Stirling Bryan

Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial

Summary Background Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patients prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control). Methods 1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406. Findings 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06–2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25–1·86]), equating to effect sizes of 0·32 (0·19–0·45) and 0·19 (0·04–0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group. Interpretation The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care. Funding Arthritis Research UK.

Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial

BACKGROUND Control of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care. METHODS This randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35-85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN17585681. FINDINGS 527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12.9 mm Hg (95% CI 10.4-15.5) from baseline to 6 months in the self-management group and by 9.2 mm Hg (6.7-11.8) in the control group (difference between groups 3.7 mm Hg, 0.8-6.6; p=0.013). From baseline to 12 months, systolic blood pressure decreased by 17.6 mm Hg (14.9-20.3) in the self-management group and by 12.2 mm Hg (9.5-14.9) in the control group (difference between groups 5.4 mm Hg, 2.4-8.5; p=0.0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients [32%]; control, 55 patients [22%]; p=0.022). INTERPRETATION Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care. FUNDING Department of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium.

Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial

Objectives To assess whether screening improves the detection of atrial fibrillation (cluster randomisation) and to compare systematic and opportunistic screening. Design Multicentred cluster randomised controlled trial, with subsidiary trial embedded within the intervention arm. Setting 50 primary care centres in England, with further individual randomisation of patients in the intervention practices. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practices. Interventions Patients in intervention practices were randomly allocated to systematic screening (invitation for electrocardiography) or opportunistic screening (pulse taking and invitation for electrocardiography if the pulse was irregular). Screening took place over 12 months in each practice from October 2001 to February 2003. No active screening took place in control practices. Main outcome measure Newly identified atrial fibrillation. Results The detection rate of new cases of atrial fibrillation was 1.63% a year in the intervention practices and 1.04% in control practices (difference 0.59%, 95% confidence interval 0.20% to 0.98%). Systematic and opportunistic screening detected similar numbers of new cases (1.62% v 1.64%, difference 0.02%, −0.5% to 0.5%). Conclusion Active screening for atrial fibrillation detects additional cases over current practice. The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography. Trial registration Current Controlled Trials ISRCTN19633732.

Modelling in the economic evaluation of health care: selecting the appropriate approach.

Objectives: To provide an overview of alternative approaches to modelling in economic evaluation, and to highlight situations where each of the alternative modelling techniques should be employed. Methods: A review of the available approaches to modelling in the economic evaluation of health care interventions with a leading discussion of examples of published studies leading to guidance in the selection of an appropriate approach in different circumstances. Results: The main approaches to modelling used in economic evaluations in health care are decision trees, Markov models and individual sampling models. These methods assume independence of individuals within the model. Where interaction between individuals is important, other methods such as discrete-event simulation or system dynamics are preferable. Conclusions: The paper highlights the crucial question to be answered when selecting the approach to modelling: can the individuals being simulated in the model be regarded as independent? This issue is very commonly not recognised by analysts but is fundamental to the appropriate application of modelling in economic evaluation.

EQ-5D in patients with dementia: an investigation of inter-rater agreement.

Background.There are difficulties in obtaining health-related quality of life (HRQL) data from patients with dementia due to variation in their cognitive ability, degree of insight and capacity to make judgments. The use of proxies is one solution. Objectives.To examine the inter-rater agreement of patient and proxy completion of the EuroQol EQ-5D instrument (EQ-5D). Research Design.The EQ-5D instrument was completed separately by patients, their caregivers and a physician. Assessment of inter-rater agreement involved comparison of self-completed (patient) and proxy-completed (caregiver and physician) responses for each dimension of EQ-5D, using a weighted kappa score. Three key hypotheses were tested. (1) Interrater agreement would be stronger between patient and caregiver than between patient and physician. (2) Interrater agreement would be stronger on the ‘observable’ and objective dimensions of EQ-5D. (3) Interrater agreement between patient and proxies would be stronger for patients with earlier dementia. Subjects.The sample comprised 64 patients with a range of dementia severity. Measures.The EQ-5D health state classification system and visual analogue scale were used to assess HRQL. Global severity of dementia was determined using the Clinical Dementia Rating Scale. Results.The principal finding of this study was that responses to EQ-5D questions were highly variable across the three raters such that none of the three hypotheses were strongly supported. Conclusions.The data provide some support for the use of EQ-5D when interviewer administered. However, there are serious concerns regarding the validity of patient self-rated HRQL data obtained in this study and uncertainty exists regarding who the appropriate proxy should be, as different groups of proxies provide different results. It was not clear whether caregivers or physicians represent better proxies. Further research should focus on the comparison of caregivers and physicians as proxies.

