nFalls are one of the most common complications after stroke, with a reported incidence ranging between 7% in the first week and 73% in the first year post stroke. This is an updated version of the original Cochrane Review published in 2013.\nObjectives\nTo evaluate the effectiveness of interventions aimed at preventing falls in people after stroke. Our primary objective was to determine the effect of interventions on the rate of falls (number of falls per person-year) and the number of fallers. Our secondary objectives were to determine the effects of interventions aimed at preventing falls on 1) the number of fall-related fractures; 2) the number of fall-related hospital admissions; 3) near-fall events; 4) economic evaluation; 5) quality of life; and 6) adverse effects of the interventions.\nSearch methods\nWe searched the trials registers of the Cochrane Stroke Group (September 2018) and the Cochrane Bone, Joint and Muscle Trauma Group (October 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 9) in the Cochrane Library; MEDLINE (1950 to September 2018); Embase (1980 to September 2018); CINAHL (1982 to September 2018); PsycINFO (1806 to August 2018); AMED (1985 to December 2017); and PEDro (September 2018). We also searched trials registers and checked reference lists.\nSelection criteria\nRandomised controlled trials of interventions where the primary or secondary aim was to prevent falls in people after stroke.\nData collection and analysis\nTwo review authors (SD and WS) independently selected studies for inclusion, assessed trial quality and risk of bias, and extracted data. We resolved disagreements through discussion, and contacted study authors for additional information where required. We used a rate ratio and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person-year) between intervention and control groups. For risk of falling we used a risk ratio and 95% CI based on the number of people falling (fallers) in each group. We pooled results where appropriate and applied GRADE to assess the quality of the evidence.\nMain results\nWe included 14 studies (of which six have been published since the first version of this review in 2013), with a total of 1358 participants. We found studies that investigated exercises, predischarge home visits for hospitalised patients, the provision of single lens distance vision glasses instead of multifocal glasses, a servo-assistive rollator and non-invasive brain stimulation for preventing falls.\nExercise compared to control for preventing falls in people after stroke\nThe pooled result of eight studies showed that exercise may reduce the rate of falls but we are uncertain about this result (rate ratio 0.72, 95% CI 0.54 to 0.94, 765 participants, low-quality evidence). Sensitivity analysis for single exercise interventions, omitting studies using multiple/multifactorial interventions, also found that exercise may reduce the rate of falls (rate ratio 0.66, 95% CI 0.50 to 0.87, 626 participants). Sensitivity analysis for the effect in the chronic phase post stroke resulted in little or no difference in rate of falls (rate ratio 0.58, 95% CI 0.31 to 1.12, 205 participants). A sensitivity analysis including only studies with low risk of bias found little or no difference in rate of falls (rate ratio 0.88, 95% CI 0.65 to 1.20, 462 participants). Methodological limitations mean that we have very low confidence in the results of these sensitivity analyses.\nFor the outcome of number of fallers, we are very uncertain of the effect of exercises compared to the control condition, based on the pooled result of 10 studies (risk ratio 1.03, 95% CI 0.90 to 1.19, 969 participants, very low quality evidence). The same sensitivity analyses as described above gives us very low certainty that there are little or no differences in number of fallers (single interventions: risk ratio 1.09, 95% CI 0.93 to 1.28, 796 participants; chronic phase post stroke: risk ratio 0.94, 95% CI 0.73 to 1.22, 375 participants; low risk of bias studies: risk ratio 0.96, 95% CI 0.77 to 1.21, 462 participants).\nOther interventions for preventing falls in people after stroke\nWe are very uncertain whether interventions other than exercise reduce the rate of falls or number of fallers. We identified very low certainty evidence when investigating the effect of predischarge home visits (rate ratio 0.85, 95% CI 0.43 to 1.69; risk ratio 1.48, 95% CI 0.71 to 3.09; 85 participants), provision of single lens distance glasses to regular wearers of multifocal glasses (rate ratio 1.08, 95% CI 0.52 to 2.25; risk ratio 0.74, 95% CI 0.47 to 1.18; 46 participants) and a servo-assistive rollator (rate ratio 0.44, 95% CI 0.16 to 1.21; risk ratio 0.44, 95% CI 0.16 to 1.22; 42 participants).\nFinally, transcranial direct current stimulation (tDCS) was used in one study to examine the effect on falls post stroke. We have low certainty that active tDCS may reduce the number of fallers compared to sham tDCS (risk ratio 0.30, 95% CI 0.14 to 0.63; 60 participants).\nAuthors' conclusions\nAt present there exists very little evidence about interventions other than exercises to reduce falling post stroke. Low to very low quality evidence exists that this population benefits from exercises to prevent falls, but not to reduce number of fallers.\nFall research does not in general or consistently follow methodological gold standards, especially with regard to fall definition and time post stroke. More well-reported, adequately-powered research should further establish the value of exercises in reducing falling, in particular per phase, post stroke.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "After searching the literature, we included 14 studies with a total of 1358 participants. We found studies that investigated various interventions for preventing falls: physical exercises; predischarge home visits for hospitalised patients; the provision of single lens distance vision glasses instead of multifocal glasses; a servo-assistive rollator; and non-invasive brain stimulation. Included studies conducted their investigations in early to chronic inpatient, outpatient, and community dwelling settings."
}
] |
query-laysum
|
21814
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-alcohol related fatty liver disease (commonly called non-alcoholic fatty liver disease (NAFLD)) is liver steatosis in the absence of significant alcohol consumption, use of hepatotoxic medication, or other disorders affecting the liver such as hepatitis C virus infection, Wilson's disease, and starvation. NAFLD embraces the full spectrum of disease from pure steatosis (i.e. uncomplicated fatty liver) to non-alcoholic steatohepatitis (NASH), via NASH-cirrhosis to cirrhosis. The optimal pharmacological treatment for people with NAFLD remains uncertain.\nObjectives\nTo assess the comparative benefits and harms of different pharmacological interventions in the treatment of NAFLD through a network meta-analysis and to generate rankings of the available pharmacological treatments according to their safety and efficacy. However, it was not possible to assess whether the potential effect modifiers were similar across different comparisons. Therefore, we did not perform the network meta-analysis, and instead, assessed the comparative benefits and harms of different interventions using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.com to August 2016.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with NAFLD. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various pharmacological interventions compared with each other or with placebo or no intervention.\nData collection and analysis\nWe calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models based on an available participant analysis with Review Manager. We assessed risk of bias according to the Cochrane risk of bias tool, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nWe identified 77 trials including 6287 participants that met the inclusion criteria of this review. Forty-one trials (3829 participants) provided information for one or more outcomes. Only one trial was at low risk of bias in all domains. All other trials were at high risk of bias in one or more domains. Overall, all the evidence was very low quality. Thirty-five trials included only participants with non-alcohol related steatohepatitis (NASH) (based on biopsy confirmation). Five trials included only participants with diabetes mellitus; 14 trials included only participants without diabetes mellitus. The follow-up in the trials ranged from one month to 24 months.\nWe present here only the comparisons of active intervention versus no intervention in which two or more trials reported at least one of the following outcomes: mortality at maximal follow-up, serious adverse events, and health-related quality of life, the outcomes that determine whether a treatment should be used.\nAntioxidants versus no intervention\nThere was no mortality in either group (87 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the trial which reported the proportion of people with serious adverse events (87 participants; 1 trial; very low quality evidence). There was no evidence of difference in the number of serious adverse events between antioxidants and no intervention (rate ratio 0.89, 95% CI 0.36 to 2.19; 254 participants; 2 trials; very low quality evidence). None of the trials reported health-related quality of life.\nBile acids versus no intervention\nThere was no evidence of difference in mortality at maximal follow-up (OR 5.11, 95% CI 0.24 to 107.34; 659 participants; 4 trials; very low quality evidence), proportion of people with serious adverse events (OR 1.56, 95% CI 0.84 to 2.88; 404 participants; 3 trials; very low quality evidence), or the number of serious adverse events (rate ratio 1.01, 95% CI 0.66 to 1.54; 404 participants; 3 trials; very low quality evidence) between bile acids and no intervention. None of the trials reported health-related quality of life.\nThiazolidinediones versus no intervention\nThere was no mortality in either group (74 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the two trials which reported the proportion of people with serious adverse events (194 participants; 2 trials; very low quality evidence). There was no evidence of difference in the number of serious adverse events between thiazolidinediones and no intervention (rate ratio 0.25, 95% CI 0.06 to 1.05; 357 participants; 3 trials; very low quality evidence). None of the trials reported health-related quality of life.\nSource of funding\nTwenty-six trials were partially- or fully-funded by pharmaceutical companies that would benefit, based on the results of the trial. Twelve trials did not receive any additional funding or were funded by parties with no vested interest in the results. The source of funding was not provided in 39 trials.\nAuthors' conclusions\nDue to the very low quality evidence, we are very uncertain about the effectiveness of pharmacological treatments for people with NAFLD including those with steatohepatitis. Further well-designed randomised clinical trials with sufficiently large sample sizes are necessary.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 77 randomised clinical trials that involved a total of 6287 participants. Of these, 41 trials (3829 participants) provided information for one or more outcomes for this review. Thirty-five trials only included participants with NASH; five included only people with diabetes mellitus; and 14 included only people who did not have diabetes mellitus. The average follow-up period in the trials ranged from one month to two years in the trials that reported this information. We excluded trials in which participants with NAFLD had undergone liver transplantation before the trial. As well as conducting standard Cochrane analysis, we also planned to conduct network meta-analysis (a technique that enables comparison of different treatments that are not directly compared to each other in the trials). However, the nature of available information meant we could not determine if the network meta-analysis results were reliable.\nSpecific outcomes we looked for were numbers of deaths, adverse events, and assessment of health-related quality of life."
}
] |
query-laysum
|
21815
|
[
{
"role": "user",
"content": "Abstract: Background\nWomen may experience differing types of pain and discomfort following birth, including cramping pain (often called after-birth pain) associated with uterine involution, where the uterus contracts to reduce blood loss and return the uterus to its non-pregnant size. This is an update of a review first published in 2011.\nObjectives\nTo assess the effectiveness and safety of pharmacological and non-pharmacological pain relief/analgesia for the relief of after-birth pains following vaginal birth.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (31 October 2019), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials comparing two different types of analgesia or analgesia versus placebo or analgesia versus no treatment, for the relief of after-birth pains following vaginal birth. Types of analgesia included pharmacological and non-pharmacological. Quasi-randomised trials were not eligible for inclusion.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, conducted 'Risk of bias' assessment, extracted data and assessed the certainty of the evidence using the GRADE approach.\nMain results\nIn this update, we include 28 studies (involving 2749 women). The evidence identified in this review comes from middle- to high-income countries. Generally the trials were at low risk of selection bias, performance bias and attrition bias, but some trials were at high risk of bias due to selective reporting and lack of blinding. Our GRADE certainty of evidence assessments ranged from moderate to very low certainty, with downgrading decisions based on study limitations, imprecision, and (for one comparison) indirectness.\nMost studies reported our primary outcome of adequate pain relief as reported by the women. No studies reported data relating to neonatal adverse events, duration of hospital stay, or breastfeeding rates. Almost half of the included studies (11/28) excluded breastfeeding women from participating, making the evidence less generalisable to a broader group of women.\nNon-steroidal anti-inflammatory drugs (NSAIDs) compared to placebo\nNSAIDs are probably better than placebo for adequate pain relief as reported by the women (risk ratio (RR) 1.66, 95% confidence interval (CI) 1.45 to 1.91; 11 studies, 946 women; moderate-certainty evidence). NSAIDs may reduce the need for additional pain relief compared to placebo (RR 0.15, 95% CI 0.07 to 0.33; 4 studies, 375 women; low-certainty evidence). There may be a similar risk of maternal adverse events (RR 1.05, 95% CI 0.78 to 1.41; 9 studies, 598 women; low-certainty evidence).\nNSAIDs compared to opioids\nNSAIDs are probably better than opioids for adequate pain relief as reported by the women (RR 1.33, 95% CI 1.13 to 1.57; 5 studies, 560 women; moderate-certainty evidence) and may reduce the risk of maternal adverse events (RR 0.62, 95% CI 0.43 to 0.89; 3 studies, 255 women; low-certainty evidence). NSAIDs may be better than opioids for the need for additional pain relief, but the wide CIs include the possibility that the two classes of drugs are similarly effective or that opioids are better (RR 0.37, 95% CI 0.12 to 1.12; 2 studies, 232 women; low-certainty evidence).\nOpioids compared to placebo\nOpioids may be better than placebo for adequate pain relief as reported by the women (RR 1.26, 95% CI 0.99 to 1.61; 5 studies, 299 women; low-certainty evidence). Opioids may reduce the need for additional pain relief compared to placebo (RR 0.48, 95% CI 0.28 to 0.82; 3 studies, 273 women; low-certainty evidence). Opioids may increase the risk of maternal adverse events compared with placebo, although the certainty of evidence is low (RR 1.59, 95% CI 0.99 to 2.55; 3 studies, 188 women; low-certainty evidence).\nParacetamol compared to placebo\nVery low-certainty evidence means we are uncertain if paracetamol is better than placebo for adequate pain relief as reported by the women, the need for additional pain relief, or risk of maternal adverse events (2 studies, 123 women).\nParacetamol compared to NSAIDs\nVery low-certainty evidence means we are uncertain if there are any differences between paracetamol and NSAIDs for adequate pain relief as reported by the women, or the risk of maternal adverse events. No data were reported about the need for additional pain relief comparing paracetamol and NSAIDs (2 studies, 112 women).\nNSAIDs compared to herbal analgesia\nWe are uncertain if there are any differences between NSAIDs and herbal analgesia for adequate pain relief as reported by the women, the need for additional pain relief, or risk of maternal adverse events, because the certainty of evidence is very low (4 studies, 394 women).\nTranscutaneous nerve stimulation (TENS) compared to no TENS\nVery low-certainty evidence means we are uncertain if TENS is better than no TENS for adequate pain relief as reported by the women. No other data were reported comparing TENS with no TENS (1 study, 32 women).\nAuthors' conclusions\nNSAIDs may be better than placebo and are probably better than opioids at relieving pain from uterine cramping/involution following vaginal birth. NSAIDs and paracetamol may be as effective as each other, whereas opioids may be more effective than placebo. Due to low-certainty evidence, we are uncertain about the effectiveness of other forms of pain relief. Future trials should recruit adequate numbers of women and ensure greater generalisability by including breastfeeding women. In addition, further research is required, including a survey of postpartum women to describe appropriately their experience of uterine cramping and involution. We identified nine ongoing studies, which may help to increase the level of certainty of the evidence around pain relief due to uterine cramping in future updates of this review.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "NSAIDs may be better than placebo and are probably better than opioids at relieving after-birth pains following vaginal birth. The quality of the evidence was poor and we are uncertain about the effectiveness of other forms of pain relief. Future trials should recruit adequate numbers of women and ensure greater relevance by including breastfeeding women. Further research could also include a survey of women after delivery to capture their experience of after-birth pains following vaginal birth."
