Dataset Information

Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

ABSTRACT:

Background

Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials.

Methods

We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials. We then interviewed 13 participants from different subspecialties and geographic locations to gain a more detailed description of how their experiences and attitudes towards research interacted with trial design and conduct.

Results

The survey response rate was 23.0% (186/807). 68.1% of respondents agreed that bias is a problem in pediatric RCTs and 72.0% felt that there is sufficient evidence to support changing some aspects of how trials are conducted. Knowledge related to bias was variable, with inconsistent awareness of study design features that may introduce bias into a study. Interview participants highlighted a lack of formal training in research methods, a negative research culture, and the pragmatics of trial conduct as barriers. Facilitators included contact with knowledgeable and supportive colleagues and infrastructure for research.

Conclusions

A lack of awareness of bias and negative attitudes towards research present significant barriers in terms of conducting methodologically rigorous pediatric RCTs. Knowledge translation efforts must focus on these issues to ensure the relevance and validity of trial results.

SUBMITTER: Hamm MP

PROVIDER: S-EPMC3503580 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

Hamm Michele P MP Scott Shannon D SD Klassen Terry P TP Moher David D Hartling Lisa L

BMC medical research methodology 20121018

<h4>Background</h4>Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials.<h4>Methods</h4>We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived bar ...[more]

PMID: 23078589

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Project description:BackgroundIn November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland.MethodsThis is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues.ResultsSurvey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants' legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials.ConclusionThe results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake.

Project description:BackgroundWhile patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)'s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU's role in PPI.MethodsA mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors.Results(1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors (n=8), TMs (n=5), chief investigators (n=3), PPI coordinators (n=2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10-50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI.ConclusionsWhile highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported.

Project description:BackgroundClinical practice guideline (CPG)-consistent care improves patient outcomes, but CPG implementation is poor. Little is known about CPG implementation in pediatric oncology. This study aimed to understand supportive care CPG implementation facilitators and barriers at pediatric oncology National Cancer Institute (NCI) Community Oncology Research Program (NCORP) institutions.MethodsHealthcare professionals at 26 pediatric, Children's Oncology Group-member, NCORP institutions were invited to participate in face-to-face focus groups. Serial focus groups were held until saturation of ideas was reached. Supportive care CPG implementation facilitators and barriers were solicited using nominal group technique (NGT), and implementation of specific supportive care CPG recommendations was discussed. Notes from each focus group were analyzed using a directed content analysis. The top five themes arising from an analysis of NGT items were identified, first from each focus group and then across all focus groups.ResultsSaturation of ideas was reached after seven focus groups involving 35 participants from 18 institutions. The top five facilitators of CPG implementation identified across all focus groups were organizational factors including charging teams with CPG implementation, individual factors including willingness to standardize care, user needs and values including mentorship, system factors including implementation structure, and implementation strategies including a basis in science. The top five barriers of CPG implementation identified were organizational factors including tolerance for inconsistencies, individual factors including lack of trust, system factors including administrative hurdles, user needs and values including lack of inclusivity, and professional including knowledge gaps.ConclusionsHealthcare professionals at pediatric NCORP institutions believe that organizational factors are the most important determinants of supportive care CPG implementation. They believe that CPG-consistent supportive care is most likely to be delivered in organizations that prioritize evidence-based care, provide structure and resources to implement CPGs, and eliminate implementation barriers.Trial registrationClinicalTrials.gov Identifier: NCT02847130. Date of registration: July 28, 2016.

Project description:BackgroundApp-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use.ObjectiveThe goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure.MethodsWe used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment.ResultsFour interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms).ConclusionsThis study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app.International registered report identifier (irrid)RR2-10.1002/nau.23507.

Dataset Information

Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

Background

Methods

Results

Conclusions

Publications

Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

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