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.

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.

Agreeing the content of a patient-reported outcome measure for primary care: a Delphi consensus study.

BACKGROUND: As the first contact for any health-related need, primary care clinicians often address multiple patient problems, with a range of possible outcomes. There is currently no patient-reported outcome measure (PROM) which covers this range of outcomes. Therefore, many research studies into primary care services use PROMs that do not capture the full impact of these services. OBJECTIVE: The study aim was to identify outcomes sought by primary care patients which clinicians can influence, thus providing the basis for a new primary care PROM. METHODS: We used a Delphi process starting with an outcomes list inductively derived in a prior qualitative study. Thirty-five experts were recruited into patient, clinician and academic panels. Participants rated each outcome on whether it was (i) relevant to health, (ii) influenced by primary care and (iii) detectable by patients. In each round, outcomes which passed/failed preset levels of agreement were accepted/rejected. Remaining outcomes continued to the next round. RESULTS: The process resulted in a set of outcomes occupying the domains of health status, health empowerment (internal and external), and health perceptions. Twenty-six of 36 outcomes were accepted for inclusion in a PROM. Primary care having insufficient influence was the main reason for exclusion. CONCLUSIONS: To our knowledge, this is the first time PROM outcomes have been agreed through criteria which explicitly exclude outcomes less relevant to health, uninfluenced by primary care or undetected by patients. The PROM in development covers a unique set of outcomes and offers an opportunity for enhanced research into primary care.

Patient and practitioners' views on the most important outcomes arising from primary care consultations: a qualitative study.

BACKGROUND: Primary care clinicians often address multiple patient problems, with a range of possible outcomes. There is currently no patient-reported outcome measure (PROM) which covers this range of outcomes. Consequently, many researchers use PROMs that do not capture the full impact of primary care services. In order to identify what outcomes a PROM for primary care would need to include, we conducted interviews with patients and practitioners. This paper reports these patient and practitioners' views on the outcomes arising from primary care consultations. METHODS: Semi-structured interviews were held with 30 patients and eight clinicians across five sites in Bristol. Interviews were audio-recorded, transcribed and analysed thematically. We used a broad definition of health outcome as 'the impacts of healthcare on health, or a patient's ability to impact health' to identify outcomes through this process. RESULTS: 10 outcome groups were identified. These occupied 3 domains: Health Empowerment: These are the internal and external resources which enable patients to improve their health. This involves 1) patients' understanding of their illnesses, 2) ability to self-care and stay healthy, 3) agreeing and adhering to a patient-clinician shared plan, 4) confidence in seeking healthcare and 5) access to support. Health Status: This involves 6) reduction of symptoms and 7) reducing the impact of symptoms on patients' lives. Health Perceptions: This involves 8) patients' satisfaction with their health, 9) health concerns, and 10) confidence in their future health. The structure, organisation and nature of primary care means it can affect all 3 domains. CONCLUSIONS: No existing PROM captures all these outcomes. For example, many health empowerment PROMs do not consider patient preference on empowerment. Many health status tools are not responsive to changes resulting from primary care. Health perceptions PROMs have generally been designed for measuring personality traits rather than outcomes. This study provides a platform for designing a new PROM containing outcomes that matter to patients and can be influenced by primary care. Such a PROM would greatly enhance the value of primary care research.

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.

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.

The experience of conducting collaborative and intensive pragmatic qualitative (CLIP-Q) research to support rapid public health and healthcare innovation.

A key challenge for qualitative methods in applied health research is the fast pace that can characterize the public health and health and care service landscape, where there is a need for research informed by immediate pragmatic questions and relevant findings are required quickly to inform decision-making. The COVID-19 pandemic accelerated the pace at which evidence was needed to inform urgent public health and healthcare decision-making. This required qualitative researchers to step up to the challenge of conducting research at speed whilst maintaining rigor and ensuring the findings are credible. This article illustrates how working with multidisciplinary, collaborative teams and the tailoring of qualitative methods to be more pragmatic and efficient can provide timely and credible results. Using time-limited case studies of applied qualitative health research drawn from the work of the Behavioral and Qualitative Science Team from the National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West), we illustrate our collaborative and intensive pragmatic qualitative (CLIP-Q) approach. CLIP-Q involves (i) collaboration at all stages of the design, conduct and implementation of projects and, where possible, co-production with people with lived experience, (ii) an intensive team-based approach to data collection and analysis at pace, and (iii) pragmatic study design and efficient strategies at each stage of the research process. The case studies include projects conducted pre COVID-19 and during the first wave of the pandemic, where urgent evidence was required in weeks rather than months to inform rapid public health and healthcare decision making.

