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Following the World Health Organization (WHO) guidance on strategic purchasing in 2000, low- and middle-income countries (LMICs) are trying to shift from passive purchasing (using fixed budgets) to strategic purchasing of healthcare which ties reimbursement to outcomes. However, there is limited evidence on strategic purchasing in Africa. We conducted a scoping literature review aimed at summarizing the roles played by governments, purchasers and providers in relation to citizens/population in strategic purchasing in Africa. The review searched for scientific journal articles that contained data on strategic purchasing collected from Africa. The literature search identified 957 articles of which 80 matched the inclusion criteria and were included in the review. The study revealed that in some countries strategic purchasing has been used as a tool for healthcare reforms or for strengthening systems that were not functional under fixed budgets. However, there was some evidence of a lack of government commitment in taking leading roles and funding strategic purchasing. Further, in some countries the laws need to be revised to accommodate new arrangements that were not part of fixed budgets. The review also established that there were some obstacles within the public health systems that deterred purchasers from promoting efficiency among providers and that prevented providers from having full autonomy in decision making. As African countries strive to shift from passive to strategic purchasing of healthcare, there is need for full government commitment on strategic purchasing. There is need to further revise appropriate legal frameworks to support strategic purchasing, conduct assessments of the healthcare systems before designing strategic purchasing schemes and to sensitize the providers and citizens on their roles and entitlements respectively.

Risk-based stratified care shows clinical effectiveness and cost-effectiveness versus usual primary care for non-specific low back pain but is untested for other common musculoskeletal disorders. We aimed to test the clinical effectiveness and cost-effectiveness of point-of-care risk stratification (using Keele's STarT MSK Tool and risk-matched treatments) versus usual care for the five most common musculoskeletal presentations (back, neck, knee, shoulder, and multi-site pain).In this cluster-randomised, controlled trial in UK primary care with embedded qualitative and health economic studies we recruited patients from 24 general practices in the West Midlands region of England. Eligible patients were those aged 18 years or older whose general practitioner (GP) confirmed a consultation for a musculoskeletal presentation. General practices that consented to participate via a representative of the cluster were randomly assigned (1:1) to intervention or usual care, using stratified block randomisation. Researchers involved in data collection, outcome data entry, and statistical analysis were masked at both the cluster and individual participant level. Participating patients were told the study was examining GP treatment of common aches and pains and were not aware they were in a randomised trial. GPs in practices allocated to the intervention group were supported to deliver risk-based stratified care using a bespoke computer-based template, including the risk-stratification tool, and risk-matched treatment options for patients at low, medium, or high risk of poor disability or pain outcomes. There were 15 risk-matched treatment options. In the usual care group, patients with musculoskeletal pain consulting their GP received treatment as usual, typically including advice and education, medication, referral for investigations or tests, or referral to other services. The primary outcome was time-averaged pain intensity over 6 months. All analyses were done by intention to treat. The trial is registered with ISRCTN, ISRCTN15366334.Between May 1, 2018, and April 30, 2019, 104 GPs from 24 practices (12 per study group) identified 2494 patients with musculoskeletal pain. 1211 (49%) participants consented to questionnaires (534 in the intervention group and 677 in the usual care group), with 1070 (88%) completing the follow-up questionnaire at 6 months. We found no significant difference in time-averaged pain intensity (mean(SD) mean 4·4 [SD 2·3] in the intervention groupRisk stratification for patients in primary care with common musculoskeletal presentations did not lead to significant improvements in pain or function, although some aspects of GP decision making were affected, and GP and patients had positive experiences. The costs of risk-based stratified care were similar to usual care, and such a strategy only offers marginal changes in cost-effectiveness outcomes. The clinical implications from this trial are largely inconclusive.National Institute for Health Research.

