Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial.

BACKGROUND: Self-administration of medicines by patients whilst in hospital is being increasingly promoted despite little evidence to show the risks and benefits. Pain control after total knee replacement (TKR) is known to be poor. The aim of the study was to determine if patients operated on with a TKR who self-medicate their oral analgesics in the immediate post-operative period have better pain control than those who receive their pain control by nurse-led drug rounds (Treatment as Usual (TAU)). METHODS: A prospective, parallel design, open-label, randomised controlled trial comparing pain control in patient-directed self-management of pain (PaDSMaP) with nurse control of oral analgesia (TAU) after a TKR. Between July 2011 and March 2013, 144 self-medicating adults were recruited at a secondary care teaching hospital in the UK. TAU patients (n = 71) were given medications by a nurse after their TKR. PaDSMaP patients (n = 73) took oral medications for analgesia and co-morbidities after two 20 min training sessions reinforced with four booklets. Primary outcome was pain (100 mm visual analogue scale (VAS)) at 3 days following TKR surgery or at discharge (whichever came soonest). Seven patients did not undergo surgery for reasons unrelated to the study and were excluded from the intention-to-treat (ITT) analysis. RESULTS: ITT analysis did not detect any significant differences between the two groups' pain scores. A per protocol (but underpowered) analysis of the 60% of patients able to self-medicate found reduced pain compared to the TAU group at day 3/discharge, (VAS -9.9 mm, 95% CI -18.7, - 1.1). One patient in the self-medicating group over-medicated but suffered no harm. CONCLUSION: Self-medicating patients did not have better (lower) pain scores compared to the nurse-managed patients following TKR. This cohort of patients were elderly with multiple co-morbidities and may not be the ideal target group for self-medication. TRIAL REGISTRATION: ISRCTN10868989 . Registered 22 March 2012, retrospectively registered.

Economic Evaluation of Complete Revascularization for Patients with Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention.

OBJECTIVES: To determine the cost-effectiveness of complete revascularization at index admission compared with infarct-related artery (IRA) treatment only, in patients with multivessel disease undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction. METHODS: An economic evaluation of a multicenter randomized trial was conducted, comparing complete revascularization at index admission to IRA-only P-PCI in patients with multivessel disease (12-month follow-up). Overall hospital costs (costs for P-PCI procedure(s), hospital length of stay, and any subsequent re-admissions) were estimated. Outcomes were major adverse cardiac events (MACEs, a composite of all-cause death, recurrent myocardial infarction, heart failure, and ischemia-driven revascularization) and quality-adjusted life-years (QALYs) derived from the three-level EuroQol five-dimensional questionnaire. Multiple imputation was undertaken. The mean incremental cost and effect, with associated 95% confidence intervals, the incremental cost-effectiveness ratio, and the cost-effectiveness acceptability curve were estimated. RESULTS: On the basis of 296 patients, the mean incremental overall hospital cost for complete revascularization was estimated to be -£215.96 (-£1390.20 to £958.29), compared with IRA-only, with a per-patient mean reduction in MACEs of 0.170 (0.044 to 0.296) and a QALY gain of 0.011 (-0.019 to 0.041). According to the cost-effectiveness acceptability curve, the probability of complete revascularization being cost-effective was estimated to be 72.0% at a willingness-to-pay threshold value of £20,000 per QALY. CONCLUSIONS: Complete revascularization at index admission was estimated to be more effective (in terms of MACEs and QALYs) and cost-effective (overall costs were estimated to be lower and complete revascularization thereby dominated IRA-only). There was, however, some uncertainty associated with this decision.

Differences in Longer-Term Smoking Abstinence After Treatment by Specialist or Nonspecialist Advisors: Secondary Analysis of Data From a Relapse Prevention Trial.

