Further development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ).

OBJECTIVES: To undertake further psychometric testing of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and examine whether reversing the scale reduced floor effects. DESIGN: Survey. SETTING: UK primary care. PARTICIPANTS: Adults (≥18 years) with three or more long-term conditions randomly selected from four general practices and invited by post. MEASURES: Baseline survey: sociodemographics, MTBQ (original or version with scale reversed), Treatment Burden Questionnaire (TBQ), four questions (from QQ-10) on ease of completing the questionnaires. Follow-up survey (1-4 weeks after baseline): MTBQ, TBQ and QQ-10. Anonymous data collected from electronic GP records: consultations (preceding 12 months) and long-term conditions. The proportion of missing data and distribution of responses were examined for the original and reversed versions of the MTBQ and the TBQ. Intraclass correlation coefficient (ICC) and Spearman's rank correlation (Rs) assessed test-retest reliability and construct validity, respectively. Ease of completing the MTBQ and TBQ was compared. Interpretability was assessed by grouping global MTBQ scores into 0 and tertiles (>0). RESULTS: 244 adults completed the baseline survey (consent rate 31%, mean age 70 years) and 225 completed the follow-up survey. Reversing the scale did not reduce floor effects or data skewness. The global MTBQ scores had good test-retest reliability (ICC for agreement at baseline and follow-up 0.765, 95% CI 0.702 to 0.816). Global MTBQ score was correlated with global TBQ score (Rs 0.77, p<0.001), weakly correlated with number of consultations (Rs 0.17, p=0.010), and number of different general practitioners consulted (Rs 0.23, p<0.001), but not correlated with number of long-term conditions (Rs -0.063, p=0.330). Most participants agreed that both the MTBQ and TBQ were easy to complete and included aspects they were concerned about. CONCLUSION: This study demonstrates test-retest reliability and ease of completion of the MTBQ and builds on a previous study demonstrating good content validity, construct validity and internal consistency reliability of the questionnaire.

A primary care research agenda for multiple long-term conditions: a Delphi study.

BACKGROUND: Multiple long-term conditions (MLTC), also known as multimorbidity, has been identified as a priority research topic globally. Research priorities from the perspectives of patients and research funders have been described. Although most care for MLTC is delivered in primary care, the priorities of academic primary care have not been identified. AIM: To identify and prioritise the academic primary care research agenda for MLTC. DESIGN AND SETTING: This was a three-phase study with primary care MLTC researchers from the UK and other high-income countries. METHOD: The study consisted of: an open-ended survey question, a face-to-face workshop to elaborate questions with researchers from the UK and Ireland, and a two-round Delphi consensus survey with international multimorbidity researchers. RESULTS: Twenty-five primary care researchers responded to the initial open-ended survey and generated 84 potential research questions. In the subsequent workshop discussion (n = 18 participants), this list was reduced to 31 questions. The longlist of 31 research questions was included in round 1 of the Delphi; 27 of the 50 (54%) round 1 invitees and 24 of the 27 (89%) round 2 invitees took part in the Delphi. Ten questions reached final consensus. These questions focused broadly on addressing the complexity of the patient group with development of new models of care for multimorbidity, and methods and data development. CONCLUSION: These high-priority research questions offer funders and researchers a basis on which to build future grant calls and research plans. Addressing complexity in this research is needed to inform improvements in systems of care and for disease prevention.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Educational inequality in multimorbidity: causality and causal pathways. A mendelian randomisation study in UK Biobank.

