Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial.

The vast majority of smokers are unable or unwilling to quit, but many are open to reducing smoking. No treatment options exist for these smokers besides medication-based therapies. Thus, this study investigated the efficacy of a cognitive behavioral therapy (CBT) smoking reduction program, Smoke_less. A sample of 155 outpatient smokers aged 18-70 years was recruited at the Tobacco Dependence Outpatient Clinic of the Medical Center of the University of Munich, Germany, and randomly assigned to the experimental group (Smoke_less: four weekly CBT group sessions and two telephone calls over 5 weeks, n = 51), active comparator group (one 15-minute counseling session, n = 49), or waiting control group (no intervention during the study, n = 55). The primary endpoint was a ≥50% smoking reduction in the intention-to-treat group 1 week and 6 months after the intervention. We evaluated also abstinence rates at follow-up. Significantly more participants in the Smoke_less group had reduced smoking ≥50% compared to the waiting group at 1 week [OR 7.59 (2.59-22.19)] and 6 months [OR 5.00 (1.68-14.84)] and compared to the active comparison group at 1 week [OR 8.58 (2.67-27.31)] but not at 6 months [OR 1.73 (0.71-4.20)]. We found no significant effects on abstinence rates. The CBT smoking reduction program Smoke_less is effective for smoking reduction but is superior to brief counseling only in the short term. Further research is required to improve its efficacy in long-term smoking reduction to provide a valid, non-medication-based alternative to smokers unable or unwilling to quit. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02337400.

Hand deformities are important signs of disease severity in patients with early rheumatoid arthritis.

OBJECTIVES: The aim of this study was to investigate the occurrence and significance of hand deformities during the first 10 years of RA. METHODS: One hundred and eighty-three early RA patients were included in the study during 1985-89. Mean +/- S.D. of age at onset was 51.4 +/- 12.4 years, and mean duration of symptoms before inclusion 12 +/- 7 months; 64% were women. The patients were followed annually. Assessment of hand deformities was standardized. Hand mobility was measured by signals of functional impairment (SOFI), disability by HAQ and hand HAQ, disease activity by ESR and radiographic changes by the Larsen method. RESULTS: One hundred and eight (59%) patients developed at least one hand deformity during the study time. The majority occurred during the first years. After 10 years, the rate of ulnar deviation, button hole deformity and swan neck deformity was 44, 24 and 23.5%, respectively. The deformity group showed significantly higher disease activity during the first 5 years, and significantly more hand impairment, more disability and more severe radiographic changes throughout the study. Presence of a deformity after 1 year increased the risk of developing a Larsen score above median after 5 years. Odds ratio (95% CI) was 2.1 (1.023, 4.385). CONCLUSIONS: More than half of the patients in this early RA cohort had developed hand deformities after 10 years. Most deformities occurred during the first year of the disease. Presence of hand deformities had an impact on daily life function and added useful prognostic information, being an early sign of a more severe disease.

Repair of Erosions in Patients with Rheumatoid Arthritis.

OBJECTIVE: The aim of this study was to examine the occurrence of repair in a cohort of conventionally treated patients with early rheumatoid arthritis over 8 years. METHODS: There were 395 patients included in the BARFOT study having radiographs of hands and feet at inclusion, and at 1, 2, 5, and 8 years, which were chronologically scored for erosions by the Sharp/van der Heijde method. An erosion with repair was defined as an erosion that has become partially or totally filled, with or without sclerosis. RESULTS: Erosions with repair were observed in 64 patients (16%) at 1 year, 113 (29%) at 2 years, 142 (36%) at 5 years, and 200 (51%) at 8 years. At the 1-year visit, 13% of the patients with at least 1 new erosion showed repair versus 3% of the patients with no new erosions (p = 0.001). At 2, 5, and 8 years the corresponding figures were 22% and 6%, 28% and 8%, and 39% and 11%, respectively (all p = 0.001). The sum of all repaired erosions correlated strongly with the sum of all erosions and with the sum of all erosion scores (ρ = 0.79 and 0.77). Presence of rheumatoid factor (RF) and anticyclic citrullinated peptide antibodies (anti-CCP) was significantly associated with both new erosions and repair. CONCLUSION: Repair was more common than previously described. The frequency of repair increased over time and was associated with the number of erosions. RF- and anti-CCP-positivity, patient age, and presence of erosions at baseline were independent predictors of repair.

Importance of Measuring Hand and Foot Function Over the Disease Course in Rheumatoid Arthritis: An Eight-Year Follow-Up Study.

