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22240
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[
{
"role": "user",
"content": "Abstract: Background\nPrimary hyperparathyroidism (PHPT), a disorder in which the parathyroid glands produce excessive amounts of parathyroid hormone, is most common in older adults and postmenopausal women. While most people with PHPT are asymptomatic at diagnosis, symptomatic disease can lead to hypercalcaemia, osteoporosis, renal stones, cardiovascular abnormalities and reduced quality of life. Surgical removal of abnormal parathyroid tissue (parathyroidectomy) is the only established treatment for adults with symptomatic PHPT to prevent exacerbation of symptoms and to be cured of PHPT. However, the benefits and risks of parathyroidectomy compared to simple observation or medical therapy for asymptomatic and mild PHPT are not well established.\nObjectives\nTo evaluate the benefits and harms of parathyroidectomy in adults with PHPT compared to simple observation or medical therapy.\nSearch methods\nWe searched CENTRAL, MEDLINE, LILACS, ClinicalTrials.gov and WHO ICTRP from their date of inception until 26 November 2021. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing parathyroidectomy with simple observation or medical therapy for the treatment of adults with PHPT.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. cure of PHPT, 2. morbidity related to PHPT and 3. serious adverse events. Our secondary outcomes were 1. all-cause mortality, 2. health-related quality of life and 3. hospitalisation for hypercalcaemia, acute renal impairment or pancreatitis. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe identified eight eligible RCTs that included 447 adults with (mostly asymptomatic) PHPT; 223 participants were randomised to parathyroidectomy. Follow-up duration varied from six months to 24 months.\nOf the 223 participants (37 men) randomised to surgery, 164 were included in the analyses, of whom 163 were cured at six to 24 months (overall cure rate 99%). Parathyroidectomy compared to observation probably results in a large increase in cure rate at six to 24 months follow-up: 163/164 participants (99.4%) in the parathyroidectomy group and 0/169 participants in the observation or medical therapy group were cured of their PHPT (8 studies, 333 participants; moderate certainty).\nNo studies explicitly reported intervention effects on morbidities related to PHPT, such as osteoporosis, osteopenia, kidney dysfunction, urolithiasis, cognitive dysfunction or cardiovascular disease, although some studies reported surrogate outcomes for osteoporosis and cardiovascular disease. A post-hoc analysis revealed that parathyroidectomy, compared to observation or medical therapy, may have little or no effect after one to two years on bone mineral density (BMD) at the lumbar spine (mean difference (MD) 0.03 g/cm2,95% CI −0.05 to 0.12; 5 studies, 287 participants; very low certainty). Similarly, compared to observation, parathyroidectomy may have little or no effect on femoral neck BMD after one to two years (MD −0.01 g/cm2, 95% CI −0.13 to 0.11; 3 studies, 216 participants; very low certainty). However, the evidence is very uncertain for both BMD outcomes. Furthermore, the evidence is very uncertain about the effect of parathyroidectomy on improving left ventricular ejection fraction (MD −2.38%, 95% CI −4.77 to 0.01; 3 studies, 121 participants; very low certainty).\nFour studies reported serious adverse events. Three of these reported zero events in both the intervention and control groups; consequently, we were unable to include data from these three studies in the pooled analysis. The evidence suggests that parathyroidectomy compared to observation may have little or no effect on serious adverse events (RR 3.35, 95% CI 0.14 to 78.60; 4 studies, 168 participants; low certainty).\nOnly two studies reported all-cause mortality. One study could not be included in the pooled analysis as zero events were observed in both the intervention and control groups. Parathyroidectomy compared to observation may have little or no effect on all-cause mortality, but the evidence is very uncertain (RR 2.11, 95% CI 0.20 to 22.60; 2 studies, 133 participants; very low certainty).\nThree studies measured health-related quality of life using the 36-Item Short Form Health Survey (SF-36) and reported inconsistent differences in scores for different domains of the questionnaire between parathyroidectomy and observation.\nSix studies reported hospitalisations for the correction of hypercalcaemia. Two studies reported zero events in both the intervention and control groups and could not be included in the pooled analysis. Parathyroidectomy, compared to observation, may have little or no effect on hospitalisation for hypercalcaemia (RR 0.91, 95% CI 0.20 to 4.25; 6 studies, 287 participants; low certainty). There were no reported hospitalisations for renal impairment or pancreatitis.\nAuthors' conclusions\nIn accordance with the literature, our review findings suggest that parathyroidectomy, compared to simple observation or medical (etidronate) therapy, probably results in a large increase in cure rates of PHPT (with normalisation of serum calcium and parathyroid hormone levels to laboratory reference values). Parathyroidectomy, compared with observation, may have little or no effect on serious adverse events or hospitalisation for hypercalcaemia, and the evidence is very uncertain about the effect of parathyroidectomy on other short-term outcomes, such as BMD, all-cause mortality and quality of life. The high uncertainty of evidence limits the applicability of our findings to clinical practice; indeed, this systematic review provides no new insights with regard to treatment decisions for people with (asymptomatic) PHPT. In addition, the methodological limitations of the included studies, and the characteristics of the study populations (mainly comprising white women with asymptomatic PHPT), warrant caution when extrapolating the results to other populations with PHPT.\nLarge-scale multi-national, multi-ethnic and long-term RCTs are needed to explore the potential short- and long-term benefits of parathyroidectomy compared to non-surgical treatment options with regard to osteoporosis or osteopenia, urolithiasis, hospitalisation for acute kidney injury, cardiovascular disease and quality of life.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date to 26 November 2021."
}
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query-laysum
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22241
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[
{
"role": "user",
"content": "Abstract: Background\nGerminal matrix-intraventricular haemorrhage (GMH-IVH) and encephalopathy of prematurity (EoP) remain substantial issues in neonatal intensive care units worldwide. Current therapies to prevent or treat these conditions are limited. Stem cell-based therapies offer a potential therapeutic approach to repair, restore, or regenerate injured brain tissue. These preclinical findings have now culminated in ongoing human neonatal studies. This is an update of the 2019 review, which did not include EoP.\nObjectives\nTo evaluate the benefits and harms of stem cell-based interventions for prevention or treatment of GM-IVH and EoP in preterm infants.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was April 2022.\nSelection criteria\nWe attempted to include randomised controlled trials, quasi-randomised controlled trials, and cluster trials comparing 1. stem cell-based interventions versus control; 2. mesenchymal stromal cells (MSCs) of type or source versus MSCs of other type or source; 3. stem cell-based interventions other than MSCs of type or source versus stem cell-based interventions other than MSCs of other type or source; or 4. MSCs versus stem cell-based interventions other than MSCs. For prevention studies, we included extremely preterm infants (less than 28 weeks' gestation), 24 hours of age or less, without ultrasound diagnosis of GM-IVH or EoP; for treatment studies, we included preterm infants (less than 37 weeks' gestation), of any postnatal age, with ultrasound diagnosis of GM-IVH or with EoP.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. all-cause neonatal mortality, 2. major neurodevelopmental disability, 3. GM-IVH, 4. EoP, and 5. extension of pre-existing non-severe GM-IVH or EoP. We planned to use GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified no studies that met our inclusion criteria. Three studies are currently registered and ongoing. Phase 1 trials are described in the 'Excluded studies' section.\nAuthors' conclusions\nNo evidence is currently available to evaluate the benefits and harms of stem cell-based interventions for treatment or prevention of GM-IVH or EoP in preterm infants. We identified three ongoing studies, with a sample size range from 20 to 200. In two studies, autologous cord blood mononuclear cells will be administered to extremely preterm infants via the intravenous route; in one, intracerebroventricular injection of MSCs will be administered to preterm infants up to 34 weeks' gestational age.\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 were unable to include any studies in our review. We did identify nine studies, but we excluded them because of the way they were designed, which meant that their results could not answer our review question."
}
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query-laysum
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22242
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[
{
"role": "user",
"content": "Abstract: Background\nRoad traffic suicides are common. However, due to the difficulty in distinguishing between motor vehicle crash fatalities and actual suicides, no official figures exist for this method of suicide. Restricting access to means is an important universal or population-based approach to suicide prevention with clear evidence of its effectiveness. However, the evidence with respect to means restriction for the prevention of suicide on roads is not well established. We conducted a systematic review to assess the impact of restrictions on the availability of, or access to, means of suicide on roads.\nObjectives\nTo evaluate the effectiveness of interventions to restrict the availability of, or access to, means of suicide on roads.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, PsycINFO, and the Transport Research International Documentation (TRID) Database from the date of database inception to March 2020. We conducted searches of the World Health Organization International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov to identify unpublished and ongoing studies. We applied no date, language, or publication status restrictions to these searches.\nSelection criteria\nEligible studies were randomised or quasi-randomised controlled trials, controlled intervention studies without randomisation, before-after studies, or studies using interrupted time series designs, which evaluated interventions to restrict the availability of, or access to, means of suicide on roads.\nData collection and analysis\nTwo review authors screened abstracts and full-text publications against the inclusion criteria. Two review authors planned to independently extract data and assess risk of bias of included studies. However, we identified no studies eligible for inclusion.\nMain results\nWe identified no studies that met the inclusion criteria for this review.\nAuthors' conclusions\nThis systematic review highlights the paucity of research around road traffic suicides and the need for future robust studies that aim to investigate the effectiveness of interventions to prevent suicide on roads. Suicide ascertainment is a key issue; therefore, clear objective criteria are necessary in order to scale up and study this method more accurately. In the absence of any substantial evidence, we advocate for more awareness on road traffic suicides and its inclusion in future government suicide prevention policies. Further research exploring effective measures, particularly those that do not require driver compliance, are also needed.\n\nGiven the provided abstract, please respond to the following query: \"Searching for evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched several medical databases to find studies that assessed the impact of restricting access to means of suicide on roads. We searched the databases up to March 2020. We also searched international trial registries for unpublished and ongoing studies. Our main outcomes of interest were suicide and attempted suicide or self-harm."
}
] |
query-laysum
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22243
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[
{
"role": "user",
"content": "Abstract: Background\nPterygium, a growth of the conjunctiva over the cornea, is a progressive disease leading in advanced stages to visual impairment, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence can be a problem. Currently the best surgical option in terms of recurrence is conjunctival autograft. To date the most common surgical methods of attaching conjunctival autografts to the sclera are through suturing or fibrin glue. Each method presents its own advantages and disadvantages. Sutures require considerable skill from the surgeon and can be associated with a prolonged operation time, postoperative discomfort and suture-related complications, whereas fibrin glue may give a decreased operation time, improve postoperative comfort and avoid suture-related problems.\nObjectives\nTo assess the effectiveness of fibrin glue compared to sutures in conjunctival autografting for the surgical treatment of pterygium.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2016), Embase (January 1980 to October 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 14 October 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) in any setting where fibrin glue was compared with sutures to treat people with pterygium.\nData collection and analysis\nTwo review authors independently screened the search results, assessed trial quality, and extracted data using standard methodological procedures expected by Cochrane. Our primary outcome was recurrence of pterygium defined as any re-growth of tissue from the area of excision across the limbus onto the cornea. The secondary outcomes were surgical time and complication rate. We graded the certainty of the evidence using GRADE.\nMain results\nWe included 14 RCTs conducted in Brazil, China, Egypt, India, Malaysia, New Zealand, Philippines, Saudi Arabia, Sweden and Turkey. The trials were published between 2004 and 2016, and were assessed as a mixture of unclear and low risk of bias with three studies at high risk of attrition bias. Only adults were enrolled in these studies.\nUsing fibrin glue for the conjunctival autograft may result in less recurrence of pterygium compared with using sutures (risk ratio (RR) 0.47, 95% CI 0.27 to 0.82, 762 eyes, 12 RCTs; low-certainty evidence). If pterygium recurs after approximately 10 in every 100 surgeries with sutures, then using fibrin glue may result in approximately 5 fewer cases of recurrence in every 100 surgeries (95% CI 2 fewer to 7 fewer cases). Using fibrin glue may lead to more complications compared with sutures (RR 1.92; 95% CI 1.22 to 3.02, 11 RCTs, 673 eyes, low-certainty evidence). The most common complications reported were: graft dehiscence, graft retraction and granuloma. On average using fibrin glue may mean that surgery is quicker compared with suturing (mean difference (MD) -17.01 minutes 95% CI -20.56 to -13.46), 9 RCTs, 614 eyes, low-certainty evidence).\nAuthors' conclusions\nThe meta-analyses, conducted on people with pterygium in a hospital or outpatient setting, show fibrin glue may result in less recurrence and may take less time than sutures for fixing the conjunctival graft in place during pterygium surgery. There was low-certainty evidence to suggest a higher proportion of complications in the fibrin glue group.\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": "Sometimes a piece of tissue can grow on the front of the eye, and if it grows large enough it can affect vision. This tissue is known as a pterygium. People who live in hot, dusty places with high sunlight are more likely to get a pterygium. A pterygium can be uncomfortable and itchy, and may affect the appearance of the eye.\nDoctors can remove this tissue and replace it with tissue from another part of the body, usually from another part of the conjunctiva (which covers the white part of the eye). This is known as a graft or autograft.\nCochrane researchers looked at two different methods of attaching this graft during pterygium surgery, either with fibrin glue or with stitches."
}
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query-laysum
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22244
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[
{
"role": "user",
"content": "Abstract: Background\nRandomised controlled trials (RCTs) show that breastfeeding newborn infants during painful procedures reduces pain. Mechanisms are considered to be multifactorial and include sucking, skin-to-skin contact, warmth, rocking, sound and smell of the mother, and possibly endogenous opiates present in the breast milk.\nObjectives\nTo determine the effect of breastfeeding on procedural pain in infants beyond the neonatal period (first 28 days of life) up to one year of age compared to no intervention, placebo, parental holding, skin-to-skin contact, expressed breast milk, formula milk, bottle feeding, sweet-tasting solutions (e.g. sucrose or glucose), distraction, or other interventions.\nSearch methods\nWe searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE including In-Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (apps.who.int/trialsearch/) for ongoing trials.\nSelection criteria\nWe included RCTs and quasi-RCTs involving infants aged 28 days postnatal to 12 months and receiving breastfeeding while undergoing a painful procedure. Comparators included, but were not limited to, oral administration of water, sweet-tasting solutions, expressed breast or formula milk, no intervention, use of pacifiers, positioning, cuddling, distraction, topical anaesthetics, and skin-to-skin care. Procedures included, but were not limited to: subcutaneous or intramuscular injection, venipuncture, intravenous line insertion, heel lance, and finger lance. We applied no language restrictions.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. The main outcome measures were behavioural or physiological indicators and composite pain scores, as well as other clinically important outcomes reported by the authors of included studies. We pooled data for the most comparable outcomes and where data from at least two studies could be included. We used mean difference (MD) with 95% confidence interval (CI), employing a random-effects model for continuous outcomes measured on the same scales. For continuous outcomes measured on different scales, we pooled standardised mean differences (SMDs) and associated 95% CIs. For dichotomous outcomes, we planned to pool events between groups across studies using risk ratios (RRs) and 95% CIs. However, as insufficient studies reported dichotomous outcomes, we did not pool such events. We assessed the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe included 10 studies with a total of 1066 infants. All studies were conducted during early childhood immunisation. As the breastfeeding intervention cannot be blinded, we rated all studies as being at high risk of bias for blinding of participants and personnel. We assessed nine studies as being at low risk of bias for incomplete outcome data. In addition, we rated nine studies as high risk for blinding of outcome assessment. We scored risk of bias related to random sequence generation, allocation concealment, and selective reporting as unclear for the majority of the studies due to lack of information.\nOur primary outcome was pain. Breastfeeding reduced behavioural pain responses (cry time and pain scores) during vaccination compared to no treatment, oral water, and other interventions such as cuddling, oral glucose, topical anaesthetic, massage, and vapocoolant. Breastfeeding did not consistently reduce changes in physiological indicators, such as heart rate. We pooled data for duration of cry from six studies (n = 547 infants). Breastfeeding compared to water or no treatment resulted in a 38-second reduction in cry time (MD -38, 95% CI -50 to -26; P < 0.00001). The quality of the evidence according to GRADE for this outcome was moderate, as most infants were 6 months or younger, and outcomes may be different for infants during their 12-month immunisation. We pooled data for pain scores from five studies (n = 310 infants). Breastfeeding was associated with a 1.7-point reduction in standardised pain scores (SMD -1.7, 95% CI -2.2 to -1.3); we considered this evidence to be of moderate quality as data were primarily from infants younger than 6 months of age. We could pool heart rate data following injections for only two studies (n = 186); we considered this evidence to be of low quality due to insufficient data. There were no differences between breastfeeding and control (MD -3.6, -23 to 16).\nFour of the 10 studies had more than two study arms. Breastfeeding was more effective in reducing crying duration or pain scores during vaccination compared to: 25% dextrose and topical anaesthetic cream (EMLA), vapocoolant, maternal cuddling, and massage.\nNo included studies reported adverse events.\nAuthors' conclusions\nWe conclude, based on the 10 studies included in this review, that breastfeeding may help reduce pain during vaccination for infants beyond the neonatal period. Breastfeeding consistently reduced behavioural responses of cry duration and composite pain scores during and following vaccinations. However, there was no evidence that breastfeeding had an effect on physiological responses. No studies included in this review involved populations of hospitalised infants undergoing other skin-breaking procedures. Although it may be possible to extrapolate the review results to this population, further studies of efficacy, feasibility, and acceptability in this population are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that breastfeeding before and during vaccination injections helped to reduce pain in most babies up to the age of one year."
}
] |
query-laysum
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22245
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[
{
"role": "user",
"content": "Abstract: Background\nSchool-based sexual and reproductive health programmes are widely accepted as an approach to reducing high-risk sexual behaviour among adolescents. Many studies and systematic reviews have concentrated on measuring effects on knowledge or self-reported behaviour rather than biological outcomes, such as pregnancy or prevalence of sexually transmitted infections (STIs).\nObjectives\nTo evaluate the effects of school-based sexual and reproductive health programmes on sexually transmitted infections (such as HIV, herpes simplex virus, and syphilis), and pregnancy among adolescents.\nSearch methods\nWe searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for published peer-reviewed journal articles; and ClinicalTrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform for prospective trials; AIDS Educaton and Global Information System (AEGIS) and National Library of Medicine (NLM) gateway for conference presentations; and the Centers for Disease Control and Prevention (CDC), UNAIDS, the WHO and the National Health Service (NHS) centre for Reviews and Dissemination (CRD) websites from 1990 to 7 April 2016. We handsearched the reference lists of all relevant papers.\nSelection criteria\nWe included randomized controlled trials (RCTs), both individually randomized and cluster-randomized, that evaluated school-based programmes aimed at improving the sexual and reproductive health of adolescents.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, evaluated risk of bias, and extracted data. When appropriate, we obtained summary measures of treatment effect through a random-effects meta-analysis and we reported them using risk ratios (RR) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included eight cluster-RCTs that enrolled 55,157 participants. Five trials were conducted in sub-Saharan Africa (Malawi, South Africa, Tanzania, Zimbabwe, and Kenya), one in Latin America (Chile), and two in Europe (England and Scotland).\nSexual and reproductive health educational programmes\nSix trials evaluated school-based educational interventions.\nIn these trials, the educational programmes evaluated had no demonstrable effect on the prevalence of HIV (RR 1.03, 95% CI 0.80 to 1.32, three trials; 14,163 participants; low certainty evidence), or other STIs (herpes simplex virus prevalence: RR 1.04, 95% CI 0.94 to 1.15; three trials, 17,445 participants; moderate certainty evidence; syphilis prevalence: RR 0.81, 95% CI 0.47 to 1.39; one trial, 6977 participants; low certainty evidence). There was also no apparent effect on the number of young women who were pregnant at the end of the trial (RR 0.99, 95% CI 0.84 to 1.16; three trials, 8280 participants; moderate certainty evidence).\nMaterial or monetary incentive-based programmes to promote school attendance\nTwo trials evaluated incentive-based programmes to promote school attendance.\nIn these two trials, the incentives used had no demonstrable effect on HIV prevalence (RR 1.23, 95% CI 0.51 to 2.96; two trials, 3805 participants; low certainty evidence). Compared to controls, the prevalence of herpes simplex virus infection was lower in young women receiving a monthly cash incentive to stay in school (RR 0.30, 95% CI 0.11 to 0.85), but not in young people given free school uniforms (Data not pooled, two trials, 7229 participants; very low certainty evidence). One trial evaluated the effects on syphilis and the prevalence was too low to detect or exclude effects confidently (RR 0.41, 95% CI 0.05 to 3.27; one trial, 1291 participants; very low certainty evidence). However, the number of young women who were pregnant at the end of the trial was lower among those who received incentives (RR 0.76, 95% CI 0.58 to 0.99; two trials, 4200 participants; low certainty evidence).\nCombined educational and incentive-based programmes\nThe single trial that evaluated free school uniforms also included a trial arm in which participants received both uniforms and a programme of sexual and reproductive education. In this trial arm herpes simplex virus infection was reduced (RR 0.82, 95% CI 0.68 to 0.99; one trial, 5899 participants; low certainty evidence), predominantly in young women, but no effect was detected for HIV or pregnancy (low certainty evidence).\nAuthors' conclusions\nThere is a continued need to provide health services to adolescents that include contraceptive choices and condoms and that involve them in the design of services. Schools may be a good place in which to provide these services. There is little evidence that educational curriculum-based programmes alone are effective in improving sexual and reproductive health outcomes for adolescents. Incentive-based interventions that focus on keeping young people in secondary school may reduce adolescent pregnancy but further trials are needed to confirm this.\n\nGiven the provided abstract, please respond to the following query: \"What the research says\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sexual and reproductive health education programmes\nAs they are currently configured, educational programmes alone probably have no effect on the number of young people infected with HIV during adolescence (low certainty evidence). They also probably have no effect on the number of young people infected with other STIs (herpes simplex virus: moderate certainty evidence; syphilis: low certainty evidence), or the number of adolescent pregnancies (moderate certainty evidence).\nMaterial or monetary incentive-based programmes to promote school attendance\nGiving monthly cash, or free school uniforms, to encourage students to stay in school may have no effect on the number of young people infected with HIV during adolescence (low certainty evidence). We do not currently know whether monthly cash or free school uniforms will reduce the number of young people infected with other STIs (very low certainty evidence). However, incentives to promote school attendance may reduce the number of adolescent pregnancies (low certainty evidence).\nCombined educational and incentive-based programmes\nBased on a single included trial, giving an incentive such as a free school uniform combined with a programme of sexual and reproductive health education may reduce STIs (herpes simplex virus; low certainty evidence) in young women, but no effect was detected for HIV or pregnancy (low certainty evidence)."
}
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query-laysum
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22246
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[
{
"role": "user",
"content": "Abstract: Background\nComprehensive geriatric assessment (CGA) is a multi-dimensional, multi-disciplinary diagnostic and therapeutic process conducted to determine the medical, mental, and functional problems of older people with frailty so that a co-ordinated and integrated plan for treatment and follow-up can be developed. This is an update of a previously published Cochrane review.\nObjectives\nWe sought to critically appraise and summarise current evidence on the effectiveness and resource use of CGA for older adults admitted to hospital, and to use these data to estimate its cost-effectiveness.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 5 October 2016; we also checked reference lists and contacted study authors.\nSelection criteria\nWe included randomised trials that compared inpatient CGA (delivered on geriatric wards or by mobile teams) versus usual care on a general medical ward or on a ward for older people, usually admitted to hospital for acute care or for inpatient rehabilitation after an acute admission.\nData collection and analysis\nWe followed standard methodological procedures expected by Cochrane and Effective Practice and Organisation of Care (EPOC). We used the GRADE approach to assess the certainty of evidence for the most important outcomes. For this update, we requested individual patient data (IPD) from trialists, and we conducted a survey of trialists to obtain details of delivery of CGA. We calculated risk ratios (RRs), mean differences (MDs), or standardised mean differences (SMDs), and combined data using fixed-effect meta-analysis. We estimated cost-effectiveness by comparing inpatient CGA versus hospital admission without CGA in terms of cost per quality-adjusted life year (QALY) gained, cost per life year (LY) gained, and cost per life year living at home (LYLAH) gained.\nMain results\nWe included 29 trials recruiting 13,766 participants across nine, mostly high-income countries. CGA increases the likelihood that patients will be alive and in their own homes at 3 to 12 months' follow-up (risk ratio (RR) 1.06, 95% confidence interval (CI) 1.01 to 1.10; 16 trials, 6799 participants; high-certainty evidence), results in little or no difference in mortality at 3 to 12 months' follow-up (RR 1.00, 95% CI 0.93 to 1.07; 21 trials, 10,023 participants; high-certainty evidence), decreases the likelihood that patients will be admitted to a nursing home at 3 to 12 months follow-up (RR 0.80, 95% CI 0.72 to 0.89; 14 trials, 6285 participants; high-certainty evidence) and results in little or no difference in dependence (RR 0.97, 95% CI 0.89 to 1.04; 14 trials, 6551 participants; high-certainty evidence). CGA may make little or no difference to cognitive function (SMD ranged from -0.22 to 0.35 (5 trials, 3534 participants; low-certainty evidence)). Mean length of stay ranged from 1.63 days to 40.7 days in the intervention group, and ranged from 1.8 days to 42.8 days in the comparison group. Healthcare costs per participant in the CGA group were on average GBP 234 (95% CI GBP -144 to GBP 605) higher than in the usual care group (17 trials, 5303 participants; low-certainty evidence). CGA may lead to a slight increase in QALYs of 0.012 (95% CI -0.024 to 0.048) at GBP 19,802 per QALY gained (3 trials; low-certainty evidence), a slight increase in LYs of 0.037 (95% CI 0.001 to 0.073), at GBP 6305 per LY gained (4 trials; low-certainty evidence), and a slight increase in LYLAH of 0.019 (95% CI -0.019 to 0.155) at GBP 12,568 per LYLAH gained (2 trials; low-certainty evidence). The probability that CGA would be cost-effective at a GBP 20,000 ceiling ratio for QALY, LY, and LYLAH was 0.50, 0.89, and 0.47, respectively (17 trials, 5303 participants; low-certainty evidence).\nAuthors' conclusions\nOlder patients are more likely to be alive and in their own homes at follow-up if they received CGA on admission to hospital. We are uncertain whether data show a difference in effect between wards and teams, as this analysis was underpowered. CGA may lead to a small increase in costs, and evidence for cost-effectiveness is of low-certainty due to imprecision and inconsistency among studies. Further research that reports cost estimates that are setting-specific across different sectors of care are required.\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": "Review authors found 29 relevant trials from nine countries that recruited 13,766 people. These studies compared CGA with routine care for patients over 65 who were admitted to hospital. Most trials evaluated CGA that was provided on a specialised hospital ward or across several wards by a mobile team. The review shows that older people who receive CGA rather than routine medical care after admission to hospital are more likely to be living at home and are less likely to be admitted to a nursing home at up to a year after hospital admission.\nWe found no evidence that CGA reduces risk of death during follow-up at up to a year after admission, and we noted that CGA appeared to make little or no difference in dependence (whether patients need help for everyday activities such as feeding and walking).\nWe found too much variation in cognitive function and length of hospital stay to draw a conclusion. Uncertainty regarding the cost-effectiveness analysis suggests that further research is needed."
}
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query-laysum
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22247
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[
{
"role": "user",
"content": "Abstract: Background\nProximal dental lesions, limited to dentine, are traditionally treated by invasive (drill and fill) means. Non-invasive alternatives (e.g. fluoride varnish, flossing) might avoid substance loss but their effectiveness depends on patients' adherence. Recently, micro-invasive approaches for treating proximal caries lesions have been tried. These interventions install a barrier either on top (sealing) or within (infiltrating) the lesion. Different methods and materials are currently available for micro-invasive treatments, such as sealing via resin sealants, (polyurethane) patches/tapes, glass ionomer cements (GIC) or resin infiltration.\nObjectives\nTo evaluate the effects of micro-invasive treatments for managing proximal caries lesions in primary and permanent dentition in children and adults.\nSearch methods\nWe searched the following databases to 31 December 2014: the Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via OVID, EMBASE via OVID, LILACs via BIREME Virtual Health Library, Web of Science Conference Proceedings, ZETOC Conference Proceedings, Proquest Dissertations and Theses, ClinicalTrials.gov, OpenGrey and the World Health Organization (WHO) International Clinical Trials Registry Platform. We searched the metaRegister of Controlled Trials to 1 October 2014. There were no language or date restrictions in the searches of the electronic databases.\nSelection criteria\nWe included randomised controlled trials of at least six months' duration that compared micro-invasive treatments for managing non-cavitated proximal dental decay in primary teeth, permanent teeth or both, versus non-invasive measures, invasive means, no intervention or placebo. We also included studies that compared different types of micro-invasive treatments.\nData collection and analysis\nTwo review authors independently screened search results, extracted data and assessed the risk of bias. We used standard methodological procedures expected by Cochrane to evaluate risk of bias and synthesise data. We conducted meta-analyses with the random-effects model, using the Becker-Balagtas method to calculate the odds ratio (OR) for lesion progression. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe included eight trials, which randomised 365 participants. The trials all used a split-mouth design, some with more than one pair of lesions treated within the same participant. Studies took place in university or dental public health clinics in Brazil, Colombia, Denmark, Germany, Thailand, Greenland and Chile. Six studies evaluated the effects of micro-invasive treatments in the permanent dentition and two studies on the primary dentition, with caries risk ranging from low to high. Investigators measured caries risk in different studies either by caries experience alone or by using the Cariogram programme, which combines eight contributing factors, including caries experience, diet, saliva and other factors related to caries. The follow-up period in the trials ranged from one to three years. All studies used lesion progression as the primary outcome, evaluating it by different methods of reading radiographs. Four studies received industry support to carry out the research, with one of them being carried out by inventors of the intervention.\nWe judged seven studies to be at high overall risk of bias, primarily due to lack of blinding of participants and personnel. We evaluated intervention effects for all micro-invasive therapies and analysed subgroups according to the different treatment methods reported in the included studies.\nOur meta-analysis, which pooled the most sensitive set of data (in terms of measurement method) from studies presenting data in a format suitable for meta-analysis, showed that micro-invasive treatment significantly reduced the odds of lesion progression compared with non-invasive treatment (e.g fluoride varnish) or oral hygiene advice (e.g to floss) (OR 0.24, 95% CI 0.14 to 0.41; 602 lesions; seven studies; I2 = 32%). There was no evidence of subgroup differences (P = 0.36).\nThe four studies that measured adverse events reported no adverse events after micro-invasive treatment. Most studies did not report on any further outcomes.\nWe assessed the quality of evidence for micro-invasive treatments as moderate. It remains unclear which micro-invasive treatment is more advantageous, or if certain clinical conditions or patient characteristics are better suited for micro-invasive treatments than others.\nAuthors' conclusions\nThe available evidence shows that micro-invasive treatment of proximal caries lesions arrests non-cavitated enamel and initial dentinal lesions (limited to outer third of dentine, based on radiograph) and is significantly more effective than non-invasive professional treatment (e.g. fluoride varnish) or advice (e.g. to floss). We can be moderately confident that further research is unlikely to substantially change the estimate of effect. Due to the small number of studies, it does remain unclear which micro-invasive technique offers the greatest benefit, or whether the effects of micro-invasive treatment confer greater or lesser benefit according to different clinical or patient considerations.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"content": "Although further research could possibly change our findings, the available evidence gives us moderate confidence that micro-invasive treatments are much more effective than non-invasive treatments for stopping tooth decay."
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"content": "Abstract: Background\nThymic carcinoma or advanced thymoma is a rare cancer of the thymus gland that tends to be aggressive and infiltrate neighbouring organs, making total resection very difficult. Induction or adjuvant chemotherapy, or both, are often used in a multimodality approach to treat people affected by this condition, but the effectiveness of chemotherapy for thymic carcinoma or advanced thymoma remains uncertain.\nObjectives\nTo assess the role of chemotherapy in adults with thymic carcinoma or advanced thymoma.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2012, Issue 7), MEDLINE (accessed via Ovid from 1966 to July 2012), EMBASE (accessed via Ovid, from 1980 to July 2012), Latin American and Caribbean Literature on Health Sciences (LILACS), the Chinese Biological Medicine Database (CBM, 1978 to July 2012), China National Knowledge Infrastructure (CNKI, 1980 to July 2012) and the Chinese scientific periodical database VIP Information (VIP, 1989 to July 2012). There was no language restriction in searching for studies.\nSelection criteria\nWe planned to include randomised controlled trials (RCTs) of trials using chemotherapy (either single-agent or combination chemotherapy plus surgery, radiotherapy or not) for thymic carcinoma and/or advanced thymoma. We planned to include all adults (aged 18 years and over) diagnosed with thymic carcinoma and/or with Masaoka stage III or IV thymic tumours. The intended primary outcomes were overall survival (OS) and progression-free survival (PFS).\nData collection and analysis\nTwo review authors independently evaluated the search results according to the inclusion and exclusion criteria. There were no studies identified for inclusion and therefore no data extraction was completed.\nMain results\nNo RCTs were eligible for inclusion in this review. We report details of excluded prospective studies in an additional table and try to provide some useful evidence regarding current practice.\nAuthors' conclusions\nThere were no RCTs eligible for inclusion in this review. In current practice the most common regimen for adult patients with thymic carcinoma or advanced thymoma is cisplatin-based chemotherapy. Considering the condition is rare, it is suggested that an international group is set up to organise and evaluate prospective collection of data from cohorts of patients to inform current clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "While various treatment options are used, cisplatin-based chemotherapy is currently the usual regimen of choice, however this is not supported by good-quality trials."
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"content": "Abstract: Background\nEndometriosis is a common gynaecological condition which affects many women of reproductive age worldwide and is a major cause of pain and infertility. The combined oral contraceptive pill (COCP) is widely used to treat pain occurring as a result of endometriosis, although the evidence for its efficacy is limited.\nObjectives\nTo determine the effectiveness, safety and cost-effectiveness of oral contraceptive preparations in the treatment of painful symptoms ascribed to the diagnosis of laparoscopically proven endometriosis.\nSearch methods\nWe searched the following from inception to 19 October 2017: the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, the Cochrane CENTRAL Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the trial registers ClinicalTrials.gov and the World Health Organization Clinical Trials Registry Platform (WHO ICTRP). We also handsearched reference lists of relevant trials and systematic reviews retrieved by the search.\nSelection criteria\nWe included randomised controlled trials (RCT) of the use of COCPs in the treatment of women of reproductive age with symptoms ascribed to the diagnosis of endometriosis that had been made visually at a surgical procedure.\nData collection and analysis\nTwo review authors independently assessed study quality and extracted data. One review author was an expert in the content matter. We contacted study authors for additional information. The primary outcome was self-reported pain (dysmenorrhoea) at the end of treatment.\nMain results\nFive trials (612 women) met the inclusion criteria. Only three trials (404 women) provided data that were suitable for analysis.\nCombined oral contraceptive pill versus placebo\nTwo trials compared COCP with a placebo. These studies were at high risk of bias. For GRADE outcomes (self-reported pain (dysmenorrhoea) at the end of treatment), the quality of the evidence very low. Evidence was downgraded for imprecision as it was based on a single, small trial and for the visual analogue scale data there were wide confidence intervals (CIs). There appeared to have been substantial involvement of the pharmaceutical company funding the trials.\nTreatment with the COCP was associated with an improvement in self-reported pain at the end of treatment as evidenced by a lower score on the Dysmenorrhoea verbal rating scale (scale 0 to 3) compared with placebo (mean difference (MD) -1.30 points, 95% CI -1.84 to -0.76; 1 RCT, 96 women; very low quality evidence), a lower score on the Dysmenorrhoea visual analogue scale (no details of scale) compared with placebo (MD -23.68 points, 95% CI -28.75 to -18.62, 2 RCTs, 327 women; very low quality evidence) and a reduction in menstrual pain from baseline to the end of treatment (MD 2.10 points, 95% CI 1.38 to 2.82; 1 RCT, 169 women; very low quality evidence).\nCombined oral contraceptive pill versus medical therapies\nOne underpowered trial compared the COCP with another medical treatment (goserelin). The study was at high risk of bias; the trial was unblinded and there was insufficient detail to judge allocation concealment and randomisation. For GRADE outcomes (self-reported pain (dysmenorrhoea) at the end of treatment), the quality of the evidence ranged from low to very low.\nAt the end of treatment, the women in the goserelin group were amenorrhoeic and therefore no comparisons could be made between the groups for the primary outcome. At six months' follow-up, there was no clear evidence of a difference between women treated with the COCP and women treated with goserelin for measures of dysmenorrhoea on a visual analogue scale (scale 1 to 10) (MD -0.10, 95% CI -1.28 to 1.08; 1 RCT, 50 women; very low quality evidence) or a verbal rating scale (scale 0 to 3) (MD -0.10, 95% CI -0.99 to 0.79; 1 RCT, 50 women; very low quality evidence). At six months' follow-up, there was no clear evidence of a difference between the COCP and goserelin groups for reporting complete absence of pain as measured by the visual analogue scale (risk ratio (RR) 0.36, 95% CI 0.02 to 8.43; 1 RCT, 50 women; very low quality evidence) or the verbal rating scale (RR 1.00, 95% CI 0.93 to 1.08; 1 RCT, 49 women; low quality evidence).\nAuthors' conclusions\nBased on the limited evidence from two trials at high risk of bias and limited data for the prespecified outcomes for this review, there is insufficient evidence to make a judgement on the effectiveness of the COCP compared with placebo and the findings cannot be generalised.\nBased on the limited evidence from one small trial that was at high risk of bias, there is insufficient evidence to make a judgement on the effectiveness of the COCP compared with other medical treatments. Only one comparison was possible, with the medical intervention being goserelin, and the findings cannot be generalised.\nFurther research is needed to fully evaluate the role of COCPs in managing pain-related symptoms associated with endometriosis. There are other formulations of the combined hormonal contraception such as the transdermal patch, vaginal ring or combined injectable contraceptives which this review did not cover but should be considered in future updates.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Cochrane authors searched for clinical studies on 19 October 2017. We found five trials, including 612 women, that met the inclusion criteria. The studies took place in Egypt, the US, Japan and Italy."
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"content": "Abstract: Background\nAnti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis.\nObjectives\nThe primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching.\nSelection criteria\nWe included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane.\nMain results\nThis review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high.\nThere was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%.\nIn terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials.\nAuthors' conclusions\nOral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low.\nThe decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "Oral antifungal medicines probably clear yeast from the vagina better than intravaginal antifungal medicines, although there is probably little to no difference between them for getting rid of thrush symptoms.\nThe risk of women stopping treatment because of unwanted effects is low for both oral and intravaginal antifungal medicines."
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"content": "Abstract: Background\nThere is a large body of evidence evaluating quality improvement (QI) programmes to improve care for adults living with diabetes. These programmes are often comprised of multiple QI strategies, which may be implemented in various combinations. Decision-makers planning to implement or evaluate a new QI programme, or both, need reliable evidence on the relative effectiveness of different QI strategies (individually and in combination) for different patient populations.\nObjectives\nTo update existing systematic reviews of diabetes QI programmes and apply novel meta-analytical techniques to estimate the effectiveness of QI strategies (individually and in combination) on diabetes quality of care.\nSearch methods\nWe searched databases (CENTRAL, MEDLINE, Embase and CINAHL) and trials registers (ClinicalTrials.gov and WHO ICTRP) to 4 June 2019. We conducted a top-up search to 23 September 2021; we screened these search results and 42 studies meeting our eligibility criteria are available in the awaiting classification section.\nSelection criteria\nWe included randomised trials that assessed a QI programme to improve care in outpatient settings for people living with diabetes. QI programmes needed to evaluate at least one system- or provider-targeted QI strategy alone or in combination with a patient-targeted strategy.\n- System-targeted: case management (CM); team changes (TC); electronic patient registry (EPR); facilitated relay of clinical information (FR); continuous quality improvement (CQI).\n- Provider-targeted: audit and feedback (AF); clinician education (CE); clinician reminders (CR); financial incentives (FI).\n- Patient-targeted: patient education (PE); promotion of self-management (PSM); patient reminders (PR). Patient-targeted QI strategies needed to occur with a minimum of one provider or system-targeted strategy.\nData collection and analysis\nWe dual-screened search results and abstracted data on study design, study population and QI strategies. We assessed the impact of the programmes on 13 measures of diabetes care, including: glycaemic control (e.g. mean glycated haemoglobin (HbA1c)); cardiovascular risk factor management (e.g. mean systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), proportion of people living with diabetes that quit smoking or receiving cardiovascular medications); and screening/prevention of microvascular complications (e.g. proportion of patients receiving retinopathy or foot screening); and harms (e.g. proportion of patients experiencing adverse hypoglycaemia or hyperglycaemia). We modelled the association of each QI strategy with outcomes using a series of hierarchical multivariable meta-regression models in a Bayesian framework. The previous version of this review identified that different strategies were more or less effective depending on baseline levels of outcomes. To explore this further, we extended the main additive model for continuous outcomes (HbA1c, SBP and LDL-C) to include an interaction term between each strategy and average baseline risk for each study (baseline thresholds were based on a data-driven approach; we used the median of all baseline values reported in the trials). Based on model diagnostics, the baseline interaction models for HbA1c, SBP and LDL-C performed better than the main model and are therefore presented as the primary analyses for these outcomes. Based on the model results, we qualitatively ordered each QI strategy within three tiers (Top, Middle, Bottom) based on its magnitude of effect relative to the other QI strategies, where 'Top' indicates that the QI strategy was likely one of the most effective strategies for that specific outcome. Secondary analyses explored the sensitivity of results to choices in model specification and priors.\nAdditional information about the methods and results of the review are available as Appendices in an online repository. This review will be maintained as a living systematic review; we will update our syntheses as more data become available.\nMain results\nWe identified 553 trials (428 patient-randomised and 125 cluster-randomised trials), including a total of 412,161 participants. Of the included studies, 66% involved people living with type 2 diabetes only. Participants were 50% female and the median age of participants was 58.4 years. The mean duration of follow-up was 12.5 months. HbA1c was the commonest reported outcome; screening outcomes and outcomes related to cardiovascular medications, smoking and harms were reported infrequently. The most frequently evaluated QI strategies across all study arms were PE, PSM and CM, while the least frequently evaluated QI strategies included AF, FI and CQI. Our confidence in the evidence is limited due to a lack of information on how studies were conducted.\nFour QI strategies (CM, TC, PE, PSM) were consistently identified as 'Top' across the majority of outcomes. All QI strategies were ranked as 'Top' for at least one key outcome. The majority of effects of individual QI strategies were modest, but when used in combination could result in meaningful population-level improvements across the majority of outcomes. The median number of QI strategies in multicomponent QI programmes was three.\nCombinations of the three most effective QI strategies were estimated to lead to the below effects:\n- PR + PSM + CE: decrease in HbA1c by 0.41% (credibility interval (CrI) -0.61 to -0.22) when baseline HbA1c < 8.3%;\n- CM + PE + EPR: decrease in HbA1c by 0.62% (CrI -0.84 to -0.39) when baseline HbA1c > 8.3%;\n- PE + TC + PSM: reduction in SBP by 2.14 mmHg (CrI -3.80 to -0.52) when baseline SBP < 136 mmHg;\n- CM + TC + PSM: reduction in SBP by 4.39 mmHg (CrI -6.20 to -2.56) when baseline SBP > 136 mmHg;\n- TC + PE + CM: LDL-C lowering of 5.73 mg/dL (CrI -7.93 to -3.61) when baseline LDL < 107 mg/dL;\n- TC + CM + CR: LDL-C lowering by 5.52 mg/dL (CrI -9.24 to -1.89) when baseline LDL > 107 mg/dL.\nAssuming a baseline screening rate of 50%, the three most effective QI strategies were estimated to lead to an absolute improvement of 33% in retinopathy screening (PE + PR + TC) and 38% absolute increase in foot screening (PE + TC + Other).\nAuthors' conclusions\nThere is a significant body of evidence about QI programmes to improve the management of diabetes. Multicomponent QI programmes for diabetes care (comprised of effective QI strategies) may achieve meaningful population-level improvements across the majority of outcomes. For health system decision-makers, the evidence summarised in this review can be used to identify strategies to include in QI programmes. For researchers, this synthesis identifies higher-priority QI strategies to examine in further research regarding how to optimise their evaluation and effects. We will maintain this as a living systematic review.\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"
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"content": "Overall, case management, team changes, patient education and promotion of self-management appeared to be the most effective quality improvement strategies for diabetes care.\nWhen considering three-strategy combinations (the median number of quality improvement strategies in multicomponent interventions), the combination of clinician education, promotion of self-management and patient reminders may lead to the most improvement in blood sugar control in people who begin with lower HbA1c. Whereas the combination of case management, patient education and electronic patient registries may lead to the largest improvement in blood sugar control for people who begin with higher HbA1c.\nFor blood pressure, people who have lower systolic blood pressure may see the most improvement with the combination of patient education, team changes and promotion of self-management. People who have higher systolic blood pressure may improve the most with the combination of case management, team changes and promotion of self-management.\nFor cholesterol, we found that team changes, patient education and case management may lead to the most improvement in people who already have lower low-density lipoprotein levels. For those who have higher levels of low-density lipoprotein, team changes, case management and clinician reminders may lead to the largest improvement.\nPatient education, patient reminders and team changes may lead to an increase in retinopathy screening rates. Patient education, team changes and audit and feedback, financial incentives and continuous quality improvement strategies combined may lead to an increase in foot screening rates."
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"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia and is a highly disabling movement disorder, characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. Before BtA, anticholinergics were the most widely accepted treatment.\nObjectives\nTo compare the efficacy, safety, and tolerability of BtA versus anticholinergic drugs in adults with cervical dystonia.\nSearch methods\nWe searched the Cochrane Movement Disorders' Trials Register to June 2003, screened reference lists of articles and conference proceedings to September 2018, and searched CENTRAL, MEDLINE, and Embase, with no language restrictions, to July 2020.\nSelection criteria\nDouble-blind, parallel, randomised trials (RCTs) of BtA versus anticholinergic drugs in adults with cervical dystonia.\nData collection and analysis\nTwo review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias and quality of the evidence. We resolved disagreements by consensus or by consulting a third review author. If enough data had been available, we were to perform meta-analyses using a random-effects model for the comparison of BtA versus anticholinergic drugs to estimate pooled effects and corresponding 95% confidence intervals (95% CI). The primary efficacy outcome was improvement in cervical dystonia-specific impairment. The primary safety outcome was the proportion of participants with any adverse event.\nMain results\nWe included one RCT of moderate overall risk of bias (as multiple domains were at unclear risk of bias), which included 66 BtA-naive participants with cervical dystonia. Two doses of BtA (Dysport; week 0 and 8; mean dose 262 to 292 U) were compared with daily trihexyphenidyl (up to 24 mg daily). The trial was sponsored by the BtA producer.\nBtA reduced cervical dystonia severity by an average of 2.5 points (95% CI 0.68 to 4.32) on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale 12 weeks after injection, compared to trihexyphenidyl. More participants reported adverse events in the trihexyphenidyl treatment group (76 events), compared with the BtA group (31 events); however, the difference in dropouts due to adverse events was inconclusive between groups. There was a decreased risk of dry mouth, and memory problems with BtA, but the differences were inconclusive between groups for the other reported side effects (blurred vision, dizziness, depression, fatigue, pain at injection site, dysphagia, and neck weakness).\nAuthors' conclusions\nWe found very low-certainty evidence that BtA is more effective, better tolerated, and safer than trihexyphenidyl.\nWe found no information on a dose-response relationship with BtA, differences between BtA formulations or different anticholinergics, the utility of electromyography-guided injections, or the duration of treatment effect.\n\nGiven the provided abstract, please respond to the following query: \"Certainty in the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "Due to limitations in the study methods and size of the study, we have very little confidence in the results.\nThese conclusions may not apply to all people with cervical dystonia. They do not apply to long-term use of either treatment."