INTRODUCTION: Smokers receiving support in specialist centers tend to have a higher short-term quit rate, compared with those receiving support in other settings from professionals for whom smoking cessation is only a part of their work. We investigated the difference in longer-term abstinence after short-term smoking cessation treatment from specialist and nonspecialist smoking cessation services. METHODS: We conducted a secondary analysis of data from a randomized controlled trial of self-help booklets for the prevention of smoking relapse. The trial included 1088 short-term quitters from specialist stop smoking clinics and 316 from nonspecialist cessation services (such as general practice, pharmacies, and health trainer services). The difference in prolonged smoking abstinence from months 4 to 12 between specialist and nonspecialist services was compared. Multivariable logistic regression analyses were conducted to investigate the association between continuous smoking abstinence and the type of smoking cessation services, adjusted for possible confounding factors (including demographic, socioeconomic, and smoking history variables). RESULTS: The proportion of continuous abstinence from 4 to 12 months was higher in short-term quitters from specialist services compared with those from nonspecialist services (39% vs. 32%; P = .023). After adjusting for a range of participant characteristics and smoking variables, the specialist service was significantly associated with a higher rate of longer-term smoking abstinence (odds ratio: 1.48, 95% CI = 1.09% to 2.00%; P = .011). CONCLUSIONS: People who receive support to stop smoking from a specialist appear to be at lower risk of relapse than those receiving support from a nonspecialist advisor.

Cost-effectiveness of nurse-led versus doctor-led antiretroviral treatment in South Africa: pragmatic cluster randomised trial.

OBJECTIVE: To estimate the cost-effectiveness of nurse-led versus doctor-led antiretroviral treatment (ART) for HIV-infected people. DESIGN: Cost-effectiveness analysis alongside a pragmatic cluster randomised controlled trial in 31 primary care clinics (16 intervention, 15 controls) in Free State Province, South Africa. Participants were HIV-infected patients, aged ≥16 years. Cohort 1 (CD4 count ≤350 cells/µl, not yet receiving ART at enrolment): consisted of 5 390 intervention patients and 3 862 controls; Cohort 2 (already received ART for ≥6 months at enrolment) of 3 029 intervention patients and 3 202 controls. Nurses were authorised and trained to initiate and represcribe ART. Management and ART provision were decentralised to primary care clinics. In control clinics, doctors initiated and re-prescribed ART, nurses monitored ART. Main outcome measure(s) were health service costs, death (cohort 1) and undetectable viral load (<400 copies/ml) (cohort 2) during the 12 months after enrolment. RESULTS: For Cohort 1, the intervention had an estimated incremental cost of US$102.52, an incremental effect of 0.42% fewer deaths and an incremental cost-effectiveness ratio (ICER) of US$24 500 per death averted. For Cohort 2, the intervention had an estimated incremental cost of US$59.48, an incremental effect of 0.47% more undetectable viral loads and an ICER of US$12 584 per undetectable viral load. CONCLUSIONS: Nurse-led ART was associated with higher mean health service costs than doctor-led care, with small effects on primary outcomes, and a high associated level of uncertainty. Given this, and the shortage of doctors, further implementation of nurse-led ART should be considered, although this may increase health service costs.

The at-risk registers in severe asthma (ARRISA) study: a cluster-randomised controlled trial examining effectiveness and costs in primary care.

BACKGROUND: Patients at risk of severe exacerbations contribute disproportionally to asthma mortality, morbidity and costs. We evaluated the effectiveness and costs of using 'asthma risk registers' for these patients in primary care. METHODS: In a cluster-randomised trial, 29 primary care practices identified 911 at-risk asthma patients using British asthma guideline criteria (severe asthma plus adverse psychosocial characteristics). Intervention practices added electronic alerts to identified patients' records to flag their at-risk status and received practice-based training about using the alerts to improve patient access and opportunistic management. Control practices continued routine care. Numbers of patients experiencing the primary outcome of a moderate-severe exacerbation (resulting in death, hospitalisation, accident and emergency attendance, out-of-hours contact, or a course/boost in oral prednisolone for asthma), other healthcare and medication usage, and costs over 1 year were derived from practice-based records. RESULTS: There was no significant effect on exacerbations (control: 46.5%; intervention: 53.6%, OR, 95% CI 1.30, 0.93 to 1.80). However, this composite outcome masked relative reductions in intervention patients experiencing hospitalisations (OR 0.50, 95% CI 0.26 to 0.94), accident and emergency (OR 0.74, 95% CI 0.42 to 1.31) and out-of-hours contacts (OR 0.79, 95% CI 0.45 to 1.37); and a relative increase in prednisolone prescription for exacerbations (OR 1.31, 95% CI 0.92 to 1.85). Furthermore, prescription of nebulised short-acting ß-agonists reduced and long-acting ß-agonists increased for intervention relative to control patients. The adjusted mean per patient healthcare cost was £138.21 lower (p=0.837) among intervention practices. CONCLUSION: Using asthma risk registers in primary care did not reduce treated exacerbations, but reduced hospitalisations and increased prescriptions of recommended preventative therapies without increasing costs.

