David G. T. Whitehurst

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.

A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol

BackgroundBack pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain.Methods/DesignWe will recruit 800 participants aged 18 years and over with non-specific low back pain from 8–10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care.DiscussionThis paper presents detail on the rationale, design, methods and operational aspects of the trial.Trial registrationCurrent Controlled Trials ISRCTN37113406.

Systematic Review and Empirical Comparison of Contemporaneous EQ-5D and SF-6D Group Mean Scores

Background. Group mean estimates and their underlying distributions are the focus of assessment for cost and outcome variables in economic evaluation. Research focusing on the comparability of alternative preference-based measures of health-related quality of life has typically focused on analysis of individual-level data within specific clinical specialties or community-based samples. Purpose. To explore the relationship between group mean scores for the EQ-5D and SF-6D across the utility scoring range. Methods. Studies were identified via a systematic search of 13 online electronic databases, a review of reference lists of included papers, and hand searches of key journals. Studies were included if they reported contemporaneous mean EQ-5D and SF-6D health state scores. All (sub)group comparisons of group mean EQ-5D and SF-6D scores identifiable from text, tables, or figures were extracted from identified studies. A total of 921 group mean comparisons were extracted from 56 studies. The nature of the relationship between the paired scores was examined using ranked scatter graphs and analysis of agreement. Results. Systematic differences in group mean estimates were observed at both ends of the utility scale. At the lower (upper) end of the scale, the SF-6D (EQ-5D) provides higher mean utility estimates. Conclusions. These findings show that group mean EQ-5D and SF-6D scores are not directly comparable. This raises serious concerns about the cross-study comparability of economic evaluations that differ in the choice of preference-based measures, although the review focuses on 2 of the available instruments only. Further work is needed to address the practical implications of noninterchangeable utility estimates for cost-per-QALY estimates and decision making.

Cost-Effectiveness of Acupuncture Care as an Adjunct to Exercise-Based Physical Therapy for Osteoarthritis of the Knee

Background The delivery of acupuncture alongside mainstream interventions and the cost-effectiveness of “alternative” treatments remain areas of controversy. Objective The aim of this study was to assess the cost-utility of adding acupuncture to a course of advice and exercise delivered by UK National Health Service (NHS) physical therapists to people with osteoarthritis of the knee. Design A cost-utility analysis was performed alongside a randomized controlled trial. Methods A total of 352 adults (aged 50 years or older) were randomly assigned to receive 1 of 3 interventions. The primary analysis focused on participants receiving advice and exercise (AE) or advice and exercise plus true acupuncture (AE+TA). A secondary analysis considered participants receiving advice and exercise plus nonpenetrating acupuncture (AE+NPA). The main outcome measures were quality-adjusted life years (QALYs), measured by the EQ-5D, and UK NHS costs. Results were expressed as the incremental cost per QALY gained over 12 months. Sensitivity analyses included a broader cost perspective to incorporate private out-of-pocket costs. Results NHS costs were higher for AE+TA (£314 [British pounds sterling]) than for AE alone (£229), and the difference in mean QALYs favored AE+TA (mean difference=0.022). The base-case cost per QALY gained was £3,889; this value was associated with a 77% probability that AE+TA would be more cost-effective than AE at a threshold of £20,000 per QALY. Cost-utility data for AE+NPA provided cost-effectiveness estimates similar to those for AE+TA. Limitations As with all trial-based economic evaluations, caution should be exercised when generalizing results beyond the study perspectives. Conclusions A package of AE+TA delivered by NHS physical therapists provided a cost-effective use of health care resources despite an associated increase in costs. However, the economic benefits could not be attributed to the penetrating nature of conventional acupuncture; therefore, further research regarding the mechanisms of acupuncture is needed. An analysis of alternative cost perspectives suggested that the results are generalizable to other health care settings.

A review of preference-based health-related quality of life questionnaires in spinal cord injury research

