Dataset Information

A continuous PREMs and PROMs Observatory for elective hip and knee arthroplasty: study protocol.

ABSTRACT:

Introduction

Scholars, healthcare practitioners and policymakers have increasingly focused their attention on patient-centredness. Patient-reported metrics support patient-driven improvement actions in healthcare systems. Despite the great interest, patient-reported outcome measures (PROMs) are still not extensively collected in many countries and not integrated with the collection of patient-reported experience measures (PREMs). This protocol describes the methodology behind an innovative observatory implemented in Tuscany, Italy, aiming at continuously and longitudinally collecting PROMs and PREMs for elective hip and knee total replacement.

Methods and analysis

The Observatory is digital. Enrolled patients are invited via SMS or email to online questionnaires, which include the Oxford Hip Score or the Oxford Knee Score. Data are real-time reported to healthcare professionals and managers in a raw format, anonymised and aggregated on a web platform. The data will be used to investigate the relationship between the PROMs trend and patients' characteristics, surgical procedure, hospital characteristics, and PREMs. Indicators using patient data will be computed, and they will integrate the healthcare performance evaluation system adopted in Tuscany.

Ethics and dissemination

The data protection officers of local healthcare organisations and the regional privacy office framed the initiative referring to the national and regional guidelines that regulate patient surveys. The findings will be reported both in real time and for publication in peer-reviewed journals.

SUBMITTER: De Rosis S

PROVIDER: S-EPMC8458328 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe number of hip, knee and shoulder arthroplasties continues to rise worldwide. The Organization for Economic Cooperation and Development has launched an initiative (called PaRIS Initiative) for the systematic collection of Patient Reported Outcome Measures (PROMs) in patients undergoing elective hip and knee arthroplasty. The Rizzoli Orthopedic Institute (IOR) was selected as a pilot center for the launch of the Initiative in Italy given that IOR hosts the Registry of Orthopedic Prosthetic Implants (RIPO), a region-wide registry which collects joint implant data from all the hospitals in the Emilia-Romagna Region. In this specific geographic area information related to PROMs after joint replacement is unknown. This paper describes the protocol of a study (PaRIS-IOR) that aims to implement the collection of a set of PROMs within an existing implant registry in Italy. The study will also investigate the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.MethodsThe PaRIS-IOR study is a prospective, single site, cohort study that consists of the administration of PROMs questionnaires to patients on the list for elective arthroplasty. The questionnaires will be administered to the study population within 30 days before surgery, and then at 6 and 12 months following surgery. The study population will consist of consecutive adult patients undergoing either hip, knee or shoulder arthroplasty. The collected data will be linked with those routinely collected by the RIPO in order to assess the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.DiscussionThe PaRIS-IOR study could have important implications in targeting the factors influencing functional outcomes and quality of life reported by patients after hip, knee and shoulder arthroplasty, and will also represent the first systematic collection of PROMs related to arthroplasty in Italy.Trial registrationProtocol version (1.0) and trial registration data are available on the platform www.clinicaltrial.gov with the identifier NCT03790267 , first posted on December 31, 2018.

Project description:IntroductionTo evaluate the quality of clinical practice, patient-reported outcome measures (PROMs) are important as certain questions could only be answered by the patient himself. PROMs help to get a better understanding what is meaningful to a patient and directly affects daily functioning. To move beyond traditional measures, we are interested in what matters to patients and developed this project. The aim of this article is to provide the protocol for our study collecting PROMs in daily medical practice from patients who undergo knee arthroplasty.Methods and analysisThis study is a single-site, observational, prospective cohort study. We will recruit patients scheduled for a knee arthroplasty in our medical office, situated in a private clinic. After signed informed consent, patients complete self-reported questionnaires before the surgery, after 4 months, 1 year, 2 years, 3 years, 4 years and 5 years. We will use the following PROMs: Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, EuroQol five dimensions and satisfaction. Additionally, the surgeon will complete the objective Knee Society Score. Administration of the questionnaires will be electronically or paper-based. We will assess differences between preoperative and postoperative data with paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess subgroup differences, we will use unpaired t-test for continuous variables and Mann-Whitney U test for categorical variables. To assess possible presence of bias, we will conduct sensitivity analyses.Ethics and disseminationThe study has been reviewed and approved by the local ethics committee in Basel, Switzerland. Written informed consent will be obtained from all patients. We will disseminate the results of the study through peer-reviewed journals, national and international conference presentations and presentations to relevant stakeholders through appropriate channels.

