AbstractObjectivesColchicine has been proposed as a COVID-19 treatment, but its effect on time to recovery is unknown. We aimed to determine whether colchicine is effective at reducing time to recovery and COVID-19 related hospitalisations/deaths among people in the community.DesignProspective, multicentre, open-label, multi-arm, adaptive Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE).SettingNational trial run remotely from a central trial site and at multiple primary care centres across the United Kingdom.ParticipantsAdults aged ≥65, or ≥18 years with comorbidities or shortness of breath, and unwell ≤14 days with suspected COVID-19 in the community.InterventionsParticipants were randomised to usual care, usual care plus colchicine (500µg daily for 14 days), or usual care plus other interventions.Main outcome measuresThe co-primary endpoints were time to first self-reported recovery, and hospitalisation/death related to COVID-19, within 28 days, analysed using Bayesian models. The hypothesis for the time to recovery endpoint is evaluated first, and if superiority is declared on time to recovery, the hypothesis for the second co-primary endpoint of hospitalisation/death is then evaluated. To determine futility, we pre-specified a clinically meaningful benefit in time to first reported recovery as a hazard ratio of 1.2 or larger (equating to approximately 1.5 days benefit in the colchicine arm, assuming 9 days recovery in the usual care arm).ResultsThe trial opened on April 2, 2020, with randomisation to colchicine starting on March 04, 2021 and stopping on May 26, 2021, because the pre-specified time to recovery futility criterion was met. The primary analysis model included 2755 SARS-CoV-2 positive participants, randomised to colchicine (n=156), usual care (n=1145), and other treatments (n=1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.919 [95% credible interval 0.72 to 1.16] and an estimated increase of 1.14 days [−1.86 to 5.21] in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. Results were similar in comparisons with concurrent controls. COVID-19 related hospitalisations/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 [0.28 to 1.89] and an estimated difference of −0.4% [−2.7% to 2.4]. One serious adverse event occurred in the colchicine group and one in usual care.ConclusionsColchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.Trial registrationISRCTN86534580.

For the past ten years, the UK Government has attempted ‘to improve the health and wealth of the nation through research’. Investment into the NIHR and its CRNs has helped make the healthcare system safer, more effective and cost-efficient, as well as improve the research agenda. However, due to commissioning and the service contract tendering process, changes in contract provider (specifically to non-NHS organisations) can hamper ongoing clinical research, affecting both organisations and patients. This paper explores the issues and discusses next steps in the continuity of research activity.

BACKGROUND: This article is the second part of a novel scoping review of the international literature that presents those key elements that underpin the foundational activities of Practice-Based Research Networks (PBRNs). In this article, we examine the external environment and the intersection between the internal and external environment domains. METHODS: We searched electronic databases, including MEDLINE (PubMed), OVID, CINAHL (EBSCOhost), Scopus, and SAGE for publications in English between 1/1/1965 and 9/15/2021. We also searched reference lists of selected publications, gray literature and other online sources. Inductive thematic analysis was applied to construct the main themes, subthemes, and key elements from a scoping review covering up to 10 years of reported experiences of each of the 98 PBRNs that met the inclusion criteria. RESULTS: in this study we present 2 main themes: "Stakeholders at the Intersection Between the Internal and External Environment" and the "External Environment." the first is linked to the subthemes "Patient and Community Stakeholders" and "Other Healthcare Stakeholders" and 11 key elements. The second relates to the subthemes "National Health System," "Institutional/Governmental Support, National/State Policy and Regulatory Environment" "Professional Organizations," "Leveraging Previous Research and PBRN Experience and Interacting with Other Networks" and "Health Information Technology (HIT) and HIT Vendors" and 21 key elements. CONCLUSIONS: Despite variations in geography, time, and healthcare context, PBRNs shared many similar developmental experiences over the past 5 decades. Their external environment contributed significantly to their developmental trajectories during the first 10 years of their operation.

BackgroundColchicine has been proposed as a COVID-19 treatment.AimTo determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community.Design and settingProspective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE).MethodAdults aged ≥65 years or ≥18 years with comorbidities or shortness of breath, and unwell for ≤14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models.ResultsThe trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (n = 156), usual care (n = 1145), and other treatments (n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95% CrI = 0.28 to 1.89) and an estimated difference of −0.4% (95% CrI = −2.7 to 2.4).ConclusionColchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.

Improvement of glucose levels into the normal range can occur in some people living with diabetes, either spontaneously or after medical interventions, and in some cases can persist after withdrawal of glucose-lowering pharmacotherapy. Such sustained improvement may now be occurring more often due to newer forms of treatment. However, terminology for describing this process and objective measures for defining it are not well established, and the long-term risks versus benefits of its attainment are not well understood. To update prior discussions of this issue, an international expert group was convened by the American Diabetes Association to propose nomenclature and principles for data collection and analysis, with the goal of establishing a base of information to support future clinical guidance. This group proposed "remission" as the most appropriate descriptive term, and HbA1câ€

Improvement of glucose levels into the normal range can occur in some people living with diabetes, either spontaneously or after medical interventions, and in some cases can persist after withdrawal of glucose-lowering pharmacotherapy. Such sustained improvement may now be occurring more often due to newer forms of treatment. However, terminology for describing this process and objective measures for defining it are not well established, and the long-term risks versus benefits of its attainment are not well understood. To update prior discussions of this issue, an international expert group was convened by the American Diabetes Association to propose nomenclature and principles for data collection and analysis, with the goal of establishing a base of information to support future clinical guidance. This group proposed "remission" as the most appropriate descriptive term, and HbA1c

BACKGROUND: Higher continuity of GP care (CGPC), that is, consulting the same doctor consistently, can improve doctor-patient relationships and increase quality of care; however, its effects on patients with dementia are mostly unknown. AIM: to estimate the associations between CGPC and potentially inappropriate prescribing (PIP), and with the incidence of adverse health outcomes (AHOs) in patients with dementia. DESIGN AND SETTING: a retrospective cohort study with 1 year of follow-up anonymised medical records from 9324 patients with dementia, aged ≥65 years living in England in 2016. METHOD: CGPC measures include the Usual Provider of Care (UPC), Bice-Boxerman Continuity of Care (BB), and Sequential Continuity (SECON) indices. Regression models estimated associations with PIPs and survival analysis with incidence of AHOs during the follow-up adjusted for age, sex, deprivation level, 14 comorbidities, and frailty. RESULTS: the highest quartile (HQ) of UPC (highest continuity) had 34.8% less risk of delirium (odds ratio [OR] 0.65, 95% confidence interval [CI] = 0.51 to 0.84), 57.9% less risk of incontinence (OR 0.42, 95% CI = 0.31 to 0.58), and 9.7% less risk of emergency admissions to hospital (OR 0.90, 95% CI = 0.82 to 0.99) compared with the lowest quartile. Polypharmacy and PIP were identified in 81.6% (n = 7612) and 75.4% (n = 7027) of patients, respectively. The HQ had fewer prescribed medications (HQ: mean 8.5, lowest quartile (LQ): mean 9.7, P

BACKGROUND: in order to integrate genomic medicine into routine patient care and stratify personal risk, it is increasingly important to record family history (FH) information in general/family practice records. This is true for classic genetic disease as well as multifactorial conditions. Research suggests that FH recording is currently inadequate. OBJECTIVES: to provide an up-to-date analysis of the frequency, quality, and accuracy of FH recording in UK general/family practice. METHODS: an exploratory study, based at St Leonard's Practice, Exeter-a suburban UK general/family practice. Selected adult patients registered for over 1 year were contacted by post and asked to complete a written FH questionnaire. The reported information was compared with the patients' electronic medical record (EMR). Each EMR was assessed for its frequency (how often information was recorded), quality (the level of detail included), and accuracy (how closely the information matched the patient report) of FH recording. RESULTS: Two hundred and forty-one patients were approached, 65 (27.0%) responded and 62 (25.7%) were eligible to participate. Forty-three (69.4%) EMRs contained FH information. The most commonly recorded conditions were bowel cancer, breast cancer, diabetes, and heart disease. The mean quality score was 3.64 (out of 5). There was little negative recording. 83.2% of patient-reported FH information was inaccurately recorded or missing from the EMRs. CONCLUSION: FH information in general/family practice records should be better prepared for the genomic era. Whilst some conditions are well recorded, there is a need for more frequent, higher quality recording with greater accuracy, especially for multifactorial conditions.

