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query-laysum | 3944 | [
{
"role": "user",
"content": "Abstract: Background\nAcupuncture has a history of traditional use in China for women's health conditions including premenstrual syndrome (PMS), but its effectiveness for this condition remains unclear. This review examined the available evidence supporting the use of acupuncture or acupressure to treat PMS.\nObjectives\nTo evaluate the effectiveness and safety of acupuncture or acupressure for women with PMS or premenstrual dysphoric disorder (PMDD).\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Specialised Register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, AMED, PsycINFO, CINAHL (from inception to 21 September 2017), two clinical trial databases (from their inception to 21 September 2017), and four electronic databases in China (from their inception to 15 October 2017): Chinese Biomedical Literature database (CBM), China National Knowledge Infrastructure (CNKI), VIP information/ Chinese Scientific Journals database and WANFANG. Reference lists from included articles were handsearched.\nSelection criteria\nWe included studies if they randomised women with PMS and associated disorders (PMDD and late luteal phase dysphoric disorder/LPDD) to receive acupuncture or acupressure versus sham, usual care/waiting-list control or pharmaceutical interventions mentioned by the International Society for Premenstrual Disorders (ISPMD). If acupuncture or acupressure were combined with another therapy, these studies were also included where the additional therapy was the same in both groups. Cross-over studies were eligible for inclusion, but only data from the first phase could be used.\nData collection and analysis\nTwo review authors independently selected the studies, assessed eligible studies for risk of bias, and extracted data from each study. Study authors were contacted for missing information. The quality of the evidence was assessed using GRADE. Our primary outcomes were overall premenstrual symptoms and adverse events. Secondary outcomes included specific PMS symptoms, response rate and quality of life.\nMain results\nFive trials (277 women) were included in this review. No trials compared acupuncture or acupressure versus other active treatments. The number of treatment sessions ranged from seven to 28. The quality of the evidence ranged from low to very low quality, the main limitations being imprecision due to small sample sizes and risk of bias related to detection bias and selective reporting.\nAcupuncture versus sham acupuncture\nAcupuncture may provide a greater reduction in mood-related PMS symptoms (mean difference (MD) -9.03, 95% confidence interval (CI) -10.71 to -7.35, one randomised controlled trial (RCT), n = 67, low-quality evidence) and in physical PMS symptoms (MD -9.11, 95% CI -10.82 to -7.40, one RCT, n = 67, low-quality evidence) than sham acupuncture, as measured by the Daily Record of Severity of Problems scale (DRSP). The evidence suggests that if women have a mood score of 51.91 points with sham acupuncture, their score with acupuncture would be between 10.71 and 7.35 points lower and if women have a physical score of 46.11 points, their score with acupuncture would be between 10.82 and 7.4 points lower.There was insufficient evidence to determine whether there was any difference between the groups in the rate of adverse events (risk ratio (RR) 1.74, 95% CI 0.39 to 7.76, three RCTs, n = 167, I2 = 0%, very low-quality evidence).\nSpecific PMS symptoms were not reported\nThere may be little or no difference between the groups in response rates. Use of a fixed-effect model suggested a higher response rate in the acupuncture group than in the sham group (RR 2.59, 95% CI 1.71 to 3.92; participants = 100; studies = 2; I2 = 82%), but owing to the high heterogeneity we tested the effect of using a random-effects model, which provided no clear evidence of benefit for acupuncture (RR 4.22, 95% CI 0.45 to 39.88, two RCTs, n = 100, I2 = 82%, very low-quality evidence).\nAcupuncture may improve quality of life (measured by the WHOQOL-BREF) compared to sham (MD 2.85, 95% CI 1.47 to 4.23, one RCT, n = 67, low-quality evidence).\nAcupuncture versus no treatment\nDue to the very low quality of the evidence, we are uncertain whether acupuncture reduces PMS symptoms compared to a no treatment control (MD -13.60, 95% CI -15.70 to -11.50, one RCT, n = 14).\nNo adverse events were reported in either group.\nNo data were available on specific PMS symptoms, response rate or quality of life outcomes.\nAcupressure versus sham acupressure\nWe found low-quality evidence that acupressure may reduce the number of women with moderate to severe PMS symptoms at the end of the trial compared to sham acupressure (RR 0.64 95% CI 0.52 to 0.79, one RCT, n = 90, low-quality evidence). The evidence suggests that if 97 women out of 100 in the sham acupressure group had moderate to severe PMS symptoms, the number of women in the acupressure group with moderate to severe symptoms would be 50 to 76 women.\nAcupressure may improve both physical (MD 24.3, 95% CI 17.18 to 31.42, one RCT, n = 90, low-quality evidence) and mental (MD 17.17, 95% CI 13.08 to 21.26, one RCT, n = 90, low-quality evidence) quality of life.\nNo data were available on adverse events, specific symptoms or response rates.\nAuthors' conclusions\nThe limited evidence available suggests that acupuncture and acupressure may improve both physical and psychological symptoms of PMS when compared to a sham control. There was insufficient evidence to determine whether there was a difference between the groups in rates of adverse events.There is no evidence comparing acupuncture or acupressure versus current ISPMD recommended treatments for PMS such as selective serotonin reuptake inhibitors (SSRIs). Further research is required, using validated outcome measures for PMS, adequate blinding and suitable comparator groups reflecting current best practice.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We wanted to know whether using acupuncture or acupressure therapy was better than receiving sham acupuncture, no treatment or currently recommended pharmaceutical medications for PMS such as serotonin reuptake inhibitors (SSRIs - a type of anti-depressant)."
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query-laysum | 3945 | [
{
"role": "user",
"content": "Abstract: Background\nIn acute asthma inhaled beta₂-agonists are often administered by nebuliser to relieve bronchospasm, but some have argued that metered-dose inhalers with a holding chamber (spacer) can be equally effective. Nebulisers require a power source and need regular maintenance, and are more expensive in the community setting.\nObjectives\nTo assess the effects of holding chambers (spacers) compared to nebulisers for the delivery of beta₂-agonists for acute asthma.\nSearch methods\nWe searched the Cochrane Airways Group Trial Register and reference lists of articles. We contacted the authors of studies to identify additional trials. Date of last search: February 2013.\nSelection criteria\nRandomised trials in adults and children (from two years of age) with asthma, where spacer beta₂-agonist delivery was compared with wet nebulisation.\nData collection and analysis\nTwo review authors independently applied study inclusion criteria (one review author for the first version of the review), extracted the data and assessed risks of bias. Missing data were obtained from the authors or estimated. Results are reported with 95% confidence intervals (CIs).\nMain results\nThis review includes a total of 1897 children and 729 adults in 39 trials. Thirty-three trials were conducted in the emergency room and equivalent community settings, and six trials were on inpatients with acute asthma (207 children and 28 adults). The method of delivery of beta₂-agonist did not show a significant difference in hospital admission rates. In adults, the risk ratio (RR) of admission for spacer versus nebuliser was 0.94 (95% CI 0.61 to 1.43). The risk ratio for children was 0.71 (95% CI 0.47 to 1.08, moderate quality evidence). In children, length of stay in the emergency department was significantly shorter when the spacer was used. The mean duration in the emergency department for children given nebulised treatment was 103 minutes, and for children given treatment via spacers 33 minutes less (95% CI -43 to -24 minutes, moderate quality evidence). Length of stay in the emergency department for adults was similar for the two delivery methods. Peak flow and forced expiratory volume were also similar for the two delivery methods. Pulse rate was lower for spacer in children, mean difference -5% baseline (95% CI -8% to -2%, moderate quality evidence), as was the risk of developing tremor (RR 0.64; 95% CI 0.44 to 0.95, moderate quality evidence).\nAuthors' conclusions\nNebuliser delivery produced outcomes that were not significantly better than metered-dose inhalers delivered by spacer in adults or children, in trials where treatments were repeated and titrated to the response of the participant. Spacers may have some advantages compared to nebulisers for children with acute asthma. The studies excluded people with life-threatening asthma; therefore, the results of this meta-analysis should not be extrapolated to this patient population.\n\nGiven the provided abstract, please respond to the following query: \"What do the studies tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Taking beta-agonists through either a spacer or a nebuliser in the emergency department did not make a difference to the number of adults being admitted to hospital, whilst in children we can be fairly confident that nebulisers are not better than spacers at preventing admissions.\nIn children, the length of stay in the emergency department was significantly shorter when the spacer was used instead of a nebuliser. The average stay in the emergency department for children given nebulised treatment was 103 minutes. Children given treatment via spacers spent an average of 33 minutes less.\nIn adults, the length of stay in the emergency department was similar for the two delivery methods. However the adult studies were conducted slightly differently which may have made it more difficult to show a difference in the length of stay in the emergency department. Because all the adult studies used a so-called \"double-dummy\" design, the adults received a spacer AND a nebuliser (either beta-agonist in a spacer and a dummy nebuliser or vice versa) which meant both groups of people were in the emergency department for as long as it took to take both treatments.\nLung function tests were also similar for the two delivery methods in both adults and children. Pulse rate was lower in children taking beta-agonists through a spacer (mean difference -5% baseline), and there was a lower risk of developing tremor."
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query-laysum | 3946 | [
{
"role": "user",
"content": "Abstract: Background\nStatins are one of the most prescribed classes of drugs worldwide. Atorvastatin, the most prescribed statin, is currently used to treat conditions such as hypercholesterolaemia and dyslipidaemia. By reducing the level of cholesterol, which is the precursor of the steroidogenesis pathway, atorvastatin may cause a reduction in levels of testosterone and other androgens. Testosterone and other androgens play important roles in biological functions. A potential reduction in androgen levels, caused by atorvastatin might cause negative effects in most settings. In contrast, in the setting of polycystic ovary syndrome (PCOS), reducing excessive levels of androgens with atorvastatin could be beneficial.\nObjectives\nPrimary objective\nTo quantify the magnitude of the effect of atorvastatin on total testosterone in both males and females, compared to placebo or no treatment.\nSecondary objectives\nTo quantify the magnitude of the effects of atorvastatin on free testosterone, sex hormone binding globin (SHBG), androstenedione, dehydroepiandrosterone sulphate (DHEAS) concentrations, free androgen index (FAI), and withdrawal due to adverse effects (WDAEs) in both males and females, compared to placebo or no treatment.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to 9 November 2020: the Cochrane Hypertension Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; ;two international trials registries, and the websites of the US Food and Drug Administration, the European Patent Office and the Pfizer pharmaceutical corporation. These searches had no language restrictions. We also contacted authors of relevant articles regarding further published and unpublished work.\nSelection criteria\nRCTs of daily atorvastatin for at least three weeks, compared with placebo or no treatment, and assessing change in testosterone levels in males or females.\nData collection and analysis\nTwo review authors independently screened the citations, extracted the data and assessed the risk of bias of the included studies. We used the mean difference (MD) with associated 95% confidence intervals (CI) to report the effect size of continuous outcomes,and the risk ratio (RR) to report effect sizes of the sole dichotomous outcome (WDAEs). We used a fixed-effect meta-analytic model to combine effect estimates across studies, and risk ratio to report effect size of the dichotomous outcomes. We used GRADE to assess the certainty of the evidence.\nMain results\nWe included six RCTs involving 265 participants who completed the study and their data was reported. Participants in two of the studies were male with normal lipid profile or mild dyslipidaemia (N = 140); the mean age of participants was 68 years. Participants in four of the studies were female with PCOS (N = 125); the mean age of participants was 32 years. We found no significant difference in testosterone levels in males between atorvastatin and placebo, MD -0.20 nmol/L (95% CI -0.77 to 0.37). In females, atorvastatin may reduce total testosterone by -0.27 nmol/L (95% CI -0.50 to -0.04), FAI by -2.59 nmol/L (95% CI -3.62 to -1.57), androstenedione by -1.37 nmol/L (95% CI -2.26 to -0.49), and DHEAS by -0.63 μmol/l (95% CI -1.12 to -0.15). Furthermore, compared to placebo, atorvastatin increased SHBG concentrations in females by 3.11 nmol/L (95% CI 0.23 to 5.99). We identified no studies in healthy females (i.e. females with normal testosterone levels) or children (under age 18). Importantly, no study reported on free testosterone levels.\nAuthors' conclusions\nWe found no significant difference between atorvastatin and placebo on the levels of total testosterone in males. In females with PCOS, atorvastatin lowered the total testosterone, FAI, androstenedione, and DHEAS. The certainty of evidence ranged from low to very low for both comparisons. More RCTs studying the effect of atorvastatin on testosterone are needed.\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 wanted to measure the effect of atorvastatin on testosterone and other androgens.We searched for all studies in the medical literature that compared the effect of different doses of atorvastatin to placebo or no treatment in males and females, and also reported on their levels of testosterone and other androgens. We looked for studies in which the treatments people received were decided at random. This type of study usually gives the most reliable evidence about the effects of a treatment. Studies could have participants of any age.\nAfter we identified these studies, we compared the results, and summarized the evidence from all the studies. Finally, we rated our confidence in the evidence (\"certainty of the evidence\"), based on such factors such as study methods and sizes, and how consistent the findings were across studies."
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query-laysum | 3947 | [
{
"role": "user",
"content": "Abstract: Background\nIn areas where vitamin A deficiency (VAD) is a public health concern, the maternal dietary intake of vitamin A may be not sufficient to meet either the maternal nutritional requirements, or those of the breastfed infant, due the low retinol concentrations in breast milk.\nObjectives\nTo evaluate the effects of vitamin A supplementation for postpartum women on maternal and infant health.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (8 February 2016), LILACS (1982 to December 2015), Web of Science (1945 to December 2015), and the reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) or cluster-randomised trials that assessed the effects of vitamin A supplementation for postpartum women on maternal and infant health (morbidity, mortality and vitamin A nutritional status).\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias and checked for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nFourteen trials of mainly low or unclear risk of bias, enrolling 25,758 women and infant pairs were included. The supplementation schemes included high, single or double doses of vitamin A (200,000 to 400,000 internation units (IU)), or 7.8 mg daily beta-carotene compared with placebo, no treatment, other (iron); or higher (400,000 IU) versus lower dose (200,000 IU). In all trials, a considerable proportion of infants were at least partially breastfed until six months.\nSupplement (vitamin A as retinyl, water-miscible or beta-carotene) 200,000 to 400,000 IU versus control (placebo or no treatment)\nMaternal: We did not find evidence that vitamin A supplementation reduced maternal mortality at 12 months (hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.44 to 2.21; 8577 participants; 1 RCT, moderate-quality evidence). Effects were less certain at six months (risk ratio (RR) 0.50, 95% CI 0.09 to 2.71; 564 participants; 1 RCT; low-quality evidence). The effect on maternal morbidity (diarrhoea, respiratory infections, fever) was uncertain because the quality of evidence was very low (50 participants, 1 RCT). We found insufficient evidence that vitamin A increases abdominal pain (RR 1.28, 95% CI 0.95 to 1.73; 786 participants; 1 RCT; low-quality evidence). We found low-quality evidence that vitamin A supplementation increased breast milk retinol concentrations by 0.20 µmol/L at three to three and a half months (mean difference (MD) 0.20 µmol/L, 95% CI 0.08 to 0.31; 837 participants; 6 RCTs).\nInfant: We did not find evidence that vitamin A supplementation reduced infant mortality at two to 12 months (RR 1.08, 95% CI 0.77 to 1.52; 6090 participants; 5 RCTs; low-quality evidence). Effects on morbidity (gastroenteritis at three months) was uncertain (RR 6.03, 95% CI 0.30 to 121.82; 84 participants; 1 RCT; very low-quality evidence). There was low-quality evidence for the effect on infant adverse outcomes (bulging fontanelle at 24 to 48 hours) (RR 2.00, 95% CI 0.61 to 6.55; 444 participants; 1 RCT).\nSupplement (vitamin A as retinyl) 400,000 IU versus 200,000 IU\nThree studies (1312 participants) were included in this comparison. None of the studies assessed maternal mortality, maternal morbidity or infant mortality. Findings from one study showed that there may be little or no difference in infant morbidity between the doses (diarrhoea, respiratory illnesses, and febrile illnesses) (312 participants, data not pooled). No firm conclusion could be drawn on the impact on maternal and infant adverse outcomes (limited data available).The effect on breast milk retinol was also uncertain due to the small amount of information available.\nAuthors' conclusions\nThere was no evidence of benefit from different doses of vitamin A supplementation for postpartum women on maternal and infant mortality and morbidity, compared with other doses or placebo. Although maternal breast milk retinol concentrations improved with supplementation, this did not translate to health benefits for either women or infants. Few studies reported on maternal and infant mortality and morbidity. Future studies should include these important outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In areas where vitamin A deficiency is a public health concern, the maternal dietary intake of vitamin A may be not sufficient to meet either the maternal nutritional requirements, or those of the breastfed infant, due the low concentrations in breast milk. Many studies have been carried out to address this concern in countries where vitamin A deficiency is common."
}
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query-laysum | 3948 | [
{
"role": "user",
"content": "Abstract: Background\nSelf-management education programmes are complex interventions specifically targeted at patient education and behaviour modification. They are designed to encourage people with chronic disease to take an active self-management role to supplement medical care and improve outcomes.\nObjectives\nTo assess the effectiveness of self-management education programmes for people with osteoarthritis.\nSearch methods\nThe Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PyscINFO, SCOPUS and the World Health Organization (WHO) International Clinical Trial Registry Platform were searched, without language restriction, on 17 January 2013. We checked references of reviews and included trials to identify additional studies.\nSelection criteria\nRandomised controlled trials of self-management education programmes in people with osteoarthritis were included. Studies with participants receiving passive recipients of care and studies comparing one type of programme versus another were excluded.\nData collection and analysis\nIn addition to standard methods we extracted components of the self-management interventions using the eight domains of the Health Education Impact Questionnaire (heiQ), and contextual and participant characteristics using PROGRESS-Plus and the Health Literacy Questionnaire (HLQ). Outcomes included self-management of osteoarthritis, participant's positive and active engagement in life, pain, global symptom score, self-reported function, quality of life and withdrawals (including dropouts and those lost to follow-up). We assessed the quality of the body of evidence for these outcomes using the GRADE approach.\nMain results\nWe included twenty-nine studies (6,753 participants) that compared self-management education programmes to attention control (five studies), usual care (17 studies), information alone (four studies) or another intervention (seven studies). Although heterogeneous, most interventions included elements of skill and technique acquisition (94%), health-directed activity (85%) and self-monitoring and insight (79%); social integration and support were addressed in only 12%. Most studies did not provide enough information to assess all PROGRESS-Plus items. Eight studies included predominantly Caucasian, educated female participants, and only four provided any information on participants' health literacy. All studies were at high risk of performance and detection bias for self-reported outcomes; 20 studies were at high risk of selection bias, 16 were at high risk of attrition bias, two were at high risk of reporting bias and 12 were at risk of other biases. We deemed attention control as the most appropriate and thus the main comparator.\nCompared with attention control, self-management programmes may not result in significant benefits at 12 months. Low-quality evidence from one study (344 people) indicates that self-management skills were similar in active and control groups: 5.8 points on a 10-point self-efficacy scale in the control group, and the mean difference (MD) between groups was 0.4 points (95% confidence interval (CI) -0.39 to 1.19). Low-quality evidence from four studies (575 people) indicates that self-management programmes may lead to a small but clinically unimportant reduction in pain: the standardised mean difference (SMD) between groups was -0.26 (95% CI -0.44 to -0.09); pain was 6 points on a 0 to 10 visual analogue scale (VAS) in the control group, treatment resulted in a mean reduction of 0.8 points (95% CI -0.14 to -0.3) on a 10-point scale, with number needed to treat for an additional beneficial outcome (NNTB) of 8 (95% CI 5 to 23). Low-quality evidence from one study (251 people) indicates that the mean global osteoarthritis score was 4.2 on a 0 to 10-point symptom scale (lower better) in the control group, and treatment reduced symptoms by a mean of 0.14 points (95% CI -0.54 to 0.26). This result does not exclude the possibility of a clinically important benefit in some people (0.5 point reduction included in 95% CI). Low-quality evidence from three studies (574 people) showed no signficant difference in function between groups (SMD -0.19, 95% CI -0.5 to 0.11); mean function was 1.29 points on a 0 to 3-point scale in the control group, and treatment resulted in a mean improvement of 0.04 points with self-management (95% CI -0.10 to 0.02). Low-quality evidence from one study (165 people) showed no between-group difference in quality of life (MD -0.01, 95% CI -0.03 to 0.01) from a control group mean of 0.57 units on 0 to 1 well-being scale. Moderate-quality evidence from five studies (937 people) shows similar withdrawal rates between self-management (13%) and control groups (12%): RR 1.11 (95% CI 0.78 to 1.57). Positive and active engagement in life was not measured.\nCompared with usual care, moderate-quality evidence from 11 studies (up to 1,706 participants) indicates that self-management programmes probably provide small benefits up to 21 months, in terms of self-management skills, pain, osteoarthritis symptoms and function, although these are of doubtful clinical importance, and no improvement in positive and active engagement in life or quality of life. Withdrawal rates were similar. Low to moderate quality evidence indicates no important differences in self-management , pain, symptoms, function, quality of life or withdrawal rates between self-management programmes and information alone or other interventions (exercise, physiotherapy, social support or acupuncture).\nAuthors' conclusions\nLow to moderate quality evidence indicates that self-management education programmes result in no or small benefits in people with osteoarthritis but are unlikely to cause harm.\nCompared with attention control, these programmes probably do not improve self-management skills, pain, osteoarthritis symptoms, function or quality of life, and have unknown effects on positive and active engagement in life. Compared with usual care, they may slightly improve self-management skills, pain, function and symptoms, although these benefits are of unlikely clinical importance.\nFurther studies investigating the effects of self-management education programmes, as delivered in the trials in this review, are unlikely to change our conclusions substantially, as confounding from biases across studies would have likely favoured self-management. However, trials assessing other models of self-management education programme delivery may be warranted. These should adequately describe the intervention they deliver and consider the expanded PROGRESS-Plus framework and health literacy, to explore issues of health equity for recipients.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to people with osteoarthritis who undergo self-management programmes\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "People who completed a self-management programme rated their self-management skills to be 0.4 points better (0.4 points worse to 1.2 points better) on a scale of 1 to 10 (higher score means better self-management) after 12 months (4% absolute improvement; 4% worse to 12% better).\n- People who completed a self-management programme rated their self-management skills as 6.2 points on a scale of 1 to 10.\n- People who received attention control rated their self-management skills as 5.8 points on a scale of 1 to 10.\nPeople who completed a self-management programme rated their pain to be 0.8 points lower (0.3 to 0.14 points lower) on a scale of 0 to 10 (lower score means less pain) after 12 months (8% absolute improvement).\n- People who completed a self-management programme rated their pain as 5 points on a scale of 0 to 10.\n- People who received attention control rated their pain as 5.8 points on a scale of 0 to 10.\nPeople who completed a self-management programme rated their osteoarthritis symptoms to be 0.14 points lower (0.54 points lower to 0.26 points higher) on a scale of 0 to 10 (lower score means fewer symptoms) after 12 months (1% absolute improvement).\n- People who completed a self-management programme rated their symptoms as 4.1 points on a scale of 0 to 10.\n- People who received attention control rated their symptoms as 4.2 points on a scale of 0 to 10.\nPeople who completed a self-management programme rated their function to be 0.04 points lower (0.02 points lower to 0.10 points higher) on a scale of 0 to 3 (lower score means better function) after 12 months (4% absolute improvement).\n- People who completed a self-management programme rated their function as 1.25 points on a scale of 0 to 3.\n- People who received attention control rated their function as 1.29 points on a scale of 0 to 3.\nPeople who completed a self-management programme rated their quality of life to be 0.01 points lower (0.03 points lower to 0.01 points higher) on a scale of 0 to 1 (higher score means better quality of life) after 12 months (1% absolute worsening).\n- People who completed a self-management programme rated their quality of life as 0.56 points on a scale of 0 to 1.\n- People who received attention control rated their quality of life as 0.57 points on a scale of 0 to 1.\nOne more person out of 100 dropped out of self-management programmes (1% absolute improvement).\n- 13 out of 100 people who received a self-management programme dropped out.\n- 12 out of 100 people who received attention control dropped out."
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query-laysum | 3949 | [
{
"role": "user",
"content": "Abstract: Background\nSleep disturbances occur frequently in people with dementia with a reported prevalence of up to 40%. Common problems are increased number and duration of awakenings and increased percentage of light sleep. Sleep disturbances are associated with a number of problems for people with dementia, their relatives, and carers. In people with dementia, they may lead to worsening of cognitive symptoms, challenging behaviours such as restlessness or wandering, and further harms, such as accidental falls. Sleep disturbances are also associated with significant carer distress and have been reported as a factor contributing to institutionalisation of people with dementia. As pharmacological approaches have shown unsatisfactory results, there is a need to synthesise the research evidence on non-pharmacological strategies to improve sleep in people with dementia. As interventions are often complex, consisting of more than one active component, and implemented in complex contexts, it may not be easy to identify effective intervention components.\nObjectives\nTo evaluate the benefits and harms of non-pharmacological interventions on sleep disturbances in people with dementia compared to usual care, no treatment, any other non-pharmacological intervention, or any drug treatment intended to improve sleep, and to describe the components and processes of any complex intervention included.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 13 January 2022.\nSelection criteria\nWe included individually or cluster-randomised controlled trials in people with dementia comparing non-pharmacological interventions to improve sleep compared to usual care or to other interventions of any type. Eligible studies had to have a sleep-related primary outcome. We included people with a diagnosis of dementia and sleep problems at baseline irrespective of age, type of dementia, severity of cognitive impairment, or setting. Studies reporting results on a mixed sample (e.g. in a nursing home) were only considered for inclusion if at least 80% of participants had dementia.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. objective sleep-related outcomes (e.g. total nocturnal sleep time, consolidated sleep time at night, sleep efficiency, total wake time at night (or time spent awake after sleep onset), number of nocturnal awakenings, sleep onset latency, daytime/night-time sleep ratio, night-time/total sleep ratio over 24 hours) and 2. adverse events. Our secondary outcomes were 3. subjective sleep-related outcomes, 4. behavioural and psychological symptoms of dementia, 5. quality of life, 6. functional status, 7. institutionalisation, 8. compliance with the intervention, and 9. attrition rates. We used GRADE to assess the certainty of evidence and chose key outcomes to be included in summary of findings tables.\nMain results\nWe included 19 randomised controlled trials with 1335 participants allocated to treatment or control groups. Fourteen studies were conducted in nursing homes, three included community residents, one included 'inpatients', one included people from a mental health centre, and one included people from district community centres for older people. Fourteen studies were conducted in the US. We also identified nine ongoing studies.\nAll studies applied one or more non-pharmacological intervention aiming to improve physiological sleep in people with dementia and sleep problems. The most frequently examined single intervention was some form of light therapy (six studies), five studies included physical or social activities, three carer interventions, one daytime sleep restriction, one slow-stroke back massage, and one transcranial electrostimulation. Seven studies examined multimodal complex interventions.\nRisk of bias of included studies was frequently unclear due to incomplete reporting. Therefore, we rated no study at low risk of bias.\nWe are uncertain whether light therapy has any effect on sleep-related outcomes (very low-certainty evidence). Physical activities may slightly increase the total nocturnal sleep time and sleep efficiency, and may reduce the total time awake at night and slightly reduce the number of awakenings at night (low-certainty evidence). Social activities may slightly increase total nocturnal sleep time and sleep efficiency (low-certainty evidence). Carer interventions may modestly increase total nocturnal sleep time, may slightly increase sleep efficiency, and may modestly decrease the total awake time during the night (low-certainty evidence from one study). Multimodal interventions may modestly increase total nocturnal sleep time and may modestly reduce the total wake time at night, but may result in little to no difference in number of awakenings (low-certainty evidence). We are uncertain about the effects of multimodal interventions on sleep efficiency (very low-certainty evidence). We found low-certainty evidence that daytime sleep restrictions, slow-stroke back massage, and transcranial electrostimulation may result in little to no difference in sleep-related outcomes.\nOnly two studies reported information about adverse events, detecting only few such events in the intervention groups.\nAuthors' conclusions\nDespite the inclusion of 19 randomised controlled trials, there is a lack of conclusive evidence concerning non-pharmacological interventions for sleep problems in people with dementia. Although neither single nor multimodal interventions consistently improved sleep with sufficient certainty, we found some positive effects on physical and social activities as well as carer interventions. Future studies should use rigorous methods to develop and evaluate the effectiveness of multimodal interventions using current guidelines on the development and evaluation of complex interventions. At present, no single or multimodal intervention can be clearly identified as suitable for widespread implementation.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "– Physical activity interventions, social activities, carer interventions, and multimodal interventions may slightly or modestly improve night-time sleep in people with dementia.\n– We found no evidence that light therapy, slow-stroke back massage, or transcranial electrostimulation reduce sleep problems in people with dementia."
}
]
|
query-laysum | 3950 | [
{
"role": "user",
"content": "Abstract: Background\nPublished audits have demonstrated that corneal abrasions are a common presenting eye complaint. Eye patches are often recommended for treating corneal abrasions despite the lack of evidence for their use. This systematic review was conducted to determine the effects of the eye patch when used to treat corneal abrasions.\nObjectives\nThe objective of this review was to assess the effects of patching for corneal abrasion on healing and pain relief.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2016), EMBASE (January 1980 to May 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to May 2016), System for Information on Grey Literature in Europe (OpenGrey) (January 1995 to May 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 9 May 2016. We also searched the reference lists of included studies, unpublished 'grey' literature and conference proceedings and contacted pharmaceutical companies for details of unpublished trials.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials that compared patching the eye with no patching to treat simple corneal abrasions.\nData collection and analysis\nTwo authors independently assessed the risk of bias and extracted data. Investigators were contacted for further information regarding the quality of trials. The primary outcome was healing at 24, 48 and 72 hours while secondary outcomes included measures of pain, quality of life and adverse effects. We graded the certainty of the evidence using GRADE.\nMain results\nWe included 12 trials which randomised a total of 1080 participants in the review. Four trials were conducted in the United Kingdom, another four in the United States of America, two in Canada, one in Brazil and one in Switzerland. Seven trials were at high risk of bias in one or more domains and one trial was judged to be low risk of bias in all domains. The rest were a combination of low risk or unclear.\nPeople receiving a patch may be less likely to have a healed corneal abrasion after 24 hours compared to those not receiving a patch (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.79 to 1.00, 7 trials, 531 participants, low certainty evidence). Similar numbers of people in the patch and no-patch groups were healed by 48 hours (RR 0.97, 95% CI 0.91 to 1.02, 6 trials, 497 participants, moderate certainty evidence) and 72 hours (RR 1.01, 95% CI 0.97 to 1.05, 4 trials, 430 participants, moderate certainty evidence). Participants receiving a patch took slightly longer to heal but the difference was small and probably unimportant (mean difference (MD) 0.14 days longer, 95% CI 0 to 0.27 days longer, 6 trials, 642 participants, moderate certainty evidence).\nTen trials reported pain scores. Most studies reported pain on a visual analogue scale (VAS). It was not possible to pool the data because it was skewed. In general, similar pain ratings were seen between patch and no-patch groups. Data from two trials reporting presence or absence of pain at 24 hours was inconclusive. There was a higher risk of reported pain in the patch group but wide confidence intervals compatible with higher or lower risk of pain (RR 1.51, 95% CI 0.86 to 2.65, 2 trials, 193 participants, low certainty evidence). Five trials compared analgesic use between the patch and no-patch groups. Data from three of these trials could be combined and suggested similar analgesic use in the patch and no-patch groups but with some uncertainty (RR 0.95, 95% CI 0.69 to 1.32, 256 participants, low certainty evidence). Frequently reported symptoms included photophobia, lacrimation, foreign body sensation and blurred vision but there was little evidence to suggest any difference in these symptoms in people with or without a patch.\nActivities of daily living (ADL) were assessed in one study involving children. There was little difference in ADL with the exception of walking which was reported to be more difficult with a patch on: VAS 1.7 cm (SD 2.1) versus 0.3 cm (SD 0.7).\nComplication rates were low across studies and there is uncertainty about the relative effects of patching or not patching with respect to these (RR 3.24, 95% CI 0.87 to 12.05, 8 trials, 660 participants, low certainty evidence). Three trials reporting rates of compliance to treatment found that 22% of participants did not have their eye patches during follow-up. No-patch groups generally received more adjuvant treatment with antibiotics or cycloplegics, or both, than the patch group. There were limited data on the effect of patching on abrasions greater than 10mm2 in size.\nAuthors' conclusions\nTrials included in this review suggest that treating simple corneal abrasions with a patch may not improve healing or reduce pain. It must be noted that, in these trials, participants who did not receive a patch were more likely to receive additional treatment, for example with antibiotics. Overall we judged the certainty of evidence to be moderate to low. Further research should focus on designing and implementing better quality trials and examining the effectiveness of patching for large abrasions.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors found 12 relevant studies. 6 were from North America, 5 from Europe, and 1 from South America (Brazil). These studies compared the use of eye patches with no patching.\nPeople receiving a patch may be less likely to have a healed corneal abrasion after 24 hours compared with people not receiving a patch (low certainty evidence). Using eye patches probably makes little or no difference to the number of people whose abrasion heals after 48 and 72 hours (moderate certainty evidence).\nCorneal abrasions in people receiving patches probably take slightly longer to heal than in people not receiving patches but the difference is small and probably unimportant (moderate certainty evidence).\nUsing eye patches may lead to more pain at 24 hours (low certainty evidence). However, the range where the actual effect may be shows that eye patches may lead to more pain, but may also lead to less pain.\nPeople with corneal abrasions frequently experience sensitivity to light, watery eyes, a foreign body sensation and blurred vision. There was little evidence to suggest any difference in these symptoms in people with or without a patch.\nThere were limited data available on quality of life, visual acuity and adverse effects."
}
]
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query-laysum | 3951 | [
{
"role": "user",
"content": "Abstract: Background\nResearch suggests that the number of intellectually disabled people with children is increasing. Intellectual disabilities do not inevitably cause parenting difficulties, but it may impact on an individual's capacity to parent a child effectively. Children of parents with intellectual disabilities may be at increased risk of neglectful care, which could lead to health, developmental and behavioural problems, or increased risk of intellectual disability. Compared with other parents, those with intellectual disabilities are more likely to be involved in care proceedings.\nObjectives\nTo assess the effectiveness of parent training interventions for parents with intellectual disabilities designed to support parenting, parent-child relations, safe parenting or family environments, or to develop parenting skills.\nSearch methods\nIn July 2017, we searched CENTRAL, Ovid MEDLINE, Embase, CINAHL and six other databases as well as two trials registers. We also searched reference lists of included studies and contacted experts in the field to identify additional ongoing and unpublished studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs comparing parent training interventions for parents with intellectual disabilities with treatment as usual or a control group.\nData collection and analysis\nWe used standardised Cochrane methods.\nMain results\nAs of July 2017, we identified four trials with 192 participants that met the review inclusion criteria. Participating parents were mostly mothers (seven fathers were included in two studies), and children's ages ranged from one month to six years and five months.\nOne study was conducted in Australia, one in Canada, one in the Netherlands, and one in the USA. Each studied a different intervention and considered different outcomes. Three interventions were delivered at home, and one in a community venue (e.g. a church). Interventions varied in duration from seven weeks to 12 months. They included a range of practical childcare skills, home safety and developing parents' ability to respond sensitively to their children. Parents in the comparison groups included in the review received treatment as usual and most of these received the index intervention after the study was complete.\nOne study was funded by the Ontario Mental Health Foundation and the Ontario Ministry of Community and Social Services Research Grants Program; one by the Alabama Development Disabilities Council; one by the Best Practice Parenting Education Initiative of the Commonwealth Department of Family and Community Services and the New South Wales Aging and Disability Department; and one by ZonMw, The Netherlands Organisation for Health Research and Development.\nIt was not possible for us to conduct a meta-analysis. The GRADE quality assessment varied from very low to moderate across the studies.\nPrimary outcomes\nNo study reported on the 'attainment of specific parenting skill targets'.\n'Safe home practices' and 'understanding of child health': one study (30 parents, very low-quality evidence) reported some improvements in parents' knowledge of life-threatening emergencies, ability to recognise dangers, and identify precautions, in favour of the intervention group. It also found limited, very low-quality evidence that parent training improved parents' ability to understand child health, implement precautions, use medicines safely, recognise child illness and symptoms, and seek medical advice (i.e. visit the doctor). Another study (22 mothers, very low-quality evidence) reported improved attainment of skills related to childcare and safety, in favour of the intervention group.\nSecondary outcomes\n'Parent-child interaction': one study (40 mothers, very low-quality evidence) reported improved maternal-child interaction following parent training at 12 months follow-up. Another study (83 mothers, 2 fathers, moderate-quality evidence) reported that inclusion in the intervention group led to a steeper decline in parenting stress related to the child compared to the control group.\n'Parents' retention of child': one study (22 participants; very low-quality evidence) reported that before joining the programme nine of 11 (82%) families with a previous child had had the child removed from their care by child protection authorities due to maternal maltreatment, compared with only four of 22 (19%) families after participating in the programme (only one of these four mothers had also had a previous child removed).\nNo study reported data on: 'return to independent care of child' or 'lifting of child-related court order'.\nAuthors' conclusions\nThere is some very low-quality evidence that some parents, mainly mothers, with intellectual disabilities are able to provide adequate parenting if they are given appropriate training and support to learn the parenting skills they need. However, there are few studies exploring how interventions might work, for whom and in what circumstances. In particular, there have been few studies that include fathers with intellectual disabilities, or that explore the views of parents themselves.\nThere is a need for larger RCTs of parenting interventions, with longer follow-up, before conclusions can be drawn about the effectiveness of parent training for this group of parents.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Each study was sponsored by different funders. One study was funded by the Ontario Mental Health Foundation and the Ontario Ministry of Community and Social Services Research Grants Program. Another was funded by the Alabama Development Disabilities Council. A third was funded by the Best Practice Parenting Education Initiative of the Commonwealth Department of Family and Community Services and the New South Wales Aging and Disability Department. The fourth study was funded by ZonMw, The Netherlands Organisation for Health Research and Development."
}
]
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query-laysum | 3952 | [
{
"role": "user",
"content": "Abstract: Background\nSocial networking platforms offer a wide reach for public health interventions allowing communication with broad audiences using tools that are generally free and straightforward to use and may be combined with other components, such as public health policies. We define interactive social media as activities, practices, or behaviours among communities of people who have gathered online to interactively share information, knowledge, and opinions.\nObjectives\nWe aimed to assess the effectiveness of interactive social media interventions, in which adults are able to communicate directly with each other, on changing health behaviours, body functions, psychological health, well-being, and adverse effects.\nOur secondary objective was to assess the effects of these interventions on the health of populations who experience health inequity as defined by PROGRESS-Plus. We assessed whether there is evidence about PROGRESS-Plus populations being included in studies and whether results are analysed across any of these characteristics.\nSearch methods\nWe searched CENTRAL, CINAHL, Embase, MEDLINE (including trial registries) and PsycINFO. We used Google, Web of Science, and relevant web sites to identify additional studies and searched reference lists of included studies. We searched for published and unpublished studies from 2001 until June 1, 2020. We did not limit results by language.\nSelection criteria\nWe included randomised controlled trials (RCTs), controlled before-and-after (CBAs) and interrupted time series studies (ITSs). We included studies in which the intervention website, app, or social media platform described a goal of changing a health behaviour, or included a behaviour change technique. The social media intervention had to be delivered to adults via a commonly-used social media platform or one that mimicked a commonly-used platform. We included studies comparing an interactive social media intervention alone or as a component of a multi-component intervention with either a non-interactive social media control or an active but less-interactive social media comparator (e.g. a moderated versus an unmoderated discussion group).\nOur main outcomes were health behaviours (e.g. physical activity), body function outcomes (e.g. blood glucose), psychological health outcomes (e.g. depression), well-being, and adverse events. Our secondary outcomes were process outcomes important for behaviour change and included knowledge, attitudes, intention and motivation, perceived susceptibility, self-efficacy, and social support.\nData collection and analysis\nWe used a pre-tested data extraction form and collected data independently, in duplicate. Because we aimed to assess broad outcomes, we extracted only one outcome per main and secondary outcome categories prioritised by those that were the primary outcome as reported by the study authors, used in a sample size calculation, and patient-important.\nMain results\nWe included 88 studies (871,378 participants), of which 84 were RCTs, three were CBAs and one was an ITS. The majority of the studies were conducted in the USA (54%). In total, 86% were conducted in high-income countries and the remaining 14% in upper middle-income countries. The most commonly used social media platform was Facebook (39%) with few studies utilising other platforms such as WeChat, Twitter, WhatsApp, and Google Hangouts. Many studies (48%) used web-based communities or apps that mimic functions of these well-known social media platforms.\nWe compared studies assessing interactive social media interventions with non-interactive social media interventions, which included paper-based or in-person interventions or no intervention. We only reported the RCT results in our 'Summary of findings' table. We found a range of effects on health behaviours, such as breastfeeding, condom use, diet quality, medication adherence, medical screening and testing, physical activity, tobacco use, and vaccination. For example, these interventions may increase physical activity and medical screening tests but there was little to no effect for other health behaviours, such as improved diet or reduced tobacco use (20,139 participants in 54 RCTs). For body function outcomes, interactive social media interventions may result in small but important positive effects, such as a small but important positive effect on weight loss and a small but important reduction in resting heart rate (4521 participants in 30 RCTs). Interactive social media may improve overall well-being (standardised mean difference (SMD) 0.46, 95% confidence interval (CI) 0.14 to 0.79, moderate effect, low-certainty evidence) demonstrated by an increase of 3.77 points on a general well-being scale (from 1.15 to 6.48 points higher) where scores range from 14 to 70 (3792 participants in 16 studies). We found no difference in effect on psychological outcomes (depression and distress) representing a difference of 0.1 points on a standard scale in which scores range from 0 to 63 points (SMD -0.01, 95% CI -0.14 to 0.12, low-certainty evidence, 2070 participants in 12 RCTs).\nWe also compared studies assessing interactive social media interventions with those with an active but less interactive social media control (11 studies). Four RCTs (1523 participants) that reported on physical activity found an improvement demonstrated by an increase of 28 minutes of moderate-to-vigorous physical activity per week (from 10 to 47 minutes more, SMD 0.35, 95% CI 0.12 to 0.59, small effect, very low-certainty evidence). Two studies found little to no difference in well-being for those in the intervention and control groups (SMD 0.02, 95% CI -0.08 to 0.13, small effect, low-certainty evidence), demonstrated by a mean change of 0.4 points on a scale with a range of 0 to 100.\nAdverse events related to the social media component of the interventions, such as privacy issues, were not reported in any of our included studies.\nWe were unable to conduct planned subgroup analyses related to health equity as only four studies reported relevant data.\nAuthors' conclusions\nThis review combined data for a variety of outcomes and found that social media interventions that aim to increase physical activity may be effective and social media interventions may improve well-being. While we assessed many other outcomes, there were too few studies to compare or, where there were studies, the evidence was uncertain. None of our included studies reported adverse effects related to the social media component of the intervention. Future studies should assess adverse events related to the interactive social media component and should report on population characteristics to increase our understanding of the potential effect of these interventions on reducing health inequities.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Compared with non-interactive programmes, social media programmes:\n- may improve some health behaviours, such as increasing the number of daily steps taken, or taking part in screening tests, but may show little to no effect on other health behaviours, such as better diet or reducing tobacco use (evidence from 54 studies in 20,139 people).\n- may cause small improvements in health, such as a small increase in amount of weight lost, and a small reduction in resting heart rate (evidence from 30 studies in 4521 people).\n- may improve people's well-being (evidence from 16 studies in 3792 people).\n- may have little to no effect on people's mental health, such as depression (evidence from 12 studies in 2070 people).\nNo studies reported any unwanted effects related to using social media."
}
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query-laysum | 3953 | [
{
"role": "user",
"content": "Abstract: Background\nThe choice of surgical approach for the management of subaxial cervical spine facet dislocations is a controversial subject amongst spine surgeons. Reasons for this include differences in the technical familiarity and experience of surgeons with the different surgical approaches, and variable interpretation of image studies regarding the existence of a traumatic intervertebral disc herniation and of the neurological status of the patient. Moreover, since the approaches are dissimilar, important variations are likely in neurological, radiographical and clinical outcomes.\nObjectives\nTo compare the effects (benefits and harms) of the different surgical approaches used for treating adults with acute cervical spine facet dislocation.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (9 May 2014), The Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014 Issue 4), MEDLINE (1946 to April Week 5 2014), MEDLINE In-Process & Other Non-Indexed Citations (8 May 2013), EMBASE (1980 to 2014 Week 18), Latin American and Caribbean Health Sciences (9 May 2014), trial registries, conference proceedings and reference lists of articles to May 2014.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials that compared surgical approaches for the management of adults with acute cervical spine facet dislocations with and without spinal cord injury.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias and extracted data.\nMain results\nWe included one randomised and one quasi-randomised controlled trial involving a total of 94 participants and reporting results for a maximum of 84 participants. One trial included patients with spinal cord injuries and the other included patients without spinal cord injuries. Both trials compared anterior versus posterior surgical approaches. Both trials were at high risk of bias, including selection bias (one trial), performance bias (both trials) and attrition bias (one trial). Data were pooled for one outcome only: non-union. Reflecting also the imprecision of the results, the evidence was deemed to be of very low quality for all outcomes; which means that our level of uncertainty about the estimates is high.\nNeither trial found differences between the two approaches in neurological recovery or status, as shown in one study by small clinically insignificant differences in NASS (Northern American Spine Society) neurological scores (0 to 100: optimal score) at one year of follow-up: anterior mean score: 85.23 versus posterior mean score: 83.86; mean difference (MD) 1.37 favouring anterior approach, 95% confidence interval (CI) -9.76 to 12.50; 33 participants; 1 study). The same trial found no relevant between-approach differences at one year in patient-reported quality of life measured using the 36-item Short Form Survey physical (MD -0.08, 95% CI -7.26 to 7.10) and mental component scores (MD 2.88, 95% CI -3.32 to 9.08). Neither trial found evidence of significant differences in long-term pain, or non-union (2/38 versus 2/46; risk ratio (RR) 1.18, 95% CI 0.04 to 34.91). One trial found better sagittal and more 'normal' alignment after the anterior approach (MD -10.31 degrees favouring anterior approach, 95% CI -14.95 degrees to -5.67 degrees), while the other trial reported no significant differences in cervical alignment. There was insufficient evidence to indicate between-group differences in medical adverse events, rates of instrumentation failure and infection. One trial found that the several participants had voice and swallowing disorders after anterior approach surgery (11/20) versus none (0/22) in the posterior approach group: RR 25.19, 95% CI 1.58 to 401.58); all had recovered by three months.\nAuthors' conclusions\nVery low quality evidence from two trials indicated little difference in long-term neurological status, pain or patient-reported quality of life between anterior and posterior surgical approaches to the management of individuals with subaxial cervical spine facet dislocations. Sagittal alignment may be better achieved with the anterior approach. There was insufficient evidence available to indicate between-group differences in medical adverse events, rates of instrumentation failure and infection. The disorders of the voice and swallowing that occurred exclusively in the anterior approach group all resolved by three months. We are very uncertain about this evidence and thus we cannot say whether one approach is better than the other. There was no evidence available for other approaches. Further higher quality multicentre randomised trials are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was very low, meaning that we are very uncertain about the direction and size of effect. Thus we are unable to say whether either an anterior or posterior approach to the surgical management of individuals with dislocations to the cervical spine facet joints is better than the other. We suggest that further research is needed to inform the choice of surgical approach."
}
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query-laysum | 3954 | [
{
"role": "user",
"content": "Abstract: Background\nWhile many cessation programmes are available to assist smokers in quitting, research suggests that support from individual partners, family members, or 'buddies' may encourage abstinence.\nObjectives\nTo determine if an intervention to enhance one-to-one partner support for smokers attempting to quit improves smoking cessation outcomes, compared with cessation interventions lacking a partner-support component.\nSearch methods\nWe limited the search to the Cochrane Tobacco Addiction Group Specialised Register, which was updated in April 2018. This includes the results of searches of the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (via OVID); Embase (via OVID); and PsycINFO (via OVID). The search terms used were smoking (prevention, control, therapy), smoking cessation and support (family, marriage, spouse, partner, sexual partner, buddy, friend, cohabitant and co-worker). We also reviewed the bibliographies of all included articles for additional trials.\nSelection criteria\nWe included randomised controlled trials recruiting people who smoked. Trials were eligible if they had at least one treatment arm that included a smoking cessation intervention with a partner-support component, compared to a control condition providing behavioural support of similar intensity, without a partner-support component. Trials were also required to report smoking cessation at six months follow-up or more.\nData collection and analysis\nTwo review authors independently identified the included studies from the search results, and extracted data using a structured form. A third review author helped resolve discrepancies, in line with standard methodological procedures expected by Cochrane. Smoking abstinence, biochemically verified where possible, was the primary outcome measure and was extracted at two post-treatment intervals where possible: at six to nine months and at 12 months or longer. We used a random-effects model to pool risk ratios from each study and estimate a summary effect.\nMain results\nOur update search identified 465 citations, which we assessed for eligibility. Three new studies met the criteria for inclusion, giving a total of 14 included studies (n = 3370). The definition of partner varied among the studies. We compared partner support versus control interventions at six- to nine-month follow-up and at 12 or more months follow-up. We also examined outcomes among three subgroups: interventions targeting relatives, friends or coworkers; interventions targeting spouses or cohabiting partners; and interventions targeting fellow cessation programme participants. All studies gave self-reported smoking cessation rates, with limited biochemical verification of abstinence. The pooled risk ratio (RR) for abstinence was 0.97 (95% confidence interval (CI) 0.83 to 1.14; 12 studies; 2818 participants) at six to nine months, and 1.04 (95% CI 0.88 to 1.22; 7 studies; 2573 participants) at 12 months or more post-treatment. Of the 11 studies that measured partner support at follow-up, only two reported a significant increase in partner support in the intervention groups. One of these studies reported a significant increase in partner support in the intervention group, but smokers' reports of partner support received did not differ significantly. We judged one of the included studies to be at high risk of selection bias, but a sensitivity analysis suggests that this did not have an impact on the results. There were also potential issues with detection bias due to a lack of validation of abstinence in five of the 14 studies; however, this is not apparent in the statistically homogeneous results across studies. Using the GRADE system we rated the overall quality of the evidence for the two primary outcomes as low. We downgraded due to the risk of bias, as we judged studies with a high weighting in analyses to be at a high risk of detection bias. In addition, a study in both analyses was insufficiently randomised. We also downgraded the quality of the evidence for indirectness, as very few studies provided any evidence that the interventions tested actually increased the amount of partner support received by participants in the relevant intervention group.\nAuthors' conclusions\nInterventions that aim to enhance partner support appear to have no impact on increasing long-term abstinence from smoking. However, most interventions that assessed partner support showed no evidence that the interventions actually achieved their aim and increased support from partners for smoking cessation. Future research should therefore focus on developing behavioural interventions that actually increase partner support, and test this in small-scale studies, before large trials assessing the impact on smoking cessation can be justified.\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 combined 12 studies (2818 participants) to measure successful quitting at six to nine months follow-up, and seven studies (2573 participants) to measure quitting at 12-month follow-up. Partner support did not increase the chances of stopping smoking at either time point. We also split the studies in each analysis based on the type of partner giving support (relatives/friends/co-workers versus spouses/cohabiting partners versus fellow cessation-programme participants). There was no difference in quit rates between study groups, regardless of the type of partner providing the support. Only one study reported that partner support improved more in the group given the partner-support intervention than in the group where no partner-support intervention was provided. Another study reported that partner support improved more in a more intensive partner-support intervention than a less intensive partner-support intervention."
}
]
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query-laysum | 3955 | [
{
"role": "user",
"content": "Abstract: Background\nChronic infection with Pseudomonas aeruginosa (PA) in cystic fibrosis (CF) is a source of much morbidity and mortality. Eradication of early PA infection is possible, but can recur in many individuals. We sought to examine strategies to delay the time to PA recurrence in people with CF.\nObjectives\nTo establish whether secondary prevention strategies, using antibiotics or other therapies, increase the chances of people with CF remaining free from PA infection following successful eradication therapy.\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 ongoing trials registries and the reference lists of relevant articles and reviews.\nDate of last search: 21 August 2019.\nSelection criteria\nRandomised controlled trials (and quasi-randomised trials where the risk of bias was low) comparing any treatment modality aimed at preventing recurrence of PA infection with placebo, standard therapy or any other treatment modality in people with CF who have undergone successful eradication of PA.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias. Quality of the evidence was assessed using GRADE. Conflicts were resolved by discussion and the opinion of a third review author was sought where necessary. Only a subset of participants in the included trial were eligible, therefore individual participant data were requested and obtained from the trial investigators.\nMain results\nWe included one trial (n = 306) in the review; however, only 253 participants had undergone successful eradication of PA, so fulfilling the inclusion criteria for our review. Information presented relates only to the included subset of participants. The trial recruited children aged one to 12 years (mean (standard deviation (SD)) age of 5.8 (3.5) years), 129 participants (51.0%) were female and the median follow-up was 494 days. We compared cycled therapy with tobramycin inhalation solution (TIS), in which participants underwent 28 days of TIS every three months, with culture-based therapy, in which participants were only prescribed medication when a quarterly sputum sample was positive for PA. Reasons for downgrading the quality of the evidence included applicability (only included children), incomplete outcome data and a small number of participants.\nThe time to next isolation of PA was probably shorter with cycled TIS therapy than with culture-based therapy, hazard ratio (HR) 2.04 days (95% confidence interval (CI) 1.28 to 3.26) (moderate-quality evidence). This is in contrast to the main publication of the only included trial, which examined rate of PA positivity rather than time to PA infection and included participants not eligible for inclusion in this review. At the end of the trial, there was no difference between the cycled and culture-based groups in the change from baseline in forced expiratory volume in one second (FEV1) L, mean difference (MD) 0.0 L (95% CI -0.09 to 0.09) or in FEV1 % predicted, MD 0.70% (95% CI -4.33 to 5.73) (both very low-quality evidence). There was no difference in the change from baseline for FVC between the groups. There was also no difference in the frequency of pulmonary exacerbations between groups, MD -0.18 (95% CI -0.51 to 0.14) (moderate-quality evidence). Similarly, there was no difference between groups in the risk of participants developing novel resistant bacteria, RR 1.00 (95% CI 0.67 to 1.5) (moderate-quality evidence). There were more severe adverse events in the cycled group, but the type of treatment probably makes little or no difference to the results, RR 0.65 (95% CI 0.39 to 1.11) (moderate-quality evidence).\nThere was no difference between groups in the change in weight or height from baseline or in rates of adherence to tobramycin or all trial medicines. The included trial did not assess changes in quality of life, the time to chronic infection with PA or the cost-effectiveness of treatment.\nAuthors' conclusions\nCycled TIS therapy may be beneficial in prolonging the time to recurrence of PA after successful eradication, but further trials are required, specifically addressing this question and in both adults and children.\n\nGiven the provided abstract, please respond to the following query: \"Trial characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included one trial with 306 participants. Only 253 of these people had had successful treatment of PA and so could be included in our review. There were only children in the trial who were aged between one and 12 years old; 51% were girls. The trial compared treatment with one month of an inhaled antibiotic every three months ('cycled treatment') with antibiotic treatment given only when the person was found to have PA ('culture-based treatment'). People were selected randomly to have either cycled or culture-based treatment. The trial followed people up for an average of 70 weeks."