Project description:Background Patient-reported outcome measures (PROMs) are increasingly being used to assess the effectiveness of elective total knee arthroplasty (TKA). However, little is known about how PROMs scores change over time in these patients. The aim of this study was to identify the trajectories of quality of life and joint functioning, and their associated demographic and clinical features in patients undergoing elective TKA. Methods A prospective, cohort study was conducted, in which PROMs questionnaires (Euro Quality 5 Dimensions 3L, EQ-5D-3L, and Knee injury and Osteoarthritis Outcome Score Patient Satisfaction, KOOS-PS) were administered to patients at a single center undergoing elective TKA before surgery, and at 6 and 12 months after surgery. Latent class growth mixture models were used to analyze the patterns of change in PROMs scores over time. Multinomial logistic regression was used to investigate the association between patient characteristics and PROMs trajectories. Results A total of 564 patients were included in the study. The analysis highlighted differential patterns of improvement after TKA. Three distinct PROMs trajectories were identified for each PROMs questionnaire, with one trajectory indicating the most favorable outcome. Female gender appears to be associated with a presentation to surgery with worse perceived quality of life and joint function than males, but also more rapid improvement after surgery. Having an ASA score greater than 3 is instead associated with a worse functional recovery after TKA. Conclusion The results suggest three main PROMs trajectories in patients undergoing elective TKA. Most patients reported improved quality of life and joint functioning at 6 months, which then stabilized. However, other subgroups showed more varied trajectories. Further research is needed to confirm these findings and to explore the potential clinical implications of these results. Supplementary Information The online version contains supplementary material available at 10.1186/s12891-023-06373-2.

Project description:ImportanceThe Enhanced Recovery After Surgery (ERAS) care protocol has been shown to improve outcomes compared with traditional care in certain types of surgery.ObjectiveTo assess the association of use of the ERAS protocols with complications in patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA).Design, setting, and participantsThis multicenter, prospective cohort study included patients recruited from 131 centers in Spain from October 22 through December 22, 2018. All consecutive adults scheduled for elective THA or TKA were eligible for inclusion. Patients were stratified between those treated in a self-designated ERAS center (ERAS group) and those treated in a non-ERAS center (non-ERAS group). Data were analyzed from June 15 through September 15, 2019.ExposuresTotal hip or knee arthroplasty and perioperative management. Sixteen individual ERAS items were assessed in all included patients, whether they were treated at a center that was part of an established ERAS protocol or not.Main outcomes and measuresThe primary outcome was postoperative complications within 30 days after surgery. Secondary outcomes included length of stay and mortality.ResultsDuring the 2-month recruitment period, 6146 patients were included (3580 women [58.2%]; median age, 71 [interquartile range (IQR), 63-76] years). Of these, 680 patients (11.1%) presented with postoperative complications. No differences were found in the number of patients with overall postoperative complications between ERAS and non-ERAS groups (163 [10.2%] vs 517 [11.4%]; odds ratio [OR], 0.89; 95% CI, 0.74-1.07; P?=?.22). Fewer patients in the ERAS group had moderate to severe complications (73 [4.6%] vs 279 [6.1%]; OR, 0.74; 95% CI, 0.56-0.96; P?=?.02). The median overall adherence rate with the ERAS protocol was 50.0% (IQR, 43.8%-62.5%), with the rate for ERAS facilities being 68.8% (IQR, 56.2%-81.2%) vs 50.0% (IQR, 37.5%-56.2%) at non-ERAS centers (P?<?.001). Among the patients with the highest and lowest quartiles of adherence to ERAS components, the patients with the highest adherence had fewer overall postoperative complications (144 [10.6%] vs 270 [13.0%]; OR, 0.80; 95% CI, 0.64-0.99; P?<?.001) and moderate to severe postoperative complications (59 [4.4%] vs 143 [6.9%]; OR, 0.62; 95% CI, 0.45-0.84; P?<?.001) and shorter median length of hospital stay (4 [IQR, 3-5] vs 5 [IQR, 4-6] days; OR, 0.97; 95% CI, 0.96-0.99; P?<?.001).Conclusions and relevanceAn increase in adherence to the ERAS program was associated with a decrease in postoperative complications, although only a few ERAS items were individually associated with improved outcomes.

Project description:BackgroundPatient-reported outcome measures (PROMs) are an extensively used tool to assess and improve the quality of healthcare services. PROMs can be related to individual demographic and clinical characteristics in patients undergoing hip arthroplasty (HA). The aim of this study is to identify distinct subgroups of patients with unique trajectories of PROMS scores and to determine patients' features associated with these subgroups.MethodsWe conducted a prospective, cohort study in which PROMs questionnaires (Euro Quality 5 Dimensions 3L, EQ-5D-3L, Euro-Quality-Visual-Analytic-Score, EQ-VAS, Hip disability and Osteoarthritis Outcome Score, HOOS-PS) were administered to patients undergoing elective HA pre-operatively, and at 6 and 12 months after surgery. For each measure, latent class growth analysis and growth mixture models were used to identify subgroups of patients with distinct trajectories of scores. Demografic and clinical predictors of the latent classes in growth mixture model were identified using a 3-step approach.ResultsWe found three distinct trajectories for each PROM score. These trajectories indicated a response heterogeneity to the HA among the patients (n = 991). Patient's gender, ASA score, and obesity were significantly associated with different PROMs trajectories.ConclusionsWe identified three distinct trajectories for each of the three PROMs indicators. Several demographic and clinical characteristics are associated with the different trajectories of PROMs at 6 and 12 months after HA and could be used to identify groups of patients with different outcomes following HA surgery. These findings underline the importance of patient-centered care, supporting the usefulness of integrating PROMs data alongside routinely collected healthcare records for guiding clinical care and maximizing patients' positive outcomes.Trial registrationProtocol version (1.0) and trial registration data are available on the platform www.Clinicaltrialgov with the identifier NCT03790267, posted on December 31, 2018.