Study design:Systematic reviewObjectives:Review the use of generic preference-based measures of health-related quality of life (HRQoL) within the context of spinal cord injury (SCI).Methods:A systematic search was conducted to identify SCI-related publications that contained any of the following preference-based HRQoL instruments: 15D, Assessment of Quality of Life (AQoL)-4D, AQoL-6D, EQ-5D, EQ-5D-5L, Health Utilities Index (HUI)-2, HUI-3, Quality of Well-Being Scale Self-Administered (QWB-SA), SF-6D(SF-36) or SF-6D(SF-12). In addition to providing an overview of how different preference-based measures have been adopted in SCI research to-date, a focus of evaluation was to collate and appraise evidence for measurement properties and identify knowledge gaps.Results:Twenty-two articles were identified. No studies have used preference-based measures in their conventional form, that is, to calculate quality-adjusted life years using patient-level data. Eleven papers reported mean utility scores (across six different instruments). Directly comparable data exists for only one SCI-specific sample, which showed variation across EQ-5D (0.63), HUI-2 (0.81) and HUI-3 (0.68) index scores. Indirect comparisons suggested differences between QWB-SA and SF-6D index scores within tetraplegic and paraplegic patient groups. Only the QWB-SA and SF-6D have undergone (partial) psychometric evaluation, with the respective authors concluding that the measures have potential for SCI research.Conclusions:Despite ‘cost-effectiveness’ being an increasingly important consideration for decision makers in all areas of health care, there is a distinct lack of conceptual or empirical research regarding the appropriateness of alternative preference-based HRQoL measures for SCI populations. Given the support for economic evaluation within a cost-utility framework and the paucity of psychometric evidence regarding current instruments, further research is needed.

Self management, joint protection and exercises in hand osteoarthritis: a randomised controlled trial with cost effectiveness analyses

BackgroundThere is limited evidence for the clinical and cost effectiveness of occupational therapy (OT) approaches in the management of hand osteoarthritis (OA). Joint protection and hand exercises have been proposed by European guidelines, however the clinical and cost effectiveness of each intervention is unknown.This multicentre two-by-two factorial randomised controlled trial aims to address the following questions:• Is joint protection delivered by an OT more effective in reducing hand pain and disability than no joint protection in people with hand OA in primary care?• Are hand exercises delivered by an OT more effective in reducing hand pain and disability than no hand exercises in people with hand OA in primary care?• Which of the four management approaches explored within the study (leaflet and advice, joint protection, hand exercise, or joint protection and hand exercise combined) provides the most cost-effective use of health care resourcesMethods/DesignParticipants aged 50 years and over registered at three general practices in North Staffordshire and Cheshire will be mailed a health survey questionnaire (estimated mailing sample n = 9,500). Those fulfilling the eligibility criteria on the health survey questionnaire will be invited to attend a clinical assessment to assess for the presence of hand or thumb base OA using the ACR criteria. Eligible participants will be randomised to one of four groups: leaflet and advice; joint protection (looking after your joints); hand exercises; or joint protection and hand exercises combined (estimated n = 252). The primary outcome measure will be the OARSI/OMERACT responder criteria combining hand pain and disability (measured using the AUSCAN) and global improvement, 6 months post-randomisation. Secondary outcomes will also be collected for example pain, functional limitation and quality of life. Outcomes will be collected at baseline and 3, 6 and 12 months post-randomisation. The main analysis will be on an intention to treat basis and will assess the clinical and cost effectiveness of joint protection and hand exercises for managing hand OA.DiscussionThe findings will improve the cost-effective evidence based management of hand OA.Trial registrationidentifier:ISRCTN33870549

Cost-Effectiveness of Non-Invasive and Non-Pharmacological Interventions for Low Back Pain: a Systematic Literature Review

BackgroundLow back pain (LBP) is a major health problem, having a substantial effect on peoples’ quality of life and placing a significant economic burden on healthcare systems and, more broadly, societies. Many interventions to alleviate LBP are available but their cost effectiveness is unclear.ObjectivesTo identify, document and appraise studies reporting on the cost effectiveness of non-invasive and non-pharmacological treatment options for LBP.MethodsRelevant studies were identified through systematic searches in bibliographic databases (EMBASE, MEDLINE, PsycINFO, Cochrane Library, CINAHL and the National Health Service Economic Evaluation Database), ‘similar article’ searches and reference list scanning. Study selection was carried out by three assessors, independently. Study quality was assessed using the Consensus on Health Economic Criteria checklist. Data were extracted using customized extraction forms.ResultsThirty-three studies were identified. Study interventions were categorised as: (1) combined physical exercise and psychological therapy, (2) physical exercise therapy only, (3) information and education, and (4) manual therapy. Interventions assessed within each category varied in terms of their components and delivery. In general, combined physical and psychological treatments, information and education interventions, and manual therapies appeared to be cost effective when compared with the study-specific comparators. There is inconsistent evidence around the cost effectiveness of physical exercise programmes as a whole, with yoga, but not group exercise, being cost effective.ConclusionsThe identified evidence suggests that combined physical and psychological treatments, medical yoga, information and education programmes, spinal manipulation and acupuncture are likely to be cost-effective options for LBP.