The primary aim of this study is to assess the evidence on the cost-effectiveness of type 2 diabetes mellitus (T2DM) interventions with a focus on diabetes education, lifestyle modifications, surgical intervention, and pharmacological therapy in low- and middle-income countries (LMICs). A systematic review was conducted to identify economic evaluations of T2DM interventions published in LMICs for the period 2009-2019. A total of 25 studies were identified, with more than half of the studies being decision analytic models. Critical appraisal of the identified studies showed they were of good quality. Overall, the reported interventions in this review were very heterogeneous, which made them difficult to compare. However, there was strong evidence suggesting that diabetes education was a very cost-effective strategy in LMICs. Further evidence on affordability and budget impact of bariatric surgery is required before adopting the intervention. Metformin-based therapy showed promising evidence on cost-effectiveness and thus should be offered to T2DM patients in LMICs. On the contrary, the cost-effectiveness of lifestyle modifications remains understudied in LMICs. The findings in this review can inform policy guidance toward the inclusion of T2DM interventions in the benefit packages for Universal Health Coverage in LMICs.

Purpose Microbial keratitis (MK) is the most common non-surgical ophthalmic emergency admission in the UK. However, few prospective health-economic studies of MK have been performed, and no specific healthcare resources group (HRG) code exists. This study is designed to determine the feasibility of a data collection tool derived from the microbiology ophthalmology group (MOG) clinical record form, to enable quantification of direct costs of inpatient care, as well as prospective capture of epidemiological data relating to outcomes of MK. Methods Clinical, demographic and economic data were collected retrospectively between January and December 2013 for 101 consecutive patients admitted with MK, using an adaption of the MOG toolset. The direct cost of admission (COA) was calculated using national reference costs and compared to actual income to generate profit/deficit profiles for individual patients. Indices of multiple deprivation were used to assess effect of deprivation on the COA. Results The total income generated through discharge coding was £252,116, compared to a COA of £357,075, yielding a deficit of £104,960 (median: £754 per patient). The cost deficit increased significantly with length of stay (LOS, p Conclusion LOS is the key driver for COA of care for MK admissions. Protocols should encourage discharge of patients who are able to self-administer treatment after the sterilisation phase. The MOG-derived data collection toolset captures pertinent clinical data for quantification of COA. Further development into a multiuser and multisite platform is required for robust prospective testing, together with expansion to capture indirect costs of disease burden, including impact of treatment, visual morbidity and quality of life.

ObjectiveTo compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis.DesignPragmatic, three arm, parallel group, single blind, randomised controlled trial.SettingTwo community musculoskeletal services in England.Participants199 adults aged ≥40 years with hip osteoarthritis and at least moderate pain: 67 were randomly assigned to receive advice and education (best current treatment (BCT)), 66 to BCT plus ultrasound guided injection of triamcinolone and lidocaine, and 66 to BCT plus ultrasound guided injection of lidocaine.InterventionsBCT alone, BCT plus ultrasound guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 mL 1% lidocaine hydrochloride, or BCT plus ultrasound guided intra-articular hip injection of 5 mL 1% lidocaine. Participants in the ultrasound guided arms were masked to the injection they received.Main outcome measuresThe primary outcome was self-reported current intensity of hip pain (0-10 Numerical Rating Scale) over six months. Outcomes were self-reported at two weeks and at two, four, and six months.ResultsMean age of the study sample was 62.8 years (standard deviation 10.0) and 113 (57%) were women. Average weighted follow-up rate across time points was 93%. Greater mean improvement in hip pain intensity over six months was reported with BCT plus ultrasound-triamcinolone-lidocaine compared with BCT: mean difference −1.43 (95% confidence interval −2.15 to −0.72), PConclusionsUltrasound guided intra-articular hip injection of triamcinolone is a treatment option to add to BCT for people with hip osteoarthritis.Trial registrationEudraCT 2014-003412-37; ISRCTN50550256.

Summary Background Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. Methods We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as “completely recovered” or “much better” on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. Findings Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4–13·6) in the stratified care arm and 12 weeks (9·4–14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89–1·46]). Stratified care was not cost-effective compared to usual care. Interpretation The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. Funding National Institute for Health Research.

