Choice and Trade-offs: Parent Decision Making for Neurotechnologies for Pediatric Drug-Resistant Epilepsy.

This qualitative study investigated factors that guide caregiver decision making and ethical trade-offs for advanced neurotechnologies used to treat children with drug-resistant epilepsy. Caregivers with affected children were recruited to semi-structured focus groups or interviews at one of 4 major epilepsy centers in Eastern and Western Canada and the USA (n = 22). Discussions were transcribed and qualitative analytic methods applied to examine values and priorities (eg, risks, benefits, adherence, invasiveness, reversibility) of caregivers pertaining to novel technologies to treat drug-resistant epilepsy. Discussions revealed 3 major thematic branches for decision making: (1) features of the intervention-risks and benefits, with an emphasis on an aversion to perceived invasiveness; (2) decision drivers-trust in the clinical team, treatment costs; and (3) quality of available information about neurotechnological options. Overall, caregivers' definition of treatment success is more expansive than seizure freedom. The full involvement of their values and priorities must be considered in the decision-making process.

Novel Neurotechnological Interventions for Pediatric Drug-Resistant Epilepsy: Physician Perspectives.

This qualitative study investigated factors that guide physicians' choices for minimally invasive and neuromodulatory interventions as alternatives to conventional surgery or medical management for pediatric drug-resistant epilepsy. North American physicians were recruited to one of 4 focus groups at national conferences. Discussions were analyzed using qualitative content analysis. A pragmatic neuroethics framework was applied to interpret results. Discussions revealed 2 major thematic branches: (1) clinical decision making and (2) ethical considerations. Under clinical decision making, physicians emphasized scientific evidence and patient candidacy when assessing neurotechnologies for patients. Ongoing seizures without intervention was important for safety and neurodevelopment. Under ethical considerations, resource allocation, among other financial considerations for technology adoption, were considerable sources of pressure on decision making. Access to neurotechnology was a salient theme differentiating Canadian and American contexts. When assessing novel neurotechnological interventions for pediatric drug-resistant epilepsy, physicians balance clinical and ethical factors to guide decision making and best practice.

Assessment of atrial fibrillation patients' education needs from patient and clinician perspectives: A qualitative descriptive study.

INTRODUCTION: Patients' lack of knowledge is a key barrier to therapy adherence. We aimed to gather insights into atrial fibrillation (AF) patients' education needs from patient and clinician viewpoints. METHODS: We conducted a qualitative descriptive study using purposive sampling and semi-structured interviews with AF patients and clinicians recruited from AF clinics. Data from patients and clinicians were analyzed independently and iteratively through inductive qualitative thematic analysis. RESULTS: Eleven clinicians and 10 patients were interviewed. Three themes emerged from analysis of clinician data: (1) patients' knowledge gaps and misconceptions, (2) clinicians' experiences teaching AF patients, and (3) clinicians' suggestions for AF education programs. Four themes emerged from the patient data: (1) emotional appraisal of the disease, (2) information seeking behavior, (3) knowledge gaps, and (4) education preferences. A key finding was identification of the need for education that addresses patients' unjustified anxieties by emphasizing that AF is not fatal, and that many patients with AF live a normal life. Risk communication was identified as the most challenging aspect of AF education. In synthesizing our findings, we developed evidence-based recommendations for educational strategies for AF. CONCLUSION: We found that AF patients have many knowledge gaps and misconceptions, significant emotional education needs, and a positive attitude towards online and classroom education. In synthesizing our findings, we developed evidence-based recommendations which can inform the design of AF patient education programs and initiatives.

Effect of a national primary care pay for performance scheme on emergency hospital admissions for ambulatory care sensitive conditions: controlled longitudinal study.

