Strategies to promote implementation of core outcomes for medication adherence trials in rheumatology: A report from the OMERACT-Adherence Group.

OBJECTIVES: To identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions. METHODS: Preliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions. RESULTS: Implementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers. CONCLUSION: Ongoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS.

Evolving and evaluating the OMERACT fellows program: insights and implications from OMERACT 2023 fellows.

OBJECTIVE: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program. METHODS: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program. RESULTS: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions. CONCLUSION: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT.

Effect of a smart temperature logger on correctly storing biological disease-modifying antirheumatic drugs at home: a pre-post study.

OBJECTIVES: Biological disease-modifying antirheumatic drugs (bDMARDs) require specific storage temperatures, but are frequently stored outside the recommended range of 2-8°C. As incorrect storage may affect therapy effectiveness and consequently lead to higher disease activity, compliance with recommended storage temperatures should be improved. eHealth interventions can provide insight into storage temperatures and alerts in case of deviations from recommended temperatures. Therefore, this study aims to assess the effect of a smart temperature logger on correctly storing bDMARDs at home by patients with rheumatic diseases. METHODS: A pre-post study was performed in a hospital in the Netherlands. The baseline period consisted of 12 weeks of storage temperature measurement with a passive temperature logger, and the intervention period consisted of 12 weeks of storage temperature measurement with a smart temperature logger. This smart logger included a smartphone application which provided insight into storage temperatures and real-time alerts when exceeding recommended temperatures. The main outcome measure was the difference in the number of patients who stored their bDMARDs correctly between baseline and intervention. Secondary outcomes were the difference in the proportion of measurement time within 2-8°C between baseline and intervention, the distribution of measurement time among temperature categories, and the patient's acceptance measured using a questionnaire based on the Technology Acceptance Model. RESULTS: In total, 48 participants (median age 55 years (IQR 47-64), 53% male) were analysed. The proportion of participants correctly storing bDMARDs increased from 18.8% (n=9) during baseline to 39.6% (n=19) during intervention (p=0.004). The median proportion of measurement time between 2-8°C improved by 6% (IQR 0-34%) (p<0.0001). Technology acceptance was scored as moderate. CONCLUSIONS: Temperature monitoring and real-time feedback with a smart temperature logger shows potential to improve at-home storage of bDMARDs, provided that continuous connection is realised to ensure real-time alerts and data collection.

Cost Savings and Waste Reduction Through Redispensing Unused Oral Anticancer Drugs: The ROAD Study.

Importance: New strategies targeting waste are required to improve financial and ecologic sustainability of expensive therapies, such as oral anticancer drugs, that frequently remain unused by patients. Redispensing unused oral anticancer drugs seems to be a promising strategy when drug quality is guaranteed. Objectives: To determine the waste reduction and net cost savings attained by redispensing oral anticancer drugs that go unused by patients compared with the standard practice of disposal. Design, Settings, and Participants: The ROAD study was a prospective single-group intervention conducted in the outpatient pharmacies of 4 hospitals in the Netherlands from February 1, 2021, to February 1, 2023, with 12-month follow-up of each patient. Patients with cancer and who had a prescription for an oral anticancer drug that could be stored at room temperature were included. Of 2426 eligible patients, 602 did not consent and 601 did not respond. Data analyses were performed from August 25, 2022, to April 19, 2023. Intervention: Participants received oral anticancer drugs for use at home in special packaging (ie, sealed packaging with time-temperature indicator), to be returned to the pharmacy should these remain unused. The pharmacy ensured quality of returned drugs based on authenticity, appearance, remaining shelf life and adequate storage temperature. Drugs fulfilling quality requirements were redispensed to other patients. Main Outcome and Measure: Total waste reduction and mean net annual cost savings per patient compared with the standard practice of disposal. Optimization of cost savings was explored by introducing variations in the quality assurance procedure and patient population. All analyses used the average exchange rate for 2021 €1 = US $1.18. Results: Of 1223 patients with cancer who consented, 1071 participated (median [IQR] age, 70 [62-75] years; 622 [58.1%] were male). In all, 171 patients (16.0%; 95% CI, 13.8%-18.3%) returned 335 unused oral anticancer drug packages. Of the returned drugs, 228 packages were redispensed, which reduced waste by 68.1% (95% CI, 67.7%-68.5%) compared with the standard practice (disposal). Redispensing unused oral anticancer drugs comprised 2.4% (95% CI, 2.2%-2.5%) of total drug costs, providing mean net annual cost savings of US $680 (95% CI, $524-$837) up to $1591 (95% CI, $1226-$2002) per participant. Conclusions and Relevance: The findings of this multicenter intervention study indicate that redispensing unused oral anticancer drugs is associated with waste reduction and cost savings, which in turn may improve the affordability and sustainability of cancer treatment. Trial Registration: World Health Organization International Clinical Trials Registry Platform Identifier: NL9208.

