An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial.

BACKGROUND: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality. METHODS: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%. DISCUSSION: There is a high potential for transferring the intervention into routine practice if the evaluation is positive. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021.

Implementation of patient-reported outcome assessment in routine cancer care: A systematic review of multicentric programs in Europe.

INTRODUCTION: To give an overview of patient-reported outcome measures (PROMs) programs in routine cancer care that allow for both major purposes of PROM assessment: 1) monitoring of an individual patient's outcome to assist treatment decision making, and 2) use in quality improvement initiatives including the benchmarking of providers. We synthesize information on program elements like the mode of assessment and questionnaire used, as well as information relevant for adaptation following a PDCA scheme. METHOD: We carried out a systematic literature research in the databases PubMed and EMBASE using MeSH terms and keywords related to PROM assessment in routine cancer care to identify eligible studies published between January 2003 and November 2018 (PROSPERO reg. no. CRD42019141402). We included studies in which PROM assessment programs had been reported as being implemented in clinical practice as well as collected multicentrically with at least one site in Europe and in which PROMs had been collected before and at least once after intervention. Study authors were queried to verify or correct the program elements extracted and merged during the review. Study quality assessment was not done, since it is not expedient for the objective of this review. RESULTS: Overall, 5,545 unique references were identified, 5,416 of which were excluded after the screening of titles and abstracts. Of the 29 references assessed, five programs were identified and included in the synthesis. The programs included those from Germany, Austria, Denmark, the Netherlands and the UK, and patients with different cancer types and tumor stages, which used paper-based or purely electronic PROM assessment. DISCUSSION AND CONCLUSION: Few reports have so far been published on PROM programs that allow for both the monitoring of an individual patient's outcome and use in quality improvement initiatives. The studies revealed relevant information on existing PROM programs and gave valuable insight into issues that need to be considered when setting up such an infrastructure. Some critical issues, however, were hardly addressed, among them costs, staff resources and methods of reporting and responding.