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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.

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.

BackgroundAlthough problems that impair task completion — known as operational failures — are an important focus of concern in primary care, they have remained little studied.AimTo 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 settingMixed-method triangulation study with 61 GPs in 28 NHS general practices in England from December 2018 to December 2019.MethodTime–motion methods, ethnographic observations, and interviews were used.ResultsTime–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.ConclusionGPs 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.

BackgroundOptimal 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.AimTo explore GPs’ decision-making on deprescribing antihypertensives in patients with multimorbidity aged ≥80 years, drawing on the concept of mindlines.Design and settingQualitative interview study set in English general practice.MethodThematic 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.ResultsGPs 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.ConclusionIn 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.

BackgroundOperational 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.AimTo identify operational failures in the primary care work environment and to examine how they influence GPs’ work.Design and settingQualitative interview study in the East of England.MethodSemi-structured interviews were conducted with GPs (n = 21). Data analysis was based on the constant comparison method.ResultsGPs 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.ConclusionOperational 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.

BACKGROUND Interventions to prevent childhood obesity increasingly focus on infant feeding, but demonstrate inconsistent effects. A comprehensive qualitative evidence synthesis is essential to better understand feeding behaviours and inform intervention development. The aim of this study is to synthesize evidence on perceptions and experiences of infant feeding and complementary feeding recommendations. METHODS Databases CINAHL, EMBASE, MEDLINE, PsycINFO, Academic Search Complete, SocIndex and Maternity and Infant Care were searched from inception to May 2017. Eligible studies examined parents' experiences of complementary feeding of children (

Aims The aim of this study was firstly to reveal the determinants of GP prescribing behaviour for older adults in primary care and secondly to elicit GPs’ views on the potential role for broad intervention strategies involving pharmacists and/or information technology systems in general practice. Methods Semi-structured qualitative interviews were carried out with a purposive sample of GPs. Three multidisciplinary researchers independently coded the interview data using a framework approach. Emerging themes were mapped to the Theoretical Domains Framework (TDF), a tool used to apply behaviour change theories. Results Sixteen GPs participated in the study. The following domains in the TDF were identified as being important determinants of GP prescribing behaviour: “Knowledge”, “Skills” “Reinforcement”, “Memory Attention and Decision Process”, “Environmental Context and Resources”, “Social influences”, “Social/Professional Role and Identity”. Participants reported that the challenges associated with prescribing for an increasingly older population will require them to become more knowledgeable in pharmacology and drug interactions and they called for extra training in these topics. GPs viewed strategies such as academic detailing sessions delivered by pharmacists or information technology systems as having a positive role to play in optimising prescribing. Conclusion This study highlights the complexities of behavioural determinants of prescribing for older people in primary care and the need for additional supports to optimise prescribing for this growing cohort of patients. Interventions that incorporate, but are not limited to interprofessional collaboration with pharmacists and information technology systems, were identified by GPs as being potentially useful for improving prescribing behaviour, therefore require further exploration.

Background Using clinical guidelines in the management of patients with multimorbidity can lead to the prescription of multiple and sometimes conflicting medications. Aim To explore how GPs make decisions when prescribing for multimorbid patients, with a view to informing intervention design. Design and setting In-depth qualitative interviews incorporating chart-stimulated recall with purposively sampled GPs in the Republic of Ireland. Method Grounded theory analysis with iterative theory development. Results Twenty GPs were interviewed about 51 multimorbid cases. In these cases, GPs integrated information from multiple sources including the patient, specialists, and evidence-based medicine. Difficulties arose when recommendations or preferences conflicted, to which GPs responded by ‘satisficing’: accepting care that they deemed satisfactory and sufficient for a particular patient. Satisficing was manifest as relaxing targets for disease control, negotiating compromise with the patient, or making ‘best guesses’ about the most appropriate course of action to take. In multimorbid patients perceived as stable, GPs preferred to ‘maintain the status quo’ rather than rationalise medications, even in cases with significant polypharmacy. Proactive changes in medications were facilitated by continuity of care, sufficient consultation time, and open lines of communication with the patient, other healthcare professionals, and other GPs. Conclusion GPs respond to conflicts in the management of multimorbid patients by making compromises between patient-centred and evidence-based care. These findings will be used to inform interventions that aim to care in multimorbidity.