Improvement, Implementation, and Evaluation of the CMyLife Digital Care Platform: Participatory Action Research Approach.

BACKGROUND: The evaluation of a continuously evolving eHealth tool in terms of improvement and implementation in daily practice is unclear. The CMyLife digital care platform provides patient-centered care by empowering patients with chronic myeloid leukemia, with a focus on making medication compliance insightful, discussable, and optimal, and achieving optimal control of the biomarker BCR-ABL1. OBJECTIVE: The aim of this study was to investigate to what extent the participatory action research approach is suitable for the improvement and scientific evaluation of eHealth innovations in daily clinical practice (measured by user experiences) combined with the promotion of patient empowerment. METHODS: The study used iterative cycles of planning, action, and reflection, whereby participants' experiences (patients, health care providers, the CMyLife team, and app suppliers) with the platform determined next actions. Co-design workshops were the foundation of this cyclic process. Moreover, patients filled in 2 sets of questionnaires for assessing experiences with CMyLife, the actual use of the platform, and the influence of the platform after 3 and at least 6 months. Data collected during the workshops were analyzed using content analysis, which is often used for making a practical guide to action. Descriptive statistics were used to characterize the study population in terms of information related to chronic myeloid leukemia and sociodemographics, and to describe experiences with the CMyLife digital care platform and the actual use of this platform. RESULTS: The co-design workshops provided insights that contributed to the improvement, implementation, and evaluation of CMyLife and empowered patients with chronic myeloid leukemia (for example, simplification of language, and improvement of the user friendliness of functionalities). The results of the questionnaires indicated that (1) the platform improved information provision on chronic myeloid leukemia in 67% (33/49) of patients, (2) the use of the medication app improved medication compliance in 42% (16/38) of patients, (3) the use of the guideline app improved guideline adherence in 44% (11/25) of patients, and (4) the use of the platform caused patients to feel more empowered. CONCLUSIONS: A participatory action research approach is suited to scientifically evaluate digital care platforms in daily clinical practice in terms of improvement, implementation, and patient empowerment. Systematic iterative evaluation of users' needs and wishes is needed to keep care centered on patients and keep the innovation up-to-date and valuable for users.

Implementing medication adherence interventions in four Dutch living labs; context matters.

BACKGROUND: Despite the abundant availability of effective medication adherence interventions, uptake of these interventions into routine care often lacks. Examples of effective medication adherence interventions include telephone counseling, consult preparation and the teach-back method. Assessing context is an important step in understanding implementation success of interventions, but context is often not reported or only moderately described. This study aims to describe context-specific characteristics in four living labs prior to the implementation of evidence-based interventions aiming to improve medication adherence. METHODS: A qualitative study was conducted within four living labs using individual interviews (n = 12) and focus groups (n = 4) with project leaders and involved healthcare providers. The four living labs are multidisciplinary collaboratives that are early adopters of medication adherence interventions in the Dutch primary care system. Context is defined as the environment or setting in which the proposed change is to be implemented. Interview topics to assess context were formulated based on the 'inner setting' and 'outer setting' domains of the Consolidated Framework for Implementation Research (CFIR). Interviews were recorded and transcribed verbatim. Transcripts were deductively analyzed. RESULTS: A total of 39 community pharmacists, pharmacy technicians, general practitioners and a home care employee participated in the (focus group) interviews. All four living labs proved to be pharmacy-driven and characterized by a high regard for innovation by staff members, a positive implementation climate, high levels of leadership engagement and high compatibility between the living labs and the interventions. Two living labs were larger in size and characterized by more formal communication. Two living labs were characterized by higher levels of cosmopolitanism which resulted in more adaptable interventions. Worries about external policy, most notably lack of reimbursement for sustainment and upscaling of the interventions, were shared among all living labs. CONCLUSIONS: Contextual characteristics of four living labs that are early adopters of medication adherence interventions provide detailed examples of a positive implementation setting. These can be used to inform dissemination of medication adherence interventions in settings less experienced in implementing medication adherence interventions.

Factors Influencing Preferences of Patients With Rheumatic Diseases Regarding Telehealth Channels for Support With Medication Use: Qualitative Study.

