Patient-reported outcome measures: it is time for authors, reviewers, journal editors and health care strategists to take sufficient responsibility

Abstract

The misuse and abuse of patient-reported outcome measures (PROMs) in musculoskeletal research is leading to increasingly irresponsible healthcare recommendations. PROMs are progressively used as primary outcomes in clinical studies of musculoskeletal conditions, and there are multiple examples of the marked impact of such studies on recommended healthcare strategies. Typically, these studies ind no diference in patient-reported outcome scores when comparing surgical treatment with other interventions (in most cases physiotherapy), or ind diferences believed not to be clinically relevant. A number of these studies have been published in high-ranking journals, and consequently, many national healthcare strategies do not recommend surgical treatment, at least not as the irst choice. For essentially all these high-impact studies, it is well-documented that the PROMs are of questionable quality.Strangely, there is no universal standard for documenting the quality of PROMs as outcomes. It is essential that clinical studies involving humans follow rules related to ethical issues according to the Helsinki declaration, to the handling of data according to the General Data Protection Regulation, to authorship according to criteria of the International Committee of Medical Journal Editors, and to the validity of clinical measurement methods (i.e., clinical biochemical analyses or physical measurements), and also that data are structurally meticulously prepared and presented, for example according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All these issues must be

No difference in return to play rates between different elite sports after primary autograft ACL reconstruction

“…The lack of validated, patient reported outcome measures (PROM) can also be considered a limitation. However, it has recently been argued that a clinical outcome such as return to sport is more appropriate than a PROM that has not been validated for use in the condition or outcome being studied [18]. RTP rates and times, better understanding of the performance levels after ACL-R and the risks of further surgery and re-rupture are of far more importance to the athletes and their teams than a score result.…”

Quality of life in adolescents with chronic non-traumatic knee pain: An analysis of 323 adolescents with Patellofemoral Pain and Osgood-Schlatter Disease

“…Adolescents reporting use of pain medication did not score lower quality of life compared to adolescents reporting no use of pain medication. Sex was not associated with lower QoL, and older participants (age [17][18][19] reported lower QoL than younger participants (Figure 2). Adolescents having bilateral knee pain reported similar levels of QoL as adolescents having unilateral knee pain, and lastly, for BMI, we observed no difference in perceived QoL between any of the predefined groups.…”

“…Second, recent studies emphasize that current measures of QoL are prone to conceptual and methodological challenges and may lack validity of the target construct 10,11,19 . This means our data must be interpreted cautiously as we may have missed important dimensions of QoL 11,18,19,45 .…”

MCID and PASS in Knee Surgeries. Theoretical Aspects and Clinical Relevance References

“…The final result is presented on a 0–100 scale, with zero representing extreme knee problems and 100 equating no problems. However, when this scale is applied to assess the outcomes following procedures such as opening wedge high tibial osteotomy (OWHTO) or anterior cruciate ligament (ACL) reconstruction, the individual subscale and overall total score can be difficult to interpret and convey to both clinicians and patients [16, 26, 54].…”