PURPOSE: Practice-based research networks (PBRNs) have developed dynamically across the world, paralleling the emergence of the primary care discipline. While this review focuses on the internal environment of PBRNs, the complete framework will be presented incrementally in future publications. METHODS: We conducted a scoping review of the published and gray literature. Electronic databases, including MEDLINE (PubMed), OVID, CINAHL (EBSCOhost), Scopus, and SAGE Premier, were searched for publications between January 1, 1965 and December 31, 2020 for English-language articles. Rigorous inclusion/exclusion criteria were implemented to identify relevant publications, and inductive thematic analysis was applied to elucidate key elements, subthemes, and themes. Social network theory was used to synthesize findings. RESULTS: a total of 229 publications described the establishment of 93 PBRNs in 15 countries that met the inclusion criteria. The overall framework yielded 3 main themes, 12 subthemes, and 57 key elements. Key PBRN activities included relationship building between academia and practitioners and development of a learning environment through multidirectional communication. CONCLUSIONS: PBRNs across many countries contributed significantly to shaping the landscape of primary health care and became an integral part of it. Many common features within the sphere of PBRNs can be identified that seem to promote their establishment across the world.

Improvement of glucose levels into the normal range can occur in some people living with diabetes, either spontaneously or after medical interventions, and in some cases can persist after withdrawal of glucose-lowering pharmacotherapy. Such sustained improvement may now be occurring more often due to newer forms of treatment. However, terminology for describing this process and objective measures for defining it are not well established, and the long-term risks versus benefits of its attainment are not well understood. To update prior discussions of this issue, an international expert group was convened by the American Diabetes Association to propose nomenclature and principles for data collection and analysis, with the goal of establishing a base of information to support future clinical guidance. This group proposed "remission" as the most appropriate descriptive term, and HbA1c

Improvement of glucose levels into the normal range can occur in some people living with diabetes, either spontaneously or after medical interventions, and in some cases can persist after withdrawal of glucose-lowering pharmacotherapy. Such sustained improvement may now be occurring more often due to newer forms of treatment. However, terminology for describing this process and objective measures for defining it are not well established, and the long-term risks vs benefits of its attainment are not well understood. To update prior discussions of this issue, an international expert group was convened by the American Diabetes Association to propose nomenclature and principles for data collection and analysis, with the goal of establishing a base of information to support future clinical guidance. This group proposed 'remission' as the most appropriate descriptive term, and HbA1c

BACKGROUND: Doxycycline is often used for treating COVID-19 respiratory symptoms in the community despite an absence of evidence from clinical trials to support its use. We aimed to assess the efficacy of doxycycline to treat suspected COVID-19 in the community among people at high risk of adverse outcomes. METHODS: We did a national, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in older people (PRINCIPLE) across primary care centres in the UK. We included people aged 65 years or older, or 50 years or older with comorbidities (weakened immune system, heart disease, hypertension, asthma or lung disease, diabetes, mild hepatic impairment, stroke or neurological problem, and self-reported obesity or body-mass index of 35 kg/m2 or greater), who had been unwell (for ≤14 days) with suspected COVID-19 or a positive PCR test for SARS-CoV-2 infection in the community. Participants were randomly assigned using response adaptive randomisation to usual care only, usual care plus oral doxycycline (200 mg on day 1, then 100 mg once daily for the following 6 days), or usual care plus other interventions. The interventions reported in this manuscript are usual care plus doxycycline and usual care only; evaluations of other interventions in this platform trial are ongoing. The coprimary endpoints were time to first self-reported recovery, and hospitalisation or death related to COVID-19, both measured over 28 days from randomisation and analysed by intention to treat. This trial is ongoing and is registered with ISRCTN, 86534580. FINDINGS: the trial opened on April 2, 2020. Randomisation to doxycycline began on July 24, 2020, and was stopped on Dec 14, 2020, because the prespecified futility criterion was met; 2689 participants were enrolled and randomised between these dates. of these, 2508 (93·3%) participants contributed follow-up data and were included in the primary analysis: 780 (31·1%) in the usual care plus doxycycline group, 948 in the usual care only group (37·8%), and 780 (31·1%) in the usual care plus other interventions group. Among the 1792 participants randomly assigned to the usual care plus doxycycline and usual care only groups, the mean age was 61·1 years (SD 7·9); 999 (55·7%) participants were female and 790 (44·1%) were male. In the primary analysis model, there was little evidence of difference in median time to first self-reported recovery between the usual care plus doxycycline group and the usual care only group (9·6 [95% Bayesian Credible Interval [BCI] 8·3 to 11·0] days vs 10·1 [8·7 to 11·7] days, hazard ratio 1·04 [95% BCI 0·93 to 1·17]). The estimated benefit in median time to first self-reported recovery was 0·5 days [95% BCI -0·99 to 2·04] and the probability of a clinically meaningful benefit (defined as ≥1·5 days) was 0·10. Hospitalisation or death related to COVID-19 occurred in 41 (crude percentage 5·3%) participants in the usual care plus doxycycline group and 43 (4·5%) in the usual care only group (estimated absolute percentage difference -0·5% [95% BCI -2·6 to 1·4]); there were five deaths (0·6%) in the usual care plus doxycycline group and two (0·2%) in the usual care only group. INTERPRETATION: in patients with suspected COVID-19 in the community in the UK, who were at high risk of adverse outcomes, treatment with doxycycline was not associated with clinically meaningful reductions in time to recovery or hospital admissions or deaths related to COVID-19, and should not be used as a routine treatment for COVID-19. FUNDING: UK Research and Innovation, Department of Health and Social Care, National Institute for Health Research.

INTRODUCTION: There is an urgent need to idenfy treatments for COVID-19 that reduce illness duration and hospital admission in those at higher risk of a longer illness course and complications. METHODS AND ANALYSIS: the Platform Randomised trial of INterventions against COVID-19 in older peoPLE trial is an open-label, multiarm, prospective, adaptive platform, randomised clinical trial to evaluate potential treatments for COVID-19 in the community. A master protocol governs the addition of new interventions as they become available, as well as the inclusion and cessation of existing intervention arms via frequent interim analyses. The first three interventions are hydroxychloroquine, azithromycin and doxycycline. Eligible participants must be symptomatic in the community with possible or confirmed COVID-19 that started in the preceding 14 days and either (1) aged 65 years and over or (2) aged 50-64 years with comorbidities. Recruitment is through general practice, health service helplines, COVID-19 'hot hubs' and directly through the trial website. Participants are randomised to receive either usual care or a study drug plus usual care, and outcomes are collected via daily online symptom diary for 28 days from randomisation. The research team contacts participants and/or their study partner following days 7, 14 and 28 if the online diary is not completed. The trial has two coprimary endpoints: time to first self-report of feeling recovered from possible COVID-19 and hospital admission or death from possible COVID-19 infection, both within 28 days from randomisation. Prespecified interim analyses assess efficacy or futility of interventions and to modify randomisation probabilities that allocate more participants to interventions with better outcomes. ETHICS AND DISSEMINATION: Ethical approval Ref: 20/SC/0158 South Central - Berkshire Research Ethics Committee; IRAS Project ID: 281958; EudraCT Number: 2020-001209-22. Results will be presented to policymakers and at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN86534580.

Abstract
Background
Research is fundamental to high-quality care, but concerns have been raised about whether health research is conducted in the populations most affected by high disease prevalence. Geographical distribution of research activity is important for many reasons. Recruitment is a major barrier to research delivery, and undertaking recruitment in areas of high prevalence could be more efficient. Regional variability exists in risk factors and outcomes, so research done in healthier populations may not generalise. Much applied health research evaluates interventions, and their impact may vary by context (including geography). Finally, fairness dictates that publically funded research should be accessible to all, so that benefits of participating can be fairly distributed. We explored whether recruitment of patients to health research is aligned with disease prevalence in England.

Methods
We measured disease prevalence using the Quality and Outcomes Framework in England (total long-term conditions, mental health and diabetes). We measured research activity using data from the NIHR Clinical Research Network. We presented descriptive data on geographical variation in recruitment rates. We explored associations between the recruitment rate and disease prevalence rate. We calculated the share of patient recruitment that would need to be redistributed to align recruitment with prevalence. We assessed whether associations between recruitment rate and disease prevalence varied between conditions, and over time.

