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Objective.The Outcome Measures in Rheumatology (OMERACT) Shared Decision Making (SDM) Working Group aims to determine the core outcome domain set for measuring the effectiveness of SDM interventions in rheumatology trials.Methods.A white paper was developed to clarify the draft core domain set. It was then used to prepare for interviews to investigate reasons for lack of consensus on it and to suggest further improvements.Results.OMERACT scientists/clinicians (n = 13) and patients (n = 10) suggested limiting the core domain set to outcome domains, removing process domains, and clarifying remaining domains.Conclusion.A revised core domain set will undergo further consensus-building.

Objective.The Outcome Measures in Rheumatology (OMERACT) Safety Working Group is identifying core safety domains that matter most to patients with rheumatic disease.Methods.International focus groups were held with 39 patients with inflammatory arthritis to identify disease-modifying antirheumatic drug (DMARD) experiences and concerns. Themes were identified by pragmatic thematic coding and discussed in small groups by meeting attendees.Results.Patients view DMARD side effects as a continuum and consider the cumulative effect on day-to-day function. Disease and drug experiences, personal factors, and life circumstances influence tolerance of side effects and treatment persistence.Conclusion.Patients weigh overall adverse effects and benefits over time in relation to experiences and life circumstances.

Objective.Despite the importance of shared decision making for delivering patient-centered care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this Outcome Measures in Rheumatology (OMERACT) working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspectives of patients, health professionals, and researchers.Methods.We followed the OMERACT Filter 2.0 method to develop a draft core domain set by (1) forming an OMERACT working group; (2) conducting a review of domains of shared decision making; and (3) obtaining opinions of all those involved using a modified nominal group process held at a session activity at the OMERACT 12 meeting.Results.In all, 26 people from Europe, North America, and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the draft core set: (1) identifying the decision, (2) exchanging information, (3) clarifying views, (4) deliberating, (5) making the decision, (6) putting the decision into practice, and (7) assessing the effect of the decision. Contextual factors were also suggested.Conclusion.We proposed a draft core set of shared decision-making domains for OA intervention research studies. Next steps include a workshop at OMERACT 13 to reach consensus on these proposed domains in the wider OMERACT group, as well as to detail subdomains and assess instruments to develop a core outcome measurement set.

There is great concern about clearly defining benefit and risk in the context of both drug development and clinical practice. In view of this pressure, the OMERACT Executive identified the need to bring together clinical trialists, pharmacoepidemiologists, clinicians, clinical epidemiologists, statistical experts, and regulatory representatives to discuss different approaches to define risk and perhaps improved ways to express it. Each attendee spoke on a given topic and the group was charged to consider the issue of risk in the context of formally posed questions. This article provides a summary of the presentations and outlines the discussions that followed.

Programs and initiatives have been created to empower, educate, and provide information to consumers; these are sometimes generically known as self-management interventions. Evaluating and comparing such programs has been a challenge, as many skills that consumers believe are important to manage and participate in their individual healthcare are not currently captured by existing tools. The objective of the Effective Musculoskeletal Consumer Project is to develop a scale to measure an effective consumer. A review of the literature, interviews, workshops, and preliminary surveys at OMERACT 7 (May 2005) were conducted in the first phases of the Project. A questionnaire consisting of 64 items was developed to measure the skills and attributes of an effective musculoskeletal (MSK) consumer. Content experts on our team reduced this scale to 48 items, which was pilot-tested with consumers from Canada and Australia. Dimensionality assessment showed that the scale was unidimensional. Classical and item response theory analyses showed that the 48-item scale had quite high reliability, but that 2 items were very poor. Based on the item analysis, 35 items were retained. The revised scale was presented at OMERACT 8, where a panel reviewed the scale and provided input. This input and another expert review by our team was used to further refine the Effective Consumer Scale to 17 items. Plans are now under way to validate this 17-item scale in self-management interventions.