}
] |
query-laysum
|
21816
|
[
{
"role": "user",
"content": "Abstract: Background\nCongenital cataracts are lens opacities in one or both eyes of babies or children present at birth. These may cause a reduction in vision severe enough to require surgery. Cataracts are proportionally the most treatable cause of visual loss in childhood, and are a particular problem in low-income countries, where early intervention may not be possible. Paediatric cataracts provide different challenges to those in adults. Intense inflammation, amblyopia (vision is obstructed by cataract from birth which prevents normal development of the visual system), posterior capsule opacification and uncertainty about the final trajectory of ocular growth parameters can affect results of treatment. Two options currently considered for children under 2 years of age with bilateral congenital cataracts are: (i) intraocular lens (IOL) implantation; or (ii) leaving a child with primary aphakia (no lens in the eye), necessitating the need for contact lenses or aphakic glasses. Other important considerations regarding surgery include the prevention of visual axis opacification (VAO), glaucoma and the route used to perform lensectomy.\nObjectives\nTo assess the effectiveness of infant cataract surgery or lensectomy to no surgery for bilateral congenital cataracts in children aged 2 years and under.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 1); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 25 January 2022.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared infant cataract surgery or lensectomy to no surgery, in children with bilateral congenital cataracts aged 2 years and younger. This update (of a review published in 2001 and updated in 2006) does not include children over 2 years of age because they have a wider variety of aetiologies, and are therefore managed differently, and have contrasting outcomes.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two review authors extracted data independently. We assessed the risk of bias of included studies using RoB 1 and assessed the certainty of the evidence using GRADE.\nMain results\nWe identified three RCTs that met our inclusion criteria with each trial comparing a different aspect of surgical intervention for this condition. The trials included a total of 79 participants under 2 years of age, were conducted in India and follow-up ranged from 1 to 5 years. Study participants and outcome assessors were not masked in these trials.\nOne study (60 children) compared primary IOL implantation with primary aphakia. The results from this study suggest that there may be little or no difference in visual acuity at 5 years comparing children with pseudophakia (mean logMAR 0.50) and aphakia (mean logMAR 0.59) (mean difference (MD) -0.09 logMAR, 95% confidence intervals (CIs) -0.24 to 0.06; 54 participants; very low-certainty evidence), but the evidence is very uncertain. The evidence is very uncertain as to the effect of IOL implantation compared with aphakia on visual axis opacification (VAO) (risk ratio (RR) 1.29, 95% CI 0.23 to 7.13; 54 participants; very low-certainty evidence). The trial investigators did not report on the cases of amblyopia. There was little evidence of a difference betwen the two groups in cases of glaucoma at 5 years follow-up (RR 0.86, 95% CI 0.24 to 3.10; 54 participants; very low-certainty evidence). Cases of retinal detachment and reoperation rates were not reported. The impact of IOL implantation on adverse effects is very uncertain because of the sparse data available: of the children who were pseudophakic, 1/29 needed a trabeculectomy and 8/29 developed posterior synechiae. In comparison, no trabeculectomies were needed in the aphakic group and 2/25 children had posterior synechiae (54 participants; very low-certainty evidence).\nThe second study (14 eyes of 7 children under 2 years of age) compared posterior optic capture of IOL without vitrectomy versus endocapsular implantations with anterior vitrectomy (commonly called 'in-the-bag surgery'). The authors did not report on visual acuity, amblyopia, glaucoma and reoperation rate. They had no cases of VAO in either group. The evidence is very uncertain as to the effect of in-the-bag implantation in children aged under 1 year. There was a higher incidence of inflammatory sequelae: 4/7 in-the-bag implantation eyes and 1/7 in optic capture eyes (P = 0.04, 7 participants; very low-certainty evidence). We graded the certainty of evidence as low or very low for imprecision in all outcomes because their statistical analysis reported that a sample size of 13 was needed in each group to achieve a power of 80%, whereas their subset of children under the age of 1 year had only 7 eyes in each group.\nThe third study (24 eyes of 12 children) compared a transcorneal versus pars plana route using a 25-gauge transconjunctival sutureless vitrectomy system. The evidence is very uncertain as to the effect of the route chosen on the incidence of VAO, with no cases reported at 1 year follow-up in either group. The investigators did not report on visual acuity, amblyopia, glaucoma, retinal detachment and reoperation rate. The pars plana route had the adverse effects of posterior capsule rupture in 2/12 eyes, and 1/12 eyes needing sutures. Conversely, 1/12 eyes operated on by the transcorneal route needed sutures. We graded the outcomes with very low-certainty because of the small sample size and the absence of a priori sample size calculation.\nAuthors' conclusions\nThere is no high level evidence for the effectiveness of one type of surgery for bilateral congenital cataracts over another, or whether surgery itself is better than primary aphakia. Further RCTs are required to inform modern practice about concerns, including the timing of surgery, age at which surgery should be undertaken, age for implantation of an IOL and development of complications, such as reoperations, glaucoma and retinal detachment. Standardising the methods used to measure visual function, along with objective monitoring of compliance with the use of aphakic glasses/contact lenses would greatly improve the quality of study data and enable more reliable interpretation of outcomes.\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 trials that involved 90 children with bilateral congenital cataracts; of which 79 children were under the age of 2 years. The childen were followed up for 1 to 5 years after surgery. All three trials were conducted in India and compared different interventions.\nOne study (60 children) compared implanting an intraocular lens during surgery with leaving the eye without a lens and managing the child's vision with a combination of spectacles and contact lenses. It reported no difference in the resulting vision or postoperative complications between the two groups.\nOne study (7 children under 2 years old) compared two surgical techniques for inserting an intraocular lens that can reduce the rate of reclouding of vision. They found no significant difference in their effectiveness, but they studied very few children.\nOne study (12 children) used a smaller instrument to remove the cataract and compared two routes of removal: an anterior approach (in front of the lens) and a posterior approach (behind the lens). The study reported no reclouding using either route and no significant difference in complication rates."
}
] |
query-laysum
|
21817
|
[
{
"role": "user",
"content": "Abstract: Background\nPenetrating keratoplasty is a corneal transplantation procedure in which a full-thickness cornea from the host is replaced by a graft from a donor. The use of various immunosuppressants to prevent graft rejection, the most common cause of graft failure in the late postoperative period, is increasing.\nObjectives\nTo assess the effectiveness of immunosuppressants in the prophylaxis of corneal allograft rejection after high- and normal-risk keratoplasty.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2015), EMBASE (January 1980 to May 2015), China National Knowledge Infrastructure (CNKI) (January 1913 to February 2015), VIP database (January 1989 to February 2015), Wanfang Data (www.wanfangdata.com) (January 1990 to February 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the English language databases on 18 May 2015 and the Chinese language databases on 20 February 2015.\nSelection criteria\nWe included all randomised controlled trials (RCTs) assessing the use of immunosuppressants in the prevention of graft rejection, irrespective of publication language.\nData collection and analysis\nWe used standard procedures expected by Cochrane. The primary outcome was clear graft survival at 12 months after penetrating keratoplasty. Secondary outcomes included graft rejection, best-corrected visual acuity, and quality of life. We defined 'high-risk keratoplasty' as repeat keratoplasty and other indications of reduced graft survival.\nMain results\nWe included six studies conducted in Germany (three studies), Iran, India, and China. Three studies were conducted in people undergoing high-risk keratoplasty and investigated three different comparisons: systemic mycophenolate mofetil (MMF) versus no MMF; systemic MMF versus systemic cyclosporine A (CsA); and topical CsA versus placebo. One study compared topical tacrolimus to topical steroid in people with normal-risk keratoplasty, and two studies compared topical CsA to placebo in people experiencing graft rejection after normal-risk keratoplasty. Overall, we considered the trials to be at unclear or high risk of bias.\nMMF may not improve clear graft survival (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.84 to 1.33, 1 RCT, 87 participants, low-quality evidence) but may reduce the risk of graft rejection (RR 0.49, 95% CI 0.22 to 1.08, 1 RCT, 87 participants, low-quality evidence) compared to no MMF. Visual acuity was not reported.\nIn 1 study of 52 people comparing systemic MMF and systemic CsA, there were no graft failures in the first year of follow-up. Data from the longest follow-up (three years) suggest that there may be little difference in the effect of these two treatments on clear graft survival (RR 1.10, 95% CI 0.90 to 1.35, low-quality evidence). There was low-quality evidence of an increased risk of graft rejection with systemic MMF compared to systemic CsA, but with wide CIs compatible with increased risk with systemic CsA (RR 1.48, 95% CI 0.56 to 3.93, low-quality evidence). Visual acuity was not reported.\nOne study of 84 people comparing topical CsA to placebo did not report clear graft survival at 1 year, which suggests that all grafts survived to 1 year. This study suggests that the use of topical CsA probably leads to little or no difference in graft rejection (RR 1.00, 95% CI 0.39 to 2.58, moderate-quality evidence). At one year, the mean difference (MD) between the two groups in visual acuity was 0.07 (95% CI -0.01 to 0.15, moderate-quality evidence).\nTopical CsA probably does not have an effect on clear graft survival in people experiencing graft rejection after normal-risk keratoplasty compared to placebo (RR 1.03, 95% CI 0.96 to 1.10, 2 RCTs, 283 participants, moderate-quality evidence). There were inconsistent findings on graft rejection, with one study reporting a reduced incidence of graft rejection in the CsA group (RR 0.35, 95% CI 0.14 to 0.87, 230 participants) but the other study reporting a higher average number of episodes of graft rejection in people treated with CsA (MD 1.30, 95% CI 0.39 to 2.21, 43 participants). Overall, we judged this to be low-quality evidence due to risk of bias and inconsistency. There was no evidence for a difference in visual acuity between the 2 groups at final follow-up (approximately 18 months, range 2 to 33 months) (MD 0.04, 95% CI -0.10 to 0.18, 1 RCT, 43 participants, low-quality evidence).\nIn 1 study comparing topical tacrolimus to topical steroid, the graft survived in all of the 12 treated participants and 20 control participants at 6 months. Graft rejection was rare (0 out of 12 versus 2 out of 20) (RR 0.32, 95% CI 0.02 to 6.21, low-quality evidence). Visual acuity was not reported.\nNone of the studies reported on quality of life. We identified an unpublished trial of basiliximab (Simulect) (NCT00409656), probably completed in 2005.\nAuthors' conclusions\nCurrent evidence on the effect of immunosuppressants in the prevention of graft failure and rejection after high- and normal-risk keratoplasty is largely low quality because the number of trials was limited, and, in general, the trials were small and at risk of bias. Future trials should be large enough to detect important clinical effects, conducted with a view to minimising the risk of bias, and they should measure outcomes important to patients.\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 cornea is the transparent front part of the eye that if damaged, can be replaced by a corneal transplant (keratoplasty) using healthy cornea tissue from a donor. A penetrating keratoplastyinvolves replacing all the damaged cornea. It is necessary to prevent the transplanted material (graft) from being rejected. The current strategies for preventing graft rejection are topical and oral steroids. The use of cyclosporine A (CsA), tacrolimus, mycophenolate mofetil (MMF), sirolimus, and leflunomide is increasing. However, the benefits and adverse reactions of these immunosuppressants have not yet been systematically reviewed."