Background and objectivesThe health workforce (HWF) is at the core of ensuring an efficient, effective and functional health system, but it faces chronic underinvestment. This paper presents a fiscal space analysis of 20 countries in East and Southern Africa to generate sustained evidence-based advocacy for significant and smarter investment in the HWF.MethodsWe adapted an established empirical framework for fiscal space analysis and applied it to the HWF. Country-specific data were curated and triangulated from publicly available datasets and government reports to model the fiscal space for the HWF for each country. Based on the current knowledge, three scenarios (business as-usual, optimistic and very optimistic) were modelled and compared.FindingsA business-as-usual scenario shows that the cumulative fiscal space across the 20 countries is US$12.179 billion, which would likely increase by 28% to US$15.612 billion by 2026 but varies across countries—the highest proportional increases expected in Seychelles (117%) and Mozambique (69%) but lowest in Zambia (15%). Under optimistic assumptions, allocating an additional 1.5% of gross domestic product (GDP) to health even without further prioritising the proportional allocation to the wage bill could boost the cumulative fiscal space for HWF by US$4.639 billion. In a very optimistic scenario of a 1.5% increase in health expenditure as a proportion of GDP and further prioritisation of HWF within the health expenditure, the cumulative fiscal space for HWF could improve by some 105%—ranging from 24% in Zambia to 330% in Lesotho.ConclusionSmall increments in government health expenditure and increased prioritisation of HWF in funding in tandem with the 57% global average could potentially increase the fiscal space for HWF by at least 32% in 11 countries. Unless the HWF is sufficiently prioritised within the health expenditures, only increasing the overall health expenditure to even recommended levels would still portend severe underinvestment in HWF amid unabating shortages to deliver health services. Thus, HWF strategies and investment plans should include fiscal space analysis to deepen advocacy for sustainable investment in the HWF.

BackgroundBrace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.Methods and analysisA multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.Ethics and disseminationNorth West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.Trial registration numberISRCTN28555470.

Background Sciatica has a substantial impact on patients and society. Current care is ‘stepped’, comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. Objectives The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. Design This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. Setting Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. Participants Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. Interventions In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. Main outcome measures The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost–utility analysis was undertaken over 12 months. A qualitative study explored patients’ and clinicians’ views of the fast-track care pathway to a spinal specialist. Results A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. Conclusions The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. Limitations Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. Future work Other approaches to stratified care may provide superior outcomes for sciatica. Trial registration Current Controlled Trials ISRCTN75449581. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.

The evidence of the economic burden of road traffic injuries (RTIs) in Nepal is limited. The most recent study, conducted in 2008, is now considered outdated because there has been a rapid increase in vehicle numbers and extensive road building over the last decade. This study estimated the current economic costs of RTIs in Nepal, including the direct costs, productivity costs, and valuation of pain, grief, and suffering. An incidence-based cost-of-illness analysis was conducted from a societal perspective, employing a bottom-up approach using secondary data. All costs incurred by the patients, their family members, and costs to society were estimated, with sensitivity analyses to consider uncertainty around the data estimates available. Productivity loss was valued using the human capital approach. The total costs of RTIs in 2017 were estimated at USD 122.88 million. Of these, the costs of productivity loss were USD 91.57 million (74.52%) and the pain, grief, and suffering costs were USD 18.31 million (14.90%). The direct non-medical costs were USD 11.50 million (9.36%) whereas the direct medical costs were USD 1.50 million (1.22%). The economic costs of RTIs increased by threefold since 2007 and are equivalent to 1.52% of the gross national product, indicating the growing national financial burden associated with preventable RTIs. National Institute for Health Research

