Dataset Information

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

ABSTRACT:

Background

Adherence reflects the extent to which individuals experience or engage with the content of online interventions and poses a major challenge. Neglecting to examine and report adherence and its relation to outcomes can compromise the interpretation of research findings.

Objective

The aim of this systematic review is to analyze how adherence is accounted for in publications and to propose standards for measuring and reporting adherence to online interventions.

Methods

We performed a systematic review of randomized controlled trials on online interventions for the prevention and treatment of common mental disorders (depression, anxiety disorders, substance related disorders, and eating disorders) published between January 2006 and May 2018 and indexed in Medline and Web of Science. We included primary publications on manualized online treatments (more than 1 session and successive access to content) and examined how adherence was reported in these publications.

Results

We identified 216 publications that met our inclusion criteria. Adherence was addressed in 85% of full-text manuscripts, but only in 31% of abstracts. A median of three usage metrics were reported; the most frequently reported usage metric (61%) was intervention completion. Manuscripts published in specialized electronic health journals more frequently included information on the relation of adherence and outcomes.

Conclusions

We found substantial variety in the reporting of adherence and the usage metrics used to operationalize adherence. This limits the comparability of results and impedes the integration of findings from different studies. Based on our findings, we propose reporting standards for future publications on online interventions.

SUBMITTER: Beintner I

PROVIDER: S-EPMC6713038 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

Beintner Ina I Vollert Bianka B Zarski Anna-Carlotta AC Bolinski Felix F Musiat Peter P Görlich Dennis D Ebert David Daniel DD Jacobi Corinna C

Journal of medical Internet research 20190815 8

<h4>Background</h4>Adherence reflects the extent to which individuals experience or engage with the content of online interventions and poses a major challenge. Neglecting to examine and report adherence and its relation to outcomes can compromise the interpretation of research findings.<h4>Objective</h4>The aim of this systematic review is to analyze how adherence is accounted for in publications and to propose standards for measuring and reporting adherence to online interventions.<h4>Methods< ...[more]

PMID: 31414664

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Project description:BackgroundPatients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants' privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether COVID-19 human research publications report compliance with these ethical safeguards.MethodsA rapid systematic literature review was conducted in MEDLINE using the search term 'COVID-19'. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were 'Full free text available' and 'English Language'. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy.ResultsThe searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies.ConclusionsWhile the majority of journal's editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently.

Project description:INTRODUCTION:There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions. METHODS AND ANALYSIS:Our review will follow the Joanna Briggs Institute scoping review methods manual. We will search for relevant studies in MEDLINE, EMBASE and Cochrane Library databases. Moreover, we will carry out lateral searches from the reference lists of the included studies, as well as from the lists of articles citing the included ones. One reviewer will screen the full list, which will be randomly split into two halves and independently screened by the other two reviewers. Two reviewers will perform data extraction independently. Discrepancies will be solved through discussion. In addition, this search strategy will be supplemented by a grey literature search. The interventions found will be classified as assessed or suggested, as well as according to different criteria, in relation to their target (journal policies, journal editors, authors, reviewers, funders, ethical boards or others) or the research stage at which they are performed (design, conducting, reporting or peer review). Descriptive statistical analysis will be performed. ETHICS AND DISSEMINATION:A paper summarising the findings from this review will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding and a broader perspective on how the problem of adhering better to reporting guidelines has been tackled so far. This could be a major first step towards developing future strategies to improve compliance with reporting guidelines in health research.