}
] |
query-laysum
|
21818
|
[
{
"role": "user",
"content": "Abstract: Background\nAdrenaline and vasopressin are widely used to treat people with cardiac arrest, but there is uncertainty about the safety, effectiveness and the optimal dose.\nObjectives\nTo determine whether adrenaline or vasopressin, or both, administered during cardiac arrest, afford any survival benefit.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase and DARE from their inception to 8 May 2018, and the International Liaison Committee on Resuscitation 2015 Advanced Life Support Consensus on Science and Treatment Recommendations. We also searched four trial registers on 5 September 2018 and checked the reference lists of the included studies and review papers to identify potential papers for review.\nSelection criteria\nAny randomised controlled trial comparing: standard-dose adrenaline versus placebo; standard-dose adrenaline versus high-dose adrenaline; and adrenaline versus vasopressin, in any setting, due to any cause of cardiac arrest, in adults and children. There were no language restrictions.\nData collection and analysis\nTwo review authors independently identified trials for review, assessed risks of bias and extracted data, resolving disagreements through re-examination of the trial reports and by discussion. We used risk ratios (RRs) with 95% confidence intervals (CIs) to compare dichotomous outcomes for clinical events. There were no continuous outcomes reported. We examined groups of trials for heterogeneity. We report the quality of evidence for each outcome, using the GRADE approach.\nMain results\nWe included 26 studies (21,704 participants).\nModerate-quality evidence found that adrenaline increased survival to hospital discharge compared to placebo (RR 1.44, 95% CI 1.11 to 1.86; 2 studies, 8538 participants; an increase from 23 to 32 per 1000, 95% CI 25 to 42). We are uncertain about survival to hospital discharge for high-dose compared to standard-dose adrenaline (RR 1.10, 95% CI 0.75 to 1.62; participants = 6274; studies = 10); an increase from 33 to 36 per 1000, 95% CI 24 to 53); standard-dose adrenaline versus vasopressin (RR 1.25, 95% CI 0.84 to 1.85; 6 studies; 2511 participants; an increase from 72 to 90 per 1000, 95% CI 60 to 133); and standard-dose adrenaline versus vasopressin plus adrenaline (RR 0.76, 95% CI 0.47 to 1.22; 3 studies; 3242 participants; a possible decrease from 24 to 18 per 1000, 95% CI 11 to 29), due to very low-quality evidence.\nModerate-quality evidence found that adrenaline compared with placebo increased survival to hospital admission (RR 2.51, 95% CI 1.67 to 3.76; 2 studies, 8489 participants; an increase from 83 to 209 per 1000, 95% CI 139 to 313). We are uncertain about survival to hospital admission when comparing standard-dose with high-dose adrenaline, due to very low-quality evidence. Vasopressin may improve survival to hospital admission when compared with standard-dose adrenaline (RR 1.27, 95% CI 1.04 to 1.54; 3 studies, 1953 participants; low-quality evidence; an increase from 260 to 330 per 1000, 95% CI 270 to 400), and may make little or no difference when compared to standard-dose adrenaline plus vasopressin (RR 0.95, 95% CI 0.83 to 1.08; 3 studies; 3249 participants; low-quality evidence; a decrease from 218 to 207 per 1000 (95% CI 181 to 236).\nThere was no evidence that adrenaline (any dose) or vasopressin improved neurological outcomes.\nThe rate of return of spontaneous circulation (ROSC) was higher for standard-dose adrenaline versus placebo (RR 2.86, 95% CI 2.21 to 3.71; participants = 8663; studies = 3); moderate-quality evidence; an increase from 115 to 329 per 1000, 95% CI 254 to 427). We are uncertain about the effect on ROSC for the comparison of standard-dose versus high-dose adrenaline and standard-does adrenaline compared to vasopressin, due to very low-quality evidence. Standard-dose adrenaline may make little or no difference to ROSC when compared to standard-dose adrenaline plus vasopressin (RR 0.97, 95% CI 0.87 to 1.08; 3 studies, 3249 participants; low-quality evidence; a possible decrease from 299 to 290 per 1000, 95% CI 260 to 323).\nThe source of funding was not stated in 11 of the 26 studies. The study drugs were provided by the manufacturer in four of the 26 studies, but neither drug represents a profitable commercial option. The other 11 studies were funded by organisations such as research foundations and government funding bodies.\nAuthors' conclusions\nThis review provides moderate-quality evidence that standard-dose adrenaline compared to placebo improves return of spontaneous circulation, survival to hospital admission and survival to hospital discharge, but low-quality evidence that it did not affect survival with a favourable neurological outcome. Very low -quality evidence found that high-dose adrenaline compared to standard-dose adrenaline improved return of spontaneous circulation and survival to admission. Vasopressin compared to standard dose adrenaline improved survival to admission but not return of spontaneous circulation, whilst the combination of adrenaline and vasopressin compared with adrenaline alone had no effect on these outcomes. Neither standard dose adrenaline, high-dose adrenaline,vasopressin nor a combination of adrenaline and vasopressin improved survival with a favourable neurological outcome. Many of these studies were conducted more than 20 years ago. Treatment has changed in recent years, so the findings from older studies may not reflect current practice.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do the drugs adrenaline or vasopressin improve survival in cardiac arrest."
}
] |
query-laysum
|
21819
|
[
{
"role": "user",
"content": "Abstract: Background\nMillions of people worldwide suffer from hepatitis C, which can lead to severe liver disease, liver cancer, and death. Direct-acting antivirals (DAAs), e.g. sofosbuvir, are relatively new and expensive interventions for chronic hepatitis C, and preliminary results suggest that DAAs may eradicate hepatitis C virus (HCV) from the blood (sustained virological response). Sustained virological response (SVR) is used by investigators and regulatory agencies as a surrogate outcome for morbidity and mortality, based solely on observational evidence. However, there have been no randomised trials that have validated that usage.\nObjectives\nTo assess the benefits and harms of DAAs in people with chronic HCV.\nSearch methods\nWe searched for all published and unpublished trials in The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, LILACS, and BIOSIS; the Chinese Biomedical Literature Database (CBM), China Network Knowledge Information (CNKI), the Chinese Science Journal Database (VIP), Google Scholar, The Turning Research into Practice (TRIP) Database, ClinicalTrials.gov, European Medicines Agency (EMA) (www.ema.europa.eu/ema/), WHO International Clinical Trials Registry Platform (www.who.int/ictrp), the Food and Drug Administration (FDA) (www.fda.gov), and pharmaceutical company sources for ongoing or unpublished trials. Searches were last run in October 2016.\nSelection criteria\nRandomised clinical trials comparing DAAs versus no intervention or placebo, alone or with co-interventions, in adults with chronic HCV. We included trials irrespective of publication type, publication status, and language.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were hepatitis C-related morbidity, serious adverse events, and health-related quality of life. Our secondary outcomes were all-cause mortality, ascites, variceal bleeding, hepato-renal syndrome, hepatic encephalopathy, hepatocellular carcinoma, non-serious adverse events (each reported separately), and SVR. We systematically assessed risks of bias, performed Trial Sequential Analysis, and followed an eight-step procedure to assess thresholds for statistical and clinical significance. We evaluated the overall quality of the evidence, using GRADE.\nMain results\nWe included a total of 138 trials randomising a total of 25,232 participants. The trials were generally short-term trials and designed primarily to assess the effect of treatment on SVR. The trials evaluated 51 different DAAs. Of these, 128 trials employed matching placebo in the control group. All included trials were at high risk of bias. Eighty-four trials involved DAAs on the market or under development (13,466 participants). Fifty-seven trials administered DAAs that were discontinued or withdrawn from the market. Study populations were treatment-naive in 95 trials, had been exposed to treatment in 17 trials, and comprised both treatment-naive and treatment-experienced individuals in 24 trials. The HCV genotypes were genotype 1 (119 trials), genotype 2 (eight trials), genotype 3 (six trials), genotype 4 (nine trials), and genotype 6 (one trial). We identified two ongoing trials.\nWe could not reliably determine the effect of DAAs on the market or under development on our primary outcome of hepatitis C-related morbidity or all-cause mortality. There were no data on hepatitis C-related morbidity and only limited data on mortality from 11 trials (DAA 15/2377 (0.63%) versus control 1/617 (0.16%); OR 3.72, 95% CI 0.53 to 26.18, very low-quality evidence). We did not perform Trial Sequential Analysis on this outcome.\nThere is very low quality evidence that DAAs on the market or under development do not influence serious adverse events (DAA 5.2% versus control 5.6%; OR 0.93, 95% CI 0.75 to 1.15 , 15,817 participants, 43 trials). The Trial Sequential Analysis showed that there was sufficient information to rule out that DAAs reduce the relative risk of a serious adverse event by 20% when compared with placebo. The only DAA that showed a lower risk of serious adverse events when meta-analysed separately was simeprevir (OR 0.62, 95% CI 0.45 to 0.86). However, Trial Sequential Analysis showed that there was not enough information to confirm or reject a relative risk reduction of 20%, and when one trial with an extreme result was excluded, the meta-analysis result showed no evidence of a difference.\nDAAs on the market or under development may reduce the risk of no SVR from 54.1% in untreated people to 23.8% in people treated with DAA (RR 0.44, 95% CI 0.37 to 0.52, 6886 participants, 32 trials, low quality evidence). Trial Sequential Analysis confirmed this meta-analysis result.\nOnly 1/84 trials on the market or under development assessed the effects of DAAs on health-related quality of life (SF-36 mental score and SF-36 physical score).\nThere was insufficient evidence from trials on withdrawn or discontinued DAAs to determine their effect on hepatitis C-related morbidity and all-cause mortality (OR 0.64, 95% CI 0.23 to 1.79; 5 trials, very low-quality evidence). However, these DAAs seemed to increase the risk of serious adverse events (OR 1.45, 95% CI 1.22 to 1.73; 29 trials, very low-quality evidence). Trial Sequential Analysis confirmed this meta-analysis result.\nNone of the 138 trials provided useful data to assess the effects of DAAs on the remaining secondary outcomes (ascites, variceal bleeding, hepato-renal syndrome, hepatic encephalopathy, and hepatocellular carcinoma).\nAuthors' conclusions\nThe evidence for our main outcomes of interest come from short-term trials, and we are unable to determine the effect of long-term treatment with DAAs. The rates of hepatitis C morbidity and mortality observed in the trials are relatively low and we are uncertain as to how DAAs affect this outcome. Overall, there is very low quality evidence that DAAs on the market or under development do not influence serious adverse events. There is insufficient evidence to judge if DAAs have beneficial or harmful effects on other clinical outcomes for chronic HCV. Simeprevir may have beneficial effects on risk of serious adverse event. In all remaining analyses, we could neither confirm nor reject that DAAs had any clinical effects. DAAs may reduce the number of people with detectable virus in their blood, but we do not have sufficient evidence from randomised trials that enables us to understand how SVR affects long-term clinical outcomes. SVR is still an outcome that needs proper validation in randomised clinical trials.\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 could not reliably determine the effect of DAAs on hepatitis C-related morbidity or death from any cause. There were no data on hepatitis C-related morbidity and very few deaths occurred over the course of the trials (15 deaths/2377 direct-acting antiviral participants (0.63%) versus 1 death/617 control participants (0.16%), very low quality evidence). Based on very low quality evidence, 5.2% people treated with DAAs had one or more serious adverse events versus 5.6% participants who were untreated during the observation period. When analysed separately, simeprevir was the only direct-acting antiviral that showed evidence of a beneficial effect when assessing risk of a serious adverse event. Our analyses, however, showed that the validity of this result is questionable and that 'play of chance' might be the cause for the difference. There was not enough information to determine if there was any effect of DAAs on other clinically relevant outcomes. Our results confirm that DAAs seem to reduce the number of people who have the hepatitis C virus in their blood from 54.1% in untreated people to 23.8% in those who were treated. Because the loss of detectable hepatitis C virus in the blood stream is only a blood test, the studies could not tell what this result means in the long term."
