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.

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.

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.

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).

The contribution of depressive 'disorder characteristics' to determinations of prognosis for adults with depression: an individual patient data meta-analysis.

BACKGROUND: This study aimed to investigate general factors associated with prognosis regardless of the type of treatment received, for adults with depression in primary care. METHODS: We searched Medline, Embase, PsycINFO and Cochrane Central (inception to 12/01/2020) for RCTs that included the most commonly used comprehensive measure of depressive and anxiety disorder symptoms and diagnoses, in primary care depression RCTs (the Revised Clinical Interview Schedule: CIS-R). Two-stage random-effects meta-analyses were conducted. RESULTS: Twelve (n = 6024) of thirteen eligible studies (n = 6175) provided individual patient data. There was a 31% (95%CI: 25 to 37) difference in depressive symptoms at 3-4 months per standard deviation increase in baseline depressive symptoms. Four additional factors: the duration of anxiety; duration of depression; comorbid panic disorder; and a history of antidepressant treatment were also independently associated with poorer prognosis. There was evidence that the difference in prognosis when these factors were combined could be of clinical importance. Adding these variables improved the amount of variance explained in 3-4 month depressive symptoms from 16% using depressive symptom severity alone to 27%. Risk of bias (assessed with QUIPS) was low in all studies and quality (assessed with GRADE) was high. Sensitivity analyses did not alter our conclusions. CONCLUSIONS: When adults seek treatment for depression clinicians should routinely assess for the duration of anxiety, duration of depression, comorbid panic disorder, and a history of antidepressant treatment alongside depressive symptom severity. This could provide clinicians and patients with useful and desired information to elucidate prognosis and aid the clinical management of depression.

The Impact of Digital-First Consultations on Workload in General Practice: Modeling Study.

BACKGROUND: Health services in many countries are promoting digital-first models of access to general practice based on offering online, video, or telephone consultations before a face-to-face consultation. It is claimed that this will improve access for patients and moderate the workload of doctors. However, improved access could also potentially increase doctors' workload. OBJECTIVE: The aim of this study was to explore whether and under what circumstances digital-first access to general practice is likely to decrease or increase general practice workload. METHODS: A process map to delineate primary care access pathways was developed and a model to estimate general practice workload constructed in Microsoft Excel (Microsoft Corp). The model was populated using estimates of key variables obtained from a systematic review of published studies. A MEDLINE search was conducted for studies published in English between January 1, 2000, and September 30, 2019. Included papers provided quantitative data about online, telephone, or video consultations for unselected patients requesting a general practice in-hours consultation for any problem. We excluded studies of general practitioners consulting specialists, consultations not conducted by doctors, and consultations conducted after hours, in secondary care, in specialist services, or for a specific health care problem. Data about the following variables were extracted from the included papers to form the model inputs: the proportion of consultations managed digitally, the proportion of digital consultations completed without a subsequent consultation, the proportion of subsequent consultations conducted by telephone rather than face-to-face, consultation duration, and the proportion of digital consultations that represent new demand. The outcome was general practice workload. The model was used to test the likely impact of different digital-first scenarios, based on the best available evidence and the plausible range of estimates from the published studies. The model allows others to test the impact on workload of varying assumptions about model inputs. RESULTS: Digital-first approaches are likely to increase general practice workload unless they are shorter, and a higher proportion of patients are managed without a subsequent consultation than observed in most published studies. In our base-case scenarios (based on the best available evidence), digital-first access models using online, telephone, or video consultations are likely to increase general practitioner workload by 25%, 3%, and 31%, respectively. An important determinant of workload is whether the availability of digital-first approaches changes the demand for general practice consultations, but there is little robust evidence to answer this question. CONCLUSIONS: Digital-first approaches to primary care could increase general practice workload unless stringent conditions are met. Justification for these approaches should be based on evidence about the benefits in relation to the costs, rather than assumptions about reductions in workload. Given the potential increase in workload, which in due course could worsen problems of access, these initiatives should be implemented in a staged way alongside careful evaluation.

Private Video Consultation Services and the Future of Primary Care.