BACKGROUND: Multimorbidity, typically defined as having two or more long-term health conditions, is associated with reduced wellbeing and life expectancy. Understanding the determinants of multimorbidity, including whether they are causal, may help with the design and prioritisation of prevention interventions. This study seeks to assess the causality of education, BMI, smoking and alcohol as determinants of multimorbidity, and the degree to which BMI, smoking and alcohol mediate differences in multimorbidity by level of education. METHODS: Participants were 181,214 females and 155,677 males, mean ages 56.7 and 57.1 years respectively, from UK Biobank. We used a Mendelian randomization design; an approach that uses genetic variants as instrumental variables to interrogate causality. RESULTS: The prevalence of multimorbidity was 55.1%. Mendelian randomization suggests that lower education, higher BMI and higher levels of smoking causally increase the risk of multimorbidity. For example, one standard deviation (equivalent to 5.1 years) increase in genetically-predicted years of education decreases the risk of multimorbidity by 9.0% (95% CI: 6.5 to 11.4%). A 5 kg/m2 increase in genetically-predicted BMI increases the risk of multimorbidity by 9.2% (95% CI: 8.1 to 10.3%) and a one SD higher lifetime smoking index increases the risk of multimorbidity by 6.8% (95% CI: 3.3 to 10.4%). Evidence for a causal effect of genetically-predicted alcohol consumption on multimorbidity was less strong; an increase of 5 units of alcohol per week increases the risk of multimorbidity by 1.3% (95% CI: 0.2 to 2.5%). The proportions of the association between education and multimorbidity explained by BMI and smoking are 20.4% and 17.6% respectively. Collectively, BMI and smoking account for 31.8% of the educational inequality in multimorbidity. CONCLUSIONS: Education, BMI, smoking and alcohol consumption are intervenable causal risk factors for multimorbidity. Furthermore, BMI and lifetime smoking make a considerable contribution to the generation of educational inequalities in multimorbidity. Public health interventions that improve population-wide levels of these risk factors are likely to reduce multimorbidity and inequalities in its occurrence.

Treatment burden in multiple long-term conditions: a mixed-methods study protocol.

BACKGROUND: Treatment burden represents the work patients undertake because of their health care, and the impact of that effort on the patient. Most research has focused on older adults (aged >65 years) with multiple long-term conditions (multimorbidity) (MLTC-M), but there are now more younger adults (aged 18-65 years) living with MLTC-M and they may experience treatment burden differently. Understanding experiences of treatment burden, and identifying those most at risk of high treatment burden, are important for designing primary care services to meet their needs. AIM: To understand the treatment burden associated with MLTC-M, for people aged 18-65 years, and how primary care services affect this burden. DESIGN & SETTING: Mixed-methods study in up to 33 primary care practices in two UK regions. METHOD: The following two approaches will be used: (i) in-depth qualitative interviews with adults living with MLTC-M (approximately 40 participants) to understand their experiences of treatment burden and the impact of primary care, with a think-aloud aspect to explore face validity of a novel short treatment burden questionnaire (STBQ) for routine clinical use in the initial 15 interviews; (ii) cross-sectional patient survey (approximately 1000 participants), with linked routine medical record data to examine the factors associated with treatment burden for people living with MLTC-M, and to test the validity of STBQ. CONCLUSION: This study will generate in-depth understanding of the treatment burden experienced by people aged 18-65 years living with MLTC-M, and how primary care services affect this burden. This will inform further development and testing of interventions to reduce treatment burden, and potentially influence MLTC-M trajectories and improve health outcomes.

Association between continuity of primary care and both prescribing and adherence of common cardiovascular medications: a cohort study among patients in England.

