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Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

ABSTRACT: An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories) and the severity of 36 barriers (grouped in 6 topical categories) to implementing pediatric antibacterial drug trials. Analysis focused on the identification of key factors that facilitate the successful implementation of pediatric antibacterial drug trials and the key barriers to implementation. Almost all investigators identified two factors as very important facilitators: having site personnel for enrollment and having adequate funding. Other top factors were related to staffing. Among the barriers, factors related to parent concerns and consent were prominent, particularly obtaining parental consent when there was disagreement between parents, concerns about the number of blood draws, and concerns about the number of invasive procedures. Having overly narrow eligibility criteria was also identified as a major barrier. The survey findings suggest three areas in which to focus efforts to help facilitate ongoing drug development: (1) improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial, (2) broadening inclusion criteria to allow more participants to enroll, and (3) ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks. The pediatric antibacterial drug trials enterprise is likely to benefit from focused efforts by all stakeholders to remove barriers and enhance facilitation.

SUBMITTER: Corneli A

PROVIDER: S-EPMC5898492 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

Corneli Amy A Wheeler Chris C Bradley John J Gamel Breck B Nambiar Sumathi S Noel Gary J GJ Lin Li L Roberts Jamie N JN Benjamin Daniel K DK

Contemporary clinical trials communications 20180131

An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories) and the severity of 36 barriers (grouped in 6 topical categories) to implementing pediatric antibacterial drug trials. Analysis focused on the ide ...[more]

PMID: 29696233

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Project description:BackgroundRecruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire.MethodsA literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i) trial, (ii) site, (iii) patient, (iv) clinical team, (v) information and consent and (vi) study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment.ResultsA web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes.ConclusionsWe have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using this tool with appropriate trial-specific adaptations to monitor and improve recruitment performance in an ongoing trial or conduct the survey at trial completion to gather information on facilitators and barriers to recruitment that can form the basis of interventions and strategies to improve recruitment to future clinical trials.

Project description:BackgroundThere is an urgent need to align human diets with goals for environmental sustainability and population health. The OPTIMAT™-intervention study was developed to implement and evaluate a nutritionally adequate and climate-friendly 4-week lunch menu in Swedish primary schools. This study aimed to explore pupils' and kitchen staff's experiences of the intervention and to identify barriers and facilitators to successful implementation of sustainable school meals.MethodsAn inductive manifest qualitative method was used. Nine focus group discussions (FGDs) were conducted, six with pupils in grades 5 (ages 10-11) and 8 (ages 14-15) (n = 29) and three with kitchen staff (n = 13). Data were analyzed using qualitative content analysis.ResultsFive main categories and 11 subcategories at a manifest level emerged. The five main categories were: 1) Experiences with the new menu, unfolding variations in how the new menu was received and kitchen staff's experiences of working with it; 2) The meaning of diet sustainability, comprising pupils' and kitchen staff's perceptions about diet sustainability as a concept and part of their everyday lives; 3) Factors influencing plant-based food acceptance, covering aspects such as the influence of sensory factors, habits and peer pressure; 4) Opportunities to increase plant-based eating, including factors related to pupils' and kitchen staff's ideas for how to increase plant-based food acceptance; and 5) Need for a supportive environment to achieve dietary change, comprising pupils' and kitchen staff's thoughts on the importance of more knowledge, resources and involvement of stakeholders to eat more plant-based meals in schools.ConclusionsSuccessful implementation of sustainable school meals would require more knowledge among pupils and kitchen staff. Staff also need more training in cooking of sustainable meals. Barriers among pupils could be tackled by introducing new plant-based meals more gradually and by more carefully considering the seasoning, naming and aesthetics of dishes. An increased leadership support for change and involvement of stakeholders from multiple levels within society will be key in the transition to sustainable school meals at scale.Trial registrationThe trial registration for the OPTIMAT™-intervention may be found at clinicaltrials.gov ( NCT04168632 Fostering Healthy and Sustainable Diets Through School Meals (OPTIMAT)).

