Understanding access to general practice through the lens of Candidacy: a critical review of the literature.

BACKGROUND: Dominant conceptualisations of access to healthcare are limited, framed in terms of speed and supply. The Candidacy Framework offers a more comprehensive approach, identifying diverse influences on how access is accomplished. AIM: We aimed to characterise how the Candidacy Framework can explain access to general practice - an increasingly fraught area of public debate and policy. DESIGN AND SETTING: Qualitative review guided by the principles of critical interpretive synthesis. METHODS: We conducted a literature review using an "author-led" approach, involving iterative analytically-guided searches. Papers were eligible for inclusion if they related to the context of general practice, without geographical or time limitations. Key themes relating to access to general practice were extracted and synthesised using the Candidacy Framework. RESULTS: 229 papers were included in the final synthesis. Each of the seven features identified in the original Candidacy Framework is highly salient to general practice. Using the lens of candidacy demonstrates that access to general practice is subject to multiple influences that are highly dynamic, contingent and subject to constant negotiation. These influences are socio-economically and institutionally patterned, creating risks to access for some groups. This analysis enables understanding of the barriers to access that may exist even though general practice in the UK is free at the point of care, but also demonstrates that a Candidacy Framework specific to this setting is needed. CONCLUSION: The Candidacy Framework has considerable value as a way of understanding access to general practice, offering new insights for policy and practice. The original framework would benefit from further customisation for the distinctive setting of general practice.

Operational failures in general practice: a consensus-building study on the priorities for improvement.

BACKGROUND: System problems, known as operational failures, can greatly affect the work of GPs, with negative consequences for patient and professional experience, efficiency, and effectiveness. Many operational failures are tractable to improvement, but which ones should be prioritised is less clear. AIM: To build consensus among GPs and patients on the operational failures that should be prioritised to improve NHS general practice. DESIGN AND SETTING: Two modified Delphi exercises were conducted online among NHS GPs and patients in several regions across England. METHOD: Between February and October 2021, two modified Delphi exercises were conducted online: one with NHS GPs, and a subsequent exercise with patients. Over two rounds, GPs rated the importance of a list of operational failures (n = 45) that had been compiled using existing evidence. The resulting shortlist was presented to patients for rating over two rounds. Data were analysed using median scores and interquartile ranges. Consensus was defined as 80% of responses falling within one value below and above the median. RESULTS: Sixty-two GPs responded to the first Delphi exercise, and 53.2% (n = 33) were retained through to round two. This exercise yielded consensus on 14 failures as a priority for improvement, which were presented to patients. Thirty-seven patients responded to the first patient Delphi exercise, and 89.2% (n = 33) were retained through to round two. Patients identified 13 failures as priorities. The highest scoring failures included inaccuracies in patients' medical notes, missing test results, and difficulties referring patients to other providers because of problems with referral forms. CONCLUSION: This study identified the highest-priority operational failures in general practice according to GPs and patients, and indicates where improvement efforts relating to operational failures in general practice should be focused.

Design as a quality improvement strategy: The case for design expertise.

Bad design in safety-critical environments like healthcare can lead to users being frustrated, excluded or injured. In contrast, good design can make it easier to use a service correctly, with impacts on both the safety and efficiency of healthcare delivery, as well as the experience of patients and staff. The participative dimension of design as an improvement strategy has recently gained traction in the healthcare quality improvement literature. However, the role of design expertise and professional design has been much less explored. Good design does not happen by accident: it takes expertise and the specific reasoning that expert designers develop through practical experience and training. Here, we define design, show why poor design can be disastrous and illustrate the benefits of good design. We argue for the recognition of distinctive design expertise and describe some of its characteristics. Finally, we discuss how design could be better promoted in healthcare improvement.

Great expectations? GPs' estimations of time required to deliver BMJ's '10 minute consultations'.

