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Adverse drug events, Community dwelling, Older adult, General Practice
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Waldron C, Hughes J, Wallace E et al. Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.12688/hrbopenres.13580.1)
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Systematic Review
Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review
[version 1; peer review: 1 approved, 1 approved with reservations]
PUBLISHED 21 Jul 2022
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Ageing Populations collection.
Abstract
Corresponding author:
Catherine Waldron
Competing interests:
No competing interests were disclosed.
Grant information:
HRB research leader award (RLA-15-1579)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2022 Waldron C et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Waldron C, Hughes J, Wallace E et al. Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.12688/hrbopenres.13580.1)
First published: 21 Jul 2022, 5:53 (https://doi.org/10.12688/hrbopenres.13580.1)
Latest published: 28 Dec 2023, 5:53 (https://doi.org/10.12688/hrbopenres.13580.2)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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of this article available.
Introduction
Adverse drug events (ADEs) are defined as ‘harmful unintended consequences of medication usage including medical errors, side effects, adverse drug reactions (ADR) and overdoses’1,2. An alternative definition is “any untoward occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relation to the treatment”, which acknowledges that not all events are necessarily drug-related and that it is not always possible to ascribe causality3. Polypharmacy is most commonly defined as the concurrent use of ≥5 drugs4–6, which may contribute to increased levels of potentially inappropriate prescribing (PIP)7–9.
Older adults in Ireland are at risk of ADEs due in part to multimorbidity and the increasing rates of polypharmacy in this age group rising from 17.8% to 82.6% among those aged ≥65 years over the past 25 years10. Rates of hospital admissions due to ADR in Ireland for this population were 8.8% of which 57% were considered potentially avoidable11. These rates are similar to other international studies12.
The likelihood of an ADE increases significantly with increasing exposure to PIP and contributes to the economic burden of healthcare9. The number of repeat prescriptions and patients’ adherence to their medications have also been shown to be significantly associated with adverse health outcomes13,14.
Consideration of strategies that may reduce the risk of ADEs is important. These include regular review of patients’ medical conditions, medications, effects of treatment in conjunction with the use of World Health Organisation prescribing indicators, use of alert tools within electronic health records (EHR) and clear patient communication in relation to the benefits and risks and importance of correct adherence to the medication are all means used to prevent ADEs15. Another factor that may increase the risk of ADEs include a previous history of ADEs so clear documentation of such events in the patient record is important.
However, interventions to reduce the incidence of ADEs, or their causes, in older patients in primary care settings have had little or no success; a number of systematic reviews on the topic concluded that new approaches were required to reduce ADEs in older adults and patient‐related outcomes should be assessed15–17. In order to develop a better understanding of how, why, when, where and for whom these interventions are effective or not, a closer examination of the data is required. A realist approach is particularly suited to the synthesis of evidence about complex interventions as it uses a different lens to examine why and how the interventions are supposed to work rather than if, they worked18–22. Using a diverse range of evidence, including theoretical and empirical literature and involving key stakeholders in the process will increase the clarity and understanding of why an intervention succeeds or not.
Realist reviews aim to identify what it is about interventions that generate change (i.e., the mechanisms) and under which circumstances the mechanisms are triggered (i.e., the contexts), which result in changes in the behaviour of the participants of the intervention (i.e., the outcome). These three elements, i) context, ii) mechanism and iii) outcome, are presented together as a statement or theory which attempts to describe what needs to happen for an intervention to work23. Mechanisms can be divided into resource mechanisms and reasoning mechanisms. Resource mechanisms tend to be more concrete i.e. environmental, organisational or political, while reasoning mechanisms are more invisible responses to the context i.e. trust or confidence. We have differentiated between the two in this review where possible. By differentiating between them, it is hoped that the necessary resources can be more clearly identified.
The products of realist reviews are theories, often produced in the form of “if …. then” statements developed from one or more Context Mechanism Outcome Configurations (CMOCs) found in the available data that outlines the individual or collective responses to intervention strategies and resources. This methodology is supported by methodological guidance, publication standards and training materials for realist reviews24.
A rapid realist review (RRR) is a more focused and accelerated version of a full realist review which aims to produce theories in a time-sensitive way and that is useful to a specific audience about emerging issues, while preserving the core elements of realist methodology25.
The aim of this RRR is to identify and examine the contexts and mechanisms that play a role in preventing or increasing outcomes relevant to the reduction of ADEs in community dwelling older adults (CDOA) in the general practice setting that could inform the development of a successful intervention in the Irish community setting. Specifically, we examined evidence in the literature in relation to:
1. The mechanisms that cause GPs and their community dwelling older patients to respond to interventions to reduce the incidence of ADEs.
2. The contexts believed to influence whether different mechanisms produce their intended outcomes.
3. The circumstances in which interventions in GP practices to reduce ADEs in community dwelling older adults are most likely to be effective.
