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Background Medication review is a core aspect of medicine optimisation, yet existing models of review vary substantially in structure and content and are not necessarily easy to implement in clinical practice. This study aimed to use evidence from the existing literature to identify key medication review components and use this to inform the design of an improved review model. Methods A systematic review was conducted (PROSPERO: CRD42018109788) to identify randomised control trials of stand-alone medication review in adults (18+ years). The review updated that by Huiskes et al. (BMC Fam Pract. 18:5, 2017), using the same search strategy implemented in MEDLINE and Embase. Studies were assessed using the Cochrane risk of bias tool. Key review components were identified, alongside relevant clinical and health service outcomes. A working group (patients, doctors and pharmacists) developed the model through an iterative consensus process (appraisal of documents plus group discussions), working from the systematic review findings, brief evidence summaries for core review components and examples of previous models, to agree on the main purpose of the review model, overarching model structure, review components and supporting material. Results We identified 28 unique studies, with moderate bias overall. Consistent medication review components included reconciliation (26 studies), safety assessment (22), suboptimal treatment (19), patient knowledge/preferences (18), adherence (14), over-the-counter therapy (13) and drug monitoring (10). There was limited evidence from studies for improvement in key clinical outcomes. The review structure was underpinned by patient values and preferences, with parallel information gathering and evaluation stages, feeding into the final decision-making and implementation. Most key components identified in the literature were included. The final model was considered to benefit from a patient-centred, holistic approach, which captured both patient-orientated and medication-focused problems, and aligned with traditional consultation methods thus facilitating implementation in practice. Conclusions The Bristol Medication Review Model provides a framework for standardised delivery of structured reviews. The model has the potential for use by all healthcare professionals with relevant clinical experience and is designed to offer flexibility of implementation not limited to a particular healthcare setting.

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

BackgroundMedication reviews may improve the safety of prescribing and the National Institute for Health and Care Excellence (NICE) highlights the importance of involving patients in this process.AimTo explore GP and pharmacist perspectives on how medication reviews were conducted in general practice in the UK.Design and settingAnalysis of semi-structured interviews with GPs and pharmacists working in the South West of England, Northern England, and Scotland, sampled for heterogeneity. Interviews took place between January and October 2017.MethodInterviews focused on experience of medication review. Data saturation was achieved when no new insights arose from later interviews. Interviews were analysed thematically.ResultsIn total, 13 GPs and 10 pharmacists were interviewed. GPs and pharmacists perceived medication review as an opportunity to improve prescribing safety. Although interviewees thought patients should be involved in decisions about their medicines, high workload pressures meant that most medication reviews were conducted with limited or no patient input. For some GPs, a medication review was done ‘in the quickest way possible to say that it was done’. Pharmacists were perceived by both professions as being more thorough but less time efficient than GPs, and few pharmacists were routinely involved in medication reviews even in practices employing a pharmacist. Interviewees argued that it was easier to continue medicines than it was to stop them, particularly because stopping medicines required involving the patient and this generated extra work.ConclusionPractices tended to prioritise being efficient (getting the work done) rather than being thorough (doing it well), so that most medication reviews were carried out with little or no patient involvement, and medicines were rarely stopped or reduced. Time and resource constraints are an important barrier to implementing NICE guidance.

Background Up to 50% of medicines are not used as intended, resulting in poor health and economic outcomes. Medicines optimisation is ‘a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines’. The purpose of this exercise was to co-produce a prioritised research agenda for medicines optimisation using a multi-stakeholder (patient, researcher, public and health professionals) approach. Methods A three-stage, multiple method process was used including: generation of preliminary research questions (Stage 1) using a modified Nominal Group Technique; electronic consultation and ranking with a wider multi-stakeholder group (Stage 2); a face-to-face, one-day consensus meeting involving representatives from all stakeholder groups (Stage 3). Results In total, 92 research questions were identified during Stages 1 and 2 and ranked in order of priority during stage 3. Questions were categorised into four areas: ‘Patient Concerns’ [e.g. is there a shared decision (with patients) about using each medicine?], ‘Polypharmacy’ [e.g. how to design health services to cope with the challenge of multiple medicines use?], ‘Non-Medical Prescribing’ [e.g. how can the contribution of non-medical prescribers be optimised in primary care?], and ‘Deprescribing’ [e.g. what support is needed by prescribers to deprescribe?]. A significant number of the 92 questions were generated by Patient and Public Involvement representatives, which demonstrates the importance of including this stakeholder group when identifying research priorities. Conclusions A wide range of research questions was generated reflecting concerns which affect patients, practitioners, the health service, as well the ethical and philosophical aspects of the prescribing and deprescribing of medicines. These questions should be used to set future research agendas and funding commissions.