OBJECTIVES: To investigate whether better continuity of care is associated with increased prescribing of clinically relevant medication and improved medication adherence. SETTING: Random sample of 300 000 patients aged 30+ in 2017 within 83 English general practitioner (GP) practices from the Clinical Practice Research Datalink. DESIGN: Patients were assigned to a randomly selected index date in 2017 on which medication use and continuity of care were determined. Adjusted associations between continuity of care and the prescribing and adherence of five cardiovascular medication groups were examined using logistic regression. PARTICIPANTS: Continuity of Care Index was calculated for 173 993 patients with 4+ GP consultations 2 years prior to their index date and divided into five categories: absence of continuity, below-average continuity, average, above-average continuity and perfect continuity. MAIN OUTCOME MEASURES: (A) Prescription for statins (primary or secondary prevention separately), anticoagulants, antiplatelet agents and antihypertensives covering the patient's index date. (B) Adherence (>80%) estimated using medication possession ratio. RESULTS: There was strong evidence (p<0.01) that prescription of all five cardiovascular medication groups increased with greater continuity of care. Patients with absence of continuity were less likely to be prescribed cardiovascular medications than patients with above-average continuity (statins primary prevention OR 0.73, 95% CI 0.59 to 0.85; statins secondary prevention 0.77, 95% CI 0.57 to 1.03; antiplatelets 0.55, 95% CI 0.33 to 0.92; antihypertensives 0.51, 95% CI 0.39 to 0.65). Furthermore, patients with perfect continuity were more likely to be prescribed cardiovascular medications than those with above-average continuity (statins primary prevention OR 1.23, 95% CI 1.01 to 1.49; statins secondary prevention 1.37, 95% CI 1.10 to 1.71; antiplatelets 1.37, 95% CI 1.08 to 1.74; antihypertensives 1.10, 95% CI 0.99 to 1.23). Continuity was generally not associated with medication adherence, except for adherence to statins for secondary prevention (OR 0.75, 95% CI 0.60 to 0.94 for average compared with above-average continuity). CONCLUSION: Better continuity of care is associated with improved prescribing of medication to patients at higher risk of cardiovascular disease but does not appear to be related to patient's medication adherence.

Do general practitioners working in or alongside the emergency department improve clinical outcomes or experience? A mixed-methods study.

OBJECTIVES: To examine the effect of general practitioners (GPs) working in or alongside the emergency department (GPED) on patient outcomes and experience, and the associated impacts of implementation on the workforce. DESIGN: Mixed-methods study: interviews with service leaders and NHS managers; in-depth case studies (n=10) and retrospective observational analysis of routinely collected national data. We used normalisation process theory to map our findings to the theory's four main constructs of coherence, cognitive participation, collective action and reflexive monitoring. SETTING AND PARTICIPANTS: Data were collected from 64 EDs in England. Case site data included: non-participant observation of 142 clinical encounters; 467 semistructured interviews with policy-makers, service leaders, clinical staff, patients and carers. Retrospective observational analysis used routinely collected Hospital Episode Statistics alongside information on GPED service hours from 40 hospitals for which complete data were available. RESULTS: There was disagreement at individual, stakeholder and organisational levels regarding the purpose and potential impact of GPED (coherence). Participants criticised policy development and implementation, and staff engagement was hindered by tensions between ED and GP staff (cognitive participation). Patient 'streaming' processes, staffing and resource constraints influenced whether GPED became embedded in routine practice. Concerns that GPED may increase ED attendance influenced staff views. Our quantitative analysis showed no detectable impact on attendance (collective action). Stakeholders disagreed whether GPED was successful, due to variations in GPED model, site-specific patient mix and governance arrangements. Following statistical adjustment for multiple testing, we found no impact on: ED reattendances within 7 days, patients discharged within 4 hours of arrival, patients leaving the ED without being seen; inpatient admissions; non-urgent ED attendances and 30-day mortality (reflexive monitoring). CONCLUSIONS: We found a high degree of variability between hospital sites, but no overall evidence that GPED increases the efficient operation of EDs or improves clinical outcomes, patient or staff experience. TRIAL REGISTRATION NUMBER: ISCRTN5178022.

The person-based development and realist evaluation of a summary report for GP consultations [version 1; peer review: 2 approved].

