Evaluation of the EQ-5D-3L and 5L versions in low back pain patients.

BACKGROUND: The EuroQol EQ-5D is one of the most widely researched and applied patient-reported outcome measures worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). METHODS: LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). RESULTS: At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon's indices showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. CONCLUSION: The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended. TRIAL REGISTRATION: retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT01704677 .

Measurement properties for the revised patient-reported OsteoArthritis Quality Indicator questionnaire.

OBJECTIVES: To assess validity, reliability, responsiveness and interpretability of the revised OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2) assessing patient-reported quality of osteoarthritis care. METHODS: The OA-QI v2 (16 items, score range 0-100 (100 = best score)) was included in a longitudinal cohort study. Attendees of a 4.5 h osteoarthritis patient education programme at Diakonhjemmet Hospital, Norway, completed the OA-QI at four time points: 2 weeks before, immediately before, immediately after, and 3 months after the programme. Test-retest reliability and measurement error over a 2-week time period were assessed in those that had not seen health professionals in the interim. Construct validity and responsiveness were assessed with predefined hypotheses. Floor and ceiling effects, smallest detectable change (SDC95%) and minimal important change (MIC) were assessed to evaluate interpretability. RESULTS: The intraclass correlation coefficient for all 16 items was 0.89. For single items the test-retest kappa estimates ranged 0.38-0.85 and percent agreement 69-92%. Construct validity was acceptable with all six predefined hypotheses confirmed. Responsiveness was acceptable with 33 of 48 and three of four predefined hypotheses confirmed for single items and all items, respectively. There were no floor or ceiling effects. The SDC95% was 29.1 and 3.0 at the individual and group levels, respectively. MIC was 20.4. CONCLUSIONS: The OA-QI v2 had higher reliability estimates compared to v1, showed acceptable validity, and is the recommended version for future use. The results of responsiveness testing further support the use of the OA-QI v2 as an outcome measure in studies aiming to improve osteoarthritis care.

Measurement properties and normative data for the Norwegian SF-36: results from a general population survey.

BACKGROUND: The interpretation of the SF-36 in Norwegian populations largely uses normative data from 1996. This study presents data for the general population from 2002-2003 which has been used for comparative purposes but has not been assessed for measurement properties. METHODS: As part of the Norwegian Level of Living Survey 2002-2003, a postal survey was conducted comprising 9,164 members of the general population aged 16 years and over representative for Norway who received the Norwegian SF-36 version 1.2. The SF-36 was assessed against widely applied criteria including data completeness and assumptions relating to the construction and scoring of multi-item scales. Normative data are given for the eight SF-36 scales and the two summary scales (PCS, MCS) for eight age groups and gender. RESULTS: There were 5,396 (58.9%) respondents. Item levels of missing data ranged from 0.6 to 3.0% with scale scores computable for 97.5 to 99.8% of respondents. All item-total correlations were above 0.4 and were of a similar level with the exceptions of the easiest and most difficult physical function items and two general health items. Cronbach's alpha exceeded 0.8 for all scales. Under 5% of respondents scored at the floor for five scales. Role-physical had the highest floor effect (14.6%) and together with role-emotional had the highest ceiling effects (66.3-76.8%). With three exceptions for the eight age groups, females had lower scores than males across the eight health scales. The two youngest age groups (<30 years) had the highest scores for physical aspects of health; physical function, role-physical, bodily pain and general health. The age groups 40-49 and 60-69 years had the highest scores for role-emotional and mental health respectively. CONCLUSIONS: This SF-36 data meet necessary criteria for applications of normative data. The data is more recent, has more respondents including older people than the original Norwegian normative data from 1996, and can help the interpretation of SF-36 scores in applications that include clinical and health services research.

Rasch analysis of the Norwegian version of the Arthritis Self-Efficacy Scale (ASES).

