Quality of reporting of randomized clinical trials in abstracts of the 2005 annual meeting of the American College of Rheumatology.

Objective: To determine the quality of abstracts reporting randomized clinical trials (RCT) at the 2005 Annual Scientific Meeting of the American College of Rheumatology.

Methods: All 2005 abstracts including late-breaking abstracts were assessed. An abstract was deemed to be reporting an RCT if it indicated that participants were randomized in the title or body of the abstract. RCT were excluded if they included only pharmacokinetic data. The CONSORT checklist was applied and relevant data extracted. We defined manufacturer support as acknowledgment of industry support or industry employee as co-author.

Results: Of 2146 abstracts, 143 (6.7%) reported RCT. Of these, 78.3% were drug trials, and 63.6% indicated manufacturer support. Only 30.8% of abstracts used "randomized" in the title, 44.1% did not explicitly state whether blinding was undertaken, and only 7.0% clearly stated who was blinded. Thirty percent of studies did not give an explicit definition of eligibility criteria of participants. While 84.6% explicitly described the experimental intervention, only 37.1% explicitly described the comparator intervention. Only 21% explicitly stated that an intention to treat analysis was performed. Baseline demographic and clinical characteristics were reported in 48.3%. While most abstracts reported summary results for each treatment group, only 35.7% reported effect size with its precision.

Conclusion: The quality of reporting is suboptimal in many RCT abstracts. Abstracts reporting RCT would benefit from a structured approach that ensures more detailed reporting of eligibility criteria, active and comparator interventions, flow of participants, and adequate summary and precision of results.

Stakeholder satisfaction with the Australian Rheumatology Association Database (ARAD)

Background: The Australian Rheumatology Association Database (ARAD) is a voluntary national registry for monitoring the long-term benefits and safety of biological disease-modifying anti-rheumatic drugs (bDMARDs) for inflammatory arthritis. Both rheumatologists and patients contribute data to the ARAD.

Objective: To evaluate the satisfaction of patients and rheumatologists with the ARAD.

Methods: Cross-sectional surveys were distributed to a random sample of 100 community-dwelling ARAD patients in 2007 and to rheumatologists attending the 2007 AustralianRheumatologyAssociation (ARA) annual scientific meeting.

Survey questions included items about the usefulness of the ARAD, workload for participants, frequency of questionnaires, and experience of contact with ARAD staff.

Results: A total of 92.5% of patients perceived the ARAD as very important (scoring 9-10 on a numeric rating scale). Patients reported minimal difficulty in completing questionnaires, and 95.0% indicated that a 6-month interval between questionnaires was reasonable. Of responding rheumatologists, 32.3%, 62.1%, and 53.8% indicated that the ARAD was very important (scoring 8-10) with respect to clinical information, research, and the profession, respectively, while 68% of those participating in the ARAD reported that the workload required to enroll patients was manageable and 30% found it difficult or onerous.

Conclusion: Key stakeholders in the ARAD view it as an important resource and are satisfied with its operations. Efforts will be directed towards assisting those rheumatologists who find the associated workload difficult and to improving the perceived clinical value of information available from the ARAD.

Ankylosing spondylitis patients commencing biologic therapy have high baseline levels of comorbidity: a report from the Australian Rheumatology Association Database

Aims: To compare the baseline characteristics of a population-based cohort of patients with ankylosing spondylitis (AS) commencing biological therapy to the reported characteristics of bDMARD randomised controlled trials (RCTs) participants.
Methods: Descriptive analysis of AS participants in the Australian Rheumatology Association Database (ARAD) who were commencing bDMARD therapy.
Results: Up to December 2008, 389 patients with AS were enrolled in ARAD. 354 (91.0%) had taken bDMARDs at some time, and 198 (55.9%) completed their entry questionnaire prior to or within 6 months of commencing bDMARDs. 131 (66.1%) had at least one comorbid condition, and 24 (6.8%) had a previous malignancy (15 nonmelanoma skin, 4 melanoma, 2 prostate, 1 breast, cervix, and bowel). Compared with RCT participants, ARAD participants were older, had longer disease duration and higher baseline disease activity.
Conclusions: AS patients commencing bDMARDs in routine care are significantly different to RCT participants and have significant baseline comorbidities.