An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia

Objective To evaluate the relative health service cost of endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia and the value women attach to their health state before and after surgery.

Effect of Self-monitoring and Medication Self-titration on Systolic Blood Pressure in Hypertensive Patients at High Risk of Cardiovascular Disease The TASMIN-SR Randomized Clinical Trial

IMPORTANCE Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups. OBJECTIVE To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN87171227.

Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial

AIMS Whilst the CArdiac REsynchronization in Heart Failure (CARE-HF) trial has shown that cardiac resynchronization therapy (CRT) leads to reduced morbidity and mortality, the cost-effectiveness of this therapy remains uncertain. The aim of this study was to evaluate the incremental cost per quality adjusted life year (QALY) gained and incremental cost per life year gained of CRT plus medical therapy compared to medical therapy alone. METHODS AND RESULTS This prospective analysis based on intention to treat data from all patients enrolled in the CARE-HF trial at 82 clinical centres in 12 European countries. A total of 813 patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony were randomized to CRT plus medical therapy (n = 409) vs. medical therapy alone (n = 404). During a mean follow-up of 29.4 months CRT was associated with increased costs (4316, 95% CI: 1327-7485), survival (0.10 years, 95% CI: -0.01-0.21), and QALYs (0.22, 95% CI: 0.13-0.32). The incremental cost-effectiveness ratio was 19 319 per QALY gained (95% CI: 5482-45 402) and 43 596 per life-year gained (95% CI: -146 236-223 849). These results were sensitive to the costs of the device, procedure, and hospitalization. CONCLUSION Treatment with CRT appears cost-effective at the notional willingness to pay threshold of 29 400 (20,000 pounds sterlings) per QALY gained.

Patients' preferences for the management of non-metastatic prostate cancer: discrete choice experiment

Abstract Objective To establish which attributes of conservative treatments for prostate cancer are most important to men. Design Discrete choice experiment. Setting Two London hospitals. Participants 129 men with non-metastatic prostate cancer, mean age 70 years; 69 of 118 (58%) with T stage 1 or 2 cancer at diagnosis. Main outcome measures Mens preferences for, and trade-offs between, the attributes of diarrhoea, hot flushes, ability to maintain an erection, breast swelling or tenderness, physical energy, sex drive, life expectancy, and out of pocket expenses. Results The mens responses to changes in attributes were all statistically significant. When asked to assume a starting life expectancy of five years, the men were willing to make trade-offs between life expectancy and side effects. On average, they were most willing to give up life expectancy to avoid limitations in physical energy (mean three months) and least willing to trade life expectancy to avoid hot flushes (mean 0.6 months to move from a moderate to mild level or from mild to none). Conclusions Men with prostate cancer are willing to participate in a relatively complex exercise that weighs up the advantages and disadvantages of various conservative treatments for their condition. They were willing to trade off some life expectancy to be relieved of the burden of troublesome side effects such as limitations in physical energy.

An international multicenter randomized study of computer‐assisted oral anticoagulant dosage vs. medical staff dosage

Summary.  Background: Increased demand for oral anticoagulants is overwhelming facilities worldwide, resulting in increasing use of computer assistance. A multicenter clinical endpoint study has been performed to compare the safety and effectiveness of computer‐assisted dosage with dosage by experienced medical staff at the same centers. Methods: A randomized study of dosage of two commercial computer‐assisted dosage programs (PARMA 5 and DAWN AC) vs. manual dosage at 32 centers with an established interest in oral anticoagulation in 13 countries. The aim was to recruit a minimum of 16 000 patient‐years randomized to medical staff or computer‐assisted dosage. In total, 13 219 patients participated, 6503 patients being randomized to medical staff and 6716 to computer‐assisted dosage. The safety and effectiveness of computer‐assisted dosage were compared with those of medical staff dosage. Results: In total, 13 052 patients were recruited (18 617 patient‐years). International Normalized Ratio (INR) tests numbered 193 890 with manual dosage and 193 424 with computer‐assisted dosage. The number of clinical events with computer‐assisted dosage was lower (P = 0.1), but in the 3209 patients with deep vein thrombosis/pulmonary embolism, they were reduced by 37 (24%, P = 0.001). Time in target INR range was significantly improved by computer assistance as compared with medical staff dosage at the majority of centers (P < 0.001). Conclusions: The safety and effectiveness of computer‐assisted dosage has been demonstrated using two different marketed programs in comparison with experienced medical staff dosage at the centers with established interest in anticoagulation. Significant prevention of clinical events in patients with deep vein thrombosis/pulmonary embolism and the achievement of target INR in all clinical groups has been observed. The reliability and safety of other marketed computer‐assisted dosage programs need to be established.