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Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol.

ABSTRACT: Introduction: To 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 analysis: This 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 dissemination: The 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.

SUBMITTER: Vogel N

PROVIDER: S-EPMC7722830 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol.

Vogel Nicole N Rychen Thomas T Kaelin Raphael R Arnold Markus P MP

BMJ open 20201207 12

<h4>Introduction</h4>To 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 ...[more]

PMID: 33293317

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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: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.

Project description:PurposeThe aim of this study is to investigate the prognostic value of tibial component coverage (over-hang and under-hang) and the alignment of total knee arthroplasty (TKA) components 1 week after surgery. We select patient-reported outcome measures (PROMS) (the Knee Society score (KSS score) and the Western Ontario and McMaster Universities Osteoarthritis Index-pain score (WOMAC pain score)) and tibial bone resorption (TBR) 2 years after surgery as the end points.MethodsThe study retrospectively analyzed 109 patients undergoing TKA (fixed-bearing prosthesis with asymmetrical tibial tray) from January 2014 to December 2017 in Huashan Hospital. By using standard long-leg X-rays, anteroposterior (AP) and lateral X-rays of the knee, tibial component coverage (under-hang or over-hang), AP tibial-femoral anatomical angle (AP-TFA), AP femoral angle (AP-FA), AP tibial angle (AP-TA), and lateral tibial angle (L-TA) were measured at 1 week after surgery, while TBR was measured through postoperative 1-week and 2-year AP and lateral radiographs of the knee on three sides (medial side, lateral side on AP radiograph, and anterior side on lateral radiograph). The Pearson correlation analysis, simple linear regression, multiple linear regression, the Student's t test, and one-way ANOVA together with Tukey's post hoc test (or Games-Howell post hoc test) were used in the analyses.ResultsTibial under-hang was more likely to appear in our patients following TKA (42%, medially, 39%, laterally, and 25%, anteriorly). In multivariate linear regression analysis of TBR, tibial under-hang (negative value) 1 week after surgery was positively correlated with TBR 2 years later on the medial (p = 0.003) and lateral (p = 0.026) side. Tibial over-hang (positive value) 1 week after surgery on the medial side was found negatively related with KSS score (p = 0.004) and positively related with WOMAC pain score (p = 0.036) 2 years later in multivariate linear regression analysis of PROMS. Both scores were better in the anatomically sized group than in the mild over-hang group (or severe over-hang) (p < 0.001). However, no significant relationship was found between the alignment of TKA components at 1 week after surgery and the end points (TBR and PROMS) 2 years later.ConclusionUnder-hang of the tibial component on both the medial and lateral sides can increase the risk of TBR 2 years later. Over-hang of tibial component on the medial side decreases the PROMS (KSS score and WOMAC pain score) 2 years later. An appropriate size of tibial component during TKA is extremely important for patient's prognosis, while the alignment of components might not be as important.

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:BackgroundThere is growing interest in the use of routine patient-reported outcome measures (PROMs) to influence the care of individual patients with stroke. However, there are significant gaps in our understanding as to how PROMs influence post-stroke patient care and clinical practice. This is due to factors including the number of purported uses for PROMs and that PROMs are complex interventions, which attempt to stimulate varied actions or behaviours. Therefore, the objective of this realist synthesis is to offer theory-based explanations as to how PROMs influence post-stroke clinical practice and patient care.MethodsThis is a protocol for a realist synthesis, which involves three distinct phases: theory building (phase 1), theory testing and refinement (phase 2) and synthesis (phase 3). Phase 1 will develop initial rough programme theories (IRPTs), through literature searches (from January 2000 onwards) of MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Library and the grey literature. Only secondary sources will be included that contribute to the development of IRPTs. Only two IRPTs, prioritised by the stakeholder group, will be taken forward to be tested and refined during phase 2. Further novel searches will be employed in phase 2, utilising the same criteria as phase 1; however, phase 2 searches will not utilise grey literature searches, and only primary research studies that contribute to the refinement of programme theories under investigation will be included. Two independent reviewers will screen and select all returned results. The reviewers will code and annotate relevant sources, resulting in 'fragments' to be extracted and graded based on the richness of their contribution to explanation and causal insight. Further, these fragments will be organised into 'Context-Mechanism-Outcome' configurations. Phase 3 of the review will involve the synthesis of context-mechanism-outcome configurations to form middle-range theory-based explanations and developed logic models for stakeholders to understand how PROMs in post-stroke clinical practice and patient care work for whom, how and under what circumstances.DiscussionThe resulting realist synthesis will provide guidance on the implementation of PROMs within routine post-stroke clinical practice and patient care and act as a touchstone for further testing and refinement of PROMs programmes.Systematic review registrationPROSPERO CRD42020138649 .