Evaluation of stroke services in Anglia Stroke Clinical Network to examine the variation in acute services and stroke outcomes.

BACKGROUND: Stroke is the third leading cause of death in developed countries and the leading cause of long-term disability worldwide. A series of national stroke audits in the UK highlighted the differences in stroke care between hospitals. The study aims to describe variation in outcomes following stroke and to identify the characteristics of services that are associated with better outcomes, after accounting for case mix differences and individual prognostic factors. METHODS/DESIGN: We will conduct a cohort study in eight acute NHS trusts within East of England, with at least one year of follow-up after stroke. The study population will be a systematically selected representative sample of patients admitted with stroke during the study period, recruited within each hospital. We will collect individual patient data on prognostic characteristics, health care received, outcomes and costs of care and we will also record relevant characteristics of each provider organisation. The determinants of one year outcome including patient reported outcome will be assessed statistically with proportional hazards regression models. Self (or proxy) completed EuroQol (EQ-5D) questionnaires will measure quality of life at baseline and follow-up for cost utility analyses. DISCUSSION: This study will provide observational data about health service factors associated with variations in patient outcomes and health care costs following hospital admission for acute stroke. This will form the basis for future RCTs by identifying promising health service interventions, assessing the feasibility of recruiting and following up trial patients, and provide evidence about frequency and variances in outcomes, and intra-cluster correlation of outcomes, for sample size calculations. The results will inform clinicians, public, service providers, commissioners and policy makers to drive further improvement in health services which will bring direct benefit to the patients.

Cost-effectiveness of a lifestyle intervention in preventing Type 2 diabetes.

OBJECTIVES: Previous research has suggested people with impaired fasting glucose (IFG) are less likely to develop Type 2 diabetes (T2DM) if they receive prolonged structured diet and exercise advice. This study examined the within-trial cost-effectiveness of such lifestyle interventions. METHODS: Screen-detected participants with either newly diagnosed T2DM or IFG were randomized 2:1 to intervention versus control (usual care) between February and December 2009, in Norfolk (UK). The intervention consisted of group based education, physiotherapy and peer support sessions, plus telephone contacts from T2DM volunteers. We monitored healthcare resource use, intervention costs, and quality of life (EQ-5D). The incremental cost per quality-adjusted life-year (QALY) gain (incremental cost effectiveness ratio [ICER]), and cost effectiveness acceptability curves (CEAC) were estimated. RESULTS: In total, 177 participants were recruited (118 intervention, 59 controls), with a mean follow-up of 7 months. Excluding screening and recruitment costs, the mean cost was estimated to be £551 per participant in the intervention arm, compared with £325 in the control arm. The QALY gains were -0.001 and -0.004, respectively. The intervention was estimated to have an ICER of £67,184 per QALY (16 percent probability of being cost-effective at the £20,000/QALY threshold). Cost-effectiveness estimates were more favorable for IFG participants and those with longer follow-up (≥ 4 months) (ICERs of £20,620 and £17,075 per QALY, respectively). CONCLUSIONS: Group sessions to prevent T2DM were not estimated to be within current limits of cost-effectiveness. However, there was a large degree of uncertainty surrounding these estimates, suggesting the need for further research.

Comparing cost-utility estimates: does the choice of EQ-5D or SF-6D matter?

