Leanne Idzerda

OMERACT : An international initiative to improve outcome measurement in rheumatology

OMERACT is the acronym for an international, informally organized network initiated in 1992 aimed at improving outcome measurement in rheumatology. Chaired by an executive committee, it organizes consensus conferences in a 2-yearly cycle that circles the globe. Data driven recommendations are prepared and updated by expert working groups. Recommendations include core sets of measures for most of the major rheumatologic conditions. Since 2002 patients have been actively engaged in the process.

Assessing Quality of Sleep in Patients with Rheumatoid Arthritis

We sought to identify instruments assessing sleep quality that measure the domains of sleep applicable to rheumatoid arthritis (RA) patients and are feasible to use and have appropriate reliability, validity, and responsiveness properties. A systematic review of sleep instruments was conducted. In particular, domains related to sleep that were assessed in the instruments were identified and evaluated. Feasibility characteristics and psychometric properties of instruments were reviewed. At OMERACT 9, the preparatory work was described at the plenary session of the Patient Perspective Workshop, and the tasks of 3 breakout groups in ranking and scoring the domains and sleep instruments were outlined. Each breakout group considered different aspects of sleep: sleep domains, feasibility, and psychometric properties. The rapporteur for each breakout group reported back to the plenary on the domains and sleep instruments that achieved the highest rank/score. The systematic review identified 45 sleep instruments of interest. Based on these instruments, 14 domains of sleep were identified. The top ranked domains were: Sleep Adequacy (1), Sleep Maintenance (2), Sleep Initiation (3) and Daytime Functioning (4). The top ranked instruments on feasibility were: Athens Insomnia Scale (2.3), Medical Outcome Study (MOS) Sleep (4.0), Insomnia Severity Index (4.9), and Women’s Health Insomnia Rating Scale (5.5). The highest scored instruments on psychometric properties were: Athens Insomnia Scale (13.6), Sleep Assessment Questionnaire (13), Pittsburgh Sleep Diary (12), and MOS Sleep (11). Sleep domains have been reviewed, and several sleep instruments have been identified. These instruments should be considered for use in planned clinical trials of RA patients to assess their applicability.

Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets

Objective. The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. Methods. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Results. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of the end product. Conclusion. This scoping review reinforced the need for clear methods and standards for core set development. Based on these findings, OMERACT will make its own conceptual framework and working process more explicit. Proposals for how to achieve this were discussed at the OMERACT 11 conference.

Toward a generalized framework of core measurement areas in clinical trials: a position paper for OMERACT 11.

Objective. The Outcome Measures in Rheumatology (OMERACT) international consensus initiative has successfully developed core sets of outcome measures for trials of many rheumatologic conditions, but its expanding scope called for clarification and updating of its underlying conceptual framework and working process. To develop a core set of what we propose to call outcome measurement instruments, consensus must be reached both on what to measure and how to measure. This article deals with the first part: a framework necessary to ensure comprehensiveness of the domains chosen for measurement. We formulated a conceptual framework of core measurement areas in clinical trials, for discussion at the OMERACT 11 conference. Methods. We formulated a framework and definitions of key concepts adapted from the literature, and followed an iterative consensus process (small group processes and an Internet-based survey) of those involved including patients, health professionals, and methodologists within and outside rheumatology. Results. The draft framework comprises 4 core “areas”: death, life impact (all aspects of how a patient feels or functions), resource use (monetary and other costs of the health condition and interventions), and pathophysiologic manifestations (disease-specific clinical and psychological signs, biomarkers, and potential surrogate outcome measures necessary to assess specific effects). The survey responses (262 of 2293, response rate 11%) indicated broad agreement with the draft framework and the proposed definitions of key concepts, including understandability and feasibility. A total of 283 comments were processed. Conclusion. In an iterative process, we have developed a generic framework for outcome measurement and working definitions of key concepts ready for discussion at the OMERACT 11 conference.

Access to primary healthcare services for the Roma population in Serbia: a secondary data analysis

