Objective: We evaluated whether sample size differences between arms of two-arm parallel group randomized controlled trials (RCTs) published in American Psychological Association (APA)-affiliated ...journals were consistently smaller than expected by chance with simple randomization. Method: We searched PsycINFO for two-arm parallel group RCTs in APA-affiliated journals published January 2007 to September 2017 that used individual randomization (1:1 allocation ratio), reported the number of participants randomized, and did not describe employing restrictive randomization (e.g., blocking). We queried authors because randomization processes were often not described in articles, and we conducted a post hoc logistic regression analysis to attempt to identify factors associated with overly balanced groups. Results: We identified 203 eligible trials, but after the author query, it was determined that only 115 used simple randomization. Among those 115 trials, there was a significantly greater number of trials with smaller sample size differences between trial arms than would be expected by chance (p < .001); 89 of 115 (77%) had differences in trial arm sample sizes smaller than the 50% prediction interval threshold for these differences. Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI 0.08, 0.94 for N > 200 vs. N ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant. Conclusions: Education is needed to ensure that randomization procedures are implemented as intended and fully and accurately reported and that balanced group sample sizes are not understood as an indicator of trial quality.
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CEKLJ, FFLJ, NUK, ODKLJ, PEFLJ
Objectives
Depression screening tool accuracy studies should be conducted with large enough sample sizes to generate precise accuracy estimates. We assessed the proportion of recently published ...depression screening tool diagnostic accuracy studies that reported sample size calculations; the proportion that provided confidence intervals (CIs); and precision, based on the width and lower bounds of 95% CIs for sensitivity and specificity. In addition, we assessed whether these results have improved since a previous review of studies published in 2013–2015.
Methods
MEDLINE was searched from January 1, 2018, through May 21, 2021.
Results
Twelve of 106 primary studies (11%) described a viable sample size calculation, which represented an improvement of 8% since the last review. Thirty‐six studies (34%) provided reasonably accurate CIs. Of 103 studies where 95% CIs were provided or could be calculated, seven (7%) had sensitivity CI widths of ≤10%, whereas 58 (56%) had widths of ≥21%. Eighty‐four studies (82%) had lower bounds of CIs <80% for sensitivity and 77 studies (75%) for specificity. These results were similar to those reported previously.
Conclusion
Few studies reported sample size calculations, and the number of included individuals in most studies was too small to generate reasonably precise accuracy estimates.
Abstract Objective Database searches for studies of diagnostic test accuracy are notoriously difficult to filter, highly resource-intensive, and a potential barrier to quality evidence synthesis. We ...examined published meta-analyses of depression screening tool accuracy to evaluate the (1) proportion of included primary studies found in any online database in the original meta-analyses that were indexed in MEDLINE; (2) the proportion of patients from MEDLINE-indexed studies; and (3) the proportion of depression cases from studies indexed in MEDLINE. Methods MEDLINE and PsycINFO were searched from January 1, 2005 through October 31, 2014 for meta-analyses in any language on the accuracy of depression screening tools. Results We identified 16 eligible meta-analyses that included 398 primary study citations, which had been identified via an online database in the original meta-analyses, including 257 unique citations and 234 unique patient samples. The 234 unique patient samples included 69,957 total patients and 11,867 depression cases. Of these, 220 samples (94%) were from studies indexed in MEDLINE, including 97% of all patients and 96% of all depression cases. When applying a peer-reviewed search strategy in MEDLINE, 91% of all samples, 96% of patients and 95% of depression cases were retrieved. Results were similar for total and unique citations. Conclusions Restricting searches to MEDLINE may capture almost all eligible studies, patients and depression cases. Although not examined in the present study, MEDLINE may not be indexed as quickly as other databases. Thus, MEDLINE searches should be complemented by date-limited searches of other databases for recent citations.
Informal caregivers provide ongoing assistance to a loved one with a health condition. No studies have compared caregiving intensity and perception of burden across chronic medical conditions.
...Databases were searched from inception through 11 September 2020 to identify studies that included the Level of Care Index or the Zarit Burden Inventory (ZBI) among caregivers for people with chronic diseases. Pooled mean ZBI scores and 95% confidence intervals by medical condition were calculated using a random effects model and heterogeneity with I
2
.
Ninety-seven included articles reported on 98 unique samples across 21 chronic diseases. No study used the Level of Care Index. Among 12 disease groups with more than one study, heterogeneity was too high (I
2
range: 0-99.6%, ≥76.5% in 11 groups) to confidently estimate burden. The percent of studies rated high risk of bias ranged from 0% to 98%, but all external validity items were rated as high-risk in >50% of studies.
