Collaborative discussions between pharmacists and general practitioners to optimise patient medication: a qualitative study within a clinical trial.

BACKGROUND: There has been significant investment in pharmacists working in UK general practice to improve the effective and safe use of medicines. However, evidence of how to optimise collaboration between GPs and pharmacists in the context of polypharmacy (multiple medication) is lacking. AIM: To explore GP and pharmacist views and experiences of in-person, inter-professional collaborative discussions (IPCDs) as part of a complex intervention to optimise medication use for patients with polypharmacy in general practice. DESIGN AND SETTING: A mixed-method process evaluation embedded within the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial conducted in Bristol and the West Midlands. METHOD: Audio-recordings of IPCDs between GPs and pharmacists, and individual semi-structured interviews exploring their reflections on these discussions. All recordings were transcribed verbatim and analysed thematically. RESULTS: Fourteen practices took part in the process evaluation (Feb 2021- Sept 2023). Seventeen IPCD meetings were audio recorded discussing 30 patients (range of 1-6 patients per meeting). Six GPs and 13 pharmacists were interviewed. The IPCD was highly valued by GPs and pharmacists who described benefits including: strengthening their working relationship; learning from each other; and gaining in confidence to manage more complex patients. It was often challenging, however, to find time for the IPCDs. CONCLUSION: The model of IPCD studied provided protected time for GPs and pharmacists to work together to deliver whole-patient care, with both professions finding this beneficial. Protected time for inter-professional liaison and collaboration, and structured interventions may facilitate improved patient care.

Understanding non-recreational prescription medication-sharing behaviours: a systematic review.

BACKGROUND: Prescription medication sharing refers to the lending or borrowing of prescription medications where the recipient is someone other than the person for whom the prescription is intended. Sharing prescription medication can cause significant harm. Adverse consequences include an increased risk of side effects, delayed health seeking, and severity of disease. Prevalence estimates vary across different populations and people's reasons for, and perceptions of risks from, sharing are poorly understood. AIM: To better understand prescription medication-sharing behaviours and practices - specifically, the prevalence, types of medications, reasons, perceived benefits and risks, and factors associated with medication sharing. DESIGN AND SETTING: This systematic review included primary studies in any setting, focusing on people who engage in medication sharing. METHOD: Electronic databases were searched from inception of databases to February 2023. RESULTS: In total, 19 studies were included. Prevalence of lifetime sharing ranged from 13% to 78%. All 19 studies reported that analgesics were the most shared, followed by antibiotics (n = 12) and allergy medication (n = 9). Common reasons for sharing were running out of medication (n = 7), cost (n = 7), and emergency (n = 6). Perceived benefits included resolution of the problem and convenience. Perceived risks included adverse drug reactions and misdiagnosis. Characteristics associated with sharing included age, female sex, having asthma, and unused medicines stored at home. CONCLUSION: Findings suggest that medication-sharing behaviour is common and involves a range of medicines for a variety of reasons. Data on the prevalence and predictors of prescription medication sharing are inconsistent. A better understanding of non-modifiable and potentially modifiable behavioural factors that contribute to sharing is needed to support development of effective interventions aimed at mitigating unsafe sharing practices.

Patient perceptions and experiences of medication review: qualitative study in general practice.