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.

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 to achieve consensus, 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 dissemination method as developed by lead study site in Glasgow, Scotland). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two dissemination methods. Results Patients want to receive results of clinical trials, with qualitative findings of perspectives and preferences 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 by researchers, trial participants and adult literacy experts. One hundred and one TRUST participants were then randomised to receive the patient-preferred result method or the standard dissemination method. 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 dissemination methods. Conclusion Patient and Public Involvement (PPI) is advocated for every step of the trial process. We have demonstrated that it is feasible to do this 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.

Background Implementation strategies are needed to ensure that evidence-based healthcare interventions are adopted successfully. However, strategies are generally poorly described and those used in everyday practice are seldom reported formally or fully understood. Characterising the active ingredients of existing strategies is necessary to test and refine implementation. We examined whether an implementation strategy, delivered across multiple settings targeting different stakeholders to support a fall prevention programme, could be characterised using the Behaviour Change Technique (BCT) Taxonomy. Methods Data sources included project plans, promotional material, interviews with a purposive sample of stakeholders involved in the strategy’s design and delivery and observations of staff training and information meetings. Data were analysed using TIDieR to describe the strategy and determine the levels at which it operated (organisational, professional, patient). The BCT Taxonomy identified BCTs which were mapped to intervention functions. Data were coded by three researchers and finalised through consensus. Results We analysed 22 documents, 6 interviews and 4 observation sessions. Overall, 21 out a possible 93 BCTs were identified across the three levels. At an organisational level, identifiable techniques tended to be broadly defined; the most common BCT was restructuring the social environment. While some activities were intended to encourage implementation, they did not have an immediate behavioural target and could not be coded using BCTs. The largest number and variety of BCTs were used at the professional level to target the multidisciplinary teams delivering the programme and professionals referring to the programme. The main BCTs targeting the multidisciplinary team were instruction on how to perform the (assessment) behaviour and demonstration of (assessment) behaviour; the main BCT targeting referrers was adding objects to the environment. At the patient level, few BCTs were used to target attendance. Conclusion In this study, several behaviour change techniques were evident at the individual professional level; however, fewer techniques were identifiable at an organisational level. The BCT Taxonomy was useful for describing components of a multilevel implementation strategy that specifically target behaviour change. To fully and completely describe an implementation strategy, including components that involve organisational or systems level change, other frameworks may be needed. Electronic supplementary material The online version of this article (10.1186/s13012-018-0798-6) contains supplementary material, which is available to authorized users.

peer-reviewed 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. peer-reviewed

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.

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.

Objective: To evaluate studies of pharmacist-led interventions on potentially inappropriate prescribing among community-dwelling older adults receiving primary care to identify the components of a successful intervention. Data sources: An electronic search of the literature was conducted using the following databases from inception to December 2015: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, MEDLINE (through Ovid), Trip, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews, ISI Web of Science, ScienceDirect, ClinicalTrials.gov , metaRegister of Controlled Trials, ProQuest Dissertations & Theses Database (Theses in Great Britain, Ireland and North America). Review methods: Studies were included if they were randomised controlled trials or quasi-randomised studies involving a pharmacist-led intervention compared to usual/routine care which aimed to reduce potentially inappropriate prescribing in older adults in primary care. Methodological quality of the included studies was independently assessed. Results: A comprehensive literature search was conducted which identified 2193 studies following removal of duplicates. Five studies met the inclusion criteria. Four studies involved a pharmacist conducting a medication review and providing feedback to patients or their family physician. One randomised controlled trial evaluated the effect of a computerised tool that alerted pharmacists when elderly patients were newly prescribed potentially inappropriate medications. Four studies were associated with an improvement in prescribing appropriateness. Conclusion: Overall, this review demonstrates that pharmacist-led interventions may improve prescribing appropriateness in community-dwelling older adults. However, the quality of evidence is low. The role of a pharmacist working as part of a multidisciplinary primary care team requires further investigation to optimise prescribing in this group of patients.

ObjectivesTo 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.DesignA secondary analysis of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial dataset.ParticipantsA 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.ResultsThe 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, PConclusionsThis 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.

