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1.  Validation of the German version of the STarT-Back Tool (STarT-G): a cohort study with patients from primary care practices 
Current research emphasizes the high prevalence and costs of low back pain (LBP). The STarT Back Tool was designed to support primary care decision making for treatment by helping to determine the treatment prognosis of patients with non-specific low back pain. The German version is the STarT-G. The cross-cultural translation of the tool followed a structured and widely accepted process but to date it was only partially validated with a small sample.
The aim of the study was to test the psychometric properties construct validity, discriminative ability, internal consistency and test-retest-reliability of the STarT-G and to compare them with values given for the original English version.
A consecutive cohort study with a two-week retest was conducted among patients with non-specific LBP, aged 18 to 60 years, from primary care practices. Questionnaires were collected before the first consultation, and two weeks later by post, using the following reference standards: the Roland and Morris disability questionnaire, the Tampa Scale of Kinesiophobia, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale. Psychometric properties examined included the tool’s discriminative abilities, whether the psychosocial subscale was one factor, internal consistency, item redundancy, test-retest reliability and floor and ceiling effects.
There were 228 patients recruited with a mean age of 42.2 (SD 11.0) years, and 53 % were female. The areas under the curve (AUC) for discriminative ability ranged from 0.70 (STarT-G Subscale - Pain Catastrophizing Scale; CI95 0.63, 0.78) to 0.77 (STarT-G Total - Composite reference standard, CI95 0.60, 0.94). Factor loadings ranged from 0.49 to 0.74. Cronbach’s alpha testing the internal consistency and redundancy for the total/subscale scores were α = 0.52/0.55 respectively. The STarT-G test-retest reliability Kappa values for the total/subscale scores were 0.67/0.68 respectively. No floor or ceiling effects were present.
The STarT-G shows acceptable psychometric properties although not in exact agreement with the original English version. The items previously regarded as a psychosocial subscale may be better seen as an index of different individual psychosocial constructs. The relevance of using the tool at the point of consultation should be further examined.
PMCID: PMC4642614  PMID: 26559635
Low back pain; Questionnaire; Psychosocial factors; Therapy prognosis
2.  Using an internet intervention to support self-management of low back pain in primary care: protocol for a randomised controlled feasibility trial (SupportBack) 
BMJ Open  2015;5(9):e009524.
Low back pain (LBP) is a prevalent and costly condition. The majority of patients experiencing LBP are managed in primary care, where first-line care recommendations consist of advice to self-manage and remain active. Internet interventions present a potential means of providing patients with tailored self-management advice and evidence-based support for increasing physical activity.
This protocol describes a single-blind, randomised controlled feasibility trial of an internet intervention developed to support the self-management of LBP in primary care. Patients are being randomised to 1 of 3 groups receiving either usual primary care, usual primary care with the addition of an internet intervention or an internet intervention with physiotherapist telephone support. Patients are followed up at 3 months. Primary outcomes are the feasibility of (1) the trial design/methods, (2) the delivery of the internet intervention and (3) the provision of telephone support by physiotherapists. Secondary outcomes will include exploratory analysis of estimates and variation in clinical outcomes of pain and disability, in order to inform a future main trial.
This feasibility trial has undergone ethical scrutiny and been approved by the National Health Service (NHS) Research Ethics Committee, REC Reference 13/SC/0202. The feasibility findings will be disseminated to the research community through presentations at conferences and publication in peer review journals. Broader dissemination will come following a definitive trial.
Trial registration number
ISRCTN 31034004.
PMCID: PMC4593135  PMID: 26399575
3.  General Practitioners Views of Implementing a Stratified Treatment Approach for Low Back Pain in Germany: A Qualitative Study 
PLoS ONE  2015;10(8):e0136119.
Background and Objective
The STarT Back stratified primary care approach has demonstrated clinical and cost effectiveness in the UK, and is commonly used by General Practitioners (GPs). However, it remains unknown how this approach could be implemented into the German healthcare system. The aim of this study was therefore to explore the views and perceptions of German GPs in respect to using a stratified primary care for low back pain (LBP).