OBJECTIVES: To apply the Rasch model to the Norwegian version of the Arthritis Self-Efficacy Scale (ASES). METHOD: The ASES was included in a self-administered questionnaire sent to 224 patients attending one of three rehabilitation centres for rheumatic diseases in Norway in 2009. The fit of the ASES to the Rasch model was assessed together with hypothesized associations with the Modified Health Assessment Questionnaire (MHAQ), the 36-item Short Form Health Survey (SF-36), the numerical rating scale (NRS) for pain, and NRS fatigue. RESULTS: A total of 145 (64.7%) patients responded to the questionnaire. The two scales of other symptoms and pain showed good fit to the Rasch model with no evidence for differential item functioning (DIF) according to eight sociodemographic and disease-related variables. The Person Separation Index (PSI), which is equivalent to Cronbach's alpha, ranged from 0.74 to 0.78. Correlations with scores for other instruments were as hypothesized: ASES pain had the highest correlations with SF-36 pain and NRS pain and ASES other symptoms had the highest correlations with other aspects of the SF-36 and NRS fatigue. CONCLUSIONS: The ASES had good fit to the Rasch model and correlations with other instrument scores that followed hypotheses, lending further support to the application of the instrument in patients with rheumatic diseases.

Current practice and barriers to the management of sexual issues in rheumatology: results of a survey of health professionals.

OBJECTIVES: To explore multidisciplinary health professionals' (HPs) management of disease-related sexual issues in patients with rheumatic diseases, including their perceptions and assessments, and identify factors that prevent HPs from addressing sexuality as a topic with patients. METHODS: A self-constructed questionnaire was sent to 647 nurses, physicians, physiotherapists, occupational therapists, social workers, and psychologists working within rheumatology care. A multivariate logistic regression model of significant determinants for initiating sexual topics with patients was built. RESULTS: The mean age of the responders (n = 274, 42% response rate, 87% female) was 46 years. While 96% considered sexuality a relevant topic in rheumatology care, 71% seldom/never raised the topic. The patient was the main initiator (53%), and 88% of HPs gave the patient responsibility to initiate. The HPs with relevant education in sexuality were significantly more comfortable talking about sexuality (p < 0.001) and raised sexual issues significantly more often (p < 0.001). In the multivariate analyses, higher age [odds ratio (OR) 3.69], having relevant education (OR 3.16), and being comfortable to some extent (OR 3.62) or to a large extent (OR 5.58) remained significant predictors to initiating sexual topics. CONCLUSIONS: Although HPs regarded sexuality as a relevant topic in rheumatic health care, they seldom raised the topic in consultations. Those with further education in sexuality addressed sexual issues more frequently and felt more comfortable. Correspondingly, the majority of respondents requested more education. Such training should be part of the basic HPs' education, as well as part of postgraduate courses.

Patients with well-established ankylosing spondylitis show limited deterioration in a ten-year prospective cohort study.

This study aims to describe the deterioration of well-established ankylosing spondylitis (AS) over a 10-year period. Patients with well-established AS under secondary care review were assessed at baseline and re-assessed after a 10-year period. Data on patient characteristics, spinal mobility and self-reported health status (AS Quality of Life, Bath AS Disease Activity Index, EuroQoL, Revised Leeds Disability Questionnaire and Short Form-12) were compared between the two time points. One hundred fifty-nine patients took part in the initial assessment. After 10 years, 69/117 patients still under secondary care follow-up attended a second assessment. At the second assessment, this cohort was predominately male (92.8 %), mean age of 48.7 years (SD 9.7) and mean disease and symptom duration of 14.9 (SD 9.0) and 21.9 years (SD 13.3), respectively. Amongst the physical and patient-reported measures, only tragus to wall (p < 0.001), cervical rotation (p = 0.001) and disability (p = 0.02) had significantly deteriorated over time. The percentage of patients who had withdrawn from the workforce before normal retirement age increased from 37 to 53 % over the 10-year period. Many of the measures used in the assessment of AS do not generally deteriorate over time in those with well-established disease. This suggests that deterioration may plateau in established disease. However, AS has a long-term social impact with levels of employment in this cohort 30 % lower than the general population. Interventions directed at preventing deterioration may be more effective earlier in their disease course, before this plateau is reached.

BACE1 Dependent Neuregulin Proteolysis.

