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Study Protocol

Describing the characteristics, treatment pathways, outcomes, and costs of people with persistent noncancer pain managed by community pain clinics and generating an indicative estimate of cost-effectiveness: feasibility study protocol

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Pages 237-245 | Published online: 18 May 2016

Abstract

Background

Low back pain (LBP) and fibromyalgia (FM), also known as chronic widespread pain (CWP), are highly prevalent chronic painful conditions that have substantial impact on patients, health care systems, and society. Diagnosis is complex and management strategies are associated with various levels of evidence for effectiveness and cost-effectiveness. Multidisciplinary pain services have been shown to be effective in some settings and therefore are recommended by clinical practice guidelines as a rational treatment option to manage these patients. Knowing that these services are resource intensive, evidence is needed to demonstrate their cost-effectiveness. This study aims to describe the management of patients with LBP and FM in two community pain clinics to derive an indicative estimate of cost-effectiveness compared with standard practice.

Methods

This is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. Newly referred patients with LBP and FM who provide written consent will be included. We will collect data on functional disability, pain intensity, quality of life, and health resource utilization. Follow-up data at the 3- and 6-month points will be collected by patient-completed questionnaires and health care contact diaries. Health care resource use from diaries will be compared with patient electronic records to assess the agreement between these recording methods. Patient cohort characteristics, treatment pathways, resource use, and outcomes derived from this study will be integrated in a decision analysis model to assess the cost-effectiveness of community pain clinics compared with standard care. This feasibility study will address key methodological issues such as sample estimates and retention rate to inform the design of a future randomized controlled trial.

Introduction

Low back pain (LBP) and fibromyalgia (FM), which is also known as chronic widespread pain (CWP), are highly prevalent worldwide,Citation1,Citation2 affecting 9.4% and 2.7% of the general population, respectively.Citation3,Citation4 Both conditions have substantial effects on physical function, psychological well-being, and quality of life.Citation5Citation10 According to the global burden of disease study in 2010,Citation11 back pain was the leading cause of years lived with disability and the third leading cause of disability adjusted life years (DALYs) after ischemic heart disease and chronic obstructive pulmonary disease.

The economic burden of both conditions is also substantial. People with these conditions are regarded as great utilizers of health care resources.Citation12Citation15 Recently, it has been reported that health resource utilization such as prescriptions and visits for patients with back pain and FM were double those of the matched controls.Citation14,Citation15 In the United Kingdom,Citation15 primary care consultations and referral to secondary care for LBP accounted for 58% and 22.3% of the total health care costs for back pain, respectively. Furthermore, indirect costs to society are significant, due to lower productivity and higher absenteeism.Citation16,Citation17

Managing these conditions is challenging due to many factors. First, the etiology is complex and not specific.Citation18Citation20 Also, they can be exacerbated by a wide range of sociodemographic and psychosocial factors such as illness behavior beliefs and distress.Citation18,Citation21,Citation22 Therefore, no single treatment is adequate to control all symptoms.

In order to manage pain within a biopsychosocial framework, which addresses pain as a dynamic interaction between physiological, social, and psychological elements, a multidisciplinary management approach is recommended by national and international guidelines.Citation21,Citation23Citation25 Effectiveness of the multidisciplinary management approach has been widely investigated in LBP and FM.

In LBP, a systematic review of randomized controlled trials suggested that multidisciplinary pain services are more effective than standard care (SC) in reducing functional disability using the Roland Morris Disability (RMD) score (standardized mean difference [SMD]: 0.23, 95% confidence interval [CI]: 0.06–0.4) and pain intensity using visual analogue scale (VAS) (SMD: 0.21, 95% CI: 0.04–0.37).Citation26 In 2008, results from a systematic review indicated that multidisciplinary pain services were better than standard medical treatment in FM.Citation27 However, results are inconclusive due to the great variability of the interventions, outcomes, and study durations. The major limitation with these systematic reviews is that the methodological quality of most studies included was low.