Is continuity of primary care declining in England? Practice-level longitudinal study from 2012 to 2017.

BACKGROUND: Continuity of care is a core principle of primary care related to improved patient outcomes and reduced healthcare costs. Evidence suggests continuity of care in England is declining. AIM: To confirm reports of declining continuity of care, explore differences in decline according to practice characteristics, and examine associations between practice populations or appointment provision and changes in continuity of care. DESIGN AND SETTING: Longitudinal design on GP Patient Survey data reported annually in June or July from 2012 to 2017, whereby the unit of analysis was English general practices that existed in 2012. METHOD: Linear univariable and bivariable multilevel models were used to determine decline in average annual percentage of patients having a preferred GP and seeing this GP 'usually' according to practicelevel continuity of care, rural/urban location, and deprivation. Associations between percentage of patients having a preferred GP or seeing this GP usually and patients' experiences with the appointment system and practice population characteristics were modelled. RESULTS: In 2012, 56.7% of patients had a preferred GP, which had declined by 9.4 percentage points (pp) (95% CI = -9.6 to -9.2) by 2017. Of patients with a preferred GP, 66.4% saw that GP 'usually' in 2012; this had declined by 9.7 pp (95% CI = -10.0 to -9.4) by 2017. This decline was visible in all types of practices, irrespective of baseline continuity, rural/urban location, or level of deprivation. At practice level, an increase over time in the percentage of patients reporting good overall experience of making appointments was associated with an increase in both the percentage of patients having a preferred GP and those able to see that GP 'usually'. CONCLUSION: Patients reported a steady decline in continuity of care over time, which should concern clinicians and policymakers. Ability of practices to offer patients a satisfactory appointment system could partly counteract this decline.

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.

Changes in presentations with features potentially indicating cancer in primary care during the COVID-19 pandemic: a retrospective cohort study.

OBJECTIVES: To investigate how the COVID-19 pandemic affected the number of people aged 50+ years presenting to primary care with features that could potentially indicate cancer, and to explore how reporting differed by patient characteristics and in face-to-face vs remote consultations. DESIGN, SETTING AND PARTICIPANTS: A retrospective cohort study of general practitioner (GP), nurse and paramedic primary care consultations in 21 practices in South-West England covering 123 947 patients. The models compared potential cancer indicators reported in April-July 2019 with April-July 2020. MAIN OUTCOME MEASURES: Potential indicators of cancer were identified using code lists for symptoms, signs, test results and diagnoses listed in the National Institute for Health and Care Excellence suspected cancer referral guidance (NG12). RESULTS: During April-July 2019, 17% of registered patients aged 50+ years reported a potential cancer indicator in a consultation with a GP or nurse. During April-July 2020, this reduced to 11% (incidence rate ratio (IRR) 0.64, 95% CI 0.62 to 0.67, p<0.001). Reductions in potential cancer indicators were stable across age group, sex, ethnicity, index of multiple deprivation quintile and shielding status, but less marked in patients with mental health conditions than without (IRR 0.75, 95% CI 0.72 to 0.79, interaction p<0.001). Proportions of GP consultations with potential indicators of cancer reduced between 2019 and 2020 for face-to-face consultations (IRR 0.84, 95% CI 0.76 to 0.92, p<0.001) and increased for remote consultations (IRR 1.17, 95% CI 1.07 to 1.29, p=0.001), although it remained lower in remote consulting than face-to-face in April-July 2020. This difference was greater for nurse/paramedic consultations (face-to-face: IRR 0.61, 95% CI 0.44 to 0.83, p=0.002; remote: IRR 1.60, 95% CI 1.10 to 2.333, p=0.014). CONCLUSION: The number of patients consulting with presentations that could potentially indicate cancer reduced during the first wave of the COVID-19 pandemic. Patients should be encouraged to continue contacting primary care for persistent signs and symptoms, and GPs and nurses should be encouraged to probe patients for further information during remote consulting, in the absence of non-verbal cues.

Implementation of remote consulting in UK primary care following the COVID-19 pandemic: a mixed-methods longitudinal study.