Findings highlight the need for studies on caregiver burden to improve sampling techniques; better report sampling procedures and caregiver and care recipient characteristics; and develop a standard set of outcomes, including a measure of caregiving intensity. Systematic Review Registration: CRD42017080962
IMPLICATIONS FOR REHABILITATION
The amount of burden reported by caregivers to loved ones is associated with reduced physical and mental health.
We found considerable heterogeneity in perceived burden reported by informal caregivers across different studies within disease groups, which is likely related to methodological issues, including sampling techniques.
Health care providers who use research on caregiver burden should assess how representative study samples may be and exercise caution in drawing conclusions.
Reproducibility is a central tenant of research. We aimed to synthesize the literature on reproducibility and describe its epidemiological characteristics, including how reproducibility is defined ...and assessed. We also aimed to determine and compare estimates for reproducibility across different fields.
We conducted a scoping review to identify English language replication studies published between 2018 and 2019 in economics, education, psychology, health sciences, and biomedicine. We searched Medline, Embase, PsycINFO, Cumulative Index of Nursing and Allied Health Literature - CINAHL, Education Source via EBSCOHost, ERIC, EconPapers, International Bibliography of the Social Sciences (IBSS), and EconLit. Documents retrieved were screened in duplicate against our inclusion criteria. We extracted year of publication, number of authors, country of affiliation of the corresponding author, and whether the study was funded. For the individual replication studies, we recorded whether a registered protocol for the replication study was used, whether there was contact between the reproducing team and the original authors, what study design was used, and what the primary outcome was. Finally, we recorded how reproducibilty was defined by the authors, and whether the assessed study(ies) successfully reproduced based on this definition. Extraction was done by a single reviewer and quality controlled by a second reviewer.
Our search identified 11,224 unique documents, of which 47 were included in this review. Most studies were related to either psychology (48.6%) or health sciences (23.7%). Among these 47 documents, 36 described a single reproducibility study while the remaining 11 reported at least two reproducibility studies in the same paper. Less than the half of the studies referred to a registered protocol. There was variability in the definitions of reproduciblity success. In total, across the 47 documents 177 studies were reported. Based on the definition used by the author of each study, 95 of 177 (53.7%) studies reproduced.
This study gives an overview of research across five disciplines that explicitly set out to reproduce previous research. Such reproducibility studies are extremely scarce, the definition of a successfully reproduced study is ambiguous, and the reproducibility rate is overall modest.
No external funding was received for this work.
The refinement of brain morphology extends across childhood, and exposure to environmental toxins during this period may alter typical trends. Radon is a highly common radiologic toxin with a ...well-established role in cancer among adults. However, effects on developmental populations are understudied in comparison. This study investigated whether home radon exposure is associated with altered brain morphology in youths. Fifty-four participants (6–14 yrs, M=10.52 yrs, 48.15% male, 89% White) completed a T1-weighted MRI and home measures of radon. We observed a significant multivariate effect of home radon concentrations, which was driven by effects on GMV. Specifically, higher home radon was associated with smaller GMV (F=6.800, p=.012, ηp2=.13). Conversely, there was a trending radon-by-age interaction on WMV, which reached significance when accounting for the chronicity of radon exposure (F=4.12, p=.049, ηp2=.09). We found that youths with above-average radon exposure showed no change in WMV with age, whereas low radon was linked with normative, age-related WMV increases. These results suggest that everyday home radon exposure may alter sensitive structural brain development, impacting developmental trajectories in both gray and white matter.
Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of ...RCTs using registries.
We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.
We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).
Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.