Project description:IntroductionA multitude of HRSN interventions are undergoing testing in the U.S., with the CMS Accountable Health Communities (AHC) Model as the largest. HRSN interventions typically include screening for social needs, referral to community resources, and patient navigation to ensure needs are met. There is currently a paucity of evidence on implementation of HRSN interventions. The Consolidated Framework for Implementation Research (CFIR) is a determinant framework widely used to plan and assess implementation. To the authors knowledge, there are no published studies assessing CFIR constructs for HRSN intervention implementation in the U.S. In the Assessment step of the Strengthening Peer AHC Navigation (SPAN) model, a between-site qualitative assessment methodology was used to examine implementation within and between AHC bridge organizations (BOs) within six ERIC implementation strategies identified by the authors based on AHC Model requirements.ObjectiveOur aim was to identify and present between-site barriers and facilitators to AHC Model implementation strategies.DesignA multi-site qualitative analysis methodology was used. CFIR determinants were linked to six Expert Recommendations for Implementing Change (ERIC) strategies: staff training, identify and prepare champions, facilitation, community resource engagement (alignment through advisory boards and working groups), data systems, and quality monitoring and assurance. Interviews were analyzed using thematic content analysis in NVivo 12 (QSR International).SettingFive health-related bridge organizations participating in the AHC Model.ResultsFifty-eight interviews were completed with 34 staff and 24 patients or patient proxies. Facilitators were identified across five of the six ERIC strategies. Barriers were identified across all six. While organizations found the AHC Model compatible and facilitators to implementation included previous experience, meeting patient needs and resources, and leadership engagement and support, a number of barriers presented challenges to implementation. Issues with adequate staff training, staff skills to resolve HRSN, including patient communication and boundary spanning, setting staff goals, beneficiary caseloads and measurement of progress, data infrastructure (including EHR), available resources to implement and differences in perceptions between clinical delivery site (CDS), and CSP of how to measure and resolve HRSN.Conclusions and relevanceThe conduct of a pre-implementation readiness assessment benefited from identifying CFIR determinants linked to various ERIC implementation strategies.

Project description:On a global scale, implementation science has developed considerably as a discipline in recent years. In German-speaking countries, the field has been gaining significance as well, but respective efforts in building capacity and advancing the research infrastructure are still rare. The present study investigates barriers and facilitators for conducting implementation science in German-speaking countries with the goal of formulating recommendations for creating a more supportive research infrastructure. We conducted an interview study with nine well-established implementation researchers affiliated with universities in Austria, Germany, or Switzerland. The interviews were held via Zoom or phone in November and December 2020, transcribed verbatim and analyzed using thematic analysis. Barriers that relate to characteristics of the discipline were difficulties in building a common understanding of the field and the complexity of implementation research projects. Although supportive scientific networks were important facilitators, interviewees mentioned challenges in connecting with likeminded researchers. A further barrier was the lack of opportunities for education and training in implementation science, especially in the German language. Also, participants reported a missing readiness in academia for establishing implementation science that should be addressed by advocacy of the discipline toward academic decision makers. Moreover, since most national funding agencies prioritize basic research over applied research, some interviewees named flexibility in handling research funds as a facilitator for implementation research. The results inform an agenda for promoting implementation science in German-speaking countries and can be beneficial to other countries that are currently advancing their implementation research capacity and infrastructure.Supplementary informationThe online version contains supplementary material available at 10.1007/s43477-022-00046-3.

Project description:ObjectivesClinical trials provide 'gold standard' evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives.DesignExploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3).SettingFieldwork took place in Ethiopia during March 2011.ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20).Outcome measuresDetailed discussion notes were analysed using thematic coding analysis and key themes were identified.ResultsAll participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity.ConclusionsBarriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely.

Project description:BackgroundCare bundles are small sets of evidence-based recommendations, designed to support the implementation of evidence-based best clinical practice. However, there is variation in the design and implementation of care bundles, which may impact on the fidelity of delivery and subsequently their clinical effectiveness.MethodsA scoping review was carried out using the Arksey and O'Malley framework to identify the literature reporting on the design, implementation and evaluation of care bundles. The Embase, CINAHL, Cochrane and Ovid MEDLINE databases were searched for manuscripts published between 2001 and November 2017; hand-searching of references and citations was also undertaken. Data were initially assessed using a quality assessment tool, the Downs and Black checklist, prior to further analysis and narrative synthesis. Implementation strategies were classified using the Expert Recommendations for Implementing Change (ERIC) criteria.ResultsTwenty-eight thousand six hundred ninety-two publications were screened and 348 articles retrieved in full text. Ninety-nine peer-reviewed quantitative publications were included for data extraction. These consisted of one randomised crossover trial, one randomised cluster trial, one case-control study, 20 prospective cohort studies and 76 non-parallel cohort studies. Twenty-three percent of studies were classified as poor based on Downs and Black checklist, and reporting of implementation strategies lacked structure. Negative associations were found between the number of elements in a bundle and compliance (Spearman's rho = - 0.47, non-parallel cohort and - 0.65, prospective cohort studies), and between the complexity of elements and compliance (p < 0.001, chi-squared = 23.05). Implementation strategies associated with improved compliance included evaluative and iterative approaches, development of stakeholder relationships and education and training strategies.ConclusionCare bundles with a small number of simple elements have better compliance rates. Standardised reporting of implementation strategies may help to implement care bundles into clinical practice with high fidelity.Trial registrationThis review was registered on the PROSPERO database: CRD 42015029963 in December 2015.

Dataset Information

Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

Publications

Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

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