ResearchPad - randomized-controlled-trials https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[The effect of monetary incentive on survey response for vulnerable children and youths: A randomized controlled trial]]> https://www.researchpad.co/article/elastic_article_13807 In surveys non-responders may introduce bias and lower the validity of the studies. Ways to increase response rates are therefore important. The purpose of the study was to investigate if an unconditional monetary incentive can increase the response rate for vulnerable children and youths in a postal questionnaire survey.MethodsThe study was designed as a randomized controlled trial. The study population consisted of 262 children and youth who participated in an established intervention study aimed at creating networks for different groups of vulnerable children and youths. The mean age of the participants was 16.7 years (range 11–28) and 67.9% were female. The questionnaire was adapted to three different age groups and covered different aspects of the participants’ life situation, including the dimensions from the Strengths and Difficulties Questionnaire (SDQ). In the follow-up survey, participants were randomly allocated to two groups that either received a €15 voucher for a supermarket together with the questionnaire or only received the questionnaire. We used Poisson regression to estimate the differences in response rate (Rate Ratio RR) between the intervention group and the control group.ResultsThe response rate was 75.5% in the intervention group and 42.9% in the control group. The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38–2.17). We did not find any significant differences in scales scores between the two groups for the five scales of the SDQ. In stratified analyses, we found the effect of the incentive to be higher for males (RR 2.81; 95% CI 1.61–4.91) than for females (1.43; 95% CI 1.12–1.84).ConclusionsMonetary incentives can increase the response rate for vulnerable children and youths in surveys.Trial registrationThe trial was retrospectively registered at ClinicalTrials.gov Identifier: NCT01741675. ]]> <![CDATA[Pooling individual participant data from randomized controlled trials: Exploring potential loss of information]]> https://www.researchpad.co/article/elastic_article_7838 Pooling individual participant data to enable pooled analyses is often complicated by diversity in variables across available datasets. Therefore, recoding original variables is often necessary to build a pooled dataset. We aimed to quantify how much information is lost in this process and to what extent this jeopardizes validity of analyses results.MethodsData were derived from a platform that was developed to pool data from three randomized controlled trials on the effect of treatment of cardiovascular risk factors on cognitive decline or dementia. We quantified loss of information using the R-squared of linear regression models with pooled variables as a function of their original variable(s). In case the R-squared was below 0.8, we additionally explored the potential impact of loss of information for future analyses. We did this second step by comparing whether the Beta coefficient of the predictor differed more than 10% when adding original or recoded variables as a confounder in a linear regression model. In a simulation we randomly sampled numbers, recoded those < = 1000 to 0 and those >1000 to 1 and varied the range of the continuous variable, the ratio of recoded zeroes to recoded ones, or both, and again extracted the R-squared from linear models to quantify information loss.ResultsThe R-squared was below 0.8 for 8 out of 91 recoded variables. In 4 cases this had a substantial impact on the regression models, particularly when a continuous variable was recoded into a discrete variable. Our simulation showed that the least information is lost when the ratio of recoded zeroes to ones is 1:1.ConclusionsLarge, pooled datasets provide great opportunities, justifying the efforts for data harmonization. Still, caution is warranted when using recoded variables which variance is explained limitedly by their original variables as this may jeopardize the validity of study results. ]]> <![CDATA[Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial]]> https://www.researchpad.co/article/N3889b1ed-7187-41ba-b4d5-94f42ba3d649

Background

Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women’s risk for IPV. There are few evidence-based interventions to address these problems in low- and middle-income countries (LMICs). We evaluated the effectiveness of an evidence-based, multi-problem, flexible, transdiagnostic intervention, the Common Elements Treatment Approach (CETA) in reducing (a) women’s experience of IPV and (b) their male partner’s alcohol misuse among couples in urban Zambia.

Methods and findings

This was a single-blind, parallel-assignment randomized controlled trial in Lusaka, Zambia. Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use were enrolled as a couple and randomized to CETA or treatment as usual plus safety checks (TAU-Plus). The primary outcome, IPV, was assessed by the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT). Assessors were blinded. Analyses were intent-to-treat. Primary outcome assessments were planned at post-treatment, 12 months post-baseline, and 24 months post-baseline. Enrollment was conducted between May 23, 2016, and December 17, 2016. In total, 123 couples were randomized to CETA, 125 to TAU-Plus. The majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age. Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (−8.2, 95% CI −14.9 to −1.5, p = 0.02, Cohen’s d effect size = 0.49). Similarly, mean reduction in AUDIT score at 12 months post-baseline was statistically significantly greater among men who received CETA compared to men who received TAU (−4.5, 95% CI −6.9 to −2.2, p < 0.001, Cohen’s d effect size = 0.43). The Data and Safety Monitoring Board recommended the trial be stopped early due to treatment effectiveness following the 12-month post-baseline assessment, and CETA was offered to control participants. Limitations of the trial included the lack of a true control condition (i.e., that received no intervention), self-reported outcomes that may be subject to social desirability bias, and low statistical power for secondary IPV outcomes.