Baseline comorbidities in a population-bases cohort of rheumatoid arthritis patients receiving biological therapy: data from the Australian Rheumatology Association database

Aims: To describe the baseline characteristics of an Australian population-based cohort of rheumatoid arthritis (RA) patients commencing biological therapy.

Methods: Descriptive analysis from the Australian Rheumatology Association Database (ARAD).

Results: Up to October 2006, there were 681 RA patients taking biologics enrolled in ARAD. Baseline data were available for 624 (72% female, mean (SD) age 57.0 (12.5) years). Of these, 59.5% reported at least one comorbid condition, most commonly hypertension (35.7%) and osteoporosis (30.4%); 61 (9.8%) had a history of malignancy (35 nonmelanoma skin, 5 breast, 4 bowel, 5 cervix, 3 melanoma, 3 prostate and 1 each of lip, lung, myeloma, testis, uterus, vagina). Self-reported infections within the previous 6 months were common (71.5%).

Conclusions: History of comorbidities, including recent infections, is common among Australian RA patients commencing biologics, and 10% have a history of malignancy. This may impact future evaluations of health outcomes among this population, including attribution of adverse events of biologic therapy.

Tenocyte responses to mechanical loading in vivo : A role for local insulin-like growth factor 1 signaling in early tendinosis in rats

Objective
To investigate tenocyte regulatory events during the development of overuse supraspinatus tendinosis in rats.

Methods
Supraspinatus tendinosis was induced by running rats downhill at 1 km/hour for 1 hour a day. Tendons were harvested at 4, 8, 12, and 16 weeks and processed for brightfield, polarized light, or transmission electron microscopy. The development of tendinosis was assessed semiquantitatively using a modified Bonar histopathologic scale. Apoptosis and proliferation were examined using antibodies against fragmented DNA or proliferating cell nuclear antigen, respectively. Insulin-like growth factor 1 (IGF-1) expression was determined by computer-assisted quantification of immunohistochemical reaction. Local IGF-1 signaling was probed using antibodies to phosphorylated insulin receptor substrate 1 (IRS-1) and ERK-1/2.

Results
Tendinosis was present after 12 weeks of downhill running and was characterized by tenocyte rounding and proliferation as well as by glycosaminoglycan accumulation and collagen fragmentation. The proliferation index was elevated in CD90+ tenocytes in association with tendinosis and correlated with increased local IGF-1 expression by tenocytes and phosphorylation of IRS-1 and ERK-1/2. Both apoptosis and cellular inflammation were absent at all time points.

Conclusion
In this animal model, early tendinosis was associated with local stimulation of tenocytes rather than with extrinsic inflammation or apoptosis. Our data suggest a role for IGF-1 in the load-induced tenocyte responses during the pathogenesis of overuse tendon disorders.

Low-intensity pulsed ultrasound for chronic patellar tendinopathy : a randomized, double-blind, placebo-controlled trial

Objective. Patellar tendinopathy (PT) is a common and significant clinical condition for which there are few established interventions. One intervention that is currently being used clinically to manage PT symptoms is the introduction of low-intensity pulsed ultrasound (LIPUS). The aim of this study was to investigate the clinical efficacy of LIPUS in the management of PT symptoms.

Methods. A randomized, double-blind, placebo-controlled study was conducted. Volunteers with clinically and radiologically confirmed PT were randomly allocated to either an active-LIPUS (treatment) or inactive-LIPUS (placebo) group. LIPUS was self-administered by participants for 20 min/day, 7 days/week for 12 weeks. All participants also completed a daily, standardized eccentric exercise programme based on best practice. Primary outcomes were change in pain during the participant's most aggravating activity in the preceding week, measured on 10 cm visual analogue scales for both usual (VAS-U) and worst (VAS-W) tendon pain.

Results. Out of 156 individuals who volunteered, 37 met the eligibility criteria and were randomized to either active-LIPUS (n = 17) or inactive-LIPUS (n = 20). Using an intention-to-treat analysis, VAS-U and VAS-W for the entire cohort decreased by 1.6 ± 1.9 cm (P < 0.01) and 2.5 ± 2.4 cm (P < 0.01), respectively. There were no differences between the active- and inactive-LIPUS groups for change in VAS-U (–0.2 cm; 95% CI, –1.5, 1.1 cm) (P = 0.74) or VAS-W (–0.5 cm; 95% CI, –2.1, 1.1 cm) (P = 0.57). A per-protocol analysis provided similar results.