Methods
The protocol for this RRR was published on PROSPERO (CRD4202127757) in October 2021.
There are several stages to a RRR, some are similar to a conventional systematic review, but others are quite different (Table 1)24. As the process is an iterative one, the steps may not move in a linear fashion, at times steps were retraced or revisited.
Table 1. Stages in a Rapid Realist Review.
1. Gathering an expert research team
The expert team included two authors from the 2020 systematic review of interventions to reduce ADE-related outcomes in older adults17, with expertise in data science and population health (KB, CC), an academic general practitioner (EW), a healthcare professional with a background in Realist methodology (CW), a pharmacist and PhD student (JH), and an information specialist (PM).
2. Developing the Candidate Theories (CTs)
Candidate theories were developed in relation to how an intervention is expected to work based on the research teams’ assumptions, experience and knowledge of the field and on a brief search for evidence from recent literature. The research team developed eight candidate theories.
3. Reference Panel feedback and revision of the CTs
These candidate theories were reviewed by a reference panel of general practitioners (GP) in Ireland providing practical feedback using their local contextual knowledge. The reference panel completed an online survey on how well the theories were understood, how relevant they considered them and how feasible they would be to implement in an Irish setting (Extended Data File 1). The survey was emailed to academic GP colleagues, posted on Twitter with tags to GP organisations in Ireland and emailed to GP members of the Primary Care Clinical Trials Network Ireland group.
Details of the findings of the Reference Panel Survey are in Extended Data File 2. In summary, two of the eight theories were amalgamated, as they were judged to have overlapping themes: communication, providing information and shared decision-making. A theory relating to home visits was excluded as the respondents indicated that although home visits could be helpful, they were impractical in practice. The candidate theories were revised based on this feedback. The revised candidate theories are presented in Table 2. The six revised candidate theories formed the basis for the search strategy for the review.
Table 2. Revised candidate theories.
4. Developing and undertaking the search strategy
Six electronic databases were searched (Ovid Medline, Embase, CINAHL, Web of Science, Cochrane Library and Lens). Four broad search strings were used, older adult, adverse drug event, primary healthcare and community dwelling. Details of the search terms and findings for each database are outlined in Extended Data File 3. Filters included a date limitation (Jan 2011 – September 2021) and articles in the English language only.
5. Screening, selecting and appraising of articles
The theories influenced the inclusion and exclusion criteria for the RRR search. A pilot screening of ten articles allowed some clarifications to be made to the inclusion and exclusion criteria. Conflicts were resolved by discussion and input from a third reviewer (KB). Table 3 outlines the broad inclusion and exclusion criteria used. A detailed inclusion and exclusion criteria document was prepared for the two reviewers (CW, JH) (Extended Data File 4). Following the screening by title and abstract, a full text reading of the included articles was undertaken by one reviewer (CW). A second reviewer (JH) reviewed 20% of the excluded articles.
Table 3. Broad inclusion and exclusion criteria.
Quality assessment (QA) of realist data is considered under the headings of relevance, rigour and richness26,27, defined in Table 4. A scoring system was developed to rate the articles.
Table 4. Quality Assessment definitions and scoring system.
Ten percent of the articles included for full text review had QA by two reviewers independently and disagreements were discussed and resolved (CW, JH). The refined QA process was applied by one reviewer (CW) to the remaining articles. Relevance, rigour and richness was scored for those articles that met all inclusion criteria at the full text stage review. Richness was reassessed at the data extraction stage.
The richness assessment at full text reading ensured only those with the most potential for providing rich data were included in the RRR. Only those articles with a score of three or four for richness were included.
6. Extraction of the data
The included articles were imported into NVivo© and data extraction was carried out using this software by CW. Retroductive and abductive reasoning are used to make inferences in relation to how the data might be configured to explain how, why and in what context an intervention might work. The candidate theories formed the basis for the extraction process; sub themes, contexts, mechanisms, outcomes and some intervention details were extracted under a selection of codes. These codes provided an extraction template and were modified and developed throughout the process following familiarisation with the data. The final codebook can be found in Extended Data File 5.
Results
The details of the search and screening processes and findings are presented in the Prisma Flow Chart (Figure 1). After removal of duplicates, 606 articles and an additional 27 articles from other sources were screened for relevance by one reviewer (N=633) (CW). Of these, 145 broadly relevant articles were more carefully screened independently by two reviewers (CW and JH). Eighty full texts were assessed for eligibility using the agreed inclusion and exclusion criteria (Extended Data File 5). Twenty-seven of these were included in the final review. Forward chasing added a further five articles reporting more details on already included interventions. In addition, a selection of Policy or Guidance documents on medication safety, polypharmacy or multimorbidity, which were identified by the team as being relevant to the review (N=13), were also included. The final number of articles/documents included in this RRR was 45 (Extended Data File 6).
