Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information:A Qualitative Study

Introduction A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage. Objective Our aim was to reveal the factors that may influence healthcare professionals (HCPs) and patients to use an app for two-way risk communication. Methods Focus group discussions and face-to-face interviews were conducted in the Netherlands, Spain and the UK. Patients with type 2 diabetes mellitus, patients with a rare disease or their caregivers and adolescents with health conditions were eligible to participate. HCPs included pharmacists, paediatricians, general practitioners, internists, practice nurses and professionals caring for patients with a rare disease. Patients and HCPs were recruited through various channels. The recorded discussions and interviews were transcribed verbatim. The dataset was analysed using thematic analysis and arranged according to the Unified Theory of Acceptance and Use of Technology. Results Seven focus group discussions and 13 interviews were conducted. In total, 21 HCPs and 50 patients participated. Identified factors that may influence the use of the app were the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. Also mentioned were other functions of the app, ease of use, type of language, the source of safety information provided through the app, security of the app, layout, the operating systems on which the app can be used and the costs. Conclusions Further research is needed to assess associations between user characteristics and the direction (positive or negative) of the factors potentially influencing app use

Interest in a Mobile App for Two-Way Risk Communication:A Survey Study Among European Healthcare Professionals and Patients

Previously, an app has been developed for healthcare professionals (HCPs) and patients to report adverse drug reactions (ADRs) to national medicines agencies and to receive drug safety information. This study aimed to assess (1) European HCPs' and patients' interest in an app for this two-way risk communication; (2) their preferences and perceptions towards specific app characteristics; and (3) which HCPs and patients are particularly interested in the app. In addition, these aspects were studied specifically for the countries where such an app was already available, i.e. Croatia, The Netherlands, and The UK. European HCPs and patients were asked to complete a web-based survey developed in the context of the Web-Recognizing Adverse Drug Reactions (Web-RADR) project. Data on app interest and preferences and perceptions towards app characteristics were analysed descriptively. Logistic regression analyses were conducted to assess the association of HCP characteristics and patient characteristics on the level of interest in the app (i.e. very interested vs. not/somewhat interested). In total, 399 HCPs and 656 patients completed the survey. About half of the patients (48%; ranging from 38% from The Netherlands to 54% from The UK), and 61% of the HCPs (ranging from 42% from The Netherlands to 54% from The UK) were very interested in the app. A faster means of reporting ADRs and easier access to the reporting form were the main perceived benefits. HCPs and patients who already use a health app were particularly interested in the app (HCPs: odds ratio [OR] 3.52; 95% confidence interval [CI] 1.96-6.30, patients: OR 1.64; 95% CI 1.19-2.27). An app is positively perceived by HCPs and patients for reporting ADRs quickly and for receiving drug safety information from national medicines agencies. In particular, HCPs and patients who already use other health apps were interested in the app

Participation de l’AFM-Téléthon (2012-2016) au Réseau Européen Help Lines d’Eurordis

Les informations sur les maladies rares sont souvent de compréhension complexe et d’accès difficile. Un accompagnement est souvent nécessaire. Des services d’assistance du réseau européen ENRDHL (European Network ofRare Disease Help Lines) travaillent ensemble à travers l’Europe pour répondre aux demandes de renseignements de tout public, incluant les patients et leurs proches, ainsi que les parties prenantes. Dans cet article, nous rapportons des données spécifiques aux maladies neuromusculaires sur la période 2012-2016, durant laquelle l’AFM-Téléthon a participé à l’enquête annuelle sur un mois donné de ce réseau coordonné par Eurordis

Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations

Introduction Transparent collaborations between patient organisations (POs) and clinical research sponsors (CRS) can identify and address the unmet needs of patients and caregivers. These insights can improve clinical trial participant experience and delivery of medical innovations necessary to advance health outcomes and standards of care. We share our experiences from such a collaboration undertaken surrounding the SENSCIS® clinical trial (NCT02597933), and discuss its impact during, and legacy beyond, the trial.Summary We describe the establishment of a community advisory board (CAB): a transparent, multiyear collaboration between the scleroderma patient community and a CRS. We present shared learnings from the collaboration, which is split into three main areas: (1) the implementation and conduct of the clinical trial; (2) analysis and dissemination of the results; and (3) aspects of the collaboration not related to the trial.1. The scleroderma CAB reviewed and provided advice on trial conduct and reporting. This led to the improvement and optimisation of trial procedures; meaningful, patient-focused adaptations were made to address challenges relevant to scleroderma-associated interstitial lung disease patients.2. To ensure that results of the trial were accessible to lay audiences and patients, written lay summaries were developed by the trial sponsor with valuable input from the CAB to ensure that language and figures were understandable.3. The CAB and the CRS also collaborated to co-develop opening tools for medication blister packs and bottles. In addition, to raise disease awareness among physicians, patients and caregivers, educational materials to improve diagnosis and management of scleroderma were co-created and delivered by the CAB and CRS.Conclusions This collaboration between POs and a CRS, in a rare disease condition, led to meaningful improvements in patient safety, comfort and self-management and addressed information needs. This collaboration may serve as a template of best practice for future collaborations between POs, research sponsors and other healthcare stakeholders

Monitoring and Evaluation of Patient Engagement in Health Product Research and Development: Co-Creating a Framework for Community Advisory Boards

Purpose: While patient engagement is becoming more customary in developing health products, its monitoring and evaluation to understand processes and enhance impact are challenging. This article describes a patient engagement monitoring and evaluation (PEME) framework, co-created and tailored to the context of community advisory boards (CABs) for rare diseases in Europe. It can be used to stimulate learning and evaluate impacts of engagement activities. Methods: A participatory approach was used in which data collection and analysis were iterative. The process was based on the principles of interactive learning and action and guided by the PEME framework. Data were collected via document analysis, reflection sessions, a questionnaire, and a workshop. Results: The tailored framework consists of a theory of change model with metrics explaining how CABs can reach their objectives. Of 61 identified metrics, 17 metrics for monitoring the patient engagement process and short-term outcomes were selected, and a “menu” for evaluating long-term impacts was created. Example metrics include “Industry representatives’ understanding of patients’ unmet needs;” “Feeling of trust between stakeholders;” and “Feeling of preparedness.” “Alignment of research programs with patients’ needs” was the highest-ranked metric for long-term impact. Conclusions: Findings suggest that process and short-term outcome metrics could be standardized across CABs, whereas long-term impact metrics may need to be tailored to the collaboration from a proposed menu. Accordingly, we recommend that others adapt and refine the PEME framework as appropriate. The next steps include implementing and testing the evaluation framework to stimulate learning and share impacts