Conclusions. These findings suggest that LIPUS does not provide any additional benefit over and above placebo in the management of symptoms associated with PT.

Evaluating quality of life in hip and knee replacement: psychometric properties of the World Health Organization Quality of Life short version instrument

Objective: To evaluate the psychometric properties of the World Health Organization Quality of Life short version instrument (WHOQOL-BREF), and to determine its responsiveness in assessing early outcome after total hip or knee replacement surgery.

Methods: At baseline (entry to an orthopedic waiting list), 279 participants completed the WHOQOL-BREF instrument, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Assessment of Quality of Life (AQOL) instrument, Kessler Psychological Distress (K10) scale, and the modified Health Assessment Questionnaire (MHAQ). A total of 74 patients completed reassessments 3 months after surgery.

Results: The WHOQOL-BREF demonstrated acceptable internal consistency for all domains (Cronbach's = 0.76-0.84) and moderate concurrent validity for the physical and psychological domains (r = 0.67 for physical versus AQOL; r = -0.71 for psychological versus K10). Minimal ceiling or floor effects were identified at baseline or 3 months, except for the social relationships domain. The disease-specific WOMAC subscales were most responsive to change (relative efficiency [RE] 0.66-1.00). Apart from social relationships, all WHOQOL-BREF scores improved significantly after surgery. The physical domain was more responsive than the AQOL (RE 0.50 versus 0.42) and was similar to the MHAQ (RE 0.55 for MHAQ). The responsiveness of the psychological domain was similar to that of the K10 scale (RE 0.11 versus 0.08).

Conclusion: The WHOQOL-BREF has good psychometric properties for use in persons with severe joint disease, and by providing complementary information, it offers clinicians and researchers an additional tool for comprehensively assessing quality of life in this patient group.

Change of perspective: a measurable and desired outcome of chronic disease self-management intervention programs that violates the premise of preintervention/postintervention assessment

Objective: To determine if participants in chronic disease self-management courses have a change of perspective of their health status (a response shift), and if this is measurable with a paper-based questionnaire.

Methods: Nine items were developed to measure potential benefits of self-management courses. These were based on the constructs of a previous questionnaire, the Health Education Impact Questionnaire (HEI-Q). Cognitive interviews elicited spontaneous statements about the reasons for paper-based answers. Sensitivity, specificity, and overall accuracy of items were calculated using the interview as a relative gold standard. Response shift can be negative (i.e., after the course, participants realize that, before the course, they were worse than they thought they were), positive (i.e., participants now realize they were better than they thought they were), or absent (no change).

Results: Interviews (n = 39) reflected that true response shift occurred in approximately half the replies to questionnaire items. Of these, 31% were negative response shift, 20% were positive response shift. Response shift was absent in 32% of replies. Presence or absence of response shift could not be determined in 17% of replies across items. Significant concordance between questionnaires and cognitive interviews (average overall accuracy 0.79) indicated that the HEI-Q Perspective questionnaire detects response shift in participants of self-management courses. The questionnaire revealed that 87% of participants had response shift in at least 1 item.

Conclusion: This study suggests that preintervention/postintervention assessments of interventions such as self-management courses are confounded by a change in perspective of a large proportion of respondents. It also indicates response shift is a valuable outcome of self-management courses that can be measured with a paper-based questionnaire.

Role of age, sex, and obesity in the higher prevalence of arthritis among lower socioeconomic groups: a population-based survey

Objective: To compare the prevalence of arthritis among population groups based on demographic, socioeconomic, and body mass index (BMI) characteristics; to investigate the combined influence of these factors on arthritis; and to assess the relationship between self-reported health and psychological distress and arthritis.

Methods: Data from the Victorian Population Health Survey (n = 7,500) were used in the study. Psychological distress was assessed using the Kessler Psychological Distress scale, and self-reported health was assessed by a single item. Multiple logistic regression was used to investigate the combined influence of demographic and socioeconomic factors and BMI on arthritis.