OBJECTIVE: To assess function using the Signals of Functional Impairment (SOFI) instrument over 8 years, to study clinical variables associated with the change, and to study change over time of the SOFI items. METHODS: In total, 1,223 patients with early rheumatoid arthritis (RA) from the Better Anti-Rheumatic Farmacotherapy (BARFOT) cohort (mean ± SD age 56.9 ± 15.4 years, 67% women) were included in the analysis. Data from baseline and from 1 and 8 years were studied. The SOFI instrument includes measures of range of motion in the hand, shoulder/arm, and lower extremity (range 0-44, best to worst). The effects of baseline variables (sociodemographic, disease activity, joint destruction, and function) on change in SOFI scores were studied by linear regression analysis. RESULTS: During the first year, the improvement in mean ± SD SOFI scores was 2.7 ± 5.7 (P < 0.001). Worse scores in the Disease Activity Score in 28 joints and Health Assessment Questionnaire score at baseline were associated with this improvement (r2 ≤ 0.11). During the next 7 years, the deterioration in SOFI scores was mean ± SD 1.5 ± 4.9 (P < 0.001). Based on change scores, we found that finger flexion, pincer grip, and toe-standing were the most important items to measure, explaining 58-61% of the total SOFI score, and these items were also associated with radiographic changes at the 8-year follow-up. CONCLUSION: Function as assessed with SOFI scores improved during the first year in patients with early RA, but it deteriorated slowly thereafter. Impaired hand and foot function was associated with joint destruction at the 8-year follow-up. Measures of hand and foot function will complement self-reported and medical data, both in clinical work and in long-term research studies.

Occupational therapy during the first 10 years of rheumatoid arthritis.

OBJECTIVE: To describe disease development and occupational therapy during the first 10 years of rheumatoid arthritis (RA), and to assess patients' experiences of occupational therapy and comprehensive care. METHODS: A total of 168 early RA patients with variable disease severity were followed up with regular team visits. The occupational therapist evaluated hand function and activity and performed the necessary interventions. These were recorded and the number of visits generating interventions was calculated. Semi-structured interview of 11 patients regarding their views of occupational therapy and team contact was performed. RESULTS: Impairments of hand function were in general mild to moderate and remained fairly unchanged over time. Activity limitations increased slowly. Half of the follow-up visits generated interventions. Most common were prescriptions of assistive devices and orthoses, hand-training instructions and patient education. The patients interviewed were positive regarding occupational therapy and felt safe with comprehensive care. CONCLUSION: RA patients in all stages of the disease benefit from regular contact with an occupational therapist and team care.

Development of functional impairment and disability in rheumatoid arthritis patients followed for 20 years: relation to disease activity, joint damage, and comorbidity.

OBJECTIVE: To study the course of impairment measured by Signals of Functional Impairment (SOFI) and disability measured by the Health Assessment Questionnaire (HAQ) over 20 years in rheumatoid arthritis (RA) patients followed from the time of diagnosis, and to explore the contribution of disease activity, joint damage, and comorbidity to variation of SOFI and HAQ over time. METHODS: Patients diagnosed with RA from 1985-1989 were prospectively monitored. There were 183 patients, 63% women, mean ± SD age 52 ± 12 years. Disease activity was measured by the 44-joint Disease Activity Score (DAS), joint damage by Larsen score, and comorbidity by the Charlson Comorbidity Index. The contribution of comorbidity, DAS, and joint damage on development of SOFI and HAQ was studied at 0, 5, 10, 15, and 20 years followup (hierarchical regression model) and over the total study period using a longitudinal regression model. RESULTS: SOFI progressed over 20 years while progression of HAQ levelled off after 10 years. For SOFI, DAS and joint damage contributed the most (2-28% and 3-31%, respectively). Over 20 years, SOFI was explained by DAS (20%), joint damage (20%), age (7%), and comorbidity (4%). For HAQ, DAS contributed the most (4-24%). Over 20 years, HAQ was explained by DAS (20%), joint damage (2%), sex (7%), comorbidity (6%), and age (4%). CONCLUSION: Over 20 years, 51% of the variation of SOFI and 39% of the variation of HAQ could be explained by age, sex, variations in comorbidity, disease activity, and joint damage. Over time, disease activity contributed significantly to both SOFI and HAQ. Joint damage contributed predominantly to SOFI.

Experiences from a prospective early rheumatoid arthritis study in southern Sweden.

Characteristics of an ongoing longitudinal observational study of patients with established rheumatoid arthritis (RA) are described. The sample comprised 183 patients enrolled from 1985 to 1989. Disease duration at inclusion was 1 year. Patients were referred from primary care and were included in the study irrespective of disease severity, with evaluation at a team care unit every 6 to 12 months. The assessment comprised a broad spectrum of standardized measures that covered the potentially most important disease outcomes. After 10 years the dropout rate was only 3%. Results to date from this study are summarized. Findings include disease course and remission rate, physical function, radiographic progression, hip involvement, mortality, work disability, and economic consequences.

Early changes in bone mineral density measured by digital X-ray radiogrammetry predict up to 20 years radiological outcome in rheumatoid arthritis.