Given that multidisciplinary pain services are resource intensive;Citation28,Citation29 evidence is needed to demonstrate the cost-effectiveness of these services in LBP and FM. A small number of cost-effectiveness studies have been undertaken in Europe and the USA,Citation30Citation40 others are still in progress in Spain and the Netherlands.Citation41,Citation42 These studies were conducted alongside clinical trials; however, they have methodological limitations in study design. Compliance to treatment was either inadequateCitation32,Citation33,Citation35,Citation36,Citation38Citation40 or not clearly reported.Citation30,Citation31,Citation37 Moreover, some aspects of treatments/sessions did not appear to be equally used by all participants.Citation32,Citation34,Citation36,Citation38 Therefore, the effect cannot be directly attributed to multidisciplinary pain service.

In addition, threats to external validity may impede the application of the results to real practice.Citation43 These threats come from restrictive patient eligibility criteria such as employees,Citation30,Citation33 recruiting from various practice settings, ie, primary and secondary care setting, and variability of intervention. This variability is either between intervention in terms of treatment components and health care staff or between study participants.

Among these studies, a wide range of comparators were used such as surgeryCitation36,Citation37 physiotherapy/exercise,Citation32,Citation39,Citation40 and cognitive behavioral therapy.Citation32,Citation34,Citation39,Citation40 Six studies compared multidisciplinary pain service with usual care.Citation30,Citation31,Citation33,Citation38Citation40 The definition of usual care varies according to the country and study context, this will also limit the applicability of results. Therefore, results about the cost-effectiveness of these services have been inconclusive because of the variety of interventions, participants, and outcome measures.

Community pain clinic in Nottingham

The project will take place in two community pain clinics (CPC) in Nottingham, UK. These two clinics are operated by the same clinic staff, therefore, the type and quality of health care provided are the same in both clinics. Patients may have consultations with members of the multidisciplinary team (including a pain consultant, a physiotherapist, a biopsychosocial practitioner, and a nurse) for supported self-care management, or community services such as physiotherapy, or more specialist secondary care services. The community pain clinic facilitates access to a wide range of diagnostic and treatment pathways such as MRI, rehabilitation programs, and minor procedures such as trigger point injections. In addition, complex surgical interventions can be offered. Further details on the community pain clinic in Nottingham can be found in the review by Hobbs and Knaggs.Citation44

LBP and FM represent the majority of patients referred to the clinic, therefore these conditions will be the main focus of this study.

Before establishing the CPC, patients with LBP and FM were treated initially by their GPs. If treatment failed to improve patients’ outcomes, then referrals to secondary care may have been considered. This SC pathway may lead to increased rates of development of chronic pain due to the delay in diagnosis and treatment and the long waiting time to be referred to secondary care.Citation45Citation47 Alongside the detrimental effects of treatment delay, there appears to be a high level of inappropriate spinal surgery unit referrals, suggesting that more targeted use of this service is needed.Citation48

Anecdotally, impressions are that patients are benefiting from the CPC and if it were expanded, patients in the locality would benefit from better pain management. However, financial constraints prevent the possibility of expanding, or even continuity, of the current service. Evidence so far suggests that multidisciplinary pain clinics can be effective, although the effectiveness of the Nottingham CPC is not known. Given that it is likely that these types of services are highly costly and require integration between health care sectors, the effectiveness, patient acceptability, and cost-effectiveness of CPCs needs to be investigated.

Electronic administrative records can be used to estimate health resource use. It reduces data recording burden for patients, and generally provides more detail about types of health care contacts. However, the data can be time-consuming to access, and may only be reliable and complete for a specific sector (eg, hospital stays are not always recorded reliably in GP recording systemsCitation49). In addition, in the management of LBP, we envisage that people will use other treatments maybe outside the NHS, such as private osteopathy and physiotherapy. Patient diaries allow us to capture that patient cost. Therefore, in this observational study, we will use both methods to capture resource use data to allow us to assess which method is more reliable for future work in this patient group.