}
] |
query-laysum
|
21820
|
[
{
"role": "user",
"content": "Abstract: Background\nMpox was declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO) on 23 July 2022, following the identification of thousands of cases in several non-endemic countries in previous months. There are currently no licenced therapeutics for treating mpox; however, some medications may be authorized for use in an outbreak. The efficacy and safety of possible therapeutic options has not been studied in humans with mpox. There is a need to investigate the evidence on safety and effectiveness of treatments for mpox in humans; should any therapeutic option be efficacious and safe, it may be approved for use around the world.\nObjectives\nThere are two parts to this Cochrane Review: a review of evidence from randomized controlled trials (RCTs), and a narrative review of safety data from non-randomized studies.\nRandomized controlled trials review\nTo systematically review the existing evidence on the effectiveness of therapeutics for mpox infection in humans compared to:\na) another different therapeutic for mpox, or\nb) placebo, or\nc) supportive care, defined as the treatment of physical and psychological symptoms arising from the disease.\nNon-randomized studies review\nTo assess the safety of therapeutics for mpox infection from non-randomized studies (NRS).\nSearch methods\nRandomized controlled trials review\nWe searched the following databases up to 25 January 2023: MEDLINE (OVID), Embase (OVID), Biosis previews (Web of Science), CAB Abstracts (Web of science), and Cochrane CENTRAL (Issue 1 2023). We conducted a search of trial registries (Clinicaltrials.gov and International Clinical Trials Registry Platform (ICTRP)) on 25 January 2023. There were no date or language limits placed on the search. We undertook a call to experts in the field for relevant studies or ongoing trials to be considered for inclusion in the review.\nNon-randomized studies review\nWe searched the following databases on 22 September 2022: Cochrane Central Register of Controlled Trials (CENTRAL; Issue 9 of 12, 2022), published in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); and Scopus (Elsevier). We also searched the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov for trials in progress.\nSelection criteria\nFor the RCT review and the narrative review, any therapeutic for the treatment of mpox in humans was eligible for inclusion, including tecovirimat, brincidofovir, cidofovir, NIOCH-14, immunomodulators, and vaccine immune globulin.\nRandomized controlled trials review\nStudies were eligible for the main review if they were of randomized controlled design and investigated the effectiveness or safety of therapeutics in human mpox infection.\nNon-randomized studies review\nStudies were eligible for inclusion in the review of non-randomized studies if they were of non-randomized design and contained data concerning the safety of any therapeutic in human mpox infection.\nData collection and analysis\nRandomized controlled trials review\nTwo review authors independently applied study inclusion criteria to identify eligible studies. If we had identified any eligible studies, we planned to assess the risk of bias, and report results with 95% confidence intervals (CI). The critical outcomes were serious adverse events, development of disease-related complications, admission to hospital for non-hospitalized participants, pain as judged by any visual or numerical pain scale, level of virus detected in clinical samples, time to healing of all skin lesions, and mortality.\nWe planned to perform subgroup analysis to explore whether the effect of the therapeutic on the planned outcomes was modified by disease severity and days from symptom onset to therapeutic administration. We also intended to explore the following subgroups of absolute effects: immunosuppression, age, and pre-existing skin disease.\nNon-randomized studies review\nOne review author applied study inclusion criteria to identify eligible studies and extracted data. Studies of a non-randomized design containing data on the safety of therapeutics could not be meta-analyzed due to the absence of a comparator; we summarized these data narratively in an appendix.\nMain results\nRandomized controlled trials review\nWe did not identify any completed RCTs investigating the effectiveness of therapeutics for treating mpox for the main review. We identified five ongoing trials that plan to assess the effectiveness of one therapeutic option, tecovirimat, for treating mpox in adults and children. One of these ongoing trials intends to include populations with, or at greater risk of, severe disease, which will allow an assessment of safety in more vulnerable populations.\nNon-randomized studies review\nThree non-randomized studies met the inclusion criteria for the narrative review, concerning data on the safety of therapeutics in mpox. Very low-certainty evidence from non-randomized studies of small numbers of people indicates no serious safety signals emerging for the use of tecovirimat in people with mpox infection, but a possible safety signal for brincidofovir. All three participants who received brincidofovir had raised alanine aminotransferase (ALT), but not bilirubin, suggesting mild liver injury. No study reported severe drug-induced liver injury with brincidofovir.\nAuthors' conclusions\nRandomized controlled trials review\nThis review found no evidence from randomized controlled trials concerning the efficacy and safety of therapeutics in humans with mpox.\nNon-randomized studies review\nVery low-certainty evidence from non-randomized studies indicates no serious safety signals emerging for the use of tecovirimat in people with mpox infection. In contrast, very low-certainty evidence raises a safety signal that brincidofovir may cause liver injury. This is also suggested by indirect evidence from brincidofovir use in smallpox. This warrants further investigation and monitoring.\nThis Cochrane Review will be updated as new evidence becomes available to assist policymakers, health professionals, and consumers in making appropriate decisions for the treatment of mpox.\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": "Randomized controlled trials review\nThe review authors searched for studies available up to 25 January 2023.\nNon-randomized studies review\nThe review authors searched for studies available up to 22 September 2022."
}
] |
query-laysum
|
21821
|
[
{
"role": "user",
"content": "Abstract: Background\nHospital-acquired infection is a frequent adverse event in patient care; it can lead to longer stays in the intensive care unit (ICU), additional medical complications, permanent disability or death. Whilst all hospital-based patients are susceptible to infections, prevalence is particularly high in the ICU, where people who are critically ill have suppressed immunity and are subject to increased invasive monitoring. People who are mechanically-ventilated are at infection risk due to tracheostomy and reintubation and use of multiple central venous catheters, where lines and tubes may act as vectors for the transmission of bacteria and may increase bloodstream infections and ventilator-associated pneumonia (VAP). Chlorhexidine is a low-cost product, widely used as a disinfectant and antiseptic, which may be used to bathe people who are critically ill with the aim of killing bacteria and reducing the spread of hospital-acquired infections.\nObjectives\nTo assess the effects of chlorhexidine bathing on the number of hospital-acquired infections in people who are critically ill.\nSearch methods\nIn December 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared chlorhexidine bathing with soap-and-water bathing of patients in the ICU.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and undertook risk of bias and GRADE assessment of the certainty of the evidence .\nMain results\nWe included eight studies in this review. Four RCTs included a total of 1537 individually randomised participants, and four cluster-randomised cross-over studies included 23 randomised ICUs with 22,935 participants. We identified one study awaiting classification, for which we were unable to assess eligibility.\nThe studies compared bathing using 2% chlorhexidine-impregnated washcloths or dilute solutions of 4% chlorhexidine versus soap-and-water bathing or bathing with non-antimicrobial washcloths.\nEight studies reported data for participants who had a hospital-acquired infection during the ICU stay. We are uncertain whether using chlorhexidine for bathing of critically ill people reduces the rate of hospital-acquired infection, because the certainty of the evidence is very low (rate difference 1.70, 95% confidence interval (CI) 0.12 to 3.29; 21,924 participants). Six studies reported mortality (in hospital, in the ICU, and at 48 hours). We cannot be sure whether using chlorhexidine for bathing of critically-ill people reduces mortality, because the certainty of the evidence is very low (odds ratio 0.87, 95% CI 0.76 to 0.99; 15,798 participants). Six studies reported length of stay in the ICU. We noted that individual studies found no evidence of a difference in length of stay; we did not conduct meta-analysis because data were skewed. It is not clear whether using chlorhexidine for bathing of critically ill people reduced length of stay in the ICU, because the certainty of the evidence is very low. Seven studies reported skin reactions as an adverse event, and five of these reported skin reactions which were thought to be attributable to the bathing solution. Data in these studies were reported inconsistently and we were unable to conduct meta-analysis; we cannot tell whether using chlorhexidine for bathing of critically ill people reduced adverse events, because the certainty of the evidence is very low.\nWe used the GRADE approach to downgrade the certainty of the evidence of each outcome to very low. For all outcomes, we downgraded evidence because of study limitations (most studies had a high risk of performance bias, and we noted high risks of other bias in some studies). We downgraded evidence due to indirectness, because some participants in studies may have had hospital-acquired infections before recruitment. We noted that one small study had a large influence on the effect for hospital-acquired infections, and we assessed decisions made in analysis of some cluster-randomised cross-over studies on the effect for hospital-acquired infections and for mortality; we downgraded the evidence for these outcomes due to inconsistency. We also downgraded the evidence on length of stay in the ICU, because of imprecision. Data for adverse events were limited by few events and so we downgraded for imprecision.\nAuthors' conclusions\nDue to the very low-certainty evidence available, it is not clear whether bathing with chlorhexidine reduces hospital-acquired infections, mortality, or length of stay in the ICU, or whether the use of chlorhexidine results in more skin reactions.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most studies did not use methods to conceal the type of bathing solution that staff were using, which increases the risk that staff may have treated patients differently depending on whether patients were in the chlorhexidine study group or the soap-and-water study group. Participants in some studies may have already caught an infection before the start of the study and we were concerned that this might have affected our results. We also noticed wide differences in some results, and some outcomes had few reported events. These were reasons to judge the quality of the evidence to be very low."
}
] |
query-laysum
|
21822
|
[
{
"role": "user",
"content": "Abstract: Background\nExacerbations of chronic obstructive pulmonary disease (COPD) are a major cause of hospital admissions, disease-related morbidity and mortality. COPD is a heterogeneous disease with distinct inflammatory phenotypes, including eosinophilia, which may drive acute exacerbations in a subgroup of patients. Monoclonal antibodies targeting interleukin 5 (IL-5) or its receptor (IL-5R) have a role in the care of people with severe eosinophilic asthma, and may similarly provide therapeutic benefit for people with COPD of eosinophilic phenotype.\nObjectives\nTo assess the efficacy and safety of monoclonal antibody therapies targeting IL-5 signalling (anti-IL-5 or anti-IL-5Rα) compared with placebo in the treatment of adults with COPD.\nSearch methods\nWe searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, clinical trials registries, manufacturers' websites, and reference lists of included studies. Our most recent search was 23 September 2020.\nSelection criteria\nWe included randomised controlled trials comparing anti-IL-5 therapy with placebo in adults with COPD.\nData collection and analysis\nTwo review authors independently extracted data and analysed outcomes using a random-effects model.The primary outcomes were exacerbations requiring antibiotics or oral steroids, hospitalisations due to exacerbation of COPD, serious adverse events, and quality of life. We used standard methods expected by Cochrane. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nSix studies involving a total of 5542 participants met our inclusion criteria. Three studies used mepolizumab (1530 participants), and three used benralizumab (4012 participants). The studies were on people with COPD, which was similarly defined with a documented history of COPD for at least one year. We deemed the risk of bias to be generally low, with all studies contributing data of robust methodology.\nMepolizumab 100 mg reduces the rate of moderate or severe exacerbations by 19% in those with an eosinophil count of at least 150/μL (rate ratio (RR) 0.81, 95% confidence interval (CI) 0.71 to 0.93; participants = 911; studies = 2, high-certainty evidence). When participants with lower eosinophils are included, mepolizumab 100 mg probably reduces the exacerbation rate by 8% (RR 0.92, 95% CI 0.82 to 1.03; participants = 1285; studies = 2, moderate-certainty evidence). Mepolizumab 300 mg probably reduces the rate of exacerbations by 14% in participants all of whom had raised eosinophils (RR 0.86, 95% CI 0.70 to 1.06; participants = 451; studies = 1, moderate-certainty evidence); the evidence was uncertain for a single small study of mepolizumab 750 mg. In participants with high eosinophils, mepolizumab probably reduces the rate of hospitalisation by 10% (100 mg, RR 0.90, 95% CI 0.65 to 1.24; participants = 911; studies = 2, moderate-certainty evidence) and 17% (300 mg, RR 0.83, 95% CI 0.51 to 1.35; participants = 451; studies = 1, moderate-certainty evidence). Mepolizumab 100 mg increases the time to first moderate or severe exacerbation compared to the placebo group, in people with the eosinophilic phenotype (hazard ratio (HR) 0.78, 95% CI 0.66 to 0.92; participants = 981; studies 2, high-certainty evidence). When participants with lower eosinophils were included this difference was smaller and less certain (HR 0.87, 95% CI 0.75 to 1.0; participants = 1285; studies 2, moderate-certainty evidence). Mepolizumab 300 mg probably increases the time to first moderate or severe exacerbation in participants who all had eosinophilic phenotype (HR 0.77, 95% CI 0.60 to 0.99; participants = 451; studies = 1, moderate-certainty evidence).\nBenralizumab 100 mg reduces the rate of severe exacerbations requiring hospitalisation in those with an eosinophil count of at least 220/μL (RR 0.63, 95% CI 0.49 to 0.81; participants = 1512; studies = 2, high-certainty evidence). Benralizumab 10 mg probably reduces the rate of severe exacerbations requiring hospitalisation in those with an eosinophil count of at least 220/μL (RR 0.68, 95% CI 0.49 to 0.94; participants = 765; studies = 1, moderate-certainty evidence).\nThere was probably little or no difference between the intervention and placebo for quality of life measures. Where there were differences the mean difference fell below the pre-specified minimum clinically significant difference.\nTreatment with mepolizumab and benralizumab appeared to be safe. All pooled analyses showed that there was probably little or no difference in serious adverse events, adverse events, or side effects between the use of a monoclonal antibody therapy compared to placebo.\nAuthors' conclusions\nWe found that mepolizumab and benralizumab probably reduce the rate of moderate and severe exacerbations in the highly selected group of people who have both COPD and higher levels of blood eosinophils. This highlights the importance of disease phenotyping in COPD, and may play a role in the personalised treatment strategy in disease management.\nFurther research is needed to elucidate the role of monoclonal antibodies in the management of COPD in clinical practice. In particular, it is not clear whether there is a threshold blood eosinophil level above which these drugs may be effective. Studies including cost effectiveness analysis may be beneficial given the high cost of these therapies, to support use if appropriate.\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 included studies were for the most part very well-designed and robust, and the evidence was generally of high quality."
