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Improving assent in health research: a rapid systematic review.

ABSTRACT: BACKGROUND:Enrolment in a research study requires the participant's informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the underage p articipant. Since comprehension of the information provided may be limited, effective interventions to improve understanding should be identified. Thus, it is the objective of this study to review quantitative studies that tested interventions to improve the understanding of information provided during assent processes in health research. The studied population consisted of minors that participated or were willing to participate in research. The primary outcome was the level of comprehension after intervention. METHODS:A systematic search was conducted in eleven databases including regional databases: PubMed, Web of Science, ERIC, PsycINFO, CINAHL, POPLINE, AIM, LILACS, WPRIM, IMSEAR, and IMEMR and included references from inception of the database until July 2018 except PubMed which spanned the period from May 2013 to July 2018. Search terms focused on Informed Consent/Assent, Minors, and Comprehension. To complement the search, reference lists of retrieved publications were additionally searched. We included all quantitative studies that were conducted in minors, tested an intervention, covered assent processes in health research, and assessed comprehension. One reviewer screened titles, abstracts, and full-texts to determine eligibility and collected data on study design, population, intervention, methods, outcome, and for critical appraisal. Interventions comprised enhanced paper forms, interspersed questions, multimedia format, and others. RESULTS:Out of 7089 studies initially identified, 19 studies comprising 2805 participants and conducted in seven countries were included in the review. Fourteen studies (74 %) tested an intervention against control and ten (53 %) were randomized controlled trials. Heterogeneous methodology as well as incomplete outcome and statistical reporting impaired the reliability of the collected data. Positive effects were suggested for use of enhanced paper forms, interspersed questions, use of pie charts, and organizational factors. CONCLUSIONS:Improving assent in health research is an under-researched area with little reliable evidence. While some interventions are proposed to improve understanding in assent processes, further investigation is necessary to be able to give evidence-based recommendations. TRIAL REGISTRATION:PROSPERO ID: 106808.

SUBMITTER: Soll D

PROVIDER: S-EPMC7222594 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Improving assent in health research: a rapid systematic review.

Soll Dominik D Guraiib Maria Magdalena MM Rollins Nigel Campbell NC Reis Andreas Alois AA Reis Andreas Alois AA

BMC medical research methodology 20200513 1

<h4>Background</h4>Enrolment in a research study requires the participant's informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the underage p articipant. Since comprehension of the information provided may be limited, effective interventions to improve understanding should be identified. Thus, it is the objective of this study to review quantitative studies that tested interventions to improve the understa ...[more]

PMID: 32404063

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Project description:BACKGROUND:Despite an exponential growth in research on mindfulness-based interventions, the body of scientific evidence supporting these treatments has been criticized for being of poor methodological quality. OBJECTIVES:The current systematic review examined the extent to which mindfulness research demonstrated increased rigor over the past 16 years regarding six methodological features that have been highlighted as areas for improvement. These feature included using active control conditions, larger sample sizes, longer follow-up assessment, treatment fidelity assessment, and reporting of instructor training and intent-to-treat (ITT) analyses. DATA SOURCES:We searched PubMed, PsychInfo, Scopus, and Web of Science in addition to a publically available repository of mindfulness studies. STUDY ELIGIBILITY CRITERIA:Randomized clinical trials of mindfulness-based interventions for samples with a clinical disorder or elevated symptoms of a clinical disorder listed on the American Psychological Association's list of disorders with recognized evidence-based treatment. STUDY APPRAISAL AND SYNTHESIS METHODS:Independent raters screened 9,067 titles and abstracts, with 303 full text reviews. Of these, 171 were included, representing 142 non-overlapping samples. RESULTS:Across the 142 studies published between 2000 and 2016, there was no evidence for increases in any study quality indicator, although changes were generally in the direction of improved quality. When restricting the sample to those conducted in Europe and North America (continents with the longest history of scientific research in this area), an increase in reporting of ITT analyses was found. When excluding an early, high-quality study, improvements were seen in sample size, treatment fidelity assessment, and reporting of ITT analyses. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS:Taken together, the findings suggest modest adoption of the recommendations for methodological improvement voiced repeatedly in the literature. Possible explanations for this and implications for interpreting this body of research and conducting future studies are discussed.