OBJECTIVES: To estimate the time required to undertake consultations according to BMJ's 10-minute consultation articles.To quantify the tasks recommended in 10-minute consultation articles.To determine if, and to what extent, the time required and the number of tasks recommended have increased over the past 22 years. DESIGN: Analysis of estimations made by four general practitioners (GPs) of the time required to undertake tasks recommended in BMJ's 10-minute consultation articles. SETTING: Primary care in the UK. PARTICIPANTS: Four doctors with a combined total of 79 years of experience in the UK National Health Service following qualification as GPs. MAIN OUTCOME MEASURES: Median minimum estimated consultation length (the estimated time required to complete tasks recommended for all patients) and median maximum estimated consultation length (the estimated time required to complete tasks recommended for all patients and the additional tasks recommended in specific circumstances). Minimum, maximum and median consultation lengths reported for each year and for each 5-year period. RESULTS: Data were extracted for 44 articles. The median minimum and median maximum estimated consultation durations were 15.7 minutes (IQR 12.6-20.9) and 28.4 minutes (IQR 22.4-33.8), respectively. A median of 17 tasks were included in each article. There was no change in durations required over the 22 years examined. CONCLUSIONS: The approximate times estimated by GPs to deliver care according to 10-minute consultations exceed the time available in routine appointments. '10 minute consultations' is a misleading title that sets inappropriate expectations for what GPs can realistically deliver in their routine consultations. While maintaining aspirations for high-quality care is appropriate, practice recommendations need to take greater account of the limited time doctors have to deliver routine care.

The multimorbidity collaborative medication review and decision making (MyComrade) study: a pilot cluster randomised trial in two healthcare systems.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. AIM: The pilot study aimed to assess the feasibility of a definitive trial of the MyComrade intervention across two healthcare systems (Republic of Ireland (ROI) and Northern Ireland (NI)). DESIGN: A pilot cluster-randomised controlled trial was conducted (clustered at general practice level), using specific progression criteria and a process evaluation framework. SETTING: General practices in the ROI and NI. PARTICIPANTS: Eligible practices were those in defined geographical areas who had GP's and Practice Based Pharmacists (PBP's) (in NI) willing to conduct medication reviews. Eligible patients were those aged 18 years and over, with multi morbidity and on ten or more medications. INTERVENTION: The MyComrade intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care, using a planned collaborative approach guided by an agreed checklist, within a specified timeframe. OUTCOME MEASURES: Feasibility outcomes, using pre-determined progression criteria, assessed practice and patient recruitment and retention and intervention acceptability and fidelity. Anonymised patient-related quantitative data, from practice medical records and patient questionnaires were collected at baseline, 4 and 8 months, to inform potential outcome measures for a definitive trial. These included (i) practice outcomes-completion of medication reviews; (ii) patient outcomes-treatment burden and quality of life; (iii) prescribing outcomes-number and changes of prescribed medications and incidents of potentially inappropriate prescribing; and (iv) economic cost analysis. The framework Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria and process evaluation was used to guide the collection and analysis of quantitative and qualitative data. RESULTS: The recruitment of practices (n = 15) and patients (n = 121, mean age 73 years and 51% female), representing 94% and 38% of a priori targets respectively, was more complex and took longer than anticipated; impacted by the global COVID-19 pandemic. Retention rates of 100% of practices and 85% of patients were achieved. Both practice staff and patients found the intervention acceptable and reported strong fidelity to the My Comrade intervention components. Some practice staff highlighted concerns such as poor communication of the reviews to patients, dissatisfaction regarding incentivisation and in ROI the sustainability of two GPs collaboratively conducting the medication reviews. Assessing outcomes from the collected data was found feasible and appropriate for a definitive trial. Two progression criteria met the 'Go' criterion (practice and patient retention), two met the 'Amend' criterion (practice recruitment and intervention implementation) and one indicated a 'Stop - unless changes possible' (patient recruitment). CONCLUSION: The MyComrade intervention was found to be feasible to conduct within two different healthcare systems. Recruitment of participants requires significant time and effort given the nature of this population and the pairing of GP and pharmacist may be more sustainable to implement in routine practice. TRIAL REGISTRATION: Registry: ISRCTN, ISRCTN80017020 ; date of confirmation 4/11/2019; retrospectively registered.

The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). METHODS: A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. DISCUSSION: The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN80017020 . Date of confirmation is 4/11/2019.

Identifying how GPs spend their time and the obstacles they face: a mixed-methods study.