}
] |
query-laysum
|
21823
|
[
{
"role": "user",
"content": "Abstract: Background\nStudies consistently show a relationship between social disadvantage and low birthweight. Many countries have programmes offering special assistance to women thought to be at risk for giving birth to a low birthweight infant. These programmes, collectively referred to in this review as additional social support, may include emotional support, which gives a person a feeling of being loved and cared for, tangible/instrumental support, in the form of direct assistance/home visits, and informational support, through the provision of advice, guidance and counselling. The programmes may be delivered by multidisciplinary teams of health professionals, specially trained lay workers, or a combination of lay and professional workers. This is an update of a review first published in 2003 and updated in 2010.\nObjectives\nThe primary objective was to assess the effects of programmes offering additional social support (emotional, instrumental/tangible and informational) compared with routine care, for pregnant women believed to be at high risk for giving birth to babies that are either preterm (less than 37 weeks' gestation) or weigh less than 2500 g, or both, at birth. Secondary objectives were to determine whether the effectiveness of support was mediated by timing of onset (early versus later in pregnancy) or type of provider (healthcare professional or lay person).\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) on 5 February 2018, and reference lists of retrieved studies.\nSelection criteria\nRandomised trials of additional social support during at-risk pregnancy by either a professional (social worker, midwife, or nurse) or specially trained lay person, compared to routine care. We defined additional social support as some form of emotional support (e.g. caring, empathy, trust), tangible/instrumental support (e.g. transportation to clinic appointments, home visits complemented with phone calls, help with household responsibilities) or informational support (advice and counselling about nutrition, rest, stress management, use of alcohol/recreational drugs).\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nThis updated review includes a total of 25 studies, with outcome data for 11,246 mothers and babies enrolled in 21 studies. We assessed the overall risk of bias of included studies to be low or unclear, mainly because of limited reporting or uncertainty in how randomisation was generated or concealed (which led us to downgrade the quality of most outcomes to moderate), and the impracticability of blinding participants.\nWhen compared with routine care, programmes offering additional social support for at-risk pregnant women may slightly reduce the number of babies born with a birthweight less than 2500 g from 127 per 1000 to 120 per 1000 (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.86 to 1.04; 16 studies, n = 11,770; moderate-quality evidence), and the number of babies born with a gestational age less than 37 weeks at birth from 128 per 1000 to 117 per 1000 (RR 0.92, 95% CI 0.84 to 1.01, 14 studies, n = 12,282; moderate-quality evidence), though the confidence intervals for the pooled effect for both of these outcomes just crossed the line of no effect, suggesting any effect is not large. There may be little or no difference between interventions for stillbirth/neonatal death (RR 1.11, 95% CI 0.88 to 1.41; 15 studies, n = 12,091; low-quality evidence). Secondary outcomes of moderate quality suggested that there is probably a reduction in caesarean section (from 215 per 1000 to 194 per 1000; RR 0.90, 95% CI 0.83 to 0.97; 15 studies, n = 9550), a reduction in the number of antenatal hospital admissions per participant (RR 0.78, 95% CI 0.68 to 0.91; 4 studies; n = 787), and a reduction in the mean number of hospitalisation episodes (mean difference −0.05, 95% CI −0.06 to −0.04; 1 study, n = 1525) in the social support group, compared to the controls.\nPostnatal depression and women's satisfaction were reported in different ways in the studies that considered these outcomes and so we could not include data in a meta-analysis. In one study postnatal depression appeared to be slightly lower in the support group in women who screened positively on the Edinbugh Postnatal Depression Scale at eight to 12 weeks postnatally (RR 0.74, 95% CI 0.55 to 1.01; 1 study, n = 1008; moderate-quality evidence). In another study, again postnatal depression appeared to be slightly lower in the support group and this was a self-report measure assessed at six weeks postnatally (RR 0.85, 95% CI 0.69 to 1.05; 1 study, n = 458; low-quality evidence). A higher proportion of women in one study reported that their prenatal care was very helpful in the supported group (RR 1.17, 95% CI 1.05 to 1.30; 1 study, n = 223; moderate-quality evidence), although in another study results were similar. Another study assessed satisfaction with prenatal care as being \"not good\" in 51 of 945 in the additional support group, compared with 45 of 942 in the usual care group.\nNo studies considered long-term morbidity for the infant. No single outcome was reported in all studies. Subgroup analysis demonstrated consistency of effect when the support was provided by a healthcare professional or a trained lay worker.\nThe descriptions of the additional social support were generally consistent across all studies and included emotional support, tangible support such as home visits, and informational support.\nAuthors' conclusions\nPregnant women need the support of caring family members, friends, and health professionals. While programmes that offer additional social support during pregnancy are unlikely to have a large impact on the proportion of low birthweight babies or birth before 37 weeks' gestation and no impact on stillbirth or neonatal death, they may be helpful in reducing the likelihood of caesarean birth and antenatal hospital admission.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence on 5 February 2018. We identified 21 randomised controlled trials from which 11,246 mother-baby pairs contributed results for this review. Examples of the additional social support include information, home visits, telephone calls and stress management. The overall quality of evidence for most outcomes was moderate. It was not possible to blind women to which group they were in.\nWe found that women who received additional social support during pregnancy may be slightly less likely to have a baby with low birthweight (16 studies, 11,770 babies), or give birth too early (14 studies, 12,282 babies). The number of babies that died around the time of birth was similar for both groups of women (15 studies, 12,091 babies). Women who received the additional social support were, however, probably less likely to be admitted to hospital during their pregnancy (4 studies, 787 women), or to have a caesarean birth (15 studies, 9550 women). Women with additional social support may be less likely to be depressed (1 study, 1008 women). Findings around satisfaction with care were mixed, with one study reporting the support group being more satisfied, whilst another study suggested women in the usual care group were more satisfied. The findings did not appear to be different if the social support was provided by trained lay people or health professionals."
}
] |
query-laysum
|
21824
|
[
{
"role": "user",
"content": "Abstract: Background\nPoor retention of participants in randomised trials can lead to missing outcome data which can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to improve retention but few have been formally evaluated.\nObjectives\nTo quantify the effect of strategies to improve retention of participants in randomised trials and to investigate if the effect varied by trial setting.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Scopus, PsycINFO, CINAHL, Web of Science Core Collection (SCI-expanded, SSCI, CPSI-S, CPCI-SSH and ESCI) either directly with a specified search strategy or indirectly through the ORRCA database. We also searched the SWAT repository to identify ongoing or recently completed retention trials. We did our most recent searches in January 2020.\nSelection criteria\nWe included eligible randomised or quasi-randomised trials of evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance.\nData collection and analysis\nWe extracted data on: the retention strategy being evaluated; location of study; host trial setting; method of randomisation; numbers and proportions in each intervention and comparator group. We used a risk difference (RD) and 95% confidence interval (CI) to estimate the effectiveness of the strategies to improve retention. We assessed heterogeneity between trials. We applied GRADE to determine the certainty of the evidence within each comparison.\nMain results\nWe identified 70 eligible papers that reported data from 81 retention trials. We included 69 studies with more than 100,000 participants in the final meta-analyses, of which 67 studies evaluated interventions aimed at trial participants and two evaluated interventions aimed at trial staff involved in retention. All studies were in health care and most aimed to improve postal questionnaire response. Interventions were categorised into broad comparison groups: Data collection; Participants; Sites and site staff; Central study management; and Study design.\nThese intervention groups consisted of 52 comparisons, none of which were supported by high-certainty evidence as determined by GRADE assessment. There were four comparisons presenting moderate-certainty evidence, three supporting retention (self-sampling kits, monetary reward together with reminder or prenotification and giving a pen at recruitment) and one reducing retention (inclusion of a diary with usual follow-up compared to usual follow-up alone). Of the remaining studies, 20 presented GRADE low-certainty evidence and 28 presented very low-certainty evidence.\nOur findings do provide a priority list for future replication studies, especially with regard to comparisons that currently rely on a single study.\nAuthors' conclusions\nMost of the interventions we identified aimed to improve retention in the form of postal questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. None of the comparisons are supported by high-certainty evidence. Comparisons in the review where the evidence certainty could be improved with the addition of well-done studies should be the focus for future evaluations.\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": "Randomised trials are a type of scientific study typically used to test new healthcare treatments. In a randomised trial, people who agree to take part are randomly (by chance) put into one of two or more treatment groups and then studied for a period of time. The research team try to keep in touch with them to collect information about how they are doing. This 'follow up' can last from days to years depending on the trial, but the longer the trial lasts, the more difficult it can be. This might be because people are too busy to reply, are unable to come to a clinic, or just do not want to participate any longer. Keeping people in a trial is called 'retention'. If retention is poor, it can make the trial results less certain but most trials do not get data from all the people who started out in the trial.\nThe information gathered during follow-up, sometimes called data, helps the trial team to determine which of the treatments being tested works the best. Often this information is collected directly from patients by asking them to complete a questionnaire or by asking them to come back for a clinic visit.\nThere are many ways to collect data from people in trials. These include using letters, the internet, telephone calls, text messaging, face-to-face meetings or the return of medical test kits. Research teams use different methods to try to collect data and it's important to know which strategies are effective and worthwhile, which is why we did this review to compare the success of different strategies."
}
] |
query-laysum
|
21825
|
[
{
"role": "user",
"content": "Abstract: Background\nClavicle (collarbone) fractures account for around 4% of all fractures. Most (76%) clavicle fractures involve the middle-third section of the clavicle. Treatment of these fractures is usually non-surgical (conservative). Commonly used treatments are arm slings, strapping and figure-of-eight bandages.\nThis is an update of a Cochrane review first published in 2009 and updated in 2014.\nObjectives\nTo evaluate the effects (benefits and harms) of different methods for conservative (non-operative) treatment for acute (treated soon after injury) middle third clavicle fractures in adolescents and adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE (from 1966), Embase (from 1980), LILACS (from 1982), trial registers, orthopaedic proceedings and reference lists of articles. We applied no language or publication restrictions. The date of the last search was 5 January 2016.\nSelection criteria\nRandomised and quasi-randomised controlled trials testing conservative interventions for treating adolescents and adults with acute middle third clavicle fractures. The primary outcomes were shoulder function or disability, pain and treatment failure.\nData collection and analysis\nFor this update, two review authors selected eligible trials, independently assessed risk of bias and cross-checked data extraction. We calculated risk ratios and 95% confidence intervals for dichotomous variables, and mean differences and 95% confidence intervals for continuous variables. There was very limited pooling of data.\nMain results\nWe included four trials in this review with 416 participants, who were aged 14 years or above. One new trial was included in this update.\nVery low quality evidence was available from three trials (296 participants) that compared the figure-of-eight bandage with an arm sling for treating acute middle third clavicle fractures. The three trials were underpowered and compromised by poor methodology. Shoulder function was assessed in different ways in the three trials (data for 51, 61 and 152 participants); each trial provided very low quality evidence of similar shoulder function in the two groups. Pooled data from two trials (203 participants) showed no clinical difference between groups after two weeks in pain (visual analogue scale: 0 (no pain) to 10 (worst pain); mean difference (MD) 0.43, 95% confidence interval (CI) -0.35 to 1.21; I² = 74%; very low quality evidence). A third trial (61 participants) provided very low quality evidence based on a non-validated scoring system of more pain and discomfort during the course of treatment in the figure-of-eight group. Treatment failure, measured in terms of subsequent surgery, was not reported in two trials; the third trial (152 participants) reported one participant in the arm sling group had surgery for secondary plexus nerve palsy. There was very low quality evidence from one trial (148 participants) of little difference in time to clinical fracture healing (MD 0.2 weeks, 95% CI -0.11 to 0.51); data from four non-symptomatic non-unions in the figure-of-eight group were not included. The very low evidence quality data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non-symptomatic non-union and permanent pain) did not confirm a difference between the two groups. There was no clear between group difference in the time to return to school or work activities (MD -0.12 weeks, 95% CI -0.69 to 0.45; 176 participants; very low quality evidence).\nModerate quality evidence was available from one trial (120 participants; reporting data for 101 participants), which evaluated therapeutic ultrasound. This trial was at low risk of bias but was underpowered and did not report on shoulder function or quality of life. The trial found no evidence of a difference between low-intensity pulsed ultrasound and placebo in pain, treatment failure (subsequent surgery: 6/52 versus 5/49; RR 1.13, 95% CI 0.37 to 3.47), the time to clinical fracture healing (MD -0.32 days, 95% CI -5.85 to 5.21), adverse events (one case of skin irritation was reported in each group) or time to resume previous activities.\nAuthors' conclusions\nThe current evidence available from randomised controlled trials is insufficient to determine which methods of conservative treatment are the most appropriate for acute middle third clavicle fractures in adolescents and adults. Further research is warranted.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The three studies (296 participants) comparing the figure-of-eight bandage versus an arm sling found similar shoulder function in the two groups at the end of follow-up. Although data from two studies did not show a difference in pain at two weeks after injury, the third study reported more pain and discomfort in people in the figure-of-eight bandage group. One participant was recorded as having surgery for a complication. None of the three studies found differences in time for fracture healing, adverse outcomes or time to return to school or work activities.\nThe fourth study compared therapeutic ultrasound with sham treatment in 120 people with clavicle fractures. It found no difference in outcome, including the time for fracture healing, between the two groups."