Figure 1. Prisma flow chart.
Of the 45 articles, 13 were policy or guidance documents from Ireland, the UK and the World Health Organisation (WHO), published between 2015 and 202028–40, of which only two were specifically targeting older people35,40. The remaining 32 articles were published between 2007 and 2020 in Australia (N=5), Canada (N=1), Germany (N=7), Ireland (N=9), Switzerland (N=2), Thailand (N=1), The Netherlands (N=1), UK (N=3) and USA (N=3). Eleven articles reported on the design, implementation or evaluation of six different interventions. The remaining 21 articles were qualitative interviews, observational studies or expert opinion pieces.
Six articles included patients under 65 years as they were considered to contain relevant rich realist data. Of these, two included patients ≥18 years in relation to their experiences of adverse drug reactions41 or polypharmacy42, another three included patients ≥50 years43–45 and one included patients ≥60 years46. Seven included patients who were ≥65 years47–53, five included patients who were ≥70 years54–59, three included patients who were ≥75 years60–62, one included patients who were ≥85 years63. Of the remaining nine articles, four described the patients as living with multimorbidity64–67, four as elderly or old68–71 and one did not provide details72.
7. Analysis and synthesis of the findings
Data were extracted relevant to the candidate theories under a series of iteratively developed sub-themes. The sub-themes, analysed as the interaction of specific contexts and mechanisms, were perceived to have a positive or negative impact on outcomes of relevance to reducing ADEs for CDOA in the GP setting. The analysis allowed the development of Context Mechanism Outcome Configurations (CMOCs) from the data to test the candidate theories to determine if they were supported, rejected or if any refinements were required based on the data. The resulting final theories are evidence-based, and intended to provide guidance in relation to the development of relevant interventions in the Irish GP setting. The CMOCs can be used to supplement their related theories in specific contexts. Each of the six theories, the analysis and related CMOCs are outlined below. Quotations from the articles to support the themes are presented in Table 5.
Table 5. Quotations from the articles to support the themes.
Theory 1: Engagement of GPs with interventions
This theory focused on the challenges of engaging GPs with any planned intervention to reduce the levels of ADEs in CDOA. We hypothesised that the competing demands on their time, the complexity of their older patients, and the challenges associated with changing or deprescribing medications, must be addressed in order for the intervention to be accepted and implemented by them in a sustainable way.
Facilitators
Involving GPs in the design and implementation of interventions. It was generally accepted that involving GPs in the content and development of the intervention aided engagement and improved their practical implementation by identifying and minimising potential barriers45,56,67,69,73,74. The use of qualitative methods were thought to be useful at the development stage, many studies described focus groups and individual interviews with key stakeholders.
Having a plan that outlined how to implement an intervention helped. However, it was important that it should not impact excessively on existing processes in the practice or how GPs engage with their patients. Providing GPs with choices and options in relation to how they could adapt/tailor the intervention to suit their practice setting was highlighted.
Feedback and support. Receiving follow-up support, seeing the benefits of their efforts, being given the opportunity to give and receive feedback were all seen as useful strategies in relation to successful implementation and sustainability of interventions.
Challenges
Research element. The research element of interventions resulted in additional pressures on GPs and the research team in relation to patient enrolment and consent.
Beyond the design and implementation of interventions, other contexts that challenged the success of interventions were identified; how these challenges could be overcome were suggested or applied in the interventions. Some of these contexts are outlined below.
Time. A lack of time for medication review, for undertaking shared decision-making or for fully understanding the patient’s perspectives, was a consistent theme in most of the articles30,32,34,39,42–47,49,51–54,56,58,63,65–67,69,72,73,75. Facilitators to make the most of the GPs’ time were identified from these articles and are outlined in Table 6.
Table 6. Facilitators to making the most of GPs time.
Case complexity. A number of the studies reported that GPs are often not in agreement with each other or with the guidelines in relation to the medications that are appropriate to prescribe for older patients with multimorbidity. There was evidence that GPs acknowledged or recognised that potentially inappropriate prescribing occurs in practice43,57. However, regardless of whether this awareness of PIP was raised following an intervention, or already existed, GPs did not believe there was always a need for change. The GP's in-depth knowledge of the patient and their consideration of the importance of the GP-patient relationship supported their confidence in their individual decisions. GPs were confident about making "informed decisions" to use medications that had potentially adverse effects once these were balanced against treatment benefits, in the patient’s best interest53,61,72.
Professional isolation. Professional isolation was identified as a factor for GPs. To address this, using existing relationships for example, informal peer support and relationships with Community Pharmacists could be means to providing support. Collaboration with Community Pharmacists and other GPs (which was the limited focus of this RRR), not only for their additional knowledge, but also to 'share the onus of responsibility', were identified as supportive strategies65,67,75.