In many countries, private companies provide primary care services based predominantly on offering video consultations via smartphones. One example is Babylon GP at Hand (BGPaH), which offers video consultations to National Health Service patients, 24 hours a day, and has grown rapidly in London over the last 3 years. The development of this type of service has been controversial, particularly in the United Kingdom, but there has been little formal published evaluation of these services in any country. This paper outlines the main controversies about the use of privately provided video consultation services for primary care and shows how they are informed by the limited evaluations that have been conducted, particularly the evaluation of BGPaH. This paper describes the advantages of these services in terms of convenience, speed of access, the ability to consult without traveling or face-to-face patient-doctor contact, and the possibility of recruiting doctors who cannot work in conventional settings or do not live near the patients. It also highlights the concerns and uncertainties about quality and safety, demand, fragmentation of care, impact on other health services, efficiency, and equity. There are questions about whether private primary care services based on video consultations have a sustainable business model and whether they will undermine other health care providers. During the recent COVID-19 pandemic, the use of video consulting has become more widespread within conventional primary care services, and this is likely to have lasting consequences for the future delivery of primary care. It is important to understand the extent to which lessons from the evaluation of BGPaH and other private services based on a video-first model are relevant to the use of video consulting within conventional general practices, and to consider the advantages and disadvantages of these developments, before video consultation-based services in primary care become more widely established.

Predictive value of inflammatory markers for cancer diagnosis in primary care: a prospective cohort study using electronic health records.

BACKGROUND: Early identification of cancer in primary care is important and challenging. This study examined the diagnostic utility of inflammatory markers (C-reactive protein, erythrocyte sedimentation rate and plasma viscosity) for cancer diagnosis in primary care. METHODS: Cohort study of 160,000 patients with inflammatory marker testing in 2014, plus 40,000 untested matched controls, using Clinical Practice Research Datalink (CPRD), with Cancer Registry linkage. Primary outcome was one-year cancer incidence. RESULTS: Primary care patients with a raised inflammatory marker have a one-year cancer incidence of 3.53% (95% CI 3.37-3.70), compared to 1.50% (1.43-1.58) in those with normal inflammatory markers, and 0.97% (0.87-1.07) in untested controls. Cancer risk is greater with higher inflammatory marker levels, with older age and in men; risk rises further when a repeat test is abnormal but falls if it normalises. Men over 50 and women over 60 with raised inflammatory markers have a cancer risk which exceeds the 3% NICE threshold for urgent investigation. Sensitivities for cancer were 46.1% for CRP, 43.6% ESR and 49.7% for PV. CONCLUSION: Cancer should be considered in patients with raised inflammatory markers. However, inflammatory markers have a poor sensitivity for cancer and are therefore not useful as 'rule-out' test.

Management of multimorbidity using a patient-centred care model: a pragmatic cluster-randomised trial of the 3D approach.

BACKGROUND: The management of people with multiple chronic conditions challenges health-care systems designed around single conditions. There is international consensus that care for multimorbidity should be patient-centred, focus on quality of life, and promote self-management towards agreed goals. However, there is little evidence about the effectiveness of this approach. Our hypothesis was that the patient-centred, so-called 3D approach (based on dimensions of health, depression, and drugs) for patients with multimorbidity would improve their health-related quality of life, which is the ultimate aim of the 3D intervention. METHODS: We did this pragmatic cluster-randomised trial in general practices in England and Scotland. Practices were randomly allocated to continue usual care (17 practices) or to provide 6-monthly comprehensive 3D reviews, incorporating patient-centred strategies that reflected international consensus on best care (16 practices). Randomisation was computer-generated, stratified by area, and minimised by practice deprivation and list size. Adults with three or more chronic conditions were recruited. The primary outcome was quality of life (assessed with EQ-5D-5L) after 15 months' follow-up. Participants were not masked to group assignment, but analysis of outcomes was blinded. We analysed the primary outcome in the intention-to-treat population, with missing data being multiply imputed. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN06180958. FINDINGS: Between May 20, 2015, and Dec 31, 2015, we recruited 1546 patients from 33 practices and randomly assigned them to receive the intervention (n=797) or usual care (n=749). In our intention-to-treat analysis, there was no difference between trial groups in the primary outcome of quality of life (adjusted difference in mean EQ-5D-5L 0·00, 95% CI -0·02 to 0·02; p=0·93). 78 patients died, and the deaths were not considered as related to the intervention. INTERPRETATION: To our knowledge, this trial is the largest investigation of the international consensus about optimal management of multimorbidity. The 3D intervention did not improve patients' quality of life. FUNDING: National Institute for Health Research.