Results
There was significant geographical variation in recruitment rates. When areas were ranked by disease prevalence, recruitment was not aligned with prevalence, with disproportionately low recruitment in areas with higher prevalence of total long-term and mental health conditions. At the level of 15 local networks, analyses suggested that around 12% of current recruitment activity would need to be redistributed to align with disease prevalence. Overall, alignment showed little change over time, but there was variation in the trends over time in individual conditions.

Conclusions
Geographical variations in recruitment do not reflect the suitability of the population for research. Indicators should be developed to assess the fit between research and need, and to allow assessment of interventions among funders, researchers and patients to encourage closer alignment between research activity and burden.

the exceptional advances in genomic medicine in the last two decades, since the sequencing of the human genome, have already had a major impact on healthcare in the UK. Until recently this was predominantly in secondary and tertiary care, but we must now integrate ‘mainstream’ genomics in primary care. So far integration has of necessity been empirical, but must progress towards implementation research. We describe recent work undertaken by the RCGP and the NIHR CRN outlining areas where research is needed to fully integrate genomics into routine primary care and secure the future of these exciting developments.

Objective Continuity of care is a long-standing feature of healthcare, especially of general practice. It is associated with increased patient satisfaction, increased take-up of health promotion, greater adherence to medical advice and decreased use of hospital services. This review aims to examine whether there is a relationship between the receipt of continuity of doctor care and mortality. Design Systematic review without meta-analysis. Data sources MEDLINE, Embase and the Web of Science, from 1996 to 2017. Eligibility criteria for selecting studies Peer-reviewed primary research articles, published in English which reported measured continuity of care received by patients from any kind of doctor, in any setting, in any country, related to measured mortality of those patients. Results of the 726 articles identified in searches, 22 fulfilled the eligibility criteria. The studies were all cohort or cross-sectional and most adjusted for multiple potential confounding factors. These studies came from nine countries with very different cultures and health systems. We found such heterogeneity of continuity and mortality measurement methods and time frames that it was not possible to combine the results of studies. However, 18 (81.8%) high-quality studies reported statistically significant reductions in mortality, with increased continuity of care. 16 of these were with all-cause mortality. Three others showed no association and one demonstrated mixed results. These significant protective effects occurred with both generalist and specialist doctors. Conclusions This first systematic review reveals that increased continuity of care by doctors is associated with lower mortality rates. Although all the evidence is observational, patients across cultural boundaries appear to benefit from continuity of care with both generalist and specialist doctors. Many of these articles called for continuity to be given a higher priority in healthcare planning. Despite substantial, successive, technical advances in medicine, interpersonal factors remain important. PROSPERO registration number CRD42016042091.

BACKGROUND: the treatment of people with diabetes with metformin can reduce cardiovascular disease (CVD) and may reduce the risk of cancer. However, it is unknown whether or not metformin can reduce the risk of these outcomes in people with elevated blood glucose levels below the threshold for diabetes [i.e. non-diabetic hyperglycaemia (NDH)]. OBJECTIVE: to assess the feasibility of the Glucose Lowering in Non-diabetic hyperglycaemia Trial (GLINT) and to estimate the key parameters to inform the design of the full trial. These parameters include the recruitment strategy, randomisation, electronic data capture, postal drug distribution, retention, study medication adherence, safety monitoring and remote collection of outcome data. DESIGN: a multicentre, individually randomised, double-blind, parallel-group, pragmatic, primary prevention trial. Participants were individually randomised on a 1 : 1 basis, blocked within each site. SETTING: General practices and clinical research facilities in Cambridgeshire, Norfolk and Leicestershire. PARTICIPANTS: Males and females aged ≥ 40 years with NDH who had a high risk of CVD. INTERVENTIONS: Prolonged-release metformin (500 mg) (Glucophage® SR, Merck KGaA, Bedfont Cross, Middlesex, UK) or the matched placebo, up to three tablets per day, distributed by post. MAIN OUTCOME MEASURES: Recruitment rates; adherence to study medication; laboratory results at baseline and 3 and 6 months; reliability and acceptability of study drug delivery; questionnaire return rates; and quality of life. RESULTS: We sent 5251 invitations, with 511 individuals consenting to participate. of these, 249 were eligible and were randomised between March and November 2015 (125 to the metformin group and 124 to the placebo group). Participants were followed up for 0.99 years [standard deviation (SD) 0.30 years]. The use of electronic medical records to identify potentially eligible individuals in individual practices was resource intensive. Participants were generally elderly [mean age 70 years (SD 6.7 years)], overweight [mean body mass index 30.1 kg/m2 (SD 4.5 kg/m2)] and male (88%), and the mean modelled 10-year CVD risk was 28.8% (SD 8.5%). Randomisation, postal delivery of the study drug and outcome assessment using registers/medical records were feasible and acceptable to participants. Most participants were able to take three tablets per day, but premature discontinuation of the study drug was common (≈30% of participants by 6 months), although there were no differences between the groups. All randomised participants returned questionnaires at baseline and 67% of participants returned questionnaires by the end of the study. There was no between-group difference in Short Form questionnaire-8 items or EuroQol-5 Dimensions scores. Compared with placebo, metformin was associated with small improvements in the mean glycated haemoglobin level [-0.82 mmol/mol, 95% confidence interval (CI) -1.39 to -0.24 mmol/mol], mean estimated glomerular filtration rate (2.31 ml/minute/1.73 m2, 95% CI -0.2 to 4.81 ml/minute/1.73 m2) and mean low-density lipoprotein cholesterol level (-0.11 mmol/l, 95% CI -0.25 to 0.02 mmol/l) and a reduction in mean plasma vitamin B12 level (-16.4 ng/l, 95% CI -32.9 to -0.01 ng/l). There were 35 serious adverse events (13 in the placebo group, 22 in the metformin group), with none deemed to be treatment related. LIMITATIONS: Changes to sponsorship reduced the study duration, the limited availability of information in medical records reduced recruitment efficiency and discontinuation of study medication exceeded forecasts. CONCLUSIONS: a large, pragmatic trial comparing the effects of prolonged-release metformin and placebo on the risk of CVD events is potentially feasible. However, changes to the study design and conduct are recommended to enable an efficient scaling up of the trial. Recommendations include changing the inclusion criteria to recruit people with pre-existing CVD to increase the recruitment and event rates, using large primary/secondary care databases to increase recruitment rates, conducting follow-up remotely to improve efficiency and including a run-in period prior to randomisation to optimise trial adherence. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34875079. FUNDING: the project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 18. See the NIHR Journals Library website for further project information. Merck KGaA provided metformin and matching placebo.

BACKGROUND: Skin tears are common in older adults and those taking steroids and warfarin. They are traumatic, often blunt injuries caused by oblique knocks to the extremities. The epidermis may separate from the dermis or both layers from underlying tissues leaving a skin flap or total loss of tissue, which is painful and prone to infection. 'Dermatuff™' knee-length socks containing Kevlar fibres (used in stab-proof vests and motorcyclists' clothing) aim to prevent skin tears. The acceptability of the socks and the feasibility of a randomised controlled trial (RCT) had not been explored. METHODS: in this pilot parallel group RCT, 90 people at risk of skin-tear injury from Devon care homes and primary care were randomised to receive the socks or treatment as usual (TAU). The pilot aimed to estimate parameters to inform the design of a substantive trial and record professionals' views and participants' acceptability of the intervention and of study participation. RESULTS: Participants were randomised from July 2013 and followed up until February 2015. Community participants were easier to recruit than care homes residents but were 10 years younger on average and more active. To recruit 90 participants, 395 had to be approached overall as 77% were excluded or declined. Seventy-nine participants (88%) completed the trial and 27/44 (61%) wore the socks for 16 weeks. There were 31 skin tear injuries affecting 18 (20%) of the 90 participants. The TAU group received more injuries, more repeated episodes, and larger tears with greater severity. Common daily diary reasons for not wearing the socks included perceived warmth in hot weather or not being available (holiday, in hospital, bed rest). Resource use data were obtainable and indicated that sock wearing gave a reduction in treatment costs whilst well-completed questionnaires showed improvements in secondary outcomes. CONCLUSIONS: This pilot trial has successfully informed the design and conduct of a future definitive cost-effectiveness RCT. It would need to be conducted in primary care with 880 active at-risk, elderly patients (440 per arm). Skin tear incidence and quality of life (from EQ5D5L) over a 4-month period would be the primary and secondary outcomes respectively. TRIAL REGISTRATION: ISRCTN, ISRCTN96565376.