BACKGROUND: To reduce contagion of COVID-19, in March 2020 UK general practices implemented predominantly remote consulting via telephone, video, or online consultation platforms. AIM: To investigate the rapid implementation of remote consulting and explore impact over the initial months of the COVID-19 pandemic. DESIGN AND SETTING: Mixed-methods study in 21 general practices in Bristol, North Somerset and South Gloucestershire. METHOD: Longitudinal observational quantitative analysis compared volume and type of consultation in April to July 2020 with April to July 2019. Negative binomial models were used to identify if changes differed among different groups of patients. Qualitative data from 87 longitudinal interviews with practice staff in four rounds investigated practices' experience of the move to remote consulting, challenges faced, and solutions. A thematic analysis utilised Normalisation Process Theory. RESULTS: There was universal consensus that remote consulting was necessary. This drove a rapid change to 90% remote GP consulting (46% for nurses) by April 2020. Consultation rates reduced in April to July 2020 compared to 2019; GPs and nurses maintained a focus on older patients, shielding patients, and patients with poor mental health. Telephone consulting was sufficient for many patient problems, video consulting was used more rarely, and was less essential as lockdown eased. SMS-messaging increased more than three-fold. GPs were concerned about increased clinical risk and some had difficulties setting thresholds for seeing patients face-to-face as lockdown eased. CONCLUSION: The shift to remote consulting was successful and a focus maintained on vulnerable patients. It was driven by the imperative to reduce contagion and may have risks; post-pandemic, the model will need adjustment.

Measuring the complexity of general practice consultations: a Delphi and cross-sectional study in English primary care.

BACKGROUND: The complexity of general practice consultations may be increasing and varies in different settings. A measure of complexity is required to test these hypotheses. AIM: To develop a valid measure of general practice consultation complexity applicable to routine medical records. DESIGN AND SETTING: Delphi study to select potential indicators of complexity followed by a cross-sectional study in English general practices to develop and validate a complexity measure. METHOD: The online Delphi study over two rounds identified potential indicators of consultation complexity. The cross-sectional study used an age-sex stratified random sample of patients and general practice face-to-face consultations from 2013/2014 in the Clinical Practice Research Datalink. The authors explored independent relationships between each indicator and consultation duration using mixed-effects regression models, and revalidated findings using data from 2017/2018. The proportion of complex consultations in different age-sex groups was assessed. RESULTS: A total of 32 GPs participated in the Delphi study. The Delphi panel endorsed 34 of 45 possible complexity indicators after two rounds. After excluding factors because of low prevalence or confounding, 17 indicators were retained in the cross-sectional study. The study used data from 173 130 patients and 725 616 face-to-face GP consultations. On defining complexity as the presence of any of these 17 factors, 308 370 consultations (42.5%) were found to be complex. Mean duration of complex consultations was 10.49 minutes, compared to 9.64 minutes for non-complex consultations. The proportion of complex consultations was similar in males and females but increased with age. CONCLUSION: The present consultation complexity measure has face and construct validity. It may be useful for research, management and policy, and for informing decisions about the range of resources needed in different practices.

Relational continuity and patients' perception of GP trust and respect: a qualitative study.

BACKGROUND: Despite the benefits of relational continuity of care, particularly for patients with multimorbidity, the traditional model of continuity is changing. Revisiting what patients with ongoing problems want from relational continuity could encourage initiatives to achieve these within a modern healthcare system. AIM: To examine the attributes of GPs that patients with long-term conditions value most, and which attributes patients believe are facilitated by relational continuity. DESIGN AND SETTING: Qualitative study in UK general practice. METHOD: A thematic analysis was carried out, based on secondary analysis of interviews with 25 patients with long-term conditions that were originally conducted to inform a patient-reported outcome measure for primary care. RESULTS: Patients with long-term conditions wanted their GPs to be clinically competent, to examine, listen to, care for, and take time with them, irrespective of whether they have seen them before. They believed that relational continuity facilitates a GP knowing their history, giving consistent advice, taking responsibility and action, and trusting and respecting them. Patients acknowledged practical difficulties and safety issues in achieving the first three of these without relational continuity. However, patients felt that GPs should trust and respect them even when continuity was not possible. CONCLUSION: Policy initiatives promoting continuity with a GP or healthcare team should continue. Many patients see continuity as a safety issue. When patients experience relationship discontinuity, they often feel that they are not taken seriously or believed by their GP. GPs should therefore consistently seek to visibly demonstrate trust in their patients, particularly when they have not seen them before.