}
] |
query-laysum
|
21826
|
[
{
"role": "user",
"content": "Abstract: Background\nMost people with cystic fibrosis (CF) (80% to 90%) need pancreatic enzyme replacement therapy (PERT) to prevent malnutrition. Enzyme preparations need to be taken whenever food is taken, and the dose needs to be adjusted according to the food consumed. A systematic review on the efficacy and safety of PERT is needed to guide clinical practice, as there is variability between centres with respect to assessment of pancreatic function, time of commencing treatment, dose and choice of supplements. This is an updated version of a published review.\nObjectives\nTo evaluate the efficacy and safety of PERT in children and adults with CF and to compare the efficacy and safety of different formulations of PERT and their appropriateness in different age groups. Also, to compare the effects of PERT in CF according to different diagnostic subgroups (e.g. different ages at introduction of therapy and different categories of pancreatic function).\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 07 November 2019.\nWe also searched an ongoing trials website and the websites of the pharmaceutical companies who manufacture pancreatic enzyme replacements for any additional trials. Most recent search: 26 December 2019.\nSelection criteria\nRandomised and quasi-randomised controlled trials in people of any age, with CF and receiving PERT, at any dosage and in any formulation, for a period of not less than four weeks, compared to placebo or other PERT preparations.\nData collection and analysis\nTwo authors independently assessed trials and extracted outcome data. They also assessed the risk of bias and quality of the evidence (GRADE) of the trials included in the review.\nMain results\n14 trials were included in the review (641 children and adults with CF), two of these were parallel trials and 12 were cross-over trials. Interventions included different enteric and non-enteric-coated preparations of varying formulations in comparison to each other. The number of participants in each trial varied between 14 and 129. 13 trials were for a duration of four weeks and one trial lasted seven weeks. The majority of the trials had an unclear risk of bias from the randomisation process as the details of this were not given; they also had a high risk of attrition bias and reporting bias. The quality of the evidence ranged from moderate to very low.\nWe mostly could not combine data from the trials as they compared different formulations and the findings from individual trials provided insufficient evidence to determine the size and precision of the effects of different formulations.\nAuthors' conclusions\nThere is limited evidence of benefit from enteric-coated microspheres when compared to non-enteric coated pancreatic enzyme preparations up to one month. In the only comparison where we could combine any data, the fact that these were cross-over trials is likely to underestimate the level of inconsistency between the results of the trials due to over-inflation of CIs from the individual trials.There is no evidence on the long-term effectiveness and risks associated with PERT. There is also no evidence on the relative dosages of enzymes needed for people with different levels of severity of pancreatic insufficiency, optimum time to start treatment and variations based on differences in meals and meal sizes. There is a need for a properly designed trial that can answer these questions.\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 assessed 14 trials (641 adults and children with CF); 13 trials gave treatment for four weeks and one for seven weeks. Trials compared different formulations of PERT, some were treated to delay the release of the medication until they passed from the stomach into the intestine, while others were not. In 12 trials participants took both types of supplement for four weeks each, although the order in which they took them was random. These factors made it difficult to analyse trial results. Most of the trials were old; the most recent was from 2017, but the oldest was from 1986."
}
] |
query-laysum
|
21827
|
[
{
"role": "user",
"content": "Abstract: Background\nVarious rehabilitation treatments may be offered following carpal tunnel syndrome (CTS) surgery. The effectiveness of these interventions remains unclear. This is the first update of a review first published in 2013.\nObjectives\nTo review the effectiveness and safety of rehabilitation interventions following CTS surgery compared with no treatment, placebo, or another intervention.\nSearch methods\nOn 29 September 2015, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL Plus, AMED, LILACS, and PsycINFO. We also searched PEDro (3 December 2015) and clinical trials registers (3 December 2015).\nSelection criteria\nRandomised or quasi-randomised clinical trials that compared any postoperative rehabilitation intervention with either no intervention, placebo, or another postoperative rehabilitation intervention in individuals who had undergone CTS surgery.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, assessed risk of bias, and assessed the quality of the body of evidence for primary outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach according to standard Cochrane methodology.\nMain results\nIn this review we included 22 trials with a total of 1521 participants. Two of the trials were newly identified at this update. We studied different rehabilitation treatments including immobilisation using a wrist orthosis, dressings, exercise, controlled cold therapy, ice therapy, multi-modal hand rehabilitation, laser therapy, electrical modalities, scar desensitisation, and arnica. Three trials compared a rehabilitation treatment to a placebo, four compared rehabilitation to a no treatment control, three compared rehabilitation to standard care, and 15 compared various rehabilitation treatments to one another.\nOverall, the included studies were very low in quality. Thirteen trials explicitly reported random sequence generation; of these, five adequately concealed the allocation sequence. Four trials achieved blinding of both participants and outcome assessors. Five were at high risk of bias from incompleteness of outcome data at one or more time intervals, and eight had high risk of selective reporting bias.\nThese trials were heterogeneous in terms of treatments provided, duration of interventions, the nature and timing of outcomes measured, and setting. Therefore, we were not able to pool results across trials.\nFour trials reported our primary outcome, change in self reported functional ability at three months or more. Of these, three trials provided sufficient outcome data for inclusion in this review. One small high-quality trial studied a desensitisation programme compared with standard treatment and revealed no statistically significant functional benefit based on the Boston Carpal Tunnel Questionnaire (BCTQ) (mean difference (MD) -0.03, 95% confidence interval (CI) -0.39 to 0.33). One low-quality trial assessed participants six months post surgery using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and found no significant difference between a no formal therapy group and a group given a two-week course of multi-modal therapy commenced at five to seven days post surgery (MD 1.00, 95% CI -4.44 to 6.44). One very low-quality quasi-randomised trial found no statistically significant difference in function on the BCTQ at three months post surgery with early immobilisation (plaster wrist orthosis worn until suture removal) compared with a splint and late mobilisation (MD 0.39, 95% CI -0.45 to 1.23).\nDifferences between treatments for secondary outcome measures (change in self reported functional ability measured at less than three months; change in CTS symptoms; change in CTS-related impairment measures; presence of iatrogenic symptoms from surgery; return to work or occupation; and change in neurophysiological parameters) were generally small and not statistically significant. Few studies reported adverse events.\nAuthors' conclusions\nThere is limited and, in general, low quality evidence for the benefit of the reviewed interventions. People who have undergone CTS surgery should be informed about the limited evidence of effectiveness of postoperative rehabilitation interventions. Until researchers provide results of more high-quality trials that assess the effectiveness and safety of various rehabilitation treatments, the decision to provide rehabilitation following CTS surgery should be based on the clinician's expertise, the patient's preferences and the context of the rehabilitation environment. It is important for researchers to identify patients who respond to a particular treatment and those who do not, and to undertake high-quality studies that evaluate the severity of iatrogenic symptoms from surgery, measure function and return-to-work rates, and control for confounding variables.\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": "Carpal tunnel syndrome (CTS) is a condition in which a nerve that runs through a bony and fibrous tunnel in the wrist is compressed. This leads to pain, numbness and tingling in the hand, sometimes extending into the forearm. At advanced stages, some people with CTS have weakness and muscle wasting in the hand. CTS is more common in women and individuals with certain risk factors, such as diabetes, obesity, arthritis, older age, working in certain occupations, and previous wrist fracture. Many people undergo surgery to reduce pressure on the nerve, to lessen pain, and improve sensation and hand function. Sometimes individuals receive rehabilitation following CTS surgery. Rehabilitation treatments are believed to speed up recovery and manage pain or symptoms from the surgery itself. This is the first update of a review first published in 2013."
}
] |
query-laysum
|
21828
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review previously published in 2016.\nEpilepsy is a common neurological disorder, affecting 0.5% to 1% of the population. For nearly 30% of these people, their epilepsy is resistant to currently available drugs. Pharmacological treatment remains the first choice to control epilepsy. Lamotrigine is one of the newer antiepileptic drugs. Lamotrigine, in combination with other antiepileptic drugs (add-on), can reduce seizures, but with some adverse effects.\nObjectives\nTo determine the effects of lamotrigine on (1) seizures, (2) adverse-effect profile, and (3) cognition and quality of life, compared to placebo, when used as an add-on treatment for people with drug-resistant focal epilepsy.\nSearch methods\nFor the latest update of the review, we searched the following databases on 9 March 2020: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to March 06, 2020). CRS Web includes randomized or quasi-randomized, 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 Specialized Registers of Cochrane Review Groups including Epilepsy. No language restrictions were imposed.\nSelection criteria\nRandomised placebo-controlled trials of people with drug-resistant focal epilepsy of any age, in which an adequate method of concealment of randomisation was used. The studies were double-, single- or unblinded, placebo-controlled. For cross-over studies, the first treatment period was treated as a parallel trial. Eligible participants were adults or children with drug-resistant focal epilepsy.\nData collection and analysis\nFor this update, two review authors independently assessed the trials for inclusion, and extracted data. Outcomes included 50% or greater reduction in seizure frequency, treatment withdrawal (any reason), adverse effects, effects on cognition and quality of life. Primary analyses were by intention-to-treat. Sensitivity best- and worse-case analyses were undertaken to account for missing outcome data. Pooled risk ratios (RRs) with 95% confidence intervals (95% Cls) were estimated for the primary outcomes of seizure frequency and treatment withdrawal. For adverse effects, we calculated pooled RRs and 99% Cls.\nMain results\nWe did not identify any new studies for this update, therefore, the results and conclusions are unchanged.\nIn previous updates of this review, the authors found five parallel add-on studies, eight cross-over studies in adults or children with drug-resistant focal epilepsy, and one parallel add-on study with a responder-enriched design in infants. In total, these 14 studies included 1806 eligible participants (38 infants, 199 children, 1569 adults). Baseline phases ranged from four to 12 weeks; treatment phases from eight to 36 weeks. Overall, 11 studies (1243 participants) were rated as having low risk of bias, and three (697 participants) had unclear risk of bias due to lack of reported information around study design. Effective blinding of studies was reported in four studies (563 participants).\nThe overall risk ratio (RR) for 50% or greater reduction in seizure frequency was 1.80 (95% CI 1.45 to 2.23; 12 trials, 1322 participants (adults and children); moderate-certainty evidence) indicating that lamotrigine was significantly more effective than placebo in reducing seizure frequency. The overall RR for treatment withdrawal (for any reason) was 1.11 (95% CI 0.91 to 1.37; 14 trials; 1806 participants; moderate-certainty evidence). The adverse events significantly associated with lamotrigine were: ataxia, dizziness, diplopia (double vision), and nausea. The RR of these adverse effects were as follows: ataxia 3.34 (99% Cl 2.01 to 5.55; 12 trials; 1525 participants; high-certainty evidence); dizziness 2.00 (99% Cl 1.52 to 2.64;13 trials; 1768 participants; moderate-certainty evidence); diplopia 3.79 (99% Cl 2.15 to 6.68; 3 trials, 944 participants; high-certainty evidence); nausea 1.81 (99% Cl 1.22 to 2.68; 12 studies,1486 participants; moderate-certainty evidence). The limited data available precluded any conclusions about effects on cognition and quality of life. No important heterogeneity between studies was found for any of the outcomes. Overall, we assessed the evidence as high to moderate certainty, due to incomplete data for some outcomes.\nAuthors' conclusions\nLamotrigine as an add-on treatment for drug-resistant focal seizures appears to be effective in reducing seizure frequency, and seems to be fairly well-tolerated. However, the trials were of relatively short duration and provided no evidence for the long term. Further trials are needed to assess the long-term effects of lamotrigine, and to compare lamotrigine with other add-on drugs.\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": "Lamotrigine, used in combination with other AEDs in patients who have drug-resistant focal epilepsy can decrease the frequency of seizures further. However, adding lamotrigine to the usual treatment is more often associated with an increase in adverse effects such as unsteadiness (ataxia), dizziness, double vision (diplopia), and nausea."