BACKGROUND: Clinical medication reviews are a recognised strategy to address polypharmacy, a key part of general practice and positively associated with patient safety and clinical effectiveness. To date there has been little investigation of the patient perspective of medication reviews. OBJECTIVE: To explore patient experiences of medication review including the processes and activities that led up to and shaped the review. METHODS: Qualitative interview study within 10 general practices in Bristol. Participants were adults with polypharmacy (≥ 4 medications) and ≥ 2 long-term conditions who had a record of medication review with either a GP or pharmacist. Interviews were transcribed verbatim and analysed thematically using a data driven approach. Co-design work was undertaken with four patient and public involvement advisers to design and develop resources to support patient preparation for medication review. RESULTS: Twenty-one patients were interviewed (10 female, mean age 73 years, range 59-88 years). Medication review was viewed as an opportunity to assess the effectiveness and need for medications. Participants expected the review to focus upon medication related concerns, side-effects and symptoms. Those who were newer to review, were uncertain of the intended purpose, and described their review as a box-ticking exercise. Some participants were unfamiliar with the role of the pharmacist and expressed a lack of confidence in their clinical skills and knowledge. Face-to-face consultation and relationship continuity were considered important for efficient and effective medication review. Results informed co-production of a patient information leaflet to facilitate greater patient engagement and involvement in medication review. CONCLUSIONS: A lack of understanding of the rationale for medication review can limit the value patients attach to these healthcare encounters. Improved prior communication and information around the intended purpose and potential benefits of medication review may enhance patient engagement and improve patient experience and outcomes.

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

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

A multi-stakeholder approach to the co-production of the research agenda for medicines optimisation.

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.

Barriers and enablers to collaborative working between GPs and pharmacists: a qualitative interview study.

BACKGROUND: Many 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. AIM: To explore GP and pharmacist perspectives on collaborative working within the context of optimising medications for patients with multimorbidity. DESIGN AND SETTING: A qualitative analysis of semi-structured interviews with GPs and pharmacists working in the West of England, Northern England, and Scotland. METHOD: Thirteen 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. RESULTS: GPs 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. CONCLUSION: A 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.

Subclinical thyroid dysfunction symptoms in older adults: cross-sectional study in UK primary care.

BACKGROUND: Subclinical 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. AIM: To compare the prevalence of those symptoms typically associated with overt thyroid dysfunction in older individuals with a subclinical and euthyroid serum profile. DESIGN AND SETTING: Cross-sectional study, nested within the Birmingham Elderly Thyroid Study (BETS); from 19 UK general practices. METHOD: Adults 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. RESULTS: A 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. CONCLUSION: Findings 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.

Efficiency versus thoroughness in medication review: a qualitative interview study in UK primary care.

BACKGROUND: Medication 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. AIM: To explore GP and pharmacist perspectives on how medication reviews were conducted in general practice in the UK. DESIGN AND SETTING: Analysis 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. METHOD: Interviews focused on experience of medication review. Data saturation was achieved when no new insights arose from later interviews. Interviews were analysed thematically. RESULTS: In 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. CONCLUSION: Practices 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.

Stability of thyroid function in older adults: the Birmingham Elderly Thyroid Study.

BACKGROUND: Thyroid 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. AIM: To establish the stability of thyroid function over time, and identify predictors of development of overt thyroid dysfunction. DESIGN AND SETTING: Longitudinal follow-up in 19 general practices in the UK. METHOD: A 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. RESULTS: Participants 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). CONCLUSION: High 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.

An evaluation of a coagulation system (Xprecia Stride) for utilisation in anticoagulation management.

AIM: To evaluate the reliability and performance of the Xprecia Stride coagulometer under the conditions in which it is most likely to be used. METHODS: The 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. RESULTS: A 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. CONCLUSION: INRs 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.

MICE or NICE? An economic evaluation of clinical decision rules in the diagnosis of heart failure in primary care.

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 £4400 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.

Assessing the utility of an online registry for patients monitoring their own warfarin therapy.

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.

Enhancing adherence in trials promoting change in diet and physical activity in individuals with a diagnosis of colorectal adenoma; a systematic review of behavioural intervention approaches.

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.

The burden of common chronic disease on health-related quality of life in an elderly community-dwelling population in the UK.

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.

A randomised controlled trial of a probiotic 'functional food' in the management of irritable bowel syndrome.

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.

Why are GPs treating subclinical hypothyroidism? Case note review and GP survey.

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.

Does self-management of oral anticoagulation therapy improve quality of life and anxiety?

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.

Patient self-management of anticoagulation therapy: a trial-based cost-effectiveness analysis.

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.

SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375].

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.