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"role": "user",
"content": "Abstract: Background\nInfantile colic is a common disorder in the first months of life, affecting somewhere between 4% and 28% of infants worldwide, depending on geography and definitions used. Although it is self limiting and resolves by four months of age, colic is perceived by parents as a problem that requires action. Pain-relieving agents, such as drugs, sugars and herbal remedies, have been suggested as interventions to reduce crying episodes and severity of symptoms.\nObjectives\nTo assess the effectiveness and safety of pain-relieving agents for reducing colic in infants younger than four months of age.\nSearch methods\nWe searched the following databases in March 2015 and again in May 2016: CENTRAL, Ovid MEDLINE, Embase and PsycINFO, along with 11 other databases. We also searched two trial registers, four thesis repositories and the reference lists of relevant studies to identify unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of pain-relieving agents given to infants with colic.\nData collection and analysis\nWe used the standard methodological procedures of The Cochrane Collaboration.\nMain results\nWe included 18 RCTs involving 1014 infants. All studies were small and at high risk of bias, often presenting major shortcomings across multiple design factors (e.g. selection, performance, attrition, lack of washout period).\nThree studies compared simethicone with placebo, and one with Mentha piperita; four studies compared herbal agents with placebo; two compared sucrose or glucose with placebo; five compared dicyclomine with placebo; and two compared cimetropium - one against placebo and the other at two different dosages. One multiple-arm study compared sucrose and herbal tea versus no treatment.\nSimethicone. Comparison with placebo revealed no difference in daily hours of crying reported for simethicone at the end of treatment in one small, low-quality study involving 27 infants. A meta-analysis of data from two cross-over studies comparing simethicone with placebo showed no difference in the number of of infants who responded positively to treatment (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.73 to 1.23; 110 infants, low-quality evidence).\nOne small study (30 participants) compared simethicone with Mentha piperita and found no difference in crying duration, number of crying episodes or number of responders.\nHerbal agents. We found low-quality evidence suggesting that herbal agents reduce the duration of crying compared with placebo (mean difference (MD) 1.33, 95% CI 0.71 to 1.96; three studies, 279 infants), with different magnitude of benefit noted across studies (I² = 96%). We found moderate-quality evidence indicating that herbal agents increase response over placebo (RR 2.05, 95% CI 1.56 to 2.70; three studies, 277 infants).\nSucrose. One very low-quality study involving 35 infants reported that sucrose reduced hours spent crying compared with placebo (MD 1.72, 95% CI 1.38 to 2.06).\nDicyclomine. We could consider only one of the five studies of dicyclomine (48 infants) for the primary comparison. In this study, more of the infants given dicyclomine responded than than those given placebo (RR 2.50, 95% CI 1.17 to 5.34).\nCimetropium bromide. Data from one very low-quality study comparing cimetropium bromide with placebo showed reduced crying duration among infants treated with cimetropium bromide (MD -30.20 minutes per crisis, 95% CI -39.51 to -20.89; 86 infants). The same study reported that cimetropium increased the number of responders (RR 2.29, 95% CI 1.44 to 3.64).\nNo serious adverse events were reported for all of the agents considered, with the exception of dicyclomine, for which two of five studies reported relevant adverse effects (longer sleep 4%, wide-eyed state 4%, drowsiness 13%).\nAuthors' conclusions\nAt the present time, evidence of the effectiveness of pain-relieving agents for the treatment of infantile colic is sparse and prone to bias. The few available studies included small sample sizes, and most had serious limitations. Benefits, when reported, were inconsistent.\nWe found no evidence to support the use of simethicone as a pain-relieving agent for infantile colic.\nAvailable evidence shows that herbal agents, sugar, dicyclomine and cimetropium bromide cannot be recommended for infants with colic.\nInvestigators must conduct RCTs using standardised measures that allow comparisons among pain-relieving agents and pooling of results across studies. Parents, who most often provide the intervention and assess the outcome, should always be blinded.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Available data provide no evidence that sugar, dicyclomine and cimetropium are effective interventions in the treatment of colic. Some evidence suggests that, compared with placebo or no treatment, herbal agents may reduce crying time. However, because the quality of these studies was very poor and the extent of the benefit observed was variable, these results should be interpreted with caution. The same is true for sugar, dicyclomine and cimetropium, for which we judged the quality of evidence as low or very low.\nStudies that tested simethicone reported no benefit from administration of this drug over placebo.\nTwo studies reported side effects for dicyclomine, for example, difficulty awakening, wide-eyed state and drowsiness. Studies of other pain-relieving agents reported no side effects as a result of treatment."
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22254
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[
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"role": "user",
"content": "Abstract: Background\nEducation of family members about infant weaning practices could affect nutrition, growth, and development of children in different settings across the world.\nObjectives\nTo compare effects of family nutrition educational interventions for infant weaning with conventional management on growth and neurodevelopment in childhood.\nSearch methods\nWe used the standard strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 5), MEDLINE via PubMed (1966 to 26 June 2018), Embase (1980 to 26 June 2018), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 26 June 2018). We searched clinical trials databases, conference proceedings, and references of retrieved articles.\nWe ran an updated search from 1 January 2018 to 12 December 2019 in the following databases: CENTRAL via CRS Web, MEDLINE via Ovid, and CINAHL via EBSCOhost.\nSelection criteria\nWe included randomised controlled trials that examined effects of nutrition education for weaning practices delivered to families of infants born at term compared to conventional management (standard care in the population) up to one year of age.\nData collection and analysis\nTwo review authors independently identified eligible trial reports from the literature search and performed data extraction and quality assessments for each included trial. We synthesised effect estimates using risk ratios (RRs), risk differences (RDs), and mean differences (MDs), with 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included 21 trials, recruiting 14,241 infants. Five of the trials were conducted in high-income countries and the remaining 16 were conducted in middle- and low-income countries. Meta-analysis showed that nutrition education targeted at improving weaning-related feeding practices probably increases both weight-for-age z scores (WAZ) (MD 0.15 standard deviations, 95% CI 0.07 to 0.22; 6 studies; 2551 infants; I² = 32%; moderate-certainty evidence) and height-for-age z scores (0.12 standard deviations, 95% CI 0.05 to 0.19; 7 studies; 3620 infants; I² = 49%; moderate-certainty evidence) by 12 months of age. Meta-analysis of outcomes at 18 months of age was heterogeneous and inconsistent in the magnitude of effects of nutrition education on WAZ and weight-for-height z score across studies. One trial that assessed effects of nutrition education on growth at six years reported an uncertain effect on change in height and body mass index z score. Two studies investigated effects of nutrition education on neurodevelopment at 12 to 24 months of age with conflicting results. No trials assessed effects of nutrition education on long-term neurodevelopmental outcomes.\nAuthors' conclusions\nNutrition education for families of infants may reduce the risk of undernutrition in term-born infants (evidence of low to moderate certainty due to limitations in study design and substantial heterogeneity of included studies). Modest effects on growth during infancy may not be of clinical significance. However, it is unclear whether these small improvements in growth parameters in the first two years of life affect long-term childhood growth and development. Further studies are needed to resolve this question.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Around the world, over 150 million children are undernourished and over 42 million are overweight and obese. Providing families with appropriate education about feeding practices during weaning may help to optimise nutrition while helping to protect children who are at risk of undernutrition, as well as those susceptible to being overweight and obese."
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22255
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"role": "user",
"content": "Abstract: Background\nTransfer of more than one embryo during in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) increases multiple pregnancy rates resulting in an increased risk of maternal and perinatal morbidity. Elective single embryo transfer offers a means of minimising this risk, but this potential gain needs to be balanced against the possibility of jeopardising the overall live birth rate (LBR).\nObjectives\nTo evaluate the effectiveness and safety of different policies for the number of embryos transferred in infertile couples undergoing assisted reproductive technology cycles.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group specialised register of controlled trials, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform from inception to March 2020. We handsearched reference lists of articles and relevant conference proceedings. We also communicated with experts in the field regarding any additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing different policies for the number of embryos transferred following IVF or ICSI in infertile women. Studies of fresh or frozen and thawed transfer of one to four embryos at cleavage or blastocyst stage were eligible.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial eligibility and risk of bias. The primary outcomes were LBR and multiple pregnancy rate. The secondary outcomes were clinical pregnancy and miscarriage rates. We analysed data using risk ratios (RR), Peto odds ratio (Peto OR) and a fixed effect model.\nMain results\nWe included 17 RCTs in the review (2505 women). The main limitation was inadequate reporting of study methods and moderate to high risk of performance bias due to lack of blinding. A majority of the studies had low numbers of participants.\nNone of the trials compared repeated single embryo transfer (SET) with multiple embryo transfer. Reported results of multiple embryo transfer below refer to double embryo transfer.\nRepeated single embryo transfer versus multiple embryo transfer in a single cycle\nRepeated SET was compared with double embryo transfer (DET) in four studies of cleavage-stage transfer. In these studies the SET group received either two cycles of fresh SET (one study) or one cycle of fresh SET followed by one frozen SET (three studies). The cumulative live birth rate after repeated SET may be little or no different from the rate after one cycle of DET (RR 0.95, 95% CI (confidence interval) 0.82 to 1.10; I² = 0%; 4 studies, 985 participants; low-quality evidence). This suggests that for a woman with a 42% chance of live birth following a single cycle of DET, the repeated SET would yield pregnancy rates between 34% and 46%. The multiple pregnancy rate associated with repeated SET is probably reduced compared to a single cycle of DET (Peto OR 0.13, 95% CI 0.08 to 0.21; I² = 0%; 4 studies, 985 participants; moderate-quality evidence). This suggests that for a woman with a 13% risk of multiple pregnancy following a single cycle of DET, the risk following repeated SET would be between 0% and 3%. The clinical pregnancy rate (RR 0.99, 95% CI 0.87 to 1.12; I² = 47%; 3 studies, 943 participants; low-quality evidence) after repeated SET may be little or no different from the rate after one cycle of DET. There may be little or no difference in the miscarriage rate between the two groups.\nSingle versus multiple embryo transfer in a single cycle\nA single cycle of SET was compared with a single cycle of DET in 13 studies, 11 comparing cleavage-stage transfers and three comparing blastocyst-stage transfers.One study reported both cleavage and blastocyst stage transfers.\nLow-quality evidence suggests that the live birth rate per woman may be reduced in women who have SET in comparison with those who have DET (RR 0.67, 95% CI 0.59 to 0.75; I² = 0%; 12 studies, 1904 participants; low-quality evidence). Thus, for a woman with a 46% chance of live birth following a single cycle of DET, the chance following a single cycle of SET would be between 27% and 35%. The multiple pregnancy rate per woman is probably lower in those who have SET than those who have DET (Peto OR 0.16, 95% CI 0.12 to 0.22; I² = 0%; 13 studies, 1952 participants; moderate-quality evidence). This suggests that for a woman with a 15% risk of multiple pregnancy following a single cycle of DET, the risk following a single cycle of SET would be between 2% and 4%. Low-quality evidence suggests that the clinical pregnancy rate may be lower in women who have SET than in those who have DET (RR 0.70, 95% CI 0.64 to 0.77; I² = 0%; 10 studies, 1860 participants; low-quality evidence). There may be little or no difference in the miscarriage rate between the two groups.\nAuthors' conclusions\nAlthough DET achieves higher live birth and clinical pregnancy rates per fresh cycle, the evidence suggests that the difference in effectiveness may be substantially offset when elective SET is followed by a further transfer of a single embryo in fresh or frozen cycle, while simultaneously reducing multiple pregnancies, at least among women with a good prognosis.\nThe quality of evidence was low to moderate primarily due to inadequate reporting of study methods and absence of masking those delivering, as well as receiving the interventions.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 17 randomised controlled trials with a total of 2505 participants. Most were not commercially funded. None of the trials compared repeated single embryo transfer (SET) with multiple embryo transfer. A majority of the studies had low numbers of participants. Reported results of multiple embryo transfer below refer to double embryo transfer."
}
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query-laysum
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22256
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[
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"role": "user",
"content": "Abstract: Background\nKeloid scarring is one of the most common types of pathological scarring. Keloid scars that fail to heal can affect a person's physical and psychological function by causing pain, pruritus, contractures, and cosmetic disfigurement. Silicone gel sheeting (SGS) is made from medical-grade silicone reinforced with a silicone membrane backing and is one of the most commonly used treatments for keloid scars. However, there is no up-to-date systematic review assessing the effectiveness of SGS for keloid scars. A clear and rigorous review of current evidence is required to guide clinicians, healthcare managers and people with keloid scarring.\nObjectives\nTo assess the effectiveness of silicone gel sheeting for the treatment of keloid scars compared with standard care or other therapies.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was December 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) that recruited people with any keloid scars and assessed the effectiveness of SGS.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment, data extraction and GRADE assessment of the certainty of evidence. We resolved initial disagreements by discussion, or by consulting a third review author when necessary.\nMain results\nTwo studies met the inclusion criteria. Study sample sizes were 16 and 20 participants. The trials were clinically heterogeneous with differences in causes for scarring (e.g. surgery, infected wounds, and trauma), site (e.g. chest and back), and ages of scars. The duration of follow-up was three and four and a half months. The included studies reported three comparisons; SGS compared with no treatment, SGS compared with non-silicone gel sheeting (a dressing similar to SGS but which does not contain silicone), and SGS compared with intralesional injections of triamcinolone acetonide. One trial had a split-body design and one trial had an unclear design (resulting in a mix of paired and clustered data).\nThe included studies reported limited outcome data for the primary review outcome of scar severity measured by health professionals and no data were reported for severity of scar measured by patients or adverse events. For secondary outcomes some data on pain were reported, but health-related quality of life and cost-effectiveness were not reported. Both trials had suboptimal outcome reporting, thus many domains in the risk of bias were assessed as unclear. All evidence was rated as being very low-certainty, mainly due to risk of bias, indirectness, and imprecision.\nSGS compared with no treatment\nTwo studies with 33 participants (76 scars) reported the severity of scar assessed by health professionals, and we are uncertain about the effect of SGS on scar severity compared with no treatment (very low-certainty evidence, downgraded once for risk of bias, once for inconsistency, once for indirectness, and once for imprecision). We are uncertain about the effect of SGS on pain compared with no treatment (21 participants with 40 scars; very low-certainty evidence, downgraded once for risk of bias, once for inconsistency, once for indirectness, and once for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness.\nSGS compared with non-SGS\nOne study with 16 participants (25 scars) was included in this comparison. We are uncertain about the effect of SGS on scar severity assessed by health professionals compared with non-SGS (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). We are also uncertain about the effect of SGS on pain compared with non-SGS (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness.\nSGS compared with intralesional injections of triamcinolone acetonide\nOne study with 17 participants (51 scars) reported scar severity assessed by health professionals, and we are uncertain about the effect of SGS on scar severity compared with intralesional injections of triamcinolone acetonide (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). This study also reported pain assessed by health professionals among 5 participants (15 scars) and we are uncertain about the effect of SGS on pain compared with intralesional injections of triamcinolone acetonide (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and twice for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness.\nAuthors' conclusions\nThere is currently a lack of RCT evidence about the clinical effectiveness of SGS in the treatment of keloid scars. From the two studies identified, there is insufficient evidence to demonstrate whether the use of SGS compared with no treatment, non-SGS, or intralesional injections of triamcinolone acetonide makes any difference in the treatment of keloid scars. Evidence from the included studies is of very low certainty, mainly driven by the risk of bias, indirectness, and imprecision due to small sample size. Further well-designed studies that have good reporting methodologies and address important clinical, quality of life and economic outcomes are required to reduce uncertainty around decision-making in the use of SGS to treat keloid scars.\n\nGiven the provided abstract, please respond to the following query: \"How are keloid scars treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Silicone gel sheeting is a soft and flexible wound dressing containing an elastic form of silicone. It has a soft, rubbery texture and can be easily attached to the skin. Silicone gel sheeting is thought to be an optimal option in the treatment of keloid scars. It can be used on healing skin to help soften and flatten a keloid scar."
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22257
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[
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"role": "user",
"content": "Abstract: Background\nFalls and fall-related injuries are common. A third of community-dwelling people aged over 65 years fall each year. Falls can have serious consequences including restricting activity or institutionalisation. This review updates the previous evidence for environmental interventions in fall prevention.\nObjectives\nTo assess the effects (benefits and harms) of environmental interventions (such as fall-hazard reduction, assistive technology, home modifications, and education) for preventing falls in older people living in the community.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, other databases, trial registers, and reference lists of systematic reviews to January 2021. We contacted researchers in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials evaluating the effects of environmental interventions (such as reduction of fall hazards in the home, assistive devices) on falls in community-residing people aged 60 years and over.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcome was rate of falls.\nMain results\nWe included 22 studies from 10 countries involving 8463 community-residing older people. Participants were on average 78 years old, and 65% were women. For fall outcomes, five studies had high risk of bias and most studies had unclear risk of bias for one or more risk of bias domains. For other outcomes (e.g. fractures), most studies were at high risk of detection bias. We downgraded the certainty of the evidence for high risk of bias, imprecision, and/or inconsistency.\nHome fall-hazard reduction (14 studies, 5830 participants)\nThese interventions aim to reduce falls by assessing fall hazards and making environmental safety adaptations (e.g. non-slip strips on steps) or behavioural strategies (e.g. avoiding clutter).\nHome fall-hazard interventions probably reduce the overall rate of falls by 26% (rate ratio (RaR) 0.74, 95% confidence interval (CI) 0.61 to 0.91; 12 studies, 5293 participants; moderate-certainty evidence); based on a control group risk of 1319 falls per 1000 people a year, this is 343 (95% CI 118 to 514) fewer falls. However, these interventions were more effective in people who are selected for higher risk of falling, with a reduction of 38% (RaR 0.62, 95% CI 0.56 to 0.70; 9 studies, 1513 participants; 702 (95% CI 554 to 812) fewer falls based on a control risk of 1847 falls per 1000 people; high-certainty evidence). We found no evidence of a reduction in rate of falls when people were not selected for fall risk (RaR 1.05, 95% CI 0.96 to 1.16; 6 studies, 3780 participants; high-certainty evidence).\nFindings were similar for the number of people experiencing one or more falls. These interventions probably reduce the overall risk by 11% (risk ratio (RR) 0.89, 95% CI 0.82 to 0.97; 12 studies, 5253 participants; moderate-certainty evidence); based on a risk of 519 per 1000 people per year, this is 57 (95% CI 15 to 93) fewer fallers. However, for people at higher risk of falling, we found a 26% decrease in risk (RR 0.74, 95% CI 0.65 to 0.85; 9 studies, 1473 participants), but no decrease for unselected populations (RR 0.99, 95% CI 0.92 to 1.07; 6 studies, 3780 participants) (high-certainty evidence).\nThese interventions probably make little or no important difference to health-related quality of life (HRQoL) (standardised mean difference 0.09, 95% CI −0.10 to 0.27; 5 studies, 1848 participants; moderate-certainty evidence). They may make little or no difference to the risk of fall-related fractures (RR 1.00, 95% 0.98 to 1.02; 2 studies, 1668 participants), fall-related hospitalisations (RR 0.96, 95% CI 0.87 to 1.06; 3 studies, 325 participants), or in the rate of falls requiring medical attention (RaR 0.91, 95% CI 0.58 to 1.43; 3 studies, 946 participants) (low-certainty evidence). The evidence for number of fallers requiring medical attention was unclear (2 studies, 216 participants; very low-certainty evidence). Two studies reported no adverse events.\nAssistive technology\nVision improvement interventions may make little or no difference to the rate of falls (RaR 1.12, 95% CI 0.84 to 1.50; 3 studies, 1489 participants) or people experiencing one or more falls (RR 1.09, 95% CI 0.79 to 1.50) (low-certainty evidence). We are unsure of the evidence for fall-related fractures (2 studies, 976 participants) and falls requiring medical attention (1 study, 276 participants) because the certainty of the evidence is very low. There may be little or no difference in HRQoL (mean difference 0.40, 95% CI −1.12 to 1.92) or adverse events (falls while switching glasses; RR 1.00, 95% CI 0.98 to 1.02) (1 study, 597 participants; low-certainty evidence).\nResults for other assistive technology - footwear and foot devices, and self-care and assistive devices (5 studies, 651 participants) - were not pooled due to the diversity of interventions and contexts.\nEducation\nWe are uncertain whether an education intervention to reduce home fall hazards reduces the rate of falls or the number of people experiencing one or more falls (1 study; very low-certainty evidence). These interventions may make little or no difference to the risk of fall-related fractures (RR 1.02, 95% CI 0.96 to 1.08; 1 study, 110 participants; low-certainty evidence).\nHome modifications\nWe found no trials of home modifications that measured falls as an outcome for task enablement and functional independence.\nAuthors' conclusions\nWe found high-certainty evidence that home fall-hazard interventions are effective in reducing the rate of falls and the number of fallers when targeted to people at higher risk of falling, such as having had a fall in the past year and recently hospitalised or needing support with daily activities. There was evidence of no effect when interventions were targeted to people not selected for risk of falling. Further research is needed to examine the impact of intervention components, the effect of awareness raising, and participant-interventionist engagement on decision-making and adherence.\nVision improvement interventions may or may not impact the rate of falls. Further research is needed to answer clinical questions such as whether people should be given advice or take additional precautions when changing eye prescriptions, or whether the intervention is more effective when targeting people at higher risk of falls.\nThere was insufficient evidence to determine whether education interventions impact falls.\n\nGiven the provided abstract, please respond to the following query: \"Why is it important to consider environmental hazards as part of a fall prevention programme?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Falls are common and can be deadly, but they are preventable. Approximately one-third of people age 65 years and older fall each year. Most falls occur in the home, and more than 30% of all falls are caused by environmental hazards. Environmental fall-hazard removal programmes are interventions delivered by professionals that identify and remove environmental fall hazards."
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query-laysum
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22258
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[
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"role": "user",
"content": "Abstract: Background\nSince the introduction of endotracheal intubation in paediatrics, uncuffed endotracheal tubes (ETTs) have been the standard of care for children under eight years old, based on the presumption that complications, particularly postoperative stridor, are higher with cuffed ETTs. The major disadvantages of uncuffed ETTs cited for this shift in procedure include the difficulty in achieving tidal volumes due to leakage around an uncuffed ETT. To seal the airway adequately, uncuffed tubes may need to be exchanged for another tube with a larger diameter, which sometimes requires several attempts before the appropriate size is found. Uncuffed tubes also allow waste anaesthetic gases to escape, contributing significantly to operating room contamination and rendering the anaesthetic procedure more expensive. Our review summarizes the available data, to provide a current perspective on the use of cuffed versus uncuffed endotracheal tubes in children of eight years old or less.\nObjectives\nTo assess the risks and benefits of cuffed versus uncuffed endotracheal tubes during general anaesthesia in children up to eight years old.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS and Google Scholar databases from their inception until March 2017. We also searched databases of ongoing trials, and checked references and citations. We imposed no restriction by language.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials in which the effects of using cuffed and uncuffed tubes were investigated in children up to eight years old undergoing general anaesthesia. We excluded studies conducted solely in newborn babies.\nData collection and analysis\nWe applied standard methodological procedures, as defined in the Methodological Expectations of Cochrane Intervention Reviews (MECIR).\nMain results\nWe included three trials (2804 children), comparing cuffed with uncuffed ETTs. We rated the risks of bias in all three trials as high. Outcome data were limited. The largest trial was supported by Microcuff GmbH, who provided the cuffed tubes used. The other two trials were small, and should be interpreted with caution. Based on the GRADE approach, we rated the quality of evidence as low to very low.\nTwo trials comparing cuffed versus uncuffed ETTs found no difference between the groups for postextubation stridor (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.65 to 1.33; 2734 children; quality of evidence very low). However, those two trials demonstrated a statistically significantly lower rate of endotracheal tube exchange in the cuffed ETT group (RR 0.07, 95% CI 0.05 to 0.10; 2734 children; quality of evidence very low).\nOne trial with 70 participants found that costs per case were lower in the cuffed ETT group (mean difference (MD) EUR 19.0 lower; 95% CI 24.23 to 13.77 lower; quality of evidence low), since the higher cost of the cuffed tubes may be offset by the savings made with anaesthetic gases.\nNo clear evidence emerged to suggest any difference between cuffed and uncuffed tubes for outcomes such as the need to treat postextubation stridor with tracheal re-intubation (RR 1.85, 95% CI 0.17 to 19.76; 115 children; 2 trials; quality of evidence very low), epinephrine (RR 0.70, 95% CI 0.38 to 1.28; 115 children; 2 trials; quality of evidence very low) or corticosteroid (RR 0.87, 95% CI 0.51 to 1.49; 102 children; 1 trial; quality of evidence very low), or need for intensive care unit (ICU) admission to treat postextubation stridor (RR 2.77, 95% CI 0.30 to 25.78; 102 children; 1 trial; quality of evidence very low).\nNone of the trials included in this review evaluated the ability to deliver appropriate tidal volume.\nAuthors' conclusions\nImplications for practice\nWe are unable to draw definitive conclusions about the comparative effects of cuffed or non-cuffed endotracheal tubes in children undergoing general anaesthesia. Our confidence is limited by risks of bias, imprecision and indirectness. The lower requirement for exchange of tubes with cuffed ETTs was very low-quality evidence, and the requirement for less medical gas used and consequent lower cost was low-quality evidence. In some cases, tracheal re-intubation is required to guarantee an open airway when adequate oxygenation is difficult after removal of the tube, for a variety of reasons including stridor, muscle weakness or obstruction. No data were available to permit evaluation of whether appropriate tidal volumes were delivered.\nImplications for research\nLarge randomized controlled trials of high methodological quality should be conducted to help clarify the risks and benefits of cuffed ETTs for children. Such trials should investigate the capacity to deliver appropriate tidal volume. Future trials should also address cost effectiveness and respiratory complications. Such studies should correlate the age of the child with the duration of intubation, and with possible complications. Studies should also be conducted in newborn babies. Future research should be conducted to compare the effects of the different types or brands of cuffed tubes used worldwide. Finally, trials should be designed to perform more accurate assessments and to diagnose the complications encountered with cuffed compared to uncuffed ETTs.\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"
},
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"role": "assistant",
"content": "The quality of evidence was low to very low, as there were problems with the study designs. Comparisons between cuffed and uncuffed tubes need to be interpreted with caution. Further studies are needed to evaluate the benefits and risks of the two types of tubes."
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query-laysum
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22259
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[
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"role": "user",
"content": "Abstract: Background\nJellyfish envenomation is common in many coastal regions and varies in severity depending upon the species. Stings cause a variety of symptoms and signs including pain, dermatological reactions, and, in some species, Irukandji syndrome (which may include abdominal/back/chest pain, tachycardia, hypertension, cardiac phenomena, and, rarely, death). Many treatments have been suggested for these symptoms, but their effectiveness is unclear. This is an update of a Cochrane Review last published in 2013.\nObjectives\nTo determine the benefits and harms associated with the use of any intervention, in both adults and children, for the treatment of jellyfish stings, as assessed by randomised and quasi-randomised trials.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and Web of Science up to 27 October 2022. We searched clinical trials registers and the grey literature, and conducted forward-citation searching of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs of any intervention given to treat stings from any species of jellyfish stings. Interventions were compared to another active intervention, placebo, or no treatment. If co-interventions were used, we included the study only if the co-intervention was used in each group.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included nine studies (six RCTs and three quasi-RCTs) involving a total of 574 participants. We found one ongoing study. Participants were either stung accidentally, or were healthy volunteers exposed to stings in a laboratory setting. Type of jellyfish could not be confirmed in beach settings and was determined by investigators using participant and local information.\nWe categorised interventions into comparison groups: hot versus cold applications; topical applications. A third comparison of parenteral administration included no relevant outcome data: a single study (39 participants) evaluated intravenous magnesium sulfate after stings from jellyfish that cause Irukandji syndrome (Carukia). No studies assessed a fourth comparison group of pressure immobilisation bandages.\nWe downgraded the certainty of the evidence due to very serious risk of bias, serious and very serious imprecision, and serious inconsistency in some results.\nApplication of heat versus application of cold\nFour studies involved accidental stings treated on the beach or in hospital. Jellyfish were described as bluebottles (Physalia; location: Australia), and box jellyfish that do not cause Irukandji syndrome (Hawaiian box jellyfish (Carybdea alata) and major box jellyfish (Chironex fleckeri, location: Australia)). Treatments were applied with hot packs or hot water (showers, baths, buckets, or hoses), or ice packs or cold packs.\nThe evidence for all outcomes was of very low certainty, thus we are unsure whether heat compared to cold leads to at least a clinically significant reduction in pain within six hours of stings from Physalia (risk ratio (RR) 2.25, 95% confidence interval (CI) 1.42 to 3.56; 2 studies, 142 participants) or Carybdea alata and Chironex fleckeri (RR 1.66, 95% CI 0.56 to 4.94; 2 studies, 71 participants). We are unsure whether there is a difference in adverse events due to treatment (RR 0.50, 95% CI 0.05 to 5.19; 2 studies, 142 participants); these were minor adverse events reported for Physalia stings. We are also unsure whether either treatment leads to a clinically significant reduction in pain in the first hour (Physalia: RR 2.66, 95% CI 1.71 to 4.15; 1 study, 88 participants; Carybdea alata and Chironex fleckeri: RR 1.16, 95% CI 0.71 to 1.89; 1 study, 42 participants) or cessation of pain at the end of treatment (Physalia: RR 1.63, 95% CI 0.81 to 3.27; 1 study, 54 participants; Carybdea alata and Chironex fleckeri: RR 3.54, 95% CI 0.82 to 15.31; 1 study, 29 participants). Evidence for retreatment with the same intervention was only available for Physalia, with similar uncertain findings (RR 0.19, 95% CI 0.01 to 3.90; 1 study, 96 participants), as was the case for retreatment with the alternative hot or cold application after Physalia (RR 1.00, 95% CI 0.55 to 1.82; 1 study, 54 participants) and Chironex fleckeri stings (RR 0.48, 95% CI 0.02 to 11.17; 1 study, 42 participants). Evidence for dermatological signs (itchiness or rash) was available only at 24 hours for Physalia stings (RR 1.02, 95% CI 0.63 to 1.65; 2 studies, 98 participants).\nTopical applications\nOne study (62 participants) included accidental stings from Hawaiian box jellyfish (Carybdea alata) treated on the beach with fresh water, seawater, Sting Aid (a commercial product), or Adolph's (papain) meat tenderiser. In another study, healthy volunteers (97 participants) were stung with an Indonesian sea nettle (Chrysaora chinensis from Malaysia) in a laboratory setting and treated with isopropyl alcohol, ammonia, heated water, acetic acid, or sodium bicarbonate. Two other eligible studies (Carybdea alata and Physalia stings) did not measure the outcomes of this review.\nThe evidence for all outcomes was of very low certainty, thus we could not be certain whether or not topical applications provided at least a clinically significant reduction in pain (1 study, 62 participants with Carybdea alata stings, reported only as cessation of pain). For adverse events due to treatment, one study (Chrysaora chinensis stings) withdrew ammonia as a treatment following a first-degree burn in one participant. No studies evaluated clinically significant reduction in pain, retreatment with the same or the alternative treatment, or dermatological signs.\nAuthors' conclusions\nFew studies contributed data to this review, and those that did contribute varied in types of treatment, settings, and range of jellyfish species. We are unsure of the effectiveness of any of the treatments evaluated in this review given the very low certainty of all the evidence. This updated review includes two new studies (with 139 additional participants). The findings are consistent with the previous review.\n\nGiven the provided abstract, please respond to the following query: \"Parenteral treatment\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "These treatments are injected directly into the body (under the skin, into muscles, veins, or spine). In one study, people were treated in hospital after accidental stings by box jellyfish that cause Irukandji syndrome. Treatment included magnesium sulfate or a placebo (which looked like the treatment but had no active ingredients), which was given intravenously (directly into the bloodstream through a vein).\nThis study did not measure pain relief in a way that could be included in this review, and did not measure any of the outcomes that we were interested in."
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query-laysum
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22260
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[
{
"role": "user",
"content": "Abstract: Background\nChronic lung disease (CLD) remains a common complication among preterm infants. There is increasing evidence that inflammation plays an important role in the pathogenesis of CLD. Due to their strong anti-inflammatory properties, corticosteroids are an attractive intervention strategy. However, there are growing concerns regarding short- and long-term effects of systemic corticosteroids. Theoretically, administration of inhaled corticosteroids may allow for beneficial effects on the pulmonary system with a lower risk of undesirable systemic side effects.\nObjectives\nTo determine the impact of inhaled corticosteroids administered to preterm infants with birth weight up to 1500 grams (VLBW) beginning in the first two weeks after birth for the prevention of CLD as reflected by the requirement for supplemental oxygen at 36 weeks' postmenstrual age (PMA).\nSearch methods\nRandomised and quasi-randomised trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12) in the Cochrane Library (searched 5 January 2016), MEDLINE (1966 to 5 January 2016), Embase (1980 to 5 January 2016), CINAHL (1982 to 5 January 2016), reference lists of published trials and abstracts published in Pediatric Research or electronically on the Pediatric Academic Societies web-site (1990 to May 2016).\nSelection criteria\nWe included in this review randomised controlled trials of inhaled corticosteroid therapy initiated within the first two weeks of life in VLBW preterm infants.\nData collection and analysis\nWe evaluated data regarding clinical outcomes, including: CLD at 28 days or 36 weeks' PMA; mortality; combined outcome of death or CLD at 28 days of age and at 36 weeks' PMA; the need for systemic corticosteroids; failure to extubate within 14 days; and adverse effects of corticosteroids. All data were analysed using Review Manager (RevMan) 5. Meta-analyses were performed using relative risk (RR) and risk difference (RD), along with their 95% confidence intervals (CI). If RD was significant, the number needed to treat for an additional beneficial outcome (NNTB) was calculated. We used the GRADE approach to assess the quality of evidence.\nMain results\nAccording to GRADE the quality of the studies was moderate. Three additional trials are included in this update. The present review includes data analyses based on 10 qualifying trials that enrolled 1644 neonates. There was no significant difference in the incidence of CLD at 36 weeks' PMA in the inhaled steroid versus the placebo group (5 trials, 429 neonates) among all randomised (typical RR 0.97, 95% CI 0.62 to 1.52; typical RD −0.00, 95% CI −0.07 to 0.06). There was no heterogeneity for this outcome (typical RR I² = 11%; typical RD I² = 0%). There was a significant reduction in the incidence of CLD at 36 weeks' PMA among survivors (6 trials, 1088 neonates) (typical RR 0.76, 95% CI 0.63 to 0.93; typical RD −0.07, 95% CI −0.13 to −0.02; NNTB 14, 95% CI 8 to 50). There was a significant reduction in the combined outcome of death or CLD at 36 weeks' PMA among all randomised neonates (6 trials, 1285 neonates) (typical RR 0.86, 95% CI 0.75 to 0.99; typical RD −0.06, 95% CI −0.11 to −0.00) (P = 0.04); NNTB 17, 95% CI 9 to infinity). There was no significant heterogeneity for any of these analyses (I² = 0%). A lower rate of reintubation was noted in the inhaled steroid group compared with the control group in one study. There were no statistically significant differences in short-term complications between groups and no differences in adverse events at long-term follow-up reported. Long-term follow-up of infants enrolled in the study by Bassler 2015 is ongoing.\nAuthors' conclusions\nBased on this updated review, there is increasing evidence from the trials reviewed that early administration of inhaled steroids to VLBW neonates is effective in reducing the incidence of death or CLD at 36 weeks' PMA among either all randomised infants or among survivors. Even though there is statistical significance, the clinical relevance is of question as the upper CI limit for the outcome of death or CLD at 36 weeks' PMA is infinity. The long-term follow-up results of the Bassler 2015 study may affect the conclusions of this review. Further studies are needed to identify the risk/benefit ratio of different delivery techniques and dosing schedules for the administration of these medications. Studies need to address both the short- and long-term benefits and adverse effects of inhaled steroids with particular attention to neurodevelopmental outcome.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "From literature searches updated to 5 January 2016, 10 randomised controlled trials that enrolled 1644 infants were included."
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query-laysum
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22261
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[
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"role": "user",
"content": "Abstract: Background\nSacrococcygeal pilonidal sinus disease is a common debilitating condition that predominantly affects young adults, with a profound impact on their activities of daily living. The condition is treated surgically, and in some cases the wound in the natal cleft is left open to heal by itself. Many dressings and topical agents are available to aid healing of these wounds.\nObjectives\nTo assess the effects of dressings and topical agents for the management of open wounds following surgical treatment for sacrococcygeal pilonidal sinus in any care setting.\nSearch methods\nIn March 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and we scanned reference lists of included studies, 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 parallel-group randomised controlled trials (RCTs) only. We included studies with participants who had undergone any type of sacrococcygeal pilonidal sinus disease surgery and were left with an open wound.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 11 RCTs comprising 932 participants. Two studies compared topical negative pressure wound therapy (TNPWT) with conventional open wound healing, two studies compared platelet-rich plasma with sterile absorbent gauze, and the other seven studies compared various dressings and topical agents. All studies were at high risk of bias in at least one domain, whilst one study was judged to be at low risk of bias in all but one domain. All studies were conducted in secondary care. Mean participant ages were between 20 and 30 years, and nearly 80% of participants were male. No studies provided data on quality of life, cost-effectiveness, pain at first dressing change or proportion of wounds healed at 6 or 12 months, and very few adverse effects were recorded in any study.\nIt is unclear whether TNPWT reduces time to wound healing compared with conventional open wound healing (comparison 1), as the certainty of evidence is very low. The two studies provided conflicting results, with one study showing benefit (mean difference (MD) −24.01 days, 95% confidence interval (CI) −35.65 to −12.37; 19 participants), whilst the other reported no difference. It is also unclear whether TNPWT has any effect on the proportion of wounds healed by 30 days (risk ratio (RR) 3.60, 95% CI 0.49 to 26.54; 19 participants, 1 study; very low-certainty evidence). Limited data were available for our secondary outcomes time to return to normal daily activities and recurrence rate; we do not know whether TNPWT has any effect on these outcomes.\nLietofix cream may increase the proportion of wounds that heal by 30 days compared with an iodine dressing (comparison 4; RR 8.06, 95% CI 1.05 to 61.68; 205 participants, 1 study; low-certainty evidence). The study did not provide data on time to wound healing.\nWe do not know whether hydrogel dressings reduce time to wound healing compared with wound cleaning with 10% povidone iodine (comparison 5; MD −24.54 days, 95% CI −47.72 to −1.36; 31 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. It is unclear whether hydrogel dressings have any effect on adverse effects as the certainty of the evidence is very low.\nPlatelet-rich plasma may reduce time to wound healing compared with sterile absorbent gauze (comparison 6; MD −19.63 days, 95% CI −34.69 to −4.57; 210 participants, 2 studies; low-certainty evidence). No studies provided data on the proportion of wounds healed. Platelet-rich plasma may reduce time to return to normal daily activities (MD −15.49, 95% CI −28.95 to −2.02; 210 participants, 2 studies; low-certainty evidence).\nZinc oxide mesh may make little or no difference to time to wound healing compared with placebo (comparison 2; median 54 days in the zinc oxide mesh group versus 62 days in the placebo mesh group; low-certainty evidence). We do not know whether zinc oxide mesh has an effect on the proportion of wounds healed by 30 days as the certainty of the evidence is very low (RR 2.35, 95% CI 0.49 to 11.23).\nIt is unclear whether gentamicin-impregnated collagen sponge reduces time to wound healing compared with no dressing (comparison 7; MD −1.40 days, 95% CI −5.05 to 2.25; 50 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed.\nDialkylcarbamoyl chloride (DACC)-coated dressings may make little or no difference to time to wound healing compared with alginate dressings (comparison 8; median 69 (95% CI 62 to 72) days in the DACC group versus 71 (95% CI 69 to 85) days in the alginate group; 1 study, 246 participants; low-certainty evidence).\nOne study compared a polyurethane foam hydrophilic dressing with an alginate dressing (comparison 3) whilst another study compared a hydrocolloid dressing with an iodine dressing (comparison 9). It is unclear whether either intervention has any effect on time to wound healing as the certainty of evidence is very low.\nAuthors' conclusions\nAt present, the evidence that any of the dressings or topical agents contained in this review have a benefit on time to wound healing, the proportion of wounds that heal at a specific time point or on any of the secondary outcomes of our review ranges from low certainty to very low certainty. There is low-certainty evidence on the benefit on wound healing of platelet-rich plasma from two studies and of Lietofix cream and hydrogel dressings from single studies. Further studies are required to investigate these interventions further.\n\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 11 studies with a combined total of 932 participants. Two studies compared topical negative pressure wound therapy (which applies controlled suction to the surface of the wound) with simple wound dressings. Two studies compared platelet-rich plasma with sterile absorbent gauze. The other seven studies compared various dressings and topical agents. All the studies took place in hospitals.\n- No studies provided data on quality of life, value for money or pain at the first dressing change.\n- We do not know if topical negative pressure wound therapy helps wounds to heal faster than simple wound dressings.\n- Lietofix skin repair cream may help wounds to heal by 30 days.\n- We do not know if hydrogel dressings help wounds to heal faster or protect better against surgical site infection compared with wound cleaning with 10% povidone iodine.\n- Platelet-rich plasma may reduce the time to wound healing compared with sterile absorbent gauze. \n- Compared with placebo mesh, mesh with zinc oxide (which is thought to have healing properties) may have little or no effect on whether wounds heal by 30 days, and it is unclear if it reduces the time to wound healing.\n- We do not know if collagen sponge soaked in antibiotic has any effect on the time to wound healing compared with no dressing.\n- Dressings coated with dialkylcarbamoyl chloride (a substance that bacteria sticks to) may make little to no difference to wound healing time compared with alginate dressings (derived from seaweed)."
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query-laysum
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22262
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[
{
"role": "user",
"content": "Abstract: Background\nDiverticular disease is a common condition that increases in prevalence with age. Recent theories on the pathogenesis of diverticular inflammation have implicated chronic inflammation similar to that seen in ulcerative colitis. Mesalamine, or 5-aminosalicylic acid (5-ASA), is a mainstay of therapy for individuals with ulcerative colitis. Accordingly, 5-ASA has been studied for prevention of recurrent diverticulitis.\nObjectives\nTo evaluate the efficacy of mesalamine (5-ASA) for prevention of recurrent diverticulitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 8), in the Cochrane Library; Ovid MEDLINE (from 1950 to 9 September 2017); Ovid Embase (from 1974 to 9 September 2017); and two clinical trials registries for ongoing trials - Clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform database (9 September 2017).\nWe also searched proceedings from major gastrointestinal conferences - Digestive Disease Week (DDW), United European Gastroenterology Week (UEGW), and the American College of Gastroenterology (ACG) Annual Scientific Meeting - from 2010 to September 2017. In addition, we scanned reference lists from eligible publications, and we contacted corresponding authors to ask about additional trials.\nSelection criteria\nWe included randomised controlled clinical trials comparing the efficacy of 5-ASA versus placebo or another active drug for prevention of recurrent diverticulitis.\nData collection and analysis\nWe used standard methodological procedures as defined by Cochrane. Three review authors assessed eligibility for inclusion. Two review authors selected studies, extracted data, and assessed methodological quality independently. We calculated risk ratios (RRs) for prevention of diverticulitis recurrence using an intention-to-treat principle and random-effects models. We assessed heterogeneity using criteria for Chi2 (P < 0.10) and I2 tests (> 50%). To explore sources of heterogeneity, we conducted a priori subgroup analyses. To assess the robustness of our results, we carried out sensitivity analyses using different summary statistics (RR vs odds ratio (OR)) and meta-analytical models (fixed-effect vs random-effects).\nMain results\nWe included in this review seven studies with a total of 1805 participants.\n\nWe judged all seven studies to have unclear or high risk of bias. Investigators found no evidence of an effect when comparing 5-ASA versus control for prevention of recurrent diverticulitis (31.3% vs 29.8%; RR 0.69, 95% confidence interval (CI) 0.43 to 1.09); very low quality of evidence).\nFive of the seven studies provided data on adverse events of 5-ASA therapy. The most commonly reported side effects were gastrointestinal symptoms (epigastric pain, nausea, and diarrhoea). No significant difference was seen between 5-ASA and control (67.8% vs 64.6%; RR 0.98, 95% CI 0.91 to 1.06; P = 0.63; moderate quality of evidence), nor was significant heterogeneity observed (I2 = 0%; P = 0.50).\nAuthors' conclusions\nThe effects of 5-ASA on recurrence of diverticulitis are uncertain owing to the small number of heterogenous trials included in this review. Rates of recurrent diverticulitis were similar among participants using 5-ASA and control participants. Effective medical strategies for prevention of recurrent diverticulitis are needed, and further randomised, double-blinded, placebo-controlled trials of rigorous design are warranted to specify the effects of 5-ASA (mesalamine) in the management of diverticulitis.\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"
},
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"role": "assistant",
"content": "Diverticula are small bulging pouches that can form in the lining of the digestive system, particularly in the colon. Diverticulitis is inflammation of these pouches, and it is an important complication of diverticular disease. Approximately one-third to one-quarter of patients who recover from one episode of diverticulitis will experience recurrence. The inflammation underlying diverticulitis may be similar to that seen in inflammatory bowel disease. 5-Aminosalicylic acid (5-ASA) is an anti-inflammatory drug that has proved effective as treatment for ulcerative colitis and therefore may be useful for prevention of recurrent diverticulitis"
}
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query-laysum
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22263
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[
{
"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: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up-to-date to April 2021."
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query-laysum
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22264
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[
{
"role": "user",
"content": "Abstract: Background\nCohort studies have suggested that nasal continuous positive airway pressure (CPAP) starting in the immediate postnatal period before the onset of respiratory disease (prophylactic CPAP) may be beneficial in reducing the need for intubation and intermittent positive pressure ventilation (IPPV), and in preventing bronchopulmonary dysplasia (BPD), in preterm or low birth weight infants.\nObjectives\nTo determine if prophylactic nasal CPAP (started within the first 15 minutes) or very early nasal CPAP regardless of respiratory status (started within the first hour of life), reduces the use of mechanical ventilation and the incidence of bronchopulmonary dysplasia without any adverse effects in preterm infants.\nSearch methods\nA comprehensive search was run on 6 November 2020 in the Cochrane Central Register of Controlled Trials (CENTRAL via CRS Web) and MEDLINE via Ovid. We also searched the reference lists of retrieved studies.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs in preterm infants (under 37 weeks of gestation). We included trials if they compared prophylactic nasal CPAP (started within the first 15 minutes) or very early nasal CPAP (started within the first hour of life) in infants with minimal signs of respiratory distress with 'supportive care', such as supplemental oxygen therapy, standard nasal cannula, or mechanical ventilation. We excluded studies where prophylactic CPAP was compared with CPAP along with co-interventions.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal, including independent study selection, assessment of trial quality, and extraction of data by two review authors.\nMain results\nWe included eight trials (seven from the previous version of the review and one new study), recruiting 3201 babies, in the meta-analysis. Four trials, involving 765 babies, compared CPAP with supportive care, and three trials (2364 babies) compared CPAP with mechanical ventilation. One trial (72 babies) compared prophylactic CPAP with very early CPAP. Apart from a lack of blinding of the intervention, we judged seven studies to have a low risk of bias. However, one study had a high risk of selection bias.\nProphylactic or very early CPAP compared to supportive care\nThere may be a reduction in failed treatment (risk ratio (RR) 0.6, 95% confidence interval (CI) 0.49 to 0.74; risk difference (RD) -0.16, 95% CI -0.34 to 0.02; 4 studies, 765 infants; very low certainty evidence). CPAP possibly reduces BPD at 36 weeks (RR 0.76, 95% CI 0.51 to 1.14; 3 studies, 683 infants, moderate certainty evidence); there may be little or no difference in death (RR 1.04, 95% CI 0.56 to 1.93; 4 studies, 765 infants; moderate certainty evidence). Prophylactic CPAP may reduce the composite outcome of death or BPD (RR 0.69, 95% CI 0.40 to 1.19; 1 study, 256 infants; low certainty evidence). There may be no difference in pulmonary air leak (pneumothorax) (RR 0.75, 95% CI 0.35 to 1.16; 3 studies, 568 infants; low certainty evidence), or intraventricular haemorrhage (IVH) Grade 3 or 4 (RR 0.96, 95% CI 0.39 to 2.37; 2 studies, 486 infants; moderate certainty evidence). Neurodevelopmental impairment was not reported in any of the studies.\nProphylactic or very early CPAP compared to mechanical ventilation\nThere was probably a reduction in the incidence of BPD at 36 weeks (RR 0.89, 95% CI 0.8 to 0.99; RD -0.04, 95% CI -0.08 to 0.00; 3 studies, 2150 infants; moderate certainty evidence); and death or BPD (RR 0.89, 95% CI 0.81 to 0.97; RD -0.05, 95% CI -0.09 to 0.01; 3 studies, 2358 infants; moderate certainty evidence). There was also probably a reduction in the need for mechanical ventilation (failed treatment) (RR 0.49, 95% CI 0.45 to 0.54; RD -0.50, 95% CI -0.54 to -0.45; 2 studies, 1042 infants; moderate certainty evidence). There was probably a reduction in the incidence of death (RR 0.82, 95% CI 0.66 to 1.03; 3 studies, 2358 infants; moderate certainty evidence); pulmonary air leak (pneumothorax) (RR 1.24, 95% CI 0.91 to 1.69; 3 studies, 2357 infants; low certainty evidence); and IVH Grade 3 or 4 (RR 1.09, 95% CI 0.86 to 1.39; 3 studies, 2301 infants; moderate certainty evidence). One study in this comparison reported that there was probably little or no difference between the groups in the incidence of neurodevelopmental impairment at 18 to 22 months (RR 0.91, 95% CI 0.62 to 1.32; 976 infants; moderate certainty evidence).\nProphylactic CPAP compared with very early CPAP\nThere was one study in this comparison. We are very uncertain whether there is any difference in the incidence of BPD (RR 0.5, 95% CI 0.05 to 5.27; very low certainty evidence). The combined outcome of death and BPD was not reported, and failed treatment was reported but without data. There may have been little to no effect on death (RR 0.75, 95% CI 0.29 to1.94; 1 study, 72 infants; very low certainty evidence). Intraventricular haemorrhage Grade 3 or 4 and neurodevelopmental outcomes were not reported in this study. Pulmonary air leak (pneumothorax) was reported in this study, but there were no events in either group.\nAuthors' conclusions\nFor preterm and very preterm infants, there is insufficient evidence to evaluate prophylactic CPAP compared to oxygen therapy and other supportive care. When compared to mechanical ventilation, prophylactic nasal CPAP in very preterm infants reduces the incidence of BPD, the combined outcome of death and BPD, and mechanical ventilation. There is probably no difference in neurodevelopmental impairment at 18 to 22 months of age.\nWhen prophylactic CPAP is compared to early CPAP, we are very uncertain about whether there is any difference between prophylactic and very early CPAP.\nThere is no information about the effect of prophylactic or very early CPAP in late preterm infants.\nThere is one study awaiting classification.\n\nGiven the provided abstract, please respond to the following query: \"What is continuous positive airway pressure?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Continuous positive airway pressure (CPAP) helps people with breathing difficulties by pushing air into their lungs through the nose at a constant pressure. Air is delivered through a mask that fits over the nose, or prongs that sit in the nostrils. CPAP is less invasive than mechanical ventilation, when a tube is put down the throat into the lungs and a machine (a ventilator) ‘breathes’ for the patient. CPAP provides more breathing support than just giving oxygen."