Internationally, primary care is under pressure. In 10 developed nations surveyed for the 2015 Commonwealth report, primary care physicians reported their struggle to find ways to care for ageing populations with complex healthcare needs.1 Practice consultation rates, average consultation duration and total patient-facing clinical workload have increased substantially in primary care in recent years.2 Increases in demand have not been matched by growth in either funding or in workforce: in the UK alone, the shortage of general practitioners (GPs) is expected to worsen from 3300 in 2015 to 8000 by 2020. Over and above rising demand, factors such as advances in technology, the shifting workload from secondary to primary care, and patients’ growing health and social care needs (including more complicated drug regimens and challenging national clinical standards) have all added to complexity.3 Much discussion has focused on how to increase the supply of primary care physicians. But, despite rapidly accelerating changes in the composition of the primary care workforce and its practices, far less attention has been given to understanding the teams that support physicians in primary care and how these individuals work together. Grant and Guthrie4 draw back the veil in an intriguing ethnographic study that shows how eight heterogeneous primary care practices in England and Scotland implement team …

To effectively meet the health care needs of multimorbid patients, the most important psychosocial factors associated with multimorbidity must be discerned. Our aim was to examine the association between self-reported adverse childhood experiences (ACEs) and multimorbidity and the contribution of other social, behavioural and psychological factors to this relationship.We analysed cross-sectional data from the Mitchelstown study, a population-based cohort recruited from a large primary care centre. ACE was measured by self-report using the Centre for Disease Control ACE questionnaire. Multimorbidity status was categorized as 0, 1 or ≥2 chronic diseases, which were ascertained by self-report of doctor diagnosis. Ordinal logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs) for multimorbidity, using ACE as the independent variable with adjustment for social (education, public health cover), behavioural (smoking, exercise, diet, body mass index) and psychological factors (anxiety/depression scores).Of 2047 participants, 45.3% (n = 927, 95% CI: 43.1-47.4) reported multimorbidity. ACE was reported by 28.4% (n = 248, 95% CI: 25.3-31.3%) of multimorbid participants, 21% (n = 113, 95% CI: 18.0-25.1%) of single chronic disease participants and 16% (n = 83, 95% CI: 13.2-19.7%) of those without chronic disease. The OR for multimorbidity with any history of ACE was 1.6 (95% CI: 1.4-2.0, P0.001). Adjusting for social, behavioural and psychological factors only marginally ameliorated this association, OR 1.4 (95% CI: 1.1-1.7, P = 0.002).Multimorbidity is independently associated with a history of ACEs. These findings demonstrate the psychosocial complexity associated with multimorbidity and should be used to inform health care provision in this patient cohort.

Background In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists’ readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. Methods This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. Results Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants’ legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. Conclusion The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2148-4) contains supplementary material, which is available to authorized users.

Background Chart-stimulated recall (CSR) is a case-based interviewing technique, which is used in the assessment of clinical decision-making in medical education and professional certification. Increasingly, clinical decision-making is a concern for clinical research in primary care. In this study, we review the prior application and utility of CSR as a technique for research interviews in primary care. Methods Following Arksey & O’Malley’s method for scoping reviews, we searched seven databases, grey literature, reference lists, and contacted experts in the field. We excluded studies on medical education or competence assessment. Retrieved citations were screened by one reviewer and full texts were ordered for all potentially relevant abstracts. Two researchers independently reviewed full texts and performed data extraction and quality appraisal if inclusion criteria were met. Data were collated and summarised using a published framework on the reporting of qualitative interview techniques, which was chosen a priori. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines informed the review report. Results From an initial list of 789 citations, eight studies using CSR in research interviews were included in the review: six from North America, one from the Netherlands, and one from Ireland. The most common purpose of included studies was to examine the influence of guidelines on physicians’ decisions. The number of interviewees ranged from seven to twenty nine, while the number of charts discussed per interview ranged from one to twelve. CSR gave insights into physicians’ reasoning for actions taken or not taken; the unrecorded social and clinical influences on decisions; and discrepancies between physicians’ real and perceived practice. Ethical concerns and the training and influence of the researcher were poorly discussed in most of the studies. Potential pitfalls included the risk of recall, selection and observation biases. Conclusions Despite the proven validity, reliability and acceptability of CSR in assessment interviews in medical education, its use in clinical research is limited. Application of CSR in qualitative research brings interview data closer to the reality of practice. Although further development of the approach is required, we recommend a role for CSR in research interviews on decision-making in clinical practice. Electronic supplementary material The online version of this article (doi:10.1186/s12913-017-2539-y) contains supplementary material, which is available to authorized users.