}
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query-laysum | 3956 | [
{
"role": "user",
"content": "Abstract: Background\nAn intraocular lens (IOL) is a synthetic lens that is surgically implanted within the eye following removal of the crystalline lens, during cataract surgery. While all modern IOLs attenuate the transmission of ultra-violet (UV) light, some IOLs, called blue-blocking or blue-light filtering IOLs, also reduce short-wavelength visible light transmission. The rationale for blue-light filtering IOLs derives primarily from cell culture and animal studies, which suggest that short-wavelength visible light can induce retinal photoxicity. Blue-light filtering IOLs have been suggested to impart retinal protection and potentially prevent the development and progression of age-related macular degeneration (AMD). We sought to investigate the evidence relating to these suggested benefits of blue-light filtering IOLs, and to consider any potential adverse effects.\nObjectives\nTo assess the effects of blue-light filtering IOLs compared with non-blue-light filtering IOLs, with respect to providing protection to macular health and function.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 9); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 25 October 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs), involving adult participants undergoing cataract extraction, where a blue-light filtering IOL was compared with an equivalent non-blue-light filtering IOL.\nData collection and analysis\nThe prespecified primary outcome was the change in distance best-corrected visual acuity (BCVA), as a continuous outcome, between baseline and 12 months of follow-up. Prespecified secondary outcomes included postoperative contrast sensitivity, colour discrimination, macular pigment optical density (MPOD), proportion of eyes with a pathological finding at the macula (including, but not limited to the development or progression of AMD, or both), daytime alertness, reaction time and patient satisfaction. We evaluated findings related to ocular and systemic adverse effects.\nTwo review authors independently screened abstracts and full-text articles, extracted data from eligible RCTs and judged the risk of bias using the Cochrane tool. We reached a consensus on any disagreements by discussion. Where appropriate, we pooled data relating to outcomes and used random-effects or fixed-effect models for the meta-analyses. We summarised the overall certainty of the evidence using GRADE.\nMain results\nWe included 51 RCTs from 17 different countries, although most studies either did not report relevant outcomes, or provided data in a format that could not be extracted. Together, the included studies considered the outcomes of IOL implantation in over 5000 eyes. The number of participants ranged from 13 to 300, and the follow-up period ranged from one month to five years. Only two of the studies had a trial registry record and no studies referred to a published protocol. We did not judge any of the studies to have a low risk of bias in all seven domains. We judged approximately two-thirds of the studies to have a high risk of bias in domains relating to ‘blinding of participants and personnel' (performance bias) and ‘blinding of outcome assessment' (detection bias).\nWe found with moderate certainty, that distance BCVA with a blue-light filtering IOL, at six to 18 months postoperatively, and measured in logMAR, was not clearly different to distance BCVA with a non-blue-light filtering IOL (mean difference (MD) -0.01 logMAR, 95% confidence interval (CI) -0.03 to 0.02, P = 0.48; 2 studies, 131 eyes).\nThere was very low-certainty evidence relating to any potential inter-intervention difference for the proportion of eyes that developed late-stage AMD at three years of follow-up, or any stage of AMD at one year of follow-up, as data derived from one trial and two trials respectively, and there were no events in either IOL intervention group, for either outcome. There was very low-certainty evidence for the outcome for the proportion of participants who lost 15 or more letters of distance BCVA at six months of follow-up; two trials that considered a total of 63 eyes reported no events, in either IOL intervention group.\nThere were no relevant, combinable data available for outcomes relating to the effect on contrast sensitivity at six months, the proportion of eyes with a measurable loss of colour discrimination from baseline at six months, or the proportion of participants with adverse events with a probable causal link with the study interventions after six months.\nWe were unable to draw reliable conclusions on the relative equivalence or superiority of blue-light filtering IOLs versus non-blue-light filtering IOLs in relation to longer-term effects on macular health. We were also not able to determine with any certainty whether blue-light filtering IOLs have any significant effects on MPOD, contrast sensitivity, colour discrimination, daytime alertness, reaction time or patient satisfaction, relative to non-blue-light filtering IOLs.\nAuthors' conclusions\nThis systematic review shows with moderate certainty that there is no clinically meaningful difference in short-term BCVA with the two types of IOLs. Further, based upon available data, these findings suggest that there is no clinically meaningful difference in short-term contrast sensitivity with the two interventions, although there was a low level of certainty for this outcome due to a small number of included studies and their inherent risk of bias. Based upon current, best-available research evidence, it is unclear whether blue-light filtering IOLs preserve macular health or alter risks associated with the development and progression of AMD, or both. Further research is required to fully understand the effects of blue-light filtering IOLs for providing protection to macular health and function.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out if blue-light filtering artifical lenses, also known as intraocular lenses (IOLs) protect the back of the eye. Cochrane Review authors collected and analysed all relevant studies to answer this question and found 51 studies."
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query-laysum | 3957 | [
{
"role": "user",
"content": "Abstract: Background\nNeuraminidase inhibitors (NIs) are stockpiled and recommended by public health agencies for treating and preventing seasonal and pandemic influenza. They are used clinically worldwide.\nObjectives\nTo describe the potential benefits and harms of NIs for influenza in all age groups by reviewing all clinical study reports of published and unpublished randomised, placebo-controlled trials and regulatory comments.\nSearch methods\nWe searched trial registries, electronic databases (to 22 July 2013) and regulatory archives, and corresponded with manufacturers to identify all trials. We also requested clinical study reports. We focused on the primary data sources of manufacturers but we checked that there were no published randomised controlled trials (RCTs) from non-manufacturer sources by running electronic searches in the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE (Ovid), EMBASE, Embase.com, PubMed (not MEDLINE), the Database of Reviews of Effects, the NHS Economic Evaluation Database and the Health Economic Evaluations Database.\nSelection criteria\nRandomised, placebo-controlled trials on adults and children with confirmed or suspected exposure to naturally occurring influenza.\nData collection and analysis\nWe extracted clinical study reports and assessed risk of bias using purpose-built instruments. We analysed the effects of zanamivir and oseltamivir on time to first alleviation of symptoms, influenza outcomes, complications, hospitalisations and adverse events in the intention-to-treat (ITT) population. All trials were sponsored by the manufacturers.\nMain results\nWe obtained 107 clinical study reports from the European Medicines Agency (EMA), GlaxoSmithKline and Roche. We accessed comments by the US Food and Drug Administration (FDA), EMA and Japanese regulator. We included 53 trials in Stage 1 (a judgement of appropriate study design) and 46 in Stage 2 (formal analysis), including 20 oseltamivir (9623 participants) and 26 zanamivir trials (14,628 participants). Inadequate reporting put most of the zanamivir studies and half of the oseltamivir studies at a high risk of selection bias. There were inadequate measures in place to protect 11 studies of oseltamivir from performance bias due to non-identical presentation of placebo. Attrition bias was high across the oseltamivir studies and there was also evidence of selective reporting for both the zanamivir and oseltamivir studies. The placebo interventions in both sets of trials may have contained active substances.\nTime to first symptom alleviation. For the treatment of adults, oseltamivir reduced the time to first alleviation of symptoms by 16.8 hours (95% confidence interval (CI) 8.4 to 25.1 hours, P < 0.0001). This represents a reduction in the time to first alleviation of symptoms from 7 to 6.3 days. There was no effect in asthmatic children, but in otherwise healthy children there was (reduction by a mean difference of 29 hours, 95% CI 12 to 47 hours, P = 0.001). Zanamivir reduced the time to first alleviation of symptoms in adults by 0.60 days (95% CI 0.39 to 0.81 days, P < 0.00001), equating to a reduction in the mean duration of symptoms from 6.6 to 6.0 days. The effect in children was not significant. In subgroup analysis we found no evidence of a difference in treatment effect for zanamivir on time to first alleviation of symptoms in adults in the influenza-infected and non-influenza-infected subgroups (P = 0.53).\nHospitalisations. Treatment of adults with oseltamivir had no significant effect on hospitalisations: risk difference (RD) 0.15% (95% CI -0.78 to 0.91). There was also no significant effect in children or in prophylaxis. Zanamivir hospitalisation data were unreported.\nSerious influenza complications or those leading to study withdrawal. In adult treatment trials, oseltamivir did not significantly reduce those complications classified as serious or those which led to study withdrawal (RD 0.07%, 95% CI -0.78 to 0.44), nor in child treatment trials; neither did zanamivir in the treatment of adults or in prophylaxis. There were insufficient events to compare this outcome for oseltamivir in prophylaxis or zanamivir in the treatment of children.\nPneumonia. Oseltamivir significantly reduced self reported, investigator-mediated, unverified pneumonia (RD 1.00%, 95% CI 0.22 to 1.49); number needed to treat to benefit (NNTB) = 100 (95% CI 67 to 451) in the treated population. The effect was not significant in the five trials that used a more detailed diagnostic form for pneumonia. There were no definitions of pneumonia (or other complications) in any trial. No oseltamivir treatment studies reported effects on radiologically confirmed pneumonia. There was no significant effect on unverified pneumonia in children. There was no significant effect of zanamivir on either self reported or radiologically confirmed pneumonia. In prophylaxis, zanamivir significantly reduced the risk of self reported, investigator-mediated, unverified pneumonia in adults (RD 0.32%, 95% CI 0.09 to 0.41); NNTB = 311 (95% CI 244 to 1086), but not oseltamivir.\nBronchitis, sinusitis and otitis media. Zanamivir significantly reduced the risk of bronchitis in adult treatment trials (RD 1.80%, 95% CI 0.65 to 2.80); NNTB = 56 (36 to 155), but not oseltamivir. Neither NI significantly reduced the risk of otitis media and sinusitis in both adults and children.\nHarms of treatment. Oseltamivir in the treatment of adults increased the risk of nausea (RD 3.66%, 95% CI 0.90 to 7.39); number needed to treat to harm (NNTH) = 28 (95% CI 14 to 112) and vomiting (RD 4.56%, 95% CI 2.39 to 7.58); NNTH = 22 (14 to 42). The proportion of participants with four-fold increases in antibody titre was significantly lower in the treated group compared to the control group (RR 0.92, 95% CI 0.86 to 0.97, I2 statistic = 0%) (5% absolute difference between arms). Oseltamivir significantly decreased the risk of diarrhoea (RD 2.33%, 95% CI 0.14 to 3.81); NNTB = 43 (95% CI 27 to 709) and cardiac events (RD 0.68%, 95% CI 0.04 to 1.0); NNTB = 148 (101 to 2509) compared to placebo during the on-treatment period. There was a dose-response effect on psychiatric events in the two oseltamivir \"pivotal\" treatment trials, WV15670 and WV15671, at 150 mg (standard dose) and 300 mg daily (high dose) (P = 0.038). In the treatment of children, oseltamivir induced vomiting (RD 5.34%, 95% CI 1.75 to 10.29); NNTH = 19 (95% CI 10 to 57). There was a significantly lower proportion of children on oseltamivir with a four-fold increase in antibodies (RR 0.90, 95% CI 0.80 to 1.00, I2 = 0%).\nProphylaxis. In prophylaxis trials, oseltamivir and zanamivir reduced the risk of symptomatic influenza in individuals (oseltamivir: RD 3.05% (95% CI 1.83 to 3.88); NNTB = 33 (26 to 55); zanamivir: RD 1.98% (95% CI 0.98 to 2.54); NNTB = 51 (40 to 103)) and in households (oseltamivir: RD 13.6% (95% CI 9.52 to 15.47); NNTB = 7 (6 to 11); zanamivir: RD 14.84% (95% CI 12.18 to 16.55); NNTB = 7 (7 to 9)). There was no significant effect on asymptomatic influenza (oseltamivir: RR 1.14 (95% CI 0.39 to 3.33); zanamivir: RR 0.97 (95% CI 0.76 to 1.24)). Non-influenza, influenza-like illness could not be assessed due to data not being fully reported. In oseltamivir prophylaxis studies, psychiatric adverse events were increased in the combined on- and off-treatment periods (RD 1.06%, 95% CI 0.07 to 2.76); NNTH = 94 (95% CI 36 to 1538) in the study treatment population. Oseltamivir increased the risk of headaches whilst on treatment (RD 3.15%, 95% CI 0.88 to 5.78); NNTH = 32 (95% CI 18 to 115), renal events whilst on treatment (RD 0.67%, 95% CI -2.93 to 0.01); NNTH = 150 (NNTH 35 to NNTB > 1000) and nausea whilst on treatment (RD 4.15%, 95% CI 0.86 to 9.51); NNTH = 25 (95% CI 11 to 116).\nAuthors' conclusions\nOseltamivir and zanamivir have small, non-specific effects on reducing the time to alleviation of influenza symptoms in adults, but not in asthmatic children. Using either drug as prophylaxis reduces the risk of developing symptomatic influenza. Treatment trials with oseltamivir or zanamivir do not settle the question of whether the complications of influenza (such as pneumonia) are reduced, because of a lack of diagnostic definitions. The use of oseltamivir increases the risk of adverse effects, such as nausea, vomiting, psychiatric effects and renal events in adults and vomiting in children. The lower bioavailability may explain the lower toxicity of zanamivir compared to oseltamivir. The balance between benefits and harms should be considered when making decisions about use of both NIs for either the prophylaxis or treatment of influenza. The influenza virus-specific mechanism of action proposed by the producers does not fit the clinical evidence.\n\nGiven the provided abstract, please respond to the following query: \"Why we have taken this approach\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In previous versions of this review we identified unresolved discrepancies in the data presented in published trial reports and substantial publication bias. As a consequence, we elected not to use data from journal articles but included the documents generated during licensing processes. We have accessed such data from the UK, USA, European Medicines Agency (EMA), Japanese regulators and clinical study reports from the manufacturers (after a protracted media campaign). This has enabled us to verify information from the randomised, placebo-controlled trials on adults and children with confirmed or suspected exposure to naturally occurring influenza.\nBased on our assessments of the regulatory documents (in excess of 160,000 pages), we came to the conclusion that there were substantial problems with the design, conduct, reporting and availability of information from many of the trials."
}
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query-laysum | 3958 | [
{
"role": "user",
"content": "Abstract: Background\nPeople undergoing major amputation of the lower limb are at increased risk of venous thromboembolism (VTE). Risk factors for VTE in amputees include advanced age, sedentary lifestyle, longstanding arterial disease and an identifiable hypercoagulable condition. Evidence suggests that pharmacological prophylaxis (e.g. heparin, factor Xa inhibitors, vitamin K antagonists, direct thrombin inhibitors, antiplatelets) is effective in preventing deep vein thrombosis (DVT), but is associated with an increased risk of bleeding. Mechanical prophylaxis (e.g. antiembolism stockings, intermittent pneumatic compression and foot impulse devices), on the other hand, is non-invasive and has minimal side effects. However, mechanical prophylaxis is not always appropriate for people with contraindications such as peripheral arterial disease (PAD), arteriosclerosis or bilateral lower limb amputations. It is important to determine the most effective thromboprophylaxis for people undergoing major amputation and whether this is one treatment alone or in combination with another. This is an update of the review first published in 2013.\nObjectives\nTo determine the effectiveness of thromboprophylaxis in preventing VTE in people undergoing major amputation of the lower extremity.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase and Cumulative Index to Nursing and Allied Health Literature databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 5 November 2019. We planned to undertake reference checking of identified trials to identify additional studies. We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised controlled trials which allocated people undergoing a major unilateral or bilateral amputation (e.g. hip disarticulation, transfemoral, knee disarticulation and transtibial) of the lower extremity to different types or regimens of thromboprophylaxis (including pharmacological or mechanical prophylaxis) or placebo.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed risk of bias. We resolved any disagreements by discussion. Outcomes of interest were VTE (DVT and pulmonary embolism (PE)), mortality, adverse events and bleeding. We used GRADE criteria to assess the certainty of the evidence. The two included studies compared different treatments, so we could not pool the data in a meta-analysis.\nMain results\nWe did not identify any eligible new studies for this update. Two studies with a combined total of 288 participants met the inclusion criteria for this review.\nUnfractionated heparin compared to low molecular weight heparin\nOne study compared unfractionated heparin with low molecular weight heparin and found no evidence of a difference between the treatments in the prevention of DVT (odds ratio (OR) 1.23, 95% confidence interval (CI) 0.28 to 5.35; 75 participants; very low-certainty evidence). No bleeding events occurred in either group. Deaths and adverse events were not reported. This study was open-label and therefore at a high risk of performance bias. Additionally, the study did not report the method of randomisation, so the risk of selection bias was unclear.\nHeparin compared to placebo\nIn the second study, there was no evidence of a benefit from heparin use in preventing PE when compared to placebo (OR 0.84, 95% CI 0.35 to 2.01; 134 participants; low-certainty evidence). Similarly, no evidence of improvement was detected when the level of amputation was considered, with a similar incidence of PE between the two treatment groups: above knee amputation (OR 0.79, 95% CI 0.31 to 1.97; 94 participants; low-certainty evidence); and below knee amputation (OR 1.53, 95% CI 0.09 to 26.43; 40 participants; low-certainty evidence). Ten participants died during the study; five underwent a post-mortem and three were found to have had a recent PE, all of whom had been on placebo (low-certainty evidence). Bleeding events were reported in less than 10% of participants in both treatment groups, but the study did not present specific data (low-certainty evidence). There were no reports of other adverse events. This study did not report the methods used to conceal allocation of treatment, so it was unclear whether selection bias occurred. However, this study appeared to be free from all other sources of bias.\nNo study looked at mechanical prophylaxis.\nAuthors' conclusions\nWe did not identify any eligible new studies for this update. As we only included two studies in this review, each comparing different interventions, there is insufficient evidence to make any conclusions regarding the most effective thromboprophylaxis regimen in people undergoing lower limb amputation. Further large-scale studies of good quality are required.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics and main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review was first published in 2013, and we searched for any studies that have taken place since then (up to 5 November 2019). We did not find any eligible new studies for this update. The review includes the original two studies with a combined total of 288 participants.\nOne study compared two forms of the anticoagulant heparin. We found no evidence of a difference between unfractionated heparin and low molecular weight heparin in the prevention of DVT. None of the participants reported any bleeding. However, in this study both the participants and study personnel were aware of which treatment was being administered. This may have biased the results. It is unclear if other bias was introduced because the study did not adequately describe the process of randomly allocating treatment.\nThe second study found no evidence of a benefit for heparin compared with placebo in preventing a PE, whether the amputation was above or below the knee. Bleeding occurred in less than 10% of each treatment group, but the study authors did not report specific numbers and therefore we could not analyse this. This study did not report the methods used to conceal how treatment was allocated, but we judged it to be free from other sources of bias.\nThis review found that there are too few trials to determine the most effective strategy in preventing VTE in people undergoing amputation of the lower limb. No study looked at mechanical forms of preventing VTE, such as compression devices, and therefore it is not possible to make any conclusions about these. Further good quality and large-scale studies are required."
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query-laysum | 3959 | [
{
"role": "user",
"content": "Abstract: Background\nResistance to antiretroviral therapy (ART) among people living with human immunodeficiency virus (HIV) compromises treatment effectiveness, often leading to virological failure and mortality. Antiretroviral drug resistance tests may be used at the time of initiation of therapy, or when treatment failure occurs, to inform the choice of ART regimen. Resistance tests (genotypic or phenotypic) are widely used in high-income countries, but not in resource-limited settings. This systematic review summarizes the relative merits of resistance testing in treatment-naive and treatment-exposed people living with HIV.\nObjectives\nTo evaluate the effectiveness of antiretroviral resistance testing (genotypic or phenotypic) in reducing mortality and morbidity in HIV-positive people.\nSearch methods\nWe attempted to identify all relevant studies, regardless of language or publication status, through searches of electronic databases and conference proceedings up to 26 January 2018. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and ClinicalTrials.gov to 26 January 2018. We searched Latin American and Caribbean Health Sciences Literature (LILACS) and the Web of Science for publications from 1996 to 26 January 2018.\nSelection criteria\nWe included all randomized controlled trials (RCTs) and observational studies that compared resistance testing to no resistance testing in people with HIV irrespective of their exposure to ART.\nPrimary outcomes of interest were mortality and virological failure. Secondary outcomes were change in mean CD4-T-lymphocyte count, clinical progression to AIDS, development of a second or new opportunistic infection, change in viral load, and quality of life.\nData collection and analysis\nTwo review authors independently assessed each reference for prespecified inclusion criteria. Two review authors then independently extracted data from each included study using a standardized data extraction form. We analysed data on an intention-to-treat basis using a random-effects model. We performed subgroup analyses for the type of resistance test used (phenotypic or genotypic), use of expert advice to interpret resistance tests, and age (children and adolescents versus adults). We followed standard Cochrane methodological procedures.\nMain results\nEleven RCTs (published between 1999 and 2006), which included 2531 participants, met our inclusion criteria. All of these trials exclusively enrolled patients who had previous exposure to ART. We found no observational studies. Length of follow-up time, study settings, and types of resistance testing varied greatly. Follow-up ranged from 12 to 150 weeks. All studies were conducted in Europe, USA, or South America. Seven studies used genotypic testing, two used phenotypic testing, and two used both phenotypic and genotypic testing. Only one study was funded by a manufacturer of resistance tests.\nResistance testing made little or no difference in mortality (odds ratio (OR) 0.89, 95% confidence interval (CI) 0.36 to 2.22; 5 trials, 1140 participants; moderate-certainty evidence), and may have slightly reduced the number of people with virological failure (OR 0.70, 95% CI 0.56 to 0.87; 10 trials, 1728 participants; low-certainty evidence); and probably made little or no difference in change in CD4 cell count (mean difference (MD) -1.00 cells/mm³, 95% CI -12.49 to 10.50; 7 trials, 1349 participants; moderate-certainty evidence) or progression to AIDS (OR 0.64, 95% CI 0.31 to 1.29; 3 trials, 809 participants; moderate-certainty evidence). Resistance testing made little or no difference in adverse events (OR 0.89, 95% CI 0.51 to 1.55; 4 trials, 808 participants; low-certainty evidence) and probably reduced viral load (MD -0.23, 95% CI -0.35 to -0.11; 10 trials, 1837 participants; moderate-certainty evidence). No studies reported on development of new opportunistic infections or quality of life. We found no statistically significant heterogeneity for any outcomes, and the I² statistic value ranged from 0 to 25%. We found no subgroup effects for types of resistance testing (genotypic versus phenotypic), the addition of expert advice to interpretation of resistance tests, or age. Results for mortality were consistent when we compared studies at high or unclear risk of bias versus studies at low risk of bias.\nAuthors' conclusions\nResistance testing probably improved virological outcomes in people who have had virological failure in trials conducted 12 or more years ago. We found no evidence in treatment-naive people. Resistance testing did not demonstrate important patient benefits in terms of risk of death or progression to AIDS. The trials included very few participants from low- and middle-income countries.\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": "Drug resistance to ART implies that specific antiretroviral drugs will be less effective. This happens either because the virus has changed to become resistant, or because an individual was infected with a resistant virus. To determine which drugs will be less effective, healthcare providers may conduct a resistance test. Two kinds of resistance tests are available: the genotypic test, in which the virus is examined to determine which drugs it is resistant to, and the phenotypic test, in which the virus is exposed to antiretroviral drugs to see which one it is resistant to. Use of resistance tests is common only in high-income countries. Before we prepared this review, we did not know how well the use of resistance tests may reduce the number of deaths and improve HIV suppression."
}
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query-laysum | 3960 | [
{
"role": "user",
"content": "Abstract: Background\nCancer of ovarian, fallopian tube and peritoneal origin, referred to collectively as ovarian cancer, is the eighth most common cancer in women and is often diagnosed at an advanced stage. Women with relapsed epithelial ovarian cancer (EOC) are less well and have a limited life expectancy, therefore maintaining quality of life with effective symptom control is an important aim of treatment. However, the unwanted effects of chemotherapy agents may be severe, and optimal treatment regimens are unclear. Pegylated liposomal doxorubicin (PLD), which contains a cytotoxic drug called doxorubicin hydrochloride, is one of several treatment modalities that may be considered for treatment of relapsed EOCs. This is an update of the original Cochrane Review which was published in Issue 7, 2013.\nObjectives\nTo evaluate the efficacy and safety of PLD, with or without other anti-cancer drugs, in women with relapsed high grade epithelial ovarian cancer (EOC).\nSearch methods\nWe searched CENTRAL, MEDLINE (via Ovid) and Embase (via Ovid) from 1990 to January 2022. We also searched online registers of clinical trials, abstracts of scientific meetings and reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated PLD in women diagnosed with relapsed epithelial ovarian cancer.\nData collection and analysis\nTwo review authors independently extracted data to a pre-designed data collection form and assessed the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions guidelines. Where possible, we pooled collected data in meta-analyses.\nMain results\nThis is an update of a previous review with 12 additional studies, so this updated review includes a total of 26 RCTs with 8277 participants that evaluated the effects of PLD alone or in combination with other drugs in recurrent EOC: seven in platinum-sensitive disease (2872 participants); 11 in platinum-resistant disease (3246 participants); and eight that recruited individuals regardless of platinum sensitivity status (2079 participants). The certainty of the evidence was assessed for the three most clinically relevant comparisons out of eight comparisons identified in the included RCTs.\nRecurrent platinum-sensitive EOC\nPLD with conventional chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.83 to 1.04; 5 studies, 2006 participants; moderate-certainty evidence) but likely increases progression-free survival (PFS) (HR 0.81, 95% CI 0.74 to 0.89; 5 studies, 2006 participants; moderate-certainty evidence). The combination may slightly improve quality of life at three months post-randomisation, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (mean difference 4.80, 95% CI 0.92 to 8.68; 1 study, 608 participants; low-certainty evidence), but this may not represent a clinically meaningful difference.\nPLD in combination with another chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in the rate of overall severe adverse events (grade ≥ 3) (risk ratio (RR) 1.11, 95% CI 0.95 to 1.30; 2 studies, 834 participants; moderate-certainty evidence). PLD with chemotherapy likely increases anaemia (grade ≥ 3) (RR 1.37, 95% CI 1.02 to 1.85; 5 studies, 1961 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD with conventional chemotherapy on hand-foot syndrome (HFS)(grade ≥ 3) (RR 4.01, 95% CI 1.00 to 16.01; 2 studies, 1028 participants; very low-certainty evidence) and neurological events (grade ≥ 3) (RR 0.38, 95% CI 0.20 to 0.74; 4 studies, 1900 participants; very low-certainty evidence).\nRecurrent platinum-resistant EOC\nPLD alone compared to another conventional chemotherapy likely results in little to no difference in OS (HR 0.96, 95% CI 0.77 to 1.19; 6 studies, 1995 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD on PFS (HR 0.94, 95% CI 0.85 to 1.04; 4 studies, 1803 participants; very low-certainty evidence), overall severe adverse events (grade ≥ 3) (RR ranged from 0.61 to 0.97; 2 studies, 964 participants; very low-certainty evidence), anaemia (grade ≥ 3) (RR ranged from 0.19 to 0.82; 5 studies, 1968 participants; very low-certainty evidence), HFS (grade ≥ 3) (RR ranged from 15.19 to 109.15; 6 studies, 2184 participants; very low-certainty evidence), and the rate of neurological events (grade ≥ 3)(RR ranged from 0.08 to 3.09; 3 studies, 1222 participants; very low-certainty evidence).\nPLD with conventional chemotherapy compared to PLD alone likely results in little to no difference in OS (HR 0.92, 95% CI 0.70 to 1.21; 1 study, 242 participants; moderate-certainty evidence) and it may result in little to no difference in PFS (HR 0.94, 95% CI 0.73 to 1.22; 2 studies, 353 participants; low-certainty evidence). The combination likely increases overall severe adverse events (grade ≥ 3) (RR 2.48, 95% CI 1.98 to 3.09; 1 study, 663 participants; moderate-certainty evidence) and anaemia (grade ≥ 3) (RR 2.38, 95% CI 1.46 to 3.87; 2 studies, 785 participants; moderate-certainty evidence), but likely results in a large reduction in HFS (grade ≥ 3) (RR 0.24, 95% CI 0.14 to 0.40; 2 studies, 785 participants; moderate-certainty evidence). It may result in little to no difference in neurological events (grade ≥ 3) (RR 1.40, 95% CI 0.85 to 2.31; 1 study, 663 participants; low-certainty evidence).\nAuthors' conclusions\nIn platinum-sensitive relapsed EOC, including PLD in a combination chemotherapy regimen probably makes little to no difference in OS compared to other combinations, but likely improves PFS. Choice of chemotherapy will therefore be guided by symptoms from previous chemotherapy and other patient considerations. Single-agent PLD remains a useful agent for platinum-resistant relapsed EOC and choice of agent at relapse will depend on patient factors, e.g. degree of bone marrow suppression or neurotoxicity from previous treatments. Adding another agent to PLD likely increases overall grade ≥ 3 adverse events with little to no improvement in survival outcomes. The limited evidence relating to PLD in combination with other agents in platinum-resistant relapsed EOC does not indicate a benefit, but there is some evidence of increased side effects.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Women whose EOC returned more than six months after finishing their last treatment who were treated with PLD alongside other chemotherapy survived for a similar length of time to women treated with alternative combinations. It may also take longer for their cancer to re-grow than with alternative combinations. Quality of life may slightly improve with PLD treatment. Apart from anaemia, which was more common in women taking the PLD treatment, severe side effects were similar to those seen in women on alternative combinations.\nIn women whose EOC returned within six months of finishing their last platinum treatment, PLD alongside other chemotherapy, versus alterative combination chemotherapy, probably works as well in terms of improving how long they live, but we are uncertain about other unwanted effects and benefits. PLD alongside other chemotherapy versus PLD alone likely makes little difference in how long women survive, and may make little difference in how long it takes for their cancer to re-grow, but the combination likely increases overall severe unwanted effects and the risk of severe anaemia."
}
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query-laysum | 3961 | [
{
"role": "user",
"content": "Abstract: Background\nDental caries (tooth decay) and periodontal diseases (gingivitis and periodontitis) affect the majority of people worldwide, and treatment costs place a significant burden on health services. Decay and gum disease can cause pain, eating and speaking difficulties, low self-esteem, and even tooth loss and the need for surgery. As dental plaque is the primary cause, self-administered daily mechanical disruption and removal of plaque is important for oral health. Toothbrushing can remove supragingival plaque on the facial and lingual/palatal surfaces, but special devices (such as floss, brushes, sticks, and irrigators) are often recommended to reach into the interdental area.\nObjectives\nTo evaluate the effectiveness of interdental cleaning devices used at home, in addition to toothbrushing, compared with toothbrushing alone, for preventing and controlling periodontal diseases, caries, and plaque. A secondary objective was to compare different interdental cleaning devices with each other.\nSearch methods\nCochrane Oral Health’s Information Specialist searched: Cochrane Oral Health’s Trials Register (to 16 January 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2018, Issue 12), MEDLINE Ovid (1946 to 16 January 2019), Embase Ovid (1980 to 16 January 2019) and CINAHL EBSCO (1937 to 16 January 2019). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication.\nSelection criteria\nRandomised controlled trials (RCTs) that compared toothbrushing and a home-use interdental cleaning device versus toothbrushing alone or with another device (minimum duration four weeks).\nData collection and analysis\nAt least two review authors independently screened searches, selected studies, extracted data, assessed studies' risk of bias, and assessed evidence certainty as high, moderate, low or very low, according to GRADE. We extracted indices measured on interproximal surfaces, where possible. We conducted random-effects meta-analyses, using mean differences (MDs) or standardised mean differences (SMDs).\nMain results\nWe included 35 RCTs (3929 randomised adult participants). Studies were at high risk of performance bias as blinding of participants was not possible. Only two studies were otherwise at low risk of bias. Many participants had a low level of baseline gingival inflammation.\nStudies evaluated the following devices plus toothbrushing versus toothbrushing: floss (15 trials), interdental brushes (2 trials), wooden cleaning sticks (2 trials), rubber/elastomeric cleaning sticks (2 trials), oral irrigators (5 trials). Four devices were compared with floss: interdental brushes (9 trials), wooden cleaning sticks (3 trials), rubber/elastomeric cleaning sticks (9 trials) and oral irrigators (2 trials). Another comparison was rubber/elastomeric cleaning sticks versus interdental brushes (3 trials).\nNo trials assessed interproximal caries, and most did not assess periodontitis. Gingivitis was measured by indices (most commonly, Löe-Silness, 0 to 3 scale) and by proportion of bleeding sites. Plaque was measured by indices, most often Quigley-Hein (0 to 5).\nPrimary objective: comparisons against toothbrushing alone\nLow-certainty evidence suggested that flossing, in addition to toothbrushing, may reduce gingivitis (measured by gingival index (GI)) at one month (SMD -0.58, 95% confidence interval (CI) -1.12 to -0.04; 8 trials, 585 participants), three months or six months. The results for proportion of bleeding sites and plaque were inconsistent (very low-certainty evidence).\nVery low-certainty evidence suggested that using an interdental brush, plus toothbrushing, may reduce gingivitis (measured by GI) at one month (MD -0.53, 95% CI -0.83 to -0.23; 1 trial, 62 participants), though there was no clear difference in bleeding sites (MD -0.05, 95% CI -0.13 to 0.03; 1 trial, 31 participants). Low-certainty evidence suggested interdental brushes may reduce plaque more than toothbrushing alone (SMD -1.07, 95% CI -1.51 to -0.63; 2 trials, 93 participants).\nVery low-certainty evidence suggested that using wooden cleaning sticks, plus toothbrushing, may reduce bleeding sites at three months (MD -0.25, 95% CI -0.37 to -0.13; 1 trial, 24 participants), but not plaque (MD -0.03, 95% CI -0.13 to 0.07).\nVery low-certainty evidence suggested that using rubber/elastomeric interdental cleaning sticks, plus toothbrushing, may reduce plaque at one month (MD -0.22, 95% CI -0.41 to -0.03), but this was not found for gingivitis (GI MD -0.01, 95% CI -0.19 to 0.21; 1 trial, 12 participants; bleeding MD 0.07, 95% CI -0.15 to 0.01; 1 trial, 30 participants).\nVery-low certainty evidence suggested oral irrigators may reduce gingivitis measured by GI at one month (SMD -0.48, 95% CI -0.89 to -0.06; 4 trials, 380 participants), but not at three or six months. Low-certainty evidence suggested that oral irrigators did not reduce bleeding sites at one month (MD -0.00, 95% CI -0.07 to 0.06; 2 trials, 126 participants) or three months, or plaque at one month (SMD -0.16, 95% CI -0.41 to 0.10; 3 trials, 235 participants), three months or six months, more than toothbrushing alone.\nSecondary objective: comparisons between devices\nLow-certainty evidence suggested interdental brushes may reduce gingivitis more than floss at one and three months, but did not show a difference for periodontitis measured by probing pocket depth. Evidence for plaque was inconsistent.\nLow- to very low-certainty evidence suggested oral irrigation may reduce gingivitis at one month compared to flossing, but very low-certainty evidence did not suggest a difference between devices for plaque.\nVery low-certainty evidence for interdental brushes or flossing versus interdental cleaning sticks did not demonstrate superiority of either intervention.\nAdverse events\nStudies that measured adverse events found no severe events caused by devices, and no evidence of differences between study groups in minor effects such as gingival irritation.\nAuthors' conclusions\nUsing floss or interdental brushes in addition to toothbrushing may reduce gingivitis or plaque, or both, more than toothbrushing alone. Interdental brushes may be more effective than floss. Available evidence for tooth cleaning sticks and oral irrigators is limited and inconsistent. Outcomes were mostly measured in the short term and participants in most studies had a low level of baseline gingival inflammation. Overall, the evidence was low to very low-certainty, and the effect sizes observed may not be clinically important. Future trials should report participant periodontal status according to the new periodontal diseases classification, and last long enough to measure interproximal caries and periodontitis.\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": "How effective are home-use interdental cleaning devices, plus toothbrushing, compared with toothbrushing only or use of another device, for preventing and controlling periodontal (gum) diseases (gingivitis and periodontitis), tooth decay (dental caries) and plaque?"
}
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query-laysum | 3962 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in the Cochrane Library, Issue 5, 2015.\nYoga may induce relaxation and stress reduction, and influence the electroencephalogram and the autonomic nervous system, thereby controlling seizures. Yoga would be an attractive therapeutic option for epilepsy if proved effective.\nObjectives\nTo assess whether people with epilepsy treated with yoga:\n(a) have a greater probability of becoming seizure free;\n(b) have a significant reduction in the frequency or duration of seizures, or both; and\n(c) have a better quality of life.\nSearch methods\nFor this update, we searched the Cochrane Epilepsy Group Specialized Register (3 January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12) in the Cochrane Library (searched 3 January 2017), MEDLINE (Ovid, 1946 to 3 January 2017), SCOPUS (1823 to 3 January 2017), ClinicalTrials.gov (searched 3 January 2017), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (searched 3 January 2017), and also registries of the Yoga Biomedical Trust and the Research Council for Complementary Medicine. In addition, we searched the references of all the identified studies. No language restrictions were imposed.\nSelection criteria\nThe following study designs were eligible for inclusion: randomised controlled trials (RCT) of treatment of epilepsy with yoga. The studies could be double-, single- or unblinded. Eligible participants were adults with uncontrolled epilepsy comparing yoga with no treatment or different behavioural treatments.\nData collection and analysis\nTwo review authors independently assessed the trials for inclusion and extracted data. The following outcomes were assessed: (a) percentage of people rendered seizure free; (b) seizure frequency and duration; (c) quality of life. Analyses were on an intention-to-treat basis. Odds ratio (OR) with 95% confidence intervals (95% Cls) were estimated for the outcomes.\nMain results\nWe did not identify any new studies for this update, therefore the results are unchanged.\nFor the previous version of the review, the authors found two unblinded trials in people with refractory epilepsy. In total these two studies included 50 people (18 treated with yoga and 32 to control interventions). Antiepileptic drugs were continued in all the participants. Baseline phase lasted three months in both studies and treatment phase from five weeks to six months in the two trials. Randomisation was by roll of a die in one study and using a computerised randomisation table in the other one but neither study provided details of concealment of allocation and were rated as unclear risk of bias. Overall, the two studies were rated as low risk of bias (all participants were included in the analysis; all expected and pre-expected outcomes were reported; no other sources of bias).\nThe overall ORs with 95% CI were as follows: (i) seizure free for six months — for yoga versus sham yoga the OR was 14.54 (95% CI 0.67 to 316.69) and for yoga versus 'no treatment' group it was 17.31 (95% CI 0.80 to 373.45); for Acceptance and Commitment Therapy (ACT) versus yoga the OR was 1.00 (95% Cl 0.16 to 6.42); (ii) reduction in seizure frequency — the mean difference between yoga versus sham yoga group was −2.10 (95% CI −3.15 to −1.05) and for yoga versus 'no treatment' group it was −1.10 (95% CI −1.80 to −0.40); (iii) more than 50% reduction in seizure frequency — for yoga versus sham yoga group, OR was 81.00 (95% CI 4.36 to 1504.46) and for the yoga versus 'no treatment' group it was 158.33 (95% CI 5.78 to 4335.63); ACT versus yoga OR was 0.78 (95% Cl 0.04 to 14.75); (iv) more than 50% reduction in seizure duration — for yoga versus sham yoga group OR was 45.00 (95% CI 2.01 to 1006.75) and for yoga versus 'no treatment' group it was 53.57 (95% CI 2.42 to 1187.26); ACT versus yoga OR was 0.67 (95% Cl 0.10 to 4.35).\nIn addition in Panjwani 1996 the authors reported that the one-way analysis of variance revealed no statistically significant differences between the three groups. A P-Lambda test taking into account the P values between the three groups also indicated that the duration of epilepsy in the three groups was not comparable. No data were available regarding quality of life. In Lundgren 2008 the authors reported that there was no significant difference between the yoga and ACT groups in seizure-free rates, 50% or greater reduction in seizure frequency or seizure duration at one-year follow-up. The yoga group showed significant improvement in their quality of life according to the Satisfaction With Life Scale (SWLS) (P < 0.05), while the ACT group had significant improvement in the World Health Organization Quality of Life-BREF (WHOQOL-BREF) scale (P < 0.01).\nOverall, we assessed the quality of evidence as low; no reliable conclusions can be drawn at present regarding the efficacy of yoga as a treatment for epilepsy.\nAuthors' conclusions\nA study of 50 subjects with epilepsy from two trials reveals a possible beneficial effect in control of seizures. Results of the overall efficacy analysis show that yoga treatment was better when compared with no intervention or interventions other than yoga (postural exercises mimicking yoga). There was no difference between yoga and Acceptance and Commitment Therapy. However no reliable conclusions can be drawn regarding the efficacy of yoga as a treatment for uncontrolled epilepsy, in view of methodological deficiencies such as limited number of studies, limited number of participants randomised to yoga, lack of blinding and limited data on quality-of-life outcome. Physician blinding would normally be taken to be the person delivering the intervention, whereas we think the 'physician' would in fact be the outcome assessor (who could be blinded), so that would be a reduction in detection bias rather than performance bias. In addition, evidence to inform outcomes is limited and of low quality. Further high-quality research is needed to fully evaluate the efficacy of yoga for refractory epilepsy.\nSince we did not find any new studies, our conclusions remain unchanged.\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": "No reliable conclusions can be drawn at present regarding the efficacy of yoga as a treatment for epilepsy. In addition, quality of the evidence to inform outcomes is limited and of low quality. Yoga can be considered as a complex intervention, similar to other forms of complementary and alternative treatments. Yoga can only be an add-on to AEDs at the present time and cannot be used as the sole method of intervention. Finally, no reliable evidence was found to support the use of yoga and further trials are needed.\nThe evidence is current to 3 January 2017."
}
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query-laysum | 3963 | [
{
"role": "user",
"content": "Abstract: Background\nIgA vasculitis (IgAV), previously known as Henoch-Schönlein purpura, is the most common vasculitis of childhood but may also occur in adults. This small vessel vasculitis is characterised by palpable purpura, abdominal pain, arthritis or arthralgia and kidney involvement. This is an update of a review first published in 2009 and updated in 2015.\nObjectives\nTo evaluate the benefits and harms of different agents (used singularly or in combination) compared with placebo, no treatment or any other agent for (1) the prevention of severe kidney disease in people with IgAV with or without kidney involvement at onset, (2) the treatment of established severe kidney disease (macroscopic haematuria, proteinuria, nephritic syndrome, nephrotic syndrome with or without acute kidney failure) in IgAV, and (3) the prevention of recurrent episodes of IgAV-associated kidney disease.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 2 February 2023 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) comparing interventions used to prevent or treat kidney disease in IgAV compared with placebo, no treatment or other agents were included.\nData collection and analysis\nTwo authors independently determined study eligibility, assessed the risk of bias and extracted data from each study. Statistical analyses were performed using the random-effects model, and the results were expressed as risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nTwenty studies (1963 enrolled participants) were identified; one three-arm study has been assessed as two studies. Nine studies were at low risk of bias for sequence generation (selection bias), and nine studies were at low risk of bias for allocation concealment (selection bias). Blinding of participants and personnel (performance bias) and outcome assessment (detection bias) was at low risk of bias in four and seven studies, respectively. Nine studies reported complete outcome data (attrition bias), while 10 studies reported expected outcomes, so were at low risk of reporting bias. Five studies were at low risk of other bias.\nEleven studies evaluated therapy to prevent persistent kidney disease in IgAV with or without kidney involvement at presentation. There was probably no difference in the risk of persistent kidney disease any time after treatment (5 studies, 746 children: RR 0.74, 95% CI 0.42 to 1.32) or at one, three, six and 12 months in children given prednisone for 14 to 28 days at presentation of IgAV compared with placebo or supportive treatment (moderate certainty evidence). There may be no differences in the risk of any persistent kidney disease with antiplatelet therapy (three studies) or heparin (two studies) in children with or without any kidney disease at study entry, although heparin may reduce the risk of proteinuria by three months compared with placebo or no specific treatment (2 studies, 317 children: RR 0.47, 95% CI 0.31 to 0.73). One study comparing montelukast with placebo found no differences in outcomes as assessed by severity scale scores.\nNine studies examined the treatment of severe IgAV-associated kidney disease. In two studies (one involving 56 children and the other involving 54 adults), there may be no differences in efficacy outcomes or adverse effects with cyclophosphamide compared with placebo or supportive treatment. In two studies, there may be no differences in the numbers achieving remission of proteinuria with intravenous (IV) cyclophosphamide compared with mycophenolate mofetil (MMF) (65 children evaluated) or tacrolimus (142 children evaluated). In three small studies comparing cyclosporin with methylprednisolone (15 children), MMF with azathioprine (26 children), or MMF with leflunomide (19 children), it is unclear whether the treatment had any effect on the numbers in remission or the degree of proteinuria between treatment groups because of small numbers of included participants. In one study comparing plasmapheresis, cyclophosphamide and methylprednisolone with cyclophosphamide and methylprednisolone, there may be no difference in the numbers achieving remission. One study compared fosinopril with no specific therapy and reported fosinopril reduced the number of participants with proteinuria. No studies were identified that evaluated the efficacy of therapy on kidney disease in participants with recurrent episodes of IgAV.\nAuthors' conclusions\nThere are no substantial changes in conclusions from this update compared with the initial review or the previous update despite the addition of five studies. From generally low to moderate certainty evidence, we found that there may be little or no benefit in the use of corticosteroids or antiplatelet agents to prevent persistent kidney disease in children with IgAV in participants with no or minimal kidney involvement at presentation. We did not find any studies which evaluated corticosteroids in children presenting with IgAV and nephritic and/or nephrotic syndrome, although corticosteroids are recommended in such children in guidelines. Though heparin may be effective in reducing proteinuria, this potentially dangerous therapy is not justified to prevent serious kidney disease when few children with IgAV develop severe kidney disease. There may be no benefit of cyclophosphamide compared with no specific treatment or corticosteroids. While there may be no benefit in the efficacy of MMF or tacrolimus compared with IV cyclophosphamide in children or adults with IgAV and severe kidney disease, adverse effects, particularly infections, may be lower in MMF or tacrolimus-treated children. Because of small patient numbers and events leading to imprecision in results, it remains unclear whether cyclosporin, MMF or leflunomide have any role in the treatment of children with IgAV and severe kidney disease. We did not identify any studies which evaluated corticosteroids\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 at information from 20 randomised controlled trials (RCT), which included 1963 participants. Eleven studies included children with IgAV with mild or no kidney involvement. Five studies compared prednisone tablets given for 14 to 28 days with placebo tablets or no treatment, five studies compared medications that reduce blood clotting, and one study compared montelukast (a medication usually used in children with asthma) with a placebo. Nine studies included children with moderate or severe kidney involvement. Five studies compared different medications which suppress the immune system (cyclophosphamide, mycophenolate mofetil, tacrolimus, cyclosporin, leflunomide, azathioprine). One study compared plasma exchange (where the patient's plasma is removed and replaced with normal plasma) and cyclophosphamide and methylprednisolone with cyclophosphamide and methylprednisolone alone. The last study compared fosinopril, which reduces the amount of protein in the urine, with no treatment."
}
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query-laysum | 3964 | [
{
"role": "user",
"content": "Abstract: Background\nDehydration is an important cause of death in patients with Ebola virus disease (EVD). Parenteral fluids are often required in patients with fluid requirements in excess of their oral intake. The peripheral intravenous route is the most commonly used method of parenteral access, but inserting and maintaining an intravenous line can be challenging in the context of EVD. Therefore it is important to consider the advantages and disadvantages of different routes for achieving parenteral access (e.g. intravenous, intraosseous, subcutaneous and intraperitoneal).\nObjectives\nTo compare the reliability, ease of use and speed of insertion of different parenteral access methods.\nSearch methods\nWe ran the search on 17 November 2014. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily, Ovid MEDLINE(R) and Ovid OLDMEDLINE(R), Embase Classic + Embase (OvidSP), CINAHL (EBSCOhost), clinicaltrials.gov and screened reference lists.\nSelection criteria\nRandomised controlled trials comparing different parenteral routes for the infusion of fluids or medication.\nData collection and analysis\nTwo review authors examined the titles and abstracts of records obtained by searching the electronic databases to determine eligibility. Two review authors extracted data from the included trials and assessed the risk of bias. Outcome measures of interest were success of insertion; time required for insertion; number of insertion attempts; number of dislodgements; time period with functional access; local site reactions; clinicians' perception of ease of administration; needlestick injury to healthcare workers; patients' discomfort; and mortality. For trials involving the administration of fluids we also collected data on the volume of fluid infused, changes in serum electrolytes and markers of renal function. We rated the quality of the evidence as 'high', 'moderate', 'low' or 'very low' according to the GRADE approach for the following outcomes: success of insertion, time required for insertion, number of dislodgements, volume of fluid infused and needlestick injuries.\nMain results\nWe included 17 trials involving 885 participants. Parenteral access was used to infuse fluids in 11 trials and medications in six trials. None of the trials involved patients with EVD. Intravenous and intraosseous access was compared in four trials; intravenous and subcutaneous access in 11; peripheral intravenous and intraperitoneal access in one; saphenous vein cutdown and intraosseous access in one; and intraperitoneal with subcutaneous access in one. All of the trials assessing the intravenous method involved peripheral intravenous access.\nWe judged few trials to be at low risk of bias for any of the assessed domains.\nCompared to the intraosseous group, patients in the intravenous group were more likely to experience an insertion failure (risk ratio (RR) 3.89, 95% confidence interval (CI) 2.39 to 6.33; n = 242; GRADE rating: low). We did not pool data for time to insertion but estimates from the trials suggest that inserting intravenous access takes longer (GRADE rating: moderate). Clinicians judged the intravenous route to be easier to insert (RR 0.15, 95% CI 0.04 to 0.61; n = 182). A larger volume of fluids was infused via the intravenous route (GRADE rating: moderate). There was no evidence of a difference between the two routes for any other outcomes, including adverse events.\nCompared to the subcutaneous group, patients in the intravenous group were more likely to experience an insertion failure (RR 14.79, 95% CI 2.87 to 76.08; n = 238; GRADE rating: moderate) and dislodgement of the device (RR 3.78, 95% CI 1.16 to 12.34; n = 67; GRADE rating: low). Clinicians also judged the intravenous route as being more difficult to insert and patients were more likely to be agitated in the intravenous group. Patients in the intravenous group were more likely to develop a local infection and phlebitis, but were less likely to develop erythema, oedema or swelling than those in the subcutaneous group. A larger volume of fluids was infused into patients via the intravenous route. There was no evidence of a difference between the two routes for any other outcome.\nThere were insufficient data to reliably determine if the risk of insertion failure differed between the saphenous vein cutdown (SVC) and intraosseous method (RR 4.00, 95% CI 0.51 to 31.13; GRADE rating: low). Insertion using SVC took longer than the intraosseous method (MD 219.60 seconds, 95% CI 135.44 to 303.76; GRADE rating: moderate). There were no data and therefore there was no evidence of a difference between the two routes for any other outcome.\nThere were insufficient data to reliably determine the relative effects of intraperitoneal or central intravenous access relative to any other parenteral access method.\nAuthors' conclusions\nThere are several different ways of achieving parenteral access in patients who are unable meet their fluid requirements with oral intake alone. The quality of the evidence, as assessed using the GRADE criteria, is somewhat limited because of the lack of adequately powered trials at low risk of bias. However, we believe that there is sufficient evidence to draw the following conclusions: if peripheral intravenous access can be achieved easily, this allows infusion of larger volumes of fluid than other routes; but if this is not possible, the intraosseous and subcutaneous routes are viable alternatives. The subcutaneous route may be suitable for patients who are not severely dehydrated but in whom ongoing fluid losses cannot be met by oral intake.\nA film to accompany this review can be viewed here (http://youtu.be/ArVPzkf93ng).\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": "Many patients with Ebola virus disease (EVD) die because they are dehydrated. Patients with EVD often experience severe vomiting and diarrhoea, which causes them to lose fluids that are difficult to replace by drinking alone. It is possible to give fluids in ways that do not involve the digestive tract; this is known as parenteral access. This includes infusing fluids into a vein (intravenously), into bone marrow (intraosseously), into fatty tissue under the skin (subcutaneously) or into the abdominal space (intraperitoneally). Giving fluids intravenously is the usual method, but can be problematic in patients with EVD because starting intravenous fluids can be difficult in very dehydrated patients, and infection control practices may make maintaining the infusion challenging. It is therefore useful if those caring for patients with EVD know the advantages and disadvantages of the other ways to give fluids, so that they can decide which is the most suitable for their patients."