Background Evidence of the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis (OA) is limited. The HIT trial compared the clinical and cost-effectiveness of an ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride combined with best current treatment (BCT) with (i) BCT alone (primary objective) and (ii) an USGI of 5ml 1% lidocaine only combined with BCT (EudraCT:2014-003412-37). Methods This was a pragmatic, three-parallel arm, single-blind, randomised controlled trial in adults with moderate-severe painful hip OA recruited from community musculoskeletal services and primary care. Participants were randomised equally to: (1) BCT alone, (2) BCT plus USGI triamcinolone/lidocaine, or (3) BCT plus USGI lidocaine only. Outcomes were collected postally at 2 weeks, 2, 4 and 6 months. The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months (repeated measures analysis). Secondary outcomes included function (WOMAC), and, for cost-utility analysis, general health (EQ-5D-5L) and healthcare utilisation. 204 participants were required to detect a minimum difference of 1 point in mean pain NRS score between arms (1) and (2) with 80% power (5% two-tailed significance level, 15% loss to follow-up). Analysis was by intention-to-treat. Results 199 participants were recruited (43% male, mean age 63 years), 67 to arm (1) and 66 each to arms (2) and (3). Primary outcome completion rates were 95% at 2 weeks, 94% at 2 months, 90% at 4 months, and 89% at 6 months. Greater mean improvement in hip pain intensity (0-10 NRS) over 6 months was seen with BCT plus USGI triamcinolone/lidocaine compared with BCT alone: -1.43 (95%CI -2.15,-0.72). Greater mean improvement in pain intensity was seen at 2 weeks (-3.17; -4.06,-2.28) and 2 months (-1.81;-2.71,-0.92), but not at 4 (-0.86;-1.78,0.05) or 6 months (0.12; -0.80,1.04). Participants treated with BCT plus USGI triamcinolone/lidocaine compared with BCT alone had greater mean improvement in function (WOMAC-F -5.47;(-9.41,-1.53)) over 6 months. There was no statistically significant difference in hip pain intensity over 6 months between BCT plus USGI triamcinolone/lidocaine compared with BCT plus USGI lidocaine (-0.52;-1.21,0.18). There was one possible treatment-related serious adverse event: a participant with no signs of infection at randomisation died from endocarditis four months after USGI triamcinolone/lidocaine. BCT plus USGI triamcinolone/lidocaine was less costly (mean cost difference per participant £-161.59) and associated with significantly higher quality-adjusted life-years (QALYs) than BCT only over 6 months (mean difference 0.0477 (0.0257,0.0699). Conclusion USGI triamcinolone/lidocaine plus BCT leads to greater improvements in pain and function over 6 months in adults with hip OA than BCT alone, and was highly cost-effective. There was no significant difference in hip pain intensity between the groups receiving USGI triamcinolone/lidocaine and USGI lidocaine only, raising the possibility of a degree of placebo effect. Disclosures Z. Paskins None. K. Bromley None. M. Lewis None. G. Hughes None. E. Hughes None. A. Cherrington None. A. Hall None. M. Holden None. R. Oppong None. J. Kigozi None. K. Stevenson None. A. Menon None. P. Roberts None. G. Peat None. C. Jinks None. N.E. Foster None. C.D. Mallen None. E. Roddy None.

Using data from the English Longitudinal Study of Ageing over the period 2004-2017, this paper explores the effects of the Great Recession and its aftermath upon health-compromising behaviours in adults aged 50 and over. We introduce new techniques into this area of research, namely dynamic random-effects logit estimators which control for initial conditions and correlated individual effects. We observe a lack of crisis effect upon the probabilities of smoking and being physically inactive, as well as of transitioning in and out of these behaviours. In line with other recent literature, this suggests that the relationship between economic recessions and smoking and physical inactivity may have broken down. Alternatively, the over 50s may have been protected from the crisis and subsequent austerity measures. Nonetheless, both the crisis and post-crisis period were associated with a lower probability of drinking frequently.

The friction cost approach has been proposed as an alternative to the human capital approach in estimating productivity costs. However, it is difficult, in practice, to apply this approach due to limited availability of context specific data. Using national and firm level data on vacancy durations sourced from four organisations, we estimated vacancy durations, and consequently length of friction period for the United Kingdom disaggregated by occupational classification. We found comparable estimates to previously reported friction periods elsewhere. The disaggregated friction period analysis confirmed occupational class has an effect on the estimated length of the friction period. The research presents estimates on vacancy durations, and friction periods necessary to use the friction cost approach in a practical way in economic evaluations.

Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of ‘wait and see’ for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. ISRCTN75449581 , date: 20.11.2014.