Patient consultation rate and clinical and NHS outcomes: a cross-sectional analysis of English primary care data from 2.7 million patients in 238 practices.

BACKGROUND: Primary care workload is high and increasing in the United Kingdom. We sought to examine the association between rates of primary care consultation and outcomes in England. METHODS: Cross sectional observational study of routine electronic health care records in 283 practices from the Clinical Practice Research Datalink from April 2013 to March 2014. Outcomes included mortality rate, hospital admission rate, Quality and Outcomes Framework (QOF) performance and patient satisfaction. Relationships between consultation rates (with a general practitioner (GP) or nurse) and outcomes were investigated using negative binomial and ordinal logistic regression models. RESULTS: Rates of GP and nurse consultation (per patient person-year) were not associated with mortality or hospital admission rates: mortality incidence rate ratio (IRR) per unit change in GP/ nurse consultation rate = 1.01, 95% CI [0.98 to 1.04]/ 0.97, 95% CI [0.93 to 1.02]; hospital admission IRR per unit change in GP/ nurse consultation rate = 1.02, 95% CI [0.99 to 1.04]/ 0.98, 95% CI [0.94 to 1.032]. Higher rates of nurse but not GP consultation were associated with higher QOF achievement: OR = 1.91, 95% CI [1.39 to 2.62] per unit change in nurse consultation rate vs. OR = 1.04, 95% CI [0.87 to 1.24] per unit change in GP consultation rate. The association between the rates of GP/ nurse consultations and patient satisfaction was mixed. CONCLUSION: There are few associations between primary care consultation rates and outcomes. Previously identified demographic and staffing factors, rather than practice workload, appear to have the strongest relationships with mortality, admissions, performance and satisfaction. Studies with more detailed patient-level data would be required to explore these findings further.

Identifying policies and strategies for general practitioner retention in direct patient care in the United Kingdom: a RAND/UCLA appropriateness method panel study.

BACKGROUND: The United Kingdom (UK) is experiencing a general practitioner (GP) workforce retention crisis. Research has focused on investigating why GPs intend to quit, but less is known about the acceptability and effectiveness of policies and strategies to improve GP retention. Using evidence from research and key stakeholder organisations, we generated a set of potential policies and strategies aimed at maximising GP retention and tested their appropriateness for implementation by systematically consulting with GPs. METHODS: 28 GP Partners and GPs working in national stakeholder organisations from South West England and London were purposively sampled, and asked to take part in a RAND/UCLA Appropriateness Method panel. Panellists were asked to read an evidence briefing summary, and then complete an online survey on two occasions. During each round, participants rated the appropriateness of policies and strategies aimed at improving GP retention using a nine point scale (1 'extremely inappropriate' to 9 'extremely appropriate'). Fifty-four potential policies and strategies (equating to 100 statements) were tested, focusing on factors influencing job satisfaction (e.g. well-being, workload, incentives and remuneration, flexible working, human resources systems). Ratings were analysed for panel consensus and categorised based on appropriateness ('appropriate', 'uncertain', 'inappropriate'). RESULTS: 12/28 GPs approached agreed to take part, 9/28 completed two rounds of the online survey between February and June 2018. Panellists identified 24/54 policy and strategy areas (41/100 statements) as 'appropriate'. Examples included providing GP practices 'at risk' of experiencing GP shortages with a toolkit for managing recruitment and retention, and interventions to facilitate peer support to enhance health and wellbeing, or support portfolio careers. Strategies to limit GP workload, and manage patient demand were also endorsed. CONCLUSIONS: The panel of experienced GPs identified a number of practical ways to improve GP retention through interventions that might enhance job satisfaction and work-life balance. Future research should evaluate the impact of implementing these recommendations.

Practice variation in the use of tests in UK primary care: a retrospective analysis of 16 million tests performed over 3.3 million patient years in 2015/16.