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query-laysum | 3965 | [
{
"role": "user",
"content": "Abstract: Background\nClinical practice is not always evidence-based and, therefore, may not optimise patient outcomes. Local opinion leaders (OLs) are individuals perceived as credible and trustworthy, who disseminate and implement best evidence, for instance through informal one-to-one teaching or community outreach education visits. The use of OLs is a promising strategy to bridge evidence-practice gaps. This is an update of a Cochrane review published in 2011.\nObjectives\nTo assess the effectiveness of local opinion leaders to improve healthcare professionals' compliance with evidence-based practice and patient outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases and two trials registers on 3 July 2018, together with searching reference lists of included studies and contacting experts in the field.\nSelection criteria\nWe considered randomised studies comparing the effects of local opinion leaders, either alone or with a single or more intervention(s) to disseminate evidence-based practice, with no intervention, a single intervention, or the same single or more intervention(s). Eligible studies were those reporting objective measures of professional performance, for example, the percentage of patients being prescribed a specific drug or health outcomes, or both. We included all studies independently of the method used to identify OLs.\nData collection and analysis\nWe used standard Cochrane procedures in this review. The main comparison was (i) between any intervention involving OLs (OLs alone, OLs with a single or more intervention(s)) versus any comparison intervention (no intervention, a single intervention, or the same single or more intervention(s)). We also made four secondary comparisons: ii) OLs alone versus no intervention, iii) OLs alone versus a single intervention, iv) OLs, with a single or more intervention(s) versus the same single or more intervention(s), and v) OLs with a single or more intervention(s) versus no intervention.\nMain results\nWe included 24 studies, involving more than 337 hospitals, 350 primary care practices, 3005 healthcare professionals, and 29,167 patients (not all studies reported this information). A majority of studies were from North America, and all were conducted in high-income countries. Eighteen of these studies (21 comparisons, 71 compliance outcomes) contributed to the median adjusted risk difference (RD) for the main comparison. The median duration of follow-up was 12 months (range 2 to 30 months). The results suggested that the OL interventions probably improve healthcare professionals' compliance with evidence-based practice (10.8% absolute improvement in compliance, interquartile range (IQR): 3.5% to 14.6%; moderate-certainty evidence).\nResults for the secondary comparisons also suggested that OLs probably improve compliance with evidence-based practice (moderate-certainty evidence): i) OLs alone versus no intervention: RD (IQR): 9.15% (-0.3% to 15%); ii) OLs alone versus a single intervention: RD (range): 13.8% (12% to 15.5%); iii) OLs, with a single or more intervention(s) versus the same single or more intervention(s): RD (IQR): 7.1% (-1.4% to 19%); iv) OLs with a single or more intervention(s) versus no intervention: RD (IQR):10.25% (0.6% to 15.75%).\nIt is uncertain if OLs alone, or in combination with other intervention(s), may lead to improved patient outcomes (3 studies; 5 dichotomous outcomes) since the certainty of evidence was very low. For two of the secondary comparisons, the IQR included the possibility of a small negative effect of the OL intervention. Possible explanations for the occasional negative effects are, for example, the possibility that the OLs may have prioritised some outcomes, at the expense of others, or that an unaccounted outcome difference at baseline, may have given a faulty impression of a negative effect of the intervention at follow-up. No study reported on costs or cost-effectiveness.\nWe were unable to determine the comparative effectiveness of different approaches to identifying OLs, as most studies used the sociometric method. Nor could we determine which methods used by OLs to educate their peers were most effective, as the methods were poorly described in most studies. In addition, we could not determine whether OL teams were more effective than single OLs.\nAuthors' conclusions\nLocal opinion leaders alone, or in combination with other interventions, can be effective in promoting evidence-based practice, but the effectiveness varies both within and between studies.The effect on patient outcomes is uncertain. The costs and the cost-effectiveness of the intervention(s) is unknown. These results are based on heterogeneous studies differing in types of intervention, setting, and outcomes. In most studies, the role and actions of the OL were not clearly described, and we cannot, therefore, comment on strategies to enhance their effectiveness. It is also not clear whether the methods used to identify OLs are important for their effectiveness, or whether the effect differs if education is delivered by single OLs or by multidisciplinary OL teams. Further research may help us to understand how these factors affect the effectiveness of OLs.\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": "The use of OLs probably improves the ability of healthcare professionals to follow evidence-based guidelines, but we do not know if patient outcomes are improved. To optimise the use of OLs, we need to know more details about what they actually do and how they do it."
}
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query-laysum | 3966 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis, a common joint disorder, is one of the leading causes of disability. Chondroitin has emerged as a new treatment. Previous meta-analyses have shown contradictory results on the efficacy of chondroitin. This, in addition to the publication of more trials, necessitates a systematic review.\nObjectives\nTo evaluate the benefit and harm of oral chondroitin for treating osteoarthritis compared with placebo or a comparator oral medication including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, opioids, and glucosamine or other \"herbal\" medications.\nSearch methods\nWe searched seven databases up to November 2013, including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, CINAHL, EMBASE, Science Citation Index (Web of Science) and Current Controlled Trials. We searched the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) websites for adverse effects. Trial registers were not searched.\nSelection criteria\nAll randomized or quasi-randomized clinical trials lasting longer than two weeks, studying adults with osteoarthritis in any joint, and comparing chondroitin with placebo, an active control such as NSAIDs, or other \"herbal\" supplements such as glucosamine.\nData collection and analysis\nTwo review authors independently performed all title assessments, data extractions, and risk of bias assessments.\nMain results\nForty-three randomized controlled trials including 4,962 participants treated with chondroitin and 4,148 participants given placebo or another control were included. The majority of trials were in knee OA, with few in hip and hand OA. Trial duration varied from 1 month to 3 years. Participants treated with chondroitin achieved statistically significantly and clinically meaningful better pain scores (0-100) in studies less than 6 months than those given placebo with an absolute risk difference of 10% lower (95% confidence interval (CI), 15% to 6% lower; number needed to treat (NNT) = 5 (95% CI, 3 to 8; n = 8 trials) (level of evidence, low; risk of bias, high); but there was high heterogeneity between the trials (T2 = 0.07; I2 = 70%, which was not easily explained by differences in risk of bias or study sample size). In studies longer than 6 months, the absolute risk difference for pain was 9% lower (95% CI 18% lower to 0%); n = 6 trials; T2 = 0.18; I2 = 83% ), again with low level of evidence.\nFor the Western Ontario and McMaster Universities Osteoarthritis Index Minimal Clinically Important Improvement (WOMAC MCII Pain subscale) outcome, a reduction in knee pain by 20% was achieved by 53/100 in the chondroitin group versus 47/100 in the placebo group, an absolute risk difference of 6% (95% CI 1% to 11%), (RR 1.12, 95% CI 1.01 to 1.24; T2 = 0.00; I2 = 0%) (n = 2 trials, 1253 participants; level of evidence, high; risk of bias, low).\nDifferences in Lequesne's index (composite of pain,function and disability) statistically significantly favoured chondroitin as compared with placebo in studies under six months, with an absolute risk difference of 8% lower (95% CI 12% to 5% lower; T2= 0.78; n = 7 trials) (level of evidence, moderate; risk of bias, unclear), also clinically meaningful. Loss of minimum joint space width in the chondroitin group was statistically significantly less than in the placebo group, with a relative risk difference of 4.7% less (95% CI 1.6% to 7.8% less; n = 2 trials) (level of evidence, high; risk of bias, low). Chondroitin was associated with statistically significantly lower odds of serious adverse events compared with placebo with Peto odds ratio of 0.40 (95% CI 0.19 to 0.82; n = 6 trials) (level of evidence, moderate). Chondroitin did not result in statistically significant numbers of adverse events or withdrawals due to adverse events compared with placebo or another drug. Adverse events were reported in a limited fashion, with some studies providing data and others not.\nComparisons of chondroitin taken alone or in combination with glucosamine or another supplement showed a statistically significant reduction in pain (0-100) when compared with placebo or an active control, with an absolute risk difference of 10% lower (95% CI 14% to 5% lower); NNT = 4 (95% CI 3 to 6); T2 = 0.33; I2 = 91%; n = 17 trials) (level of evidence, low). For physical function, chondroitin in combination with glucosamine or another supplement showed no statistically significant difference from placebo or an active control, with an absolute risk difference of 1% lower (95% CI 6% lower to 3% higher with T2 = 0.04; n = 5 trials) (level of evidence, moderate). Differences in Lequesne's index statistically significantly favoured chondroitin as compared with placebo, with an absolute risk difference of 8% lower (95% CI, 12% to 4% lower; T2 = 0.12; n = 10 trials) (level of evidence, moderate). Chondroitin in combination with glucosamine did not result in statistically significant differences in the numbers of adverse events, withdrawals due to adverse events, or in the numbers of serious adverse events compared with placebo or with an active control.\nThe beneficial effects of chondroitin in pain and Lequesne's index persisted when evidence was limited to studies with adequate blinding or studies that used appropriate intention to treat (ITT) analyses. These beneficial effects were uncertain when we limited data to studies with appropriate allocation concealment or a large study sample (> 200) or to studies without pharmaceutical funding.\nAuthors' conclusions\nA review of randomized trials of mostly low quality reveals that chondroitin (alone or in combination with glucosamine) was better than placebo in improving pain in participants with osteoarthritis in short-term studies. The benefit was small to moderate with an 8 point greater improvement in pain (range 0 to 100) and a 2 point greater improvement in Lequesne's index (range 0 to 24), both likely clinically meaningful. These differences persisted in some sensitivity analyses and not others. Chondroitin had a lower risk of serious adverse events compared with control. More high-quality studies are needed to explore the role of chondroitin in the treatment of osteoarthritis. The combination of some efficacy and low risk associated with chondroitin may explain its popularity among patients as an over-the-counter supplement.\n\nGiven the provided abstract, please respond to the following query: \"People who dropped out of the studies for adverse events\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who dropped out of the studies for adverse events\n- People who took chondroitin had no difference in the risk of dropping out of the studies for adverse events than those who took a placebo.This may have happened by chance."
}
]
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query-laysum | 3967 | [
{
"role": "user",
"content": "Abstract: Background\nHeart failure is the end stage of heart disease, and the prevalence and incidence of the condition is rapidly increasing. Although heart transplantation is one type of surgical treatment for people with end-stage heart failure, donor availability is limited. Implantable ventricular assist devices (VADs) therefore offer an alternative treatment to heart transplantation. Although two studies reported the beneficial effects of exercise-based cardiac rehabilitation (CR) on functional capacity and quality of life (QOL) by performing systematic reviews and meta-analyses, both systematic reviews included studies with limited design (e.g. non-randomised, retrospective studies) or participants with implantable or extracorporeal VADs.\nObjectives\nTo determine the benefits and harms of exercise-based CR for people with implantable VADs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, PsycINFO, Conference Proceedings Citation Index-Science (CPCI-S) on Web of Science, CINAHL, and LILACS on 3 October 2017 with no limitations on date, language, or publication status. We also searched two clinical trials registers on 10 August 2017 and checked the reference lists of primary studies and review articles.\nSelection criteria\nRandomised controlled trials (RCTs) regardless of cluster or individual randomisation, and full-text studies, those published as abstract only, and unpublished data were eligible. However, only individually RCTs and full-text publications were included.\nData collection and analysis\nTwo review authors independently extracted outcome data from the included studies. We double-checked that data were entered correctly by comparing the data presented in the systematic review with the study reports. We had no dichotomous data to analyse and used mean difference or standardised mean difference with 95% confidence intervals (CIs) for continuous data. Furthermore, we assessed the quality of evidence as it relates to those studies that contribute data to the meta-analyses for the prespecified outcomes, using GRADEpro software.\nMain results\nWe included two studies with a total of 40 participants in the review. Exercise-based CR consisted of aerobic or resistance training or both three times per week for six to eight weeks. Exercise intensity was 50% of oxygen consumption (VO2) reserve, or ranged from 60% to 80% of heart rate reserve. Two serious adverse events were observed in one trial, in which participants did not complete the study due to infections. Furthermore, a total of four participants in each group required visits to the emergency department, although these participants did complete the study. Summary scores from the 36-item Short Form Health Survey (SF-36) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) were measured as quality of life. One trial reported that the KCCQ summary score improved by 14.4 points in the exercise group compared with 0.5 points in the usual care group. The other trial reported that the SF-36 total score improved by 29.2 points in the exercise group compared with 16.3 points in the usual care group. A large difference in quality of life was observed between groups at the end of follow-up (standardised mean difference 0.88, 95% CI -0.12 to 1.88; 37 participants; 2 studies; very low-quality of evidence). However, there was no evidence for the effectiveness of exercise-based CR due to the young age of the participants, high risk of performance bias, very small sample size, and wide confidence intervals, which resulted in very low-quality evidence. Furthermore, we were not able to determine the effect of exercise-based CR on mortality, rehospitalisation, heart transplantation, and cost, as these outcomes were not reported.\nAuthors' conclusions\nThe evidence is currently inadequate to assess the safety and efficacy of exercise-based CR for people with implantable VADs compared with usual care. The amount of RCT evidence was very limited and of very low quality. In addition, the training duration was very short term, that is from six to eight weeks. Further high-quality and well-reported RCTs of exercise-based CR for people with implantable VADs are needed. Such trials need to collect data on events (mortality and rehospitalisation), patient-related outcomes (including quality of life), and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with heart failure have a decreased capacity to undertake physical exercise, which has a negative impact on their health and quality of life. Recent research has shown that exercise-based cardiac rehabilitation (CR) may improve exercise capacity and quality of life in people with implantable ventricular assist devices (VADs), which are a type of mechanical pump that supports heart function. It was therefore considered important to systemically review randomised controlled trials (a type of study in which participants are assigned to a treatment group using a random method) to determine the benefits and harms of exercise-based CR in people with implantable VADs."
}
]
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query-laysum | 3968 | [
{
"role": "user",
"content": "Abstract: Background\nPreoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.\nObjectives\nTo assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 3), MEDLINE (January 1946 to March 2014), EMBASE (January 1947 to March 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1980 to March 2014) and Web of Science (January 1900 to March 2014) databases. We did not apply language restrictions in the literature search. We searched reference lists of relevant articles and contacted known authors in the field to identify unpublished data.\nSelection criteria\nWe included all randomized controlled trials of preoperative carbohydrate treatment compared with placebo or traditional preoperative fasting in adult study participants undergoing elective surgery. Treatment groups needed to receive at least 45 g of carbohydrates within four hours before surgery or anaesthesia start time.\nData collection and analysis\nData were abstracted independently by at least two review authors, with discrepancies resolved by consensus. Data were abstracted and documented pro forma and were entered into RevMan 5.2 for analysis. Quality assessment was performed independently by two review authors according to the standard methodological procedures expected by The Cochrane Collaboration. When available data were insufficient for quality assessment or data analysis, trial authors were contacted to request needed information. We collected trial data on complication rates and aspiration pneumonitis.\nMain results\nWe included 27 trials involving 1976 participants Trials were conducted in Europe, China, Brazil, Canada and New Zealand and involved patients undergoing elective abdominal surgery (18), orthopaedic surgery (4), cardiac surgery (4) and thyroidectomy (1). Twelve studies were limited to participants with an American Society of Anaesthesiologists grade of I-II or I-III.\nA total of 17 trials contained at least one domain judged to be at high risk of bias, and only two studies were judged to be at low risk of bias across all domains. Of greatest concern was the risk of bias associated with inadequate blinding, as most of the outcomes assessed by this review were subjective. Only six trials were judged to be at low risk of bias because of blinding.\nIn 19 trials including 1351 participants, preoperative carbohydrate treatment was associated with shortened length of hospital stay compared with placebo or fasting (by 0.30 days; 95% confidence interval (CI) 0.56 to 0.04; very low-quality evidence). No significant effect on length of stay was noted when preoperative carbohydrate treatment was compared with placebo (14 trials including 867 participants; mean difference -0.13 days; 95% CI -0.38 to 0.12). Based on two trials including 86 participants, preoperative carbohydrate treatment was also associated with shortened time to passage of flatus when compared with placebo or fasting (by 0.39 days; 95% CI 0.70 to 0.07), as well as increased postoperative peripheral insulin sensitivity (three trials including 41 participants; mean increase in glucose infusion rate measured by hyperinsulinaemic euglycaemic clamp of 0.76 mg/kg/min; 95% CI 0.24 to 1.29; high-quality evidence).\nAs reported by 14 trials involving 913 participants, preoperative carbohydrate treatment was not associated with an increase or a decrease in the risk of postoperative complications compared with placebo or fasting (risk ratio of complications 0.98, 95% CI 0.86 to 1.11; low-quality evidence). Aspiration pneumonitis was not reported in any patients, regardless of treatment group allocation.\nAuthors' conclusions\nPreoperative carbohydrate treatment was associated with a small reduction in length of hospital stay when compared with placebo or fasting in adult patients undergoing elective surgery. It was found that preoperative carbohydrate treatment did not increase or decrease postoperative complication rates when compared with placebo or fasting. Lack of adequate blinding in many studies may have contributed to observed treatment effects for these subjective outcomes, which are subject to possible biases.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence on effects of carbohydrate supplements on the recovery of people undergoing planned surgical procedures. We found 27 studies investigating this question."
}
]
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query-laysum | 3969 | [
{
"role": "user",
"content": "Abstract: Background\nUndifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications.\nObjectives\nTo assess the effectiveness and safety of antibiotics in preventing bacterial complications in children aged two months to 59 months with undifferentiated ARIs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1950 to August week 1, 2015) and EMBASE (1974 to August 2015).\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing antibiotic prescriptions with placebo or no treatment in children aged two months to 59 months with an undifferentiated ARI for up to seven days.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted and analysed data using the standard Cochrane methodological procedures.\nMain results\nWe identified four trials involving 1314 children. Three trials investigated the use of amoxicillin/clavulanic acid to prevent otitis and one investigated ampicillin to prevent pneumonia.\nThe use of amoxicillin/clavulanic acid compared to placebo to prevent otitis showed a risk ratio (RR) of 0.70 (95% confidence interval (CI) 0.45 to 1.11, three trials, 414 selected children, moderate-quality evidence). Methods of random sequence generation and allocation concealment were not clearly stated in two trials. Performance, detection and reporting bias could not be ruled out in three trials.\nAmpicillin compared to supportive care (continuation of breastfeeding, clearing of the nose and paracetamol for fever control) to prevent pneumonia showed a RR of 1.05 (95% CI 0.74 to 1.49, one trial, 889 selected children, moderate-quality evidence). The trial was non-blinded. Random sequence generation and allocation concealment methods were not clearly stated, so the possibility of reporting bias could not be ruled out.\nHarm outcomes could not be analysed as they were expressed only in percentages.\nWe found no studies assessing mastoiditis, quinsy, abscess, meningitis, hospital admission or death.\nAuthors' conclusions\nThere is insufficient evidence for antibiotic use as a means of reducing the risk of otitis or pneumonia in children up to five years of age with undifferentiated ARIs. Further high-quality research is needed to provide more definitive evidence of the effectiveness of antibiotics in this population.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do antibiotics prevent more severe infections in children up to five years old with common upper acute respiratory infections (ARIs)?"
}
]
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query-laysum | 3970 | [
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Lifestyle or dietary modifications (including reducing the amount of salt or caffeine in the diet) are sometimes suggested to be of benefit for this condition. The underlying cause of Ménière's disease is unknown, as is the way in which these interventions may work. The efficacy of these different interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of lifestyle and dietary interventions versus placebo or no treatment in people with Ménière's disease.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with Ménière's disease comparing any lifestyle or dietary intervention with either placebo or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included two RCTs, one related to diet, and the other related to fluid intake and sleep. In a Swedish study, 51 participants were randomised to receive 'specially processed cereals' or standard cereals. The specially processed cereals are thought to stimulate the production of anti-secretory factor - a protein that reduces inflammation and fluid secretion. Participants received the cereals for three months. The only outcome reported by this study was disease-specific health-related quality of life.\nThe second study was conducted in Japan. The participants (223) were randomised to receive abundant water intake (35 mL/kg/day), or to sleep in darkness (in an unlit room for six to seven hours per night), or to receive no intervention. The duration of follow-up was two years. The outcomes assessed were 'improvement in vertigo' and hearing.\nAs these studies considered different interventions we were unable to carry out any meta-analysis, and for almost all outcomes the certainty of the evidence was very low. We are unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nThe evidence for lifestyle or dietary interventions for Ménière's disease is very uncertain. We did not identify any placebo-controlled RCTs for interventions that are frequently recommended for those with Ménière's disease, such as salt restriction or caffeine restriction. We identified only two RCTs that compared a lifestyle or dietary intervention to placebo or no treatment, and the evidence that is currently available from these studies is of low or very low certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\n\nGiven the provided abstract, please respond to the following query: \"How is Ménière's disease treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Oral medications (tablets) are often used as the first treatment for Ménière's disease. Other treatment options are also available (for example, injections into the ear or surgery). People with Ménière's disease are often advised to modify their diet, for example by reducing their intake of salt or caffeine, as these are thought to worsen the symptoms of the disease."
}
]
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query-laysum | 3971 | [
{
"role": "user",
"content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly occurs during autumn or winter and remits in spring. The prevalence of SAD ranges from 1.5% to 9%, depending on latitude. The predictable seasonal aspect of SAD provides a promising opportunity for prevention. This review - one of four reviews on efficacy and safety of interventions to prevent SAD - focuses on second-generation antidepressants (SGAs).\nObjectives\nTo assess the efficacy and safety of SGAs (in comparison with other SGAs, placebo, light therapy, melatonin or agomelatine, psychological therapies or lifestyle interventions) in preventing SAD and improving patient-centred outcomes among adults with a history of SAD.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 19 June 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 August 2015). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Science, the Cochrane Library, the Allied and Complementary Medicine Database and international trial registers (to 19 June 2018). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles.\nSelection criteria\nFor efficacy, we included randomised controlled trials (RCTs) on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. For adverse events, we planned to include non-randomised studies. Eligible studies compared a SGA versus another SGA, placebo, light therapy, psychological therapy, melatonin, agomelatine or lifestyle changes. We also intended to compare SGAs in combination with any of the comparator interventions versus placebo or the same comparator intervention as monotherapy.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text publications, extracted data and assessed risk of bias of included studies. When data were sufficient, we conducted random-effects (Mantel-Haenszel) meta-analyses. We assessed statistical heterogeneity by calculating the Chi2 statistic and the Cochran Q. We used the I2 statistic to estimate the magnitude of heterogeneity. We assessed publication bias by using funnel plots.We rated the strength of the evidence using the system developed by the GRADE Working Group.\nMain results\nWe identified 3745 citations after de-duplication of search results and excluded 3619 records during title and abstract reviews. We assessed 126 full-text papers for inclusion in the review, of which four publications (on three RCTs) providing data from 1100 people met eligibility criteria for this review. All three RCTs had methodological limitations due to high attrition rates.\nOverall, moderate-quality evidence indicates that bupropion XL is an efficacious intervention for prevention of recurrence of depressive episodes in people with a history of SAD (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.44 to 0.72; 3 RCTs, 1100 participants). However, bupropion XL leads to greater risk of headaches (moderate-quality evidence), insomnia and nausea (both low-quality evidence) when compared with placebo. Numbers needed to treat for additional beneficial outcomes (NNTBs) vary by baseline risks. For a population with a yearly recurrence rate of 30%, the NNTB is 8 (95% CI 6 to 12). For populations with yearly recurrence rates of 50% and 60%, NNTBs are 5 (95% CI 4 to 7) and 4 (95% CI 3 to 6), respectively.\nWe could find no studies on other SGAs and no studies comparing SGAs with other interventions of interest, such as light therapy, psychological therapies, melatonin or agomelatine.\nAuthors' conclusions\nAvailable evidence indicates that bupropion XL is an effective intervention for prevention of recurrence of SAD. Nevertheless, even in a high-risk population, three out of four people will not benefit from preventive treatment with bupropion XL and will be at risk for harm. Clinicians need to discuss with patients advantages and disadvantages of preventive SGA treatment, and might want to consider offering other potentially efficacious interventions, which might confer a lower risk of adverse events. Given the lack of comparative evidence, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences.\nFuture researchers need to assess the effectiveness and risk of harms of SGAs other than bupropion for prevention of SAD. Investigators also need to compare benefits and harms of pharmacological and non-pharmacological interventions.\n\nGiven the provided abstract, please respond to the following query: \"What questions does this review aim to answer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In light of the seasonal pattern and the high rate of recurrence, beginning antidepressant therapy in early autumn (fall) when people are still free of depressive symptoms can prevent the onset of depressed mood. The goal of this review is to examine whether benefits outweigh harms of antidepressants when they are used in healthy people with a history of winter depression to prevent onset of depression the next winter. To date, this question has not been examined in a systematic way."
}
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query-laysum | 3972 | [
{
"role": "user",
"content": "Abstract: Background\nNearly 30% of patients with epilepsy continue to have seizures despite using several antiepileptic drugs (AEDs). Such patients are regarded as having refractory, or uncontrolled, epilepsy. While there is no universally accepted definition of uncontrolled, or medically refractory, epilepsy, for the purposes of this review we will consider seizures as drug resistant if they have failed to respond to a minimum of two AEDs. Specialists consider that early surgical intervention may prevent seizures at a younger age, which in turn may improve the intellectual and social status of children. Many types of surgery are available for treating refractory epilepsy; one such procedure is known as subpial transection.\nObjectives\nTo assess the effects of subpial transection for focal-onset seizures and generalised tonic-clonic seizures in children and adults.\nSearch methods\nFor the latest update we searched the following databases on 7 August 2018: the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid, 1946 to August 06, 2018), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions.\nSelection criteria\nWe considered all randomised and quasi-randomised parallel-group studies, whether blinded or non-blinded.\nData collection and analysis\nTwo review authors (BK and SR) independently screened trials identified by the search. The same two review authors planned to independently assess the methodological quality of studies. Had we identified studies for inclusion, one review author would have extracted the data, and the other would have verified the data.\nMain results\nWe found no relevant studies.\nAuthors' conclusions\nWe found no evidence to support or refute the use of subpial transection surgery for patients with medically refractory epilepsy. Well-designed randomised controlled trials are needed to guide clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Nearly 30% of patients with epilepsy continue to have seizures despite taking several antiepileptic drugs (AEDs). Such patients are regarded as having refractory, or uncontrolled, epilepsy, which directly affects the intellectual function and social status of children. It causes considerable morbidity and mortality, affecting the person's quality of life. Some people with refractory epilepsy benefit from surgical treatment.\nMultiple subpial transection (MST) is a surgical technique by which connections of the epileptic focus are partially cut without resection. MST is one type of surgery that can be performed for people with medically refractory epilepsy, for whom the epileptogenic zone cannot be resected because of high risk of neurological deficits."
}
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query-laysum | 3973 | [
{
"role": "user",
"content": "Abstract: Background\nExtravasation injury, a complication commonly seen in the neonatal intensive care unit, can result in scarring with cosmetic and functional sequelae. A wide variety of treatments are available, including subcutaneous irrigation with saline (with or without hyaluronidase), liposuction, use of specific antidotes, topical applications, and normal wound care with dry or wet dressings. All such treatments aim to prevent or reduce the severity of complications.\nObjectives\nPrimary objective\nTo compare the efficacy and safety of saline irrigation or saline irrigation with prior hyaluronidase infiltration versus no intervention or normal wound care for tissue healing in neonates with extravasation injury.\nSecondary objectives\nTo evaluate by subgroup analysis of controlled trials the influence of type of extravasate, timing of irrigation following extravasation, and postmenstrual age (PMA) of the neonate at the time of injury on outcomes and adverse effects.\nSpecifically, we planned to perform subgroup analysis for the primary outcome, if appropriate, by examining:\n1. time to irrigation from identified extravasation injury (< 1 hour or ≥ 1 hour);\n2. type of extravasate (parenteral nutrition fluid or other fluids or medications);\n3. amount of saline used (< 500 mL or ≥ 500 mL); and\n4. PMA at injury (< 37 completed weeks or ≥ 37 completed weeks).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1), MEDLINE via PubMed (1966 to 2 February 2017), Embase (1980 to 2 February 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 2 February 2017). We also searched clinical trial databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We used the Google Scholar search tool for reverse citations of relevant articles.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-randomised controlled trials comparing saline irrigation with or without hyaluronidase infiltration versus no intervention or normal wound care for the management of extravasation injury in neonates.\nData collection and analysis\nThree review authors independently reviewed and identified articles for possible inclusion in this review. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe found no eligible studies. Our search revealed 10 case reports or case series describing successful outcomes with different interventions for this condition.\nAuthors' conclusions\nTo date, no RCTs have examined the effects of saline irrigation with or without prior hyaluronidase infiltration for management of extravasation injury in neonates. Saline irrigation is frequently reported in the literature as an intervention for management of extravasation injury in neonates. Research should focus first on evaluating the efficacy and safety of this intervention through RCTs. It will also be important for investigators to determine effect size by examining the timing of the intervention, the nature of the infusate, and severity of injury at the time of intervention.\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 no high-quality randomised or quasi-randomised studies that currently answer this question."
}
]
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query-laysum | 3974 | [
{
"role": "user",
"content": "Abstract: Background\nMajor depressive disorder (MDD), or depression, is a syndrome characterised by a number of behavioural, cognitive and emotional features. It is most commonly associated with a sad or depressed mood, a reduced capacity to feel pleasure, feelings of hopelessness, loss of energy, altered sleep patterns, weight fluctuations, difficulty in concentrating and suicidal ideation. There is a need for more effective and better tolerated antidepressants to combat this condition. Agomelatine was recently added to the list of available antidepressant drugs; it is a novel antidepressant that works on melatonergic (MT1 and MT2), 5-HT 2B and 5-HT2C receptors. Because the mechanism of action is claimed to be novel, it may provide a useful, alternative pharmacological strategy to existing antidepressant drugs.\nObjectives\nThe objective of this review was 1) to determine the efficacy of agomelatine in alleviating acute symptoms of major depressive disorder in comparison with other antidepressants, 2) to review the acceptability of agomelatine in comparison with other antidepressant drugs, and, 3) to investigate the adverse effects of agomelatine, including the general prevalence of side effects in adults.\nSearch methods\nWe searched the Cochrane Collaboration's Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to 31 July 2013. The CCDANCTR includes relevant randomised controlled trials from the following bibliographic databases: CENTRAL (the Cochrane Central Register of Controlled Trials) (all years), EMBASE (1974 onwards), MEDLINE (1950 onwards) and PsycINFO (1967 onwards). We checked reference lists of relevant studies together with reviews and regulatory agency reports. No restrictions on date, language or publication status were applied to the search. Servier Laboratories (developers of agomelatine) and other experts in the field were contacted for supplemental data.\nSelection criteria\nRandomised controlled trials allocating adult participants with major depression to agomelatine versus any other antidepressive agent.\nData collection and analysis\nTwo review authors independently extracted data and a double-entry procedure was employed. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability.\nMain results\nA total of 13 studies (4495 participants) were included in this review. Agomelatine was compared to selective serotonin reuptake inhibitors (SSRIs), namely paroxetine, fluoxetine, sertraline, escitalopram, and to the serotonin–norepinephrine reuptake inhibitor (SNRI), venlafaxine. Participants were followed up for six to 12 weeks. Agomelatine did not show any advantage or disadvantage over the other antidepressants for our primary outcome, response to treatment (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.95 to 1.08, P value 0.75 compared to SSRIs, and RR 1.06; 95% CI 0.98 to 1.16, P value 0.16 compared to venlafaxine). Also, agomelatine showed no advantage or disadvantage over other antidepressants for remission (RR 0.83; 95% CI 0.68 to 1.01, P value 0.07 compared to SSRIs, and RR 1.08; 95% CI 0.94 to 1.24, P value 0.73 compared to venlafaxine). Overall, agomelatine appeared to be better tolerated than venlafaxine in terms of lower rates of drop outs (RR 0.40; 95% CI 0.24 to 0.67, P value 0.0005), and showed the same level of tolerability as SSRIs (RR 0.95; 95% CI 0.83 to 1.09, P value 0.44). Agomelatine induced a lower rate of dizziness than venlafaxine (RR 0.19, 95% CI 0.06 to 0.64, P value 0.007).\nWith regard to the quality of the body of evidence, there was a moderate risk of bias for all outcomes, due to the number of included unpublished studies. There was some heterogeneity, particularly between published and unpublished studies. The included studies were conducted in inpatient and outpatient settings, thus limiting the generalisability of the results to primary care settings. With regard to precision, the efficacy outcomes were precise, but the tolerability outcomes were mostly imprecise. Publication bias was variable and depended on the outcome of the trial. Our review included unpublished studies, and we think that this reduced the impact of publication bias. The overall methodological quality of the studies was not very good. Almost all of the studies were sponsored by the pharmaceutical company that manufactures agomelatine (Servier), and some of these were unpublished. Attempts to contact the pharmaceutical company Servier for additional information on all unpublished studies were unsuccessful.\nAuthors' conclusions\nAgomelatine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. Agomelatine was better tolerated than paroxetine and venlafaxine in terms of overall side effects, and fewer participants treated with agomelatine dropped out of the trials due to side effects compared to sertraline and venlafaxine, but data were limited because the number of included studies was small. We found evidence that compared agomelatine with only a small number of other active antidepressive agents, and there were only a few trials for each comparison, which limits the generalisability of the results. Moreover, the overall methodological quality of the studies was low, and, therefore, no firm conclusions can be drawn concerning the efficacy and tolerability of agomelatine.\n\nGiven the provided abstract, please respond to the following query: \"Who may be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People affected by major depression.\nGeneral Practitioners (GPs), psychiatrists and pharmacists.\nProfessionals working in adult mental health services.\nFamilies and friends of people who suffer from major depression."
}
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query-laysum | 3975 | [
{
"role": "user",
"content": "Abstract: Background\nStroke is a leading cause of morbidity and mortality worldwide, with very large healthcare and social costs, and a strong demand for alternative therapeutic approaches. Preclinical studies have shown that stem cells transplanted into the brain can lead to functional improvement. However, to date, evidence for the benefits of stem cell transplantation in people with ischemic stroke is lacking. This is the first update of the Cochrane review published in 2010.\nObjectives\nTo assess the efficacy and safety of stem cell transplantation compared with control in people with ischemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched August 2018), CENTRAL (last searched August 2018), MEDLINE (1966 to August 2018), Embase (1980 to August 2018), and BIOSIS (1926 to August 2018). We handsearched potentially relevant conference proceedings, screened reference lists, and searched ongoing trials and research registers (last searched August 2018). We also contacted individuals active in the field and stem cell manufacturers (last contacted August 2018).\nSelection criteria\nWe included randomized controlled trials (RCTs) that recruited people with ischemic stroke, in any phase of the disease (acute, subacute or chronic), and an ischemic lesion confirmed by computerized tomography or magnetic resonance imaging scan. We included all types of stem cell transplantation, regardless of cell source (autograft, allograft, or xenograft; embryonic, fetal, or adult; from brain or other tissues), route of cell administration (systemic or local), and dosage. The primary outcome was efficacy (assessed as neurologic impairment or functional outcome) at longer term follow-up (minimum six months). Secondary outcomes included post-procedure safety outcomes (death, worsening of neurological deficit, infections, and neoplastic transformation).\nData collection and analysis\nTwo review authors independently applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data. If needed, we contacted study authors for additional information. We performed random effects meta-analyses when two or more RCTs were available for any outcome. We assessed the certainty of the evidence by using the GRADE approach.\nMain results\nIn this updated review, we included seven completed RCTs with 401 participants. All tested adult human non-neural stem cells; cells were transplanted during the acute, subacute, or chronic phase of ischemic stroke; administered intravenously, intra-arterially, intracerebrally, or into the lumbar subarachnoid space. Follow-up ranged from six months to seven years. Efficacy outcomes were measured with the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), or Barthel Index (BI). Safety outcomes included case fatality, and were measured at the end of the trial.\nOverall, stem cell transplantation was associated with a better clinical outcome when measured with the NIHSS (mean difference [MD] -1.49, 95% confidence interval [CI] -2.65 to -0.33; five studies, 319 participants; low-certainty evidence), but not with the mRS (MD -0.42, 95% CI -0.86 to 0.02; six studies, 371 participants; very low-certainty evidence), or the BI (MD 14.09, 95% CI -1.94 to 30.13; three studies, 170 participants; very low-certainty evidence). The studies in favor of stem cell transplantation had, on average, a higher risk of bias, and a sample size of 32 or fewer participants.\nNo significant safety concerns associated with stem cell transplantation were raised with respect to death (risk ratio [RR] 0.66, 95% CI 0.39 to 1.14; six studies, participants; low-certainty evidence).\nWe were not able to perform the sensitivity analysis according to the quality of studies, because all of them were at high risk of bias.\nAuthors' conclusions\nOverall, in participants with ischemic stroke, stem cell transplantation was associated with a reduced neurological impairment, but not with a better functional outcome. No obvious safety concerns were raised. However, these conclusions came mostly from small RCTs with high risk of bias, and the certainty of the evidence ranged from low to very low. More well-designed trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified seven randomized trials, involving 401 participants. Overall, stem cell transplantation was associated with a reduced neurological impairment, but not with a better functional outcome. No safety concerns were raised."
}
]
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query-laysum | 3976 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common side effect of orthodontic treatment. It increases in proportion to the amount of force applied to the teeth, and the type of orthodontic appliance used can affect the intensity of the pain. Pain during orthodontic treatment has been shown to be the most common reason for people wanting to discontinue treatment, and has been ranked as the worst aspect of treatment. Although pharmacological methods of pain relief have been investigated, there remains some uncertainty among orthodontists about which painkillers are most suitable and whether pre-emptive analgesia is beneficial. We conducted this Cochrane Review to assess and summarize the international evidence relating to the effectiveness of analgesics for preventing this unwanted side effect associated with orthodontic treatment.\nObjectives\nThe objectives of this review are to determine:\n- the effectiveness of drug interventions for pain relief during orthodontic treatment; and\n- whether there is a difference in the analgesic effect provided by different types, forms and doses of analgesia taken during orthodontic treatment.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: the Cochrane Oral Health Trials Register (to 19 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL;the Cochrane Library 2016, Issue 7), MEDLINE Ovid (1946 to 19 June 2017), Embase Ovid (1980 to 19 June 2017) and CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 19 June 2017). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched on the 19 June 2017 for ongoing studies. We placed no restrictions on language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomized controlled trials (RCTs) relating to pain control during orthodontic treatment. Pain could be measured on a visual analogue scale (VAS), numerical rating scale (NRS) or categorical scale.\nData collection and analysis\nTwo review authors independently screened the search results, agreed the studies to be included and extracted information from the included studies regarding methods, participants, interventions, outcomes, harms and results. We planned to resolve any discrepancies or disagreements through discussion. We used the Cochrane 'Risk of bias' tool to assess the risk of bias in the studies.\nMain results\nWe identified 32 relevant RCTs, which included 3110 participants aged 9 to 34 years, 2348 of whom we were able to include in our analyses. Seventeen of the studies had more than two arms. We were able to use data from 12 trials in meta-analyses that compared analgesics versus control (no treatment or a placebo); nine that compared non-steroidal anti-inflammatories (NSAIDs) versus paracetamol; and two that compared pre-emptive versus post-treatment ibuprofen for pain control following orthodontic treatment. One study provided data for the comparison of NSAIDs versus local anaesthetic.\nWe found moderate-quality evidence that analgesics effectively reduced pain following orthodontic treatment when compared to no treatment or a placebo at 2 hours (mean difference (MD) -11.66 mm on a 0 to 100 mm VAS, 95% confidence interval (CI) -16.15 to -7.17; 10 studies, 685 participants), 6 hours (MD -24.27 mm on a VAS, 95% CI -31.44 to -17.11; 9 studies, 535 participants) and 24 hours (MD -21.19 mm on a VAS, 95% CI -28.31 to -14.06; 12 studies, 1012 participants).\nWe did not find any evidence of a difference in efficacy between NSAID and paracetamol at 2, 6 or 24 hours (at 24 hours: MD -0.51, 95% CI -8.93 to 7.92; 9 studies, 734 participants; low-quality evidence).\nVery low-quality evidence suggested pre-emptive ibuprofen gave better pain relief at 2 hours than ibuprofen taken post treatment (MD -11.30, 95% CI -16.27 to -6.33; one study, 41 participants), however, the difference was no longer significant at 6 or 24 hours.\nA single study of 48 participants compared topical NSAIDs versus local anaesthetic and showed no evidence of a difference in the effectiveness of the interventions (very low-quality evidence).\nUse of rescue analgesia was poorly reported. The very low-quality evidence did not show evidence of a difference between participants taking ibuprofen and participants taking paracetamol (relative risk (RR) 1.5, 95% CI 0.6 to 3.6). Nor did we find evidence of a difference between groups in likelihood of requiring rescue analgesia when ibuprofen was taken pre-emptively compared to after treatment (RR 0.8, 95% CI 0.3 to 1.9).\nAdverse effects were identified in one study, with one participant developing a rash that required treatment with antihistamines. This was provisionally diagnosed as a hypersensitivity to paracetamol.\nAuthors' conclusions\nAnalgesics are more effective at reducing pain following orthodontic treatment than placebo or no treatment. Low-quality evidence did not show a difference in effectiveness between systemic NSAIDs compared with paracetamol, or topical NSAIDs compared with local anaesthetic. More high-quality research is needed to investigate these comparisons, and to evaluate pre-emptive versus post-treatment administration of analgesics.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do painkillers, taken before or after orthodontic treatment, help relieve pain? If so, which painkillers work best?"
}
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query-laysum | 3977 | [
{
"role": "user",
"content": "Abstract: Background\nNeonates born through meconium-stained amniotic fluid (MSAF) are at risk of developing meconium aspiration syndrome (MAS). Neonates who are non-vigorous due to intrapartum asphyxia are at higher risk of developing MAS. Clearance of meconium from the airways below the vocal cords by tracheal suction before initiating other steps of resuscitation may reduce the risk of development of MAS. However, conducting tracheal suction may not only be ineffective, it may also delay effective resuscitation, thus prolonging and worsening the hypoxic-ischaemic insult.\nObjectives\nTo evaluate the efficacy of tracheal suctioning at birth in preventing meconium aspiration syndrome and other complications among non-vigorous neonates born through meconium-stained amniotic fluid.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 11) in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) (1946 to 25 November 2020) for randomised controlled trials (RCTs) and quasi-randomised trials. We also searched clinical trials databases and the reference lists of retrieved articles for RCTs and quasi-randomised trials (up to November 2020).\nSelection criteria\nWe included studies enrolling non-vigorous neonates born through MSAF, if the intervention being tested included tracheal suction at the time of birth with an intent to clear the trachea of meconium before regular breathing efforts began. Tracheal suction could be performed with an endotracheal tube or a wide-gauge suction catheter. Neonates in the control group should have been resuscitated at birth with no effort made to clear the trachea of meconium.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data, consulting with a third review author about any disagreements. We used standard Cochrane methodological procedures, including assessment of risk of bias for all studies. Our primary outcomes were: MAS; all-cause neonatal mortality; and incidence of hypoxic-ischaemic encephalopathy (HIE). Secondary outcomes included: need for mechanical ventilation; incidence of pulmonary air leaks; culture-positive sepsis; and persistent pulmonary hypertension. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included four studies (enrolling 581 neonates) in the review. All four studies were conducted in tertiary care hospitals in India. Three of the four studies included neonates born at and beyond term gestation, whereas one included neonates born at and beyond 34 weeks of gestation. Due to the nature of the intervention, it was not possible to blind the healthcare personnel conducting the intervention.\nTracheal suction compared to no suction in non-vigorous neonates born through MSAF\nIn non-vigorous infants, no differences were noted in the risks of MAS (RR 1.00, 95% CI 0.80 to 1.25; RD 0.00, 95% CI -0.07 to 0.08; 4 studies, 581 neonates) or all-cause neonatal mortality (RR 1.24, 95% CI 0.76 to 2.02; RD 0.02, 95% CI -0.03 to 0.07; 4 studies, 575 neonates) with or without tracheal suctioning. No differences were reported in the risk of any severity HIE (RR 1.05, 95% CI 0.68 to 1.63; 1 study, 175 neonates) or moderate to severe HIE (RR 0.68, 95% CI 0.43 to 1.09; 1 study, 152 neonates) among non-vigorous neonates born through MSAF. We are also uncertain as to the effect of tracheal suction on other outcomes such as incidence of mechanical ventilation (RR 0.99, 95% CI 0.68 to 1.44; RD 0.00, 95% CI -0.06 to 0.06; 4 studies, 581 neonates), pulmonary air leaks (RR 1.22, 95% CI 0.38 to 3.93; RD 0.00, 95% CI -0.02 to 0.03; 3 studies, 449 neonates), persistent pulmonary hypertension (RR 1.29, 95% CI 0.60 to 2.77; RD 0.02, 95% CI -0.03 to 0.06; 3 studies, 406 neonates) and culture-positive sepsis (RR 1.32, 95% CI 0.48 to 3.57; RD 0.01, 95% CI -0.03 to 0.05; 3 studies, 406 neonates). All reported outcomes were judged as providing very low certainty evidence.\nAuthors' conclusions\nWe are uncertain about the effect of tracheal suction on the incidence of MAS and its complications among non-vigorous neonates born through MSAF. One study awaits classification and could not be included in the review. More research from well-conducted large trials is needed to conclusively answer the review question.\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 are uncertain as to the effect of tracheal suction in reducing the risk of MAS. For every 1000 neonates in whom tracheal suction is done, MAS may be observed in 70 fewer to 80 more neonates. Similarly, we are uncertain as to the effect of tracheal suction on the risk of death before discharge from the hospital (22 fewer to 92 more per 1000 neonates). We are also uncertain as to the effect of tracheal suction on the risks of other outcomes, such as the need for advanced resuscitation measures; encephalopathy (brain damage or disease) due to asphyxia (a lack of oxygen that results in unconsciousness and often death); the need for or duration of mechanical ventilation; the need for non-invasive respiratory support (a mask); duration of oxygen therapy; and duration of hospitalisation. These and other complications of MAS were not different with or without tracheal suction."
}
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query-laysum | 3978 | [
{
"role": "user",
"content": "Abstract: Background\nHelminthiasis is an infestation of the human body with parasitic worms. It is estimated to affect 44 million pregnancies, globally, each year. Intestinal helminthiasis (hookworm infestation) is associated with blood loss and decreased supply of nutrients for erythropoiesis, resulting in iron-deficiency anaemia. Over 50% of the pregnant women in low- and middle-income countries (LMIC) suffer from iron-deficiency anaemia. Though iron-deficiency anaemia is multifactorial, hookworm infestation is a major contributory cause in women of reproductive age in endemic areas. Antihelminthics are highly efficacious, but evidence of their beneficial effect and safety when given during pregnancy has not been established. This is an update of a Cochrane Review last published in 2015.\nObjectives\nTo determine the effects of mass deworming with antihelminthics for soil-transmitted helminths (STH) during the second or third trimester of pregnancy on maternal and pregnancy outcomes.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) (8 March 2021) and reference lists of retrieved studies.\nSelection criteria\nWe included all prospective randomised controlled trials evaluating the effect of administration of antihelminthics versus placebo or no treatment during the second or third trimester of pregnancy; both individual-randomised and cluster-randomised trials were eligible. We excluded quasi-randomised trials and studies that were only available as abstracts with insufficient information.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, checked accuracy and assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included a total of six trials (24 reports) that randomised 7873 pregnant women. All of the included trials were conducted in antenatal clinics within hospitals in LMICs (Uganda, Nigeria, Peru, India, Sierra Leone and Tanzania). Among primary outcomes, five trials reported maternal anaemia, one trial reported preterm birth and three trials reported perinatal mortality. Among secondary outcomes, included trials reported maternal worm prevalence, low birthweight (LBW) and birthweight. None of the included studies reported maternal anthropometric measures or infant survival at six months. Overall, we judged the included trials to be generally at low risk of bias for most domains, while the certainty of evidence ranged from low to moderate.\nAnalysis suggests that administration of a single dose of antihelminthics in the second trimester of pregnancy may reduce maternal anaemia by 15% (average risk ratio (RR) 0.85, 95% confidence interval (CI) 0.72 to 1.00; I²= 86%; 5 trials, 5745 participants; low-certainty evidence). We are uncertain of the effect of antihelminthics during pregnancy on preterm birth (RR 0.84, 95% CI 0.38 to 1.86; 1 trial, 1042 participants; low-certainty evidence) or perinatal mortality (RR 1.01, 95% CI 0.67 to 1.52; 3 trials, 3356 participants; low-certainty evidence).\nWe are uncertain of the effect of antihelminthics during pregnancy on hookworm (average RR 0.31, 95% CI 0.05 to 1.93; Tau² = 1.76, I² = 99%; 2 trials, 2488 participants; low-certainty evidence). Among other secondary outcomes, findings suggest that administration of antihelminthics during pregnancy may reduce the prevalence of trichuris (average RR 0.68, 95% CI 0.48 to 0.98; I²=75%; 2 trials, 2488 participants; low-certainty evidence) and ascaris (RR 0.24, 95% CI 0.19 to 0.29; I²= 0%; 2 trials, 2488 participants; moderate-certainty evidence). Antihelminthics during pregnancy probably make little or no difference to LBW (RR 0.89, 95% CI 0.69 to 1.16; 3 trials, 2960 participants; moderate-certainty evidence) and birthweight (mean difference 0.00 kg, 95% CI -0.03 kg to 0.04 kg; 3 trials, 2960 participants; moderate-certainty evidence).\nAuthors' conclusions\nThe evidence suggests that administration of a single dose of antihelminthics in the second trimester of pregnancy may reduce maternal anaemia and worm prevalence when used in settings with high prevalence of maternal helminthiasis. Further data is needed to establish the benefit of antihelminthic treatment on other maternal and pregnancy outcomes.\nFuture research should focus on evaluating the effect of these antihelminthics among various subgroups in order to assess whether the effect varies. Future studies could also assess the effectiveness of co-interventions and health education along with antihelminthics for maternal and pregnancy outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Women in low- and middle-income countries (LMICs) are especially likely to have worms that can lead to anaemia, since they may be pregnant or lactating for as much as half of their reproductive lives. Women who are anaemic during pregnancy are more likely to have ill health, give birth prematurely, and have low birthweight (LBW) babies with low iron reserves. A lack of iron can reduce the babies' mental abilities and development as well as their physical growth."
}
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query-laysum | 3979 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is an autosomal recessive, life-limiting, multisystem disease affecting over 70,000 individuals worldwide. Between 80% and 90% of people with CF suffer with pancreatic exocrine insufficiency, which if left untreated, leads to a poor nutritional status. Pancreatic enzyme replacement therapy (PERT) has been shown to be effective in improving nutritional status and subsequently associated with improved lung function. However, the timings of PERT administration in relation to a meal are subjective and not standardised, meaning that variations in the timing of PERT dosing persist.\nObjectives\nThe primary objective of the review is to compare the efficacy (fat absorption) and effectiveness (nutritional status, lung function and quality of life) of different PERT dosing strategies in terms of timing of administration for treating dietary malabsorption in all individuals with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews.\nDate of last search: 24 June 2021.\nWe also searched ongoing trials registers on 09 July 2021.\nSelection criteria\nRandomised controlled trials (RCTs), including cross-over RCTs with a minimum washout period of two weeks, and quasi-RCTs of PERT dosing regimens in people (of any age) with CF.\nData collection and analysis\nTwo authors independently assessed and screened the studies identified from the searches. We planned to use GRADE to assess the certainty of evidence for our pre-specified critical outcomes, but we did not identify any eligible studies.\nMain results\nNo studies met the eligibility criteria and therefore we did not include any in this review. The excluded studies were either cross-over in design (but lacking a sufficient washout period between treatments) or did not assess the timing of PERT. One study which was terminated early is awaiting assessment pending further information.\nAuthors' conclusions\nWe were unable to determine whether one dosing schedule for PERT is better than another since we identified no eligible RCTs. While the introduction of PERT to people with CF can improve their nutritional status, there are a limited number of studies which address this review question, and none met our eligibility criteria. Since malnutrition and adverse gastrointestinal symptoms remain a common feature in CF, the assessment of the relative performance of dosing schedules may provide evidence to improve outcomes in people with CF who are pancreatic insufficient.\nFurther research is needed to fully evaluate the role of dosing schedules for PERT in fat absorption. Research should also establish reliable outcome measures and minimal clinically important differences. While RCTs with a cross-over design may have advantages over a parallel group design, an adequate washout period between intervention periods is essential.\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": "CF is an inherited condition affecting over 70,000 individuals worldwide. Between 80% and 90% of people with CF are not able to produce enough pancreatic enzymes to breakdown and absorb fat, protein and fat-soluble vitamins from food. This can lead to fatty stools (poo) and weight loss. It is thought that if fat is not digested properly, it could contribute to a higher risk of developing constipation or other serious gut complications such as distal intestinal obstruction syndrome.\nPERT provides the enzymes required to breakdown fat and the dosage is based upon the fat content of a meal or the person's body weight. PERT has been shown to improve weight and is associated with improved lung function. Despite current dose guidance, there are differences in PERT doses and there is no set guidance for when the therapy should be taken in relation to a meal (i.e. before, during or after eating)."
}
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query-laysum | 3980 | [
{
"role": "user",
"content": "Abstract: Background\nGastrostomy has been established as the standard procedure for administering long-term enteral nutrition in individuals with swallowing disturbances. Percutaneous gastrostomy is a less-invasive approach than open surgical gastrostomy, and can be accomplished via endoscopy (percutaneous endoscopic gastrostomy or PEG) or sonographic or fluoroscopic guidance (percutaneous radiological gastrostomy or PRG). Both techniques have different limitations, advantages, and contraindications. In order to determine the optimal technique for long-term nutritional supplementation many studies have been conducted to compare the outcomes of these two techniques; however, it remains unclear as to which method is superior to the other with respect to both efficacy and safety.\nObjectives\nTo compare the safety and efficacy of PEG and PRG in the treatment of individuals with swallowing disturbances.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, January 2016); MEDLINE (1946 to 22 January 2016); EMBASE (1980 to 22 January 2016); the reference lists of identified articles; databases of ongoing trials, including the Chinese Cochrane Centre Controlled Trials Register; and PubMed. We applied no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing PEG with PRG in individuals with swallowing disturbances, regardless of the underlying disease.\nData collection and analysis\nTwo authors independently evaluated the search results and assessed the quality of the studies. Data analyses could not be performed as no RCTs were identified for inclusion in this review.\nMain results\nWe identified no RCTs comparing PEG and PRG for percutaneous gastrostomy in individuals with swallowing disturbances. The large body of evidence in this field comes from retrospective and non-randomised controlled studies and case series. Based on this evidence, both PEG and PRG can be safely performed in selected individuals, although both are associated with major and minor complications. A definitive RCT has yet to be conducted to identify the preferred percutaneous gastrostomy technique.\nAuthors' conclusions\nBoth PEG and PRG are effective for long-term enteral nutritional support in selected individuals, though current evidence is insufficient to recommend one technique over the other. Choice of technique should be based on indications and contraindications, operator experience and the facilities available. Large-scale RCTs are required to compare the two techniques and to determine the optimal approach for percutaneous gastrostomy.\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": "Placing a feeding (gastric) tube to the stomach percutaneously (through an opening in the skin) is a less-invasive method than open surgery. Percutaneous gastrostomy can be guided either using an optical instrument (or endoscope) that can be used to look inside the body (termed percutaneous endoscopic gastrostomy or PEG) or using guidance from external techniques that are used to obtain an image of the inside of the body (known as percutaneous radiological gastrostomy or PRG). Both PEG and PRG are associated with high rates of success in the placement of gastric tubes, but which is the best method has yet to be determined."
