Shehzad Ali

Health Outcomes in Economic Evaluation: the QALY and Utilities

The quality-adjusted life year (QALY) is routinely used as a summary measure of health outcome for economic evaluation, which incorporates the impact on both the quantity and quality of life. Key studies relating to the QALY and utility measurement are the sources of data. Areas of agreement include the need for a standard measure of health outcome to enable comparisons across different disease areas and populations, and the methods used for valuing health states in utility measurement. Areas of controversy include the limitation of the QALY approach in terms of the health benefits it can capture, its blindness towards equity concerns, the underlying theoretical assumptions and the most appropriate generic preference-based measure of utility. There is growing debate relating to whether a QALY is the same regardless of who accrues it, and also the issue as to who should value health states. Research is required to further enhance the QALY approach to deal with challenges relating to equity-weighted utility maximization and testing the validity of underlying assumptions. Issues around choosing between condition-specific measures and generic instruments also merit further investigation.

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial

BACKGROUND Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. METHODS We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. FINDINGS We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. INTERPRETATION Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. FUNDING NIHR Health Technology Assessment programme (07/60/26).

The effectiveness and cost implications of task-shifting in the delivery of antiretroviral therapy to HIV-infected patients: a systematic review

INTRODUCTION Human resource shortages are a challenge to the rollout of antiretroviral therapy (ART) for HIV-infected patients, particularly in sub-Saharan Africa. Task-shifting has been recommended as an approach to reduce the impact of human resource shortages. We conducted a systematic review of randomized controlled trials and quasi-experimental studies to assess the effectiveness of task-shifting, and its impact on costs of ART provision. METHODS We searched MEDLINE, EMBASE, PSYCINFO, Cochrane Library, Web of Knowledge and the Current Controlled Trials Register for articles published up to January 2011. We included studies evaluating any task-shifting model against any other intervention using any of the following outcomes: mortality (all causes); occurrence of new AIDS-defining illness; virological outcomes; CD4 cell count; adherence to ART medicines (e.g. self-report and pill counts); hospital admissions; clinic visits; toxicity or adverse events; quality of life indicators; costs and cost-effectiveness. We did not pool the results because of high levels of clinical heterogeneity. RESULTS We identified six effectiveness studies including a total of 19 767 patients. Non-inferior patient outcomes were achieved with task-shifting from doctors to nurses, or from health care professionals to mid-level workers or lay health workers. However, most of the identified studies were underpowered to detect any difference. Three studies were identified on the cost implications of task-shifting. Task-shifting resulted in substantial cost and physician time savings. CONCLUSIONS The reviewed evidence suggests that task-shifting from doctors to nurses, or from health care professionals to lay health workers can potentially reduce costs of ART provision without compromising health outcomes for patients. Task-shifting is therefore a potentially effective and cost-effective approach to addressing the human resource limitations to ART rollout. However, most of the studies conducted were relatively small and more evidence is needed for each task-shifting model as it is currently limited.

Clinical and Cost-Effectiveness of Therapist-Guided Internet-Delivered Cognitive Behavior Therapy for Older Adults With Symptoms of Anxiety: A Randomized Controlled Trial

UNLABELLED There is preliminary support for internet-delivered cognitive behaviour therapy (iCBT) as a way of improving access to treatment among older adults with anxiety. The aim of this randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety. Successful applicants were randomly allocated to either the treatment group (n=35) or the waitlist control group (n=37). The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email. Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90% provided data at posttreatment. Significantly lower scores on measures of anxiety (Cohens d=1.43; 95% CI: 0.89 - 1.93) and depression (Cohens d=1.79; 95% CI: 1.21 - 2.32) were found among the treatment group compared to the control group at posttreatment. These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable. The treatment group had slightly higher costs (

Smoking and absence from work: systematic review and meta-analysis of occupational studies.

92.2; 95% CI:

Early changes, attrition, and dose-response in low intensity psychological interventions.

38.7 to

How a universal health system reduces inequalities: lessons from England

149.2) and Quality-Adjusted Life-Years (QALYs=0.010; 95% CI: 0.003 to 0.018) than the control group at posttreatment and the intervention was found to have a greater than 95% probability of being cost-effective. The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety. TRIAL REGISTRATION TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry: ACTRN12611000929909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000929909.