Commissioners and decision makers need support to make decisions about service provision, so waiting for the full evaluative trial to be completed will not produce timely evidence to support decision-making. It has long been recognized that economic evaluation should be iterative, generating progressively firmer estimates of cost-effectiveness and helping to maximize the efficiency of health care research and development, while still allowing the best evidence available at any one time to support decision-making.Citation50 Therefore an indicative economic evaluation will be carried out to compare the cost-effectiveness of CPC and SC in managing LBP and FM using published estimates of effectiveness and cost.

The paucity of economic evaluations of multidisciplinary pain management services and the variable levels of evidence underpinning the effectiveness of these services suggest that cost-effectiveness studies need be conducted before this model of care is more widely implemented. Therefore, the aim of this study is to carry out an evaluation of the CPC in Nottingham to inform decision-makers and commissioners about the effectiveness and cost-effectiveness of this service and, therefore, allocating resources in an efficient manner.

Specific objectives are to:

  1. Describe the demographic characteristics of patients with LBP and FM and their treatment pathway in the CPC.

  2. Determine clinical outcomes and health care costs of the CPC using patient reported outcome measures and routinely recorded health care resource use.

  3. Assess the reconciliation between patient-reported and routinely recorded health care resource use data and derive cost estimations by combining the two methods.

  4. Derive indicative estimates of cost-effectiveness of CPC compared with SC in managing LBP and FM combining data from this study with published estimates of effectiveness for multidisciplinary pain clinics and long-term costs and outcomes associated with LBP and FM.

  5. Inform the design of a future cluster randomized trial to evaluate the effectiveness and cost-effectiveness of CPC.

Methods

Study design

This is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. The study design is summarized in .

Figure 1 Overall study design.

Figure 1 Overall study design.

Study setting

The study will be conducted at the Nottinghamshire primary–secondary care interface. Newly referred patients to Nottingham West Clinical Commissioning Group and Newark and Sherwood CCGs who fit the eligibility criteria will be invited. Recruiting from two clinics will increase the number of participants, and therefore the study will be powered to detect difference in primary outcomes.

Sample size and justification

This is not an interventional study; so, a sample size is not required to derive an effect size. However, the sample obtained in this study will provide data to inform a future sample size calculation. The largest sample possible is also required to provide richer information about the patient cohort using CPC for LBP and FM.

Ethical approval

Ethical approval for the study has been obtained from North East York and East Midland-Nottingham 1 Research Ethics Committees (REC reference numbers 15/NE/0162 and 15/EM/0190).

Inclusion criteria

  1. Adults (18 years or older), attending the pain clinic for the first time and who have LBP or FM for at least 3 months.

  2. Participants will be required to have good understanding of the English language and the ability to understand study documents and provide written consent.

As this study will include patients with different disease states, the exclusion criteria for each condition is listed below:

Exclusion criteria for people with low back pain

  1. Having an underlying organic pathology for low back pain such as infection or cancer.

  2. Having had a spinal surgical procedure in the past 6 weeks or having to undergo surgery within 3 months.

  3. Having severe psychiatric disorders such as major depression or psychosis.

  4. Being pregnant or having given birth in the past 3 months.

Exclusion criteria for people with fibromyalgia

  1. Not having a confirmed diagnosis of FM.

  2. Having severe psychiatric disorders such as major depression or psychosis.

Outcome measures

Disease-specific outcome measures will be used for each disease group population. Roland Morris Disability QuestionnaireCitation51 will be used to assess the functional disability for patients with LBP and to assess the functionality of patients with FM the Revised Symptoms Impact Questionnaire (SIQR)Citation52 will be used.

Pain intensity will be measured using the short-form Brief Pain Inventory (BPI),Citation53 whereas health status will be assessed by EuroQol-5 Dimension-3 level instrument (EQ-5D-3L).Citation54 A summary of the outcome measures recorded during the study is provided in .

Table 1 Summary of collected data

Study regimen

This study will involve three main stages. For each stage, the aim, methodological features, outcome measures or data collected, and duration are described below.