Objective Given the significant costs of reduced productivity (presenteeism) in comparison to absenteeism, and overall societal costs, presenteeism has a potentially important role to play in economic evaluations. However, these costs are often excluded. The objective of this study is to review applied cost of illness studies and economic evaluations to identify valuation methods used for, and impact of including presenteeism costs in practice. Methods A structured systematic review was carried out to explore (i) the extent to which presenteeism has been applied in cost of illness studies and economic evaluations and (ii) the overall impact of including presenteeism on overall costs and outcomes. Potential articles were identified by searching Medline, PsycINFO and NHS EED databases. A standard template was developed and used to extract information from economic evaluations and cost of illness studies incorporating presenteeism costs. Results A total of 28 studies were included in the systematic review which also demonstrated that presenteeism costs are rarely included in full economic evaluations. Estimation and monetisation methods differed between the instruments. The impact of disease on presenteeism whilst in paid work is high. Conclusions The potential impact of presenteeism costs needs to be highlighted and greater consideration should be given to including these in economic evaluations and cost of illness studies. The importance of including presenteeism costs when conducting economic evaluation from a societal perspective should be emphasised in national economic guidelines and more methodological work is required to improve the practical application of presenteeism instruments to generate productivity cost estimates.

Background There is limited research on the economic burden of low back-related leg pain, including sciatica. The aim of this study was to describe healthcare resource utilisation and factors associated with cost and health outcomes in primary care patients consulting with symptoms of low back-related leg pain including sciatica. Methods This study is a prospective cohort of 609 adults visiting their family doctor with low back-related leg pain, with or without sciatica in a United Kingdom (UK) Setting. Participants completed questionnaires, underwent clinical assessments, received an MRI scan, and were followed-up for 12-months. The economic analysis outcome was the quality-adjusted life year (QALY) calculated from the EQ-5D-3 L data obtained at baseline, 4 and 12-months. Costs were measured based on patient self-reported information on resource use due to back-related leg pain and results are presented from a UK National Health Service (NHS) and Societal perspective. Factors associated with costs and outcomes were obtained using a generalised linear model. Results Base-case results showed improved health outcomes over 12-months for the whole cohort and slightly higher QALYs for patients in the sciatica group. NHS resource use was highest for physiotherapy and GP visits, and work-related productivity loss highest from a societal perspective. The sciatica group was associated with significantly higher work-related productivity costs. Cost was significantly associated with factors such as self-rated general health and care received as part of the study, while quality of life was significantly predicted by self-rated general health, and pain intensity, depression, and disability scores. Conclusions Our results contribute to understanding the economics of low back- related leg pain and sciatica and may provide guidance for future actions on cost reduction and health care improvement strategies. Trial registration 13/09/2011 Retrospectively registered; ISRCTN62880786. Electronic supplementary material The online version of this article (10.1186/s12913-019-4257-0) contains supplementary material, which is available to authorized users.

Background Back pain is a common and costly health problem worldwide. There is yet a lack of consistent methodologies to estimate the economic burden of back pain to society. Objective To systematically evaluate the methodologies used in the published cost of illness (COI) literature for estimating the direct and indirect costs attributed to back pain, and to present a summary of the estimated cost burden. Methods Six electronic databases were searched to identify COI studies of back pain published in English up to February 2021. A total of 1,588 abstracts were screened, and 55 full-text studies were subsequently reviewed. After applying the inclusion criteria, 45 studies pertaining to the direct and indirect costs of back pain were analysed. Results The studies reported data on 15 industrialised countries. The national cost estimates of back pain in 2015 USD ranged from $259 million ($29.1 per capita) in Sweden to $71.6 billion ($868.4 per capita) in Germany. There was high heterogeneity among the studies in terms of the methodologies used for analysis and the resulting costs reported. Most of the studies assessed costs from a societal perspective (n = 29). The magnitude and accuracy of the reported costs were influenced by the case definition of back pain, the source of data used, the cost components included and the analysis method. Among the studies that provided both direct and indirect cost estimates (n = 15), indirect costs resulting from lost or reduced work productivity far outweighed the direct costs. Conclusion Back pain imposes substantial economic burden on society. This review demonstrated that existing published COI studies of back pain used heterogeneous approaches reflecting a lack of consensus on methodology. A standardised methodological approach is required to increase credibility of the findings of COI studies and improve comparison of estimates across studies.