Incentivisation. Structured medicines reviews (SMRs) with a focus on optimising appropriate polypharmacy may not be considered core work by Irish GPs56. Other international studies also reflected this sentiment52,72. Reimbursement systems that include SMRs, which acknowledged the level of expertise and time involved, or external monitoring of patient medications by pharmacists, were identified as possible incentives56,65.
Other contexts that may influence the engagement of GPs in interventions that aim to reduce ADEs will be covered under the other more specific theories.
The data support Theory 1 and provide some individual Context – Mechanism - Outcome configurations (CMOCs) that could be applied to the design, implementation and sustainability of interventions to engage GPs in the reduction of ADEs in CDOAs in the Irish GP setting (Table 7).
Table 7. Context-Mechanism-Outcome Configurations (CMOCs).
Theory 2: Health and clinical guidelines or policies
This theory considers the relevance of medication safety or prescribing policy or guidelines for older adults with multimorbidity or polypharmacy. We theorised that if guidelines or policy documents considered multimorbidity, polypharmacy, and the commonly encountered adverse drug events that occur in older adults, then they would be more relevant to GPs who would then be more likely to use them in practice thereby reducing the risk of ADEs.
Relevance
Clinical guidelines tend to focus on single diseases and usually exclude older populations or those with multimorbidity. When guidelines do refer to older patients, they tend to be general statements about considering individual drug characteristics and age-adjusted doses of medications. Hughes et al in his 2013 review of UK NICE clinical guidelines stated that one of the major challenges facing clinical guidelines is accounting for multimorbidity64. There was consensus in the articles reviewed that current clinical guidelines with their single disease focus act as a driver for polypharmacy in older multimorbid patients and do not providing guidance on how best to prioritise recommendations30,58,63,64,66,71,75.
The lack of relevance of clinical guidelines for older patients with multimorbidity was shown to have negatively influenced the level of proactive involvement of GPs in relation to managing the medications of these patients67.
However, more recently a NICE clinical guideline focusing on multimorbidity has highlighted issues to consider when caring for patients with multimorbidity and includes risk factors associated with the highest risk of experiencing ADEs. These patients could be targeted for structured medication reviews in general practice34.
Professional judgement
A number of articles addressed the dilemma for GPs when confronted with clinical guidelines that do not work for their patient53,61,63,66,69,71,72,75. The GPs used their judgement and accepted less stringent levels of disease control, stratified risk and benefits for individual diseases, prioritised the patients’ quality of life and preferences or modify guidelines in anticipation of adverse effects.
GPs felt justified in using their clinical judgement stating reasons such as the exclusion of older patients or those with multimorbidity in clinical trials underpinning clinical guidelines and the cumulative risk of polypharmacy if all guideline recommendations were followed. In addition, GPs used clinical and laboratory monitoring (e.g. blood tests, asking patients about side effects) as a means to support their decisions.
Sinnott et al. (2015) highlighted the relative autonomy experienced by GPs in the Irish healthcare system with respect to chronic disease management, which allowed them to use their judgement to a greater extent than GPs in other countries with tighter frameworks such as the UK66.
Using policy and guidelines in practice
Table 8 outlines what the data suggest in relation to the content of clinical guidelines and policy documents and the contexts that may encourage GPs caring for CDOA to use them in practice.
Table 8. Recommendations for contents and implementation of guideline and policy documents.
Irish guidelines, policies and strategies
GPs in Ireland must follow the legislative requirements, local and national clinical guidelines, and professional standards when prescribing medications.
The Health Information and Quality Authority (HIQA) and The National Clinical Effectiveness Committee (NCEC) provide the framework for developing these clinical guidelines. The various disease specific guidelines provide Summary of recommendations and Summary of Good Practice Points documents, which are available to GPs, although they do not target them specifically; they acknowledge the professional judgement of GPs when the individual guideline recommendations are not appropriate or are declined by an individual patient.
The HIQA “Guidance on Medicines management” focuses predominately on patients in residential care, but is relevant to patients in a community setting28. It recommends medicines management, which includes assessing, supplying, prescribing, dispensing, administering, reviewing and assisting people with their medicines, to reduce ADEs.
The Irish College of General Practitioners’ Quality and Safety in Practice Committee produces quick reference guidance, which can be accessed by their members. In “Medication Review – A Guide for GPs” they recommend that high-risk patients are identified and offered regular medication reviews. They also highlight the need for adequate resourcing to support the conduct of structured medication reviews in general practice30.
The recently published National Framework for the Integrated Prevention and Management of Chronic Disease in Ireland 2020–2025 strategy is likely to have a significant impact on the workload of GPs in the community29.