BACKGROUND: Patients with rheumatic diseases are known to experience drug-related problems at various times during their treatment. As these problems can negatively influence patients' health, they should be prevented or resolved as soon as possible, for which patients might benefit from additional support. Telehealth has the potential to continuously provide information and offers the possibility to easily contact a health care provider in order to support patients with medication use. Knowledge of factors influencing the patient's preference for telehealth channels can improve the actual use of telehealth channels. OBJECTIVE: This study aims to identify factors that influence the preferences of patients with rheumatic diseases regarding telehealth channels for support with medication use. METHODS: A qualitative study with face-to-face interviews was performed among patients with an inflammatory rheumatic disease in the Netherlands. A total of 4 telehealth channels were used: a frequently asked questions page, a digital human, an app for SMS text messaging with health care providers, and an app for video-calling with health care providers. Using a semistructured interview guide based on domains of the Capability, Opportunity, Motivation, and Behavior (COM-B) model, participants were questioned about (1) their general opinion on the 4 telehealth channels, (2) factors influencing preference for individual telehealth channels, and (3) factors influencing preference for individual telehealth channels in relation to the other available channels. Interviews were recorded, transcribed, and categorically analyzed. RESULTS: A total of 15 patients were interviewed (female: n=8, 53%; male: n=7, 47%; mean age 55, SD 16.8 years; median treatment duration of 41, IQR 12-106 months). The following 3 categories of factors influencing patient preference regarding telehealth channels were identified: (1) problem-related factors included problems needing a visual check, problems specifically related to the patient, and urgency of the problem; (2) patient-related factors included personal communication preference and patient characteristics; and (3) channel-related factors included familiarity with the telehealth channel, direct communication with a health care provider, methods of searching, and conversation history. CONCLUSIONS: Preference for telehealth channels is influenced by factors related to the problem experienced, the patient experiencing the problem, and telehealth channel characteristics. As the preference for telehealth channels varies between these categories, multiple telehealth channels should be offered to enable patients to tailor the support with their medication use to their needs.

How to engage healthcare providers in preventing medication waste through individualized prescribing and dispensing: A qualitative study.

BACKGROUND: Medication waste is a threat to healthcare's sustainability. To prevent medication waste in patients' homes, medication quantities prescribed and dispensed to patients could be individualized. Perspectives of healthcare providers on engaging in this strategy however remain unclear. OBJECTIVE(S): To identify factors influencing healthcare providers in preventing medication waste through individualized prescribing and dispensing. METHODS: Individual semi-structured interviews were conducted via conference calls with pharmacists and physicians prescribing and dispensing medication to outpatients of eleven Dutch hospitals. An interview guide based on the Theory of Planned Behaviour was developed. Questions related to participant's view on medication waste, current prescribing/dispensing behaviour and intention to personalising prescribing/dispensing quantities. Data was thematically analysed, following a deductive approach based on the Integrated Behavioural Model. RESULTS: Nineteen out of 45 (42%) healthcare providers were interviewed, of whom eleven were pharmacists and eight physicians. Factors influencing individualized prescribing and dispensing by healthcare providers were identified and categorized in seven themes: (1) attitude: beliefs about consequences of waste, as well as perceived benefits and concerns of the intervention; (2) perceived norm: professional and social responsibilities; (3) personal agency: available resources; (4) knowledge and skills: intervention complexity; (5) salience of behaviour: perceived need from past experiences and evaluation of actions; (6) habit: prescribing and dispensing habits; and (7) situational factors: support for change, momentum for sustainable actions, need for guidance, triad collaboration and information provision. CONCLUSIONS: Healthcare providers perceive a strong professional and social responsibility to prevent medication waste yet feel bound by limited resources available to engage in individualized prescribing and dispensing. Situational factors, including leadership, organizational awareness and strong collaborations, could help healthcare providers to engage in individualized prescribing and dispensing. Through the identified themes, this study offers directions for designing and implementing an individualized prescribing and dispensing program to prevent medication waste.

Drug-related problems reported by patients with rheumatic diseases: an observational study.