Project description:BackgroundKnowledge translation (KT) aims to facilitate the use of research evidence in decision making. Changes in technology have provided considerable opportunities for KT strategies to improve access and use of evidence in decision making by public health policy makers and practitioners. Despite this opportunity, there have been no reviews that have assessed the effects of digital technology-enabled KT (TEKT) in the field of public health.ObjectiveThis study aims to examine the effectiveness of digital TEKT strategies in (1) improving the capacity for evidence-based decision making by public health policy makers and practitioners, (2) changing public health policy or practice, and (3) changes in individual or population health outcomes.MethodsA search strategy was developed to identify randomized trials assessing the effectiveness of digital TEKT strategies in public health. Any primary research study with a randomized trial design was eligible. Searches for eligible studies were undertaken in multiple electronic bibliographic databases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], PsycINFO, Cumulative Index to Nursing and Allied Health Literature [CINAHL], and Scopus) and the reference lists of included studies. A hand search of 2 journals (Implementation Science and Journal of Medical Internet Research) and a gray literature search were also conducted. Pairs of independent review authors screened studies, assessed the risk of bias, and extracted data from relevant studies.ResultsOf the 6819 citations screened, 8 eligible randomized trials were included in the review. The studies examined the impact of digital TEKT strategies on health professionals, including nurses, child care health consultants, physiotherapists, primary health care workers, and public health practitioners. Overall, 5 of the interventions were web-training programs. The remaining 3 interventions included simulation games, access to digital resource materials and the use of tailored messaging, and a web-based registry. The findings suggest that digital TEKT interventions may be effective in improving the knowledge of public health professionals, relative to control, and may be as effective as a face-to-face KT approach. The effectiveness of digital TEKT strategies relative to a control or other digital KT interventions on measures of health professional self-efficacy to use evidence to enhance practice behavior or behavioral intention outcomes was mixed. The evidence regarding the effects on changes to health policy or practice following exposure to digital TEKT was mixed. No trials assessed the effects on individual or population-level health outcomes.ConclusionsThis review is the first to synthesize the effectiveness of digital TEKT interventions in a public health setting. Despite its potential, relatively few trials have been undertaken to investigate the impacts of digital TEKT interventions. The findings suggest that although a digital TEKT intervention may improve knowledge, the effects of such interventions on other outcomes are equivocal.

Project description:BACKGROUND:Crowdsourcing is used increasingly in health and medical research. Crowdsourcing is the process of aggregating crowd wisdom to solve a problem. The purpose of this systematic review is to summarize quantitative evidence on crowdsourcing to improve health. METHODS:We followed Cochrane systematic review guidance and systematically searched seven databases up to September 4th 2019. Studies were included if they reported on crowdsourcing and related to health or medicine. Studies were excluded if recruitment was the only use of crowdsourcing. We determined the level of evidence associated with review findings using the GRADE approach. RESULTS:We screened 3508 citations, accessed 362 articles, and included 188 studies. Ninety-six studies examined effectiveness, 127 examined feasibility, and 37 examined cost. The most common purposes were to evaluate surgical skills (17 studies), to create sexual health messages (seven studies), and to provide layperson cardio-pulmonary resuscitation (CPR) out-of-hospital (six studies). Seventeen observational studies used crowdsourcing to evaluate surgical skills, finding that crowdsourcing evaluation was as effective as expert evaluation (low quality). Four studies used a challenge contest to solicit human immunodeficiency virus (HIV) testing promotion materials and increase HIV testing rates (moderate quality), and two of the four studies found this approach saved money. Three studies suggested that an interactive technology system increased rates of layperson initiated CPR out-of-hospital (moderate quality). However, studies analyzing crowdsourcing to evaluate surgical skills and layperson-initiated CPR were only from high-income countries. Five studies examined crowdsourcing to inform artificial intelligence projects, most often related to annotation of medical data. Crowdsourcing was evaluated using different outcomes, limiting the extent to which studies could be pooled. CONCLUSIONS:Crowdsourcing has been used to improve health in many settings. Although crowdsourcing is effective at improving behavioral outcomes, more research is needed to understand effects on clinical outcomes and costs. More research is needed on crowdsourcing as a tool to develop artificial intelligence systems in medicine. TRIAL REGISTRATION:PROSPERO: CRD42017052835. December 27, 2016.

