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Importance of feasibility assessments before implementing non-interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies.

ABSTRACT: PURPOSE:Investigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long-term benefit-risk profiles. However, generating such evidence in real-world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepidemiological data. METHODS:Following an initiative launched by the International Society for Pharmacoepidemiology in May 2014, a working group including members of the private and public sectors, was formed to assess the value of conducting feasibility assessments as a necessary step before embarking on larger-scale post-licensure studies. Based on five real-life examples of feasibility assessments, lessons learned and recommendations were issued by the working group to support scientific reasoning and decision making when designing pharmacoepidemiologic vaccine studies. RESULTS:The working group developed a toolbox to provide a pragmatic approach to conducting feasibility assessments. The toolbox contains two main components: the scientific feasibility and the operational feasibility. Both components comprise a series of specific questions aimed at overcoming methodological and operational challenges. CONCLUSIONS:A feasibility assessment should be formalized as a necessary step prior to the actual start of any pharmacoepidemiologic study. It should remain a technical evaluation and not a hypothesis testing. The feasibility assessment report may facilitate communication with regulatory agencies toward improving the quality of study protocols and supporting the endorsement of study objectives and methods addressing regulatory commitments. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

SUBMITTER: Willame C

PROVIDER: S-EPMC5157751 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Importance of feasibility assessments before implementing non-interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies.

Willame Corinne C Baril Laurence L van den Bosch Judith J Ferreira Germano L C GL Williams Rachael R Rosillon Dominique D Cohet Catherine C

Pharmacoepidemiology and drug safety 20160907 12

<h4>Purpose</h4>Investigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long-term benefit-risk profiles. However, generating such evidence in real-world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepid ...[more]

PMID: 27601179

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Project description:BackgroundType 2 diabetes mellitus is preventable through lifestyle intervention. Diabetes prevention programmes (DPPs) aim to deliver prevention-based behaviour change interventions to reduce incidence. Such programmes vary from usual primary care in terms of where, how, and by whom they are delivered. Implementation is therefore likely to face new commissioning, incentive and delivery challenges. We report on the implementation of a national DPP in NHS England, and identify lessons learned in addressing the implementation challenges.MethodsIn 2017/18, we conducted 20 semi-structured telephone interviews covering 16 sampled case sites with the designated lead(s) responsible for local implementation of the programme. Interviews explored the process of implementation, including organisation of the programme, expectations and attitudes to the programme, funding, target populations and referral and clinical pathways. We drew on constant comparative methods to analyse the data and generate over-arching themes. We complemented our qualitative data with a survey focused on variation in the financial incentives used across sites to ensure usual primary care services recruited patients to new providers.ResultsWe identified five over-arching areas of learning for implementing this large-scale programme: 1) managing new providers; 2) promoting awareness of services; 3) recruiting patients; 4) incentive payments; and 5) mechanisms for sharing learning. In general, tensions appeared to be caused by a lack of clear roles/responsibilities between hierarchical actors, and lack of communication. Both local sites and the national NHS coordination team gained experience through learning by doing. Initial tensions with roles and expectations have been worked out during implementation.ConclusionsImplementing a national disease prevention programme is a major task, and one that will be increasingly faced by health systems globally as they aim to adjust to demand pressures. We provide practical learning opportunities for the wider uptake and sustainability of prevention programmes. Future implementers might wish to define clear responsibilities for each actor prior to implementation, ensure early engagement with new providers, offer mechanisms/forums for sharing learning, generate evidence and provide advice on incentive payments, and prioritise public and professional awareness of the programme.

Project description:BackgroundMicronutrient deficiencies affect many children in low-income settings due primarily to over-reliance on complementary foods low in nutrients. Home-fortification (HF) could improve children's diet quality in these settings. The Ghana Health Service, supported by UNICEF, integrated the pilot Micronutrient Powder Initiative (MPI) into Child Welfare Clinic (CWC) services in four districts (Tain, Tolon, Talensi, and Ho West), whereby micronutrient powder (MNP) is supplied for HF for children aged 6-23 months attending CWCs. This study's main aim was to identify the facilitators, barriers and "lessons learned" after 2 years of program implementation.MethodsThis was a qualitative cross-sectional study. MNP distributed and children enrolled were obtained from program records. Primary data were collected from November to December 2019 and included, by district: interviews with senior program staff; key informant interviews and focus group discussion with caregivers in each of 6 sub-districts; and discussions workshop with frontline staff from at least 10 health facilities. Besides field notes, all interactions were audio-recorded and transcribed verbatim. Qualitative data were analyzed using NVivo10.ResultsThe MPI remains on-going, with about 2.5 million MNP sachets distributed to nearly 30,000 children within 90 district-months. Caregivers generally accept the MNP; reported positive responses in children include: "increased appetite", "less frequent illnesses, "increased energy/strength", "increased weight", and "walking independently relatively early". Main facilitators are: generally regular MNP availability; increased patronage of CWC services; various contact points for supplying MNPs; fairly strong social mobilization strategy; good integration of MPI with CWC services; "one-on-one" counselling for caregivers reporting side effects; and tracing caregivers to address concerns and monitor adherence. Main barriers are: lack of counselling materials; caregivers' suspicions towards the program; absence of refresher training for frontline workers; and perceived MNP side-effects. Key lessons learned are: incorporating MNPs into CWC services is feasible, acceptable, and could reduce child micronutrient deficiencies in program districts; and MPI's success requires stronger community sensitization, equipping frontline workers to advise caregivers and manage side-effects, and consciously identifying and managing logistical challenges.ConclusionFurther research is needed to evaluate the effectiveness of the MPI in reducing micronutrient deficiencies among 6-23-months-olds in Ghana.

Dataset Information

Importance of feasibility assessments before implementing non-interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies.

Publications

Importance of feasibility assessments before implementing non-interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies.

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