BACKGROUND: Drug-related problems can negatively influence treatment outcome and well-being for patients with rheumatic diseases. Thus, it is important to support patients in preventing or resolving drug-related problems as quickly as possible. To effectively develop interventions for this purpose, knowledge on the frequency and character of drug-related problems is needed. Therefore, this study aims to quantify and characterize drug-related problems reported by patients with inflammatory rheumatic diseases along their treatment process. METHODS: A prospective observational study was conducted in a Dutch outpatient pharmacy. Adult patients with rheumatic diseases that were prescribed medication by a rheumatologist were questioned about experienced DRPs by telephone 4 times in 8 weeks using a structured interview-guide. Patient-reported DRPs were scored on uniqueness (i.e., if a specific DRP was reported in multiple interviews by one individual, this was counted as one unique DRP) and were categorized using a classification for patient-reported DRPs and analysed descriptively. RESULTS: In total, 52 participants (median age 68 years (interquartile range (IQR) 62-74), 52% male) completed 192 interviews with 45 (87%) participants completing all 4 interviews. The majority of patients (65%) were diagnosed with rheumatoid arthritis. Patients reported a median number of 3 (IQR 2-5) unique DRPs during interview 1. In subsequent interviews, patients reported median numbers of 1 (IQR 0-2), 1 (IQR 0-2) and 0 (IQR 0-1) unique DRPs for interviews 2-4 respectively. Participants reported a median number of 5 (IQR 3-9) unique DRPs over all completed interviews. Unique patient-reported DRPs were most frequently categorized into (suspected) side effects (28%), medication management (e.g., medication administering or adherence) (26%), medication concerns (e.g., concerns regarding long-term side-effects or effectiveness) (19%) and medication effectiveness (17%). CONCLUSIONS: Patients with rheumatic diseases report various unique DRPs with intervals as short as two weeks. These patients might therefore benefit from more continuous support in-between contact moments with their healthcare provider.

Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO study): study protocol for a prospective, multicentre, single-arm trial.

BACKGROUND: Dose reduction of tyrosine kinase inhibitors (TKI) in patients with chronic myeloid leukaemia (CML) with an optimal response to TKIs may support cost-effective medication use by maintaining therapeutic effectiveness while reducing adverse events and medication costs. As the choice for dose reduction depends on patients' individual needs and preferences, a patient-centred approach is warranted. Therefore, a study to evaluate the effectiveness of patient-guided dose reduction in patients with CML who are in a major or deep molecular response is designed. METHODS: This study is a prospective, multicentre, single-arm study. 147 patients with CML (aged ≥ 18 years) in chronic phase, who are treated with imatinib, bosutinib, dasatinib, nilotinib or ponatinib, and have reached at least major molecular response (defined as having BCR-ABL levels < 0.1% for an uninterrupted period of 6 months) are eligible. Patients will use an online patient decision aid and a shared decision making consultation will be held, after which patients who choose to will receive a personalised, lower TKI dose. Primary outcome is the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response. For this, BCR-ABL1 levels will be analysed from blood samples drawn at baseline, 6 weeks after dose reduction and 3-monthly thereafter. Secondary outcomes include the proportion of patients with intervention failure at 6 and 18 months after dose reduction. Other outcomes include differences before and after dose reduction regarding the number and severity of patient-reported side effects; quality of life; beliefs about medicines; and medication adherence. Patients' level of decisional conflict and regret after choosing dose reduction will be assessed, as will the decisional process experienced by patients and healthcare providers. DISCUSSION: Outcomes of this trial using a personalised approach will provide clinical and patient-reported data to guide future dose reduction of TKIs in CML. If the strategy appears to be effective, it may be implemented as another valid option to offer next to standard of care to prevent potential unnecessary exposure to higher TKI doses in this selected group of patients. TRIAL REGISTRATION: EudraCT number 2021-006581-20.

Feasibility of an Individualized Dispensing Program for Patients Prescribed Oral Anticancer Drugs to Prevent Waste.

PURPOSE: Waste of oral anticancer drugs (OACDs) causes financial and environmental burdens. This study evaluates the feasibility of an individualized dispensing program to prevent waste of OACDs. METHODS: Adult patients were dispensed individualized quantities of niraparib, abiraterone, enzalutamide, ruxolitinib, osimertinib, or imatinib as standard care, during the first 6 months of treatment. The first 50 patients participated in an feasibility evaluation conform five domains of Bowen's Framework. (1) implementation: reach (eligible patients included) and protocol fidelity (executions following protocol) assessed from pharmacy data, (2) acceptability: rated from 1 to 10 and agreement with theoretical framework acceptability domains via a survey among patients and pharmacy technicians, (3) practicality: program's costs, (4) effect: compared with previous practice (full package supply per month), defined as difference in unused OACD unit doses and net cost-savings, and (5) demand: potential scale-up of the program by including more OACDs. RESULTS: Participants' median age was 67 (interquartile range [IQR], 58-71) years, and 76% was male. (1) Implementation: reach and protocol fidelity were 89% and 90%, respectively. (2) Acceptability was high among patients (median, 9; IQR, 8-9) and pharmacy technicians (median, 7; IQR, 6-8). All acceptability domains were agreed on. (3) Practicality: program costs were €4,289. (4) Effect: unused OACD unit doses were reduced by 34%, causing net cost-savings of €693 per discontinued patient. (5) Demand: the program could be scaled up to seven times by including all OACDs. CONCLUSION: Individualized dispensing for patients prescribed OACDs is feasible for preventing waste in terms of implementation, acceptability, practicality, effect, and demand.