}
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query-laysum | 3981 | [
{
"role": "user",
"content": "Abstract: Background\nSystemic lupus erythematosus (SLE) is a rare, chronic autoimmune inflammatory disease with a prevalence varying from 4.3 to 150 people in 100,000, or approximately five million people worldwide. Systemic manifestations frequently include internal organ involvement, a characteristic malar rash on the face, pain in joints and muscles, and profound fatigue. Exercise is purported to be beneficial for people with SLE. For this review, we focused on studies that examined all types of structured exercise as an adjunctive therapy in the management of SLE.\nObjectives\nTo evaluate the benefits and harms of structured exercise as adjunctive therapy for adults with SLE compared with usual pharmacological care, usual pharmacological care plus placebo and usual pharmacological care plus non-pharmacological care.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 30 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of exercise as an adjunct to usual pharmacological treatment in SLE compared with placebo, usual pharmacological care alone and another non-pharmacological treatment. Major outcomes were fatigue, functional capacity, disease activity, quality of life, pain, serious adverse events, and withdrawals due to any reason, including any adverse events.\nData collection and analysis\nWe used standard Cochrane methods. Our major outcomes were 1. fatigue, 2. functional capacity, 3. disease activity, 4. quality of life, 5. pain, 6. serious adverse events, and 7. withdrawals due to any reason. Our minor outcomes were 8. responder rate, 9. aerobic fitness, 10. depression, and 11. anxiety. We used GRADE to assess certainty of evidence. The primary comparison was exercise compared with placebo.\nMain results\nWe included 13 studies (540 participants) in this review. Studies compared exercise as an adjunct to usual pharmacological care (antimalarials, immunosuppressants, and oral glucocorticoids) with usual pharmacological care plus placebo (one study); usual pharmacological care (six studies); and another non-pharmacological treatment such as relaxation therapy (seven studies). Most studies had selection bias, and all studies had performance and detection bias. We downgraded the evidence for all comparisons because of a high risk of bias and imprecision.\nExercise plus usual pharmacological care versus placebo plus usual pharmacological care\nEvidence from a single small study (17 participants) that compared whole body vibration exercise to whole body placebo vibration exercise (vibrations switched off) indicated that exercise may have little to no effect on fatigue, functional capacity, and pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). The study did not report disease activity, quality of life, and serious adverse events.\nThe study measured fatigue using the self-reported Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue), scale 0 to 52; lower score means less fatigue. People who did not exercise rated their fatigue at 38 points and those who did exercise rated their fatigue at 33 points (mean difference (MD) 5 points lower, 95% confidence interval (CI) 13.29 lower to 3.29 higher).\nThe study measured functional capacity using the self-reported 36-item Short Form health questionnaire (SF-36) Physical Function domain, scale 0 to 100; higher score means better function. People who did not exercise rated their functional capacity at 70 points and those who did exercise rated their functional capacity at 67.5 points (MD 2.5 points lower, 95% CI 23.78 lower to 18.78 higher).\nThe study measured pain using the SF-36 Pain domain, scale 0 to 100; lower scores mean less pain. People who did not exercise rated their pain at 43 points and those who did exercise rated their pain at 34 points (MD 9 points lower, 95% CI 28.88 lower to 10.88 higher).\nMore participants from the exercise group (3/11, 27%) withdrew from the study than the placebo group (1/10, 10%) (risk ratio (RR) 2.73, 95% CI 0.34 to 22.16).\nExercise plus usual pharmacological care versus usual pharmacological care alone\nThe addition of exercise to usual pharmacological care may have little to no effect on fatigue, functional capacity, and disease activity (low-certainty evidence). We are uncertain whether the addition of exercise improves pain (very low-certainty evidence), or results in fewer or more withdrawals (very low-certainty evidence). Serious adverse events and quality of life were not reported.\nExercise plus usual care versus another non-pharmacological intervention such as receiving information about the disease or relaxation therapy\nCompared with education or relaxation therapy, exercise may reduce fatigue slightly (low-certainty evidence), may improve functional capacity (low-certainty evidence), probably results in little to no difference in disease activity (moderate-certainty evidence), and may result in little to no difference in pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). Quality of life and serious adverse events were not reported.\nAuthors' conclusions\nDue to low- to very low-certainty evidence, we are not confident on the benefits of exercise on fatigue, functional capacity, disease activity, and pain, compared with placebo, usual care, or advice and relaxation therapy. Harms data were not well reported.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Exercise in addition to 'usual care' may have little benefit on fatigue, functional capacity, and pain in people with systemic lupus erythematosus (SLE).\nNo studies reported side effects during exercise. However, we have low confidence in the overall evidence."
}
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query-laysum | 3982 | [
{
"role": "user",
"content": "Abstract: Background\nPatients with brain tumour usually suffer from increased pressure in the skull due to swelling of brain tissue. A swollen brain renders surgical removal of the brain tumour difficult. To ease surgical tumour removal, measures are taken to reduce brain swelling, often referred to as brain relaxation. Brain relaxation can be achieved with intravenous fluids such as mannitol or hypertonic saline. This review was conducted to find out which of the two fluids may have a greater impact on brain relaxation.\nObjectives\nThe objective of this review was to compare the effects of mannitol versus those of hypertonic saline on intraoperative brain relaxation in patients undergoing craniotomy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 10), MEDLINE via Ovid SP (1966 to October 2013) and EMBASE via Ovid SP (1980 to October 2013). We also searched specific websites, such as www.indmed.nic.in, www.cochrane-sadcct.org and www.Clinicaltrials.gov. We reran the search in January 2017 and found five potential studies of interest which have been added to a list of ‘Studies Awaiting Classification' and will be incorporated into the formal review findings during the review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared the use of hypertonic saline versus mannitol for brain relaxation. We also included studies in which any other method used for intraoperative brain relaxation was compared with mannitol or hypertonic saline. Primary outcomes were longest follow-up mortality, Glasgow Outcome Scale score at three months and any adverse events related to mannitol or hypertonic saline. Secondary outcomes were intraoperative brain relaxation, intensive care unit (ICU) stay, hospital stay and quality of life.\nData collection and analysis\nWe used standardized methods for conducting a systematic review, as described by the Cochrane Handbook for Systematic Reviews of Interventions. Two review authors independently extracted details of trial methodology and outcome data from reports of all trials considered eligible for inclusion. All analyses were made on an intention-to-treat basis. We used a fixed-effect model when no evidence was found of significant heterogeneity between studies, and a random-effects model when heterogeneity was likely.\nMain results\nWe included six RCTs with 527 participants. Only one RCT was judged to be at low risk of bias. The remaining five RCTs were at unclear or high risk of bias. No trial mentioned the primary outcomes of longest follow-up mortality, Glasgow Outcome Scale score at three months or any adverse events related to mannitol or hypertonic saline. Three trials mentioned the secondary outcomes of intraoperative brain relaxation, hospital stay and ICU stay; quality of life was not reported in any of the trials. Brain relaxation was inadequate in 42 of 197 participants in the hypertonic saline group and in 68 of 190 participants in the mannitol group. The risk ratio for brain bulge or tense brain in the hypertonic saline group was 0.60 (95% confidence interval (CI) 0.44 to 0.83, low-quality evidence). One trial reported ICU and hospital stay. The mean (standard deviation (SD)) duration of ICU stay in the mannitol and hypertonic saline groups was 1.28 (0.5) and 1.25 (0.5) days (P value 0.64), respectively; the mean (SD) duration of hospital stay in the mannitol and hypertonic saline groups was 5.7 (0.7) and 5.7 (0.8) days (P value 1.00), respectively\nAuthors' conclusions\nFrom the limited data available on the use of mannitol and hypertonic saline for brain relaxation during craniotomy, it is suggested that hypertonic saline significantly reduces the risk of tense brain during craniotomy. A single trial suggests that ICU stay and hospital stay are comparable with the use of mannitol or hypertonic saline. However, focus on other related important issues such as long-term mortality, long-term outcome, adverse events and quality of life is needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed evidence on the effectiveness of mannitol and hypertonic saline for brain relaxation in people having surgery (craniotomy) for brain tumour."
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query-laysum | 3983 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic retinopathy (DR) remains a major cause of sight loss worldwide, despite new therapies and improvements in the metabolic control of people living with diabetes. Therefore, DR creates a physical and psychological burden for people, and an economic burden for society. Preventing the development and progression of DR, or avoiding the occurrence of its sight-threatening complications is essential, and must be pursued to save sight. Fenofibrate may be a useful strategy to achieve this goal, by reversing diabetes’ effects and reducing inflammation in the retina, as well as improving dyslipidaemia and hypertriglyceridaemia.\nObjectives\nTo investigate the benefits and harms of fenofibrate for preventing the development and progression of diabetic retinopathy in people with type 1 (T1D) or type 2 diabetes (T2D), compared with placebo or observation.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and three trials registers (February 2022).\nSelection criteria\nWe included randomised controlled trials (RCTs) that included people with T1D or T2D, when these compared fenofibrate with placebo or with observation, and assessed the effect of fenofibrate on the development or progression of DR (or both).\nData collection and analysis\nWe used standard Cochrane methods for data extraction and analysis.\nOur primary outcome was progression of DR, a composite outcome of 1) incidence of overt retinopathy for participants who did not have DR at baseline, or 2) advancing two or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale for participants who had any DR at baseline (or both), based on the evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period. Overt retinopathy was defined as the presence of any DR observed on stereoscopic or non-stereoscopic colour fundus photographs.\nSecondary outcomes included the incidence of overt retinopathy, reduction in visual acuity of participants with a reduction in visual acuity of 10 ETDRS letters or more, proliferative diabetic retinopathy, and diabetic macular oedema; mean vision-related quality of life, and serious adverse events of fenofibrate.\nWe used GRADE to assess the certainty of evidence.\nMain results\nWe included two studies and their eye sub-studies (15,313 participants) in people with T2D. The studies were conducted in the US, Canada, Australia, Finland, and New Zealand; follow-up period was four to five years. One was funded by the government, the other by industry.\nCompared to placebo or observation, fenofibrate likely results in little to no difference in progression of DR (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.60 to 1.25; 1 study, 1012 participants; moderate-certainty evidence) in a population with and without overt retinopathy at baseline. Those without overt retinopathy at baseline showed little or no progression (RR 1.00, 95% CI 0.68 to 1.47; 1 study, 804 participants); those with overt retinopathy at baseline found that their DR progressed slowly (RR 0.21, 95% CI 0.06 to 0.71; 1 study, 208 people; test for interaction P = 0.02).\nCompared to placebo or observation, fenofibrate likely resulted in little to no difference in either the incidence of overt retinopathy (RR 0.91; 95% CI 0.76 to 1.09; 2 studies, 1631 participants; moderate-certainty evidence); or the incidence of diabetic macular oedema (RR 0.39; 95% CI 0.12 to 1.24; 1 study, 1012 participants; moderate-certainty evidence).\nThe use of fenofibrate increased severe adverse effects (RR 1.55; 95% CI 1.05 to 2.27; 2 studies, 15,313 participants; high-certainty evidence).\nThe studies did not report on incidence of a reduction in visual acuity of 10 ETDRS letters or more, incidence of proliferative diabetic retinopathy, or mean vision-related quality of life.\nAuthors' conclusions\nCurrent, moderate-certainty evidence suggests that in a mixed group of people with and without overt retinopathy, who live with T2D, fenofibrate likely results in little to no difference in progression of diabetic retinopathy. However, in people with overt retinopathy who live with T2D, fenofibrate likely reduces the progression.\nSerious adverse events were rare, but the risk of their occurrence was increased by the use of fenofibrate.\nThere is no evidence on the effect of fenofibrate in people with T1D. More studies, with larger sample sizes, and participants with T1D are needed. They should measure outcomes that are important to people with diabetes, e.g. change in vision, reduction in visual acuity of 10 ETDRS letters or more, developing proliferative diabetic retinopathy; and evaluating the requirement of other treatments, e.g. injections of anti-vascular endothelial growth factor therapies, steroids.\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"
},
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"role": "assistant",
"content": "DR, a condition that occurs when the blood vessels in the back of your eye develop problems, is a major cause of sight loss worldwide and a burden to society. Preventing its occurrence, and if present, slowing or preventing its progression must be pursued to save sight. This review summarised the evidence about whether fenofibrate may be useful for this purpose (when compared to placebo or observation)."
}
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query-laysum | 3984 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the second update of a Cochrane Review originally published in 2009. Millions of workers worldwide are exposed to noise levels that increase their risk of hearing disorders. There is uncertainty about the effectiveness of hearing loss prevention interventions.\nObjectives\nTo assess the effectiveness of non-pharmaceutical interventions for preventing occupational noise exposure or occupational hearing loss compared to no intervention or alternative interventions.\nSearch methods\nWe searched the CENTRAL; PubMed; Embase; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; and OSH UPDATE to 3 October 2016.\nSelection criteria\nWe included randomised controlled trials (RCT), controlled before-after studies (CBA) and interrupted time-series (ITS) of non-clinical interventions under field conditions among workers to prevent or reduce noise exposure and hearing loss. We also collected uncontrolled case studies of engineering controls about the effect on noise exposure.\nData collection and analysis\nTwo authors independently assessed study eligibility and risk of bias and extracted data. We categorised interventions as engineering controls, administrative controls, personal hearing protection devices, and hearing surveillance.\nMain results\nWe included 29 studies. One study evaluated legislation to reduce noise exposure in a 12-year time-series analysis but there were no controlled studies on engineering controls for noise exposure. Eleven studies with 3725 participants evaluated effects of personal hearing protection devices and 17 studies with 84,028 participants evaluated effects of hearing loss prevention programmes (HLPPs).\nEffects on noise exposure\nEngineering interventions following legislation\nOne ITS study found that new legislation in the mining industry reduced the median personal noise exposure dose in underground coal mining by 27.7 percentage points (95% confidence interval (CI) −36.1 to −19.3 percentage points) immediately after the implementation of stricter legislation. This roughly translates to a 4.5 dB(A) decrease in noise level. The intervention was associated with a favourable but statistically non-significant downward trend in time of the noise dose of −2.1 percentage points per year (95% CI −4.9 to 0.7, 4 year follow-up, very low-quality evidence).\nEngineering intervention case studies\nWe found 12 studies that described 107 uncontrolled case studies of immediate reductions in noise levels of machinery ranging from 11.1 to 19.7 dB(A) as a result of purchasing new equipment, segregating noise sources or installing panels or curtains around sources. However, the studies lacked long-term follow-up and dose measurements of workers, and we did not use these studies for our conclusions.\nHearing protection devices\nIn general hearing protection devices reduced noise exposure on average by about 20 dB(A) in one RCT and three CBAs (57 participants, low-quality evidence). Two RCTs showed that, with instructions for insertion, the attenuation of noise by earplugs was 8.59 dB better (95% CI 6.92 dB to 10.25 dB) compared to no instruction (2 RCTs, 140 participants, moderate-quality evidence).\nAdministrative controls: information and noise exposure feedback\nOn-site training sessions did not have an effect on personal noise-exposure levels compared to information only in one cluster-RCT after four months' follow-up (mean difference (MD) 0.14 dB; 95% CI −2.66 to 2.38). Another arm of the same study found that personal noise exposure information had no effect on noise levels (MD 0.30 dB(A), 95% CI −2.31 to 2.91) compared to no such information (176 participants, low-quality evidence).\nEffects on hearing loss\nHearing protection devices\nIn two studies the authors compared the effect of different devices on temporary threshold shifts at short-term follow-up but reported insufficient data for analysis. In two CBA studies the authors found no difference in hearing loss from noise exposure above 89 dB(A) between muffs and earplugs at long-term follow-up (OR 0.8, 95% CI 0.63 to 1.03 ), very low-quality evidence). Authors of another CBA study found that wearing hearing protection more often resulted in less hearing loss at very long-term follow-up (very low-quality evidence).\nCombination of interventions: hearing loss prevention programmes\nOne cluster-RCT found no difference in hearing loss at three- or 16-year follow-up between an intensive HLPP for agricultural students and audiometry only. One CBA study found no reduction of the rate of hearing loss (MD −0.82 dB per year (95% CI −1.86 to 0.22) for a HLPP that provided regular personal noise exposure information compared to a programme without this information.\nThere was very-low-quality evidence in four very long-term studies, that better use of hearing protection devices as part of a HLPP decreased the risk of hearing loss compared to less well used hearing protection in HLPPs (OR 0.40, 95% CI 0.23 to 0.69). Other aspects of the HLPP such as training and education of workers or engineering controls did not show a similar effect.\nIn three long-term CBA studies, workers in a HLPP had a statistically non-significant 1.8 dB (95% CI −0.6 to 4.2) greater hearing loss at 4 kHz than non-exposed workers and the confidence interval includes the 4.2 dB which is the level of hearing loss resulting from 5 years of exposure to 85 dB(A). In addition, of three other CBA studies that could not be included in the meta-analysis, two showed an increased risk of hearing loss in spite of the protection of a HLPP compared to non-exposed workers and one CBA did not.\nAuthors' conclusions\nThere is very low-quality evidence that implementation of stricter legislation can reduce noise levels in workplaces. Controlled studies of other engineering control interventions in the field have not been conducted. There is moderate-quality evidence that training of proper insertion of earplugs significantly reduces noise exposure at short-term follow-up but long-term follow-up is still needed.\nThere is very low-quality evidence that the better use of hearing protection devices as part of HLPPs reduces the risk of hearing loss, whereas for other programme components of HLPPs we did not find such an effect. The absence of conclusive evidence should not be interpreted as evidence of lack of effectiveness. Rather, it means that further research is very likely to have an important impact.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": ""
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query-laysum | 3985 | [
{
"role": "user",
"content": "Abstract: Background\nPersistent postural-perceptual dizziness (PPPD) is a chronic balance disorder, which is characterised by subjective unsteadiness or dizziness that is worse on standing and with visual stimulation. The condition was only recently defined and therefore the prevalence is currently unknown. However, it is likely to include a considerable number of people with chronic balance problems. The symptoms can be debilitating and have a profound impact on quality of life. At present, little is known about the optimal way to treat this condition. A variety of medications may be used, as well as other treatments, such as vestibular rehabilitation.\nObjectives\nTo evaluate the benefits and harms of pharmacological interventions for persistent postural-perceptual dizziness (PPPD).\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 21 November 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with PPPD, which compared selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) with either placebo or no treatment. We excluded studies that did not use the Bárány Society criteria to diagnose PPPD and studies that followed up participants for less than three months.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vestibular symptoms (assessed as a dichotomous outcome - improved or not improved), 2) change in vestibular symptoms (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) generic health-related quality of life and 6) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We planned to use GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified no studies that met our inclusion criteria.\nAuthors' conclusions\nAt present, there is no evidence from placebo-controlled randomised trials regarding pharmacological treatments - specifically SSRIs and SNRIs - for PPPD. Consequently, there is great uncertainty over the use of these treatments for this condition. Further work is needed to establish whether any treatments are effective at improving the symptoms of PPPD, and whether their use is associated with any adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We wanted to find out:\n- whether there was evidence that medication (SSRIs and SNRIs) helps to improve the symptoms of PPPD;\n- whether these treatments might cause any harm."
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query-laysum | 3986 | [
{
"role": "user",
"content": "Abstract: Background\nMinor oral surgery or dental extractions (oral or dental procedures) are widely performed and can be complicated by hazardous oral bleeding, especially in people with an inherited bleeding disorder such as haemophilia or Von Willebrand disease (VWD). The amount and severity of singular bleedings depend on disease-related factors, such as the severity of the haemophilia, both local and systemic patient factors (such as periodontal inflammation, vasculopathy or platelet dysfunction) and intervention-related factors (such as the type and number of teeth extracted or the dimension of the wound surface). Similar to local haemostatic measures and suturing, antifibrinolytic therapy is a cheap, safe and potentially effective treatment to prevent bleeding complications in individuals with bleeding disorders undergoing oral or dental procedures. However, a systematic review of trials reporting outcomes after oral surgery or a dental procedure in people with an inherited bleeding disorder, with or without, the use of antifibrinolytic agents has not been performed to date. This is an update of a previously published Cochrane Review.\nObjectives\nPrimarily, we aim to assess the efficacy of antifibrinolytic agents to prevent bleeding complications in people with haemophilia or VWD undergoing oral or dental procedures.\nSecondary objectives are to assess if antifibrinolytic agents can replace or reduce the need for clotting factor concentrate therapy in people with haemophilia or VWD and to establish the effects of these agents on bleeding in oral or dental procedures for each of these patient populations.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches of the Cochrane Central Register of Controlled Trials (CENTRAL), of MEDLINE and from handsearching of journals and conference abstract books. We additionally searched the reference lists of relevant articles and reviews. We searched PubMed, Embase, Cinahl and the Cochrane Library. Additional searches were performed in ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP).\nDate of last search of the Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register: 01 March 2019.\nSelection criteria\nRandomised and quasi-randomised controlled trials in people with haemophilia or VWD undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid or epsilon aminocaproic acid (EACA)) to prevent perioperative bleeding compared to no intervention or usual care with or without placebo.\nData collection and analysis\nTwo authors independently screened the titles and abstracts of all identified articles. Full texts were obtained for potentially relevant abstracts and two authors independently assessed these for inclusion based on the selection criteria. A third author verified trial eligibility. Two authors independently performed data extraction and risk of bias assessments using standardised forms.\nMain results\nWhile there were no eligible trials in people with VWD identified, two randomised, double-blind, placebo-controlled trials (total of 59 participants) in people with haemophilia undergoing dental extraction were included. One trial of tranexamic acid published in 1972 included 28 participants with mild, moderate or severe haemophilia A and B and one of EACA published in 1971 included 31 people with haemophilia with factor VIII or factor IX levels less than 15%. Overall, the two included trials showed a beneficial effect of tranexamic acid and EACA, administered systemically, in reducing the number of bleedings, the amount of blood loss and the need for therapeutic clotting factor concentrates. Regarding postoperative bleeding, the tranexamic acid trial showed a risk difference (RD) of -0.64 (95% confidence interval (CI) -0.93 to - 0.36) and the EACA trial a RD of -0.50 (95% CI 0.77 to -0.22). The combined RD of both trials was -0.57 (95% CI -0.76 to -0.37), with the quality of the evidence (GRADE) for this outcome is rated as moderate. Side effects occurred once and required stopping EACA (combined RD of -0.03 (95% CI -0.08 to 0.13). There was heterogeneity between the two trials regarding the proportion of people with severe haemophilia included, the concomitant standard therapy and fibrinolytic agent treatment regimens used. We cannot exclude that a selection bias has occurred in the EACA trial, but overall the risk of bias appeared to be low for both trials.\nAuthors' conclusions\nDespite the discovery of a beneficial effect of systemically administered tranexamic acid and EACA in preventing postoperative bleeding in people with haemophilia undergoing dental extraction, the limited number of randomised controlled trials identified, in combination with the small sample sizes and heterogeneity regarding standard therapy and treatment regimens between the two trials, do not allow us to conclude definite efficacy of antifibrinolytic therapy in oral or dental procedures in people with haemophilia. No trials were identified in people with VWD.\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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"role": "assistant",
"content": "The evidence is current to: 01 March 2019"
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query-laysum | 3987 | [
{
"role": "user",
"content": "Abstract: Background\nPoint-of-care (POC) tests for diagnosing schistosomiasis include tests based on circulating antigen detection and urine reagent strip tests. If they had sufficient diagnostic accuracy they could replace conventional microscopy as they provide a quicker answer and are easier to use.\nObjectives\nTo summarise the diagnostic accuracy of: a) urine reagent strip tests in detecting active Schistosoma haematobium infection, with microscopy as the reference standard; and b) circulating antigen tests for detecting active Schistosoma infection in geographical regions endemic for Schistosoma mansoni or S. haematobium or both, with microscopy as the reference standard.\nSearch methods\nWe searched the electronic databases MEDLINE, EMBASE, BIOSIS, MEDION, and Health Technology Assessment (HTA) without language restriction up to 30 June 2014.\nSelection criteria\nWe included studies that used microscopy as the reference standard: for S. haematobium, microscopy of urine prepared by filtration, centrifugation, or sedimentation methods; and for S. mansoni, microscopy of stool by Kato-Katz thick smear. We included studies on participants residing in endemic areas only.\nData collection and analysis\nTwo review authors independently extracted data, assessed quality of the data using QUADAS-2, and performed meta-analysis where appropriate. Using the variability of test thresholds, we used the hierarchical summary receiver operating characteristic (HSROC) model for all eligible tests (except the circulating cathodic antigen (CCA) POC for S. mansoni, where the bivariate random-effects model was more appropriate). We investigated heterogeneity, and carried out indirect comparisons where data were sufficient. Results for sensitivity and specificity are presented as percentages with 95% confidence intervals (CI).\nMain results\nWe included 90 studies; 88 from field settings in Africa. The median S. haematobium infection prevalence was 41% (range 1% to 89%) and 36% for S. mansoni (range 8% to 95%). Study design and conduct were poorly reported against current standards.\nTests for S. haematobium\nUrine reagent test strips versus microscopy\nCompared to microscopy, the detection of microhaematuria on test strips had the highest sensitivity and specificity (sensitivity 75%, 95% CI 71% to 79%; specificity 87%, 95% CI 84% to 90%; 74 studies, 102,447 participants). For proteinuria, sensitivity was 61% and specificity was 82% (82,113 participants); and for leukocyturia, sensitivity was 58% and specificity 61% (1532 participants). However, the difference in overall test accuracy between the urine reagent strips for microhaematuria and proteinuria was not found to be different when we compared separate populations (P = 0.25), or when direct comparisons within the same individuals were performed (paired studies; P = 0.21).\nWhen tests were evaluated against the higher quality reference standard (when multiple samples were analysed), sensitivity was marginally lower for microhaematuria (71% vs 75%) and for proteinuria (49% vs 61%). The specificity of these tests was comparable.\nAntigen assay\nCompared to microscopy, the CCA test showed considerable heterogeneity; meta-analytic sensitivity estimate was 39%, 95% CI 6% to 73%; specificity 78%, 95% CI 55% to 100% (four studies, 901 participants).\nTests for S. mansoni\nCompared to microscopy, the CCA test meta-analytic estimates for detecting S. mansoni at a single threshold of trace positive were: sensitivity 89% (95% CI 86% to 92%); and specificity 55% (95% CI 46% to 65%; 15 studies, 6091 participants) Against a higher quality reference standard, the sensitivity results were comparable (89% vs 88%) but specificity was higher (66% vs 55%). For the CAA test, sensitivity ranged from 47% to 94%, and specificity from 8% to 100% (four studies, 1583 participants).\nAuthors' conclusions\nAmong the evaluated tests for S. haematobium infection, microhaematuria correctly detected the largest proportions of infections and non-infections identified by microscopy.\nThe CCA POC test for S. mansoni detects a very large proportion of infections identified by microscopy, but it misclassifies a large proportion of microscopy negatives as positives in endemic areas with a moderate to high prevalence of infection, possibly because the test is potentially more sensitive than microscopy.\n\nGiven the provided abstract, please respond to the following query: \"What do the results say?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included 90 studies involving almost 200,000 people, with 88 of these studies carried out in Africa in field settings. Study design and conduct were poorly reported against current expectations. Based on our statistical model, we found:\n• Among the urine strips for detecting urinary schistosomiasis, the strips for detecting blood were better than those detecting protein or white cells (sensitivity and specificity for blood 75% and 87%; for protein 61% and 82%; and for white cells 58% and 61%, respectively).\n• For urinary schistosomiasis, the parasite antigen test performance was worse (sensitivity, 39% and specificity, 78%) than urine strips for detecting blood.\n• For intestinal schistosomiasis, the parasite antigen urine test, detected many infections identified by microscopy but wrongly labelled many uninfected people as sick (sensitivity, 89% and specificity, 55%)."
}
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query-laysum | 3988 | [
{
"role": "user",
"content": "Abstract: Background\nSalvage systemic therapy has become the new standard of care in patients with advanced gastric and oesophago-gastric junction (OGJ) adenocarcinoma, following disease progression on first-line fluoropyrimidine and platinum-containing chemotherapy. Pharmacological agents proven to be effective in this setting include both chemotherapy and biological therapy, however, the consensus on the best salvage systemic therapy has not been reached.\nObjectives\nTo assess the effects of systemic chemotherapy and biological therapy, either alone or in combination, on overall survival (OS) and progression-free survival (PFS) in patients with advanced gastric and OGJ adenocarcinoma, whose disease has progressed on, or relapsed after first-line fluoropyrimidine and platinum-containing chemotherapy. Adverse events (AEs), tumour response rate (TRR) and quality of life (QoL) associated with systemic chemotherapy and/or biological therapy were additionally assessed.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, trial registries and proceedings of the major oncology conferences up to October 2020. We additionally handsearched the reference lists of studies. No language restriction was applied.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing salvage systemic therapy (chemotherapy and/or biological therapy) and either another type of salvage systemic therapy, placebo, best supportive care (BSC) or no treatment in patients with gastric and OGJ adenocarcinoma refractory to first-line fluoropyrimidine and platinum-containing chemotherapy.\nData collection and analysis\nTwo review authors independently performed selection of eligible studies and the primary author extracted study characteristics and outcome data from included studies. We assessed the quality and risk of bias of eligible studies according to the Cochrane Handbook for Systematic Reviews of Interventions. We expressed pooled estimates of effect using hazard ratio (HR) calculated using an inverse variance random-effects model for time-to-event data, and risk ratio (RR) calculated using Mantel-Haenszel random-effects model for binary data. The certainty of evidence was graded using GRADEpro.\nMain results\nWe identified 17 RCTs with 5110 participants for inclusion in this review. Tweenty-nine studies are ongoing and twenty studies are awaiting classification. No studies examined the following comparisons: chemotherapy combined with biological therapy versus placebo, BSC or no treatment, chemotherapy combined with biological therapy versus biological therapy, biological therapy versus biological therapy and chemotherapy combined with biological therapy versus chemotherapy combined with biological therapy.\nChemotherapy versus placebo, best supportive care or no treatment\nChemotherapy probably improves OS (HR = 0.66, 95% CI 0.52 to 0.83, moderate-certainty evidence) based on two studies involving 547 participants and improves PFS (HR = 0.57, 95% CI 0.47 to 0.69, high-certainty evidence) based on one study involving 507 participants over placebo and BSC. Chemotherapy probably increases serious AEs (SAEs) (RR = 1.38, 95% CI 1.20 to 1.59, moderate-certainty evidence) based on one study involving 503 participants.\nBiological therapy versus placebo, best supportive care or no treatment\nBiological therapy improves OS (HR = 0.55, 95% CI 0.41 to 0.73, high-certainty evidence) and probably improves PFS (HR = 0.33, 95% CI 0.19 to 0.57, moderate-certainty evidence) over placebo based on three studies involving 781 participants. There is currently insufficient evidence for increased SAEs from biological therapy (RR = 1.14, 95% CI 0.95 to 1.37, low-certainty evidence) based on two studies involving 638 participants.\nChemotherapy versus biological therapy\nThis comparison only considered immunotherapy. There is probably no evidence of a difference for OS (HR = 0.82, 95% CI 0.66 to 1.02, moderate-certainty evidence) between chemotherapy and immunotherapy, and immunotherapy probably reduces PFS (HR = 1.27, 95% CI 1.03 to 1.57, moderate-certainty evidence) based on one study involving 395 participants. SAEs may be less frequent with immunotherapy compared to chemotherapy (RR = 0.41, 95% CI 0.30 to 0.57, low-certainty evidence).\nChemotherapy combined with biological therapy versus chemotherapy\nAddition of biological therapy to chemotherapy probably does not improve OS (HR = 0.93, 95% CI 0.83 to 1.04, moderate-certainty evidence) and we are uncertain whether it improves PFS (HR = 0.87, 95% CI 0.74 to 1.02, very low-certainty evidence) based on seven studies involving 2743 participants. We are similarly uncertain whether combined chemotherapy and biological therapy increases SAEs (RR = 1.17, 95% CI 0.95 to 1.44, very low-certainty evidence) based on four studies involving 1618 participants.\nChemotherapy versus chemotherapy\nThere is no evidence of a difference for OS and PFS between irinotecan and paclitaxel (HR = 1.13, 95% CI 0.86 to 1.48, low-certainty evidence for OS; HR = 1.14, 95% CI 0.88 to 1.48, low-certainty evidence for PFS) based on one study involving 219 participants. Similarly, there is no evidence to indicate improved OS and PFS from addition of another chemotherapy to docetaxel (HR = 1.05, 95% CI 0.72 to 1.54, low-certainty evidence for OS; HR = 0.75, 95% CI 0.52 to 1.09, low-certainty evidence for PFS) based on two studies involving 121 participants. Grade ≥ 3 neutropenia occurred commonly with both mono- and poly-chemotherapy except for docetaxel-S1 and EOX chemotherapy.\nAuthors' conclusions\nSurvival outcome of patients with advanced gastric and OGJ adenocarcinoma whose disease progressed on first-line fluoropyrimidine and platinum-containing chemotherapy can be improved by chemotherapy and biological therapy. Biological therapy, in particular, achieves this without clear increase in SAEs or QoL impairment. Whether biological therapy is preferred over chemotherapy is still unclear and there is no evidence of a difference for OS outcome, although immunotherapy may be associated with less SAEs. Addition of biological therapy to chemotherapy and poly-chemotherapy are associated with frequent treatment-related toxicity without clear survival benefit.\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": "If advanced stomach or OGJ cancer has not responded to standard chemotherapy, further chemotherapy or biological therapy help people to live longer than placebo treatment, best supportive care, or no treatment. However, chemotherapy is more clearly associated with unwanted effects than biological therapy.\nWe are unsure if biological therapies work better than chemotherapy, but they may cause fewer unwanted effects. Combining chemotherapy and biological therapies may cause more unwanted effects without giving any extra benefit."
}
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query-laysum | 3989 | [
{
"role": "user",
"content": "Abstract: Background\nRespiratory failure or respiratory distress in infants is the most common reason for non-elective admission to hospitals and neonatal intensive care units. Non-invasive methods of respiratory support have become the preferred mode of treating respiratory problems as they avoid some of the complications associated with intubation and mechanical ventilation. High flow nasal cannula (HFNC) therapy is increasingly being used as a method of non-invasive respiratory support. However, the evidence pertaining to its use in term infants (defined as infants ≥ 37 weeks gestational age to the end of the neonatal period (up to one month postnatal age)) is limited and there is no consensus of opinion regarding the safety and efficacy HFNC in this population.\nObjectives\nTo assess the safety and efficacy of high flow nasal cannula oxygen therapy for respiratory support in term infants when compared with other forms of non-invasive respiratory support.\nSearch methods\nWe searched the following databases in December 2022: Cochrane CENTRAL; PubMed; Embase; CINAHL; LILACS; Web of Science; Scopus. We also searched the reference lists of retrieved studies and performed a supplementary search of Google Scholar.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated the use of high flow nasal cannula oxygen therapy in infants ≥ 37 weeks gestational age up to one month postnatal age (the end of the neonatal period).\nData collection and analysis\nTwo review authors independently assessed trial eligibility, performed data extraction, and assessed risk of bias in the included studies. Where studies were sufficiently similar, we performed a meta-analysis using mean differences (MD) for continuous data and risk ratios (RR) for dichotomous data, with their respective 95% confidence intervals (CIs). For statistically significant RRs, we calculated the number needed to treat for an additional beneficial outcome (NNTB). We used the GRADE approach to evaluate the certainty of the evidence for clinically important outcomes.\nMain results\nWe included eight studies (654 participants) in this review. Six of these studies (625 participants) contributed data to our primary analyses.\nFour studies contributed to our comparison of high flow nasal cannula (HFNC) oxygen therapy versus continuous positive airway pressure (CPAP) for respiratory support in term infants. The outcome of death was reported in two studies (439 infants) but there were no events in either group. HFNC may have little to no effect on treatment failure, but the evidence is very uncertain (RR 0.98, 95% CI 0.47 to 2.04; 3 trials, 452 infants; very low-certainty evidence). The outcome of chronic lung disease (need for supplemental oxygen at 28 days of life) was reported in one study (375 participants) but there were no events in either group. HFNC may have little to no effect on the duration of respiratory support (any form of non-invasive respiratory support with or without supplemental oxygen), but the evidence is very uncertain (MD 0.17 days, 95% CI -0.28 to 0.61; 4 trials, 530 infants; very low-certainty evidence). HFNC likely results in little to no difference in the length of stay at the intensive care unit (ICU) (MD 0.90 days, 95% CI -0.31 to 2.12; 3 trials, 452 infants; moderate-certainty evidence). HFNC may reduce the incidence of nasal trauma (RR 0.16, 95% CI 0.04 to 0.66; 1 trial, 78 infants; very low-certainty evidence) and abdominal overdistension (RR 0.22, 95% CI 0.07 to 0.71; 1 trial, 78 infants; very low-certainty evidence), but the evidence is very uncertain.\nTwo studies contributed to our analysis of HFNC versus low flow nasal cannula oxygen therapy (LFNC) (supplemental oxygen up to a maximum flow rate of 2 L/min). The outcome of death was reported in both studies (95 infants) but there were no events in either group. The evidence suggests that HFNC may reduce treatment failure slightly (RR 0.44, 95% CI 0.21 to 0.92; 2 trials, 95 infants; low-certainty evidence). Neither study reported results for the outcome of chronic lung disease (need for supplemental oxygen at 28 days of life). HFNC may have little to no effect on the duration of respiratory support (MD -0.07 days, 95% CI -0.83 to 0.69; 1 trial, 74 infants; very low-certainty evidence), length of stay at the ICU (MD 0.49 days, 95% CI -0.83 to 1.81; 1 trial, 74 infants; very low-certainty evidence), or hospital length of stay (MD -0.60 days, 95% CI -2.07 to 0.86; 2 trials, 95 infants; very low-certainty evidence), but the evidence is very uncertain. Adverse events was an outcome reported in both studies (95 infants) but there were no events in either group.\nThe risk of bias across outcomes was generally low, although there were some concerns of bias. The certainty of evidence across outcomes ranged from moderate to very low, downgraded due to risk of bias, imprecision, indirectness, and inconsistency.\nAuthors' conclusions\nWhen compared with CPAP, HFNC may result in little to no difference in treatment failure. HFNC may have little to no effect on the duration of respiratory support, but the evidence is very uncertain. HFNC likely results in little to no difference in the length of stay at the intensive care unit. HFNC may reduce the incidence of nasal trauma and abdominal overdistension, but the evidence is very uncertain.\nWhen compared with LFNC, HFNC may reduce treatment failure slightly. HFNC may have little to no effect on the duration of respiratory support, length of stay at the ICU, or hospital length of stay, but the evidence is very uncertain.\nThere is insufficient evidence to enable the formulation of evidence-based guidelines on the use of HFNC for respiratory support in term infants. Larger, methodologically robust trials are required to further evaluate the possible health benefits or harms of HFNC in this patient population.\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": "When compared with CPAP, HFNC may result in little to no difference in treatment failure. HFNC may have little to no effect on the duration of respiratory support, but the evidence is very uncertain. HFNC likely results in little to no difference in the length of stay at the intensive care unit. HFNC may reduce the incidence of nasal trauma and abdominal overdistension, but the evidence is very uncertain.\nWhen compared with LFNC, HFNC may reduce treatment failure slightly. HFNC may have little to no effect on the duration of respiratory support, length of stay at the ICU, or hospital length of stay, but the evidence is very uncertain.\nThere is insufficient evidence to enable the formulation of evidence-based guidelines on the use of HFNC for respiratory support in term infants. Larger, methodologically robust trials are required to further evaluate the possible health benefits or harms of HFNC in this patient population."
}
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query-laysum | 3990 | [
{
"role": "user",
"content": "Abstract: Background\nHeated, humidified air has long been used by people with the common cold. The theoretical basis is that steam may help congested mucus drain better and that heat may destroy the cold virus as it does in vitro. This is an update of a review last published in 2013.\nObjectives\nTo assess the effects of inhaling heated water vapour (steam) in the treatment of the common cold by comparing symptoms, viral shedding, and nasal resistance.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (to February 2017), MEDLINE (1966 to 24 February 2017), Embase (1990 to 24 February 2017), and Current Contents (1998 to 24 February 2017). We also searched World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (8 March 2017) and ClinicalTrials.gov (8 March 2017) as well as reference lists of included studies.\nSelection criteria\nRandomised controlled trials using heated water vapour in participants with the common cold or experimentally induced common cold were eligible for inclusion.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Three review authors independently screened titles and abstracts for inclusion of potential studies identified from the search. We recorded the selection process in sufficient detail to complete a PRISMA flow diagram. We used a data collection form for study characteristics and outcome data that was developed and used for previous versions of this review. Two review authors independently extracted data, and a third review author resolved any disagreements. We used Review Manager 5 software to analyse data.\nMain results\nWe included six trials from five publications involving a total of 387 participants. We included no new studies in this 2017 update. The 'Risk of bias' assessment suggested an unclear risk of bias in the domain of randomisation and a low risk of bias in performance, detection, attrition, and reporting.\nIt was uncertain whether heated, humidified air provides symptomatic relief for the common cold, as the fixed-effect analysis showed evidence of an effect (odds ratio (OR) 0.30, 95% confidence interval (CI) 0.16 to 0.56; 2 studies, 149 participants), but the random-effects analysis showed no significant difference in the results (OR 0.22, 95% CI 0.03 to 1.95). There is an argument for using either form of analysis. No studies demonstrated an exacerbation of clinical symptom scores. One study conducted in the USA demonstrated worsened nasal resistance, but an earlier Israeli study showed improvement. One study examined viral shedding in nasal washings, finding no significant difference between treatment and placebo groups (OR 0.47, 95% CI 0.04 to 5.19). As judged by the subjective response to therapy (i.e. therapy did not help), the number of participants reporting resolution of symptoms was not significantly higher in the heated humidified group (OR 0.58, 95% CI 0.28 to 1.18; 2 studies, 124 participants). There was significant heterogeneity in the effects of heated, humidified air on different outcomes, therefore we graded the quality of the evidence as low. Some studies reported minor adverse events (including discomfort or irritation of the nose).\nAuthors' conclusions\nThe current evidence does not show any benefits or harms from the use of heated, humidified air delivered via the RhinoTherm device for the treatment of the common cold. There is a need for more double-blind, randomised trials that include standardised treatment modalities.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The RhinoTherm devices were provided by Netzer Sereni in four studies and A Beacham in two studies. One study was funded by Cleveland Clinic internal funding, and another was supported by authors' discretionary funds. The remaining studies did not mention funding sources."
}
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query-laysum | 3991 | [
{
"role": "user",
"content": "Abstract: Background\nSkin and soft-tissue infections (SSTIs) are common infections of the epidermis, dermis or subcutaneous tissue. SSTIs range in severity from minor, self-limiting, superficial infections to deep, aggressive, gangrenous, life-threatening infections. Some classifications divide SSTIs into 'complicated' and 'uncomplicated' infections based on clinical severity. Treatments of SSTIs involves antibiotic therapy, surgical debridement or drainage, and resuscitation if required. Sometimes these treatments are limited by high treatment costs, bacterial resistance to antibiotics and side effects, therefore, many people with SSTIs are turning to Chinese herbal medicines to treat this problem.\nChinese herbal medicines are natural substances that have been used for centuries in China where they are generally considered to be effective for SSTIs. Some Chinese herbal medicines have been shown to have antibacterial and anti-inflammatory properties, although a few herbal medicines have been reported to have side effects. Therefore there is a need to review the current clinical evidence systematically to inform current practice and guide future studies on Chinese herbal medicines for SSTIs.\nObjectives\nTo evaluate the benefits and harms of Chinese herbal medicines for treating skin and soft-tissue infections (SSTIs).\nSearch methods\nSearches were not restricted by date, language or publication status. In July 2014 we searched the following electronic databases: the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; Ovid AMED (Allied and Complementary Medicine); and EBSCO CINAHL.\nSelection criteria\nAll randomised controlled trials (RCTs) in people with SSTIs that compared Chinese herbal medicines with another intervention or control.\nData collection and analysis\nTwo review authors screened the literature search results independently; there were no disagreements.\nMain results\nWe identified no RCTs that met the inclusion criteria.\nAuthors' conclusions\nThere is currently no information available from RCTs to support or refute the use of Chinese herbal medicines in treating people with SSTIs.\n\nGiven the provided abstract, please respond to the following query: \"What are Chinese herbal medicines?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chinese herbal medicines are mostly extracts of plants, or parts of plants, that are used individually, or combined, as medicines. These traditional medicines have been used in China for centuries, and Chinese doctors currently prescribe them to treat SSTIs."
}
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query-laysum | 3992 | [
{
"role": "user",
"content": "Abstract: Background\nMalaria causes ill health and death in Africa. Treating illness promptly with artemisinin-based combination therapy (ACT) is likely to cure people and avoid the disease progressing to more severe forms and death. In many countries, ACT use remains low. Part of the problem is that most people seek treatment from the retail sector where ACTs are expensive; this expense is a barrier to their use.\nThe Global Fund and other international organisations are subsidising the cost of ACTs for private retail providers to improve access to ACTs. The subsidy was initially organised through a stand-alone initiative, called the Affordable Medicines Facility-malaria (AMFm), but has since been integrated into the Global Fund core grant management and financial processes.\nObjectives\nTo assess the effect of programmes that include ACT price subsidies for private retailers on ACT use, availability, price and market share.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 1, The Cochrane Library, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register); MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EbscoHost), EconLit (ProQuest), Global Health (OvidSP), Regional Indexes (Global Health Library, WHO), LILACS (Global Health Library, WHO), Science Citation Index and Social Sciences Citation Index (ISI Web of Science) and Health Management (ProQuest). All databases were searched February 2015, except for Health Management which was searched November 2013, without any date, language or publication status restrictions. We also searched the International Clinical Trials Registry Platform (ICTRP; WHO), ClinicalTrials.gov (NIH) and various grey literature sources. We also conducted a cited reference search for all included studies in ISI Web of Knowledge, checked references of identified articles and contacted authors to identify additional studies.\nSelection criteria\nRandomised trials, non-randomised trials, controlled before-after studies and interrupted-time-series studies that compared the effects of ACT price subsidies for private retailers to no subsidies or alternative ACT financing mechanisms were eligible for inclusion. Two authors independently screened and selected studies for inclusion.\nData collection and analysis\nTwo review authors independently extracted data, assessed study risk of bias and confidence in effect estimates (certainty of evidence) using Grading of Recommendations, Assessment, Development and Evaluation (GRADE).\nMain results\nWe included four trials (two cluster-randomised trials reported in three articles and two non-randomised cluster trials). Three trials assessed retail sector ACT subsidies combined with supportive interventions (retail outlet provider training, community awareness and mass media campaigns). One trial assessed vouchers provided to households to purchase subsidised ACTs. Price subsidies ranged from 80% to 95%. One trial enrolled children under five years of age; the other three trials studied people of all age groups. The studies were done in rural districts in East Africa (Kenya, Uganda and Tanzania).\nIn this East Africa setting, these ACT subsidy programmes increased the percentage of children under five years of age receiving ACTs on the day, or following day, of fever onset by 25 percentage points (95% confidence interval (CI) 14.1 to 35.9 percentage points; 1 study, high certainty evidence). This suggests that in practice, among febrile children under five years of age with an ACT usage rate of 5% without a subsidy, subsidy programmes would increase usage by between 19% and 41% over a one year period.\nThe ACT subsidy programmes increased the percentage of retail outlets stocking ACTs for children under five years of age by 31.9 percentage points (95% CI 26.3 to 37.5 percentage points; 1 study, high certainty evidence). Effects on ACT stocking for patients of any age is unknown because the certainty of evidence was very low.\nThe ACT subsidy programmes decreased the median cost of ACTs for children under five years of age by US$ 0.84 (median cost per ACT course without subsidy: US$ 1.08 versus with subsidy: US$ 0.24; 1 study, high certainty evidence).\nThe ACT subsidy programmes increased the market share of ACTs for children under five years of age by between 23.6 and 63.0 percentage points (1 study, high certainty evidence).\nThe ACT subsidy programmes decreased the use of older antimalarial drugs (such as amodiaquine and sulphadoxine-pyrimethamine) among children under five years of age by 10.4 percentage points (95% CI 3.9 to 16.9 percentage points; 1 study, high certainty evidence).\nNone of the three studies of ACT subsidies reported the number of patients treated who had confirmed malaria.\nVouchers increased the likelihood that an illness is treated with an ACT by 16 to 23 percentage points; however, vouchers were associated with a high rate of over-treatment of malaria (only 56% of patients taking ACTs from the drug shop tested positive for malaria under the 92% subsidy; 1 study, high certainty evidence).\nAuthors' conclusions\nProgrammes that include substantive subsidies for private sector retailers combined with training of providers and social marketing improved use and availability of ACTs for children under five years of age with suspected malaria in research studies from three countries in East Africa. These programmes also reduced prices of ACTs, improved market share of ACTs and reduced the use of older antimalarial drugs among febrile children under five years of age. The research evaluates drug delivery but does not assess whether the patients had confirmed (parasite-diagnosed) malaria. None of the included studies assessed patient outcomes; it is therefore not known whether the effects seen in the studies would translate to an impact on health.\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": "Malaria causes ill health and death in Africa, particularly in children under five years of age and poor rural populations. The World Health Organization recommends that people use ACT to treat malaria. ACT drugs are available at shops and pharmacies, but these drugs are expensive and people often choose cheaper, older, less effective drugs instead. The Global Fund and other international organisations have therefore decided to subsidise the cost of ACT drugs so that people can buy them from shops and pharmacies at prices similar to, or lower than, those of the older, less effective drugs."
}
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query-laysum | 3993 | [
{
"role": "user",
"content": "Abstract: Background\nMucopolysaccharidosis II, also known as Hunter syndrome, is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase, which catalyses a step in the catabolism of glycosaminoglycans. The glycosaminoglycans accumulate within tissues affecting multiple organs and physiologic systems. The clinical manifestations include neurologic involvement, severe airways obstruction, skeletal deformities and cardiomyopathy. The disease has a variable age of onset and variable rate of progression. In those with severe disease, death usually occurs in the second decade of life, whereas those individuals with less severe disease may survive into adulthood. Enzyme replacement therapy with intravenous infusions of idursulfase has emerged as a new treatment for mucopolysaccharidosis type II. This is an update of a previously published version of this review.\nObjectives\nTo evaluate the effectiveness and safety of enzyme replacement therapy with idursulfase compared to other interventions, placebo or no intervention, for treating mucopolysaccharidosis type II.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register (date of last search 23 November 2015).\nWe also searched Embase, PubMed and the Literature Latino-Americana e do Caribe em Ciências da Saúde (LILACS) (date of last search 28 November 2015).\nSelection criteria\nRandomised and quasi-randomised controlled trials of enzyme replacement therapy with idursulfase compared to no intervention, placebo or other options (e.g. behavioral strategies, transplantation).\nData collection and analysis\nTwo authors independently screened the trials identified, appraised quality of papers and extracted data.\nMain results\nOne study (96 male participants) met the inclusion criteria, although the primary outcome of this review - z score for height and weight, was not assessed in the study. This trial was considered to be of overall good quality. Following 53 weeks of treatment, participants in the weekly idursulfase 0.5 mg/kg group demonstrated a significant improvement rate compared with placebo for the primary outcome: distance walked in six minutes on the basis of the sum of ranks of change from baseline, mean difference 37.00 (95% confidence interval 6.52 to 67.48). The every-other-week idursulfase 0.5 mg/kg group also showed an improvement, which was not significant compared with placebo, mean difference 23.00 (95% confidence interval -4.49 to 50.49). After 53 weeks, there was no statistical significance difference in per cent predicted forced vital capacity between the three groups and absolute forced vital capacity was significantly increased from baseline in the weekly dosing group compared to placebo, mean difference 0.16 (95% confidence interval CI 0.05 to 0.27). No difference was observed between the every-other-week idursulfase 0.5 mg/kg group and placebo.\nIn addition, liver and spleen volumes and urine glycosaminoglycan excretion were significantly reduced from baseline by both idursulfase dosing regimens. Idursulfase was generally well tolerated, but infusion reactions did occur. Idursulfase antibodies were detected in 31.7% of participants at the end of the study and they were related to a smaller reduction in urine glycosaminoglycan levels.\nAuthors' conclusions\nThe current evidence is limited. While the randomised clinical trial identified was considered to be of good quality, it failed to describe important outcomes. It has been demonstrated that enzyme replacement therapy with idursulfase is effective in relation to functional capacity (distance walked in six minutes and forced vital capacity), liver and spleen volumes and urine glycosaminoglycan excretion in people with mucopolysaccharidosis type II compared with placebo. There is no available evidence in the included study and in the literature on outcomes such as improvement in growth, sleep apnoea, cardiac function, quality of life and mortality. More studies are needed to obtain more information on the long-term effectiveness and safety of enzyme replacement therapy.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 23 November 2015."
}
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query-laysum | 3994 | [
{
"role": "user",
"content": "Abstract: Background\nCesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane Review first published in 2010 and subsequently updated in 2012, twice in 2014, in 2017 and 2018.\nObjectives\nTo determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (7 July 2019), and reference lists of retrieved studies.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity.\nCluster-RCTs were eligible for inclusion, but we did not identify any. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design. We included trials published in abstract form only if sufficient information was present in the abstract on methods and outcomes to analyze.\nData collection and analysis\nAt least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies.\nMain results\nWe included 21 trials, reporting results for 7038 women evaluating the effects of vaginal cleansing (17 using povidone-iodine, 3 chlorhexidine, 1 benzalkonium chloride) on post-cesarean infectious morbidity. Trials used vaginal preparations administered by sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (17 trials) or the use of a saline vaginal preparation (4 trials). One trial did not report on any outcomes of interest. Trials were performed in 10 different countries (Saudi Arabia, Pakistan, Iran, Thailand, Turkey, USA, Egypt, UK, Kenya and India). The overall risk of bias was low for areas of attrition, reporting, and other bias. About half of the trials had low risk of selection bias, with most of the remainder rated as unclear. Due to lack of blinding, we rated performance bias as high risk in nearly one-third of the trials, low risk in one-third, and unclear in one-third.\nVaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 7.1% in control groups to 3.1% in vaginal cleansing groups (average risk ratio (aRR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; 20 trials, 6918 women; moderate-certainty evidence). This reduction in endometritis was seen for both iodine-based solutions and chlorhexidine-based solutions. Risks of postoperative fever and postoperative wound infection are also probably reduced by vaginal antiseptic preparation (fever: aRR 0.64, 0.50 to 0.82; 16 trials, 6163 women; and wound infection: RR 0.62, 95% CI 0.50 to 0.77; 18 trials, 6385 women; both moderate-certainty evidence). Two trials found that there may be a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82; 2 trials, 499 women; low-certainty evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing.\nSubgroup analysis suggested a greater effect with vaginal preparations for those women in labour versus those not in labour for four out of five outcomes examined (post-cesarean endometritis; postoperative fever; postoperative wound infection; composite wound complication or endometritis). This apparent difference needs to be investigated further in future trials. We did not observe any subgroup differences between women with ruptured membranes and women with intact membranes.\nAuthors' conclusions\nVaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis, postoperative fever, and postoperative wound infection. Subgroup analysis found that these benefits were typically present whether iodine-based or chlorhexidine-based solutions were used and when women were in labor before the cesarean. The suggested benefit in women in labor needs further investigation in future trials.\nThere was moderate-certainty evidence using GRADE for all reported outcomes, with downgrading decisions based on limitations in study design or imprecision.\nAs a simple intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries. Future research on this intervention being incorporated into bundles of care plans for women receiving cesarean delivery will be needed.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cleansing the vagina before the cesarean delivery can reduce the number of bacteria that are naturally present in the vagina. These bacteria in the vagina and cervix can move up into the uterus during the surgical procedure and cause infection in the lining of the uterus and in the surgical wound. Antibiotics are routinely given before the surgery to reduce the risk of infections, but some women still suffer from these complications. Some antibiotics do not always eradicate all bacteria, and antibiotic resistant bacteria may be present. Vaginal preparation may not be included in the care provided to women to reduce infection following surgery. Vaginal cleansing solutions, such as chlorhexidine and povidone-iodine are inexpensive, and have very few side effects."