Objectives: to clarify the relationship between social deprivation and age as two factors associated with emergency admissions to hospital. Design: Emergency admissions for 12 months were analysed for patients in the NHS NEW Devon CCG. Social deprivation was measured by the Index of Multiple Deprivation (IMD). Logistic regression models estimated the separate and combined effects of social deprivation and age on the risk of emergency admissions for people aged under and over 65. Setting: East Devon, UK-area of the NEW Devon CCG. Population: 765 861 patients in the CCG database. Main outcome measure: Emergency admission to any English hospital. Results: Age (p

BACKGROUND: Continuity of care has been defined as relational continuity between patient and doctor and longitudinal continuity describing the duration of the relationship. Measurement of longitudinal continuity alone is associated with outcomes including patient satisfaction, medical costs, hospital admissions and mortality. METHODS: in one UK general practice, records were searched for patients with continuous registration for 50 or more years. Characteristics of these patients were analysed for age, gender, social deprivation, partner registration and length of registration. Trends in numbers and proportions of this group over the previous 14 years were determined. A comparison group of patients, aged 50 or more, and registered in the same practice within the last 2-4 years, was identified. RESULTS: Patients registered for 50 years or more with a median registration of 56.2 years numbered 190 out of a population of 8420 (2.3%). These patients increased in number by 35.3% (1.7-2.3%) over 14 consecutive years. There were no differences between groups for GP consultation rate, number of repeat medications and hospital use, despite the significantly higher prevalence of multi-morbidity, depression and diabetes in patients with high continuity. CONCLUSIONS: This is the first report of 50-year continuity in general practice. Numbers of such patients and proportions are increasing. Longitudinal continuity is easily measured in general practice and associated with important clinical outcomes.

Background
Depression is associated with physical inactivity, which may mediate the relationship between depression and a range of chronic physical health conditions. However, few interventions have combined a psychological intervention for depression with behaviour change techniques, such as behavioural activation (BA), to promote increased physical activity.

Methods
To determine procedural and clinical uncertainties to inform a definitive randomised controlled trial (RCT), a pilot parallel-group RCT was undertaken within two Improving Access to Psychological Therapies (IAPT) services in South West England. We aimed to recruit 80 adults with depression and randomise them to a supported, written self-help programme based on either BA or BA plus physical activity promotion (BAcPAc). Data were collected at baseline and 4 months post-randomisation to evaluate trial retention, intervention uptake and variance in outcomes to inform a sample size calculation. Qualitative data were collected from participants and psychological wellbeing practitioners (PWPs) to assess the acceptability and feasibility of the trial methods and the intervention. Routine data were collected to evaluate resource use and cost.

Results
Sixty people with depression were recruited, and a 73 % follow-up rate was achieved. Accelerometer physical activity data were collected for 64 % of those followed. Twenty participants (33 %) attended at least one treatment appointment. Interview data were analysed for 15 participants and 9 study PWPs. The study highlighted the challenges of conducting an RCT within existing IAPT services with high staff turnover and absences, participant scheduling issues, PWP and participant preferences for cognitive focussed treatment, and deviations from BA delivery protocols. The BAcPAc intervention was generally acceptable to patients and PWPs.

Conclusions
Although recruitment procedures and data collection were challenging, participants generally engaged with the BAcPAc self-help booklets and reported willingness to increase their physical activity. A number of feasibility issues were identified, in particular the under-use of BA as a treatment for depression, the difficulty that PWPs had in adapting their existing procedures for study purposes and the instability of the IAPT PWP workforce. These problems would need to be better understood and resolved before proceeding to a full-scale RCT.

People with prediabetes (those who have "borderline" hyperglycaemia) are at high risk for developing type 2 diabetes, but progression to diabetes is by no means inevitable. A number of interventions for individuals who are at high risk have been shown to reduce the risk. The WAKEUP (Ways of Addressing Knowledge Education and Understanding in Pre-diabetes) information toolkit for people with prediabetes and their health practitioners was developed in 2007 and updated in 2014. Principles for delivering a brief intervention based on the freely available WAKEUP materials are presented.

BACKGROUND: Skin tears are traumatic injuries occurring mostly on the extremities due to shearing and friction forces that separate the epidermis and the dermis from underlying tissues. They are common and occur mostly in older adults and those taking medications that compromise skin integrity. Pretibial skin tears can develop into leg ulcers, which require lengthy, expensive treatment to heal. Traumatic injuries are the second most common type of wounds after pressure ulcers in care homes and are the commonest reason for older adults to require the attention of a community nurse. Common causes of skin tear injuries are bumping into furniture and other obstacles, using mobility aids, transfer to/from wheelchairs, getting in and out of bed and falls. No effective preventative measures currently exist but knee-length, protective socks are now available that contain impact-resistant Kevlar fibres (of the type used in stab-proof vests) and cushioning layers underneath. METHODS/DESIGN: in this pilot parallel group, randomised controlled trial, 90 people at risk of skin-tear injury will be randomised with equal allocation to receive the intervention or usual care. They will be recruited from care homes and from the community via general practices and a research volunteer database. Pilot outcomes include recruitment, eligibility, attrition, ascertainment of injuries and completion of outcome measures. Acceptability of the intervention and of study participation will be explored using semi-structured interviews. The proposed primary outcome for the future definitive trial is skin tear-free days. Secondary outcomes are skin tear severity, health status, specific skin-tears quality of life, capability and fear of falling, measured at baseline and the end of the study and in the event of a skin tear. DISCUSSION: the results of this study will be used to inform the development and design of a future randomised controlled trial to assess the effectiveness and cost-effectiveness of a unique and innovative approach to skin tear prevention. Approval was granted by the NRES - Cornwall and Plymouth Research Ethics Committee (13/SW/013). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN96565376.

Background: in the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight. Methods: Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months. Results: 108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% and 85% provided data at 4 and 12 months respectively. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and comorbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p=0.025). No significant differences were found in physical activity. Conclusions: the Waste the Waist intervention is deliverable in UK primary care, has acceptable recruitment and retention rates and produces promising preliminary weight loss results. Subject to refinement of the physical activity component, it is now ready for evaluation in a full-scale trial. Trial registration: Current Controlled Trials ISRCTN10707899. Funding source: National Institute of Health Research.

BACKGROUND: Challenges remain to find ways to support patients with depression who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting patients to restore activities that have been avoided, but practitioners have no specific training in promoting PA. We aimed to design and evaluate an integrated BA and PA (BAcPAc) practitioner-led, written, self-help intervention to enhance both physical and mental health. METHODS/DESIGN: This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial (RCT) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT. Following development of the augmented written self-help intervention (BAcPAc) incorporating behavioural activation with physical activity promotion, depressed adults are randomised to receive up to 12 sessions over a maximum of 4 months of either BAcPAc or behavioural activation alone within a written self-help format, which represents treatment as usual. The study is located within two 'Improving Access to Psychological Therapies' services in South West England, with both written self-help interventions supported by mental health paraprofessionals. Measures assessed at 4, 9, and 12 month follow-up include the following: CIS-R, PHQ-9, accelerometer recorded (4 months only) and self-reported PA, body mass index, blood pressure, Insomnia Severity Index, quality of life, and health and social care service use. Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews. At the time of writing the study has recruited 60 patients. DISCUSSION: the feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self-help intervention to reduce depression and depressive relapse, and bring about improvements across a range of physical health outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74390532, 26.03.2013.

BACKGROUND: in the UK, people aged 85 and over are the fastest growing population group and are predicted to double in number by 2030. Emergency hospital admissions are also rising. METHODS: all emergency admissions for the registered population in Devon to all English hospitals were analysed by age, and admission rates per thousand registered were calculated. The Devon Predictive Model (DPM) was built, using local data, to predict emergency admissions in the following 12 months. This model was compared with the Combined Predictive Model over five risk categories. RESULTS: the registered Devon population on 31 March 2011 was 761 652 with 65 892 emergency admissions in 2010/2011. The DPM had 89 variables including several local factors which strengthened the model. Three of the four most powerful predictors were age 85-89, 90-94 and 95 and over. The positive predictive value for the DPM was better than the CPM's in all five risk categories. Half (49.6%) of all emergency admissions were from those aged 65 or over. Admissions rose progressively and significantly in each successive elderly age band. At age 85 and over there were 420 emergency admissions per thousand registered. CONCLUSIONS: Age, especially 85 and over, has been undervalued as a risk factor for emergency hospital admissions.