One element already being rolled out in Ireland is the Health Services Executive (HSE) Structured Chronic Disease Management (CDM) Programme, currently available to patients eligible for free GP care through a general medical services card who meet other criteria e.g. certain chronic medical conditions e.g. Type 2 diabetes, asthma, cardiovascular disease. A clinical data repository is proposed in the National Framework, that will gather information electronically on demographics, diagnoses, clinical examination results, diagnostic results and life-style risk factors on patients from GPs.
This National framework, if successfully implemented, goes some way to providing the elements outlined from the data in relation to the content of guidelines and the contexts that may encourage GPs caring for CDOA to use them in practice if they are properly resourced. To account for multimorbidity and polypharmacy, the theory might be amended to include respect for the GPs’ professional judgement, adequate resourcing to support the conduct of structured medication reviews, which are often complex and time-consuming and an electronic system of data collection and audit/feedback. The CMOCs for this theory are outlined in Table 6.
Theory 3: Continuity of care
This theory focused on the relationship between the patient and the GP and continuity of care. It hypothesised that when CDOA have continuity of care, they feel more understood and supported and have increased trust in their GP, the GP will be more familiar with their patient’s individual needs and confident when providing care thus improving medication management and reducing the risk of ADEs.
A smaller number of articles addressed the issue of continuity of care; while they all acknowledged its importance, most also acknowledged the changing work environment that has reduced the level of continuity and increased the risk of fragmentation of care52,55,65,73,75.
Improving the level and quality of communication between healthcare professionals and assigning a specific GP to patients identified as complex were the limited proposed solutions to this issue52. The National Framework strategy aims to support improved sharing of patient health records and speaks about co-ordination of care but does not specifically refer to continuity of care.
In summary, while continuity of care was acknowledged as being important, there was insufficient evidence in the included articles to support or reject this theory.
Theory 4: Health information technology
This theory focused on the use of health information technology (HIT) to manage medications. We also collected data in relation to the use of any other forms of technology likely to have an impact on patient care and ADEs.
We hypothesised that if HIT, including electronic summary care medical records and clinically useful medication alert systems, are available to GPs and are easy to use then GPs will feel more supported, informed and confident when prescribing or changing medications, thereby reducing the risk of ADEs.
4.1 Use of technology
Use of technology in general was felt to be a positive addition to improving medication safety, however the data related to its proposed use in the future rather than any current or past experience with it33,52.
4.2 Alert tools
Most of the data gathered from the included articles related to the use of medication alert systems42–44,47,51–54,56,61,63,67,69,70,73. When using an electronic alert system it was considered important to have it integrated into the general practice software for ease of use. Commonly handheld computers or tablets were used due to their mobility, robustness, simplicity of use, and low needs for technical support44,70. GPs used electronic and hardcopy versions of the tools either alone or together.
It was acknowledged that the alert tool needed to be specific to the country in which it was being used due to country-specific differences with respect to drug approval, prescribing practices, and treatment guidelines53,54. However, even when considerable effort was put into developing a specific tool for a specific setting, this did not guarantee successful implementation57. Some level of frustration and confusion was expressed by researchers attempting to address the multiple barriers to their use, as their interventions failed to show impact57,63.
GPs were often sceptical in relation to the value of alert tools. Reasons for the scepticism included: tools not considering multimorbidity or polypharmacy, not designed for use with older patients, not easily used in daily practice, creating too many irrelevant alerts, too time consuming or not trusted to be up to date35,44,47,53,61,70.
Positive features that were identified or suggested in relation to making alert tools more acceptable in practice included: focusing on a select number of high-risk drugs, provision of clinical validation and intelligent alternative recommendations for alerts, allowing for clinical judgement, acknowledging the complexity of prescribing for older adults, allowing for patients’ preference, provision of training to ensure correct use of the system, understanding of its limitations and providing reminders to review existing medications or follow-up on pathology35,51–53,56,61,65,70,73.
In summary, there were limited data in relation to the use of electronic summary care records to reduce ADEs for CDOA. There was some evidence in relation to the use of alert tools. However, although a number of articles reported on interventions that had attempted to addresses the issues identified in our theory, accessibility and ease of use of alert tools, there appeared to be many other factors that needed to be taken into account. Training and building trust in the system, providing alternative recommendations, acknowledging the complexities and personal choices of older patients and the judgement of GPs are contexts and mechanisms that would need to be added to this theory and a new search for this specific data undertaken.
Theory 5: Shared decision making
Shared decision-making (SDM) involves two-way communication between GPs and their patients. GPs share the best available evidence to patients and their carers so that they can consider all the options available to make informed decisions regarding their healthcare. It often includes medication review, deprescribing and discussions around adherence to recommendations37.