Inpatients Self-Administration of Medication: Stakeholders' views and prerequisites.

AIMS AND OBJECTIVES: To identify stakeholders' views on inpatient Self-Administration of Medication and corresponding prerequisites for successful implementation. BACKGROUND: Self-Administration of Medication allows capable patients to manage their medication regimen throughout hospitalisation. It is assumed to facilitate continuity of care, increase medication safety and patient empowerment. To enable sustainable implementation stakeholders should support it. Knowledge about stakeholders' views regarding Self-Administration of Medication is currently lacking. DESIGN: A qualitative study was conducted among stakeholders using semi-structured interviews. METHODS: Using purposive and snowball sampling fourteen representatives from Dutch healthcare associations, organisations and authorities were interviewed between April and July 2019. These stakeholders were asked to reflected on Self-Administration of Medication and its implementation. Data were examined using inductive thematic content analysis and reported following the COREQ checklist. RESULTS: Most stakeholders were positive towards Self-Administration of Medication and foresaw benefits in terms of the following: improvements to patient-centred care, contributions to sustainable use of healthcare assets and the need and opportunity for change. Critical concerns included reflecting potential risks for patient safety, concerns about implementation feasibility and questions regarding implementation necessity. Stakeholders highlighted prerequisites pertaining to the implementation process in which the following two themes emerged: (1) initiate a supported change and (2) perform research for best practices and identification of benefits. Other prerequisites concerned distinct levels within healthcare including individual patients (i.e. adequate communication), hospital organisation (i.e. to establish a workflow to secure medication safety) and healthcare system (i.e. to facilitate multidisciplinary collaboration in healthcare). CONCLUSION: Stakeholders were predominantly positive about Self-Administration of Medication. For successful and sustainable implementation of Self-Administration of Medication, prerequisites identified in this study should be met. RELEVANCE TO CLINICAL PRACTICE: This study provided knowledge about stakeholders' views which could foster implementation and evaluation of Self-Administration of Medication, which may, in turn, promote effective deployment and patient empowerment.

Gaming for Adherence to Medication using Ehealth in Rheumatoid arthritis (GAMER) study: a randomised controlled trial.

OBJECTIVE: To examine the effect on adherence to disease modifying anti-rheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) of a serious game that targeted implicit attitudes toward medication. METHODS: A multicentre randomised controlled trial (RCT) was performed with adults with RA that used DMARDs and possessed a smartphone/tablet. Control and intervention groups received care as usual. The intervention group played the serious game at will during 3 months. Game play data and online questionnaires Compliance Questionnaire on Rheumatology (CQR), Beliefs about Medicine Questionnaire (BMQ), Health Assessment Questionnaire (HAQ) and Rheumatoid Arthritis Disease Activity Index (RADAI) were collected. Primary outcome was DMARD implementation adherence operationalised as the difference in proportion of non-adherent participants (<80% taking adherence) between intervention and control group after 3 months using a Chi-squared test. Two sample t-tests and Wilcoxon rank-sum test were performed to test for differences on secondary outcomes. RESULTS: Of the 110 intervention participants that started the study, 87 participants (79%) installed the game and had a median playtime of 9.7 hours at 3 months. Overall, 186 participants completed the study. Adherence in intervention group (63%) and control group (54%) did not differ significantly (p=0.13) at 3 months. Neither were there differences oberved in CQR continuous score, beliefs about medication (BMQ) or clinical outcomes (HAQ and RADAI). CONCLUSION: A serious game aimed at reinterpreting attitudes toward medication failed to show an effect on adherence to DMARDs or clinical outcomes in patients with RA. The game was played frequently indicating that it can be an effective channel for reaching patients. TRIAL REGISTRATION NUMBER: NL7217.

Patients' views on Self-administration of Medication during hospitalisation: a mixed-methods study.

