Reporting of treatment fidelity in behavioural paediatric obesity intervention trials: a systematic review.
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SUBMITTER: JaKa MM
PROVIDER: S-EPMC5193220 | biostudies-literature | 2016 Dec
REPOSITORIES: biostudies-literature
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Reporting of treatment fidelity in behavioural paediatric obesity intervention trials: a systematic review.
JaKa M M MM Haapala J L JL Trapl E S ES Kunin-Batson A S AS Olson-Bullis B A BA Heerman W J WJ Berge J M JM Moore S M SM Matheson D D Sherwood N E NE
Obesity reviews : an official journal of the International Association for the Study of Obesity 20160909 12
Behavioural interventions for paediatric obesity are promising, but detailed information on treatment fidelity (i.e. design, training, delivery, receipt and enactment) is needed to optimize the implementation of more effective interventions. Little is known about current practices for reporting treatment fidelity in paediatric obesity studies. This systematic review, in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, describes the methods used to re ...[more]
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Project description:IntroductionAdoption of rigorous standards for reporting treatment fidelity is essential for advancing discovery, validation, and implementation of behavioral treatments. Whereas the NIH Behavior Change Consortium (BCC) developed an assessment tool to assess the quality of reporting and monitoring of treatment fidelity across health behavior change interventions, it has not yet been applied specifically to treatment fidelity in behavioral tobacco treatment trials.Aims and methodsWe conducted a scoping review of peer-reviewed, clinical trials of behavioral adult tobacco treatment interventions published in English between 2006 and 2018. Using the BCC treatment fidelity checklist, articles were coded for the presence or absence of various treatment fidelity strategies within each of 5 domains: Design, Training, Delivery, Receipt, and Enactment. Eligible articles (N = 755) were coded by two independent coders.ResultsThe proportion of reporting strategies varied within the fidelity domains, ranging from 5.2% to 96.3% in Design, 1.9% to 24.9% in Training, 2.6% to 32.3% in Delivery, 5.2% to 44.3% in Receipt, and 6.7% to 43.2% in Enactment. The mean proportion of adherence to treatment fidelity strategies within each domain was: Design (68%), Training (14%), Delivery (15%), Receipt (16%), and Enactment (25%). Only 11 studies achieved ≥80% reporting across >1 fidelity domain. There was no evidence for improvement in fidelity reporting across the 13-year time frame from the initial BCC publication to the present.ConclusionsThese findings illustrate the lack of consistency in fidelity reporting in tobacco treatment trials and underscore the challenges faced in evaluating rigor and reproducibility, as well as interpretation and dissemination of findings. Recommendations are made for improving fidelity reporting in tobacco treatment trials.ImplicationsThe SRNT Treatment Research Network sponsored a scoping review to summarize the current state of reporting treatment fidelity and make recommendations for best practices in reporting fidelity in tobacco treatment trials. The review identified a lack of consistency in fidelity reporting, illustrating the challenges faced in evaluating rigor, and reproducibility, as well as interpretation and dissemination of findings.
| S-EPMC9013002 | biostudies-literature
Project description:Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events.Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data.Of 11?816 unique references, 231?T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events.Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials.
| S-EPMC5743897 | biostudies-other
Project description:BackgroundTelehealth-delivered dietary interventions are effective for chronic disease management and are an emerging area of clinical practice. However, to apply interventions from the research setting in clinical practice, health professionals need details of each intervention component.ObjectiveThe aim of this study was to evaluate the completeness of intervention reporting in published dietary chronic disease management trials that used telehealth delivery methods.MethodsEligible randomized controlled trial publications were identified through a systematic review. The completeness of reporting of experimental and comparison interventions was assessed by two independent assessors using the Template for Intervention Description and Replication (TIDieR) checklist that consists of 12 items including intervention rationale, materials used, procedures, providers, delivery mode, location, when and how much intervention delivered, intervention tailoring, intervention modifications, and fidelity. Where reporting was incomplete, further information was sought from additional published material and through email correspondence with trial authors.ResultsWithin the 37 eligible trials, there were 49 experimental interventions and 37 comparison interventions. One trial reported every TIDieR item for their experimental intervention. No publications reported every item for the comparison intervention. For the experimental interventions, the most commonly reported items were location (96%), mode of delivery (98%), and rationale for the essential intervention elements (96%). Least reported items for experimental interventions were modifications (2%) and intervention material descriptions (39%) and where to access them (20%). Of the 37 authors, 14 responded with further information, and 8 could not be contacted.ConclusionsMany details of the experimental and comparison interventions in telehealth-delivered dietary chronic disease management trials are incompletely reported. This prevents accurate interpretation of trial results and implementation of effective interventions in clinical practice.