BACKGROUND: A number of different measures can be used within cost-utility analyses, we compared results according to both the EQ-5D and SF-6D. METHODS: A randomized trial was conducted to compare 4 options for people with knee pain. Over the 2 year trial period, the change in cost to health-service was estimated, and both the EQ-5D and SF-6D were used to estimate the change in quality-adjusted life years (QALYs). Using a complete case analysis, the cost-utility (incremental cost-effectiveness ratio [ICER]) of each option, according to both the EQ-5D and SF-6D, was calculated and assessed in relation to the cost-effectiveness threshold of pound20,000 per QALY. RESULTS: Of the 389 participants, 247 had complete cost, EQ-5D and SF-6D data. According to the EQ-5D, option 1 had an estimated ICER of pound10,815 (compared with option 4), option 2 was dominated by option 1, and option 3 was subject to extended dominance. Conversely, according to the SF-6D, option 3 had an ICER of pound9999 (compared with option 4), option 2 had an ICER of pound36,883 (compared with option 3), and option 1 was subject to extended dominance. CONCLUSION: The EQ-5D and SF-6D estimated that different options (1 and 3, respectively) were cost-effective at the pound20,000 per QALY threshold, demonstrating that the choice of measure does matter.

Measuring the benefits of treatment for psychosis: validity and responsiveness of the EQ-5D.

BACKGROUND: The UK National Institute for Health and Clinical Excellence (NICE) has recommended that cost-effectiveness analysis includes the EQ-5D; however, this is often not implemented in the area of mental health. AIMS: To assess the appropriateness of using the EQ-5D to measure improvements in mental health. METHOD: Seventy-seven participants with psychosis were rated according to the EQ-5D and seven measures of mental health at both pre- and post-intervention. To assess construct validity we compared the (pre-intervention) mean EQ-5D scores for those with milder and more severe scores, according to each of the seven measures. To assess responsiveness we estimated the mean EQ-5D change score for those who improved (post-intervention), according to each of the measures. RESULTS: The mean EQ-5D score was more favourable for both those with milder scores (mean difference: 0.044 to 0.301) and for those who improved post-intervention (mean change: 0.029 to 0.117). CONCLUSIONS: This suggests the EQ-5D should be considered for use in future cost-effectiveness studies in the area of mental health.

Comparing the performance of the EQ-5D and SF-6D when measuring the benefits of alleviating knee pain.

OBJECTIVE: To assess the practicality, validity and responsiveness of using each of two utility measures (the EQ-5D and SF-6D) to measure the benefits of alleviating knee pain. METHODS: Participants in a randomised controlled trial, which was designed to compare four different interventions for people with self-reported knee pain, were asked to complete the EQ-5D, SF-6D, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at both pre- and post-intervention. For both utility measures, we assessed their practicality (completion rate), construct validity (ability to discriminate between baseline WOMAC severity levels), and responsiveness (ability to discriminate between three groups: those whose total WOMAC score, i) did not improve, ii) improved by <20%, and iii) improved by > or = 20%). RESULTS: The EQ-5D was completed by 97.7% of the 389 participants, compared to 93.3% for the SF-6D. Both the EQ-5D and SF-6D were able to discriminate between participants with different levels of WOMAC severity (p < 0.001). The mean EQ-5D change was -0.036 for group i), 0.091 for group ii), and 0.127 for group iii), compared to 0.021, 0.023 and 0.053 on the SF-6D. These change scores were significantly different according to the EQ-5D (p < 0.001), but not the SF-6D. CONCLUSION: The EQ-5D and SF-6D had largely comparable practicality and construct validity. However, in contrast to the EQ-5D, the SF-6D could not discriminate between those who improved post-intervention, and those who did not. This suggests that it is more appropriate to use the EQ-5D in future cost-effectiveness analyses of interventions which are designed to alleviate knee pain.

Optimal cost-effectiveness decisions: the role of the cost-effectiveness acceptability curve (CEAC), the cost-effectiveness acceptability frontier (CEAF), and the expected value of perfection information (EVPI).