Background: Use of telephone, video and e-consultations is increasing. These can make consultations more transactional. This study aimed to develop a complex intervention to address patients' concerns more comprehensively in general practice and test the feasibility of this in a cluster-randomised framework.The complex intervention used two technologies: a patient-completed pre-consultation form used at consultation opening and a doctor-provided summary report provided at consultation closure. This paper reports on the development and realist evaluation of the summary report. Methods: A person-based approach was used to develop the summary report. An electronic protocol was designed to automatically generate the report after GPs complete a clinical template in the patient record. This was tested with 45 patients in 3 rounds each, with iterative adjustments made based on feedback after each round. Subsequently, an intervention incorporating the pre-consultation form with the summary report was then tested in a cluster-randomised framework with 30 patients per practice in six practices: four randomised to intervention, and two to control. An embedded realist evaluation was carried out. The main feasibility study results are reported elsewhere. Results: Intervention Development: 15 patients were recruited per practice. Eight patients and six GPs were interviewed and 18 changes made. The summary report improved substantially; GPs and patients in the final practice were more satisfied with the report than the first practice.Realist evaluation: The summary was most useful for consultations when safety-netting advice was important or with multiple complex follow-up steps in patients who have difficulty remembering or communicating. It generated greater clarity on the follow-up and greater patient empowerment and reassurance. Conclusions: The person-based approach was successful. The summary report creates clarity, empowerment and reassurance in certain consultations and patients. As it takes a few minutes per patient, GPs prefer to select patients who will benefit most.

'I guess I'll wait to hear'- communication of blood test results in primary care a qualitative study.

BACKGROUND: Rates of blood testing in primary care are rising. Communicating blood test results generates significant workload for patients, GPs, and practice staff. AIM: To explore GPs' and patients' experience of systems of blood test communication. DESIGN AND SETTING: Qualitative interviews with patients and GPs in UK primary care in both urban and rural practices in the West of England. METHOD: A total of 28 patients and 19 GPs from six practices were recruited, with a range of socioeconomic and demographic characteristics. Patients were interviewed at two time points: a) at or soon after their blood test and b) after they had received their test results. The GPs who requested the tests were also interviewed (they could complete a maximum of two interviews about different patients). Eighty qualitative interviews were undertaken; 54 patient interviews and 26 GP interviews. RESULTS: Methods of test result communication varied between doctors and were based on habits, unwritten heuristics, and personal preferences rather than protocols. Doctors expected patients to know how to access their test results. In contrast, patients were often uncertain and used guesswork to decide when and how to access their tests. Patients and doctors generally assumed that the other party would make contact, with potential implications for patient safety. Text messaging and online methods of communication have benefits, but were perceived by some patients as 'flippant' or 'confusing'. Delays and difficulties obtaining and interpreting test results can lead to anxiety and frustration for patients. CONCLUSION: Current systems of test result communication are complex and confusing, and mostly based on habits and routines rather than clear protocols. This has important implications for patient-centred care and patient safety.

Blood tests in primary care: A qualitative study of communication and decision-making between doctors and patients.

OBJECTIVE: Blood tests are commonly used in primary care as a tool to aid diagnosis, and to offer reassurance and validation for patients. If doctors and patients do not have a shared understanding of the reasons for testing and the meaning of results, these aims may not be fulfilled. Shared decision-making is widely advocated; yet, most research focusses on treatment decisions rather than diagnostic decisions. The aim of this study was to explore communication and decision-making around diagnostic blood tests in primary care. METHODS: Qualitative interviews were undertaken with patients and clinicians in UK primary care. Patients were interviewed at the time of blood testing, with a follow-up interview after they received test results. Interviews with clinicians who requested the tests provided paired data to compare clinicians' and patients' expectations, experiences and understandings of tests. Interviews were analysed thematically using inductive and deductive coding. RESULTS: A total of 80 interviews with 28 patients and 19 doctors were completed. We identified a mismatch in expectations and understanding of tests, which led to downstream consequences including frustration, anxiety and uncertainty for patients. There was no evidence of shared decision-making in consultations preceding the decision to test. Doctors adopted a paternalistic approach, believing that they were protecting patients from anxiety. CONCLUSION: Patients were not able to develop informed preferences and did not perceive that choice is possible in decisions about testing, because they did not have sufficient information and a shared understanding of tests. A lack of shared understanding at the point of decision-making led to downstream consequences when test results did not fulfil patients' expectations. Although shared decision-making is recommended as best practice, it does not reflect the reality of doctors' and patients' accounts of testing; a broader model of shared understanding seems to be more relevant to the complexity of primary care diagnosis. PATIENT OR PUBLIC CONTRIBUTION: A patient and public involvement group comprising five participants with lived experience of blood testing in primary care met regularly during the study. They contributed to the development of the research objectives, planning recruitment methods, reviewing patient information leaflets and topic guides and also contributed to discussion of emerging themes at an early stage in the analysis process.