Can simvastatin improve erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction? : Results of the Erectile Dysfunction and Statins Trial [ISRCTN66772971]

AIMS This study aimed to assess the association between smoking and absenteeism in working adults. METHODS A systematic review and meta-analysis was performed by electronic database searches in MEDLINE, EMBASE, CAB Abstracts, PubMed, Science Direct and National Health Service Economic Evaluation Database (February 2012). Longitudinal, prospective cohorts or retrospective cohorts were included in the review. Summary effect estimates were calculated using random-effects meta-analysis. Heterogeneity was assessed by I(2) and publication bias was investigated. RESULTS A total of 29 longitudinal or cohort studies were included. Compared with non-smokers, current smokers had a 33% increase in risk of absenteeism [95% confidence interval (CI): 1.25-1.41; I(2)  = 62.7%; 17 studies]. Current smokers were absent for an average of 2.74 more days per year compared with non-smokers (95% CI: 1.54-3.95; I(2)  = 89.6%; 13 studies). Compared with never smokers, ex-smokers had a 14% increase in risk of absenteeism (95% CI: 1.08-1.21; I(2)  = 62.4%; eight studies); however, no increase in duration of absence could be detected. Current smokers also had a 19% increase in risk of absenteeism compared with ex-smokers (95% CI: 1.09-1.32, P < 0.01, eight studies). There was no evidence of publication bias. The total cost of absenteeism due to smoking in the United Kingdom was estimated to be £1.4 billion in 2011. CONCLUSIONS Quitting smoking appears to reduce absenteeism and result in substantial cost-savings for employers.

Lifetime indirect cost of childhood overweight and obesity: A decision analytic model

OBJECTIVES To investigate if early symptom changes in brief low intensity psychological interventions (guided self-help and psycho-education using cognitive behavioural therapy principles) are predictive of final treatment outcome. DESIGN Retrospective cohort data analysis. METHOD Clinical records for 1,850 patients who screened positive for depression and/or an anxiety disorder were analysed. Reliable and clinically significant improvement (RCSI) on depression (Patient Health Questionnaire-9: PHQ-9) or anxiety (generalized anxiety disorder-7: GAD-7) outcome measures after treatment was the primary outcome. Change scores ≥6 on PHQ-9 and ≥5 on GAD-7 were taken as indicative of reliable improvement (RI). The model assumed that RI in the earliest treatment sessions would be predictive of RCSI post-treatment. Predictive accuracy was assessed by calculating the area under the curve (AUC), as well as positive and negative predictive values. Diagnostic odds ratios were also estimated, adjusting for confounders such as baseline severity, use of medication, and pre-treatment symptom change. RESULTS The AUC estimates for session-to-session change scores ranged between .62 and .88, indicative of modest to high predictive reliability. Predictive accuracy was higher for patients who had four or more treatment sessions, with more than 70% of patients with RCSI being accurately identified as early as sessions 1-3. Attrition rates were significantly associated with poor outcomes. Results suggest that at least four therapy sessions are necessary to achieve more than 50% RCSI rates, and the dose-response effect appears to decline in treatments longer than six sessions. CONCLUSIONS Patients showing RI early in treatment were at least twice as likely to fully recover compared to those without early RI.

Beyond Food Promotion: A Systematic Review on the Influence of the Food Industry on Obesity-Related Dietary Behaviour among Children

Background Provision of universal coverage is essential for achieving equity in healthcare, but inequalities still exist in universal healthcare systems. Between 2004/2005 and 2011/2012, the National Health Service (NHS) in England, which has provided universal coverage since 1948, made sustained efforts to reduce health inequalities by strengthening primary care. We provide the first comprehensive assessment of trends in socioeconomic inequalities of primary care access, quality and outcomes during this period. Methods Whole-population small area longitudinal study based on 32 482 neighbourhoods of approximately 1500 people in England from 2004/2005 to 2011/2012. We measured slope indices of inequality in four indicators: (1) patients per family doctor, (2) primary care quality, (3) preventable emergency hospital admissions and (4) mortality from conditions considered amenable to healthcare. Results Between 2004/2005 and 2011/2012, there were larger absolute improvements on all indicators in more-deprived neighbourhoods. The modelled gap between the most-deprived and least-deprived neighbourhoods in England decreased by: 193 patients per family doctor (95% CI 173 to 213), 3.29 percentage points of primary care quality (3.13 to 3.45), 0.42 preventable hospitalisations per 1000 people (0.29 to 0.55) and 0.23 amenable deaths per 1000 people (0.15 to 0.31). By 2011/2012, inequalities in primary care supply and quality were almost eliminated, but socioeconomic inequality was still associated with 158 396 preventable hospitalisations and 37 983 deaths amenable to healthcare. Conclusions Between 2004/2005 and 2011/2012, the NHS succeeded in substantially reducing socioeconomic inequalities in primary care access and quality, but made only modest reductions in healthcare outcome inequalities.