Polycystic ovary syndrome (PCOS) is a significant risk factor for developing type 2 diabetes and increased cardiovascular disease risk (together referred to as 'cardiometabolic disease', CMD). Primary prevention of CMD may be possible in women with PCOS but the diagnostic criteria for PCOS are controversial and this often hampers optimal clinical management. PCOS affects as many as 18% of women of reproductive age, and at least 70% remain undiagnosed in primary care. Screening women with PCOS for diabetes is seldom undertaken, largely through difficulties in diagnosis due to identification and management of PCOS continuing to focus on treatment of infertility and hirsutism. This article focuses on the diagnostic challenges of making the initial diagnosis of PCOS and considers how screening, detection and prevention of CMD might become routine clinical practice. It explores the unique challenges associated with PCOS and highlights the need for better evidence to justify screening and intervention. Finally, a pragmatic approach to assessing women with PCOS is suggested for use within primary care. © the Author(s) 2013.

AIMS: Type 2 diabetes is associated with serious complications and shortens life. Its prevalence is increasing rapidly worldwide and no cure is available. One logical response is to diagnose the condition as early as possible. Clinical opportunistic screening is one mechanism for making the diagnosis before symptoms are reported. This paper reports the cost of using this technique in UK general practice. METHODS: in one UK general practice, the electronic medical records were searched to determine the number of blood glucose and oral glucose tolerance tests undertaken for non-pregnant adults without known diabetes over three consecutive years. The laboratory, staff and administrative costs associated with these screening tests were calculated. The records of all patients newly diagnosed with Type 2 diabetes during the same period were reviewed to identify diagnoses made by clinical opportunistic screening. Total costs were divided by the number of diagnoses to determine a cost per diagnosis detected by opportunistic screening. RESULTS: During the study period, 5720 screening tests were conducted for 2763 patients. Over the 3 years, 86 patients were diagnosed with Type 2 diabetes, 54 (63%) via screening (yield 2.0%; number needed to screen 51.2). The screening costs totalled £ 20,372. The average cost per new screen-detected diagnosis was £ 377. CONCLUSIONS: Almost two-thirds of new cases of Type 2 diabetes can be detected before symptoms are reported, at reasonable cost by opportunistic screening in general practice, without the use of extra resources. As an affordable alternative to population screening, clinical opportunistic screening merits further consideration.

BACKGROUND: to develop more efficient programmes for promoting dietary and/or physical activity change (in order to prevent type 2 diabetes) it is critical to ensure that the intervention components and characteristics most strongly associated with effectiveness are included. The aim of this systematic review of reviews was to identify intervention components that are associated with increased change in diet and/or physical activity in individuals at risk of type 2 diabetes. METHODS: MEDLINE, EMBASE, CINAHL, PsycInfo, and the Cochrane Library were searched for systematic reviews of interventions targeting diet and/or physical activity in adults at risk of developing type 2 diabetes from 1998 to 2008. Two reviewers independently selected reviews and rated methodological quality. Individual analyses from reviews relating effectiveness to intervention components were extracted, graded for evidence quality and summarised. RESULTS: of 3856 identified articles, 30 met the inclusion criteria and 129 analyses related intervention components to effectiveness. These included causal analyses (based on randomisation of participants to different intervention conditions) and associative analyses (e.g. meta-regression). Overall, interventions produced clinically meaningful weight loss (3-5 kg at 12 months; 2-3 kg at 36 months) and increased physical activity (30-60 mins/week of moderate activity at 12-18 months). Based on causal analyses, intervention effectiveness was increased by engaging social support, targeting both diet and physical activity, and using well-defined/established behaviour change techniques. Increased effectiveness was also associated with increased contact frequency and using a specific cluster of "self-regulatory" behaviour change techniques (e.g. goal-setting, self-monitoring). No clear relationships were found between effectiveness and intervention setting, delivery mode, study population or delivery provider. Evidence on long-term effectiveness suggested the need for greater consideration of behaviour maintenance strategies. CONCLUSIONS: This comprehensive review of reviews identifies specific components which are associated with increased effectiveness in interventions to promote change in diet and/or physical activity. To maximise the efficiency of programmes for diabetes prevention, practitioners and commissioning organisations should consider including these components.

AIM: to systematically review studies reporting the effectiveness of various models of follow-up in primary care on a range of outcomes (physical, psychological, social functioning, or quality of life) for survivors of stroke and their caregivers. BACKGROUND: Stroke is a major cause of disability globally. Current UK policy calls for a primary care-based review of healthcare and social-care needs at six weeks and six months after hospital discharge and then annually. METHODS: Trials meeting the pre-defined inclusion criteria were identified by the systematic searching of electronic databases. Data were extracted by two independent researchers. Studies were rated using the McMaster University Quality Assessment Tool. FINDINGS: Nine randomised controlled trials that met the inclusion criteria were identified. These studies included interventions using stroke support workers, care coordinators or case managers. The methodological quality of the studies was variable, and models of care demonstrated inconsistent working relationships with general practitioners. Patients and caregivers receiving formal primary care-based follow-up did not show any gains in physical function, mood, or quality of life when compared with those who did not. Patients and caregivers receiving follow-up were generally more satisfied with some aspects of communication, and had a greater knowledge of stroke. CONCLUSIONS: the limited quality of these studies and the lack of a sound theoretical basis for the development of interventions together highlight the urgent need for high-quality research studies in this area.

Background: the prevalence and socioeconomic burden of type 2 diabetes (T2DM) and associated co-morbidities are rising worldwide. Aims: This guideline provides evidence-based recommendations for preventing T2DM. Methods: a European multidisciplinary consortium systematically reviewed the evidence on the effectiveness of screening and interventions for T2DM prevention using SIGN criteria. Results: Obesity and sedentary lifestyle are the main modifiable risk factors. Age and ethnicity are non-modifiable risk factors. Case-finding should follow a step-wise procedure using risk questionnaires and oral glucose tolerance testing. Persons with impaired glucose tolerance and/or fasting glucose are at high-risk and should be prioritized for intensive intervention. Interventions supporting lifestyle changes delay the onset of T2DM in high-risk adults (number needed- to-treat: 6.4 over 1.8-4.6 years). These should be supported by inter-sectoral strategies that create health promoting environments. Sustained body weight reduction by >= 5% lowers risk. Currently metformin, acarbose and orlistat can be considered as second-line prevention options. The population approach should use organized measures to raise awareness and change lifestyle with specific approaches for adolescents, minorities and disadvantaged people. Interventions promoting lifestyle changes are more effective if they target both diet and physical activity, mobilize social support, involve the planned use of established behaviour change techniques, and provide frequent contacts. Cost-effectiveness analysis should take a societal perspective. Conclusions: Prevention using lifestyle modifications in high risk individuals is cost-effective and should be embedded in evaluated models of care. Effective prevention plans are predicated upon sustained government initiatives comprising advocacy, community support, fiscal and legislative changes, private sector engagement and continuous media communication.

Objective to determine the preferred means by which participants in a study of cardiac rehabilitation wish to be informed of the study's results. Design Postal questionnaire survey of participants in a randomized controlled trial. Setting Cornwall, southwest England. Participants Patients recruited to the Cornwall Heart Attack Rehabilitation Management Study (CHARMS). Method Participants recruited to CHARMS who were alive 3 years and 9 months after the trial was completed were contacted by letter and invited to return a reply slip with four short questions indicating how they would prefer to be informed about the published results of the study. Results in March 2008, 191/230 participants originally recruited to CHARMS were still alive. General practitioners deemed 166/191 (88%) survivors medically appropriate to be contacted through a postal survey, and 154/166 (93%) participants responded to the invitation to participate in the follow-up survey. 86% (143/166) of participants indicated that they wished to be informed about the results: 115 (80%) of these elected to receive information by letter and 25 (18%) of these preferred to attend a meeting. Men older than 65 years predominated in this latter group. Women respondents preferred to receive the study results by letter; none preferred communication by email or the web. Conclusion Survivors of acute myocardial infarction who participated in a RCT of cardiac rehabilitation wanted to receive a summary of the aggregate study results. Participants had preferences regarding how they would wish to be informed about the results of the study. Most participants preferred to be informed by letter or email, but some preferred the interaction of a group or a meeting. © 2009 the Authors. Journal compilation © 2009 Blackwell Publishing Ltd.