}
]
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query-laysum | 3995 | [
{
"role": "user",
"content": "Abstract: Background\nIt is estimated that up to 75% of cancer survivors may experience cognitive impairment as a result of cancer treatment and given the increasing size of the cancer survivor population, the number of affected people is set to rise considerably in coming years. There is a need, therefore, to identify effective, non-pharmacological interventions for maintaining cognitive function or ameliorating cognitive impairment among people with a previous cancer diagnosis.\nObjectives\nTo evaluate the cognitive effects, non-cognitive effects, duration and safety of non-pharmacological interventions among cancer patients targeted at maintaining cognitive function or ameliorating cognitive impairment as a result of cancer or receipt of systemic cancer treatment (i.e. chemotherapy or hormonal therapies in isolation or combination with other treatments).\nSearch methods\nWe searched the Cochrane Centre Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PUBMED, Cumulative Index of Nursing and Allied Health Literature (CINAHL) and PsycINFO databases. We also searched registries of ongoing trials and grey literature including theses, dissertations and conference proceedings. Searches were conducted for articles published from 1980 to 29 September 2015.\nSelection criteria\nRandomised controlled trials (RCTs) of non-pharmacological interventions to improve cognitive impairment or to maintain cognitive functioning among survivors of adult-onset cancers who have completed systemic cancer therapy (in isolation or combination with other treatments) were eligible. Studies among individuals continuing to receive hormonal therapy were included. We excluded interventions targeted at cancer survivors with central nervous system (CNS) tumours or metastases, non-melanoma skin cancer or those who had received cranial radiation or, were from nursing or care home settings. Language restrictions were not applied.\nData collection and analysis\nAuthor pairs independently screened, selected, extracted data and rated the risk of bias of studies. We were unable to conduct planned meta-analyses due to heterogeneity in the type of interventions and outcomes, with the exception of compensatory strategy training interventions for which we pooled data for mental and physical well-being outcomes. We report a narrative synthesis of intervention effectiveness for other outcomes.\nMain results\nFive RCTs describing six interventions (comprising a total of 235 participants) met the eligibility criteria for the review. Two trials of computer-assisted cognitive training interventions (n = 100), two of compensatory strategy training interventions (n = 95), one of meditation (n = 47) and one of physical activity intervention (n = 19) were identified. Each study focused on breast cancer survivors. All five studies were rated as having a high risk of bias. Data for our primary outcome of interest, cognitive function were not amenable to being pooled statistically. Cognitive training demonstrated beneficial effects on objectively assessed cognitive function (including processing speed, executive functions, cognitive flexibility, language, delayed- and immediate- memory), subjectively reported cognitive function and mental well-being. Compensatory strategy training demonstrated improvements on objectively assessed delayed-, immediate- and verbal-memory, self-reported cognitive function and spiritual quality of life (QoL). The meta-analyses of two RCTs (95 participants) did not show a beneficial effect from compensatory strategy training on physical well-being immediately (standardised mean difference (SMD) 0.12, 95% confidence interval (CI) -0.59 to 0.83; I2= 67%) or two months post-intervention (SMD - 0.21, 95% CI -0.89 to 0.47; I2 = 63%) or on mental well-being two months post-intervention (SMD -0.38, 95% CI -1.10 to 0.34; I2 = 67%). Lower mental well-being immediately post-intervention appeared to be observed in patients who received compensatory strategy training compared to wait-list controls (SMD -0.57, 95% CI -0.98 to -0.16; I2 = 0%). We assessed the assembled studies using GRADE for physical and mental health outcomes and this evidence was rated to be low quality and, therefore findings should be interpreted with caution. Evidence for physical activity and meditation interventions on cognitive outcomes is unclear.\nAuthors' conclusions\nOverall, the, albeit low-quality evidence may be interpreted to suggest that non-pharmacological interventions may have the potential to reduce the risk of, or ameliorate, cognitive impairment following systemic cancer treatment. Larger, multi-site studies including an appropriate, active attentional control group, as well as consideration of functional outcomes (e.g. activities of daily living) are required in order to come to firmer conclusions about the benefits or otherwise of this intervention approach. There is also a need to conduct research into cognitive impairment among cancer patient groups other than women with breast cancer.\n\nGiven the provided abstract, please respond to the following query: \"What is the quality of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was low. There were problems with study designs and, so, we need to be cautious about our conclusions."
}
]
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query-laysum | 3996 | [
{
"role": "user",
"content": "Abstract: Background\nAcquired adult-onset hearing loss is a common long-term condition for which the most common intervention is hearing aid fitting. However, up to 40% of people fitted with a hearing aid either fail to use it or may not gain optimal benefit from it. This is an update of a review first published in The Cochrane Library in 2014.\nObjectives\nTo assess the long-term effectiveness of interventions to promote the use of hearing aids in adults with acquired hearing loss fitted with at least one hearing aid.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2016, Issue 5); PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 13 June 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) of interventions designed to improve or promote hearing aid use in adults with acquired hearing loss compared with usual care or another intervention. We excluded interventions that compared hearing aid technology. We classified interventions according to the 'chronic care model' (CCM). The primary outcomes were hearing aid use (measured as adherence or daily hours of use) and adverse effects (inappropriate advice or clinical practice, or patient complaints). Secondary patient-reported outcomes included quality of life, hearing handicap, hearing aid benefit and communication. Outcomes were measured over the short (</= 12 weeks), medium (> 12 to < 52 weeks) and long term (one year plus).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nWe included 37 studies involving a total of 4129 participants. Risk of bias across the included studies was variable. We judged the GRADE quality of evidence to be very low or low for the primary outcomes where data were available.\nThe majority of participants were over 65 years of age with mild to moderate adult-onset hearing loss. There was a mix of new and experienced hearing aid users. Six of the studies (287 participants) assessed long-term outcomes.\nAll 37 studies tested interventions that could be classified using the CCM as self-management support (ways to help someone to manage their hearing loss and hearing aid(s) better by giving information, practice and experience at listening/communicating or by asking people to practise tasks at home) and/or delivery system design interventions (just changing how the service was delivered).\nSelf-management support interventions\nWe found no studies that investigated the effect of these interventions on adherence, adverse effects or hearing aid benefit. Two studies reported daily hours of hearing aid use but we were unable to combine these in a meta-analysis. There was no evidence of a statistically significant effect on quality of life over the medium term. Self-management support reduced short- to medium-term hearing handicap (two studies, 87 participants; mean difference (MD) -12.80, 95% confidence interval (CI) -23.11 to -2.48 (0 to 100 scale)) and increased the use of verbal communication strategies in the short to medium term (one study, 52 participants; MD 0.72, 95% CI 0.21 to 1.23 (0 to 5 scale)). The clinical significance of these statistical findings is uncertain. It is likely that the outcomes were clinically significant for some, but not all, participants. Our confidence in the quality of this evidence was very low. No self-management support studies reported long-term outcomes.\nDelivery system design interventions\nThese interventions did not significantly affect adherence or daily hours of hearing aid use in the short to medium term, or adverse effects in the long term. We found no studies that investigated the effect of these interventions on quality of life. There was no evidence of a statistically or clinically significant effect on hearing handicap, hearing aid benefit or the use of verbal communication strategies in the short to medium term. Our confidence in the quality of this evidence was low or very low. Long-term outcome measurement was rare.\nCombined self-management support/delivery system design interventions\nOne combined intervention showed evidence of a statistically significant effect on adherence in the short term (one study, 167 participants, risk ratio (RR) 1.06, 95% CI 1.00 to 1.12). However, there was no evidence of a statistically or clinically significant effect on daily hours of hearing aid use over the long term, or the short to medium term. No studies of this type investigated adverse effects. There was no evidence of an effect on quality of life over the long term, or short to medium term. These combined interventions reduced hearing handicap in the short to medium term (14 studies, 681 participants; standardised mean difference (SMD) -0.26, 95% CI -0.50 to -0.02). This represents a small-moderate effect size but there is no evidence of a statistically significant effect over the long term. There was evidence of a statistically, but not clinically, significant effect on long-term hearing aid benefit (two studies, 69 participants, MD 0.30, 95% CI 0.02 to 0.58 (1 to 5 scale)), but no evidence of an effect over the short to medium term. There was evidence of a statistically, but not clinically, significant effect on the use of verbal communication strategies in the short term (four studies, 223 participants, MD 0.45, 95% CI 0.15 to 0.74 (0 to 5 scale)), but not the long term. Our confidence in the quality of this evidence was low or very low.\nWe found no studies that assessed the effect of other CCM interventions (decision support, the clinical information system, community resources or health system changes).\nAuthors' conclusions\nThere is some low to very low quality evidence to support the use of self-management support and complex interventions combining self-management support and delivery system design in adult auditory rehabilitation. However, effect sizes are small. The range of interventions that have been tested is relatively limited. Future research should prioritise: long-term outcome assessment; development of a core outcome set for adult auditory rehabilitation; and study designs and outcome measures that are powered to detect incremental effects of rehabilitative healthcare system changes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date as of June 2016. We found 37 studies involving a total of 4129 people. Most of the people in the studies were aged over 65. There was a mix of new and experienced hearing aid users. Seven studies funded by the United States Veterans Association dominate the evidence. The 1297 people in these studies were serving in the military or military veterans. All but two of the other studies included fewer than 100 people in each study."
}
]
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query-laysum | 3997 | [
{
"role": "user",
"content": "Abstract: Background\nFluoxetine is a serotonin reuptake inhibitor indicated for major depression. It is also thought to affect weight control: this seems to happen through appetite changes resulting in decreased food intake and normalisation of unusual eating behaviours. However, the benefit-risk ratio of this off-label medication is unclear.\nObjectives\nTo assess the effects of fluoxetine for overweight or obese adults.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, LILACS, the ICTRP Search Portal and ClinicalTrials.gov and World Health Organization (WHO) ICTRP Search Portal. The last date of the search was December 2018 for all databases, to which we applied no language restrictions .\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the administration of fluoxetine versus placebo, other anti-obesity agents, non-pharmacological therapy or no treatment in overweight or obese adults without depression, mental illness or abnormal eating patterns.\nData collection and analysis\nTwo review authors independently screened abstracts and titles for relevance. Screening for inclusion, data extraction and risk of bias assessment was performed by one author and checked by the second. We assessed trials for the overall certainty of the evidence using the GRADE instrument. For additional information we contacted trial authors by email. We performed random-effects meta-analyses and calculated the risk ratio (RR) with 95% confidence intervals (95% CI) for dichotomous outcomes and the mean difference (MD) with 95% CI for continuous outcomes.\nMain results\nWe identified 1036 records, scrutinized 52 full-text articles and included 19 completed RCTs (one trial is awaiting assessment). A total of 2216 participants entered the trials, 1280 participants were randomly assigned to fluoxetine (60 mg/d, 40 mg/d, 20 mg/d and 10 mg/d) and 936 participants were randomly assigned to various comparison groups (placebo; the anti-obesity agents diethylpropion, fenproporex, mazindol, sibutramine, metformin, fenfluramine, dexfenfluramine, fluvoxamine, 5-hydroxy-tryptophan; no treatment; and omega-3 gel). Within the 19 RCTs there were 56 trial arms. Fifteen trials were parallel RCTs and four were cross-over RCTs. The participants in the included trials were followed up for periods between three weeks and one year. The certainty of the evidence was low or very low: the majority of trials had a high risk of bias in one or more of the risk of bias domains.\nFor our main comparison group — fluoxetine versus placebo — and across all fluoxetine dosages and durations of treatment, the MD was −2.7 kg (95% CI −4 to −1.4; P < 0.001; 10 trials, 956 participants; low-certainty evidence). The 95% prediction interval ranged between −7.1 kg and 1.7 kg. The MD in body mass index (BMI) reduction across all fluoxetine dosages compared with placebo was −1.1 kg/m² (95% CI −3.7 to 1.4; 3 trials, 97 participants; very low certainty evidence). Only nine placebo-controlled trials reported adverse events. A total of 399 out of 627 participants (63.6%) receiving fluoxetine compared with 352 out of 626 participants (56.2%) receiving placebo experienced an adverse event. Random-effects meta-analysis showed an increase in the risk of having at least one adverse event of any type in the fluoxetine groups compared with placebo (RR 1.18, 95% CI 0.99 to 1.42; P = 0.07; 9 trials, 1253 participants; low-certainty evidence). The 95% prediction interval ranged between 0.74 and 1.88. Following fluoxetine treatment the adverse events of dizziness, drowsiness, fatigue, insomnia and nausea were observed approximately twice as often compared to placebo. A total of 15 out of 197 participants (7.6%) receiving fluoxetine compared with 12 out of 196 participants (6.1%) receiving placebo experienced depression. The RR across all fluoxetine doses compared with placebo was 1.20 (95% CI 0.57 to 2.52; P = 0.62; 3 trials, 393 participants; very low certainty evidence). All-cause mortality, health-related quality of life and socioeconomic effects were not reported.\nThe comparisons of fluoxetine with other anti-obesity agents (3 trials, 234 participants), omega-3 gel (1 trial, 48 participants) and no treatment (1 trial, 60 participants) showed inconclusive results (very low certainty evidence).\nAuthors' conclusions\nLow-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo. However, low-certainty evidence suggests an increase in the risk for dizziness, drowsiness, fatigue, insomnia and nausea following fluoxetine treatment.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 19 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) evaluating mainly women receiving different doses of fluoxetine. A total of 1280 overweight or obese participants received fluoxetine and 936 participants received mainly placebo or another anti-obesity medication. The participants in the included studies were followed up for periods varying between three weeks and one year."
}
]
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query-laysum | 3998 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is a highly prevalent mood disorder that is characterised by persistent low mood, diminished interest, and loss of pleasure. Music therapy may be helpful in modulating moods and emotions. An update of the 2008 Cochrane review was needed to improve knowledge on effects of music therapy for depression.\nObjectives\n1. To assess effects of music therapy for depression in people of any age compared with treatment as usual (TAU) and psychological, pharmacological, and/or other therapies.\n2. To compare effects of different forms of music therapy for people of any age with a diagnosis of depression.\nSearch methods\nWe searched the following databases: the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR; from inception to 6 May 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; to 17 June 2016); Thomson Reuters/Web of Science (to 21 June 2016); Ebsco/PsycInfo, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, and PubMed (to 5 July 2016); the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, the National Guideline Clearing House, and OpenGrey (to 6 September 2016); and the Digital Access to Research Theses (DART)-Europe E-theses Portal, Open Access Theses and Dissertations, and ProQuest Dissertations and Theses Database (to 7 September 2016). We checked reference lists of retrieved articles and relevant systematic reviews and contacted trialists and subject experts for additional information when needed. We updated this search in August 2017 and placed potentially relevant studies in the \"Awaiting classification\" section; we will incorporate these into the next version of this review as appropriate.\nSelection criteria\nAll randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing music therapy versus treatment as usual (TAU), psychological therapies, pharmacological therapies, other therapies, or different forms of music therapy for reducing depression.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated standardised mean difference (SMD) for continuous data and odds ratio (OR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic.\nMain results\nWe included in this review nine studies involving a total of 421 participants, 411 of whom were included in the meta-analysis examining short-term effects of music therapy for depression. Concerning primary outcomes, we found moderate-quality evidence of large effects favouring music therapy and TAU over TAU alone for both clinician-rated depressive symptoms (SMD -0.98, 95% CI -1.69 to -0.27, 3 RCTs, 1 CCT, n = 219) and patient-reported depressive symptoms (SMD -0.85, 95% CI -1.37 to -0.34, 3 RCTs, 1 CCT, n = 142). Music therapy was not associated with more or fewer adverse events than TAU. Regarding secondary outcomes, music therapy plus TAU was superior to TAU alone for anxiety and functioning. Music therapy and TAU was not more effective than TAU alone for improved quality of life (SMD 0.32, 95% CI -0.17 to 0.80, P = 0.20, n = 67, low-quality evidence). We found no significant discrepancies in the numbers of participants who left the study early (OR 0.49, 95% CI 0.14 to 1.70, P = 0.26, 5 RCTs, 1 CCT, n = 293, moderate-quality evidence). Findings of the present meta-analysis indicate that music therapy added to TAU provides short-term beneficial effects for people with depression if compared to TAU alone. Additionally, we are uncertain about the effects of music therapy versus psychological therapies on clinician-rated depression (SMD -0.78, 95% CI -2.36 to 0.81, 1 RCT, n = 11, very low-quality evidence), patient-reported depressive symptoms (SMD -1.28, 95% CI -3.75 to 1.02, 4 RCTs, n = 131, low-quality evidence), quality of life (SMD -1.31, 95% CI - 0.36 to 2.99, 1 RCT, n = 11, very low-quality evidence), and leaving the study early (OR 0.17, 95% CI 0.02 to 1.49, 4 RCTs, n = 157, moderate-quality evidence). We found no eligible evidence addressing adverse events, functioning, and anxiety. We do not know whether one form of music therapy is better than another for clinician-rated depressive symptoms (SMD -0.52, 95% CI -1.87 to 0.83, 1 RCT, n = 9, very low-quality evidence), patient-reported depressive symptoms (SMD -0.01, 95% CI -1.33 to 1.30, 1 RCT, n = 9, very low-quality evidence), quality of life (SMD -0.24, 95% CI -1.57 to 1.08, 1 RCT, n = 9, very low-quality evidence), or leaving the study early (OR 0.27, 95% CI 0.01 to 8.46, 1 RCT, n = 10). We found no eligible evidence addressing adverse events, functioning, or anxiety.\nAuthors' conclusions\nFindings of the present meta-analysis indicate that music therapy provides short-term beneficial effects for people with depression. Music therapy added to treatment as usual (TAU) seems to improve depressive symptoms compared with TAU alone. Additionally, music therapy plus TAU is not associated with more or fewer adverse events than TAU alone. Music therapy also shows efficacy in decreasing anxiety levels and improving functioning of depressed individuals.\nFuture trials based on adequate design and larger samples of children and adolescents are needed to consolidate our findings. Researchers should consider investigating mechanisms of music therapy for depression. It is important to clearly describe music therapy, TAU, the comparator condition, and the profession of the person who delivers the intervention, for reproducibility and comparison purposes.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Depression is a common problem that causes changes in mood and loss of interest and pleasure. Music therapy, an intervention that involves regular meetings with a qualified music therapist, may help in improving mood through emotional expression. This review might add new information about effects of music therapy in depressed individuals."
}
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query-laysum | 3999 | [
{
"role": "user",
"content": "Abstract: Background\nGlaucoma is a chronic optic neuropathy characterized by retinal ganglion cell death resulting in damage to the optic nerve head and the retinal nerve fiber layer. Pigment dispersion syndrome is characterized by a structural disturbance in the iris pigment epithelium (the densely pigmented posterior surface of the iris) that leads to dispersion of the pigment and its deposition on various structures within the eye. Pigmentary glaucoma is a specific form of open-angle glaucoma found in patients with pigment dispersion syndrome.\nTopcial medical therapy is usually the first-line treatment; however, peripheral laser iridotomy has been proposed as an alternate treatment. Peripheral laser iridotomy involves creating an opening in the iris tissue to allow drainage of fluid from the posterior chamber to the anterior chamber and vice versa. Equalizing the pressure within the eye may help to alleviate the friction that leads to pigment dispersion and prevent visual field deterioration. However, the effectiveness of peripheral laser iridotomy in reducing the development or progression of pigmentary glaucoma is unknown.\nObjectives\nThe objective of this review was to assess the effects of peripheral laser iridotomy compared with other interventions, including medication, trabeculoplasty, and trabeculectomy, or no treatment, for pigment dispersion syndrome and pigmentary glaucoma.\nSearch methods\nWe searched a number of electronic databases including CENTRAL, MEDLINE and EMBASE and clinical trials websites such as (mRCT) and ClinicalTrials.gov. We last searched the electronic databases on 2 November 2015.\nSelection criteria\nWe included randomized controlled trials (RCTs) that had compared peripheral laser iridotomy versus no treatment or other treatments for pigment dispersion syndrome and pigmentary glaucoma.\nData collection and analysis\nWe used standard methodological procedures for systematic reviews. Two review authors independently screened articles for eligibility, extracted data, and assessed included trials for risk of bias. We did not perform a meta-analysis because of variability in reporting and follow-up intervals for primary and secondary outcomes of interest.\nMain results\nWe included five RCTs (260 eyes of 195 participants) comparing yttrium-aluminum-garnet (YAG) laser iridotomy versus no laser iridotomy. Three trials included participants with pigmentary glaucoma at baseline, and two trials enrolled participants with pigment dispersion syndrome. Only two trials reported the country of enrollment: one - Italy, the other - United Kingdom. Overall, we assessed trials as having high or unclear risk of bias owing to incomplete or missing data and selective outcome reporting.\nData on visual fields were available for one of three trials that included participants with pigmentary glaucoma at baseline. At an average follow-up of 28 months, the risk of progression of visual field damage was uncertain when comparing laser iridotomy with no iridotomy (risk ratio (RR) 1.00, 95% confidence interval (95% CI) 0.16 to 6.25; 32 eyes; very low-quality evidence). The two trials that enrolled participants with pigment dispersion syndrome at baseline reported the proportion of participants with onset of glaucomatous visual field changes during the study period. At three-year follow-up, one trial reported that the risk ratio for conversion to glaucoma was 2.72 (95% CI 0.76 to 9.68; 42 eyes; very low-quality evidence). At 10-year follow-up, the other trial reported that no eye showed visual field progression.\nOne trial reported the mean change in intraocular pressure (IOP) in eyes with pigmentary glaucoma: At an average of nine months of follow-up, the mean difference in IOP between groups was 2.69 mmHg less in the laser iridotomy group than in the control group (95% CI -6.05 to 0.67; 14 eyes; very low-quality evidence). This trial also reported the mean change in anterior chamber depth at an average of nine months of follow-up and reported no meaningful differences between groups (mean difference 0.04 mm, 95% CI -0.07 to 0.15; 14 eyes; very low-quality evidence). No other trial reported mean change in anterior chamber depth. Two trials reported greater flattening of iris configuration in the laser iridotomy group than in the control group among eyes with pigmentary glaucoma; however, investigators provided insufficient data for analysis. No trial reported data related to mean visual acuity, aqueous melanin granules, costs, or quality of life outcomes.\nTwo trials assessed the need for additional treatment for control of IOP. One trial that enrolled participants with pigmentary glaucoma reported that more eyes in the laser iridotomy group required additional treatment between six and 23 months of follow-up than eyes in the control group (RR 1.73, 95% CI 1.08 to 2.75; 46 eyes); however, the other trial enrolled participants with pigment dispersion syndrome and indicated that the difference between groups at three-year follow-up was uncertain (RR 0.91, 95% CI 0.38 to 2.17; 105 eyes). We graded the certainty of evidence for this outcome as very low.\nTwo trials reported that no serious adverse events were observed in either group among eyes with pigment dispersion syndrome. Mild adverse events included postoperative inflammation; two participants required cataract surgery (at 18 and 34 months after baseline), and two participants required a repeat iridotomy.\nAuthors' conclusions\nWe found insufficient evidence of high quality on the effectiveness of peripheral iridotomy for pigmentary glaucoma or pigment dispersion syndrome. Although adverse events associated with peripheral iridotomy may be minimal, the long-term effects on visual function and other patient-important outcomes have not been established. Future research on this topic should focus on outcomes that are important to patients and the optimal timing of treatment in the disease process (eg, pigment dispersion syndrome with normal IOP, pigment dispersion syndrome with established ocular hypertension, pigmentary glaucoma).\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": "What are the effects of peripheral laser iridotomy compared with other treatments or no treatment for patients with pigment dispersion syndrome or pigmentary glaucoma?"
}
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query-laysum | 4000 | [
{
"role": "user",
"content": "Abstract: Background\nCritical illness is associated with uncontrolled inflammation and vascular damage which can result in multiple organ failure and death. Antithrombin III (AT III) is an anticoagulant with anti-inflammatory properties but the efficacy and any harmful effects of AT III supplementation in critically ill patients are unknown. This review was published in 2008 and updated in 2015.\nObjectives\nTo examine:\n1. The effect of AT III on mortality in critically ill participants.\n2. The benefits and harms of AT III.\nWe investigated complications specific and not specific to the trial intervention, bleeding events, the effect on sepsis and disseminated intravascular coagulation (DIC) and the length of stay in the intensive care unit (ICU) and in hospital in general.\nSearch methods\nWe searched the following databases from inception to 27 August 2015: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid SP), EMBASE (Ovid SP,), CAB, BIOSIS and CINAHL. We contacted the main authors of trials to ask for any missed, unreported or ongoing trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) irrespective of publication status, date of publication, blinding status, outcomes published, or language. We contacted the investigators and the trial authors in order to retrieve missing data. In this updated review we include trials only published as abstracts.\nData collection and analysis\nOur primary outcome measure was mortality. Two authors each independently abstracted data and resolved any disagreements by discussion. We presented pooled estimates of the intervention effects on dichotomous outcomes as risk ratios (RR) with 95% confidence intervals (CI). We performed subgroup analyses to assess risk of bias, the effect of AT III in different populations (sepsis, trauma, obstetrics, and paediatrics), and the effect of AT III in patients with or without the use of concomitant heparin. We assessed the adequacy of the available number of participants and performed trial sequential analysis (TSA) to establish the implications for further research.\nMain results\nWe included 30 RCTs with a total of 3933 participants (3882 in the primary outcome analyses).\nCombining all trials, regardless of bias, showed no statistically significant effect of AT III on mortality with a RR of 0.95 (95% CI 0.88 to 1.03), I² statistic = 0%, fixed-effect model, 29 trials, 3882 participants, moderate quality of evidence). For trials with low risk of bias the RR was 0.96 (95% Cl 0.88 to 1.04, I² statistic = 0%, fixed-effect model, 9 trials, 2915 participants) and for high risk of bias RR 0.94 (95% Cl 0.77 to 1.14, I² statistic = 0%, fixed-effect model, 20 trials, 967 participants).\nFor participants with severe sepsis and DIC the RR for mortality was non-significant, 0.95 (95% Cl 0.88 to 1.03, I² statistic = 0%, fixed-effect model, 12 trials, 2858 participants, moderate quality of evidence).\nWe conducted 14 subgroup and sensitivity analyses with respect to the different domains of risk of bias, but detected no statistically significant benefit in any subgroup analyses.\nOur secondary objective was to assess the benefits and harms of AT III. For complications specific to the trial intervention the RR was 1.26 (95% Cl 0.83 to 1.92, I² statistic = 0%, random-effect model, 3 trials, 2454 participants, very low quality of evidence). For complications not specific to the trial intervention, the RR was 0.71 (95% Cl 0.08 to 6.11, I² statistic = 28%, random-effects model, 2 trials, 65 participants, very low quality of evidence). For complications other than bleeding, the RR was 0.72 ( 95% Cl 0.42 to 1.25, I² statistic = 0%, fixed-effect model, 3 trials, 187 participants, very low quality of evidence). Eleven trials investigated bleeding events and we found a statistically significant increase, RR 1.58 (95% CI 1.35 to 1.84, I² statistic = 0%, fixed-effect model, 11 trials, 3019 participants, moderate quality of evidence) in the AT III group. The amount of red blood cells administered had a mean difference (MD) of 138.49 (95% Cl -391.35 to 668.34, I² statistic = 84%, random-effect model, 4 trials, 137 participants, very low quality of evidence). The effect of AT III in patients with multiple organ failure (MOF) was a MD of -1.24 (95% Cl -2.18 to -0.29, I² statistic = 48%, random-effects model, 3 trials, 156 participants, very low quality of evidence) and for patients with an Acute Physiology and Chronic Health Evaluation score (APACHE) at II and III the MD was -2.18 (95% Cl -4.36 to -0.00, I² statistic = 0%, fixed-effect model, 3 trials, 102 participants, very low quality of evidence). The incidence of respiratory failure had a RR of 0.93 (95% Cl 0.76 to 1.14, I² statistic = 32%, random-effects model, 6 trials, 2591 participants, moderate quality of evidence). AT III had no statistically significant impact on the duration of mechanical ventilation (MD 2.20 days, 95% Cl -1.21 to 5.60, I² statistic = 0%, fixed-effect model, 3 trials, 190 participants, very low quality of evidence); on the length of stay in the ICU (MD 0.24, 95% Cl -1.34 to 1.83, I² statistic = 0%, fixed-effect model, 7 trials, 376 participants, very low quality of evidence) or on the length of stay in hospital in general (MD 1.10, 95% Cl -7.16 to 9.36), I² statistic = 74%, 4 trials, 202 participants, very low quality of evidence).\nAuthors' conclusions\nThere is insufficient evidence to support AT III substitution in any category of critically ill participants including the subset of patients with sepsis and DIC. We did not find a statistically significant effect of AT III on mortality, but AT III increased the risk of bleeding events. Subgroup analyses performed according to duration of intervention, length of follow-up, different patient groups, and use of adjuvant heparin did not show differences in the estimates of intervention effects. The majority of included trials were at high risk of bias (GRADE; very low quality of evidence for most of the analyses). Hence a large RCT of AT III is needed, without adjuvant heparin among critically ill patients such as those with severe sepsis and DIC, with prespecified inclusion criteria and good bias protection.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Three of the 30 included trials reported receiving money from drug companies."
}
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query-laysum | 4001 | [
{
"role": "user",
"content": "Abstract: Background\nIn response to the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the impact of coronavirus disease 2019 (COVID-19), governments have implemented a variety of measures to control the spread of the virus and the associated disease. Among these, have been measures to control the pandemic in primary and secondary school settings.\nObjectives\nTo assess the effectiveness of measures implemented in the school setting to safely reopen schools, or keep schools open, or both, during the COVID-19 pandemic, with particular focus on the different types of measures implemented in school settings and the outcomes used to measure their impacts on transmission-related outcomes, healthcare utilisation outcomes, other health outcomes as well as societal, economic, and ecological outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Educational Resources Information Center, as well as COVID-19-specific databases, including the Cochrane COVID-19 Study Register and the WHO COVID-19 Global literature on coronavirus disease (indexing preprints) on 9 December 2020. We conducted backward-citation searches with existing reviews.\nSelection criteria\nWe considered experimental (i.e. randomised controlled trials; RCTs), quasi-experimental, observational and modelling studies assessing the effects of measures implemented in the school setting to safely reopen schools, or keep schools open, or both, during the COVID-19 pandemic. Outcome categories were (i) transmission-related outcomes (e.g. number or proportion of cases); (ii) healthcare utilisation outcomes (e.g. number or proportion of hospitalisations); (iii) other health outcomes (e.g. physical, social and mental health); and (iv) societal, economic and ecological outcomes (e.g. costs, human resources and education). We considered studies that included any population at risk of becoming infected with SARS-CoV-2 and/or developing COVID-19 disease including students, teachers, other school staff, or members of the wider community.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full texts. One review author extracted data and critically appraised each study. One additional review author validated the extracted data. To critically appraise included studies, we used the ROBINS-I tool for quasi-experimental and observational studies, the QUADAS-2 tool for observational screening studies, and a bespoke tool for modelling studies. We synthesised findings narratively. Three review authors made an initial assessment of the certainty of evidence with GRADE, and several review authors discussed and agreed on the ratings.\nMain results\nWe included 38 unique studies in the analysis, comprising 33 modelling studies, three observational studies, one quasi-experimental and one experimental study with modelling components.\nMeasures fell into four broad categories: (i) measures reducing the opportunity for contacts; (ii) measures making contacts safer; (iii) surveillance and response measures; and (iv) multicomponent measures. As comparators, we encountered the operation of schools with no measures in place, less intense measures in place, single versus multicomponent measures in place, or closure of schools.\nAcross all intervention categories and all study designs, very low- to low-certainty evidence ratings limit our confidence in the findings. Concerns with the quality of modelling studies related to potentially inappropriate assumptions about the model structure and input parameters, and an inadequate assessment of model uncertainty. Concerns with risk of bias in observational studies related to deviations from intended interventions or missing data. Across all categories, few studies reported on implementation or described how measures were implemented. Where we describe effects as 'positive', the direction of the point estimate of the effect favours the intervention(s); 'negative' effects do not favour the intervention.\nWe found 23 modelling studies assessing measures reducing the opportunity for contacts (i.e. alternating attendance, reduced class size). Most of these studies assessed transmission and healthcare utilisation outcomes, and all of these studies showed a reduction in transmission (e.g. a reduction in the number or proportion of cases, reproduction number) and healthcare utilisation (i.e. fewer hospitalisations) and mixed or negative effects on societal, economic and ecological outcomes (i.e. fewer number of days spent in school).\nWe identified 11 modelling studies and two observational studies assessing measures making contacts safer (i.e. mask wearing, cleaning, handwashing, ventilation). Five studies assessed the impact of combined measures to make contacts safer. They assessed transmission-related, healthcare utilisation, other health, and societal, economic and ecological outcomes. Most of these studies showed a reduction in transmission, and a reduction in hospitalisations; however, studies showed mixed or negative effects on societal, economic and ecological outcomes (i.e. fewer number of days spent in school).\nWe identified 13 modelling studies and one observational study assessing surveillance and response measures , including testing and isolation, and symptomatic screening and isolation. Twelve studies focused on mass testing and isolation measures, while two looked specifically at symptom-based screening and isolation. Outcomes included transmission, healthcare utilisation, other health, and societal, economic and ecological outcomes. Most of these studies showed effects in favour of the intervention in terms of reductions in transmission and hospitalisations, however some showed mixed or negative effects on societal, economic and ecological outcomes (e.g. fewer number of days spent in school).\nWe found three studies that reported outcomes relating to multicomponent measures , where it was not possible to disaggregate the effects of each individual intervention, including one modelling, one observational and one quasi-experimental study. These studies employed interventions, such as physical distancing, modification of school activities, testing, and exemption of high-risk students, using measures such as hand hygiene and mask wearing. Most of these studies showed a reduction in transmission, however some showed mixed or no effects.\nAs the majority of studies included in the review were modelling studies, there was a lack of empirical, real-world data, which meant that there were very little data on the actual implementation of interventions.\nAuthors' conclusions\nOur review suggests that a broad range of measures implemented in the school setting can have positive impacts on the transmission of SARS-CoV-2, and on healthcare utilisation outcomes related to COVID-19. The certainty of the evidence for most intervention-outcome combinations is very low, and the true effects of these measures are likely to be substantially different from those reported here. Measures implemented in the school setting may limit the number or proportion of cases and deaths, and may delay the progression of the pandemic. However, they may also lead to negative unintended consequences, such as fewer days spent in school (beyond those intended by the intervention). Further, most studies assessed the effects of a combination of interventions, which could not be disentangled to estimate their specific effects. Studies assessing measures to reduce contacts and to make contacts safer consistently predicted positive effects on transmission and healthcare utilisation, but may reduce the number of days students spent at school. Studies assessing surveillance and response measures predicted reductions in hospitalisations and school days missed due to infection or quarantine, however, there was mixed evidence on resources needed for surveillance. Evidence on multicomponent measures was mixed, mostly due to comparators. The magnitude of effects depends on multiple factors. New studies published since the original search date might heavily influence the overall conclusions and interpretation of findings for this review.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 38 relevant studies. Most of these were modelling studies (33 studies). Five studies used real-world data. Twenty studies were conducted in North or South America, 16 in Europe and two in China.\nBelow we summarise the main findings by category."
}
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query-laysum | 4002 | [
{
"role": "user",
"content": "Abstract: Background\nDiarrhoea is a major contributor to the global disease burden, particularly amongst children under five years in low- and middle-income countries (LMICs). As many of the infectious agents associated with diarrhoea are transmitted through faeces, sanitation interventions to safely contain and manage human faeces have the potential to reduce exposure and diarrhoeal disease.\nObjectives\nTo assess the effectiveness of sanitation interventions for preventing diarrhoeal disease, alone or in combination with other WASH interventions.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, and Chinese language databases available under the China National Knowledge Infrastructure (CNKI-CAJ). We also searched the metaRegister of Controlled Trials (mRCT) and conference proceedings, contacted researchers, and searched references of included studies. The last search date was 16 February 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs, non-randomized controlled trials (NRCTs), controlled before-and-after studies (CBAs), and matched cohort studies of interventions aimed at introducing or expanding the coverage and/or use of sanitation facilities in children and adults in any country or population. Our primary outcome of interest was diarrhoea and secondary outcomes included dysentery (bloody diarrhoea), persistent diarrhoea, hospital or clinical visits for diarrhoea, mortality, and adverse events. We included sanitation interventions whether they were conducted independently or in combination with other interventions.\nData collection and analysis\nTwo review authors independently assessed eligible studies, extracted relevant data, assessed risk of bias, and assessed the certainty of evidence using the GRADE approach. We used meta-analyses to estimate pooled measures of effect, described results narratively, and investigated potential sources of heterogeneity using subgroup analyses.\nMain results\nFifty-one studies met our inclusion criteria, with a total of 238,535 participants. Of these, 50 studies had sufficient information to be included in quantitative meta-analysis, including 17 cluster-RCTs and 33 studies with non-randomized study designs (20 NRCTs, one CBA, and 12 matched cohort studies). Most were conducted in LMICs and 86% were conducted in whole or part in rural areas. Studies covered three broad types of interventions: (1) providing access to any sanitation facility to participants without existing access practising open defecation, (2) improving participants' existing sanitation facility, or (3) behaviour change messaging to improve sanitation access or practices without providing hardware or subsidy, although many studies overlapped multiple categories. There was substantial heterogeneity amongst individual study results for all types of interventions.\nProviding access to any sanitation facility\nProviding access to sanitation facilities was evaluated in seven cluster-RCTs, and may reduce diarrhoea prevalence in all age groups (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.73 to 1.08; 7 trials, 40,129 participants, low-certainty evidence). In children under five years, access may have little or no effect on diarrhoea prevalence (RR 0.98, 95% CI 0.83 to 1.16, 4 trials, 16,215 participants, low-certainty evidence). Additional analysis in non-randomized studies was generally consistent with these findings. Pooled estimates across randomized and non-randomized studies provided similar protective estimates (all ages: RR 0.79, 95% CI 0.66 to 0.94; 15 studies, 73,511 participants; children < 5 years: RR 0.83, 95% CI 0.68 to 1.02; 11 studies, 25,614 participants).\nSanitation facility improvement\nInterventions designed to improve existing sanitation facilities were evaluated in three cluster-RCTs in children under five and may reduce diarrhoea prevalence (RR 0.85, 95% CI 0.69 to 1.06; 3 trials, 14,900 participants, low-certainty evidence). However, some of these interventions, such as sewerage connection, are not easily randomized. Non-randomized studies across participants of all ages provided estimates that improving sanitation facilities may reduce diarrhoea, but may be subject to confounding (RR 0.61, 95% CI 0.50 to 0.74; 23 studies, 117,639 participants, low-certainty evidence). Pooled estimates across randomized and non-randomized studies provided similar protective estimates (all ages: RR 0.65, 95% CI 0.55 to 0.78; 26 studies, 132,539 participants; children < 5 years: RR 0.70, 95% CI 0.54 to 0.91, 12 studies, 23,353 participants).\nBehaviour change messaging only (no hardware or subsidy provided)\nStrategies to promote behaviour change to construct, upgrade, or use sanitation facilities were evaluated in seven cluster-RCTs in children under five, and probably reduce diarrhoea prevalence (RR 0.82, 95% CI 0.69 to 0.98; 7 studies, 28,909 participants, moderate-certainty evidence). Additional analysis from two non-randomized studies found no effect, though with very high uncertainty. Pooled estimates across randomized and non-randomized studies provided similar protective estimates (RR 0.85, 95% CI 0.73 to 1.01; 9 studies, 31,080 participants). No studies measured the effects of this type of intervention in older populations.\nAny sanitation intervention\nA pooled analysis of cluster-RCTs across all sanitation interventions demonstrated that the interventions may reduce diarrhoea prevalence in all ages (RR 0.85, 95% CI 0.76 to 0.95, 17 trials, 83,938 participants, low-certainty evidence) and children under five (RR 0.87, 95% CI 0.77 to 0.97; 14 trials, 60,024 participants, low-certainty evidence). Non-randomized comparisons also demonstrated a protective effect, but may be subject to confounding. Pooled estimates across randomized and non-randomized studies provided similar protective estimates (all ages: RR 0.74, 95% CI 0.67 to 0.82; 50 studies, 237,130 participants; children < 5 years: RR 0.80, 95% CI 0.71 to 0.89; 32 studies, 80,047 participants). In subgroup analysis, there was some evidence of larger effects in studies with increased coverage amongst all participants (75% or higher coverage levels) and also some evidence that the effect decreased over longer follow-up times for children under five years.\nThere was limited evidence on other outcomes. However, there was some evidence that any sanitation intervention was protective against dysentery (RR 0.74, 95% CI 0.54 to 1.00; 5 studies, 34,025 participants) and persistent diarrhoea (RR 0.57, 95% CI 0.43 to 0.75; 2 studies, 2665 participants), but not against clinic visits for diarrhoea (RR 0.86, 95% CI 0.44 to 1.67; 2 studies, 3720 participants) or all-cause mortality (RR 0.99, 95% CI 0.89 to1.09; 7 studies, 46,123 participants).\nAuthors' conclusions\nThere is evidence that sanitation interventions are effective at preventing diarrhoea, both for young children and all age populations. The actual level of effectiveness, however, varies by type of intervention and setting. There is a need for research to better understand the factors that influence effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diarrhoea is a major cause of death and disease, especially amongst young children in low-income countries. Many of the pathogens that cause diarrhoea are transmitted through exposure to human faeces. Sanitation facilities, such as toilets and latrines, serve as a primary barrier to separate pathogens excreted in human faeces from the environment. This review examined intervention studies to improve sanitation access, facilities, or use. We identified 51 studies of such interventions, most of which were from low- or middle-income countries."
}
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query-laysum | 4003 | [
{
"role": "user",
"content": "Abstract: Background\nMany survivors of stroke report attentional impairments, such as diminished concentration and distractibility. However, the effectiveness of cognitive rehabilitation for improving these impairments is uncertain.This is an update of the Cochrane Review first published in 2000 and previously updated in 2013.\nObjectives\nTo determine whether people receiving cognitive rehabilitation for attention problems 1. show better outcomes in their attentional functions than those given no treatment or treatment as usual, and 2. have a better functional recovery, in terms of independence in activities of daily living, mood, and quality of life, than those given no treatment or treatment as usual.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PsycBITE, REHABDATA and ongoing trials registers up to February 2019. We screened reference lists and tracked citations using Scopus.\nSelection criteria\nWe included controlled clinical trials (CCTs) and randomised controlled trials (RCTs) of cognitive rehabilitation for impairments of attention for people with stroke. We did not consider listening to music, meditation, yoga, or mindfulness to be a form of cognitive rehabilitation. We only considered trials that selected people with demonstrable or self-reported attentional deficits. The primary outcomes were measures of global attentional functions, and secondary outcomes were measures of attentional domains (i.e. alertness, selective attention, sustained attention, divided attention), functional abilities, mood, and quality of life.\nData collection and analysis\nTwo review authors independently selected trials, extracted data, and assessed the risk of bias. We used the GRADE approach to assess the certainty of evidence for each outcome.\nMain results\nWe included no new trials in this update. The results are unchanged from the previous review and are based on the data of six RCTs with 223 participants. All six RCTs compared cognitive rehabilitation with a usual care control.\nMeta-analyses demonstrated no convincing effect of cognitive rehabilitation on subjective measures of attention either immediately after treatment (standardised mean difference (SMD) 0.53, 95% confidence interval (CI) –0.03 to 1.08; P = 0.06; 2 studies, 53 participants; very low-quality evidence) or at follow-up (SMD 0.16, 95% CI –0.23 to 0.56; P = 0.41; 2 studies, 99 participants; very low-quality evidence).\nPeople receiving cognitive rehabilitation (when compared with control) showed that measures of divided attention recorded immediately after treatment may improve (SMD 0.67, 95% CI 0.35 to 0.98; P < 0.0001; 4 studies, 165 participants; low-quality evidence), but it is uncertain that these effects persisted (SMD 0.36, 95% CI –0.04 to 0.76; P = 0.08; 2 studies, 99 participants; very low-quality evidence). There was no evidence for immediate or persistent effects of cognitive rehabilitation on alertness, selective attention, and sustained attention.\nThere was no convincing evidence for immediate or long-term effects of cognitive rehabilitation for attentional problems on functional abilities, mood, and quality of life after stroke.\nAuthors' conclusions\nThe effectiveness of cognitive rehabilitation for attention deficits following stroke remains unconfirmed. The results suggest there may be an immediate effect after treatment on attentional abilities, but future studies need to assess what helps this effect persist and generalise to attentional skills in daily life. Trials also need to have higher methodological quality and better reporting.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no evidence that cognitive rehabilitation improved general (global) measures of attention. The group that received cognitive rehabilitation performed better than the control group on tasks that required people to divide attention. However, this benefit was only seen immediately after the rehabilitation period with no suggestion that the benefits persist for longer. There was no evidence to suggest that cognitive rehabilitation was beneficial for other types of attention problems, or daily life activities, mood, or quality of life. More research is needed."
}
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query-laysum | 4004 | [
{
"role": "user",
"content": "Abstract: Background\nTrabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intraocular pressure. The surgery involves creating a channel through the sclera, through which intraocular fluid can leave the eye. If scar tissue blocks the exit of the surgically created channel, intraocular pressure rises and the operation fails. Antimetabolites such as 5-Fluorouracil (5-FU) are used to inhibit wound healing to prevent the conjunctiva scarring down on to the sclera. This is an update of a Cochrane review first published in 2000, and previously updated in 2009.\nObjectives\nTo assess the effects of both intraoperative application and postoperative injections of 5-FU in eyes of people undergoing surgery for glaucoma at one year.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2013), EMBASE (January 1980 to July 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the 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 25 July 2013. We also searched the reference lists of relevant articles and the Science Citation Index and contacted investigators and experts for details of additional relevant trials.\nSelection criteria\nWe included randomised trials of intraoperative application and postoperative 5-FU injections compared with placebo or no treatment in trabeculectomy for glaucoma.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data. We used standard methodological procedures expected by The Cochrane Collaboration. We contacted trial investigators for missing information. Data were summarised using risk ratio (RR), Peto odds ratio and mean difference, as appropriate.\nThe participants were divided into three separate subgroup populations (high risk of failure, combined surgery and primary trabeculectomy) and the interventions were divided into three subgroups of 5-FU injections (intraoperative, regular dose postoperative and low dose postoperative). The low dose was defined as a total dose less than 19 mg.\nMain results\nTwelve trials, which randomised 1319 participants, were included in the review. As far as can be determined from the trial reports, the methodological quality of the trials was not high, including a high risk of detection bias in many. Of note, only one study reported low-dose postoperative 5-FU and this paper was at high risk of reporting bias.\nNot all studies reported population characteristics, of those that did mean age ranged from 61 to 75 years. 83% of participants were white and 40% were male. All studies were a minimum of one year long.\nA significant reduction in surgical failure in the first year after trabeculectomy was detected in eyes at high risk of failure and those undergoing surgery for the first time receiving regular-dose 5-FU postoperative injections (RR 0.44, 95% confidence interval (CI) 0.29 to 0.68 and 0.21, 0.06 to 0.68, respectively). No surgical failures were detected in studies assessing combined surgery. No difference was detected in the low-dose postoperative 5-FU injection group in patients undergoing primary trabeculectomy (RR 0.93, 95% CI 0.70 to 1.24). Peroperative 5-FU in patients undergoing primary trabeculectomy significantly reduced risk of failure (RR 0.67, 95% CI 0.51 to 0.88). This translates to a number needed to treat for an additional beneficial outcome of 4.1 for the high risk of failure patients, and 5.0 for primary trabeculectomy patients receiving postoperative 5-FU.\nIntraocular pressure was also reduced in the primary trabeculectomy group receiving intraoperative 5-FU (mean difference (MD) -1.04, 95% CI -1.65 to -0.43) and regular-dose postoperative 5-FU (MD -4.67, 95% CI -6.60 to -2.73). No significant change occurred in the primary trabeculectomy group receiving low-dose postoperative 5-FU (MD -0.50, 95% CI -2.96 to 1.96). Intraocular pressure was particularly reduced in the high risk of failure population receiving regular-dose postoperative 5-FU (MD -16.30, 95% CI -18.63 to -13.97). No difference was detected in the combined surgery population receiving regular-dose postoperative 5-FU (MD -1.02, 95% CI -2.40 to 0.37).\nWhilst no evidence was found of an increased risk of serious sight-threatening complications, other complications are more common after 5-FU injections. None of the trials reported on the participants' perspective of care.\nThe quality of evidence varied between subgroups and outcomes, most notably the evidence for combined surgery and low-dose postoperative 5-FU was found to be very low using GRADE. The combined surgery postoperative 5-FU subgroup because no surgical failures have been reported and the sample size is small (n = 118), and the low-dose postoperative 5-FU group because of the small sample size (n = 76) and high risk of bias of the only contributing study.\nAuthors' conclusions\nPostoperative injections of 5-FU are now rarely used as part of routine packages of postoperative care but are increasingly used on an ad hoc basis. This presumably reflects an aspect of the treatment that is unacceptable to both patients and doctors. None of the trials reported on the participants' perspective of care, which constitutes a serious omission for an invasive treatment such as this.\nThe small but statistically significant reduction in surgical failures and intraocular pressure at one year in the primary trabeculectomy group and high-risk group must be weighed against the increased risk of complications and patient preference.\n\nGiven the provided abstract, please respond to the following query: \"5-FU injections after glaucoma surgery\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "For patients who have never had eye surgery before, 5-FU injections after surgery can slightly reduce the pressure in the eye after one year and also the risk of having more surgery in the first year.\nFor patients having both cataract surgery and glaucoma surgery at the same time, no difference has been detected between injections and no injections.\nSome people are at higher risk of having problems following trabeculectomy, for instance people that have had previous surgery on the eye. For this group, the 5-FU injections can reduce the pressure in the eye a little and also reduce the risk of having more surgery in the first year."
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query-laysum | 4005 | [
{
"role": "user",
"content": "Abstract: Background\nHaloperidol used alone is recommended to help calm situations of aggression or agitation for people with psychosis. It is widely accessible and may be the only antipsychotic medication available in limited-resource areas.\nObjectives\nTo examine whether haloperidol alone is an effective treatment for psychosis-induced aggression or agitation, wherein clinicians are required to intervene to prevent harm to self and others.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (26th May 2016). This register is compiled by systematic searches of major resources (including AMED, BIOSIS CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings, with no language, date, document type, or publication status limitations for inclusion of records into the register.\nSelection criteria\nRandomised controlled trials (RCTs) involving people exhibiting aggression and/or agitation thought to be due to psychosis, allocated rapid use of haloperidol alone (by any route), compared with any other treatment. Outcomes of interest included tranquillisation or asleep by 30 minutes, repeated need for rapid tranquillisation within 24 hours, specific behaviours (threat or injury to others/self), adverse effects. We included trials meeting our selection criteria and providing useable data.\nData collection and analysis\nWe independently inspected all citations from searches, identified relevant abstracts, and independently extracted data from all included studies. For binary data we calculated risk ratio (RR), for continuous data we calculated mean difference (MD), and for cognitive outcomes we derived standardised mean difference (SMD) effect sizes, all with 95% confidence intervals (CI) and using a fixed-effect model. We assessed risk of bias for the included studies and used the GRADE approach to produce 'Summary of findings' tables which included our pre-specified main outcomes of interest.\nMain results\nWe found nine new RCTs from the 2016 update search, giving a total of 41 included studies and 24 comparisons. Few studies were undertaken in circumstances that reflect real-world practice, and, with notable exceptions, most were small and carried considerable risk of bias. Due to the large number of comparisons, we can only present a summary of main results.\nCompared with placebo, more people in the haloperidol group were asleep at two hours (2 RCTs, n=220, RR 0.88, 95%CI 0.82 to 0.95, very low-quality evidence) and experienced dystonia (2 RCTs, n=207, RR 7.49, 95%CI 0.93 to 60.21, very low-quality evidence).\nCompared with aripiprazole, people in the haloperidol group required fewer injections than those in the aripiprazole group (2 RCTs, n=473, RR 0.78, 95%CI 0.62 to 0.99, low-quality evidence). More people in the haloperidol group experienced dystonia (2 RCTs, n=477, RR 6.63, 95%CI 1.52 to 28.86, very low-quality evidence).\nFour trials (n=207) compared haloperidol with lorazepam with no significant differences with regard to number of participants asleep at one hour (1 RCT, n=60, RR 1.05, 95%CI 0.76 to 1.44, very low-quality of evidence) or those requiring additional injections (1 RCT, n=66, RR 1.14, 95%CI 0.91 to 1.43, very low-quality of evidence).\nHaloperidol's adverse effects were not offset by addition of lorazepam (e.g. dystonia 1 RCT, n=67, RR 8.25, 95%CI 0.46 to 147.45, very low-quality of evidence).\nAddition of promethazine was investigated in two trials (n=376). More people in the haloperidol group were not tranquil or asleep by 20 minutes (1 RCT, n=316, RR 1.60, 95%CI 1.18 to 2.16, moderate-quality evidence). Acute dystonia was too common in the haloperidol alone group for the trial to continue beyond the interim analysis (1 RCT, n=316, RR 19.48, 95%CI 1.14 to 331.92, low-quality evidence).\nAuthors' conclusions\nAdditional data from new studies does not alter previous conclusions of this review. If no other alternative exists, sole use of intramuscular haloperidol could be life-saving. Where additional drugs are available, sole use of haloperidol for extreme emergency could be considered unethical. Addition of the sedating promethazine has support from better-grade evidence from within randomised trials. Use of an alternative antipsychotic drug is only partially supported by fragmented and poor-grade evidence. Adding a benzodiazepine to haloperidol does not have strong evidence of benefit and carries risk of additional harm.\nAfter six decades of use for emergency rapid tranquillisation, this is still an area in need of good independent trials relevant to real-world practice.\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": "The review authors conclude there is weak evidence that haloperidol calms people down and helps manage difficult situations. However, this is not based on good-quality trails and therefore health professionals and people with mental health problems are left without clear evidence-based guidance. In some situations, haloperidol may be the only choice, but this is far from ideal because although haloperidol is effective at calming people down it has side effects (e.g. restlessness, shaking of the head, hands and body, heart problems). These side effects can be just as distressing as psychosis and may act as a barrier that stops people coming back for future treatment. More research is needed to help people consider and understand which medication is better at calming people down; has fewer side effects; works quickly and rapidly; and can be used at lower dosages (or less frequent injections).\nThis plain language summary is based on a summary written by a consumer Ben Gray from Rethink."