OBJECTIVE: To demonstrate how the optimal decision and level of uncertainty associated with that decision, can be presented when assessing the cost-effectiveness of multiple options. To explore and explain potentially counterintuitive results that can arise when analyzing multiple options. METHODS: A template was created, based on the assumption of multivariate normality, in order to replicate a previous analysis that compared the cost-effectiveness of multiple options. We used this template to explain some of the different shapes that the cost-effectiveness acceptability curve (CEAC), cost-effectiveness acceptability frontier (CEAF), and expected value of perfection information (EVPI) may take, with changing correlation structure and variance between the multiple options. RESULTS: We show that it is possible for 1) an option that is subject to extended dominance to have the highest probability of being cost-effective for some values of the cost-effectiveness threshold; 2) the most cost-effective (optimal) option to never have the highest probability of being cost-effective; and 3) the EVPI to increase when the probability of making the wrong decision decreases. Changing the correlation structure between multiple options did not change the presentation of results on the cost-effectiveness plane. CONCLUSION: The cost-effectiveness plane has limited use in representing the uncertainty surrounding multiple options as it cannot represent correlation between the options. CEACs can represent decision uncertainty, but should not be used to determine the optimal decision. Instead, the CEAF shows the decision uncertainty surrounding the optimal choice and this can be augmented by the EVPI to show the potential gains to further research.

Do estimates of cost-utility based on the EQ-5D differ from those based on the mapping of utility scores?

BACKGROUND: Mapping has been used to convert scores from condition-specific measures into utility scores, and to produce estimates of cost-effectiveness. We sought to compare the QALY gains, and incremental cost per QALY estimates, predicted on the basis of mapping to those based on actual EQ-5D scores. METHODS: In order to compare 4 different interventions 389 individuals were asked to complete both the EQ-5D and the Western Ontartio and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 6, 12, and 24 months post-intervention. Using baseline data various mapping models were developed, where WOMAC scores were used to predict the EQ-5D scores. The performance of these models was tested by predicting the EQ-5D post-intervention scores. The preferred model (that with the lowest mean absolute error (MAE)) was used to predict the EQ-5D scores, at all time points, for individuals who had complete WOMAC and EQ-5D data. The mean QALY gain associated with each intervention was calculated, using both actual and predicted EQ-5D scores. These QALY gains, along with previously estimated changes in cost, were also used to estimate the actual and predicted incremental cost per QALY associated with each of the four interventions. RESULTS: The EQ-5D and the WOMAC were completed at baseline by 348 individuals, and at all time points by 259 individuals. The MAE in the preferred model was 0.129, and the mean QALY gains for each of the four interventions was predicted to be 0.006, 0.058, 0.058, and 0.136 respectively, compared to the actual mean QALY gains of 0.087, 0.081, 0.120, and 0.149. The most effective intervention was estimated to be associated with an incremental cost per QALY of pound6,068, according to our preferred model, compared to pound13,154 when actual data was used. CONCLUSION: We found that actual QALY gains, and incremental cost per QALY estimates, differed from those predicted on the basis of mapping. This suggests that though mapping may be of value in predicting the cost-effectiveness of interventions which have not been evaluated using a utility measure, future studies should be encouraged to include a method of actual utility measurement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN93206785.

An assessment of the discriminative ability of the EQ-5Dindex, SF-6D, and EQ VAS, using sociodemographic factors and clinical conditions.

OBJECTIVE: To assess whether three health-related quality-of-life (HRQL) measures (the EQ-5Dindex, SF-6D, and EQ VAS) can discriminate between the HRQL of different groups of individuals. METHODS: In one UK general practice a cross-sectional survey requested information on six sociodemographic factors, 10 clinical conditions, and the three HRQL measures. Regression analyses were used to assess whether there was a significant difference in HRQL between groups with different sociodemographic factors and those with and without clinical conditions. RESULTS: One thousand eight hundred and sixty-five questionnaires were returned. There was a significant difference between the HRQL of the majority of different groups according to each HRQL measure. However, not all of the measures could discriminate between groups of different ethnicity, gender, or smoking status, or those with and without asthma, stroke, cancer or diabetes. CONCLUSION: The HRQL of the majority of different groups could be discriminated between by the EQ-5Dindex, SF-6D, and EQ VAS.