Background Deep-vein thrombosis and pulmonary embolism, collectively known as venous thromboembolism when clots are formed in the venous circulation, are common disorders that are often unprovoked (i.e. there is no obvious reason for the clot occurring). Some people, after having an unprovoked clot, are at a high risk of developing another, or at risk of developing a secondary clot, most importantly in the lungs. Furthermore, in the long term, some patients will develop circulation problems known as post-thrombotic syndrome. The aim of this programme was to improve the understanding of both the prevention and the treatment of thrombosis in people at the highest risk of recurrence. Objectives To clarify if it is possible to identify those people at the highest risk of having a recurrent venous thromboembolism, and if it is possible to prevent this happening by giving anticoagulation treatment for longer. To clarify if it is possible to identify those people at the highest risk of developing post-thrombotic syndrome. To document the current knowledge level about prevention and treatment of venous thromboembolism. To find what the barriers are to implementing measures to prevent venous thromboembolism. To find the most cost-effective means of treating venous thromboembolism. Design Mixed methods, comprising a randomised controlled trial, qualitative studies, cost-effectiveness analyses and questionnaire studies, including patient preferences. Setting UK general practices and hospitals, predominantly from the Midlands and Shropshire. Participants Adults attending participating anticoagulation clinics with a diagnosis of first unprovoked deep-vein thrombosis or pulmonary embolism, and health-care professionals, patients and other stakeholders who were involved in the prevention and treatment of venous thromboembolism. Intervention Extended treatment with oral anticoagulation therapy (2 years) versus standard care (treatment with oral anticoagulation therapy for at least 3 months). Results Work package 1 demonstrated that extended anticoagulation for up to 2 years was clinically effective and cost-effective in reducing the incidence of recurrent venous thromboembolism, with a small increase in the risk of bleeding. There was no difference in post-thrombotic syndrome incidence or severity, or quality of life, between those undergoing the extended treatment and those receiving the standard care. Work package 2 identified five common themes with regard to the prevention of hospital-acquired thrombosis: communication, knowledge, role of primary care, education and training, and barriers to patient adherence. Work package 3 suggested that extended anticoagulation with novel oral anticoagulants was cost-effective only at the £20,000-per-quality-adjusted life-year level for a recurrence rate of between 17.5% and 22.5%, depending on drug acquisition costs, while identifying a strong patient preference for extended anticoagulation based on a fear of recurrent venous thromboembolism. Limitations The major limitation was the failure to reach the planned recruitment target for work package 1. Conclusions Extended anticoagulation with warfarin for a first unprovoked venous thromboembolism is clinically effective and cost-effective and is strongly preferred by patients to the alternative of not having treatment. There are significant barriers to the implementation of preventative measures for hospital-acquired thrombosis. Further research is required on identifying patients in whom it is safe to discontinue anticoagulation, and at what time point following a first unprovoked venous thromboembolism this should be done. Trial registration Current Controlled Trials ISRCTN73819751 and EudraCT 2101-022119-20. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 5. See the NIHR Journals Library website for further project information.

BackgroundMany UK GP practices now employ a practice pharmacist, but little is known about how GPs and pharmacists work together to optimise medications for complex patients with multimorbidity.AimTo explore GP and pharmacist perspectives on collaborative working within the context of optimising medications for patients with multimorbidity.Design and settingA qualitative analysis of semi-structured interviews with GPs and pharmacists working in the West of England, Northern England, and Scotland.MethodThirteen GPs and 10 pharmacists were sampled from practices enrolled in the 3D trial (a complex intervention for people with multimorbidity). Participants’ views on collaborative working were explored with interviews that were audiorecorded, transcribed, and analysed thematically. Saturation of data was achieved with no new insights arising from later interviews.ResultsGPs from surgeries that employed a pharmacist tended to value their expertise more than GPs who had not worked with one. Three key themes were identified: resources and competing priorities; responsibility; and professional boundaries. GPs valued pharmacist recommendations that were perceived to improve patient safety, as opposed to those that were technical and unlikely to benefit the patient. Pharmacists who were not known to GPs felt undervalued and wanted feedback from the GPs about their recommendations, particularly those that were not actioned.ConclusionA good working relationship between the GP and pharmacist, where each profession understood the other’s skills and expertise, was key. The importance of face-to-face meetings and feedback should be considered in future studies of interdisciplinary interventions, and by GP practices that employ pharmacists and other allied health professionals.