INTRODUCTION: Changes in bone mineral density (BMD) in the hand as evaluated by digital X-ray radiogrammetry (DXR) of the second to fourth metacarpal bones has been suggested to predict future joint damage in patients with rheumatoid arthritis (RA). This study's objective was to investigate whether DXR-BMD loss early in the course of the disease predicts the development of joint damage in RA patients followed for up to 20 years. METHODS: A total of 183 patients (115 women and 68 men) with early RA (mean disease duration, 11 months) included from 1985 to 1989 were followed prospectively (the Lund early RA cohort). Clinical and functional measures were assessed yearly. Joint damage was evaluated according to the Larsen score on radiographs of the hands and feet obtained in years 0 to 5 and years 10, 15 and 20. These radiographs were digitized, and BMD of the second to fourth metacarpal bones was evaluated by DXR. Early DXR-BMD change rate (that is, bone loss) per year calculated from the first two radiographs obtained on average 9 months apart (SD ± 4.8) were available for 135 patients. Mean values of the right and left hand were used. RESULTS: Mean early DXR-BMD loss during the first year calculated was -0.023 g/cm2 (SD ± 0.025). Patients with marked bone loss, that is, early DXR-BMD loss above the median for the group, had significantly worse progression of joint damage at all examinations during the 20-year period. CONCLUSIONS: Early DXR-BMD progression rate predicted the development of joint damage evaluated according to Larsen score at year 1 and for up to 20 years in this cohort of early RA patients.

Work disability in rheumatoid arthritis--development over 15 years and evaluation of predictive factors over time.

OBJECTIVE: To investigate work disability rates over 15 years in an early rheumatoid arthritis (RA) cohort and to evaluate predictive factors during the course of the study. METHODS: All patients with early RA of working age (n = 148) were followed and treated at a team care unit. Mean disease duration at inclusion was 1 year. Work characteristics and disease-related variables were recorded annually. Logistic regression analyses were performed to identify predictors for work disability after 5, 10, and 15 years. RESULTS: Work disability rates were 28%, 35%, 39%, and 44% at study start and after 5, 10, and 15 years, respectively. Forty-seven patients reduced working hours and 34 changed work tasks during the study time. Older age, less education, heavy manual work, and much activity limitation assessed by Health Assessment Questionnaire (HAQ) were predictors of work disability. Demographics and work factors had best predictive value in the early phase, while HAQ was a strong predictor at all points in time. Odds ratios for baseline HAQ, 5 year HAQ, and 10 year HAQ were 6.3, 9.6, and 4.1 for work disability after 5, 10, and 15 years, respectively. CONCLUSION: The prevalence of work disability was 28% at inclusion. After 15 years' followup the prevalence was 44%, which is lower than previously reported. HAQ was the single prognostic factor with strong predictive value throughout the study.

Modeling the progression of rheumatoid arthritis: a two-country model to estimate costs and consequences of rheumatoid arthritis.

OBJECTIVE: Two simulation models were developed to analyze the cost-effectiveness of new treatments that affect the progression of rheumatoid arthritis (RA). METHODS: We used data from 2 cohorts of patients with early RA who had been followed up since disease onset (up to 15 years). In the Swedish study, 183 patients were followed up for a mean of 11.3 years. In the UK study, 916 patients were followed up for a mean of 7.8 years. Disease progression over 10 years was modeled as annual transitions between disease states, defined by Health Assessment Questionnaire (HAQ) scores. A regression model was used to estimate transition probabilities conditional on age, sex, and time since onset of disease, in order to allow simulation of different patient cohorts. Costs and utilities associated with different HAQ levels were based on data from the cohort studies and cross-sectional surveys. RESULTS: Costs increase and quality of life decreases as RA progresses. In Sweden, total annual costs range from 4,900 dollars to 33,000 dollars per patient, compared with 4,900 dollars to 14,600 dollars in the UK. Cumulative costs over 10 years for patients starting in disease state 1 (HAQ < 0.6) are 54,600 dollars in Sweden and 26,600 dollars in the UK. The cumulative numbers of quality-adjusted life-years (QALYs) are 5.5 and 5.6, respectively. Both costs and QALYs were discounted at 3%. CONCLUSION: The 2 models, which were based on different patient cohorts, reach a similar conclusion in terms of the effect of RA over 10 years. They appear to accurately capture disease progression and its effects and can therefore be useful in estimating the cost-effectiveness of new treatments in RA.

Measuring health related quality of life in patients with rheumatoid arthritis--reliability, validity, and responsiveness of a Swedish version of RAQoL.

OBJECTIVE: To adapt the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire for Swedish patients and evaluate psychometric properties in a prospective study. METHODS: Reliability was assessed in 61 patients filling in RAQoL two times with one week's interval. 114 patients completed RAQoL and Nottingham Health Profile (NHP) on 2-3 occasions 6 months apart. Validity was evaluated comparing RAQoL-scores to disease-related variables and NHP subscales. Standardized response mean was applied to calculate responsiveness with the RA-related variables as external indicators of change. RESULTS: Test-retest reliability was high and internal consistency sufficient. RAQoL correlated as expected to NHP section scores. In a multivariate model the Stanford Health Assessment Questionnaire disability index (HAQ) and general health could explain 40% and disease activity measures 13% of the variance of RAQoL. Correlations between change scores of clinical variables and RAQoL and NHP were weak but positive. Standardized response means regarding change of disease activity, HAQ, and general health were small but in the same range for both RAQoL and NHP. CONCLUSION: The Swedish RAQoL had similar measurement properties as the original version. However, responsiveness regarding condition specific measures was not better than for the generic instrument NHP.