BACKGROUND: Although problems that impair task completion - known as operational failures - are an important focus of concern in primary care, they have remained little studied. AIM: To quantify the time GPs spend on different activities during clinical sessions; to identify the number of operational failures they encounter; and to characterise the nature of operational failures and their impact for GPs. DESIGN AND SETTING: Mixed-method triangulation study with 61 GPs in 28 NHS general practices in England from December 2018 to December 2019. METHOD: Time-motion methods, ethnographic observations, and interviews were used. RESULTS: Time-motion data on 7679 GP tasks during 238 hours of practice in 61 clinical sessions suggested that operational failures were responsible for around 5.0% (95% confidence interval [CI] = 4.5% to 5.4%) of all tasks undertaken by GPs and accounted for 3.9% (95% CI = 3.2% to 4.5%) of clinical time. However, qualitative data showed that time-motion methods, which depend on pre-programmed categories, substantially underestimated operational failures. Qualitative data also enabled further characterisation of operational failures, extending beyond those measured directly in the time-motion data (for example, interruptions, deficits in equipment/supplies, and technology) to include problems linked to GPs' coordination role and weaknesses in work systems and processes. The impacts of operational failures were highly consequential for GPs' experiences of work. CONCLUSION: GPs experience frequent operational failures, disrupting patient care, impairing experiences of work, and imposing burden in an already pressurised system. This better understanding of the nature and impact of operational failures allows for identification of targets for improvement and indicates the need for coordinated action to support GPs.

GPs' mindlines on deprescribing antihypertensives in older patients with multimorbidity: a qualitative study in English general practice.

BACKGROUND: Optimal management of hypertension in older patients with multimorbidity is a cornerstone of primary care practice. Despite emphasis on personalised approaches to treatment in older patients, there is little guidance on how to achieve medication reduction when GPs are concerned that possible risks outweigh potential benefits of treatment. Mindlines - tacit, internalised guidelines developed over time from multiple sources - may be of particular importance in such situations. AIM: To explore GPs' decision-making on deprescribing antihypertensives in patients with multimorbidity aged ≥80 years, drawing on the concept of mindlines. DESIGN AND SETTING: Qualitative interview study set in English general practice. METHOD: Thematic analysis of face-to-face interviews with a sample of 15 GPs from seven practices in the East of England, using a chart-stimulated recall approach to explore approaches to treatment for older patients with multimorbidity with hypertension. RESULTS: GPs are typically confident making decisions to deprescribe antihypertensive medication in older patients with multimorbidity when prompted by a trigger, such as a fall or adverse drug event. GPs are less confident to attempt deprescribing in response to generalised concerns about polypharmacy, and work hard to make sense of multiple sources (including available evidence, shared experiential knowledge, and non-clinical factors) to guide decision-making. CONCLUSION: In the absence of a clear evidence base on when and how to attempt medication reduction in response to concerns about polypharmacy, GPs develop 'mindlines' over time through practicebased experience. These tacit approaches to making complex decisions are critical to developing confidence to attempt deprescribing and may be strengthened through reflective practice.

Healthcare utilization among migrants to the UK: cross-sectional analysis of two national surveys.

OBJECTIVE: To contribute objective evidence on health care utilization among migrants to the UK to inform policy and service planning. METHODS: We analysed data from Understanding Society, a household survey with fieldwork from 2015 to 2017, and the European Health Interview Survey with data collected between 2013 and 2014. We explored health service utilization among migrants to the UK across primary care, inpatient admissions and maternity care, outpatient care, mental health, dental care and physiotherapy. We adjusted for age, sex, long-term health conditions and time since moving to the UK. RESULTS: Health care utilization among migrants to the UK was lower than utilization among the UK-born population for all health care dimensions except inpatient admissions for childbirth; odds ratio (95%CI) range 0.58 (0.50-0.68) for dental care to 0.88 (0.78-0.98) for primary care). After adjusting for differences in age and self-reported health, these differences were no longer observed, except for dental care (odds ratio 0.57, 95%CI 0.49-0.66, P < 0.001). Across primary care, outpatient and inpatient care, utilization was lower among those who had recently migrated, increasing to the levels of the nonmigrant population after 10 years or more since migrating to the UK. CONCLUSIONS: This study finds that newly arrived migrants tend to utilize less health care than the UK population and that this pattern was at least partly explained by better health, and younger age. Our findings contribute nationally representative evidence to inform public debate and decision-making on migration and health.