Neuregulin-1 (NRG1), which is also called acetylcholine receptor inducing activity (ARIA) or glial growth factor (GGF), signals as a ligand of ErbB receptors in a variety of important developmental processes but also later in life. NRG1 mediated signaling is crucial for cardiogenesis and the development of the breast. In the nervous system, NRG1 functions are essential for peripheral myelination, the establishment and maintenance of neuromuscular and sensorimotoric systems as well as for the plasticity of cortical neuronal circuits. There is strong evidence that deregulation of NRG1 is involved in breast cancer and schizophrenia. Many splice variants of NRG1 are expressed in the brain and all contain an EGF-like domain, which exerts the NRG1 function by limited proteolysis from its membrane bound precursor protein. In addition, most NRG1 isoforms contain a transmembrane domain, which is processed by γ-secretase after shedding. ß-Secretase (ß-site amyloid precursor protein cleaving enzyme 1; BACE1) has been identified based on its role as the rate limiting enzyme of amyloid-ß-peptide (Aß) production. Aß is the major component of amyloid plaques in Alzheimer`s disease (AD). More recently it was shown that Neuregulin-1 activity is highly dependent on the cleavage by BACE1 during early postnatal development. In BACE1 KO mice a role for BACE1 dependent proteolysis of NRG1 in the process of peripheral myelination could be demonstrated. Here we summarize the current knowledge about the role of NRG1 proteolysis for ErbB receptor mediated signaling during development and in Alzheimer`s disease.

Evaluation of a modified arthritis self-efficacy scale for an ankylosing spondylitis UK population.

OBJECTIVES: To evaluate an Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS) United Kingdom (UK) secondary care population. METHODS: The ASES-AS is based on the 8-item ASES with minor alterations in phraseology. Patients from ten secondary care rheumatology centres across England were asked to complete a postal questionnaire concerning sociodemographic and clinical characteristics: Bath AS Functional Index (BASFI), Bath AS Disease Activity Index (BASDAI), numerical pain rating scale (NRS), Hospital Anxiety and Depression Scale (HADS), Short Form 36 (SF-36), Evaluation of AS Quality of Life questionnaire (EASi-QoL) and ASES-AS. Respondents received repeat questionnaires at 2 weeks and 6 months including health transition questions assessing change in AS-specific and general health. The ASES-AS was assessed for data quality, reliability, validity, and responsiveness. RESULTS: Response rate was 64% (n=612), 72% (n=438) were male, mean age 50.8yrs (SD 12.2 yrs), mean disease duration 17.3 yrs (SD 11.7 yrs) and mean symptom duration 22.4 yrs (SD 12.4 yrs). Missing data for each item/total score range was 0.7%-3.1%. Item-total correlations range was 0.66 to 0.83. Cronbach's alpha was 0.93 and test-retest reliability (intraclass correlation coefficient) 0.77. A priori hypothesised associations between ASAS-AS and disease status measures were supported. Social variables potentially related to self-efficacy demonstrated evidence of convergent validity (employment p<0.001, educational level p<0.005). A Modified Standard Response Mean (MSRM) of 0.44 and 0.26 in AS-specific and general health respectively at 6 months indicates moderate responsiveness. CONCLUSIONS: ASES-AS has good evidence supporting its application as an AS-specific self-efficacy measure in research including clinical trials at a group level.

Impact of ankylosing spondylitis on work in patients across the UK.

OBJECTIVES: To examine the impact of ankylosing spondylitis (AS) on patients across the UK and to identify factors associated with unemployment, absenteeism, and presenteeism. METHODS: One thousand patients with AS from 10 specialist rheumatology centres across the UK were invited to participate in a study evaluating a new outcome measure. Patients completed a questionnaire, which included questions relating to their work, sociodemographic and clinical characteristics. RESULTS: The questionnaire was completed by 612 patients (438 males; 72%). The mean age of the participants was 50.8 (SD 12.2) years, mean disease duration was 17.3 (SD 11.7) years, and mean symptom duration 22.4 (SD 12.4) years. A total of 206 (40%) patients of working age were not employed. Factors associated with not being employed were social deprivation [odds ratio (OR) 3.52, 95% confidence interval (CI) 2.14-5.80], poor function (OR 3.42, 95% CI 1.90-6.13), depression (OR 2.05, 95% CI 1.12-3.78), increasing age (OR 1.05 per year, 95% CI 1.02-1.08), and longer disease duration (OR 1.03 per year, 95% CI 1.01-1.06). Disease activity (OR 3.24, 95% CI 1.11-9.48) and depression (OR 3.22, 95% CI 1.22-8.48) were associated with absenteeism, while depression (OR 5.69, 95% CI 1.77-18.27, disease activity (OR 3.97, 95% CI 1.76-8.98), anxiety (OR 3.90, 95% CI 1.83-8.31), self-efficacy (OR 0.71, 95% CI 0.58-0.86), and increasing age (OR 1.04 per year, 95% CI 1.00-1.08) were associated with presenteeism. CONCLUSION: Psychological, sociodemographic, and disease-related factors were all found to be related to work status. These factors should be taken into account when considering early treatment and management. Depression, in particular, appears to be associated with employment, absenteeism, and presenteeism, and should therefore be prioritized in clinical practice.

Patient experiences of rehabilitation in rheumatology: association with process and outcome.

OBJECTIVE: To evaluate health-care experiences of patients following inpatient rheumatology rehabilitation and to assess the association between these experiences and aspects of health-care delivery and patient characteristics. METHODS: Data were collected from 435 patients with a rehabilitation stay of >or= 1 week at 12 institutions in Norway in 2006. At discharge, patients completed the Rehabilitation Patient Experiences Questionnaire (Re-PEQ), which includes four important aspects of patient experiences. Multiple regression analysis was used to assess associations between Re-PEQ scores, health-care process, health and sociodemographic variables. RESULTS: A total of 412 (94.7%) patients completed the Re-PEQ; scores ranged from 69 (social environment) to 83 (care/organization) on the 0-100 scale, where 100 represents the best possible experience. The social environment scale had the largest component of variation explained by the independent variables, which included number of doctor visits, amount of group education, and individual exercise (p < 0.01). The type of institution, number of doctor visits, mental health, and gender also explained significant components of variation in the other Re-PEQ scale scores. CONCLUSION: Patients reported good experiences with rheumatology rehabilitation. Areas where poorer experiences emerged can help target areas for future initiatives aimed at improving the quality of care. Health and sociodemographic variables should be controlled for in studies of patient experiences.

The OutPatient Experiences Questionnaire (OPEQ): data quality, reliability, and validity in patients attending 52 Norwegian hospitals.

OBJECTIVE: To describe the development and evaluation of the OutPatient Experiences Questionnaire (OPEQ) for somatic outpatients. DESIGN: Literature review, patient interviews, pretesting of questionnaire items, and a cross sectional survey. SETTING: Postal survey of adult outpatient clinics at 52 hospitals in all five regions of Norway during 2003 and 2004. SUBJECTS: 35,719 patients who had attended an outpatient clinic within the previous 3 weeks. RESULTS: 19,266 patients (53.9%) responded to the questionnaire. Low levels of missing data suggest that the questionnaire is acceptable to patients. Factor analysis of items applicable to all patients produced three factors: clinic access (two items), communication (six items), and organisation (four items). The remaining items contributed to the hypothesised scales of hospital standards (three items), information (six items), and pre-visit communication (three items). With the exception of the pre-visit communication scale, the levels of Cronbach's alpha were >0.7. With the exception of the hospital standards scale, all produced test-retest correlations that exceeded 0.7. Most of the results of validity testing were as hypothesised. Correlations between the OPEQ scores ranged from 0.30 (clinic access and hospital standards) to 0.73 (communication and information). As hypothesised, scores were significantly related to patient responses to questions about overall satisfaction, general health and age. CONCLUSIONS: The OPEQ is a self-administered questionnaire that includes the most important aspects of patient experience from an outpatient perspective. It has good evidence for internal consistency, test-retest reliability, and validity.

Quality of life in older people: a structured review of generic self-assessed health instruments.

OBJECTIVE: To review evidence relating to the measurement properties of multi-item generic patient or self-assessed measures of health in older people. METHODS: Systematic literature searches to identify instruments. Pre-defined criteria relating to reliability, validity and responsiveness. RESULTS: 122 articles relating to 15 instruments met the inclusion criteria. The most extensive evidence was found for the SF-36, COOP Charts, EQ-5D, Nottingham Health Profile (NHP) and SIP. Four instruments have evidence of both internal consistency and test-retest reliability--NHP, SF-12, SF-20, SF-36. Four instruments lack evidence of reliability--HSQ-12, IHQL, QWB, SQL. Most instruments were assessed for validity through comparisons with other instruments, global judgements of health, or clinical and socio-demographic variables. Five instruments lack evidence of responsiveness--GQL, HSQ-12, IHQL, QLI and QWB. CONCLUSION: There is good evidence for reliability, validity and responsiveness for the SF-36, EQ-5D and NHP. There is more limited evidence for the COOP, SF-12 and SIP. The SF-36 is recommended where a detailed and broad ranging assessment of health is required, particularly in community dwelling older people with limited morbidity. The EQ-5D is recommended where a more succinct assessment is required, particularly where a substantial change in health is expected. Instrument content should be assessed for relevance before application. The concurrent evaluation of generic instruments in older people is recommended.

Patient-assessed health in ankylosing spondylitis: a structured review.

OBJECTIVE: To review evidence relating to the measurement properties for all disease-specific, multi-item, patient-assessed health instruments in patients with ankylosing spondylitis (AS). METHODS: Systematic literature searches were made to identify instruments, using predefined criteria relating to reliability, validity, responsiveness and precision. RESULTS: Twelve AS-specific and three arthritis-specific instruments met the inclusion criteria. Three AS-specific instruments that measure health-related quality of life (HRQL) were reviewed. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Dougados Functional Index (DFI) had the greatest amount of evidence for reliability, validity and responsiveness across a range of settings. Four instruments lacked evidence for test-retest or internal consistency reliability. Most were assessed for validity through comparisons with other instruments, global judgements of health, mobility or clinical and sociodemographic variables. Most were assessed for responsiveness through mean score changes. Three instruments lacked evidence of responsiveness. CONCLUSION: This review provides a contribution to AS assessment. AS-specific multi-item measures specific to the assessment of pain, stiffness, fatigue and global health were not identified; where assessed, these domains were largely measured with single-item visual analogue scales. Single items may provide a limited reflection of these important domains. The BASFI and DFI remain the instruments of choice for functional assessment. HRQL is recommended as a core assessment domain. Further concurrent evaluation is recommended.

Child Health Assessment at School Entry (CHASE) project: evaluation in 10 London primary schools.

AIMS: To assess the feasibility of implementing the Child Health Assessment at School Entry (CHASE) questionnaire, developed to capture the multiple dimensions of the health of children in their first year at school, and to evaluate data quality, reliability and validity. METHODS: Parents of 278 year-1 children, from 10 primary schools in two London boroughs, received a parent questionnaire and school nurses completed a separate questionnaire from health and education records for children whose parents consented. Additional data on free school meal eligibility and ethnicity were obtained from the two Local Education Authorities. The parent questionnaire included the Strengths and Difficulties Questionnaire (SDQ) and four dimensions of the Child Health Questionnaire Parent Form-28 (CHQ-PF28). RESULTS: Response rate was 61%. The association between school free school meals eligibility and response rate in each school approached significance (r = -0.62, P = 0.05). Data completeness of the parent questionnaire was high (mean 98%). Data completeness of the school nurse questionnaire was more variable (mean 82%). Cronbach's Alpha was greater than 0.6 for four of the five SDQ scales and greater than 0.7 for the two CHQ-PF28 multi-item scales. Relative to parents with qualifications, parents with no qualifications rated their children as having significantly more conduct problems, peer problems, and overall mental health problems (P < 0.01) as assessed by the SDQ, and significantly lower global health (P < 0.01) as assessed by the CHQ-PF28. Children with special educational needs and children with long-standing illness or disability were rated as having significantly lower global health (P < 0.05) than children without these. Sample tables of inter-school and inter-borough comparison of key findings demonstrate considerable differences in physical and mental health status. DISCUSSION: The questionnaire was acceptable to parents and school nurses, and feasible to implement within existing school resources. Initial tests of internal reliability and validity are satisfactory. These data have the potential to inform interventions and service provision at school and borough level, and public health trends over time.

Patient-assessed health instruments for the knee: a structured review.

OBJECTIVES: To identify patient-assessed health instruments specific to the knee and review evidence for reliability, validity and responsiveness. METHODS: Instruments were identified through systematic searches of the literature. Information relating to instrument content, patient population, reliability, validity and responsiveness was extracted from published papers. RESULTS: The 16 instruments that met the inclusion criteria varied in length from 4 to 42 items. The majority form a single index; six produce a profile of scores. Eight have been evaluated in patients with a variety of knee problems. All instruments have satisfactory internal or test-retest reliability. However, there is limited empirical support for the health domains of six instruments. Patients informed the development of items within just five instruments. Few authors gave explicit consideration to the size of expected relationships in tests of construct validity. Eleven instruments have evidence for responsiveness to changes in health. The minimally important difference was not determined for any of the instruments. CONCLUSIONS: In the absence of comparative evidence, the large number of patient-assessed instruments for knee problems makes instrument selection difficult. The Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Pain Scale and Oxford Knee Score have good evidence for reliability, content validity and construct validity. The KOOS and Oxford instruments also have evidence for responsiveness. The instruments have not been evaluated for all knee problems, and instrument appropriateness, including content relevance, must be assessed before application. The comparative evaluation of instruments is recommended.

Spinal mobility in ankylosing spondylitis: reliability, validity and responsiveness.

OBJECTIVE: To evaluate the measurement properties of an evidence-based selection of measures of spinal mobility in patients with ankylosing spondylitis (AS). METHODS: Measurements of spinal mobility were taken by trained observers within a UK rheumatology centre. Inter-observer reliability was assessed. Intra-observer reliability was assessed in patients reporting no change in AS-specific health at 2 weeks. Validity was assessed and scores were correlated with responses to health transition questions. Responsiveness was evaluated for patients reporting change in health at 6 months. RESULTS: Reliability estimates support the use of all measures in individual evaluation (intraclass correlation>0.90). Correlations between measures of spinal mobility were in the hypothesized direction; the largest was between the modified Schober index (15 cm) (MSI) and the other measures. As hypothesized, small to moderate levels of correlation were found between mobility measures and patient-assessed health status. There was no significant linear relationship between mobility measures and self-reported health transition. Fingertip-to-floor distance following trunk forward flexion (FFD) was the most responsive mobility measure but was not as responsive as two AS-specific patient-assessed instruments, the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The MSI and cervical rotation (Crot) also had evidence of responsiveness. Low levels of responsiveness were found for the remaining measures. CONCLUSION: All mobility measures had adequate levels of reliability and validity. The MSI had a strong relationship with all mobility measures, and the FFD and Crot were the most responsive to self-perceived changes in health at 6 months. The MSI, FFD and Crot are recommended for clinical practice and research.

UK Back pain Exercise And Manipulation (UK BEAM) trial--national randomised trial of physical treatments for back pain in primary care: objectives, design and interventions [ISRCTN32683578].

BACKGROUND: Low back pain has major health and social implications. Although there have been many randomised controlled trials of manipulation and exercise for the management of low back pain, the role of these two treatments in its routine management remains unclear. A previous trial comparing private chiropractic treatment with National Health Service (NHS) outpatient treatment, which found a benefit from chiropractic treatment, has been criticised because it did not take treatment location into account. There are data to suggest that general exercise programmes may have beneficial effects on low back pain. The UK Medical Research Council (MRC) has funded this major trial of physical treatments for back pain, based in primary care. It aims to establish if, when added to best care in general practice, a defined package of spinal manipulation and a defined programme of exercise classes (Back to Fitness) improve participant-assessed outcomes. Additionally the trial compares outcomes between participants receiving the spinal manipulation in NHS premises and in private premises. DESIGN: Randomised controlled trial using a 3 x 2 factorial design. METHODS: We sought to randomise 1350 participants with simple low back pain of at least one month's duration. These came from 14 locations across the UK, each with a cluster of 10-15 general practices that were members of the MRC General Practice Research Framework (GPRF). All practices were trained in the active management of low back pain. Participants were randomised to this form of general practice care only, or this general practice care plus manipulation, or this general practice care plus exercise, or this general practice care plus manipulation followed by exercise. Those randomised to manipulation were further randomised to receive treatment in either NHS or private premises. Follow up was by postal questionnaire one, three and 12 months after randomisation. The primary analysis will consider the main treatment effects before interactions between the two treatment packages. Economic analysis will estimate the cost per unit of health utility gained by adding either or both of the treatment packages to general practice care.

Generic measures of health-related quality of life in ankylosing spondylitis: reliability, validity and responsiveness.

OBJECTIVE: To assess the acceptability and measurement properties of two generic measures of health-related quality of life (HRQL): the EuroQol and the Short Form 12-item Health Survey Questionnaire (SF-12) in ankylosing spondylitis (AS). METHODS: Instruments were administered by means of a self-completed questionnaire to AS patients recruited from across the United Kingdom. Instruments were assessed for data quality and scaling assumptions. Test-retest reliability was assessed in those patients reporting no change in general health at 2 weeks. The convergent validity of both instruments was assessed and scores were correlated with responses to health transition questions. Responsiveness was assessed for patients reporting change in health at 6 months. RESULTS: The instruments had high completion rates. Although slightly skewed towards better levels of health, scores covered the available range for both sections of the EuroQol [EQ-5D and EQ-visual analogue scale (EQ-VAS)]. Score distributions approximated normality for the SF-12. Test-retest reliability estimates support the use of both instruments in group evaluation and the SF-12 Physical Component Summary score (PCS) in individual evaluation (>0.90). Correlations between instruments were in the hypothesized direction and were of a moderate level. The EQ-VAS had the strongest linear relationship, with responses to both specific and general health transition questions (P<0.01). The EQ-VAS and SF-12 PCS were the most responsive instruments. The EQ-5D was the least responsive instrument. CONCLUSION: The instruments have undergone a comprehensive comparative evaluation to assess the measurement properties required for patient-assessed measures of health outcome in AS. Adequate levels of acceptability, reliability and validity were found for both instruments. Although evidence supporting instrument responsiveness was strong for the EQ-VAS and SF-12 PCS, it was very weak for the EQ-5D and SF-12 Mental Component Summary Scale (MCS). The EQ-VAS and SF-12 PCS can both be recommended for use in group evaluation, and the SF-12 PCS is recommended in routine practice or research. However, the lower reliability of the SF-12 MCS and the limited ability of both the EQ-5D and SF-12 MCS to detect change in health may restrict these roles.

Disease-specific, patient-assessed measures of health outcome in ankylosing spondylitis: reliability, validity and responsiveness.

OBJECTIVE: To assess the acceptability and measurement properties of four ankylosing spondylitis (AS)-specific, patient-assessed measures of health outcome: AS Quality of Life Questionnaire (ASQoL), Bath AS Disease Activity Index (BASDAI), the Body Chart and the Revised Leeds Disability Questionnaire (RLDQ). METHODS: Instruments were administered by means of a self-completed questionnaire to patients recruited from across the United Kingdom (UK). Instruments were assessed for data quality and scaling assumptions. Where appropriate, dimensionality was assessed using principle component analysis (PCA). Internal consistency reliability was tested using Cronbach's alpha. Test-retest reliability was assessed in those patients reporting no change in AS-specific health at 2 weeks. The convergent validity of the instruments was assessed and scores were correlated with responses to the health transition questions. Responsiveness was assessed for patients reporting change in health at 6 months. RESULTS: The BASDAI and Body Chart have low self-completion rates. Item responses for the RLDQ were skewed towards higher levels of functional ability. PCA supported instrument unidimensionality. Cronbach's alpha ranged from 0.87 (BASDAI) to 0.93 (RLDQ). Test-retest reliability estimates support the use of the ASQoL and RLDQ in individual evaluation (>0.90). Correlations between instruments were in the hypothesized direction; the largest was between the ASQoL and BASDAI (0.79). The BASDAI had the strongest linear relationship, with responses to both specific and general health transition questions (P<0.01). With the exception of the Body Chart, instruments had a stronger relationship with general health transition. The BASDAI was the most responsive instrument. The Body Chart and RLDQ had low levels of responsiveness. CONCLUSION: The instruments have undergone a comprehensive comparative evaluation to assess the measurement properties required for patient-assessed measures of health outcome. Adequate levels of reliability and validity were found for all instruments. The BASDAI and the ASQoL were the most responsive to self-perceived change in health, but the BASDAI had low levels of self-completion.