Conclusions

Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future research and programming should include tertiary prevention approaches to IPV, such as CETA, rather than offering only community mobilization and primary prevention.

Trial registration

The trial was registered on ClinicalTrials.gov (NCT02790827).

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<![CDATA[Reporting quality and spin in abstracts of randomized clinical trials of periodontal therapy and cardiovascular disease outcomes]]> https://www.researchpad.co/article/N5a52c97b-59d0-4564-8bd9-d8b1530b3570

Objective

Poor reporting in randomized clinical trial (RCT) abstracts reduces quality and misinforms readers. Spin, a biased presentation of findings, could frequently mislead clinicians to accept a clinical intervention despite non-significant primary outcome. Therefore, good reporting practices and absence of spin enhances research quality. We aim to assess the reporting quality and spin in abstracts of RCTs evaluating the effect of periodontal therapy on cardiovascular (CVD) outcomes.

Methods

PubMed, Scopus, the Cochrane Central Register of Controlled Trials (CENTRAL), and 17 trial registration platforms were searched. Cohort, non-randomized, non-English studies, and pediatric studies were excluded. RCT abstracts were reviewed by 2 authors using the CONSORT for abstracts and spin checklists for data extraction. Cohen’s Kappa statistic was used to assess inter-rater agreement. Data on the selected RCT publication metrics were collected. Descriptive analysis was performed with non-parametric methods. Correlation analysis between quality, spin and bibliometric parameters was conducted.

Results

24 RCTs were selected for CONSORT analysis and 14 fulfilled the criteria for spin analysis. Several important RCT elements per CONSORT were neglected in the abstract including description of the study population (100%), explicitly stated primary outcome (87%), methods of randomization and blinding (100%), trial registration (87%). No RCT examined true outcomes (CVD events). A significant fraction of the abstracts appeared with at least one form of spin in the results and conclusions (86%) and claimed some treatment benefit in spite of non-significant primary outcome (64%). High-quality reporting had a significant positive correlation with reporting of trial registration (p = 0.04) and funding (p = 0.009). Spinning showed marginal negative correlation with reporting quality (p = 0.059).

Conclusion

Poor adherence to the CONSORT guidelines and high levels of data spin were found in abstracts of RCTs exploring the effects of periodontal therapy on CVD outcomes. Our findings indicate that journal editors and reviewers should consider strict adherence to proper reporting guidelines to improve reporting quality and reduce waste.

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<![CDATA[Ivermectin as an adjuvant to anti-epileptic treatment in persons with onchocerciasis-associated epilepsy: A randomized proof-of-concept clinical trial]]> https://www.researchpad.co/article/N2a703e18-6320-408f-bd4d-1f677396d877

Introduction

Recent findings from onchocerciasis-endemic foci uphold that increasing ivermectin coverage reduces the epilepsy incidence, and anecdotal evidence suggests seizure frequency reduction in persons with onchocerciasis-associated epilepsy, when treated with ivermectin. We conducted a randomized clinical trial to assess whether ivermectin treatment decreases seizure frequency.

Methods

A proof-of-concept randomized clinical trial was conducted in the Logo health zone in the Ituri province, Democratic Republic of Congo, to compare seizure frequencies in onchocerciasis-infected persons with epilepsy (PWE) randomized to one of two treatment arms: the anti-epileptic drug phenobarbital supplemented with ivermectin, versus phenobarbital alone. The primary endpoint was defined as the probability of being seizure-free at month 4. A secondary endpoint was defined as >50% reduction in seizure frequency at month 4, compared to baseline. Both endpoints were analyzed using multiple logistic regression. In longitudinal analysis, the probability of seizure freedom during the follow-up period was assessed for both treatment arms by fitting a logistic regression model using generalized estimating equations (GEE).

Results

Ninety PWE enrolled between October and November 2017 were eligible for analysis. A multiple logistic regression analysis showed a borderline association between ivermectin treatment and being seizure-free at month 4 (OR: 1.652, 95% CI 0.975–2.799; p = 0.062). There was no significant difference in the probability of experiencing >50% reduction of the seizure frequency at month 4 between the two treatment arms. Also, treatment with ivermectin did not significantly increase the odds of being seizure-free during the individual follow-up visits.

Conclusion

Whether ivermectin has an added value in reducing the frequency of seizures in PWE treated with AED remains to be determined. A larger study in persons with OAE on a stable AED regimen and in persons with recent epilepsy onset should be considered to further investigate the potential beneficial effect of ivermectin treatment in persons with OAE.

Trial registration

Registration: www.clinicaltrials.gov; NCT03052998.