Relapse to smoking and health-related quality of life: Secondary analysis of data from a study of smoking relapse prevention.

BACKGROUND: Previous studies have shown that smoking and smoking cessation may be associated with health-related quality of life (HRQoL). In this study, we compared changes in HRQoL in people who maintained abstinence with people who had relapsed to smoking. METHODS: This was a secondary analysis of data from a trial of a relapse prevention intervention in 1,407 short-term quitters. The European Quality of Life -5 Dimensions (EQ-5D) measured HRQoL at baseline, 3 and 12 months. Smoking outcome was continuous abstinence from 2 to 12 months, and 7-day smoking at 3 and 12 months. We used nonparametric test for differences in EQ-5D utility scores, and chi-square test for dichotomised response to each of the five EQ-5D dimensions. Multivariable regression analyses were conducted to evaluate associations between smoking relapse and HRQoL or anxiety/depression problems. RESULTS: The mean EQ-5D tariff score was 0.8252 at baseline. People who maintained abstinence experienced a statistically non-significant increase in the EQ-5D score (mean change 0.0015, P = 0.88), while returning to smoking was associated with a statistically significant decrease in the EQ-5D score (mean change -0.0270, P = 0.004). After adjusting for multiple baseline characteristics, the utility change during baseline and 12 months was statistically significantly associated with continuous abstinence, with a difference of 0.0288 (95% CI: 0.0006 to 0.0571, P = 0.045) between relapsers and continuous quitters. The only difference in quality of life dimensions between those who relapsed and those who maintained abstinence was in the proportion of participants with anxiety/depression problems at 12 months (30% vs. 22%, P = 0.001). Smoking relapse was associated with a simultaneous increase in anxiety/depression problems. CONCLUSIONS: People who achieve short-term smoking abstinence but subsequently relapse to smoking have a reduced quality of life, which appears mostly due to worsening of symptoms of anxiety and depression. Further research is required to more fully understand the relationship between smoking and health-related quality of life, and to develop cessation interventions by taking into account the impact of anxiety or depression on smoking.

Nurse-Facilitated Health Checks for Persons With Severe Mental Illness: A Cluster-Randomized Controlled Trial.

OBJECTIVE: This study tested the effectiveness of a nurse-delivered health check with the Health Improvement Profile (HIP), which takes approximately 1.5 hours to complete and code, for persons with severe mental illness. METHODS: A single-blind, cluster-randomized controlled trial was conducted in England to test whether health checks improved the general medical well-being of persons with severe mental illness at 12-month follow-up. RESULTS: Sixty nurses were randomly assigned to the HIP group or the treatment-as-usual group. From their case lists, 173 patients agreed to participate. HIP group nurses completed health checks for 38 of their 90 patients (42%) at baseline and 22 (24%) at follow-up. No significant between-group differences were noted in patients' general medical well-being at follow-up. CONCLUSIONS: Nurses who had volunteered for a clinical trial administered health checks only to a minority of participating patients, suggesting that it may not be feasible to undertake such lengthy structured health checks in routine practice.

Interpreting parental proxy reports of (health-related) quality of life for children with unilateral cochlear implants.

OBJECTIVE: To examine what factors are associated with EuroQol EQ-5D scores in children after unilateral cochlear implantation and to explore parental conceptualisations of health-related quality of life (HRQL) and quality of life (QoL). METHODS: Face to face interviews were conducted with the parents of 222 implanted children, in an attempt to elicit information on their child's HRQL and QoL. Post-implant, the child's HRQL was measured using the EQ-5D, completed by parental proxy. Regression analysis was undertaken in order to estimate the association between the child EQ-5D score and child characteristics, child performance, and parental characteristics, in order to assess the construct validity of the EQ-5D. HRQL was also measured using the EuroQol visual analogue scale (VAS), where the endpoints were the best and worst imaginable health state, and a VAS was also used to measure QoL (endpoints: best/worst imaginable QoL). Parents were asked to estimate scores on both these VAS measures both post-implantation and (retrospectively) pre-implantation. Throughout the HRQL and QoL elicitation process, subjects' comments, and observations were noted. RESULTS: Children who had an additional disability (p<0.001), were male (p<0.05) or had a lower level of auditory perception (p<0.001) were estimated to have lower EQ-5D scores, as were children whose parents who left school before age 18 years (p<0.05). According to the EuroQol VAS the mean difference between pre- and post-implantation score was 0.14, compared to 0.35 for the QoL VAS, demonstrating that parents tended not to see HRQL and QoL as equivalent. As 67% of parents deemed there to be no difference between the pre- and post-implant EuroQol VAS scores we also infer that the majority of parents rejected the notion of deafness being a HRQL issue. CONCLUSION: The evidence relating to the construct validity of the EQ-5D is variable-though it was able to discriminate between children with certain levels of auditory performance, it could not discriminate between children who differed in other ways. By limiting outcome from cochlear implantation to HRQL, as opposed to QoL, the benefits of cochlear implants are likely to be underestimated.