BackgroundSerbia has proclaimed access to healthcare as a human right. In a context wherein the Roma population are disadvantaged, the aim of this study was to assess whether the Roma population are able to effectively access primary care services, and if not, what barriers prevent them from doing so. The history of the Roma in Serbia is described in detail so as to provide a context for their current vulnerable position.MethodsDisaggregated data were analyzed from three population groups in Serbia; the general population, the Roma population, and the poorest quintile of the general population not including the Roma. The effective coverage framework, which incorporates availability, affordability, accessibility, acceptability, and effectiveness of health services, was used to structure the secondary data analysis. Acute respiratory infection (ARI) in children less than five years of age was used as an example as this is the leading cause of death in children under 5 years old in Serbia.ResultsRoma children were significantly more likely to experience an ARI than either the general population or the poorest quintile of the general population, not including the Roma. All three population groups were equally likely to not receive the correct treatment regime of antibiotics. An analysis of the factors that affect quality of access to health services reveal that personal documentation is a statistically significant problem; availability of health services is not an issue that disproportionately affects the Roma; however the geographical accessibility and affordability are substantive issues that disproportionately affect the Roma population. Affordability of services affected the Roma and the poorest quintile and affordability of medications significantly affected all three population groups. With regards to acceptability, mothers from all three population groups are equally likely to recognize the importance of seeking treatment.ConclusionsThe Roma should be assisted in applying for personal documentation, the geographical accessibility of clinics needs to be addressed, and the costs of healthcare visits and medications should be reviewed. Areas for improvement specific to ARI are the costs of antibiotics and the diagnostic accuracy of providers. A range of policy recommendations are outlined.

Definitions and framework for knowledge translation to continue to evolve

Turning research into action should be a major aspect of any researcher’s livelihood. In this month’s issue of the Journal of Clinical Epidemiology, we start with an extremely interesting and relevant series on knowledge translation. We begin with a commentary by Beverly Shea who states that there is no one agreed-upon definition for knowledge translation e she indicates that there are in fact over 90 synonyms for knowledge translation, each with a myriad of definitions. The article by Straus et al. provides an overview of the science and practice of knowledge translation, including a framework for its use. The framework, adapted from the Canadian Institutes of Health Research (CIHR), provides an approach that clearly links knowledge generation and synthesis to knowledge translation and practice. As indicated in the CIHR knowledge to action cycle, knowledge syntheses are central to knowledge translation. The first article in this series by Tricco et al. provides a very useful step-by-step guide for conducting knowledge syntheses in the form of systematic reviews; other knowledge synthesis methods such as realist reviews and narrative reviews are also discussed. Majumdar examines three case studies with the intention of demonstrating high-quality and successful knowledge-to-action processes. The three case studies all share the following features; they evaluate well-designed interventions, have adequate sample sizes, use reasonable and robust analytic plans without any unitof-analysis errors, deliver valid results, and were published in high-impact mainstream general medical journals. As indicated in the CIHR knowledge to action framework, once the evidence has been synthesized it must undergo a process of dissemination and exchange with the affected parties to ensure the ethically sound application of knowledge. Gagnon presents and discusses approaches to knowledge dissemination and exchange and provides a summary of factors that appear to influence the effectiveness of these processes. In addition, they offer practical advice for researchers and knowledge users on what to include in the dissemination and exchange plans developed as part of grant applications. As with any intervention, it is important that the implementation process is monitored and evaluated for both impact and cost. Battacharyya et al. provide an overview of the useful and relevant resources that are available to guide the evaluation process. In addition, they discuss how study designs can focus on establishing inter-

Clinical epidemiology is alive and well in India

This month we are extremely pleased to present a series of articles written in collaboration with the International Clinical Epidemiology Network (INCLEN) groups in India. INCLEN is an international network of researchers that support and strengthen clinical epidemiological research in low and middle income countries. In 2007 an agreement was signed between INCLEN and the Journal of Clinical Epidemiology. Since then, the ties between the two organizations have strengthened. This series, authored by members of the India Clinical Epidemiology Units, is the latest of the fruits of that collaboration. Because the core function of the clinical epidemiology units in India is to develop and promote evidence-based medicine, the articles presented in this issue cover a wide variety of topics, including the burden of illness, diagnosis, scale validation, effectiveness, cost-effectiveness, the interpretation of evidence, reporting guidelines, and knowledge translation. The designs range from surveys, to case control studies, to randomized studies. These are all applied in the context of relevant clinical and community health problems seen in India. See the overview and summary of the articles included in the editorial by this month’s guest editor, Kurien Thomas. In other articles, Shiwa and colleagues investigated whether the methodological quality is influenced by language of publication in reports of randomized controlled trials and controlled clinical trials of physiotherapy interventions in the Physiotherapy Evidence Database [PEDro] scale. They assessed 13,392 reports of trials in either English or another language. They found that although English reports were more likely to have better methodological quality than reports written in other languages, the magnitude of this influence was small. The methodology used in this involved the use of total scores of study quality, which is contentious, as is pointed out by an accompanying commentary from da Costa et al. Quality scales assess several criteria related to the design, conduct, and analysis of trials, and each earns points that are aggregated into an overall score. The score determines the classification of the study as one of the higher or lower methodological quality, with the implication that bias has been prevented to a greater or lesser degree. The authors argue that the PEDro database’s inappropriate emphasis on the use of summary scores from a quality scale likely introduces a bias into systematic reviews and meta-analyses when these scores are

Influencing health equity : role of the effective consumer scale in measuring skills and abilities in a middle income country