Project description:BACKGROUND:Chronic pain affects a significant proportion of the population and presents a major challenge to clinicians and pain specialists. Despite the availability of pharmacologic treatment options such as opioids, many patients continue to experience persistent pain. Cannabinoids present an alternative option with some data on efficacy; however, to date, a systematic review of adverse events (AEs) assessment and reporting in randomized clinical trials (RCTs) involving cannabinoids has not been performed. As a result, it is unclear whether a clear profile of cannabinoid-associated AEs has been accurately detailed in the literature. As cannabinoids are likely to become readily available for patients in the near future, it is important to study how well AEs have been reported in trials so that the safety profile of cannabinoids can be better understood. OBJECTIVE:With a potentially enormous shift toward cannabinoid use for managing chronic pain and spasticity, this study aims to reveal the adequacy of AE reporting and cannabinoid-specific AEs in this setting. Spasticity is a major contributor to chronic pain in patients with multiple sclerosis (MS), with a comorbidity of 75%. Many cannabinoid studies have been performed in MS-related painful spasticity with relevant pain outcomes, and these studies will be included in this review for comprehensiveness. The primary outcome will be the quality of AE assessment and reporting by adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Secondary outcomes will include the type of AE, method of AE reporting, severity of AE, frequency of AEs, patient withdrawals, and reasons for withdrawals. METHODS:We will perform a systematic review by searching for primary reports of double-blind, randomized controlled trials of cannabinoids compared with placebo and any active comparator treatments for chronic pain, with a primary outcome directly related to pain (eg, pain intensity, pain relief, and pain-related interference). We will search the following databases: MEDLINE, Embase, Cochrane Library, and PsycINFO. RevMan software will be used for meta-analysis. RESULTS:The protocol has been registered on the International Prospective Register of Systematic Reviews (CRD42018100401). The project was funded in 2018 and screening has been completed. Data extraction is under way and the first results are expected to be submitted for publication in January or February 2019. CONCLUSIONS:This review will better elucidate the safety of cannabinoids for the treatment of chronic pain and spasticity through identifying gaps in the literature for AE reporting. Like in any new therapy, it is essential that accurate information surrounding the safety and efficacy of cannabinoids be clearly outlined and identified to balance the benefit and harm described for patients. TRIAL REGISTRATION:PROSPERO CRD42018100401; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=100401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11637.

Project description:Importance:Incomplete reporting of diagnostic accuracy research impairs assessment of risk of bias and limits generalizability. Point-of-care ultrasound has become an important diagnostic tool for acute care physicians, but studies assessing its use are of varying methodological quality. Objective:To assess adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 guidelines in the literature on acute care point-of-care ultrasound. Evidence Review:MEDLINE was searched to identify diagnostic accuracy studies assessing point-of-care ultrasound published in critical care, emergency medicine, or anesthesia journals from 2016 to 2019. Studies were evaluated for adherence to the STARD 2015 guidelines, with the following variables analyzed: journal, country, STARD citation, STARD-adopting journal, impact factor, patient population, use of supplemental material, and body region. Data analysis was performed in November 2019. Findings:Seventy-four studies were included in this systematic review for assessment. Overall adherence to STARD was moderate, with 66% (mean [SD], 19.7 [2.9] of 30 items) of STARD items reported. Items pertaining to imaging specifications, patient population, and readers of the index test were frequently reported (>66% of studies). Items pertaining to blinding of readers to clinical data and to the index or reference standard, analysis of heterogeneity, indeterminate and missing data, and time intervals between index and reference test were either moderately (33%-66%) or infrequently (<33%) reported. Studies in STARD-adopting journals (mean [SD], 20.5 [2.9] items in adopting journals vs 18.6 [2.3] items in nonadopting journals; P?=?.002) and studies citing STARD (mean [SD], 21.3 [0.9] items in citing studies vs 19.5 [2.9] items in nonciting studies; P?=?.01) reported more items. Variation by country and journal of publication were identified. No differences in STARD adherence were identified by body region imaged (mean [SD], abdominal, 20.0 [2.5] items; head and neck, 17.8 [1.6] items; musculoskeletal, 19.2 [3.1] items; thoracic, 20.2 [2.8] items; and other or procedural, 19.8 [2.7] items; P?=?.29), study design (mean [SD], prospective, 19.7 [2.9] items; retrospective, 19.7 [1.8] items; P?>?.99), patient population (mean [SD], pediatric, 20.0 [3.1] items; adult, 20.2 [2.7] items; mixed, 17.9 [1.9] items; P?=?.09), use of supplementary materials (mean [SD], yes, 19.2 [3.0] items; no, 19.7 [2.8] items; P?=?.91), or journal impact factor (mean [SD], higher impact factor, 20.3 [3.1] items; lower impact factor, 19.1 [2.4] items; P?=?.08). Conclusions and Relevance:Overall, the literature on acute care point-of-care ultrasound showed moderate adherence to the STARD 2015 guidelines, with more complete reporting found in studies citing STARD and those published in STARD-adopting journals. This study has established a current baseline for reporting; however, future studies are required to understand barriers to complete reporting and to develop strategies to mitigate them.

Dataset Information

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

Background

Objective

Methods

Results

Conclusions

Publications

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

Similar Datasets

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