A 90-minute think-tank workshop was conducted with 14 male and five female GPs, during which the STarT-Back-Screening-Tool (SBST) and related research evidence was presented. This was followed by two focus groups, based on a semi-structured interview guideline to identify potential implementation barriers and opportunities. Discussions were audiotaped, transcribed and coded using a content analysis approach.
For the three deductively developed main themes, 15 subthemes emerged: (1) application of the SBST, with the following subthemes: which health profession should administer it, patients known to the GP practice, the reason for the GP consultation, scoring the tool, the tool format, and the anticipated impact on GP practice; (2) psychologically informed physiotherapy, with subthemes including: provision by a physiotherapist, anticipated impact, the skills of physiotherapists, management of patients with severe psychosocial problems, referral and remuneration; (3) the management of low-risk patients, with subthemes including: concern about the appropriate advising health professional, information and media, length of consultation, and local exercise venues.
The attitudes of GPs towards stratified primary care for LBP indicated positive support for pilot-testing in Germany. However, there were mixed reactions to the ability of German physiotherapists to manage high-risk patients and handle their complex clinical needs. GPs also mentioned practical difficulties in providing extended advice to low-risk patients, which nevertheless could be addressed by involvement of specifically trained medical assistants.
PMCID: PMC4554726  PMID: 26322985
4.  German Translation and Cross-Cultural Adaptation of the STarT Back Screening Tool 
PLoS ONE  2015;10(7):e0132068.
Although evidence based treatment approaches for acute low back pain are available, the prevention of persistent disabling symptoms remains a challenge. Subgroup targeted treatment using adequate screening tools may be a key component for the development of new treatment concepts and is demonstrating promising early evidence. The Keele STarT Back Screening Tool is a practical instrument, developed to stratify patients with back pain according to their risk of persistent disabling symptoms. The aim of this study was to translate and cross-culturally adapt the STarT tool into German (STarT-G) and to investigate its psychometric properties.
The translation was performed according to internationally accepted guidelines and pretested to assess face validity among patients. Psychometric testing was then performed within a cross-sectional cohort of adult patients attending physiotherapy practices for back pain. Patients completed a booklet containing STarT-G and 5 reference standard questionnaires. Measurement properties of the STarT-G were explored including construct validity, floor and ceiling effects, and discriminative abilities.
The pretests (n=25) showed good face validity including strong comprehension and acceptability of the STarT-G with only item 5 (fear avoidance) manifesting some ambiguities. The questionnaires were sent to 74 and completed by 50 patients (68%) of whom mean age was 46 (SD 14.5) years and 52% were male. Spearman’s rank correlations for construct validity ranged from 0.35 to 0.56. AUCs for discriminative ability ranged from 0.79 to 0.91. Neither floor nor ceiling effects were observed. There were 28 (57%) participants defined as low risk, 17 (35%) as medium risk, and 4 (8%) as high risk.
STarT-G is linguistically valid for German speaking countries. For the selected population, the correlations indicate acceptable validity and AUC showed satisfying discrimination. Data for psychometric properties have to be confirmed in a large scale study with a representative sample.
PMCID: PMC4498888  PMID: 26161669
5.  Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM) 
PLoS ONE  2015;10(4):e0124557.
To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders.
Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425).
The consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice.
We have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings.
PMCID: PMC4415910  PMID: 25928807
6.  Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial 
Lancet  2011;378(9802):1560-1571.
Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control).
1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406.
851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06–2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25–1·86]), equating to effect sizes of 0·32 (0·19–0·45) and 0·19 (0·04–0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group.
The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care.
Arthritis Research UK.
PMCID: PMC3208163  PMID: 21963002
7.  The predictive and external validity of the STarT Back Tool in Danish primary care 
European Spine Journal  2013;22(8):1859-1867.
The STarT Back Tool (SBT) was recently translated into Danish and its concurrent validity described. This study tested the predictive validity of the Danish SBT.
Danish primary care patients (n = 344) were compared to a UK cohort. SBT subgroup validity for predicting high activity limitation at 3 months’ follow-up was assessed using descriptive proportions, relative risks, AUC and odds ratios.