}
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query-laysum
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22265
|
[
{
"role": "user",
"content": "Abstract: Background\nBreast surgery encompasses oncologic, reconstructive, and cosmetic procedures. With the recent focus on the over-prescribing of opioids in the literature, it is important to assess the effectiveness and safety of non-opioid pain medication regimens including nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID pain medications. Clinicians have differing opinions on the safety of perioperative (relating to, occurring in, or being the period around the time of a surgical operation) NSAIDs for breast surgery given the unclear risk/benefit ratio. NSAIDs have been shown to decrease inflammation, pain, and fever, while potentially increasing the risks of bleeding complications.\nObjectives\nTo assess the effects of perioperative NSAID use versus non-NSAID analgesics (other pain medications) in women undergoing any form of breast surgery.\nSearch methods\nThe Cochrane Breast Information Specialist searched the Cochrane Breast Cancer Group (CBCG) Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, The WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to 21 September 2020. Full articles were retrieved for potentially eligible trials.\nSelection criteria\nWe considered all randomized controlled trials (RCTs) looking at perioperative NSAID use in women undergoing breast surgery.\nData collection and analysis\nTwo review authors independently screened studies, extracted data and assessed risk of bias, and certainty of the evidence using the GRADE approach. The main outcomes were incidence of breast hematoma within 90 days (requiring reoperation, interventional drainage, or no treatment) of breast surgery and pain intensity 24 hours following surgery, incidence rate or severity of postoperative nausea, vomiting or both, bleeding from any location within 90 days, need for blood transfusion, other side effects of NSAID use, opioid use within 24 hours of surgery, length of hospital stay, breast cancer recurrence, and non-prescribed NSAID use. Data were presented as risk ratios (RRs) for dichotomous outcomes and standardized mean differences (SMDs) for continuous outcomes.\nMain results\nWe included 12 RCTs with a total of 1596 participants. Seven studies compared NSAIDs (ketorolac, diclofenac, flurbiprofen, parecoxib and celecoxib) to placebo. Four studies compared NSAIDs (ketorolac, flurbiprofen, ibuprofen, and celecoxib) to other analgesics (morphine, hydrocodone, hydromorphone, fentanyl). One study compared NSAIDs (diclofenac) to no intervention.\nNSAIDs compared to placebo\nMost outcomes are judged to have low-certainty evidence unless stated otherwise. There may be little to no difference in the incidence of breast hematomas within 90 days of breast surgery (RR 0.33, 95% confidence interval (CI) 0.05 to 2.02; 2 studies, 230 participants; I2 = 0%). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery compared to placebo (SMD -0.26, 95% CI -0.49 to -0.03; 3 studies, 310 participants; I2 = 73%). There may be little to no difference in the incidence rates or severities of postoperative nausea, vomiting, or both (RR 1.15, 95% CI 0.58 to 2.27; 4 studies, 939 participants; I2 = 81%), bleeding from any location within 90 days (RR 1.05, 95% CI 0.89 to 1.24; 2 studies, 251 participants; I2 = 8%), or need for blood transfusion compared to placebo groups, but we are very uncertain (RR 4.62, 95% CI 0.23 to 91.34; 1 study, 48 participants; very low-certainty evidence). There may be no difference in other side effects (RR 1.12, 95% CI 0.44 to 2.86; 2 studies, 251 participants; I2 = 0%). NSAIDs may reduce opioid use within 24 hours of surgery compared to placebo (SMD -0.45, 95% CI -0.85 to -0.05; 4 studies, 304 participants; I2 = 63%).\nNSAIDs compared to other analgesics\nThere is little to no difference in the incidence of breast hematomas within 90 days of breast surgery, but we are very uncertain (RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; very low-certainty evidence). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery (SMD -0.68, 95% CI -0.97 to -0.39; 3 studies, 200 participants; I2 = 89%; low-certainty evidence) and probably reduce the incidence rates or severities of postoperative nausea, vomiting, or both compared to other analgesics (RR 0.18, 95% CI 0.06 to 0.57; 3 studies, 128 participants; I2 = 0%; moderate-certainty evidence). There is little to no difference in the development of bleeding from any location within 90 days of breast surgery or in other side effects, but we are very uncertain (bleeding: RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; other side effects: RR 0.11, 95% CI 0.01 to 1.80; 1 study, 48 participants; very low-certainty evidence). NSAIDs may reduce opioid use within 24 hours of surgery compared to other analgesics (SMD -6.87, 95% CI -10.93 to -2.81; 3 studies, 178 participants; I2 = 96%; low-certainty evidence).\nNSAIDs compared to no intervention\nThere is little to no difference in pain intensity 24 (± 12) hours following surgery compared to no intervention, but we are very uncertain (SMD -0.54, 95% CI -1.09 to 0.00; 1 study, 60 participants; very low-certainty evidence).\nAuthors' conclusions\nLow-certainty evidence suggests that NSAIDs may reduce postoperative pain, nausea and vomiting, and postoperative opioid use. However, there was very little evidence to indicate whether NSAIDs affect the rate of breast hematoma or bleeding from any location within 90 days of breast surgery, the need for blood transfusion and incidence of other side effects compared to placebo or other analgesics. High-quality large-scale RCTs are required before definitive conclusions can be made.\n\nGiven the provided abstract, please respond to the following query: \"NSAIDs compared to placebo\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "the use of NSAIDs seems to make little difference to the incidence of breast hematoma (a collection of blood inside the armpit or breast surgical site) and bleeding from any location or increase in blood transfusions within 90 days of breast surgery. There was no increase in postoperative nausea and vomiting. NSAIDs may reduce pain within 24 hours after surgery and reduce the use of opioids within 24 hours after surgery."
}
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query-laysum
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22266
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[
{
"role": "user",
"content": "Abstract: Background\nSleep disturbances, including reduced nocturnal sleep time, sleep fragmentation, nocturnal wandering, and daytime sleepiness are common clinical problems in dementia, and are associated with significant carer distress, increased healthcare costs, and institutionalisation. Although non-drug interventions are recommended as the first-line approach to managing these problems, drug treatment is often sought and used. However, there is significant uncertainty about the efficacy and adverse effects of the various hypnotic drugs in this clinically vulnerable population.\nObjectives\nTo assess the effects, including common adverse effects, of any drug treatment versus placebo for sleep disorders in people with dementia.\nSearch methods\nWe searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, on 19 February 2020, using the terms: sleep, insomnia, circadian, hypersomnia, parasomnia, somnolence, rest-activity, and sundowning.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared a drug with placebo, and that had the primary aim of improving sleep in people with dementia who had an identified sleep disturbance at baseline.\nData collection and analysis\nTwo review authors independently extracted data on study design, risk of bias, and results. We used the mean difference (MD) or risk ratio (RR) with 95% confidence intervals (CI) as the measures of treatment effect, and where possible, synthesised results using a fixed-effect model. Key outcomes to be included in our summary tables were chosen with the help of a panel of carers. We used GRADE methods to rate the certainty of the evidence.\nMain results\nWe found nine eligible RCTs investigating: melatonin (5 studies, n = 222, five studies, but only two yielded data on our primary sleep outcomes suitable for meta-analysis), the sedative antidepressant trazodone (1 study, n = 30), the melatonin-receptor agonist ramelteon (1 study, n = 74, no peer-reviewed publication), and the orexin antagonists suvorexant and lemborexant (2 studies, n = 323).\nParticipants in the trazodone study and most participants in the melatonin studies had moderate-to-severe dementia due to Alzheimer's disease (AD); those in the ramelteon study and the orexin antagonist studies had mild-to-moderate AD. Participants had a variety of common sleep problems at baseline. Primary sleep outcomes were measured using actigraphy or polysomnography. In one study, melatonin treatment was combined with light therapy. Only four studies systematically assessed adverse effects. Overall, we considered the studies to be at low or unclear risk of bias.\nWe found low-certainty evidence that melatonin doses up to 10 mg may have little or no effect on any major sleep outcome over eight to 10 weeks in people with AD and sleep disturbances. We could synthesise data for two of our primary sleep outcomes: total nocturnal sleep time (TNST) (MD 10.68 minutes, 95% CI –16.22 to 37.59; 2 studies, n = 184), and the ratio of day-time to night-time sleep (MD –0.13, 95% CI –0.29 to 0.03; 2 studies; n = 184). From single studies, we found no evidence of an effect of melatonin on sleep efficiency, time awake after sleep onset, number of night-time awakenings, or mean duration of sleep bouts. There were no serious adverse effects of melatonin reported.\nWe found low-certainty evidence that trazodone 50 mg for two weeks may improve TNST (MD 42.46 minutes, 95% CI 0.9 to 84.0; 1 study, n = 30), and sleep efficiency (MD 8.53%, 95% CI 1.9 to 15.1; 1 study, n = 30) in people with moderate-to-severe AD. The effect on time awake after sleep onset was uncertain due to very serious imprecision (MD –20.41 minutes, 95% CI –60.4 to 19.6; 1 study, n = 30). There may be little or no effect on number of night-time awakenings (MD –3.71, 95% CI –8.2 to 0.8; 1 study, n = 30) or time asleep in the day (MD 5.12 minutes, 95% CI –28.2 to 38.4). There were no serious adverse effects of trazodone reported.\nThe small (n = 74), phase 2 trial investigating ramelteon 8 mg was reported only in summary form on the sponsor's website. We considered the certainty of the evidence to be low. There was no evidence of any important effect of ramelteon on any nocturnal sleep outcomes. There were no serious adverse effects.\nWe found moderate-certainty evidence that an orexin antagonist taken for four weeks by people with mild-to-moderate AD probably increases TNST (MD 28.2 minutes, 95% CI 11.1 to 45.3; 1 study, n = 274) and decreases time awake after sleep onset (MD –15.7 minutes, 95% CI –28.1 to –3.3: 1 study, n = 274) but has little or no effect on number of awakenings (MD 0.0, 95% CI –0.5 to 0.5; 1 study, n = 274). It may be associated with a small increase in sleep efficiency (MD 4.26%, 95% CI 1.26 to 7.26; 2 studies, n = 312), has no clear effect on sleep latency (MD –12.1 minutes, 95% CI –25.9 to 1.7; 1 study, n = 274), and may have little or no effect on the mean duration of sleep bouts (MD –2.42 minutes, 95% CI –5.53 to 0.7; 1 study, n = 38). Adverse events were probably no more common among participants taking orexin antagonists than those taking placebo (RR 1.29, 95% CI 0.83 to 1.99; 2 studies, n = 323).\nAuthors' conclusions\nWe discovered a distinct lack of evidence to guide decisions about drug treatment of sleep problems in dementia. In particular, we found no RCTs of many widely prescribed drugs, including the benzodiazepine and non-benzodiazepine hypnotics, although there is considerable uncertainty about the balance of benefits and risks for these common treatments. We found no evidence for beneficial effects of melatonin (up to 10 mg) or a melatonin receptor agonist. There was evidence of some beneficial effects on sleep outcomes from trazodone and orexin antagonists and no evidence of harmful effects in these small trials, although larger trials in a broader range of participants are needed to allow more definitive conclusions to be reached. Systematic assessment of adverse effects in future trials is essential.\n\nGiven the provided abstract, please respond to the following query: \"Shortcomings of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Although we searched for them, we were unable to find any trials of other sleeping medications that are commonly prescribed to people with dementia. All participants had dementia due to Alzheimer's disease, although sleep problems are also common in other forms of dementia. No trials assessed how long participants spent asleep without interruption, a high priority outcome to our panel of carers. Only four trials measured side effects systematically.\nWe concluded that there are significant gaps in the evidence needed to guide decisions about medicines for sleeping problems in dementia. More trials are required to inform medical practice. It is essential that trials include careful assessment of side effects."
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query-laysum
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22267
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[
{
"role": "user",
"content": "Abstract: Background\nPatent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. Phototherapy is a common treatment for jaundice in preterm infants. However, phototherapy has been associated with failure of closure of the ductus arteriosus in preterm infants.\nObjectives\nTo determine if chest shielding of preterm infants receiving phototherapy reduces the incidence of clinically and/or haemodynamically significant PDA and reduces morbidity secondary to PDA.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2015, Issue 3), MEDLINE, EMBASE, CINAHL, previous reviews, cross-references, abstracts, proceedings of scientific meetings, and trial registries through March 2015.\nSelection criteria\nRandomised controlled trials (RCTs), cluster-RCTs, or quasi-RCTs of chest shielding during phototherapy compared to sham shielding or no shielding for the prevention of a haemodynamically or clinically significant PDA in preterm infants.\nData collection and analysis\nThree review authors independently assessed studies for eligibility and quality and extracted data. We defined a clinically significant PDA as the presence of a PDA with clinical signs of an effect on organ function attributable to the ductus arteriosus. We defined a haemodynamically significant PDA as clinical and/or echocardiographic signs of a significant ductus arteriosus effect on blood flow.\nMain results\nWe included two small trials enrolling very preterm infants (Rosenfeld 1986; Travadi 2006). We assessed both as at high risk of bias. No study reported clinically significant PDA, defined as the presence of a PDA with clinical symptoms or signs attributable to the effect of a ductus arteriosus on organ function. Rosenfeld 1986 reported a non-significant reduction in haemodynamically significant PDA with left atrial to aortic root ratio greater than 1.2 (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.05 to 1.01; 74 infants) but a statistically significant risk difference (RD -0.18, 95% CI -0.34 to -0.03; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 3 to 33). Rosenfeld 1986 reported a significant reduction in PDA detected by murmur (RR 0.50, 95% CI 0.29 to 0.88; RD -0.30, 95% CI -0.52 to -0.08; NNTB 3, 95% CI 2 to 12; 74 infants). Rosenfeld 1986 reported a significant reduction in treatment with indomethacin (RR 0.12, 95% CI 0.02 to 0.88; RD -0.21, 95% CI -0.35 to -0.06; NNTB 5, 95% CI 3 to 17; 74 infants), and only one infant had a ductal ligation in the no-shield group. There were no other significant outcomes, including mortality to discharge or 28 days, days in oxygen, days on mechanical ventilation, days in hospital, intraventricular haemorrhage, retinopathy of prematurity, or exchange transfusion.\nAuthors' conclusions\nThe available evidence is very low quality and insufficient to assess the safety or efficacy of chest shield during phototherapy for prevention of PDA in preterm infants. Further trials of chest shielding are warranted, particularly in settings where infants are not receiving prophylactic or early echocardiographic targeted cyclo-oxygenase inhibitors for PDA.\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": "Two small randomised trials."
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query-laysum
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22268
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[
{
"role": "user",
"content": "Abstract: Background\nScalpels or electrosurgery can be used to make abdominal incisions. The potential benefits of electrosurgery may include reduced blood loss, dry and rapid separation of tissue, and reduced risk of cutting injury to surgeons. Postsurgery risks possibly associated with electrosurgery may include poor wound healing and complications such as surgical site infection.\nObjectives\nTo assess the effects of electrosurgery compared with scalpel for major abdominal incisions.\nSearch methods\nThe first version of this review included studies published up to February 2012. In October 2016, for this first update, we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, EBSCO CINAHL Plus, and the registry for ongoing trials (www.clinicaltrials.gov). We did not apply date or language restrictions.\nSelection criteria\nStudies considered in this analysis were randomised controlled trials (RCTs) that compared electrosurgery to scalpel for creating abdominal incisions during major open abdominal surgery. Incisions could be any orientation (vertical, oblique, or transverse) and surgical setting (elective or emergency). Electrosurgical incisions were made through major layers of the abdominal wall, including subcutaneous tissue and the musculoaponeurosis (a sheet of connective tissue that attaches muscles), regardless of the technique used to incise the skin and peritoneum. Scalpel incisions were made through major layers of abdominal wall including skin, subcutaneous tissue, and musculoaponeurosis, regardless of the technique used to incise the abdominal peritoneum. Primary outcomes analysed were wound infection, time to wound healing, and wound dehiscence. Secondary outcomes were postoperative pain, wound incision time, wound-related blood loss, and adhesion or scar formation.\nData collection and analysis\nTwo review authors independently carried out study selection, data extraction, and risk of bias assessment. When necessary, we contacted trial authors for missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) for dichotomous data, and mean differences (MD) and 95% CI for continuous data.\nMain results\nThe updated search found seven additional RCTs making a total of 16 included studies (2769 participants). All studies compared electrosurgery to scalpel and were considered in one comparison. Eleven studies, analysing 2178 participants, reported on wound infection. There was no clear difference in wound infections between electrosurgery and scalpel (7.7% for electrosurgery versus 7.4% for scalpel; RR 1.07, 95% CI 0.74 to 1.54; low-certainty evidence downgraded for risk of bias and serious imprecision). None of the included studies reported time to wound healing.\nIt is uncertain whether electrosurgery decreases wound dehiscence compared to scalpel (2.7% for electrosurgery versus 2.4% for scalpel; RR 1.21, 95% CI 0.58 to 2.50; 1064 participants; 6 studies; very low-certainty evidence downgraded for risk of bias and very serious imprecision).\nThere was no clinically important difference in incision time between electrosurgery and scalpel (MD -45.74 seconds, 95% CI -88.41 to -3.07; 325 participants; 4 studies; moderate-certainty evidence downgraded for serious imprecision). There was no clear difference in incision time per wound area between electrosurgery and scalpel (MD -0.58 seconds/cm2, 95% CI -1.26 to 0.09; 282 participants; 3 studies; low-certainty evidence downgraded for very serious imprecision).\nThere was no clinically important difference in mean blood loss between electrosurgery and scalpel (MD -20.10 mL, 95% CI -28.16 to -12.05; 241 participants; 3 studies; moderate-certainty evidence downgraded for serious imprecision). Two studies reported on mean wound-related blood loss per wound area; however, we were unable to pool the studies due to considerable heterogeneity. It was uncertain whether electrosurgery decreased wound-related blood loss per wound area. We could not reach a conclusion on the effects of the two interventions on pain and appearance of scars for various reasons such as small number of studies, insufficient data, the presence of conflicting data, and different measurement methods.\nAuthors' conclusions\nThe certainty of evidence was moderate to very low due to risk of bias and imprecise results. Low-certainty evidence shows no clear difference in wound infection between the scalpel and electrosurgery. There is a need for more research to determine the relative effectiveness of scalpel compared with electrosurgery for major abdominal incisions.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "There was no clear difference between scalpel and electrosurgery in the number of people whose wounds became infected. It is uncertain whether electrosurgery prevents wound breakdown (a complication that involves the breaking open of the surgical incision along the stitches/staples) following surgery, while the difference in blood loss and time required for incision between electrosurgery and scalpel was not clinically important. There was not enough information available to determine how electrosurgery compared with scalpel-based surgery in relation to time required for wounds to heal, amount of pain during healing, and appearance of scars. More studies need to be conducted before conclusions can be drawn as to whether one method is better for pain after an operation and time to wound healing following abdominal surgery."
}
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query-laysum
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22269
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[
{
"role": "user",
"content": "Abstract: Background\nOpen fractures of the major long bones are complex limb-threatening injuries that are predisposed to deep infection. Treatment includes antibiotics and surgery to debride the wound, stabilise the fracture and reconstruct any soft tissue defect to enable infection-free bone repair. There is a need to assess the effect of timing and duration of antibiotic administration and timing and staging of surgical interventions to optimise outcomes.\nObjectives\nTo assess the effects (risks and benefits) of the timing of antibiotic administration, wound debridement and the stages of surgical interventions in managing people with open long bone fractures of the upper and lower limbs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trial registers in February 2021. We also searched conference proceedings and reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that recruited adults with open fractures of the major long bones, comparing: 1) timings of prophylactic antibiotic treatment, 2) duration of prophylactic antibiotic treatment, 3) timing of wound debridement following injury or 4) timing of the stages of reconstructive surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We aimed to collect data for the following outcomes: limb function, health-related quality of life (HRQoL), deep surgical site infection, delayed or non-union, adverse events (in the short- and long-term course of recovery), and resource-related outcomes.\nMain results\nWe included three RCTs of 613 randomised participants with 617 open fractures. Studies were conducted in medical and trauma centres in the USA and Kenya. Where reported, there was a higher proportion of men and a mean age of participants between 30 and 34 years old. Fractures were in the upper and lower limbs in one study, and were tibia fractures in two studies; where reported, these were the result of high-energy trauma such as road traffic accidents. No studies compared the timing of antibiotic treatment or wound debridement.\nDuration of prophylactic antibiotic treatment (1 study, 77 participants available for analysis)\nOne study compared antibiotic treatment for 24 hours with antibiotic treatment for five days. We are very uncertain about the effects of different durations of antibiotic treatment on superficial infections (risk ratio (RR) 1.19, 95% CI 0.49 to 2.87, favours 5 day treatment; 1 study, 77 participants); this was very low-certainty evidence derived from one small study with unclear and high risks of bias, and with an imprecise effect estimate. This study reported no other review outcomes.\nReconstructive surgery: timing of the stages of surgery (2 studies, 458 participants available for analysis)\nTwo studies compared the timing of wound closure, which was completed immediately or delayed. In one study, the mean time of delay was 5.9 days; in the other study, the time of delay was not reported. We are very uncertain about the effects of different timings of wound closure on deep infections (RR 0.82, 95% CI 0.37 to 1.80, favours immediate closure; 2 studies, 458 participants), delayed union or non-union (RR 1.13, 95% CI 0.83 to 1.55, favours delayed closure; 1 study, 387 participants), or superficial infections (RR 6.45, 95% CI 0.35 to 120.43, favours delayed closure; 1 study, 71 participants); this was very low-certainty evidence. We downgraded the certainty of the evidence for very serious risks of bias because both studies had unclear and high risks of bias. We also downgraded for serious imprecision because effect estimates were imprecise, including the possibility of benefits as well as harms, and very serious imprecision when the data were derived from single small study. These studies reported no other review outcomes.\nAuthors' conclusions\nWe could not determine the risks and benefits of different treatment protocols for open long bone fractures because the evidence was very uncertain for the two comparisons and we did not find any studies addressing the other possible comparisons. Well-designed randomised trials with adequate power are needed to guide surgical and antibiotic treatment of open fractures, particularly with regard to timing and duration of antibiotic administration and timing and staging of surgery.\n\nGiven the provided abstract, please respond to the following query: \"Are we confident in what we found?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are not very confident in these findings because:\n- we only had information from one small study about how long antibiotics are given, and from two studies about when the wound is closed;\n- the studies were not well reported, and one was only reported in a short summary;\n- all of the findings included the possibility of benefit (for example, fewer infections with a short course of antibiotics) as well as the possibility of harm (for example, more infections with a short course of antibiotics)."
}
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query-laysum
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22270
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[
{
"role": "user",
"content": "Abstract: Background\nSore throat is a common reason for people to present for medical care and to be prescribed antibiotics. Overuse of antibiotics in primary medicine is a concern, hence it is important to establish their efficacy in treating sore throat and preventing secondary complications.\nObjectives\nTo assess the effects of antibiotics for reducing symptoms of sore throat for child and adult patients.\nSearch methods\nWe searched CENTRAL 2021, Issue 2, MEDLINE (January 1966 to April week 1, 2021), Embase (January 1990 to April 2021), and two trial registries (searched 6 April 2021).\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs of antibiotics versus control assessing typical sore throat symptoms or complications amongst children and adults seeking medical care for sore throat symptoms.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane. Two review authors independently screened studies for inclusion and extracted data, resolving any differences in opinion by discussion. We contacted the trial authors from three studies for additional information. We used GRADE to assess the certainty of the evidence for the efficacy of antibiotics on our primary outcomes (sore throat at day three and one week) and secondary outcomes (fever and headache symptoms and incidence of acute rheumatic fever, acute glomerulonephritis, acute otitis media, acute sinusitis, and quinsy).\nMain results\nWe included 29 trials with 15,337 cases of sore throat. The majority of included studies were conducted in the 1950s, during which time the rates of serious complications (especially acute rheumatic fever) were much higher than today. Although clinical antibiotic trials for sore throat and respiratory symptoms are still being conducted, it is unusual for them to include placebo or 'no treatment' control arms, which is a requirement for inclusion in the review.\nThe age of participants ranged from younger than one year to older than 50 years, but most participants across all studies were adults. Although all studies recruited patients presenting with symptoms of sore throat, few of them distinguished between bacterial and viral aetiology. Bias may have been introduced through non-clarity in treatment allocation procedures and lack of blinding in some studies. Harms from antibiotics were poorly or inconsistently reported, and were thus not quantified for this review.\n1. Symptoms\nThroat soreness and headache at day three were reduced by using antibiotics, although 82% of participants in the placebo or no treatment group were symptom-free by one week. The reduction in sore throat symptoms at day three (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.60 to 0.80; 16 studies, 3730 participants; moderate-certainty evidence) was greater than at one week in absolute numbers (RR 0.50, 95% CI 0.34 to 0.75; 14 studies, 3083 participants; moderate-certainty evidence) due to many cases in both treatment groups having resolved by this time. The number needed to treat for an additional beneficial outcome (NNTB) to prevent one sore throat at day three was less than six; at week one it was 18. Compared with placebo or no treatment, antibiotics did not significantly reduce fever at day three (RR 0.75, 95% CI 0.53 to 1.07; 8 studies, 1443 participants; high-certainty evidence), but did reduce headache at day three (RR 0.49, 95% CI 0.34 to 0.70; 4 studies, 1020 participants; high-certainty evidence).\n2. Suppurative complications\nWhilst the prevalence of suppurative complications was low, antibiotics reduced the incidence of acute otitis media within 14 days (Peto odds ratio (OR) 0.21, 95% CI 0.11 to 0.40; 10 studies, 3646 participants; high-certainty evidence) and quinsy within two months (Peto OR 0.16, 95% CI 0.07 to 0.35; 8 studies, 2433 participants; high-certainty evidence) compared to those receiving placebo or no treatment, but not acute sinusitis within 14 days (Peto OR 0.46, 95% CI 0.10 to 2.05; 8 studies, 2387 participants; high-certainty evidence).\n3. Non-suppurative complications\nThere were too few cases of acute glomerulonephritis to determine whether there was a protective effect of antibiotics compared with placebo against this complication (Peto OR 0.07, 95% CI 0.00 to 1.32; 10 studies, 5147 participants; low-certainty evidence). Antibiotics reduced acute rheumatic fever within two months when compared to the control group (Peto OR 0.36, 95% CI 0.26 to 0.50; 18 studies, 12,249 participants; moderate-certainty evidence). It should be noted that the overall prevalence of acute rheumatic fever was very low, particularly in the later studies.\nAuthors' conclusions\nAntibiotics probably reduce the number of people experiencing sore throat, and reduce the likelihood of headache, and some sore throat complications. As the effect on symptoms can be small, clinicians must judge on an individual basis whether it is clinically justifiable to use antibiotics to produce this effect, and whether the underlying cause of the sore throat is likely to be of bacterial origin. Furthermore, the balance between modest symptom reduction and the potential hazards of antimicrobial resistance must be recognised. Few trials have attempted to measure symptom severity. If antibiotics reduce the severity as well as the duration of symptoms, their benefit will have been underestimated in this meta-analysis. Additionally, more trials are needed in low-income countries, in socio-economically deprived sections of high-income countries, as well as in children.\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"
},
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"role": "assistant",
"content": "Sore throats are infections caused by bacteria or viruses. Pain or discomfort is the most distinguishing feature. However, fever and headache are also common accompanying symptoms. People usually recover quickly (after three or four days), although some develop complications. A serious but rare complication is rheumatic fever, which affects the heart and joints. Other complications include acute infection of the sinuses, middle ear, tonsils, and kidney. Antibiotics reduce infections caused by bacteria, but not those caused by viruses, and they can cause diarrhoea, rash, and other adverse effects. In addition, communities build resistance to them."
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22271
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"content": "Abstract: Background\nA new Cochrane Review entitled 'Cognitive behavioural therapy for anxiety disorders in children and adolescents' was published on 16 November 2020 which supersedes this publication.\nCitation: James AC, Reardon T, Soler A, James G, Creswell C. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No.: CD013162. DOI: 10.1002/14651858.CD013162.pub2.\nA previous Cochrane review (James 2005) showed that cognitive behavioural therapy (CBT) was effective in treating childhood anxiety disorders; however, questions remain regarding (1) the relative efficacy of CBT versus non-CBT active treatments; (2) the relative efficacy of CBT versus medication and the combination of CBT and medication versus placebo; and (3) the long-term effects of CBT.\nObjectives\nTo examine (1) whether CBT is an effective treatment for childhood and adolescent anxiety disorders in comparison with (a) wait-list controls; (b) active non-CBT treatments (i.e. psychological placebo, bibliotherapy and treatment as usual (TAU)); and (c) medication and the combination of medication and CBT versus placebo; and (2) the long-term effects of CBT.\nSearch methods\nSearches for this review included the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Depression, Anxiety and Neurosis Group Register, which consists of relevant randomised controlled trials from the bibliographic databases－The Cochrane Library (1970 to July 2012), EMBASE, (1970 to July 2012) MEDLINE (1970 to July 2012) and PsycINFO (1970 to July 2012).\nSelection criteria\nAll randomised controlled trials (RCTs) of CBT versus waiting list, active control conditions, TAU or medication were reviewed. All participants must have met the criteria of the Diagnostic and Statistical Manual (DSM) or the International Classification of Diseases (ICD) for an anxiety diagnosis, excluding simple phobia, obsessive-compulsive disorder, post-traumatic stress disorder and elective mutism.\nData collection and analysis\nThe methodological quality of included trials was assessed by three reviewers independently. For the dichotomous outcome of remission of anxiety diagnosis, the odds ratio (OR) with 95% confidence interval (CI) based on the random-effects model, with pooling of data via the inverse variance method of weighting, was used. Significance was set at P < 0.05. Continuous data on each child’s anxiety symptoms were pooled using the standardised mean difference (SMD).\nMain results\nForty-one studies consisting of 1806 participants were included in the analyses. The studies involved children and adolescents with anxiety of mild to moderate severity in university and community clinics and school settings. For the primary outcome of remission of any anxiety diagnosis for CBT versus waiting list controls, intention-to-treat (ITT) analyses with 26 studies and 1350 participants showed an OR of 7.85 (95% CI 5.31 to 11.60, Z = 10.34, P < 0.0001), but with evidence of moderate heterogeneity (P = 0.05, I² = 30%). The number needed to treat (NNT) was 3.0 (95% CI 1.75 to 3.03). No difference in outcome was noted between individual, group and family/parental formats. ITT analyses revealed that CBT was no more effective than non-CBT active control treatments (six studies, 426 participants) or TAU in reducing anxiety diagnoses (two studies, 88 participants). The few controlled follow-up studies (n = 4) indicate that treatment gains in the remission of anxiety diagnosis are not statistically significant.\nAuthors' conclusions\nCognitive behavioural therapy is an effective treatment for childhood and adolescent anxiety disorders; however, the evidence suggesting that CBT is more effective than active controls or TAU or medication at follow-up, is limited and inconclusive.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "Parents, children and young people; people working in education; professionals working in mental health services for children and young people; and general practitioners."
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"content": "Abstract: Background\nTargeted temperature management (also known under 'therapeutic hypothermia', 'induced hypothermia'\", or 'cooling') has been shown to be beneficial for neurological outcome in patients who have had successful resuscitation from sudden cardiac arrest, but it remains unclear when this intervention should be initiated.\nObjectives\nTo assess the effects of pre-hospital initiation of cooling on survival and neurological outcome in comparison to in-hospital initiation of cooling for adults with pre-hospital cardiac arrest.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, CINAHL, BIOSIS, and three trials registers from inception to 5 March 2015, and carried out reference checking, citation searching, and contact with study authors to identify additional studies.\nSelection criteria\nWe searched for randomized controlled trials (RCTs) in adults with out-of-hospital cardiac arrest comparing cooling in the pre-hospital setting to in-hospital cooling. Our primary outcomes were survival and neurological outcome; our secondary outcomes were adverse events, quality of life, and length of stay in the intensive care unit (ICU) and in the hospital.\nData collection and analysis\nWe used Cochrane's standard methodological procedures.\nMain results\nWe included seven RCTs (2369 participants randomized) on the induction of pre-hospital cooling in comparison to in-hospital cooling. There was considerable methodological heterogeneity and risk of bias mainly due to deficits in the administration of cooling, therefore we refrained from pooling the results for survival and neurological outcome and we presented the results for each study separately. Adverse events were rare: based on four studies with 1713 adults pre-hospital induction of cooling may increase the risk of cardiac re-arrests. Risk of bias within the seven individual studies was generally moderate. Overall the quality of the evidence was very low. This was mainly driven by inconsistency and low precision.\nAuthors' conclusions\nCurrently, there is no convincing evidence to clearly delineate beneficial or harmful effects of pre-hospital induction of cooling in comparison to in-hospital induction of cooling. This conclusion is based on very low quality evidence.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The seven studies included had a total of 2369 participants and compared the effects of cooling before and after being admitted to the hospital. The mean age of the participants in the studies was between 59 and 68 years with the majority being male. People that were not included in the trials were generally those with trauma, those with a terminal disease, those at the natural end of their life, pregnant women, and those that already had a low body temperature."
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"content": "Abstract: Background\nSchizophrenia is one of the most common and disabling mental disorders. About 20% of people with schizophrenia do not respond to antipsychotics, which are the mainstay of the treatment for schizophrenia today, and need to seek other treatment options. Magnetic seizure therapy (MST) is one of the novel non-invasive brain stimulation techniques that are being investigated in recent years.\nObjectives\nTo evaluate the efficacy and tolerability of MST for people with schizophrenia.\nSearch methods\nOn 6 March 2022, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials which is based on CENTRAL, CINAHL, ClinicalTrials.Gov, Embase, ISRCTN, MEDLINE, PsycINFO, PubMed, and WHO ICTRP.\nSelection criteria\nAll randomised controlled trials (RCTs) comparing MST alone or plus standard care with ECT or any other interventions for people with schizophrenia.\nData collection and analysis\nWe performed reference screening, study selection, data extraction and risk of bias and quality assessment in duplicate. We calculated the risk ratios (RRs) and their 95% confidence intervals (CIs) for binary outcomes and the mean difference (MD) and their 95% CIs for continuous outcomes. We used the original risk of bias tool for risk of bias assessment and created a Summary of findings table using GRADE.\nMain results\nWe included one four-week study with 79 adults in acute schizophrenia, comparing MST plus standard care to ECT plus standard care in this review. We rated the overall risk of bias as high due to high risk of bias in the domains of selective reporting and other biases (early termination and baseline imbalance) and unclear risk of bias in the domain of blinding of participants and personnel.\nWe found that MST and ECT may not differ in improving the global state (n = 79, risk ratio (RR) 1.12, 95% confidence interval (CI) 0.73 to 1.70), overall (n = 79, mean difference (MD) -0.20, 95% CI -8.08 to 7.68), the positive symptoms (n = 79, MD 1.40, 95% CI -1.97 to 4.77) and the negative symptoms (n = 79, MD -1.00, 95% CI -3.85 to 1.85) in people with schizophrenia.\nWe found that MST compared to ECT may cause less delayed memory deficit and less cognitive deterioration (n = 79, number of people with a delayed memory deficit, RR 0.63, 95% CI 0.41 to 0.96; n = 79, mean change in global cognitive function, MD 5.80, 95% CI 0.80 to 10.80), but also may improve more cognitive function (n = 47, number of people with any cognitive improvement, RR 3.30, 95% CI 1.29 to 8.47).\nWe found that there may be no difference between the two groups in terms of leaving the study early due to any reason (n = 79, RR 2.51, 95% CI 0.73 to 8.59), due to adverse effects (n = 79, RR 3.35, 95% CI 0.39 to 28.64) or due to inefficacy (n = 79, RR 2.52, 95% CI 0.11 to 60.10).\nSince all findings were based on one study with high risk of bias and the confidence in the evidence was very low, we were not sure these comparable or favourable effects of MST over ECT were its true effects.\nAuthors' conclusions\nDue to the paucity of data, we cannot draw any conclusion on the efficacy and tolerability of MST for people with schizophrenia. Well-designed RCTs are warranted to answer the question.\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"
},
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"role": "assistant",
"content": ""
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22274
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"role": "user",
"content": "Abstract: Background\nVertigo is a symptom in which individuals experience a false sensation of movement. This type of dizziness is thought to originate in the inner ear labyrinth or its neural connections. It is a commonly experienced symptom and can cause significant problems with carrying out normal activities. Betahistine is a drug that may work by improving blood flow to the inner ear. This review examines whether betahistine is more effective than a placebo at treating symptoms of vertigo from different causes.\nObjectives\nTo assess the effects of betahistine in patients with symptoms of vertigo from different causes.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. We also contacted manufacturers and researchers in the field. The date of the search was 21 September 2015.\nSelection criteria\nWe included randomised controlled trials of betahistine versus placebo in patients of any age with vertigo from any neurotological diagnosis in any settings.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcome was the proportion of patients with reduction in vertigo symptoms (considering together the intensity, frequency and duration those symptoms).\nMain results\nWe included 17 studies, with a total of 1025 participants; 12 studies were published (567 patients) and five were unpublished (458 patients). Sixteen studies including 953 people compared betahistine with placebo. All studies with analysable data lasted three months or less. The majority were at high risk of bias, but in some the risk of bias was unclear. One study, at high risk of bias, included 72 people with benign paroxysmal positional vertigo (BPPV) and compared betahistine with placebo; all patients also had particle repositioning manoeuvres. The studies varied considerably in terms of types of participants, their diagnoses, the dose of betahistine and the length of time it was taken for, the study methods and the way any improvement in vertigo symptoms was measured. Using the GRADE system, we judged the quality of evidence overall to be low for two outcomes (proportion of patients with improvement and proportion with adverse events).\nPooled data showed that the proportion of patients reporting an overall reduction in their vertigo symptoms was higher in the group treated with betahistine than the placebo group: risk ratio (RR) 1.30, 95% confidence interval (CI) 1.05 to 1.60; 606 participants; 11 studies). This result should be interpreted with caution as the test for statistical heterogeneity as measured by the I2 value was high.\nAdverse effects (mostly gastrointestinal symptoms and headache) were common but medically serious events in the study were rare and isolated: there was no difference in the frequency of adverse effects between the betahistine and placebo groups, where the rates were 16% and 15% respectively (weighted values, RR 1.03, 95% CI 0.76 to 1.40; 819 participants; 12 studies).\nSixteen per cent of patients from both the betahistine and the placebo groups withdrew (dropped out) from the studies (RR 0.96, 95% CI 0.65 to 1.42; 481 participants; eight studies).\nThree studies looked at objective vestibular function tests as an outcome; the numbers of participants were small, techniques of measurement very diverse and reporting details sparse, so analysis of this outcome was inconclusive.\nWe looked for information on generic quality of life and falls, but none of the studies reported on these outcomes.\nAuthors' conclusions\nLow quality evidence suggests that in patients suffering from vertigo from different causes there may be a positive effect of betahistine in terms of reduction in vertigo symptoms. Betahistine is generally well tolerated with a low risk of adverse events. Future research into the management of vertigo symptoms needs to use more rigorous methodology and include outcomes that matter to patients and their families.\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"
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"role": "assistant",
"content": "Low quality evidence suggests that patients suffering from vertigo from different causes may have some benefit from betahistine in terms of reduction in vertigo symptoms. Betahistine is generally well tolerated. Future research into the management of vertigo symptoms needs to use more rigorous methodology and include outcomes that matter to patients and their families."
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"content": "Abstract: Background\nPreoperative anaemia is common and occurs in 5% to 76% of patients preoperatively. It is associated with an increased risk of perioperative allogeneic blood transfusion, longer hospital stay, and increased morbidity and mortality. Iron deficiency is one of the most common causes of anaemia. Oral and intravenous iron therapy can be used to treat anaemia. Parenteral iron preparations have been shown to be more effective in conditions such as inflammatory bowel disease, chronic heart failure and postpartum haemorrhage due to rapid correction of iron stores. A limited number of studies has investigated iron therapy for the treatment of preoperative anaemia. The aim of this Cochrane Review is to summarise the evidence for iron supplementation, both enteral and parenteral, for the management of preoperative anaemia.\nObjectives\nTo evaluate the effects of preoperative iron therapy (enteral or parenteral) in reducing the need for allogeneic blood transfusions in anaemic patients undergoing surgery.\nSearch methods\nWe ran the search on 30 July 2018. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic and Embase (Ovid), CINAHL Plus (EBSCO), PubMed, and clinical trials registries, and we screened reference lists. We ran a top-up search on 28 November 2019; one study is now awaiting classification.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared preoperative iron monotherapy to placebo, no treatment, standard care or another form of iron therapy for anaemic adults undergoing surgery. We defined anaemia as haemoglobin values less than 13 g/dL for males and 12 g/dL for non-pregnant females.\nData collection and analysis\nTwo review authors collected data and a third review author checked all collected data. Data were collected on the proportion of patients who receive a blood transfusion, the amount of blood transfused per patient (units), quality of life, ferritin levels and haemoglobin levels, measured as continuous variables at the following predetermined time points: pretreatment (baseline), preoperatively but postintervention, and postoperatively. We performed statistical analysis using the Cochrane software, Review Manager 5. We summarised outcome data in tables and forest plots. We used the GRADE approach to describe the quality of the body of evidence.\nMain results\nSix RCTs, with a total of 372 participants, evaluated preoperative iron therapy to correct anaemia before planned surgery. Four studies compared iron therapy (either oral (one study) or intravenous (three studies)) with no treatment, placebo or usual care, and two studies compared intravenous iron therapy with oral iron therapy. Iron therapy was delivered over a range of periods that varied from 48 hours to three weeks prior to surgery. The 372 participants in our analysis fall far short of the 819 required - as calculated by our information size calculation - to detect a 30% reduction in blood transfusions. Five trials, involving 310 people, reported the proportion of participants who received allogeneic blood transfusions.\nMeta-analysis of iron therapy versus placebo or standard care showed no difference in the proportion of participants who received a blood transfusion (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.87 to 1.70; 4 studies, 200 participants; moderate-quality evidence). Only one study that compared oral versus intravenous iron therapy measured this outcome, and reported no difference in risk of transfusion between groups.\nThere was no difference between the iron therapy and placebo/standard care groups for haemoglobin level preoperatively at the end of the intervention (mean difference (MD) 0.63 g/dL, 95% CI -0.07 to 1.34; 2 studies, 83 participants; low-quality evidence). However, intravenous iron therapy produced an increase in preoperative postintervention haemoglobin levels compared with oral iron (MD 1.23 g/dL, 95% CI 0.80 to 1.65; 2 studies, 172 participants; low-quality evidence). Ferritin levels were increased by intravenous iron, both when compared to standard care ((MD 149.00, 95% CI 25.84 to 272.16; 1 study, 63 participants; low-quality evidence) or to oral iron (MD 395.03 ng/mL, 95% CI 227.72 to 562.35; 2 studies, 151 participants; low-quality evidence).\nNot all studies measured quality of life, short-term mortality or postoperative morbidity. Some measured the outcomes, but did not report the data, and the studies which did report the data were underpowered. Therefore, uncertainty remains regarding these outcomes. The inclusion of new research in the future is very likely to change these results.\nAuthors' conclusions\nThe use of iron therapy for preoperative anaemia does not show a clinically significant reduction in the proportion of trial participants who received an allogeneic blood transfusion compared to no iron therapy. Results for intravenous iron are consistent with a greater increase in haemoglobin and ferritin when compared to oral iron, but do not provide reliable evidence. These conclusions are drawn from six studies, three of which included very small numbers of participants. Further, well-designed, adequately powered, RCTs are required to determine the true effectiveness of iron therapy for preoperative anaemia. Two studies are currently in progress, and will include 1500 randomised participants.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "iron treatment did not reduce the risk of blood transfusion. There is currently insufficient evidence to say whether iron therapy given before surgery prevents transfusions. To date, too few studies involving too small a number of people have been undertaken, and it is not yet possible to obtain a reliable result for the effects of this treatment."
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"role": "user",
"content": "Abstract: Background\nPeople in the intensive care unit (ICU) experience sleep deprivation caused by environmental disruption, such as high noise levels and 24-hour lighting, as well as increased patient care activities and invasive monitoring as part of their care. Sleep deprivation affects physical and psychological health, and people perceive the quality of their sleep to be poor whilst in the ICU. Propofol is an anaesthetic agent which can be used in the ICU to maintain patient sedation and some studies suggest it may be a suitable agent to replicate normal sleep.\nObjectives\nTo assess whether the quantity and quality of sleep may be improved by administration of propofol to adults in the ICU and to assess whether propofol given for sleep promotion improves both physical and psychological patient outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 10), MEDLINE (1946 to October 2017), Embase (1974 to October 2017), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 to October 2017) and PsycINFO (1806 to October 2017). We searched clinical trials registers for ongoing studies, and conducted backward and forward citation searching of relevant articles.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials with adults, over the age of 16 years, admitted to the ICU with any diagnoses, given propofol versus a comparator to promote overnight sleep. We included participants who were and were not mechanically ventilated. We included studies that compared the use of propofol, given at an appropriate clinical dose with the intention of promoting night-time sleep, against: no agent; propofol at a different rate or dose; or another agent, administered specifically to promote sleep. We included only studies in which propofol was given during 'normal' sleeping hours (i.e. between 10 pm and 7 am) to promote a sleep-like state with a diurnal rhythm.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, assessed risk of bias and synthesized findings.\nMain results\nWe included four studies with 149 randomized participants. We identified two studies awaiting classification for which we were unable to assess eligibility and one ongoing study.\nParticipants differed in severity of illness as assessed by APACHE II scores in three studies and further differences existed between comparisons and methods. One study compared propofol versus no agent, one study compared different doses of propofol and two studies compared propofol versus a benzodiazepine (flunitrazepam, one study; midazolam, one study). All studies reported randomization and allocation concealment inadequately. We judged all studies to have high risk of performance bias from personnel who were unblinded. We noted that some study authors had blinded study outcome assessors and participants for relevant outcomes.\nIt was not appropriate to combine data owing to high levels of methodological heterogeneity.\nOne study comparing propofol with no agent (13 participants) measured quantity and quality of sleep using polysomnography; study authors reported no evidence of a difference in duration of sleep or sleep efficiency, and reported disruption to usual REM (rapid eye movement sleep) with propofol.\nOne study comparing different doses of propofol (30 participants) measured quantity and quality of sleep by personnel using the Ramsay Sedation Scale; study authors reported that more participants who were given a higher dose of propofol had a successful diurnal rhythm, and achieved a greater sedation rhythmicity.\nTwo studies comparing propofol with a different agent (106 participants) measured quantity and quality of sleep using the Pittsburgh Sleep Diary and the Hospital Anxiety and Depression Scale; one study reported fewer awakenings of reduced duration with propofol, and similar total sleep time between groups, and one study reported no evidence of a difference in sleep quality. One study comparing propofol with another agent (66 participants) measured quantity and quality of sleep with the Bispectral Index and reported longer time in deep sleep, with fewer arousals. One study comparing propofol with another agent (40 participants) reported higher levels of anxiety and depression in both groups, and no evidence of a difference when participants were given propofol.\nNo studies reported adverse events.\nWe used the GRADE approach to downgrade the certainty of the evidence for each outcome to very low. We identified sparse data with few participants, and methodological differences in study designs and comparative agents introduced inconsistency, and we noted that measurement tools were imprecise or not valid for purpose.\nAuthors' conclusions\nWe found insufficient evidence to determine whether administration of propofol would improve the quality and quantity of sleep in adults in the ICU. We noted differences in study designs, methodology, comparative agents and illness severity amongst study participants. We did not pool data and we used the GRADE approach to downgrade the certainty of our evidence to very low.\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"
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"content": "We judged the evidence to be very low quality. We found only four small randomized controlled studies and the results of the studies were not consistent. We noted differences in illness severity of participants and the medicines that were compared with propofol in the included studies. Measuring quality of sleep using diaries, questionnaires and scoring systems is based on, or is influenced by, personal feelings or opinions, and we were concerned that staff and participants were aware which medicine they had been given; we believed that this could have influenced the results. Only one study used polysomnography, which is the most appropriate unbiased measurement tool for sleep."