Stage 1: observational study – assess the clinical outcomes and health care use in CPC

The pain clinic consultant will have the responsibility of identifying eligible patients at triage.Citation44 The initial patient approach will be from the pain clinic consultant, who will inform the participant of all aspects pertaining to participation in the study.

The questionnaires will be piloted using a small number of patients (approximately 5–10 patients) attending the two CPCs to examine the type, accuracy, and practicality of resource use data collection tools and outcome measure tools.Citation55 These patients will be included in the final analysis if no further amendments to the study design or data collection tools are made.

This pilot study will follow the same procedure of the main study in terms of identification, recruitment, and contact method. The main study will follow the procedure detailed: The pain clinic consultant will identify and invite eligible patients to take part in the study and will explain the study to the eligible patient. If the patient has initially expressed interest in being involved in the study, the consultant will provide the patient with the study information pack. The patient will be asked to provide his/her contact details by clinic staff to arrange a telephone call with the researcher within 24–72 hours to allow the patient to consider participation in the study. To maximize retention of the study participants, each patient will determine the preferred time slot of the day for researcher to contact him/her.

Within 24–72 hours of the initial patient encounter, the researcher will contact the patient to confirm the consent and answer any questions related to the study. The patient will need to sign the consent form and send it back to the researcher by post.

The patient will be asked to answer questions related to his/her baseline pain, physical function, and health status. In addition, demographic data of patients will be obtained. The researcher will contact the patient by phone to collect clinical outcome data after 3 and 6 months. Patients will be encouraged to record their health resource use using diaries. These diaries will be returned by post at 3 and 6 months.

Stage 2: assess the agreement between patients’ self-reported health resource use and medical records in CPC

This stage aims to assess health care utilization data collection methods, when resource use data are obtained from either medical records or patient self-report using a diary, by assessing the reconciliation between these two approaches and resulting cost estimations derived from the resource use data obtained. Health care resource use data from the previous stage, using patient-reported methods, will be compared with health care resource data elicited from medical records of CPC patients.

These data will be collected retrospectively for 6 months from the date of CPC referral. A data analyst will extract the data required. Data extracted will include medication use and primary and secondary health care service use; principally GP visits, emergency department visits, inpatient, outpatient attendances, and other community services (ie, physiotherapy). The data will be extracted from GP practices that use SystmOneCitation56 and EMISCitation57 to record patients’ data electronically.

Stage 3: indicative economic evaluation

Data collected from the study will be used to inform an indicative economic evaluation. Cost-effectiveness will be investigated by generating differences in costs and outcomes between SC and CPC. Published evidence on costs and outcomes for SC will be combined with outcomes and costs from the patient cohort in this study to generate mean incremental quality adjusted life years (QALY) and costs. The data will be gathered from participants for 6 months. The costs and benefits of CPC will be calculated over a 6-month period (short term). The long-term (5–10 years) costs and outcomes will be estimated using decision analysis modelling. This period will be sufficient to observe the effect of intervention on costs and outcomes;Citation58 therefore, two models will be constructed. The data sources for the two models are illustrated in .

Table 2 Data sources for economic models

The costs will be collected from health provider perspective. Intervention cost will be calculated using a “bottom–up” approach. Patients’ visits to CPC and the types of treatments received will be gathered from the medical records. Direct medical cost such as visits to GP, nurses, other health care professionals, and hospitals will be recorded in costing diary. Direct nonmedical costs such as travel expenses will be also recorded in costing diary. These diaries will be administered twice during the study (3 months period).

Direct health care costs will be obtained from the following sources: costs of treatment interventions and investigations will be derived from NHS reference costs,Citation59 costs of health staff from the Personal Social Services Research Unit (PSSRU),Citation60 and medication costs from the British National FormularyCitation61 (March–September 2015). All costs will be expressed in 2015–2016 pounds sterling. The discount will be applied in the long-term model only; we will discount effects and costs at an annual rate of 3.5%. The UK Treasury recommended 3.5% discount rate for both costs and outcomes.Citation62 In addition, different discount rates will be tested in the sensitivity analysis.

