UNASSIGNED: Evaluate methodological quality of type 2 diabetes RCTs conducted in Iran and cited in clinical practice guidelines and systematic reviews and meta-analyses.
UNASSIGNED: We conducted a descriptive methodological quality review, analyzing 286 Randomized Controlled Trials (RCTs) on diabetes mellitus published in Iran from July 2004 to 2021. We searched six databases systematically and evaluated eligible articles using the CONSORT 2010 checklist for abstracts. Two investigators assessed the data using a 17-item checklist derived from CONSORT. Additionally, we examined the citations of each RCT in 260 clinical practice guidelines, with a specific focus on the adequate reporting of outcomes.
UNASSIGNED: Out of 6667 articles, 286 analyzed. Poor reporting and failure to meet criteria observed. Only 3.8% cited in guidelines. Reporting rates: primary outcomes (41.9%), randomization (61.8%), trial recruitment (12.6%), blinding (50.8%). 27.9% cited in systematic reviews, 50.34% in systematic reviews and meta-analyses, 26.57% in meta-analyses. 67.8% of papers cited in systematic reviews. Adherence highest for participants, objective, randomization, intervention, outcome; lowest for recruitment, trial design, funding source, harms, and reporting primary outcomes.
UNASSIGNED: Poor methodological reporting and adherence to CONSORT checklist in evaluated RCTs, especially in methodological sections. Improvements needed for reliable and applicable results in guidelines, reviews, and meta-analyses. Inadequate outcome reporting challenges researchers, clinicians, and policymakers, impacting evidence-based decision-making. Urgent improvements in RCT registration necessary.

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BACKGROUND: Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies.
METHODS: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items.
RESULTS: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%).
CONCLUSIONS: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.

OBJECTIVE: The use of secondary databases has become popular for evaluating the effectiveness and safety of interventions in real-life settings. However, the absence of important confounders in these databases is challenging. To address this issue, the high-dimensional propensity score (hdPS) algorithm was developed in 2009. This algorithm uses proxy variables for mitigating confounding by combining information available across several healthcare dimensions. This study assessed the methodology and reporting of the hdPS in comparative effectiveness and safety research.
METHODS: In this methodological review, we searched PubMed and Google Scholar from July 2009 to May 2022 for studies that used the hdPS for evaluating the effectiveness or safety of healthcare interventions. Two reviewers independently extracted study characteristics and assessed how the hdPS was applied and reported. Risk of bias was evaluated with the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool.
RESULTS: In total, 136 studies met the inclusion criteria; the median publication year was 2018 (Q1-Q3 2016-2020). The studies included 192 datasets, mostly North American databases (n = 132, 69%). The hdPS was used in primary analysis in 120 studies (88%). Dimensions were defined in 101 studies (74%), with a median of 5 (Q1-Q3 4-6) dimensions included. A median of 500 (Q1-Q3 200-500) empirically identified covariates were selected. Regarding hdPS reporting, only 11 studies (8%) reported all recommended items. Most studies (n = 81, 60%) had a moderate overall risk of bias.
CONCLUSIONS: There is room for improvement in the reporting of hdPS studies, especially regarding the transparency of methodological choices that underpin the construction of the hdPS.

Background: Evidence indicates that the reporting of serious injury in long-term residential care has increased substantially over the past decade. However, what constitutes a serious injury in residential care is poorly and inconsistently defined. This may result in incidences being unnecessarily reported as a serious injury. It is therefore, crucial to develop a consistent definition of serious injury to reduce reporting burden and to facilitate comparison between different residential care settings and across jurisdictions. This protocol describes the methods for a systematic review of existing definitions from the literature to inform the development of a consistent definition of serious injury in long-term residential care. Methods: A wide range of published peer-reviewed and grey literature will be sought for this review, including guidance and policy documents. Searches will be conducted of databases including MEDLINE, CINAHL, SocINDEX, Academic Search Ultimate, and Westlaw International. Grey literature database searches will include Trip and Social Care Online. Country specific searches of government and health and social care websites will be conducted. Quality appraisal will be facilitated using the Quality Assessment for Diverse Studies (QuADS) tool and Tyndall\'s checklist. The level of confidence in the findings will be assessed using the GRADE CERQual approach. A customised data extraction form will be used to extract data to reduce the risk of bias. Conceptual content analysis of data will facilitate identification of definitions of serious injury and their frequency within texts. Conclusions: The findings will inform the development of a consistent definition of serious injury in long-term residential care that will reduce reporting burden, facilitate the accuracy of data collected and allow for comparison across jurisdictions. A more universal and consistent definition will enable regulators, policy makers, service providers and researchers to develop policy and practical interventions to prevent the occurrence of serious injury in long-term residential care.