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<![CDATA[Acute kidney injury and adverse renal events in patients receiving SGLT2-inhibitors: A systematic review and meta-analysis]]> https://www.researchpad.co/article/N25fa93a0-706a-4469-9476-c6f8ced4ff6a

Background

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) represent a new class of oral hypoglycemic agents used in the treatment of type 2 diabetes mellitus. They have a positive effect on the progression of chronic kidney disease, but there is a concern that they might cause acute kidney injury (AKI).

Methods and findings

We conducted a systematic review and meta-analysis of the effect of SGLT2is on renal adverse events (AEs) in randomized controlled trials and controlled observational studies. PubMed, EMBASE, Cochrane library, and ClinicalTrials.gov were searched without date restriction until 27 September 2019. Data extraction was performed using a standardized data form, and any discrepancies were resolved by consensus. One hundred and twelve randomized trials (n = 96,722) and 4 observational studies with 5 cohorts (n = 83,934) with a minimum follow-up of 12 weeks that provided information on at least 1 adverse renal outcome (AKI, combined renal AE, or hypovolemia-related events) were included. In 30 trials, 410 serious AEs due to AKI were reported. SGLT2is reduced the odds of suffering AKI by 36% (odds ratio [OR] 0.64 [95% confidence interval (CI) 0.53–0.78], p < 0.001). A total of 1,089 AKI events of any severity (AEs and serious AEs [SAEs]) were published in 41 trials (OR 0.75 [95% CI 0.66–0.84], p < 0.001). Empagliflozin, dapagliflozin, and canagliflozin had a comparable benefit on the SAE and AE rate. AEs related to hypovolemia were more commonly reported in SGLT2i-treated patients (OR 1.20 [95% CI 1.10–1.31], p < 0.001). In the observational studies, 777 AKI events were reported. The odds of suffering AKI were reduced in patients receiving SGLT2is (OR 0.40 [95% CI 0.33–0.48], p < 0.001). Limitations of this study are the reliance on nonadjudicated safety endpoints, discrepant inclusion criteria and baseline hypoglycemic therapy between studies, inconsistent definitions of renal AEs and hypovolemia, varying follow-up times in different studies, and a lack of information on the severity of AKI (stages I–III).

Conclusions

SGLT2is reduced the odds of suffering AKI with and without hospitalization in randomized trials and the real-world setting, despite the fact that more AEs related to hypovolemia are reported.

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<![CDATA[Surgical management of intraocular lens dislocation: A meta-analysis]]> https://www.researchpad.co/article/5c76fe14d5eed0c484e5b438

Purpose

To compare the efficacy and safety of intraocular lens (IOL) repositioning and IOL exchange for the treatment of patients with IOL dislocation.

Methods

We systematically searched for relevant publications in English or Chinese in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, WHO International Clinical Trial Registration Platform, Clinical Trial.gov, China Biology Medicine Database, China National Knowledge Infrastructure Database and grey literature sources. Study quality was assessed using the STROBE template for observational studies and the Cochrane template for randomized controlled trials (RCTs). Data were meta-analyzed using RevMan 5.3.

Results

The review included 14 English-language studies reporting 1 RCT and 13 retrospective case series involving 1,082 eyes. Average follow-up time was 13.7 months. Pooled analysis of 10 studies showed that the two procedures had a similarly effect on best corrected visual acuity (MD -0.00, 95%CI: -0.08 to 0.08, P = 0.99). Pooled analysis of nine studies showed no significant difference in incidence of IOL redislocation (RR 2.12, 95%CI 0.85 to 5.30, P = 0.11); pooled analysis of seven studies showed greater extent of incidence of cystoid macular edema in IOL exchange (RR 0.47, 95%CI 0.21 to 1.30, P = 0.06). Pooled analysis of three studies showed greater extent of incidence of anterior vitrectomy in IOL exchange (RR 0.11, 95%CI 0.04 to 0.33, P<0.0001). Pooled analysis of two studies showed greater postoperative spherical equivalents in IOL repositioning (MD 1.02, 95%CI 0.51 to 1.52, P<0.0001). pooled analysis suggested no significant differences between the two procedures in terms of intraocular pressure, endothelial cell density, surgically induced astigmatism, or incidence of retinal detachment, intraocular hemorrhage or pupillary block.

Conclusion

IOL repositioning and exchange are safe and effective procedures for treating IOL dislocation. Neither procedure significantly affects best corrected visual acuity and IOL redislocation. IOL exchange was superior to repositioning in terms of postoperative SE, but IOL repositioning was associated with lower incidence of anterior vitrectomy, potentially lower incidence of cystoid macular edema.