The SBT had a statistically similar predictive ability in Danish primary care as in UK primary care. Unadjusted relative risks for poor clinical outcome on activity limitation in the Danish cohort were 2.4 (1.7–3.4) for the medium-risk subgroup and 2.8 (1.8–3.8) for the high-risk subgroup versus 3.1 (2.5–3.9) and 4.5 (3.6–5.6) for the UK cohort. Adjusting for confounders appeared to explain the lower predictive ability of the Danish high-risk group.
The Danish SBT distinguished between low- and medium-risk subgroups with a similar predictive ability of the UK SBT. That distinction is useful information for informing patients about their expected prognosis and may help guiding clinicians’ choice of treatment. However, cross-cultural differences in the SBT psychosocial subscale may reduce the predictive ability of the high-risk subgroup in Danish primary care.
PMCID: PMC3731474  PMID: 23397189
Classification; Predictive value of tests; Validation; Low back pain; STarT Back Tool
8.  Translation validation of a new back pain screening questionnaire (the STarT Back Screening Tool) in French 
Archives of Public Health  2012;70(1):12.
Low back pain (LBP) is a major public health problem and the identification of individuals at risk of persistent LBP poses substantial challenges to clinical management. The STarT Back questionnaire is a validated nine-item patient self-report questionnaire that classifies patients with LBP at low, medium or high-risk of poor prognosis for persistent non-specific LBP. The objective of this study was to translate and cross-culturally adapt the English version of the STarT Back questionnaire into French.
The translation was performed using best practice translation guidelines. The following phases were performed: contact with the STarT Back questionnaire developers, initial translations (English into French), synthesis, back translations, expert committee review, test of the pre-final version on 44 individuals with LBP, final version.
The linguistic translation required minor semantic alterations. The participants interviewed indicated that all items of the questionnaire were globally clear and comprehensible. However, 6 subjects (14%) wondered if two questions were related to back pain or general health. After discussion within the expert committee and with the developer of the STarT Back tool, it was decided to modify the questionnaire and to add a reference to back pain in these two questions.
The French version of the STarT Back questionnaire has been shown to be comprehensible and adapted to the French speaking general population. Investigations are now required to test the psychometric properties (reliability, internal and external validity, responsiveness) of this translated version of the questionnaire.
PMCID: PMC3436683  PMID: 22958224
Low back pain; Questionnaire; Translation
9.  Targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281) 
Family Practice  2011;29(1):50-62.
Background. The IMPaCT Back study (IMplementation to improve Patient Care through Targeted treatment for Back pain) is a quality improvement study which aims to investigate the effects of introducing and supporting a subgrouping for targeted treatment system for patients with low back pain (LBP) in primary care. This paper details the subgrouping for targeted treatment system and the clinical training and mentoring programmes aimed at equipping clinicians to deliver it.
The subgrouping and targeted treatment system. This system differs from ‘one-size fits all’ usual practice as it suggests that first contact health care practitioners should systematically allocate LBP patients to one of the three subgroups according to key modifiable prognostic indicators for chronicity. Patients in each subgroup (those at low, medium or high risk of chronicity) are then managed according to a targeted treatment system of increasing complexity.
The subgrouping tools. Subgrouping tools help guide clinical decision-making about treatment and onward referral. Two subgrouping tools have been used in the IMPaCT Back study, a 9-item version used by participating physiotherapists and a 6-item version used by GPs.
The targeted treatments. The targeted treatments include a minimal intervention delivered by GPs (for those patients at low risk of poor outcome) or referral to primary care physiotherapists who can apply physiotherapy approaches to addressing pain and disability (for those at medium risk) and additional cognitive-behavioural approaches to help address psychological and social obstacles to recovery (for those at high risk).
The training packages. Building on previous interventions for other pilot studies and randomized trials, we have developed and delivered clinical training and support programmes for GPs and physiotherapists.
Discussion. This paper describes in detail the IMPaCT Back study’s subgrouping for targeted treatment system and the training and mentoring packages aimed at equipping clinicians to deliver it, within the IMPaCT Back study.
Study registration. ISRCTN55174281.
PMCID: PMC3261797  PMID: 21708984
Implementation; low back pain; primary care; subgrouping; targeted treatment
10.  The relationship between patient and practitioner expectations and preferences and clinical outcomes in a trial of exercise and acupuncture for knee osteoarthritis 
We investigated the relationship between patient and therapist preferences and expectations and clinical outcomes in a trial of exercise and acupuncture for clinical knee osteoarthritis.