Background Osteoarthritis (OA) is the most common long-term condition managed in UK general practice. However, care is suboptimal despite evidence that primary care and community-based interventions can reduce OA pain and disability. Objectives The overall aim was to improve primary care management of OA and the health of patients with OA. Four parallel linked workstreams aimed to (1) develop a health economic decision model for estimating the potential for cost-effective delivery of primary care OA interventions to improve population health, (2) develop and evaluate new health-care models for delivery of core treatments and support for self-management among primary care consulters with OA, and to investigate prioritisation and implementation of OA care among the public, patients, doctors, health-care professionals and NHS trusts, (3) determine the effectiveness of strategies to optimise specific components of core OA treatment using the example of exercise and (4) investigate the effect of interventions to tackle barriers to core OA treatment, using the example of comorbid anxiety and depression in persons with OA. Data sources The North Staffordshire Osteoarthritis Project database, held by Keele University, was the source of data for secondary analyses in workstream 1. Methods Workstream 1 used meta-analysis and synthesis of published evidence about effectiveness of primary care treatments, combined with secondary analysis of existing longitudinal population-based cohort data, to identify predictors of poor long-term outcome (prognostic factors) and design a health economic decision model to estimate cost-effectiveness of different hypothetical strategies for implementing optimal primary care for patients with OA. Workstream 2 used mixed methods to (1) develop and test a ‘model OA consultation’ for primary care health-care professionals (qualitative interviews, consensus, training and evaluation) and (2) evaluate the combined effect of a computerised ‘pop-up’ guideline for general practitioners (GPs) in the consultation and implementing the model OA consultation on practice and patient outcomes (parallel group intervention study). Workstream 3 developed and investigated in a randomised controlled trial (RCT) how to optimise the effect of exercise in persons with knee OA by tailoring it to the individual and improving adherence. Workstream 4 developed and investigated in a cluster RCT the extent to which screening patients for comorbid anxiety and depression can improve OA outcomes. Public and patient involvement included proposal development, project steering and analysis. An OA forum involved public, patient, health professional, social care and researcher representatives to debate the results and formulate proposals for wider implementation and dissemination. Results This programme provides evidence (1) that economic modelling can be used in OA to extrapolate findings of cost-effectiveness beyond the short-term outcomes of clinical trials, (2) about ways of implementing support for self-management and models of optimal primary care informed by National Institute for Health and Care Excellence recommendations, including the beneficial effects of training in a model OA consultation on GP behaviour and of pop-up screens in GP consultations on the quality of prescribing, (3) against adding enhanced interventions to current effective physiotherapy-led exercise for knee OA and (4) against screening for anxiety and depression in patients with musculoskeletal pain as an addition to current best practice for OA. Conclusions Implementation of evidence-based care for patients with OA is feasible in general practice and has an immediate impact on improving the quality of care delivered to patients. However, improved levels of quality of care, changes to current best practice physiotherapy and successful introduction of psychological screening, as achieved by this programme, did not substantially reduce patients’ pain and disability. This poses important challenges for clinical practice and OA research. Limitations The key limitation in this work is the lack of improvement in patient-reported pain and disability despite clear evidence of enhanced delivery of evidence-based care. Future work recommendations (1) New thinking and research is needed into the achievable and desirable long-term goals of care for people with OA, (2) continuing investigation into the resources needed to properly implement clinical guidelines for management of OA as a long-term condition, such as regular monitoring to maintain exercise and physical activity and (3) new research to identify subgroups of patients with OA as a basis for stratified primary care including (i) those with good prognosis who can self-manage with minimal investigation or specialist treatment, (ii) those who will respond to, and benefit from, specific interventions in primary care, such as physiotherapy-led exercise, and (iii) develop research into effective identification and treatment of clinically important anxiety and depression in patients with OA and into the effects of pain management on psychological outcomes in patients with OA. Trial registration Current Controlled Trials ISRCTN06984617, ISRCTN93634563 and ISRCTN40721988. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research Programme and will be published in full in Programme Grants for Applied Research Programme; Vol. 6, No. 4. See the NIHR Journals Library website for further project information.