Operational failures and how they influence the work of GPs: a qualitative study in primary care.

BACKGROUND: Operational failures, defined as inadequacies or errors in the information, supplies, or equipment needed for patient care, are known to be highly consequential in hospital environments. Despite their likely relevance for GPs' experiences of work, they remain under-explored in primary care. AIM: To identify operational failures in the primary care work environment and to examine how they influence GPs' work. DESIGN AND SETTING: Qualitative interview study in the East of England. METHOD: Semi-structured interviews were conducted with GPs (n = 21). Data analysis was based on the constant comparison method. RESULTS: GPs reported a large burden of operational failures, many of them related to information transfer with external healthcare providers, practice technology, and organisation of work within practices. Faced with operational failures, GPs undertook 'compensatory labour' to fulfil their duties of coordinating and safeguarding patients' care. Dealing with operational failures imposed significant additional strain in the context of already stretched daily schedules, but this work remained largely invisible. In part, this was because GPs acted to fix problems in the here-and-now rather than referring them to source, and they characteristically did not report operational failures at system level. They also identified challenges in making process improvements at practice level, including medicolegal uncertainties about delegation. CONCLUSION: Operational failures in primary care matter for GPs and their experience of work. Compensatory labour is burdensome with an unintended consequence of rendering these failures largely invisible. Recognition of the significance of operational failures should stimulate efforts to make the primary care work environment more attractive.

Impacts of Operational Failures on Primary Care Physicians' Work: A Critical Interpretive Synthesis of the Literature.

PURPOSE: Operational failures are system-level errors in the supply of information, equipment, and materials to health care personnel. We aimed to review and synthesize the research literature to determine how operational failures in primary care affect the work of primary care physicians. METHODS: We conducted a critical interpretive synthesis. We searched 7 databases for papers published in English from database inception until October 2017 for primary research of any design that addressed problems interfering with primary care physicians' work. All potentially eligible titles/abstracts were screened by 1 reviewer; 30% were subject to second screening. We conducted an iterative critique, analysis, and synthesis of included studies. RESULTS: Our search retrieved 8,544 unique citations. Though no paper explicitly referred to "operational failures," we identified 95 papers that conformed to our general definition. The included studies show a gap between what physicians perceived they should be doing and what they were doing, which was strongly linked to operational failures-including those relating to technology, information, and coordination-over which physicians often had limited control. Operational failures actively configured physicians' work by requiring significant compensatory labor to deliver the goals of care. This labor was typically unaccounted for in scheduling or reward systems and had adverse consequences for physician and patient experience. CONCLUSIONS: Primary care physicians' efforts to compensate for suboptimal work systems are often concealed, risking an incomplete picture of the work they do and problems they routinely face. Future research must identify which operational failures are highest impact and tractable to improvement.

Shifting gears versus sudden stops: qualitative study of consultations about driving in patients with cognitive impairment.

OBJECTIVE: General practitioners (GPs) report finding consultations on fitness to drive (FtD) in people with cognitive impairment difficult and potentially damaging to the physician-patient relationship. We aimed to explore GP and patient experiences to understand how the negative impacts associated with FtD consultations may be mitigated. METHODS: Individual qualitative interviews were conducted with GPs (n=12) and patients/carers (n=6) in Ireland. We recruited a maximum variation sample of GPs using criteria of length of time qualified, practice location and practice size. Patients with cognitive impairment were recruited via driving assessment services and participating general practices. Interviews were audio-recorded, transcribed and analysed thematically by the multidisciplinary research team using an approach informed by the framework method. RESULTS: The issue of FtD arose in consultations in two ways: introduced by GPs to proactively prepare patients for future driving cessation or by patients who urgently needed a medical report for an expiring driving license. The former strategy, implementable by GPs who had strong relational continuity with their patients, helped prevent crisis consultations from arising. The latter scenario became acrimonious if cognition had not been openly discussed with patients previously and was now potentially impacting on their right to drive. Patients called for greater clarity and empathy for the threat of driving cessation from their GPs. CONCLUSION: GPs used their longitudinal relationship with cognitively impaired patients to reduce the potential for conflict in consultations on FtD. These efforts could be augmented by explicit discussion of cognitive impairment at an earlier stage for all affected patients. Patients would benefit from greater input into planning driving cessation and acknowledgement from their GPs of the impact this may have on their quality of life.