BackgroundSubclinical thyroid dysfunction — abnormal serum thyrotrophin (thyroid-stimulating hormone; TSH) concentrations with normal free thyroxine (FT4) is common in older people. It remains unclear whether individuals with subclinical serum status experience an increased symptom profile.AimTo compare the prevalence of those symptoms typically associated with overt thyroid dysfunction in older individuals with a subclinical and euthyroid serum profile.Design and settingCross-sectional study, nested within the Birmingham Elderly Thyroid Study (BETS); from 19 UK general practices.MethodAdults living in a community setting (aged ≥65 years), without overt thyroid dysfunction or associated treatment, self-reported the presence or absence of 18 symptoms (while serum result naïve). Serum concentrations of TSH and FT4 were measured to establish thyroid status.ResultsA total of 2870 individuals were screened: 2703 (94%) were categorised as euthyroid (normal), 29 (1%) subclinically hyperthyroid, and 138 (5%) subclinically hypothyroid. Symptoms were common in all groups. No significant differences in the prevalence of individual symptoms were observed between the euthyroid and subclinically hypothyroid groups nor in comparison with the subclinically hyperthyroid group. Multivariate logistic regression analysis failed to reveal an association between individual or multiple symptoms and subclinical status.ConclusionFindings suggest that subclinical thyroid dysfunction does not confer a symptom burden in older individuals and support adherence to guidelines in the non-treatment of subclinical thyroid dysfunction. GPs may use the findings to reassure older people presenting with symptoms that subclinical thyroid dysfunction is an unlikely explanation. The presence of persistently abnormal TSH concentrations may be linked to long-term risks of cardiovascular disease, especially atrial fibrillation, but whether this should prompt treatment and whether such treatment alters vascular outcomes is unknown.

Objectives:To determine the proportion of UK surfers aware of external auditory canal exostosis, to identify surfer characteristics associated with knowledge of the condition and to explore attitudes to earplug use.Method:An online, cross-sectional survey of UK-based surfers.Results:Of 375 surfers, 86.1 per cent (n = 323; 95 per cent confidence interval = 82.3–89.3) reported awareness of external auditory canal exostosis. Further investigation revealed that, despite their awareness of the condition, 23.4 per cent of these surfers (88 out of 323; 95 per cent confidence interval = 19.5–28.0) had little or no knowledge about external auditory canal exostosis. Predictors of knowledge included: distance from nearest surfing beach (p = 0.001), surfing standard (ability) (p = 0.008), earplug use (p = 0.024) and positive external auditory canal exostosis diagnosis (p = 0.009).Conclusion:The findings suggest that a significant minority of UK surfers have no knowledge about this condition. Knowledge of external auditory canal exostosis was significantly associated with earplug use when surfing. Efforts to improve surfers’ knowledge are required to enable surfers to better protect themselves, which could reduce the incidence of external auditory canal exostosis.

BackgroundThyroid function tests (TFTs) are among the most requested tests internationally. However, testing practice is inconsistent, and potentially suboptimal and overly costly. The natural history of thyroid function remains poorly understood.AimTo establish the stability of thyroid function over time, and identify predictors of development of overt thyroid dysfunction.Design and settingLongitudinal follow-up in 19 general practices in the UK.MethodA total of 2936 participants from the Birmingham Elderly Thyroid Study (BETS 1) with a baseline TFT result indicating euthyroid or subclinical state were re-tested after approximately 5 years. Change in thyroid-stimulating hormone (TSH), free thyroxine (FT4), and thyroid status between baseline and follow-up was determined. Predictors of progression to overt dysfunction were modelled.ResultsParticipants contributed 12 919 person-years; 17 cases of overt thyroid dysfunction were identified, 13 having been classified at baseline as euthyroid and four as having subclinical thyroid dysfunction. Individuals with subclinical results at baseline were 10- and 16-fold more likely to develop overt hypothyroidism and hyperthyroidism, respectively, compared with euthyroid individuals. TSH and FT4 demonstrated significant stability over time, with 61% of participants having a repeat TSH concentration within 0.5 mIU/L of their original result. Predictors of overt hypothyroidism included new treatment with amiodarone (odds ratio [OR] 92.1), a new diagnosis of atrial fibrillation (OR 7.4), or renal disease (OR 4.8).ConclusionHigh stability of thyroid function demonstrated over the 5-year interval period should discourage repeat testing, especially when a euthyroid result is in the recent clinical record. Reduced repeat TFTs in older individuals is possible without conferring risk, and could result in significant cost savings.