This theory considered the contexts around SDM and what influence they have on its success. We examined evidence to support or reject the theory that if GPs communicate effectively, engage and support their patients and/ or carers in SDM, there will be increased mutual trust and understanding about their illnesses and medications and patients will feel empowered, thereby reducing the risk of ADEs. All but four of the included articles provide data relating to this theory28,31,47,64. The contexts relevant to GPs and patients are outlined separately.
GPs perspectives
Training and skills in SDM. It was recognised that GPs required SDM training focusing on eliciting patient preferences, using decision-making tools, incorporating SDM into routine practice, communicating risks and benefits of treatments, broaching and discussing care plans, quality of life and end of life issues33,37,44,53,71.
The types of training described included role-play, emphasis on practical skills, the opportunity to challenge and discuss embedded attitudes, online courses and the use of peer support37,65,67.
Facilitators. One facilitator identified to support the implementation of SDM in general practice included having it as a policy recommendation; making it routine practice, such as the “no decision about me, without me” strategy in the UK33.
Providing GPs with the opportunities to experience SDM and receive affirmation of its usefulness and effectiveness had the potential to increase engagement in the process, provide empowerment, encouragement, motivation and build confidence and competence54.
A positive relationship between the GP and their patient and the resulting mutual trust between them was identified by many as being a major facilitator for SDM55,61,62,65,66.
The GP’s trust in the patient related to their belief in the accuracy of the information the patients communicated to them, in relation to symptoms, adherence etc. and the patient’s ability to understand the information they were sharing with them, fearing the information would only serve to confuse and worry them30,40,44
Challenges. The main challenge for implementing SDM identified in the articles was the time consuming element of SDM in an environment where consultation times were short, the workload extensive and, as already outlined in Theory 1 in relation to SMR, there was a lack of incentivisation30,49,54,57.
Some of the suggestions for overcoming this challenge included identifying those patients most at risk or adopting extended consultations for particularly complex patients30,34,38,44,51,75. The complexities of the patient, of prescribing and managing third party prescriptions, left GPs feeling overwhelmed, frustrated and lacking in confidence in relation to SDM, and its associated elements of medication review and deprescribing45,49,57,58,63.
Patient perspectives
Patient knowledge/education. The patient's awareness of and level of interest in their medications, how to use them and treatment options varied and was influenced by their level of polypharmacy and their need for the support of others50,52,59,60.
Methods to provide information to patients included information leaflets, use of technology; patient friendly interactive training tools or’ serious gaming’ approaches and posters to act as reminders about medication use. There were mixed results in relation to their use. One intervention using technology had referenced research supporting the use of iPads/tablets for patients with dementia but found the patients in their study were unable to use them43–45. Information leaflets were seen as useful by the GPs but not always valued by patients44,54.
Providing health education to patients so that they can play their role in SDM may require structural changes to the health services in relation to funding and access29,37.
Patient preferences. In general, patients regarded their Quality of Life (QoL) as being more important than mortality69. Patients’ decisions regarding their treatment was influenced by their emotions, treatment goals and willingness to experiment. Patients’ willingness, and ability to be involved in decision making varied widely in the included articles29,30,32,35,37,40,54,69,71.
This theory focused on the role of the GP in SDM process. However, the data suggest that for SDM to be successful, the role of the patient must be equally supported.
The theory should be amended thus; if GPs and their patients and/ or carers are supported to engage and communicate effectively in SDM, there will be increased mutual trust, empowerment, awareness and understanding about their illnesses and medications, thereby reducing the risk of ADEs. The CMOCs for this theory are outlined in Table 6.
Theory 6: Collaboration with community pharmacists
This theory focused on collaboration with Community Pharmacists only. It proposed that when GPs and pharmacists in primary care work together when caring for CDOA with polypharmacy, GPs will feel more supported, aware and confident in relation to their patients’ individual health needs resulting in more appropriate prescribing, thereby reducing the risk of ADEs.
Facilitators
Respect. The data showed that, in general, GPs valued and respected the input of pharmacists for medication review or advice in relation to prescribing43,62,65,70,71,75. This existing positive perception is likely to enhance any collaboration between them.
Supportive relationships. Developing and maintaining a positive relationship between the GP and the community pharmacist was regarded as an important prerequisite to collaboration, this included a willingness to share patient information. It was also identified as a means to reduce the sense of isolation felt by GPs and a way to share the responsibility of caring for complex patients56,57,62,67. This collaboration was perceived to facilitate patient centred care and medication management, and to reduce fragmentation of care43,44,46,52,62,65,73.
Patient trust. Patients were most likely to ask either their GP or their pharmacist if they needed information or had concerns about their medicines. They trusted and had generally positive relationships with their pharmacists41,55.