The 2008 World Health Report emphasizes the need for patient-centered primary care service delivery models in which patients are equal partners in the planning and management of their health. It is argued that this involvement will lead to improved management of disease, improved health outcomes and patient satisfaction, better informed decision-making, increased compliance with healthcare decisions, and better resource utilization. This article investigates the domains captured by the Effective Consumer Scale (EC-17) in relation to vulnerable population groups that experience health inequity. Particular focus is paid to the domain of health literacy as an area fundamental to patients’ involvement in managing their condition and negotiating the healthcare system. In examining the possible influence of Outcome Measures in Rheumatology Clinical Trials (OMERACT) on health equity, we used the recent translation and validation of the EC-17 scale into Spanish and tested Argentina as an example. Future plans to use the EC-17 with vulnerable groups include formal collaboration and needs assessment with the community to tailor an intervention to meet its needs in a culturally relevant manner. Some systematic reviews have questioned whether interventions to improve effective consumer skills are appropriate in vulnerable populations. We propose that these populations may have the most to gain from such interventions since they might be expected to have relatively lower skills and health literacy than other groups.

Informed consent forms fail to reflect best practice.

Informed consent is a critical component of all clinical research; however, this process is often not appropriately administered with research participants. Informed consent has typically emphasized the provision of information over support to people making a difficult decision. In a study by Brehaut et al, informed consent documents were assessed for the degree to which they conform to the International Patient Decision Aid Standards for supporting decision making. They found that informed consent documents do not meet most validated standards for encouraging good decision making. Vested interest’s influence on guidelines is not always from industry involvement! Norris et al examined the relationship between guideline panel members’ conflicts of interest and guideline recommendations for mammography screening in asymptomatic women. They found that a guideline with at least 1 author who is a radiologist was more likely to recommend routine screening. In addition, the odds of a recommendation in favor of routine screening were related to the number of recent publications on breast disease diagnosis and treatment by the lead guideline author. The authors conclude that recommendations regarding mammography screening may reflect the specialty and intellectual interests of the guideline authors. Akl et al propose a new strategy to manage conflicts of interest within the context of guideline development. They propose giving primary responsibility to methodologists and making the content experts members of the guideline committee. This is a reversal in the dominant power structure. Following a series of semi-structured interviews with both methodologists and content experts, the authors found that methodologists believe this change will lead to more rigorous guidelines, while the content experts were worried that the methodologists’ lack of content knowledge could hurt the guidelines. In an interesting response to this article, Sniderman and Furberg contest this change in structure and propose their thoughts on addressing this issue of conflict of interest. Bias at the level of the systematic review is also alive and well! Orestis and Ioannidis investigated whether interpretation bias in meta-analyses might be an issue. They found that when interpreting meta-analyses that included their own study, authors who had published significant results were more likely to believe that a strong association existed as compared with methodologists with no vested interests.

Comparative effectiveness reviews need to pay as much attention to external validity as to internal validity risks of bias

This month we present the second part of the extremely interesting series from the Agency for Healthcare Research and Quality (AHRQ) on Comparative Effectiveness Reviews (CER) [1]. Atkins et al state in the opening paragraph of their article, the defining characteristic of comparative effectiveness research is that it includes ‘‘the conduct and synthesis of research comparing the benefits and harms of different interventions in real world settings with the purpose of determining which interventions are most effective for which patients in real world settings under specific circumstances.’’ A CER must therefore make judgments about whether the available research evidence reflects ‘real world’ practice, and should make clear for which patients or populations and which circumstances the review’s conclusions can be used to make clinical or policy decisions. Their article describes a systematic approach for identifying, reporting, and synthesizing information to allow consistent and transparent consideration of the applicability of the evidence in a systematic review (SR) using the PICO[S] framework (Population, Intervention, Comparator, Outcome, and Setting domains). Relevo and Balshem discuss the challenges of the complex search methodologies required to identify evidence for CERs. The search methods they describe attempt to overcome the bias inherent in the publication and distribution of clinical evidence. Bibliographic databases and search strategies are discussed, with special emphasis placed on searching for observational studies and harms data. Other techniques described include obtaining summary reports from regulatory agencies, the use of key articles, citation tracking, hand searching, and personal communications. Norris et al address the controversial issue of whether and when to include observational studies in systematic reviews of interventions. This centers around the fact that systematic reviewers disagree about the ability of observation studies to answer questions about intended effects of interventions. Many decision-makers, clinicians, and consumer groups now expect, even require this. Norris et al conclude that because it is unusual to find sufficient evidence from randomized controlled trials (RCTs) to answer all the key questions, particularly concerning the balance of benefits and harms, CERs should also routinely consider the inclusion of observational designs and propose a framework for doing so. Members of AHRQ and the Campbell and Cochrane Collaborations