Objectives Evidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA. Methods A trial-based cost–utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective. Results The UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £−62.10 to £562.60; TEA-UC: £141.80, 95% CI: £−135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: −0.015, 95% CI: −0.057 to 0.026; TEA-UC: −0.003, 95% CI: −0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability

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 (GP) with musculoskeletal pain, were employed and struggling at work or absent from work

Introduction Around 17% of general practitioner (GP) consultations are for musculoskeletal conditions, which will rise as the population ages. Patient direct access to physiotherapy provides one solution, yet adoption in the National Health Service (NHS) has been slow. Setting A pilot, pragmatic, non-inferiority, cluster randomised controlled trial (RCT) in general practice and physiotherapy services in the UK. Objectives Investigate feasibility of a main RCT. Participants Adult patients registered in participating practices and consulting with a musculoskeletal problem. Interventions 4 general practices (clusters) randomised to provide GP-led care as usual or the addition of a patient direct access to physiotherapy pathway. Outcomes Process outcomes and exploratory analyses of clinical and cost outcomes. Data collection Participant-level data were collected via questionnaires at identification, 2, 6 and 12 months and through medical records. Blinding The study statistician and research nurses were blinded to practice allocation. Results Of 2696 patients invited to complete study questionnaires, 978 participated (intervention group n=425, control arm n=553) and were analysed. Participant recruitment was completed in 6 months. Follow-up rates were 78% (6 months) and 71% (12 months). No evidence of selection bias was observed. The direct access pathway was used by 90% of patients in intervention practices needing physiotherapy. Some increase in referrals to physiotherapy occurred from one practice, although waiting times for physiotherapy did not increase (28 days before, 26 days after introduction of direct access). No safety issues were identified. Clinical and cost outcomes were similar in both groups. Exploratory estimates of between group effect (using 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS)) at 6 months was −0.28 (95% CI −1.35 to 0.79) and at 12 months 0.12 (95% CI −1.27 to 1.51). Conclusions A full RCT is feasible and will provide trial evidence about the clinical and cost-effectiveness of patient direct access to physiotherapy. Trial registration number ISRCTN23378642.

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.

Background Low 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. Methods This 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. Results One 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. Conclusions A full RCT is feasible and would provide evidence about the effectiveness of acupuncture and inform treatment choices for women with pregnancy-related LBP. Trial registration ISRCTN49955124

BackgroundMany pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness.ObjectivesTo assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain.DesignPhase 1: a questionnaire survey described current care for pregnancy-related back pain. Focus groups and interviews with midwives, physiotherapists and pregnant women explored acceptability and feasibility of acupuncture and the proposed RCT. Phase 2: a single-centre pilot RCT. Participants were identified using six methods and randomised to SC, SC plus true acupuncture or SC plus non-penetrating acupuncture.ParticipantsPhase 1: 1093 physiotherapists were surveyed and 15 midwives, 21 physiotherapists and 17 pregnant women participated in five focus groups and 20 individual interviews. Phase 2: 125 women with pregnancy-related back pain participated.InterventionsSC: a self-management booklet and onward referral for one-to-one physiotherapy (two to four sessions) for those who needed it. SC plus true acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising true (penetrating) acupuncture, advice and exercise. SC plus non-penetrating acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising non-penetrating acupuncture, advice and exercise.Main outcome measuresPilot RCT outcomes included recruitment rates, treatment fidelity, follow-up rate, patient-reported pain and function, quality of life and health-care resource use. Birth and neonatal outcomes were also assessed. Staff overseeing outcome data collection were blind to treatment allocation.ResultsPhase 1: 629 (57.5%) physiotherapists responded to the survey, 499 were experienced in treating pregnancy-related back pain and reported 16 advice and 18 treatment options. Typical treatment comprised two to four individual sessions of advice and exercise over 6 weeks. Acupuncture was reported by 24%. Interviews highlighted the impact of back pain and paucity of effective interventions. Women and midwives strongly supported a RCT and expressed few concerns. Physiotherapists’ concerns about acupuncture in pregnancy informed a training programme prior to the pilot RCT. Phase 2: We recruited 125 of 280 potentially eligible women (45%) in 6 months and randomised 41 to SC and 42 each to the SC plus true acupuncture and SC plus non-penetrating acupuncture arms. Analysis was conducted with 124 participants (41, 42 and 41, respectively) as one participant was randomised in error. Three of six recruitment methods were the most successful. In total, 10% of women (n = 4) randomised to SC alone accessed one-to-one physiotherapy and received an average of two treatments. The average number of treatments was six for both SC plus true acupuncture and SC plus non-penetrating acupuncture. Treatments were in line with protocols. Eight-week follow-up was 74%. Patient-reported outcomes (pain, function and quality of life) favoured the addition of acupuncture. There was no evidence of serious adverse events on mothers or birth and neonatal outcomes. The Pelvic Girdle Questionnaire was found to be an appropriate outcome measure for a future trial.ConclusionsA future main RCT is feasible and would be welcomed by women and clinicians. Longer-term follow-up and further follow-up efforts are recommended for a main trial.Trial registrationCurrent Controlled Trials ISRCTN49955124.FundingThis project was funded by the National Institute of Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 33. See the NIHR Journals Library website for further project information.