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query-laysum
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22277
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{
"role": "user",
"content": "Abstract: Background\nDemodex blepharitis is a chronic condition commonly associated with recalcitrant dry eye symptoms though many people with Demodex mites are asymptomatic. The primary cause of this condition in humans is two types of Demodex mites: Demodex folliculorum and Demodex brevis. There are varying reports of the prevalence of Demodex blepharitis among adults, and it affects both men and women equally. While Demodex mites are commonly treated with tea tree oil, the effectiveness of tea tree oil for treating Demodex blepharitis is not well documented.\nObjectives\nTo evaluate the effects of tea tree oil on ocular Demodex infestation in people with Demodex blepharitis.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); Ovid MEDLINE; Embase.com; PubMed; LILACS; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions in the electronic search for trials. We last searched the databases on 18 June 2019.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared treatment with tea tree oil (or its components) versus another treatment or no treatment for people with Demodex blepharitis.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts and then full text of records to determine their eligibility. The review authors independently extracted data and assessed risk of bias using Covidence. A third review author resolved any conflicts at all stages.\nMain results\nWe included six RCTs (1124 eyes of 562 participants; 17 to 281 participants per study) from the US, Korea, China, Australia, Ireland, and Turkey. The RCTs compared some formulation of tea tree oil to another treatment or no treatment. Included participants were both men and women, ranging from 39 to 55 years of age. All RCTs were assessed at unclear or high risk of bias in one or more domains. We also identified two RCTs that are ongoing or awaiting publications.\nData from three RCTs that reported a short-term mean change in the number of Demodex mites per eight eyelashes contributed to a meta-analysis. We are uncertain about the mean reduction for the groups that received the tea tree oil intervention (mean difference [MD] 0.70, 95% confidence interval [CI] 0.24 to 1.16) at four to six weeks as compared to other interventions. Only one RCT reported data for long-term changes, which found that the group that received intense pulse light as the treatment had complete eradication of Demodex mites at three months. We graded the certainty of the evidence for this outcome as very low.\nThree RCTs reported no evidence of a difference for participant reported symptoms measured on the Ocular Surface Disease Index (OSDI) between the tea tree oil group and the group receiving other forms of intervention. Mean differences in these studies ranged from -10.54 (95% CI – 24.19, 3.11) to 3.40 (95% CI -0.70 7.50). We did not conduct a meta-analysis for this outcome given substantial statistical heterogeneity and graded the certainty of the evidence as low.\nOne RCT provided information concerning visual acuity but did not provide sufficient data for between-group comparisons. The authors noted that mean habitual LogMAR visual acuity for all study participants improved post-treatment (mean LogMAR 1.16, standard deviation 0.26 at 4 weeks). We graded the certainty of evidence for this outcome as low. No RCTs provided data on mean change in number of cylindrical dandruff or the proportion of participants experiencing conjunctival injection or experiencing meibomian gland dysfunction.\nThree RCTs provided information on adverse events. One reported no adverse events. The other two described a total of six participants randomized to treatment with tea tree oil who experienced ocular irritation or discomfort that resolved with re-educating the patient on application techniques and continuing use of the tea tree oil. We graded the certainty of the evidence for this outcome as very low.\nAuthors' conclusions\nThe current review suggests that there is uncertainty related to the effectiveness of 5% to 50% tea tree oil for the short-term treatment of Demodex blepharitis; however, if used, lower concentrations may be preferable in the eye care arena to avoid induced ocular irritation. Future studies should be better controlled, assess outcomes at long term (e.g. 10 to 12 weeks or beyond), account for patient compliance, and study the effects of different tea tree oil concentrations.\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"
},
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"role": "assistant",
"content": "We are uncertain if tea tree oil is better compared to other treatments. Other factors such as dosage, ocular hygiene, and patient compliance likely affect treatment outcomes; however, more and better-designed studies are needed to confirm these findings."
}
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query-laysum
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22278
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[
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are susceptible to hyperglycaemia and hypoglycaemia, which may lead to adverse neurodevelopment. The use of continuous glucose monitoring (CGM) devices might help in keeping glucose levels in the normal range, and reduce the need for blood sampling. However, the use of CGM might be associated with harms in the preterm infant.\nObjectives\nTo assess the benefits and harms of CGM versus intermittent modalities to measure glycaemia in preterm infants 1. at risk of hypoglycaemia or hyperglycaemia; 2. with proven hypoglycaemia; or 3. with proven hyperglycaemia.\nSearch methods\nWe searched CENTRAL (2021, Issue 4); PubMed; Embase; and CINAHL in April 2021. We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs comparing the use of CGM versus intermittent modalities to measure glycaemia in preterm infants at risk of hypoglycaemia or hyperglycaemia; with proven hypoglycaemia; or with proven hyperglycaemia.\nData collection and analysis\nWe assessed the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) with 95% confidence intervals (CI) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included four trials enrolling 300 infants in our updated review. We included one new study and excluded another previously included study (because the inclusion criteria of the review have been narrowed). We compared the use of CGM to intermittent modalities in preterm infants at risk of hypoglycaemia or hyperglycaemia; however, one of these trials was analyzed separately because CGM was used as a standalone device, without being coupled to a control algorithm as in the other trials. We identified no studies in preterm infants with proven hypoglycaemia or hyperglycaemia.\nNone of the four included trials reported the neurodevelopmental outcome (i.e. the primary outcome of this review), or seizures. The effect of the use of CGM on mortality during hospitalization is uncertain (RR 0.59, 95% CI 0.16 to 2.13; RD −0.02, 95% CI −0.07 to 0.03; 230 participants; 2 studies; very low-certainty evidence). The certainty of the evidence was very low for all outcomes because of limitations in study design, and imprecision of estimates. One study is ongoing (estimated sample size 60 infants) and planned to be completed in 2022.\nAuthors' conclusions\nThere is insufficient evidence to determine if CGM affects preterm infant mortality or morbidities. We are very uncertain of the safety of CGM and the available management algorithms, and many morbidities remain unreported. Preterm infants at risk of hypoglycaemia or hyperglycaemia were enrolled in all four included studies. No studies have been conducted in preterm infants with proven hypoglycaemia or hyperglycaemia. Long-term outcomes were not reported. Events of necrotizing enterocolitis, reported in the study published in 2021, were lower in the CGM group. However, the effect of CGM on this outcome remains very uncertain. Clinical trials are required to determine the most effective CGM and glycaemic management regimens in preterm infants before larger studies can be performed to assess the efficacy of CGM for reducing mortality, morbidity, and long-term neurodevelopmental impairments.\n\nGiven the provided abstract, please respond to the following query: \"Review questions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "What are the benefits and harms of the use of subcutaneous (under the skin) sensors for continuous glucose monitoring (CGM) with or without an algorithm (a set of mathematical rules) to correct too high or too low levels of blood glucose versus intermittent modalities to measure blood glucose with or without an algorithm to guide the correction of too high or too low blood glucose in preterm infants 1. at risk of too high or too low levels of blood glucose; 2. with proven too low levels of blood glucose; and 3. with proven too high levels of blood glucose?"
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22279
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[
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"role": "user",
"content": "Abstract: Background\nSeptic arthritis is an acute infection of the joints characterised by erosive disruption of the articular space. It is the most common non-degenerative articular disease in developing countries. The most vulnerable population for septic arthritis includes infants and preschoolers, especially boys. Septic arthritis disproportionately affects populations of low socioeconomic status. Systemic corticosteroids and antibiotic therapy may be beneficial for treatment of septic arthritis. Even if the joint infection is eradicated by antibiotic treatment, the inflammatory process may produce residual joint damage and sequelae.\nObjectives\nTo determine the benefits and harms of corticosteroids as adjunctive therapy in children with a diagnosis of septic arthritis.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, Latin American Caribbean Health Sciences Literature (LILACS), the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/), ClinicalTrials.gov (www.ClinicalTrials.gov), and Google Scholar. We searched all databases from their inception to 17 April 2018, with no restrictions on language of publication.\nSelection criteria\nWe included randomised controlled trials (RCTs) with patients from two months to 18 years of age with a diagnosis of septic arthritis who were receiving corticosteroids in addition to antibiotic therapy or as an adjuvant to other therapies such as surgical drainage, intra-articular puncture, arthroscopic irrigation, or debridement.\nData collection and analysis\nTwo review authors independently assessed eligibility, data extraction, and evaluation of risk of bias. We considered as major outcomes the presence of pain, activities of daily living, normal physical joint function, days of antibiotic treatment, length of hospital stay, and numbers of total and serious adverse events. We used standard methodological procedures expected by Cochrane. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created a 'Summary of findings' table.\nMain results\nWe included two RCTs involving a total of 149 children between three months and 18 years of age who were receiving antibiotics for septic arthritis. The most commonly affected joints were hips and knees. These studies were performed in Costa Rica and Israel. In both studies, dexamethasone administered intravenously (ranging from 0.15 to 0.2 mg/kg/dose every six to eight hours) during four days was the corticosteroid, and the comparator was placebo. Trials excluded patients with any degree of immunodeficiency or immunosuppression. The longest follow-up was one year. Trials did not report activities of daily living nor length of hospital stay. Both studies used adequate processes for randomisation, allocation concealment, and blinding, and review authors judged them to have low risk of selection and performance bias. Losses to follow-up were substantive in both studies, and we judged them to have high risk of attrition bias and of selective outcome reporting. We graded all outcomes as low quality due to concerns about study limitations and imprecision.\nThe risk ratio (RR) for absence of pain at 12 months of follow-up was 1.33, favouring corticosteroids (95% confidence interval (CI) 1.03 to 1.72; P = 0.03; number needed to treat for an additional beneficial outcome (NNTB) = 13, 95% CI 6 to 139; absolute risk difference 24%, 95% CI 5% to 43%).\nThe RR for normal function of the affected joint at 12 months of follow-up was 1.32, favouring corticosteroids (95% CI 1.12 to 1.57; P = 0.001; NNTB = 13, 95% CI 7 to 33; absolute risk difference 24%, 95% CI 11% to 37%).\nWe found a reduction in the number of days of intravenous antibiotic treatment favouring corticosteroids (mean difference (MD) -2.77, 95% CI -4.16 to -1.39) based on two trials with 149 participants.\nResearchers did not report length of hospital stay. One trial (49 participants) reported that treatment with dexamethasone was associated with a shorter duration of IV antibiotic treatment, leading to a shorter hospital stay, and although duration of hospitalisation was a primary outcome of the study, study authors did not provide data on the duration of hospitalisation. We downgraded the quality by one level for concerns about study limitations (high risk of attrition bias and selective reporting), and by another level for imprecision.\nIn one trial of 49 participants, researchers followed 29 children for 12 months, and parents reported that no children demonstrated adverse effects of the intervention.\nAuthors' conclusions\nEvidence for corticosteroids as adjunctive therapy in children with a diagnosis of septic arthritis is of low quality and is derived from the findings of two trials (N = 149). Corticosteroids may increase the proportion of patients without pain and the proportion of patients with normal function of the affected joint at 12 months, and may also reduce the number of days of antibiotic treatment. However, we cannot draw strong conclusions based upon these trial results. Additional randomised clinical trials in children with relevant outcomes are needed.\n\nGiven the provided abstract, please respond to the following query: \"Total or serious adverse events\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "1. None of the patients treated with corticosteroids reported adverse effects at 12 months"
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query-laysum
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22280
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[
{
"role": "user",
"content": "Abstract: Background\nResin-based composite (RBC) is currently accepted as a viable material for the restoration of caries for posterior permanent teeth requiring surgical treatment. Despite the fact that the thermal conductivity of the RBC restorative material closely approximates that of natural tooth structure, postoperative hypersensitivity is sometimes still an issue. Dental cavity liners have historically been used to protect the pulp from the toxic effects of some dental restorative materials and to prevent the pain of thermal conductivity by placing an insulating layer between restorative material and the remaining tooth structure. This is an update of the Cochrane Review first published in 2016.\nObjectives\nThe objective of this review was to assess the effects of using dental cavity liners in the placement of Class I and Class II resin-based composite posterior restorations in permanent teeth in children and adults.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 12 November 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 10) in the Cochrane Library (searched 12 November 2018), MEDLINE Ovid (1946 to 12 November 2018), Embase Ovid (1980 to 12 November 2018) and LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 12 November 2018). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomized controlled trials assessing the effects of the use of liners under Class I and Class II posterior resin-based composite restorations in permanent teeth (in both adults and children). We included both parallel and split-mouth designs.\nData collection and analysis\nWe utilized standard methodological procedures prescribed by Cochrane for data collection and analysis. Two review authors screened the search results and assessed the eligibility of studies for inclusion against the review inclusion criteria. We conducted risk of bias assessments and data extraction independently and in duplicate. Where information was unclear we contacted study authors for clarification.\nMain results\nEight studies, recruiting over 700 participants, compared the use of dental cavity liners to no liners for Class I and Class II resin-based composite restorations.\nSeven studies evaluated postoperative hypersensitivity measured by various methods. All studies were at unclear or high risk of bias. There was inconsistent evidence regarding postoperative hypersensitivity (either measured using cold response or patient-reported), with a benefit shown at some, but not all, time points (low-quality evidence).\nFour trials measured restoration longevity. Two of the studies were judged to be at high risk and two at unclear risk of bias. No difference in restoration failure rates were shown at 1 year follow-up, with no failures reported in either group for three of the four studies; the fourth study had a risk ratio (RR) 1.00 (95% confidence interval (CI) 0.07 to 15.00) (low-quality evidence). Three studies evaluated restoration longevity at 2 years follow-up and, again, no failures were shown in either group.\nNo adverse events were reported in any of the included studies.\nAuthors' conclusions\nThere is inconsistent, low-quality evidence regarding the difference in postoperative hypersensitivity subsequent to placing a dental cavity liner under Class I and Class II posterior resin-based composite restorations in permanent posterior teeth in adults or children 15 years or older. Furthermore, no evidence was found to demonstrate a difference in the longevity of restorations placed with or without dental cavity liners.\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": "Tooth decay is the most common disease affecting children and adults worldwide. If left untreated, acid produced by bacteria in the dental plaque or biofilm forms cavities or holes in the teeth. A number of techniques and a variety of materials can be used to restore or fill teeth affected by decay. One of these materials is tooth-colored, resin-based composite or RBC. This material is increasingly used as an alternative to amalgam (a mixture of mercury and metal alloy particles).\nSince the 19th century liners have often been placed in cavities in the teeth under the filling material. The liners are thought to protect the living pulp of the tooth from filling materials themselves and also from their potential to allow more heat or cold through than the natural tooth would. Although RBC filling materials are thought to be similar to the natural material of teeth in terms of how they conduct heat, sensitivity to temperature change is sometimes still an issue for people after treatment."
}
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query-laysum
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22281
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[
{
"role": "user",
"content": "Abstract: Background\nAfter decades of decline since 2005, the global prevalence of undernourishment reverted and since 2015 has increased to levels seen in 2010 to 2011. The prevalence is highest in low- and middle-income countries (LMICs), especially Africa and Asia. Food insecurity and associated undernutrition detrimentally affect health and socioeconomic development in the short and long term, for individuals, including children, and societies. Physical and economic access to food is crucial to ensure food security. Community-level interventions could be important to increase access to food in LMICs.\nObjectives\nTo determine the effects of community-level interventions that aim to improve access to nutritious food in LMICs, for both the whole community and for disadvantaged or at-risk individuals or groups within a community, such as infants, children and women; elderly, poor or unemployed people; or minority groups.\nSearch methods\nWe searched for relevant studies in 16 electronic databases, including trial registries, from 1980 to September 2019, and updated the searches in six key databases in February 2020. We applied no language or publication status limits.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster randomised controlled trials (cRCTs) and prospective controlled studies (PCS). All population groups, adults and children, living in communities in LMICs exposed to community-level interventions aiming to improve food access were eligible for inclusion. We excluded studies that only included participants with specific diseases or conditions (e.g. severely malnourished children).\nEligible interventions were broadly categorised into those that improved buying power (e.g. create income-generation opportunities, cash transfer schemes); addressed food prices (e.g. vouchers and subsidies); addressed infrastructure and transport that affected physical access to food outlets; addressed the social environment and provided social support (e.g. social support from family, neighbours or government).\nData collection and analysis\nTwo authors independently screened titles and abstracts, and full texts of potentially eligible records, against the inclusion criteria. Disagreements were resolved through discussion or arbitration by a third author, if necessary.\nFor each included study, two authors independently extracted data and a third author arbitrated disagreements. However, the outcome data were extracted by one author and checked by a biostatistician.\nWe assessed risk of bias for all studies using the Effective Practice and Organization of Care (EPOC) risk of bias tool for studies with a separate control group.\nWe conducted meta-analyses if there was a minimum of two studies for interventions within the same category, reporting the same outcome measure and these were sufficiently homogeneous. Where we were able to meta-analyse, we used the random-effects model to incorporate any existing heterogeneity. Where we were unable to conduct meta-analyses, we synthesised using vote counting based on effect direction.\nMain results\nWe included 59 studies, including 214 to 169,485 participants, and 300 to 124, 644 households, mostly from Africa and Latin America, addressing the following six intervention types (three studies assessed two different types of interventions).\nInterventions that improved buying power:\nUnconditional cash transfers (UCTs) (16 cRCTs, two RCTs, three PCSs): we found high-certainty evidence that UCTs improve food security and make little or no difference to cognitive function and development and low-certainty evidence that UCTs may increase dietary diversity and may reduce stunting. The evidence was very uncertain about the effects of UCTs on the proportion of household expenditure on food, and on wasting. Regarding adverse outcomes, evidence from one trial indicates that UCTs reduce the proportion of infants who are overweight.\nConditional cash transfers (CCTs) (nine cRCTs, five PCSs): we found high-certainty evidence that CCTs result in little to no difference in the proportion of household expenditure on food and that they slightly improve cognitive function in children; moderate-certainty evidence that CCTs probably slightly improve dietary diversity and low-certainty evidence that they may make little to no difference to stunting or wasting. Evidence on adverse outcomes (two PCSs) shows that CCTs make no difference to the proportion of overweight children.\nIncome generation interventions (six cRCTs, 11 PCSs): we found moderate-certainty evidence that income generation interventions probably make little or no difference to stunting or wasting; and low-certainty evidence that they may result in little to no difference to food security or that they may improve dietary diversity in children, but not for households.\nInterventions that addressed food prices:\nFood vouchers (three cRCTs, one RCT): we found moderate-certainty evidence that food vouchers probably reduce stunting; and low-certainty evidence that that they may improve dietary diversity slightly, and may result in little to no difference in wasting.\nFood and nutrition subsidies (one cRCT, three PCSs): we found low-certainty evidence that food and nutrition subsidies may improve dietary diversity among school children. The evidence is very uncertain about the effects on household expenditure on healthy foods as a proportion of total expenditure on food (very low-certainty evidence).\nInterventions that addressed the social environment:\nSocial support interventions (one cRCT, one PCS): we found moderate-certainty evidence that community grants probably make little or no difference to wasting; low-certainty evidence that they may make little or no difference to stunting. The evidence is very uncertain about the effects of village savings and loans on food security and dietary diversity.\nNone of the included studies addressed the intervention category of infrastructure changes. In addition, none of the studies reported on one of the primary outcomes of this review, namely prevalence of undernourishment.\nAuthors' conclusions\nThe body of evidence indicates that UCTs can improve food security. Income generation interventions do not seem to make a difference for food security, but the evidence is unclear for the other interventions. CCTs, UCTs, interventions that help generate income, interventions that help minimise impact of food prices through food vouchers and subsidies can potentially improve dietary diversity. UCTs and food vouchers may have a potential impact on reducing stunting, but CCTs, income generation interventions or social environment interventions do not seem to make a difference on wasting or stunting. CCTs seem to positively impact cognitive function and development, but not UCTs, which may be due to school attendance, healthcare visits and other conditionalities associated with CCTs.\n\nGiven the provided abstract, please respond to the following query: \"Conditional cash transfers\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "make little to no difference in the proportion of household expenditure on food and slightly improve cognitive function in children (high-quality evidence), probably slightly improve dietary diversity (moderate-quality evidence), and may make little to no difference to stunting or wasting (low bodyweight) (low-quality evidence). Evidence on adverse outcomes (two studies) shows that CCTs make no difference to the proportion of overweight children."
}
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query-laysum
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22282
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[
{
"role": "user",
"content": "Abstract: Background\nGlycaemic control is a key component in diabetes mellitus (diabetes) management. Periodontitis is the inflammation and destruction of the underlying supporting tissues of the teeth. Some studies have suggested a bidirectional relationship between glycaemic control and periodontitis.\nTreatment for periodontitis involves subgingival instrumentation, which is the professional removal of plaque, calculus, and debris from below the gumline using hand or ultrasonic instruments. This is known variously as scaling and root planing, mechanical debridement, or non-surgical periodontal treatment. Subgingival instrumentation is sometimes accompanied by local or systemic antimicrobials, and occasionally by surgical intervention to cut away gum tissue when periodontitis is severe.\nThis review is part one of an update of a review published in 2010 and first updated in 2015, and evaluates periodontal treatment versus no intervention or usual care.\nObjectives\nTo investigate the effects of periodontal treatment on glycaemic control in people with diabetes mellitus and periodontitis.\nSearch methods\nAn information specialist searched six bibliographic databases up to 7 September 2021 and additional search methods were used to identify published, unpublished, and ongoing studies.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) of people with type 1 or type 2 diabetes mellitus and a diagnosis of periodontitis that compared subgingival instrumentation (sometimes with surgical treatment or adjunctive antimicrobial therapy or both) to no active intervention or 'usual care' (oral hygiene instruction, education or support interventions, and/or supragingival scaling (also known as PMPR, professional mechanical plaque removal)). To be included, the RCTs had to have lasted at least 3 months and have measured HbA1c (glycated haemoglobin).\nData collection and analysis\nAt least two review authors independently examined the titles and abstracts retrieved by the search, selected the included trials, extracted data from included trials, and assessed included trials for risk of bias. Where necessary and possible, we attempted to contact study authors.\nOur primary outcome was blood glucose levels measured as glycated (glycosylated) haemoglobin assay (HbA1c), which can be reported as a percentage of total haemoglobin or as millimoles per mole (mmol/mol).\nOur secondary outcomes included adverse effects, periodontal indices (bleeding on probing, clinical attachment level, gingival index, plaque index, and probing pocket depth), quality of life, cost implications, and diabetic complications.\nMain results\nWe included 35 studies, which randomised 3249 participants to periodontal treatment or control. All studies used a parallel-RCT design and followed up participants for between 3 and 12 months. The studies focused on people with type 2 diabetes, other than one study that included participants with type 1 or type 2 diabetes. Most studies were mixed in terms of whether metabolic control of participants at baseline was good, fair, or poor. Most studies were carried out in secondary care.\nWe assessed two studies as being at low risk of bias, 14 studies at high risk of bias, and the risk of bias in 19 studies was unclear. We undertook a sensitivity analysis for our primary outcome based on studies at low risk of bias and this supported the main findings.\nModerate-certainty evidence from 30 studies (2443 analysed participants) showed an absolute reduction in HbA1c of 0.43% (4.7 mmol/mol) 3 to 4 months after treatment of periodontitis (95% confidence interval (CI) -0.59% to -0.28%; -6.4 mmol/mol to -3.0 mmol/mol). Similarly, after 6 months, we found an absolute reduction in HbA1c of 0.30% (3.3 mmol/mol) (95% CI -0.52% to -0.08%; -5.7 mmol/mol to -0.9 mmol/mol; 12 studies, 1457 participants), and after 12 months, an absolute reduction of 0.50% (5.4 mmol/mol) (95% CI -0.55% to -0.45%; -6.0 mmol/mol to -4.9 mmol/mol; 1 study, 264 participants).\nStudies that measured adverse effects generally reported that no or only mild harms occurred, and any serious adverse events were similar in intervention and control arms. However, adverse effects of periodontal treatments were not evaluated in most studies.\nAuthors' conclusions\nOur 2022 update of this review has doubled the number of included studies and participants, which has led to a change in our conclusions about the primary outcome of glycaemic control and in our level of certainty in this conclusion. We now have moderate-certainty evidence that periodontal treatment using subgingival instrumentation improves glycaemic control in people with both periodontitis and diabetes by a clinically significant amount when compared to no treatment or usual care. Further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The main question addressed by this review is: how effective is gum disease (periodontitis) treatment for controlling blood sugar levels (known as glycaemic control) in people with diabetes, compared to no active treatment or usual care?"
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query-laysum
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22283
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[
{
"role": "user",
"content": "Abstract: Background\nPsychosis is an illness characterised by alterations in thoughts and perceptions resulting in delusions and hallucinations. Psychosis is rare in adolescents but can have serious consequences. Antipsychotic medications are the mainstay treatment, and have been shown to be effective. However, there is emerging evidence on psychological interventions such as cognitive remediation therapy, psycho-education, family therapy and group psychotherapy that may be useful for adolescents with psychosis.\nObjectives\nTo assess the effects of various psychological interventions for adolescents with psychosis.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's study-based Register of Trials including clinical trials registries (latest, 8 March 2019).\nSelection criteria\nAll randomised controlled trials comparing various psychological interventions with treatment-as-usual or other psychological treatments for adolescents with psychosis. For analyses, we included trials meeting our inclusion criteria and reporting useable data.\nData collection and analysis\nWe independently and reliably screened studies and we assessed risk of bias of the included studies. For dichotomous data, we calculated risk ratios (RRs) and 95% confidence intervals (CIs) on an intention-to-treat basis. For continuous data, we used mean differences (MDs) and the 95% CIs. We used a random-effects model for analyses. We created a ‘Summary of findings' table using GRADE.\nMain results\nThe current review includes 7 studies (n = 319) assessing a heterogenous group of psychological interventions with variable risk of bias. Adverse events were not reported by any of the studies. None of the studies was sponsored by industry. Below, we summarise the main results from four of six comparisons, and the certainty of these results (based on GRADE). All scale scores are average endpoint scores.\nCognitive Remediation Therapy (CRT) + Treatment-as-Usual (TAU) versus TAU\nTwo studies compared adding CRT to participants' TAU with TAU alone. Global state (CGAS, high = good) was reported by one study. There was no clear difference between treatment groups (MD -4.90, 95% CI -11.05 to 1.25; participants = 50; studies = 1, very low-certainty). Mental state (PANSS, high = poor) was reported by one study. Scores were clearly lower in the TAU group (MD 8.30, 95% CI 0.46 to 16.14; participants = 50; studies = 1; very low-certainty). Clearly more participants in the CRT group showed improvement in cognitive functioning (Memory digit span test) compared to numbers showing improvement in the TAU group (1 study, n = 31, RR 0.58, 95% CI 0.37 to 0.89; very low-certainty). For global functioning (VABS, high = good), our analysis of reported scores showed no clear difference between treatment groups (MD 5.90, 95% CI -3.03 to 14.83; participants = 50; studies = 1; very low-certainty). The number of participants leaving the study early from each group was similar (RR 0.93, 95% CI 0.32 to 2.71; participants = 91; studies = 2; low-certainty).\nGroup Psychosocial Therapy (GPT) + TAU versus TAU\nOne study assessed the effects of adding GPT to participants' usual medication. Global state scores (CGAS, high = good) were clearly higher in the GPT group (MD 5.10, 95% CI 1.35 to 8.85; participants = 56; studies = 1; very low-certainty) but there was little or no clear difference between groups for mental state scores (PANSS, high = poor, MD -4.10, 95% CI -8.28 to 0.08; participants = 56; studies = 1, very low-certainty) and no clear difference between groups for numbers of participants leaving the study early (RR 0.43, 95% CI 0.15 to 1.28; participants = 56; studies = 1; very low-certainty).\nCognitive Remediation Programme (CRP) + Psychoeducational Treatment Programme (PTP) versus PTP\nOne study assessed the effects of combining two types psychological interventions (CRP + PTP) with PTP alone. Global state scores (GAS, high = good) were not clearly different (MD 1.60, 95% CI -6.48 to 9.68; participants = 25; studies = 1; very low-certainty), as were mental state scores (BPRS total, high = poor, MD -5.40, 95% CI -16.42 to 5.62; participants = 24; studies = 1; very low-certainty), and cognitive functioning scores (SPAN-12, high = good, MD 2.40, 95% CI -2.67 to 7.47; participants = 25; studies = 1; very low-certainty).\nPsychoeducational (PE) + Multifamily Treatment (MFT) Versus Nonstructured Group Therapy (NSGT, all long-term)\nOne study compared (PE + MFT) with NSGT. Analysis of reported global state scores (CGAS, high = good, MD 3.38, 95% CI -4.87 to 11.63; participants = 49; studies = 1; very low-certainty) and mental state scores (PANSS total, high = poor, MD -8.23, 95% CI -17.51 to 1.05; participants = 49; studies = 1; very low-certainty) showed no clear differences. The number of participants needing hospital admission (RR 0.84, 95% CI 0.36 to 1.96; participants = 49; studies = 1) and the number of participants leaving the study early from each group were also similar (RR 0.52, 95% CI 0.10 to 2.60; participants = 55; studies = 1; low-certainty).\nAuthors' conclusions\nMost of our estimates of effect for our main outcomes are equivocal. An effect is suggested for only four outcomes in the SOF tables presented. Compared to TAU, CRT may have a positive effect on cognitive functioning, however the same study reports data suggesting TAU may have positive effect on mental state. Another study comparing GPT with TAU reports data suggesting GPT may have a positive effect on global state. However, the estimate of effects for all the main outcomes in our review should be viewed with considerable caution as they are based on data from a small number of studies with variable risk of bias. Further data could change these results and larger and better quality studies are needed before any firm conclusions regarding the effects of psychological interventions for adolescents with psychosis can be made.\n\nGiven the provided abstract, please respond to the following query: \"Review questions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Are psychological interventions effective and safe for adolescents with psychosis? Are there any differences in effect between different psychological interventions?"
}
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query-laysum
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22284
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[
{
"role": "user",
"content": "Abstract: Background\nSurgical options for treating stress urinary incontinence (SUI) are usually explored after conservative interventions have failed. Surgeries fall into two categories: traditional techniques (open surgery) and minimally invasive procedures, such as laparoscopic procedures, midurethral sling and injections with urethral bulking agents. Postsurgery infections, such as infections of the surgical site or urinary tract, are common complications. To minimise the risk of postoperative bacterial infections, prophylactic antibiotics may be given before or during surgery.\nObjectives\nTo assess the effects of prophylactic antibiotics for preventing infection following continence surgery in women with stress urinary incontinence.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov and WHO ICTRP; and handsearched journals and conference proceedings to 18 March 2021. We also searched the reference lists of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs assessing prophylactic antibiotics in women undergoing continence surgery to treat SUI.\nData collection and analysis\nTwo review authors selected potentially eligible trials, extracted data and assessed risk of bias. We expressed results as risk ratios (RR) for dichotomous outcomes and as mean differences (MD) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach.\nMain results\nWe identified one quasi-RCT and two RCTs, involving a total of 390 women. One study performed retropubic urethropexy surgery requiring a transverse suprapubic incision, while the other two studies performed midurethral sling surgery. It should be noted that none of the included studies clearly specified the timing of outcome assessment.\nWe are very uncertain whether prophylactic antibiotics (cefazolin) have an effect on surgical site infections (RR 0.56, 95% CI 0.03 to 12.35; 2 studies, 85 women; very low-certainty evidence) or urinary tract infections or bacteriuria (RR 0.84, 95% CI 0.05 to 13.24; 2 studies, 85 women; very low-certainty evidence). The effect of prophylactic antibiotics (cefazolin) on febrile morbidity is also uncertain (RR 0.08, 95% CI 0.00 to 1.29; 2 studies, 85 women; very low-certainty evidence). We are very uncertain whether prophylactic antibiotics (cefazolin) have any effect on mesh exposure (RR 0.32, 95% CI 0.01 to 7.61; 1 study, 59 women; very low-certainty evidence). None of the three included studies described the assessment of adverse events from antibiotic use, sepsis or bacteraemia in their reports.\nAuthors' conclusions\nOnly limited data are available from the three included studies and, overall, the certainty of evidence was very low. Moreover, the three included studies evaluated different surgical procedures and dosages of antibiotic administration.\nThus, there is insufficient evidence to support or refute the use of prophylactic antibiotics to prevent infection following anti-incontinence surgery. In addition, there were no data regarding adverse effects of prophylactic antibiotics. More RCTs are required.\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": "Preventive antibiotics may have little to no effect on surgical site infections, urinary tract infections or bacteriuria (presence of bacteria in the urine), fever after surgery or the appearance of the artificial tape or mesh used in the surgery through the skin beneath the urethra, but we are very uncertain about the results.\nNone of the included studies reported data on adverse effects, sepsis or bacteraemia related to taking antibiotics, or bacterial antibiotic resistance."
}
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query-laysum
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22285
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[
{
"role": "user",
"content": "Abstract: Background\nPeripheral arterial disease (PAD), caused by narrowing of the arteries in the limbs, is increasing in incidence and prevalence as our population is ageing and as diabetes is becoming more prevalent. PAD can cause pain in the limbs while walking, known as intermittent claudication, or can be more severe and cause pain while at rest, ulceration, and ultimately gangrene and limb loss. This more severe stage of PAD is known as 'critical limb ischaemia'. Treatments for PAD include medications that help to reduce the increased risk of cardiovascular events and help improve blood flow, as well as endovascular or surgical repair or bypass of the blocked arteries. However, many people are unresponsive to medications and are not suited to surgical or endovascular treatment, leaving amputation as the last option. Gene therapy is a novel approach in which genetic material encoding for proteins that may help increase revascularisation is injected into the affected limbs of patients. This type of treatment has been shown to be safe, but its efficacy, especially regarding ulcer healing, effects on quality of life, and other symptomatic outcomes remain unknown.\nObjectives\nTo assess the effects of gene therapy for symptomatic peripheral arterial disease.\nSearch methods\nThe Cochrane Vascular Information Specialist searched Cochrane CENTRAL, the Cochrane Vascular Specialised Register, MEDLINE Ovid, Embase Ovid, CINAHL, and AMED, along with trials registries (all searched 27 November 2017). We also checked reference lists of included studies and systematic reviews for further studies.\nSelection criteria\nWe included randomised and quasi-randomised studies that evaluated gene therapy versus no gene therapy in people with PAD. We excluded studies that evaluated direct growth hormone treatment or cell-based treatments.\nData collection and analysis\nTwo review authors independently selected studies, performed quality assessment, and extracted data from the included studies. We collected pertinent information on each study, as well as data for the outcomes of amputation-free survival, ulcer healing, quality of life, amputation, all-cause mortality, ankle brachial index, symptom scores, and claudication distance.\nMain results\nWe included in this review a total of 17 studies with 1988 participants (evidence current until November 2017). Three studies limited their inclusion to people with intermittent claudication, 12 limited inclusion to people with varying levels of critical limb ischaemia, and two included people with either condition. Study investigators evaluated many different types of gene therapies, using different protocols. Most studies evaluated growth factor-encoding gene therapy, with six studies using vascular endothelial growth factor (VEGF)-encoding genes, four using hepatocyte growth factor (HGF)-encoding genes, and three using fibroblast growth factor (FGF)-encoded genes. Two studies evaluated hypoxia-inducible factor 1-alpha (HIF-1α) gene therapy, one study used a developmental endothelial locus-1 gene therapy, and the final study evaluated a stromal cell-derived factor-1 (SDF-1) gene therapy. Most studies reported outcomes after 12 months of follow-up, but follow-up ranged from three months to two years.\nOverall risk of bias varied between studies, with many studies not providing sufficient detail for adequate determination of low risk of bias for many domains. Two studies did not utilise a placebo control, leading to risk of performance bias. Several studies reported in previous protocols or in their Methods sections that they would report on certain outcomes for which no data were then reported, increasing risk of reporting bias. All included studies reported sponsorships from corporate entities that led to unclear risk of other bias. The overall quality of evidence ranged from moderate to very low, generally as the result of heterogeneity and imprecision, with few or no studies reporting on outcomes.\nEvidence suggests no clear differences for the outcomes of amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving this treatment (all moderate-quality evidence). Low-quality evidence suggests improvement in complete ulcer healing with gene therapy (odds ratio (OR) 2.16, 95% confidence interval (CI) 1.02 to 4.59; P = 0.04). We could not combine data on quality of life and can draw no conclusions at this time regarding this outcome (very low-quality evidence). We included one study in the meta-analysis for ankle brachial index, which showed no clear differences between treatments, but we can draw no overall association (low-quality evidence). We combined in a meta-analysis pain symptom scores as assessed by visual analogue scales from two studies and found no clear differences between treatment groups (very low-quality evidence). We carried out extensive subgroup analyses by PAD classification, dosage schedule, vector type, and gene used but identified no substantial differences.\nAuthors' conclusions\nModerate-quality evidence shows no clear differences in amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving gene therapy. Some evidence suggests that gene therapy may lead to improved complete ulcer healing, but this outcome needs to be explored with improved reporting of the measure, such as decreased ulcer area in cm², and better description of ulcer types and healing. Further standardised data that are amenable to meta-analysis are needed to evaluate other outcomes such as quality of life, ankle brachial index, symptom scores, and claudication distance.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "When combining the data, we found no clear differences between people who received gene therapy and those who did not in terms of amputation-free survival (patients who did not have an amputation and did not die), major amputation (above the ankle), or death. We did see improvement in complete ulcer healing in the gene therapy treatment group compared to the control group. Studies show no clear differences in pain symptom scores, but we evaluated only two studies for this outcome. Not enough data are available to show if there was a difference between groups for the measure of blood flow known as the 'ankle brachial index'. We were not able to combine data on quality of life or pain-free walking distances (distances one can walk without experiencing leg pain)."
}
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query-laysum
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22286
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[
{
"role": "user",
"content": "Abstract: Background\nNeonatal endotracheal intubation is a common and potentially life-saving intervention. It is a mandatory skill for neonatal trainees, but one that is difficult to master and maintain. Intubation opportunities for trainees are decreasing and success rates are subsequently falling. Use of a stylet may aid intubation and improve success. However, the potential for associated harm must be considered.\nObjectives\nTo compare the benefits and harms of neonatal orotracheal intubation with a stylet versus neonatal orotracheal intubation without a stylet.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and previous reviews. We also searched cross-references, contacted expert informants, handsearched journals, and looked at conference proceedings. We searched clinical trials registries for current and recently completed trials. We conducted our most recent search in April 2017.\nSelection criteria\nAll randomised, quasi–randomised, and cluster-randomised controlled trials comparing use versus non-use of a stylet in neonatal orotracheal intubation.\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 used the standard methods of the Cochrane Collaboration, as documented in the Cochrane Handbook for Systemic Reviews of Interventions, and of the Cochrane Neonatal Review Group.\nMain results\nWe included a single-centre non-blinded randomised controlled trial that reported a total of 302 intubation attempts in 232 infants. The median gestational age of enrolled infants was 29 weeks. Paediatric residents and fellows performed the intubations. We judged the study to be at low risk of bias overall. Investigators compared success rates of first-attempt intubation with and without use of a stylet and reported success rates as similar between stylet and no-stylet groups (57% and 53%) (P = 0.47). Success rates did not differ between groups in subgroup analyses by provider level of training and infant weight. Results showed no differences in secondary review outcomes, including duration of intubation, number of attempts, participant instability during the procedure, and local airway trauma. Only 25% of all intubations took less than 30 seconds to perform. Study authors did not report neonatal morbidity nor mortality. We considered the quality of evidence as low on GRADE analysis, given that we identified only one unblinded study.\nAuthors' conclusions\nCurrent available evidence suggests that use of a stylet during neonatal orotracheal intubation does not significantly improve the success rate among paediatric trainees. However, only one brand of stylet and one brand of endotracheal tube have been tested, and researchers performed all intubations on infants in a hospital setting. Therefore, our results cannot be generalised beyond these limitations.\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 use of a stylet increase success rates of newborn intubation without increasing risk of harm?"
}
] |
query-laysum
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22287
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[
{
"role": "user",
"content": "Abstract: Background\nThe central venous catheter (CVC) is a device used for many functions, including monitoring haemodynamic indicators and administering intravenous medications, fluids, blood products and parenteral nutrition. However, as a foreign object, it is susceptible to colonisation by micro-organisms, which may lead to catheter-related blood stream infection (BSI) and in turn, increased mortality, morbidities and health care costs.\nObjectives\nTo assess the effects of skin antisepsis as part of CVC care for reducing catheter-related BSIs, catheter colonisation, and patient mortality and morbidities.\nSearch methods\nIn May 2016 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations and Epub Ahead of Print); Ovid EMBASE and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) that assessed any type of skin antiseptic agent used either alone or in combination, compared with one or more other skin antiseptic agent(s), placebo or no skin antisepsis in patients with a CVC in place.\nData collection and analysis\nTwo authors independently assessed the studies for their eligibility, extracted data and assessed risk of bias. We expressed our results in terms of risk ratio (RR), absolute risk reduction (ARR) and number need to treat for an additional beneficial outcome (NNTB) for dichotomous data, and mean difference (MD) for continuous data, with 95% confidence intervals (CIs).\nMain results\nThirteen studies were eligible for inclusion, but only 12 studies contributed data, with a total of 3446 CVCs assessed. The total number of participants enrolled was unclear as some studies did not provide such information. The participants were mainly adults admitted to intensive care units, haematology oncology units or general wards. Most studies assessed skin antisepsis prior to insertion and regularly thereafter during the in-dwelling period of the CVC, ranging from every 24 h to every 72 h. The methodological quality of the included studies was mixed due to wide variation in their risk of bias. Most trials did not adequately blind the participants or personnel, and four of the 12 studies had a high risk of bias for incomplete outcome data.\nThree studies compared different antisepsis regimens with no antisepsis. There was no clear evidence of a difference in all outcomes examined, including catheter-related BSI, septicaemia, catheter colonisation and number of patients who required systemic antibiotics for any of the three comparisons involving three different antisepsis regimens (aqueous povidone-iodine, aqueous chlorhexidine and alcohol compared with no skin antisepsis). However, there were great uncertainties in all estimates due to underpowered analyses and the overall very low quality of evidence presented.There were multiple head-to-head comparisons between different skin antiseptic agents, with different combinations of active substance and base solutions. The most frequent comparison was chlorhexidine solution versus povidone-iodine solution (any base). There was very low quality evidence (downgraded for risk of bias and imprecision) that chlorhexidine may reduce catheter-related BSI compared with povidone-iodine (RR of 0.64, 95% CI 0.41 to 0.99; ARR 2.30%, 95% CI 0.06 to 3.70%). This evidence came from four studies involving 1436 catheters. None of the individual subgroup comparisons of aqueous chlorhexidine versus aqueous povidone-iodine, alcoholic chlorhexidine versus aqueous povidone-iodine and alcoholic chlorhexidine versus alcoholic povidone-iodine showed clear differences for catheter-related BSI or mortality (and were generally underpowered). Mortality was only reported in a single study.\nThere was very low quality evidence that skin antisepsis with chlorhexidine may also reduce catheter colonisation relative to povidone-iodine (RR of 0.68, 95% CI 0.56 to 0.84; ARR 8%, 95% CI 3% to 12%; ; five studies, 1533 catheters, downgraded for risk of bias, indirectness and inconsistency).\nEvaluations of other skin antiseptic agents were generally in single, small studies, many of which did not report the primary outcome of catheter-related BSI. Trials also poorly reported other outcomes, such as skin infections and adverse events.\nAuthors' conclusions\nIt is not clear whether cleaning the skin around CVC insertion sites with antiseptic reduces catheter related blood stream infection compared with no skin cleansing. Skin cleansing with chlorhexidine solution may reduce rates of CRBSI and catheter colonisation compared with cleaning with povidone iodine. These results are based on very low quality evidence, which means the true effects may be very different. Moreover these results may be influenced by the nature of the antiseptic solution (i.e. aqueous or alcohol-based). Further RCTs are needed to assess the effectiveness and safety of different skin antisepsis regimens in CVC care; these should measure and report critical clinical outcomes such as sepsis, catheter-related BSI and mortality.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three studies examined the effect of cleansing versus no cleansing, and found no clear evidence of differences in blood infections, infections in the catheter and need for antibiotics between patients who received cleansing compared to those who did not. Chlorhexidine solution may reduce blood infections associated with the catheter compared with povidone-iodine solution (reducing the infection rate from 64 cases per 1000 patients with a CVC with povidone iodine to 41 cases of infection per 1000 with chlorhexidine). This translates into the need to treat 44 people to avoid one additional bloodstream infection. Chlorhexidine solution may (compared with povidone iodine solution) also reduce the presence of infectious organisms within the catheter (reduced from 240 infected catheters per 1000 people to 189 infected catheters per 1000 people). It is unclear whether antiseptic skin cleansing influences mortality rates as only one study reported this and although similar death rates were observed with povidone iodine and chlorhexidine, small numbers mean a difference cannot be ruled out."
}
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query-laysum
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22288
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[
{
"role": "user",
"content": "Abstract: Background\nIn the perioperative period, dexamethasone is widely and effectively used for prophylaxis of postoperative nausea and vomiting (PONV), for pain management, and to facilitate early discharge after ambulatory surgery.\nLong-term treatment with steroids has many side effects, such as adrenal insufficiency, increased infection risk, hyperglycaemia, high blood pressure, osteoporosis, and development of diabetes mellitus. However, whether a single steroid load during surgery has negative effects during the postoperative period has not yet been studied.\nObjectives\nTo assess the effects of a steroid load of dexamethasone on postoperative systemic or wound infection, delayed wound healing, and blood glucose change in adult surgical patients (with planned subgroup analysis of patients with and without diabetes).\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, and the Web of Science for relevant articles on 29 January 2018. We searched without language or date restriction two clinical trial registries to identify ongoing studies, and we handsearched the reference lists of relevant publications to identify all eligible trials.\nSelection criteria\nWe searched for randomized controlled trials comparing an incidental steroid load of dexamethasone versus a control intervention for adult patients undergoing surgery. We required that studies include a follow-up of 30 days for proper assessment of the number of postoperative infections, delayed wound healing, and the glycaemic response.\nData collection and analysis\nTwo review authors independently screened studies for eligibility, extracted data from relevant studies, and assessed all included studies for bias. We resolved differences by discussion and pooled included studies in a meta-analysis. We calculated Peto odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes. Our primary outcomes were postoperative systemic or wound infection, delayed wound healing, and glycaemic response within 24 hours. We created a funnel plot for the primary outcome postoperative (wound or systemic) infection. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included in the meta-analysis 37 studies that included adults undergoing a large variety of surgical procedures (i.e. abdominal surgery, cardiac surgery, neurosurgery, and orthopaedic surgery). We excluded one previously included study, as this study was recently retracted. Age range of participants was 18 to 80 years. There is probably little or no difference in the risk of postoperative (wound or systemic) infection with dexamethasone compared with no treatment, placebo, or active control (ramosetron, ondansetron, or tropisetron) (Peto OR 1.01, 95% confidence interval (CI) 0.80 to 1.27; 4603 participants, 26 studies; I² = 32%; moderate-quality evidence). The effects of dexamethasone on delayed wound healing are unclear because the wide confidence interval includes both meaningful benefit and harm (Peto OR 0.99, 95% CI 0.28 to 3.43; 1072 participants, eight studies; I² = 0%; low-quality evidence). Dexamethasone may produce a mild increase in glucose levels among participants without diabetes during the first 12 hours after surgery (MD 13 mg/dL, 95% CI 6 to 21; 10 studies; 595 participants; I² = 50%; low-quality evidence). We identified two studies reporting on glycaemic response after dexamethasone in participants with diabetes within 24 hours after surgery (MD 32 mg/dL, 95% CI 15 to 49; 74 participants; I² = 0%; very low-quality evidence).\nAuthors' conclusions\nA single dose of dexamethasone probably does not increase the risk for postoperative infection. It is uncertain whether dexamethasone has an effect on delayed wound healing in the general surgical population owing to imprecision in trial results. Participants with increased risk for delayed wound healing (e.g. participants with diabetes, those taking immunosuppressive drugs) were not included in the randomized studies reporting on delayed wound healing included in this meta-analysis; therefore our findings should be extrapolated to the clinical setting with caution. Furthermore, one has to keep in mind that dexamethasone induces a mild increase in glucose. For patients with diabetes, very limited evidence suggests a more pronounced increase in glucose. Whether this influences wound healing in a clinically relevant way remains to be established. Once assessed, the two studies awaiting classification and three that are ongoing may alter the conclusions of this review.\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": ""
}
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query-laysum
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22289
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[
{
"role": "user",
"content": "Abstract: Background\nCustom foot orthoses are commonly recommended for the treatment of foot pain.\nObjectives\nTo evaluate the effectiveness of custom foot orthoses for different types of foot pain.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (from January 1966), EMBASE (from January 1980), CINAHL (from January 1982) and the Physiotherapy Evidence Database (PEDro) (to June 2007). We also contacted authors of included trials and known researchers in the field and checked the reference lists of included trials to identify trials. No language or publication restrictions were applied.\nSelection criteria\nRandomised controlled trials and controlled clinical trials evaluating custom-made foot orthoses for any type of foot pain. Outcomes included quantifiable levels of foot pain, function, disability, health-related quality of life, participant satisfaction, adverse effects and compliance.\nData collection and analysis\nTwo authors independently selected trials, rated methodological quality and cross checked data extraction. Data were analysed separately for different diagnoses of foot pain and follow-up time points.\nMain results\nEleven trials involving 1332 participants were included: five trials evaluated custom-made foot orthoses for plantar fasciitis (691 participants); three for foot pain in rheumatoid arthritis (231 participants); and one each for foot pain in pes cavus (154 participants), hallux valgus (209 participants) and juvenile idiopathic arthritis (JIA) (47 participants). Comparisons to custom-made foot orthoses included sham orthoses; no intervention; standardised interventions given to all participants; non-custom (prefabricated) foot orthoses; combined manipulation, mobilisation or stretching; night splints; and surgery. Follow up ranged from one week to three years. Custom-made foot orthoses were effective for painful pes cavus (NNTB:5), rearfoot pain in rheumatoid arthritis (NNTB:4), foot pain in JIA (NNTB:3) and painful hallux valgus (NNTB:6); however, surgery was even more effective for hallux valgus and non-custom foot orthoses appeared just as effective for JIA but the analysis may have lacked sufficient power to detect a difference in effect. It is unclear if custom-made foot orthoses were effective for plantar fasciitis or metatarsophalangeal joint pain in rheumatoid arthritis. Custom-made foot orthoses were a safe intervention in all studies.\nAuthors' conclusions\nThere is limited evidence on which to base clinical decisions regarding the prescription of custom-made foot orthoses for the treatment of foot pain. Currently, there is gold level evidence for painful pes cavus and silver level evidence for foot pain in JIA, rheumatoid arthritis, plantar fasciitis and hallux valgus.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to children with JIA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "After 3 months, custom-made foot orthoses improve foot pain by 19 more points on a scale of 0 to 100 (possibly as many as 36 points or as few as 3 points)."