The "Mikidney" smartphone app pilot study: Empowering patients with Chronic Kidney Disease.

BACKGROUND: Successful management of chronic kidney disease (CKD) depends on patients' self-management efforts. Mobile health applications can empower patients with CKD to manage their own condition. We developed, with patient involvement, the MiKidney smartphone application. AIM: Evaluate the MiKidney app as an aid to empowering patients with CKD to become more engaged in the management of their condition. DESIGN: Pilot single group pre- and post-test intervention study. SETTING: Renal clinic of an urban University Hospital in Ireland. PATIENTS: Aged over 18 years with CKD and able to use a smartphone. Sample size based on expression of interest and availability of free smartphones (n = 23); three patients withdrew prior to T3 data collection (n = 20). MEASUREMENTS: Data were collected at T1 (baseline), T2 (week 6) and when exiting the study (T3, 12 weeks) on physical activity, body measurements and blood parameters. Information on app usage and patient satisfaction collected at T2 and T3. RESULTS: There was significant improvement in the six-minute walking test (p = 0.02), total cholesterol (p = 0.023) and LDL cholesterol (p = 0.005) serum levels and a significant decrease in waist circumstance (p = 0.00) and body fat (p = 0.01) measurements. Eighteen participants found the MiKidney app easy to navigate. CONCLUSION: The MiKidney study highlights the viability and usability of the MiKidney app. It has the potential to empower and motivate patients to understand and self-manage their condition by providing them with the necessary information on renal diet and symptom management. Additionally, tools such as exercise tracker and reminder alerts are available on a readily accessible user-friendly platform.

Primary Care Outcomes Questionnaire: psychometric testing of a new instrument.

BACKGROUND: Patients attend primary care for many reasons and to achieve a range of possible outcomes. There is currently no Patient Reported Outcome Measure (PROM) designed to capture these diverse outcomes, and trials of interventions in primary care may thus fail to detect beneficial effects. AIM: This study describes the psychometric testing of the Primary Care Outcomes Questionnaire (PCOQ), which was designed to capture a broad range of outcomes relevant to primary care. DESIGN AND SETTING: Questionnaires were administered in primary care in South West England. METHOD: Patients completed the PCOQ in GP waiting rooms before a consultation, and a second questionnaire, including the PCOQ and seven comparator PROMs, after 1 week. Psychometric testing included exploratory factor analysis on the PCOQ, internal consistency, correlation coefficients between domain scores and comparator measures, and repeated measures effect sizes indicating change across 1 week. RESULTS: In total, 602 patients completed the PCOQ at baseline, and 264 (44%) returned the follow-up questionnaire. Exploratory factor analysis suggested four dimensions underlying the PCOQ items: health and wellbeing, health knowledge and self-care, confidence in health provision, and confidence in health plan. Each dimension was internally consistent and correlated as expected with comparator PROMs, providing evidence of construct validity. Patients reporting an improvement in their main problem exhibited small to moderate improvements in relevant domain scores on the PCOQ. CONCLUSION: The PCOQ was acceptable, feasible, showed strong psychometric properties, and was responsive to change. It is a promising new tool for assessment of outcomes of primary care interventions from a patient perspective.

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

OBJECTIVE: To develop and validate a new scale to assess treatment burden (the effort of looking after one's health) for patients with multimorbidity. DESIGN: Mixed-methods. SETTING: UK primary care. PARTICIPANTS: Content of the Multimorbidity Treatment Burden Questionnaire (MTBQ) was based on a literature review and views from a patient and public involvement group. Face validity was assessed through cognitive interviews. The scale was piloted and the final version was tested in 1546 adults with multimorbidity (mean age 71 years) who took part in the 3D Study, a cluster randomised controlled trial. For each question, we examined the proportion of missing data and the distribution of responses. Factor analysis, Cronbach's alpha, Spearman's rank correlations and longitudinal regression assessed dimensional structure, internal consistency reliability, construct validity and responsiveness, respectively. We assessed interpretability by grouping the global MTBQ scores into zero and tertiles (>0) and comparing participant characteristics across these categories. RESULTS: Cognitive interviews found good acceptability and content validity. Factor analysis supported a one-factor solution. Cronbach's alpha was 0.83, indicating internal consistency reliability. The MTBQ score had a positive association with a comparator treatment burden scale (rs 0.58, P<0.0001) and with self-reported disease burden (rs 0.43, P<0.0001), and a negative association with quality of life (rs-0.36, P<0.0001) and self-rated health (rs-0.36, P<0.0001). Female participants, younger participants and participants with mental health conditions were more likely to have high treatment burden scores. Changes in MTBQ score over 9-month follow-up were associated, as expected, with changes in measures of quality of life (EuroQol five dimensions, five level questionnaire) and patient-centred care (Patient Assessment of Chronic Illness Care). CONCLUSION: The MTBQ is a 10-item measure of treatment burden for patients with multimorbidity that has demonstrated good content validity, construct validity, reliability and responsiveness. It is a useful research tool for assessing the impact of interventions on treatment burden. TRIAL REGISTRATION NUMBER: ISRCTN06180958.