Pharmacist-led academic detailing intervention in primary care: a mixed methods feasibility study.

Background Academic detailing is a form of continuing medical education in which a trained health professional such as a physician or pharmacist visits prescribers in their practice to provide evidence-based information. While academic detailing has been adopted in other countries, this strategy is not routinely used in Ireland. Objective The aim of this study was to assess the feasibility and acceptability to General Practitioners (GPs) of a pharmacist-led academic detailing intervention in Ireland. Setting General Practice in County Cork, Ireland. Method A mixed methods feasibility study comprising a pharmacist-led academic detailing intervention on urinary incontinence in older people, quantitative data from patient medical records, and qualitative data from focus groups with GPs. The medical records for all patients aged ≥ 65 years who were attending a participating GP with a diagnosis of urinary incontinence were analysed using a before-after approach. The measures of prescribing assessed before and after the intervention were: LUTS-FORTA criteria, Drug Burden Index, and the Anticholinergic Cognitive Burden scale. Focus groups were carried out with GPs who participated in the academic detailing intervention. Main outcome measure The quantitative prescribing patterns of the GPs and their qualitative responses from the focus groups. Results Twenty-three GPs participated in the academic detailing intervention from a selection of different types of general practice. The medical records of 154 patients were analysed. There was minimal or no change in any of the prescribing measures used. Fourteen GPs attended focus groups. GPs considered the topic of urinary incontinence as relevant to general practice. Participants appreciated the succinct nature of the information in the educational materials but expressed a preference for a more easily retrievable format, such as an online version rather than paper-based. Conclusion This study demonstrated that a pharmacist-led academic detailing intervention was acceptable to GPs in Ireland. Further research is needed in a larger population evaluating the impact and cost effectiveness of academic detailing to optimise patient care.

Consultations on driving in people with cognitive impairment in primary care: A scoping review of the evidence.

OBJECTIVES: To review the empirical evidence on approaches used by Primary Care Physicians (PCPs) in fitness to drive (FtD) consultations with people living with cognitive impairment. DESIGN: Scoping review of empirical literature focused on primary studies of any design. SETTING: Primary care practice. PARTICIPANTS: PCPs or their equivalent and/ or individuals with cognitive impairment across the spectrum of mild cognitive impairment to dementia. MEASUREMENTS: Systematic search of Medline, Cinahl, PsychINFO, Academic Search Complete, Psychological and Behavioural Sciences Collection, SocIndex and Social Sciences FT were conducted. Records screened by two reviewers against agreed inclusion criteria. Mixed studies (qualitative and quantitative) were synthesized within overarching themes. RESULTS: Eighteen studies met our inclusion criteria. Synthesized data showed PCPs have mixed feelings on the appropriateness of their role in FtD assessments, with many feeling particularly uncomfortable and lacking confidence in the context of possible cognitive impairment. Reasons include lack of familiarity with legal requirements and local resources; fear of damaging the doctor-patient relationship; and impact on the patient's quality of life. Patients voiced their desire to maintain agency in planning their driving cessation. Studies evaluating pragmatic educational programmes suggest these can improve physician confidence in FtD consultations. CONCLUSION: The increasing number of older people affected by cognitive impairment, for whom driving may be a concern, has implications for primary care practice. Addressing the reasons for PCPs lack of comfort in dealing with this issue is essential in order for them to better engage in, collaborative discussion with patients on plans and preferences for driving cessation.

Exploring Antipsychotic Prescribing Behaviors for Nursing Home Residents With Dementia: A Qualitative Study.

