From numbers to meaningful change:Minimal important change by using PROMIS in a cohort of fracture patients

Introduction: use of the Patient-Reported Outcomes measurement Information System (PROMIS®) is slowly increasing in patients with a fracture. Yet, minimal important change of PROMIS in patients with fractures has been addressed in a very limited number of studies. As the minimal important change (MIC) is important to interpret PROMIS-scores, the goal is to estimate the MIC for PROMIS physical function (PF), PROMIS pain interference (PI) and PROMIS ability to participate in social roles and activities (APSRA) in patients with a fracture. Secondly, the smallest detectable change was determined. Materials and methods: A longitudinal cohort study on patients ≥ 18 years receiving surgical or non-surgical care for fractures was conducted. Patients completed PROMIS PF V1.1, PROMIS PI V1.1 and PROMIS APSRA V2.0. For follow-up, patients completed three additional anchor questions evaluating patient-reported improvement on a seven point rating scale. The predictive modeling method was used to estimate the MIC value of all three PROMIS questionnaires. Results: Hundred patients with a mean age of 55.4 ± 12.6 years were included of which sixty (60%) were female. Seventy-two (72%) patients were recovering from a surgical procedure. PROMIS-CAT T-scores of all PROMIS measures showed significant correlations with their anchor questions. The predictive modeling method showed a MIC value of +2.4 (n = 98) for PROMIS PF, -2.9 (n = 96) for PROMIS PI and +3.2 (n = 91) for PROMIS APSRA. Conclusion: By using the anchor based predictive modeling method, PROMIS MIC-values for improvement of respectively +2.4 points on a T-score metric for PROMIS-PF, -2.9 for PROMIS-PI and +3.2 for PROMIS APSRA give the impression of being meaningful to patients. These values can be used in clinical practice for managing patient expectations; to inform on treatment results; and to assess if patients experience significant change. This in order to encourage patient centered care.</p

There are more things in physical function and pain: a systematic review on physical, mental and social health within the orthopedic fracture population using PROMIS

Background: The Patient-Reported Outcomes Information System (PROMIS®) is more and more extensively being used in medical literature in patients with an orthopedic fracture. Yet, many articles studied heterogeneous groups with chronic orthopedic disorders in which fracture patients were included as well. At this moment, there is no systematic overview of the exact use of PROMIS measures in the orthopedic fracture population. Therefore this review aimed to provide an overview of the PROMIS health domains physical health, mental health and social health in patients suffering an orthopedic fracture. Methods: This systematic review was documented according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. We searched Embase, Medline, Web of Science Core Collection, and Cochrane Central Register of controlled Trials, CINAHL and Google Scholar in December 2020 using a combination of MeSH terms and specific index terms related to orthopedic fractures and PROMIS questionnaires. Inclusion criteria were available full text articles that were describing the use of any PROMIS questionnaires in both the adult and pediatric extremity fracture population. Results: We included 51 relevant articles of which most were observational studies (n = 47, 92.2%). A single fracture population was included in 47 studies of which 9 involved ankle fractures (9/51; 17.6%), followed by humeral fractures (8/51; 15.7%), tibia fractures (6/51; 11.8%) and radial -or ulnar fractures (5/51; 9.8%). PROMIS Physical Function (n = 32, 32/51 = 62.7%) and PROMIS Pain Interference (n = 21, 21/51 = 41.2%) were most frequently used questionnaires. PROMIS measures concerning social (n = 5/51 = 9.8%) and mental health (10/51 = 19.6%) were much less often used as outcome measures in the fracture population. A gradually increasing use of PROMIS questionnaires in the orthopedic fracture population was seen since 2017. Conclusion: Many different PROMIS measures on multiple domains are available and used in previous articles with orthopedic fracture patients. With physical function and pain interference as most popular PROMIS measures, it is important to emphasize that other health-domains such as mental and social health can also be essential to fracture patients

Explaining prediction models to trauma patients: An experiment and interview study

Objectives: Recently, efforts have been made to collect and model data on quality of life after an injury. Although such prediction models could be used for clinical guidance, patients might also benefit from knowing how their life will be affected after an injury. We therefore conducted two studies to (1) gain more insight into the effect different information types have on understanding personalized predictions and (2) explore how patients feel about receiving such predictions. Methods: In the first study (N=983, normal population), we manipulated comparative risk information (e.g., performing better or worse than the average patient) and communication format (e.g., textual only or text and visual information). We tested if this affected (1) risk understanding, (2) risk perceptions and (3) negative feelings. Our pre-registered hypotheses were that people who received worse-than-average-risks would have higher risk perceptions (H1a) and more negative feelings (H1b) than people who received better-than-average-risks. Additionally, we hypothesized that people receiving the information in text and visuals would have higher risk perceptions (H2a), risk understanding (H2b) and more negative feelings (H2c) than people in the text-only condition. In the second study, we conducted interviews (N=30 trauma patients). Relevant themes were identified using thematic analysis. Results: For study 1, we did not find support for our hypotheses. We found that in general, understanding risks was problematic. However, patients do have a need for personalized predictions. For study 2, we found that patients valued personalized predictions, although they are sometimes hard to understand. Receiving such predictions would help with planning for life after an injury better. Conclusions: We conclude that although understanding personalized predictions might be difficult, patients do have a need for them and receiving such predictions does not lead to overly worrying as the information would help with planning for life after an injury better

Using PROM(I)S to measure health-related quality of life in patients with a bone fracture:An observational cohort study

Introduction: The incidence of patients with fractures is increasing and so is the impact on health care systems and society. To improve patient care, measurement of disabilities and impaired health experiences after traumatic musculoskeletal injuries are important. Next to objective clinical parameters, PROM(I)S can be used to map health domains important to patients. We aimed to objectify different aspects of (health-related) quality of life in fracture patients, including the ability to participate in social roles and activities using PROMIS among other PROMs. Methods: An observational cohort study was performed in which health-related quality of life in fracture patients was measured. Patients aged 18 year and older either treated conservatively or surgically between November 2020 and June 2022 were included. Participants were followed for a maximum of one year and completed the following PROMs: PROMIS-CAT physical function, PROMIS-CAT pain interference, PROMIS-CAT ability to participate in social roles and activities and LEFS or QDASH. We applied a univariate linear mixed model to evaluate significance of improvement. Results: Seven hundred-forty six patients with a mean age of 54.4 years were included. Mean PROMIS scores were structurally inferior in the lower extremity (LE) fracture group in comparison with the upper extremity (UE) fracture group. For “PROMIS physical function”, UE fracture patients performed better and showed physical progression earlier. For “PROMIS pain interference”, UE fracture patients experienced fewer limitations, but it took longer to experience improvement in this group. For “PROMIS ability to participate in social roles”, significant improvement was only seen in the UE fracture group at one year follow up.Conclusion: Upper -and lower extremity fractures can have a significant impact on physical function and social health. Patients with UE fractures tend to have fewer limitations compared to LE fracture patients. Physical function and pain interference is most impaired shortly after the injury in all fracture patients and show significant changes over time, social health improves less over time. Moment of measurement should be based on type of fracture and can differ between individual patients, but when generic measures and outcomes are desirable, PROMIS questionnaires can potentially be used measurement.</p