OBJECTIVE: To estimate the impact of a national primary care pay for performance scheme, the Quality and Outcomes Framework in England, on emergency hospital admissions for ambulatory care sensitive conditions (ACSCs). DESIGN: Controlled longitudinal study. SETTING: English National Health Service between 1998/99 and 2010/11. PARTICIPANTS: Populations registered with each of 6975 family practices in England. MAIN OUTCOME MEASURES: Year specific differences between trend adjusted emergency hospital admission rates for incentivised ACSCs before and after the introduction of the Quality and Outcomes Framework scheme and two comparators: non-incentivised ACSCs and non-ACSCs. RESULTS: Incentivised ACSC admissions showed a relative reduction of 2.7% (95% confidence interval 1.6% to 3.8%) in the first year of the Quality and Outcomes Framework compared with ACSCs that were not incentivised. This increased to a relative reduction of 8.0% (6.9% to 9.1%) in 2010/11. Compared with conditions that are not regarded as being influenced by the quality of ambulatory care (non-ACSCs), incentivised ACSCs also showed a relative reduction in rates of emergency admissions of 2.8% (2.0% to 3.6%) in the first year increasing to 10.9% (10.1% to 11.7%) by 2010/11. CONCLUSIONS: The introduction of a major national pay for performance scheme for primary care in England was associated with a decrease in emergency admissions for incentivised conditions compared with conditions that were not incentivised. Contemporaneous health service changes seem unlikely to have caused the sharp change in the trajectory of incentivised ACSC admissions immediately after the introduction of the Quality and Outcomes Framework. The decrease seems larger than would be expected from the changes in the process measures that were incentivised, suggesting that the pay for performance scheme may have had impacts on quality of care beyond the directly incentivised activities.

Use of Bayesian multivariate meta-analysis to estimate the HAQ for mapping onto the EQ-5D questionnaire in rheumatoid arthritis.

BACKGROUND: In health technology assessment, decisions about reimbursement for new health technologies are largely based on effectiveness estimates. Sometimes, however, the target effectiveness estimates are not readily available. This may be because many alternative instruments measuring these outcomes are being used (and not all always reported) or an extended follow-up time of clinical trials is needed to evaluate long-term end points, leading to the limited data on the target clinical outcome. In the areas of highest priority in health care, decisions are required to be made on a short time scale. Therefore, alternative clinical outcomes, including surrogate end points, are increasingly being considered for use in evidence synthesis as part of economic evaluation. OBJECTIVE: To illustrate the potential effect of reduced uncertainty around the clinical outcome on the utility when estimating it from a multivariate meta-analysis. METHODS: Bayesian multivariate meta-analysis has been used to synthesize data on correlated outcomes in rheumatoid arthritis and to incorporate external data in the model in the form of informative prior distributions. Estimates of Health Assessment Questionnaire were then mapped onto the health-related quality-of-life measure EuroQol five-dimensional questionnaire, and the effect was compared with mapping the Health Assessment Questionnaire obtained from the univariate approach. RESULTS: The use of multivariate meta-analysis can lead to reduced uncertainty around the effectiveness parameter and ultimately uncertainty around the utility. CONCLUSIONS: By allowing all the relevant data to be incorporated in estimating clinical effectiveness outcomes, multivariate meta-analysis can improve the estimation of health utilities estimated through mapping methods. While reduced uncertainty may have an effect on decisions based on economic evaluation of new health technologies, the use of short-term surrogate end points can allow for early decisions. More research is needed to determine the circumstances under which uncertainty is reduced.

Multivariate meta-analysis of mixed outcomes: a Bayesian approach.

Multivariate random effects meta-analysis (MRMA) is an appropriate way for synthesizing data from studies reporting multiple correlated outcomes. In a Bayesian framework, it has great potential for integrating evidence from a variety of sources. In this paper, we propose a Bayesian model for MRMA of mixed outcomes, which extends previously developed bivariate models to the trivariate case and also allows for combination of multiple outcomes that are both continuous and binary. We have constructed informative prior distributions for the correlations by using external evidence. Prior distributions for the within-study correlations were constructed by employing external individual patent data and using a double bootstrap method to obtain the correlations between mixed outcomes. The between-study model of MRMA was parameterized in the form of a product of a series of univariate conditional normal distributions. This allowed us to place explicit prior distributions on the between-study correlations, which were constructed using external summary data. Traditionally, independent 'vague' prior distributions are placed on all parameters of the model. In contrast to this approach, we constructed prior distributions for the between-study model parameters in a way that takes into account the inter-relationship between them. This is a flexible method that can be extended to incorporate mixed outcomes other than continuous and binary and beyond the trivariate case. We have applied this model to a motivating example in rheumatoid arthritis with the aim of incorporating all available evidence in the synthesis and potentially reducing uncertainty around the estimate of interest.

The humanistic and economic burden of systemic lupus erythematosus : a systematic review.