Short form health surveys and related variants in spinal cord injury research : a systematic review

Abstract Context ‘Short Form’ health surveys – such as the SF-36 and SF-12 – are widely used in medical research. Spinal cord injury (SCI) is no exception, despite oft-cited concerns regarding measurement properties for populations with physical impairment. Objective To provide a comprehensive overview of the use of Short Form health surveys and their variants within the SCI literature. Methods Papers published between database inception and September 2012 were identified from 11 electronic databases; a supplementary reference list search was also conducted. Data extraction focused on details regarding the range of different Short Form surveys and variants used in SCI research, the respective frequency of use, the nature of reporting (complete versus partial reporting) and the method of survey administration. Results One hundred seventy-four papers were identified. Thirty-six-item Short Form health surveys were frequently administered as complete instruments (n = 82); in 69 of these 82 studies (84%), it was not clearly stated which 36-item version had been used (e.g. SF-36v1, SF-36v2, RAND-36). Data for individual items and domains were often reported (29% of identified studies), indicating significant partial use of standardized measures. Modified variants of standardized health surveys were administered in 12 studies. Conclusion Although standardized Short Form health surveys are common within SCI research, attempts to add, delete, or modify items have resulted in a number of variants, often with minimal supportive psychometric evidence. Using established, generic outcome measures is appealing for a number of reasons. However, validity is paramount and requires further explicit consideration within the SCI research community.

Inconsistencies in NICE guidance for acupuncture: reanalysis and discussion

Background Acupuncture received a positive recommendation in the National Institute for Health and Clinical Excellence (NICE) clinical guideline for low back pain (LBP). However, no such recommendation was forthcoming in the NICE clinical guideline for osteoarthritis (OA). Importantly, the two guidelines adopted different treatment comparators in their economic analyses of acupuncture; in the LBP guideline ‘usual care’ was used (with no consideration of placebo/sham interventions), whereas ‘sham acupuncture’ was the comparator in the OA guideline. Objective To analyse the implications of using different control group comparators when estimating the cost-effectiveness of acupuncture therapy. Methods The NICE OA economic analysis for acupuncture was replicated using ‘usual care’ (ie, no placebo/sham component) as the treatment comparator. A ‘transfer-to-utility’ technique was used to transform Western Ontario and McMaster Osteoarthritis scores into EQ-5D utility scores to allow quality-adjusted life year (QALY) gains to be estimated. QALY estimates were combined with direct incremental cost estimates of acupuncture treatment to determine incremental cost-effectiveness ratios (ICERs). Results When ‘usual care’ was used as the treatment comparator, ICER point estimates were below £20 000 per QALY gained for each acupuncture trial analysed in the OA clinical guideline. In the original analysis, using placebo/sham acupuncture as the treatment comparator, ICERs were generally above £20 000 per QALY gained. Conclusion The treatment comparator chosen in economic evaluations of acupuncture therapy is likely to be a strong determinant of the cost-effectiveness results. Different comparators used in the OA and LBP NICE guidelines may have led to the divergent recommendations in the guidelines.

EXCLUSION CRITERIA IN NATIONAL HEALTH STATE VALUATION STUDIES: A SYSTEMATIC REVIEW

Background. Health state valuation data are often excluded from studies that aim to provide a nationally representative set of values for preference-based health-related quality of life (HRQoL) instruments. The purpose was to provide a systematic examination of exclusion criteria used in the derivation of societal scoring algorithms for preference-based HRQoL instruments. Methods. Data sources included MEDLINE, official instrument websites, and publication reference lists. Analyses that used data from national valuation studies and reported a scoring algorithm for a generic preference-based HRQoL instrument were included. Data extraction included exclusion criteria and associated justifications, exclusion rates, the characteristics of excluded respondents, and analyses that explored consequential implications of exclusion criteria on the respective national tariff. Results. Seventy-six analyses (from 70 papers) met the inclusion criteria. In addition to being excluded for logical inconsistencies, respondents were often excluded if they valued fewer than 3 health states or if they gave the same value to all health states. Numerous other exclusion criteria were identified, with varying degrees of justification, often based on an assumption that respondents did not understand the task or as a consequence of the chosen statistical modeling techniques. Rates of exclusion ranged from 0% to 65%, with excluded respondents more likely to be older, less educated, and less healthy. Limitations included that the database search was confined to MEDLINE; study selection focused on national valuation studies that used standard gamble, time tradeoff, and/or visual analog scale techniques; and only English-language studies were included. Conclusion. Exclusion criteria used in national valuation studies vary considerably. Further consideration is necessary in this important and influential area of research, from the design stage to the reporting of results.