Integrating palliative care into national health systems in Africa: a multi-country intervention study.

BACKGROUND: The WHO is calling for the integration of palliative care in all health care settings globally. METHODS: A 3.5-year program was implemented in 12 government hospitals, three each in Kenya, Rwanda, Uganda and Zambia. A four-pillared approach of advocacy, staff training, service delivery strengthening and international and regional partnership working was utilized. A baseline assessment was undertaken to ascertain needs, and 27 indicators were agreed to guide and evaluate the intervention. Data were also collected through surveys, interviews and focus groups. RESULTS: Palliative care was integrated into all 12 hospital settings to various degrees through concurrent interventions of these four approaches. Overall, 218 advocacy activities were undertaken and 4153 community members attended awareness training. 781 staff were equipped with the skills and resources to cascade palliative care through their hospitals and into the community. Patients identified for palliative care increased by a factor of 2.7. All 12 hospitals had oral morphine available and consumption increased by a factor of 2.4 over two years. Twenty-two UK mentors contributed 750 volunteer days to support colleagues in each hospital transfer knowledge and skills. CONCLUSIONS: Integration of palliative care within different government health services in Africa can be achieved through agreed interventions being delivered concurrently. These include advocacy at Ministry, Provincial and District level, intensive and wide-ranging training, clinical and support services supported by resources, including essential medicines, and an investment in partnerships between hospital, district and community.

14-3-3η Autoantibodies: Diagnostic Use in Early Rheumatoid Arthritis.

OBJECTIVE: To describe the expression and diagnostic use of 14-3-3η autoantibodies in early rheumatoid arthritis (RA). METHODS: 14-3-3η autoantibody levels were measured using an electrochemiluminescent multiplexed assay in 500 subjects (114 disease-modifying antirheumatic drug-naive patients with early RA, 135 with established RA, 55 healthy, 70 autoimmune, and 126 other non-RA arthropathy controls). 14-3-3η protein levels were determined in an earlier analysis. Two-tailed Student t tests and Mann-Whitney U tests compared differences among groups. Receiver-operator characteristic (ROC) curves were generated and diagnostic performance was estimated by area under the curve (AUC), as well as specificity, sensitivity, and likelihood ratios (LR) for optimal cutoffs. RESULTS: Median serum 14-3-3η autoantibody concentrations were significantly higher (p < 0.0001) in patients with early RA (525 U/ml) when compared with healthy controls (235 U/ml), disease controls (274 U/ml), autoimmune disease controls (274 U/ml), patients with osteoarthritis (259 U/ml), and all controls (265 U/ml). ROC curve analysis comparing early RA with healthy controls demonstrated a significant (p < 0.0001) AUC of 0.90 (95% CI 0.85-0.95). At an optimal cutoff of ≥ 380 U/ml, the ROC curve yielded a sensitivity of 73%, a specificity of 91%, and a positive LR of 8.0. Adding 14-3-3η autoantibodies to 14-3-3η protein positivity enhanced the identification of patients with early RA from 59% to 90%; addition of 14-3-3η autoantibodies to anticitrullinated protein antibodies (ACPA) and/or rheumatoid factor (RF) increased identification from 72% to 92%. Seventy-two percent of RF- and ACPA-seronegative patients were positive for 14-3-3η autoantibodies. CONCLUSION: 14-3-3η autoantibodies, alone and in combination with the 14-3-3η protein, RF, and/or ACPA identified most patients with early RA.