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Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study.

ABSTRACT: BACKGROUND:The 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. METHODS:The 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. DISCUSSION:The 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 REGISTRATION:Protocol 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.

SUBMITTER: Grassi A

PROVIDER: S-EPMC6694507 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study.

Grassi Alberto A Golinelli Davide D Tedesco Dario D Rolli Maurizia M Bordini Barbara B Amabile Marilina M Rucci Paola P Fantini Maria Pia MP Zaffagnini Stefano S

BMC musculoskeletal disorders 20190815 1

<h4>Background</h4>The 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 Orthop ...[more]

PMID: 31416443

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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: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.

Project description:BACKGROUND:Patient reported outcome measures (PROMs) have been integrated in national quality registries or specific national monitoring initiatives to inform the improvement of quality of care on a national scale. However there are many unanswered questions, such as: how these systems are set up, whether they lead to improved quality of care, which stakeholders use the information once it is available. The aim of this study was to examine supporting and hindering factors relevant to integrating patient-reported outcome measures (PROMs) in selected health information systems (HIS) tailored toward improving quality of care across the entire health system. METHODS:First, a systematic search and review was conducted to outline previously identified factors relevant to the integration of PROMs in the selected HIS. A social network analysis was performed to identify networks of experts in these systems. Second, expert interviews were conducted to discuss and elaborate on the identified factors. Directive content analysis was applied using a HIS Evaluation Framework as the frame of reference. This framework is structured into four components: Organization, Human, Technology, and Net benefits. RESULTS:The literature review revealed 37 papers for the NHS PROMs Programme and 26 papers for the SHPR and SKAR: Five networks of researchers were identified for the NHS PROMs Programme and 1 for the SHPR and SKAR. Seven experts related to the NHS PROMs Programme and 3 experts related to the SKAR and SHPR participated in the study. The main themes which revealed in relation to Organization were Governance and Capacity building; to Human: Reporting and Stakeholder Engagement; to Technology: the Selection and Collection of PROMs and Data linkage. In relation to Net benefits, system-specific considerations are presented. CONCLUSION:Both examples succeeded in integrating PROMs into HIS on a national scale. The lack of an established standard on what change PROMs should be achieved by an intervention limits their usefulness for monitoring quality of care. Whether the PROMs data collected within these systems can be used in routine clinical practice is considered a challenge in both countries.

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:BackgroundHealthcare requires patient feedback to improve outcomes and experience. This study undertook a systematic review of the depth, variability, and digital suitability of current patient-reported outcome measures (PROMs) in patients undergoing laparoscopic cholecystectomy.MethodsA PROSPERO-registered (registration number CRD42021261707) systematic review was undertaken for all relevant English language articles using PubMed version of MEDLINE, Scopus, and Web of Science electronic databases in June 2021. The search used Boolean operators and wildcards and included the keywords: laparoscopic cholecystectomy AND patient outcome OR patient-reported outcome OR patient-reported outcome measure OR PRO OR PROM. Medical Subjects Heading terms were used to search PubMed and Scopus. Articles published from 1 January 2011 to 2 June 2021 were included.ResultsA total of 4960 individual articles were reviewed in this study, of which 44 were found to evaluate PROMs in patients undergoing laparoscopic cholecystectomy and underwent methodological index for non-randomized studies (MINORS) grading. Twenty-one articles spanning 19 countries and four continents met all inclusion criteria and were included in the qualitative data synthesis. There was significant heterogeneity in PROMs identified with eight different comprehensive PROM tools used in the 21 studies. There was wide variation in the time points at which PROMs were recorded. Fourteen of 21 studies recorded PROMs before and after surgery, and 7 of 21 recorded PROMs only after surgery. Follow-up intervals ranged from 3 days to 2 years after surgery.ConclusionsThis study identified that while post-laparoscopic cholecystectomy PROMs are infrequently measured currently, tools are widely available to achieve this in clinical practice. PROMs may not capture all the outcomes but should be incorporated into future cholecystectomy outcome research. The EQ-5D™ (EuroQoL Group, Rotterdam, the Netherlands) provides a simple platform for the modern digital era.

Dataset Information

Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study.

Publications

Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study.

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