Challenges
Responsibility. A lack of clarity in relation to roles and responsibilities for medication management, particularly because of fragmentation or lack of continuity of care was reported in UK settings and identified as a potential gap in the integrated care process52. Irish GPs have also indicated that they do not consider SMR to be their core responsibility56.
Workload. The existing workload of community pharmacists may limit the role they can currently play49,67.
Collaboration in the Irish setting. While existing Irish policy, guidance and strategy documents acknowledge the importance of collaboration in general and specifically between GPs and pharmacists, there is currently no formal arrangement and existing shortages of community pharmacists limit the impact of informal collaboration29,31,34,67. Research is required in the Irish setting to provide further evidence.
The data support this theory in relation to positive and respectful relationships and providing support and increased drug knowledge to GPs. However, a number of barriers must be surmounted to facilitate a more formal and structured approach to medicines management between GPs and pharmacists in the community in the Irish setting. There is a need to identify which HCP is responsible for conducting a structured medication review, with sufficient resourcing to support this, and improved communication and HIT must all be in place before this collaboration can be included in any future intervention to reduce ADEs for CDOA. For this reason, the theory was rejected by the team.
Discussion
Three theories were supported by data (Theory 1, Theory 2, and Theory 5), one theory was supported to some extent (Theory 6) and two theories lacked sufficient data to make any firm conclusions (Theory 3 and Theory 4). The theories, relating to GP engagement in interventions (Theory 1), relevance of health and clinical guidelines or policies (Theory T2), and shared decision-making (Theory 5), provided some context-mechanism-outcome configurations that can be used to guide future interventions to reduce ADEs for CDOA in an Irish setting by highlighting the facilitators and barriers to success.
Involving GPs in the design and implementation of interventions that target them was identified as a facilitator by ensuring that the intervention was relevant and easy to apply in practice (Theory 1). However, insufficient internal or external support in the form of health policy or legislation, funding, incentivisation, feedback and follow-up were likely to hamper success. A SR of Australian GPs involvement in interventions to improve patient management by Bernardes et al. (2019) reported on the challenges of engaging GPs in interventions and concluded similarly that communicating directly with GPs, exchanging ideas and ensuring that the topics were relevant and useful to them, improved their engagement. Feedback was also identified as useful76.
Clinical guidelines and policies that account for multimorbidity and polypharmacy, respect GPs’ professional judgement and that have adequately resourced and monitored recommendations, are more likely to be used by GPs (Theory 2). Recent Irish policy and guidelines, such as the National Framework for the Integrated Prevention and Management of Chronic Disease in Ireland 2020–2025 strategy, if successfully implemented, could support these requirements. A number of other studies have identified challenges in relation to the use of clinical guidelines by GPs; mistrust, being overloaded with information, lack of respect for their expertise and loss of autonomy to make their own decisions, as barriers, but acknowledge that knowing recommended practice is helpful76,77.
The role of both the GP and the patient in the SDM process must be equally supported for it to have an impact on reducing ADEs in the community (Theory 5). The need for tailored training for both stakeholders to acquire the skills for this complex interaction was identified, as were the challenges already identified in Theory 1 and Theory 2. The complexity of learning and using the skills of SDM for both the healthcare professional and the patient has been the topic of a number of recent publications, these publications are likely to assist in understanding what is required to support GPs and their patients in this process78.
Theory 1 and Theory 2 are dependent on each other, Theory 5 could be tested independently, once the contexts identified in Theory 1 and Theory 2 are in place (Figure 2).
Figure 2. Summary “If..then” statements.
Collaboration with community pharmacists was supported to some extent by the data (Theory 6), but existing barriers in the Irish settings made it impractical. There is currently no formal arrangement in Ireland for this type of collaboration and existing shortages of community pharmacists limit the impact of informal collaboration. The role of clinical pharmacists as part of the primary care team, similar to those introduced in the UK, and tested in Ireland in a pilot study shows some promise79.
There were insufficient data for two theories to make any firm conclusions (Theory 3 and Theory 4). There were insufficient data in relation to the impact of continuity of care for either the patient or their GP in relation to ADEs (Theory 3). In addition, the changing work environment for GPs in the community was highlighted, resulting in reduced levels of continuity of care.
Theory 4 focused on electronic care records and medication alert systems and evidence was in relation to the future rather than any current or past experience. There was some evidence in relation to the use of alert tools. Our theory focused on the accessibility and ease of use of alert tools; however, the data suggested that many other factors need to be taken into account including access to training, building trust in the system, providing alternative recommendations, acknowledging the complexities and personal choices of older patients and the judgement of GPs. A complete revision of this theory and new search for relevant data is proposed based on these findings.
Strengths and limitations
The strength of this review is the additional insight it has provided in relation to past interventions, and their application specifically to an Irish context based on interventions limited to countries where GPs have gate-keeping functions. The date limitation (2011 – 2021) has also ensured the findings were relevant to current practice.