Short term

We will conduct a short-term (6 months) cost-effectiveness decision analysis model from NHS perspective. Markov model inputs will be based on the data derived from the current observational study and published literature. The short-term effect of SC on outcomes and cost will be obtained by conducting a systematic review of cost-effectiveness studies of multidisciplinary pain management services in LBP and FM.

Long term

The long-term benefit of multidisciplinary pain management services needs to be evaluated as these services are cost intensive. Moreover, little is known about the long-term effectiveness. Therefore, the model input will be based on data from published literature. Longitudinal observational studies which aim to evaluate the effectiveness and cost-effectiveness of multidisciplinary pain management services in LBP and FM will be used. The data source for the models is illustrated in .

Analyses

Stage 1: observational study

We will describe the study population and their outcomes using simple descriptive statistics, percentages for categorical, and mean and SD for continuous variables.

Changes within outcome measures over the duration of the study will be assessed using paired t-tests for continuous data and McNemar tests for dichotomous data.

Unit costs will be combined with resource-use from the two collection methods to generate two estimates of patient-level costs.

We will determine baseline factors associated with change of outcome measures or cost over the course of patient follow-up. This will be performed using multiple linear and logistic regression for continuous and binary outcome variables, respectively. P-values less than 0.05 will be considered statistically significant.

Stage 2: costing methods comparative study

Nonparametric bootstrapping will be used to compare arithmetic means of costs data.Citation63 Pairwise t-tests will be applied to the data generated by bootstrapping. Level of agreement between electronic and self-reported resource-use will be estimated by using the Lin concordance correlation coefficient,Citation64 which can be applied to nonnormally distributed data such as resource use data. The Lin coefficient value lies between 1, indicative of perfect agreement, and –1, indicative of perfect inverse agreement.

Stage 3: indicative economic evaluation

This economic study will be performed according to the intention-to-treat principles. For missing data during follow-up, we will use complete case analysis.

We will carry out incremental analysis, which is mean difference in cost between CPC and SC divided by the mean in QALY difference to generate incremental cost-effectiveness ratio (ICER). Nonparametric bootstrapping with 1,000 iterations will be used to calculate the confidence interval around the ICER and cost difference.

To assess the robustness of the results, deterministic univariate and multivariate sensitivity analyses will be performed. Probabilistic sensitivity analysis (PSA) will be undertaken for base-case scenario and univariate and multivariate analysis. Sampling incremental costs and QALY will be conducted by Monte Carlo simulation using TreeAge Pro. We will use cost-effectiveness planes and cost-effectiveness acceptability curves (CEACs) to present the results. All statistical analyses will be conducted using STATA 11.1.Citation65 TreeAge ProCitation66 will be used to build the decision analysis model.

Discussion

The major strengths in this study design are that we will use validated gold standard measures for each of these patient outcomes to assess which best reflects the success and acceptability of the service from the patient perspective. We also need to obtain detailed information on treatment pathways. This is essential to understand the nature and variability of the complex intervention. It is also needed to allow us to estimate resource use and cost, associated with managing patients by the CPC. Treatment pathway and associated resource use data can be obtained either by accessing routine medical records, or by patient report. Neither method is without its limitations. In this study, we will use both methods to capture resource use data to allow us to assess which method is more reliable for future work in this patient group.