BACKGROUND: The UK's National Health Service (NHS) is currently subject to unprecedented financial strain. The identification of unnecessary healthcare resource use has been suggested to reduce spending. However, there is little very research quantifying wasteful test use, despite the £3 billion annual expenditure. Geographical variation has been suggested as one metric in which to quantify inappropriate use. We set out to identify tests ordered from UK primary care that are subject to the greatest between-practice variation in their use. METHODS: We used data from 444 general practices within the Clinical Practice Research Datalink to calculate a coefficient of variation (CoV) for the ordering of 44 specific tests from UK general practices. The coefficient of variation was calculated after adjusting for differences between practice populations. We also determined the tests that had both a higher-than-average CoV and a higher-than-average rate of use. RESULTS: In total, 16,496,218 tests were ordered for 4,078,091 patients over 3,311,050 person-years from April 1, 2015, to March 31, 2016. The tests subject to the greatest variation were drug monitoring 158% (95%CI 153 to 163%), urine microalbumin (52% (95%CI 49.9 to 53.2%)), pelvic CT (51% (95%CI 50 to 53%)) and Pap smear (49% (95%CI 48 to 51%). Seven tests were classified as high variability and high rate (clotting, vitamin D, urine albumin, prostate-specific antigen (PSA), bone profile, urine MCS and C-reactive protein (CRP)). CONCLUSIONS: There are wide variations in the use of common tests, which is unlikely to be explained by clinical indications. Since £3 billion annually are spent on tests, this represents considerable variation in the use of resources and inefficient management in the NHS. Our results can be of value to policy makers, researchers, patients and clinicians as the NHS strives towards identifying overuse and underuse of tests.

A Core Outcome Set for Multimorbidity Research (COSmm).

PURPOSE: We aimed to develop a consensus-based set of core outcomes specifically for studies in multimorbidity. METHODS: We undertook a consensus study following the COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines for the design and reporting of core outcome sets. A Delphi panel of experts completed a web-based survey with 2 rounds. Panelists were presented with a range of outcomes that had been identified in previous workshops and a related systematic review. They indicated their level of agreement on whether each outcome should be included in the core set using a 5-point Likert scale, and outcomes reaching a prespecified consensus level were included. RESULTS: Of 30 individuals invited to be panelists, 26 from 13 countries agreed. All 26 completed both rounds of the survey. The Delphi panel reached consensus on 17 outcomes for inclusion in a core outcome set for multimorbidity (COSmm). The highest-ranked outcomes were health-related quality of life, mental health outcomes, and mortality. Other outcomes were grouped into overarching themes of patient-reported impacts and behaviors (treatment burden, self-rated health, self-management behavior, self-efficacy, adherence); physical activity and function (activities of daily living, physical function, physical activity); consultation related (communication, shared decision making, prioritization); and health systems (health care use, costs, quality of health care). CONCLUSIONS: This consensus study involved a wide range of international experts who identified a large number of outcomes for multimorbidity intervention studies. Our results suggest that quality of life, mental health outcomes, and mortality should be regarded as essential core outcomes. Researchers should, however, also consider the full range of outcomes when designing studies to capture important domains in multimorbidity depending on individual study aims and interventions.

Qualitative assessment of the primary care outcomes questionnaire: a cognitive interview study.

BACKGROUND: The Primary Care Outcomes Questionnaire (PCOQ) is a new patient-reported outcome measure designed specifically for primary care. This paper describes the developmental process of improving the item quality and testing the face validity of the PCOQ through cognitive interviews with primary care patients. METHODS: Two formats of the PCOQ were developed and assessed: the PCOQ-Status (which has an adjectival scale) and the PCOQ-Change (which has the same items as the PCOQ-Status, but a transitional scale). Three rounds of cognitive interviews were held with twenty patients from four health centres in Bristol. Patients seeking healthcare were recruited directly by their GP or practice nurse, and others not currently seeking healthcare were recruited from patient participation groups. An adjusted form of Tourangeau's model of cognitive processing was used to identify problems. This contained four categories: general comprehension, temporal comprehension, decision process, and response process. The resultant pattern of problems was used to assess whether the items and scales were working as intended, and to make improvements to the questionnaires. RESULTS: The problems identified in the PCOQ-Status reduced from 41 in round one to seven in round three. It was noted that the PCOQ-Status seemed to be capturing a subjective view of health which might not vary with age or long-term conditions. However, as it is designed to be evaluative (measuring change over time) as opposed to discriminative (measuring change between different groups of people), this does not present a problem for validity. The PCOQ-Status was both understood by patients and was face valid. The PCOQ-Change had less face validity, and was misunderstood by three out of six patients in round 1. It was not taken forward after this round. CONCLUSIONS: The cognitive interviews successfully contributed to the development of the PCOQ. Through this study, the PCOQ-Status was found to be well understood by patients, and it was possible to improve comprehension through each round of interviews. The PCOQ-Change was poorly understood and, given that this corroborates existing research, this may call into question the use of transitional questionnaires generally.