AimTo evaluate the reliability and performance of the Xprecia Stride coagulometer under the conditions in which it is most likely to be used.MethodsThe performance of the Xprecia Stride coagulometer was compared with a local laboratory and the CoaguChek systems routinely used for international normalised ratio (INR) estimation within one primary and one secondary care based anticoagulation clinic in Birmingham. Anticoagulation clinic personnel were trained to use the Xprecia Stride. Patients attending the clinics were eligible if aged ≥18 years and had received warfarin for at least 3 months. Consenting participants provided capillary blood samples for parallel testing on the Xprecia Stride and CoaguChek systems. At the secondary care clinic, a venous blood sample was also collected for laboratory INR estimation. INR results were compared using linear regression analysis and Bland–Altman plots.ResultsA total of 102 laboratory and 205 parallel coagulometer INR tests were performed. Linear regression revealed strong correlation between the Xprecia Stride and the laboratory (r=0.83) and between the Xprecia Stride and CoaguChek systems (r=0.92). Within the therapeutic range, agreement between the systems was very good with 87% of the Xprecia Stride and laboratory INR results and 93% of the Xprecia Stride and CoaguChek INR results being within 0.5 INR units of each other.ConclusionINRs tested using the Xprecia Stride system showed good agreement with the laboratory and CoaguChek systems. Findings indicate that in the hands of the intended users the Xprecia Stride is accurate, reliable and acceptable for use in a routine clinical setting.

Introduction: Atrial fibrillation (AF) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk. Active screening strategies improve detection of AF in comparison with routine care; however, whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear. Using data derived from the screening for AF in the elderly (SAFE) study, the aim of this article was to determine if patients with AF detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation. Methods: Secondary analysis of data derived from 25 general practices within which cohorts of 200 patients were randomly allocated to opportunistic [pulse and electrocardiogram (ECG)] or systematic screening (postal invitation for ECG). Stroke risk assessment was undertaken using baseline data extracted from medical records and CHADS2 criteria. CHADS2 scores were compared between the screening groups. Results: One hundred and forty-nine new cases of AF were detected, 75 via opportunistic screening and 74 via systematic screening. CHADS2 scores were ≥1 in 83% [95% confidence interval (CI) 72.6-89.6] of patients detected via opportunistic screening and 78% (95% CI 67.7-86.2) detected via systematic screening. There were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings. Conclusion: Stroke risk profiles of patients detected via opportunistic and systematic screenings were similar. Data derived from the SAFE study suggest that active screening for AF in patients aged ≥65 years in primary care is a useful screening programme with 78-83% of patients identified eligible for anticoagulation treatment according to the CHADS2 criteria. © The Author 2014. Published by Oxford University Press. All rights reserved.

Background Detection and treatment of heart failure (HF) can improve quality of life and reduce premature mortality. However, symptoms such as breathlessness are common in primary care, have a variety of causes and not all patients require cardiac imaging. In systems where healthcare resources are limited, ensuring those patients who are likely to have HF undergo appropriate and timely investigation is vital. Design A decision tree was developed to assess the cost-effectiveness of using the MICE (Male, Infarction, Crepitations, Edema) decision rule compared to other diagnostic strategies to identify HF patients presenting to primary care. Methods Data from REFER (REFer for EchocaRdiogram), a HF diagnostic accuracy study, was used to determine which patients received the correct diagnosis decision. The model adopted a UK National Health Service (NHS) perspective. Results The current recommended National Institute for Health and Care Excellence (NICE) guidelines for identifying patients with HF was the most cost-effective option with a cost of £4,400 per Quality Adjusted Life Year (QALY) gained compared to a “do nothing” strategy. That is, patients presenting with symptoms suggestive of HF should be referred straight for echocardiography if they had a history of myocardial infarction or if their NT-proBNP level was ≥ 400pg/ml. The MICE rule was more expensive and less effective than the other comparators. Base-case results were robust to sensitivity analyses. Conclusions This represents the first cost-utility analysis comparing HF diagnostic strategies for symptomatic patients. Current guidelines in England were the most cost-effective option for identifying patients for confirmatory HF diagnosis. The low number of HF with Reduced Ejection Fraction patients (12%) in the REFER patient population limited the benefits of early detection.