}
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query-laysum
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22290
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[
{
"role": "user",
"content": "Abstract: Background\nPain on propofol injection is an untoward effect and this condition can reduce patient satisfaction. Intravenous lidocaine injection has been commonly used to attenuate pain on propofol injection. Although many studies have reported that lidocaine was effective in reducing the incidence and severity of pain, nevertheless, no systematic review focusing on lidocaine for preventing high-intensity pain has been published.\nObjectives\nThe objective of this review was to determine the efficacy and adverse effects of lidocaine in preventing high-intensity pain on propofol injection.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), Ovid MEDLINE (1950 To October 2014), Ovid Embase (1988 to October 2014), LILACS (1992 to October 2014) and searched reference lists of articles.\nWe reran the search in November 2015. We found 11 potential studies of interest, those studies were added to the list of ‘Studies awaiting classification' and will be fully incorporated into the formal review findings when we update the review.\nSelection criteria\nWe included randomized controlled trials (RCTs) using intravenous lidocaine injection as an intervention to decrease pain on propofol injection in adults. We excluded studies without a placebo or control group.\nData collection and analysis\nWe collected selected studies with relevant criteria. We identified risk of bias in five domains according to the following criteria: random sequence generation, allocation concealment, adequacy of blinding, completeness of outcome data and selective reporting. We performed meta-analysis by direct comparisons of intervention versus control. We estimated the summary odds ratios (ORs) and 95% confidence intervals using the random-effects Mantel-Haenszel method in RevMan 5.3. We used the I2 statistic to assess statistical heterogeneity. We assessed overall quality of evidence using the GRADE approach.\nMain results\nWe included 85 studies, 82 of which (10,350 participants) were eligible for quantitative analysis in the review. All participants, aged 13 years to 89 years, were American Society of Anesthesiologists (ASA) I-III patients undergoing elective surgery. Each study was conducted in a single centre in high- , middle- and low-income countries worldwide. According to the risk of bias assessment, all except five studies were identified as being of satisfactory methodological quality, allowing 82 studies to be combined in the meta-analysis. Five of the 82 studies were assessed as high risk of bias: one for participant and personnel blinding, one for incomplete outcome data, and three for other potential sources of bias.\nThe overall incidence of pain and high-intensity pain following propofol injection in the control group were 63.7% (95% CI 60% to 67.9%) and 37.9% (95% CI 33.4% to 43.1%), respectively while those in the lidocaine group were 30.2% (95% CI 26.7% to 33.7%) and 11.8% (95% CI 9.7% to 13.8%). Both lidocaine admixture and pretreatment were effective in reducing pain on propofol injection (lidocaine admixture OR 0.19, 95% CI 0.15 to 0.25, 31 studies, 4927 participants, high-quality evidence; lidocaine pretreatment OR 0.13, 95% CI 0.10 to 0.18, 41 RCTs, 3918 participants, high-quality evidence). Similarly, lidocaine administration could considerably decrease the incidence of pain when premixed with the propofol (OR 0.19, 95% CI 0.15 to 0.24, 36 studies, 5628 participants, high-quality evidence) or pretreated prior to propofol injection (OR 0.14, 95% CI 0.11 to 0.18, 50 studies, 4722 participants, high-quality evidence). Adverse effects of lidocaine administration were rare. Thrombophlebitis was reported in only two studies (OR not estimated, low-quality evidence). No studies reported patient satisfaction.\nAuthors' conclusions\nOverall, the quality of the evidence was high. Currently available data from RCTs are sufficient to confirm that both lidocaine admixture and pretreatment were effective in reducing pain on propofol injection. Furthermore, there were no significant differences of effect between the two techniques.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The overall quality of evidence was high with a very large beneficial effect obtained by the administration of lidocaine to reduce painful propofol injections."
}
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query-laysum
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22291
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[
{
"role": "user",
"content": "Abstract: Background\nDelivering the diagnosis of a serious illness is an important skill in most fields of medicine, including mental health. Research has found that communication skills can impact on a person's recall and understanding of the diagnosis, treatment options and prognosis. People may feel confused and perplexed when information about their illness is not communicated properly. Sharing information about diagnosis of a serious mental illness is particularly challenging. The nature of mental illness is often difficult to explain since there may be no clear aetiology, and the treatment options and prognosis may vary enormously. In addition, newly diagnosed psychiatric patients, who are actively ill, often may not accept their diagnosis due to lack of insight or stigma attached to the condition. There are several interventions that aim to help clinicians to communicate life changing medical diagnoses to people; however, little is known specifically for delivering a diagnosis of schizophrenia.\nObjectives\nTo evaluate evidence from randomised controlled trials (RCTs) for the efficacy of different communication strategies used by clinicians to inform people about the diagnosis and outcome of schizophrenia compared with treatment as usual and to compare efficacy between different communication strategies.\nSearch methods\nOn 22 June 2015 and 29 June 2016, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials. We also searched sources of grey literature (e.g., dissertations, theses, clinical reports, evaluations published on websites, clinical guidelines and reports from regulatory agencies).\nSelection criteria\nWe planned to include all relevant RCTs that included adults with schizophrenia or related disorders, including schizophreniform disorder, schizoaffective disorder and delusional disorder. The trials would have investigated the effects of communication strategy or strategies that helped clinicians deliver information specifically about a diagnosis of schizophrenia (which can also include communication regarding the treatment options available and prognosis).\nData collection and analysis\nReview authors independently examined all reports from the searches for any relevant studies. We planned to extract data independently. For binary outcomes, we would have calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we would have estimated the mean difference (MD) between groups and its 95% CI. We would have employed a random-effects model for analyses. We planned to assess risk of bias for included studies. We created a 'Summary of findings' table using GRADE.\nMain results\nThe searches identified 44 records which appeared to be relevant to the aims of the review. We obtained full reports for seven potential studies; however, after close inspection none of these studies met the inclusion criteria.\nAuthors' conclusions\nGood communication of diagnosis can affect treatment planning, compliance and patient outcomes, especially in the case of conditions such as schizophrenia, which has the potential to cause serious life disruption for both people with schizophrenia and their carers. Currently, there is no evidence based on findings from RCTs assessing the effects of communication strategies for disclosing the diagnosis of schizophrenia and related disorders. Research is required.\n\nGiven the provided abstract, please respond to the following query: \"Searching for evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In June 2015 and June 2016, we explored the medical literature and the Cochrane Schizophrenia Group's study-based register using appropriate keywords to find any studies which evaluated a method that guided or helped health professionals with how to deliver the news about the diagnosis of schizophrenia. We specifically searched for randomised controlled trials as these are considered the best way (gold standard) to evaluate the effects of treatments. We identified 44 publications and inspected these. From these, we obtained seven full reports of trials and that we thought could be relevant; however, none of these studies could be included in the review."
}
] |
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22292
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[
{
"role": "user",
"content": "Abstract: Background\nFluvastatin is thought to be the least potent statin on the market, however, the dose-related magnitude of effect of fluvastatin on blood lipids is not known.\nObjectives\nPrimary objective\nTo quantify the effects of various doses of fluvastatin on blood total cholesterol, low-density lipoprotein (LDL cholesterol), high-density lipoprotein (HDL cholesterol), and triglycerides in participants with and without evidence of cardiovascular disease.\nSecondary objectives\nTo quantify the variability of the effect of various doses of fluvastatin.\n\nTo quantify withdrawals due to adverse effects (WDAEs) in randomised placebo-controlled trials.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to February 2017: the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 1), MEDLINE (1946 to February Week 2 2017), MEDLINE In-Process, MEDLINE Epub Ahead of Print, Embase (1974 to February Week 2 2017), the World Health Organization International Clinical Trials Registry Platform, CDSR, DARE, Epistemonikos and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. No language restrictions were applied.\nSelection criteria\nRandomised placebo-controlled and uncontrolled before and after trials evaluating the dose response of different fixed doses of fluvastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without evidence of 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 placebo-controlled and uncontrolled before and after trials into Review Manager 5 as continuous and generic inverse variance data, respectively. WDAEs information was collected from the placebo-controlled trials. We assessed all trials using the 'Risk of bias' tool under the categories of sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other potential biases.\nMain results\nOne-hundred and forty-five trials (36 placebo controlled and 109 before and after) evaluated the dose-related efficacy of fluvastatin in 18,846 participants. The participants were of any age with and without evidence of cardiovascular disease, and fluvastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 2.5 mg to 80 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and a weak linear dose-related effect on blood triglycerides. There was no dose-related effect of fluvastatin on blood HDL cholesterol. Fluvastatin 10 mg/day to 80 mg/day reduced LDL cholesterol by 15% to 33%, total cholesterol by 11% to 25% and triglycerides by 3% to 17.5%. For every two-fold dose increase there was a 6.0% (95% CI 5.4 to 6.6) decrease in blood LDL cholesterol, a 4.2% (95% CI 3.7 to 4.8) decrease in blood total cholesterol and a 4.2% (95% CI 2.0 to 6.3) decrease in blood triglycerides. The quality of evidence for these effects was judged to be high. When compared to atorvastatin and rosuvastatin, fluvastatin was about 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin at reducing LDL cholesterol. Very low quality of evidence showed no difference in WDAEs between fluvastatin and placebo in 16 of 36 of these short-term trials (risk ratio 1.52 (95% CI 0.94 to 2.45).\nAuthors' conclusions\nFluvastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, fluvastatin is 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin. This review did not provide a good estimate of the incidence of harms associated with fluvastatin because of the short duration of the trials and the lack of reporting of adverse effects in 56% of the placebo-controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to February 2017."
}
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22293
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[
{
"role": "user",
"content": "Abstract: Background\nLow back pain has been the leading cause of disability globally for at least the past three decades and results in enormous direct healthcare and lost productivity costs.\nObjectives\nThe primary objective of this systematic review is to assess the impact of exercise treatment on pain and functional limitations in adults with chronic non-specific low back pain compared to no treatment, usual care, placebo and other conservative treatments.\nSearch methods\nWe searched CENTRAL (which includes the Cochrane Back and Neck trials register), MEDLINE, Embase, CINAHL, PsycINFO, PEDro, SPORTDiscus, and trials registries (ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform), and conducted citation searching of relevant systematic reviews to identify additional studies. The review includes data for trials identified in searches up to 27 April 2018. All eligible trials have been identified through searches to 7 December 2020, but have not yet been extracted; these trials will be integrated in the next update.\nSelection criteria\nWe included randomised controlled trials that assessed exercise treatment compared to no treatment, usual care, placebo or other conservative treatment on the outcomes of pain or functional limitations for a population of adult participants with chronic non-specific low back pain of more than 12 weeks’ duration.\nData collection and analysis\nTwo authors screened and assessed studies independently, with consensus. We extracted outcome data using electronic databases; pain and functional limitations outcomes were re-scaled to 0 to 100 points for meta-analyses where 0 is no pain or functional limitations. We assessed risk of bias using the Cochrane risk of bias (RoB) tool and used GRADE to evaluate the overall certainty of the evidence. When required, we contacted study authors to obtain missing data. To interpret meta-analysis results, we considered a 15-point difference in pain and a 10-point difference in functional limitations outcomes to be clinically important for the primary comparison of exercise versus no treatment, usual care or placebo.\nMain results\nWe included 249 trials of exercise treatment, including studies conducted in Europe (122 studies), Asia (38 studies), North America (33 studies), and the Middle East (24 studies). Sixty-one per cent of studies (151 trials) examined the effectiveness of two or more different types of exercise treatment, and 57% (142 trials) compared exercise treatment to a non-exercise comparison treatment. Study participants had a mean age of 43.7 years and, on average, 59% of study populations were female. Most of the trials were judged to be at risk of bias, including 79% at risk of performance bias due to difficulty blinding exercise treatments.\nWe found moderate-certainty evidence that exercise treatment is more effective for treatment of chronic low back pain compared to no treatment, usual care or placebo comparisons for pain outcomes at earliest follow-up (MD -15.2, 95% CI -18.3 to -12.2), a clinically important difference. Certainty of evidence was downgraded mainly due to heterogeneity. For the same comparison, there was moderate-certainty evidence for functional limitations outcomes (MD -6.8 (95% CI -8.3 to -5.3); this finding did not meet our prespecified threshold for minimal clinically important difference. Certainty of evidence was downgraded mainly due to some evidence of publication bias.\nCompared to all other investigated conservative treatments, exercise treatment was found to have improved pain (MD -9.1, 95% CI -12.6 to -5.6) and functional limitations outcomes (MD -4.1, 95% CI -6.0 to -2.2). These effects did not meet our prespecified threshold for clinically important difference. Subgroup analysis of pain outcomes suggested that exercise treatment is probably more effective than education alone (MD -12.2, 95% CI -19.4 to -5.0) or non-exercise physical therapy (MD -10.4, 95% CI -15.2 to -5.6), but with no differences observed for manual therapy (MD 1.0, 95% CI -3.1 to 5.1).\nIn studies that reported adverse effects (86 studies), one or more adverse effects were reported in 37 of 112 exercise groups (33%) and 12 of 42 comparison groups (29%). Twelve included studies reported measuring adverse effects in a systematic way, with a median of 0.14 (IQR 0.01 to 0.57) per participant in the exercise groups (mostly minor harms, e.g. muscle soreness), and 0.12 (IQR 0.02 to 0.32) in comparison groups.\nAuthors' conclusions\nWe found moderate-certainty evidence that exercise is probably effective for treatment of chronic low back pain compared to no treatment, usual care or placebo for pain. The observed treatment effect for the exercise compared to no treatment, usual care or placebo comparisons is small for functional limitations, not meeting our threshold for minimal clinically important difference. We also found exercise to have improved pain (low-certainty evidence) and functional limitations outcomes (moderate-certainty evidence) compared to other conservative treatments; however, these effects were small and not clinically important when considering all comparisons together. Subgroup analysis suggested that exercise treatment is probably more effective than advice or education alone, or electrotherapy, but with no differences observed for manual therapy treatments.\n\nGiven the provided abstract, please respond to the following query: \"Is exercise an effective therapy to treat long-lasting low back pain?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
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query-laysum
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22294
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[
{
"role": "user",
"content": "Abstract: Background\nThe unanticipated difficult airway is a potentially life-threatening event during anaesthesia or acute conditions. An unsuccessfully managed upper airway is associated with serious morbidity and mortality. Several bedside screening tests are used in clinical practice to identify those at high risk of difficult airway. Their accuracy and benefit however, remains unclear.\nObjectives\nThe objective of this review was to characterize and compare the diagnostic accuracy of the Mallampati classification and other commonly used airway examination tests for assessing the physical status of the airway in adult patients with no apparent anatomical airway abnormalities. We performed this individually for each of the four descriptors of the difficult airway: difficult face mask ventilation, difficult laryngoscopy, difficult tracheal intubation, and failed intubation.\nSearch methods\nWe searched major electronic databases including CENTRAL, MEDLINE, Embase, ISI Web of Science, CINAHL, as well as regional, subject specific, and dissertation and theses databases from inception to 16 December 2016, without language restrictions. In addition, we searched the Science Citation Index and checked the references of all the relevant studies. We also handsearched selected journals, conference proceedings, and relevant guidelines. We updated this search in March 2018, but we have not yet incorporated these results.\nSelection criteria\nWe considered full-text diagnostic test accuracy studies of any individual index test, or a combination of tests, against a reference standard. Participants were adults without obvious airway abnormalities, who were having laryngoscopy performed with a standard laryngoscope and the trachea intubated with a standard tracheal tube. Index tests included the Mallampati test, modified Mallampati test, Wilson risk score, thyromental distance, sternomental distance, mouth opening test, upper lip bite test, or any combination of these. The target condition was difficult airway, with one of the following reference standards: difficult face mask ventilation, difficult laryngoscopy, difficult tracheal intubation, and failed intubation.\nData collection and analysis\nWe performed screening and selection of the studies, data extraction and assessment of methodological quality (using QUADAS-2) independently and in duplicate. We designed a Microsoft Access database for data collection and used Review Manager 5 and R for data analysis. For each index test and each reference standard, we assessed sensitivity and specificity. We produced forest plots and summary receiver operating characteristic (ROC) plots to summarize the data. Where possible, we performed meta-analyses to calculate pooled estimates and compare test accuracy indirectly using bivariate models. We investigated heterogeneity and performed sensitivity analyses.\nMain results\nWe included 133 (127 cohort type and 6 case-control) studies involving 844,206 participants. We evaluated a total of seven different prespecified index tests in the 133 studies, as well as 69 non-prespecified, and 32 combinations. For the prespecified index tests, we found six studies for the Mallampati test, 105 for the modified Mallampati test, six for the Wilson risk score, 52 for thyromental distance, 18 for sternomental distance, 34 for the mouth opening test, and 30 for the upper lip bite test. Difficult face mask ventilation was the reference standard in seven studies, difficult laryngoscopy in 92 studies, difficult tracheal intubation in 50 studies, and failed intubation in two studies. Across all studies, we judged the risk of bias to be variable for the different domains; we mostly observed low risk of bias for patient selection, flow and timing, and unclear risk of bias for reference standard and index test. Applicability concerns were generally low for all domains. For difficult laryngoscopy, the summary sensitivity ranged from 0.22 (95% confidence interval (CI) 0.13 to 0.33; mouth opening test) to 0.67 (95% CI 0.45 to 0.83; upper lip bite test) and the summary specificity ranged from 0.80 (95% CI 0.74 to 0.85; modified Mallampati test) to 0.95 (95% CI 0.88 to 0.98; Wilson risk score). The upper lip bite test for diagnosing difficult laryngoscopy provided the highest sensitivity compared to the other tests (P < 0.001). For difficult tracheal intubation, summary sensitivity ranged from 0.24 (95% CI 0.12 to 0.43; thyromental distance) to 0.51 (95% CI 0.40 to 0.61; modified Mallampati test) and the summary specificity ranged from 0.87 (95% CI 0.82 to 0.91; modified Mallampati test) to 0.93 (0.87 to 0.96; mouth opening test). The modified Mallampati test had the highest sensitivity for diagnosing difficult tracheal intubation compared to the other tests (P < 0.001). For difficult face mask ventilation, we could only estimate summary sensitivity (0.17, 95% CI 0.06 to 0.39) and specificity (0.90, 95% CI 0.81 to 0.95) for the modified Mallampati test.\nAuthors' conclusions\nBedside airway examination tests, for assessing the physical status of the airway in adults with no apparent anatomical airway abnormalities, are designed as screening tests. Screening tests are expected to have high sensitivities. We found that all investigated index tests had relatively low sensitivities with high variability. In contrast, specificities were consistently and markedly higher than sensitivities across all tests. The standard bedside airway examination tests should be interpreted with caution, as they do not appear to be good screening tests. Among the tests we examined, the upper lip bite test showed the most favourable diagnostic test accuracy properties. Given the paucity of available data, future research is needed to develop tests with high sensitivities to make them useful, and to consider their use for screening difficult face mask ventilation and failed intubation. The 27 studies in 'Studies awaiting classification' may alter the conclusions of the review, once we have assessed them.\n\nGiven the provided abstract, please respond to the following query: \"Population\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included studies of adults aged 16 years or older without obvious airway abnormalities who were to receive standard intubation."
}
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query-laysum
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22295
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[
{
"role": "user",
"content": "Abstract: Background\nSmoking is a leading cause of cardiovascular disease (CVD), particularly coronary heart disease (CHD). However, quitting smoking may prevent secondary CVD events in people already diagnosed with CHD.\nObjectives\nTo examine the impact of smoking cessation on death from CVD and major adverse cardiovascular events (MACE), in people with incident CHD.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and the trials registries clinicaltrials.gov and the International Clinical Trials Registry Platform. We ran all searches from database inception to 15 April 2021.\nSelection criteria\nWe included cohort studies, and both cluster- and individually randomised controlled trials of at least six months' duration. We treated all included studies as cohort studies and analysed them by smoking status at follow-up. Eligible studies had to recruit adults (> 18 years) with diagnosed CHD and who smoked tobacco at diagnosis, and assess whether they quit or continued smoking during the study. Studies had to measure at least one of our included outcomes with at least six months' follow-up. Our primary outcomes were death from CVD and MACE. Secondary outcomes included all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, new-onset angina and change in quality of life.\nData collection and analysis\nWe followed standard Cochrane methods for screening and data extraction.\nWe assessed the risk of bias for the primary outcomes using the ROBINS-I tool. We compared the incidence of death from CVD and of MACE (primary outcomes) between participants who quit smoking versus those who continued to smoke for each included study that reported these outcomes. We also assessed differences in all-cause mortality, incidence of non-fatal myocardial infarction, incidence of non-fatal stroke and new onset angina. We calculated hazard ratios (HRs) and 95% confidence intervals (95% CI). For our outcome, change in quality of life, we calculated the pooled standardised mean difference (SMD) and 95% CI for the difference in change in quality of life from baseline to follow-up between those who had quit smoking and those who had continued to smoke. For all meta-analyses we used a generic inverse variance random-effects model and quantified statistical heterogeneity using the I²statistic.\nWe assessed the certainty of evidence for our primary outcomes using the eight GRADE considerations relevant to non-randomised studies.\nMain results\nWe included 68 studies, consisting of 80,702 participants.\nFor both primary outcomes, smoking cessation was associated with a decreased risk compared with continuous smoking: CVD death (HR 0.61, 95% CI 0.49 to 0.75; I² = 62%; 18 studies, 17,982 participants; moderate-certainty evidence) and MACE (HR 0.57, 95% CI 0.45 to 0.71; I² = 84%; 15 studies, 20,290 participants; low-certainty evidence). These findings were robust to our planned sensitivity analyses. Through subgroup analysis, for example comparing adjusted versus non-adjusted estimates, we found no evidence of differences in the effect size. While there was substantial heterogeneity, this was primarily in magnitude rather than the direction of the effect estimates. Overall, we judged 11 (16%) studies to be at moderate risk of bias and 18 (26%) at serious risk, primarily due to possible confounding. There was also some evidence of funnel plot asymmetry for MACE outcomes. For these reasons, we rated our certainty in the estimates for CVD death as moderate and MACE as low.\nFor our secondary outcomes, smoking cessation was associated with a decreased risk in all-cause mortality (HR 0.60, 95% CI 0.55 to 0.66; I² = 58%; 48 studies, 59,354 participants), non-fatal myocardial infarction (HR 0.64, 95% CI 0.58 to 0.72; I² = 2%; 24 studies, 23,264 participants) and non-fatal stroke (HR 0.70, 95% CI 0.53 to 0.90; I² = 0%; 9 studies, 11,352 participants). As only one study reported new onset of angina, we did not conduct meta-analysis, but this study reported a lower risk in people who stopped smoking. Quitting smoking was not associated with a worsening of quality of life and suggested improvement in quality of life, with the lower bound of the CI also consistent with no difference (SMD 0.12, 95% CI 0.01 to 0.24; I² = 48%; 8 studies, 3182 participants).\nAuthors' conclusions\nThere is moderate-certainty evidence that smoking cessation is associated with a reduction of approximately one-third in the risk of recurrent cardiovascular disease in people who stop smoking at diagnosis. This association may be causal, based on the link between smoking cessation and restoration of endothelial and platelet function, where dysfunction of both can result in increased likelihood of CVD events.\nOur results provide evidence that there is a decreased risk of secondary CVD events in those who quit smoking compared with those who continue, and that there is a suggested improvement in quality of life as a result of quitting smoking. Additional studies that account for confounding, such as use of secondary CVD prevention medication, would strengthen the evidence in this area.\n\nGiven the provided abstract, please respond to the following query: \"Smoking and heart disease\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Smoking increases the chances that a person will have a heart attack, however there is less information on whether stopping smoking can reduce the risk of having a second heart attack."
}
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query-laysum
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22296
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[
{
"role": "user",
"content": "Abstract: Background\nA detailed summary and meta-analysis of the dose-related effect of pravastatin on lipids is not available.\nObjectives\nPrimary objective\nTo assess the pharmacology of pravastatin by characterizing the dose-related effect and variability of the effect of pravastatin on the surrogate marker: low-density lipoprotein (LDL cholesterol). The effect of pravastatin on morbidity and mortality is not the objective of this systematic review.\nSecondary objectives\n• To assess the dose-related effect and variability of effect of pravastatin on the following surrogate markers: total cholesterol; high-density lipoprotein (HDL cholesterol); and triglycerides. \n• To assess the effect of pravastatin on withdrawals due to adverse effects.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to September 2021: CENTRAL (2021, Issue 8), Ovid MEDLINE, Ovid Embase, Bireme LILACS, the WHO 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\nRandomized placebo-controlled trials evaluating the dose response of different fixed doses of pravastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without evidence of cardiovascular disease.\nData collection and analysis\nTwo review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered lipid data from placebo-controlled trials into Review Manager 5 as continuous data and withdrawal due to adverse effects (WDAEs) data as dichotomous data. We searched for WDAEs information from all trials. We assessed all trials using Cochrane's risk of bias tool under the categories of sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other potential biases.\nMain results\nSixty-four RCTs evaluated the dose-related efficacy of pravastatin in 9771 participants. The participants were of any age, with and without evidence of cardiovascular disease, and pravastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over the doses of 5 mg to 160 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol, and a weak linear dose-related effect on blood triglycerides. There was no dose-related effect of pravastatin on blood HDL cholesterol. Pravastatin 10 mg/day to 80 mg/day reduced LDL cholesterol by 21.7% to 31.9%, total cholesterol by 16.1% to 23.3%,and triglycerides by 5.8% to 20.0%. The certainty of evidence for these effects was judged to be moderate to high. For every two-fold dose increase there was a 3.4% (95% confidence interval (CI) 2.2 to 4.6) decrease in blood LDL cholesterol. This represented a dose-response slope that was less than the other studied statins: atorvastatin, rosuvastatin, fluvastatin, pitavastatin and cerivastatin. From other systematic reviews we conducted on statins for its effect to reduce LDL cholesterol, pravastatin is similar to fluvastatin, but has a decreased effect compared to atorvastatin, rosuvastatin, pitavastatin and cerivastatin. The effect of pravastatin compared to placebo on WADES has a risk ratio (RR) of 0.81 (95% CI 0.63 to 1.03). The certainty of evidence was judged to be very low.\nAuthors' conclusions\nPravastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. This review did not provide a good estimate of the incidence of harms associated with pravastatin because of the lack of reporting of adverse effects in 48.4% of the randomized placebo-controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"What are the main limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Many studies did not report unwanted effects nor the number of people who left the studies because of unwanted effects."
}
] |
query-laysum
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22297
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[
{
"role": "user",
"content": "Abstract: Background\nCommunity pharmacies are an easily accessible and cost-effective platform for delivering health care worldwide, and the range of services provided has undergone rapid expansion in recent years. Thus, in addition to dispensing medication, pharmacy workers within community pharmacies now give advice on a range of health-promoting behaviours that aim to improve health and to optimise the management of long-term conditions. However, it remains uncertain whether these health-promotion interventions can change the professional practice of pharmacy workers, improve health behaviours and outcomes for pharmacy users and have the potential to address health inequalities.\nObjectives\nTo assess the effectiveness and safety of health-promotion interventions to change community pharmacy workers' professional practice and improve outcomes for users of community pharmacies.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL, six other databases and two trials registers to 6 February 2018. We also conducted reference checking, citation searches and contacted study authors to identify any additional studies.\nSelection criteria\nWe included randomised trials of health-promotion interventions in community pharmacies targeted at, or delivered by, pharmacy workers that aimed to improve the health-related behaviour of people attending the pharmacy compared to no treatment, or usual treatment received in the community pharmacy. We excluded interventions where there was no interaction between pharmacy workers and pharmacy users, and those that focused on medication use only.\nData collection and analysis\nWe used standard procedures recommended by Cochrane and the Effective Practice and Organisation of Care review group for both data collection and analysis. We compared intervention to no intervention or to usual treatment using standardised mean differences (SMD) and 95% confidence intervals (95% CI) (higher scores represent better outcomes for pharmacy user health-related behaviour and quality of life, and lower scores represent better outcomes for clinical outcomes, costs and adverse events). Interpretation of effect sizes (SMD) was in line with Cochrane recommendations.\nMain results\nWe included 57 randomised trials with 16,220 participants, described in 83 reports. Forty-nine studies were conducted in high-income countries, and eight in middle-income countries. We found no studies that had been conducted in low-income countries. Most interventions were educational, or incorporated skills training. Interventions were directed at pharmacy workers (n = 8), pharmacy users (n = 13), or both (n = 36). The clinical areas most frequently studied were diabetes, hypertension, asthma, and modification of cardiovascular risk. Duration of follow-up of interventions was often unclear. Only five studies gave details about the theoretical basis for the intervention, and studies did not provide sufficient data to comment on health inequalities.\nThe most common sources of bias were lack of protection against contamination - mainly in individually randomised studies - and inadequate blinding of participants. The certainty of the evidence for all outcomes was moderate. We downgraded the certainty because of the heterogeneity across studies and evidence of potential publication bias.\nProfessional practice outcomes\nWe conducted a narrative analysis for pharmacy worker behaviour due to high heterogeneity in the results. Health-promotion interventions probably improve pharmacy workers' behaviour (2944 participants; 9 studies; moderate-certainty evidence) when compared to no intervention. These studies typically assessed behaviour using a simulated patient (mystery shopper) methodology.\nPharmacy user outcomes\nHealth-promotion interventions probably lead to a slight improvement in health-related behaviours of pharmacy users when compared to usual treatment (SMD 0.43, 95% CI 0.14 to 0.72; I2 = 89%; 10 trials; 2138 participants; moderate-certainty evidence). These interventions probably also lead to a slight improvement in intermediate clinical outcomes, such as levels of cholesterol or glycated haemoglobin, for pharmacy users (SMD -0.43, 95% CI -0.65 to -0.21; I2 = 90%; 20 trials; 3971 participants; moderate-certainty evidence).\nWe identified no studies that evaluated the impact of health-promotion interventions on event-based clinical outcomes, such as stroke or myocardial infarction, or the psychological well-being of pharmacy users.\nHealth-promotion interventions probably lead to a slight improvement in quality of life for pharmacy users (SMD 0.29, 95% CI 0.08 to 0.50; I2= 82%; 10 trials, 2687 participants; moderate-certainty evidence).\nAdverse events\nNo studies reported adverse events for either pharmacy workers or pharmacy users.\nCosts\nWe found that health-promotion interventions are likely to be cost-effective, based on moderate-certainty evidence from five of seven studies that reported an economic evaluation.\nAuthors' conclusions\nHealth-promotion interventions in the community pharmacy context probably improve pharmacy workers' behaviour and probably have a slight beneficial effect on health-related behaviour, intermediate clinical outcomes, and quality of life for pharmacy users.\nSuch interventions are likely to be cost-effective and the effects are seen across a range of clinical conditions and health-related behaviours. Nevertheless the magnitude of the effects varies between conditions, and more effective interventions might be developed if greater consideration were given to the theoretical basis of the intervention and mechanisms for effecting behaviour change.\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": "We aimed to find out whether interventions that support people to change health behaviours, and are delivered in community pharmacies, can change the way that pharmacy workers interact with pharmacy users and can improve health outcomes for those users."
}
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query-laysum
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22298
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[
{
"role": "user",
"content": "Abstract: Background\nErysipelas and cellulitis (hereafter referred to as 'cellulitis') are common bacterial skin infections usually affecting the lower extremities. Despite their burden of morbidity, the evidence for different prevention strategies is unclear.\nObjectives\nTo assess the beneficial and adverse effects of antibiotic prophylaxis or other prophylactic interventions for the prevention of recurrent episodes of cellulitis in adults aged over 16.\nSearch methods\nWe searched the following databases up to June 2016: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and LILACS. We also searched five trials registry databases, and checked reference lists of included studies and reviews for further references to relevant randomised controlled trials (RCTs). We searched two sets of dermatology conference proceedings, and BIOSIS Previews.\nSelection criteria\nRandomised controlled trials evaluating any therapy for the prevention of recurrent cellulitis.\nData collection and analysis\nTwo authors independently carried out study selection, data extraction, assessment of risks of bias, and analyses. Our primary prespecified outcome was recurrence of cellulitis when on treatment and after treatment. Our secondary outcomes included incidence rate, time to next episode, hospitalisation, quality of life, development of resistance to antibiotics, adverse reactions and mortality.\nMain results\nWe included six trials, with a total of 573 evaluable participants, who were aged on average between 50 and 70. There were few previous episodes of cellulitis in those recruited to the trials, ranging between one and four episodes per study.\nFive of the six included trials assessed prevention with antibiotics in participants with cellulitis of the legs, and one assessed selenium in participants with cellulitis of the arms. Among the studies assessing antibiotics, one study evaluated oral erythromycin (n = 32) and four studies assessed penicillin (n = 481). Treatment duration varied from six to 18 months, and two studies continued to follow up participants after discontinuation of prophylaxis, with a follow-up period of up to one and a half to two years. Four studies were single-centre, and two were multicentre; they were conducted in five countries: the UK, Sweden, Tunisia, Israel, and Austria.\nBased on five trials, antibiotic prophylaxis (at the end of the treatment phase ('on prophylaxis')) decreased the risk of cellulitis recurrence by 69%, compared to no treatment or placebo (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.13 to 0.72; n = 513; P = 0.007), number needed to treat for an additional beneficial outcome (NNTB) six, (95% CI 5 to 15), and we rated the certainty of evidence for this outcome as moderate.\nUnder prophylactic treatment and compared to no treatment or placebo, antibiotic prophylaxis reduced the incidence rate of cellulitis by 56% (RR 0.44, 95% CI 0.22 to 0.89; four studies; n = 473; P value = 0.02; moderate-certainty evidence) and significantly decreased the rate until the next episode of cellulitis (hazard ratio (HR) 0.51, 95% CI 0.34 to 0.78; three studies; n = 437; P = 0.002; moderate-certainty evidence).\nThe protective effects of antibiotic did not last after prophylaxis had been stopped ('post-prophylaxis') for risk of cellulitis recurrence (RR 0.88, 95% CI 0.59 to 1.31; two studies; n = 287; P = 0.52), incidence rate of cellulitis (RR 0.94, 95% CI 0.65 to 1.36; two studies; n = 287; P = 0.74), and rate until next episode of cellulitis (HR 0.78, 95% CI 0.39 to 1.56; two studies; n = 287). Evidence was of low certainty.\nEffects are relevant mainly for people after at least two episodes of leg cellulitis occurring within a period up to three years.\nWe found no significant differences in adverse effects or hospitalisation between antibiotic and no treatment or placebo; for adverse effects: RR 0.87, 95% CI 0.58 to 1.30; four studies; n = 469; P = 0.48; for hospitalisation: RR 0.77, 95% CI 0.37 to 1.57; three studies; n = 429; P = 0.47, with certainty of evidence rated low for these outcomes. The existing data did not allow us to fully explore its impact on length of hospital stay.\nThe common adverse reactions were gastrointestinal symptoms, mainly nausea and diarrhoea; rash (severe cutaneous adverse reactions were not reported); and thrush. Three studies reported adverse effects that led to discontinuation of the assigned therapy. In one study (erythromycin), three participants reported abdominal pain and nausea, so their treatment was changed to penicillin. In another study, two participants treated with penicillin withdrew from treatment due to diarrhoea or nausea. In one study, around 10% of participants stopped treatment due to pain at the injection site (the active treatment group was given intramuscular injections of benzathine penicillin).\nNone of the included studies assessed the development of antimicrobial resistance or quality-of-life measures.\nWith regard to the risks of bias, two included studies were at low risk of bias and we judged three others as being at high risk of bias, mainly due to lack of blinding.\nAuthors' conclusions\nIn terms of recurrence, incidence, and time to next episode, antibiotic is probably an effective preventive treatment for recurrent cellulitis of the lower limbs in those under prophylactic treatment, compared with placebo or no treatment (moderate-certainty evidence). However, these preventive effects of antibiotics appear to diminish after they are discontinued (low-certainty evidence). Treatment with antibiotic does not trigger any serious adverse events, and those associated are minor, such as nausea and rash (low-certainty evidence). The evidence is limited to people with at least two past episodes of leg cellulitis within a time frame of up to three years, and none of the studies investigated other common interventions such as lymphoedema reduction methods or proper skin care. Larger, high-quality studies are warranted, including long-term follow-up and other prophylactic measures.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Our main outcome was prevention of repeated episodes of cellulitis. Our other outcomes included the number of repeated attacks of cellulitis, time to next attack, hospitalisation, quality of life, development of antibiotic resistance, adverse reactions and death.\nCombining the results of all five trials that used antibiotics, we found moderate-certainty evidence that for those people under preventative treatment, antibiotic treatment in general, and penicillin in particular, is probably both effective and safe for the prevention of repeated episodes of leg cellulitis when compared with no treatment or placebo.\nThe analyses showed that, compared with no treatment or placebo, taking antibiotics decreased the risk of future episodes by 69%, reduced their number by more than 50%, and significantly reduced the rate until the next attack (moderate-certainty evidence). However, we found low-certainty evidence that the protective effect of antibiotics for these three outcomes tailed off over time after treatment had been stopped. In addition, the beneficial effect of antibiotics was relevant for people with at least two past episodes of cellulitis within a time frame of up to three years.\nWe found low-certainty evidence that there is no difference between antibiotics and no treatment/placebo for side effects and hospitalisation. The evidence did not allow for full exploration of the treatment's effect on length of hospital stay.\nNo serious adverse effects were reported, and common side effects included diarrhoea, nausea, rash (severe skin adverse reactions were not reported) and thrush. In three studies, adverse effects caused those taking part to stop taking the antibiotic. Three people taking erythromycin had abdominal pain and nausea, causing them to stop taking the treatment and to take penicillin instead. In one study, two people withdrew from treatment with penicillin because of diarrhoea or nausea. In another study, because of pain at the site of injection, around 10% of those taking part stopped taking intramuscular injections of benzathine penicillin.\nNone of the included studies measured quality of life or the development of antibiotic resistance."
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query-laysum
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22299
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[
{
"role": "user",
"content": "Abstract: Background\nRaynaud's phenomenon is a vasospastic disease characterized by digital pallor, cyanosis, and extremity pain. Primary Raynaud's phenomenon is not associated with underlying disease, but secondary Raynaud's phenomenon is associated with connective tissue disorders such as systemic sclerosis, systemic lupus erythematosus, and mixed connective tissue disease. Calcium channel blockers promote vasodilation and are commonly used when drug treatment for Raynaud's phenomenon is required.\nObjectives\nTo assess the benefits and harms of calcium channel blockers (CCBs) versus placebo for treatment of individuals with Raynaud's phenomenon with respect to Raynaud's type (primary vs secondary) and type and dose of CCBs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (May 19, 2017), MEDLINE (1946 to May 19, 2017), Embase (1947 to May 19, 2017), clinicaltrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Portal. We applied no language restrictions. We also searched bibliographies of retrieved articles and contacted key experts for additional and unpublished data.\nSelection criteria\nAll randomized controlled trials (RCTs) comparing calcium channel blockers versus placebo.\nData collection and analysis\nTwo review authors independently assessed search results and risk of bias and extracted trial data. We used the GRADE approach to assess the quality of evidence.\nMain results\nThis review contains 38 RCTs (33 cross-over RCTs) with an average duration of 7.4 weeks and 982 participants; however, not all trials reported all outcomes of interest. Nine of the identified trials studied patients with primary Raynaud's phenomenon (N = 365), five studied patients with secondary Raynaud's phenomenon (N = 63), and the rest examined a mixture of patients with primary and secondary Raynaud's phenomenon (N = 554). The most frequently encountered risk of bias types were incomplete outcome data and poor reporting of randomization and allocation methods.\nWhen researchers considered both primary and secondary Raynaud's phenomenon, evidence of moderate quality (downgraded for inconsistency) from 23 trials with 528 participants indicates that calcium channel blockers (CCBs) were superior to placebo in reducing the frequency of attacks. CCBs reduced the average number of attacks per week by six ( weighted mean difference (WMD) -6.13, 95% confidence interval (CI) -6.60 to - 5.67; I² = 98%) compared with 13.7 attacks per week with placebo. When review authors excluded Kahan 1985C, a trial showing a very large reduction in the frequency of attacks, data showed that CCBs reduced attack frequency by 2.93 per week (95% CI -3.44 to -2.43; I² = 77%).\nLow-quality evidence (downgraded for imprecision and inconsistency) from six trials with 69 participants suggests that the average duration of attacks did not differ in a statistically significant or clinically meaningful way between CCBs and placebo (WMD -1.67 minutes, 95% CI -3.29 to 0); this is equivalent to a -9% difference (95% CI -18% to 0%).\nModerate-quality evidence (downgraded for inconsistency) based on 16 trials and 415 participants showed that CCBs reduced attack severity by 0.62 cm (95% CI -0.72 to - 0.51) on a 10-cm visual analogue scale (lower scores indicate less severity); this was equivalent to absolute and relative percent reductions of 6% (95% CI -11% to -8%) and 9% (95% CI -11% to -8%), respectively, which may not be clinically meaningful.\nImprovement in Raynaud's pain (low-quality evidence; downgraded for imprecision and inconsistency) and in disability as measured by a patient global assessment (moderate-quality evidence; downgraded for imprecision) favored CCBs (pain: WMD -1.47 cm, 95% CI -2.21 to -0.74; patient global: WMD -0.37 cm, 95% CI -0.73 to 0, when assessed on a 0 to 10 cm visual analogue scale, with lower scores indicating less pain and less disability). However, these effect estimates were likely underpowered, as they were based on limited numbers of participants, respectively, 62 and 92. For pain assessment, absolute and relative percent improvements were 15% (95% -22% to -7%) and 47% (95% CI -71% to -24%), respectively. For patient global assessment, absolute and relative percent improvements were 4% (95% CI -7% to 0%) and 9% (95% CI -19% to 0%), respectively.\nSubgroup analyses by Raynaud's type, CCB class, and CCB dose suggest that dihydropyridine CCBs in higher doses may be more effective for primary Raynaud's than for secondary Raynaud's, and CCBs likely have a greater effect in primary than in secondary Raynaud's. However, differences were small and were not found for all outcomes. Dihydropyridine CCBs were studied as they are the subgroup of CCBs that are not cardioselective and are traditionally used in RP treatment whereas other CCBs such as verapamil are not routinely used and diltiazem is not used as first line subtype of CCBs. Most trial data pertained to nifedipine.\nWithdrawals from studies due to adverse effects were inconclusive owing to a wide CI (risk ratio [RR] 1.30, 95% CI 0.51 to 3.33) from two parallel studies with 63 participants (low-quality evidence downgraded owing to imprecision and a high attrition rate); absolute and relative percent differences in withdrawals were 6% (95% CI -14% to 26%) and 30% (95% CI -49% to 233%), respectively. In cross-over trials, although a meta-analysis was not performed, withdrawals were more common with CCBs than with placebo. The most common side effects were headache, dizziness, nausea, palpitations, and ankle edema. However, in all trials, no serious adverse events (death or hospitalization) were reported.\nAuthors' conclusions\nRandomized controlled trials with evidence of low to moderate quality showed that CCBs (especially the dihydropyridine class) may be useful in reducing the frequency, duration, severity of attacks, pain and disability associated with Raynaud's phenomenon. Higher doses may be more effective than lower doses and these CCBs may be more effective in primary RP. Although there were more withdrawals due to adverse events in the treatment groups, no serious adverse events were reported.\n\nGiven the provided abstract, please respond to the following query: \"Best estimates of what happens to people with RP who take CCBs for 2 to 20 weeks\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "When investigators considered both primary and secondary RP, they reported that 528 people who took CCBs experienced six fewer attacks per week than those who took placebo. People who took a CCB had an average of 8 attacks per week, compared with 14 attacks per week among those taking placebo.\nDuration of attacks (in minutes) was about the same for people taking CCBs or placebo. However, this finding was based on a small number of people.\nSeverity of attacks measured on a 10-cm scale (lower scores indicate less severe attacks) was 0.62 cm lower with CCBs; this was equal to a 6% reduction. People who took a CCB rated the severity of an attack as 6.1 cm, compared with 6.7 cm for those taking placebo.\nPain was reduced by 1.5 points on a 0 to 10 scale (15% absolute reduction, lower score means less pain) with CCBs compared with placebo. People who took a CCB reported a pain score of 1.6 points, compared with 3.1 points for those taking placebo.\nOverall disability was reduced by 0.4 points on a 0 to 10 scale (4% absolute reduction, lower score means less disability) among people who took CCBs compared with placebo. People who took a CCB reported a disability score of 3.5 points, compared with 3.9 points for those taking placebo.\nSix more people out of 100 who took a CCB withdrew from the study owing to adverse events (6% more withdrawals). Out of 100 people taking a CCB, 25 withdrew from the study, compared with 19 out of 100 taking placebo.\nThis review suggests that CCBs (particularly drugs in the dihydropyridine class such as nifedipine) in higher doses may be beneficial for the management of RP, particularly primary RP. Although slightly more participants taking CCBs withdrew as the result of treatment side effects, no reported side effects were serious."
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query-laysum
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22300
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[
{
"role": "user",
"content": "Abstract: Background\nDrugs used to treat psychotic illnesses may take weeks to be effective. In the interim, additional 'as required' doses of medication can be used to calm patients in psychiatric wards. The practice is widespread, with 20% to 50% of people on acute psychiatric wards receiving at least one 'as required' dose of psychotropic medication during their admission.\nObjectives\nTo compare the effects of 'as required' medication regimens with regular patterns of medication for the treatment of psychotic symptoms or behavioural disturbance, thought to be secondary to psychotic illness. These regimens may be given alone or in addition to any regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register, which is based on regular searches of MEDLINE, EMBASE, PubMed, CINAHL, BIOSIS, AMED, PsycINFO and registries of clinical trials, in November 2001, March 2006, July 2012 andOctober 2013.\nSelection criteria\nWe aimed to include all relevant randomised controlled trials involving hospital inpatients with schizophrenia or schizophrenia-like illnesses, comparing any regimen of medication administered for the short-term relief of behavioural disturbance, or psychotic symptoms, to be given at the discretion of ward staff ('as required', 'prn') with fixed non-discretionary patterns of drug administration of the same drug(s). This was in addition to regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses where prescribed.\nData collection and analysis\nWe independently inspected abstracts and papers for inclusion. If trials had been found, we would have extracted data from the papers and quality assessed the data. For dichotomous data we would have calculated the risk ratios (RR), with the 95% confidence intervals (CI). We would have conducted analyses on an intention-to-treat basis. If data were available we would have completed a 'Summary of findings' table using GRADE.\nMain results\nWe have not been able to identify any randomised trials comparing 'as required' medication regimens to regular regimens of the same drug. Our main outcomes of interest were important changes in (i) mental state, (ii) behaviour, (iii) dose of medication used, (iv) adverse events, (v) satisfaction with care and (iv) cost of care.\nAuthors' conclusions\nThere is currently no evidence from within randomised trials to support this common practice. Current practice is based on clinical experience and habit rather than high quality evidence.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review attempts to find evidence to find out whether the use of 'as required' medication is good clinical practice or not, when compared to the same drug given regularly, for people with schizophrenia who are in hospital. Searches for randomised trials investigating this question have been run by the Cochrane Schizophrenia Group in 2001, 2006, 2012 and 2013."
