Jesse Kigozi

Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe

Background Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART) have rarely been evaluated. Methods Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM) or laboratory and clinical monitoring (LCM); individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial. Results 3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults (median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm3) were followed for median 4.9 years. LCM had a mean 0.112 year (41 days) survival benefit at an additional mean cost of

Estimating productivity costs using the friction cost approach in practice: a systematic review

765 [95%CI:685,845], translating into an adjusted incremental cost of

Construct validity and responsiveness of the single-item presenteeism question in patients with lower back pain for the measurement of presenteeism.

7386 [3277,dominated] per life-year gained and

The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial): A cluster randomised trial in primary care.

7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below

Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124)

3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks). CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term. Conclusions There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African countries. CD4 monitoring, restricted to the second year on ART onwards, could be cost-effective with lower cost second-line therapy and development of a cheaper, ideally point-of-care, CD4 test.

Effectiveness and costs of a vocational advice service to improve work outcomes in patients with musculoskeletal pain in primary care: a cluster randomised trial (SWAP trial ISRCTN 52269669)

IntroductionThe choice of the most appropriate approach to valuing productivity loss has received much debate in the literature. The friction cost approach has been proposed as a more appropriate alternative to the human capital approach when valuing productivity loss, although its application remains limited. This study reviews application of the friction cost approach in health economic studies and examines how its use varies in practice across different country settings.MethodsA systematic review was performed to identify economic evaluation studies that have estimated productivity costs using the friction cost approach and published in English from 1996 to 2013. A standard template was developed and used to extract information from studies meeting the inclusion criteria.ResultsThe search yielded 46 studies from 12 countries. Of these, 28 were from the Netherlands. Thirty-five studies reported the length of friction period used, with only 16 stating explicitly the source of the friction period. Nine studies reported the elasticity correction factor used. The reported friction cost approach methods used to derive productivity costs varied in quality across studies from different countries.ConclusionsFew health economic studies have estimated productivity costs using the friction cost approach. The estimation and reporting of productivity costs using this method appears to differ in quality by country. The review reveals gaps and lack of clarity in reporting of methods for friction cost evaluation. Generating reporting guidelines and country-specific parameters for the friction cost approach is recommended if increased application and accuracy of the method is to be realized.

The Estimation and Inclusion of Presenteeism Costs in Applied Economic Evaluation: A Systematic Review

Study Design. Validity and responsiveness study using a randomized clinical trial and prospective cohort study of patients with low back pain (LBP). Objective. To provide evidence for construct validity and responsiveness to change of a single-item presenteeism question (SIPQ) in patients with LBP. Summary of Background Data. The SIPQ is a simple, easy to administer tool that has been used to measure the impact of back pain on reduced productivity at work (presenteeism) as a standalone measure. Evidence supporting the validity and responsiveness of the SIPQ among patients with back pain is however lacking. Methods. The SIPQ was administered to patients consulting for back pain in a randomized controlled trial (N = 851) and a cohort intervention study (N = 922). Construct validity was assessed using convergent, divergent, and known-group validity. The validity investigation included assessing associations between the SIPQ and pain, disability, psychological, health status, and quality of life measures. Responsiveness was assessed using external indicators of change as comparators, evaluating correlation of clinical change scores and effect size statistics. Results. Moderate to strong correlations were found between presenteeism and pain (r: 0.44–0.77), disability (r: 0.53–0.70), and 12-Item Short Form Health Survey physical dimensions (r: −0.66 to −0.55). Presenteeism was strongly associated with disease-specific pain and disability scales. The SIPQ was responsive to changes in productivity—presenteeism change scores indicated strong correlation with change scores, and high responsiveness in distribution- and anchor-based testing. Conclusion. The SIPQ is a potentially valid and responsive tool for assessing the impact of back pain on presenteeism. This SIPQ could, with relative ease, facilitate further research on the estimation of presenteeism within economic evaluation studies of musculoskeletal conditions, thus providing policymakers with estimates of economic impact of musculoskeletal disease. Further evidence is, however, merited to assess its relationship with standardized presenteeism questionnaires. Level of Evidence: 2

The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581)