Moreover, the choice of study design was based on the Medical Research Council (MRC) recommendation for evaluating complex intervention. Multidisciplinary pain clinics such as the Nottingham CPC are considered as “complex” interventions. This complexity is derived by the number of interacting components within the clinic and variety of intended outcomes. There are known difficulties and methodological challenges in evaluating complex interventions. The MRC published a framework which recommends evaluating the intervention through observational and developmental work, followed by an exploratory trial before conducting the definitive evaluation. This is required to identify key uncertainties in the design and assessment of the intervention and its evaluation.Citation67

Recruitment and retention rates are major limitations on any prospective study design. In this study, several data collection methods were considered, such as postal questionnaires, face-to-face interviews, and phone calls. However, there are some practical difficulties in using interviews, as patients may be referred to other health care specialists outside the clinic during the study period. For postal questionnaires, there is a risk of low response rate. Given that the study period is relatively short (6 months), telephone calls were chosen for data collection over other methods to maximize the response rate and to facilitate patient tracking. In addition, each patient will determine the preferred time slot of the day for researcher to contact him/her. If the patients did not respond to the first phone call, the researcher will contact the patient twice within 1 hour. The total number of calls will be three times, each is 20 minutes apart. Another attempt will be made on the following day in case of no response. Furthermore, the patient will be approached by letter to re-establish the contact. Participants who do not respond to phone calls after these attempts will be presumed to have withdrawn from the study and no further contact will be made.

Acknowledgments

All patient-related paperwork, which include questionnaires, diaries, patient information sheet, and the consent form have been reviewed by Antony Chuter. Mr Chuter has significant experience in providing the patient perspective to health services research projects; he was the PPI coinvestigator for an evaluation of the New Medicine Service Project and worked with the Expert Patient Program, Royal College of General Practitioners, and currently he is Chair of the Patient Liaison Committee (British Pain Society) and Chair of Pain UK.

Disclosure

SA and SA are funded by doctoral studentships from the Ministry of Higher Education in Saudi Arabia. The authors report no other conflicts of interest in this work.