The Cochrane Musculoskeletal Group (CMSG), one of 50 groups of the not-for-profit international Cochrane Collaboration, prepares, maintains, and disseminates systematic reviews of treatments for musculoskeletal diseases. To enhance the quality and usability of systematic reviews, the CMSG has developed tailored methodological guidelines for authors of CMSG systematic reviews. Recommendations specific to musculoskeletal disorders are provided for various aspects of undertaking a systematic review, including literature searching, inclusion criteria, quality assessment, grading of evidence, data collection, and data analysis. These guidelines will help researchers design, conduct, and report results of systematic reviews of trials in the following fields of musculoskeletal health: gout, osteoarthritis, osteoporosis, pediatric rheumatology, rheumatoid arthritis, soft tissue rheumatism, spondyloarthropathy, systemic lupus erythematosus, systemic sclerosis, and vasculitis. Systematic reviews need to be conducted according to high methodological standards. These recommendations on developing and performing a systematic review will help improve consistency among CMSG reviews.

Hip fractures are a major cause of morbidity for older women, which result in impaired health related quality of life (HRQOL). Few studies have prospectively evaluated the effect of hip fractures in women on HRQOL with different health state preference measures. We compared how 4 different preference measures change in women post-hip fracture and evaluated the responsiveness of the preference measures. We also compared HRQOL in women with recent hip fractures to a control sample at baseline and to normative Canadian data at followup.Health status measures [the Medical Outcomes Study Short Form-36 (SF-36)] and preferences (direct and indirect) of women over age 50 years with hip fractures were measured at baseline and at 3 and 9 months. Baseline preferences [Health Utilities Index (HUI), Feeling Thermometer, Standard Gamble, and SF-36] were obtained from women without hip fractures for comparison. Independent sample t tests were used to compare baseline scores of fracture and nonfracture controls. Correlations between preference and health status measures were assessed and repeated measures ANOVA was used to assess change in health status and preferences over time.Health status and preference measures were lower in women with hip fractures in comparison to nonfracture controls. After 9 months, the SF-36, HUI, Feeling Thermometer, and SF-6D scores improved significantly. Values for the SF-36 remained lower than an age-matched normative sample. The HUI and SF-6D were sensitive to change over time, but the Standard Gamble was not.HRQOL and preference measures improve over time in women with recent hip fractures, with the majority of the change occurring in the initial 3 months. Our results suggest that the HUI and SF-6D are valid measures to assess change over time post-hip fracture.

To assess the quality of reporting in Cochrane musculoskeletal systematic reviews (excluding back and injury reviews).This study assessed all the Cochrane Musculoskeletal Group's systematic reviews from Issue 4, 2002, of the Cochrane Library Database of Systematic Reviews. Two reviewers independently extracted data and assessed quality. Two assessment tools were used, including an 18 item checklist and flow chart developed by the Quality of Reporting of Meta-analysis (QUOROM) consensus group, and a 10 item scale, the Oxman-Guyatt Overview Quality Assessment Questionnaire (OQAQ). One question on the latter scale (item 10) scores overall quality on a 7 point scale, with high scores indicating superior quality. Data were analyzed using univariate approaches.The 57 systematic reviews assessed were found to have good overall quality, with scores on individual items revealing only minor flaws. Documenting the flow of included and excluded studies and summarizing the results are 2 areas needing improvement in reporting. According to the Oxman-Guyatt scale the overall scientific quality of the Cochrane musculoskeletal reviews was good [mean 5.02 (95% CI 3.71-6.32)].Our study found that the reporting quality of Cochrane musculoskeletal systematic reviews was generally good, although there was room for improvement. For example, it might be feasible to develop specific guidelines for reporting protocols. Certainly more work is needed in reporting search results, documentation of the flow of studies, identification of the type of studies, and summarization of the key findings.

The OMERACT 7 Effective Musculoskeletal Consumer Workshop brought together people with rheumatoid arthritis, healthcare professionals, and researchers to discuss what they thought made a musculoskeletal consumer effective at managing their disease. Preliminary work before OMERACT provided a draft list of potential characteristics of an effective consumer. Participants at the workshop provided feedback about the list including relevance, missing items, format, and language. The feedback provided was useful and will be incorporated into a revised list to aid in the development of an instrument to measure health consumer effectiveness.