Perspectives of GPs working in or alongside emergency departments in England: qualitative findings from the GPs and Emergency Departments Study.

BACKGROUND: Around 43% of emergency department (ED) attendances can be managed in general practice. Strategies to address this include directing appropriate patients to GPs working in or alongside EDs (GPED). Views of GPs choosing to work in GPED roles may inform planning and implementation of GPED services as well as wider general practice provision. AIM: To explore the experiences and motivations of GPs choosing to work in GPED services in England, and to identify factors that may support or hinder GPs working in GPED roles. DESIGN AND SETTING: Thematic analysis of 42 semi-structured interviews of GPs working in 10 GPED case sites across England. METHOD: Qualitative GP interviews from a mixed-methods study of GPs in GPED roles were thematically analysed in relation to research aims. RESULTS: Four themes were generated: the 'pull' of a portfolio career; the 'push' of disillusionment with general practice; professional reciprocity; sustainability of GPED services and core general practice. Flexible, favourable working conditions, collaboration, and professional development made GPED an attractive workplace, often as part of a portfolio career or after retiring from core general practice. Working in GPED services was largely driven by disillusionment with core general practice. Both GPED and core general practice were thought to benefit from GPED GPs' skills. There were concerns about GPED sustainability and destabilisation of core general practice. CONCLUSION: GPED may extend the clinical careers of experienced GPs and support recruitment and retention of more recently qualified GPs. Despite some benefits, GPED may destabilise core general practice and increase pressure on both environments.

Danish validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and findings from a population health survey: a mixed-methods study.

OBJECTIVE: To validate the Danish Multimorbidity Treatment Burden Questionnaire (MTBQ) and obtain a population-based evaluation of treatment burden. DESIGN: Mixed-methods. SETTING: Danish population-based survey. PARTICIPANTS: Translation by professional translators and an expert group. The scale was tested by 13 407 participants (aged ≥25 years) in treatment. MEASURES: The 10-item MTBQ was translated into Danish using forward-backward translation and used in a large population health survey. A global MTBQ score was calculated and factor analysis and Cronbach's alpha assessed dimensional structure and internal consistency reliability, respectively. Spearman's rank correlations between global MTBQ scores and scores of self-rated health, health-related quality of life and the number of long-term conditions, respectively, assessed construct validity. MTBQ scores were grouped into four categories (no, low, medium, high burden) to assess interpretability and population-based evaluation of treatment burden. RESULTS: The scale showed high internal consistency (α=0.87), positive skewness and large floor effects. Factor analysis supported a one-dimensional structure of the scale with a three-dimensional structure as a less parsimonious alternative. The MTBQ score was negatively associated with self-rated health (rS-0.45, p<0.0001) and health-related quality of life (rS-0.46/-0.51, p<0.0001), and positively associated with the number of long-term conditions (rS 0.26, p<0.0001) and perceived stress (rS 0.44, p<0.0001). Higher treatment burden was associated with young age, male sex, high educational level, unemployment, being permanently out of work, not living with a spouse/cohabitant, living with child(ren) and long-term conditions (eg, heart attack, stroke, diabetes and mental illness). CONCLUSION: The Danish MTBQ is a valid measure of treatment burden with good construct validity and high internal reliability. This is the first study to explore treatment burden at a population level and provides important evidence to policy makers and clinicians about sociodemographic groups at risk of higher treatment burden.

The person-based development and realist evaluation of a pre-consultation form for GP consultations.