Background: Inpatient Self-administration of Medication (SAM) increases patient involvement in medication management and may increase medication safety. Its implementation is impeded. Successful and sustainable implementation of SAM strongly depends on patients' willingness to participate. This study aimed to identify and quantify patients' views on SAM, related (dis)advantages and prerequisites, patient's willingness to engage in SAM schemes, and their preferences in medication management during hospitalisation. Methods: A mixed-methods study was conducted among hospitalised adult patients in four Dutch hospitals during December 2018 and March 2019. Semi-structured one-to-one interviews were performed to identify patients' views on SAM. Interview transcripts were subjected to thematic-content analysis. These outcomes were used to construct a questionnaire about patient's willingness to engage in SAM schemes, their preferences for inpatient medication management and level of agreement with statements about SAM's (dis)advantages and prerequisites of SAM. Data were descriptively analysed. Results: Nineteen hospitalised patients [mean (standard deviation; SD) age 61.0 (13.4) years old; 52.6% male] were interviewed. Most patients had a positive view on SAM, but some doubted the necessity to change standard care. Also, patients expressed concerns about medication safety. Prerequisites for SAM implementation were identified. These covered four main themes: information provision, accessible and safe storage, assurance of safety, and clear responsibilities. A total of 234 patients [mean (SD), age 65.3 (13.5) years; 54.7% male] participated in the questionnaire. Although 50.0% of the patients were willing to self-administer medication, patients were ambivalent as only 36.5% preferred SAM over nurse-led administration. Conclusion: The majority of patients were positive about SAM. Although half of the patients were willing to perform SAM, most patients did not prefer SAM over standard care. This ambivalent attitude may be overcome when the stated prerequisites are met and patients experience SAM in clinical practice. Based on patients' views, it can be concluded that implementation of SAM seems possible. Plain Language Summary: Research to identify patients' views on Self-administration of Medication during hospitalisation Background: Patient involvement is desired by patients. Nevertheless, currently healthcare providers take over patient's medication management when hospitalised. Capable patients administering their own medication during hospitalisation, known as 'Self-administration of Medication' (SAM) is one possible way to increase patient involvement in hospital care and to improve medication safety. Understanding patients' views on SAM, before its actual practice, could help to successfully implement it. In this research, we aimed to identify and measurepatients' views on SAM,(dis)advantages of and requirements for SAM stated by patients,patients' willingness to self-administrate medication,patients' preferences in medication management during hospitalisation.Methods: Our study consisted of two parts and was conducted among hospitalised adult patients in four Dutch hospitals during December 2018 and March 2019. First, patients were interviewed to identify patients'views on SAM,requirements for SAM.Second, the outcomes of these interviews were used to construct a questionnaire aiming to identify patient'swillingness to self-administrate,preferences for self- or nurse-led medication administration,level of agreement with statements about SAM's (dis)advantages and requirements.Results: Nineteen hospitalised patients were interviewed. Most patients had a positive view on SAM, some doubted the necessity to change nurse-led medication administration. Patients mentioned many advantages of SAM, such as increased patient empowerment and contribution to sustainability. Some patients had concerns about medication safety, for example, risking omissions or double administrations.In total, 234 patients completed the questionnaire. Half (50%) of the patients were willing to self-administer medication. However, only 37% of patients preferred SAM over nurse-led medication administration which indicates that the majority of patients were hesitant to actually self-administer medication. The most important requirements for SAM by patients were, 'I want to be informed before my hospitalisation that I have to bring my own medication' (80% agreed) and 'Healthcare professionals must assess per patient whether the patient is able to manage and use his or her own medication' (74% agreed).Conclusion: Most patients mentioned many advantages and had positive views on SAM. Although half of the patients were willing to perform SAM, most patients did not prefer SAM over nurse-led medication administration. This reservation may be overcome when the stated requirements are met and patients experience SAM when admitted to hospital.

A Serious Puzzle Game to Enhance Adherence to Antirheumatic Drugs in Patients With Rheumatoid Arthritis: Systematic Development Using Intervention Mapping.