IMPORTANCE: Many interventions that are important to the health care of patients are not subject to regulation by the US Food and Drug Administration (FDA) or comparable regulatory bodies in other ...nations. OBJECTIVE: To determine whether specialty journals that publish trials of primarily nonregulated health care interventions require prospective registration and whether the prospective registration policies are associated with the publication of prospectively registered trials, trials with adequately registered outcomes, and trials with primary outcomes consistent with the registered primary outcomes. DESIGN AND METHODS: PubMed was searched daily, from March 18, 2016, to September 17, 2016, for nonregulated intervention randomized clinical trials. The search included all journals in the Clarivate Analytics Science Citation Index Expanded categories of behavioral sciences, nursing, nutrition and dietetics, psychology, rehabilitation, and surgery. Trials of interventions not subject to FDA regulation were included. One investigator extracted journal registration policy and trial registration status. Two investigators independently extracted trial registration and publication characteristics. MAIN OUTCOMES AND MEASURES: For journals, the main outcome was the trial registration policy. For trials, the main outcomes were prospective registration, adequacy of outcome registration, and concordance of registered with published primary outcomes. RESULTS: In total, 953 nonregulated intervention trials published in 254 journals were identified. Prospective registration was required for publication by 29 (11.4%) of 254 journals, and an additional 12 journals (4.7%) had conditional date-based requirements. Only 189 (19.8%) of the 953 trials were registered prospectively, including 33 of 98 published in journals with prospective registration policies as compared with 156 of 855 in journals without policies (33.7% vs 18.2%; P = .004). Among the 17 journals that required prospective registration and had at least 2 included trials, none had a prospective registration of more than 50%. In journals with policies, only 3 of 98 trials included primary outcomes consistent with prospectively, adequately registered outcomes, as compared with 34 of 852 trials in journals without policies (3.1% vs 4.0%; P = .62). CONCLUSIONS AND RELEVANCE: Few journals in behavioral sciences or psychology, nursing, nutrition and dietetics, rehabilitation, and surgery require prospective trial registration, and those with existing registration policies rarely enforce them; this finding suggests that strategies for encouraging prospective registration of clinical trials not subject to FDA regulation should be developed and tested.
Objectives
Our objective was to assess the effects of mental health interventions for children, adolescents, and adults not quarantined or undergoing treatment due to COVID-19 infection.
Methods
We ...searched 9 databases (2 Chinese-language) from December 31, 2019, to March 22, 2021. We included randomised controlled trials of interventions to address COVID-19 mental health challenges among people not hospitalised or quarantined due to COVID-19 infection. We synthesized results descriptively due to substantial heterogeneity of populations and interventions and risk of bias concerns.
Results
We identified 9 eligible trials, including 3 well-conducted, well-reported trials that tested interventions designed specifically for COVID-19 mental health challenges, plus 6 other trials with high risk of bias and reporting concerns, all of which tested standard interventions (e.g., individual or group therapy, expressive writing, mindfulness recordings) minimally adapted or not specifically adapted for COVID-19. Among the 3 well-conducted and reported trials, 1 (N = 670) found that a self-guided, internet-based cognitive-behavioural intervention targeting dysfunctional COVID-19 worry significantly reduced COVID-19 anxiety (standardized mean difference SMD 0.74, 95% confidence interval CI, 0.58 to 0.90) and depression symptoms (SMD 0.38, 95% CI, 0.22 to 0.55) in Swedish general population participants. A lay-delivered telephone intervention for homebound older adults in the United States (N = 240) and a peer-moderated education and support intervention for people with a rare autoimmune condition from 12 countries (N = 172) significantly improved anxiety (SMD 0.35, 95% CI, 0.09 to 0.60; SMD 0.31, 95% CI, 0.03 to 0.58) and depressive symptoms (SMD 0.31, 95% CI, 0.05 to 0.56; SMD 0.31, 95% CI, 0.07 to 0.55) 6-week post-intervention, but these were not significant immediately post-intervention. No trials in children or adolescents were identified.
Conclusions
Interventions that adapt evidence-based strategies for feasible delivery may be effective to address mental health in COVID-19. More well-conducted trials, including for children and adolescents, are needed.
Support Groups in Scleroderma Rice, Danielle B.; Thombs, Brett D.
Current rheumatology reports,
04/2019, Volume:
21, Issue:
4
Journal Article
Peer reviewed
Open access
Purpose of Review
This review presents evidence on support group effectiveness in common diseases, research on support groups in systemic sclerosis (SSc), and work underway by the Scleroderma ...Patient-centered Intervention Network in collaboration with patient organizations to train SSc support group leaders in order to improve support group access and the experiences of support groups for members and leaders.
Recent Findings
Giving and receiving emotional and practical support from others with SSc is an important reason that individuals with SSc attend support groups, but many patients cannot access support groups. SSc support group leaders report confidence in their ability to facilitate groups, but are less confident in tasks such as managing group dynamics and sustaining the group.
Summary
The Scleroderma Support group Leader EDucation (SPIN-SSLED) Program was developed to provide training to support group leaders and was recently tested through a feasibility trial. A full-scale trial will commence in 2019.
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