| S-EPMC5742660 | biostudies-literature
Project description:BackgroundPrevious reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials.Objective/designWe conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials.Data sources(1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes.Results(1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors."ConclusionExisting reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and behavioural sciences do not ask authors to follow reporting standards. Findings demonstrate a need to develop a CONSORT extension with updated standards for social and psychological intervention trials.
| S-EPMC3666983 | biostudies-literature
Project description:ContextTo aid translation of childhood obesity interventions evidence into practice, research studies must report results in a way that better supports pragmatic decision making. The current review evaluated the extent to which information on key external validity dimensions, participants, settings, interventions, outcomes, and maintenance of effects, was included in research studies on behavioral treatments for childhood obesity.Evidence acquisitionPeer-reviewed studies of behavioral childhood obesity treatments published between 1980 and 2008 were identified from (1) electronic searches of social science and medical databases; (2) research reviews of childhood obesity interventions; and (3) reference lists cited in these reviews. Included studies reported on a controlled obesity intervention trial, targeted overweight or obese children aged 2-18 years, included a primary or secondary anthropometric outcome, and targeted change in dietary intake or physical activity behaviors.Evidence synthesis1071 publications were identified and 77 met selection criteria. Studies were coded on established review criteria for external validity elements. All studies lacked full reporting of generalizability elements. Across criteria, the average reporting was 23.9% (range=0%-100%). Infrequently reported were setting-level selection criteria and representativeness, characteristics regarding intervention staff, implementation of the intervention content, costs, and program sustainability.ConclusionsEnhanced reporting of relevant and pragmatic information in behavioral investigations of childhood obesity interventions is needed to improve the ability to evaluate the applicability of results to practice implementation. Such evidence would improve translation of research to practice, provide additional explanation for variability in intervention outcomes, and provide insights into successful adaptations of interventions to local conditions.
| S-EPMC4573550 | biostudies-literature
Project description:BACKGROUND:The development of clinical guidelines for the surgical management of gastric cancer should be based on robust evidence from well-designed trials. Being able to reliably compare and combine the outcomes of these trials is a key factor in this process. OBJECTIVES:To examine variation in outcome reporting by surgical trials for gastric cancer and to identify outcomes for prioritisation in an international consensus study to develop a core outcome set in this field. DATA SOURCES:Systematic literature searches (Evidence Based Medicine, MEDLINE, EMBASE, CINAHL, ClinicalTrials.gov and WHO ICTRP) and a review of study protocols of randomised controlled trials, published between 1996 and 2016. INTERVENTION:Therapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorised into groups (outcome themes) and examined for definitions and measurement instruments. RESULTS:Of 1919 abstracts screened, 32 trials (9073 participants) were identified. A total of 749 outcomes were reported of which 96 (13%) were accompanied by an attempted definition. No single outcome was reported by all trials. 'Adverse events' was the most frequently reported 'outcome theme' in which 240 unique terms were described. 12 trials (38%) classified complications according to severity, with 5 (16%) using a formal classification system (Clavien-Dindo or Accordion scale). Of 27 trials which described 'short-term' mortality, 15 (47%) used one of five different definitions. 6 out of the 32 trials (19%) described 'patient-reported outcomes'. CONCLUSION:Reporting of outcomes in gastric cancer surgery trials is inconsistent. A consensus approach to develop a minimum set of well-defined, standardised outcomes to be used by all future trials examining therapeutic surgical interventions for gastric cancer is needed. This should consider the views of all key stakeholders, including patients.
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Project description:BackgroundSelective outcome reporting (SOR) is a bias that occurs when the primary outcome of a randomised clinical trial (RCT) is omitted or changed.AimTo evaluate the prevalence of SOR in RCTs on restorative treatment in primary teeth.DesignWe conducted an electronic search on ClinicalTrials.gov and the World Health Organization platform (International Clinical Trials Registry Platform) on 1st of April 2021, with no registry time or language restrictions. We included RCT protocols that evaluated restorative treatments in primary teeth and excluded trials that did not have a complete publication in a scientific journal. The chi-squared test was used to identify the association between SOR and variables as a discrepancy in the follow-up period, the timing of registration, the type of sponsorship and the type of study design (α = 5%).ResultsOf the 294 identified protocols, 30 were included in the study. 83.3% of trials were registered retrospectively. SOR was observed in 53.3% (n = 16) of the published trials and was significantly associated with a discrepancy in the follow-up period (p = .017).ConclusionsThe high prevalence of SOR in RCTs on restorative treatment proves that this is a prominent threat. A proper preregistered protocol, declaration of any protocol deviation and allowance of stakeholders to compare the protocol with that of the submitted papers will achieve transparency.