Patient understanding of two commonly used patient reported outcome measures for primary care: a cognitive interview study.

BACKGROUND: Standardised generic patient-reported outcome measures (PROMs) which measure health status are often unresponsive to change in primary care. Alternative formats, which have been used to increase responsiveness, include individualised PROMs (in which respondents specify the outcomes of interest in their own words) and transitional PROMs (in which respondents directly rate change over a period). The objective of this study was to test qualitatively, through cognitive interviews, two PROMs, one using each respective format. METHODS: The individualised PROM selected was the Measure Yourself Medical Outcomes Profile (MYMOP). The transitional PROM was the Patient Enablement Instrument (PEI). Twenty patients who had recently attended the GP were interviewed while completing the questionnaires. Interview data was analysed using a modification of Tourangeau's model of cognitive processing: comprehension, response, recall and face validity. RESULTS: Patients found the PEI simple to complete, but for some it lacked face validity. The transitional scale was sometimes confused with a status scale and was problematic in situations when the relevant GP appointment was part of a longer episode of care. Some patients reported a high enablement score despite verbally reporting low enablement but high regard for their GP, which suggested hypothesis-guessing. The interpretation of the PEI items was inconsistent between patients. MYMOP was more difficult for patients to complete, but had greater face validity than the PEI. The scale used was open to response-shift: some patients suggested they would recalibrate their definition of the scale endpoints as their illness and expectations changed. CONCLUSIONS: The study provides information for both users of PEI/MYMOP and developers of individualised and transitional questionnaires. Users should heed the recommendation that MYMOP should be interview-administered, and this is likely to apply to other individualised scales. The PEI is open to hypothesis-guessing and may lack face-validity for a longer episode of care (e.g. in patients with chronic conditions). Developers should be cognisant that transitional scales can be inconsistently completed: some patients forget during completion that they are measuring change from baseline. Although generic questionnaires require the content to be more general than do disease-specific questionnaires, developers should avoid questions which allow broad and varied interpretations.

Identification, description and appraisal of generic PROMs for primary care: a systematic review.

BACKGROUND: Patients attend primary care with many types of problems and to achieve a range of possible outcomes. There is currently a lack of patient-reported outcome measures (PROMs) designed to capture these diverse outcomes. The objective of this systematic review was to identify, describe and appraise generic PROMs suitable for measuring outcomes from primary care. METHODS: We carried out a systematic Medline search, supplemented by other online and hand-searches. All potentially relevant PROMs were itemised in a long-list. Each PROM in the long-list which met inclusion criteria was included in a short-list. Short-listed PROMs were then described in terms of their measurement properties and construct, based on a previously published description of primary care outcome as three constructs: health status, health empowerment and health perceptions. PROMs were appraised in terms of extent of psychometric testing (extensive, moderate, low) and level of responsiveness (high, medium, low, unknown). RESULTS: More than 5000 abstracts were identified and screened to identify PROMs potentially suitable for measuring outcomes from primary care. 321 PROMs were long-listed, and twenty PROMs were catalogued in detail. There were five PROMs which measured change directly, without need for a baseline. Although these had less strong psychometric properties, they may be more responsive to change than PROMs which capture status at a point in time. No instruments provided coverage of all three constructs. Of the health status questionnaires, the most extensively tested was the SF-36. Of the health empowerment instruments, the PEI, PAM and heiQ provided the best combination of responsiveness and psychometric testing. The health perceptions instruments were all less responsive to change, and may measure a form of health perception which is difficult to shift in primary care. CONCLUSIONS: This systematic review is the first of its kind to identify papers describing the development and validation of generic PROMs suitable for measuring outcomes from primary care. It identified that: 1) to date, there is no instrument which comprehensively covers the outcomes commonly sought in primary care, and 2) there are different benefits both to PROMs which measure status at a point in time, and PROMs which measure change directly.

Clinical workload in UK primary care: a retrospective analysis of 100 million consultations in England, 2007-14.