Accounting for the increase in NSAID expenditure: substitution or leakage?

BACKGROUND: National Institute of Health and Clinical Excellence (NICE) guidance stated that a new form of non-steroidal anti-inflammatory drug (NSAID) (selective COX-2 inhibitors) should only be an option for arthritis patients at high risk of a gastro-intestinal (GI) event. Total expenditure on NSAIDs has risen by 57% over five years, to 247 pounds sterling million in 2004. We assess whether this expenditure increase can be accounted for by substitution--an increased prescribing of two (more expensive) selective COX-2 inhibitors (celecoxib and rofecoxib) and a simultaneous equivalent reduction in the prescribing volume of three (cheaper) older NSAIDs (diclofenac, ibuprofen and naproxen). METHODS: Quarterly prescription data was collated from January 1999 to September 2004. Over this period, the level of correlation between the total prescribing volumes for i) celecoxib and rofecoxib, and ii) diclofenac, ibuprofen, and naproxen were compared, the change in total expenditure on the five NSAIDs was also estimated. The latter was apportioned into that which was estimated to have arisen due to i) substitution, and ii) increased NSAID prescription volume. RESULTS: Total prescription volumes for the two NSAID groups were negatively correlated (r = -0.97, p < 0.001). In the last quarter there were 1.23 million prescriptions for celecoxib and rofecoxib, and 0.46 million fewer prescriptions for naproxen, diclofenac, and ibuprofen (than in the first quarter, when celecoxib and rofecoxib were not prescribed). Total expenditure for the five NSAIDs was 32.7 pounds sterling million higher in the last quarter, than the first, 12.2 pounds sterling million of which was estimated to be due to substitution, and 20.4 pounds sterling million due to increased volume. CONCLUSION: The introduction of celecoxib and rofecoxib was associated with a reduction in the prescription volume for naproxen, diclofenac, and ibuprofen. However, overall quarterly prescription volume for these five NSAIDs increased by 0.76 million, and we estimate that quarterly expenditure increased by 20.4 pounds sterling million more than would have been expected if overall NSAID volume had remained constant. This suggests that the prescription of both celecoxib and rofecoxib may have 'leaked' to population groups who would not previously have received an older NSAID.

An Occupational Therapy intervention for residents with stroke-related disabilities in UK Care Homes (OTCH): cluster randomised controlled trial with economic evaluation.