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<![CDATA[Efficient design and analysis of randomized controlled trials in rare neurological diseases: An example in Guillain-Barré syndrome]]> https://www.researchpad.co/article/5c76fe48d5eed0c484e5b7f7

Background

Randomized controlled trials (RCTs) pose specific challenges in rare and heterogeneous neurological diseases due to the small numbers of patients and heterogeneity in disease course. Two analytical approaches have been proposed to optimally handle these issues in RCTs: covariate adjustment and ordinal analysis. We investigated the potential gain in efficiency of these approaches in rare and heterogeneous neurological diseases, using Guillain-Barré syndrome (GBS) as an example.

Methods

We analyzed two published GBS trials with primary outcome ‘at least one grade improvement’ on the GBS disability scale. We estimated the treatment effect using logistic regression models with and without adjustment for prognostic factors. The difference between the unadjusted and adjusted estimates was disentangled in imbalance (random differences in baseline covariates between treatment arms) and stratification (change of the estimate due to covariate adjustment). Second, we applied proportional odds regression, which exploits the ordinal nature of the GBS disability score. The standard error of the estimated treatment effect indicated the statistical efficiency.

Results

Both trials were slightly imbalanced with respect to baseline characteristics, which was corrected in the adjusted analysis. Covariate adjustment increased the estimated treatment effect in the two trials by 8% and 18% respectively. Proportional odds analysis resulted in lower standard errors indicating more statistical power.

Conclusion

Covariate adjustment and proportional odds analysis most efficiently use the available data and ensure balance between the treatment arms to obtain reliable and valid treatment effect estimates. These approaches merit application in future trials in rare and heterogeneous neurological diseases like GBS.

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<![CDATA[Supported employment: Meta-analysis and review of randomized controlled trials of individual placement and support]]> https://www.researchpad.co/article/5c76fe41d5eed0c484e5b7ab

Supported employment is a treatment whereby those with severe mental illness (or other disabilities) receive aid searching for competitive employment and mental health (or other) treatments concurrently. The most popular implementation of supported employment is individual placement and support (IPS). We conducted meta-analytic analyses of the randomized controlled trials of IPS. We found that subjects in IPS, compared to usual treatment conditions, had better vocational outcomes (obtained any competitive employment: RR = 1.63, 95%CI = [1.46, 1.82]; job tenure: d = 0.55, 95%CI = [0.33, 0.79]; job length: d = 0.46, 95%CI = [0.35, 0.57]; income: d = 0.48, 95%CI = [0.36, 0.59]) Non-vocational outcomes estimates, while favoring IPS, included the null (quality of life: d = 0.30, 95%CI = [-0.07, 0.67]; global functioning: d = 0.09, 95%CI = [-0.09, 0.27]; mental health: d = 0.03, 95%CI = [-0.15, 0.21]). Analysis of the expected proportion of studies with a true effect on non-vocational outcomes with d>0.2 showed some reason to expect a possible improvement for quality of life for at least some settings (Prop = 0.57, 95%CI = [0.30, 0.84]).

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<![CDATA[Use of Prophylactic Mesh When Creating a Colostomy Does Not Prevent Parastomal Hernia]]> https://www.researchpad.co/article/5c8bf7efd5eed0c484b1eaca

Objective:

The aim of this study was to determine whether parastomal hernia (PSH) rate can be reduced by using synthetic mesh in the sublay position when constructing permanent end colostomy. The secondary aim was to investigate possible side-effects of the mesh.

Background:

Prevention of PSH is important as it often causes discomfort and leakage from stoma dressing. Different methods of prevention have been tried, including several mesh techniques. The incidence of PSH is high; up to 78%.

Methods:

Randomized controlled double-blinded multicenter trial. Patients undergoing open colorectal surgery, including creation of a permanent end colostomy, were randomized into 2 groups, with and without mesh. A lightweight polypropylene mesh was placed around the colostomy in the sublay position. Follow up after 1 month and 1 year. Computerized tomography and clinical examination were used to detect PSH at the 1-year follow up. Data were analyzed on an intention-to-treat basis.

Results:

After 1 year, 211 of 232 patients underwent clinical examination and 198 radiologic assessments. Operation time was 36 minutes longer in the mesh arm. No difference in rate of PSH was revealed in the analyses of clinical (P = 0.866) and radiologic (P = 0.748) data. There was no significant difference in perioperative complications.

Conclusions:

The use of reinforcing mesh does not alter the rate of PSH. No difference in complication rate was seen between the 2 arms. Based on these results, the prophylactic use of mesh to prevent PSH cannot be recommended.

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<![CDATA[Violence against Afghan women by husbands, mothers-in-law and siblings-in-law/siblings: Risk markers and health consequences in an analysis of the baseline of a randomised controlled trial]]> https://www.researchpad.co/article/5c65dce9d5eed0c484dec55d

Background

Violence by mothers-in-law, as well as husbands, is a recognised problem in many countries. It has been given little attention in research on violence and its importance as a health problem, and aggravator of husband violence, has not been well established. Our aim was to describe patterns and the frequency of mother-in-law and sibling-in-law/sibling physical violence in relation to physical violence from husbands, and to describe risk characteristics and associated health behaviours of women with different abuse exposures.

Methods

1,463 women aged 18–48 were recruited into a randomised controlled trial (RCT) to evaluate a women empowerment intervention in 6 villages of Kabul and Nangarhar provinces. The women were interviewed at baseline. The analysis uses bi-variable and multivariable logistic regression.

Results

932 of the women were currently married. Of these, 14% of women experienced mother-in-law physical violence and 23.2% of women experienced physical spousal violence in the previous 12 months. For 7.0% of women, these exposures were combined. Physical violence was associated with food insecurity and having to borrow for food, being in a polygamous marriage, living with their mother-in-law, as well as province of residence (higher in Nangarhar). Women who had earnings were relatively protected. Whilst most mothers-in-law were described in positive terms, those who used physical violence were much less likely to be described so and a quarter were described as very strict and controlling and 16.8% as cruel. Overall slightly more women described their husband in positive terms than their mother-in-law, but there was a very strong correlation between the way in which husbands were perceived and the violence of their mothers.

Women’s mental health (depression, suicidal thoughts and PTSD symptoms score), self-rated general health, disability and beating of their children were all strongly associated with intimate partner violence (IPV) exposure. The strength of the association was much greater for all of these problems if the IPV was combined with physical violence from a mother-in-law or sibling-in-law/sibling. Experienced alone, violence from the mother-in-law or a sibling-in-law/sibling was associated with an elevated risk of all of these problems except depression.

Interpretation

Mother-in-law and sibling-in-law/sibling physical violence is an appreciable problem among the women studied in Afghanistan, linked to poverty. It has a major impact on women’s health, componding the heath impact of IPV. In this setting conceptualising women’s risk and exposure to violence at home as only in terms of IPV is inadequate and the framing of domestic violence much more appropriately captures women’s risks and exposures. We suggest that it may be fruitful for many women to target violence prevention at the domestic unit rather than just at women and their husbands.

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<![CDATA[A meta-analysis of anti-interleukin-13 monoclonal antibodies for uncontrolled asthma]]> https://www.researchpad.co/article/5c5ca306d5eed0c48441f014

More and more clinical trials have tried to assess the clinical benefit of anti-interleukin (IL)-13 monoclonal antibodies for uncontrolled asthma. The aim of this study is to evaluate the efficacy and safety of anti-IL-13 monoclonal antibodies for uncontrolled asthma. Major databases were searched for randomized controlled trials comparing the anti-IL-13 treatment and a placebo in uncontrolled asthma. Outcomes, including asthma exacerbation rate, forced expiratory volume in 1 second (FEV1), Asthma Quality of Life Questionnaire (AQLQ) scores, rescue medication use, and adverse events were extracted from included studies for systematic review and meta-analysis. Five studies involving 3476 patients and two anti-IL-13 antibodies (lebrikizumab and tralokinumab) were included in this meta-analysis. Compared to the placebo, anti-IL-13 treatments were associated with significant improvement in asthma exacerbation, FEV1 and AQLQ scores, and reduction in rescue medication use. Adverse events and serious adverse events were similar between two groups. Subgroup analysis showed patients with high periostin level had a lower risk of asthma exacerbation after receiving anti-IL-13 treatment. Our study suggests that anti-IL-13 monoclonal antibodies could improve the management of uncontrolled asthma. Periostin may be a good biomarker to detect the specific subgroup who could get better response to anti-IL-13 treatments. In view of blocking IL-13 alone is possibly not enough to achieve asthma control because of the overlapping pathophysiological roles of IL-13/IL-4 in inflammatory pathways, combined blocking of IL-13 and IL-4 with monoclonal antibodies may be more encouraging.

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<![CDATA[Reporting of “dialysis adequacy” as an outcome in randomised trials conducted in adults on haemodialysis]]> https://www.researchpad.co/article/5c633962d5eed0c484ae65b8

Background

Clinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients.

Objective

To assess the scope and consistency of the construct dialysis adequacy as reported in randomised controlled trials in hemodialysis, and evaluate whether these align to the insights and understanding of this construct by patients.

Methods

To assess scope and consistency of dialysis adequacy by professionals, we performed a systematic review searching the Cochrane Central Register of Controlled Trials (CENTRAL) up to July 2017. We identified all randomised controlled trails (RCT) including patients on hemodialysis and reporting dialysis adequacy, adequacy or adequacy of dialysis and extracted and classified all reported outcomes. To explore interpretation and meaning of the construct of adequacy by patients, we conducted 11 semi-structured interviews with HD patients using thematic analysis. Belgian registration number B670201731001.

Findings

From the 31 included trials, we extracted and classified 98 outcome measures defined by the authors as adequacy of dialysis, of which 94 (95%) were biochemical, 3 (3%) non-biochemical surrogate and 2 (2%) patient-relevant. The three most commonly reported measures were all biochemical. None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life. Patients had a substantially different understanding of the construct dialysis adequacy than the biochemical interpretation reported in the literature. Being alive, time spent while being on dialysis, fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy.

Conclusion

Adequacy of dialysis as reported in the literature refers to biochemical outcome measures, most of which are not related with patient relevant outcomes. For patients, adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible.

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<![CDATA['Nasal mask’ in comparison with ‘nasal prongs’ or ‘rotation of nasal mask with nasal prongs’ reduce the incidence of nasal injury in preterm neonates supported on nasal continuous positive airway pressure (nCPAP): A randomized controlled trial]]> https://www.researchpad.co/article/5c5ca2add5eed0c48441e87c

Background

With increasing use of nCPAP, the safety and comfort associated with nCPAP have come into the forefront. The reported incidence of nasal injuries associated with the use of nCPAP is 20% to 60%. A recent meta-analysis concluded that the use of nasal masks significantly decreases CPAP failure and the incidence of moderate to severe nasal injury and stress the need for a well powered RCT to confirm their findings.

Methods

In this Open label, 3 arms, sequential, stratified randomized controlled trial, we evaluated the incidence and severity of nasal injury at removal of nCPAP when using two different nasal interfaces and in three groups (i.e. rotation group, mask continue group, prong continue group). Preterm infants with gestation ≤ 30 weeks and respiratory distress within the first 6 hours of birth and in need of CPAP were eligible for the study.

Results

Among the 175 newborns included in the study, incidence of nasal injury in mask continue group [n = 19/57 (33.3%)] was significantly less as compared to prong continue group [n = 55/60 (91.6%)] and rotation group [33/ 58 (56.9%), p value <0.0001]. Median maximum nasal injury score was significantly less in Mask continue group as compared to Prong continue group and Rotation group [Injury Score 0 (IQR 0–1) vs. Injury Score 3 (IQR 2–5) vs. Injury Score 1 (IQR 0–2), p value = <0.0001] respectively. The proportion of infants failing nCPAP was similar across the three groups.

Conclusion

nCPAP with nasal masks significantly reduces nasal injury in comparison with nasal prongs or rotation of nasal prongs and nasal masks. However, the type of interface did not affect the nCPAP failure rates.

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<![CDATA[Carpal tunnel release with versus without flexor retinaculum reconstruction for carpal tunnel syndrome at short- and long-term follow up—A meta-analysis of randomized controlled trials]]> https://www.researchpad.co/article/5c58d617d5eed0c4840315cb

Background

Carpal tunnel syndrome is a common neuropathy disorder for which surgical treatment consists of release and reconstruction of the flexor retinaculum. Reports of postoperative clinical outcomes after carpal tunnel release with or without flexor retinaculum reconstruction in several studies are controversial. This meta-analysis aimed to compare the efficacy and safety of carpal tunnel release with or without flexor retinaculum reconstruction.

Methods

The PubMed, EMBASE, Web of Science, Ovid, Cochrane Library and Clinical Tri Org databases were searched for randomized controlled trials that compared carpal release with and without transverse carpal ligament reconstruction for carpal tunnel syndrome. Outcomes included postoperative Boston Carpal Tunnel Questionnaire Symptom Severity Scale (SSS), Functional Status Scale (FSS), grip strength and complications. The follow-up time was categorized into short-term (0-3mon) and long-term(>3mon).

Results

A total of 7 studies with 613 patients met the inclusion criteria and were analyzed in detail. Statistical analysis showed no significant difference between two groups on postoperative long-term grip strength (MD 5.85, 95% CI -1.05 to 12.76) long-term SSS (MD -0.31, 95% CI -0.75 to 0.13) and occurrence of complications (RR 1.14, 95% CI 0.84 to 1.54), whereas statistically significant difference was found between groups regarding short-term grip strength (MD 1.51, 95% CI 0.86 to 2.17) and long-term FSS (MD -0.34, 95% CI -0.47 to -0.21).

Conclusion

Carpal tunnel release with flexor retinaculum reconstruction for carpal tunnel syndrome may result in improved long-term functional status while there’s no advantage regarding grip strength, symptom severity and safety over individual carpal tunnel release in short- and long-term outcomes.

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<![CDATA[Physician characteristics associated with proper assessment of overstated conclusions in research abstracts: A secondary analysis of a randomized controlled trial]]> https://www.researchpad.co/article/5c6448e6d5eed0c484c2f14b

Objectives

Little is known about the physician characteristics associated with appraisal skills of research evidence, especially the assessment of the validity of study methodology. This study aims to explore physician characteristics associated with proper assessment of overstated conclusions in research abstracts.