| S-EPMC10087835 | biostudies-literature
Project description:ObjectiveTo systematically review the conduct and reporting of formula trials.DesignSystematic review.Data sourcesMedline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1 January 2006 to 31 December 2020.Review methodsIntervention trials comparing at least two formula products in children less than three years of age were included, but not trials of human breast milk or fortifiers of breast milk. Data were extracted in duplicate and primary outcome data were synthesised for meta-analysis with a random effects model weighted by the inverse variance method. Risk of bias was evaluated with Cochrane risk of bias version 2.0, and risk of undermining breastfeeding was evaluated according to published consensus guidance. Primary outcomes of the trials included in the systematic review were identified from clinical trial registries, protocols, or trial publications.Results22 201 titles were screened and 307 trials were identified that were published between 2006 and 2020, of which 73 (24%) trials in 13 197 children were prospectively registered. Another 111 unpublished but registered trials in 17 411 children were identified. Detailed analysis was undertaken for 125 trials (23 757 children) published since 2015. Seventeen (14%) of these recently published trials were conducted independently of formula companies, 26 (21%) were prospectively registered with a clear aim and primary outcome, and authors or sponsors shared prospective protocols for 11 (9%) trials. Risk of bias was low in five (4%) and high in 100 (80%) recently published trials, mainly because of inappropriate exclusions from analysis and selective reporting. For 68 recently published superiority trials, a pooled standardised mean difference of 0.51 (range -0.43 to 3.29) was calculated with an asymmetrical funnel plot (Egger's test P<0.001), which reduced to 0.19 after correction for asymmetry. Primary outcomes were reported by authors as favourable in 86 (69%) trials, and 115 (92%) abstract conclusions were favourable. One of 38 (3%) trials in partially breastfed infants reported adequate support for breastfeeding and 14 of 87 (16%) trials in non-breastfed infants confirmed the decision not to breastfeed was firmly established before enrolment in the trial.ConclusionsThe results show that formula trials lack independence or transparency, and published outcomes are biased by selective reporting.Systematic review registrationPROSPERO 2018 CRD42018091928.
| S-EPMC8513520 | biostudies-literature
Project description:BackgroundTo date, few studies have investigated perceived barriers among those who participate in and drop out of family-based behavioural treatment (FBT) for paediatric obesity. Examining experienced barriers during treatment, and their role in participation and completion of treatment has important implications for clinical practice.ObjectivesTo compare perceived barriers to participating in a family-based behavioural social facilitation treatment (FBSFT) for obesity among families who completed and did not complete treatment.MethodsData were analysed from 90 families of children and adolescents (mean (M) age = 12.8 years, standard deviation (SD) = 3.05) with severe obesity enrolled in a 17-session FBSFT program. After completing 12 sessions or at the time of dropout, parents and therapists completed the Barriers to Treatment Participation Scale (BTPS), a 5-point Likert scale (1 = never a problem, 5 = very often a problem) which includes four subscales: 1. Stressors and obstacles that compete with treatment, 2. Treatment demands and issues, 3. Perceived relevance of treatment, 4. Relationship with the therapist.ResultsFamilies who did not complete treatment scored significantly higher on the BTPS subscales stressors and obstacles that compete with treatment (M = 2.03, SD = 0.53 vs. M = 1.70, SD = 0.42), p = 0.010 and perceived relevance of treatment (M = 2.27, SD = 0.48 vs. M = 1.80, SD = 0.50), p < 0.001 than families who completed treatment. No other significant differences between groups were observed.ConclusionFamilies are more likely to drop out of FBSFT when experiencing a high burden from life stressors or when treatment is not meeting the expectations and perceived needs of the family.
| S-EPMC10078207 | biostudies-literature
Project description:ContextDespite their important influence on child health, it is assumed that fathers are less likely than mothers to participate in pediatric obesity treatment and prevention research.ObjectiveThis review investigated the involvement of fathers in obesity treatment and prevention programs targeting children and adolescents (0-18 years).Data sourcesA systematic review of English, peer-reviewed articles across 7 databases. Retrieved records included at least 1 search term from 2 groups: "participants" (eg, child*, parent*) and "outcomes": (eg, obes*, diet*).Study selectionRandomized controlled trials (RCTs) assessing behavioral interventions to prevent or treat obesity in pediatric samples were eligible. Parents must have "actively participated" in the study.Data extractionTwo authors independently extracted data using a predefined template.ResultsThe search retrieved 213 eligible RCTs. Of the RCTs that limited participation to 1 parent only (n = 80), fathers represented only 6% of parents. In RCTs in which participation was open to both parents (n = 133), 92% did not report objective data on father involvement. No study characteristics moderated the level of father involvement, with fathers underrepresented across all study types. Only 4 studies (2%) suggested that a lack of fathers was a possible limitation. Two studies (1%) reported explicit attempts to increase father involvement.LimitationsThe review was limited to RCTs published in English peer-reviewed journals over a 10-year period.ConclusionsExisting pediatric obesity treatment or prevention programs with parent involvement have not engaged fathers. Innovative strategies are needed to make participation more accessible and engaging for fathers.
| S-EPMC6200318 | biostudies-literature