Systematic reviews and quality assessment of patient-reported outcome measures for physical function in comparative effectiveness studies regarding acute postoperative pain after total knee arthroplasty—Do we need to start all over again?

Background and Objective
Recently, a consensus process specified a core outcome set (COS) of domains to be assessed in each comparative effectiveness research and clinical practice related to acute postoperative pain. Physical function (PF) was one of these domains. The aim of this review was to investigate which patient-reported outcome measures (PROMs) are used to assess PF after total knee arthroplasty (TKA) in clinical trials and if they fulfil basic requirements for a COS of PROMs based on their psychometric properties.

Methods
A systematic review of randomized controlled trials and observational studies based on a search in MEDLINE, EMBASE and CENTRAL was undertaken. PROMs and performance measures were extracted and investigated, including evaluation of psychometric properties of PROMs based on COSMIN recommendations.

Results
From initially 2896 identified records, 479 studies were included in the qualitative synthesis. Only 87 of these trials (18%) assessed PF using PROMs, whereas especially performance outcome measures were used in 470 studies (98%). Application of the ‘COSMIN Risk-of-Bias-Box 1’ to 13 of the 14 identified PROMs resulted in insufficient content validity of the included PROMs regarding the target population based on the inauguration or development articles.

Conclusion
Our data indicate that a patient-centred postoperative assessment of PF in pain-related clinical trials early after TKA is not common, even though patient-reported assessment is widely recommended. In addition, none of the applied PROMs shows content validity based on their inauguration or development articles for the assessment of postoperative pain-related PF after TKA.

Significance
A systematic search for patient-reported outcome measures assessing postoperative, pain-related physical function after total knee arthroplasty in clinical trials and assessment of their content validity revealed none that fulfilled requirements based on COSMIN recommendations.

Aim

The aim of this review was to investigate which patient-reported outcome measures (PROMs) are used to assess PF after total knee arthroplasty (TKA) in clinical trials and if they fulfil basic requirements for a COS of PROMs based on their psychometric properties.

Contributors

H. Heitkamp, D. Heußner, D. C. Rosenberger, K. Schnabel, D. Rosenthal, S. Bigalke, T. V. Maeßen, D. Hohenschurz-Schmidt, H. Liedgens, U. Kaiser, E. M. Pogatzki-Zahn

Publication

Journal: European Journal of Pain
Volume:
Issue:
Pages: -
Year: 2024
DOI: 10.1002/ejp.2272

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No (777500). This joint undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA


Health Area

Disease Category: Anaesthesia & pain control

Disease Name: Postoperative pain

Target Population

Age Range: 18 - 99

Sex: Either

Nature of Intervention: Management of care

Stakeholders Involved

Study Type

- Recommendations made

Method(s)

- Systematic review

A systematic review of randomized controlled trials and observational studies based on a search in MEDLINE, EMBASE and CENTRAL was undertaken. PROMs and performance measures were extracted and investigated, including evaluation of psychometric properties of PROMs based on COSMIN recommendations.