Design

A secondary analysis of a randomized controlled trial.

Setting and participants

We recruited 567 volunteers from the Japan Primary Care Association.

Methods

Participants were randomly assigned to read the abstract of a research paper, with or without an overstatement, and to rate its validity. Our primary outcome was proper assessment of the validity of its conclusions. We investigated the association of physician characteristics and proper assessment using logistic regression models and evaluated the interaction between the associated characteristics and overstatement.

Results

We found significant associations between proper assessment and post-graduate year (odds ratio [OR] = 0.67, 95% confidence interval [CI] 0.49 to 0.91, for every 10-year increase) and research experience as a primary investigator (PI; OR = 2.97, 95% CI 1.65 to 5.34). Post-graduate year and PI had significant interaction with overstatement (P = 0.015 and < 0.001, respectively). Among participants who read abstracts without an overstatement, post-graduate year was not associated with proper assessment (OR = 1.04, 95% CI 0.82 to 1.33), and PI experience was associated with lower scores of the validity (OR = 0.58, 95% CI 0.35 to 0.96).

Conclusion

Physicians who have been in practice longer should be trained in distinguishing overstatements in abstract conclusions. Physicians with research experience might be informed that they tend to rate the validity of research lower regardless of the presence or absence of overstatements.

Trial registration

UMIN000026269.

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<![CDATA[Fecal microbiota transplantation for treatment of recurrent C. difficile infection: An updated randomized controlled trial meta-analysis]]> https://www.researchpad.co/article/5c5217d8d5eed0c4847946a2

Objectives

Although systematic evaluation has confirmed the efficacy of fresh fecal microbiota transplantation (FMT) for treatment of recurrent and/or refractory and/or relapse C. difficile infection (RCDI), it lacks the support of well-designed randomized controlled trials (RCTs), and the latest guidelines do not optimize the management of FMT. In this paper, we focus on an in-depth study of fresh FMT and fecal infusion times to guide clinical practice.

Methods

We reviewed studies in PubMed, Medline, Embase, the Cochrane library and Cochrane Central written in English. The retrieval period was from the establishment of the databases to September 20th, 2018. The retrieval objects were published RCTs of RCDI treated by fresh FMT. The intervention group was fresh FMT group, while the control group included antibiotic therapy or placebo or frozen FMT or capsule. The primary and secondary outcomes were the clinical remission of diarrhea without relapse after 8–17 weeks and the occurrence of severe adverse events, respectively. Subgroup analysis analyzed the effect of single and multiple fecal infusions. Two authors independently completed the information extraction and assessed risk of bias and overall quality of the evidence.

Results

8 randomized controlled trials met the inclusion criteria, involving 537 patients (273 in the fresh FMT group and 264 in the control group). The recurrence rate of clinical diarrhea in the fresh FMT group was 11.0% (30/273), which was significantly lower than the control group (24.6%, 65/264; P < 0.05); the pooled relative risk (RR) was 0.38 (95%CI:0.16–0.87; I2 = 67%; P = 0.02) in the fresh FMT group, and the clinical heterogeneity was significant and random effects model was used; However, there was no significant difference neither for the effect of antibiotic treatment/frozen feces transplanted by enema (RR = 1.07; 95%CI: 0.64–1.80; I2 = 0%; P = 0.79) or capsule/frozen feces transplanted by colonoscopy (RR = 0.42; 95%CI: 0.05–3.94; I2 = 43%; P = 0.45) compared with fresh FMT. The subgroup analysis showed that FMT by multiple infusions could effectively and significantly (RR = 0.24; 95%CI:0.10–0.58; I2 = 0%; P = 0.001) improve the clinical diarrhea remission rate. Most mild to moderate adverse events caused by FMT were self-limited and could be quickly alleviated; no severe adverse events happened because of FMT.

Conclusions

Overall, the use of fresh feces for bacterial transplantation was the best efficiency for RCDI compared to antibiotic therapy or placebo. The fecal transmission method by enema was not ideal, but capsules or frozen feces transported by colonoscopy could be an alternative treatment compared to fresh FMT. For patients with severe RCDI, multiple fecal transplants can effectively improve their diarrhea remission rate. The focus of future research should be on how to standardize the production of capsules or frozen feces to better guide the clinical management of RCDI patients by FMT.

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<![CDATA[A systematic review of the quality of distal radius systematic reviews: Methodology and reporting assessment]]> https://www.researchpad.co/article/5c52187cd5eed0c484798844

Background

Many systematic reviews (SRs) have been published about the various treatments for distal radius fractures (DRF). The heterogeneity of SRs results may come from the misuse of SR methods, and literature overviews have demonstrated that SRs should be considered with caution as they may not always be synonymous with high-quality standards. Our objective is to evaluate the quality of published SRs on the treatment of DRF through these tools.