References

  • KohlmannTMusculoskeletal pain in the populationSchmerz2003176405411 German14648312
  • WoolfADPflegerBBurden of major musculoskeletal conditionsBull World Health Organ200381964665614710506
  • HoyDMarchLBrooksPThe global burden of low back pain: estimates from the Global Burden of Disease 2010 studyAnn Rheum Dis201473696897424665116
  • QueirozLPWorldwide epidemiology of fibromyalgiaCurr Pain Headache Rep201317835623801009
  • YilmazFSahinFErgozEQuality of life assessments with SF-36 in different musculoskeletal diseasesClin Rheumatol200827332733217851709
  • VerbuntJAPernotDHSmeetsRJDisability and quality of life in patients with fibromyalgiaHealth Qual Life Outcomes20086814777525
  • BirtaneMUzuncaKTastekinNTunaHThe evaluation of quality of life in fibromyalgia syndrome: a comparison with rheumatoid arthritis by using SF-36 Health SurveyClin Rheumatol200726567968416897118
  • HoffmanDLDukesEMThe health status burden of people with fibromyalgia: a review of studies that assessed health status with the SF-36 or the SF-12Int J Clin Pract200862111512618039330
  • BuchbinderRBlythFMMarchLMBrooksPWoolfADHoyDGPlacing the global burden of low back pain in contextBest Pract Res Clin Rheumatol201327557558924315140
  • FroudRPattersonSEldridgeSA systematic review and meta-synthesis of the impact of low back pain on people’s livesBMC Musculoskelet Disord2014155024559519
  • MurrayCJLLopezADMeasuring the global burden of diseaseN Engl J Med2013369544845723902484
  • WolfeFAndersonJHarknessDA prospective, longitudinal, multicenter study of service utilization and costs in fibromyalgiaArthritis Rheum1997409156015709324009
  • RobinsonRLBirnbaumHGMorleyMASisitskyTGreenbergPEClaxtonAJEconomic cost and epidemiological characteristics of patients with fibromyalgia claimsJ Rheumatol20033061318132512784409
  • HughesGMartinezCMyonETaiebCWesselySThe impact of a diagnosis of fibromyalgia on health care resource use by primary care patients in the UK: an observational study based on clinical practiceArthritis Rheum200654117718316385513
  • HongJReedCNovickDHappichMCosts associated with treatment of chronic low back pain: an analysis of the UK General Practice Research DatabaseSpine2013381758223038621
  • KnightTSchaeferCChandranAZlatevaGWinkelmannAPerrotSHealth-resource use and costs associated with fibromyalgia in France, Germany, and the United StatesClinicoecon Outcomes Res2013517118023637545
  • RicciJAStewartWFCheeELeottaCFoleyKHochbergMCBack pain exacerbations and lost productive time costs in United States workersSpine197631263052306017173003
  • FourneyDRAnderssonGArnoldPMChronic low back pain: a heterogeneous condition with challenges for an evidence-based approachSpine20113621 SupplS1S921952181
  • RussellIJLarsonAANeurophysiopathogenesis of fibromyalgia syndrome: a unified hypothesisRheum Dis Clinic North Am2009352421435
  • ClauwDJArnoldLMMcCarbergBHThe science of fibromyalgiaMayo Clin Proc201186990791121878603
  • WaddellGThe Back Pain RevolutionEdinburgh, ScotlandChurchill Livingstone2004
  • WolfeFSmytheHAYunusMBThe American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria CommitteeArthritis Rheum19903321601722306288
  • SavignyPKuntzeSWatsonPLow Back Pain: Early Management of Persistent Non-Specific Low Back PainLondon, UKNational Collaborating Centre for Primary Care and Royal College of General Practitioners2009
  • CarvilleSFArendt-NielsenSBliddalHEULAR evidence-based recommendations for the management of fibromyalgia syndromeAnn Rheum Dis200867453654117644548
  • KeelPPain management strategies and team approachBaillieres Best Pract Res Clin Rheumatol199913349350610562381
  • KamperSJApeldoornATChiarottoAMultidisciplinary biopsychosocial rehabilitation for chronic low back painCochrane Database Syst Rev20149CD00096325180773
  • ScascighiniLTomaVDober-SpielmannSSprottHMultidisciplinary treatment for chronic pain: a systematic review of interventions and outcomesRheumatology (Oxford)200847567067818375406
  • GatchelRJOkifujiAEvidence-based scientific data documenting the treatment and cost-effectiveness of comprehensive pain programs for chronic nonmalignant painJ Pain200671177979317074616
  • RobinsonRLJonesMLIn search of pharmacoeconomic evaluations for fibromyalgia treatments: a reviewExpert Opin Pharmacother2006781027103916722813
  • SkouenJSGrasdalALHaldorsenEMUrsinHRelative cost-effectiveness of extensive and light multidisciplinary treatment programs versus treatment as usual for patients with chronic low back pain on long-term sick leave: randomized controlled studySpine2002279901909 discussion 909–91011979157
  • LucianoJVSabes-FigueraRCardenosaECost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trialClin J Pain201329870271123328339
  • SmeetsRJSeverensJLBeelenSVlaeyenJWKnottnerusJAMore is not always better: cost-effectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back painEur J Pain2009131718118434221
  • LambeekLCBosmansJEVan RoyenBJVan TulderMWVan MechelenWAnemaJREffect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trialBMJ2010341c641421118874
