EFORT Congress program to include Diversity in Clinical Outcome Assessment Symposium
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Every EFORT annual congress highlights a specific main theme that is aligned with its mission of improving patient care. Each selected overarching topic or theme is reflected in the scientific program and used as a topic that drives all discussions and exchanges onsite. For the upcoming 2020 EFORT Congress in Vienna, EFORT will put forward the need to promote harmonization and diversity within the orthopaedics and traumatology community.
Harmonization is essential to build guidelines that apply equally on local, national and international levels, and lead to general agreement for treatment. However, diversity in orthopaedics and traumatology (O&T) practice implies that a same total amount of evidence will not necessarily prompt or result in the same guideline.
Orthopaedic patient populations of increasing diversity present themselves in the hospitals and clinical practices where orthopaedic surgeons work or are included in clinical trials and registers. Orthopaedic treatments are also available to more diverse patient groups due to globalization, worldwide economic growth and widening indications. Also, the variety of assessment tools and analysis methods is considerable.
This symposium investigates how the various dimensions of diversity, such as gender, ethnicity, culture, language, socioeconomic and educational background, age and other factors, not only can affect disease prevalence and treatment, but clinical outcome, its assessment, choice of tools and their usability and validity, design of clinical trials and outcome analysis.
According to the FDA, a clinical outcome assessment (COA) is “a measure that describes or reflects how a patient feels, functions or survives.”
More specifically, in the daily O&T medical practice, a COA is an assessment that provides direct or indirect evidence of the benefit of a given treatment. The tracking of clinical outcomes has been used in many ways to give providers feedback about implant design improvement (ie, the use of hip registries, which has led to the use of crosslinked polyethylene in hip replacement surgery) or improved perioperative care, unveiling the big potential of COAs. Indeed, in the past years, the development and use of COA measures within the medical device research specialty has exponentially grown, leading to the need of more accurate interpretation of the data. However, a COA might be influenced by the diversity of human choices or subjective judgments and will always depend on interpretation by and reporting from a clinician, patient or observer. Thus, it becomes imperative to take into account the limitations of COA measures linked to the challenges of data capture, analysis and non-standardized interpretation.
The main theme session at the upcoming EFORT 2020 Congress in Vienne, under the lead of Bernd Grimm, PhD, from the Sylvia Lawry Centre – The Human Motion Institute, in Munich, will analyze the pros and cons of different tools for human motion analysis, as well as discuss the variability in interpretation of patient-reported outcomes (PROs) that influence the O&T basic research specialty.
Diversity in Clinical Outcome Assessment
Symposium - General Topics - Basic Sciences
Wednesday 10 June 2020; 17:00 to 18:30 – Auditorium Geneva
Moderation: Bernd Grimm (Germany)
- Homogeneity and Diversity in Patients and Outcome Assessments in Orthopedic Studies: Potential and Limitations; Caroline Mouton (Luxembourg)
- Chronic Pain in Orthopaedics: Assessment and Diversity; Vikki Wylde (United Kingdom)
- Considering Diversity With Wearable Sensors and Objective Outcomes; Benedikt Braun (Germany)
- The Forgotten Joint Score: Assessment of Knee and Hip Outcomes in Diverse Populations; Karlmeinrad Giesinger (Switzerland)
When treating a patient, the main goal of any O&T surgeon is to find the best solution to improve the quality of the patient’s life while entirely fulfilling the patient’s expectations. Generally speaking, a bad preoperative score is associated with low postoperative satisfaction results. However, patients with severe preoperative diseases tend to have larger improvements following surgery. Literature has broadly analyzed factors that may or may not be related to satisfaction following surgery. Some factors that should be given consideration include age, sex, diagnosis, preoperative quality of life, type of surgical procedure, mental health and pain perception. In any orthopaedic treatment, diversity may also account for inhomogeneity in the patient characteristics, such as weight/BMI, comorbidities and others.
In addition to these defined factors, practitioners need also to consider if the study design for the research analysis does have an influence on the interpretation of outcomes. For instance, when considering the study groups to be used, it is legitimate to question whether the interpretation of the outcomes is distorted by the effect of the groups’ diversity alone. Although accurate studies always ensure comparison between diverse and homogeneous groups, the homogeneous group is most often considered as the baseline or reference point from which the change of response is measured. Linking evidence to the responses in homogenous groups appears, therefore, to be an essential step to build robust data and establish objective interpretation. Moreover, it could be interesting to understand to what extent the patient’s medical history, external to the clinical condition for which the outcome is assessed, influences his or her inclusion in either a diverse or homogenous group.
In the same sense, it may be possible that the patient behavior itself influences the treatment satisfaction scores. One parameter that clearly influences the objectivity of the assessment is the patient perception of pain. Indeed, the available tools for pain assessment (numerical rating scales, self-report pain questionnaires, etc.) might not be accurate enough to efficiently communicate to the practitioner how the pain is actually perceived by the patient. As pain is a highly subjective experience, reporting pain is a process directly affected by the patient’s cultural background (ethnicity/race), gender and psychological and social factors. By contrast, pain management necessitates objective standards of care to avoid inappropriate long-term complications in both acute and chronic scenarios.
The panel of speakers selected for this symposium will therefore broadly discuss advantages and disadvantages of homogeneity and diversity in patients, the pros and cons of subjective and objective assessment parameters, as well as how to evaluate the reliability of the clinical outcomes reported. To better illustrate this, specific examples of assessment tools will also be presented and reviewed. The use of wearable sensors for human motion analyses will be discussed. Knowing that joint kinematics can highly vary with morphological and function diversity, several questions will be raised regarding how different types of morphology and physical condition can influence the data collected by motion sensors. The last presentation will describe the Forgotten Joint Score (FJS), which comprises measures for the assessment of joint-specific outcomes focusing on the patient’s awareness of the joint (unintended perception linked to pain, stiffness, dysfunction or discomfort) in his or her everyday life. The FJS has been shown to have a better discriminatory power and less ceiling effect compared to traditional questionnaires that measure pain or function, but it can appear as an extremely variable parameter at different follow-up time points.
Homogeneity and diversity in patients and outcome assessments in orthopaedic studies are addressed, in general, which identify both potential and limitations in this context of variety and the need for compatibility. A special focus is placed on chronic pain and its assessment in the context of diversity. Using the FJS as an example it is shown how usability and validity can be achieved across diverse populations with a PRO measure. Considering the emergence of wearable sensors to monitor objective outcomes, the specific aspects of their usability validity and meaning, as well as the digital outcomes they provide, are explored in the symposium with patient diversity in mind.
Although diversity is the genuine reflection of different practices worldwide, harmonization becomes necessary for the standards of knowledge. Therefore, EFORT seeks to advocate the safety of patients as the absolute priority of harmonization and diversity through the detailed program of all the main theme sessions that are scheduled for the upcoming annual congress in Vienna.
The Diversity in Clinical Outcome Assessment Symposium is part of the core scientific program of the 2020 EFORT Congress and is open to fully registered attendees.
All details to sign-up are available on the congress registration platform. Visit the 2020 Congress website on a regular basis.
- For more information:
- All about the EFORT Annual Congress, 10 to 12 June 2020, Vienna, Austria.
- EFORT Annual Congress main theme: Harmonization and Diversity.