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Women with pelvic floor disorders (PFDs) typically undergo surgery involving transvaginal mesh implants; however, transvaginal mesh surgery is associated with many adverse events including post-surgical pain. Assessment of pain as a symptom is necessary using patient-reported outcome measures (PROMs). This scoping review aimed to describe and compare existing PROMs previously used to measure pain in women with PFDs. A scoping search of Ovid MEDLINE, EMBASE, CINAHL Plus, Ovid PsycInfo, and grey literature was conducted. Studies published in English describing the development, implementation, and application of PFD-associated pain PROMs among adult women before and after pelvic floor surgery were included. From each article, a descriptive summary organised by study first author, publication year, country, setting, aim, study characteristics, and results were extracted. From 2,604 articles identified, 54 studies were included, describing 44 PROMs. Most studies described at least 2 to 3 instruments. The Pelvic Floor Distress Inventory-20 was most commonly described by 12 studies followed by the Patient Global Impression of Improvement scale. Of the 44 PROMs, 27 were condition-specific, of which 9 included items on pain; 17 generic PROMs, 4 of which contained items on pain; and 6 pain-specific PROMs. PROMs identified in our review measured pain not related to PFDs or pelvic floor surgery and quantified the pain experienced. These PROMs did not measure all areas of pain including region, sensation, impact, and triggers. The findings of this review will assist with developing a new pain-specific PROM in this population. PERSPECTIVE: Women with pelvic floor disorders often undergo surgery involving transvaginal mesh, from which they experience debilitating pain. Pain is a major issue impacting women's lives. Patient-reported outcome measures can be used to assess the pain; however, it is unclear whether existing instruments are relevant., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs)., Objective: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs' implementation in CQRs, which is the aim of the broader project., Methods: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs' implementation will be extracted. A narrative synthesis of included publications will be conducted., Results: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024., Conclusions: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs' implementation in CQRs., Trial Registration: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x., International Registered Report Identifier (irrid): DERR1-10.2196/52572., (©Randi Thisakya Jayasinghe, Susannah Ahern, Ashika D Maharaj, Lorena Romero, Rasa Ruseckaite. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.05.2024.)

Background: Patient-reported outcome measures (PROMs) are an important tool for evaluating outcomes following breast device procedures and are used by breast device registries. PROMs can assist with device monitoring through benchmarked outcomes but need to account for demographic and clinical factors that may affect PROM responses., Objectives: This study aimed to develop appropriate risk-adjustment models for the benchmarking of PROM data to accurately track device outcomes and identify outliers in an equitable manner., Methods: Data for this study were obtained from the Australian Breast Device Registry, which consists of a large prospective cohort of patients with primary breast implants. The 5-question BREAST-Q implant surveillance module was used to assess PROMs at 1 year following implant insertion. Logistic regression models were used to evaluate associations between demographic and clinical characteristics and PROMs separately by implant indication. Final multivariate risk-adjustment models were built sequentially, assessing the independent significant association of these variables., Results: In total, 2221 reconstructive and 12,045 aesthetic primary breast implants with complete 1-year follow-up PROMs were included in the study. Indication for operation (post-cancer, risk reduction, or developmental deformity) was included in the final model for all reconstructive implant PROMs. Site type (private or public hospital) was included in the final breast reconstruction model for look, rippling, and tightness. Age at operation was included in the reconstruction models for rippling and tightness and in the aesthetic models for look, rippling, pain, and tightness., Conclusions: These multivariate models will be useful for equitable benchmarking of breast devices by PROMs to help track device performance., (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Background: Clinical quality registries (CQRs) monitor compliance against optimal practice and provide feedback to the clinical community and wider stakeholder groups. Despite a number of CQRs having incorporated the patient perspective to support the evaluation of healthcare delivery, no recommendations for inclusion of patient-reported outcome measures (PROMs) in CQRs exist. The aim of this study was to develop a core set of recommendations for PROMs inclusion of in CQRs., Method: An online two-round Delphi survey was performed among CQR data custodians, quality of life researchers, biostatisticians and clinicians largely recruited in Australia. A list of statements for the recommendations was identified from a literature and survey of the Australian registries conducted in 2019. The statements were grouped into the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback and reporting. Eighteen experts were invited to participate, 11 agreed to undertake the first online survey (round 1). Of these, nine experts completed the online survey for round 2., Results: From 117 statements presented to the Delphi panel in round 1, a total of 72 recommendations (55 from round 1 and 17 from round 2) with median importance (MI) ≥ 7 and disagreement index (DI) < 1 were proposed for inclusion into the final draft set and were reviewed by the project team. Recommendations were refined for clarity and to read as stand-alone statements. Ten overlapped conceptually and, therefore, were merged to reduce repetition. The final 62 recommendations were sent for review to the panel members for their feedback, which was incorporated into the final set., Conclusion: This is the first study to develop preliminary recommendations for PROMs inclusion in CQRs. Recommendations for PROMs implementation are critically important for registries to assure meaningful PROMs data capture, use, interpretation, and reporting to improve health outcomes and healthcare value., (© 2022. The Author(s).)