Background Exercise for osteoarthritis (OA) is recommended as a core treatment but we currently don9t know whether changing the characteristics of exercise improves patients9 outcomes. Objectives To determine whether altering physiotherapy-led exercise programmes can improve outcomes for older adults with knee OA. Methods The BEEP trial was a randomised controlled trial (ISRCTN93634563) investigating the effectiveness of two physiotherapy-led exercise interventions compared with Usual Physiotherapy Care (UPC), for pain and function in older adults with knee pain. 65 general practices and 5 NHS physiotherapy services recruited adults aged ≥45 years with knee OA who were randomised to 1 of 3 interventions. These included: UPC, up to 4 sessions of advice and exercise over 12 weeks; Individually Tailored Exercise (ITE), an individualised, supervised and progressed lower limb exercise programme in 6 to 8 sessions over 12 weeks; or Targeted Exercise Adherence (TEA), transitioning from lower limb exercise to general physical activity in 8 to 10 contacts over 6 months. 47 physiotherapists delivered the interventions; 15 UPC, 17 ITE and 15 TEA. Primary outcomes were pain and function measured by the WOMAC at 6 months. A range of secondary outcomes was measured at 0, 3, 6, 9 and 18 months. An economic evaluation was conducted at 18 months using data collected on quality-adjusted life years (QALYs) and knee OA related resource use. Blinding of participants and physiotherapists wasn9t possible, but data collection and analyses were conducted blind to allocation. Analysis was by intention-to-treat Results 514 adults with knee OA were randomised and 87% provided primary outcome data at 6 months. There were no clinically or statistically significant differences between groups at 6 months (UPC mean (SD) WOMAC pain 6.4 (4.0) and function 21.4 (14.1); ITE pain 6.4 (4.0) and function 22.3 (13.7); TEA pain 6.2 (3.8) and function 21.5 (13.2)) or at any other time-point. On average, all participants improved during treatment and the benefits of treatment were fairly stable over 18 months. At 6 months, 50%, 51% and 55% were categorised as treatment responders in UPC, ITE and TEA respectively. Self-reported exercise adherence was high at 3 months in all groups (UC 75%, ITE 81%, TEA 81%) but remained higher for longer in the TEA group at 6 months (UPC 55%, ITE 68% and TEA 77%). The economic evaluation suggested that UPC was the most cost-effective intervention with lower costs (UPC £383, ITE £656, TEA £524) and higher QALYs (UPC 1.035, ITE 1.020, TEA 1.032). Conclusions Changing the characteristics of exercise programmes for older adults with knee OA did not improve pain and function compared to UPC. UPC was found to be cost-effective and should be an attractive option to policy-makers. Clearer identification of those who respond to exercise, rather than changing the characteristics of exercise programmes, is needed in future research. Acknowledgements This paper presents independent research funded by the National Institute for Health Research (NIHR) (Number: RP-PG-0407-10386) and an NIHR Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Disclosure of Interest None declared