}
] |
query-laysum
|
21829
|
[
{
"role": "user",
"content": "Abstract: Background\nMany people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not effective for pain in all people, neither are they well tolerated by all people. The aim of this review was to assess whether oxycodone is associated with better pain relief and tolerability than other analgesic options for adults with cancer pain. This is an updated Cochrane review previously published in 2017.\nObjectives\nTo assess the effectiveness and tolerability of oxycodone by any route of administration for pain in adults with cancer.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and MEDLINE In-Process (Ovid), Embase (Ovid), Science Citation Index, Conference Proceedings Citation Index - Science (ISI Web of Science), BIOSIS (ISI), and PsycINFO (Ovid) to November 2021. We also searched four trial registries, checked the bibliographic references of relevant studies, and contacted the authors of the included studies. We applied no language, date, or publication status restrictions.\nSelection criteria\nWe included randomised controlled trials (parallel-group or cross-over) comparing oxycodone (any formulation or route of administration) with placebo or an active drug (including oxycodone) for cancer background pain in adults by examining pain intensity/relief, adverse events, quality of life, and participant preference.\nData collection and analysis\nTwo review authors independently sifted the search, extracted data and assessed the included studies using standard Cochrane methodology. We meta-analysed pain intensity data using the generic inverse variance method, and pain relief and adverse events using the Mantel-Haenszel method, or summarised these data narratively along with the quality of life and participant preference data. We assessed the overall certainty of the evidence using GRADE.\nMain results\nFor this update, we identified 19 new studies (1836 participants) for inclusion. In total, we included 42 studies which enrolled/randomised 4485 participants, with 3945 of these analysed for efficacy and 4176 for safety. The studies examined a number of different drug comparisons.\nControlled-release (CR; typically taken every 12 hours) oxycodone versus immediate-release (IR; taken every 4-6 hours) oxycodone\nPooled analysis of three of the four studies comparing CR oxycodone to IR oxycodone suggest that there is little to no difference between CR and IR oxycodone in pain intensity (standardised mean difference (SMD) 0.12, 95% confidence interval (CI) -0.1 to 0.34; n = 319; very low-certainty evidence). The evidence is very uncertain about the effect on adverse events, including constipation (RR 0.71, 95% CI 0.45 to 1.13), drowsiness/somnolence (RR 1.03, 95% CI 0.69 to 1.54), nausea (RR 0.85, 95% CI 0.56 to 1.28), and vomiting (RR 0.66, 95% CI 0.38 to 1.15) (very low-certainty evidence). There were no data available for quality of life or participant preference, however, three studies suggested that treatment acceptability may be similar between groups (low-certainty evidence).\nCR oxycodone versus CR morphine\nThe majority of the 24 studies comparing CR oxycodone to CR morphine reported either pain intensity (continuous variable), pain relief (dichotomous variable), or both. Pooled analysis indicated that pain intensity may be lower (better) after treatment with CR morphine than CR oxycodone (SMD 0.14, 95% CI 0.01 to 0.27; n = 882 in 7 studies; low-certainty evidence). This SMD is equivalent to a difference of 0.27 points on the Brief Pain Inventory scale (0-10 numerical rating scale), which is not clinically significant. Pooled analyses also suggested that there may be little to no difference in the proportion of participants achieving complete or significant pain relief (RR 1.02, 95% CI 0.95 to 1.10; n = 1249 in 13 studies; low-certainty evidence).\nThe RR for constipation (RR 0.75, 95% CI 0.66 to 0.86) may be lower after treatment with CR oxycodone than after CR morphine. Pooled analyses showed that, for most of the adverse events, the CIs were wide, including no effect as well as potential benefit and harm: drowsiness/somnolence (RR 0.88, 95% CI 0.74 to 1.05), nausea (RR 0.93, 95% CI 0.77 to 1.12), and vomiting (RR 0.81, 95% CI 0.63 to 1.04) (low or very low-certainty evidence). No data were available for quality of life. The evidence is very uncertain about the treatment effects on treatment acceptability and participant preference.\nOther comparisons\nThe remaining studies either compared oxycodone in various formulations or compared oxycodone to different alternative opioids. None found any clear superiority or inferiority of oxycodone for cancer pain, neither as an analgesic agent nor in terms of adverse event rates and treatment acceptability. The certainty of this evidence base was limited by the high or unclear risk of bias of the studies and by imprecision due to low or very low event rates or participant numbers for many outcomes.\nAuthors' conclusions\nThe conclusions have not changed since the previous version of this review (in 2017). We found low-certainty evidence that there may be little to no difference in pain intensity, pain relief and adverse events between oxycodone and other strong opioids including morphine, commonly considered the gold standard strong opioid. Although we identified a benefit for pain relief in favour of CR morphine over CR oxycodone, this was not clinically significant and did not persist following sensitivity analysis and so we do not consider this important. However, we found that constipation and hallucinations occurred less often with CR oxycodone than with CR morphine; but the certainty of this evidence was either very low or the finding did not persist following sensitivity analysis, so these findings should be treated with utmost caution. Our conclusions are consistent with other reviews and suggest that, while the reliability of the evidence base is low, given the absence of important differences within this analysis, it seems unlikely that larger head-to-head studies of oxycodone versus morphine are justified, although well-designed trials comparing oxycodone to other strong analgesics may well be useful. For clinical purposes, oxycodone or morphine can be used as first-line oral opioids for relief of cancer pain in adults.\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": "For this update, in November 2021, we found 19 additional relevant studies. In total, we included 42 studies with 4485 participants. These studies compared the painkilling ability (benefit) and side effects (harms) of different types of oxycodone to each other or to other strong painkillers."
}
] |
query-laysum
|
21830
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane Review last published in 2017. Survivors of stroke due to intracerebral haemorrhage (ICH) are at risk of major adverse cardiovascular events (MACE). Antithrombotic (antiplatelet or anticoagulant) treatments may lower the risk of ischaemic MACE after ICH, but they may increase the risk of bleeding.\nObjectives\nTo determine the overall effectiveness and safety of antithrombotic drugs on MACE and its components for people with ICH.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (5 October 2021). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL: the Cochrane Library 2021, Issue 10), MEDLINE Ovid (from 1948 to October 2021) and Embase Ovid (from 1980 to October 2021). The online registries of clinical trials searched were the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (5 October 2021). We screened the reference lists of included randomised controlled trials (RCTs) for additional, potentially relevant RCTs.\nSelection criteria\nWe selected RCTs in which participants with ICH of any age were allocated to a class of antithrombotic treatment as intervention or comparator.\nData collection and analysis\nIn accordance with standard methodological procedures recommended by Cochrane, two review authors assessed each selected RCT for its risk of bias and extracted data independently. The primary outcome was a composite of MACE, and secondary outcomes included death, individual components of the MACE composite, ICH growth, functional status and cognitive status. We estimated effects using the frequency of outcomes that occurred during the entire duration of follow-up and calculated a risk ratio (RR) for each RCT. We grouped RCTs separately for analysis according to 1) the class(es) of antithrombotic treatment used for the intervention and comparator, and 2) the duration of antithrombotic treatment use (short term versus long term). We pooled the intention-to-treat populations of RCTs using a fixed-effect model for meta-analysis, but used a random-effects model if RCTs differed substantially in their design or there was considerable heterogeneity (I2 ≥ 75%) in their results. We applied GRADE to assess the certainty of the evidence.\nMain results\nWe identified seven new completed RCTs for this update, resulting in the inclusion of a total of nine RCTs based in secondary care, comprising 1491 participants (average age ranged from 61 to 79 years and the proportion of men ranged from 44% to 67%). The proportion of included RCTs at low risk of bias, by category was: random sequence generation (67%), allocation concealment (67%), performance (22%), detection (78%), attrition (89%), and reporting (78%).\nFor starting versus avoiding short-term prophylactic dose anticoagulation after ICH, no RCT reported MACE. The evidence is very uncertain about the effect of starting short-term prophylactic dose anticoagulation on death (RR 1.00, 95% CI 0.59 to 1.70, P = 1.00; 3 RCTs; very low-certainty evidence), venous thromboembolism (RR 0.84, 95% CI 0.51 to 1.37, P = 0.49; 4 RCTs; very low-certainty evidence), ICH (RR 0.24, 95% CI 0.04 to 1.38, P = 0.11; 2 RCTs; very low-certainty evidence), and independent functional status (RR 2.03, 95% CI 0.78 to 5.25, P = 0.15; 1 RCT; very low-certainty evidence) over 90 days.\nFor starting versus avoiding long-term therapeutic dose oral anticoagulation for atrial fibrillation after ICH, starting long-term therapeutic dose oral anticoagulation probably reduces MACE (RR 0.61, 95% CI 0.40 to 0.94, P = 0.02; 3 RCTs; moderate-certainty evidence) and probably reduces all major occlusive vascular events (RR 0.27, 95% CI 0.14 to 0.53, P = 0.0002; 3 RCTs; moderate-certainty evidence), but probably results in little to no difference in death (RR 1.05, 95% CI 0.62 to 1.78, P = 0.86; 3 RCTs; moderate-certainty evidence), probably increases intracranial haemorrhage (RR 2.43, 95% CI 0.88 to 6.73, P = 0.09; 3 RCTs; moderate-certainty evidence), and may result in little to no difference in independent functional status (RR 0.98, 95% CI 0.78 to 1.24, P = 0.87; 2 RCTs; low-certainty evidence) over one to three years.\nFor starting versus avoiding long-term antiplatelet therapy after ICH, the evidence is uncertain about the effects of starting long-term antiplatelet therapy on MACE (RR 0.89, 95% CI 0.64 to 1.22, P = 0.46; 1 RCT; moderate-certainty evidence), death (RR 1.08, 95% CI 0.76 to 1.53, P = 0.66; 1 RCT; moderate-certainty evidence), all major occlusive vascular events (RR 1.03, 95% CI 0.68 to 1.55, P = 0.90; 1 RCT; moderate-certainty evidence), ICH (RR 0.52, 95% CI 0.27 to 1.03, P = 0.06; 1 RCT; moderate-certainty evidence) and independent functional status (RR 0.95, 95% CI 0.77 to 1.18, P = 0.67; 1 RCT; moderate-certainty evidence) over a median follow-up of two years.\nFor adults within 180 days of non-cardioembolic ischaemic stroke or transient ischaemic attack and a clinical history of prior ICH, there was no evidence of an effect of long-term cilostazol compared to aspirin on MACE (RR 1.33, 95% CI 0.74 to 2.40, P = 0.34; subgroup of 1 RCT; low-certainty evidence), death (RR 1.65, 95% CI 0.55 to 4.91, P = 0.37; subgroup of 1 RCT; low-certainty evidence), or ICH (RR 1.29, 95% CI 0.35 to 4.69, P = 0.70; subgroup of 1 RCT; low-certainty evidence) over a median follow-up of 1.8 years; all major occlusive vascular events and functional status were not reported.\nAuthors' conclusions\nWe did not identify beneficial or hazardous effects of short-term prophylactic dose parenteral anticoagulation and long-term oral antiplatelet therapy after ICH on important outcomes. Although there was a significant reduction in MACE and all major occlusive vascular events after long-term treatment with therapeutic dose oral anticoagulation for atrial fibrillation after ICH, the pooled estimates were imprecise, the certainty of evidence was only moderate, and effects on other important outcomes were uncertain. Large RCTs with a low risk of bias are required to resolve the ongoing dilemmas about antithrombotic treatment after ICH.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Although antithrombotic drugs appear to be promising after brain haemorrhage, we cannot be certain on the basis of the trials that have been done so far. Larger trials are needed to be sure about the effects of these drugs after brain haemorrhage. Eight ongoing trials will help resolve these uncertainties if they recruit large numbers of participants."