}
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query-laysum
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22301
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[
{
"role": "user",
"content": "Abstract: Background\nA range of strategies are used to communicate with parents, caregivers and communities regarding child vaccination in order to inform decisions and improve vaccination uptake. These strategies include interventions in which information is aimed at larger groups in the community, for instance at public meetings, through radio or through leaflets. This is one of two reviews on communication interventions for childhood vaccination. The companion review focuses on face-to-face interventions for informing or educating parents.\nObjectives\nTo assess the effects of interventions aimed at communities to inform and/or educate people about vaccination in children six years and younger.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE and five other databases up to July 2012. We searched for grey literature in the Grey Literature Report and OpenGrey. We also contacted authors of included studies and experts in the field. There were no language, date or settings restrictions.\nSelection criteria\nIndividual or cluster-randomised and quasi-randomised controlled trials, interrupted time series (ITS) and repeated measures studies, and controlled before-and-after (CBA) studies. We included interventions aimed at communities and intended to inform and/or educate about vaccination in children six years and younger, conducted in any setting. We defined interventions aimed at communities as those directed at a geographic area, and/or interventions directed to groups of people who share at least one common social or cultural characteristic. Primary outcomes were: knowledge among participants of vaccines or vaccine-preventable diseases and of vaccine service delivery; child immunisation status; and unintended adverse effects. Secondary outcomes were: participants' attitudes towards vaccination; involvement in decision-making regarding vaccination; confidence in the decision made; and resource use or cost of intervention.\nData collection and analysis\nTwo authors independently reviewed the references to identify studies for inclusion. We extracted data and assessed risk of bias in all included studies.\nMain results\nWe included two cluster-randomised trials that compared interventions aimed at communities to routine immunisation practices. In one study from India, families, teachers, children and village leaders were encouraged to attend information meetings where they received information about childhood vaccination and could ask questions. In the second study from Pakistan, people who were considered to be trusted in the community were invited to meetings to discuss vaccine coverage rates in their community and the costs and benefits of childhood vaccination. They were asked to develop local action plans and to share the information they had been given and continue the discussions in their communities.\nThe trials show low certainty evidence that interventions aimed at communities to inform and educate about childhood vaccination may improve knowledge of vaccines or vaccine-preventable diseases among intervention participants (adjusted mean difference 0.121, 95% confidence interval (CI) 0.055 to 0.189). These interventions probably increase the number of children who are vaccinated. The study from India showed that the intervention probably increased the number of children who received vaccinations (risk ratio (RR) 1.67, 95% CI 1.21 to 2.31; moderate certainty evidence). The study from Pakistan showed that there is probably an increase in the uptake of both measles (RR 1.63, 95% CI 1.03 to 2.58) and DPT (diptheria, pertussis and tetanus) (RR 2.17, 95% CI 1.43 to 3.29) vaccines (both moderate certainty evidence), but there may be little or no difference in the number of children who received polio vaccine (RR 1.01, 95% CI 0.97 to 1.05; low certainty evidence). There is also low certainty evidence that these interventions may change attitudes in favour of vaccination among parents with young children (adjusted mean difference 0.054, 95% CI 0.013 to 0.105), but they may make little or no difference to the involvement of mothers in decision-making regarding childhood vaccination (adjusted mean difference 0.043, 95% CI -0.009 to 0.097).\nThe studies did not assess knowledge among participants of vaccine service delivery; participant confidence in the vaccination decision; intervention costs; or any unintended harms as a consequence of the intervention. We did not identify any studies that compared interventions aimed at communities to inform and/or educate with interventions directed to individual parents or caregivers, or studies that compared two interventions aimed at communities to inform and/or educate about childhood vaccination.\nAuthors' conclusions\nThis review provides limited evidence that interventions aimed at communities to inform and educate about early childhood vaccination may improve attitudes towards vaccination and probably increase vaccination uptake under some circumstances. However, some of these interventions may be resource intensive when implemented on a large scale and further rigorous evaluations are needed. These interventions may achieve most benefit when targeted to areas or groups that have low childhood vaccination rates.’\n\nGiven the provided abstract, please respond to the following query: \"What happens when members of the community are informed or educated about vaccines?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The studies showed that community-based information or education:\n- may improve knowledge of vaccines or vaccine-preventable diseases;\n- probably increases the number of children who get vaccinated (both the study in India and the study in Pakistan showed that there is probably an increase in the number of vaccinated children);\n- may make little or no difference to the involvement of mothers in decision-making about vaccination;\n- may change attitudes in favour of vaccination among parents with young children;\nWe assessed all of this evidence to be of low or moderate certainty.\nThe studies did not assess whether this type of information or education led to better knowledge among participants about vaccine service delivery or increased their confidence in the decision made. Nor did the studies assess how much this information and education cost or whether it led to any unintended harms."
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query-laysum
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22302
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[
{
"role": "user",
"content": "Abstract: Background\nEczema is a common and chronic, relapsing, inflammatory skin disorder. It seriously impacts quality of life and economic outcomes, especially for those with moderate to severe eczema. Various treatments allow sustained control of the disease; however, their relative benefit remains unclear due to the limited number of trials directly comparing treatments.\nObjectives\nTo assess the comparative efficacy and safety of different types of systemic immunosuppressive treatments for moderate to severe eczema using NMA and to generate rankings of available systemic immunosuppressive treatments for eczema according to their efficacy and safety.\nSearch methods\nWe searched the following databases up to August 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase.\nSelection criteria\nAll randomised controlled trials (RCTs) of systemic immunosuppressive agents for moderate to severe atopic eczema when compared against placebo or any other eligible eczema treatment.\nData collection and analysis\nWe synthesised data using pair-wise analysis and NMA to compare treatments and rank them according to their effectiveness.\nEffectiveness was assessed primarily by determining the proportion of participants who achieved at least 75% improvement in the Eczema Area and Severity Index (EASI75) and improvement in the Patient-Oriented Eczema Measure (POEM). Safety was evaluated primarily by considering the proportion of participants with serious adverse events (SAEs) and infection.\nWe deemed short-term follow-up as ≤ 16 weeks and long-term follow-up as > 16 weeks.\nWe assessed the certainty of the body of evidence from the NMA for these primary outcomes using six domains of CiNEMA grading.\nMain results\nWe included a total of 74 studies, with 8177 randomised participants. Approximately 55% of participants were male, with average age of 32 years (range 2 to 84 years), although age and gender were unreported for 419 and 902 participants, respectively. Most of the included trials were placebo controlled (65%), 34% were head-to-head studies (15% assessed the effects of different doses of the same drug), and 1% were multi-armed studies with both an active comparator and a placebo.\nAll trials included participants with moderate to severe eczema, but 62% of studies did not separate data by severity; 38% of studies assessed only severe eczema. The total duration of included trials ranged from 2 weeks to 60 months, whereas treatment duration varied from a single dose (CIM331, KPL-716) to 60 months (methotrexate (MTX)).\nSeventy studies were available for quantitative synthesis; this review assessed 29 immunosuppressive agents from three classes of interventions. These included (1) conventional treatments, with ciclosporin assessed most commonly; (2) small molecule treatments, including phosphodiesterase (PDE)-4 inhibitors, tyrosine kinase inhibitors, and Janus kinase (JAK) inhibitors; and (3) biological treatments, including anti-CD31 receptors, anti-interleukin (IL)-22, anti-IL-31, anti-IL-13, anti-IL-12/23p40, anti-OX40, anti-TSLP, anti-CRTH2, and anti-immunoglobulin E (IgE) monoclonal antibodies, but most commonly dupilumab.\nMost trials (73) assessed outcomes at a short-term duration ranging from 2 to 16 weeks, whereas 33 trials assessed long-term outcomes, with duration ranging from 5 to 60 months. All participants were from a hospital setting. Fifty-two studies declared a source of funding, and of these, pharmaceutical companies funded 88%. We rated 37 studies as high risk; 21, unclear risk, and 16, low risk of bias, with studies most commonly at high risk of attrition bias.\nNetwork meta-analysis suggests that dupilumab ranks first for effectiveness when compared with other biological treatments. Dupilumab is more effective than placebo in achieving EASI75 (risk ratio (RR) 3.04, 95% confidence interval (CI) 2.51 to 3.69) and improvement in POEM score (mean difference 7.30, 95% CI 6.61 to 8.00) at short-term follow-up (high-certainty evidence).\nVery low-certainty evidence means we are uncertain of the effects of dupilumab when compared with placebo, in terms of the proportion of participants who achieve EASI75 (RR 2.59, 95% CI 1.87 to 3.60) at longer-term follow-up.\nLow-certainty evidence indicates that tralokinumab may be more effective than placebo in achieving short-term EASI75 (RR 2.54, 95% CI 1.21 to 5.34), but there was no evidence for tralokinumab to allow us to assess short-term follow-up of POEM or long-term follow-up of EASI75.\nWe are uncertain of the effect of ustekinumab compared with placebo in achieving EASI75 (long-term follow-up: RR 1.17, 95% CI 0.40 to 3.45; short-term follow-up: RR 0.91, 95% CI 0.28 to 2.97; both very low certainty). We found no evidence on ustekinumab for the POEM outcome.\nWe are uncertain whether other immunosuppressive agents that targeted our key outcomes influence the achievement of short-term EASI75 compared with placebo due to low- or very low-certainty evidence.\nDupilumab and ustekinumab were the only immunosuppressive agents evaluated for longer-term EASI75. Dupilumab was the only agent evaluated for improvement in POEM during short-term follow-up.\nLow- to moderate-certainty evidence indicates a lower proportion of participants with SAEs after treatment with QAW039 and dupilumab compared to placebo during short-term follow-up, but low- to very low-certainty evidence suggests no difference in SAEs during short-term follow-up of other immunosuppressive agents compared to placebo.\nEvidence for effects of immunosuppressive agents on risk of any infection during short-term follow-up and SAEs during long-term follow-up compared with placebo was of low or very low certainty but did not indicate a difference.\nWe did not identify differences in other adverse events (AEs), but dupilumab is associated with specific AEs, including eye inflammation and eosinophilia.\nAuthors' conclusions\nOur findings indicate that dupilumab is the most effective biological treatment for eczema. Compared to placebo, dupilumab reduces eczema signs and symptoms in the short term for people with moderate to severe atopic eczema. Short-term safety outcomes from clinical trials did not reveal new safety concerns with dupilumab. Overall, evidence for the efficacy of most other immunosuppressive treatments for moderate to severe atopic eczema is of low or very low certainty.\nGiven the lack of data comparing conventional with newer biological treatments for the primary outcomes, there remains high uncertainty for ranking the efficacy and safety of conventional treatments such as ciclosporin and biological treatments such as dupilumab.\nMost studies were placebo-controlled and assessed only short-term efficacy of immunosuppressive agents. Further adequately powered head-to-head RCTs should evaluate comparative long-term efficacy and safety of available treatments for moderate to severe eczema.\n\nGiven the provided abstract, please respond to the following query: \"Why this question is important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Eczema is a persistent condition that causes dry, cracked, and itchy skin. People with mild eczema have small patches of dry skin, and people with moderate eczema have larger, redder, or swollen areas of skin. People with severe eczema have red crusts and broken skin (which may ooze fluid) that develop all over the body.\nAlthough there is currently no cure for eczema, treatments that aim to relieve symptoms are available. Usually, the first treatment option is to apply creams, ointments, or liquids to the affected skin. If this does not work, it is possible to take oral or injected (systemic) medicines that work throughout the body.\nMany systemic medicines are available for eczema. To help people decide which one is most appropriate for managing their symptoms, we reviewed the evidence on benefits and risks of different systemic medicines for people with moderate or severe eczema. We particularly wanted to find out:\n• whether some medicines were more likely than others to have an important positive effect on symptoms (defined as either at least a 75% improvement on the Eczema Area and Severity Index (EASI), or improvement on the Patient-Oriented Eczema Measure (POEM)—two scales that are used by clinicians to evaluate changes in eczema symptoms); and\n• whether some medicines are associated with more serious unwanted events, including infection, than others."
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query-laysum
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22303
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[
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is the most common form of joint disease and the leading cause of pain and physical disability in the elderly. Therapeutic ultrasound is one of several physical therapy modalities suggested for the management of pain and loss of function due to osteoarthritis (OA).\nObjectives\nTo compare therapeutic ultrasound with sham or no specific intervention in terms of effects on pain and function safety outcomes in patients with knee or hip OA.\nSearch methods\nWe updated the search in CENTRAL, CINAHL, EMBASE, MEDLINE and PEDro up to 23 July 2009, checked conference proceedings, reference lists, and contacted authors.\nSelection criteria\nStudies were included if they were randomised or quasi-randomised controlled trials that compared therapeutic ultrasound with a sham intervention or no intervention in patients with osteoarthritis of the knee or hip.\nData collection and analysis\nTwo independent review authors extracted data using standardized forms. Investigators were contacted to obtain missing outcome information. Standardised mean differences (SMDs) were calculated for pain and function, relative risks for safety outcomes. Trials were combined using inverse-variance random-effects meta-analysis.\nMain results\nCompared to the previous version of the review, four additional trials were identified resulting in the inclusion of five small sized trials in a total of 341 patients with knee OA. No trial included patients with hip OA. Two evaluated pulsed ultrasound, two continuous and one evaluated both pulsed and continuous ultrasound as the active treatment. The methodological quality and the quality of reporting was poor and a high degree of heterogeneity among the trials was revealed for function (88%). For pain, there was an effect in favour of ultrasound therapy, which corresponded to a difference in pain scores between ultrasound and control of -1.2 cm on a 10-cm VAS (95% CI -1.9 to -0.6 cm). For function, we found a trend in favour of ultrasound, which corresponded to a difference in function scores of -1.3 units on a standardised WOMAC disability scale ranging from 0 to 10 (95% CI -3.0 to 0.3). Safety was evaluated in two trials including up to 136 patients; no adverse event, serious adverse event or withdrawals due to adverse events occurred in either trial.\nAuthors' conclusions\nIn contrast to the previous version of this review, our results suggest that therapeutic ultrasound may be beneficial for patients with osteoarthritis of the knee. Because of the low quality of the evidence, we are uncertain about the magnitude of the effects on pain relief and function, however. Therapeutic ultrasound is widely used for its potential benefits on both knee pain and function, which may be clinically relevant. Appropriately designed trials of adequate power are therefore warranted.\n\nGiven the provided abstract, please respond to the following query: \"What is osteoarthritis and what is therapeutic ultrasound?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Osteoarthritis is a disease of the joints, such as your knee or hip. When the joint loses cartilage, the bone grows to try and repair the damage. Instead of making things better, however, the bone grows abnormally and makes things worse. For example, the bone can become misshapen and make the joint painful and unstable. This can affect your physical function or ability to use your knee. \nTherapeutic ultrasound means using sound waves to try and relieve pain or disability. Your doctor or physiotherapist will use a round-headed wand or probe on the skin of the painful area. Ultrasound gel is used on the wand and on your skin to make it more comfortable and help the sound waves reach the affected area."
}
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query-laysum
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22304
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[
{
"role": "user",
"content": "Abstract: Background\nSurgical options for treating stress urinary incontinence (SUI) are usually explored after conservative interventions have failed. Surgeries fall into two categories: traditional techniques (open surgery) and minimally invasive procedures, such as laparoscopic procedures, midurethral sling and injections with urethral bulking agents. Postsurgery infections, such as infections of the surgical site or urinary tract, are common complications. To minimise the risk of postoperative bacterial infections, prophylactic antibiotics may be given before or during surgery.\nObjectives\nTo assess the effects of prophylactic antibiotics for preventing infection following continence surgery in women with stress urinary incontinence.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov and WHO ICTRP; and handsearched journals and conference proceedings to 18 March 2021. We also searched the reference lists of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs assessing prophylactic antibiotics in women undergoing continence surgery to treat SUI.\nData collection and analysis\nTwo review authors selected potentially eligible trials, extracted data and assessed risk of bias. We expressed results as risk ratios (RR) for dichotomous outcomes and as mean differences (MD) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach.\nMain results\nWe identified one quasi-RCT and two RCTs, involving a total of 390 women. One study performed retropubic urethropexy surgery requiring a transverse suprapubic incision, while the other two studies performed midurethral sling surgery. It should be noted that none of the included studies clearly specified the timing of outcome assessment.\nWe are very uncertain whether prophylactic antibiotics (cefazolin) have an effect on surgical site infections (RR 0.56, 95% CI 0.03 to 12.35; 2 studies, 85 women; very low-certainty evidence) or urinary tract infections or bacteriuria (RR 0.84, 95% CI 0.05 to 13.24; 2 studies, 85 women; very low-certainty evidence). The effect of prophylactic antibiotics (cefazolin) on febrile morbidity is also uncertain (RR 0.08, 95% CI 0.00 to 1.29; 2 studies, 85 women; very low-certainty evidence). We are very uncertain whether prophylactic antibiotics (cefazolin) have any effect on mesh exposure (RR 0.32, 95% CI 0.01 to 7.61; 1 study, 59 women; very low-certainty evidence). None of the three included studies described the assessment of adverse events from antibiotic use, sepsis or bacteraemia in their reports.\nAuthors' conclusions\nOnly limited data are available from the three included studies and, overall, the certainty of evidence was very low. Moreover, the three included studies evaluated different surgical procedures and dosages of antibiotic administration.\nThus, there is insufficient evidence to support or refute the use of prophylactic antibiotics to prevent infection following anti-incontinence surgery. In addition, there were no data regarding adverse effects of prophylactic antibiotics. More RCTs are required.\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": "We are uncertain about our findings as they are based on only three small studies. Each study assessed the effectiveness of preventive antibiotics in different surgical procedures, antibiotic dosages and outcomes. In addition, each included study had a small sample size and some were conducted in ways that might incorporate flaws into their results. Our findings may alter when results from better quality and large RCTs become available."
}
] |
query-laysum
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22305
|
[
{
"role": "user",
"content": "Abstract: Background\nSelf-harm (SH; intentional self-poisoning or self-injury regardless of degree of suicidal intent or other types of motivation) is a growing problem in most countries, often repeated, and associated with suicide. Evidence assessing the effectiveness of pharmacological agents and/or natural products in the treatment of SH is lacking, especially when compared with the evidence for psychosocial interventions. This review therefore updates a previous Cochrane Review (last published in 2015) on the role of pharmacological interventions for SH in adults.\nObjectives\nTo assess the effects of pharmacological agents or natural products for SH compared to comparison types of treatment (e.g. placebo or alternative pharmacological treatment) for adults (aged 18 years or older) who engage in SH.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Specialised Register, the Cochrane Library (Central Register of Controlled Trials [CENTRAL] and Cochrane Database of Systematic Reviews [CDSR]), together with MEDLINE. Ovid Embase and PsycINFO (to 4 July 2020).\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing pharmacological agents or natural products with placebo/alternative pharmacological treatment in individuals with a recent (within six months of trial entry) episode of SH resulting in presentation to hospital or clinical services. The primary outcome was the occurrence of a repeated episode of SH over a maximum follow-up period of two years. Secondary outcomes included treatment acceptability, treatment adherence, depression, hopelessness, general functioning, social functioning, suicidal ideation, and suicide.\nData collection and analysis\nWe independently selected trials, extracted data, and appraised trial quality. For binary outcomes, we calculated odds ratios (ORs) and their 95% confidence internals (CIs). For continuous outcomes we calculated the mean difference (MD) or standardised mean difference (SMD) and 95% CI. The overall certainty of evidence for the primary outcome (i.e. repetition of SH at post-intervention) was appraised for each intervention using the GRADE approach.\nMain results\nWe included data from seven trials with a total of 574 participants. Participants in these trials were predominately female (63.5%) with a mean age of 35.3 years (standard deviation (SD) 3.1 years). It is uncertain if newer generation antidepressants reduce repetition of SH compared to placebo (OR 0.59, 95% CI 0.29 to 1.19; N = 129; k = 2; very low-certainty evidence). There may be a lower rate of SH repetition for antipsychotics (21%) as compared to placebo (75%) (OR 0.09, 95% CI 0.02 to 0.50; N = 30; k = 1; low-certainty evidence). However, there was no evidence of a difference between antipsychotics compared to another comparator drug/dose for repetition of SH (OR 1.51, 95% CI 0.50 to 4.58; N = 53; k = 1; low-certainty evidence). There was also no evidence of a difference for mood stabilisers compared to placebo for repetition of SH (OR 0.99, 95% CI 0.33 to 2.95; N = 167; k = 1; very low-certainty evidence), or for natural products compared to placebo for repetition of SH (OR 1.33, 95% CI 0.38 to 4.62; N = 49; k = 1; lo- certainty) evidence.\nAuthors' conclusions\nGiven the low or very low quality of the available evidence, and the small number of trials identified, there is only uncertain evidence regarding pharmacological interventions in patients who engage in SH. More and larger trials of pharmacotherapy are required, preferably using newer agents. These might include evaluation of newer atypical antipsychotics. Further work should also include evaluation of adverse effects of pharmacological agents. Other research could include evaluation of combined pharmacotherapy and psychological treatment.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is currently no clear evidence for the effectiveness of antidepressants, antipsychotics, mood stabilisers, or natural products in preventing repetition of SH."
}
] |
query-laysum
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22306
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[
{
"role": "user",
"content": "Abstract: Background\nThe development of severe coronavirus disease 2019 (COVID-19) and poor clinical outcomes are associated with hyperinflammation and a complex dysregulation of the immune response. Colchicine is an anti-inflammatory medicine and is thought to improve disease outcomes in COVID-19 through a wide range of anti-inflammatory mechanisms. Patients and healthcare systems need more and better treatment options for COVID-19 and a thorough understanding of the current body of evidence.\nObjectives\nTo assess the effectiveness and safety of Colchicine as a treatment option for COVID-19 in comparison to an active comparator, placebo, or standard care alone in any setting, and to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (comprising CENTRAL, MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv), Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index), and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 21 May 2021.\nSelection criteria\nWe included randomised controlled trials evaluating colchicine for the treatment of people with COVID-19, irrespective of disease severity, age, sex, or ethnicity.\nWe excluded studies investigating the prophylactic effects of colchicine for people without severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but at high risk of SARS-CoV-2 exposure.\nData collection and analysis\nWe followed standard Cochrane methodology. We used the Cochrane risk of bias tool (ROB 2) to assess bias in included studies and GRADE to rate the certainty of evidence for the following prioritised outcome categories considering people with moderate or severe COVID-19: all-cause mortality, worsening and improvement of clinical status, quality of life, adverse events, and serious adverse events and for people with asymptomatic infection or mild disease: all-cause mortality, admission to hospital or death, symptom resolution, duration to symptom resolution, quality of life, adverse events, serious adverse events.\nMain results\nWe included three RCTs with 11,525 hospitalised participants (8002 male) and one RCT with 4488 (2067 male) non-hospitalised participants. Mean age of people treated in hospital was about 64 years, and was 55 years in the study with non-hospitalised participants. Further, we identified 17 ongoing studies and 11 studies completed or terminated, but without published results.\nColchicine plus standard care versus standard care (plus/minus placebo)\nTreatment of hospitalised people with moderate to severe COVID-19\nAll-cause mortality: colchicine plus standard care probably results in little to no difference in all-cause mortality up to 28 days compared to standard care alone (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93 to 1.08; 2 RCTs, 11,445 participants; moderate-certainty evidence).\nWorsening of clinical status: colchicine plus standard care probably results in little to no difference in worsening of clinical status assessed as new need for invasive mechanical ventilation or death compared to standard care alone (RR 1.02, 95% CI 0.96 to 1.09; 2 RCTs, 10,916 participants; moderate-certainty evidence).\nImprovement of clinical status: colchicine plus standard care probably results in little to no difference in improvement of clinical status, assessed as number of participants discharged alive up to day 28 without clinical deterioration or death compared to standard care alone (RR 0.99, 95% CI 0.96 to 1.01; 1 RCT, 11,340 participants; moderate-certainty evidence).\nQuality of life, including fatigue and neurological status: we identified no studies reporting this outcome.\nAdverse events: the evidence is very uncertain about the effect of colchicine on adverse events compared to placebo (RR 1.00, 95% CI 0.56 to 1.78; 1 RCT, 72 participants; very low-certainty evidence).\nSerious adverse events: the evidence is very uncertain about the effect of colchicine plus standard care on serious adverse events compared to standard care alone (0 events observed in 1 RCT of 105 participants; very low-certainty evidence).\nTreatment of non-hospitalised people with asymptomatic SARS-CoV-2 infection or mild COVID-19\nAll-cause mortality: the evidence is uncertain about the effect of colchicine on all-cause mortality at 28 days (Peto odds ratio (OR) 0.57, 95% CI 0.20 to 1.62; 1 RCT, 4488 participants; low-certainty evidence).\nAdmission to hospital or death within 28 days: colchicine probably slightly reduces the need for hospitalisation or death within 28 days compared to placebo (RR 0.80, 95% CI 0.62 to 1.03; 1 RCT, 4488 participants; moderate-certainty evidence).\nSymptom resolution: we identified no studies reporting this outcome.\nQuality of life, including fatigue and neurological status: we identified no studies reporting this outcome.\nAdverse events: the evidence is uncertain about the effect of colchicine on adverse events compared to placebo . Results are from one RCT reporting treatment-related events only in 4412 participants (low-certainty evidence).\nSerious adverse events: colchicine probably slightly reduces serious adverse events (RR 0.78, 95% CI 0.61 to 1.00; 1 RCT, 4412 participants; moderate-certainty evidence).\nColchicine versus another active treatment (e.g. corticosteroids, anti-viral drugs, monoclonal antibodies)\nNo studies evaluated this comparison.\nDifferent formulations, doses, or schedules of colchicine\nNo studies assessed this.\nAuthors' conclusions\nBased on the current evidence, in people hospitalised with moderate to severe COVID-19 the use of colchicine probably has little to no influence on mortality or clinical progression in comparison to placebo or standard care alone. We do not know whether colchicine increases the risk of (serious) adverse events.\nWe are uncertain about the evidence of the effect of colchicine on all-cause mortality for people with asymptomatic infection or mild disease. However, colchicine probably results in a slight reduction of hospital admissions or deaths within 28 days, and the rate of serious adverse events compared with placebo.\nNone of the studies reported data on quality of life or compared the benefits and harms of colchicine versus other drugs, or different dosages of colchicine.\nWe identified 17 ongoing and 11 completed but not published RCTs, which we expect to incorporate in future versions of this review as their results become available.\nEditorial note: due to the living approach of this work, we monitor newly published results of RCTs on colchicine on a weekly basis and will update the review when the evidence or our certainty in the evidence changes.\n\nGiven the provided abstract, please respond to the following query: \"Non-hospitalised people with no symptoms or mild COVID-19 (1 study, 4488 people)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "○We are uncertain whether colchicine prevents deaths up to 28 days after treatment.\n○Colchicine probably slightly reduces the risk of hospitalisation or death.\n○We are uncertain about the effect of colchicine on side effects, but it probably slightly reduces serious side effects."
}
] |
query-laysum
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22307
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[
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic immune-mediated condition of transmural inflammation in the gastrointestinal tract, associated with significant morbidity and decreased quality of life. The endocannabinoid system provides a potential therapeutic target for cannabis and cannabinoids and animal models have shown benefit in decreasing inflammation. However, there is also evidence to suggest transient adverse events such as weakness, dizziness and diarrhea, and an increased risk of surgery in people with CD who use cannabis.\nObjectives\nThe objectives were to assess the efficacy and safety of cannabis and cannabinoids for induction and maintenance of remission in people with CD.\nSearch methods\nWe searched MEDLINE, Embase, AMED, PsychINFO, the Cochrane IBD Group Specialized Register, CENTRAL, ClinicalTrials.Gov, and the European Clinical Trials Register up to 17 October 2018. We searched conference abstracts, references and we also contacted researchers in this field for upcoming publications.\nSelection criteria\nRandomized controlled trials comparing any form of cannabis or its cannabinoid derivatives (natural or synthetic) to placebo or an active therapy for adults with Crohn’s disease were included.\nData collection and analysis\nTwo authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. The primary outcomes were clinical remission and relapse. Remission is commonly defined as a Crohn's disease activity index (CDAI) of < 150. Relapse is defined as a CDAI > 150. Secondary outcomes included clinical response, endoscopic remission, endoscopic improvement, histological improvement, quality of life, C-reactive protein (CRP) and fecal calprotectin measurements, adverse events (AEs), serious AEs, withdrawal due to AEs, and cannabis dependence and withdrawal effects. We calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) and 95% CI. Data were combined for analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). Data were analyzed on an intention-to-treat basis and the overall certainty of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nThree studies (93 participants) that assessed cannabis in people with active CD met the inclusion criteria. One ongoing study was also identified. Participants in two of the studies were adults with active Crohn's disease who had failed at least one medical treatment. The inclusion criteria for the third study were unclear. No studies that assessed cannabis therapy in quiescent CD were identified. The studies were not pooled due to differences in the interventional drug.\nOne small study (N = 21) compared eight weeks of treatment with cannabis cigarettes containing 115 mg of D9-tetrahydrocannabinol (THC) to placebo cigarettes containing cannabis with the THC removed in participants with active CD. This study was rated as high risk of bias for blinding and other bias (cannabis participants were older than placebo). The effects of cannabis on clinical remission were unclear. Forty-five per cent (5/11) of the cannabis group achieved clinical remission compared with 10% (1/10) of the placebo group (RR 4.55, 95% CI 0.63 to 32.56; very low certainty evidence). A difference was observed in clinical response (decrease in CDAI score of >100 points) rates. Ninety-one per cent (10/11) of the cannabis group achieved a clinical response compared to 40% (4/10) of the placebo group (RR 2.27, 95% CI 1.04 to 4.97; very low certainty evidence). More AEs were observed in the cannabis cigarette group compared to placebo (RR 4.09, 95% CI 1.15 to 14.57; very low certainty evidence). These AEs were considered to be mild in nature and included sleepiness, nausea, difficulty with concentration, memory loss, confusion and dizziness. This study did not report on serious AEs or withdrawal due to AEs.\nOne small study (N = 22) compared cannabis oil (5% cannabidiol) to placebo oil in people with active CD. This study was rated as high risk of bias for other bias (cannabis participants were more likely than placebo participants to be smokers). There was no difference in clinical remission rates. Forty per cent (4/10) of cannabis oil participants achieved remission at 8 weeks compared to 33% (3/9) of the placebo participants (RR 1.20, 95% CI 0.36 to 3.97; very low certainty evidence). There was no difference in the proportion of participants who had a serious adverse event. Ten per cent (1/10) of participants in the cannabis oil group had a serious adverse event compared to 11% (1/9) of placebo participants (RR 0.90, 95% CI 0.07 to 12.38, very low certainty evidence). Both serious AEs were worsening Crohn's disease that required rescue intervention. This study did not report on clinical response, CRP, quality of life or withdrawal due to AEs.\nOne small study (N= 50) compared cannabis oil (15% cannabidiol and 4% THC) to placebo in participants with active CD. This study was rated as low risk of bias. Differences in CDAI and quality of life scores measured by the SF-36 instrument were observed. The mean quality of life score after 8 weeks of treatment was 96.3 in the cannabis oil group compared to 79.9 in the placebo group (MD 16.40, 95% CI 5.72 to 27.08, low certainty evidence). After 8 weeks of treatment, the mean CDAI score was118.6 in the cannabis oil group compared to 212.6 in the placebo group (MD -94.00, 95%CI -148.86 to -39.14, low certainty evidence). This study did not report on clinical remission, clinical response, CRP or AEs.\nAuthors' conclusions\nThe effects of cannabis and cannabis oil on Crohn's disease are uncertain. Thus no firm conclusions regarding the efficacy and safety of cannabis and cannabis oil in adults with active Crohn's disease can be drawn. The effects of cannabis or cannabis oil in quiescent Crohn's disease have not been investigated. Further studies with larger numbers of participants are required to assess the potential benefits and harms of cannabis in Crohn's disease. Future studies should assess the effects of cannabis in people with active and quiescent Crohn's disease. Different doses of cannabis and delivery modalities should be investigated.\n\nGiven the provided abstract, please respond to the following query: \"What did the researchers find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The researchers extensively searched the literature up to 17 October 2018 and found three studies (93 participants) that met the inclusion criteria. One ongoing study was also identified. All of the studies were small in size and had some quality issues. One small study (21 participants) compared eight weeks of treatment with cannabis cigarettes containing 115 mg of D9-tetrahydrocannabinol (THC) to placebo cigarettes containing cannabis with the THC removed in participants with active Crohn's disease who had failed at least one medical treatment. Although no difference in clinical remission rates was observed, more participants in the cannabis group had improvement in their Crohn's disease symptoms than participants in the placebo group. More side effects were observed in the cannabis cigarette group compared to placebo. These side effects were considered to be mild in nature and included sleepiness, nausea, difficulty with concentration, memory loss, confusion and dizziness. Participants in the cannabis cigarette group reported improvements in pain, appetite and satisfaction with treatment.\nOne small study (22 participants) compared cannabis oil (10 mg of cannabidiol twice daily) to placebo oil (i.e. olive oil) in participants with active Crohn's disease who had failed at least one medical treatment. No difference in clinical remission rates was observed. There was no difference in serious side effects. Serious side effects included worsening Crohn's disease in one participant in each group.\nOne small study (50 participants) compared cannabis oil (composed of 15% cannabidiol and 4% THC) to placebo oil in participants with active Crohn's disease. Positive differences in quality of life and the Crohn's disease activity index were observed."
}
] |
query-laysum
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22308
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[
{
"role": "user",
"content": "Abstract: Background\nAutogenic drainage is an airway clearance technique that was developed by Jean Chevaillier in 1967. The technique is characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation. The technique requires training, concentration and effort from the individual but it has previously been shown to be an effective treatment option for those who are seeking techniques to support and promote independence. However, at a time where the trajectory and demographics of the disease are changing, it is important to systematically review the evidence demonstrating that autogenic drainage is an effective intervention for people with cystic fibrosis.\nObjectives\nTo compare the clinical effectiveness of autogenic drainage in people with cystic fibrosis with other physiotherapy airway clearance techniques.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews, as well as two ongoing trials registers (02 February 2021).\nDate of most recent search of the Cochrane Cystic Fibrosis Trials Register: 06 July 2021.\nSelection criteria\nWe identified randomised and quasi-randomised controlled studies comparing autogenic drainage to another airway clearance technique or no therapy in people with cystic fibrosis for at least two treatment sessions.\nData collection and analysis\nData extraction and assessments of risk of bias were independently performed by three authors. The authors assessed the quality of the evidence using the GRADE system. The authors contacted seven teams of investigators for further information pertinent to their published studies.\nMain results\nSearches retrieved 64 references to 37 individual studies, of which eight (n = 212) were eligible for inclusion. One study was of parallel design with the remaining seven being cross-over in design; participant numbers ranged from 4 to 75. The total study duration varied between four days and two years. The age of participants ranged between seven and 63 years with a wide range of disease severity reported. Six studies enrolled participants who were clinically stable, whilst participants in two studies received treatment whilst hospitalised with an infective exacerbation. All studies compared autogenic drainage to one (or more) other recognised airway clearance technique. Exercise is commonly used as an alternative therapy by people with cystic fibrosis; however, there were no studies identified comparing exercise with autogenic drainage.\nThe certainty of the evidence was generally low or very low. The main reasons for downgrading the level of evidence were the frequent use of a cross-over design, outcome reporting bias and the inability to blind participants.\nThe review's primary outcome, forced expiratory volume in one second, was the most common outcome measured and was reported by all eight studies; only three studies reported on quality of life (also a primary outcome of the review). One study reported on adverse events and described a decrease in oxygen saturation levels whilst performing active cycle of breathing techniques, but not with autogenic drainage. Seven of the eight included studies measured forced vital capacity and three of the studies used mid peak expiratory flow (per cent predicted) as an outcome. Six studies reported sputum weight. Less commonly used outcomes included oxygen saturation levels, personal preference, hospital admissions, intravenous antibiotics and pseudomonas gene expression. There were no statistically significant differences found between any of the techniques used with respect to the outcomes measured except when autogenic drainage was described as being the preferred technique of the participants in one study over postural drainage and percussion.\nAuthors' conclusions\nAutogenic drainage is a challenging technique that requires commitment from the individual. As such, this intervention merits systematic review to ensure its effectiveness for people with cystic fibrosis, particularly in an era where treatment options are changing rapidly. From the studies assessed, autogenic drainage was not found to be superior to any other form of airway clearance technique. Larger studies are required to better evaluate autogenic drainage in comparison to other airway clearance techniques in view of the relatively small number of participants in this review and the complex study designs. The studies recruited a range of participants and were not powered to assess non-inferiority. The varied length and design of the studies made the analysis of pooled data challenging.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We did not find any clear evidence that autogenic drainage was better than the other techniques for lung function or quality of life in either the short-term or long-term studies. This was also true for our other outcome measures such as hospital admissions, additional antibiotic treatment, exercise tolerance and oxygen saturation, but people in one study autogenic drainage preferred autogenic drainage compared to postural drainage and percussion. The authors of this review wanted to compare exercise to autogenic drainage for airway clearance, but found no studies with this comparison, even though exercise is often used as an alternative by people with cystic fibrosis."
}
] |
query-laysum
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22309
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original review published in 2005. Acute laryngitis is a common illness worldwide. Diagnosis is often made by case history alone and treatment often targets symptoms.\nObjectives\nTo assess the effectiveness and safety of different antibiotic therapies in adults with acute laryngitis. A secondary objective was to report the rates of adverse events associated with these treatments.\nSearch methods\nWe searched CENTRAL (2014, Issue 11), MEDLINE (January 1966 to November week 3, 2014), EMBASE (1974 to December 2014), LILACS (1982 to December 2014) and BIOSIS (1980 to December 2014).\nSelection criteria\nRandomised controlled trials (RCTs) comparing any antibiotic therapy with placebo for acute laryngitis. The main outcome was objective voice scores.\nData collection and analysis\nTwo review authors independently extracted and synthesised data.\nMain results\nWe included three RCTs (351 participants) that had moderate to high risk of bias. The quality of the evidence was very low for all outcomes. We downgraded the studies because of limitations in study design or execution (risk of bias), imprecision and inconsistency of results. We included a new trial presented only as a conference abstract in this update.\nIn one study of acute laryngitis in adults, 100 participants were randomised to receive penicillin V (800 mg twice daily for five days) or an identical placebo. A recording of each patient reading a standardised text was made at the first visit, during re-examination after one and two weeks, and at follow-up after two to six months. No significant differences were found between the groups. The trial also measured symptoms reported by participants and found no significant differences.\nOne study investigated erythromycin for acute laryngitis in 106 adults. The mean objective voice scores measured at the first visit, at re-examination after one and two weeks, and at follow-up after two to six months did not significantly differ between the groups. At one week there were significant beneficial differences in the severity of reported vocal symptoms (slight, moderate and severe) as judged by participants (P value = 0.042). However, the rates of participants having improved voice disturbance (subjective symptoms) at one and two weeks were not significantly different among groups. Comparing erythromycin and placebo groups on the rate of persistence of cough at two weeks, the risk ratio (RR) was 0.38 (95% confidence interval (CI) 0.15 to 0.97, P value = 0.04) and the number needed to treat for an additional beneficial outcome (NNTB) was 5.87 (95% CI 3.09 to 65.55). We calculated a RR of 0.64 (95% CI 0.46 to 0.90, P value = 0.034) and a NNTB of 3.76 (95% CI 2.27 to 13.52; P value = 0.01) for the subjective voice scores at one week.\nA third trial from Russia included 145 patients with acute laryngitis symptoms. Participants were randomised to three treatment groups: Group 1: seven-day course of fusafungine (six times a day by inhalation); Group 2: seven-day course of fusafungine (six times a day by inhalation) plus clarithromycin (250 mg twice daily for seven days); Group 3: no treatment. Clinical cure rates were measured at days 5 ± 1, 8 ± 1 and 28 ± 2. The authors reported significant differences in the rates of clinical cure at day 5 ± 1 favouring fusafungine (one trial; 93 participants; RR 1.50, 95% CI 1.02 to 2.20; P value = 0.04) and fusafungine plus clarithromycin (one trial 97 participants; RR 1.47, 95% CI 1.00 to 2.16; P value = 0.05) when compared to no treatment. However, no significant differences were found at days 8 ± 1 and 28 ± 2. Also, no significant differences were found when comparing fusafungine to fusafungine plus clarithromycin at days 5 ± 1, 8 ± 1 and 28 ± 2.\nAuthors' conclusions\nAntibiotics do not appear to be effective in treating acute laryngitis when assessing objective outcomes. They appear to be beneficial for some subjective outcomes. Erythromycin could reduce voice disturbance at one week and cough at two weeks when measured subjectively. Fusafungine could increase the cure rate at day five. The included RCTs had important methodological problems and these modest benefits from antibiotics may not outweigh their cost, adverse effects or negative consequences for antibiotic resistance patterns.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review found three studies involving 351 participants evaluating the effectiveness of different antibiotic therapies in adults with acute laryngitis. The evidence is current to December 2014."
}
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query-laysum
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22310
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[
{
"role": "user",
"content": "Abstract: Background\nNon-invasive ventilation (NIV) with bi-level positive airway pressure (BiPAP) is commonly used to treat patients admitted to hospital with acute hypercapnic respiratory failure (AHRF) secondary to an acute exacerbation of chronic obstructive pulmonary disease (AECOPD).\nObjectives\nTo compare the efficacy of NIV applied in conjunction with usual care versus usual care involving no mechanical ventilation alone in adults with AHRF due to AECOPD. The aim of this review is to update the evidence base with the goals of supporting clinical practice and providing recommendations for future evaluation and research.\nSearch methods\nWe identified trials from the Cochrane Airways Group Specialised Register of trials (CAGR), which is derived from systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), and PsycINFO, and through handsearching of respiratory journals and meeting abstracts. This update to the original review incorporates the results of database searches up to January 2017.\nSelection criteria\nAll randomised controlled trials that compared usual care plus NIV (BiPAP) versus usual care alone in an acute hospital setting for patients with AECOPD due to AHRF were eligible for inclusion. AHRF was defined by a mean admission pH < 7.35 and mean partial pressure of carbon dioxide (PaCO2) > 45 mmHg (6 kPa). Primary review outcomes were mortality during hospital admission and need for endotracheal intubation. Secondary outcomes included hospital length of stay, treatment intolerance, complications, changes in symptoms, and changes in arterial blood gases.\nData collection and analysis\nTwo review authors independently applied the selection criteria to determine study eligibility, performed data extraction, and determined risk of bias in accordance with Cochrane guidelines. Review authors undertook meta-analysis for data that were both clinically and statistically homogenous, and analysed data as both one overall pooled sample and according to two predefined subgroups related to exacerbation severity (admission pH between 7.35 and 7.30 vs below 7.30) and NIV treatment setting (intensive care unit-based vs ward-based). We reported results for mortality, need for endotracheal intubation, and hospital length of stay in a 'Summary of findings' table and rated their quality in accordance with GRADE criteria.\nMain results\nWe included in the review 17 randomised controlled trials involving 1264 participants. Available data indicate that mean age at recruitment was 66.8 years (range 57.7 to 70.5 years) and that most participants (65%) were male. Most studies (12/17) were at risk of performance bias, and for most (14/17), the risk of detection bias was uncertain. These risks may have affected subjective patient-reported outcome measures (e.g. dyspnoea) and secondary review outcomes, respectively.\nUse of NIV decreased the risk of mortality by 46% (risk ratio (RR) 0.54, 95% confidence interval (CI) 0.38 to 0.76; N = 12 studies; number needed to treat for an additional beneficial outcome (NNTB) 12, 95% CI 9 to 23) and decreased the risk of needing endotracheal intubation by 65% (RR 0.36, 95% CI 0.28 to 0.46; N = 17 studies; NNTB 5, 95% CI 5 to 6). We graded both outcomes as 'moderate' quality owing to uncertainty regarding risk of bias for several studies. Inspection of the funnel plot related to need for endotracheal intubation raised the possibility of some publication bias pertaining to this outcome. NIV use was also associated with reduced length of hospital stay (mean difference (MD) -3.39 days, 95% CI -5.93 to -0.85; N = 10 studies), reduced incidence of complications (unrelated to NIV) (RR 0.26, 95% CI 0.13 to 0.53; N = 2 studies), and improvement in pH (MD 0.05, 95% CI 0.02 to 0.07; N = 8 studies) and in partial pressure of oxygen (PaO2) (MD 7.47 mmHg, 95% CI 0.78 to 14.16 mmHg; N = 8 studies) at one hour. A trend towards improvement in PaCO2 was observed, but this finding was not statistically significant (MD -4.62 mmHg, 95% CI -11.05 to 1.80 mmHg; N = 8 studies). Post hoc analysis revealed that this lack of benefit was due to the fact that data from two studies at high risk of bias showed baseline imbalance for this outcome (worse in the NIV group than in the usual care group). Sensitivity analysis revealed that exclusion of these two studies resulted in a statistically significant positive effect of NIV on PaCO2. Treatment intolerance was significantly greater in the NIV group than in the usual care group (risk difference (RD) 0.11, 95% CI 0.04 to 0.17; N = 6 studies). Results of analysis showed a non-significant trend towards reduction in dyspnoea with NIV compared with usual care (standardised mean difference (SMD) -0.16, 95% CI -0.34 to 0.02; N = 4 studies). Subgroup analyses revealed no significant between-group differences.\nAuthors' conclusions\nData from good quality randomised controlled trials show that NIV is beneficial as a first-line intervention in conjunction with usual care for reducing the likelihood of mortality and endotracheal intubation in patients admitted with acute hypercapnic respiratory failure secondary to an acute exacerbation of chronic obstructive pulmonary disease (COPD). The magnitude of benefit for these outcomes appears similar for patients with acidosis of a mild (pH 7.30 to 7.35) versus a more severe nature (pH < 7.30), and when NIV is applied within the intensive care unit (ICU) or ward setting.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "When people have a severe attack of COPD, their breathing becomes very difficult. This can turn into breathing failure (acute hypercapnic respiratory failure (AHRF)) that often requires urgent hospital-based medical care. One of the treatments that may be given is breathing support (intubation and mechanical ventilation). This involves delivery of air and/or oxygen via a ventilator connected to a tube inserted down the throat and into the lungs. This is undoubtedly a lifesaving procedure for patients with severe life-threatening exacerbations of COPD, but it is associated with several possible unwanted side effects.\nNon-invasive ventilation (NIV) involves delivery of breathing support via a ventilator connected to a nose mask or a face mask. NIV is used more frequently nowadays to help such patients in many hospitals. This review aimed to determine the effectiveness of adding NIV to usual care for this patient group."
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query-laysum
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22311
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane review published in 2013, Issue 10.\nImmunosuppressed cancer patients are at increased risk of serious influenza-related complications. Guidelines, therefore, recommend influenza vaccination for these patients. However, data on vaccine effectiveness in this population are lacking, and the value of vaccination in this population remains unclear.\nObjectives\nTo assess the effectiveness of influenza vaccine in immunosuppressed adults with malignancies. The primary review outcome is all-cause mortality, preferably at the end of the influenza season. Influenza-like illness (ILI, a clinical definition), confirmed influenza, pneumonia, any hospitalisations, influenza-related mortality and immunogenicity were defined as secondary outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and LILACS databases up to May 2017. We searched the following conference proceedings: ICAAC, ECCMID, IDSA (infectious disease conferences), ASH, ASBMT, EBMT (haematological), and ASCO (oncological) between the years 2006 to 2017. In addition, we scanned the references of all identified studies and pertinent reviews. We searched the websites of the manufacturers of influenza vaccine. Finally, we searched for ongoing or unpublished trials in clinical trial registry databases.\nSelection criteria\nRandomised controlled trials (RCTs), prospective and retrospective cohort studies and case-control studies were considered, comparing inactivated influenza vaccines versus placebo, no vaccination or a different vaccine, in adults (16 years and over) with cancer. We considered solid malignancies treated with chemotherapy, haematological cancer patients treated or not treated with chemotherapy, cancer patients post-autologous (up to six months after transplantation) or allogeneic (at any time) haematopoietic stem cell transplantation (HSCT).\nData collection and analysis\nTwo review authors independently assessed the risk of bias and extracted data from included studies adhering to Cochrane methodology. Meta-analysis could not be performed because of different outcome and denominator definitions in the included studies.\nMain results\nWe identified six studies with a total of 2275 participants: five studies comparing vaccination with no vaccination, and one comparing adjuvanted vaccine with non-adjuvanted vaccine. Three studies were RCTs, one was a prospective observational cohort study and two were retrospective cohort studies.\nFor the comparison of vaccination with no vaccination we included two RCTs and three observational studies, including 2202 participants. One study reported results in person-years while the others reported results per person. The five studies were performed between 1993 and 2015 and included adults with haematological diseases (three studies), patients following bone marrow transplantation (BMT) (two studies) and solid malignancies (three studies).\nOne RCT and two observational studies reported all-cause mortality; the RCT showed similar mortality rates in both arms (odds ratio (OR) 1.25 (95% CI 0.43 to 3.62; 1 study, 78 participants, low-certainty evidence)); and the observational studies demonstrated a significant association between vaccine receipt and lower risk of death, adjusted hazard ratio 0.88 (95% CI 0.78 to 1; 1 study, 1577 participants, very low-certainty evidence) in one study and OR 0.42 (95% CI 0.24 to 0.75; 1 study, 806 participants, very low-certainty evidence) in the other. One RCT reported a reduction in ILI with vaccination, while no difference was observed in one observational study. Confirmed influenza rates were lower with vaccination in one RCT and the three observational studies, the difference reaching statistical significance in one. Pneumonia was observed significantly less frequently with vaccination in one observational study, but no difference was detected in another or in the RCT. One RCT showed a reduction in hospitalisations following vaccination, while an observational study found no difference. No life-threatening or persistent adverse effects from vaccination were reported. The strength of evidence was limited by the low number of included studies and by their low methodological quality and the certainty of the evidence for the mortality outcome according to GRADE was low to very low.\nFor the comparison of adjuvanted vaccine with non-adjuvanted vaccine, we identified one RCT, including 73 patients. No differences were found for the primary and all secondary outcomes assessed. Mortality risk ratio was 0.54 (95% CI 0.05 to 5.73; low-certainty evidence) in the adjuvanted vaccine group. The quality of evidence was low due to the small sample size and the large confidence intervals for all outcomes.\nAuthors' conclusions\nObservational data suggest lower mortality and infection-related outcomes with influenza vaccination. The strength of evidence is limited by the small number of studies and low grade of evidence. It seems that the evidence, although weak, shows that the benefits overweigh the potential risks when vaccinating adults with cancer against influenza. However, additional placebo or no-treatment controlled RCTs of influenza vaccination among adults with cancer is ethically questionable.There is no conclusive evidence regarding the use of adjuvanted versus non-adjuvanted influenza vaccine in this population.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review focused on the effectiveness of influenza vaccination in adults with cancer who have a suppressed immune system because of cancer or chemotherapy. We searched the literature up to May 2017."