BACKGROUND: There is a growing interest in developing scalable interventions, including internet-based cognitive behavioral therapy (iCBT), to meet the increasing demand for mental health services. Given the growth in diversity worldwide, it is essential that the clinical trials of iCBT for depression include diverse samples or, at least, report information on the race, ethnicity, or other background indicators of their samples. Unfortunately, the field lacks data on how well diversity is currently reported and represented in the iCBT literature.
OBJECTIVE: Thus, the main objective of this systematic review was to examine the overall reporting of racial and ethnic identities in published clinical trials of iCBT for depression. We also aimed to review the representation of specific racial and ethnic minoritized groups and the inclusion of alternative background indicators such as migration status or country of residence.
METHODS: Studies were included if they were randomized controlled trials in which iCBT was compared to a waiting list, care-as-usual, active control, or another iCBT. The included papers also had to have a focus on acute treatment (eg, 4 weeks to 6 months) of depression, be delivered via the internet on a website or a smartphone app and use guided or unguided self-help. Studies were initially identified from the METAPSY database (n=59) and then extended to include papers up to 2022, with papers retrieved from Embase, PubMed, PsycINFO, and Cochrane (n=3). Risk of bias assessment suggested that reported studies had at least some risk of bias due to use of self-report outcome measures.
RESULTS: A total of 62 iCBT randomized controlled trials representing 17,210 participants are summarized in this study. Out of those 62 papers, only 17 (27%) of the trials reported race, and only 12 (19%) reported ethnicity. Reporting outside of the United States was very poor, with the United States accounting for 15 (88%) out of 17 of studies that reported race and 9 (75%) out of 12 for ethnicity. Out of 3,623 participants whose race was reported in the systematic review, the racial category reported the most was White (n=2716, 74.9%), followed by Asian (n=209, 5.8%) and Black (n=274, 7.6%). Furthermore, only 25 (54%) out of the 46 papers conducted outside of the United States reported other background demographics.
CONCLUSIONS: It is important to note that the underreporting observed in this study does not necessarily indicate an underrepresentation in the actual study population. However, these findings highlight the poor reporting of race and ethnicity in iCBT trials for depression found in the literature. This lack of diversity reporting may have significant implications for the scalability of these interventions.

OBJECTIVE: To analyze the reporting completeness of the TIDieR items 8-12, in particular intensity, dose, and dosage, in active pediatric upper limb neurorehabilitation trials.
METHODS: We searched PubMed Central, Scopus, CINAHL, OTseeker, and Web of Science for eligible publications.
METHODS: We included publications analyzing active pediatric upper limb neurorehabilitation interventions and assessed the reporting completeness of 11 items for each intervention and control group.
METHODS: Two raters independently screened titles and abstracts and selected the publications using the RYYAN platform. We unblinded the results after the raters had completed their selection and resolved the disagreements by discussion. We used the same procedures to review the full texts.
RESULTS: We included 52 randomized controlled trials with 65 intervention and 48 control groups. Authors did not report all 11 items in any of the study groups. The overall reporting completeness varied between 1% (intensity) to 95% (length of the intervention). The reporting completeness of the TIDieR items ranged from 2% (modifications) to 64% (when and how much). We found no significant differences in the reporting completeness between the intervention and control groups.
CONCLUSIONS: Information essential for dose-response calculations is often missing in randomized controlled trials of pediatric upper limb neurorehabilitation interventions. Reporting completeness should be improved, and new measures to accurately quantify intensity should be discussed and developed.