}
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query-laysum | 4006 | [
{
"role": "user",
"content": "Abstract: Background\nThere is increasing focus on providing high quality care for people at the end of life, irrespective of disease or cause, and in all settings. In the last ten years the use of care pathways to aid those treating patients at the end of life has become common worldwide. The use of the Liverpool Care Pathway (LCP) in the UK has been criticised. In England the LCP was the subject of an independent review, commissioned by a Health Minister. The resulting Neuberger Review acknowledged that the LCP was based on the sound ethical principles that provide the basis of good quality care for patients and families when implemented properly. It also found that the LCP often was not implemented properly, and had instead become a barrier to good care; it made over 40 recommendations, including education and training, research and development, access to specialist palliative care services, and the need to ensure care and compassion for all dying patients. In July 2013, the Department of Health released a statement that stated the use of the LCP should be \"phased out over the next 6-12 months and replaced with an individual approach to end of life care for each patient\".\nThe impact of opioids was a particular concern because of their potential influence on consciousness, appetite and thirst in people near the end of life. There was concern that impaired patient consciousness may lead to an earlier death, and that effects of opioids on appetite and thirst may result in unnecessary suffering. This rapid review, commissioned by the National Institute for Health Research, used standard Cochrane methodology to examine adverse effects of morphine, fentanyl, oxycodone, and codeine in cancer pain studies as a close approximation to possible effects in the dying patient.\nObjectives\nTo determine the impact of opioid treatment on patient consciousness, appetite and thirst in randomised controlled trials of morphine, fentanyl, oxycodone or codeine for treating cancer pain.\nSearch methods\nWe assessed adverse event data reported in studies included in current Cochrane reviews of opioids for cancer pain: specifically morphine, fentanyl, oxycodone, and codeine.\nSelection criteria\nWe included randomised studies using multiple doses of four opioid drugs (morphine, fentanyl, oxycodone, and codeine) in cancer pain. These were taken from four existing or ongoing Cochrane reviews. Participants were adults aged 18 and over. We included only full journal publication articles.\nData collection and analysis\nTwo review authors independently extracted adverse event data, and examined issues of study quality. The primary outcomes sought were numbers of participants experiencing adverse events of reduced consciousness, appetite, and thirst. Secondary outcomes were possible surrogate measures of the primary outcomes: delirium, dizziness, hallucinations, mood change and somnolence relating to patient consciousness, and nausea, vomiting, constipation, diarrhoea, dyspepsia, dysphagia, anorexia, asthenia, dehydration, or dry mouth relating to appetite or thirst.\nComparative measures of harm were known to be unlikely, and we therefore calculated the proportion of participants experiencing each of the adverse events of interest with each opioid, and for all four opioid drugs combined.\nMain results\nWe included 77 studies with 5619 randomised participants. There was potential bias in most studies, with small size being the most common; individual treatment groups had fewer than 50 participants in 60 studies. Participants were relatively young, with mean age in the studies typically between 50 and 70 years. Multiple major problems with adverse event reporting were found, including failing to report adverse events in all participants who received medication, all adverse events experienced, how adverse events were collected, and not defining adverse event terminology or whether a reporting system was used.\nDirect measures of patient consciousness, patient appetite, or thirst were not apparent. For opioids used to treat cancer pain adverse event incidence rates were 25% for constipation, 23% for somnolence, 21% for nausea, 17% for dry mouth, and 13% for vomiting, anorexia, and dizziness. Asthenia, diarrhoea, insomnia, mood change, hallucinations and dehydration occurred at incidence rates of 5% and below.\nAuthors' conclusions\nWe found no direct evidence that opioids affected patient consciousness, appetite or thirst when used to treat cancer pain. However, somnolence, dry mouth, and anorexia were common adverse events in people with cancer pain treated with morphine, fentanyl, oxycodone, or codeine.\nWe are aware that there is an important literature concerning the problems that exist with adverse event measurement, reporting, and attribution. Together with the known complications concerning concomitant medication, data collection and reporting, and nomenclature, this means that these adverse events cannot always be attributed unequivocally to the use of opioids, and so they provide only a broad picture of adverse events with opioids in cancer pain. The research agenda includes developing definitions for adverse events that have a spectrum of severity or importance, and the development of appropriate measurement tools for recording such events to aid clinical practice and clinical research.\n\nGiven the provided abstract, please respond to the following query: \"Description of the problem\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Care pathways are packages of care designed to ensure that patients have appropriate and effective care in particular situations. Such pathways are commonly used, and often produce good results, but they can also be used as a tick box solution that acts as a barrier to good care. Care pathways have been used to ensure appropriate care for people who are dying in hospice settings.\nThe Liverpool Care Pathway was devised for use in hospices, and has been used in general hospital settings to care for dying patients. Its use has been criticised. A government review of the use of end-of-life care pathways in the NHS in the UK recommended they should not be used because they were being misused.\nA concern, mainly raised by relatives, was that opioids were over-prescribed, used to hasten death, to reduce consciousness, and diminish the patient's desire or ability to accept food or drink."
}
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query-laysum | 4007 | [
{
"role": "user",
"content": "Abstract: Background\nAsymptomatic bacteriuria is a bacterial infection of the urine without any of the typical symptoms that are associated with a urinary infection, and occurs in 2% to 15% of pregnancies. If left untreated, up to 30% of mothers will develop acute pyelonephritis. Asymptomatic bacteriuria has been associated with low birthweight and preterm birth. This is an update of a review last published in 2015.\nObjectives\nTo assess the effect of antibiotic treatment for asymptomatic bacteriuria on the development of pyelonephritis and the risk of low birthweight and preterm birth.\nSearch methods\nFor this update, we searched the Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) on 4 November 2018, and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCT) comparing antibiotic treatment with placebo or no treatment in pregnant women with asymptomatic bacteriuria found on antenatal screening. Trials using a cluster-RCT design and quasi-RCTs were eligible for inclusion, as were trials published in abstract or letter form, but cross-over studies were not.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included 15 studies, involving over 2000 women. Antibiotic treatment compared with placebo or no treatment may reduce the incidence of pyelonephritis (average risk ratio (RR) 0.24, 95% confidence interval (CI) 0.13 to 0.41; 12 studies, 2017 women; low-certainty evidence). Antibiotic treatment may be associated with a reduction in the incidence of preterm birth (RR 0.34, 95% CI 0.13 to 0.88; 3 studies, 327 women; low-certainty evidence), and low birthweight babies (average RR 0.64, 95% CI 0.45 to 0.93; 6 studies, 1437 babies; low-certainty evidence). There may be a reduction in persistent bacteriuria at the time of delivery (average RR 0.30, 95% CI 0.18 to 0.53; 4 studies; 596 women), but the results were inconclusive for serious adverse neonatal outcomes (average RR 0.64, 95% CI 0.23 to 1.79, 3 studies; 549 babies). There were very limited data on which to estimate the effect of antibiotics on other infant outcomes, and maternal adverse effects were rarely described.\nOverall, we judged only one trial at low risk of bias across all domains; the other 14 studies were assessed as high or unclear risk of bias. Many studies lacked an adequate description of methods, and we could only judge the risk of bias as unclear, but in most studies, we assessed at least one domain at high risk of bias. We assessed the quality of the evidence for the three primary outcomes with GRADE software, and found low-certainty evidence for pyelonephritis, preterm birth, and birthweight less than 2500 g.\nAuthors' conclusions\nAntibiotic treatment may be effective in reducing the risk of pyelonephritis in pregnancy, but our confidence in the effect estimate is limited given the low certainty of the evidence. There may be a reduction in preterm birth and low birthweight with antibiotic treatment, consistent with theories about the role of infection in adverse pregnancy outcomes, but again, the confidence in the effect is limited given the low certainty of the evidence.\nResearch implications identified in this review include the need for an up-to-date cost-effectiveness evaluation of diagnostic algorithms, and more evidence to learn whether there is a low-risk group of women who are unlikely to benefit from treatment of asymptomatic bacteriuria.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Antibiotic treatment may reduce the risk of kidney infections in pregnant women who have a urine infection but show no symptoms of infection. Antibiotics may also reduce the chance a baby will be born too early or have a low birthweight. However, because of the low certainty of the evidence, it is difficult to draw conclusions; more research is needed."
}
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query-laysum | 4008 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.\nChronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Topical (intranasal) corticosteroids are used with the aim of reducing inflammation in the sinonasal mucosa in order to improve patient symptoms.\nObjectives\nTo assess the effects of different types of intranasal steroids in people with chronic rhinosinusitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.\nSelection criteria\nRandomised controlled trials (RCTs) with a follow-up period of at least three months comparing first-generation intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) with second-generation intranasal corticosteroids (e.g. ciclesonide, fluticasone furoate, fluticasone propionate, mometasone furoate, betamethasone sodium phosphate), or sprays versus drops, or low-dose versus high-dose intranasal corticosteroids.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis (nosebleed). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse event of local irritation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included nine RCTs (911 participants), including four different comparisons. None of the studies evaluated our first primary outcome measure, disease-specific HRQL.\nFluticasone propionate versus beclomethasone dipropionate\nWe identified two small studies (56 participants with polyps) that evaluated disease severity and looked at the primary adverse effect: epistaxis , but no other outcomes. We cannot report any numerical data but the study authors reported no difference between the two steroids. The evidence was of very low quality.\nFluticasone propionate versus mometasone furoate\nWe identified only one study (100 participants with polyps) that evaluated disease severity (nasal symptoms scores), which reported no difference (no numerical data available). The evidence was of very low quality.\nHigh-dose versus low-dose steroids\nWe included five studies (663 participants with nasal polyps), three using mometasone furoate (400 µg versus 200 µg in adults and older children, 200 µg versus 100 µg in younger children) and two using fluticasone propionate drops (800 µg versus 400 µg). We found low quality evidence relating to disease severity and nasal polyps size, with results from the high-dose and low-dose groups being similar. Although all studies reported more improvement in polyp score in the high-dose group, the significance of this is unclear due to the small size of the improvements.\nThe primary adverse effect, epistaxis , was more common when higher doses were used (risk ratio (RR) 2.06, 95% confidence interval (CI) 1.20 to 3.54, 637 participants, moderate quality evidence). Most of the studies that contributed data to this outcome used a broad definition of epistaxis, which ranged from frank bleeding to bloody nasal discharge to flecks of blood in the mucus.\nAqueous nasal spray versus aerosol spray\nWe identified only one poorly reported study (unclear number of participants for comparison of interest, 91 between three treatment arms), in which there were significant baseline differences between the participants in the two groups. We were unable to draw meaningful conclusions from the data.\nAuthors' conclusions\nWe found insufficient evidence to suggest that one type of intranasal steroid is more effective than another in patients with chronic rhinosinusitis, nor that the effectiveness of a spray differs from an aerosol. We identified no studies that compared drops with spray.\nIt is unclear if higher doses result in better symptom improvements (low quality evidence), but there was moderate quality evidence of an increased risk of epistaxis as an adverse effect of treatment when higher doses were used. This included all levels of severity of epistaxis and it is likely that the proportion of events that required patients to discontinue usage is low due to the low numbers of withdrawals attributed to it. If epistaxis is limited to streaks of blood in the mucus it may be tolerated by the patient and it may be safe to continue treatment. However, it may be a factor that affects compliance.\nThere is insufficient evidence to suggest that the different types of corticosteroid molecule or spray versus aerosol have different effects. Lower doses have similar effectiveness but fewer side effects.\nClearly more research in this area is needed, with specific attention given to trial design, disease-specific health-related quality of life outcomes and evaluation of longer-term outcomes and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included nine randomised controlled trials (RCTs) with a total of 910 participants in this review. The studies varied in size: some were small, with as few as 20 patients, while others included over 200 participants. Most studies recruited adult patients, but one study only included children. In the majority of the adult studies, most participants were male (72% to 79%). In all of the studies the participants had chronic rhinosinusitis with nasal polyps. The studies either compared different types of steroids (three studies), high-dose versus low-dose steroids (five studies), twice daily versus once daily steroids, or different delivery methods (aqueous nasal spray versus aerosol - one study). All of the studies had a placebo group."
}
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query-laysum | 4010 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original review that was first published in the Cochrane Database of Systematic Reviews 2008, Issue 4. Laparoscopy has become an increasingly common approach to surgical staging of apparent early-stage ovarian tumours. This review was undertaken to assess the available evidence on the benefits and risks of laparoscopy compared with laparotomy for the management of International Federation of Gynaecology and Obstetrics (FIGO) stage I ovarian cancer.\nObjectives\nTo evaluate the benefits and harms of laparoscopy in the surgical treatment of FIGO stage I ovarian cancer (stages Ia, Ib and Ic) when compared with laparotomy.\nSearch methods\nFor the original review, we searched the Cochrane Gynaecological Cancer Group Trials (CGCRG) Register, Cochrane Central Register of Controlled Trials (CENTRAL 2007, Issue 2), MEDLINE, Embase, LILACS, Biological Abstracts and CancerLit from 1 January 1990 to 30 November 2007. We also handsearched relevant journals, reference lists of identified studies and conference abstracts. For the first updated review, the search was extended to the CGCRG Specialised Register, CENTRAL, MEDLINE, Embase and LILACS to 6 December 2011. For this update we searched CENTRAL, MEDLINE, and Embase from November 2011 to September 2016.\nSelection criteria\nRandomised controlled trials (RCTs), quasi-RCTs and prospective cohort studies comparing laparoscopic staging with open surgery (laparotomy) in women with stage I ovarian cancer according to FIGO.\nData collection and analysis\nThere were no studies to include, therefore we tabulated data from non-randomised studies (NRSs) for discussion as well as important data from other meta-analyses.\nMain results\nWe performed no meta-analyses.\nAuthors' conclusions\nThis review has found no good-quality evidence to help quantify the risks and benefits of laparoscopy for the management of early-stage ovarian cancer as routine clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Stage I ovarian cancer is diagnosed when the tumour is confined to one or both ovaries, without spread to lymph nodes or other parts of the body. Approximately 25% of women with ovarian cancer will be diagnosed at an early stage, thus the diagnosis often occurs due to an accidental finding. The intention of surgical staging is to establish a diagnosis, to assess the extent of the cancer and to remove as much tumour as possible. The latter is particularly important as women with ovarian cancer survive for longer when all visible tumour has been removed."
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query-laysum | 4011 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM), or acute middle ear infection, is one of the most frequently occurring childhood diseases, and the most common reason given for prescribing antibiotics in this age group. Guidelines often recommend antibiotics as first-line treatment for severe AOM. However, antibiotics also lead to antibiotic resistance, so preventing episodes of AOM is an urgent priority.\nObjectives\nTo assess the effects of probiotics to prevent the occurrence and reduce the severity of acute otitis media in children.\nSearch methods\nWe searched CENTRAL, PubMed, Embase, and three other databases (October 2018), two trial registers (October 2018), and conducted a backwards and forwards citation analysis (August 2018). We did not apply any language, publication date, or publication status restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) of children (aged up to 18 years), comparing probiotics with placebo, usual care, or no probiotic.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials for inclusion and risk of bias of the included trials, and extracted data using pre-piloted data extraction forms. We analysed dichotomous data as either risk ratio (RR) or odds ratios (OR) and continuous data as mean differences (MD).\nMain results\nWe included 17 RCTs involving 3488 children, of which 16 RCTs were included in the meta-analyses. Of the 16 RCTs that reported the mean age of children, mean age overall was 2.4 years; in 4 RCTs the mean age of children participating in the trial was less than 1 year old; in 2 RCTs the mean age was between 1 and 2 years old; and in 10 RCTs the mean age was older than 2 years. Probiotic strains evaluated by the trials varied, with 11 of the included RCTs evaluating Lactobacillus-containing probiotics, and six RCTs evaluating Streptococcus-containing probiotics.\nThe proportion of children (i.e. the number of children in each group) experiencing one or more episodes of AOM during the treatment was lower for those taking probiotics (RR 0.77, 95% confidence interval (CI) 0.63 to 0.93; 16 trials; 2961 participants; number needed to treat for an additional beneficial outcome (NNTB) = 10; moderate-certainty evidence).\nPost hoc subgroup analysis found that among children not prone to otitis media, a lower proportion of children receiving probiotics experienced AOM (RR 0.64, 95% CI 0.49 to 0.84; 11 trials; 2227 participants; NNTB = 9; moderate-certainty evidence). However, among children who were otitis prone, there was no difference between probiotic and comparator groups (RR 0.97, 95% CI 0.85 to 1.11; 5 trials; 734 participants; high-certainty evidence). The test for subgroup differences was significant (P = 0.007).\nNone of the included trials reported on the severity of AOM.\nThe proportion of children experiencing adverse events did not differ between the probiotic and comparator groups (OR 1.54, 95% CI 0.60 to 3.94; 4 trials; 395 participants; low-certainty evidence).\nProbiotics decreased the proportion of children taking antibiotics for any infection (RR 0.66, 95% CI 0.51 to 0.86; 8 trials; 1768 participants; NNTB = 8; moderate-certainty evidence). Test for subgroup differences (use of antibiotic specifically for AOM, use of antibiotic for infections other than AOM) was not significant.\nThere was no difference in the mean number of school days lost (MD −0.95, 95% CI −2.47 to 0.57; 5 trials; 1280 participants; moderate-certainty evidence). There was no difference between groups in the level of compliance in taking the intervention (RR 1.02, 95% CI 0.99 to 1.05; 5 trials; 990 participants).\nProbiotics decreased the proportion of children having other infections (RR 0.75, 95% CI 0.65 to 0.87; 11 trials; 3610 participants; NNTB = 12; moderate-certainty evidence). Test for subgroup differences (acute respiratory infections, gastrointestinal infections) was not significant.\nProbiotic strains trialled and their dose, frequency, and duration of administration varied considerably across studies, which likely contributed to the substantial levels of heterogeneity. Sensitivity testing of funnel plots did not reveal publication bias.\nAuthors' conclusions\nProbiotics may prevent AOM in children not prone to AOM, but the inconsistency of the subgroup analyses suggests caution in interpreting these results. Probiotics decreased the proportion of children taking antibiotics for any infection. The proportion of children experiencing adverse events did not differ between the probiotic and comparator groups. The optimal strain, duration, frequency, and timing of probiotic administration still needs to be established.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute middle ear infection is very common in childhood. It is caused by bacteria that travel from the upper part of the throat, through canals (called Eustachian tubes), to the middle ear. Symptoms include fever, earache, and occasionally the eardrum may perforate, discharging pus into the ear canal.\nAntibiotics are often prescribed for acute middle ear infection, although they have only a modest effect on reducing symptoms. Moreover, excessive antibiotic use leads to antibiotic resistance, making them less effective for these and other infections. Consequently, preventing acute middle ear infection is highly desirable.\nProbiotics are often sold as tablets or powders, as a food ingredient (e.g. in yogurt), and even sprayed directly into the throat. However, it is not yet clear whether they prevent acute middle ear infection. We analysed the scientific evidence to answer this question."
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query-laysum | 4012 | [
{
"role": "user",
"content": "Abstract: Background\nAllogeneic haematopoietic stem cell transplantation (SCT) is an established treatment for many malignant and non-malignant haematological disorders. Graft-versus-host disease (GVHD), a condition frequently occurring after an allogeneic SCT, is the result of host tissues being attacked by donor immune cells. It affects more than half of the patients after transplant either as acute and or chronic GVHD. One strategy for the prevention of GVHD is the administration of anti-thymocyte globulins (ATGs), a set of polyclonal antibodies directed against a variety of immune cell epitopes, leading to immunosuppression and immunomodulation.\nObjectives\nTo assess the effect of ATG used for the prevention of GVHD in patients undergoing allogeneic SCT with regard to overall survival, incidence and severity of acute and chronic GVHD, incidence of relapse, non-relapse mortality, graft failure and adverse events.\nSearch methods\nFor this update we searched the CENTRAL, MEDLINE, Embase, trial registers and conference proceedings on the 18th November 2022 along with reference checking and contacting study authors to identify additional studies.\nWe did not apply language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating the impact of ATG on GVHD prophylaxis in adults suffering from haematological diseases and undergoing allogeneic SCT. The selection criteria were modified from the previous version of this review. Paediatric studies and studies where patients aged < 18 years constituted more than 20 % of the total number were excluded. Treatment arms had to differ only in the addition of ATG to the standard GVHD prophylaxis regimen.\nData collection and analysis\nWe used standard methodological procedures expected by the Cochrane Collaboration for data collection, extraction and analyses.\nMain results\nFor this update we included seven new RCTs, leading to a total of ten studies investigating 1413 participants. All patients had a haematological condition which warranted an allogeneic SCT. The risk of bias was estimated as low for seven and unclear for three studies.\nATG probably has little or no influence on overall survival (HR (hazard ratio) 0.93 (95 % confidence interval (CI) 0.77 to 1.13, nine studies, n = 1249, moderate-certainty evidence)). Estimated absolute effect: 430 surviving people per 1000 people not receiving ATG compared to 456 people surviving per 1000 people receiving the intervention (95 % CI 385 to 522 per 1000 people).\nATG results in a reduction in acute GVHD II to IV with relative risk (RR) 0.68 (95 % CI 0.60 to 0.79, 10 studies, n = 1413, high-certainty evidence). Estimated absolute effect: 418 acute GVHD II to IV per 1000 people not receiving ATG compared to 285 per 1000 people receiving the intervention (95 % CI 251 to 331 per 1000 people). Addition of ATG results in a reduction of overall chronic GvHD with a RR of 0.53 (95 % CI 0.45 to 0.61, eight studies, n = 1273, high-certainty evidence). Estimated absolute effect: 506 chronic GVHD per 1000 people not receiving ATG compared to 268 per 1000 people receiving the intervention (95 % CI 228 to 369 per 1000 people). Further data on severe acute GVHD and extensive chronic GVHD are available in the manuscript.\nATG probably slightly increases the incidence of relapse with a RR of 1.21 (95 % CI 0.99 to 1.49, eight studies, n =1315, moderate-certainty evidence).\nNon relapse mortality is probably slightly or not affected by ATG with an HR of 0.86 (95 % CI 0.67 to 1.11, nine studies, n=1370, moderate-certainty evidence).\nATG prophylaxis may result in no increase in graft failure with a RR of 1.55 (95 % CI 0.54 to 4.44, eight studies, n = 1240, low-certainty evidence).\nAdverse events could not be analysed due to the serious heterogeneity in the reporting between the studies, which limited comparability (moderate-certainty evidence) and are reported in a descriptive manner.\nSubgroup analyses on ATG types, doses and donor type are available in the manuscript.\nAuthors' conclusions\nThis systematic review suggests that the addition of ATG during allogeneic SCT probably has little or no influence on overall survival. ATG results in a reduction in the incidence and severity of acute and chronic GvHD. ATG intervention probably slightly increases the incidence of relapse and probably does not affect the non relapse mortality. Graft failure may not be affected by ATG prophylaxis. Analysis of data on adverse events was reported in a narrative manner. A limitation for the analysis was the imprecision in reporting between the studies thereby reducing the confidence in the certainty of evidence.\n\nGiven the provided abstract, please respond to the following query: \"Why did we do this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "ATG has been used for decades to reduce the incidence and severity of GVHD, but the effectivity of this treatment modality still remains a matter of dispute. \nThe aim of this systematic review was to update our previous review and analyse the advantages and disadvantages of the use of ATG for GVHD prophylaxis in an allogeneic SCT. We aimed to identify the role of this treatment modality in this setting."
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query-laysum | 4013 | [
{
"role": "user",
"content": "Abstract: Background\nFundal pressure during the second stage of labour (also known as the 'Kristeller manoeuvre') involves application of manual pressure to the uppermost part of the uterus directed towards the birth canal, in an attempt to assist spontaneous vaginal birth and avoid prolonged second stage or the need for operative birth. Fundal pressure has also been applied using an inflatable belt. Fundal pressure is widely used, however methods of its use vary widely. Despite strongly held opinions in favour of and against the use of fundal pressure, there is limited evidence regarding its maternal and neonatal benefits and harms. There is a need for objective evaluation of the effectiveness and safety of fundal pressure in the second stage of labour.\nObjectives\nTo determine if fundal pressure is effective in achieving spontaneous vaginal birth, and preventing prolonged second stage or the need for operative birth, and to explore maternal and neonatal adverse effects related to fundal pressure.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (30 November 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised and quasi-randomised controlled trials of fundal pressure (manual or by inflatable belt) versus no fundal pressure in women in the second stage of labour with singleton cephalic presentation.\nData collection and analysis\nTwo or more review authors independently assessed potential studies for inclusion and quality. We extracted data using a pre-designed form. We entered data into Review Manager 5 software and checked for accuracy.\nMain results\nNine trials are included in this updated review. Five trials (3057 women) compared manual fundal pressure versus no fundal pressure. Four trials (891 women) compared fundal pressure by means of an inflatable belt versus no fundal pressure. It was not possible to blind women and staff to this intervention. We assessed two trials as being at high risk of attrition bias and another at high risk of reporting bias. All other trials were low or unclear for other risk of bias domains. Most of the trials had design limitations. Heterogeneity was high for the majority of outcomes.\nManual fundal pressure versus no fundal pressure\nManual fundal pressure was not associated with changes in: spontaneous vaginal birth within a specified time (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.71 to 1.28; 120 women; 1 trial; very low-quality evidence), instrumental births (RR 3.28, 95% CI 0.14 to 79.65; 197 women; 1 trial), caesarean births (RR 1.10, 95% CI 0.07 to 17.27; 197 women; 1 trial), operative birth (average RR 0.66, 95% CI 0.12 to 3.55; 317 women; 2 studies; I² = 43%; Tau² = 0.71; very low-quality evidence), duration of second stage (mean difference (MD) -0.80 minutes, 95% CI -3.66 to 2.06 minutes; 194 women; 1 study; very low-quality evidence), low arterial cord pH in newborn babies (RR 1.07, 95% CI 0.72 to 1.58; 297 women; 2 trials; very low-quality evidence), or Apgar scores less than seven at five minutes (average RR 4.48, 95% CI 0.28 to 71.45; 2759 infants; 4 trials; I² = 89%; Tau² = 3.55; very low-quality evidence). More women who received manual fundal pressure had cervical tears than in the control group (RR 4.90, 95% CI 1.09 to 21.98; 295 women; 1 trial). No neonatal deaths occurred in either of the two studies reporting this outcome (very low-quality evidence). No trial reported the outcome severe maternal morbidity or death.\nFundal pressure by inflatable belt versus no fundal pressure\nFundal pressure by inflatable belt did not reduce the number of women havinginstrumental births (average RR 0.73, 95% CI 0.52 to 1.02; 891 women; 4 trials; I² = 52%; Tau² = 0.05) or operative births (average RR 0.62, 95% CI 0.38 to 1.01; 891 women; 4 trials; I² = 78%; Tau² = 0.14; very low-quality evidence). Heterogeneity was high for both outcomes. Duration of second stage was reported in two trials, which both showed that inflatable belts shortened duration of labour in nulliparous women (average MD -50.80 minutes, 95% CI -94.85 to -6.74 minutes; 253 women; 2 trials; I² = 97%; Tau² = 975.94; very low-quality evidence). No data on this outcome were available for multiparous women. The inflatable belt did not make any difference to rates of caesarean births (average RR 0.56, 95% CI 0.14 to 2.26; 891 women; 4 trials; I² = 70%; Tau² = 0.98), low arterial cord pH in newborn babies (RR 0.47, 95% CI 0.09 to 2.55; 461 infants; 1 trial; low-quality evidence), or Apgar scores less than seven at five minutes (RR 4.62, 95% CI 0.22 to 95.68; 500 infants; 1 trial; very low-quality evidence). Third degree perineal tears were increased in the inflatable belt group (RR 15.69, 95% CI 2.10 to 117.02; 500 women; 1 trial). Spontaneous vaginal birth within a specified time, neonatal death, andsevere maternal morbidity or death were not reported in any trial.\nAuthors' conclusions\nThere is insufficient evidence to draw conclusions on the beneficial or harmful effects of fundal pressure, either manually or by inflatable belt. Fundal pressure by an inflatable belt during the second stage of labour may shorten duration of second stage for nulliparous women, and lower rates of operative birth. However, existing studies are small and their generalizability is uncertain. There is insufficient evidence regarding safety for the baby. There is no evidence on the use of fundal pressure in specific clinical settings such as inability of the mother to bear down due to exhaustion or unconsciousness. There is currently insufficient evidence for the routine use of fundal pressure by any method on women in the second stage of labour. Because of current widespread use of the procedure and the potential for use in settings where other methods of assisted birth are not available, further good quality trials are needed. Further evaluation in other groups of women (such as multiparous women) will also be required. Future research should describe in detail how fundal pressure was applied and consider safety of the unborn baby, perineal outcomes, longer-term maternal and infant outcomes and maternal satisfaction.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The second stage of labour is the pushing stage, from when the cervix is fully dilated (to 10 cm) until the baby is born. Fetal distress, failure to progress, maternal exhaustion or a medical condition where prolonged pushing is dangerous, can complicate this stage. Applying fundal pressure by pushing on the mother’s abdomen in the direction of the birth canal is often used to assist spontaneous vaginal birth, shorten the length of the second stage and reduce the need for instrumental birth (forceps- or vacuum-assisted) or caesarean section. It is particularly relevant in low-resource settings where options for operative birth are limited or not available. Manual pressure can be applied each time the woman has a contraction. Alternatively an inflatable belt can be worn which inflates to apply pressure during the contractions.\nThis review aimed to answer whether fundal pressure during contractions in the second stage of labour helps women give birth vaginally, and whether it causes any negative consequences for the woman or her unborn baby."
}
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query-laysum | 4014 | [
{
"role": "user",
"content": "Abstract: Background\nPeritoneal dialysis (PD) has been suggested as an effective and safe dialysis modality in patients with acute kidney injury (AKI). However, whether PD is superior to extracorporeal therapy (e.g. haemodialysis) in terms of improving survival, recovery of kidney function, metabolic and clinical outcomes is still inconclusive.\nObjectives\nThe aim of this review was to evaluate the benefits and harms of PD for patients with AKI compared with extracorporeal therapy or different PD modalities.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies to 29 May 2017 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov. We also searched the China Biological Medicine Database.\nSelection criteria\nWe included patients with AKI who were randomised to receive PD, extracorporeal therapy, or different PD modalities regardless of their age, sex, primary disease and clinical course.\nData collection and analysis\nScreening, selection, data extraction and quality assessments for each retrieved article were carried out by two authors using standardised forms. Authors contacted when published data were incomplete. Statistical analyses were performed using the random effects model and results expressed as risk ratio (RR) with 95% confidence intervals (CI). Heterogeneity among studies was explored using the Cochran Q statistic and the I2 test. Outcomes of interest included all-cause mortality, recovery of kidney function, weekly delivered Kt/V, correction of acidosis, fluid removal, duration of dialysis, and infectious complications. Confidence in the evidence was assessing using GRADE.\nMain results\nSix studies (484 participants) met our inclusion criteria. Five studies compared high volume PD with daily haemodialysis, extended daily haemodialysis, or continuous renal replacement therapy. One study focused on the intensity of PD. The overall risk of bias was low to unclear. Compared to extracorporeal therapy, PD probably made little or no difference to all-cause mortality (4 studies, 383 participants: RR 1.12, 95% CI 0.81 to 1.55; I2 = 69%; moderate certainty evidence), or kidney function recovery (3 studies, 333 participants: RR 0.95, 95% CI 0.68 to 1.35; I2 = 0%; moderate certainty evidence). PD probably slightly reduces the amount of fluid removal compared to extracorporeal therapy (3 studies, 313 participants: MD -0.59 L/d, 95% CI -1.19 to 0.01; I2 = 89%; low certainty evidence), and probably made little or no difference to infectious complications (2 studies, 263 participants: RR 1.03, 95% CI 0.60 to 1.78; I2 = 0%; low certainty evidence). It is uncertain whether PD compared to extracorporeal therapy has any effects on weekly delivered Kt/V (2 studies, 263 participants: MD -2.47, 95% CI -5.17 to 0.22; I2 = 99%; very low certainty evidence), correction of acidosis (2 studies, 89 participants: RR 1.32, 95% CI 0.13 to 13.60; I2 = 96%; very low certainty evidence), or duration of dialysis (2 studies, 170 participants: MD -1.01 hours, 95% CI -91.49 to 89.47; I2 = 98%; very low certainty evidence). Heterogeneity was high and this may be due to the different extracorporeal therapies used.\nOne study (61 participants) reported little or no difference to all-cause mortality, kidney function recovery, or infection between low and high and intensity PD. Weekly delivered Kt/V and fluid removal was lower with low compared to high intensity PD.\nAuthors' conclusions\nBased on moderate (mortality, recovery of kidney function), low (infectious complications), or very low certainty evidence (correction of acidosis) there is probably little or no difference between PD and extracorporeal therapy for treating AKI. Fluid removal (low certainty) and weekly delivered Kt/V (very low certainty) may be higher with extracorporeal therapy.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute kidney injury (AKI) is an abrupt and usually reversible decline in the glomerular filtration rate. No particular form of renal replacement therapy (treatment that replaces the normal blood-filtering function of the kidneys) for patients with AKI has been clearly shown to have a benefit. The choice of renal replacement therapy is dependent upon a variety of factors including availability, the expertise of the clinician, haemodynamic stability and so on."
}
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query-laysum | 4015 | [
{
"role": "user",
"content": "Abstract: Background\nDuring intensive care unit (ICU) admission, patients experience extreme physical and psychological stressors, including the abnormal ICU environment. These experiences impact on a patient’s recovery from critical illness and may result in both physical and psychological disorders. One strategy that has been developed and implemented by clinical staff to treat the psychological distress prevalent in ICU survivors is the use of patient diaries. These provide a background to the cause of the patient’s ICU admission and an ongoing narrative outlining day-to-day activities.\nObjectives\nTo assess the effect of a diary versus no diary on patients, and their caregivers or families, during the patient's recovery from admission to an ICU.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1), Ovid MEDLINE (1950 to January 2014), EBSCOhost CINAHL (1982 to January 2014), Ovid EMBASE (1980 to January 2014), PsycINFO (1950 to January 2014), Published International Literature on Traumatic Stress (PILOTS) database (1971 to January 2014); Web of Science Conference Proceedings Citation Index - Science and Social Science and Humanities (1990 to January 2014); seven clinical trial registries and reference lists of identified trials. We applied no language restriction.\nSelection criteria\nWe included randomized controlled trials (RCTs) or clinical controlled trials (CCTs) that evaluated the effectiveness of patient diaries, when compared to no ICU diary, for patients or family members to promote recovery after admission to ICU. Outcome measures for describing recovery from ICU included the risk of post-traumatic stress disorder (PTSD), anxiety, depression and post-traumatic stress symptomatology, health-related quality of life and costs.\nData collection and analysis\nWe used standard methodological approaches as expected by The Cochrane Collaboration. Two review authors independently reviewed titles for inclusion, extracted data and undertook risk of bias according to prespecified criteria.\nMain results\nWe identified three eligible studies; two describing ICU patients (N = 358), and one describing relatives of ICU patients (N = 30). The study involving relatives of ICU patients was a substudy of family members from one of the ICU patient studies. There was a mixed risk of bias within the included studies. Blinding of participants to allocation was not possible and blinding of the outcome assessment was not adequately achieved or reported. Overall the quality of the evidence was low to very low. The patient diary intervention was not identical between studies. However, each provided a prospectively prepared, day-to-day description of the participants' ICU admission.\nNo study adequately reported on risk of PTSD as described using a clinical interview, family or caregiver anxiety or depression, health-related quality of life or costs. Within a single study there was no clear evidence of a difference in risk for developing anxiety (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.07 to 1.19) or depression (RR 0.38, 95% CI 0.12 to 1.19) in participants who received ICU diaries, in comparison to those that did not receive a patient diary. However, the results were imprecise and consistent with benefit in either group, or no difference. Within a single study there was no evidence of difference in median post-traumatic stress symptomatology scores (diaries 24, SD 11.6; no diary 24, SD 11.6) and delusional ICU memory recall (RR 1.04, 95% CI 0.84 to 1.28) between the patients recovering from ICU admission who received patient diaries, and those who did not. One study reported reduced post-traumatic stress symptomatology in family members of patients recovering from admission to ICU who received patient diaries (median 19; range 14 to 28), in comparison to no diary (median 28; range 14 to 38).\nAuthors' conclusions\nCurrently there is minimal evidence from RCTs of the benefits or harms of patient diaries for patients and their caregivers or family members. A small study has described their potential to reduce post-traumatic stress symptomatology in family members. However, there is currently inadequate evidence to support their effectiveness in improving psychological recovery after critical illness for patients and their family members.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who have been critically ill experience significant physical and psychological problems during recovery. Diaries outlining a person's intensive care unit (ICU) experience have been suggested as something that may be effective in helping survivors and their family members recover psychological function."
}
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query-laysum | 4016 | [
{
"role": "user",
"content": "Abstract: Background\nCognitive stimulation (CS) is an intervention for people with dementia offering a range of enjoyable activities providing general stimulation for thinking, concentration and memory, usually in a social setting, such as a small group. CS is distinguished from other approaches such as cognitive training and cognitive rehabilitation by its broad focus and social elements, aiming to improve domains such as quality of life (QoL) and mood as well as cognitive function.\nRecommended in various guidelines and widely implemented internationally, questions remain regarding different modes of delivery and the clinical significance of any benefits. A systematic review of CS is important to clarify its effectiveness and place practice recommendations on a sound evidence base. This review was last updated in 2012.\nObjectives\nTo evaluate the evidence for the effectiveness of CS for people with dementia, including any negative effects, on cognition and other relevant outcomes, accounting where possible for differences in its implementation.\nSearch methods\nWe identified trials from a search of the Cochrane Dementia and Cognitive Improvement Group Specialized Register, last searched on 3 March 2022. We used the search terms: cognitive stimulation, reality orientation, memory therapy, memory groups, memory support, memory stimulation, global stimulation, cognitive psychostimulation. We performed supplementary searches in a number of major healthcare databases and trial registers to ensure the search was up-to-date and comprehensive.\nSelection criteria\nWe included all randomised controlled trials (RCTs) of CS for dementia published in peer review journals in the English language incorporating a measure of cognitive change.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. As CS is a psychosocial intervention, we did not expect those receiving or delivering CS to be blinded to the nature of the intervention. Where necessary, we contacted study authors requesting data not provided in the papers. Where appropriate, we undertook subgroup analysis by modality (individual versus group), number of sessions and frequency, setting (community versus care home), type of control condition and dementia severity. We used GRADE methods to assess the overall quality of evidence for each outcome.\nMain results\nWe included 37 RCTs (with 2766 participants), 26 published since the previous update. Most evaluated CS groups; eight examined individual CS. Participants' median age was 79.7 years. Sixteen studies included participants resident in care homes or hospitals. Study quality showed indications of improvement since the previous review, with few areas of high risk of bias. Assessors were clearly blinded to treatment allocation in most studies (81%) and most studies (81%) reported use of a treatment manual by those delivering the intervention. However, in a substantial number of studies (59%), we could not find details on all aspects of the randomisation procedures, leading us to rate the risk of selection bias as unclear.\nWe entered data in the meta-analyses from 36 studies (2704 participants; CS: 1432, controls: 1272). The primary analysis was on changes evident immediately following the treatment period (median length 10 weeks; range 4 to 52 weeks). Only eight studies provided data allowing evaluation of whether effects were subsequently maintained (four at 6- to 12-week follow-up; four at 8- to 12-month follow-up). No negative effects were reported. Overall, we found moderate-quality evidence for a small benefit in cognition associated with CS (standardised mean difference (SMD) 0.40, 95% CI 0.25 to 0.55). In the 25 studies, with 1893 participants, reporting the widely used MMSE (Mini-Mental State Examination) test for cognitive function in dementia, there was moderate-quality evidence of a clinically important difference of 1.99 points between CS and controls (95% CI: 1.24, 2.74).\nIn secondary analyses, with smaller total sample sizes, again examining the difference between CS and controls on changes immediately following the intervention period, we found moderate-quality evidence of a slight improvement in self-reported QoL (18 studies, 1584 participants; SMD: 0.25 [95% CI: 0.07, 0.42]) as well as in QoL ratings made by proxies (staff or caregivers). We found high-quality evidence for clinically relevant improvements in staff/interviewer ratings of communication and social interaction (5 studies, 702 participants; SMD: 0.53 [95% CI: 0.36, 0.70]) and for slight benefits in instrumental Activities of Daily Living, self-reported depressed mood, staff/interviewer-rated anxiety and general behaviour rating scales. We found moderate-quality evidence for slight improvements in behaviour that challenges and in basic Activities of Daily Living and low-quality evidence for a slight improvement in staff/interviewer-rated depressed mood. A few studies reported a range of outcomes for family caregivers. We found moderate-quality evidence that overall CS made little or no difference to caregivers' mood or anxiety.\nWe found a high level of inconsistency between studies in relation to both cognitive outcomes and QoL. In exploratory subgroup analyses, we did not identify an effect of modality (group versus individual) or, for group studies, of setting (community versus care home), total number of group sessions or type of control condition (treatment-as-usual versus active controls). However, we did find improvements in cognition were larger where group sessions were more frequent (twice weekly or more versus once weekly) and where average severity of dementia among participants at the start of the intervention was 'mild' rather than 'moderate'. Imbalance in numbers of studies and participants between subgroups and residual inconsistency requires these exploratory findings to be interpreted cautiously.\nAuthors' conclusions\nIn this updated review, now with a much more extensive evidence base, we have again identified small, short-term cognitive benefits for people with mild to moderate dementia participating in CS programmes. From a smaller number of studies, we have also found clinically relevant improvements in communication and social interaction and slight benefits in a range of outcomes including QoL, mood and behaviour that challenges. There are relatively few studies of individual CS, and further research is needed to delineate the effectiveness of different delivery methods (including digital and remote, individual and group) and of multi-component programmes. We have identified that the frequency of group sessions and level of dementia severity may influence the outcomes of CS, and these aspects should be studied further. There remains an evidence gap in relation to the potential benefits of longer-term CS programmes and their clinical significance.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review updates our previous review from 2012, with evidence up-to-date to March 2022."
}
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query-laysum | 4017 | [
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in childhood. The psychostimulant methylphenidate is the most frequently used medication to treat it. Several studies have investigated the benefits of methylphenidate, showing possible favourable effects on ADHD symptoms, but the true magnitude of the effect is unknown. Concerning adverse events associated with the treatment, our systematic review of randomised clinical trials (RCTs) demonstrated no increase in serious adverse events, but a high proportion of participants suffered a range of non-serious adverse events.\nObjectives\nTo assess the adverse events associated with methylphenidate treatment for children and adolescents with ADHD in non-randomised studies.\nSearch methods\nIn January 2016, we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, 12 other databases and two trials registers. We also checked reference lists and contacted authors and pharmaceutical companies to identify additional studies.\nSelection criteria\nWe included non-randomised study designs. These comprised comparative and non-comparative cohort studies, patient-control studies, patient reports/series and cross-sectional studies of methylphenidate administered at any dosage or formulation. We also included methylphenidate groups from RCTs assessing methylphenidate versus other interventions for ADHD as well as data from follow-up periods in RCTs. Participants had to have an ADHD diagnosis (from the 3rd to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders or the 9th or 10th edition of theInternational Classification of Diseases, with or without comorbid diagnoses. We required that at least 75% of participants had a normal intellectual capacity (intelligence quotient of more than 70 points) and were aged below 20 years. We excluded studies that used another ADHD drug as a co-intervention.\nData collection and analysis\nFourteen review authors selected studies independently. Two review authors assessed risk of bias independently using the ROBINS-I tool for assessing risk of bias in non-randomised studies of interventions. All review authors extracted data. We defined serious adverse events according to the International Committee of Harmonization as any lethal, life-threatening or life-changing event. We considered all other adverse events to be non-serious adverse events and conducted meta-analyses of data from comparative studies. We calculated meta-analytic estimates of prevalence from non-comparative cohorts studies and synthesised data from patient reports/series qualitatively. We investigated heterogeneity by conducting subgroup analyses, and we also conducted sensitivity analyses.\nMain results\nWe included a total of 260 studies: 7 comparative cohort studies, 6 of which compared 968 patients who were exposed to methylphenidate to 166 controls, and 1 which assessed 1224 patients that were exposed or not exposed to methylphenidate during different time periods; 4 patient-control studies (53,192 exposed to methylphenidate and 19,906 controls); 177 non-comparative cohort studies (2,207,751 participants); 2 cross-sectional studies (96 participants) and 70 patient reports/series (206 participants). Participants' ages ranged from 3 years to 20 years. Risk of bias in the included comparative studies ranged from moderate to critical, with most studies showing critical risk of bias. We evaluated all non-comparative studies at critical risk of bias. The GRADE quality rating of the evidence was very low.\nPrimary outcomes\nIn the comparative studies, methylphenidate increased the risk ratio (RR) of serious adverse events (RR 1.36, 95% confidence interval (CI) 1.17 to 1.57; 2 studies, 72,005 participants); any psychotic disorder (RR 1.36, 95% CI 1.17 to 1.57; 1 study, 71,771 participants); and arrhythmia (RR 1.61, 95% CI 1.48 to 1.74; 1 study, 1224 participants) compared to no intervention.\nIn the non-comparative cohort studies, the proportion of participants on methylphenidate experiencing any serious adverse event was 1.20% (95% CI 0.70% to 2.00%; 50 studies, 162,422 participants). Withdrawal from methylphenidate due to any serious adverse events occurred in 1.20% (95% CI 0.60% to 2.30%; 7 studies, 1173 participants) and adverse events of unknown severity led to withdrawal in 7.30% of participants (95% CI 5.30% to 10.0%; 22 studies, 3708 participants).\nSecondary outcomes\nIn the comparative studies, methylphenidate, compared to no intervention, increased the RR of insomnia and sleep problems (RR 2.58, 95% CI 1.24 to 5.34; 3 studies, 425 participants) and decreased appetite (RR 15.06, 95% CI 2.12 to 106.83; 1 study, 335 participants).\nWith non-comparative cohort studies, the proportion of participants on methylphenidate with any non-serious adverse events was 51.2% (95% CI 41.2% to 61.1%; 49 studies, 13,978 participants). These included difficulty falling asleep, 17.9% (95% CI 14.7% to 21.6%; 82 studies, 11,507 participants); headache, 14.4% (95% CI 11.3% to 18.3%; 90 studies, 13,469 participants); abdominal pain, 10.7% (95% CI 8.60% to 13.3%; 79 studies, 11,750 participants); and decreased appetite, 31.1% (95% CI 26.5% to 36.2%; 84 studies, 11,594 participants). Withdrawal of methylphenidate due to non-serious adverse events occurred in 6.20% (95% CI 4.80% to 7.90%; 37 studies, 7142 participants), and 16.2% were withdrawn for unknown reasons (95% CI 13.0% to 19.9%; 57 studies, 8340 participants).\nAuthors' conclusions\nOur findings suggest that methylphenidate may be associated with a number of serious adverse events as well as a large number of non-serious adverse events in children and adolescents, which often lead to withdrawal of methylphenidate. Our certainty in the evidence is very low, and accordingly, it is not possible to accurately estimate the actual risk of adverse events. It might be higher than reported here.\nGiven the possible association between methylphenidate and the adverse events identified, it may be important to identify people who are most susceptible to adverse events. To do this we must undertake large-scale, high-quality RCTs, along with studies aimed at identifying responders and non-responders.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is methylphenidate administration associated with harmful effects in children and adolescents with attention deficit hyperactivity disorder (ADHD)?"
}
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query-laysum | 4018 | [
{
"role": "user",
"content": "Abstract: Background\nEducational meetings are used widely by health personnel to provide continuing medical education and to promote implementation of innovations or translate new knowledge to change practice within healthcare systems. Previous reviews have concluded that educational meetings can result in small changes in behaviour, but that effects vary considerably. Investigations into which characteristics of educational meetings might lead to greater impact have yielded varying results, and factors that might explain heterogeneity in effects remain unclear. This is the second update of this Cochrane Review.\nObjectives\n• To assess the effects of educational meetings on professional practice and healthcare outcomes\n• To investigate factors that might explain the heterogeneity of these effects\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, ERIC, Science Citation Index Expanded (ISI Web of Knowledge), and Social Sciences Citation Index (last search in November 2016).\nSelection criteria\nWe sought randomised trials examining the effects of educational meetings on professional practice and patient outcomes.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. One review author assessed the certainty of evidence (GRADE) and discussed with a second review author. We included studies in the primary analysis that reported baseline data and that we judged to be at low or unclear risk of bias. For each comparison of dichotomous outcomes, we measured treatment effect as risk difference adjusted for baseline compliance. We expressed adjusted risk difference values as percentages, and we noted that values greater than zero favour educational meetings. For continuous outcomes, we measured treatment effect as per cent change relative to the control group mean post test, adjusted for baseline performance; we expressed values as percentages and noted that values greater than zero favour educational meetings. We report means and 95% confidence intervals (CIs) and, when appropriate, medians and interquartile ranges to facilitate comparisons to previous versions of this review. We analysed professional and patient outcomes separately and analysed 22 variables that were hypothesised a priori to explain heterogeneity. We explored heterogeneity by using univariate meta-regression and by inspecting violin plots.\nMain results\nWe included 215 studies involving more than 28,167 health professionals, including 142 new studies for this update.\nEducational meetings as the single intervention or the main component of a multi-faceted intervention compared with no intervention\n• Probably slightly improve compliance with desired practice when compared with no intervention (65 comparisons, 7868 health professionals for dichotomous outcomes (adjusted risk difference 6.79%, 95% CI 6.62% to 6.97%; median 4.00%; interquartile range 0.29% to 13.00%); 28 comparisons, 2577 health professionals for continuous outcomes (adjusted relative percentage change 44.36%, 95% CI 41.98% to 46.75%; median 20.00%; interquartile range 6.00% to 65.00%))\n• Probably slightly improve patient outcomes compared with no intervention (15 comparisons, 2530 health professionals for dichotomous outcomes (adjusted risk difference 3.30%, 95% CI 3.10% to 3.51%; median 0.10%; interquartile range 0.00% to 4.00%); 28 comparisons, 2294 health professionals for continuous outcomes (adjusted relative percentage change 8.35%, 95% CI 7.46% to 9.24%; median 2.00%; interquartile range -1.00% to 21.00%))\nThe certainty of evidence for this comparison is moderate.\nEducational meetings alone compared with other interventions\n• May improve compliance with desired practice when compared with other interventions (6 studies, 1402 health professionals for dichotomous outcomes (adjusted risk difference 9.99%, 95% CI 9.47% to 10.52%; median 16.5%; interquartile range 0.80% to 16.50%); 2 studies, 72 health professionals for continuous outcomes (adjusted relative percentage change 12.00%, 95% CI 9.16% to 14.84%; median 12.00%; interquartile range 0.00% to 24.00%))\nNo studies met the inclusion criteria for patient outcome measurements. The certainty of evidence for this comparison is low.\nInteractive educational meetings compared with didactic (lecture-based) educational meetings\n• We are uncertain of effects on compliance with desired practice (3 studies, 370 health professionals for dichotomous outcomes; 1 study, 192 health professionals for continuous outcomes) or on patient outcomes (1 study, 54 health professionals for continuous outcomes), as the certainty of evidence is very low\nAny other comparison of different formats and durations of educational meetings\n• We are uncertain of effects on compliance with desired practice (1 study, 19 health professionals for dichotomous outcomes; 1 study, 20 health professionals for continuous outcomes) or on patient outcomes (1 study, 113 health professionals for continuous outcomes), as the certainty of evidence is very low.\nFactors that might explain heterogeneity of effects\nMeta-regression suggests that larger estimates of effect are associated with studies judged to be at high risk of bias, with studies that had unit of analysis errors, and with studies in which the unit of analysis was the provider rather than the patient.\nImproved compliance with desired practice may be associated with: shorter meetings; poor baseline compliance; better attendance; shorter follow-up; professionals provided with additional take-home material; explicit building of educational meetings on theory; targeting of low- versus high-complexity behaviours; targeting of outcomes with high versus low importance; goal of increasing rather than decreasing behaviour; teaching by opinion leaders; and use of didactic versus interactive teaching methods.\nPre-specified exploratory analyses of behaviour change techniques suggest that improved compliance with desired practice may be associated with use of a greater number of behaviour change techniques; goal-setting; provision of feedback; provision for social comparison; and provision for social support. Compliance may be decreased by the use of follow-up prompts, skills training, and barrier identification techniques.\nAuthors' conclusions\nCompared with no intervention, educational meetings as the main component of an intervention probably slightly improve professional practice and, to a lesser extent, patient outcomes. Educational meetings may improve compliance with desired practice to a greater extent than other kinds of behaviour change interventions, such as text messages, fees, or office systems. Our findings suggest that multi-strategy approaches might positively influence the effects of educational meetings.\nAdditional trials of educational meetings compared with no intervention are unlikely to change the review findings; therefore we will not further update this review comparison in the future. However, we note that randomised trials comparing different types of education are needed.\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": "Educational meetings include courses, seminars, and workshops in various formats. Doctors and other healthcare professionals often use educational meetings as part of their continuing medical education. Medical societies and employers in the healthcare system also use educational meetings to present new knowledge or new types of care and to encourage best practice. These types of meetings can vary a lot. For instance, some may be very interactive, and other may be lecture-based. Types of people leading the meetings and numbers of people who attend also vary.\nBut do these types of meetings lead to change? The review authors assessed whether healthcare professionals who went to educational meetings were more likely to follow practices recommended to them. In addition, review authors assessed whether these meetings led to any improvements in patients’ health.\nThis review is an update of an earlier Cochrane Review."