Introduction: Dissemination of results of randomised controlled trials is traditionally limited to academic and professional groups rather than clinical trial participants. While there is increasing consensus that results should be communicated to trial participants, there is a lack of evidence on the most appropriate methods of dissemination. This study within a trial (SWAT) aims to address this gap by using a public and patient involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving trial results of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial (TRUST). Methods: An experimental (intervention) study will be conducted using mixed methods to inform the development of and evaluation of a patient-preferred method of communication of trial results. The study will involve three consecutive phases. In the first phase, focus groups of trial participants will be conducted to identify a patient-preferred method of receiving trial results. The method will be developed and then assessed and refined by a patient and public expert group. In the second phase participants will be randomly assigned to the intervention (patient-preferred method) and comparison groups (standard dissemination method as developed by the lead study site in Glasgow, Scotland). In the third phase, a quantitative questionnaire will be used to measure and compare patient understanding of trial results between the two groups. Discussion: This protocol provides a template for other trialists who wish to enhance patient and public involvement and additionally, will provide empirical evidence on how trialists should best disseminate study results to their participants. Keywords: Public and patient involvement, PPI, Study within a trial, SWAT, Clinical trial result dissemination, End of trial results, Trial results

The assessment of undergraduate medical students in the clinical setting has become a key priority for medical educators. Facilitating the successful translation of undergraduate theoretical knowledge into safe and appropriate postgraduate clinical practice represents a challenge in medical education [1]. Poor clinical performance of newly qualified doctors has been highlighted as a major issue relating to patient safety [2]. Performance based assessment in the undergraduate setting may assist in addressing this issue by assessing ‘doing’ rather than ‘knowing’. The mini clinical evaluation exercise (Mini-CEX) is a formative assessment used to assess the performance of medical students in a clinical context. It incorporates assessment by, and feedback from, an assessor, based on the direct observation of a student–patient consultation [3]. Conducted in a series of stages, the Mini-CEX allows focused assessment of key competencies (see Box 1) [3].

ObjectiveTo investigate associations between adverse childhood experiences (ACEs) and later-life depressive symptoms; and to explore whether perceived social support (PSS) moderates these.MethodWe analysed baseline data from the Mitchelstown (Ireland) 2010–2011 cohort of 2047 men and women aged 50–69 years. Self-reported measures included ACEs (Centre for Disease Control ACE questionnaire), PSS (Oslo Social Support Scale) and depressive symptoms (CES-D). The primary exposure was self-report of at least one ACE. We also investigated the effects of ACE exposure by ACE scores and ACE subtypes abuse, neglect and household dysfunction. Associations between each of these exposures and depressive symptoms were estimated using logistic regression, adjusted for socio-demographic factors. We tested whether the estimated associations varied across levels of PSS (poor, moderate and strong).Results23.7% of participants reported at least one ACE (95% CI 21.9% to 25.6%). ACE exposures (overall, subtype or ACE scores) were associated with a higher odds of depressive symptoms, but only among individuals with poor PSS. Exposure to any ACE (vs none) was associated with almost three times the odds of depressive symptoms (adjusted OR 2.85; 95% CI 1.64 to 4.95) among individuals reporting poor PSS, while among those reporting moderate and strong PSS, the adjusted ORs were 2.21 (95% CI 1.52 to 3.22) and 1.39 (95% CI 0.85 to 2.29), respectively. This pattern of results was similar when exposures were based on ACE subtype and ACE scores, though the interaction was clearly strongest among those reporting abuse.ConclusionsACEs are common among older adults in Ireland and are associated with higher odds of later-life depressive symptoms, particularly among those with poor PSS. Interventions that enhance social support, or possibly perceptions of social support, may help reduce the burden of depression in older populations with ACE exposure, particularly in those reporting abuse.