Toxicity, safety, and tolerability are integral facets of patient risk/benefit decisions, yet the capacity to define, measure, and compare these aspects is underdeveloped compared to aspects of efficacy. There are many reasons for this, scientific and administrative, but all are surmountable. Probably the greatest primary obstacle is the absence of a measurement instrument designed specifically for this purpose. There are increasing calls from various stakeholders for better evidence, and therefore better ascertainment, in this area, especially in randomized trials, and for these reasons OMERACT began deliberations about these concepts in 1994. A prototype coding instrument (the Rheumatology Common Toxicity Criteria) was developed and discussed at OMERACT 5. In the 2 years before OMERACT 7, a process of concept development and iterative design and testing were conducted to develop a patient self-report and investigator-reported adverse event instruments designed for use in trials at the time of visit. The predominant workload is performed by the patient in a self-report checklist, which is then mapped by the trialist onto a medically sophisticated version. This article presents background on the process of developing a dual adverse event instrument, which was presented and critically discussed in detail at OMERACT 7.

A presentation, demonstration, and discussion of recently developed adverse event instruments were the topics for the OMERACT 7 Drug Safety Module. The module began with a plenary introducing the needs and challenges of adverse event ascertainment. It was followed by a review of module work from previous OMERACT meetings on a prototype coding instrument (Rheumatology Common Toxicity Criteria), then a brief description of the process behind the recently developed patient self-report and investigator report adverse event instruments. These current instruments are designed for use in controlled trials although they could be used in other settings. The instruments rely primarily on patient self-reporting using a checklist, which the investigator then folds into a parallel structured but more medically sophisticated instrument. In pilot testing, this innovative dual-use system has shown reliability and acceptability, while preserving validity. A "stakeholder panel" of representatives from 8 sectors followed--patient, nurse investigator, regulator, clinician scientist, industry, OMERACT, global public health/WHO, and Cochrane Collaboration--for their perspectives on the needs, challenges, and potential ways forward for adverse event ascertainment and reporting in clinical trials. At the breakout session small focus groups participated in hands-on interactive testing of one of 3 versions of the instruments, which differ in degree of comprehensiveness. Each focus group had a participatory patient with rheumatoid arthritis. At a second plenary there was group feedback by rapporteurs and presentation of results from pilot studies of iterative testing of validity, reliability, and feasibility of the instruments. During plenary discussion a frequent suggestion for improvement was to refine the process so that event ascertainment could be done entirely using the patient instrument with minimal input from the investigator at the visit, if patient-investigator agreement was high. Most found the patient checklist attractive, particularly if the patient instrument was shown to be reliable and valid. Finally, a future research agenda was discussed.

To compare the safety and efficacy of a topical diclofenac solution versus oral diclofenac in relieving the symptoms of primary osteoarthritis (OA) of the knee, in a randomized, double-blind, double-dummy equivalence trial.A total of 622 men and women with radiological evidence of primary knee OA and mild to severe symptoms were randomly assigned to treatment with a topical diclofenac solution plus placebo oral capsules, or placebo topical solution plus oral diclofenac (50 mg) capsules. Patients applied 50 drops of study solution and took 1 study capsule 3 times daily for 12 weeks. Efficacy variables were pain and physical function, measured by the Western Ontario and McMaster Universities (WOMAC) VA 3.1 OA Index, and patient global assessment (PGA). Equivalence in the per-protocol group was based on previously defined ranges of clinically significant difference. Safety was assessed by evaluation of adverse events, vital signs, and laboratory data.The difference in mean (95% CI) change scores (final minus baseline) between treatments was 13.3 mm (-8.6 to 35.2) for pain (total scale 500 mm), 71.0 mm (-2.4 to 144.5) for physical function (total scale 1700 mm), and 4.3 mm (-1.2 to 9.8) for PGA (total scale 100 mm). The CI for each efficacy variable fell within the predefined equivalence ranges (pain, +/- 75 mm; physical function, +/- 255 mm; PGA, +/- 20 mm), indicating that no clinically relevant difference was found between the 2 treatment arms. Safety analyses of patients applying topical diclofenac solution revealed some minor skin irritation at the application site--mostly skin dryness in 83/311 (27%) patients--but a significantly reduced incidence, relative to oral diclofenac, of total and severe gastrointestinal (GI) adverse events, including dyspepsia, abdominal pain, diarrhea, and nausea. The number of patients developing abnormal liver function tests (including clinically significant elevation), hemoglobin, and creatinine clearance was significantly higher in the oral diclofenac group.Application of this topical diclofenac solution to the knee of patients with OA produced relief of symptoms equivalent to oral diclofenac, with minor local skin irritation, but significantly reduced incidence of diclofenac-related GI complaints and abnormal laboratory values.