Background: Use of telephone, video and e-consultations is increasing. These can make consultations more transactional, potentially missing patients' concerns. This study aimed to develop a complex intervention to address patients' concerns more comprehensively in general practice and test the feasibility of this in a cluster-randomised framework.The complex intervention used two technologies: a patient-completed pre-consultation form used at consultation opening and a doctor-provided summary report provided at consultation closure. This paper reports on the development and realist evaluation of the pre-consultation questionnaire. Methods: A person-based approach was used to develop the pre-consultation form. An online questionnaire system was designed to allow patient self-completion of a form which could be shared with GPs. This was tested with 45 patients in three rounds, with iterative adjustments made based on feedback after each round.Subsequently, an intervention incorporating the pre-consultation form with the summary report was then tested in a cluster-randomised framework with 30 patients per practice in six practices: four randomised to intervention, and two to control. An embedded realist evaluation was carried out. The main feasibility study results are reported elsewhere. Results: Intervention Development: 15 patients were recruited per practice. Twelve patients, six GPs and three administrators were interviewed and 32 changes were made iteratively in three rounds. Recruitment rates (proportion of patients responding to the text) increased from 15% in round one to 50% in round three.Realist evaluation: The pre-consultation form was most useful for people comfortable with technology and with hidden concerns or anxiety about the consultation. It resulted in more issues being discussed and support provided, more effective use of time and greater patient satisfaction. Conclusions: The person-based approach was successful. The pre-consultation form uncovers more depth and improves satisfaction in certain consultations and patients. Technological improvements are required before this could be rolled out more widely.

THE PROBLEM: For some patients, GP consultations are too short. Sometimes patients' problems are missed. We wanted to improve GP consultations. What we did: We developed a better way to start and end consultations using a new digital method. Before a GP consultation, patients fill in a form online that lets them describe their problems. This is shared with their GP. At the end of the consultation GPs can give patients a one-page summary of what was discussed. This paper reports on how we developed and tested the online pre-consultation form. How we tested it: We first piloted the online form in three GP practices in turn. We interviewed patients, GPs and an administrator in each practice and made changes based on their suggestions. Each new version was tested in a new practice. We then tested the final online form together with the one-page summary in four practices with 30 patients each. We interviewed patients and GPs to find who it was most useful for and when. What we found: GPs and patients agreed the final version of the online form was much better than the first version. The percentage of patients who filled in a form after getting a text message increased from 15% in practice 1 to 50% in practice 3. By testing the final form in four practices, we found it worked best for people who find technology easy to use and have hidden concerns or worries about the consultation. These patients found their GP was better prepared and problems were dealt with better. GPs thought consultations were more efficient. CONCLUSIONS: The approach we took was very successful in developing the online form and patients and GPs found it useful. The technology would need to be improved before it could be rolled out more widely.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Introduction: Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. Methods: This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. Ethics and dissemination: The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. ISRCTN Registration: 90146150 (28/03/2019).

Doctor-patient communication about blood tests: Qualitative interview study in general practice.

Context: Shared decision making is widely advocated, however most research focuses on treatment decisions. Evidence for shared decision-making in relation to diagnostic testing is limited to specific tests such as prostate specific antigen, screening and genetic tests. There is a lack of evidence regarding the relevance of shared decision-making to routine blood tests, despite increasing rates of laboratory testing in primary care. Objectives: To explore shared decision making and communication around routine blood tests in primary care. Study design: Qualitative interview study Setting: UK primary care Population studied: Qualitative interviews were undertaken with patients at two time points: (a) at or soon after their blood test and (b) after they had received their test results. We also undertook interviews with the patients' GPs who requested the tests. This gave us paired data which enabled to us to examine areas of congruence and dissonance between GPs' and patients' expectations, experience and understanding of testing. A total of 80 interviews with 28 patients and 19 doctors were completed, reflecting a range of socioeconomic and demographic characteristics. Interviews were digitally recorded, transcribed and analyzed using thematic analysis using a mixture of inductive and deductive coding and constant comparison. Results: There were no examples of shared decision making identified in any of the interviews, indeed patients were frequently unaware of which blood tests had been done and why. Barriers to a shared understanding of blood testing were identified including the complexity and technical nature of information, a lack of resources for information sharing and a perception that blood tests were low priority for information sharing. Doctors perceived that a paternalistic approach to testing could be justified to protect patients from anxiety. Misunderstanding and a lack of communication around testing and test results led to uncertainty, anxiety and frustration for patients. Conclusions: The results have implications, not just for models of shared decision making, but more fundamentally, informed consent. Shared decision-making for diagnostic testing differs from treatment decisions. Promoting a shared understanding and shared decision-making could help rationalize testing, potentially reducing unnecessary investigations and improving patient-centered care.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BACKGROUND: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. METHODS: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. RESULTS: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). CONCLUSIONS: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Maintaining face-to-face contact during the COVID-19 pandemic: a longitudinal qualitative investigation in UK primary care.