Depression is a leading cause of disability worldwide. It is recommended that exercise is incorporated into the management of patients with depression, but it is not clear how best to implement this recommendation in clinical practice.The objective of this study was to evaluate a pragmatic educational intervention promoting exercise to a group of patients diagnosed with depression, in a community setting.Participants were convenience sampled from community based psychiatry clinics. WHO 5 Wellbeing and International Physical Activity Questionnaire scores were measured for each participant at baseline, and again three months after receiving the educational intervention on exercise. Open ended questions were used to elicit participants' beliefs and barriers to exercise and responses were thematically analysed.Thirty-five patients with depression were enrolled. Three months after the educational intervention, there were no significant changes in patients' activity levels or well-being scores (P0.05). Participants' responses to open ended questions revealed their varied, and often contradictory, beliefs on physical activity and exercise. Following from this, their suggestions on ways to improve the uptake of exercise advice highlighted the need for an individualized approach, with persistent patient encouragement and positive reinforcement.This study has generated valuable information on how to improve the promotion of exercise to patients with depression. Advice framed in a positive light, with persistent encouragement and tailoring to individual circumstances, is desired by patients to support their behavioural change.

Background Multimorbidity, the presence of two or more chronic conditions, affects over 60 % of patients in primary care. Due to its association with polypharmacy, the development of interventions to optimise medication management in patients with multimorbidity is a priority. The Behaviour Change Wheel is a new approach for applying behavioural theory to intervention development. Here, we describe how we have used results from a review of previous research, original research of our own and the Behaviour Change Wheel to develop an intervention to improve medication management in multimorbidity by general practitioners (GPs), within the overarching UK Medical Research Council guidance on complex interventions. Methods Following the steps of the Behaviour Change Wheel, we sought behaviours associated with medication management in multimorbidity by conducting a systematic review and qualitative study with GPs. From the modifiable GP behaviours identified, we selected one and conducted a focused behavioural analysis to explain why GPs were or were not engaging in this behaviour. We used the behavioural analysis to determine the intervention functions, behavioural change techniques and implementation plan most likely to effect behavioural change. Results We identified numerous modifiable GP behaviours in the systematic review and qualitative study, from which active medication review (rather than passive maintaining the status quo) was chosen as the target behaviour. Behavioural analysis revealed GPs’ capabilities, opportunities and motivations relating to active medication review. We combined the three intervention functions deemed most likely to effect behavioural change (enablement, environmental restructuring and incentivisation) to form the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention. MY COMRADE primarily involves the technique of social support: two GPs review the medications prescribed to a complex multimorbid patient together. Four other behavioural change techniques are incorporated: restructuring the social environment, prompts/cues, action planning and self-incentives. Conclusions This study is the first to use the Behaviour Change Wheel to develop an intervention targeting multimorbidity and confirms the usability and usefulness of the approach in a complex area of clinical care. The systematic development of the MY COMRADE intervention will facilitate a thorough evaluation of its effectiveness in the next phase of this work. Electronic supplementary material The online version of this article (doi:10.1186/s13012-015-0322-1) contains supplementary material, which is available to authorized users.

Objective To synthesise the existing published literature on the perceptions of general practitioners (GPs) or their equivalent on the clinical management of multimorbidity and determine targets for future research that aims to improve clinical care in multimorbidity. Design Systematic review and metaethnographic synthesis of primary studies that used qualitative methods to explore GPs’ experiences of clinical management of multimorbidity or multiple chronic diseases. Data sources EMBASE, MEDLINE, CINAHL, PsycInfo, Academic Search Complete, SocIndex, Social Science Full Text and digital theses/online libraries (database inception to September 2012) to identify literature using qualitative methods (focus groups or interviews). Review methods The 7-step metaethnographic approach described by Noblit and Hare, which involves cross-interpretation between studies while preserving the context of the primary data. Results Of 1805 articles identified, 37 were reviewed in detail and 10 were included, using a total of 275 GPs in 7 different countries. Four areas of difficulty specific to the management of multimorbidity emerged from these papers: disorganisation and fragmentation of healthcare; the inadequacy of guidelines and evidence-based medicine; challenges in delivering patient-centred care; and barriers to shared decision-making. A ‘line of argument’ was drawn which described GPs’ sense of isolation in decision-making for multimorbid patients. Conclusions This systematic review shows that the problem areas for GPs in the management of multimorbidity may be classified into four domains. There will be no ‘one size fits all’ intervention for multimorbidity but these domains may be useful targets to guide the development of interventions that will assist and improve the provision of care to multimorbid patients.