}
] |
query-laysum
|
21831
|
[
{
"role": "user",
"content": "Abstract: Background\nGlaucoma is a heterogeneous group of conditions involving progressive damage to the optic nerve, deterioration of retinal ganglion cells, and ultimately visual field loss. It is a leading cause of blindness worldwide. Open angle glaucoma (OAG), the most common form of glaucoma, is a chronic condition that may or may not present with increased intraocular pressure (IOP). Neuroprotection for glaucoma refers to any intervention intended to prevent optic nerve damage or cell death.\nObjectives\nThe objective of this review was to systematically examine the evidence regarding the effectiveness of neuroprotective agents for slowing the progression of OAG in adults compared with no neuroprotective agent, placebo, or other glaucoma treatment.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 7), Ovid MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily (January 1946 to August 2016), Embase (January 1980 to August 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to August 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 16 August 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which topical or oral treatments were used for neuroprotection in adults with OAG. Minimum follow-up time was four years.\nData collection and analysis\nTwo review authors independently reviewed titles and abstracts from the literature searches. We obtained full-text copies of potentially relevant studies and re-evaluated for inclusion. Two review authors independently extracted data related to study characteristics, risk of bias, and outcomes. We identified one trial for this review, thus we performed no meta-analysis. Two studies comparing memantine to placebo are currently awaiting classification until study investigators provide additional study details. We documented reasons for excluding studies from the review.\nMain results\nWe included one multicenter RCT of adults with low-pressure glaucoma (Low-pressure Glaucoma Treatment Study, LoGTS) conducted in the USA. The primary outcome was progression of visual field loss after four years of treatment with either brimonidine or timolol. Of the 190 adults enrolled in the study, the investigators excluded 12 (6.3%) after randomization; 77 participants (40.5%) did not complete four years of follow-up. The rate of attrition was unbalanced between groups with more participants dropping out of the brimonidine group (55%) than the timolol group (29%).\nOf those remaining in the study at four years, participants assigned to brimonidine showed less progression of visual field loss than participants assigned to timolol (risk ratio (RR) 0.35, 95% confidence interval (CI) 0.14 to 0.86; 101 participants). Because of high risk of attrition bias and potential selective outcome reporting, we graded the certainty of evidence for this outcome as very low. At the four-year follow-up, the mean IOP was similar in both groups among those for whom data were available (mean difference 0.20 mmHg, 95% CI -0.73 to 1.13; 91 participants; very low-certainty evidence). The study authors did not report analyzable data for visual acuity or any data related to vertical cup-disc ratio, quality of life, or economic outcomes. The most frequent adverse event was ocular allergy to the study drug, which affected more participants in the brimonidine group than the timolol group (RR 5.32, 95% CI 1.64 to 17.26; 178 participants; very low-certainty evidence).\nAuthors' conclusions\nAlthough the only trial we included in this review found less visual field loss in the brimonidine-treated group, the evidence was of such low certainty that we can draw no conclusions from this finding. Further clinical research is needed to determine whether neuroprotective agents may be beneficial for individuals with OAG. Such research should focus on outcomes important to patients, such as preservation of vision, and how these outcomes relate to cell death and optic nerve damage. As OAG is a chronic, progressive disease with variability in symptoms, RCTs designed to measure the effectiveness of neuroprotective agents require a long-term follow-up of five years or longer to detect clinically meaningful effects.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 16 August 2016."
}
] |
query-laysum
|
21832
|
[
{
"role": "user",
"content": "Abstract: Background\nAffordable, feasible and efficacious interventions to reduce neonatal infections and improve neonatal survival are needed. Chlorhexidine, a broad spectrum topical antiseptic agent, is active against aerobic and anaerobic organisms and reduces neonatal bacterial colonisation and may reduce infection.\nObjectives\nTo evaluate the efficacy of neonatal skin or cord care with chlorhexidine versus routine care or no treatment for prevention of infections in late preterm or term newborn infants in hospital and community settings.\nSearch methods\nWe searched CENTRAL, latest issue of The Cochrane Library, MEDLINE (1966 to November 2013), EMBASE (1980 to November 2013), and CINAHL (1982 to November 2013). Ongoing trials were detected by searching the following databases: www.clinicaltrials.gov and www.controlled-trials.com.\nSelection criteria\nCluster and individual patient randomised controlled trials of chlorhexidine use (for skin care, or cord care, or both) in term or late preterm neonates in hospital and community settings were eligible for inclusion. Three authors independently screened and selected studies for inclusion.\nData collection and analysis\nTwo review authors independently extracted data, and assessed study risk of bias. The quality of evidence for each outcome was assessed using GRADE. We calculated pooled risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs), and presented results using GRADE 'Summary of findings' tables.\nMain results\nWe included 12 trials in this review. There were seven hospital-based and five community-based studies. In four studies maternal vaginal wash with chlorhexidine was done in addition to neonatal skin and cord care.\nNewborn skin or cord cleansing with chlorhexidine compared to usual care in hospitals\nLow-quality evidence from one trial showed that chlorhexidine cord cleansing compared to dry cord care may lead to no difference in neonatal mortality (RR 0.11, 95% CI 0.01 to 2.04). Moderate-quality evidence from two trials showed that chlorhexidine cord cleansing compared to dry cord care probably reduces the risk of omphalitis/infections (RR 0.48, 95% CI 0.28 to 0.84).\nLow-quality evidence from two trials showed that chlorhexidine skin cleansing compared to dry cord care may lead to no difference in omphalitis/infections (RR 0.88, 95% CI 0.56 to 1.39). None of the studies in this comparison reported effects of the treatments on neonatal mortality.\nNewborn skin or cord cleansing with chlorhexidine compared to usual care in the community\nHigh-quality evidence from three trials showed that chlorhexidine cord cleansing compared to dry cord care reduces neonatal mortality (RR 0.81, 95% CI 0.71 to 0.92) and omphalitis/infections (RR 0.48, 95% CI 0.40 to 0.57).\nHigh-quality evidence from one trial showed no difference between chlorhexidine skin cleansing and usual skin care on neonatal mortality (RR 1.03, 95% CI 0.87 to 1.23). None of the studies in this comparison reported effects of the treatments on omphalitis/infections.\nMaternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention (sterile saline solution) in hospitals\nModerate-quality evidence from one trial showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on neonatal mortality (RR 0.98, 95% CI 0.67 to 1.42). High-quality evidence from two trials showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on the risk of infections (RR 0.93, 95% CI 0.82 to 1.16).\nFindings from one trial showed that maternal vaginal cleansing in addition to total body cleansing results in increased risk of hypothermia (RR 1.33, 95% CI 1.19 to 1.49).\nMaternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention (sterile saline solution) in the community\nLow-quality evidence from one trial showed no difference between maternal vaginal chlorhexidine in addition to total body cleansing and no intervention on neonatal mortality (RR 0.20, 95% CI 0.01 to 4.03). Moderate-quality evidence from one trial showed that maternal vaginal chlorhexidine in addition to total body cleansing compared to no intervention probably reduces the risk of neonatal infections (RR 0.69, 95% CI 0.49 to 0.95). These studies did not report effect on omphalitis.\nAuthors' conclusions\nThere is some uncertainty as to the effect of chlorhexidine applied to the umbilical cords of newborns in hospital settings on neonatal mortality. The quality of evidence for the effects on infection are moderate for cord application and low for application to skin. There is high-quality evidence that chlorhexidine skin or cord care in the community setting results in a 50% reduction in the incidence of omphalitis and a 12% reduction in neonatal mortality. Maternal vaginal chlorhexidine compared to usual care probably leads to no difference in neonatal mortality in hospital settings. Maternal vaginal chlorhexidine compared to usual care results in no difference in the risk of infections in hospital settings. The uncertainty over the effect of maternal vaginal chlorhexidine on mortality outcomes reflects small sample sizes and low event rates in the community settings.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
21833
|
[
{
"role": "user",
"content": "Abstract: Background\nHigh intracranial pressure (ICP) is the most frequent cause of death and disability after severe traumatic brain injury (TBI). It is usually treated with general maneuvers (normothermia, sedation, etc.) and a set of first-line therapeutic measures (moderate hypocapnia, mannitol, etc.). When these measures fail, second-line therapies are initiated, which include: barbiturates, hyperventilation, moderate hypothermia, or removal of a variable amount of skull bone (secondary decompressive craniectomy).\nObjectives\nTo assess the effects of secondary decompressive craniectomy (DC) on outcomes of patients with severe TBI in whom conventional medical therapeutic measures have failed to control raised ICP.\nSearch methods\nThe most recent search was run on 8 December 2019. We searched the Cochrane Injuries Group's Specialised Register, CENTRAL (Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic + Embase (OvidSP) and ISI Web of Science (SCI-EXPANDED & CPCI-S). We also searched trials registries and contacted experts.\nSelection criteria\nWe included randomized studies assessing patients over the age of 12 months with severe TBI who either underwent DC to control ICP refractory to conventional medical treatments or received standard care.\nData collection and analysis\nWe selected potentially relevant studies from the search results, and obtained study reports. Two review authors independently extracted data from included studies and assessed risk of bias. We used a random-effects model for meta-analysis. We rated the quality of the evidence according to the GRADE approach.\nMain results\nWe included three trials (590 participants). One single-site trial included 27 children; another multicenter trial (three countries) recruited 155 adults, the third trial was conducted in 24 countries, and recruited 408 adolescents and adults. Each study compared DC combined with standard care (this could include induced barbiturate coma or cooling of the brain, or both). All trials measured outcomes up to six months after injury; one also measured outcomes at 12 and 24 months (the latter data remain unpublished). All trials were at a high risk of bias for the criterion of performance bias, as neither participants nor personnel could be blinded to these interventions. The pediatric trial was at a high risk of selection bias and stopped early; another trial was at risk of bias because of atypical inclusion criteria and a change to the primary outcome after it had started.\nMortality: pooled results for three studies provided moderate quality evidence that risk of death at six months was slightly reduced with DC (RR 0.66, 95% CI 0.43 to 1.01; 3 studies, 571 participants; I2 = 38%; moderate-quality evidence), and one study also showed a clear reduction in risk of death at 12 months (RR 0.59, 95% CI 0.45 to 0.76; 1 study, 373 participants; high-quality evidence).\nNeurological outcome: conscious of controversy around the traditional dichotomization of the Glasgow Outcome Scale (GOS) scale, we chose to present results in three ways, in order to contextualize factors relevant to clinical/patient decision-making.\nFirst, we present results of death in combination with vegetative status, versus other outcomes. Two studies reported results at six months for 544 participants. One employed a lower ICP threshold than the other studies, and showed an increase in the risk of death/vegetative state for the DC group. The other study used a more conventional ICP threshold, and results favoured the DC group (15.7% absolute risk reduction (ARR) (95% CI 6% to 25%). The number needed to treat for one beneficial outcome (NNTB) (i.e. to avoid death or vegetative status) was seven. The pooled result for DC compared with standard care showed no clear benefit for either group (RR 0.99, 95% CI 0.46 to 2.13; 2 studies, 544 participants; I2 = 86%; low-quality evidence). One study reported data for this outcome at 12 months, when the risk for death or vegetative state was clearly reduced by DC compared with medical treatment (RR 0.68, 95% CI 0.54 to 0.86; 1 study, 373 participants; high-quality evidence).\nSecond, we assessed the risk of an 'unfavorable outcome' evaluated on a non-traditional dichotomized GOS-Extended scale (GOS-E), that is, grouping the category 'upper severe disability' into the 'good outcome' grouping. Data were available for two studies (n = 571). Pooling indicated little difference between DC and standard care regarding the risk of an unfavorable outcome at six months following injury (RR 1.06, 95% CI 0.69 to 1.63; 544 participants); heterogeneity was high, with an I2 value of 82%. One trial reported data at 12 months and indicated a clear benefit of DC (RR 0.81, 95% CI 0.69 to 0.95; 373 participants).\nThird, we assessed the risk of an 'unfavorable outcome' using the (traditional) dichotomized GOS/GOS-E cutoff into 'favorable' versus 'unfavorable' results. There was little difference between DC and standard care at six months (RR 1.00, 95% CI 0.71 to 1.40; 3 studies, 571 participants; low-quality evidence), and heterogeneity was high (I2 = 78%). At 12 months one trial suggested a similar finding (RR 0.95, 95% CI 0.83 to 1.09; 1 study, 373 participants; high-quality evidence).\nWith regard to ICP reduction, pooled results for two studies provided moderate quality evidence that DC was superior to standard care for reducing ICP within 48 hours (MD −4.66 mmHg, 95% CI −6.86 to −2.45; 2 studies, 182 participants; I2 = 0%). Data from the third study were consistent with these, but could not be pooled.\nData on adverse events are difficult to interpret, as mortality and complications are high, and it can be difficult to distinguish between treatment-related adverse events and the natural evolution of the condition. In general, there was low-quality evidence that surgical patients experienced a higher risk of adverse events.\nAuthors' conclusions\nDecompressive craniectomy holds promise of reduced mortality, but the effects of long-term neurological outcome remain controversial, and involve an examination of the priorities of participants and their families. Future research should focus on identifying clinical and neuroimaging characteristics to identify those patients who would survive with an acceptable quality of life; the best timing for DC; the most appropriate surgical techniques; and whether some synergistic treatments used with DC might improve patient 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": "We identified three relevant trials. One included 27 children (under 18 years); another trial was conducted in multiple sites and recruited 155 adults; and the third was conducted in 24 countries and recruited 408 participants (adolescents and adults). Each compared DC plus standard medical care against standard medical care alone.\nIn trials, the results are more reliable if patients and medical staff are unaware of which treatment a patient receives. However, the treatment given was evident in these trials, as it is not possible to conceal this type of surgery. The reliability of the results from the trial on children might have been affected because of the methods used to decide which children had DC, and because the trial stopped early. Similarly, the results of another trial might have been affected because of the treatment point at which DC was performed, and because of changes in methods for measuring outcomes. The third trial fit all of our criteria, and was well-conducted."
}
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.