BACKGROUND: In March 2020, the COVID-19 pandemic required a rapid reconfiguration of UK general practice to minimise face-to-face contact with patients to reduce infection risk. However, some face-to-face contact remained necessary and practices needed to ensure such contact could continue safely. AIM: To examine how practices determined when face-to-face contact was necessary and how face-to-face consultations were reconfigured to reduce COVID-19 infection risk. DESIGN & SETTING: Qualitative interview study in general practices in Bristol, North Somerset, and South Gloucestershire. METHOD: Longitudinal semi-structured interviews with clinical and managerial practice staff were undertaken at four timepoints between May and July 2020. RESULTS: Practices worked flexibly within general national guidance to determine when face-to-face contact with patients was necessary, influenced by knowledge of the patient, experience, and practice resilience. For example, practices prioritised patients according to clinical need using face-to-face contact to resolve clinician uncertainty or provide adequate reassurance to patients. To make face-to-face contact as safe as possible and keep patients separated, practices introduced a heterogeneous range of measures that exploited features of their indoor and outdoor spaces, and altered their appointment processes. As national restrictions eased in June and July, the number and proportion of patients seen face to face generally increased. However, the reconfiguration of buildings and processes reduced the available capacity and put increased pressure on practices. CONCLUSION: Practices responded rapidly and creatively to the initial lockdown restrictions. The variety of ways practices organised face-to-face contact to minimise infection highlights the need for flexibility in guidance.

The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study.

BACKGROUND: Most patients who present with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common (at least 50% of patients treated for depression will relapse after a single episode) and leads to considerable morbidity and decreased quality of life for patients. The majority of patients will relapse within 6 months, and those with a history of relapse are more likely to relapse in the future than those with no such history. GPs see a largely undifferentiated case-mix of patients, and once patients with depression reach remission, there is limited guidance to help GPs stratify patients according to risk of relapse. We aim to develop a prognostic model to predict an individual's risk of relapse within 6-8 months of entering remission. The long-term objective is to inform the clinical management of depression after the acute phase. METHODS: We will develop a prognostic model using secondary analysis of individual participant data drawn from seven RCTs and one longitudinal cohort study in primary or community care settings. We will use logistic regression to predict the outcome of relapse of depression within 6-8 months. We plan to include the following established relapse predictors in the model: residual depressive symptoms, number of previous depressive episodes, co-morbid anxiety and severity of index episode. We will use a "full model" development approach, including all available predictors. Performance statistics (optimism-adjusted C-statistic, calibration-in-the-large, calibration slope) and calibration plots (with smoothed calibration curves) will be calculated. Generalisability of predictive performance will be assessed through internal-external cross-validation. Clinical utility will be explored through net benefit analysis. DISCUSSION: We will derive a statistical model to predict relapse of depression in remitted depressed patients in primary care. Assuming the model has sufficient predictive performance, we outline the next steps including independent external validation and further assessment of clinical utility and impact. STUDY REGISTRATION: ClinicalTrials.gov ID: NCT04666662.