BACKGROUND: Increased survival in patients with systemic lupus erythematosus (SLE) has shifted attention towards the burden that SLE imposes upon patients, healthcare systems and society. New interventions aimed at alleviating this burden will require economic evaluation. A summary of the current evidence of the humanistic and economic burden provides a platform for such subsequent studies. OBJECTIVE: The objective of this study was to systematically review the current evidence on the humanistic and economic burden of SLE in terms of health-related quality of life (HR-QOL) and costs, and summarize the evidence on the factors found to be associated with this burden. METHODS: Relevant literature for the years 1990 to February 2011 were obtained from systematic searches of MEDLINE, EMBASE and Web of Science. Articles reporting the humanistic (preference-based outcome measures or an SLE disease-specific HR-QOL measure) or economic burden (costs) of SLE in adult populations published in English were identified. The following exclusion criteria were applied: studies specifically examining lupus nephritis, SLE not being the main condition of focus (e.g. SLE is a co-existing condition), studies focusing on diagnostics or tests (including genetics and antibodies), mixed patient groups from which SLE could not be separated, paediatric populations, case studies, abstract unavailable, and non-English language studies. Estimates of the burden in terms of either HR-QOL or costs were extracted, tabulated and reported narratively. Annual cost figures were also converted into year 2010 US dollars using the consumer price index (CPI) and the purchasing power parity (PPP) conversion factor to allow for greater comparability across studies. Evidence on the factors found to be independently associated with either HR-QOL or costs was also examined. RESULTS: Of the 1969 studies initially identified as being potentially relevant, 32 papers were retained for the final review. Eighteen of these presented estimates of the burden in terms of HR-QOL, and 14 in terms of the economic cost. Mean utility scores reported on preference-based measures of HR-QOL ranged from 0.6 to 0.75. Mean annual direct costs per patient ranged from US$2,214 to US$16,875, and mean annual indirect cost estimates from US$2,239 to US$35,540 (year 2010 values). Disease activity and damage, along with poor mental and physical health, were repeatedly reported to predict both reduced HR-QOL and increased costs. CONCLUSIONS: The burden of SLE was found to be substantial, not only for patients but also for the health services that provide care for them. Treatments that are able to alleviate this burden are therefore likely to be highly valued by sufferers. After an extended period in which few therapeutic advances were made or treatments licensed, fundamental developments are finally being made. These new treatments will need to be evaluated for both clinical and cost effectiveness if their use is to be widely implemented.

Construct and criterion validity of the short form-6D utility measure in patients with systemic lupus erythematosus.

OBJECTIVE: Preference-based measures, such as the Short Form-6D (SF-6D), allow quality-adjusted life-years, used in cost-utility evaluations, to be calculated. We investigated the construct and criterion validity of the SF-6D in patients with systemic lupus erythematosus (SLE). METHODS: Female patients with SLE were recruited from outpatient clinics at 2 timepoints, 5 years apart. Cross-sectional correlation of the SF-6D with domains of the disease-specific LupusQol health-related quality of life (HRQOL) measure, the Systemic Lupus International Collaborating Clinics Damage Index (SDI; for damage) and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; for activity) measures, and patient characteristics was tested. The ability to discriminate between groups defined by smoking status, presence/absence of carotid plaque, depression, and fatigue was tested using the t-test. RESULTS: In total 181 patients were recruited at baseline. The SF-6D correlated moderately to strongly with all domains of the LupusQoL (0.6-0.8) apart from intimate relationships (0.42) and body image (0.34). Correlations of the SF-6D with the demographic and disease-specific measures at baseline were small for the SDI score (-0.23) and age (-0.19) and in the expected direction. The SF-6D did not correlate with disease activity (SLEDAI -0.08). The SF-6D could distinguish those who smoked, had carotid plaque, had depression, and reported fatigue from those who did not, with the largest effect size being for depression (0.75). CONCLUSION: The SF-6D displays construct and criterion validity for use in patients with SLE, but the low correlation with aspects of intimate relationships and body image represents a concern and reinforces the need to collect disease-specific measures of HRQOL alongside generic preference-based instruments.

OMERACT 10 Patient Perspective Virtual Campus: valuing health; measuring outcomes in rheumatoid arthritis fatigue, RA sleep, arthroplasty, and systemic sclerosis; and clinical significance of changes in health.

This workshop reviewed progress in a number of areas related to patient perspective outcomes that were not specifically included within other areas of the program. A substantial review of the work of the valuing health outcomes group (the "QALY" working group) with participation and feedback from the plenary audience resulted in guidance to refocus on the use of patient preferences in the elaboration of more robust outcome measures for patient-reported outcomes and life impact measures. Progress and developments in the areas of fatigue and sleep in rheumatoid arthritis, outcome measures in hip and knee arthroplasty clinical trials, and scleroderma were outlined, and the challenge of truly understanding the nature of clinically important improvement was reviewed.

