Dataset Information

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry.

ABSTRACT: The long-term and potential rare side effects of new immunomodulating drugs for the treatment of multiple sclerosis (MS) are often not well known. Spontaneous case report systems of adverse drug effects are a valuable source in pharmacovigilance, but have several limitations. Primary data collections within registries allow a comprehensive analysis of potential side effects, but face several challenges. This article will outline the chances and challenges of registry-based adverse event reporting, using the example of the German immunotherapeutic registry REGIMS. REGIMS is an observational, clinical multicenter registry that aims to assess the incidence, type, and consequences of side effects of MS immunotherapies. Patients treated with an approved MS medication are recruited by their physicians during routine visits in hospitals, outpatient clinics, and MS-specialized practices. REGIMS incorporates an electronic physician-based documentation in each center and a paper-based patient documentation, both at baseline and regular follow-up visits. By the end of 2019, 43 REGIMS centers were actively recruiting patients and performing follow-up documentations. The majority of the first 1000 REGIMS patients were female (69.3%), had relapse-remitting MS (89.8%), and were treated with a second-line therapy. During the implementation of REGIMS, several logistic and procedural challenges had to be overcome, which are outlined in this paper. Pharmacovigilance registries such as REGIMS provide high-quality primary data from a specific patient population in a real-world care setting and enable pharmacovigilance research that cannot be carried out using secondary data. Despite the logistic and procedural challenges in establishing a multicenter pharmacovigilance registry in Germany, the advantages outweigh the drawbacks.

SUBMITTER: Simbrich A

PROVIDER: S-EPMC7813707 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry.

Simbrich Alexandra A Thibaut Jasmine J Khil Laura L Maximov Stanislav S Wiendl Heinz H Berger Klaus K

Drug safety 20201023 1

The long-term and potential rare side effects of new immunomodulating drugs for the treatment of multiple sclerosis (MS) are often not well known. Spontaneous case report systems of adverse drug effects are a valuable source in pharmacovigilance, but have several limitations. Primary data collections within registries allow a comprehensive analysis of potential side effects, but face several challenges. This article will outline the chances and challenges of registry-based adverse event reportin ...[more]

PMID: 33098059

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Project description:Introduction: The TuberOus SClerosis registry to increase disease Awareness (TOSCA) is an international disease registry designed to provide insights into the clinical characteristics of patients with Tuberous Sclerosis Complex (TSC). The aims of this study were to identify issues that arose during the design, execution, and publication phases of TOSCA, and to reflect on lessons learnt that may guide future registries in rare and complex diseases. Methods: A questionnaire was designed to identify the strengths, weaknesses, and issues that arose at any stage of development and implementation of the TOSCA registry. The questionnaire contained 225 questions distributed in 7 sections (identification of issues during registry planning, during the operation of the registry, during data analysis, during the publication of the results, other issues, assessment of lessons learnt, and additional comments), and was sent by e-mail to 511 people involved in the registry, including 28 members of the Scientific Advisory Board (SAB), 162 principal investigators (PIs), and 321 employees of the sponsor belonging to the medical department or that were clinical research associate (CRA). Questionnaires received within the 2 months from the initial mailing were included in the analysis. Results: A total of 53 (10.4%) questionnaires were received (64.3% for SAB members, 12.3% for PIs and 4.7% for employees of the sponsor), and the overall completeness rate for closed questions was 87.6%. The most common issues identified were the limited duration of the registry (38%) and issues related to handling of missing data (32%). In addition, 25% of the respondents commented that biases might have compromised the validity of the results. More than 80% of the respondents reported that the registry improved the knowledge on the natural history and manifestations of TSC, increased disease awareness and helped to identify relevant information for clinical research in TSC. Conclusions: This analysis shows the importance of registries as a powerful tool to increase disease awareness, to produce real-world evidence, and to generate questions for future research. However, there is a need to implement strategies to ensure patient retention and long-term sustainability of patient registries, to improve data quality, and to reduce biases.

Project description:BackgroundCombined lifestyle interventions (CLIs) are designed to help people who are overweight or obese maintain a healthy new lifestyle. The CooL intervention is a CLI in the Netherlands, in which lifestyle coaches counsel adults and children (and/or their parents) who are obese or at high risk of obesity to achieve a sustained healthier lifestyle. The intervention consists of coaching on lifestyle in group and individual sessions, addressing the topics of physical activity, dietary behaviours, sleep, stress management and behavioural change. The aim of this study was to evaluate the implementation process of the Coaching on Lifestyle (CooL) intervention and its facilitating and impeding factors.MethodsMixed methods were used in this action-oriented study. Both quantitative (number of referrals, attendance lists of participants and questionnaires) and qualitative (group and individual interviews, observations, minutes and open questions) data were collected among participants, lifestyle coaches, project group members and other stakeholders. The Consolidated Framework for Implementation Research was used to analyse the data.ResultsCooL was evaluated by stakeholders and participants as an accessible and useful programme, because of its design and content and the lifestyle coaches' approach. However, stakeholders indicated that the lifestyle coaches need to become more familiar in the health care network and public sectors in the Netherlands. Lifestyle coaching is a novel profession and the added value of the lifestyle coach is not always acknowledged by all health care providers. Lifestyle coaches play a crucial role in ensuring the impact of CooL by actively networking, using clear communication materials and creating stakeholders' support and understanding.ConclusionThe implementation process needs to be strengthened in terms of creating support for and providing clear information about lifestyle coaching. The CooL intervention was implemented in multiple regions, thanks to the efforts of many stakeholders. Lifestyle coaches should engage in networking activities and entrepreneurship to boost the implementation process. It takes considerable time for a lifestyle coach to become fully incorporated in primary care.Trial registrationNTR6208 ; date registered: 13-01-2017; retrospectively registered; Netherlands Trial Register.

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Dataset Information

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry.

Publications

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry.

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