Methods

The methods utilized in this review were previously published in the PROSPERO database. We considered SRs of surgical and nonsurgical interventions for acute DRF in adults. A comprehensive search strategy was performed in the MEDLINE database (inception to May 2017) and we manually searched the grey literature for non-indexed research. Data were independently extracted by two authors. We assessed SR internal validity and reporting using AMSTAR (Assessing the Methodological Quality of Systematic Reviews and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes). Scores were calculated as the sum of reported items. We also extracted article characteristics and provided Spearman’s correlation measurements.

Results

Forty-one articles fulfilled the eligibility criteria. The mean score for PRISMA was 15.90 (CI 95%, 13.9–17.89) and AMSTAR was 6.48 (CI 95% 5.72–7.23). SRs that considered only RCTs had better AMSTAR [7.56 (2.1) vs. 5.62 (2.3); p = 0.014] and PRISMA scores [18.61 (5.22) vs. 13.93 (6.47), p = 0.027]. The presence of meta-analysis on the SRs altered PRISMA scores [19.17 (4.75) vs. 10.21 (4.51), p = 0.001] and AMSTAR scores [7.68 (1.9) vs. 4.39 (1.66), p = 0.001]. Journal impact factor or declaration of conflict of interest did not change PRISMA and AMSTAR scores. We found substantial inter observer agreement for PRISMA (0.82, 95% CI 0.62–0.94; p = 0.01) and AMSTAR (0.65, 95% CI 0.43–0.81; p = 0.01), and moderate correlation between PRISMA and AMSTAR scores (0.83, 95% CI 0.62–0.92; p = 0.01).

Conclusions

DRF RCT-only SRs have better PRISMA and AMSTAR scores. These tools have substantial inter-observer agreement and moderate inter-tool correlation. We exposed the current research panorama and pointed out some factors that can contribute to improvements on the topic.

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<![CDATA[The role of the practice order: A systematic review about contextual interference in children]]> https://www.researchpad.co/article/5c50c43fd5eed0c4845e837f

Aim

We aimed to identify and evaluate the quality and evidence of the motor learning literature about intervention studies regarding the contextual interference (CI) effect (blocked vs. random practice order) in children with brain lesions and typically developing (TD) children.

Method

Eight databases (Cinahl, Cochrane, Embase, PubMed, Pedro, PsycINFO, Scopus and Web of Knowledge) were searched systematically with predefined search terms. Controlled studies examining the CI effect in children (with brain lesions or TD) were included. Evidence level, conduct quality, and risk of bias were evaluated by two authors independently. A best evidence synthesis was performed.

Results

Twenty-five papers evaluating TD children were included. One of these studies also assessed children with cerebral palsy. Evidence levels were I, II, or III. Conduct quality was low and the risk of bias high, due to methodological issues in the study designs or poor description thereof. Best evidence synthesis showed mainly no or conflicting evidence. Single tasks showed limited to moderate evidence supporting the CI effect in TD children.

Conclusion

There is a severe limitation of good-quality evidence about the CI effect in children who practice different tasks in one session, especially in children with brain lesions.

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<![CDATA[Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation]]> https://www.researchpad.co/article/5c42439ad5eed0c4845e07bc

Background

The preparation of a randomized controlled trial (RCT) requires substantial resources and the administrative processes can be burdensome. To facilitate the conduct of RCTs it is important to better understand cost drivers. In January 2014 the enactment of the new Swiss Legislation on Human Research (LHR) considerably changed the regulatory framework in Switzerland. We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethics committees (RECs) and the regulatory authority Swissmedic.

Methods

We surveyed investigators of RCTs which were approved by RECs in 2012 or in 2016 and asked for RCT preparation costs using a pre-specified item list. Additionally, we collected approval times from RECs and Swissmedic.

Results

The response rates of the investigator survey were 8.3% (19/228) for 2012 and 16.5% (47/285) in 2016. The median preparation cost of an RCT was USD 72,400 (interquartile range [IQR]: USD 59,500–87,700; n = 18) in 2012 and USD 72,600 (IQR: USD 42,800–169,600; n = 35) in 2016. For single centre RCTs a median REC approval time of 82 (IQR: 49–107; n = 38) days in 2012 and 92 (IQR: 65–131; n = 63) days in 2016 was observed. The median Swissmedic approval time for any clinical trial was 27 (IQR: 19–51; n = 213) days in 2012 and 49 (IQR: 36–67; n = 179) days in 2016. The total duration for achieving RCT approval from both authorities (REC and Swissmedic) in the parallel submission procedure applied in 2016 could not be assessed.

Conclusion

Based on limited data the costs to plan and prepare RCTs in Switzerland were approximately USD 72,000 in 2012 and 2016. For effective and valid research on costs and approval times of RCTs a greater willingness to share cost information among investigators and more collaboration between stakeholders with data linkage is necessary.

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