Valuing health for clinical and economic decisions: directions relevant for rheumatologists.

The quality-adjusted life-year (QALY) is a construct that integrates the value or preference for a health state over the period of time in that health state. The main use of QALY is in cost-utility analysis, to help make resource allocation decisions when faced with choices. Although the concept of the QALY is appealing, there is ongoing debate regarding their usefulness and approaches to deriving QALY. In 2008, OMERACT engaged in an effort to agree on QALY approaches that can be used in rheumatology. Based on a Web questionnaire and a subsequent meeting, rheumatologists questioned whether it was relevant for OMERACT (1) to investigate use of a QALY that represents the patients' perspective, (2) to explore the validity of the visual analog scale (VAS) to value health, and (3) to understand the validity of mapping health-specific instruments on existing preference instruments. This article discusses the pros and cons of these points in light of current insight from the point of view of health economics and decision-making theory. It also considers the further research agenda toward a QALY approach in rheumatology.

UK rheumatology consultant workforce provision 2007-9: results from the BSR/Arthritis Research UK Consultant Workforce Register.

The objective of this study was to describe the provision of consultant rheumatology services and the pattern of inequalities in UK rheumatology service provision, and to summarise the five-year impact of the new NHS consultant contract and the Musculoskeletal Services Framework in England and Wales. All consultants on the British Society for Rheumatology/Arthritis Research UK Consultant Workforce Register in January 2007 and January 2009 were sent questionnaires about timetable and working conditions and the personal and job-related details currently held about them on the register. Response rates were 87% in 2007 and 86% in 2009. The number of whole-time equivalent (WTE) rheumatologists in the UK increased from 470 to 531 (13%). Levels of provision in 2009 were lower in Scotland (1 WTE per 113,286 population) than the rest of the UK. There are now few regional variations in rheumatology consultant provision within the UK, and the number of WTE consultants is approaching recommended levels.

Delivery of paediatric rheumatology care in the UK--the projected shortfall.

Adult rheumatologists in the UK have historically provided a significant contribution to clinical care for children with rheumatic disease. However, changes in postgraduate training have resulted in adult rheumatology trainees no longer being trained in paediatric rheumatology (PRh), and accordingly, they will be ill-equipped to manage children when incumbent adult rheumatology specialists retire. The objectives of this work were to ascertain the number of UK adult rheumatologists currently involved in PRh care and to inform future workforce planning. As part of the British Society for Rheumatology annual consultant workforce survey, additional questions relating to PRh were included. A questionnaire was sent to 584 adult rheumatologists, of whom 403 (69%) responded to questions about PRh; of these, 75 of 403 (19%) reported seeing children and many will retire in the next 5 and 10 years (13/75 (18%) and 35/75 (48%), respectively). The majority (58/75, 78%) reported having separate clinics for children, often alongside other health care professionals (mostly consultant paediatrician, paediatric rheumatologist, or allied health professional). Notably, 4 of 75 (5%) adult rheumatologists had clinical sessions seeing children without any paediatric input. The median (IQR) number of paediatric consultations by adult rheumatologists per month was 10 (6, 15), equating to a total 931 paediatric consultations per average month. Many UK adult rheumatologists are involved in managing paediatric rheumatic disease and many will retire over the next 10 years. This will result in a shortfall in clinical provision as their replacements in adult rheumatology will not have had appropriate PRh training. This projected shortfall needs to be addressed in future workforce planning.

Exploring the validity of estimating EQ-5D and SF-6D utility values from the health assessment questionnaire in patients with inflammatory arthritis.