Demand for anticoagulation management is increasing due to an expansion of clinical indications for therapy. One possible model of care to meet demand is patient self-management (PSM), beneficial to patients who need control over their condition. This study aimed to determine the cost and cost-effectiveness of PSM of anticoagulation compared with routine clinic-based care for patients receiving long-term anticoagulation. A cost-utility analysis was conducted alongside a randomised controlled trial; 617 patients were recruited and followed up for 12 months. There was no significant difference in mean quality-adjusted life years (QALYs) between groups - after adjusting for baseline, the mean difference in QALYs was 0.009 (95% CI, -0.012 to 0.030). Overall mean healthcare costs in the PSM arm were significantly higher at pounds sterling 417 (CI pounds sterling 394- pounds sterling 442) compared with pounds sterling 122 (CI pounds sterling 103- pounds sterling 144) in the control arm. Therefore, using a formal cost-effectiveness analysis, PSM of anticoagulation does not appear to be cost-effective. However, PSM may have other benefits in relieving pressure on traditional clinic-based care, and the cost-effectiveness of this model of care for some subgroups of anticoagulation patients needs to be explored further.

Background: Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. Method: The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. Discussion: The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

Background. Research related to service requirements for anticoagulation management has focussed on clinical and health economic outcomes and paid little attention to the impact of treatment and service delivery on patients’ quality of life. This was the first large UK study to evaluate the effect of patient self-management (PSM) of oral anticoagulation on treatment-related quality of life (TRQoL) and anxiety in comparison with routine care (RC) and to explore the effect of level of therapeutic control on TRQoL and anxiety across and within each model of care. Methods. A quantitative survey, set in primary care in the West Midlands. The subjects were 517 randomized controlled trial participants, 242 receiving PSM and 275 RC. Postal questionnaires at baseline and 12 months comprised the State Trait Anxiety Inventory and a treatment-specific measure of positive (satisfaction and self-efficacy) and negative aspects (daily hassles, strained social network and psychological distress) of TRQoL. Change in anxiety and TRQoL scores were compared between PSM and RC. Subgroup analysis was based upon level of therapeutic control (high, medium and low). Results. Overall, 83% (n = 202) PSM and 55% (n = 161) RC patients contributed data. Anxiety scores were similar in both groups. PSM demonstrated greater improvement in self-efficacy than RC across the study period. A statistically significant between-group difference (PSM versus RC) in the self-efficacy also existed in subgroups with medium and high levels of therapeutic control. Conclusions. PSM is not associated with increased anxiety and has a positive effect upon some aspects of TRQoL compared to RC.

In 2003, the UK Department of Health set out the genetics white paper, a plan for action and investment with particular emphasis on integration of genetic health care into primary care. Since the delivery of the genetics white paper, there has been little exploration of UK primary care doctors' attitudes towards extending their role to include provision of routine genetics services. We explored explore general practitioners' (GPs) attitudes towards provision of genetic health care including routine family history screening and familial risk assessment for common disorders in primary care using a quantitative, evaluative postal survey. Only 25% (797 of 3160) of the GPs returned a completed questionnaire. Although 32% of GPs supported collection of family history information and 41.5% familial risk assessment, 18% were not willing to offer these services even if training is provided. Of the GPs, 50% stated they recognized when referral to genetics services is appropriate, although 43% felt unprepared to collect family history or assess familial risk. Lack of training within the last 3 years was a significant predictor of feeling unprepared to undertake these activities (OR = 2.53,p = 0.012). A substantial group of GPs remain unprepared or unwilling to provide genetic health care. GPs' attitudes to delivery of genetic health care are significantly influenced by factors such as a lack of evidence of the direct benefits to patients, local guidelines and specialist services. These factors need addressing if delivery of genetic health care is to be incorporated into routine primary care.