To determine the preferred means by which participants in a study of cardiac rehabilitation wish to be informed of the study's results. Postal questionnaire survey of participants in a randomized controlled trial. Cornwall, southwest England. Patients recruited to the Cornwall Heart Attack Rehabilitation Management Study (CHARMS). Participants recruited to CHARMS who were alive 3 years and 9 months after the trial was completed were contacted by letter and invited to return a reply slip with four short questions indicating how they would prefer to be informed about the published results of the study. In March 2008, 191/230 participants originally recruited to CHARMS were still alive. General practitioners deemed 166/191 (88%) survivors medically appropriate to be contacted through a postal survey, and 154/166 (93%) participants responded to the invitation to participate in the follow-up survey. 86% (143/166) of participants indicated that they wished to be informed about the results: 115 (80%) of these elected to receive information by letter and 25 (18%) of these preferred to attend a meeting. Men older than 65 years predominated in this latter group. Women respondents preferred to receive the study results by letter; none preferred communication by email or the web. Survivors of acute myocardial infarction who participated in a RCT of cardiac rehabilitation wanted to receive a summary of the aggregate study results. Participants had preferences regarding how they would wish to be informed about the results of the study. Most participants preferred to be informed by letter or email, but some preferred the interaction of a group or a meeting.

Current NHS policy advocates screening to identify individuals at ‘high risk’ of cardio-vascular disease (CHD) in primary care. This paper utilizes the work of Radley to explore how ‘high risk’ of CHD patients make sense of their new risk status. Results are presented here from a nested qualitative study within a quantitative randomized trial of a CHD risk intervention in primary care. ‘Discovery’ interviews were conducted with ‘high risk’ participants (n=38, mean age=55) two weeks after intervention and thematically analyzed. In response to perceived threat, many participants sought to both ‘minimize’ and ‘normalize’ their risk status. They also reported intentions to act, particularly concerning dietary change and exercise, although less so for smoking amongst the lower SES participants. Such perceptions and intentions were contextualized within the life-course of later middle-age, so that both being at risk, and being treated for risk, were normalized as part of growing older. Social position, such as gender and SES, was also implicated. CHD risk interventions should be context-sensitive to the life-course and social position of those who find themselves at ‘high risk’ of CHD in later middle-age.

The prevalence of obesity is increasing and is strongly associated with mortality, asthma morbidity, the development of cardiovascular disease, hypertension, hypercholesterolaemia, cancer and type 2 diabetes (Avenell et al, 2004; Pischon et al, 2008; Sun et al, 2009). Motivational interviewing (MI) uses a person-centred counselling style to explore an individual's motivations and barriers to change. This article reviews recent evidence about the use of MI interventions to promote changes in diet and physical activity and discusses ways of enhancing and adapting MI interventions for primary care. © John Wiley and Sons 2008.

BACKGROUND: the marked increase of type 2 diabetes necessitates active development and implementation of efficient prevention programs. A European level action has been taken by launching the IMAGE project to unify and improve the various prevention management concepts, which currently exist within the EU. This report describes the background and the methods used in the development of the IMAGE project quality indicators for diabetes primary prevention programs. It is targeted to the persons responsible for diabetes prevention at different levels of the health care systems. METHODS: Development of the quality indicators was conducted by a group of specialists representing different professional groups from several European countries. Indicators and measurement recommendations were produced by the expert group in consensus meetings and further developed by combining evidence and expert opinion. RESULTS: the quality indicators were developed for different prevention strategies: population level prevention strategy, screening for high risk, and high risk prevention strategy. Totally, 22 quality indicators were generated. They constitute the minimum level of quality assurance recommended for diabetes prevention programs. In addition, 20 scientific evaluation indicators with measurement standards were produced. These micro level indicators describe measurements, which should be used if evaluation, reporting, and scientific analysis are planned. CONCLUSIONS: We hope that these quality tools together with the IMAGE guidelines will provide a useful tool for improving the quality of diabetes prevention in Europe and make different prevention approaches comparable.

Researchers, public health physicians and frontline clinicians, including GPs, are increasingly convinced that we are entering an epidemic (if not a pandemic) of diabetes mellitus. Rates of diabetes prevalence are increasing across the world, particularly in developing countries, and an increasing number of people are being diagnosed in primary care. This article explores the classification and diagnosis of diabetes, focusing on risk factors, pre-diabetes, and management and prevention strategies for type 2 diabetes in primary care.

BACKGROUND: Previous studies have identified a substantial prevalence of a blood pressure difference between arms in various populations, but not patients with type 2 diabetes. Recognition of such a difference would be important as a potential cause of underestimation of blood pressure. AIM: to measure prevalence of an inter-arm blood pressure difference in patients with type 2 diabetes, and to estimate how frequently blood pressure measurements could be erroneously underestimated if an inter-arm difference is unrecognised. DESIGN OF STUDY: Cross-sectional study. SETTING: Five surgeries covered by three general practices, Devon, England. METHOD: Patients with type 2 diabetes underwent bilateral simultaneous blood pressure measurements using a validated protocol. Mean blood pressures were calculated for each arm to derive mean systolic and diastolic differences, and to estimate point prevalence of predefined magnitudes of difference. RESULTS: a total of 101 participants were recruited. Mean age was 66 years (standard deviation [SD] = 13.9 years); 59% were male, and mean blood pressure was 138/79 mmHg (SD = 15/10 mmHg). Ten participants (10%; 95% confidence interval [CI] = 4 to 16) had a systolic inter-arm difference > or =10 mmHg; 29 (29%; 95% CI = 20 to 38) had a diastolic difference >/=5 mmHg; and three (3%; 95% CI = 0 to 6) a diastolic difference > or =10 mmHg. No confounding variable was observed to account for the magnitude of an inter-arm difference. CONCLUSION: a systolic inter-arm difference > or =10 mmHg was observed in 10% of patients with diabetes. Failure to recognise this would misclassify half of these as normotensive rather than hypertensive using the lower-reading arm. New patients with type 2 diabetes should be screened for an inter-arm blood pressure difference.

In the UK, patients normally see their general practitioner first and 86% of the health needs of the population are managed in general practice, with 14% being referred to specialist/hospital care. Early diagnosis is the privilege of general practice since general practitioners make most medical diagnoses in the NHS. Their historic aim has been to diagnose as early as possible and if possible before patients are aware of symptoms. Over time, diagnoses are being made earlier in the trajectory of chronic diseases and pre-symptomatic diagnoses through tests like cervical screening. Earlier diagnosis benefits patients and allows earlier treatment. In diabetes, the presence of lower HbA1c levels correlates with fewer complications. Methodologically, single practice research means smaller populations but greater ability to track patients and ask clinicians about missing data. All diagnoses of type 2 diabetes, wherever made, were tracked until death or transfer out. Clinical opportunistic screening has been undervalued and is more cost-effective than population screening. It works best in generalist practice. Over 19 consecutive years, all 429 patients with type 2 diabetes in one NHS general practice were analysed. The prevalence of type 2 diabetes rose from 1.1% to 3.0% of the registered population. Since 2000, 95.9% were diagnosed within the general practice and the majority (70/121 = 57.9%) of diagnoses were made before the patients reported any diabetes-related symptom. These patients had median HbA1c levels 1.1% lower than patients diagnosed after reporting symptoms, a clinically and statistically significant difference (P = 0.01).