BACKGROUND: Primary care is the main source of health care in many health systems, including the UK National Health Service (NHS), but few objective data exist for the volume and nature of primary care activity. With rising concerns that NHS primary care workload has increased substantially, we aimed to assess the direct clinical workload of general practitioners (GPs) and practice nurses in primary care in the UK. METHODS: We did a retrospective analysis of GP and nurse consultations of non-temporary patients registered at 398 English general practices between April, 2007, and March, 2014. We used data from electronic health records routinely entered in the Clinical Practice Research Datalink, and linked CPRD data to national datasets. Trends in age-standardised and sex-standardised consultation rates were modelled with joinpoint regression analysis. FINDINGS: The dataset comprised 101,818,352 consultations and 20,626,297 person-years of observation. The crude annual consultation rate per person increased by 10·51%, from 4·67 in 2007-08, to 5·16 in 2013-14. Consultation rates were highest in infants (age 0-4 years) and elderly people (≥85 years), and were higher for female patients than for male patients of all ages. The greatest increases in age-standardised and sex-standardised rates were in GPs, with a rise of 12·36% per 10,000 person-years, compared with 0·9% for practice nurses. GP telephone consultation rates doubled, compared with a 5·20% rise in surgery consultations, which accounted for 90% of all consultations. The mean duration of GP surgery consultations increased by 6·7%, from 8·65 min (95% CI 8·64-8·65) to 9·22 min (9·22-9·23), and overall workload increased by 16%. INTERPRETATION: Our findings show a substantial increase in practice consultation rates, average consultation duration, and total patient-facing clinical workload in English general practice. These results suggest that English primary care as currently delivered could be reaching saturation point. Notably, our data only explore direct clinical workload and not indirect activities and professional duties, which have probably also increased. This and additional research questions, including the outcomes of workload changes on other sectors of health care, need urgent answers for primary care provision internationally. FUNDING: Department of Health Policy Research Programme.

Continuity of Primary Care and Emergency Hospital Admissions Among Older Patients in England.

PURPOSE: Secondary health care services have been under considerable pressure in England as attendance rates increase, resulting in longer waiting times and greater demands on staff. This study's aim was to examine the association between continuity of care and risk of emergency hospital admission among older adults. METHODS: We analyzed records from 10,000 patients aged 65 years and older in 2012 within 297 English general practices obtained from the Clinical Practice Research Datalink and linked with Hospital Episode Statistics. We used the Bice and Boxerman (BB) index and the appointed general practitioner index (last general practitioner consulted before hospitalization) to quantify patient-physician continuity. The BB index was used in a prospective cohort approach to assess impact of continuity on risk of admission. Both indices were used in a separate retrospective nested case-control approach to test the effect of changing physician on the odds of hospital admission in the following 30 days. RESULTS: In the prospective cohort analysis, the BB index showed a graded, non-significant inverse relationship of continuity of care with risk of emergency hospital admission, although the hazard ratio for patients experiencing least continuity was 2.27 (95% CI, 1.37-3.76) compared with those having complete continuity. In the retrospective nested case-control analysis, we found a graded inverse relationship between continuity of care and emergency hospital admission for both BB and appointed general practitioner indices: for the latter, the odds ratio for those experiencing least continuity was 2.32 (95% CI, 1.48-3.63) relative to those experiencing most continuity. CONCLUSIONS: Marked discontinuity of care might contribute to increased unplanned hospital admissions among patients aged 65 years and older. Schemes to enhance continuity of care have the potential to reduce hospital admissions.

The Foundations Framework for Developing and Reporting New Models of Care for Multimorbidity.

PURPOSE: Multimorbidity challenges health systems globally. New models of care are urgently needed to better manage patients with multimorbidity; however, there is no agreed framework for designing and reporting models of care for multimorbidity and their evaluation. METHODS: Based on findings from a literature search to identify models of care for multimorbidity, we developed a framework to describe these models. We illustrate the application of the framework by identifying the focus and gaps in current models of care, and by describing the evolution of models over time. RESULTS: Our framework describes each model in terms of its theoretical basis and target population (the foundations of the model) and of the elements of care implemented to deliver the model. We categorized elements of care into 3 types: (1) clinical focus, (2) organization of care, (3) support for model delivery. Application of the framework identified a limited use of theory in model design and a strong focus on some patient groups (elderly, high users) more than others (younger patients, deprived populations). We found changes in elements with time, with a decrease in models implementing home care and an increase in models offering extended appointments. CONCLUSIONS: By encouragin greater clarity about the underpinning theory and target population, and by categorizing the wide range of potentially important elements of an intervention to improve care for patients with multimorbidity, the framework may be useful in designing and reporting models of care and help advance the currently limited evidence base.