Aims To evaluate the utility of an online self-report registry for patient self-monitoring and self-management (PSM) of warfarin therapy. Methods A prospective observational study of UK-based patients undertaking PSM and recording their international normalised ratio (INR) data via an online registry. Consenting participants recorded INR test dates, results and warfarin dosages using the online registry for a period of 12 months. Participants reported demographic data, disease characteristics and treatment-related adverse events and provided feedback via a survey. Data accuracy was assessed through comparison of INR results recorded online with results stored on 19 INR testing devices. Percentage time spent within therapeutic time in range (TTR) was also examined. Results Eighty-seven per cent (39/45) completed the study period. Age ranged from 26 to 83 years, 44% had undertaken PSM for >5 years. Sixty-six per cent (25/38) reported that the registry was easy to navigate and use. Forty-two participants contributed a total of 1669 INR results. Agreement between self-reported INR results and source INR data was high (99%). Mean TTR was 76% (SD 18.58) with 83% having >60% TTR. Conclusions Findings suggest that an online PSM registry is feasible, accurate and acceptable to patients. These findings require confirmation in a larger cohort of PSM patients. An online self-report registry could provide a valuable resource for gathering real world evidence of clinical effectiveness and safety of these developing models of care.

Background Little is known about colorectal adenoma patients’ ability to adhere to behavioural interventions promoting a change in diet and physical activity. This review aimed to examine health behaviour intervention programmes promoting change in diet and/or physical activity in adenoma patients and characterise interventions to which this patient group are most likely to adhere. Methods Searches of eight databases were restricted to English language publications 2000–2014. Reference lists of relevant articles were also reviewed. All randomised controlled trials (RCTs) of diet and physical activity interventions in colorectal adenoma patients were included. Eligibility and quality were assessed and data were extracted by two reviewers. Data extraction comprised type, intensity, provider, mode and location of delivery of the intervention and data to enable calculation of four adherence outcomes. Data were subject to narrative analysis. Results Five RCTs with a total of 1932 participants met the inclusion criteria. Adherence to the goals of the intervention ranged from 18 to 86 % for diet and 13 to 47 % for physical activity. Diet interventions achieving ≥ 50 % adherence to the goals of the intervention were clinic based, grounded in cognitive theory, delivered one to one and encouraged social support. Conclusions The findings of this review indicate that behavioural interventions can encourage colorectal adenoma patients to improve their diet. This review was not however able to clearly characterise effective interventions promoting increased physical activity in this patient group. Further research is required to establish effective interventions to promote adherence to physical activity in this population.

Point of care (POC, or near patient) testing for measurement of the international normalized ratio (INR) has facilitated the devolution of service delivery from the traditional hospital outpatient setting. However it must be undertaken within the confines of safe practice involving quality control procedures. The evaluation of INR POC tests should be closely related to the clinical issues of management and, specifically, improving the quality of care. One benefit of POC testing is in the increased motivation that some practitioners feel, being able to perform diagnostic tests without sending samples to a laboratory. POC for INR testing within primary care eliminates the delay in waiting for the result to be processed by the hospital laboratory, and the subsequent delay in informing the patient of their dosing advice. This review describes the utilization of POC testing outside the laboratory setting to develop models of care for oral anticoagulation management.

Background. Given the high prevalence of chronic conditions and multimorbidity in the elderly, there is a need to determine which chronic conditions have the greatest impact on health-related quality of life (HRQL) and identify where additional intervention may be required. Objective. To explore the impact of a range of common chronic conditions on HRQL in a community-based population aged 65 years or more in the UK. Methods. Secondary analysis of data derived from a large (n = 5849) cross-sectional study. HRQL was assessed using the EuroQoL EQ-5D. Multivariable models were used to estimate the relative effect of 15 individual common chronic conditions and combinations of these conditions on HRQL. Results. Mean age of participants was 74.6 years, 49.2% were male. The mean EQ-5D index score was 0.78 (standard deviation 0.2), range −0.43 to 1.00. Overall, 53% (n = 3078) of the cohort reported problems with pain, 39% (n = 2273) with mobility and 9% (n = 529) with self-care. Multivariate modelling demonstrated that impaired HRQL was significantly associated with 13 of the 15 common chronic conditions studied. Clinically meaningful reductions in EQ-5D index scores were observed for osteoarthritis (−0.081, P = 0.0006), neurological disease (−0.172, P < 0.0001) and depression (−0.269, P < 0.001). Conclusions. This study quantifies the relative impact of 13 common chronic conditions on HRQL in a UK-based community-dwelling ageing population. Findings indicate that osteoarthritis, depression and neurological disease have a strong clinically important negative effect on HRQL. These findings may help clinical decision making and priority setting for management of individuals with multimorbidity.