BACKGROUND: Utility scores are used to estimate Quality Adjusted Life Years (QALYs), applied in determining the cost-effectiveness of health care interventions. In studies where no preference based measures are collected, indirect methods have been developed to estimate utilities from clinical instruments. The aim of this study was to evaluate a published method of estimating the EuroQol-5D (EQ-5D) and Short Form-6D (SF-6D) (preference based) utility scores from the Health Assessment Questionnaire (HAQ) in patients with inflammatory arthritis. METHODS: Data were used from 3 cohorts of patients with: early inflammatory arthritis (<10 weeks duration); established (>5 years duration) stable rheumatoid arthritis (RA); and RA being treated with anti-TNF therapy. Patients completed the EQ-5D, SF-6D and HAQ at baseline and a follow-up assessment. EQ-5D and SF-6D scores were predicted from the HAQ using a published method. Differences between predicted and observed EQ-5D and SF-6D scores were assessed using the paired t-test and linear regression. RESULTS: Predicted utility scores were generally higher than observed scores (range of differences: EQ-5D 0.01 - 0.06; SF-6D 0.05 - 0.10). Change between predicted values of the EQ-5D and SF-6D corresponded well with observed change in patients with established RA. Change in predicted SF-6D scores was, however, less than half of that in observed values (p < 0.001) in patients with more active disease. Predicted EQ-5D scores underestimated change in cohorts of patients with more active disease. CONCLUSION: Predicted utility scores overestimated baseline values but underestimated change. Predicting utility values from the HAQ will therefore likely underestimate the QALYs of interventions, particularly for patients with active disease. We recommend the inclusion of at least one preference based measure in future clinical studies.

Association of functional outcome with both personal- and area-level socioeconomic inequalities in patients with inflammatory polyarthritis.

OBJECTIVE: To describe the relationship between baseline area- and person-level social inequalities and functional disability at 3 years in patients with early inflammatory polyarthritis (IP). METHODS: A total of 1,393 patients with new-onset IP were recruited and allocated an Index of Multiple Deprivation (IMD) 2004 score based on their area of residence, and a social class based on baseline self-reported occupation. Differences in the Health Assessment Questionnaire (HAQ) score at baseline and 3 years by IMD or social class were tested. The mean 3-year change in HAQ score was compared by IMD and social class, and interactions between these measures examined. RESULTS: Patients from more deprived areas had poorer 3-year HAQ outcome than those from less deprived areas (P = 0.019, adjusted for baseline HAQ score, age, sex, and symptom duration). The mean difference in HAQ change was most notable between the most deprived (IMD4) and least deprived areas (IMD1) (0.22; 95% confidence interval [95% CI] 0.11, 0.34). There was also a significant difference in HAQ score change between patients of the highest (SCI and II) and lowest social class (SCIV and V) (0.11; 95% CI 0.02, 0.20). For the mean (95% CI) 3-year change in HAQ score, a significant interaction exists between IMD score and social class and their association with HAQ scores (P = 0.001) to modify outcome: IMD1/SC I and II -0.23 (95% CI -0.40, -0.06) versus IMD 4/SC IV and V 0.15 (95% CI -0.05, 0.34). CONCLUSION: Person- and area-level inequalities combine to modify outcome for rheumatoid arthritis. A person's social circumstance and residential environment have independent effects on outcome and are not just alternative measures of the same exposure.

Same question, different answers: a comparison of global health assessments using visual analogue scales.

PURPOSE: To compare responses to two global health VAS of patients with rheumatoid arthritis at the same assessment within the same questionnaire. METHODS: Secondary analysis of randomised controlled trial data. Patients completed the patient global assessment VAS (PG-VAS) (horizontal 10 cm scale, left (0), right (100), no incremental markers) and EQ-5D-VAS (EQ-VAS) (vertical 20 cm scale, 100 at the top, markers at each increment of 10). Both asked "how good or bad is your health today, in your opinion, from 100 'Best imaginable health state' to 0 'Worst imaginable health state'." Agreement was assessed using intra-class correlation co-efficients (ICC) and Bland-Altman plots. RESULTS: Four hundred and forty-eight patients reported median PG-VAS 66 (IQR 51, 77) and EQ-VAS 65 (IQR 50, 80) scores. Correlation of the VAS scales was moderate at baseline (ICC 0.564) and longitudinally (ICC 0.503). Bland-Altman plots suggested poor concordance of the PG-VAS and EQ-VAS; the limits of agreement were +/-32.3 on a 0-100 scale. PG-VAS scores were evenly distributed; EQ-VAS scores clustered at increments of 10; rounding did not improve agreement. CONCLUSIONS: The EQ-VAS and PG-VAS scores are not interchangeable at the individual level. The EQ-VAS correlated more strongly with disease-specific and health-related quality of life measures, therefore, appears preferable.

Why do patients with inflammatory arthritis often score states "worse than death" on the EQ-5D? An Investigation of the EQ-5D classification system.