Background Research has shown that those who have experienced adverse childhood events (ACE) are at increased risk of developing chronic diseases later in life. The relationship between ACE and health service use (HSU) is subject to potential confounding factors including those chronic diseases. Existing evidence is largely based on hospital administrative data, limiting the investigation of other influential predisposing, enabling and need factors. Our aim was to examine the association between ACE and HSU using data from a primary care-based survey. Methods We analysed cross-sectional data from the Mitchelstown study, a population based cohort of people aged 50 to 69 recruited from a large primary care centre (2010/2011). ACE was measured by self-report using the Centre for Disease Control ACE questionnaire. Health service use in the previous 12 months (number of GP consultations and hospital discharges) was extracted from electronic medical records. Negative binomial regression was conducted, adjusting for predisposing (age, sex), enabling (education, social class, having a medical card entitling holder to free GP care) and need factors (multimorbidity: 0, 1 or ≥2 chronic diseases), using Stata 12. Results HSU data were available on 2026 participants (99% of total sample = 2047), 1885 of whom completed the ACE questionnaire. Overall, 23.4% ( n = 4 41, 95% CI: 21–25%) reported a history of ACE. Adjusting for age, sex, education, social class and medical card status, a history of ACE was significantly associated with a higher number of GP consultations (incidence rate ratio, IRR = 1.2, p 0.001; 95% CI 1.0–1.3). However, the association was not significant when multimorbidity was included in the model (IRR = 1.1, p > 0 .05, 95% CI: 1.0–1.2). Significant factors included having a medical card (IRR = 1.92, 95% CI: 1.7–2.1), multimorbidity (IRR = 1.9, 95% CI: 1.7–2.2) and third level education (IRR = 0.8. 96% CI = 0.7–0.9). ACE was not significantly associated with number of hospital discharges (IRR = 1.5, p = 0 .124, 95% CI: 0.9–2.5). Discussion Adverse childhood experience has been conceptualised as a need factor which may influence health service utilisation. Our results suggest that the impact of ACE on the frequency of GP consultations may be mediated through enabling factors such as free access to services and other need factors such as multimorbidity.

Background Multimorbidity poses many dilemmas for healthcare provision, research and educational innovation. This study explores how general practitioners (GPs) currently deal with challenges in the management of multimorbid patients, with a view to identifying targets suitable for professional-orientated interventions to optimise multimorbidity care. Methods Design: In-depth qualitative interviews incorporating chart stimulated recall, a clinical assessment tool that uses a medical chart to stimulate a physician’s recall of a case and its management. Setting: Primary care in the Republic of Ireland. Participants: GPs purposively sampled from continuing professional development groups, using sampling criteria of: length of time qualified; location (rural/urban); and practice size (single/group). Analysis: Interviews were coded using the grounded theory method of constant comparison and theory was developed iteratively. Results Twenty GPs were interviewed on a total of 51 patient cases. In multimorbid patients perceived as ‘stable’, even those with high levels of polypharmacy, the default position for GPs was to ‘maintain the status quo’. This approach of not changing medications, unless there was clear evidence of harm, arose from GP fear that future events would be linked to the act of removing medications or the act would lead to patient perception of withdrawal of care. For cases with a changing disease trajectory, GPs integrated information from multiple sources, such as the patient, specialists and evidence based medicine. Difficulties arose when this information conflicted. GPs responded to this scenario by ‘satisficing’ with respect to chronic disease targets; ‘broadening the loop’ to increase the relative input of other healthcare professionals; ‘negotiation’ with specialist or patient, or GP acting as ‘final arbitrator’. Conflicts most commonly arose when GPs were isolated from other generalists, or had difficulties in the doctor-patient relationship. Conclusion This study identified potential weaknesses in the decision making process in multimorbidity, which related to lack of GP empowerment, access to professional support, and communication with patients. These novel findings will inform the development of a professional-orientated intervention, to assist GPs in the provision of multimorbidity care.

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., Road Safety Authority of Ireland