BACKGROUND: Patients' implicit attitudes toward medication need and concerns may influence their adherence. Targeting these implicit attitudes by combining game-entertainment with medication-related triggers might improve medication adherence in patients with rheumatoid arthritis (RA). OBJECTIVE: The aim of this study was to describe the systematic development of a serious game to enhance adherence to antirheumatic drugs by using intervention mapping. METHODS: A serious game was developed using the intervention mapping framework guided by a multidisciplinary expert group, which proceeded along 6 steps: (1) exploring the problem by assessing the relationship between medication adherence and implicit attitudes, (2) defining change objectives, (3) selecting evidence-based behavior change techniques that focused on adjusting implicit attitudes, (4) designing the intervention, (5) guaranteeing implementation by focusing on intrinsic motivation, and (6) planning a scientific evaluation. RESULTS: Based on the problem assessment and guided by the Dual-Attitude Model, implicit negative and illness-related attitudes of patients with RA were defined as the main target for the intervention. Consequently, the change objective was "after the intervention, participants have a more positive attitude toward antirheumatic drugs." Attention bias modification, evaluative conditioning, and goal priming were the techniques chosen to implicitly target medication needs. These techniques were redesigned into medication-related triggers and built in the serious puzzle game. Thirty-seven patients with RA tested the game at several stages. Intrinsic motivation was led by the self-determination theory and addressed the 3 needs, that is, competence, autonomy, and relatedness. The intervention will be evaluated in a randomized clinical trial that assesses the effect of playing the serious game on antirheumatic drug adherence. CONCLUSIONS: We systematically developed a serious game app to enhance adherence to antirheumatic drugs among patients with RA by using the intervention mapping framework. This paper could serve as a guideline for other health care providers when developing similar interventions.

Barriers and facilitators for systematically registering adverse drug reactions in electronic health records: a qualitative study with Dutch healthcare professionals.

BACKGROUND: Systematically registering ADRs in electronic health records (EHRs) likely contribute to patient safety as it enables the exchange of drug safety data. Currently, ADRs registrations by healthcare professionals (HCPs) is suboptimal. This study aimed to identify barriers and facilitators perceived by HCPs to register ADRs systematically in EHRs. RESEARCH DESIGN AND METHODS: A qualitative study with individual interviews was conducted among specialist physicians and hospital pharmacists from 10 different Dutch hospitals. A semi-structured interview guide was used to identify experienced barriers and facilitators for systematically registering ADRs. Data was analyzed following thematic analysis. Themes within barriers and facilitators were aligned with the Capability-Opportunity-Motivation-Behavior (COM-B) framework. RESULTS: In total, 16 HCPs were interviewed. Identified barriers were: lack of knowledge to recognize ADRs, time constraints, inadequate IT system, lack of support, stuck in routine, and not recognizing the importance of registering ADRs. Identified facilitators were: enhanced knowledge and awareness of ADRs, functional IT systems, expanding accountability for registration, and motivation toward registering. CONCLUSIONS: Barriers and facilitators for registering spanned all aspects of the COM-B model and occurred in individual, social and environmental domains. Addressing these aspects could improve the registration of ADRs and may contribute to patient safety.

The use of medication adherence guidelines in medication taking behaviour research.

Medication nonadherence continues to be a serious issue in a range of long-term medical conditions and has been studied extensively over the past few decades. However, despite the plethora of research studies on medication adherence, poor methodological rigour in many studies has contributed to limited generalisability of the positive findings, limited impact on patients' medication adherence, and inability to compare between studies. This paper focuses on current guidelines designed specifically for research on medication adherence. It discusses key elements to consider during study design, selection of adherence measurements, and reporting on medication adherence research, to ensure a higher quality of research in medication adherence. Overall, there appears to be variations in adherence terminology reported in the literature despite improvements in defining medication taking behaviour and the availability of taxonomies. In addition, limited guidance exists on how best to measure adherence. Recommendations are provided on appropriate adherence measures for the adherence behaviour being investigated, including careful consideration of adherence concepts, validity of adherence instruments, appropriate instrument selection, definition of nonadherence threshold, and how to report medication adherence. Improving adherence research requires greater clarity and standardisation of descriptions of nonadherence behaviour, increased methodological rigour in study designs, better selection of adherence measurements, and comprehensive reporting.

Application of intervention mapping to develop and evaluate a pharmaceutical discharge letter to improve information transfer between hospital and community pharmacists.

BACKGROUND: Insufficient information transfer is a major barrier in the transition from hospital to home. This study describes the systematic development and evaluation of an intervention to improve medication information transfer between hospital and community pharmacists. OBJECTIVE: To develop and evaluate an intervention to improve the medication information transfer between hospital and community pharmacists based on patients', community and hospital pharmacists' needs. METHODS: The intervention development and evaluation was guided by the six-step Intervention Mapping (IM) approach: (1) needs assessment to identify determinants of the problem, with a scoping review and focus groups with patients and healthcare providers, (2) formulation of intervention objectives with an expert group, (3) inventory of communication models to design the intervention, (4) using literature review and qualitative research with pharmacists and patients to develop the intervention (5) pilot-testing of the intervention in two hospitals, and (6) a qualitative evaluation of the intervention as part of a multicenter before-after study with hospital and community pharmacists. RESULTS: Barriers in the information transfer are mainly time and content related. The intervention was designed to target a complete, accurate and timely medication information transfer between hospital and community pharmacists. A pharmaceutical discharge letter was developed to improve medication information transfer. Hospital and community pharmacists were positive about the usability, content, and comprehensiveness of the pharmaceutical discharge letter, which gave community pharmacists sufficient knowledge about in-hospital medication changes. However, hospital pharmacists reported that it was time-consuming to draft the discharge letter and not always feasible to send it on time. The intervention showed that pharmacists are positive about the usability, content and comprehensiveness. CONCLUSION: This study developed an intervention systematically to improve medication information transfer, consisting of a discharge letter to be used by hospital and community pharmacists supporting continuity of care.