OBJECTIVES: Caution is advised when prescribing antipsychotics to people with dementia. This study explored the determinants of appropriate, evidence-based antipsychotic prescribing behaviors for nursing home residents with dementia, with a view to informing future quality improvement efforts and behavior change interventions. DESIGN: Semistructured qualitative interviews based on the Theoretical Domains Framework (TDF). SETTING AND PARTICIPANTS: A purposive sample of 27 participants from 4 nursing homes, involved in the care of nursing home residents with dementia (8 nurses, 5 general practitioners, 5 healthcare assistants, 3 family members, 2 pharmacists, 2 consultant geriatricians, and 2 consultant psychiatrists of old age) in a Southern region of Ireland. MEASURES: Using framework analysis, the predominant TDF domains and determinants influencing these behaviors were identified, and explanatory themes developed. RESULTS: Nine predominant TDF domains were identified as influencing appropriate antipsychotic prescribing behaviors. Participants' effort to achieve "a fine balance" between the risks and benefits of antipsychotics was identified as the cross-cutting theme that underpinned many of the behavioral determinants. On one hand, neither healthcare workers nor family members wanted to see residents over-sedated and without a quality of life. Conversely, the reality of needing to protect staff, family members, and residents from potentially dangerous behavioral symptoms, in a resource-poor environment, was emphasized. The implementation of best-practice guidelines was illustrated through 3 explanatory themes ("human suffering"; "the interface between resident and nursing home"; and "power and knowledge: complex stakeholder dynamics"), which conceptualize how different nursing homes strike this "fine balance." CONCLUSIONS: Implementing evidence-based antipsychotic prescribing practices for nursing home residents with dementia remains a significant challenge. Greater policy and institutional support is required to help stakeholders strike that "fine balance" and ultimately make better prescribing decisions. This study has generated a deeper understanding of this complex issue and will inform the development of an evidence-based intervention.

Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study.

OBJECTIVES: To estimate and compare the prevalence and type of potentially inappropriate prescribing (PIP) and potential prescribing omissions (PPOs) among community-dwelling older adults (≥65 years) enrolled to a clinical trial in three European countries. DESIGN: A secondary analysis of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial dataset. PARTICIPANTS: A subset of 48/80 PIP and 22/34 PPOs indicators from the Screening Tool of Older Persons Prescriptions/Screening Tool to Alert doctors to Right Treatment (STOPP/START) V2 criteria were applied to prescribed medication data for 532/737 trial participants in Ireland, Switzerland and the Netherlands. RESULTS: The overall prevalence of PIP was lower in the Irish participants (8.7%) compared with the Swiss (16.7%) and Dutch (12.5%) participants (P=0.15) and was not statistically significant. The overall prevalence of PPOs was approximately one-quarter in the Swiss (25.3%) and Dutch (24%) participants and lower in the Irish (14%) participants (P=0.04) and the difference was statistically significant. The hypnotic Z-drugs were the most frequent PIP in Irish participants, (3.5%, n=4), while it was non-steroidal anti-inflammatory drug and oral anticoagulant combination, sulfonylureas with a long duration of action, and benzodiazepines (all 4.3%, n=7) in Swiss, and benzodiazepines (7.1%, n=18) in Dutch participants. The most frequent PPOs in Irish participants were vitamin D and calcium in osteoporosis (3.5%, n=4). In the Swiss and Dutch participants, they were bone antiresorptive/anabolic therapy in osteoporosis (9.9%, n=16, 8.6%, n=22) respectively. The odds of any PIP after adjusting for age, sex, multimorbidity and polypharmacy were (adjusted OR (aOR)) 3.04 (95% CI 1.33 to 6.95, P<0.01) for Swiss participants and aOR 1.74 (95% CI 0.79 to 3.85, P=0.17) for Dutch participants compared with Irish participants. The odds of any PPOs were aOR 2.48 (95% CI 1.27 to 4.85, P<0.01) for Swiss participants and aOR 2.10 (95% CI 1.11 to 3.96, P=0.02) for Dutch participants compared with Irish participants. CONCLUSIONS: This study has estimated and compared the prevalence and type of PIP and PPOs among this cohort of community-dwelling older people. It demonstrated a significant difference in the prevalence of PPOs between the three populations. Further research is urgently needed into the impact of system level factors as this has important implications for patient safety, healthcare provision and economic costs.

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group.  There were no differences in patient understanding between the two methods.  Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.