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query-laysum
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22312
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[
{
"role": "user",
"content": "Abstract: Background\nImmunization rates for children and adults are rising, but coverage levels have not reached optimal goals. As a result, vaccine-preventable diseases still occur. In an era of increasing complexity of immunization schedules, rising expectations about the performance of primary care, and large demands on primary care providers, it is important to understand and promote interventions that work in primary care settings to increase immunization coverage. One common theme across immunization programs in many nations involves the challenge of implementing a population-based approach and identifying all eligible recipients, for example the children who should receive the measles vaccine. However, this issue is gradually being addressed through the availability of immunization registries and electronic health records. A second common theme is identifying the best strategies to promote high vaccination rates. Three types of strategies have been studied: (1) patient-oriented interventions, such as patient reminder or recall, (2) provider interventions, and (3) system interventions, such as school laws. One of the most prominent intervention strategies, and perhaps best studied, involves patient reminder or recall systems. This is an update of a previously published review.\nObjectives\nTo evaluate and compare the effectiveness of various types of patient reminder and recall interventions to improve receipt of immunizations.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL to January 2017. We also searched grey literature and trial registers to January 2017.\nSelection criteria\nWe included randomized trials, controlled before and after studies, and interrupted time series evaluating immunization-focused patient reminder or recall interventions in children, adolescents, and adults who receive immunizations in any setting. We included no-intervention control groups, standard practice activities that did not include immunization patient reminder or recall, media-based activities aimed at promoting immunizations, or simple practice-based awareness campaigns. We included receipt of any immunizations as eligible outcome measures, excluding special travel immunizations. We excluded patients who were hospitalized for the duration of the study period.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. We present results for individual studies as relative rates using risk ratios, and risk differences for randomized trials, and as absolute changes in percentage points for controlled before-after studies. We present pooled results for randomized trials using the random-effects model.\nMain results\nThe 75 included studies involved child, adolescent, and adult participants in outpatient, community-based, primary care, and other settings in 10 countries.\nPatient reminder or recall interventions, including telephone and autodialer calls, letters, postcards, text messages, combination of mail or telephone, or a combination of patient reminder or recall with outreach, probably improve the proportion of participants who receive immunization (risk ratio (RR) of 1.28, 95% confidence interval (CI) 1.23 to 1.35; risk difference of 8%) based on moderate certainty evidence from 55 studies with 138,625 participants.\nThree types of single-method reminders improve receipt of immunizations based on high certainty evidence: the use of postcards (RR 1.18, 95% CI 1.08 to 1.30; eight studies; 27,734 participants), text messages (RR 1.29, 95% CI 1.15 to 1.44; six studies; 7772 participants), and autodialer (RR 1.17, 95% CI 1.03 to 1.32; five studies; 11,947 participants). Two types of single-method reminders probably improve receipt of immunizations based on moderate certainty evidence: the use of telephone calls (RR 1.75, 95% CI 1.20 to 2.54; seven studies; 9120 participants) and letters to patients (RR 1.29, 95% CI 1.21 to 1.38; 27 studies; 81,100 participants).\nBased on high certainty evidence, reminders improve receipt of immunizations for childhood (RR 1.22, 95% CI 1.15 to 1.29; risk difference of 8%; 23 studies; 31,099 participants) and adolescent vaccinations (RR 1.29, 95% CI 1.17 to 1.42; risk difference of 7%; 10 studies; 30,868 participants). Reminders probably improve receipt of vaccinations for childhood influenza (RR 1.51, 95% CI 1.14 to 1.99; risk difference of 22%; five studies; 9265 participants) and adult influenza (RR 1.29, 95% CI 1.17 to 1.43; risk difference of 9%; 15 studies; 59,328 participants) based on moderate certainty evidence. They may improve receipt of vaccinations for adult pneumococcus, tetanus, hepatitis B, and other non-influenza vaccinations based on low certainty evidence although the confidence interval includes no effect of these interventions (RR 2.08, 95% CI 0.91 to 4.78; four studies; 8065 participants).\nAuthors' conclusions\nPatient reminder and recall systems, in primary care settings, are likely to be effective at improving the proportion of the target population who receive immunizations.\n\nGiven the provided abstract, please respond to the following query: \"Aim of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review is to determine whether strategies to remind people to receive vaccinations increase the number of people who receive vaccinations. This is an update of a previously published Cochrane Review."
}
] |
query-laysum
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22313
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[
{
"role": "user",
"content": "Abstract: Background\nUrinary incontinence is a common and potentially debilitating problem. Stress urinary, incontinence as the most common type of incontinence, imposes significant health and economic burdens on society and the women affected. Open retropubic colposuspension is a surgical treatment which involves lifting the tissues near the bladder neck and proximal urethra in the area behind the anterior pubic bones to correct deficient urethral closure to correct stress urinary incontinence.\nObjectives\nThe review aimed to determine the effects of open retropubic colposuspension for the treatment of urinary incontinence in women. A secondary aim was to assess the safety of open retropubic colposuspension in terms of adverse events caused by the procedure.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and the reference lists of relevant articles. We contacted investigators to locate extra studies.\nSelection criteria\nRandomised or quasi-randomised controlled trials in women with symptoms or urodynamic diagnoses of stress or mixed urinary incontinence that included open retropubic colposuspension surgery in at least one trial group.\nData collection and analysis\nStudies were evaluated for methodological quality or susceptibility to bias and appropriateness for inclusion and data extracted by two of the review authors. Trial data were analysed by intervention. Where appropriate, a summary statistic was calculated.\nMain results\nThis review included 55 trials involving a total of 5417 women.\nOverall cure rates were 68.9% to 88.0% for open retropubic colposuspension. Two small studies suggested lower incontinence rates after open retropubic colposuspension compared with conservative treatment. Similarly, one trial suggested lower incontinence rates after open retropubic colposuspension compared to anticholinergic treatment. Evidence from six trials showed a lower incontinence rate after open retropubic colposuspension than after anterior colporrhaphy. Such benefit was maintained over time (risk ratio (RR) for incontinence 0.46; 95% CI 0.30 to 0.72 before the first year, RR 0.37; 95% CI 0.27 to 0.51 at one to five years, RR 0.49; 95% CI 0.32 to 0.75 in periods beyond five years).\nEvidence from 22 trials in comparison with suburethral slings (traditional slings or trans-vaginal tape or transobturator tape) found no overall significant difference in incontinence rates in all time periods evaluated (as assessed subjectively RR 0.90; 95% CI 0.69 to 1.18, within one year of treatment, RR 1.18; 95%CI 1.01 to 1.39 between one and five years, RR 1.11; 95% CI 0.97 to 1.27 at five years and more, and as assessed objectively RR 1.24; 95% CI 0.93 to 1.67 within one year of treatment, RR 1.12; 95% CI 0.82 to 1.54 for one to five years follow up, RR 0.70; 95% CI 0.30 to 1.64 at more than five years). However, subgroup analysis of studies comparing traditional slings and open colposuspension showed better effectiveness with traditional slings in the medium and long term (RR 1.35; 95% CI 1.11 to 1.64 from one to five years follow up, RR 1.19; 95% CI 1.03 to 1.37).\nIn comparison with needle suspension, there was a lower incontinence rate after colposuspension in the first year after surgery (RR 0.66; 95% CI 0.42 to 1.03), after the first year (RR 0.56; 95% CI 0.39 to 0.81), and beyond five years (RR 0.32; 95% CI 15 to 0.71).\nPatient-reported incontinence rates at short, medium and long-term follow-up showed no significant differences between open and laparoscopic retropubic colposuspension, but with wide confidence intervals. In two trials incontinence was less common after the Burch (RR 0.38; 95% CI 0.18 to 0.76) than after the Marshall Marchetti Krantz procedure at one to five year follow-up. There were few data at any other follow-up times.\nIn general, the evidence available does not show a higher morbidity or complication rate with open retropubic colposuspension compared to the other open surgical techniques, although pelvic organ prolapse is more common than after anterior colporrhaphy and sling procedures. Voiding problems are also more common after sling procedures compared to open colposuspension.\nAuthors' conclusions\nOpen retropubic colposuspension is an effective treatment modality for stress urinary incontinence especially in the long term. Within the first year of treatment, the overall continence rate is approximately 85% to 90%. After five years, approximately 70% of women can expect to be dry. Newer minimal access sling procedures look promising in comparison with open colposuspension but their long-term performance is limited and closer monitoring of their adverse event profile must be carried out. Open colposuspension is associated with a higher risk of pelvic organ prolapse compared to sling operations and anterior colporrhaphy, but with a lower risk of voiding dysfunction compared to traditional sling surgery. Laparoscopic colposuspension should allow speedier recovery but its relative safety and long-term effectiveness is not yet known. A Brief Economic Commentary (BEC) identified five studies suggesting that tension-free vaginal tape (TVT) and laparoscopic colposuspension may be more cost-effective compared with open retropubic colposuspension.\n\nGiven the provided abstract, please respond to the following query: \"Adverse Events\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Laparoscopic colposuspension allows for faster recovery compared to open colposuspension. Studies did not reveal a higher complication rate with open colposuspension compared with the other surgical techniques, although pelvic organ prolapse was found to be more common. Abnormal voiding was less common after open colposuspension compared to sling surgery."
}
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query-laysum
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22314
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[
{
"role": "user",
"content": "Abstract: Background\nPreterm infants (< 37 weeks' post-menstrual age (PMA)) are often delayed in attaining oral feeding. Normal oral feeding is suggested as an important outcome for the timing of discharge from the hospital and can be an early indicator of neuromotor integrity and developmental outcomes. A range of oral stimulation interventions may help infants to develop sucking and oromotor co-ordination, promoting earlier oral feeding and earlier hospital discharge. This is an update of our 2016 review.\nObjectives\nTo determine the effectiveness of oral stimulation interventions for attainment of oral feeding in preterm infants born before 37 weeks' PMA.\nSearch methods\nSearches were run in March 2022 of the following databases: CENTRAL via CRS Web; MEDLINE and Embase via Ovid. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials. Searches were limited by date 2016 (the date of the search for the original review) forward.\nNote: Due to circumstances beyond our control (COVID and staffing shortages at the editorial base of Cochrane Neonatal), publication of this review, planned for mid 2021, was delayed. Thus, although searches were conducted in 2022 and results screened, potentially relevant studies found after September 2020 have been placed in the section, Awaiting Classification, and not incorporated into our analysis.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing a defined oral stimulation intervention with no intervention, standard care, sham treatment or non-oral intervention (e.g. body stroking protocols or gavage adjustment protocols) in preterm infants and reporting at least one of the specified outcomes.\nData collection and analysis\nFollowing the updated search, two review authors screened the titles and abstracts of studies and full-text copies when needed to identify trials for inclusion in the review. The primary outcomes of interest were time (days) to exclusive oral feeding, time (days) spent in NICU, total hospital stay (days), and duration (days) of parenteral nutrition. All review and support authors contributed to independent extraction of data and analysed assigned studies for risk of bias across the five domains of bias using the Cochrane Risk of Bias assessment tool. The GRADE system was used to rate the certainty of the evidence. Studies were divided into two groups for comparison: intervention versus standard care and intervention versus other non-oral or sham intervention. We performed meta-analysis using a fixed-effect model.\nMain results\nWe included 28 RCTs (1831 participants). Most trials had methodological weaknesses, particularly in relation to allocation concealment and masking of study personnel.\nOral stimulation compared with standard care\nFollowing meta-analysis, it is uncertain whether oral stimulation reduces the time to transition to oral feeding compared with standard care (mean difference (MD) -4.07 days, 95% confidence interval (CI) -4.81 to -3.32 days, 6 studies, 292 infants; I2 =85%, very low-certainty evidence due to serious risk of bias and inconsistency). Time (days) spent in the neonatal intensive care unit (NICU) was not reported. It is uncertain whether oral stimulation reduces the duration of hospitalisation (MD -4.33, 95% CI -5.97 to -2.68 days, 5 studies, 249 infants; i2 =68%, very low-certainty evidence due to serious risk of bias and inconsistency). Duration (days) of parenteral nutrition was not reported.\nOral stimulation compared with non-oral intervention\nFollowing meta-analysis, it is uncertain whether oral stimulation reduces the time to transition to exclusive oral feeding compared with a non-oral intervention (MD -7.17, 95% CI -8.04 to -6.29 days, 10 studies, 574 infants; I2 =80%, very low-certainty evidence due to serious risk of bias, inconsistency and precision). Time (days) spent in the NICU was not reported. Oral stimulation may reduce the duration of hospitalisation (MD -6.15, 95% CI -8.63 to -3.66 days, 10 studies, 591 infants; I2 =0%, low-certainty evidence due to serious risk of bias). Oral stimulation may have little or no effect on the duration (days) of parenteral nutrition exposure (MD -2.85, 95% CI -6.13 to 0.42, 3 studies, 268 infants; very low-certainty evidence due to serious risk of bias, inconsistency and imprecision).\nAuthors' conclusions\nThere remains uncertainty about the effects of oral stimulation (versus either standard care or a non-oral intervention) on transition times to oral feeding, duration of intensive care stay, hospital stay, or exposure to parenteral nutrition for preterm infants. Although we identified 28 eligible trials in this review, only 18 provided data for meta-analyses. Methodological weaknesses, particularly in relation to allocation concealment and masking of study personnel and caregivers, inconsistency between trials in effect size estimates (heterogeneity), and imprecision of pooled estimates were the main reasons for assessing the evidence as low or very low certainty.\nMore well-designed trials of oral stimulation interventions for preterm infants are warranted. Such trials should attempt to mask caregivers to treatment when possible, paying particular attention to blinding of outcome assessors. There are currently 32 ongoing trials. Outcome measures that reflect improvements in oral motor skill development as well as longer term outcome measures beyond six months of age need to be defined and used by researchers to capture the full impact of these 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": "This is an update of the 2016 review. Many preterm infants have delayed establishment of oral (suck) feeding and are fed at first with feeding tubes or with intravenous (parenteral) nutrition. Development of oral feeding skills needs careful co-ordination of sucking, swallowing and breathing. In preterm infants, the development of oral feeding can be challenging because of long hospitalisations, breathing difficulties and other medical conditions associated with preterm birth. Unpleasant and invasive procedures such as ventilation or frequent suctioning of secretions from the mouth or nose can negatively impact feeding skills. International guidelines for the transition from tube feeding to oral feeding vary widely. Healthcare providers use a range of interventions to improve sucking and feeding skills in preterm infants, and studies report faster transition time from tube feeds to oral feeds, reduced length of stay in hospital and improvement in infants' sucking skills. The first review in 2016 showed that while oral stimulation interventions appear to reduce length of hospital stay, reduce need for tube feeding and accelerate time to oral feeding, the studies were of poor methodological quality leaving some uncertainty about overall effects. This update assessed whether current research supports these findings and if the quality of studies has improved, leading to increased certainty of results."
}
] |
query-laysum
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22315
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[
{
"role": "user",
"content": "Abstract: Background\nConstruction workers are frequently exposed to various types of injury-inducing hazards. There are a number of injury prevention interventions, yet their effectiveness is uncertain.\nObjectives\nTo assess the effects of interventions for preventing injuries in construction workers.\nSearch methods\nWe searched the Cochrane Injuries Group's specialised register, CENTRAL (issue 3), MEDLINE, Embase and PsycINFO up to April 2017. The searches were not restricted by language or publication status. We also handsearched the reference lists of relevant papers and reviews.\nSelection criteria\nRandomised controlled trials, controlled before-after (CBA) studies and interrupted time-series (ITS) of all types of interventions for preventing fatal and non-fatal injuries among workers at construction sites.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed their risk of bias. For ITS studies, we re-analysed the studies and used an initial effect, measured as the change in injury rate in the year after the intervention, as well as a sustained effect, measured as the change in time trend before and after the intervention.\nMain results\nSeventeen studies (14 ITS and 3 CBA studies) met the inclusion criteria in this updated version of the review. The ITS studies evaluated the effects of: introducing or changing regulations that laid down safety and health requirements for the construction sites (nine studies), a safety campaign (two studies), a drug-free workplace programme (one study), a training programme (one study), and safety inspections (one study) on fatal and non-fatal occupational injuries. One CBA study evaluated the introduction of occupational health services such as risk assessment and health surveillance, one evaluated a training programme and one evaluated the effect of a subsidy for upgrading to safer scaffoldings. The overall risk of bias of most of the included studies was high, as it was uncertain for the ITS studies whether the intervention was independent from other changes and thus could be regarded as the main reason of change in the outcome. Therefore, we rated the quality of the evidence as very low for all comparisons.\nCompulsory interventions\nRegulatory interventions at national or branch level may or may not have an initial effect (effect size (ES) of −0.33; 95% confidence interval (CI) −2.08 to 1.41) and may or may not have a sustained effect (ES −0.03; 95% CI −0.30 to 0.24) on fatal and non-fatal injuries (9 ITS studies) due to highly inconsistent results (I² = 98%). Inspections may or may not have an effect on non-fatal injuries (ES 0.07; 95% CI −2.83 to 2.97; 1 ITS study).\nEducational interventions\nSafety training interventions may result in no significant reduction of non-fatal injuries (1 ITS study and 1 CBA study).\nInformational interventions\nWe found no studies that had evaluated informational interventions alone such as campaigns for risk communication.\nPersuasive interventions\nWe found no studies that had evaluated persuasive interventions alone such as peer feedback on workplace actions to increase acceptance of safe working methods.\nFacilitative interventions\nMonetary subsidies to companies may lead to a greater decrease in non-fatal injuries from falls to a lower level than no subsidies (risk ratio (RR) at follow-up: 0.93; 95% CI 0.30 to 2.91 from RR 3.89 at baseline; 1 CBA study).\nMultifaceted interventions\nA safety campaign intervention may result in an initial (ES −1.82; 95% CI −2.90 to −0.74) and sustained (ES −1.30; 95% CI −1.79 to −0.81) decrease in injuries at the company level (1 ITS study), but not at the regional level (1 ITS study). A multifaceted drug-free workplace programme at the company level may reduce non-fatal injuries in the year following implementation by −7.6 per 100 person-years (95% CI −11.2 to −4.0) and in the years thereafter by −2.0 per 100 person-years (95% CI −3.5 to −0.5) (1 ITS study). Introducing occupational health services may result in no decrease in fatal or non-fatal injuries (one CBA study).\nAuthors' conclusions\nThe vast majority of interventions to adopt safety measures recommended by standard texts on safety, consultants and safety courses have not been adequately evaluated. There is very low-quality evidence that introducing regulations as such may or may not result in a decrease in fatal and non-fatal injuries. There is also very low-quality evidence that regionally oriented safety campaigns, training, inspections or the introduction of occupational health services may not reduce non-fatal injuries in construction companies. There is very low-quality evidence that company-oriented safety interventions such as a multifaceted safety campaign, a multifaceted drug workplace programme and subsidies for replacement of scaffoldings may reduce non-fatal injuries among construction workers. More studies, preferably cluster-randomised controlled trials, are needed to evaluate different strategies to increase the employers' and workers' adherence to the safety measures prescribed by regulation.\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": "We looked at different types of workplace interventions, including the introduction of new regulations, safety campaigns, training, inspections, occupational health services, and company subsidies. We evaluated the quality of the studies and the effectiveness of interventions, rating the evidence as very low quality."
}
] |
query-laysum
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22316
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[
{
"role": "user",
"content": "Abstract: Background\nOmega-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish and plant sources are commonly considered as a promising non-medical alternative to improve brain functions and slow down the progression of dementia. This assumption is mostly based on findings of preclinical studies and epidemiological research. Resulting explanatory models aim at the role omega-3 PUFAs play in the development and integrity of the brain's neurons, their protective antioxidative effect on cell membranes and potential neurochemical mechanisms directly related to Alzheimer-specific pathology. Epidemiological research also found evidence of malnutrition in people with dementia. Considering this and the fact that omega-3 PUFA cannot be synthesised by humans, omega-3 PUFAs might be a promising treatment option for dementia.\nObjectives\nTo assess the efficacy and safety of omega-3 polyunsaturated fatty acid (PUFA) supplementation for the treatment of people with dementia.\nSearch methods\nWe searched the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (ALOIS), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 10 December 2015. We contacted manufacturers of omega-3 supplements and scanned reference lists of landmark papers and included articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which omega-3 PUFA in the form of supplements or enriched diets were administered to people with Alzheimer's disease (AD), vascular dementia (VaD), dementia with Lewy bodies (DLB), Parkinson's disease dementia (PDD) or frontotemporal dementia (FTD).\nData collection and analysis\nThe primary outcome measures of interest were changes in global and specific cognitive functions, functional performance, dementia severity and adverse effects. Two review authors independently selected studies, extracted data and assessed the quality of trials according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of the evidence using the GRADE approach. We received unpublished data from the trial authors and collected adverse effects information from the published articles. We conducted meta-analyses for available outcome measures at six months.\nMain results\nWe included three comparable randomised, placebo-controlled trials investigating omega-3 PUFA supplements in 632 participants with mild to moderate AD over six, 12 and 18 months. We found no studies investigating other types of dementia. All trials were of high methodological quality. The overall quality of evidence for most of the outcomes was high.\nThere was no evidence of a benefit from omega-3 PUFAs on cognitive function when measured at six months with the Alzheimer's Disease Assessment Scale - Cognitive subscale (standardised mean difference (SMD) -0.02, 95% confidence interval (CI) -0.19 to 0.15; 566 participants; 3 studies; high quality evidence) or Mini-Mental State Examination (mean difference (MD) 0.18, 95% CI -1.05 to 1.41; 202 participants; 2 studies; high quality evidence) or on activities of daily living (SMD -0.02, 95% CI -0.19 to 0.16; 544 participants; 2 studies; high quality evidence). There was also no effect at six months of treatment on severity of dementia measured with the Clinical Dementia Rating - Sum of Boxes (MD -0.00, 95% CI -0.58 to 0.57; 542 participants; 2 studies; high quality evidence) or on quality of life measured with the Quality of Life Alzheimer's Disease scale (MD -0.10, 95% CI -1.28 to 1.08; 322 participants; 1 study; high quality evidence). There was no difference at six months on mental health measured with the Montgomery-Åsberg Depression Rating Scale (MD -0.10, 95% CI -0.74 to 0.54; 178 participants: 1 study; high quality of evidence) or the Neuropsychiatric Inventory (SMD 0.10, 95% CI -0.07 to 0.27; 543 participants; 2 studies; high quality of evidence). One very small study showed a benefit for omega-3 PUFAs in instrumental activities of daily living after 12 months of treatment (MD -3.50, 95% CI -4.30 to -2.70; 22 participants; moderate quality evidence). The included studies did not measure specific cognitive function. The studies did not report adverse events well. Two studies stated that all adverse events were mild and that they did not differ in overall frequency between omega-3 PUFA and placebo groups. Data from one study showed no difference between groups in frequency of any adverse event (risk ratio (RR) 1.02, 95% CI 0.95 to 1.10; 402 participants; 1 study; moderate quality evidence) or any serious adverse event (RR 1.05, 95% CI 0.78 to 1.41; 402 participants; 1 study; high quality evidence) at 18 months of treatment.\nAuthors' conclusions\nWe found no convincing evidence for the efficacy of omega-3 PUFA supplements in the treatment of mild to moderate AD. This result was consistent for all outcomes relevant for people with dementia. Adverse effects of omega-3 PUFAs seemed to be low, but based on the evidence synthesised in this review, we cannot make a final statement on tolerability. The effects on other populations remain unclear.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Omega-3 polyunsaturated fatty acids (omega-3 PUFAs) are assumed to have a beneficial effect on the function of the brain. It has been suggested that they might improve or delay decline in memory and ability to carry out everyday tasks in people with dementia. In this review, we investigated randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) comparing omega-3 PUFAs, given in the form of supplements or enriched diets, with placebo (a pretend treatment) in people with the most common types of dementia."
}
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query-laysum
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22317
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[
{
"role": "user",
"content": "Abstract: Background\nPatients with rheumatoid arthritis may have an increased risk of falls due to impairments in lower-extremity joints, which may result in either mobility, or postural stability problems. There is evidence in the literature suggesting that balance, agility and coordination training techniques can induce changes in lower-extremity muscle activity patterns that result in improvement in dynamic joint stability.\nThe mechanoreceptors present in and around the joints are responsible for maintaining postural control and joint position sense. These receptors are integrated to compose the somatosensorial system. In combination with visual and auditory inputs, which improve our spatial perception even further, the systems are able to maintain a stable body posture.\nHowever, there is a lack of information on the efficacy of balance training alone in patients with rheumatoid arthritis.\nObjectives\nTo assess the effectiveness and safety of balance training (proprioceptive training) to improve functional capacity in patients with rheumatoid arthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4), MEDLINE via PubMed (January 1966 to December 2008), EMBASE (January 1980 to December 2008), LILACS (January 1982 to December 2008), CINAHL (January 1982 to December 2008), PEDro and Scirus (inception to 2008). We also handsearched conference abstracts.\nSelection criteria\nAll eligible randomised controlled trials (RCT) or controlled clinical trials (CCT) comparing balance training (proprioceptive training) with any other intervention or with no intervention.\nData collection and analysis\nTwo review authors independently assessed titles or abstracts, or both, for inclusion criteria.\nMain results\nThe electronic search identified 864 studies. From this search, 17 studies described general exercises in rheumatoid arthritis patients as the main topic. After analysing them, we observed that the main interventions were exercises to improve muscle strength, endurance, and dynamic exercises (swimming, walking, etc). As we did not find any studies investigating the effects of balance training alone or in combination with other therapies in patients with rheumatoid arthritis, it was not possible to include any data regarding the chosen topic in this systematic review.\nAuthors' conclusions\nThere is no research available examining the efficacy of balance training alone in patients with rheumatoid arthritis. The effectiveness and safety of balance training to improve functional capacity of these patients remains unclear. We suggest that future research should give more importance to balance training by either increasing the number and duration of sessions or investigating its efficacy alone.\n\nGiven the provided abstract, please respond to the following query: \"The review shows that in people with rheumatoid arthritis\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review shows that in people with rheumatoid arthritis:\nWe are unsure of the effects of balance training because no studies met the review's inclusion criteria. Further randomised controlled trials are required to evaluate the effectiveness and safety of balance exercises (proprioceptive training) alone in patients with rheumatoid arthritis"
}
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query-laysum
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22318
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[
{
"role": "user",
"content": "Abstract: Background\nVitrectomy surgery is one of the commonest ophthalmic procedures performed across the world. It may be performed using general or local anaesthesia encompassing regional or topical anaesthesia depending on a number of factors, including patient suitability, and patient, surgeon or anaesthetist preference. There have so far been no evidence-based recommendations on the best form of anaesthesia for this intervention. There is no clear collated evidence base as to the best type of anaesthesia to reduce harm, and provide best surgical conditions and optimal outcome for patients.\nObjectives\nTo compare local with general anaesthesia for adults undergoing pars plana vitrectomy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library and the reference lists of updated studies on the 25th of July 2016; MEDLINE via Ovid SP (1972 to July 2016) and Embase via Ovid SP (1972 to July 2016). In addition we searched the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) in July 2016. We searched the proceedings of the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) up to July 2016 for information about other relevant studies.\nWe also searched appropriate databases for ongoing reviews. We did not apply any language restriction. We assessed the search as up-to-date on the 25th of July 2016.\nSelection criteria\nWe planned to include all published randomized controlled trials (RCTs) involving comparison of different modalities of local anaesthesia with general anaesthesia for pars plana vitrectomy. We considered the following different modalities of local anaesthesia: sub-Tenon's anaesthesia, retrobulbar anaesthesia, topical anaesthesia, peribulbar anaesthesia. We planned to include cluster-randomized controlled trials. We excluded quasi-RCT trials.\nData collection and analysis\nTwo review authors conducted independent searches and assessed identified studies for inclusion according to the prespecified selection criteria. Two review authors assessed trial quality and planned to extract the data.\nMain results\nWe found no eligible studies that met our inclusion criteria and were therefore unable to perform a meta-analysis or conduct a methodological quality assessment.\nAuthors' conclusions\nThis systematic review failed to locate relevant clinical evidence to support or refute a pars plana vitrectomy performed with various modalities of local anaesthesia versus general anaesthesia. Good-quality clinical trials are needed to define the role of local versus general anaesthesia for pars plana vitrectomy.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of general anaesthesia compared to different types of local anaesthesia in vitreo-retinal surgery (surgery involving the inner substance of the eye and the retina (the light-sensitive layer of tissue at the back of the eyeball)).\nWe did not find any eligible studies for our review."
}
] |
query-laysum
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22319
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[
{
"role": "user",
"content": "Abstract: Background\nThis review adds to a series of reviews looking at primary medical management options for patients with chronic rhinosinusitis.\nChronic rhinosinusitis is common and characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Antifungals have been suggested as a treatment for chronic rhinosinusitis.\nObjectives\nTo assess the effects of systemic and topical antifungal agents in patients with chronic rhinosinusitis, including those with allergic fungal rhinosinusitis (AFRS) and, if possible, AFRS exclusively.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 17 November 2017.\nSelection criteria\nRandomised controlled trials (RCTs) with at least a two-week follow-up period comparing topical or systemic antifungals with (a) placebo, (b) no treatment, (c) other pharmacological interventions or (d) a different antifungal agent. We did not include post-surgical antifungal use.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the significant adverse effects of hepatic toxicity (systemic antifungals). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse effects of gastrointestinal disturbance (systemic antifungals) and epistaxis, headache or local discomfort (topical antifungals). We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included eight studies (490 adult participants). The presence of nasal polyps on examination was an inclusion criterion in three studies, an exclusion criterion in one study and the remaining studies included a mixed population. No studies specifically investigated the effect of antifungals in patients with AFRS.\nTopical antifungal treatment versus placebo or no intervention\nWe included seven studies (437 participants) that used amphotericin B (six studies; 383 participants) and one that used fluconazole (54 participants). Different delivery methods, volumes and concentrations were used.\nFour studies reported disease-specific health-related quality of life using a range of instruments. We did not meta-analyse the results due to differences in the instruments used, and measurement and reporting methods. At the end of treatment (one to six months) none of the studies reported statistically significant differences between the groups (low-quality evidence - we are uncertain about the result).\nTwo studies reported disease severity using patient-reported symptom scores. Meta-analysis was not possible. At the end of treatment (8 to 13 weeks) one study showed no difference and the second found that patients in the placebo group had less severe symptoms (very low-quality evidence - we are very uncertain about the result).\nIn terms of adverse effects , topical antifungals may lead to more local irritation compared with placebo (risk ratio (RR) 2.29, 95% confidence interval (CI) 0.61 to 8.62; 312 participants; 5 studies; low-quality evidence) but little or no difference in epistaxis (RR 0.97, 95% CI 0.14 to 6.63; 225 participants; 4 studies, low-quality evidence) or headache (RR 1.26, 95% CI 0.60 to 2.63; 195 participants; 3 studies; very low-quality evidence).\nNone of the studies found a difference in generic health-related quality of life (one study) or endoscopic score (five studies) between the treatment groups. Three studies investigated CT scan ; two found no difference between the groups and one found a significant decrease in the mean percentage of air space occluded, favouring the antifungal group.\nSystemic antifungal treatment versus placebo or no treatment\nOne study (53 participants) comparing terbinafine tablets against placebo reported that there may be little or no difference between the groups in disease-specific health-related quality of life or disease severity score (both low-quality evidence). Systemic antifungals may lead to more hepatic toxicity events (RR 3.35, 95% CI 0.14 to 78.60) but fewer gastrointestinal disturbances (RR 0.37, 95% CI 0.04 to 3.36), compared to placebo, although the evidence was of low quality.\nThis study did not find a difference in CT scan score between the groups. Generic health-related quality of life and endoscopic score were not measured.\nOther comparisons\nWe found no studies that compared antifungal agents against other treatments for chronic rhinosinusitis.\nAuthors' conclusions\nDue to the very low quality of the evidence, it is uncertain whether or not the use of topical or systemic antifungals has an impact on patient outcomes in adults with chronic rhinosinusitis compared with placebo or no treatment. Studies including specific subgroups (i.e. AFRS) are lacking.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "At the end of at least four weeks treatment, none of the studies found that patients using antifungals (topical or systemic) had a better quality of life or less severe symptoms than patients who used placebo or had no treatment.\nNot many participants in the studies reported having adverse effects. Topical antifungals may lead to more nasal irritation compared with placebo. It is uncertain if patients taking topical antifungals have more headaches or nosebleeds than with placebo.\nFor systemic antifungals, it is uncertain if patients using antifungals have more problems with their liver (hepatic toxicity) than with placebo. Systemic antifungals may lead to fewer patients with gastrointestinal disturbances compared to placebo.\nWe found no studies that compared antifungal treatment with other treatments for chronic rhinosinusitis.\nWe assessed the quality of the evidence as either low (further research is very likely to have an important impact on our confidence in the result) or very low (any estimate of the result is very uncertain), as some of the results are only from one or two studies, which do not have a lot of participants. Moreover, the different studies reported outcomes using different measurement scales making it difficult to draw conclusions."
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query-laysum
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22320
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[
{
"role": "user",
"content": "Abstract: Background\nThe surgical stress response plays an important role on the pathogenesis of perioperative cardiac complications. Alpha-2 adrenergic agonists attenuate this response and may help prevent postoperative cardiac complications.\nObjectives\nTo determine the efficacy and safety of α-2 adrenergic agonists for reducing mortality and cardiac complications in adults undergoing cardiac surgery and non-cardiac surgery.\nSearch methods\nWe searched CENTRAL (2017, Issue 4), MEDLINE (1950 to April Week 4, 2017), Embase (1980 to May 2017), the Science Citation Index, clinical trial registries, and reference lists of included articles.\nSelection criteria\nWe included randomized controlled trials that compared α-2 adrenergic agonists (i.e. clonidine, dexmedetomidine or mivazerol) against placebo or non-α-2 adrenergic agonists. Included trials had to evaluate the efficacy and safety of α-2 adrenergic agonists for preventing perioperative mortality or cardiac complications (or both), or measure one or more relevant outcomes (i.e. death, myocardial infarction, heart failure, acute stroke, supraventricular tachyarrhythmia and myocardial ischaemia).\nData collection and analysis\nTwo authors independently assessed trial quality, extracted data and independently performed computer entry of abstracted data. We contacted study authors for additional information. Adverse event data were gathered from the trials. We evaluated included studies using the Cochrane 'Risk of bias' tool, and the quality of the evidence underlying pooled treatment effects using GRADE methodology. Given the clinical heterogeneity between cardiac and non-cardiac surgery, we analysed these subgroups separately. We expressed treatment effects as pooled risk ratios (RR) with 95% confidence intervals (CI).\nMain results\nWe included 47 trials with 17,039 participants. Of these studies, 24 trials only included participants undergoing cardiac surgery, 23 only included participants undergoing non-cardiac surgery and eight only included participants undergoing vascular surgery. The α-2 adrenergic agonist studied was clonidine in 21 trials, dexmedetomidine in 24 trials and mivazerol in two trials.\nIn non-cardiac surgery, there was high quality evidence that α-2 adrenergic agonists led to a similar risk of all-cause mortality compared with control groups (1.3% with α-2 adrenergic agonists versus 1.7% with control; RR 0.80, 95% CI 0.61 to 1.04; participants = 14,081; studies = 16). Additionally, the risk of cardiac mortality was similar between treatment groups (0.8% with α-2 adrenergic agonists versus 1.0% with control; RR 0.86, 95% CI 0.60 to 1.23; participants = 12,525; studies = 5, high quality evidence). The risk of myocardial infarction was probably similar between treatment groups (RR 0.94, 95% CI 0.69 to 1.27; participants = 13,907; studies = 12, moderate quality evidence). There was no associated effect on the risk of stroke (RR 0.93, 95% CI 0.55 to 1.56; participants = 11,542; studies = 7; high quality evidence). Conversely, α-2 adrenergic agonists probably increase the risks of clinically significant bradycardia (RR 1.59, 95% CI 1.18 to 2.13; participants = 14,035; studies = 16) and hypotension (RR 1.24, 95% CI 1.03 to 1.48; participants = 13,738; studies = 15), based on moderate quality evidence.\nThere was insufficient evidence to determine the effect of α-2 adrenergic agonists on all-cause mortality in cardiac surgery (RR 0.52, 95% CI 0.26 to 1.04; participants = 1947; studies = 16) and myocardial infarction (RR 1.01, 95% CI 0.43 to 2.40; participants = 782; studies = 8), based on moderate quality evidence. There was one cardiac death in the clonidine arm of a study of 22 participants. Based on very limited data, α-2 adrenergic agonists may have reduced the risk of stroke (RR 0.37, 95% CI 0.15 to 0.93; participants = 1175; studies = 7; outcome events = 18; low quality evidence). Conversely, α-2 adrenergic agonists increased the risk of bradycardia from 6.4% to 12.0% (RR 1.88, 95% CI 1.35 to 2.62; participants = 1477; studies = 10; moderate quality evidence), but their effect on hypotension was uncertain (RR 1.19, 95% CI 0.87 to 1.64; participants = 1413; studies = 9; low quality evidence).\nThese results were qualitatively unchanged in subgroup analyses and sensitivity analyses.\nAuthors' conclusions\nOur review concludes that prophylactic α-2 adrenergic agonists generally do not prevent perioperative death or major cardiac complications. For non-cardiac surgery, there is moderate-to-high quality evidence that these agents do not prevent death, myocardial infarction or stroke. Conversely, there is moderate quality evidence that these agents have important adverse effects, namely increased risks of hypotension and bradycardia. For cardiac surgery, there is moderate quality evidence that α-2 adrenergic agonists have no effect on the risk of mortality or myocardial infarction, and that they increase the risk of bradycardia. The quality of evidence was inadequate to draw conclusions regarding the effects of alpha-2 agonists on stroke or hypotension during cardiac surgery.\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": "Heart-related complications can lead to death and long hospital stays after surgery. Each year, about 300 million people undergo major surgery, of whom nine million experience serious heart complications. These complications may occur, in part, because surgery places a large stress on the heart. This stress can lead to high blood pressure and high heart rates during surgery, neither of which are good for the heart. Alpha-2 adrenergic agonists are a group of medicines that can prevent the blood pressure and heart rate from increasing during surgery. Thus, these medicines may also protect the heart from the stress of surgery. We wanted to find out if giving these medicines around the time of surgery could protect the heart from the stress of surgery and thus prevent major heart complications."
}
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query-laysum
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22321
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[
{
"role": "user",
"content": "Abstract: Background\nTardive dyskinesia (TD) is a disfiguring movement disorder, often of the orofacial region, frequently caused by using antipsychotic drugs. A wide range of strategies have been used to help manage TD, and for those who are unable to have their antipsychotic medication stopped or substantially changed, the benzodiazepine group of drugs have been suggested as a useful adjunctive treatment. However, benzodiazepines are very addictive.\nObjectives\nTo determine the effects of benzodiazepines for antipsychotic-induced tardive dyskinesia in people with schizophrenia, schizoaffective disorder, or other chronic mental illnesses.\nSearch methods\nOn 17 July 2015 and 26 April 2017, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (including trial registers), inspected references of all identified studies for further trials and contacted authors of each included trial for additional information.\nSelection criteria\nWe included all randomised controlled trials (RCTs) focusing on people with schizophrenia (or other chronic mental illnesses) and antipsychotic-induced TD that compared benzodiazepines with placebo, no intervention, or any other intervention for the treatment of TD.\nData collection and analysis\nWe independently extracted data from the included studies and ensured that they were reliably selected, and quality assessed. For homogenous dichotomous data, we calculated random effects, risk ratio (RR), and 95% confidence intervals (CI). We synthesised continuous data from valid scales using mean differences (MD). For continuous outcomes, we preferred endpoint data to change data. We assumed that people who left early had no improvement.\nMain results\nThe review now includes four trials (total 75 people, one additional trial since 2006, 21 people) randomising inpatients and outpatients in China and the USA. Risk of bias was mostly unclear as reporting was poor. We are uncertain about all the effects as all evidence was graded at very low quality. We found no significant difference between benzodiazepines and placebo for the outcome of 'no clinically important improvement in TD' (2 RCTs, 32 people, RR 1.12, 95% CI 0.60 to 2.09, very low quality evidence). Significantly fewer participants allocated to clonazepam compared with phenobarbital (as active placebo) experienced no clinically important improvement (RR 0.44, 95% CI 0.20 to 0.96, 1 RCT, 21 people, very low quality evidence). For the outcome 'deterioration of TD symptoms,' we found no clear difference between benzodiazepines and placebo (2 RCTs, 30 people, RR 1.48, 95% CI 0.22 to 9.82, very low quality evidence). All 10 participants allocated to benzodiazepines experienced any adverse event compared with 7/11 allocated to phenobarbital (RR 1.53, 95% CI 0.97 to 2.41, 1 RCT, 21 people, very low quality evidence). There was no clear difference in the incidence of participants leaving the study early for benzodiazepines compared with placebo (3 RCTs, 56 people, RR 2.73, 95% CI 0.15 to 48.04, very low quality evidence) or compared with phenobarbital (as active placebo) (no events, 1 RCT, 21 people, very low quality evidence). No trials reported on social confidence, social inclusion, social networks, or personalised quality of life, which are outcomes designated important by patients. No trials comparing benzodiazepines with placebo or treatment as usual reported on adverse effects.\nAuthors' conclusions\nThere is only evidence of very low quality from a few small and poorly reported trials on the effect of benzodiazepines as an adjunctive treatment for antipsychotic-induced TD. These inconclusive results mean routine clinical use is not indicated and these treatments remain experimental. New and better trials are indicated in this under-researched area; however, as benzodiazepines are addictive, we feel that other techniques or medications should be adequately evaluated before benzodiazepines are chosen.\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": "To determine the effectiveness of benzodiazepines in the treatment of tardive dyskinesia in people with schizophrenia or other similar mental health problems."
}
] |
query-laysum
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22322
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[
{
"role": "user",
"content": "Abstract: Background\nEmergency departments (EDs) are facing serious and significant issues in the delivery of effective and efficient care to patients. Acute assessment services have been implemented at many hospitals internationally to assist in maintaining patient flow for identified groups of patients attending the ED. Identifying the risks and benefits, and optimal configurations of these services may be beneficial to those wishing to utilise an acute assessment service to improve patient flow.\nObjectives\nTo assess the effects of acute assessment services on patient flow following attendance at a hospital ED.\nSearch methods\nWe searched MEDLINE, CENTRAL, Embase and two trials registers on 24 September 2022 to identify studies. No restrictions were imposed on publication year, publication type, or publication language.\nSelection criteria\nStudies eligible for inclusion were randomised trials and cluster-randomised trials with at least two intervention and two control sites. Participants were adults (as defined by study authors) receiving care either in the ED or the acute assessment service, where both were based in the hospital setting. The comparison was hospital-based acute assessment services with usual, ED-only care. The outcomes of this review were mortality at time point closest to 30 days, length of stay in the service (in minutes), and waiting time to see a doctor (in minutes).\nData collection and analysis\nWe followed the standard procedures of Cochrane Effective Practice and Organisation of Care for this review (https://epoc.cochrane.org/resources).\nMain results\nWe identified a total of 5754 records in the search. Following assessment of 3609 de-duplicated records, none were found to be eligible for inclusion in this review.\nAuthors' conclusions\nAt present there are no randomised controlled trials exploring the effects of acute assessment services on patient flow in hospital-based emergency departments compared to usual, ED-only care.\n\nGiven the provided abstract, please respond to the following query: \"•\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Emergency departments see and treat people with urgent illnesses or injuries. Worldwide, emergency departments are experiencing challenges in delivering care to patients because of increasing numbers of people needing to use them.\n• Acute assessment services are an alternative place for some patients to be seen and treated instead of the emergency departments and may help to ease long waiting times in the emergency departments.\n• It is unclear how safe and effective acute assessment services are because there are no existing studies exploring these services."
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"role": "user",
"content": "Abstract: Background\nLiver resection is a major surgery with significant mortality and morbidity. Specialists have tested various methods in attempts to limit blood loss, transfusion requirements, and morbidity during elective liver resection. These methods include different approaches (anterior versus conventional approach), use of autologous blood donation, cardiopulmonary interventions such as hypoventilation, low central venous pressure, different methods of parenchymal transection, different methods of management of the raw surface of the liver, different methods of vascular occlusion, and different pharmacological interventions. A surgeon typically uses only one of the methods from each of these seven categories. The optimal method to decrease blood loss and transfusion requirements in people undergoing liver resection is unknown.\nObjectives\nTo assess the effects of different interventions for decreasing blood loss and blood transfusion requirements during elective liver resection.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Science Citation Index Expanded to September 2015 to identify randomised clinical trials. We also searched trial registers and handsearched the references lists of identified trials.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different methods of decreasing blood loss and blood transfusion requirements in people undergoing liver resection.\nData collection and analysis\nTwo review authors independently identified trials and collected data. We assessed the risk of bias using Cochrane domains. We conducted a Bayesian network meta-analysis using the Markov chain Monte Carlo method in WinBUGS 1.4, following the guidelines of the National Institute for Health and Care Excellence Decision Support Unit guidance documents. We calculated the odds ratios (OR) with 95% credible intervals (CrI) for the binary outcomes, mean differences (MD) with 95% CrI for continuous outcomes, and rate ratios with 95% CrI for count outcomes, using a fixed-effect model or random-effects model according to model-fit. We assessed the evidence with GRADE.\nMain results\nWe identified 67 randomised clinical trials involving a total of 6197 participants. All the trials were at high risk of bias. A total of 5771 participants from 64 trials provided data for one or more outcomes included in this review. There was no evidence of differences in most of the comparisons, and where there was, these differences were in single trials, mostly of small sample size. We summarise only the evidence that was available in more than one trial below. Of the primary outcomes, the only one with evidence of a difference from more than one trial under the pair-wise comparison was in the number of adverse events (complications), which was higher with radiofrequency dissecting sealer than with the clamp-crush method (rate ratio 1.85, 95% CrI 1.07 to 3.26; 250 participants; 3 studies; very low-quality evidence). Among the secondary outcomes, the only differences we found from more than one trial under the pair-wise comparison were the following: blood transfusion (proportion) was higher in the low central venous pressure group than in the acute normovolemic haemodilution plus low central venous pressure group (OR 3.19, 95% CrI 1.56 to 6.95; 208 participants; 2 studies; low-quality evidence); blood transfusion quantity (red blood cells) was lower in the fibrin sealant group than in the control (MD −0.53 units, 95% CrI −1.00 to −0.07; 122 participants; 2; very low-quality evidence); blood transfusion quantity (fresh frozen plasma) was higher in the oxidised cellulose group than in the fibrin sealant group (MD 0.53 units, 95% CrI 0.36 to 0.71; 80 participants; 2 studies; very low-quality evidence); blood loss (MD −0.34 L, 95% CrI −0.46 to −0.22; 237 participants; 4 studies; very low-quality evidence), total hospital stay (MD −2.42 days, 95% CrI −3.91 to −0.94; 197 participants; 3 studies; very low-quality evidence), and operating time (MD −15.32 minutes, 95% CrI −29.03 to −1.69; 192 participants; 4 studies; very low-quality evidence) were lower with low central venous pressure than with control. For the other comparisons, the evidence for difference was either based on single small trials or there was no evidence of differences. None of the trials reported health-related quality of life or time needed to return to work.\nAuthors' conclusions\nPaucity of data meant that we could not assess transitivity assumptions and inconsistency for most analyses. When direct and indirect comparisons were available, network meta-analysis provided additional effect estimates for comparisons where there were no direct comparisons. However, the paucity of data decreases the confidence in the results of the network meta-analysis. Low-quality evidence suggests that liver resection using a radiofrequency dissecting sealer may be associated with more adverse events than with the clamp-crush method. Low-quality evidence also suggests that the proportion of people requiring a blood transfusion is higher with low central venous pressure than with acute normovolemic haemodilution plus low central venous pressure; very low-quality evidence suggests that blood transfusion quantity (red blood cells) was lower with fibrin sealant than control; blood transfusion quantity (fresh frozen plasma) was higher with oxidised cellulose than with fibrin sealant; and blood loss, total hospital stay, and operating time were lower with low central venous pressure than with control. There is no evidence to suggest that using special equipment for liver resection is of any benefit in decreasing the mortality, morbidity, or blood transfusion requirements (very low-quality evidence). Radiofrequency dissecting sealer should not be used outside the clinical trial setting since there is low-quality evidence for increased harm without any evidence of benefits. In addition, it should be noted that the sample size was small and the credible intervals were wide, and we cannot rule out considerable benefit or harm with a specific method of liver resection.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We identified 67 randomised clinical trials involving a total of 6197 participants that met our inclusion criteria. However, we were only able to include 5771 participants from 64 trials since investigators either did not include the remaining participants in the analysis or did not report any outcomes of interest.\nSource of funding: 24 trials (35.8%) were funded by parties with no financial interest in obtaining positive results for the treatment being evaluated. The remaining trials received funding from either parties who would gain financially from the results of the study or did not report the funding."