Patient Perspectives on Outcome Domains of Medication Adherence Trials in Inflammatory Arthritis: An International OMERACT Focus Group Study.

OBJECTIVE: To describe the perspectives of patients with inflammatory arthritis (IA) on outcome domains of trials evaluating medication adherence interventions. METHODS: Adult patients (≥ 18 yrs) with IA taking disease-modifying antirheumatic drugs from centers across Australia, Canada, and the Netherlands participated in 6 focus groups to discuss outcome domains that they consider important when participating in medication adherence trials. We analyzed the transcripts using inductive thematic analysis. RESULTS: Of the 38 participants, 23 (61%) had rheumatoid arthritis and 21 (55%) were female. The mean age was 57.3 ± (SD 15.0) years. Improved outcome domains that patients wanted from participating in an adherence trial were categorized into 5 types: medication adherence, adherence-related factors (supporting adherence; e.g., medication knowledge), pathophysiology (e.g., physical functioning), life impact (e.g., ability to work), and economic impact (e.g., productivity loss). Three overarching themes reflecting why these outcome domains matter to patients were identified: how taking medications could improve patients' emotional and physical fitness to maintain their social function; how improving knowledge and confidence in self-management increases patients' trust and motivation to take medications as agreed with minimal risk of harms; and how respect and reassurance, reflecting health care that values patients' opinions and is sensitive to patients' individual goals, could improve medication-taking behavior. CONCLUSION: Patients value various outcome domains related to their overall well-being, confidence in medication use, and patient-healthcare provider relationships to be evaluated in future adherence trials.

Effect of Interactive eHealth Interventions on Improving Medication Adherence in Adults With Long-Term Medication: Systematic Review.

BACKGROUND: Medication nonadherence leads to suboptimal treatment outcomes, making it a major priority in health care. eHealth provides an opportunity to offer medication adherence interventions with minimal effort from health care providers whose time and resources are limited. OBJECTIVE: The aim of this systematic review is twofold: (1) to evaluate effectiveness of recently developed and tested interactive eHealth (including mHealth) interventions on medication adherence in adult patients using long-term medication and (2) to describe strategies among effective interventions. METHODS: MEDLINE, EMBASE, Cochrane Library, PsycINFO, and Web of Science were systematically searched from January 2014 to July 2019 as well as reference lists and citations of included articles. Eligible studies fulfilled the following inclusion criteria: (1) randomized controlled trial with a usual care control group; (2) a total sample size of at least 50 adult patients using long-term medication; (3) applying an interactive eHealth intervention aimed at the patient or patient's caregiver; and (4) medication adherence as primary outcome. Methodologic quality was assessed using the Cochrane risk of bias tool. Selection and quality assessment of studies were performed by 2 researchers (BP and BvdB or JV) independently. A best evidence synthesis was performed according to the Cochrane Back Review Group. RESULTS: Of the 9047 records screened, 22 randomized clinical trials were included reporting on 29 interventions. Most (21/29, 72%) interventions specified using a (mobile) phone for calling, SMS text messaging, or mobile apps. A majority of all interactive interventions (17/29) had a statistically significant effect on medication adherence (P<.05). Of these interventions, 9 had at least a small effect size (Cohen d ≥ 0.2) and 3 showed strong odds for becoming adherent in the intervention group (odds ratio > 2.0). Our best evidence synthesis provided strong evidence for a positive effect of interventions using SMS text messages or interactive voice response, mobile app, and calls as mode of providing adherence tele-feedback. Intervention strategies "to teach medication management skills," "to improve health care quality by coordinating medication adherence care between professionals," and "to facilitate communication or decision making between patients and health care providers" also showed strong evidence for a positive effect. CONCLUSIONS: Overall, this review supports the hypothesis that interactive eHealth interventions can be effective in improving medication adherence. Intervention strategies that improve patients' treatment involvement and their medication management skills are most promising and should be considered for implementation in practice.