OBJECTIVE: Using inflammatory arthritis patients as an example, we investigate EuroQol-5D (EQ-5D) profiles resulting in states worse than death (WTD), and the heath status of patients occupying these states. METHODS: Baseline data from two UK trials were used that reflected the range of arthritis states/severity found in routine practice. EQ-5D profiles resulting in negative valuations (i.e., states WTD) based on UK weights were identified. EQ-5D scores for these profiles from alternative valuation sets, including a reanalysis of the UK weights, were compared. The health status and characteristics of patients, and factors associated with patients in the low distribution of the EQ-5D and those with WTD EQ-5D scores were identified. RESULTS: Seven hundred patients were included in the analysis. Sixty-two (9%) patients occupied states WTD. Patients occupied 9 of the possible 84 health profiles with negative scores (53% occupied one profile); this profile was not rated WTD by any of the alternative EQ-5D scoring algorithms. All WTD profiles included severe pain/discomfort plus moderate problems in >or=3 other domains. Patients with WTD valuations reported higher levels of pain, and feeling downhearted and low on alternative health status measures. CONCLUSIONS: Pain was the predominant factor in the WTD EQ-5D profiles occupied by arthritis patients. Patients occupying states WTD have poorer health-related quality of life than patients in low "better than death" states. Valuations of profiles vary according to how sets of preference weights for health profiles were developed. Further research should explore whether WTD valuations are supported by qualitative evidence and reflect the patient's health and experience of disease.

The validity and responsiveness of generic utility measures in rheumatoid arthritis: a review.

OBJECTIVE: Cost-utility analysis is increasingly important as healthcare providers aim to invest scarce resources in interventions offering the greatest health benefit. The ability to attach utility values to health states is essential, and is increasingly performed using generic scales. However, the evidence regarding the validity of generic utility scales in rheumatoid arthritis (RA) is unclear. We summarize and review evidence on the validity and comparative performance of generic utility scales in RA. METHODS: We searched the English-language medical literature for studies using utilities in RA between 1980 and mid-2006. Reports describing primary evidence of the validity or performance of a generic utility scale in RA were selected, summarized, and reviewed using the OMERACT filter. RESULTS: In total 923 articles were identified, of which 228 reported the use of utility scales in RA; 26 studies related to the validation or evidence of generic utility scales in RA, the EQ-5D, Health Utility Index-2 (HUI2) and HUI3, SF-6D, and Quality of Well-Being Scale. The EQ-5D, HUI2 and HUI3, and SF-6D all have consistent evidence of construct validity and responsiveness in RA, but each has limitations. CONCLUSION: The EQ-5D and HUI3 have been the most extensively studied instruments and show validity and responsiveness for use in RA, but both instruments have limitations. The SF-6D is relatively new and appears to have potential for use in milder RA, but needs further evaluation. More longitudinal head-to-head evaluation of measures is needed across the spectrum of RA disease severity to further investigate their comparative properties, and to seek consensus on the best utility measure for use in economic evaluation.

The relationship between social deprivation, disease outcome measures, and response to treatment in patients with stable, long-standing rheumatoid arthritis.

OBJECTIVE: Patients with rheumatoid arthritis (RA) with lower socioeconomic status (SES) are known to have more severe disease, more comorbidity, and higher mortality. It is not known whether SES influences response to treatment in RA. We examined the relationship between area of residence (as a surrogate for SES) and baseline outcome measures and response to treatment, using data from the British Rheumatoid Outcome Study Group randomized controlled trial of aggressive versus symptomatic treatment of long-standing, stable RA. METHODS: A total of 466 patients from 5 centers were recruited to the trial. Baseline data included age, sex, smoking status, and comorbidity. Patients were assigned a Townsend score (a measure of social deprivation) according to their area of residence. Outcome measures including the Disease Activity Score (DAS28), Health Assessment Questionnaire, Medical Outcomes Study Short Form-36, and EuroQol (EQ5D) were recorded at the beginning and end of the 3 year trial. The baseline, 3 year values, and change data were examined by Townsend quintile adjusting for each treatment arm. RESULTS: Significant relationships between increasing social deprivation by area of residence and higher disease activity, higher pain, poorer physical function, poorer emotional aspects of mental health, and lower quality of life were found at baseline (adjusted for age, sex, disease duration, current smoking, treatment center, and treatment group). During the 3 year trial period, patients from the most deprived areas showed greater improvement, with statistically significant greater improvement on DAS28 (p = 0.041) and 28 tender joint count (p = 0.015). CONCLUSION: Area of residence is related to the severity of RA at recruitment and is a predictor of response in a clinical trial situation. The results suggest that measures of SES should be recorded for patients enrolled in clinical trials, longitudinal observational studies, and in the clinical setting.