Background. Patients who have had one stroke are at increased risk of another. Secondary prevention strategies that address medical risk factors and promote healthy lifestyles can reduce the risk. However, concordance with secondary prevention strategies is poor and there has been little research into patient and carer views.Objectives. To explore the experiences of patients and carers of receiving secondary prevention advice and use these to inform the development of an educational resource.Methods. A total of 38 participants (25 patients and 13 carers) took part in the study which used an action research approach. Focus groups and interviews were undertaken with patients and carers who had been discharged from hospital after stroke (between 3 and 24 months previously). Framework analysis was used to examine the data and elicit action points to develop an educational resource.Results. Participants' main concern was their desire for early access to information. They commented on their priorities for what information or support they needed, the difficulty of absorbing complex information whilst still an in-patient and how health professionals' use of language was often a barrier to understanding. They discussed the facilitators and barriers to making lifestyle changes. The educational resource was developed to include specific advice for medical and lifestyle risk factors and an individual action plan.Conclusion. An educational resource for secondary prevention of stroke was developed using a participatory methodology. Our findings suggest that this resource is best delivered in a one-to-one manner, but further work is needed to identify its potential utility.

BACKGROUND: Current primary prevention guidelines recommend the assessment of family history of coronary heart disease (CHD) to identify at-risk individuals. OBJECTIVE: to examine how clinicians and patients understand and communicate family history in the context of CHD risk assessment in primary care. METHODS: a qualitative study. Patients completed a validated family history questionnaire. Consultations with clinicians were video recorded, and semi-structured interviews conducted with patients after consultation. The participants were 21 primary care patients and seven primary care clinicians (two practice nurses, five GPs). Four practices in South West England. RESULTS: Patients and clinicians usually agreed about the patient's level of risk and how to reduce it. Patients were mostly satisfied with their consultations and having their family history assessed. However, three issues were identified from the consultations which contributed to concerns and unanswered questions for patients. Problems arose when there were few modifiable risk factors to address. Firstly, patients' explanations of their family history were not explored in the consultation. Secondly, the relationship between the patient's family history and their other risk factors, such as smoking or cholesterol, was rarely discussed. Thirdly, clinicians did not explain the integration of family history into the patient's overall cardiovascular disease risk. CONCLUSIONS: Clinicians appeared to lack a rhetoric to discuss family history, in terms of capturing both genetic and environmental factors and its relation to other risk factors. This created uncertainties for patients and carries potential clinical and social implications. There is a need for better guidance for primary care clinicians about family history assessment.

AIMS: to develop and pilot a survey instrument assessing general practitioners' (GP) attitudes to the diagnosis and management of one form of pre-diabetes, impaired glucose tolerance (IGT) and to assess the performance of the questionnaire. METHODS: Qualitative data together with an audit were used to generate questionnaire items, which were then subjected to a process of pre-piloting and piloting to generate a finalised item list. The pilot questionnaire was sent to 222 principal GPs in three PCTs in South West England. The first fifty responders were asked to complete the questionnaire again 2 weeks later. Principal components analysis with a Varimax rotation was used to detect latent factors within the data that may help to explain the attitudes of GPs. RESULTS: the response rate after one reminder was 54.1%. Four robust factors were identified which were internally consistent (range of Cronbach's alpha=0.79-0.65), homogeneous (item-total correlations=0.60-0.21), and stable (test-retest correlation=0.74-0.58) accounting for 31.1% of the variance. The predictive validity of the item list was assessed (P=0.02 for factor 1). CONCLUSIONS: the PAtH questionnaire identifies four factors that help to describe GPs attitudes to the diagnosis and management of IGT.

AIMS: to identify key messages about pre-diabetes and to design, develop and pilot an educational toolkit to address the information needs of patients and health professionals. METHODS: Mixed qualitative methodology within an action research framework. Focus group interviews with patients and health professionals and discussion with an expert reference group aimed to identify the important messages and produce a draft toolkit. Two action research cycles were then conducted in two general practices, during which the draft toolkit was used and video-taped consultations and follow-up patient interviews provided further data. Framework analysis techniques were used to examine the data and to elicit action points for improving the toolkit. RESULTS: the key messages about pre-diabetes concerned the seriousness of the condition, the preventability of progression to diabetes, and the need for lifestyle change. As well as feedback on the acceptability and use of the toolkit, four main themes were identified in the data: knowledge and education needs (of both patients and health professionals); communicating knowledge and motivating change; redesign of practice systems to support pre-diabetes management and the role of the health professional. The toolkit we developed was found to be an acceptable and useful resource for both patients and health practitioners. CONCLUSIONS: Three key messages about pre-diabetes were identified. A toolkit of information materials for patients with pre-diabetes and the health professionals and ideas for improving practice systems for managing pre-diabetes were developed and successfully piloted. Further work is needed to establish the best mode of delivery of the WAKEUP toolkit.

BACKGROUND: Home-based cardiac rehabilitation offers an alternative to traditional, hospital-based cardiac rehabilitation. AIM: to compare the cost effectiveness of home-based cardiac rehabilitation and hospital-based cardiac rehabilitation. METHODS: 104 patients with an uncomplicated acute myocardial infarction and without major comorbidity were randomized to receive home-based rehabilitation (n=60) i.e. nurse facilitated, self-help package of 6 weeks' duration (the Heart Manual) or hospital-based rehabilitation for 8-10 weeks (n=44). Complete economic data were available in 80 patients (48 who received home-based rehabilitation and 32 who received hospital-based rehabilitation). Healthcare costs, patient costs, and quality of life (EQ-5D4.13) were assessed over the 9 months of the study. RESULTS: the cost of running the home-based rehabilitation programme was slightly lower than that of the hospital-based programme (mean (95% confidence interval) difference - 30 pounds sterling (- 45 pounds sterling to - 12 pounds sterling) [-44 euro, -67 euro to -18 euro] per patient. The cost difference was largely the result of reduced personnel costs. Over the 9 months of the study, no significant difference was seen between the two groups in overall healthcare costs (78 pounds sterling, - 1102 pounds sterling to 1191 pounds sterling [-115 euro, -1631 euro to -1763 euro] per patient) or quality adjusted life-years (-0.06 (-0.15 to 0.02)). The lack of significant difference between home-based rehabilitation and hospital-based rehabilitation did not alter when different costs and different methods of analysis were used. CONCLUSIONS: the health gain and total healthcare costs of the present hospital-based and home-based cardiac rehabilitation programmes for patients after myocardial infarction appear to be similar. These initial results require affirmation by further economic evaluations of cardiac rehabilitation in different settings.

BACKGROUND: Participation in cardiac rehabilitation after acute myocardial infarction is sub-optimal. Offering home-based rehabilitation may improve uptake. We report the first randomized study of cardiac rehabilitation to include patient preference. AIM: to compare the clinical effectiveness of a home-based rehabilitation with hospital-based rehabilitation after myocardial infarction and to determine whether patient choice affects clinical outcomes. DESIGN: Pragmatic randomized controlled trial with patient preference arms. SETTING: Rural South West England. METHODS: Patients admitted with uncomplicated myocardial infarction were offered hospital-based rehabilitation classes over 8-10 weeks or a self-help package of six weeks' duration (the Heart Manual) supported by a nurse. Primary outcomes at 9 months were mean depression and anxiety scores on the Hospital Anxiety Depression scale, quality of life after myocardial infarction (MacNew) score and serum total cholesterol. RESULTS: of the 230 patients who agreed to participate, 104 (45%) consented to randomization and 126 (55%) chose their rehabilitation programme. Nine month follow-up data were available for 84/104 (81%) randomized and 100/126 (79%) preference patients. At follow-up no difference was seen in the change in mean depression scores between the randomized home and hospital-based groups (mean difference: 0; 95% confidence interval, -1.12 to 1.12) nor mean anxiety score (-0.07; -1.42 to 1.28), mean global MacNew score (0.14; -0.35 to 0.62) and mean total cholesterol levels (-0.18; -0.62 to 0.27). Neither were there any significant differences in outcomes between the preference groups. CONCLUSIONS: Home-based cardiac rehabilitation with the Heart Manual was as effective as hospital-based rehabilitation for patients after myocardial infarction. Choosing a rehabilitation programme did not significantly affect clinical outcomes.