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"content": "Abstract: Background\nEight out of 10 major antihypertensive trials in older adults attempted to achieve a target systolic blood pressure (BP) less than 160 mmHg. Collectively these trials demonstrated benefit for treatment, as compared to no treatment, for an older adult with BP greater than 160 mmHg. However an even lower BP target of less than 140 mmHg is commonly applied to all age groups. At the present time it is not known whether a lower or higher BP target is associated with better cardiovascular outcomes in older adults.\nObjectives\nTo assess the effects of a higher (less than 150 to 160/95 to 105 mmHg) BP target compared to the lower BP target of less than 140/90 mmHg in hypertensive adults 65 years of age or older.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to February 2017: the Cochrane Hypertension Specialised Register, MEDLINE, Embase, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We also contacted authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nRandomised trials, of at least one year's duration, conducted on hypertensive adults aged 65 years or older, which report the effect on mortality and morbidity of a higher systolic or diastolic BP treatment target (whether ambulatory, home, or office measurements) in the range of systolic BP less than 150 to 160 mmHg or diastolic BP less than 95 to 105 mmHg as compared to a lower BP treatment target of less than 140/90 mmHg or lower.\nData collection and analysis\nTwo authors independently screened and selected trials for inclusion, assessed risk of bias, and extracted data. We combined data for dichotomous outcomes using the risk ratio (RR) with 95% confidence interval (CI) and for continuous outcomes we used mean difference (MD). Primary outcomes were all-cause mortality, stroke, institutionalisation, and cardiovascular serious adverse events. Secondary outcomes included cardiovascular mortality, non-cardiovascular mortality, unplanned hospitalisation, each component of cardiovascular serious adverse events separately (including cerebrovascular disease, cardiac disease, vascular disease, and renal failure), total serious adverse events, total minor adverse events, withdrawals due to adverse effects, systolic BP achieved, and diastolic BP achieved.\nMain results\nWe found and included three unblinded randomised trials in 8221 older adults (mean age 74.8 years), in which higher BP targets of less than 150/90 mmHg (two trials) and less than 160/90 mmHg (one trial) were compared to a lower target of less than 140/90 mmHg. Treatment to the two different BP targets over two to four years failed to produce a difference in any of our primary outcomes, including all-cause mortality (RR 1.24 95% CI 0.99 to 1.54), stroke (RR 1.25 95% CI 0.94 to 1.67) and total cardiovascular serious adverse events (RR 1.19 95% CI 0.98 to 1.45). However, the 95% confidence intervals of these outcomes suggest the lower BP target is probably not worse, and might offer a clinically important benefit. We judged all comparisons to be based on low-quality evidence. Data on adverse effects were not available from all trials and not different, including total serious adverse events, total minor adverse events, and withdrawals due to adverse effects.\nAuthors' conclusions\nAt the present time there is insufficient evidence to know whether a higher BP target (less than150 to 160/95 to 105 mmHg) or a lower BP target (less than 140/90 mmHg) is better for older adults with high BP. Additional good-quality trials assessing BP targets in this population are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Elevated BP in older adults is common and higher pressures increase the risk of adverse health events such as stroke, heart attack, heart failure, and death. Lowering BP with drugs has been shown to reduce the risk of these serious health events but the optimal BP target when treating older adults is not known."
}
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[
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"role": "user",
"content": "Abstract: Background\nThis review is an update of a previously published review in the Cochrane Database of Systematic Reviews (2010, Issue 9 and 2013, Issue 6). Epithelial ovarian cancer accounts for about 90% of all cases of ovarian cancer. Debulking surgery and six courses of platinum-based chemotherapy results in complete clinical remission (CCR) in up to 75% of cases. However, 75% of the responders will relapse within a median time of 18 to 28 months and only 20% to 40% of women will survive beyond five years. It has been suggested that maintenance chemotherapy could assist in prolonging remission. To date, there has not been a systematic review on the impact of maintenance chemotherapy for epithelial ovarian cancer.\nObjectives\nTo assess the effectiveness and toxicity of maintenance chemotherapy for epithelial ovarian cancer and to evaluate the impact on quality of life (QoL).\nSearch methods\nIn the original review we searched the Cochrane Gynaecological Cancer Review Group Specialised Register, Cochrane Central Register of Controlled Trails (CENTRAL, the Cochrane Library 2009, Issue 1), MEDLINE, Embase, PubMed, CBMdisc, CNKI and VIP (to May 2009). We collected information from ongoing trials, checked reference lists of published articles and consulted experts in the field. For the first update the searches were extended to October 2012 and for this update to February 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing maintenance chemotherapy with no further intervention, maintenance radiotherapy or other maintenance therapy.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and quality and extracted data. We analysed overall survival (OS) and progression-free survival (PFS) rates as dichotomous variables. Toxicity and QoL data were extracted where present. All analyses were based on intention-to-treat (ITT) on the endpoint of survival. We also analysed data by subgroups of drugs.\nMain results\nNo new studies were found for inclusion in this update from the latest searches. We included eight trials (1644 women). When all chemotherapy regimens were combined, meta-analysis indicated no significant difference in three-, five- and 10-year OS or PFS. For five-year OS, the combined risk ratio (RR) was 1.03 (95% confidence interval (CI) 0.96 to 1.10; 4 studies, 899 participants; moderate-certainly evidence) and for the five-year PFS, the combined RR was 1.06 (95% CI 0.97 to 1.17; 3 studies, 761 participants; moderate-certainly evidence). Results were very similar when trials of different regimens were analysed. Comparing chemotherapy with radiotherapy, only the RR for 10-year PFS in pathological complete remission (PCR) was in favour of whole abdominal radiotherapy 0.51 (95% CI 0.27 to 1.00), while three- and five-year OS rates have no significant difference between the two groups.\nAuthors' conclusions\nThere is no evidence to suggest that the use of platinum agents, doxorubicin or paclitaxel used as maintenance chemotherapy is more effective than observation alone. Further investigations regarding the effect of paclitaxel used as maintenance chemotherapy are required.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The aim of this review was to estimate whether using maintenance chemotherapy is better than observation alone for women with epithelial ovarian cancer."
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"content": "Abstract: Background\nPlatelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.\nThis is an update of a Cochrane review first published in 2004, and updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews; this review compares different platelet transfusion doses.\nObjectives\nTo determine whether different doses of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect their efficacy and safety in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy with or without haematopoietic stem cell transplantation (HSCT).\nSearch methods\nWe searched for randomised controlled trials in the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 6), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 23 July 2015.\nSelection criteria\nRandomised controlled trials involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with malignant haematological disorders or undergoing HSCT that compared different platelet component doses (low dose 1.1 x 1011/m2 ± 25%, standard dose 2.2 x 1011/m2 ± 25%, high dose 4.4 x 1011/m2 ± 25%).\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included seven trials (1814 participants) in this review; six were conducted during one course of treatment (chemotherapy or HSCT).\nOverall the methodological quality of studies was low to moderate across different outcomes according to GRADE methodology. None of the included studies were at low risk of bias in every domain, and all the included studies had some threats to validity.\nFive studies reported the number of participants with at least one clinically significant bleeding episode within 30 days from the start of the study. There was no difference in the number of participants with a clinically significant bleeding episode between the low-dose and standard-dose groups (four studies; 1170 participants; risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.13; moderate-quality evidence); low-dose and high-dose groups (one study; 849 participants; RR 1.02, 95% CI 0.93 to 1.11; moderate-quality evidence); or high-dose and standard-dose groups (two studies; 951 participants; RR 1.02, 95% CI 0.93 to 1.11; moderate-quality evidence).\nThree studies reported the number of days with a clinically significant bleeding event per participant. There was no difference in the number of days of bleeding per participant between the low-dose and standard-dose groups (two studies; 230 participants; mean difference -0.17, 95% CI -0.51 to 0.17; low quality evidence). One study (855 participants) showed no difference in the number of days of bleeding per participant between high-dose and standard-dose groups, or between low-dose and high-dose groups (849 participants).\nThree studies reported the number of participants with severe or life-threatening bleeding. There was no difference in the number of participants with severe or life-threatening bleeding between a low-dose and a standard-dose platelet transfusion policy (three studies; 1059 participants; RR 1.33, 95% CI 0.91 to 1.92; low-quality evidence); low-dose and high-dose groups (one study; 849 participants; RR 1.20, 95% CI 0.82 to 1.77; low-quality evidence); or high-dose and standard-dose groups (one study; 855 participants; RR 1.11, 95% CI 0.73 to 1.68; low-quality evidence).\nTwo studies reported the time to first bleeding episodes; we were unable to perform a meta-analysis. Both studies (959 participants) individually found that the time to first bleeding episode was either the same, or longer, in the low-dose group compared to the standard-dose group. One study (855 participants) found that the time to the first bleeding episode was the same in the high-dose group compared to the standard-dose group.\nThree studies reported all-cause mortality within 30 days from the start of the study. There was no difference in all-cause mortality between treatment arms (low-dose versus standard-dose: three studies; 1070 participants; RR 2.04, 95% CI 0.70 to 5.93; low-quality evidence; low-dose versus high-dose: one study; 849 participants; RR 1.33, 95% CI 0.50 to 3.54; low-quality evidence; and high-dose versus standard-dose: one study; 855 participants; RR 1.71, 95% CI 0.51 to 5.81; low-quality evidence).\nSix studies reported the number of platelet transfusions; we were unable to perform a meta-analysis. Two studies (959 participants) out of three (1070 participants) found that a low-dose transfusion strategy led to more transfusion episodes than a standard-dose. One study (849 participants) found that a low-dose transfusion strategy led to more transfusion episodes than a high-dose strategy. One study (855 participants) out of three (1007 participants) found no difference in the number of platelet transfusions between the high-dose and standard-dose groups.\nOne study reported on transfusion reactions. This study's authors suggested that a high-dose platelet transfusion strategy may lead to a higher rate of transfusion-related adverse events.\nNone of the studies reported quality-of-life.\nAuthors' conclusions\nIn haematology patients who are thrombocytopenic due to myelosuppressive chemotherapy or HSCT, we found no evidence to suggest that a low-dose platelet transfusion policy is associated with an increased bleeding risk compared to a standard-dose or high-dose policy, or that a high-dose platelet transfusion policy is associated with a decreased risk of bleeding when compared to a standard-dose policy.\nA low-dose platelet transfusion strategy leads to an increased number of transfusion episodes compared to a standard-dose strategy. A high-dose platelet transfusion strategy does not decrease the number of transfusion episodes per participant compared to a standard-dose regimen, and it may increase the number of transfusion-related adverse events.\nFindings from this review would suggest a change from current practice, with low-dose platelet transfusions used for people receiving in-patient treatment for their haematological disorder and high-dose platelet transfusion strategies not being used routinely.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Overall, platelet transfusions containing smaller number of platelets appeared to have similar effects to platelet transfusions containing larger numbers of platelets. There was no difference in the number of participants who bled, the frequency of bleeding, or the severity of bleeding between participants receiving a low, standard, or high number of platelets within each platelet transfusion. This was unaffected by the participant's age (children or adults), underlying treatment, or diagnosis.\nThere was a clear increase in the number of platelet transfusion episodes in the low-dose group, compared to the standard-dose and high-dose groups. A high-dose transfusion strategy did not lead to a decrease in the number of transfusion episodes in the largest study.\nA high-dose transfusion strategy may lead to an increase in transfusion-related adverse events compared to a standard-dose or low-dose strategy.\nNone of the seven studies reported any quality-of-life outcomes."
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"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane review published in 2015.\nAround half of people with epilepsy will not achieve seizure freedom on their first antiepileptic drug; many will require add-on therapy. Around a third of people fail to achieve complete seizure freedom despite multiple antiepileptic drugs. Lacosamide has been licenced as an add-on therapy for drug-resistant focal epilepsy.\nObjectives\nTo evaluate the efficacy and tolerability of lacosamide as an add-on therapy for children and adults with drug-resistant focal epilepsy.\nSearch methods\nWe searched the following databases (22 August 2019): the Cochrane Register of Studies (CRS Web), including the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid, 1946 to 20 August 2019), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP), with no language restrictions. We contacted UCB Pharma (sponsors of lacosamide).\nSelection criteria\nRandomised controlled trials of add-on lacosamide in people with drug-resistant focal epilepsy.\nData collection and analysis\nWe used standard Cochrane methodology, assessing the following outcomes: 50% or greater reduction in seizure frequency; seizure freedom; treatment withdrawal; adverse events; quality of life; and cognitive changes. The primary analyses were intention-to-treat. We estimated summary risk ratios (RR) for each outcome presented with 99% confidence intervals (CI), except for 50% or greater seizure reduction, seizure freedom and treatment withdrawal which were presented with 95% CIs. We performed subgroup analyses according to lacosamide dose and sensitivity analyses according to population age, whereby data from children were excluded from the meta-analysis.\nMain results\nWe included five trials (2199 participants). The risk of bias for all studies was low to unclear. All studies were placebo-controlled and assessed doses from 200 mg to 600 mg per day. One study evaluated lacosamide in children; all other studies were in adults. Trial duration ranged from 24 to 26 weeks. All studies used adequate methods of randomisation and were double-blind. Overall, the certainty of the evidence for the outcomes was judged as moderate to high, with the exception of seizure freedom which was low.\nThe RR for a 50% or greater reduction in seizure frequency for all doses of lacosamide compared with placebo was 1.79 (95% CI 1.55 to 2.08; 5 studies; 2199 participants; high-certainty evidence). The RR for seizure freedom for all doses of lacosamide compared with placebo was 2.27 (95% CI 1.35 to 3.83; 5 studies; 2199 participants; low-certainty evidence). The RR for treatment withdrawal for all doses of lacosamide compared with placebo was 1.57 (95% CI 1.24 to 1.98; 5 studies; 2199 participants; moderate-certainty evidence).\nThe estimated effect size for most outcomes did not change considerably following sensitivity analysis. For seizure freedom, however, the RR nearly doubled upon the exclusion of data from children (RR 4.04, 95% CI 1.52 to 10.73).\nAdverse events associated with lacosamide included: abnormal co-ordination (RR 6.12, 99% CI 1.35 to 27.77), blurred vision (RR 4.65, 99% CI 1.24 to 17.37), diplopia (RR 5.59, 99% CI 2.27 to 13.79), dizziness (RR 2.96, 99% CI 2.09 to 4.20), nausea (RR 2.35, 99% CI 1.37 to 4.02), somnolence (RR 2.04, 99% CI 1.22 to 3.41), vomiting (RR 2.94, 99% CI 1.54 to 5.64), and number of participants experiencing one or more adverse events (RR 1.12, 99% CI 1.01 to 1.24).\nAdverse events that were not significant were: vertigo (RR 3.71, 99% CI 0.86 to 15.95), rash (RR 0.58, 99% CI 0.17 to 1.89), nasopharyngitis (RR 1.41, 99% CI 0.87 to 2.28), headache (RR 1.34, 99% CI 0.90 to 1.98), fatigue (RR 2.11, 99% CI 0.92 to 4.85), nystagmus (RR 1.47, 99% CI 0.61 to 3.52), and upper respiratory tract infection (RR 0.70, 99% CI 0.43 to 1.15).\nAuthors' conclusions\nLacosamide is effective and well-tolerated in the short term when used as add-on treatment for drug-resistant focal epilepsy. Lacosamide increases the number of people with 50% or greater reduction in seizure frequency and may increase seizure freedom, compared to placebo. Higher doses of lacosamide may be associated with higher rates of adverse events and treatment withdrawal. Additional evidence is required assessing the use of lacosamide in children and on longer-term efficacy and tolerability.\n\nGiven the provided abstract, please respond to the following query: \"Studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included five trials with a total of 2199 participants with drug-resistant focal epilepsy. Four trials included adults (aged 16 to 70), and one trial included children (aged 4 to 16). Across the five trials, people were split into two groups and given either lacosamide or a sugar pill (placebo), in addition to their existing antiepileptic medication."
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[
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"role": "user",
"content": "Abstract: Background\nAnti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis.\nObjectives\nThe primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching.\nSelection criteria\nWe included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane.\nMain results\nThis review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high.\nThere was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%.\nIn terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials.\nAuthors' conclusions\nOral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low.\nThe decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.\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"
},
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"content": "we included evidence published up to 29 August 2019."
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{
"role": "user",
"content": "Abstract: Background\nCOVID-19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well.\nObjectives\nTo assess the benefits and harms of antimicrobial mouthwashes and nasal sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection.\nSearch methods\nInformation Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.\nSelection criteria\nThis is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.\nWe sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature).\nAuthors' conclusions\nWe identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof.\nVery few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.\n\nGiven the provided abstract, please respond to the following query: \"How-up-to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We last searched for evidence on 1 June 2020. This review covered research that was available up to that date, but did not consider any evidence that may have been produced since then."
}
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query-laysum
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22330
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[
{
"role": "user",
"content": "Abstract: Background\nTypical and atypical antipsychotics are widely used to treat agitation and psychosis in dementia. However, whether or not they are beneficial is uncertain. Some trials have yielded negative results and effectiveness may be outweighed by harms.\nObjectives\nTo assess the efficacy and safety of antipsychotics for the treatment of agitation and psychosis in people with Alzheimer's disease and vascular dementia.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid Sp), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register, and the International Clinical Trials Registry Portal on 7 January 2021. Two review authors independently screened the title and abstract of the hits, and two review authors assessed the full text of studies that got through this screening.\nSelection criteria\nWe included randomised, placebo-controlled, parallel-arm trials comparing the effects of antipsychotics and placebo for the treatment of agitation or psychosis in people with dementia due to Alzheimer's disease or vascular dementia, or both, irrespective of age, severity of cognitive impairment, and setting. (The majority of) participants had to have clinically significant agitation (including aggression) or psychosis or both at baseline. We excluded studies about antipsychotics that are no longer available in the USA or EU, or that are used for emergency short-term sedation. We also excluded head-to-head trials and antipsychotic withdrawal trials.\nData collection and analysis\nThe primary outcomes were (1) reduction in agitation or psychosis in participants with agitation or psychosis, respectively at baseline, and (2) the number of participants with adverse events: somnolence, extrapyramidal symptoms, any adverse event, any serious adverse event (SAE), and death.\nTwo review authors independently extracted the necessary data and assessed risk of bias with the Cochrane risk of bias tool. We calculated the pooled effect on agitation and psychosis for typical and atypical antipsychotics separately, and the pooled risk of adverse effects independent of the target symptom (agitation or psychosis). We used RevMan Web for the analyses.\nMain results\nThe search yielded 8233 separate hits. After assessing the full-text of 35 studies, we included 24 trials that met the eligibility criteria. Six trials tested a typical antipsychotic, four for agitation and two for psychosis. Twenty trials tested an atypical antipsychotic, eight for agitation and 12 for psychosis. Two trials tested both drug types. Seventeen of 26 comparisons were performed in patients with Alzheimer’s disease specifically. The other nine comparisons also included patients with vascular dementia or mixed dementia. Together, the studies included 6090 participants (12 to 652 per study). The trials were performed in institutionalised, hospitalised and community-dwelling patients, or a combination of those.\nFor typical antipsychotics (e.g. haloperidol, thiothixene), we are uncertain whether these drugs improve agitation compared with placebo (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -0.57 to -0.15, 4 studies, n = 361); very low-certainty evidence, but typical antipsychotics may improve psychosis slightly (SMD -0.29, 95% CI -0.55 to -0.03, 2studies, n= 240; low-certainty evidence) compared with placebo. These drugs probably increase the risk of somnolence (risk ratio (RR) 2.62, 95% CI 1.51 to 4.56, 3 studies, n = 466; moderate-certainty evidence) and increase extrapyramidal symptoms (RR 2.26, 95% CI 1.58 to 3.23, 3 studies, n = 467; high-certainty) evidence. There was no evidence regarding the risk of any adverse event. The risks of SAEs (RR 1.32, 95% CI 0.65 to 2.66, 1 study, n = 193) and death (RR 1.46, 95% CI 0.54 to 4.00, 6 studies, n = 578) may be increased slightly, but these estimates were very imprecise, and the certainty was low. The effect estimates for haloperidol from five trials were in line with those of the drug class.\nAtypical antipsychotics (e.g. risperidone, olanzapine, aripiprazole, quetiapine) probably reduce agitation slightly (SMD -0.21, 95% CI -0.30 to -0.12, 7 studies, n = 1971; moderate-certainty evidence), but probably have a negligible effect on psychosis (SMD -0.11, 95% CI -0.18 to -0.03, 12 studies, n = 3364; moderate-certainty evidence). These drugs increase the risk of somnolence (RR 1.93, 95% CI 1.57 to 2.39, 13 studies, n - 3878; high-certainty evidence) and are probably also associated with slightly increased risk of extrapyramidal symptoms (RR 1.39, 95% CI 1.14 to 1.68, 15 studies, n = 4180; moderate-certainty evidence), serious adverse events (RR 1.32, 95% CI 1.09 to 1.61, 15 studies, n= 4316; moderate-certainty evidence) and death (RR 1.36, 95% CI 0.90 to 2.05, 17 studies, n= 5032; moderate-certainty evidence), although the latter estimate was imprecise. The drugs probably have a negligible effect on the risk of any adverse event (RR 1.05, 95% CI 1.02 to 1.09, 11 studies, n = 2785; moderate-certainty evidence). The findings from seven trials for risperidone were in line with those for the drug class.\nAuthors' conclusions\nThere is some evidence that typical antipsychotics might decrease agitation and psychosis slightly in patients with dementia. Atypical antipsychotics reduce agitation in dementia slightly, but their effect on psychosis in dementia is negligible. The apparent effectiveness of the drugs seen in daily practice may be explained by a favourable natural course of the symptoms, as observed in the placebo groups. Both drug classes increase the risk of somnolence and other adverse events. If antipsychotics are considered for sedation in patients with severe and dangerous symptoms, this should be discussed openly with the patient and legal representative.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, our confidence in the evidence about typical antipsychotics is limited and our confidence in the evidence about atypical antipsychotics moderate. Typical antipsychotics have been investigated in just a few studies. In addition, the studies about typical and atypical antipsychotics did not always use the best methods to carry out their investigations, or did not report the results. Consequently, the effects on agitation or psychosis may have been overestimated, and the effects on adverse events underestimated."
}
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[
{
"role": "user",
"content": "Abstract: Background\nOsteomyelitis (both acute and chronic) is one of the most common infectious complications in people with sickle cell disease. 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 osteomyelitis. This is an update of a previously published Cochrane Review.\nObjectives\nTo determine whether an empirical antibiotic treatment approach (monotherapy or combination therapy) is effective and safe as compared to pathogen-directed antibiotic treatment and whether this effectiveness and safety is dependent on different treatment regimens, age or setting.\nSearch methods\nWe searched The Group's Haemoglobinopathies Trials Register, which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also searched the LILACS database (1982 to 20 October 2016), African Index Medicus (20 October 2016), ISI Web of Knowledge (20 October 2016) and clinical trials registries (19 September 2019).\nDate of most recent search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register: 18 September 2019.\nSelection criteria\nWe searched for published or unpublished randomised and quasi-randomised controlled trials.\nData collection and analysis\nEach author intended to independently extract data and assess trial quality by standard Cochrane methodologies, but no eligible randomised controlled trials were identified.\nMain results\nThis update was unable to find any randomised or quasi-randomised controlled trials on antibiotic treatment approaches for osteomyelitis in people with sickle cell disease.\nAuthors' conclusions\nWe were unable to identify any relevant trials on the efficacy and safety of the antibiotic treatment approaches for people with sickle cell disease suffering from osteomyelitis. Randomised controlled trials are needed to establish the optimum antibiotic treatment for this condition, however, we do not envisage further trials of this intervention will be conducted, and hence the review will no longer be regularly updated.\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 conclude that a randomised controlled trial should attempt to answer these questions, however, we do not envisage further trials of this intervention will be conducted, and hence the review will no longer be regularly updated."
}
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query-laysum
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22332
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[
{
"role": "user",
"content": "Abstract: Background\nAsymptomatic retinal breaks and lattice degeneration are visible lesions that are risk factors for later retinal detachment. Retinal detachments occur when fluid in the vitreous cavity passes through tears or holes in the retina and separates the retina from the underlying retinal pigment epithelium. Creation of an adhesion surrounding retinal breaks and lattice degeneration, with laser photocoagulation or cryotherapy, has been recommended as an effective means of preventing retinal detachment. This therapy is of value in the management of retinal tears associated with the symptoms of flashes and floaters and persistent vitreous traction upon the retina in the region of the retinal break, because such symptomatic retinal tears are associated with a high rate of progression to retinal detachment. Retinal tears and holes unassociated with acute symptoms and lattice degeneration are significantly less likely to be the sites of retinal breaks that are responsible for later retinal detachment. Nevertheless, treatment of these lesions frequently is recommended, in spite of the fact that the effectiveness of this therapy is unproven.\nObjectives\nThe objective of this review was to assess the effectiveness and safety of techniques used to treat asymptomatic retinal breaks and lattice degeneration for the prevention of retinal detachment.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 2), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to February 2014), EMBASE (January 1980 to February 2014), PubMed (January 1948 to February 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 19 February 2014. Textbooks regarding retinal detachment and the reference lists of relevant reports were reviewed for additional study reports. We contacted experts in the field for details of other published and unpublished studies.\nSelection criteria\nThis review was designed to include randomized controlled trials in which one treatment for asymptomatic retinal breaks and lattice degeneration was compared with another treatment or no treatment.\nData collection and analysis\nInitially, one author assessed the search results and collected relevant studies. Since no studies met the inclusion criteria, no studies were assessed for risk of bias. No data were extracted and no meta-analysis could be performed.\nMain results\nNo trials were found that met the inclusion criteria for this review.\nAuthors' conclusions\nNo conclusions could be reached about the effectiveness of surgical interventions to prevent retinal detachment in eyes with asymptomatic retinal breaks or lattice degeneration, or both. Current recommendations for treatment, based upon a consensus of expert opinion, should be assessed in a randomized controlled trial.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about whether treatment of retinal breaks (holes or tears in the retina) and retinal lattice degeneration (thinning and atrophy of retinal tissue) can prevent retinal detachment, a serious vision-threatening problem."
}
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query-laysum
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22333
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[
{
"role": "user",
"content": "Abstract: Background\nPreterm birth remains the major risk factor for the development of intraventricular haemorrhage, an injury that occurs in 25% of very low birth weight infants. Intraventricular haemorrhage is thought to be venous in origin and intrinsic thromboses in the germinal matrix are likely to play a triggering role. Heparin activates antithrombin and promotes the inactivation of thrombin and other target proteinases. The administration of anticoagulants such as heparin may offset the increased risk of developing intraventricular haemorrhage and may also reduce the risk of developing parenchymal venous infarct, a condition known to complicate intraventricular haemorrhage.\nObjectives\nTo assess whether the prophylactic administration of heparin reduces the incidence of germinal matrix-intraventricular haemorrhage in very preterm neonates when compared to placebo, no treatment, or other anticoagulants.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015), MEDLINE (1996 to 22 November 2015), EMBASE (1980 to 22 November 2015) and CINAHL (1982 to 22 November 2015), applying no language restrictions. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015.\nSelection criteria\nRandomised controlled trials, quasi-randomised controlled trials and cluster trials comparing the administration of early, i.e. within the first 24 hours of life, heparin in very preterm infants (gestational age < 32 weeks).\nData collection and analysis\nFor each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, dose of heparin, mode of administration, and duration of therapy, etc.) and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow up). The primary outcomes considered in this review are intraventricular haemorrhage, severe intraventricular haemorrhage and neonatal mortality.\nMain results\nTwo randomised controlled trials enrolling a total of 155 infants met the inclusion criteria of this review. Both trials compared low-dose heparin to the same solution without heparin in very preterm newborns requiring umbilical catheterisation. No trials were identified that specifically studied the use of heparin in infants at risk of germinal matrix-intraventricular haemorrhage.\nWe found no differences in the rates of intraventricular haemorrhage (typical RR 0.93, 95% CI 0.61 to 1.41; typical RD −0.03, 95% CI −0.17 to 0.12; 2 studies, 155 infants; I² = 57% for RR and I² = 65% for RD), severe intraventricular haemorrhage (typical RR 1.01, 95% CI 0.46 to 2.23; typical RD 0.00, 95% CI −0.11 to 0.11; 2 studies, 155 infants; I² = 0% for RR and I² = 0% for RD) and neonatal mortality (typical RR 0.69, 95% CI 0.28 to 1.67; typical RD −0.04, 95% CI −0.14 to 0.06; 2 studies, 155 infants; I² = 28% for RR and I² = 50% for RD). We judged the quality of the evidence supporting these findings as very low (rates of intraventricular haemorrhage) and low (severe intraventricular haemorrhage and neonatal mortality) mainly because of limitations in the study designs and the imprecision of estimates. We found very few data on other relevant outcomes, such as bronchopulmonary dysplasia, pulmonary haemorrhage and patent ductus arteriosus; and no study assessing long-term outcomes (e.g. neurodevelopmental disability).\nAuthors' conclusions\nThere is very limited data on the effect of prophylactic administration of heparin on the incidence and severity of IVH in very preterm neonates. Both the identified trials used heparin in the context of maintaining umbilical line patency and not specifically as an agent to prevent germinal matrix-intraventricular haemorrhage. Given the imprecision of our estimates, the results of this systematic review are consistent with either a benefit or a detrimental effect of heparin and do not provide a definitive answer to the review question. Limited evidence is available on other clinically relevant outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of this systematic review are consistent with either a benefit or a detrimental effect of heparin and do not provide a definitive answer to the review question."
}
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query-laysum
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22334
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[
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"role": "user",
"content": "Abstract: Background\nAbortion is common worldwide and increasingly abortions are performed at less than 14 weeks’ gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks’ gestation.\nObjectives\nPrimary objective\nTo determine if there is evidence of superiority of any particular pain relief regimen in the management of combination medical abortion (mifepristone + misoprostol) under 14 weeks' gestation (i.e. up to 13 + 6 weeks or 97 days).\nSecondary objectives\nTo compare the rate of gastrointestinal side effects resulting from different methods of analgesia\nTo compare the rate of complete abortion resulting from different methods of analgesia during medical abortion\nTo determine if the induction-to-abortion interval is associated with different methods of analgesia\nTo determine if any method of analgesia is associated with unscheduled contact with the care provider in relation to pain.\nSearch methods\nOn 21 August 2019 we searched CENTRAL, MEDLINE, Embase, CINAHL, LILACs, PsycINFO, the World Health Organization International Clinical Trials Registry and ClinicalTrials.gov together with reference checking and handsearching of conference abstracts of relevant learned societies and professional organisations to identify further studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and observational studies (non-randomised studies of interventions (NRSIs)) of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks’ gestation.\nData collection and analysis\nTwo review authors (JRW and MA) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion with a third and fourth author as required (CM and SC). Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked for accuracy. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included four RCTs and one NRSI. Due to the heterogeneity of study designs, interventions and outcome reporting, we were unable to perform meta-analysis for any of the primary or secondary outcomes in this review.\nOnly one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600 mg likely reduces the pain score when compared to a dose of paracetamol 2000 mg (mean difference (MD) 2.26 out of 10 lower, 95% confidence interval (CI) 3.00 to 1.52 lower; 1 RCT 108 women; moderate-certainty evidence).\nThere may be little to no difference in pain score when comparing pregabalin 300 mg with placebo (MD 0.5 out of 10 lower, 95% CI 1.41 lower to 0.41 higher; 1 RCT, 107 women; low-certainty evidence).\nThere may be little to no difference in pain score when comparing ibuprofen 800 mg with placebo (MD 1.4 out of 10 lower, 95% CI 3.33 lower to 0.53 higher; 1 RCT, 61 women; low-certainty evidence).\nAmbulation or non-ambulation during medical abortion treatment may have little to no effect on pain score, but the evidence is very uncertain (MD 0.1 out of 5 higher, 95% CI 0.26 lower to 0.46 higher; 1 NRSI, 130 women; very low-certainty evidence).\nThere may be little to no difference in pain score when comparing therapeutic versus prophylactic administration of ibuprofen 800 mg (MD 0.2 out of 10 higher, 95% CI 0.41 lower to 0.81 higher; 1 RCT, 228 women; low-certainty evidence).\nOther outcomes of interest were reported inconsistently across studies. Where these outcomes were reported, there was no evidence of difference in incidence of gastrointestinal side effects, complete abortion rate, interval between misoprostol administration to pregnancy expulsion, unscheduled contact with a care provider, patient satisfaction with analgesia regimen nor patient satisfaction with abortion experience overall. However, the certainty of evidence was very low to low.\nAuthors' conclusions\nThe findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600 mg was shown to be effective, and it was less certain whether 800 mg was effective. Paracetamol 2000 mg does not improve pain scores as much as ibuprofen 1600 mg, however its use does not appear to cause greater frequency of side effects or reduce the success of the abortion.\nA single dose of pregabalin 300 mg does not affect pain scores during medical abortion, but like paracetamol, does not appear to cause harm. Ambulation or non-ambulation during the medical abortion procedure does not appear to affect pain scores, outcomes, or duration of treatment and so women can be advised to mobilise or not, as they wish.\nThe majority of outcomes in this review had low- to very low-certainty evidence, primarily due to small sample sizes and two studies at high risk of bias. High-quality, large-scale RCT research is needed for pain management during medical abortion at gestations less than 14 weeks. Consistent recording of pain with a validated measure would be of value to the field going forward.\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 looked for studies that compared different pain relief treatments for medical abortion in the first 14 weeks of pregnancy.\n"
}
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query-laysum
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22335
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[
{
"role": "user",
"content": "Abstract: Background\nPrimary angle closure glaucoma (PACG) accounts for 50% of glaucoma blindness worldwide. More than three-quarters of individuals with PACG reside in Asia. In these populations, PACG often develops insidiously leading to chronically raised intraocular pressure and optic nerve damage, which is often asymptomatic. Non-contact tests to identify people at risk of angle closure are relatively quick and can be carried out by appropriately trained healthcare professionals or technicians as a triage test. If the test is positive, the person will be referred for further specialist assessment.\nObjectives\nTo determine the diagnostic accuracy of non-contact tests (limbal anterior chamber depth (LACD) (van Herick test); oblique flashlight test; scanning peripheral anterior chamber depth analyser (SPAC), Scheimpflug photography; anterior segment optical coherence tomography (AS-OCT), for identifying people with an occludable angle.\nSearch methods\nWe searched the following bibliographic databases 3 October 2019: CENTRAL; MEDLINE; Embase; BIOSIS; OpenGrey; ARIF and clinical trials registries. The searches were limited to remove case reports. There were no date or language restrictions in the searches.\nSelection criteria\nWe included prospective and retrospective cross-sectional, cohort and case-control studies conducted in any setting that evaluated the accuracy of one or more index tests for identifying people with an occludable angle compared to a gonioscopic reference standard.\nData collection and analysis\nTwo review authors independently performed data extraction and quality assessment using QUADAS2 for each study. For each test, 2 x 2 tables were constructed and sensitivity and specificity were calculated. When four or more studies provided data at fixed thresholds for each test, we fitted a bivariate model using the METANDI function in STATA to calculate pooled point estimates for sensitivity and specificity. For comparisons between index tests and subgroups, we performed a likelihood ratio test comparing the model with and without the covariate.\nMain results\nWe included 47 studies involving 26,151 participants and analysing data from 23,440. Most studies were conducted in Asia (36, 76.6%). Twenty-seven studies assessed AS-OCT (analysing 15,580 participants), 17 studies LACD (7385 participants), nine studies Scheimpflug photography (1616 participants), six studies SPAC (5239 participants) and five studies evaluated the oblique flashlight test (998 participants). Regarding study quality, 36 of the included studies (76.6%) were judged to have a high risk of bias in at least one domain.The use of a case-control design (13 studies) or inappropriate exclusions (6 studies) raised patient selection concerns in 40.4% of studies and concerns in the index test domain in 59.6% of studies were due to lack of masking or post-hoc determination of optimal thresholds. Among studies that did not use a case-control design, 16 studies (20,599 participants) were conducted in a primary care/community setting and 18 studies (2590 participants) in secondary care settings, of which 15 investigated LACD.\nSummary estimates were calculated for commonly reported parameters and thresholds for each test; LACD ≤ 25% (16 studies, 7540 eyes): sensitivity 0.83 (95% confidence interval (CI) 0.74, 0.90), specificity 0.88 (95% CI 0.84, 0.92) (moderate-certainty); flashlight (grade1) (5 studies, 1188 eyes): sensitivity 0.51 (95% CI 0.25, 0.76), specificity 0.92 (95% CI 0.70, 0.98) (low-certainty); SPAC (≤ 5 and/or S or P) (4 studies, 4677 eyes): sensitivity 0.83 (95% CI 0.70, 0.91), specificity 0.78 (95% CI 0.70, 0.83) (moderate-certainty); Scheimpflug photography (central ACD) (9 studies, 1698 eyes): sensitivity 0.92 (95% CI 0.84, 0.96), specificity 0.86 (95% CI 0.76, 0.93) (moderate-certainty); AS-OCT (subjective opinion of occludability) (13 studies, 9242 eyes): sensitivity 0.85 (95% CI 0.76, 0.91); specificity 0.71 (95% CI 0.62, 0.78) (moderate-certainty).\nFor comparisons of sensitivity and specificity between index tests we used LACD (≤ 25%) as the reference category. The flashlight test (grade 1 threshold) showed a statistically significant lower sensitivity than LACD (≤ 25%), whereas AS-OCT (subjective judgement) had a statistically significant lower specificity. There were no statistically significant differences for the other index test comparisons. A subgroup analysis was conducted for LACD (≤ 25%), comparing community (7 studies, 14.4% prevalence) vs secondary care (7 studies, 42% prevalence) settings. We found no evidence of a statistically significant difference in test performance according to setting.\nPerforming LACD on 1000 people at risk of angle closure with a prevalence of occludable angles of 10%, LACD would miss about 17 cases out of the 100 with occludable angles and incorrectly classify 108 out of 900 without angle closure.\nAuthors' conclusions\nThe finding that LACD performed as well as index tests that use sophisticated imaging technologies, confirms the potential for this test for case-detection of occludable angles in high-risk populations. However, methodological issues across studies may have led to our estimates of test accuracy being higher than would be expected in standard clinical practice. There is still a need for high-quality studies to evaluate the performance of non-invasive tests for angle assessment in both community-based and secondary care settings.\n\nGiven the provided abstract, please respond to the following query: \"How reliable were the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most studies were of low quality due to the way that the participants were recruited or how the tests were performed. This could have led to the tests appearing more accurate than what they really are. We can therefore not be sure that the tests will always produce the reported results."
}
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query-laysum
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22336
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[
{
"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: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Botulism is a serious illness that starts suddenly and causes paralysis (an inability to use muscles). The cause of botulism is a germ called Clostridium botulinum. If the illness is left untreated, many people with botulism will die. There are four main types of botulism: adult and infant types where the intestine (gut) is infected; botulism from contaminated food; and wound botulism.\nWe searched for clinical trials of medical treatments for any of the four major types of botulism. We assessed the effects of treatment on the rate of deaths in hospital from any cause within four weeks of infection. We were also interested in deaths within 12 weeks, length of hospital stay, the need for a ventilator to help with breathing (mechanical ventilation), feeding by tube, and harmful events of treatment."
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22337
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[
{
"role": "user",
"content": "Abstract: Background\nRecognition of some of the limitations of titanium plates and screws used for the fixation of bones has led to the development of plates manufactured from bioresorbable materials. Whilst resorbable plates appear to offer clinical advantages over metal plates in orthognathic surgery, concerns remain about the stability of fixation and the length of time required for their degradation and the possibility of foreign body reactions. This review compares the use of titanium versus bioresorbable plates in orthognathic surgery and is an update of the Cochrane Review first published in 2007.\nObjectives\nTo compare the effects of bioresorbable fixation systems with titanium systems used during orthognathic surgery.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 20 January 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11) in the Cochrane Library (searched 20 January 2017); MEDLINE Ovid (1946 to 20 January 2017); and Embase Ovid (1980 to 20 January 2017). We searched the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov; searched 20 January 2017), and the World Health Organization International Clinical Trials Registry Platform (searched 20 January 2017) for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials comparing bioresorbable versus titanium fixation systems used for orthognathic surgery in adults.\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. We resolved disagreement by discussion. Clinical heterogeneity between the included trials precluded pooling of data, and only a descriptive summary is presented.\nMain results\nThis review included two trials, involving 103 participants, one comparing titanium with resorbable plates and screws and the other titanium with resorbable screws. Both studies were at high risk of bias and provided very limited data for the primary outcomes of this review. All participants in one trial suffered mild to moderate postoperative discomfort with no statistically significant difference between the two plating groups at different follow-up times. Mean scores of patient satisfaction were 7.43 to 8.63 (range 0 to 10) with no statistically significant difference between the two groups throughout follow-up. Adverse effects reported in one study were two plate exposures in each group occurring between the third and ninth months. Plate exposures occurred mainly in the posterior maxillary region, except for one titanium plate exposure in the mandibular premolar region. Known causes of infection were associated with loosened screws and wound dehiscence with no statistically significant difference in the infection rate between titanium (3/196), and resorbable (3/165) plates.\nAuthors' conclusions\nWe do not have sufficient evidence to determine if titanium plates or resorbable plates are superior for fixation of bones after orthognathic surgery. This review provides insufficient evidence to show any difference in postoperative pain and discomfort, level of patient satisfaction, plate exposure or infection for plate and screw fixation using either titanium or resorbable materials.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included two studies that analysed a total of 103 participants. The evidence in this review is up to date as of 20 January 2017. Study participants were adults older than 16 years of age. One study compared titanium with resorbable plates and screws and the other titanium with resorbable screws. One study was conducted in China, the other in Germany."
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22338
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[
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"role": "user",
"content": "Abstract: Background\nStimulus deprivation amblyopia (SDA) develops due to an obstruction to the passage of light secondary to a condition such as cataract. The obstruction prevents formation of a clear image on the retina. SDA can be resistant to treatment, leading to poor visual prognosis. SDA probably constitutes less than 3% of all amblyopia cases, although precise estimates of prevalence are unknown. In high-income countries, most people present under the age of one year; in low- to middle-income countries, people are likely to be older at the time of presentation. The mainstay of treatment is correction of the obstruction (e.g., removal of the cataract) and then occlusion of the better-seeing eye, but regimens vary, can be difficult to execute, and traditionally are believed to lead to disappointing results.\nObjectives\nTo evaluate the effectiveness of occlusion therapy for SDA in an attempt to establish realistic treatment outcomes and to examine evidence of any dose–response effect and assess the effect of the duration, severity, and causative factor on the size and direction of the treatment effect.\nSearch methods\nWe searched CENTRAL (2018, Issue 12), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Embase.com; and five other databases. We used no date or language restrictions in the electronic searches. We last searched the databases on 12 December 2018.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs) and controlled clinical trials of participants with unilateral SDA with visual acuity worse than 0.2 LogMAR or equivalent. We specified no restrictions for inclusion based upon age, gender, ethnicity, comorbidities, medication use, or the number of participants.\nData collection and analysis\nWe used standard Cochrane methodology.\nMain results\nWe identified no trials that met the inclusion criteria specified in the protocol for this review.\nAuthors' conclusions\nWe found no evidence from RCTs or quasi-randomized trials on the effectiveness of any treatment for SDA. RCTs are needed in order to evaluate the safety and effectiveness of occlusion, duration of treatment, level of vision that can be realistically achieved, effects of age at onset and magnitude of visual defect, optimum occlusion regimen, and factors associated with satisfactory and unsatisfactory outcomes with the use of various interventions for SDA.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for studies that had been published up to December 2018."
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query-laysum
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22339
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[
{
"role": "user",
"content": "Abstract: Background\nTubal disease accounts for 20% of infertility cases. Hydrosalpinx, caused by distal tubal occlusion leading to fluid accumulation in the tube(s), is a particularly severe form of tubal disease negatively affecting the outcomes of assisted reproductive technology (ART). It is thought that tubal surgery may improve the outcome of ART in women with hydrosalpinges.\nObjectives\nTo assess the effectiveness and safety of tubal surgery in women with hydrosalpinges prior to undergoing conventional in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, DARE, and two trial registers on 8 January 2020, together with reference checking and contact with study authors and experts in the field to identify additional trials.\nSelection criteria\nRandomised controlled trials (RCTs) comparing surgical treatment versus no surgical treatment, or comparing surgical interventions head-to-head, in women with tubal disease prior to undergoing IVF.\nData collection and analysis\nWe used Cochrane's standard methodological procedures. The primary outcomes were live birth rate (LBR) and surgical complication rate per woman randomised. Secondary outcomes included clinical, multiple and ectopic pregnancy rates, miscarriage rates and mean numbers of oocytes retrieved and of embryos obtained.\nMain results\nWe included 11 parallel-design RCTs, involving a total of 1386 participants. The included trials compared different types of tubal surgery (salpingectomy, tubal occlusion or transvaginal aspiration of hydrosalpingeal fluid) to no tubal surgery, or individual interventions to one another. We assessed no studies as being at low risk of bias across all domains, with the main limitations being lack of blinding, wide confidence intervals and low event and sample sizes. We used GRADE methodology to rate the quality of the evidence. Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged between very low- to low-quality.\nSalpingectomy versus no tubal surgery\nNo included study reported on LBR for this comparison. We are uncertain of the effect of salpingectomy on surgical complications such as the rate of conversion to laparotomy (Peto odds ratio (OR) 5.80, 95% confidence interval (CI) 0.11 to 303.69; one RCT; n = 204; very low-quality evidence) and pelvic infection (Peto OR 5.80, 95% CI 0.11 to 303.69; one RCT; n = 204; very low-quality evidence). Salpingectomy probably increases clinical pregnancy rate (CPR) versus no surgery (risk ratio (RR) 2.02, 95% CI 1.44 to 2.82; four RCTs; n = 455; I2 = 42.5%; moderate-quality evidence). This suggests that in women with a CPR of approximately 19% without tubal surgery, the rate with salpingectomy lies between 27% and 52%.\nProximal tubal occlusion versus no surgery\nNo study reported on LBR and surgical complication rate for this comparison. Tubal occlusion may increase CPR compared to no tubal surgery (RR 3.21, 95% CI 1.72 to 5.99; two RCTs; n = 209; I2 = 0%; low-quality evidence). This suggests that with a CPR of approximately 12% without tubal surgery, the rate with tubal occlusion lies between 21% and 74%.\nTransvaginal aspiration of hydrosalpingeal fluid versus no surgery\nNo study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 176). We are uncertain whether transvaginal aspiration of hydrosalpingeal fluid increases CPR compared to no tubal surgery (RR 1.67, 95% CI 1.10 to 2.55; three RCTs; n = 311; I2 = 0%; very low-quality evidence).\nLaparoscopic proximal tubal occlusion versus laparoscopic salpingectomy\nWe are uncertain of the effect of laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy on LBR (RR 1.21, 95% CI 0.76 to 1.95; one RCT; n = 165; very low-quality evidence) and CPR (RR 0.81, 95% CI 0.62 to 1.07; three RCTs; n = 347; I2 = 77%; very low-quality evidence). No study reported on surgical complication rate for this comparison.\nTransvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy\nNo study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 160). We are uncertain of the effect of transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy on CPR (RR 0.69, 95% CI 0.44 to 1.07; one RCT; n = 160; very low-quality evidence).\nAuthors' conclusions\nWe found moderate-quality evidence that salpingectomy prior to ART probably increases the CPR compared to no surgery in women with hydrosalpinges. When comparing tubal occlusion to no intervention, we found that tubal occlusion may increase CPR, although the evidence was of low quality. We found insufficient evidence of any effect on procedure- or pregnancy-related adverse events when comparing tubal surgery to no intervention. Importantly, none of the studies reported on long term fertility outcomes. Further high-quality trials are required to definitely determine the impact of tubal surgery on IVF and pregnancy outcomes of women with hydrosalpinges, particularly for LBR and surgical complications; and to investigate the relative efficacy and safety of the different surgical modalities in the treatment of hydrosalpinges prior to ART.\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": "Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged from very low- to low-quality. The main limitations in this body of research were the lack of blinding (the process where the women participating in the trial, as well as the research staff, are not aware of the intervention used), inconsistency (differences in results across studies) and imprecision (random error and small size of each study) ."
}
] |
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