Results: Overall, 23% of Victorian adults (20% men and 26% women) reported having arthritis. The presence of arthritis was associated with high psychological distress (odds ratio [OR] 1.2; 95% confidence interval [95% CI] 1.1-1.4) and poor self-reported health (OR 1.9; 95% CI 1.7-2.1). Increased prevalence of arthritis was found in older age groups, lower education and income groups, and in people who were overweight or obese. Women had higher risk of arthritis, even after adjustment for age, residence, education, occupation, income, and BMI. Age and BMI independently predicted arthritis for men and women. For men, higher risk of arthritis was also associated with lower income.

Conclusion: Arthritis is a highly prevalent condition associated with poor health and high psychological distress. Prevalence of arthritis is disproportionately high among women and individuals from lower socioeconomic backgrounds. As the prevalence of arthritis is predicted to increase, careful consideration of causal factors, and setting priorities for resource allocation for the treatment and prevention of arthritis are required.

Prevalence and cost of musculoskeletal disorders: a population-based, public hospital system healthcare consumption approach.

Objective: To use a population-level, public-hospital approach to compare the prevalence and cost of musculoskeletal diseases (MSD) with other clinical specialties.

Methods: A healthcare utilization survey of 4 million individual records over 4 years, from all major public hospitals in the state of Victoria (estimated population 4.8 million residents in 2000/01) from 1997/98 to 2000/01. Main outcome measures were inpatient episodes of care, bed-days, and outpatient clinic encounters. MSD was defined as the combination of orthopedics and rheumatology.

Results: After obstetrics, MSD was the most frequent outpatient service, with orthopedics accounting for 9.9% of all visits in 2000/01. The proportion of MSD outpatient encounters (on average 11.6% of the total) was constant over the study period. Among 26 medical specialties, MSD had the sixth highest number of inpatient episodes (6.2% in 2000/01), following renal dialysis (14.6%), general surgery (8.2%), obstetrics (7.6%), gastroenterology (7.1%), and general medicine (6.7%). MSD was the fifth highest consumer of bed-days, occupying on average 7.7% of all beds per annum in the period 1997/98 to 2000/01, behind psychiatry (10.1%), respiratory medicine (8.5%), rehabilitation (8.3%), and general medicine (7.8%). MSD was the third most-costly discipline in 2000/01, with total costs of over A dollars 169 million (9.7% of total inpatient costs that year), behind respiratory medicine (11.6%) and general surgery (11.5%).

Conclusion: Compared to other diseases, MSD consumes a substantial proportion of healthcare resources in Victorian public hospitals. These data have important implications for allocation of healthcare resources, clinical care pathways, and prevention strategies.

Does self-management lead to sustainable health benefits in people with arthritis? A 2-year transition study of 452 Australians.

Objective: To evaluate the Arthritis Self-Management Course (ASMC) when applied in a nationwide context.

Methods: Four hundred fifty-two people who participated in the ASMC across Australian states took part in a longitudinal followup study. ASMC is a 6 week, 2 h group educational program designed to assist people with chronic illness to better manage their condition. Measures of program effectiveness included health status and service utilization. Data were collected on 3 occasions: before intervention (baseline) and 6 months and 2 years after the program.

Results: Several indicators of health status showed improvement at 6 months following the ASMC. These included reduction in pain (4%; p < 0.001), fatigue (3%; p < 0.01), and health distress (12%; p < 0.001) as well as increase in self-efficacy (6%; p < 0.001). Increased self-efficacy was a significant predictor of positive change in health status. Health-related behaviors such as aerobic exercise also increased, with the proportion of people who did little or no exercise decreasing by up to 8%. These changes were sustained at 2 years. There was an increase in use of analgesics at 6 months and an increase in use of nonsteroidal antiinflammatory drugs at 2 years. No changes in healthcare utilization (physician visits, allied health visits, and hospitalizations) were observed.

Conclusion: The ASMC is a widely applied program in which participants benefit through a reduction in pain, fatigue, and health distress. Although the absolute changes in health status are small, the low cost and wide application of the intervention suggests the program may have a substantial public health effect.