}
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query-laysum | 4019 | [
{
"role": "user",
"content": "Abstract: Background\nExchange blood transfusion (EBT) is a form of whole blood transfusion in which the total blood volume is replaced within a few hours. In perinatal and neonatal medicine, EBT is most often used in the management of severe anaemia or severe hyperbilirubinaemia in the first week of life. Hypocalcaemia, one of the common morbidities associated with EBT, is thought to arise from the chelating effects of the citrate commonly used as an anticoagulant in the donor's blood. This disorder manifests with muscular and nervous irritability and cardiac arrhythmias.\nObjectives\nTo determine whether the use of prophylactic calcium reduces the risk of hypocalcaemia-related morbidities and death among newborn infants receiving EBT.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 5), MEDLINE via PubMed (1966 to 29 June 2016), Embase (1980 to 29 June 2016), and CINAHL (1982 to 29 June 2016). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nAll randomised and quasi-randomised trials of prophylactic intravenous calcium in EBT for newborns.\nData collection and analysis\nTwo review authors independently assessed and extracted data on methods, participants, interventions, and outcomes (mean total and ionised serum calcium before and after EBT and the presence of adverse events such as hypoglycaemia, apnoea, cardiac arrest, and death immediately after EBT). We reported results as means difference (MD) with 95% confidence intervals (CI) for continuous outcomes and risk ratio (RR) and risk differences (RD) and 95% CIs for dichotomous outcomes. We assessed quality using the Cochrane 'Risk of bias' assessment tool and the GRADE system.\nMain results\nWe found only one quasi-randomised trial with 30 participants that met our inclusion criteria. In the small trial, total and ionised serum calcium levels were measured immediately before and immediately after EBT. All the participants were included in the final analysis and all the important outcomes were reported.\nPrimary outcomes\nThere was one death in each group (RR 1.00, 95% CI 0.07 to 14.55; RD 0.00, 95% CI -0.18 to 0.18; participants = 30; studies = 1). The study did not report the presence of cardiac arrhythmias within one week of EBT and the number of infants with serum calcium levels (total less than 8 mg/dL (2 mmol/L) or ionised less than 4.4 mg/dL (1.1 mmol/L)).\nPair-wise comparison of EBT with intravenous 10% calcium gluconate versus EBT without intravenous calcium (change from baseline) showed mean total serum calcium was raised in the intervention group compared to the control group (MD -0.46, 95% CI -0.81 to -0.11; participants = 30; studies = 1). Very low-quality evidence also indicated an increase in the levels of mean ionised serum calcium in the intervention group compared to the control group (MD -0.22, 95% CI -0.33 to -0.11; participants = 30; studies = 1).\nSecondary outcomes\nAdverse reactions to intravenous calcium therapy included cardiac arrest in one neonate in the intervention arm (RR 3.00, 95% CI 0.13 to 68.26; RD 0.07, 95% CI -0.10 to 0.23; participants = 30; studies = 1). There was apnoea and hypoglycaemia (RR 1.00, 95% CI 0.07 to 14.55; RD 0.00, 95% CI -0.18 to 0.18; participants = 30; studies = 1) in the two neonates who died. Data were not available for other major secondary outcomes such as the number of infants with reduced serum magnesium, reduced parathormone, increased calcitonin, presence of seizures, carpopedal spasm, jitteriness and prolonged QTc interval on electrocardiography within one week of EBT.\nAuthors' conclusions\nVery low-quality data from one quasi-randomised controlled trial suggested that the mean serum total and ionised calcium increased in the study group but decreased in the control group immediately after EBT. However, the mean values of total and ionised calcium in both arms of studies remained within international reference ranges. Unfortunately, data were not available to assess the trend of total and ionised serum calcium to the end of the first week after EBT. Therefore, due to the very low quality of evidence available, it is difficult to support or reject the continual use of prophylactic intravenous calcium in newborn infants receiving EBT. Researchers are encouraged to conduct more robustly designed trials with larger numbers of participants, and particularly, addressing the pattern of differences based on gestational age of participants, type of anticoagulant used, and the volume of blood used.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "based on the findings in this review, there is no good-quality evidence to support or reject continual use of calcium during EBT. We are unable to make conclusions, as the evidence that we found is limited and of very low quality and could change if more results from larger and better-designed studies become available."
}
]
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query-laysum | 4020 | [
{
"role": "user",
"content": "Abstract: Background\nAntipsychotic medications are regularly prescribed in care home residents for the management of behavioural and psychological symptoms of dementia (BPSD) despite questionable efficacy, important adverse effects, and available non-pharmacological interventions. Prescription rates are related to organisational factors, staff training and job satisfaction, patient characteristics, and specific interventions. Psychosocial intervention programmes aimed at reducing the prescription of antipsychotic drugs are available. These programmes may target care home residents (e.g. improving communication and interpersonal relationships) or target staff (e.g. by providing skills for caring for people with BPSD). Therefore, this review aimed to assess the effectiveness of these interventions, updating our earlier review published in 2012.\nObjectives\nTo evaluate the benefits and harms of psychosocial interventions to reduce antipsychotic medication use in care home residents compared to regular care, optimised regular care, or a different psychosocial intervention.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 14 July 2022.\nSelection criteria\nWe included individual or cluster-randomised controlled trials comparing a psychosocial intervention aimed primarily at reducing the use of antipsychotic medication with regular care, optimised regular care, or a different psychosocial intervention. Psychosocial interventions were defined as non-pharmacological intervention with psychosocial components. We excluded medication withdrawal or substitution interventions, interventions without direct interpersonal contact and communication, and interventions solely addressing policy changes or structural interventions.\nData collection and analysis\nWe used standard Cochrane methods. Critical appraisal of studies addressed risks of selection, performance, attrition and detection bias, as well as criteria related to cluster randomisation. We retrieved data on the complex interventions on the basis of the TIDieR (Template for Intervention Description and Replication) checklist. Our primary outcomes were 1. use of regularly prescribed antipsychotic medication and 2. adverse events. Our secondary outcomes were 3. mortality; 4. BPSD; 5. quality of life; 6. prescribing of regularly psychotropic medication; 7. regimen of regularly prescribed antipsychotic medication; 8. antipsychotic medication administered 'as needed'; 9. physical restraints; 10. cognitive status; 11. depression; 12. activities of daily living; and 13. costs. We used GRADE to assess certainty of evidence.\nMain results\nWe included five cluster-randomised controlled studies (120 clusters, 8342 participants). We found pronounced clinical heterogeneity and therefore decided to present study results narratively. All studies investigated complex interventions comprising, among other components, educational approaches.\nBecause of the heterogeneity of the results, including the direction of effects, we are uncertain about the effects of psychosocial interventions on the prescription of antipsychotic medication. One study investigating an educational intervention for care home staff assessed the use of antipsychotic medication in days of use per 100 resident-days, and found this to be lower in the intervention group (mean difference 6.30 days, 95% confidence interval (CI) 6.05 to 6.66; 1152 participants). The other four studies reported the proportion of participants with a regular antipsychotic prescription. Of two studies implementing an intervention to promote person-centred care, one found a difference in favour of the intervention group (between-group difference 19.1%, 95% CI 0.5% to 37.7%; 338 participants), while the other found a difference in favour of the control group (between-group difference 11.4%, 95% CI 0.9% to 21.9%; 862 participants). One study investigating an educational programme described as \"academic detailing\" found no difference between groups (odds ratio 1.06, 95% CI 0.93 to 1.20; 5363 participants). The fifth study used a factorial design to compare different combinations of interventions to supplement person-centred care. Results showed a positive effect of medication review, and no clear effect of social interaction or exercise. We considered that, overall, the evidence about this outcome was of low certainty.\nWe found high-certainty evidence that psychosocial interventions intended primarily to reduce antipsychotic use resulted in little to no difference in the number of falls, non-elective hospitalisations, or unplanned emergency department visits.\nPsychosocial interventions intended primarily to reduce antipsychotic use also resulted in little to no difference in quality of life (moderate-certainty evidence), and BPSD, regular prescribing of psychotropic medication, use of physical restraints, depression, or activities of daily living (all low-certainty evidence). We also found low-certainty evidence that, in the context of these interventions, social interaction and medication review may reduce mortality, but exercise does not.\nAuthors' conclusions\nAll included interventions were complex and the components of the interventions differed considerably between studies. Interventions and intervention components were mostly not described in sufficient detail. Two studies found evidence that the complex psychosocial interventions may reduce antipsychotic medication use. In addition, one study showed that medication review might have some impact on antipsychotic prescribing rates. There were no important adverse events. Overall, the available evidence does not allow for clear generalisable recommendations.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Because of the limited benefit and the potential harm of antipsychotic medicines in people with dementia, there is much interest in finding ways to reduce the use of antipsychotics in care homes. These ways could include, for example, organisational factors, staff training, or other interventions. We were interested in so-called psychosocial interventions, focussing on the way care is organised and delivered, and promoting alternative non-medicine strategies. These interventions often comprise different components, such as education for staff, specialist medication review, and additional support and activities for residents. These interventions may improve the well-being of care home residents, or improve staff skills to support residents with dementia. One approach is called person-centred care, aiming to emphasise the need of every person to be treated as an individual and receive attention of their individual needs."
}
]
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query-laysum | 4021 | [
{
"role": "user",
"content": "Abstract: Background\nDrug insurance schemes are systems that provide access to medicines on a prepaid basis and could potentially improve access to essential medicines and reduce out-of-pocket payments for vulnerable populations.\nObjectives\nTo assess the effects on drug use, drug expenditure, healthcare utilisation and healthcare outcomes of alternative policies for regulating drug insurance schemes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, nine other databases, and two trials registers between November 2014 and September 2020, including a citation search for included studies on 15 September 2021 using Web of Science. We screened reference lists of all the relevant reports that we retrieved and reports from the Background section. Authors of relevant papers, relevant organisations, and discussion lists were contacted to identify additional studies, including unpublished and ongoing studies.\nSelection criteria\nWe planned to include randomised trials, non-randomised trials, interrupted time-series studies (including controlled ITS [CITS] and repeated measures [RM] studies), and controlled before-after (CBA) studies. Two review authors independently assessed the search results and reference lists of relevant reports, retrieved the full text of potentially relevant references and independently applied the inclusion criteria to those studies. We resolved disagreements by discussion, and when necessary by including a third review author. We excluded studies of the following pharmaceutical policies covered in other Cochrane Reviews: those that determined how decisions were made about which conditions or drugs were covered; those that placed restrictions on reimbursement for drugs that were covered; and those that regulated out-of-pocket payments for drugs.\nData collection and analysis\nTwo review authors independently extracted data from the included studies and assessed risk of bias for each study, with disagreements being resolved by consensus. We used the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials and controlled before-after studies, we planned to report relative effects. For dichotomous outcomes, we reported the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For interrupted time series and controlled interrupted time-series studies, we computed changes along two dimensions: change in level; and change in slope. We undertook a structured synthesis following the EPOC guidance on this topic, describing the range of effects found in the studies for each category of outcomes.\nMain results\nWe identified 58 studies that met the inclusion criteria (25 interrupted time-series studies and 33 controlled before-after studies). Most of the studies (54) assessed a single policy implemented in the United States (US) healthcare system: Medicare Part D. The other four assessed other drug insurance schemes from Canada and the US, but only one of them provided analysable data for inclusion in the quantitative synthesis. The introduction of drug insurance schemes may increase prescription drug use (low-certainty evidence). On the other hand, Medicare Part D may decrease drug expenditure measured as both out-of-pocket spending and total drug spending (low-certainty evidence). Regarding healthcare utilisation, drug insurance policies (such as Medicare Part D) may lead to a small increase in visits to the emergency department. However, it is uncertain whether this type of policy increases or decreases hospital admissions or outpatient visits by beneficiaries of the scheme because the certainty of the evidence was very low. Likewise, it is uncertain if the policy increases or reduces health outcomes such as mortality because the certainty of the evidence was very low.\nAuthors' conclusions\nThe introduction of drug insurance schemes such as Medicare Part D in the US health system may increase prescription drug use and may decrease out-of-pocket payments by the beneficiaries of the scheme and total drug expenditures. It may also lead to a small increase in visits to the emergency department by the beneficiaries of the policy. Its effects on other healthcare utilisation outcomes and on health outcomes are uncertain because of the very low certainty of the evidence. The applicability of this evidence to settings outside US healthcare is limited.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The USA’s Medicare Part D offers free prescription medicines to elderly people. This system may increase the amount of medicines elderly people use, but they may spend less money on medicines. We do not know if this system changes people’s health or their use of healthcare services because the certainty of the evidence was very low."
}
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query-laysum | 4022 | [
{
"role": "user",
"content": "Abstract: Background\nBronchodilators are used to treat bronchial hyper-responsiveness in asthma. Bronchial hyper-responsiveness may be a component of acute chest syndrome in people with sickle cell disease. Therefore, bronchodilators may be useful in the treatment of acute chest syndrome. This is an update of a previously published Cochrane Review.\nObjectives\nThe aim of the review is to determine whether the use of inhaled, short-acting bronchodilators for acute chest syndrome reduces morbidity and mortality in people with sickle cell disease and to assess whether this treatment causes adverse effects.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Additional searches were carried out on MEDLINE (1966 to 2004) and Embase (1981 to 2004) and ongoing trial registries (28 September 2022).\nDate of the most recent search of the Group's Haemoglobinopathies Trials Register: 25 July 2022.\nSelection criteria\nRandomised or quasi-randomised controlled trials. Trials using quasi-randomisation methods will be included in future updates of this review if there is sufficient evidence that the treatment and control groups are similar at baseline.\nData collection and analysis\nWe found no trials investigating the use of bronchodilators for acute chest syndrome in people with sickle cell disease.\nMain results\nWe found no trials investigating the use of bronchodilators for acute chest syndrome in people with sickle cell disease.\nAuthors' conclusions\nIf bronchial hyper-responsiveness is an important component of some episodes of acute chest syndrome in people with sickle cell disease, the use of inhaled bronchodilators may be indicated. There is need for a well-designed, adequately-powered randomised controlled trial to assess the benefits and risks of the addition of inhaled bronchodilators to established therapies for acute chest syndrome in people with sickle cell disease.\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": "Research needs to assess the benefits and risks of using inhaled bronchodilators for acute chest syndrome in people with sickle cell disease."
}
]
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query-laysum | 4023 | [
{
"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: \"This review shows that for people younger than 60 years of age with painful hallux vagus (a condition where the base of the big toe bulges out sideways, away from the foot) custom-made foot orthoses\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Reduce foot pain after 6 months compared to no treatment, but may not reduce foot pain after 6 or 12 months compared to surgery."
}
]
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query-laysum | 4024 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with chronic heart failure (HF) are at risk of thromboembolic events, including stroke, pulmonary embolism, and peripheral arterial embolism; coronary ischaemic events also contribute to the progression of HF. The use of long-term oral anticoagulation is established in certain populations, including people with HF and atrial fibrillation (AF), but there is wide variation in the indications and use of oral anticoagulation in the broader HF population.\nObjectives\nTo determine whether long-term oral anticoagulation reduces total deaths and stroke in people with heart failure in sinus rhythm.\nSearch methods\nWe updated the searches in CENTRAL, MEDLINE, and Embase in March 2020. We screened reference lists of papers and abstracts from national and international cardiovascular meetings to identify unpublished studies. We contacted relevant authors to obtain further data. We did not apply any language restrictions.\nSelection criteria\nRandomised controlled trials (RCT) comparing oral anticoagulants with placebo or no treatment in adults with HF, with treatment duration of at least one month. We made inclusion decisions in duplicate, and resolved any disagreements between review authors by discussion, or a third party.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, and assessed the risks and benefits of antithrombotic therapy by calculating odds ratio (OR), accompanied by the 95% confidence intervals (CI).\nMain results\nWe identified three RCTs (5498 participants). One RCT compared warfarin, aspirin, and no antithrombotic therapy, the second compared warfarin with placebo in participants with idiopathic dilated cardiomyopathy, and the third compared rivaroxaban with placebo in participants with HF and coronary artery disease.\nWe pooled data from the studies that compared warfarin with a placebo or no treatment. We are uncertain if there is an effect on all-cause death (OR 0.66, 95% CI 0.36 to 1.18; 2 studies, 324 participants; low-certainty evidence); warfarin may increase the risk of major bleeding events (OR 5.98, 95% CI 1.71 to 20.93; number needed to treat for an additional harmful outcome (NNTH) 17; 2 studies, 324 participants; low-certainty evidence). None of the studies reported stroke as an individual outcome.\nRivaroxaban makes little to no difference to all-cause death compared with placebo (OR 0.99, 95% CI 0.87 to 1.13; 1 study, 5022 participants; high-certainty evidence). Rivaroxaban probably reduces the risk of stroke compared to placebo (OR 0.67, 95% CI 0.47 to 0.95; number needed to treat for an additional beneficial outcome (NNTB) 101; 1 study, 5022 participants; moderate-certainty evidence), and probably increases the risk of major bleeding events (OR 1.65, 95% CI 1.17 to 2.33; NNTH 79; 1 study, 5008 participants; moderate-certainty evidence).\nAuthors' conclusions\nBased on the three RCTs, there is no evidence that oral anticoagulant therapy modifies mortality in people with HF in sinus rhythm. The evidence is uncertain if warfarin has any effect on all-cause death compared to placebo or no treatment, but it may increase the risk of major bleeding events. There is no evidence of a difference in the effect of rivaroxaban on all-cause death compared to placebo. It probably reduces the risk of stroke, but probably increases the risk of major bleedings.\nThe available evidence does not support the routine use of anticoagulation in people with HF who remain in sinus rhythm.\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": "The literature is current to March 2020."
}
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query-laysum | 4025 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is the most common form of joint disease and the leading cause of pain and physical disability in older people. Opioids may be a viable treatment option if people have severe pain or if other analgesics are contraindicated. However, the evidence about their effectiveness and safety is contradictory. This is an update of a Cochrane review first published in 2009.\nObjectives\nTo determine the effects on pain, function, safety, and addiction of oral or transdermal opioids compared with placebo or no intervention in people with knee or hip osteoarthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and CINAHL (up to 28 July 2008, with an update performed on 15 August 2012), checked conference proceedings, reference lists, and contacted authors.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that compared oral or transdermal opioids with placebo or no treatment in people with knee or hip osteoarthritis. We excluded studies of tramadol. We applied no language restrictions.\nData collection and analysis\nWe extracted data in duplicate. We calculated standardised mean differences (SMDs) and 95% confidence intervals (CI) for pain and function, and risk ratios for safety outcomes. We combined trials using an inverse-variance random-effects meta-analysis.\nMain results\nWe identified 12 additional trials and included 22 trials with 8275 participants in this update. Oral oxycodone was studied in 10 trials, transdermal buprenorphine and oral tapentadol in four, oral codeine in three, oral morphine and oral oxymorphone in two, and transdermal fentanyl and oral hydromorphone in one trial each. All trials were described as double-blind, but the risk of bias for other domains was unclear in several trials due to incomplete reporting. Opioids were more beneficial in pain reduction than control interventions (SMD -0.28, 95% CI -0.35 to -0.20), which corresponds to a difference in pain scores of 0.7 cm on a 10-cm visual analogue scale (VAS) between opioids and placebo. This corresponds to a difference in improvement of 12% (95% CI 9% to 15%) between opioids (41% mean improvement from baseline) and placebo (29% mean improvement from baseline), which translates into a number needed to treat (NNTB) to cause one additional treatment response on pain of 10 (95% CI 8 to 14). Improvement of function was larger in opioid-treated participants compared with control groups (SMD -0.26, 95% CI -0.35 to -0.17), which corresponds to a difference in function scores of 0.6 units between opioids and placebo on a standardised Western Ontario and McMaster Universities Arthritis Index (WOMAC) disability scale ranging from 0 to 10. This corresponds to a difference in improvement of 11% (95% CI 7% to 14%) between opioids (32% mean improvement from baseline) and placebo (21% mean improvement from baseline), which translates into an NNTB to cause one additional treatment response on function of 11 (95% CI 7 to 14). We did not find substantial differences in effects according to type of opioid, analgesic potency, route of administration, daily dose, methodological quality of trials, and type of funding. Trials with treatment durations of four weeks or less showed larger pain relief than trials with longer treatment duration (P value for interaction = 0.001) and there was evidence for funnel plot asymmetry (P value = 0.054 for pain and P value = 0.011 for function). Adverse events were more frequent in participants receiving opioids compared with control. The pooled risk ratio was 1.49 (95% CI 1.35 to 1.63) for any adverse event (9 trials; 22% of participants in opioid and 15% of participants in control treatment experienced side effects), 3.76 (95% CI 2.93 to 4.82) for drop-outs due to adverse events (19 trials; 6.4% of participants in opioid and 1.7% of participants in control treatment dropped out due to adverse events), and 3.35 (95% CI 0.83 to 13.56) for serious adverse events (2 trials; 1.3% of participants in opioid and 0.4% of participants in control treatment experienced serious adverse events). Withdrawal symptoms occurred more often in opioid compared with control treatment (odds ratio (OR) 2.76, 95% CI 2.02 to 3.77; 3 trials; 2.4% of participants in opioid and 0.9% of participants control treatment experienced withdrawal symptoms).\nAuthors' conclusions\nThe small mean benefit of non-tramadol opioids are contrasted by significant increases in the risk of adverse events. For the pain outcome in particular, observed effects were of questionable clinical relevance since the 95% CI did not include the minimal clinically important difference of 0.37 SMDs, which corresponds to 0.9 cm on a 10-cm VAS.\n\nGiven the provided abstract, please respond to the following query: \"Withdrawal symptoms\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- 24 people out of 1000 who used opioids experienced withdrawal symptoms (2.4%).\n- 9 people out of 1000 who used a placebo experienced withdrawal symptoms (0.9%).\n- 15 more people experienced withdrawal symptoms with opioids than with placebo (difference of 1.5%). (Moderate-quality evidence)"
}
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query-laysum | 4026 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical resection is the only potentially curative treatment for pancreatic and periampullary cancer. A considerable proportion of patients undergo unnecessary laparotomy because of underestimation of the extent of the cancer on computed tomography (CT) scanning. Laparoscopy can detect metastases not visualised on CT scanning, enabling better assessment of the spread of cancer (staging of cancer). This is an update to a previous Cochrane Review published in 2013 evaluating the role of diagnostic laparoscopy in assessing the resectability with curative intent in people with pancreatic and periampullary cancer.\nObjectives\nTo determine the diagnostic accuracy of diagnostic laparoscopy performed as an add-on test to CT scanning in the assessment of curative resectability in pancreatic and periampullary cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via PubMed, EMBASE via OvidSP (from inception to 15 May 2016), and Science Citation Index Expanded (from 1980 to 15 May 2016).\nSelection criteria\nWe included diagnostic accuracy studies of diagnostic laparoscopy in people with potentially resectable pancreatic and periampullary cancer on CT scan, where confirmation of liver or peritoneal involvement was by histopathological examination of suspicious (liver or peritoneal) lesions obtained at diagnostic laparoscopy or laparotomy. We accepted any criteria of resectability used in the studies. We included studies irrespective of language, publication status, or study design (prospective or retrospective). We excluded case-control studies.\nData collection and analysis\nTwo review authors independently performed data extraction and quality assessment using the QUADAS-2 tool. The specificity of diagnostic laparoscopy in all studies was 1 because there were no false positives since laparoscopy and the reference standard are one and the same if histological examination after diagnostic laparoscopy is positive. The sensitivities were therefore meta-analysed using a univariate random-effects logistic regression model. The probability of unresectability in people who had a negative laparoscopy (post-test probability for people with a negative test result) was calculated using the median probability of unresectability (pre-test probability) from the included studies, and the negative likelihood ratio derived from the model (specificity of 1 assumed). The difference between the pre-test and post-test probabilities gave the overall added value of diagnostic laparoscopy compared to the standard practice of CT scan staging alone.\nMain results\nWe included 16 studies with a total of 1146 participants in the meta-analysis. Only one study including 52 participants had a low risk of bias and low applicability concern in the patient selection domain. The median pre-test probability of unresectable disease after CT scanning across studies was 41.4% (that is 41 out of 100 participants who had resectable cancer after CT scan were found to have unresectable disease on laparotomy). The summary sensitivity of diagnostic laparoscopy was 64.4% (95% confidence interval (CI) 50.1% to 76.6%). Assuming a pre-test probability of 41.4%, the post-test probability of unresectable disease for participants with a negative test result was 0.20 (95% CI 0.15 to 0.27). This indicates that if a person is said to have resectable disease after diagnostic laparoscopy and CT scan, there is a 20% probability that their cancer will be unresectable compared to a 41% probability for those receiving CT alone.\nA subgroup analysis of people with pancreatic cancer gave a summary sensitivity of 67.9% (95% CI 41.1% to 86.5%). The post-test probability of unresectable disease after being considered resectable on both CT and diagnostic laparoscopy was 18% compared to 40.0% for those receiving CT alone.\nAuthors' conclusions\nDiagnostic laparoscopy may decrease the rate of unnecessary laparotomy in people with pancreatic and periampullary cancer found to have resectable disease on CT scan. On average, using diagnostic laparoscopy with biopsy and histopathological confirmation of suspicious lesions prior to laparotomy would avoid 21 unnecessary laparotomies in 100 people in whom resection of cancer with curative intent is planned.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The pancreas is an organ situated in the abdomen close to the junction of the stomach and small bowel. It secretes digestive juices which are necessary for the digestion of all food materials. The digestive juices secreted in the pancreas drain into the upper part of the small bowel via the pancreatic duct. The bile duct is a tube which drains bile from the liver and gallbladder. The pancreatic and bile ducts share a common path just before they drain into the small bowel. This area is called the periampullary region. Surgical removal is the only potentially curative treatment for cancers arising from the pancreatic and periampullary regions. A considerable proportion of patients undergo unnecessary major open abdominal exploratory operation (laparotomy) because their CT scan has underestimated the spread of cancer. If during the major open operation the cancer is found to have spread within the abdomen, patients are referred for alternate treatments such as chemotherapy, which do not cure the cancer but may improve survival.\nThis major open abdominal operation can be avoided if the spread of cancer within the abdomen is known, called 'staging' the cancer. The minimum test used for staging is usually the computed tomography (CT) scan. However, CT scan can understage the cancer, that is it can underestimate the spread of cancer. Laparoscopy, a procedure whereby a small telescope is inserted inside the abdomen through a small (keyhole) surgical incision, can detect spread not identified on CT scanning. Different studies report different accuracy of laparoscopy in assessing whether the cancer can be removed. Our aim therefore was to find out the average diagnostic accuracy of laparoscopy for staging pancreatic and periampullary cancers considered to be removable after a CT scan. This review is an update of our previous review.\nA glossary of terms is provided in Appendix 1."
}
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query-laysum | 4027 | [
{
"role": "user",
"content": "Abstract: Background\nThis article describes the second update of a Cochrane review on the effectiveness of laxatives for the management of constipation in people receiving palliative care. Previous versions were published in 2006 and 2010 where we also evaluated trials of methylnaltrexone; these trials have been removed as they are included in another review in press. In these earlier versions, we drew no conclusions on individual effectiveness of different laxatives because of the limited number of evaluations. This is despite constipation being common in palliative care, generating considerable suffering due to the unpleasant physical symptoms and the availability of a wide range of laxatives with known differences in effect in other populations.\nObjectives\nTo determine the effectiveness and differential efficacy of laxatives used to manage constipation in people receiving palliative care.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), MEDLINE, EMBASE, CINAHL and Web of Science (SCI & CPCI-S) for trials to September 2014.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating laxatives for constipation in people receiving palliative care.\nData collection and analysis\nTwo authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity.\nMain results\nWe identified five studies involving the laxatives lactulose, senna, co-danthramer, misrakasneham, docusate and magnesium hydroxide with liquid paraffin. Overall, the study findings were at an unclear risk of bias. As all five studies compared different laxatives or combinations of laxatives, it was not possible to perform a meta-analysis. There was no evidence on whether individual laxatives were more effective than others or caused fewer adverse effects.\nAuthors' conclusions\nThis second update found that laxatives were of similar effectiveness but the evidence remains limited due to insufficient data from a few small RCTs. None of the studies evaluated polyethylene glycol or any intervention given rectally. There is a need for more trials to evaluate the effectiveness of laxatives in palliative care populations. Extrapolating findings on the effectiveness of laxatives evaluated in other populations should proceed with caution. This is because of the differences inherent in people receiving palliative care that may impact, in a likely negative way, on the effect of a laxative.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified five studies involving 370 people. The laxatives evaluated were lactulose, senna, co-danthramer combined with poloxamer, docusate and magnesium hydroxide combined with liquid paraffin. Misrakasneham was also evaluated; this is a traditional Indian medicine and is used as a laxative, containing castor oil, ghee, milk and 21 types of herbs.\nThere was no evidence on which laxative provided the best treatment. However, the review was limited as the evidence was from only five small trials and patient preference and cost were under evaluated. Further rigorous, independent trials are needed to evaluate the effectiveness of laxatives."
}
]
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query-laysum | 4028 | [
{
"role": "user",
"content": "Abstract: Background\nIdiopathic intracranial hypertension (IIH) has an estimated incidence of one to three people per 100,000 people per year, and occurs most commonly in obese, young women. IIH is associated with severe morbidity, notably due to a significant threat to sight and severe headache. Several different management options have been proposed. Conservative measures centre on weight loss. Pharmacological therapy includes use of diuretics. Refractory and sight-threatening cases demand surgical intervention, most often in the form of cerebrospinal fluid (CSF) diversion or optic nerve sheath fenestration. Other treatments include venous sinus stenting and bariatric surgery.\nObjectives\nTo assess the effects of any intervention for IIH in any patient group.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015 Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2015), EMBASE (January 1980 to July 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 22 July 2015.\nSelection criteria\nWe included only randomised controlled trials (RCTs) in which any intervention was compared to placebo, or to another form of treatment, for people with a clinical diagnosis of IIH.\nData collection and analysis\nTwo review authors independently assessed the search results for trials to be included in the review. We resolved any discrepancies by third party decision.\nMain results\nWe identified two completed RCTs (enrolling a total of 211 participants and conducted in the UK and US) and two ongoing trials that met the inclusion criteria. Both completed trials compared acetazolamide to placebo, in conjunction with a weight loss intervention in both groups. Attrition bias was a problem in both trials with high loss to follow-up, in one study this loss to follow-up occurred particularly in the acetazolamide arm. One trial was unmasked and we judged it to be at risk of performance and detection bias.\nIn these studies, change in visual acuity was similar in the treatment and control groups as measured by logMAR acuity. In one study people in the acetalomazide group had a similar change in logMAR acuity compared to the placebo group between baseline and 12 months in the right eye (MD 0.04 logMAR, 95% CI -0.08 to 0.16) and left eye (MD 0.03 logMAR, 95% CI -0.09 to 0.15). In the other study people in the acetalomazide group had a similar change in vision over six months compared with people in the placebo group (mean difference in change in letters read was 0.01 (95% CI -1.45 to 1.46). One study reported no cases of visual loss in 21 people treated with acetalomazide compared to 2/20 cases in the placebo group (odds ratio 0.17, 95% CI 0.01, 3.82).\nThe prespecified outcome for this review was reduction in CSF pressure to normal levels which was not reported by the two trials. One trial reported that, in a subsample of 85 participants who agreed to lumbar puncture at 6 months, people in the acetalomazide group on average had a greater reduction in CSF pressure (MD -59.9 mmH2O, 95% CI -96.4, -23.4).\nIn one study, people in the acetalozamide group on average experienced a greater reduction in papilloedema as assessed by fundus photographs MD -0.70 (95% CI -1.00 to -0.40) and by clinical grading MD -0.91 (95% CI -1.27 to -0.54) between baseline and six months in the study eye.\nHeadache was recorded as present/absent in one study at 12 months (OR 0.42, 95% CI 0.12,1.41, 41 participants). Both studies reported headache on visual analogue scales (different ones) but results were inconclusive (MD for change in headache score measured on 10-point visual analogue scale at 12 months was 1.0 (-1.80, 3.70, 41 participants) and MD for change in headache score on a 6 point scale measured at 6 months was -0.45 (-3.5,2.6, number of participants unclear).\nIn one study, a similar proportion of people in the acetalomazide group were in remission (however, the trial authors did not state their definition of this term) at 12 months compared to the placebo group. However, the 95% CIs were wide and there is considerable uncertainty as to the effect (OR 1.13 (95% CI 0.32 to 3.90, 41 participants).\nIn one study of 185 participants, people in the acetalomazide group had an increased risk of decreased CO2, diarrhoea, dysgeusia, fatigue, nausea, paresthesia, tinnitus and vomiting compared to people in the placebo group. In general, the estimates of effect were uncertain with wide 95% CIs. Adverse effects were not reported in the other study.\nOne study reported that quality of life was better in acetazolamide-treated patients based on the visual quality of life (VFQ-25) (MD 6.35, 95% CI 2.22 to 10.47) and the physical (MD 3.02, 95% CI 0.34 to 5.70) and mental (MD 3.45, 95% CI 0.35 to 6.55) components of the 36-Item Short Form Health Survey tool at six months. Costs were not reported in either study.\nWe judged the evidence to be low certainty (GRADE) downgrading for imprecision and risk of bias.\nAuthors' conclusions\nAlthough the two included RCTs showed modest benefits for acetazolamide for some outcomes, there is insufficient evidence to recommend or reject the efficacy of this intervention, or any other treatments currently available, for treating people with IIH. Further high-quality RCTs are required in order to adequately assess the effect of acetazolamide therapy in people with IIH.\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 included two completed RCTs from the UK and US with a total of 211 participants and two ongoing studies. Both completed trials compared acetazolamide to placebo, together with a weight loss intervention in both groups.\nIn these studies, change in the participant’s central vision was similar in the treatment and control groups as measured by a logMAR chart (a chart with rows of letters). The outcome for this review was reduction in CSF pressure to normal levels which was not reported by the two trials. In one study, people in the acetalozamide group on average experienced a greater reduction in papilloedema as assessed by fundus photographs between baseline and six months in the study eye. Both studies reported headache on visual analogue scales but results were inconclusive. In the study that reported adverse effects, the acetazolamide group was found to have a greater number of adverse effects compared to the placebo controls including diarrhoea, nausea, tinnitus and fatigue. One study reported that quality of life was better for the acetazolamide-treated group. Costs were not reported in either study."
}
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query-laysum | 4029 | [
{
"role": "user",
"content": "Abstract: Background\nCurrent cancer care increasingly incorporates psychosocial interventions. Cancer patients use dance/movement therapy to learn to accept and reconnect with their bodies, build new self-confidence, enhance self-expression, address feelings of isolation, depression, anger and fear and to strengthen personal resources.\nObjectives\nTo update the previously published review that examined the effects of dance/movement therapy and standard care versus standard care alone or standard care and other interventions on psychological and physical outcomes in patients with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 6), MEDLINE (OvidSP, 1950 to June week 4, 2014), EMBASE (OvidSP, 1980 to 2014 week 26), CINAHL (EBSCOhost, 1982 to July 15 2014), PsycINFO (EBSCOhost, 1806 to July 15 2014), LILACS (Virual Health Library, 1982 to July 15 2014), Science Citation Index (ISI, 1974 to July 15 2014), CancerLit (1983 to 2003), International Bibliography of Theatre and Dance (1989 to July 15 2014), the National Research Register (2000 to September 2007), Proquest Digital Dissertations, ClinicalTrials.gov, and Current Controlled Trials (all to July 15 2014). We handsearched dance/movement therapy and related topics journals, reviewed reference lists and contacted experts. There was no language restriction.\nSelection criteria\nWe included all randomized and quasi-randomized controlled trials of dance/movement therapy interventions for improving psychological and physical outcomes in patients with cancer. We considered studies only if dance/movement therapy was provided by a formally trained dance/movement therapist or by trainees in a formal dance/movement therapy program.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the methodological quality, seeking additional information from the trial researchers when necessary. Results were presented using standardized mean differences.\nMain results\nWe identified one new trial for inclusion in this update. In total, the evidence for this review rests on three studies with a total of 207 participants.\nWe found no evidence for an effect of dance/movement therapy on depression (standardized mean difference (SMD) = 0.02, 95% confidence interval (CI) -0.28 to 0.32, P = 0.89, I2 = 0%) (two studies, N = 170), stress (SMD = -0.18, 95% CI -0.48 to 0.12, P = 0.24, I2 = 0%) (two studies, N = 170), anxiety (SMD = 0.21, 95% CI -0.09 to 0.51 P = 0.18, I2 = 0%) (two studies, N = 170), fatigue (SMD = -0.36, 95% -1.26 to 0.55, P = 0.44, I² = 80%) (two studies, N = 170) and body image (SMD = -0.13, 95% CI -0.61 to 0.34, P = 0.58, I2 = 0%) (two studies, N = 68) in women with breast cancer. The data of one study with moderate risk of bias suggested that dance/movement therapy had a large beneficial effect on 37 participants' quality of life (QoL) (SMD = 0.89, 95% CI 0.21 to 1.57). One study with a high risk of bias reported greater improvements in vigor and greater reduction in somatization in the dance/movement therapy group compared to a standard care control group (N = 31). The individual studies did not find support for an effect of dance/movement therapy on mood, mental health, and pain. It is unclear whether this was due to ineffectiveness of the treatment, inappropriate outcome measures or limited power of the trials. Finally, the results of one study did not find evidence for an effect of dance/movement therapy on shoulder range of motion (ROM) or arm circumference in 37 women who underwent a lumpectomy or breast surgery. However, this was likely due to large within-group variability for shoulder ROM and a limited number of participants with lymphedema.\nTwo studies presented moderate risk of bias and one study high risk of bias. Therefore, overall, the quality of the evidence is very low.\nAuthors' conclusions\nWe did not find support for an effect of dance/movement therapy on depression, stress, anxiety, fatigue and body image. The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on QoL, somatization, and vigor. However, the limited number of studies prevents us from drawing conclusions concerning the effects of dance/movement therapy on psychological and physical outcomes in cancer patients.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is an update of a previous Cochrane review from 2011, which included two studies which did not find support for an effect of dance/movement therapy on body image, the only common outcome between the two studies. The aim was to examine the impact of dance/movement therapy on psychological and physical outcomes in people with cancer.\nFor this review update, we searched for additional trials on the effect of dance/movement therapy on psychological and physical outcomes in people with cancer. We searched for published and ongoing studies up toJuly 2014. We considered all studies in which dance/movement therapy was compared with any form of standard treatment."
}
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query-laysum | 4030 | [
{
"role": "user",
"content": "Abstract: Background\nComplete deletion of both the short arm of chromosome 1 (1p) and the long arm of chromosome 19 (19q), known as 1p/19q codeletion, is a mutation that can occur in gliomas. It occurs in a type of glioma known as oligodendroglioma and its higher grade counterpart known as anaplastic oligodendroglioma. Detection of 1p/19q codeletion in gliomas is important because, together with another mutation in an enzyme known as isocitrate dehydrogenase, it is needed to make the diagnosis of an oligodendroglioma. Presence of 1p/19q codeletion also informs patient prognosis and prediction of the best drug treatment. The main two tests in use are fluorescent in situ hybridisation (FISH) and polymerase chain reaction (PCR)-based loss of heterozygosity (LOH) assays (also known as PCR-based short tandem repeat or microsatellite analysis). Many other tests are available. None of the tests is perfect, although PCR-based LOH is expected to have very high sensitivity.\nObjectives\nTo estimate the sensitivity and specificity and cost-effectiveness of different deoxyribonucleic acid (DNA)-based techniques for determining 1p/19q codeletion status in glioma.\nSearch methods\nWe searched MEDLINE, Embase and BIOSIS up to July 2019. There were no restrictions based on language or date of publication. We sought economic evaluation studies from the results of this search and using the National Health Service Economic Evaluation Database.\nSelection criteria\nWe included cross-sectional studies in adults with glioma or any subtype of glioma, presenting raw data or cross-tabulations of two or more DNA-based tests for 1p/19q codeletion. We also sought economic evaluations of these tests.\nData collection and analysis\nWe followed procedures outlined in the Cochrane Handbook for Diagnostic Test Accuracy Reviews. Two review authors independently screened titles/abstracts/full texts, performed data extraction, and undertook applicability and risk of bias assessments using QUADAS-2. Meta-analyses used the hierarchical summary ROC model to estimate and compare test accuracy. We used FISH and PCR-based LOH as alternate reference standards to examine how tests compared with those in common use, and conducted a latent class analysis comparing FISH and PCR-based LOH. We constructed an economic model to evaluate cost-effectiveness.\nMain results\nWe included 53 studies examining: PCR-based LOH, FISH, single nucleotide polymorphism (SNP) array, next-generation sequencing (NGS), comparative genomic hybridisation (CGH), array comparative genomic hybridisation (aCGH), multiplex-ligation-dependent probe amplification (MLPA), real-time PCR, chromogenic in situ hybridisation (CISH), mass spectrometry (MS), restriction fragment length polymorphism (RFLP) analysis, G-banding, methylation array and NanoString. Risk of bias was low for only one study; most gave us concerns about how patients were selected or about missing data. We had applicability concerns about many of the studies because only patients with specific subtypes of glioma were included. 1520 participants contributed to analyses using FISH as the reference, 1304 participants to analyses involving PCR-based LOH as the reference and 262 participants to analyses of comparisons between methods from studies not including FISH or PCR-based LOH.\nMost evidence was available for comparison of FISH with PCR-based LOH (15 studies, 915 participants): PCR-based LOH detected 94% of FISH-determined codeletions (95% credible interval (CrI) 83% to 98%) and FISH detected 91% of codeletions determined by PCR-based LOH (CrI 78% to 97%). Of tumours determined not to have a deletion by FISH, 94% (CrI 87% to 98%) had a deletion detected by PCR-based LOH, and of those determined not to have a deletion by PCR-based LOH, 96% (CrI 90% to 99%) had a deletion detected by FISH. The latent class analysis suggested that PCR-based LOH may be slightly more accurate than FISH. Most other techniques appeared to have high sensitivity (i.e. produced few false-negative results) for detection of 1p/19q codeletion when either FISH or PCR-based LOH was considered as the reference standard, although there was limited evidence. There was some indication of differences in specificity (false-positive rate) with some techniques. Both NGS and SNP array had high specificity when considered against FISH as the reference standard (NGS: 6 studies, 243 participants; SNP: 6 studies, 111 participants), although we rated certainty in the evidence as low or very low. NGS and SNP array also had high specificity when PCR-based LOH was considered the reference standard, although with much more uncertainty as these results were based on fewer studies (just one study with 49 participants for NGS and two studies with 33 participants for SNP array).\nG-banding had low sensitivity and specificity when PCR-based LOH was the reference standard. Although MS had very high sensitivity and specificity when both FISH and PCR-based LOH were considered the reference standard, these results were based on only one study with a small number of participants. Real-time PCR also showed high specificity with FISH as a reference standard, although there were only two studies including 40 participants.\nWe found no relevant economic evaluations. Our economic model using FISH as the reference standard suggested that the resource-optimising test depends on which measure of diagnostic accuracy is most important. With FISH as the reference standard, MLPA is likely to be cost-effective if society was willing to pay GBP 1000 or less for a true positive detected. However, as the value placed on a true positive increased, CISH was most cost-effective. Findings differed when the outcome measure changed to either true negative detected or correct diagnosis. When PCR-based LOH was used as the reference standard, MLPA was likely to be cost-effective for all measures of diagnostic accuracy at lower threshold values for willingness to pay. However, as the threshold values increased, none of the tests were clearly more likely to be considered cost-effective.\nAuthors' conclusions\nIn our review, most techniques (except G-banding) appeared to have good sensitivity (few false negatives) for detection of 1p/19q codeletions in glioma against both FISH and PCR-based LOH as a reference standard. However, we judged the certainty of the evidence low or very low for all the tests. There are possible differences in specificity, with both NGS and SNP array having high specificity (fewer false positives) for 1p/19q codeletion when considered against FISH as the reference standard. The economic analysis should be interpreted with caution due to the small number of studies.\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 wanted to find out which is the most accurate and cost-effective way to identify 1p/19q codeletion in gliomas."
}
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query-laysum | 4031 | [
{
"role": "user",
"content": "Abstract: Background\nInflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies.\nObjectives\nTo assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator.\nSearch methods\nA systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies.\nSelection criteria\nRandomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included.\nData collection and analysis\nTwo authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used.\nMain results\nWe included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy).\nElectroacupuncture\nFatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group.\nCognitive behavioural therapy (CBT) and solution-focused therapy\nCompared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants).\nPhysical activity advice\nOne 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group.\nPharmacological interventions\nCompared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence).\nFerric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence)\nAuthors' conclusions\nThe effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What are the effects of drug and non-drug treatments on fatigue in individuals with inflammatory bowel disease (IBD) compared to no treatment, placebo (e.g. a sugar pill) or active comparator (e.g. a known effective treatment)?"
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query-laysum | 4032 | [
{
"role": "user",
"content": "Abstract: Background\nVitamins and minerals play multiple functions within the central nervous system which may help to maintain brain health and optimal cognitive functioning. Supplementation of the diet with various vitamins and minerals has been suggested as a means of maintaining cognitive function, or even of preventing dementia, in later life.\nObjectives\nTo evaluate the effects of vitamin and mineral supplementation on cognitive function in cognitively healthy people aged 40 years or more.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group’s (CDCIG) specialised register, as well as MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov and the WHO Portal/ICTRP from inception to 26th January 2018.\nSelection criteria\nWe included randomised controlled trials that evaluated the cognitive effects on people aged 40 years or more of any vitamin or mineral supplements taken by mouth for at least three months.\nData collection and analysis\nStudy selection, data extraction, and quality assessments were done in duplicate. Vitamins were considered broadly in the categories of B vitamins, antioxidant vitamins, and combinations of both. Minerals were considered separately, where possible. If interventions and outcomes were considered sufficiently similar, then data were pooled. In order to separate short-term cognitive effects from possible longer-term effects on the trajectory of cognitive decline, data were pooled for various treatment durations from 3 months to 12 months and up to 10 years or more.\nMain results\nIn total, we included 28 studies with more than 83,000 participants. There were some general limitations of the evidence. Most participants were enrolled in studies which were not designed primarily to assess cognition. These studies often had no baseline cognitive assessment and used only brief cognitive assessments at follow-up. Very few studies assessed the incidence of dementia. Most study reports did not mention adverse events or made only very general statements about them. Only 10 studies had a mean follow-up > 5 years. Only two studies had participants whose mean age was < 60 years at baseline. The risk of bias in the included studies was generally low, other than a risk of attrition bias for longer-term outcomes. We considered the certainty of the evidence behind almost all results to be moderate or low.\nWe included 14 studies with 27,882 participants which compared folic acid, vitamin B12, vitamin B6, or a combination of these to placebo. The majority of participants were aged over 60 years and had a history of cardio- or cerebrovascular disease. We found that giving B vitamin supplements to cognitively healthy adults, mainly in their 60s and 70s, probably has little or no effect on global cognitive function at any time point up to 5 years (SMD values from -0.03 to 0.06) and may also have no effect at 5-10 years (SMD -0.01). There were very sparse data on adverse effects or on incidence of cognitive impairment or dementia.\nWe included 8 studies with 47,840 participants in which the active intervention was one or more of the antioxidant vitamins: ß-carotene, vitamin C or vitamin E. Results were mixed. For overall cognitive function, there was low-certainty evidence of benefit associated with ß-carotene after a mean of 18 years of treatment (MD 0.18 TICS points, 95% CI 0.01 to 0.35) and of vitamin C after 5 years to 10 years (MD 0.46 TICS points, 95% CI 0.14 to 0.78), but not at earlier time points. From two studies which reported on dementia incidence, there was low-certainty evidence of no effect of an antioxidant vitamin combination or of vitamin E, either alone or combined with selenium. One of the included studies had been designed to look for effects on the incidence of prostate cancer; it found a statistically significant increase in prostate cancer diagnoses among men taking vitamin E.\nOne trial with 4143 participants compared vitamin D3 (400 IU/day) and calcium supplements to placebo. We found low- to moderate-certainty evidence of no effect of vitamin D3 and calcium supplements at any time-point up to 10 years on overall cognitive function (MD after a mean of 7.8 years -0.1 MMSE points, 95% CI -0.81 to 0.61) or the incidence of dementia (HR 0.94, 95% CI 0.72 to 1.24). A pilot study with 60 participants used a higher dose of vitamin D3 (4000 IU on alternate days) and found preliminary evidence that this dose probably has no effect on cognitive function over six months.\nWe included data from one trial of zinc and copper supplementation with 1072 participants. There was moderate-certainty evidence of little or no effect on overall cognitive function (MD 0.6 MMSE points, 95% CI -0.19 to 1.39) or on the incidence of cognitive impairment after 5 years to 10 years. A second smaller trial provided no usable data, but reported no cognitive effects of six months of supplementation with zinc gluconate.\nFrom one study with 3711 participants, there was low-certainty evidence of no effect of approximately five years of selenium supplementation on the incidence of dementia (HR 0.83, 95% CI 0.61 to 1.13).\nFinally, we included three trials of complex supplements (combinations of B vitamins, antioxidant vitamins, and minerals) with 6306 participants. From the one trial which assessed overall cognitive function, there was low-certainty evidence of little or no effect on the TICS (MD after a mean of 8.5 years 0.12, 95% CI -0.14 to 0.38).\nAuthors' conclusions\nWe did not find evidence that any vitamin or mineral supplementation strategy for cognitively healthy adults in mid or late life has a meaningful effect on cognitive decline or dementia, although the evidence does not permit definitive conclusions. There were very few data on supplementation starting in midlife (< 60 years); studies designed to assess cognitive outcomes tended to be too short to assess maintenance of cognitive function; longer studies often had other primary outcomes and used cognitive measures which may have lacked sensitivity. The only positive signals of effect came from studies of long-term supplementation with antioxidant vitamins. These may be the most promising for further research.\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": "There is great interest in anything people might do to keep themselves mentally healthy as they age and, especially, to reduce their risk of developing dementia. Various vitamin and mineral supplements have been suggested as ways to do this. Vitamins and minerals have many functions in the body and the ways they might affect brain health are not well understood. Therefore, we were interested in the effects of any vitamins or minerals, either alone or in combination."
}
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query-laysum | 4033 | [
{
"role": "user",
"content": "Abstract: Background\nHodgkin lymphoma (HL) is one of the most common haematological malignancies in young adults and, with cure rates of 90%, has become curable for the majority of individuals. Positron emission tomography (PET) is an imaging tool used to monitor a tumour’s metabolic activity, stage and progression. Interim PET during chemotherapy has been posited as a prognostic factor in individuals with HL to distinguish between those with a poor prognosis and those with a better prognosis. This distinction is important to inform decision-making on the clinical pathway of individuals with HL.\nObjectives\nTo determine whether in previously untreated adults with HL receiving first-line therapy, interim PET scan results can distinguish between those with a poor prognosis and those with a better prognosis, and thereby predict survival outcomes in each group.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL and conference proceedings up until April 2019. We also searched one trial registry (ClinicalTrials.gov).\nSelection criteria\nWe included retrospective and prospective studies evaluating interim PET scans in a minimum of 10 individuals with HL (all stages) undergoing first-line therapy. Interim PET was defined as conducted during therapy (after one, two, three or four treatment cycles). The minimum follow-up period was at least 12 months. We excluded studies if the trial design allowed treatment modification based on the interim PET scan results.\nData collection and analysis\nWe developed a data extraction form according to the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS). Two teams of two review authors independently screened the studies, extracted data on overall survival (OS), progression-free survival (PFS) and PET-associated adverse events (AEs), assessed risk of bias (per outcome) according to the Quality in Prognosis Studies (QUIPS) tool, and assessed the certainty of the evidence (GRADE). We contacted investigators to obtain missing information and data.\nMain results\nOur literature search yielded 11,277 results. In total, we included 23 studies (99 references) with 7335 newly-diagnosed individuals with classic HL (all stages).\nParticipants in 16 studies underwent (interim) PET combined with computed tomography (PET-CT), compared to PET only in the remaining seven studies. The standard chemotherapy regimen included ABVD (16) studies, compared to BEACOPP or other regimens (seven studies). Most studies (N = 21) conducted interim PET scans after two cycles (PET2) of chemotherapy, although PET1, PET3 and PET4 were also reported in some studies. In the meta-analyses, we used PET2 data if available as we wanted to ensure homogeneity between studies. In most studies interim PET scan results were evaluated according to the Deauville 5-point scale (N = 12).\nEight studies were not included in meta-analyses due to missing information and/or data; results were reported narratively. For the remaining studies, we pooled the unadjusted hazard ratio (HR). The timing of the outcome measurement was after two or three years (the median follow-up time ranged from 22 to 65 months) in the pooled studies.\nEight studies explored the independent prognostic ability of interim PET by adjusting for other established prognostic factors (e.g. disease stage, B symptoms). We did not pool the results because the multivariable analyses adjusted for a different set of factors in each study.\nOverall survival\nTwelve (out of 23) studies reported OS. Six of these were assessed as low risk of bias in all of the first four domains of QUIPS (study participation, study attrition, prognostic factor measurement and outcome measurement). The other six studies were assessed as unclear, moderate or high risk of bias in at least one of these four domains. Four studies were assessed as low risk, and eight studies as high risk of bias for the domain other prognostic factors (covariates). Nine studies were assessed as low risk, and three studies as high risk of bias for the domain 'statistical analysis and reporting'.\nWe pooled nine studies with 1802 participants. Participants with HL who have a negative interim PET scan result probably have a large advantage in OS compared to those with a positive interim PET scan result (unadjusted HR 5.09, 95% confidence interval (CI) 2.64 to 9.81, I² = 44%, moderate-certainty evidence). In absolute values, this means that 900 out of 1000 participants with a negative interim PET scan result will probably survive longer than three years compared to 585 (95% CI 356 to 757) out of 1000 participants with a positive result.\nAdjusted results from two studies also indicate an independent prognostic value of interim PET scan results (moderate-certainty evidence).\nProgression-free survival\nTwenty-one studies reported PFS. Eleven out of 21 were assessed as low risk of bias in the first four domains. The remaining were assessed as unclear, moderate or high risk of bias in at least one of the four domains. Eleven studies were assessed as low risk, and ten studies as high risk of bias for the domain other prognostic factors (covariates). Eight studies were assessed as high risk, thirteen as low risk of bias for statistical analysis and reporting.\nWe pooled 14 studies with 2079 participants. Participants who have a negative interim PET scan result may have an advantage in PFS compared to those with a positive interim PET scan result, but the evidence is very uncertain (unadjusted HR 4.90, 95% CI 3.47 to 6.90, I² = 45%, very low-certainty evidence). This means that 850 out of 1000 participants with a negative interim PET scan result may be progression-free longer than three years compared to 451 (95% CI 326 to 569) out of 1000 participants with a positive result.\nAdjusted results (not pooled) from eight studies also indicate that there may be an independent prognostic value of interim PET scan results (low-certainty evidence).\nPET-associated adverse events\nNo study measured PET-associated AEs.\nAuthors' conclusions\nThis review provides moderate-certainty evidence that interim PET scan results predict OS, and very low-certainty evidence that interim PET scan results predict progression-free survival in treated individuals with HL. This evidence is primarily based on unadjusted data. More studies are needed to test the adjusted prognostic ability of interim PET against established prognostic factors.\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 23 studies to explore the association between interim PET scan results after one to four cycles of chemotherapy and survival outcomes in adults with HL (all stages). We contacted 10 authors, and six provided us with relevant information and/or data."