  • GoossensMERutten-van MolkenMPLeidlRMBosSGVlaeyenJWTeeken-GrubenNJCognitive-educational treatment of fibromyalgia: a randomized clinical trial. II. Economic evaluationJ Rheumatol1996237124612548823700
  • GusiNTomas-CarusPCost-utility of an 8-month aquatic training for women with fibromyalgia: a randomized controlled trialArthritis Res Ther2008101R2418294367
  • Rivero-AriasOCampbellHGrayAFairbankJFrostHWilson-MacDonaldJSurgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trialBMJ20053307502123915911536
  • JohnsenLGHellumCStorheimKCost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCTSpine2014391233224150435
  • ZijlstraTRBraakman-JansenLMTaalERaskerJJvan de LaarMACost-effectiveness of Spa treatment for fibromyalgia: general health improvement is not for freeRheumatology20074691454145917636181
  • McBethJPrescottGScotlandGCognitive behavior therapy, exercise, or both for treating chronic widespread painArch Intern Med20121721485722082706
  • BeasleyMPrescottGJScotlandGPatient-reported improvements in health are maintained 2 years after completing a short course of cognitive behaviour therapy, exercise or both treatments for chronic widespread pain: long-term results from the MUSICIAN randomised controlled trialRMD Open201511e00002626509056
  • BerengueraAPujol-RiberaERodriguez-BlancoTStudy protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trialBMC Musculoskelet Disord20111219421859489
  • LambeekLCAnemaJRvan RoyenBJMultidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness studyBMC Public Health2007725417883853
  • RamseySWillkeRBriggsAGood research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force reportValue Health20058552153316176491
  • HobbsGKnaggsRCommissioning for pain management servicesBr J Healthc Manag2011177302306
  • MellohMElferingAKaserAWhat is the best time point to identify patients at risk of developing persistent low back pain?J Back Musculoskelet Rehabil201528226727625096312
  • MellohMElferingAStantonTRLow back pain risk factors associated with persistence, recurrence and delayed presentationJ Back Musculoskelet Rehabil201427328128924284275
  • ChoyEPerrotSLeonTA patient survey of the impact of fibromyalgia and the journey to diagnosisBMC Health Serv Res20101010220420681
  • Department of HealthThe Musculoskeletal Services Framework2006 Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4138413Accessed August 18, 2015
  • ByfordSLeeseMKnappMComparison of alternative methods of collection of service use data for the economic evaluation health care interventionsHealth Econ200716553153617001749
  • SculpherMDrummondMBuxtonMThe iterative use of economic evaluation as part of the process of health technology assessmentJ Health Serv Res1997212630
  • RolandMMorrisRA study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back painSpine1983821411446222486
  • BennettRMFriendRJonesKDWardRHanBKRossRLThe Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric propertiesArthritis Res Ther2009114R12019664287
  • CleelandCSRyanKMPain assessment: global use of the Brief Pain InventoryAnn Acad Med Singapore19942321291388080219
  • EuroQol GroupEuroQol – a new facility for the measurement of health-related quality of lifeHealth Policy199016319920810109801
  • DrummondMCoyleDThe role of pilot studies in the economic evaluation of health technologiesInt J Technol Assess Health Care19981434054189780528
  • The Phoenix Partnership (TPP)SystmOne2015 Available from: http://www.tpp-uk.com/products/systmoneAccessed July 30, 2015
  • EMIS HealthEMIS2015 Available from: https://www.emishealth.com/Accessed July 30, 2015
  • ComansTRaymerMO’LearySSmithDScuffhamPCost-effectiveness of a physiotherapist-led service for orthopaedic outpatientsJ Health Serv Res Policy201419421622324819380
  • Department of HealthNHS National Schedule of Reference Costs 2012–20132013 Available from: https://www.gov.uk/government/publications/nhs-reference-costs-2012-to-2013Accessed August 18, 2015
  • Personal Social Services Research Unit (PSSRU)Unit Costs of Health and Social Care2015 Available from: http://www.pssru.ac.uk/project-pages/unit-costs/Accessed July 30, 2015
  • Joint Formulary CommitteeBritish National Formulary69th edLondon, UKBMJ Group and Pharmaceutical Press2015
  • Her Majesty’s TreasuryThe Green Book: Appraisal and Evaluation in Central Government: Treasury Guidance Great BritainLondon, UKTSO2003
  • BriggsAGrayAThe distribution of health care costs and their statistical analysis for economic evaluationJ Health Serv Res Policy19983423324510187204
  • LinLIA concordance correlation coefficient to evaluate reproducibilityBiometrics19894512552682720055
  • StataCorp LPStata Statistical Software: Release 11.1 [computer program]College Station, TXStataCorp LP2009
  • TreeAge Software, IncTreeAge Pro 2015: Release 1.0 [computer program]Williamstown, MATreeAge Software, Inc2015
  • CraigPDieppePMacintyreSMichieSNazarethIPetticrewMDeveloping and evaluating complex interventions: the new Medical Research Council guidanceBMJ2008337a165518824488