BACKGROUND: Care home residents with stroke-related disabilities have significant activity limitations. Phase II trial results suggested a potential benefit of occupational therapy (OT) in maintaining residents' capacity to engage in functional activity. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of a targeted course of OT in maintaining functional activity and reducing further health risks from inactivity for UK care home residents living with stroke-related disabilities. DESIGN: Pragmatic, parallel-group, cluster randomised controlled trial with economic evaluation. Cluster randomisation occurred at the care-home level. Homes were stratified according to trial administrative centre and type of care provided (nursing or residential), and they were randomised 1 : 1 to either the intervention or the control arm. SETTING: The setting was 228 care homes which were local to 11 trial administrative centres across England and Wales. PARTICIPANTS: Care home residents with a history of stroke or transient ischaemic attack, including residents with communication and cognitive impairments, not receiving end-of-life care. INTERVENTION: Personalised 3-month course of OT delivered by qualified therapists. Care workers participated in training workshops to support personal activities of daily living. The control condition consisted of usual care for residents. MAIN OUTCOME MEASURES: Outcome data were collected by a blinded assessor. The primary outcome at the participant level was the Barthel Index of Activities of Daily Living (BI) score at 3 months. The secondary outcomes included BI scores at 6 and 12 months post randomisation, and the Rivermead Mobility Index, Geriatric Depression Scale-15 and European Quality of Life-5 Dimensions, three levels, questionnaire scores at all time points. Economic evaluation examined the incremental cost per quality-adjusted life-year (QALY) gain. Costs were estimated from the perspective of the NHS and Personal Social Services. RESULTS: Overall, 568 residents from 114 care homes were allocated to the intervention arm and 474 residents from another 114 care homes were allocated to the control arm, giving a total of 1042 participants. Randomisation occurred between May 2010 and March 2012. The mean age of participants was 82.9 years, and 665 (64%) were female. No adverse events attributable to the intervention were recorded. Of the 1042 participants, 870 (83%) were included in the analysis of the primary outcome (intervention, n = 479; control, n = 391). The primary outcome showed no significant differences between groups. The adjusted mean difference in the BI score between groups was 0.19 points higher in the intervention arm [95% confidence interval (CI) -0.33 to 0.70, p = 0.48; adjusted intracluster correlation coefficient 0.09]. Secondary outcome measures showed no significant differences at all time points. Mean incremental cost of the Occupational Therapy intervention for residents with stroke living in UK Care Homes intervention was £438.78 (95% CI -£3360.89 to £1238.46) and the incremental QALY gain was 0.009 (95% CI -0.030 to 0.048). LIMITATIONS: A large proportion of participants with very severe activity-based limitations and cognitive impairment may have limited capacity to engage in therapy. CONCLUSION: A 3-month individualised course of OT showed no benefit in maintaining functional activity in an older care home population with stroke-related disabilities. FUTURE WORK: There is an urgent need to reduce health-related complications caused by inactivity and to provide an enabling built environment within care homes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN00757750. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 15. See the Health Technology Assessment programme website for further project information.

The four or more medicines (FOMM) support service: results from an evaluation of a new community pharmacy service aimed at over-65s.

OBJECTIVE: Inappropriate prescribing and nonadherence have a significant impact on hospital admissions and patient quality of life. The English government has identified that community pharmacy could make a significant contribution to reducing nonadherence and improving the quality of prescribing, reducing both hospital admissions and medicines wastage. The objective of this study is to evaluate a community pharmacy service aimed at patients over the age of 65 years prescribed four or more medicines. METHODS: Patients were invited to participate in the service by the community pharmacy team. The pharmacist held regular consultations with the patient and discussed risk of falls, pain management, adherence and general health. They also reviewed the patient's medication using STOPP/START criteria. Data were analysed for the first 6 months of participation in the service. KEY FINDINGS: Six hundred twenty patients were recruited with 441 (71.1%) completing the 6-month study period. Pharmacists made 142 recommendations to prescribers in 110 patients largely centred on potentially inappropriate prescribing of NSAIDs, PPIs or duplication of therapy. At follow-up, there was a significant decrease in the total number of falls (mean -0.116 (-0.217--0.014)) experienced and a significant increase in medicine adherence (mean difference in Morisky Measure of Adherence Scale-8: 0.513 (0.337-0.689)) and quality of life. Cost per quality-adjusted life year estimates ranged from £11 885 to £32 466 depending on the assumptions made. CONCLUSION: By focussing on patients over the age of 65 years with four or more medicines, community pharmacists can improve medicine adherence and patient quality of life.

Self-help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial.

AIMS: Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment. DESIGN: A parallel-arm, pragmatic individually randomized controlled trial. SETTING: Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics. INTERVENTION: Participants in the experimental group (n=703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n=704) received a leaflet currently used in practice. MEASUREMENTS: The primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self-reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables. FINDINGS: There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75-1.16; P=0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. CONCLUSIONS: In people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse.