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.

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.

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.

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.

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.

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.

A dual role of erbB2 in myelination and in expansion of the schwann cell precursor pool.

Neuregulin-1 provides an important axonally derived signal for the survival and growth of developing Schwann cells, which is transmitted by the ErbB2/ErbB3 receptor tyrosine kinases. Null mutations of the neuregulin-1, erbB2, or erbB3 mouse genes cause severe deficits in early Schwann cell development. Here, we employ Cre-loxP technology to introduce erbB2 mutations late in Schwann cell development, using a Krox20-cre allele. Cre-mediated erbB2 ablation occurs perinatally in peripheral nerves, but already at E11 within spinal roots. The mutant mice exhibit a widespread peripheral neuropathy characterized by abnormally thin myelin sheaths, containing fewer myelin wraps. In addition, in spinal roots the Schwann cell precursor pool is not correctly established. Thus, the Neuregulin signaling system functions during multiple stages of Schwann cell development and is essential for correct myelination. The thickness of the myelin sheath is determined by the axon diameter, and we suggest that trophic signals provided by the nerve determine the number of times a Schwann cell wraps an axon.

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.

A role of the cryptic gene in the correct establishment of the left-right axis.

During vertebrate embryogenesis, a left-right axis is established. The heart, associated vessels and inner organs adopt asymmetric spatial arrangements and morphologies. Secreted growth factors of the TGF-beta family, including nodal, lefty-1 and lefty-2, play crucial roles in establishing left-right asymmetries [1] [2] [3]. In zebrafish, nodal signalling requires the presence of one-eyed pinhead (oep), a member of the EGF-CFC family of membrane-associated proteins [4]. We have generated a mutant allele of cryptic, a mouse EGF-CFC gene [5]. Homozygous cryptic mutants developed to birth, but the majority died during the first week of life because of complex cardiac malformations such as malpositioning of the great arteries, and atrial-ventricular septal defects. Moreover, laterality defects, including right isomerism of the lungs, right or left positioning of the stomach and splenic hypoplasia were observed. Nodal gene expression in the node was initiated in cryptic mutant mice, but neither nodal, lefty-2 nor Pitx2 were expressed in the left lateral plate mesoderm. The laterality defects observed in cryptic(-/-) mice resemble those of mice lacking the type IIB activin receptor or the homeobox-containing factor Pitx2 [6] [7] [8] [9], and are reminiscent of the human asplenic syndrome [10]. Our results provide genetic evidence for a role of cryptic in the signalling cascade that determines left-right asymmetry.

Identification of a novel anti-integrin monoclonal antibody that recognises a ligand-induced binding site epitope on the beta 1 subunit.

Integrins are the major family of receptors involved in the adhesive interactions of cells with extracellular matrix macromolecules. Although it is known that integrins can exist in active or inactive states, the molecular mechanisms by which integrin activity is modulated are poorly understood. A novel anti-integrin monoclonal antibody, 12G10, that enhances alpha 5 beta 1-fibronectin interactions has been identified. 12G10 binds to the beta 1 subunit and appears to recognise a region of the subunit that contains the epitopes of several previously described activating or inhibitory monoclonal antibodies. However, unlike other activating anti-beta 1 antibodies, the binding of 12G10 to alpha 5 beta 1 is increased in the presence of ligands (fibronectin fragment or RGD peptide). This is the first report for the beta 1 integrin family of an antibody that recognises a ligand-induced binding site, and further emphasises the functional importance of a specific region of the beta 1 subunit in regulating integrin-ligand interactions.

The UK version of the Seattle Angina Questionnaire (SAQ-UK): reliability, validity and responsiveness.

The study assesses the reliability, validity and responsiveness of the UK version of the Seattle Angina Questionnaire (SAQ-UK). The instrument was anglicised and administered by self-completed postal questionnaire to 959 patients recruited from general practices in the North East of England. A total of 655 (68.3%) patients returned a completed questionnaire. Principal component analysis produced three important dimensions: physical limitations, anginal frequency and perception and treatment satisfaction. Four items that performed poorly were removed from the instrument. The removal of items greatly increased the number of computable scale scores. Estimates of internal reliability for the three dimensions ranged from 0.83-0.92. Estimates of test-retest reliability were above accepted standards. The correlation between the SAQ-UK scores and the SF-12, EuroQol and health transition was evidence for the validity of the instrument. The SAQ-UK produced responsiveness statistics that were comparable to the parent instrument and was more responsive to improvements in health than the generic instruments. The SAQ-UK is recommended as a measure of health outcome for the evaluation of angina management.

The UK IBDQ-a British version of the inflammatory bowel disease questionnaire. development and validation.

Measurement of health-related quality of life (HRQL) is becoming more important in studies of patients with inflammatory bowel disease. The McMaster IBDQ is the most widely used HRQL instrument for these patients. However, its use with patients in the United Kingdom has not been validated. This study develops and validates a UK version of the McMaster IBDQ (UK IBDQ). The UK IBDQ was tested with two samples of patients for its reliability, validity, reproducibility, and responsiveness. The first sample consisted of 180 patients participating in a randomized clinical trial. The second was recruited from members of the National Association for Colitis and Crohns Disease. Reliability of the subscales and the summary score of the UK IBDQ is demonstrated by Cronbach's alpha and item-total correlations. Their validity is demonstrated by their correlations with SF-36 subscales and an empirical index of disease activity. Good intraclass correlations and responsiveness ratios show their reproducibility and responsiveness. The findings support the reliability, validity, reproducibility, and responsiveness of the UK IBDQ and its acceptability to patients in UK.

Developing a condition-specific measure of health for patients with dyspepsia and ulcer-related symptoms.

A patient-administered instrument for dyspepsia and symptoms suggestive of duodenal or gastric ulcer, based on the type of questions asked when taking a patient's history, was developed and tested using the following steps: literature reviews, devising the questions, testing the responses to the questions using factor analysis and internal consistency, assessing test-retest reliability, and validating the questionnaire by comparing patient responses to the SF-36 health survey questionnaire. The main sample consisted of 135 patients referred to an outpatient clinic with dyspepsia, and 152 patients in general practice who were not referred to a specialist. The final instrument produced a Cronbach's alpha of 0.72 and an intraclass correlation coefficient of 0.69. Patient scores on the dyspepsia questionnaire had small to moderate correlations with the SF-36 health survey, the largest correlation being with the SF-36 scale of pain. Patient scores were significantly related to general practitioner perceptions of symptom severity, family history of gastric ulcer disease, and whether the patient was referred. The questions asked in taking a clinical history from a patient with dyspepsia and other symptoms suggestive of ulcer disease can be used to construct a valid and reliable measure of the effect of dyspepsia on health.

The amyotrophic lateral sclerosis assessment questionnaire (ALSAQ-40): tests of data quality, score reliability and response rate in a survey of patients.

OBJECTIVES: To evaluate response rate, data quality, and score reliability of the 40 item Amyotrophic Lateral Sclerosis Assessment Questionnaire in a survey of MND patients. DESIGN: A survey of members of the MND Association of the UK, of which half were randomly allocated to receive a survey instrument from the MND Association and the other half allocated to receive the MND Association survey instrument and also the ALSAQ-40 questionnaire. SAMPLE: Five hundred patients were randomly selected from the membership lists of the MND Association, of whom 250 received the MND Association Survey and the ALSAQ-40. RESULTS: Response rate to the survey was 59.2%. Over half of the respondents received the ALSAQ-40. Data for individual items were analysed and found to be distributed across all response categories. All items were found to be highly associated with the scales to which they contribute. Internal consistency reliability of all the five scales of the ALSAQ-40 was also found to be high. CONCLUSION: Inclusion of the ALSAQ-40 into the survey did not have an adverse effect upon response rates. Furthermore, the ALSAQ-40 was shown to have highly desirable psychometric properties. This paper provides further evidence of the reliability and validity of the measure.

Patient-assessed measures of health outcome in asthma: a comparison of four approaches.

The study compares the psychometric properties of four different approaches to patient-assessed health outcomes in asthma, including the Asthma Quality of Life Questionnaire (AQLQ), Newcastle Asthma Symptoms Questionnaire (NASQ), SF-12 and EuroQol. The instruments were administered by means of a self-completed postal questionnaire to 394 patients recruited from general practices in the North East of England. Patients completed a follow-up questionnaire at 6 months. The levels of missing data were assessed and instrument scores compared using correlational analysis. Scores were related to self-reports of smoking behaviour, socioeconomic status and health transition. Responsiveness was assessed using standardized response means. Two hundred and thirty-five patients took part in the study giving a response rate of 59.6%. There was a relatively large amount of missing data for the individualized section of the AQLQ. Correlational analysis provided evidence of convergent validity between the specific instruments; the largest correlation was found between NASQ scores and the asthma symptoms scale of the AQLQ (r = 0.84). The NASQ was found to be the most powerful at discriminating between smokers and non-smokers. All four instruments were linearly related to self-reported asthma transition (P<0.05); the specific instruments having the strongest association. The specific instruments showed good levels of responsiveness with the NASQ producing a large SRM of 0.82. SRMs for the AQLQ were of a moderate to large size (0.32-0.77) and the SRMs for the SF-12 and EuroQol were of a small size. The two specific instruments are capable of greater levels of discrimination between groups of patients and are more responsive to changes in health than the generic SF-12 and EuroQol. The greater responsiveness of the NASQ is probably due to its focus being restricted to symptoms of asthma compared to the broader focus of the AQLQ domains. The NASQ has a strong relationship with the AQLQ and is a more practical instrument that is more acceptable to patients. However, the AQLQ does measure broader patient concerns. The SF-12 and EuroQol have greater potential to capture side-effects and have wider scope for application in economic evaluation.

Developing a valid and reliable measure of health outcome for patients with low back pain.

OBJECTIVE: The authors developed and validated a measure of health outcome for patients with low back pain. RESULTS: A questionnaire was developed incorporating the type of questions asked when taking a clinical history. After testing on a sample of 568 patients, three questions were discarded from the questionnaire. The final questionnaire was found to be reliable and valid in the sense that patients' scores correlated highly with their scores on a general health profile and with GP perceptions of severity. Health status in patients with low back pain was significantly impaired when compared with the general population. CONCLUSION: A clinically based questionnaire, together with a general measure of health, can provide a valid and reliable package for the routine assessment of perceived health in patients with low back pain.

Responsiveness of generic and specific measures of health outcome in low back pain.

STUDY DESIGN: A longitudinal study using patient questionnaires was performed. OBJECTIVE: To compare the discriminatory power and responsiveness of the Aberdeen Back Pain Scale (ABPS), the Roland Disability Questionnaire (RDQ), and the EuroQol in patients with low back pain. SUMMARY OF BACKGROUND DATA: A number instruments specific to low back pain have not been compared for measurement properties. The EuroQol is a widely used generic instrument that has not been compared with specific instruments in patients with back pain. METHODS: A questionnaire incorporating the Aberdeen Back Pain Scale, the Roland Disability Questionnaire, and the EuroQol was completed by patients taking part in a clinical trial of exercise treatments for back pain. Patients completed follow-up questionnaires at 6 weeks, 6 months, and 1 year. The discriminatory power of these instruments was assessed against variables relating to activity limitations, medication, and comorbidity. Responsiveness was assessed using standardized response means. RESULTS: The questionnaire was completed by 187 patients taking part in the clinical trial. The Aberdeen instrument was found to be the most powerful at discriminating between different groups of patients on variables relating to activity limitations, medication, and comorbidity. The specific instruments demonstrated good levels of responsiveness, with the Aberdeen instrument producing the largest standardized response means. The Aberdeen instrument was more responsive to the smaller changes experienced by the control group, but was less powerful than the Roland at measuring differences in the levels of change between the two groups of patients at two of the three follow-up assessments in the trial. The EuroQol demonstrated a moderate level of responsiveness. CONCLUSIONS: The two specific instruments are capable of greater levels of discrimination between groups of patients, and are more responsive over time than the generic EuroQol. The Aberdeen instrument performed most satisfactorily in relation to these criteria, but the Roland instrument was more sensitive to differences between the two groups in the clinical trial. The measurement properties of these two instruments reflect their origin: The Aberdeen instrument is based on clinical questions, whereas the Roland instrument is based on the generic Sickness Impact Profile. Instrument content should be carefullyconsidered when selecting instruments for applications, including clinical trials.

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.

Development of a condition-specific quality of life measure for patients with dentofacial deformity: I. Reliability of the instrument.

UNLABELLED: The assessment of quality of life is becoming increasingly important in clinical research. Its importance in dentistry has been realised only relatively recently. Health-related quality of life is concerned with the aspects of quality of life that relate specifically to an individual's health. This may be measured using two groups of instruments: (i) generic measures, which provide a summary of health-related quality of life and sometimes generate a single index measure of health or (ii) condition-specific measures, which focus on a particular condition, disease, population or problem and are potentially more responsive to small, but clinically important, changes in health. OBJECTIVES: The aim of this study was to develop a condition-specific quality of life measure for those patients with severe dentofacial deformity who were requesting orthognathic treatment and to assess the reliability of this instrument. METHOD: Instrument content was derived through a literature review and interviews with clinicians and patients. The resulting instrument was tested for internal consistency and test-retest reliability. RESULTS AND CONCLUSION: The instrument was found to divide into four clinically meaningful domains. Internal consistency and test-retest reliability were good. Patient acceptance of the questionnaire was also encouraging.