352 Patients were randomised to advice and exercise or advice and exercise plus true or non-penetrating acupuncture. Before randomisation, patients recorded their general outcome expectations, treatment-specific preferences and expectations. Clinical outcome was (a) change scores on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and (b) treatment response according to the OMERACT-OARSI criteria. Physiotherapists recorded their treatment expectations and preferences for each patient following an assessment prior to randomisation. We investigated the relationship between (a) patient, (b) therapist and (c) matched patient–therapist preferences and expectations on clinical outcomes using univariate and multivariate analyses.
There was no significant relationship between patients’ treatment preferences and clinical outcomes at 6 or 12 months nor between patients’ expectations and pain (WOMAC) at 6 or 12 months. Using our secondary outcome (OMERART-OARSI), those who received the treatment for which they had high expectations of benefit were almost twice as likely to be classified as a treatment responder at 6 months (odds ratio (OR) 1.7 (95% Confidence Interval 1.06, 2.79)) and 12 months (OR) 1.9 (1.13, 3.13). Therapists’ preferences and expectations for individual patients did not add further explanation of outcomes.
There was no evidence of a relationship between patients’ treatment preferences or expectations and pain reduction. We found weak evidence, from secondary outcomes, that patients’ expectations, both general and treatment-specific, are related to clinical outcome from exercise and acupuncture.
PMCID: PMC2856919  PMID: 19665403
Preference; Expectation; Physiotherapy; Acupuncture; Exercise
11.  Subgrouping low back pain: A comparison of the STarT Back Tool with the Örebro Musculoskeletal Pain Screening Questionnaire 
Clinicians require brief, practical tools to help identify low back pain (LBP) subgroups requiring early, targeted secondary prevention. The STarT Back Tool (SBT) was recently validated to subgroup LBP patients into early treatment pathways.
To test the SBT’s concurrent validity against an existing, popular LBP subgrouping tool, the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ), and to compare the clinical characteristics of subgroups identified by each tool.
Two hundred and forty-four consecutive ‘non-specific’ LBP consulters at 8 UK GP practices aged 18–59 years were invited to complete a questionnaire. Measures included the ÖMPSQ and SBT, disability, fear, catastrophising, pain intensity, episode duration and demographics. Instruments were compared using Spearman’s correlations, tests for subgroup agreement and discriminant analysis of subgroup characteristics according to reference standards.
Completed SBT (9-items) and ÖMPSQ (24-items) data was available for 130/244 patients (53%). The correlation of SBT and ÖMPSQ scores was ‘excellent (rs = 0.80). Subgroup characteristics were similar across the low, medium and high subgroups, but, the proportions allocated to ‘low’, ‘medium’ and ‘high’ risk groups were different, with fewer patients in the SBT’s high risk group. Both instruments similarly discriminated for reference standards such as disability, catastrophising, fear, comorbid pain and time off work. The ÖMPSQ was better at discriminating pain intensity, while the SBT was better for discriminating bothersomeness of back pain and referred leg pain.
The SBT baseline psychometrics performed similarly to the ÖMPSQ, but the SBT is shorter and easier to score and is an appropriate alternative for identifying high risk LBP patients in primary care.
PMCID: PMC2809923  PMID: 19223271
Low back pain; Classification; Primary care; Early identification; Psychological factors
12.  A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol 
Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain.
We will recruit 800 participants aged 18 years and over with non-specific low back pain from 8–10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care.
This paper presents detail on the rationale, design, methods and operational aspects of the trial.
Trial registration
Current Controlled Trials ISRCTN37113406.
PMCID: PMC2377248  PMID: 18430242
13.  Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial 
BMJ : British Medical Journal  2007;335(7617):436.
Objective To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee.
Design Multicentre, randomised controlled trial.
Setting 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom.
Participants 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis.
Interventions Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119).
Main outcome measures The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months.
Results Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval −1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (−0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture.
Conclusion The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects.
Trial registration Current Controlled Trials ISRCTN88597683.
PMCID: PMC1962890  PMID: 17699546

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