Background Irritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations. Methods A multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS – Constipation or IBS – Mixed profile). Set in 13 general practices within central England. Individuals meeting the ROME III criteria for IBS, aged 18–65 completed a pre-study diary. Eligible individuals were randomized to consume dairy ‘yoghurt’ products which either did or did not contain active probiotics twice daily and to complete a daily diary. Primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes comprised, IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life. Results 179 were randomized (91 active, 88 placebo). 76 (43 active, 33 placebo) completed the study. No significant between group differences existed at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)). By week 8, 46% active vs 68% placebo reported adequate relief (p = 0.03). This was sustained at week 12. Conclusions Significant improvements were reported for most outcomes in all trial participants but improvement did not differ by group. This trial does not provide evidence for effectiveness of a probiotic in IBS, in variance with a body of published literature and review conclusions. Differential drop out may however cloud interpretation of data. UK Trial registration ISRCTN78863629

BACKGROUND: Subclinical hypothyroidism (SCHo) is a common biochemical diagnosis in older age. Evidence of impact is inconclusive and guidelines are inconsistent. With increasing numbers of thyroid function tests (TFTs) performed, GPs frequently have to make management decisions regarding this diagnosis. However, little is known about how SCHo is currently being managed in primary care. AIM: To explore management of SCHo in primary care and GP reported rationale for treatment of SCHo in older individuals. DESIGN: Descriptive study using retrospective case note review and GP survey. SETTING: Nineteen General Practices, Central England, UK. METHODS: Follow-up of a large cohort with subsequent detailed review of individuals for whom therapy had been initiated following diagnosis of SCHo. Data on practice policies, and rationale behind treatment were collected via GP questionnaire. RESULTS: Forty-two individuals were treated following identification of SCHo. Factors regarded as supporting instigation of therapy recorded by practitioners included symptoms, a positive antithyroid antibody test and history of radioiodine therapy. In all, 55% were registered at 3/19 practices suggesting significant between practice variation. Reasons for testing included chronic disease check-up (n = 14), presenting 'thyroid symptoms' (n = 5) and presenting other symptoms (n = 9). Reasons for therapy initiation were only recorded in 26 cases and included presence of symptoms, persistently high or increasing serum thyroid stimulating hormone concentration and patient request. Only 2/15 GPs reported having practice guidelines on management. CONCLUSION: Results suggest that GPs are uncertain how to interpret symptoms and TFT results in older individuals. There is considerable variation in management of SCHo between GPs with some GPs treating patients outside of all guideline recommendations.

Objective To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants. Design Multicentre open randomised controlled trial. Setting Midlands region of the UK. Participants 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention. Intervention Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin. Main outcome measure Percentage of time spent within the therapeutic range of international normalised ratio. Results No significant differences were found in percentage of time in the therapeutic range between self managment and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (χ 2 (df = 1) = 0.02, P = 0.89). Conclusion With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control. Trial registration ISRCTN 19313375.

The genetic basis of many common, multi-factorial conditions is increasingly being understood but use of the knowledge created, raises major dilemmas for primary care. Identification of individuals that may be genetically predisposed to serious medical conditions provides the opportunity to offer screening or prophylactic treatment, for early detection or prevention and delay in disease onset in many complex conditions. We describe a new pilot service development to introduce genetic risk assessment for a wide range of conditions to primary care, and discuss the findings from its evaluation. The evaluation highlighted the issues about the incorporation of genetic risk assessment in primary care. The results of the evaluation along with findings from other studies, juxtaposed with the implications of developments in genetics suggest that changes are required to accommodate the integration of genetic risk assessment into primary care clinical practice. We discuss what these changes are, the benefits and drawbacks, and whether primary care can and is ready to make the changes required, further shifting the focus from disease treatment to disease prevention.