The living systematic review (LSR) approach is based on ongoing surveillance of the literature and continual updating. Most currently available guidance documents address the conduct, reporting, publishing, and appraisal of systematic reviews (SRs), but are not suitable for LSRs per se and miss additional LSR-specific considerations. In this scoping review, we aim to systematically collate methodological guidance literature on how to conduct, report, publish, and appraise the quality of LSRs and identify current gaps in guidance.
A standard scoping review methodology was used. We searched MEDLINE (Ovid), EMBASE (Ovid), and The Cochrane Library on August 28, 2021. As for searching gray literature, we looked for existing guidelines and handbooks on LSRs from organizations that conduct evidence syntheses. The screening was conducted by two authors independently in Rayyan, and data extraction was done in duplicate using a pilot-tested data extraction form in Excel. Data was extracted according to four pre-defined categories for (i) conducting, (ii) reporting, (iii) publishing, and (iv) appraising LSRs. We mapped the findings by visualizing overview tables created in Microsoft Word.
Of the 21 included papers, methodological guidance was found in 17 papers for conducting, in six papers for reporting, in 15 papers for publishing, and in two papers for appraising LSRs. Some of the identified key items for (i) conducting LSRs were identifying the rationale, screening tools, or re-revaluating inclusion criteria. Identified items of (ii) the original PRISMA checklist included reporting the registration and protocol, title, or synthesis methods. For (iii) publishing, there was guidance available on publication type and frequency or update trigger, and for (iv) appraising, guidance on the appropriate use of bias assessment or reporting funding of included studies was found. Our search revealed major evidence gaps, particularly for guidance on certain PRISMA items such as reporting results, discussion, support and funding, and availability of data and material of a LSR.
Important evidence gaps were identified for guidance on how to report in LSRs and appraise their quality. Our findings were applied to inform and prepare a PRISMA 2020 extension for LSR.

This study aimed to provide procedure-specific estimates of the risk for symptomatic venous thromboembolism and major bleeding in noncancer gynecologic surgeries.
We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar. Furthermore, we performed separate searches for randomized trials that addressed the effects of thromboprophylaxis.
Eligible studies were observational studies that enrolled ≥50 adult patients who underwent noncancer gynecologic surgery procedures and that reported the absolute incidence of at least 1 of the following: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding that required reintervention (including re-exploration and angioembolization), bleeding that led to transfusion, or postoperative hemoglobin level <70 g/L.
A teams of 2 reviewers independently assessed eligibility, performed data extraction, and evaluated the risk of bias of the eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine the cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors and used the Grading of Recommendations Assessment, Development and Evaluation approach to rate the evidence certainty.
We included 131 studies (1,741,519 patients) that reported venous thromboembolism risk estimates for 50 gynecologic noncancer procedures and bleeding requiring reintervention estimates for 35 procedures. The evidence certainty was generally moderate or low for venous thromboembolism and low or very low for bleeding requiring reintervention. The risk for symptomatic venous thromboembolism varied from a median of <0.1% for several procedures (eg, transvaginal oocyte retrieval) to 1.5% for others (eg, minimally invasive sacrocolpopexy with hysterectomy, 1.2%-4.6% across patient venous thromboembolism risk groups). Venous thromboembolism risk was <0.5% for 30 (60%) of the procedures; 0.5% to 1.0% for 10 (20%) procedures; and >1.0% for 10 (20%) procedures. The risk for bleeding the require reintervention varied from <0.1% (transvaginal oocyte retrieval) to 4.0% (open myomectomy). The bleeding requiring reintervention risk was <0.5% in 17 (49%) procedures, 0.5% to 1.0% for 12 (34%) procedures, and >1.0% in 6 (17%) procedures.
The risk for venous thromboembolism in gynecologic noncancer surgery varied between procedures and patients. Venous thromboembolism risks exceeded the bleeding risks only among selected patients and procedures. Although most of the evidence is of low certainty, the results nevertheless provide a compelling rationale for restricting pharmacologic thromboprophylaxis to a minority of patients who undergo gynecologic noncancer procedures.

BACKGROUND: Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require \"plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols\" be included in trial protocols. It is unknown how often protocols report this retention information. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial.
METHODS: A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted.
RESULTS: Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b \"plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols\". Of the RCT protocols, 36.8% included proactive \"plans to promote participant retention\" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned \"combined strategies\" (48.1%). Of these, the joint most commonly reported were \"reminders and data collection location and method\" and \"reminders and monetary incentives\". The most popular individual retention strategy was \"reminders\" (14.7%) followed by \"monetary incentives- conditional\" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive \"plans to promote participant retention\" with the use of \"combined strategies\" being most frequent (46.3%). The use of \"monetary incentives - conditional\" (22%) was the most popular individual reported retention strategy.
CONCLUSIONS: There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.