}
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query-laysum | 4034 | [
{
"role": "user",
"content": "Abstract: Background\nNeonatal sepsis and necrotizing enterocolitis (NEC) cause significant neonatal mortality and morbidity despite appropriate antibiotic therapy. Enhancing host defense and modulating inflammation by using lactoferrin as an adjunct to antibiotics in the treatment of sepsis, NEC, or both, may improve clinical outcomes.\nObjectives\nThe primary objective was to assess safety and efficacy of oral lactoferrin as an adjunct to antibiotics in the treatment of neonates with suspected or confirmed sepsis, NEC, or both.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 9), MEDLINE via PubMed, PREMEDLINE, (1966 to 20 September 2018) Embase (1980 to 20 September 2018), and CINAHL (1982 to 20 September 2018). We also searched clinical trial databases, conference proceedings, the reference lists of retried articles and clinical trials, and the authors' personal files.\nSelection criteria\nWe included randomized or quasi-randomized controlled trials evaluating enteral lactoferrin (at any dose or duration), used as an adjunct to antibiotic therapy, compared with antibiotic therapy alone (with or without placebo) or other adjuncts to antibiotic therapy to treat neonates at any gestational age up to 44 weeks' postmenstrual age with confirmed or suspected sepsis or necrotizing enterocolitis (Bell's Stage II or III).\nData collection and analysis\nWe used the standardized methods of Cochrane Neonatal for conducting a systematic review and for assessing the methodological quality of studies (neonatal.cochrane.org/en/index.html). The titles and the abstracts of studies identified by the search strategy were independently assessed by the two review authors and full text versions were obtained for assessment if necessary. Forms were designed to record trial inclusion/exclusion and data extraction. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe did not identify any eligible trials evaluating lactoferrin for the treatment of neonatal sepsis or NEC.\nAuthors' conclusions\nImplications for practice: currently there is no evidence to support or refute the use of enteral lactoferrin, as an adjunct to antibiotic therapy, for the treatment of neonatal sepsis or necrotizing enterocolitis.\nImplications for research: given the lack of efficacy of enteral lactoferrin for preventing late-onset sepsis and necrotizing enterocolitis, evaluation of enteral lactoferrin as an adjunctive agent for treatment of sepsis or necrotizing enterocolitis does not appear to be a research priority.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that used lactoferrin supplementation feeds to treat babies with infection or gastrointestinal injury."
}
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query-laysum | 4035 | [
{
"role": "user",
"content": "Abstract: Background\nRoutine monitoring of gastric residuals in preterm infants on tube feeds is a common practice in neonatal intensive care units used to guide initiation and advancement of enteral feeding. There is a paucity of consensus on whether to re-feed or discard the aspirated gastric residuals. While re-feeding gastric residuals may aid in digestion and promote gastrointestinal motility and maturation by replacing partially digested milk, gastrointestinal enzymes, hormones, and trophic substances, abnormal residuals may result in vomiting, necrotising enterocolitis, or sepsis.\nObjectives\nTo assess the efficacy and safety of re-feeding when compared to discarding gastric residuals in preterm infants.\nSearch methods\nSearches were conducted in February 2022 in Cochrane CENTRAL via CRS, Ovid MEDLINE and Embase, and CINAHL. We also searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe selected RCTs that compared re-feeding versus discarding gastric residuals in preterm infants.\nData collection and analysis\nReview authors assessed trial eligibility and risk of bias and extracted data, in duplicate. We analysed treatment effects in individual trials and reported the risk ratio (RR) for dichotomous data and the mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe found one eligible trial that included 72 preterm infants. The trial was unmasked but was otherwise of good methodological quality.\nRe-feeding gastric residual may have little or no effect on time to regain birth weight (MD 0.40 days, 95% CI −2.89 to 3.69; 59 infants; low-certainty evidence), risk of necrotising enterocolitis stage ≥ 2 or spontaneous intestinal perforation (RR 0.71, 95% CI 0.25 to 2.04; 72 infants; low-certainty evidence), all-cause mortality before hospital discharge (RR 0.50, 95% CI 0.14 to 1.85; 72 infants; low-certainty evidence), time to establish enteral feeds ≥ 120 mL/kg/d (MD −1.30 days, 95% CI −2.93 to 0.33; 59 infants; low-certainty evidence), number of total parenteral nutrition days (MD −0.30 days, 95% CI −2.07 to 1.47; 59 infants; low-certainty evidence), and risk of extrauterine growth restriction at discharge (RR 1.29, 95% CI 0.38 to 4.34; 59 infants; low-certainty evidence). We are uncertain as to the effect of re-feeding gastric residual on number of episodes of feed interruption lasting for ≥ 12 hours (RR 0.80, 95% CI 0.42 to 1.52; 59 infants; very low-certainty evidence).\nAuthors' conclusions\nWe found only limited data from one small unmasked trial on the efficacy and safety of re-feeding gastric residuals in preterm infants. Low-certainty evidence suggests re-feeding gastric residual may have little or no effect on important clinical outcomes such as necrotising enterocolitis, all-cause mortality before hospital discharge, time to establish enteral feeds, number of total parenteral nutrition days, and in-hospital weight gain. A large RCT is needed to assess the efficacy and safety of re-feeding of gastric residuals in preterm infants with adequate certainty of evidence to inform policy and practice.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does re-feeding (giving again) stomach aspirates (partially digested milk and gut hormones withdrawn from feeding tube) in premature babies promote growth without causing feeding problems?"
}
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query-laysum | 4036 | [
{
"role": "user",
"content": "Abstract: Background\nIn the treatment of children with mild persistent asthma, low-dose inhaled corticosteroids (ICS) are recommended as the preferred monotherapy (referred to as step 2 of therapy). In children with inadequate asthma control on low doses of ICS (step 2), asthma management guidelines recommend adding an anti-leukotriene agent to existing ICS as one of three therapeutic options to intensify therapy (step 3).\nObjectives\nTo compare the efficacy and safety of the combination of anti-leukotriene agents and ICS to the use of the same, an increased, or a tapering dose of ICS in children and adolescents with persistent asthma who remain symptomatic despite the use of maintenance ICS. In addition, we wished to determine the characteristics of people or treatments, if any, that influenced the magnitude of response attributable to the addition of anti-leukotrienes.\nSearch methods\nWe identified trials from the Cochrane Airways Group Specialised Register of Trials (CAGR), which were derived from systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, AMED, and CINAHL; and the handsearching of respiratory journals and meeting abstracts, as well as the www.clinicaltrials.gov website. The search was conducted until January 2013.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) conducted in children and adolescents, aged one to 18 years, with asthma, who remained symptomatic despite the use of a stable maintenance dose of ICS and in whom anti-leukotrienes were added to the ICS if they were compared to the same, an increased, or a tapering dose of ICS for at least four weeks.\nData collection and analysis\nWe used standard methods expected by The Cochrane Collaboration.\nMain results\nFive paediatric (parallel group or cross-over) trials met the inclusion criteria. We considered two (40%) trials to be at a low risk of bias. Four published trials, representing 559 children (aged ≥ six years) and adolescents with mild to moderate asthma, contributed data to the review. No trial enrolled preschoolers. All trials used montelukast as the anti-leukotriene agent administered for between four and 16 weeks. Three trials evaluated the combination of anti-leukotrienes and ICS compared to the same dose of ICS alone (step 3 versus step 2). No statistically significant group difference was observed in the only trial reporting participants with exacerbations requiring oral corticosteroids over four weeks (N = 268 participants; risk ratio (RR) 0.80, 95% confidence interval (CI) 0.34 to 1.91). There was also no statistically significant difference in percentage change in FEV₁ (forced expiratory volume in 1 second) with mean difference (MD) 1.3 (95% CI -0.09 to 2.69) in this trial, but a significant group difference was observed in the morning (AM) and evening (PM) peak expiratory flow rates (PEFR): N = 218 participants; MD 9.70 L/min (95% CI 1.27 to 18.13) and MD 10.70 (95% CI 2.41 to 18.99), respectively. One trial compared the combination of anti-leukotrienes and ICS to a higher-dose of ICS (step 3 versus step 3). No significant group difference was observed in this trial for participants with exacerbations requiring rescue oral corticosteroids over 16 weeks (N = 182 participants; RR 0.82, 95% CI 0.54 to 1.25), nor was there any significant difference in exacerbations requiring hospitalisation. There was no statistically significant group difference in withdrawals overall or because of any cause with either protocol. No trial explored the impact of adding anti-leukotrienes as a means to taper the dose of ICS.\nAuthors' conclusions\nThe addition of anti-leukotrienes to ICS is not associated with a statistically significant reduction in the need for rescue oral corticosteroids or hospital admission compared to the same or an increased dose of ICS in children and adolescents with mild to moderate asthma. Although anti-leukotrienes have been licensed for use in children for over 10 years, the paucity of paediatric trials, the absence of data on preschoolers, and the variability in the reporting of relevant clinical outcomes considerably limit firm conclusions. At present, there is no firm evidence to support the efficacy and safety of anti-leukotrienes as add-on therapy to ICS as a step-3 option in the therapeutic arsenal for children with uncontrolled asthma symptoms on low-dose ICS.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was updated until January 2013. We found five studies of children with asthma; of them, four studies, representing 559 children (aged six to 18 years) with mild to moderate asthma, contributed data to the review. No study enrolled pre-school children (i.e. aged under six years). Three studies compared the combination of anti-leukotrienes and ICS with the same dose of ICS alone; one study compared the combination of anti-leukotrienes and ICS to a higher dose of ICS; and no study tested whether the addition of anti-leukotriene to ICS could allow the tapering of the dose of ICS while maintaining asthma control. All studies used montelukast as the anti-leukotriene agent, which was administered for four to 16 weeks. Included studies enrolled both girls and boys and between 65% and 69% were boys. All trials enrolled children with mild to moderate airway obstruction."
}
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query-laysum | 4037 | [
{
"role": "user",
"content": "Abstract: Background\nPeople experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations.\nObjectives\nTo evaluate the effects of intramuscular aripiprazole in the treatment of psychosis-induced aggression or agitation (rapid tranquillisation).\nSearch methods\nOn 11 December 2014 and 11 April 2017, we searched the Cochrane Schizophrenia Group’s Study-based Register of Trials which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, and registries of clinical trials.\nSelection criteria\nAll randomised controlled trials (RCTs) that randomised people with psychosis-induced aggression or agitation to receive either intramuscular aripiprazole or another intramuscular intervention.\nData collection and analysis\nWe independently inspected citations and, where possible, abstracts, ordered papers and re-inspected and quality assessed these. We included studies that met our selection criteria. At least two review authors independently extracted data from the included studies. We chose a fixed-effect model. We analysed dichotomous data using risk ratio (RR) and the 95% confidence intervals (CI). We analysed continuous data using mean differences (MD) and their CIs. We assessed risk of bias for included studies and used GRADE to create 'Summary of findings' tables.\nMain results\nSearching found 63 records referring to 21 possible trials. We could only include three studies, all completed over the last decade, with 885 participants, of which 707 were included for quantitative analyses in this systematic review. Due to limited comparisons, small size of trials and a paucity of investigated and reported 'pragmatic' outcomes, evidence was mostly graded as low or very low quality. No trials reported useful data for one of our primary outcomes of tranquil or asleep by 30 minutes. Economic outcomes were also not reported in the trials.\nWhen compared with placebo, fewer people in the aripiprazole group needed additional injections compared to the placebo group (2 RCTs, n = 382, RR 0.69, 95% CI 0.56 to 0.85, very low-quality evidence). Clinically important improvement in agitation at two hours favoured the aripiprazole group (2 RCTs, n = 382, RR 1.50, 95% CI 1.17 to 1.92, very low-quality evidence). The numbers of non-responders after the first injection also favoured aripiprazole (1 RCT, n = 263, RR 0.49, 95% CI 0.34 to 0.71, low-quality evidence). Although no effect was found, more people in the aripiprazole compared to the placebo group experienced adverse effects (1 RCT, n = 117, RR 1.51, 95% CI 0.93 to 2.46, very low-quality evidence).\nAripiprazole required more injections compared to haloperidol (2 RCTs, n = 477, RR 1.28, 95% CI 1.00 to 1.63, very low-quality evidence), with no significant difference in agitation (2 RCTs, n = 477, RR 0.94, 95% CI 0.80 to 1.11, very low-quality evidence), and similar non-responders after first injection (1 RCT, n = 360, RR 1.18, 95% CI 0.78 to 1.79, low-quality evidence). Aripiprazole and haloperidol did not differ when taking into account the overall number of people that experienced at least one adverse effect (1 RCT, n = 113, RR 0.91, 95% CI 0.61 to 1.35, very low-quality evidence).\nCompared to aripiprazole, olanzapine was better at reducing agitation (1 RCT, n = 80, RR 0.77, 95% CI 0.60 to 0.99, low-quality evidence) and had a more favourable effect on global state change scores (1 RCT, n = 80, MD 0.58, 95% CI 0.01 to 1.15, low-quality evidence), both at two hours. No differences were found in terms of experiencing at least one adverse effect during the 24 hours after treatment (1 RCT, n = 80, RR 0.75, 95% CI 0.45 to 1.24, very low-quality evidence). However, participants allocated to aripiprazole experienced less somnolence (1 RCT, n = 80, RR 0.25, 95% CI 0.08 to 0.82, low-quality evidence).\nAuthors' conclusions\nThe available evidence is of poor quality but there is some evidence aripiprazole is effective compared to placebo and haloperidol, but not when compared to olanzapine. However, considering that evidence comes from only three studies, caution is required in generalising these results to real-world practice. This review firmly highlights the need for more high-quality trials on intramuscular aripiprazole in the management of people with acute aggression or agitation.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with psychosis may experience hearing voices (hallucinations) or abnormal thoughts (delusions) which can make them frightened, distressed and agitated (restless, excitable or irritable). Experiencing such emotions can sometimes result in behaviour that is aggressive or violent. This poses a challenge and dilemma for mental health professionals who have to diagnose and, often quickly, give the best available treatment to prevent those who are aggressive, harming themselves or others.\nAripiprazole is a medication that can be used to treat psychosis and also calm people who are aggressive or agitated due to psychosis. It can be taken by mouth or by injection (intramuscular). However, aripiprazole can also cause unpleasant side effects such as headaches, upset stomach, and excessive sleepiness or drowsiness.\nThis review looks for evidence from randomised controlled trials that assesses the effectiveness of intramuscular aripiprazole for people who are agitated and aggressive as a result of having psychosis.\nSearching\nThe Information Specialist of the Cochrane Schizophrenia group ran an electronic search in 2014 and in 2017 for studies randomising adults with aggression due to psychosis to receive either injections of aripiprazole or injections of a placebo (dummy treatment) or injections of another antipsychotic. The search found 63 relevant records, referring to 21 trials. Review authors screened these records for inclusion or exclusion.\nMain results\nOnly three studies could be included. Evidence is limited due to the small number of trials and poor quality of data reported. Fewer people receiving aripiprazole required more injections to become calm than those receiving placebo or haloperidol. Overall, aripiprazole caused a similar number of adverse effects to placebo or haloperidol. Compared to olanzapine, aripiprazole was less effective at calming people but caused less sleepiness or drowsiness\nConclusions\nSome evidence is available, but is of poor quality, and it is difficult to make conclusions about aripiprazole's effectiveness from such data. Health professionals and people with mental health problems are therefore left without clear guidance concerning use of aripiprazole as a rapid tranquilliser. More research is needed to help people consider which medication is better at calming people down, has fewer adverse effects, and works quickly and rapidly."
}
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query-laysum | 4038 | [
{
"role": "user",
"content": "Abstract: Background\nCataract and age-related macular degeneration (AMD) are common causes of decreased vision that often occur simultaneously in people over age 50. Although cataract surgery is an effective treatment for cataract-induced visual loss, some clinicians suspect that such an intervention may increase the risk of worsening of underlying AMD and thus have deleterious effects on vision.\nObjectives\nThe objective of this review was to evaluate the effectiveness and safety of cataract surgery compared with no surgery in eyes with AMD.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), Ovid MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily (January 1946 to December 2016), Embase (January 1980 to December 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to December 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 2 December 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized trials that enrolled participants whose eyes were affected by both cataract and AMD in which cataract surgery was compared with no surgery.\nData collection and analysis\nTwo review authors independently evaluated the search results against the inclusion and exclusion criteria. Two review authors independently extracted data, assessed risk of bias for included studies, and graded the certainty of evidence. We followed methods as recommended by Cochrane.\nMain results\nWe included two RCTs with a total of 114 participants (114 study eyes) with visually significant cataract and AMD. We identified no ongoing trials. Participants in each RCT were randomized to immediate cataract surgery (within two weeks of enrollment) or delayed cataract surgery (six months after enrollment). The risk of bias was unclear for most domains in each study; one study was registered prospectively.\nIn one study conducted in Australia outcomes were reported only at six months (before participants in the delayed-surgery group had cataract surgery). At six months, the immediate-surgery group showed mean improvement in best-corrected visual acuity (BCVA) compared with the delayed-surgery group (mean difference (MD) -0.15 LogMAR, 95% confidence interval (CI) -0.28 to -0.02; 56 participants; moderate-certainty evidence). In the other study, conducted in Austria, outcomes were reported only at 12 months (12 months after participants in the immediate-surgery group and six months after participants in the delayed-surgery group had cataract surgery). There was uncertainty as to which treatment group had better improvement in distance visual acuity at 12 months (unit of measure not reported; very low-certainty evidence).\nAt 12 months, the mean change from baseline between groups in cumulated drusen or geographic atrophy area size was small and there was uncertainty which, if either, of the groups was favored (MD 0.76, 95% CI -8.49 to 10.00; 49 participants; low-certainty evidence). No participant in one study had exudative AMD develop in the study eye during 12 months of follow-up; in the other study, choroidal neovascularization developed in the study eye of 1 of 27 participants in the immediate-surgery group versus 0 of 29 participants in the delayed-surgery group at six months (risk ratio 3.21, 95% CI 0.14 to 75.68; 56 participants; very low-certainty evidence). Quality of life was measured using two different questionnaires. Scores on the Impact of Vision Impairment (IVI) questionnaire suggested that the immediate-surgery group fared better regarding vision-related quality of life than the delayed-surgery group at six months (MD in IVI logit scores 1.60, 95% CI 0.61 to 2.59; low-certainty evidence). However, we could not analyze scores from the Visual Function-14 (VF-14) questionnaire from the other study due to insufficient data. No postoperative complication was reported from either study.\nAuthors' conclusions\nAt this time, it is not possible to draw reliable conclusions from the available data as to whether cataract surgery is beneficial or harmful in people with AMD after 12 months. Although cataract surgery provides short-term (six months) improvement in BCVA in eyes with AMD compared with no surgery, it is unclear whether the timing of surgery has an effect on long-term outcomes. Physicians must make recommendations to their AMD patients regarding cataract surgery based on experience and clinical judgment until large controlled trials are conducted and their findings published.\nThere is a need for prospective RCTs in which cataract surgery is compared with no surgery in people with AMD to better evaluate whether cataract surgery is beneficial or harmful in all or a subset of AMD patients. However, ethical considerations preclude withholding surgery, or delaying it for several years, if it may be a potentially beneficial treatment. Designers of future trials are encouraged to utilize existing standardized systems for grading cataract and AMD and for measuring key outcomes: visual acuity, change in visual acuity, worsening of AMD, quality of life measures, and adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to determine whether cataract surgery is safe and improves vision in eyes with age-related macular degeneration (AMD) compared with no surgery. Cochrane researchers collected and analyzed all relevant studies to answer this question and included two studies."
}
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query-laysum | 4039 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with inflammatory bowel disease (IBD) require intensive follow-up with frequent consultations after diagnosis. IBD telehealth management includes consulting by phone, instant messenger, video, text message, or web-based services. Telehealth can be beneficial for people with IBD, but may have its own set of challenges. It is important to systematically review the evidence on the types of remote or telehealth approaches that can be deployed in IBD. This is particularly relevant following the coronavirus disease 2019 (COVID-19) pandemic, which led to increased self- and remote-management.\nObjectives\nTo identify the communication technologies used to achieve remote healthcare for people with inflammatory bowel disease and to assess their effectiveness.\nSearch methods\nOn 13 January 2022, we searched CENTRAL, Embase, MEDLINE, three other databases, and three trials registries with no limitations on language, date, document type, or publication status.\nSelection criteria\nAll published, unpublished, and ongoing randomised controlled trials (RCTs) that evaluated telehealth interventions targeted at people with IBD versus any other type of intervention or no intervention.\nWe did not include studies based on digital patient information resources or education resources, unless they formed part of a wider package including an element of telehealth. We excluded studies where remote monitoring of blood or faecal tests was the only form of monitoring.\nData collection and analysis\nTwo review authors independently extracted data from the included studies and assessed their risk of bias. We analysed studies on adult and paediatric populations separately. We expressed the effects of dichotomous outcomes as risk ratios (RRs) and the effects of continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs), each with their 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE methodology.\nMain results\nWe included 19 RCTs with a total of 3489 randomised participants, aged eight to 95 years. Three studies examined only people with ulcerative colitis (UC), two studies examined only people with Crohn's disease (CD), and the remaining studies examined a mix of IBD patients. Studies considered a range of disease activity states. The length of the interventions ranged from six months to two years. The telehealth interventions were web-based and telephone-based.\nWeb-based monitoring versus usual care\nTwelve studies compared web-based disease monitoring to usual care.\nThree studies, all in adults, provided data on disease activity. Web-based disease monitoring (n = 254) is probably equivalent to usual care (n = 174) in reducing disease activity in people with IBD (SMD 0.09, 95% CI −0.11 to 0.29). The certainty of the evidence is moderate.\nFive studies on adults provided dichotomous data that we could use for a meta-analysis on flare-ups. Web-based disease monitoring (n = 207/496) is probably equivalent to usual care (n = 150/372) for the occurrence of flare-ups or relapses in adults with IBD (RR 1.09, 95% CI 0.93 to 1.27). The certainty of the evidence is moderate. One study provided continuous data. Web-based disease monitoring (n = 465) is probably equivalent to usual care (n = 444) for the occurrence of flare-ups or relapses in adults with CD (MD 0.00 events, 95% CI −0.06 to 0.06). The certainty of the evidence is moderate. One study provided dichotomous data on flare-ups in a paediatric population. Web-based disease monitoring (n = 28/84) may be equivalent to usual care (n = 29/86) for the occurrence of flare-ups or relapses in children with IBD (RR 0.99, 95% CI 0.65 to 1.51). The certainty of the evidence is low.\nFour studies, all in adults, provided data on quality of life. Web-based disease monitoring (n = 594) is probably equivalent to usual care (n = 505) for quality of life in adults with IBD (SMD 0.08, 95% CI −0.04 to 0.20). The certainty of the evidence is moderate.\nBased on continuous data from one study in adults, we found that web-based disease monitoring probably leads to slightly higher medication adherence compared to usual care (MD 0.24 points, 95% CI 0.01 to 0.47). The results are of moderate certainty. Based on continuous data from one paediatric study, we found no difference between web-based disease monitoring and usual care in terms of their effect on medication adherence (MD 0.00, 95% CI −0.63 to 0.63), although the evidence is very uncertain. When we meta-analysed dichotomous data from two studies on adults, we found no difference between web-based disease monitoring and usual care in terms of their effect on medication adherence (RR 0.87, 95% CI 0.62 to 1.21), although the evidence is very uncertain.\nWe were unable to draw any conclusions on the effects of web-based disease monitoring compared to usual care on healthcare access, participant engagement, attendance rate, interactions with healthcare professionals, and cost- or time-effectiveness. The certainty of the evidence is very low.\nAuthors' conclusions\nThe evidence in this review suggests that web-based disease monitoring is probably no different to standard care in adults when considering disease activity, occurrence of flare-ups or relapse, and quality of life. There may be no difference in these outcomes in children, but the evidence is limited. Web-based monitoring probably increases medication adherence slightly compared to usual care.\nWe are uncertain about the effects of web-based monitoring versus usual care on our other secondary outcomes, and about the effects of the other telehealth interventions included in our review, because the evidence is limited.\nFurther studies comparing web-based disease monitoring to standard care for the clinical outcomes reported in adults are unlikely to change our conclusions, unless they have longer follow-up or investigate under-reported outcomes or populations. Studies with a clearer definition of web-based monitoring would enhance applicability, enable practical dissemination and replication, and enable alignment with areas identified as important by stakeholders and people affected by IBD.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 19 relevant RCTs, which enroled a combined total of 3489 people aged eight to 95 years. Remote care was delivered online (e.g. smartphone applications, websites) or by telephone.\nTwelve studies compared web-based care to usual care, three compared telephone-based care to usual care, three compared web-based care to \"sham\" care, one compared web-based care to self-care, and one compared psychological and telephone support to usual care.\nWeb-based remote care is probably no different to usual care in adults for improving symptoms, avoiding relapses or flare-ups, and enhancing quality of life.\nWe also found that people who receive web-based care are probably less likely to skip their medicines compared to those that receive usual care. We are moderately certain about these results based on the current evidence.\nThe evidence on children is limited.\nWith the currently available information, we cannot make any judgements on other parameters such as access to care, whether people with inflammatory bowel disease approve of these programmes and are encouraged to attend appointments, to what degree clinical professionals are involved in them, and costs or time.\nThe evidence on other forms of remote care was also very limited."
}
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query-laysum | 4040 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with type 1 diabetes mellitus (T1DM) need treatment with insulin for survival. Whether any particular type of (ultra-)long-acting insulin provides benefit especially regarding risk of diabetes complications and hypoglycaemia is unknown.\nObjectives\nTo compare the effects of long-term treatment with (ultra-)long-acting insulin analogues to NPH insulin (neutral protamine Hagedorn) or another (ultra-)long-acting insulin analogue in people with type 1 diabetes mellitus.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform and the reference lists of systematic reviews, articles and health technology assessment reports. We explored the US Food and Drug Administration (FDA) and European Medical Agency (EMA) web pages. We asked pharmaceutical companies, EMA and investigators for additional data and clinical study reports (CSRs). The date of the last search of all databases was 24 August 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of 24 weeks or more comparing one (ultra-)long-acting insulin to NPH insulin or another (ultra-)long-acting insulin in people with T1DM.\nData collection and analysis\nTwo review authors assessed risk of bias using the new Cochrane 'Risk of bias' 2 (RoB 2) tool and extracted data. Our main outcomes were all-cause mortality, health-related quality of life (QoL), severe hypoglycaemia, non-fatal myocardial infarction/stroke (NFMI/NFS), severe nocturnal hypoglycaemia, serious adverse events (SAEs) and glycosylated haemoglobin A1c (HbA1c). We used a random-effects model to perform meta-analyses and calculated risk ratios (RRs) and odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) and 95% prediction intervals for effect estimates. We evaluated the certainty of the evidence applying the GRADE instrument.\nMain results\nWe included 26 RCTs. Two studies were unpublished. We obtained CSRs, clinical study synopses or both as well as medical reviews from regulatory agencies on 23 studies which contributed to better analysis of risk of bias and improved data extraction. A total of 8784 participants were randomised: 2428 participants were allocated to NPH insulin, 2889 participants to insulin detemir, 2095 participants to insulin glargine and 1372 participants to insulin degludec. Eight studies contributing 21% of all participants comprised children. The duration of the intervention varied from 24 weeks to 104 weeks.\nInsulin degludec versus NPH insulin: we identified no studies comparing insulin degludec with NPH insulin.\nInsulin detemir versus NPH insulin (9 RCTs): five deaths reported in two studies including adults occurred in the insulin detemir group (Peto OR 4.97, 95% CI 0.79 to 31.38; 9 studies, 3334 participants; moderate-certainty evidence). Three studies with 870 participants reported QoL showing no true beneficial or harmful effect for either intervention (low-certainty evidence). There was a reduction in severe hypoglycaemia in favour of insulin detemir: 171/2019 participants (8.5%) in the insulin detemir group compared with 138/1200 participants (11.5%) in the NPH insulin group experienced severe hypoglycaemia (RR 0.69, 95% CI 0.52 to 0.92; 8 studies, 3219 participants; moderate-certainty evidence). The 95% prediction interval ranged between 0.34 and 1.39. Only 1/331 participants in the insulin detemir group compared with 0/164 participants in the NPH insulin group experienced a NFMI (1 study, 495 participants; low-certainty evidence). No study reported NFS. A total of 165/2094 participants (7.9%) in the insulin detemir group compared with 102/1238 participants (8.2%) in the NPH insulin group experienced SAEs (RR 0.95, 95% CI 0.75 to 1.21; 9 studies, 3332 participants; moderate-certainty evidence). Severe nocturnal hypoglycaemia was observed in 70/1823 participants (3.8%) in the insulin detemir group compared with 60/1102 participants (5.4%) in the NPH insulin group (RR 0.67, 95% CI 0.39 to 1.17; 7 studies, 2925 participants; moderate-certainty evidence). The MD in HbA1c comparing insulin detemir with NPH insulin was 0.01%, 95% CI -0.1 to 0.1; 8 studies, 3122 participants; moderate-certainty evidence.\nInsulin glargine versus NPH insulin (9 RCTs): one adult died in the NPH insulin group (Peto OR 0.14, 95% CI 0.00 to 6.98; 8 studies, 2175 participants; moderate-certainty evidence). Four studies with 1013 participants reported QoL showing no true beneficial effect or harmful effect for either intervention (low-certainty evidence). Severe hypoglycaemia was observed in 122/1191 participants (10.2%) in the insulin glargine group compared with 145/1159 participants (12.5%) in the NPH insulin group (RR 0.84, 95% CI 0.67 to 1.04; 9 studies, 2350 participants; moderate-certainty evidence). No participant experienced a NFMI and one participant in the NPH insulin group experienced a NFS in the single study reporting this outcome (585 participants; low-certainty evidence). A total of 109/1131 participants (9.6%) in the insulin glargine group compared with 110/1098 participants (10.0%) in the NPH insulin group experienced SAEs (RR 1.08, 95% CI 0.63 to 1.84; 8 studies, 2229 participants; moderate-certainty evidence). Severe nocturnal hypoglycaemia was observed in 69/938 participants (7.4%) in the insulin glargine group compared with 83/955 participants (8.7%) in the NPH insulin group (RR 0.83, 95% CI 0.62 to 1.12; 6 studies, 1893 participants; moderate-certainty evidence). The MD in HbA1c comparing insulin glargine with NPH insulin was 0.02%, 95% CI -0.1 to 0.1; 9 studies, 2285 participants; moderate-certainty evidence.\nInsulin detemir versus insulin glargine (2 RCTs),insulin degludec versus insulin detemir (2 RCTs), insulin degludec versus insulin glargine (4 RCTs): there was no evidence of a clinically relevant difference for all main outcomes comparing (ultra-)long-acting insulin analogues with each other.\nFor all outcomes none of the comparisons indicated differences in tests of interaction for children versus adults.\nAuthors' conclusions\nComparing insulin detemir with NPH insulin for T1DM showed lower risk of severe hypoglycaemia in favour of insulin detemir (moderate-certainty evidence). However, the 95% prediction interval indicated inconsistency in this finding. Both insulin detemir and insulin glargine compared with NPH insulin did not show benefits or harms for severe nocturnal hypoglycaemia. For all other main outcomes with overall low risk of bias and comparing insulin analogues with each other, there was no true beneficial or harmful effect for any intervention. Data on patient-important outcomes such as QoL, macrovascular and microvascular diabetic complications were sparse or missing. No clinically relevant differences were found between children and adults.\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 evidence is up-to-date as of 24 August 2020."
}
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query-laysum | 4041 | [
{
"role": "user",
"content": "Abstract: Background\nEczema and food allergy are common health conditions that usually begin in early childhood and often occur in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying to prevent or reverse an impaired skin barrier soon after birth is effective for preventing eczema or food allergy.\nObjectives\nPrimary objective\nTo assess the effects of skin care interventions such as emollients for primary prevention of eczema and food allergy in infants.\nSecondary objective\nTo identify features of study populations such as age, hereditary risk, and adherence to interventions that are associated with the greatest treatment benefit or harm for both eczema and food allergy.\nSearch methods\nWe performed an updated search of the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase in September 2021. We searched two trials registers in July 2021. We checked the reference lists of included studies and relevant systematic reviews, and scanned conference proceedings to identify further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe included RCTs of skin care interventions that could potentially enhance skin barrier function, reduce dryness, or reduce subclinical inflammation in healthy term (> 37 weeks) infants (≤ 12 months) without pre-existing eczema, food allergy, or other skin condition. Eligible comparisons were standard care in the locality or no treatment. Types of skin care interventions could include moisturisers/emollients; bathing products; advice regarding reducing soap exposure and bathing frequency; and use of water softeners. No minimum follow-up was required.\nData collection and analysis\nThis is a prospective individual participant data (IPD) meta-analysis. We used standard Cochrane methodological procedures, and primary analyses used the IPD dataset. Primary outcomes were cumulative incidence of eczema and cumulative incidence of immunoglobulin (Ig)E-mediated food allergy by one to three years, both measured at the closest available time point to two years. Secondary outcomes included adverse events during the intervention period; eczema severity (clinician-assessed); parent report of eczema severity; time to onset of eczema; parent report of immediate food allergy; and allergic sensitisation to food or inhalant allergen.\nMain results\nWe identified 33 RCTs comprising 25,827 participants. Of these, 17 studies randomising 5823 participants reported information on one or more outcomes specified in this review. We included 11 studies, randomising 5217 participants, in one or more meta-analyses (range 2 to 9 studies per individual meta-analysis), with 10 of these studies providing IPD; the remaining 6 studies were included in the narrative results only.\nMost studies were conducted at children's hospitals. Twenty-five studies, including all those contributing data to meta-analyses, randomised newborns up to age three weeks to receive a skin care intervention or standard infant skin care. Eight of the 11 studies contributing to meta-analyses recruited infants at high risk of developing eczema or food allergy, although the definition of high risk varied between studies. Durations of intervention and follow-up ranged from 24 hours to three years. All interventions were compared against no skin care intervention or local standard care. Of the 17 studies that reported information on our prespecified outcomes, 13 assessed emollients.\nWe assessed most of the evidence in the review as low certainty and had some concerns about risk of bias. A rating of some concerns was most often due to lack of blinding of outcome assessors or significant missing data, which could have impacted outcome measurement but was judged unlikely to have done so. We assessed the evidence for the primary food allergy outcome as high risk of bias due to the inclusion of only one trial, where findings varied based on different assumptions about missing data.\nSkin care interventions during infancy probably do not change the risk of eczema by one to three years of age (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.81 to 1.31; risk difference 5 more cases per 1000 infants, 95% CI 28 less to 47 more; moderate-certainty evidence; 3075 participants, 7 trials) or time to onset of eczema (hazard ratio 0.86, 95% CI 0.65 to 1.14; moderate-certainty evidence; 3349 participants, 9 trials). Skin care interventions during infancy may increase the risk of IgE-mediated food allergy by one to three years of age (RR 2.53, 95% CI 0.99 to 6.49; low-certainty evidence; 976 participants, 1 trial) but may not change risk of allergic sensitisation to a food allergen by age one to three years (RR 1.05, 95% CI 0.64 to 1.71; low-certainty evidence; 1794 participants, 3 trials). Skin care interventions during infancy may slightly increase risk of parent report of immediate reaction to a common food allergen at two years (RR 1.27, 95% CI 1.00 to 1.61; low-certainty evidence; 1171 participants, 1 trial); however, this was only seen for cow’s milk, and may be unreliable due to over-reporting of milk allergy in infants. Skin care interventions during infancy probably increase risk of skin infection over the intervention period (RR 1.33, 95% CI 1.01 to 1.75; risk difference 17 more cases per 1000 infants, 95% CI one more to 38 more; moderate-certainty evidence; 2728 participants, 6 trials) and may increase the risk of infant slippage over the intervention period (RR 1.42, 95% CI 0.67 to 2.99; low-certainty evidence; 2538 participants, 4 trials) and stinging/allergic reactions to moisturisers (RR 2.24, 95% 0.67 to 7.43; low-certainty evidence; 343 participants, 4 trials), although CIs for slippages and stinging/allergic reactions were wide and include the possibility of no effect or reduced risk.\nPreplanned subgroup analyses showed that the effects of interventions were not influenced by age, duration of intervention, hereditary risk, filaggrin (FLG) mutation, chromosome 11 intergenic variant rs2212434, or classification of intervention type for risk of developing eczema. We could not evaluate these effects on risk of food allergy. Evidence was insufficient to show whether adherence to interventions influenced the relationship between skin care interventions and eczema or food allergy development.\nAuthors' conclusions\nBased on low- to moderate-certainty evidence, skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema; may increase risk of food allergy; and probably increase risk of skin infection. Further study is needed to understand whether different approaches to infant skin care might prevent eczema or food allergy.\n\nGiven the provided abstract, please respond to the following query: \"Confidence in our results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We are moderately confident in our results for developing eczema and the time needed to develop eczema. We are less confident about our results for food allergy or sensitivity, which are based on small numbers of studies with widely varying results. These results are likely to change when more evidence becomes available. Our confidence in the review findings for skin infections is moderate, but low for stinging or allergic reactions and slipping."
}
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query-laysum | 4042 | [
{
"role": "user",
"content": "Abstract: Background\nSince the approval of tyrosine kinase inhibitors, angiogenesis inhibitors and immune checkpoint inhibitors, the treatment landscape for advanced renal cell carcinoma (RCC) has changed fundamentally. Today, combined therapies from different drug categories have a firm place in a complex first-line therapy. Due to the large number of drugs available, it is necessary to identify the most effective therapies, whilst considering their side effects and impact on quality of life (QoL).\nObjectives\nTo evaluate and compare the benefits and harms of first-line therapies for adults with advanced RCC, and to produce a clinically relevant ranking of therapies. Secondary objectives were to maintain the currency of the evidence by conducting continuous update searches, using a living systematic review approach, and to incorporate data from clinical study reports (CSRs).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, conference proceedings and relevant trial registries up until 9 February 2022. We searched several data platforms to identify CSRs.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating at least one targeted therapy or immunotherapy for first-line treatment of adults with advanced RCC. We excluded trials evaluating only interleukin-2 versus interferon-alpha as well as trials with an adjuvant treatment setting. We also excluded trials with adults who received prior systemic anticancer therapy if more than 10% of participants were previously treated, or if data for untreated participants were not separately extractable.\nData collection and analysis\nAll necessary review steps (i.e. screening and study selection, data extraction, risk of bias and certainty assessments) were conducted independently by at least two review authors. Our outcomes were overall survival (OS), QoL, serious adverse events (SAEs), progression-free survival (PFS), adverse events (AEs), the number of participants who discontinued study treatment due to an AE, and the time to initiation of first subsequent therapy. Where possible, analyses were conducted for the different risk groups (favourable, intermediate, poor) according to the International Metastatic Renal-Cell Carcinoma Database Consortium Score (IMDC) or the Memorial Sloan Kettering Cancer Center (MSKCC) criteria. Our main comparator was sunitinib (SUN). A hazard ratio (HR) or risk ratio (RR) lower than 1.0 is in favour of the experimental arm.\nMain results\nWe included 36 RCTs and 15,177 participants (11,061 males and 4116 females). Risk of bias was predominantly judged as being 'high' or 'some concerns' across most trials and outcomes. This was mainly due to a lack of information about the randomisation process, the blinding of outcome assessors, and methods for outcome measurements and analyses. Additionally, study protocols and statistical analysis plans were rarely available.\nHere we present the results for our primary outcomes OS, QoL, and SAEs, and for all risk groups combined for contemporary treatments: pembrolizumab + axitinib (PEM+AXI), avelumab + axitinib (AVE+AXI), nivolumab + cabozantinib (NIV+CAB), lenvatinib + pembrolizumab (LEN+PEM), nivolumab + ipilimumab (NIV+IPI), CAB, and pazopanib (PAZ). Results per risk group and results for our secondary outcomes are reported in the summary of findings tables and in the full text of this review. The evidence on other treatments and comparisons can also be found in the full text.\nOverall survival (OS)\nAcross risk groups, PEM+AXI (HR 0.73, 95% confidence interval (CI) 0.50 to 1.07, moderate certainty) and NIV+IPI (HR 0.69, 95% CI 0.69 to 1.00, moderate certainty) probably improve OS, compared to SUN, respectively. LEN+PEM may improve OS (HR 0.66, 95% CI 0.42 to 1.03, low certainty), compared to SUN. There is probably little or no difference in OS between PAZ and SUN (HR 0.91, 95% CI 0.64 to 1.32, moderate certainty), and we are uncertain whether CAB improves OS when compared to SUN (HR 0.84, 95% CI 0.43 to 1.64, very low certainty). The median survival is 28 months when treated with SUN. Survival may improve to 43 months with LEN+PEM, and probably improves to: 41 months with NIV+IPI, 39 months with PEM+AXI, and 31 months with PAZ. We are uncertain whether survival improves to 34 months with CAB. Comparison data were not available for AVE+AXI and NIV+CAB.\nQuality of life (QoL)\nOne RCT measured QoL using FACIT-F (score range 0 to 52; higher scores mean better QoL) and reported that the mean post-score was 9.00 points higher (9.86 lower to 27.86 higher, very low certainty) with PAZ than with SUN. Comparison data were not available for PEM+AXI, AVE+AXI, NIV+CAB, LEN+PEM, NIV+IPI, and CAB.\nSerious adverse events (SAEs)\nAcross risk groups, PEM+AXI probably increases slightly the risk for SAEs (RR 1.29, 95% CI 0.90 to 1.85, moderate certainty) compared to SUN. LEN+PEM (RR 1.52, 95% CI 1.06 to 2.19, moderate certainty) and NIV+IPI (RR 1.40, 95% CI 1.00 to 1.97, moderate certainty) probably increase the risk for SAEs, compared to SUN, respectively. There is probably little or no difference in the risk for SAEs between PAZ and SUN (RR 0.99, 95% CI 0.75 to 1.31, moderate certainty). We are uncertain whether CAB reduces or increases the risk for SAEs (RR 0.92, 95% CI 0.60 to 1.43, very low certainty) when compared to SUN. People have a mean risk of 40% for experiencing SAEs when treated with SUN. The risk increases probably to: 61% with LEN+PEM, 57% with NIV+IPI, and 52% with PEM+AXI. It probably remains at 40% with PAZ. We are uncertain whether the risk reduces to 37% with CAB. Comparison data were not available for AVE+AXI and NIV+CAB.\nAuthors' conclusions\nFindings concerning the main treatments of interest comes from direct evidence of one trial only, thus results should be interpreted with caution. More trials are needed where these interventions and combinations are compared head-to-head, rather than just to SUN. Moreover, assessing the effect of immunotherapies and targeted therapies on different subgroups is essential and studies should focus on assessing and reporting relevant subgroup data. The evidence in this review mostly applies to advanced clear cell RCC.\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"
},
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"role": "assistant",
"content": "We searched for studies that explored different drugs that are immunotherapies or targeted therapies. We examined these in adults (≥18 years) with advanced RCC who receive their first therapy. We compared these drugs to the drug SUN, which is a widely used targeted drug and a commonly used comparator drug in studies. We used a standardised process to assess the quality of the findings and our certainty in them. We rated our certainty in the findings based on factors such as study methods, the number of participants in them, and the precision of study results."
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query-laysum | 4043 | [
{
"role": "user",
"content": "Abstract: Background\nChronic venous insufficiency (CVI) is a condition in which veins are unable to transport blood unidirectionally towards the heart. CVI usually occurs in the lower limbs. It might result in considerable discomfort, with symptoms such as pain, itchiness and tiredness in the legs. Patients with CVI may also experience swelling and ulcers. Phlebotonics are a class of drugs often used to treat CVI. This is the second update of a review first published in 2005.\nObjectives\nTo assess the efficacy and safety of phlebotonics administered orally or topically for treatment of signs and symptoms of lower extremity CVI.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and Clinicaltrials.gov trials register up to 12 November 2019. We searched the reference lists of the articles retrieved by electronic searches for additional citations. We also contacted authors of unpublished studies.\nSelection criteria\nWe included randomised, double-blind, placebo-controlled trials (RCTs) assessing the efficacy of phlebotonics (rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, Centella asiatica, disodium flavodate, French maritime pine bark extract, grape seed extract and aminaftone) in patients with CVI at any stage of the disease.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of included RCTs. We estimated the effects of treatment by using risk ratios (RRs), mean differences (MDs) and standardized mean differences (SMDs), according to the outcome assessed. We calculated 95% confidence intervals (CIs) and percentage of heterogeneity (I2). Outcomes of interest were oedema, quality of life (QoL), assessment of CVI and adverse events. We used GRADE criteria to assess the certainty of the evidence.\nMain results\nWe identified three new studies for this update. In total, 69 RCTs of oral phlebotonics were included, but only 56 studies (7690 participants, mean age 50 years) provided quantifiable data for the efficacy analysis. These studies used different phlebotonics (28 on rutosides, 11 on hidrosmine and diosmine, 10 on calcium dobesilate, two on Centella asiatica, two on aminaftone, two on French maritime pine bark extract and one on grape seed extract). No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.\nModerate-certainty evidence suggests that phlebotonics probably reduce oedema slightly in the lower legs, compared with placebo (RR 0.70, 95% CI 0.63 to 0.78; 13 studies; 1245 participants); and probably reduce ankle circumference (MD -4.27 mm, 95% CI -5.61 to -2.93 mm; 15 studies; 2010 participants). Moderate-certainty evidence shows that phlebotonics probably make little or no difference in QoL compared with placebo (SMD -0.06, 95% CI -0.22 to 0.10; five studies; 1639 participants); and similarly, may have little or no effect on ulcer healing (RR 0.94, 95% CI 0.79 to 1.13; six studies; 461 participants; low-certainty evidence). Thirty-seven studies reported on adverse events. Pooled data suggest that phlebotonics probably increase adverse events slightly, compared to placebo (RR 1.14, 95% CI 1.02 to 1.27; 37 studies; 5789 participants; moderate-certainty evidence). Gastrointestinal disorders were the most frequently reported adverse events. We downgraded our certainty in the evidence from 'high' to 'moderate' because of risk of bias concerns, and further to 'low' because of imprecision.\nAuthors' conclusions\nThere is moderate-certainty evidence that phlebotonics probably reduce oedema slightly, compared to placebo; moderate-certainty evidence of little or no difference in QoL; and low-certainty evidence that these drugs do not influence ulcer healing. Moderate-certainty evidence suggests that phlebotonics are probably associated with a higher risk of adverse events than placebo. Studies included in this systematic review provided only short-term safety data; therefore, the medium- and long-term safety of phlebotonics could not be estimated. Findings for specific groups of phlebotonics are limited due to small study numbers and heterogeneous results. Additional high-quality RCTs focusing on clinically important outcomes are needed to improve the evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In chronic venous insufficiency, veins of the lower limbs are unable to transport blood towards the heart. It might be caused by genetic factors, may occur after trauma, or may result from a blood clot. Poor movement of blood up the legs may cause swelling and puffiness, feelings of heaviness, tingling, cramps, pain, varicose veins and changes in skin pigmentation. If severe insufficient blood circulation occurs, ulcers and skin wasting can develop. Drugs such as natural flavonoids extracted from plants and similar synthetic products may improve blood circulation. These drugs are known collectively as venoactive drugs or phlebotonics. This review examined evidence from randomised controlled clinical trials comparing these drugs versus inactive treatment (placebo), generally given over one to three months."
}
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query-laysum | 4044 | [
{
"role": "user",
"content": "Abstract: Background\nOral cancers are the sixth most common cancer worldwide, yet the prognosis following a diagnosis of oral cavity or oropharyngeal cancers remains poor, with approximately 50% survival at five years. Despite a sharp increase in research into molecularly targeted therapies and a rapid expansion in the number of clinical trials assessing new targeted therapies, their value for treating oral cancers is unclear. Therefore, it is important to summarise the evidence to determine the efficacy and toxicity of targeted therapies and immunotherapies for the treatment of these cancers.\nObjectives\nTo assess the effects of molecularly targeted therapies and immunotherapies, in addition to standard therapies, for the treatment of oral cavity or oropharyngeal cancers.\nSearch methods\nWe searched the following electronic databases: Cochrane Oral Health Group Trials Register (to 3 February 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2015, Issue 1), MEDLINE via Ovid (1946 to 3 February 2015) and EMBASE via Ovid (1980 to 3 February 2015). We searched the US National Institutes of Health Trials Register (clinicaltrials.gov), the World Health Organization Clinical Trials Registry Platform, the American Society of Clinical Oncology conference abstracts and the Radiation Therapy Oncology Group clinical trials protocols for ongoing trials. We placed no restrictions on the language or date of publication.\nSelection criteria\nWe included randomised controlled trials where more than 50% of participants had primary tumours of the oral cavity or oropharynx, and which compared targeted therapy or immunotherapy, plus standard therapy, with standard therapy alone.\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 attempted to contact study authors for missing data or clarification where necessary. We combined sufficiently similar studies in meta-analyses using random-effects models when there were at least four studies and fixed-effect models when fewer than four studies. We obtained or calculated a hazard ratio (HR) and 95% confidence interval (CI) for the primary outcomes where possible. For dichotomous outcomes, we reported risk ratios (RR) and 95% CIs.\nMain results\nTwelve trials (2488 participants) satisfied the inclusion criteria. In the included trials, 12% of participants (298 participants) had tumours of the oral cavity and 59% (1468 participants) had oropharyngeal tumours. The remaining 29% had tumours of the larynx or hypopharynx and less than 1% had tumours at other sites.\nNo included trial was at low risk of bias; seven had an unclear risk of bias, and five had a high risk of bias. We grouped trials by intervention type into three main comparisons: standard therapy plus epidermal growth factor receptor monoclonal antibody (EGFR mAb) therapy (follow-up period 24 to 70 months); standard therapy plus tyrosine kinase inhibitors (TKIs) (follow-up period 40 to 60 months) and standard therapy plus immunotherapy (follow-up period 24 to 70 months), all versus standard therapy alone.\nModerate quality evidence showed that EGFR mAb therapy may result in 18% fewer deaths when added to standard therapy (HR of mortality 0.82; 95% CI 0.69 to 0.97; 1421 participants, three studies, 67% oropharyngeal tumours, 2% oral cavity tumours).\nThere was also moderate quality evidence that EGFR mAb may result in 32% fewer locoregional failures when added to radiotherapy (RT) (HR 0.68; 95% CI 0.52 to 0.89; 424 participants, one study, 60% oropharyngeal tumours).\nA subgroup analysis separating studies by type of standard therapy (radiotherapy (RT) or chemoradiotherapy (CRT)) showed some evidence that adding EGFR mAb therapy to RT may result in a 30% reduction in the number of people whose disease progresses (HR 0.70; 95% CI 0.54 to 0.91; 424 participants, one study, 60% oropharyngeal tumours, unclear risk of bias). For the subgroup comparing EGFR mAb plus CRT with CRT alone there was insufficient evidence to determine whether adding EGFR mAb therapy to CRT impacts on progression-free survival (HR 1.08; 95% CI 0.89 to 1.32; 891 participants, one study, 70% oropharyngeal tumours, high risk of bias). The high subgroup heterogeneity meant that we were unable to pool these subgroups.\nThere was evidence that adding cetuximab to standard therapy may result in increased skin toxicity and rash (RR 6.56; 95% CI 5.35 to 8.03; 1311 participants, two studies), but insufficient evidence to determine any difference in skin toxicity and rash in the case of nimotuzumab (RR 1.06; 95% CI 0.85 to 1.31; 92 participants, one study).\nThere was insufficient evidence to determine whether TKIs added to standard therapy impacts on overall survival (HR 0.99; 95% CI 0.62 to 1.57; 271 participants, two studies; very low quality evidence), locoregional control (HR 0.89; 95% CI 0.53 to 1.49; 271 participants, two studies; very low quality evidence), disease-free survival (HR 1.51; 95% CI 0.61 to 3.71; 60 participants, one study; very low quality evidence) or progression-free survival (HR 0.80; 95% CI 0.51 to 1.28; 271 participants, two studies; very low quality evidence). We did find evidence of an increase in skin rash (erlotinib: RR 6.57; 95% CI 3.60 to 12.00; 191 participants, one study; lapatinib: RR 2.02; 95% CI 1.23 to 3.32; 67 participants, one study) and gastrointestinal complaints (lapatinib: RR 15.53; 95% CI 2.18 to 110.55; 67 participants, one study).\nWe found very low quality evidence from one small trial that adding recombinant interleukin (rIL-2) to surgery may increase overall survival (HR 0.52; 95% CI 0.31 to 0.87; 201 participants, 62% oral cavity tumours, 38% oropharyngeal tumours) and there was insufficient evidence to determine whether rIL-2 impacts on adverse effects.\nAuthors' conclusions\nWe found some evidence that adding EGFR mAb to standard therapy may increase overall survival, progression-free survival and locoregional control, while resulting in an increase in skin toxicity for some mAb (cetuximab).\nThere is insufficient evidence to determine whether adding TKIs to standard therapies changes any of our primary outcomes.\nVery low quality evidence from a single study suggests that rIL-2 combined with surgery may increase overall survival compared with surgery alone.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Overall, the evidence available ranges from moderate quality (for EGFR mAb) to very low quality (for TKIs and rIL-2), which limits our confidence in the reliability of our findings."
}
]
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