BACKGROUND: Patients with asthma are particularly susceptible to serious complications from influenza. The Chief Medical Officer recommends annual influenza vaccination for adult patients with asthma. The uptake of influenza vaccination by patients with asthma is only 40% and, unlike other high-risk groups, has failed to increase in recent years. AIM: to investigate the contribution of sociodemographic factors, asthma morbidity, and health beliefs to influenza vaccination uptake in patients with asthma. DESIGN OF STUDY: Cross-sectional questionnaire study. SETTING: Single urban British general practice, Exeter, UK. METHOD: a questionnaire survey was sent to adult patients with asthma. Participants were aged 16-65 years, were receiving beta(2) agonists and inhaled steroids, and had been invited for influenza vaccination in September 2003. Data were examined using univariate analysis and logistic regression. RESULTS: a total of 136/204 (66.7%) patients responded to the survey. Influenza vaccination uptake in the study population was 40%. Younger patients were less likely to have undergone vaccination than older patients. There was no difference in vaccination uptake rates between groups of patients defined by other sociodemographic factors. Asthma morbidity was similar in vaccinated and non-vaccinated groups of patients. Vaccinated individuals had a greater belief in the efficacy of the vaccination and medical advice regarding the vaccination, and felt more susceptible to influenza and its complications when compared with non-vaccinated individuals. A fear of side-effects was associated with declining the invitation for vaccination. These health beliefs were the only independent predictors of uptake of influenza vaccination among this group of patients with asthma. CONCLUSION: Improving vaccination uptake in patients with asthma is unlikely unless individual health beliefs are taken into account.

BACKGROUND: the benefits of cardiac rehabilitation (CR) after myocardial infarction (MI) are increasingly recognised and is recommended in national guidelines. AIMS: to explore patients' experience of MI and to identify the factors which influence the choice patients make given the option of hospital or home-based CR after MI. METHOD: Qualitative study using semi-structured interviews and interpretive phenomenological analysis (IPA). This study was embedded within a randomised trial with preference arms. RESULTS: Seventeen participants were interviewed before their rehabilitation programme. Ten expressed a preference for home-based and seven for hospital-based rehabilitation. Common to both groups was shock and disbelief, which led to a loss of confidence. They expressed a strong desire to make lifestyle changes and looked for specific advice, guidance and support from knowledgeable experts. The hospital-based group had an emphasis on supervision during exercise, needed the camaraderie of a group, were willing to make travel arrangements and believed they lacked self-discipline. The home-based group believed that their CR should fit in with their lives rather than their lives fitting in with the rehabilitation programme and were self-disciplined. They disliked groups and expressed practical concerns. CONCLUSIONS: Understanding the factors that influence patient's choices may help professionals guide them to the most appropriate CR method and hence improve uptake.

A blood pressure (BP) difference between arms was first reported over 100 years ago. Knowledge of its prevalence and relevance to the accurate measurement of BP remains poor. Current hypertension guidelines do not emphasise it. The objectives of this study were to establish the best estimate of prevalence of the inter-arm difference (IAD) in the population, to consider its implications for accurate BP measurement and treatment, and to discuss its aetiology and potential as a risk marker for cardiovascular disease. Systematic literature review was carried out. The data sources were Medline EMBASE and CINAHL databases, and Index of Theses. Studies reporting prevalence rates of IAD were retrieved and considered for inclusion against explicit methodological criteria. Point prevalence rates were extracted and weighted mean prevalence rates calculated. The main outcome measures were weighted mean prevalences of systolic IAD > or =10 and > or =20 mm Hg and of diastolic IAD > or =10 mm Hg. Thirty-one studies were identified. Most had methodological weaknesses; only four met the inclusion criteria. Pooled prevalences of the IAD from these four studies were 19.6% systolic > or =10 mm Hg (95% CI 18.0-21.3%), 4.2% systolic > or =20 mm Hg (95% CI 3.4-5.1%) and 8.1% diastolic > or =10 mm Hg (95%CI 6.9-9.2%). In conclusion, an IAD is present in a substantial number of patients and should be looked for whenever diagnosis and treatment depend on accurate measurements of BP. The importance of an IAD should be better emphasised in current hypertension management guidelines. There is evidence associating an IAD with peripheral vascular disease, raising the possibility that its presence may predict cardiovascular events.

BACKGROUND: Although whole population screening for type 2 diabetes is not currently considered to be justified, targeted screening within higher risk groups may be more cost-effective, and more pragmatic. OBJECTIVES: Our aim was to investigate the feasibility and performance of a pragmatic system for identifying patients with type 2 diabetes and impaired fasting glycaemia (IFG). METHODS: a clustered observational survey of the prevalence of diabetes and IFG was carried out in randomly selected patients from four at-risk groups. Patients were identified by computerized searching of practice databases for age and body mass index (BMI) risk criteria. Sixteen practices in South West England screened 1287 Caucasian patients from four groups with progressive levels of theoretical risk (age >70 and BMI >or=33, age >65 and BMI >or=31, age >60 and BMI >or=29, and age >50 and BMI >or=27). Fasting plasma glucose was measured and repeated if abnormal to determine the prevalence of new cases in each group. BMI and age data were validated against measures taken at the clinic. RESULTS: the response rate was 60.6% and the prevalence of new cases of type 2 diabetes in each group was 4.7% [95% confidence interval (CI) 2.8-7.7], 5.7% (95% CI 4.0-8.2), 3.8% (95% CI 2.4-6.0) and 2.6% (95%CI 1.4-4.7), respectively. An additional 5.2-8.4% had IFG. CONCLUSIONS: Targeted screening by searching existing GP records for age and BMI criteria is feasible for use in general practice in the UK. Screening of patients with a BMI of >or=27 and aged >50 by fasting glucose identified a substantial prevalence of undetected type 2 diabetes and IFG. The relative costs and benefits as well as the pragmatic advantages of different systems need further evaluation.

The secondary prevention of coronary heart disease (CHD) is a recognised priority for primary care and is a fundamental part of the published National Service Framework (NSF). The majority of patients receive statins to reduce their total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels. The NSF set out targets for both TC and LDL-C. This study was designed to investigate the applicability of these targets in a real-life setting. One hundred and ten patients aged under 75 with established CHD were screened and their lipids measured. Eighty (73%) were on a statin. Mean TC was 6.3 mmol/L before treatment and 4.8 mmol/L after. of these 80 patients, 46 (58%) had a TC below 5.0 mmol/L. Only 39% of patients met the stricter criterion of less than 5.0 mmol/L and a 25% fall in TC. No patient whose pretreatment TC was below 5.0 mmol/L had reached a 25% reduction as well. The use of a threshold and a percent-age may be potentially confusing to GPs and reduce the implementation of these targets.

Primary care has a key role in improving the health of patients who have had a myocardial infarction

Little is known about the impact of case-finding and protocol-driven screening at a practice level on the increasing prevalence of type 2 diabetes. This cross-sectional study investigated the diagnostic process in 154 patients with diabetes in a single practice with protocol-led screening for diabetes. A large proportion (87%) were diagnosed in primary care and of the 116 (86.6%) patients with type 2 diabetes the majority (58.6%) were also asymptomatic at the time of diagnosis. The commonest reason for screening was the presence of hypertension.

Changes in the organization of primary care in the UK are driven by a need to improve access and availability, but doctor-patient relationships may suffer. To investigate the importance of such relationships in a different setting, we analysed focus-group data obtained in a primary care facility in the USA (Rochester, NY). The findings pointed to three key factors in these relationships-namely, an asymmetry of perceptions on the two sides, belying the notion of a meeting of experts; the importance on both sides of 'liking'; and the value set by both parties on development of trust. The last two of these factors are probably related to continuity of care, now under threat.

Seven randomized trials published in the last six years have shown that warfarin reduces the risk of ischaemic strokes and death in patients with atrial fibrillation. The annual rates of major bleeding episodes in all these trials were low and, as a result, doctors in primary and secondary care are being encouraged to consider using warfarin for patients with atrial fibrillation unless there are obvious contraindications. However, the populations used in these studies were highly selected and rigorously monitored throughout the trial period to minimize the risk of bleeding in a way which probably could not be expected in routine primary care. Although the rates of major bleeding episodes were uniformly low, the rates of minor bleeding episodes were much higher and these could impact substantially on patients' views of the treatment and on the workload of the primary care team. Evidence is now at hand which allows the stratification of risk in patients with atrial fibrillation which should enable those who are at greatest risk to be considered for this form of treatment. Patients may develop risk factors over time which could render them unsuitable for continuation of warfarin therapy. The general practitioner is centrally placed to make the decision about initiating or continuing treatment or indeed stopping it. Several models for decision making in warfarin treatment from primary and secondary care are proposed.