Numerous clinical research initiatives are ongoing at CEOS. Below please find a selection of current projects.
Reporting and Methodology of Clinical trials
- We have performed several studies on the quality of reporting and the risk of bias of published clinical research. Recently, we completed 2 systematic reviews of methodology and reporting of observational studies published in top orthopaedic journals. This research highlights drawbacks in these studies with the aim of improving future work in the area.
Advancing methods for Investigating Heterogeneity in Systematic reviews and Meta-Analyses
- We have an ongoing research program which has been aimed at advancing the methods by which differences between studies included in systematic reviews are explored and reported. The overall goal of which is to improve the validity of such investigations and to increase the applicability of systematic reviews to patient care and related decision making. We are currently creating guidelines for judging the credibility of investigations of heterogeneity testing several novel biostatistical methods (e.g., recursive partitioning, conical correlation analysis) for their use in such investigations. This research is funded by the NLM.
Cohort Study of Surgical and Non-surgical interventions for Rotator Cuff Tears
- We are currently performing a pragmatic Cohort study with 230 participants in which our primary outcome is to compare the effectiveness of surgical and non-surgical approaches to managing rotator cuff tears. In addition, we all creating predictive models for a large set of variables, specifically on how such variables predict outcomes and allocation in each treatment group. We are giving patients several patient reported outcome measures (e.g., SANE, WORC, ASES, PROMIS, VR-12 etc) and following them for a 2 year period. We currently have 106 patients who have completed the 2 year follow-up and we have over 85% patient retention in our study.
Patient Transfer Checklists in Surgery
- With funding from the Blue Cross Blue Shield of Michigan Foundation, we created a patient transfer checklist by reviewing the literature, performing focus groups, pilot testing a checklist and finally revising it. We are now implementing an electronic version of the checklist that will be automatically populated, increasing its ease of use. We are testing how this checklist influence the rate of preventable adverse events in orthopaedic patients.
Michigan Shoulder Registry Initiative
- In 2009 we started the Michigan Shoulder Registry which we are still operating today. This registry includes patient with rotator cuff tears and follows them forward in time assessing outcomes and performing predictive modeling. We currently have close to 600 patients in the registry and are expanding it to 3 additional sites. This registry focuses on understanding patient progress, predictors of outcomes, predictors of allocation to treatment and health care quality. Many research questions have been examined in this population.
Minimally important Difference of patient reported outcomes
- One measure of responsiveness, the minimally important difference (MID), sometimes called the minimal clinically important difference, is the smallest detectable change in a score that is deemed relevant or meaningful. The MID is an obviously patient-centered approach in that it allows the patient themselves to determine the level of improvement or worsening deemed important and relevant. We are currently generating MID values for 3 outcomes measures in patients with rotator cuff disease. The Western Ontario Rotator Cuff Index (WORC), the American Shoulder and Elbow Society score (ASES) and the Patient Reported Outcome Measurement Information System (PROMIS).
- We are performing several studies aimed at improving the use of evidence-based medicine methods amongst practicing surgeons. A recent project surveyed orthopaedic surgeons with an effort to understand current practices. In addition, we are planning a randomized study of the interpretation of effect measures (Odds Ratios, Relative Risks, Risk Differences) for published research in orthopaedic surgeons. In addition, we are in the process of developing smart phone applications and user interfaces that can help practicing physicians and other health-acre providers to practice evidence medicine and stay atop the scientific literature.
Psychometric properties of outcome measures in Orthopaedics
- We recently completed a systematic review of the psychometric evidence for outcomes measures for use in patients with rotator cuff tears. We are currently performing similar studies for outcomes measures used in patients with knee and hip pathologies. This research will improve our knowledge of the validity, reliability and responsiveness of existing outcome measures and highlight where more work is require and what measures appear to have the “best” psychometric characteristics.
Core Outcome Set for Rotator Cuff Disease
- We are currently performing a series of projects aimed at creating a core outcome set for rotator cuff disorders. The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. A recent review of the measurement properties of patient reported outcome measures for rotator cuff disorders revealed a large selection of diverse measures, many with questionable validity, reliability and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials for a specific clinical area. These sets do not imply that outcomes in a particular trial should be restricted to those in the COS. Rather, there is an expectation that the core outcomes will always be collected and reported, and that researchers will continue to explore other outcomes. The methods include a comprehensive systematic literature review and assessment of the properties of outcome measures, identifying and involving relevant stakeholders, and using consensus based methods to develop a COS. We are currently surveying stakeholders.
Shoulder Registry and Cohort Study Involving Patients with Chronic or Acute Rotator Cuff Injuries
- These prospective pragmatic studies attempt to examine the long term outcomes of rotator cuff injuries, in particular, full thickness rotator cuff tears, on functional outcomes. Despite the prevalence of rotator cuff surgeries there is a paucity of evidence related to outcomes of operative versus non-operative treatment in the long term. These studies will allow various treatment modalities to be compared over time and attempt to better inform clinicians regarding issues such as treatment allocation.
Systematic Reviews of the Psychometric Properties of Patient-reported Outcome Instruments for Use in Patients with Rotator Cuff Disease, Total Knee Arthroplasty, Total Hip Arthroplasty, Foot & Ankle pathologies, Hand & Wrist disorders and Elbow pathologies
- Many patient-reported outcome instruments have been developed for use in patients with rotator cuff disease, and in patients who undergo total knee or total hip arthroplasties. Before implementing an outcome instrument one should carefully evaluate the psychometric properties of the instrument, and the methodological quality of studies that investigate psychometric properties of the instrument. Together, the psychometric evidence and the methodological quality can then be used to arrive at an overall estimate of an instrument’s quality.
- In the systematic review projects, we are identifying the patient-reported outcome instruments for use in the above patient groups from the published literature. We are critically appraising the psychometric properties of the identified instruments for use in these populations, together with the methodological quality of the selected studies, and finally, summarizing the results and writing manuscripts for publication.
Core Outcome Sets for Musculoskeletal Conditions
A core outcome measurement set is an agreed upon selection of outcome measures are recommended to be used in clinical research for particular conditions. These measures are not the only ones to be used, but are the core that should routinely be used. Core outcome sets (COSs) are developed through consensus methods and systematic reviews of the psychometric evidence for particular measures. We are currently developing COSs for should pain, rotator cuff disease, and neck pain.