Limitations to this review are that the resulting final theories relied on the articles identified in our search; there was a lack of evidence to assess two theories. This may imply a lack of data on these topics or that a more in-depth search of the literature is required. The time limitations for this rapid review also meant that there was only one review for some of the screening and full text review of the articles. Quality appraisal was based on the research teams’ subjective judgements. In realist reviews, reasoning mechanisms are identified that might trigger positive or negative actions within the contexts. In reporting the CMOCs in this review, the mechanisms are presented in their positive form, but they could equally be working in their negative form if the resource mechanisms are not in place.
The range of outcomes measured in the interventions tended towards the conventional, i.e. changes to numbers of hospitalisations or medicines prescribed. Patient-reported and system-related outcomes provided greater opportunity to understand what works for whom and under what circumstances, how and why.
Implications for practice
In order to improve the success of interventions to reduce ADEs for CDOA GPs must be involved in the design and implementation of the interventions to ensure their engagement. The interventions must be relevant and easily applied in practice, supported by national policy and be adequately resourced. In addition, tailored education for both GPs and patients is required to support SDM.
Conclusion
Three theories with their related CMOCs, can be applied to the design and implementation of future interventions to reduce ADEs for CDOA in the Irish GP setting, based on this RRR. Future research is required to test our theories within an intervention.
Data availability
Extended data
Zenodo: Realist-Review-of-ADEs-in-CDOA, https://doi.org/10.5281/zenodo.680344880.
This project contains the following extended data:
- Extended Data File1: Reference Panel Survey.pdf
- Extended Data File 2: Results of the Reference Panel Survey.pdf
- Extended Data File 3: Search Strings for Six Databases and Findings.pdf
- Extended Data File 4: Inclusion and Exclusion Criteria Guidelines for Reviewers.pdf
- Extended Data File 5: Full text records sought for retrieval and assessed for eligibility
- Extended Data File 6: Included articles and policy documents with characteristics and quality assessment ratings
- Extended Data File 7: NVivo Code Book
Reporting guidelines
Zenodo: Extended Data File 8: PRISMA checklist ‘Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults; a rapid realist review’, https://doi.org/10.5281/zenodo.680344880.
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
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Waldron C, Hughes J, Wallace E et al. Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.12688/hrbopenres.13580.1)
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PUBLISHED 21 Jul 2022
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Muth C. Reviewer Report For: Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.21956/hrbopenres.14833.r35047)
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Reviewer Report 21 Jul 2023
Christiane Muth,
Bielefeld University, Bielefeld, Germany
Approved with Reservations
VIEWS 46
Summary: The authors present a rapid realist review (RRR) with the aim to identify and examine the contexts and mechanisms that play a role in reducing adverse drug events (ADE) in community dwelling older adults (CDOA) in the GP setting
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HOW TO CITE THIS REPORT
Muth C. Reviewer Report For: Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.21956/hrbopenres.14833.r35047)
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https://hrbopenresearch.org/articles/5-53/v1#referee-response-35047
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Author Response 15 Jan 2024Catherine Waldron, Data Science Centre, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin 2, D02 DH60, Ireland15 Jan 2024Author ResponseResponse to reviewer 2 Christiane Muth, Bielefeld University, Bielefeld, Germany
Thank you for taking the time to review our article and providing very helpful feedback.
We will address each of ... Continue reading
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Author Response 15 Jan 2024Catherine Waldron, Data Science Centre, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin 2, D02 DH60, Ireland15 Jan 2024Author ResponseResponse to reviewer 2 Christiane Muth, Bielefeld University, Bielefeld, Germany
Thank you for taking the time to review our article and providing very helpful feedback.
We will address each of ... Continue reading
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How to cite this report:
Ryan C. Reviewer Report For: Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.21956/hrbopenres.14833.r32547)
The direct URL for this report is:
https://hrbopenresearch.org/articles/5-53/v1#referee-response-32547
https://hrbopenresearch.org/articles/5-53/v1#referee-response-32547
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 07 Sep 2022
Cristin Ryan,
School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland
Approved
VIEWS 44
Thank you for the invitation to review this rapid realist review, which aims to identify and examine the contexts and mechanisms involved in outcomes relevant to the reduction of adverse drug events in community dwelling older adults in the general
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HOW TO CITE THIS REPORT
Ryan C. Reviewer Report For: Contexts and mechanisms relevant to General Practitioner (GP) based interventions to reduce adverse drug events (ADE) in community dwelling older adults: a rapid realist review [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:53 (https://doi.org/10.21956/hrbopenres.14833.r32547)
The direct URL for this report is:
https://hrbopenresearch.org/articles/5-53/v1#referee-response-32547
https://hrbopenresearch.org/articles/5-53/v1#referee-response-32547
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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