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:BackgroundHyperhidrosis is a chronic skin condition that impairs the patient's quality of life (QoL). There are several patient-reported outcome measures (PROMs) for patients affected by hyperhidrosis available; however an evidence-based assessment of their quality has not been undertaken so far.ObjectiveIn our systematic review, we aim to identify all existing PROMs that were developed and/or validated for measuring patient-reported outcomes in patients with hyperhidrosis and assess their measurement properties in a transparent and structured way to give a recommendation for future clinical research.Methods/designOur systematic review aims to contain all PROMs developed and/or validated for patients with hyperhidrosis. We will perform a highly sensitive, systematic literature search including the databases MEDLINE (Ovid), EMBASE (Ovid), and Science Citation Index Expanded and Social Sciences Citation Index (Web of Science). Especially studies which evaluate, describe, or compare measurement properties of PROMs for patients with hyperhidrosis will be considered as eligible. Two independent reviewers will judge the eligibility of the studies found in the literature search. The study and PROM characteristics will be summarized in evidence tables. The methodological quality of each study will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. We will apply predefined and consensus-based quality criteria for good measurement properties. Subsequently, the quality of the evidence will be graded. Furthermore, aspects on interpretability and feasibility will be described. A final recommendation will be given.DiscussionIn our systematic review, we aim to provide a comprehensive description of the quality of all existing PROMs for patients with hyperhidrosis. The assessment of measurement properties, interpretability, and feasibility will serve as a guidance regarding the selection of PROMs for future clinical hyperhidrosis trials.Systematic review registrationPROSPERO CRD42020170247.

Project description:IntroductionIn the UK, it is estimated that a disabling hearing loss (HL) affects 1 in 6 people. HL has functional, economic and social-emotional consequences for affected individuals. Intervention for HL focuses on improving access to the auditory signal using hearing aids or cochlear implants. However, even if sounds are audible and speech is understood, individuals with HL often report increased effort when listening.Listening effort (LE) may be measured using self-reported measures such as patient-reported outcome measures (PROMs). PROMs are validated questionnaires completed by patients to measure their perceptions of their own functional status and well-being. When selecting a PROM for use in research or clinical practice, it is necessary to appraise the evidence of a PROM's acceptability to patients, validity, responsiveness and reliability.Methods and analysisA systematic review of studies evaluating the measurement properties of PROMs available to measure LE in HL will be undertaken. MEDLINE, EMBASE, CINAHL, PsychINFO and Web of Science will be searched electronically. Reference lists of included studies, key journals and the grey literature will be hand-searched to identify further studies for inclusion. Two reviewers will independently complete title, abstract and full-text screening to determine study eligibility. Data on the characteristics of each study and each PROM will be extracted. Methodological quality of the included studies will be appraised using the COnsensus-based Standards for the selection of health Measurement INstruments, the quality of included PROMs appraised and the credibility of the evidence assessed. A narrative synthesis will summarise extracted data.Ethics and disseminationEthical permission is not required, as this study uses data from published research. Dissemination will be through publication in peer-reviewed journals, conference presentations and the lead author's doctoral dissertation. Findings may inform the selection of PROMs used to measure LE in HL.

Dataset Information

Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol.

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Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol.

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