Background This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. Methods and findings We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire–2 for depression, a two-item Generalized Anxiety Disorder–2 questionnaire for anxiety, and a question about current pain intensity [0–10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were consistent with the primary outcome measure in reflecting better outcomes as a whole for the control group than the intervention group. Anxiety and depression scores did not reduce following the intervention. The main limitations of this study are two potential sources of bias: an imbalance in cluster size (mean practice size 7,397 [intervention] versus 5,850 [control]) and a difference in the proportion of patients for whom the GP deactivated the template (33.6% [intervention] versus 27.8% [control]). Conclusions In this study, we observed no beneficial effect on pain outcomes of prompting GPs to routinely screen for and manage comorbid anxiety and depression in patients presenting with symptoms due to OA, with those in the intervention group reporting statistically significantly higher average pain scores over the four follow-up time points than those in the control group. Trial registration ISRCTN registry ISRCTN40721988

STEMS pilot trial: a pilot cluster randomised controlled trial to investigate the addition of patient direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain

BackgroundLow back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are common and often accepted as a ‘normal’ part of pregnancy. Many women receive little in the way of treatment, and yet pain interferes with sleep, daily activities and work and leads to increasing requests for induction of labour or elective caesarean section. The aim of this study was to assess the feasibility of a full RCT evaluating the benefit of acupuncture for pregnancy-related back pain.MethodsThis study is a single-centre, three-arm pilot RCT in one large maternity unit and associated antenatal and physiotherapy clinics. Women were eligible if they had pregnancy-related LBP with or without PGP. Exclusions included a history of miscarriage, high risk of early labour or pre-eclampsia, PGP only and previous acupuncture. Interventions were standard care (SC): a self-management booklet with physiotherapy if needed. SC+TA: the booklet and physiotherapy comprising true (penetrating) acupuncture, advice and exercise. SC+NPA: the booklet and physiotherapy comprising non-penetrating acupuncture, advice and exercise. Remote telephone randomisation used a 1:1:1 allocation ratio stratified by gestational weeks. Three measures of pain/function were compared to inform the primary outcome measure in a full RCT: the Pelvic Girdle Questionnaire (PGQ), Oswestry Disability Index (ODI) and 11-point 0–10 numerical rating scale for pain. Analysis focused on process evaluation of recruitment, retention, descriptive information on outcomes, adherence to treatment, occurrence of adverse events and impact of physiotherapist training.ResultsOne hundred twenty-five women were randomised (45% of those eligible) between April and October 2013; 73% (n = 91) provided 8-week follow-up data. Three of six recruitment methods accounted for 82% of total uptake: screening questionnaire at the 20-week scan, community midwives issuing study cards, and self-referral following local awareness initiatives. Physiotherapists’ self-confidence on managing pregnancy-related LBP improved post training. The PGQ is suitable as the primary outcome in a full trial. The average number of treatment sessions in both SC+TA and SC+NPA was six (in line with treatment protocols). No serious adverse events attributable to the trial treatments were reported.ConclusionsA full RCT is feasible and would provide evidence about the effectiveness of acupuncture and inform treatment choices for women with pregnancy-related LBP.Trial registrationISRCTN49955124

Cost–utility analysis of interventions to improve effectiveness of exercise therapy for adults with knee osteoarthritis: the BEEP trial

Abstract Musculoskeletal pain is a common cause of work absence, and early intervention is advocated to prevent the adverse health and economic consequences of longer-term absence. This cluster randomised controlled trial investigated the effect of introducing a vocational advice service into primary care to provide occupational support. Six general practices were randomised; patients were eligible if they were consulting their general practitioner with musculoskeletal pain and were employed and struggling at work or absent from work <6 months. Practices in the intervention arm could refer patients to a vocational advisor embedded within the practice providing a case-managed stepwise intervention addressing obstacles to working. The primary outcome was number of days off work, over 4 months. Participants in the intervention arm (n = 158) had fewer days work absence compared with the control arm (n = 180) (mean 9.3 [SD 21·7] vs 14·4 [SD 27·7]) days, incidence rate ratio 0·51 (95% confidence interval 0·26, 0·99), P = 0·048). The net societal benefit of the intervention compared with best care was £733: £748 gain (work absence) vs £15 loss (health care costs). The addition of a vocational advice service to best current primary care for patients consulting with musculoskeletal pain led to reduced absence and cost savings for society. If a similar early intervention to the one tested in this trial was implemented widely, it could potentially reduce days absent over 12 months by 16%, equating to an overall societal cost saving of approximately £500 million (US