A catalogue of PROMs in sports science: Quality assessment of PROM development and validation

et al. 2021

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Results by patient‐reported outcome measures (PROMs) from randomized controlled trials (RCTs) in musculoskeletal research often influence healthcare strategies. We aimed to evaluate to which extent these RCTs use adequate PROMs, and how this influences the results and conclusions. We identified RCTs of sports research relevance with PROMs as primary outcomes published in 13 preselected journals between January 1, 2008, and November 1, 2019; all journals regularly publish results from musculoskeletal research. Five journals have a high impact factor (>15), and eight with lower impact factors are widely read journals. It was assessed whether the RCTs had used PROMs with high content validity and whether the most adequate PROMs were used (ie, the most well developed and well validated for the patients enrolled in the study). We registered journal impact factor, year of publication, existence of a registered protocol, and whether the study showed significant difference between interventions. A total of 54 RCTs with 56 primary outcomes comprising 26 different PROMs were identified. For 13 RCTs (24%), a protocol was not published. In only 24 of RCTs (44%), the most appropriate PROM had been used as primary outcome, independent of a registered protocol, ranking of the journal, and year of publication. In seven cases, PROMs were used to evaluate a condition that they had not been developed for. RCTs that used the most adequate PROM showed significantly more often (46%) difference in outcomes in contrast to RCTs that used inadequate PROMs (22%) (P = 0.0483). In conclusion, in the majority of RCTs, the most adequate PROM had not been used. Studies, in which the most adequate PROM had been used as outcome, were significantly more likely to show significant difference between interventions. The extent to which protocols were not available was surprisingly high. Journals should request that adequate PROMs are used in RCTs, and if this is not the case that it is discussed how it might influence the results and conclusions. Likewise, it should be requested that a protocol is published or registered.

Section: Methodsmentioning

confidence: 99%

Are adequate PROMs used as outcomes in randomized controlled trials? an analysis of 54 trials

Hansen

Jensen

et al. 2021

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“…The use of an inadequate PROM might be as bad or worse than using a creatinine kit to measure 25-OH-vitamin D. Unfortunately, only 10%-15% of PROMs for musculo-skeletal conditions can be characterized as appropriate. 11,12 Few studies have assessed the effect of using unspecific PROMs for specific conditions (such as a generic PROM like SF-36 for knee injury) or a specific PROM for a condition that is different from the one being studied (eg, a shoulder instability PROM for patients with rotator cuff tears). These studies have shown that PROMs developed and validated for the type of patients in question also are more responsive, 13 which implies that they are better tools for revealing possible treatment effects than PROMs not directly developed and validated for the targeted patients.…”

Section: Overview Of the Ten Articles Of This Seriesmentioning

confidence: 99%

What is a PROM and why do we need it?

Krogsgaard

Siersma

et al. 2020

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The purpose of this article was to introduce the reader to the nature of patient‐reported outcome measures (PROMs) and pitfalls in their use. PROMs collect subjective information directly from the patient regarding specific or general conditions and add to clinical and functional outcomes, and turn unmeasurable subjective qualities into quantitative measures. PROMs are questionnaires consisting of items: questions or statements with predefined response options. The items in an adequate PROM have been developed by involvement of patients with the condition in focus, and the PROM has been validated for these patients using suitable statistical methods. An adequate well‐targeted PROM is more responsive than an inadequate PROM. Unfortunately, many studies use inadequate PROMs as outcomes. The methods used to generate PROMs should be described as thoroughly as those used to develop any other types of measurement instruments, and the choice of PROM should always be explained and thereby justified. If the PROM used is not adequate, the consequences for the interpretation of the results should be discussed. In many cases, an adequate PROM does not exist. If the best available PROM is chosen, there are methods to validate the adequacy of the chosen PROM, which make an interpretation of the study results possible.

“…Validation of the construct(s) was not included in the analyses for this study, as this has been assessed elsewhere 8 . Also, assessment of development of the original version has been covered in 8 …”

Section: Methodsmentioning

confidence: 99%

“…In most cases, PROMs are developed in one language and culture and then translated and adapted to other languages and settings. The most commonly used PROMs in sports science were all developed within the Western culture 8 . The main and most important objective of the translation and adaptation process of a PROM across settings is to transfer the meaning of each item and construct encompassed in the PROM from the original language and culture into another language and culture.…”

Section: Introductionmentioning

confidence: 99%

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How to translate and locally adapt a PROM. Assessment of cross‐cultural differential item functioning

Krogsgaard

Christensen

et al. 2020

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Translating patient‐reported outcome measures (PROMs) can alter the meaning of items and undermine the PROM's psychometric properties (quantified as cross‐cultural differential item functioning [DIF]). The aim of this paper was to present the theoretical background for PROM translation, adaptation, and cross‐cultural validation, and assess how PROMs used in sports medicine research have been translated and adapted. We also assessed DIF for the Knee Injury and Osteoarthritis Outcome Score (KOOS) across Danish, Norwegian, and Swedish versions. We conducted a search in PubMed and Scopus to identify the method of translation, adaptation, and validation of PROMs relevant to musculoskeletal research. Additionally, 150 preoperative KOOS questionnaires were obtained from the Scandinavian knee ligament reconstruction registries, and cross‐cultural DIF was evaluated using confirmatory factor analysis and Rasch analysis. There were 392 studies identified, describing the translation of 61 PROMs. Ninety‐four percent were performed with forward‐backward technique. Forty‐nine percent used cognitive interviews to ensure appropriate wording, understandability, and adaptation to the target culture. Only two percent were validated according to modern test theory. No study assessed cross‐cultural DIF. One KOOS subscale showed no cross‐cultural DIF, two had DIF with respect to some (but not all) items, and thus conversion tables could be constructed, and two KOOS subscales could not be pooled. Most PROM translations are of undocumented quality, despite the common conclusion that they are valid and reliable. Scores from three of five KOOS subscales can be pooled across the Danish, Norwegian, and Swedish versions, but two of these must be adjusted for DIF.