Project description:OBJECTIVE:Engaging stakeholders in reviews is considered to generate more relevant evidence and to facilitate dissemination and use. As little is known about stakeholder involvement, we assessed the characteristics of their engagement in systematic and rapid reviews and the methodological quality of included studies. Stakeholders were people with a particular interest in the research topic. DESIGN:Methodological review. SEARCH STRATEGY:Four databases (Medline, Embase, Cochrane database of systematic reviews, databases of the University of York, Center for Reviews and Dissemination (CRD)) were searched based on an a priori protocol. Four types of reviews (Cochrane and non-Cochrane systematic reviews, rapid and CRD rapid reviews) were retrieved between January 2011 and October 2015, pooled by potential review type and duplicates excluded. Articles were randomly ordered and screened for inclusion and exclusion criteria until 30 reviews per group were reached. Their methodological quality was assessed using AMSTAR and stakeholder characteristics were collected. RESULTS:In total, 57 822 deduplicated citations were detected with potential non-Cochrane systematic reviews being the biggest group (56 986 records). We found stakeholder involvement in 13% (4/30) of Cochrane, 20% (6/30) of non-Cochrane, 43% (13/30) of rapid and 93% (28/30) of CRD reviews. Overall, 33% (17/51) of the responding contact authors mentioned positive effects of stakeholder involvement. A conflict of interest statement remained unmentioned in 40% (12/30) of non-Cochrane and in 27% (8/30) of rapid reviews, but not in Cochrane or CRD reviews. At most, half of non-Cochrane and rapid reviews mentioned an a priori study protocol in contrast to all Cochrane reviews. CONCLUSION:Stakeholder engagement was not general practice, except for CRD reviews, although it was more common in rapid reviews. Reporting factors, such as including an a priori study protocol and a conflict of interest statement should be considered in conjunction with involving stakeholders.

Project description:BackgroundThere is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research.MethodsBased on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (? 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel.ResultsConsensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children.ConclusionsIt is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children's developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

Project description:BackgroundSocial media holds exciting promise for advancing mental health research recruitment, however, the extent and efficacy to which these platforms are currently in use are underexplored.ObjectiveA systematic review was conducted to characterize the current use and efficacy of social media in recruiting participants for mental health research.MethodA literature review was performed using MEDLINE, EMBASE, and PsychINFO. Only non-duplicative manuscripts written in the English language and published between 1/1/2004-3/31/2019 were selected for further screening. Data extracted included study type and design, participant inclusion criteria, social media platform, advertising strategy, final recruited sample size, recruitment location, year, monetary incentives, comparison to other recruitment methods if performed, and final cost per participant.ResultsA total of 176 unique studies that used social media for mental health research recruitment were reviewed. The majority of studies were cross-sectional (62.5%) in design and recruited adults. Facebook was overwhelmingly the recruitment platform of choice (92.6%), with the use of paid advertisements being the predominant strategy (60.8%). Of the reviewed studies, substance abuse (43.8%) and mood disorders (15.3%) were the primary subjects of investigation. In 68.3% of studies, social media recruitment performed as well as or better than traditional recruitment methods in the number and cost of final enrolled participants. The majority of studies used Facebook for recruitment at a median cost per final recruited study participant of $19.47. In 55.6% of the studies, social media recruitment was the more cost-effective recruitment method when compared to traditional methods (e.g., referrals, mailing).ConclusionSocial media appears to be an effective and economical recruitment tool for mental health research. The platform raises methodological and privacy concerns not covered in current research regulations that warrant additional consideration.

Dataset Information

Improving assent in health research: a rapid systematic review.

Publications

Improving assent in health research: a rapid systematic review.

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