Background: Composite measures combine data to provide a comprehensive view of patient outcomes. Despite composite measures being a valuable tool to assess post-intervention outcomes, the patient perspective is often missing. The purpose of this study was to develop a composite measure for an established cardiac outcome registry, by combining clinical outcomes following percutaneous coronary interventions (PCI) with a patient-reported outcome measure (PROM) developed specifically for this population (MC-PROM)., Methods: Two studies were undertaken. Study 1: Patients who had undergone a PCI at one of the three participating registry hospital sites completed the 5-item MC-PROM. Clinical outcome data for the patients (e.g. death, myocardial infarction, repeat vascularisation, new bleeding event) were collected 30 days post-intervention as part of routine data collection for the cardiac registry. Exploratory factor analysis of clinical outcomes and MC-PROM data was conducted to determine the minimum number of constructs to be included in a composite measure. Study 2: Clinical experts participated in a Delphi technique, consisting of three rounds of online surveys, to determine the clinical outcomes to be included and the weighting of the clinical outcomes and MC-PROM score for the composite measure., Results: Study 1: Routine clinical outcomes and the MC-PROM data were collected from 266 patients 30 days post PCI. The MC-PROM score was not significantly correlated with any clinical outcomes. Study 2: There was a relatively consistent approach to the weighting of the clinical outcomes and MC-PROM items by the expert panel (n = 18) across the three surveys with the exception of the clinical outcome of 'deceased at 30 days'. The final composite measure included five clinical outcomes within 30 days weighted at 90% (new heart failure, new myocardial infarction, new stent thrombosis, major bleeding event, new stroke, unplanned cardiac rehospitalisation) and the MC-PROM score (comprising 10% of the total weighting)., Conclusions: A single patient level composite score, which incorporates weighted clinical outcomes and a PROM was developed. This composite score provides a more comprehensive reported measure of individual patient wellbeing at 30 days post their PCI-procedure, and may assist clinicians to further assess and address patient level factors that potentially impact on clinical recovery.

Introduction: Measuring patient reported outcomes can improve the quality and effectiveness of healthcare interventions. The aim of this study was to identify the final set of items that can be included in a patient-reported outcome measure to assess recovery of patients following percutaneous coronary interventions., Methods: A consecutive sample of 200 patients registered in the Victorian Cardiac Outcomes Registry participated in a telephone survey 30 days following their percutaneous cardiac procedure. Rasch analysis was used to select the best set of items to form a concise and psychometrically sound patient-reported outcome measure. Key measurement properties assessed included overall fit to the Rasch measurement model, unidimensionality, response formats (thresholds), targeting, internal consistency and measurement invariance., Results: Five items were identified as being reliable and valid measures of patient-reported outcomes: pain or discomfort, shortness of breath, confidence in performing usual activities, feeling unhappy and having trouble sleeping. Data showed overall fit to a Rasch model of expected item functioning (χ2 16.99; p = 0.07) and all items demonstrated unidimensionality (t-test less than 0.05 threshold value). Internal consistency was acceptable (equivalent Cronbach's α 0.65) given there are only five items, but there was a ceiling effect (mean logit score -1.24) with compromised score precision for patients with better recovery., Conclusions: We identified a succinct set of items that can be used in a patient-reported outcome measure following percutaneous coronary interventions. This patient-report outcome measure has good structural validity and acceptable internal consistency. While further psychometric evaluations are recommended, the items identified capture the patient's perspective of their recovery following a percutaneous coronary intervention., Competing Interests: The authors have declared that no competing interests exist.

Objective: To inform the development of a patient-reported outcome measure, the aim of this study was to identify which symptoms and feelings following percutaneous coronary intervention (PCI) are most important to patients., Design: Discrete-choice experiment consisting of two hypothetical scenarios of 10 symptoms and feelings (pain or discomfort; shortness of breath; concern/worry about heart problems; tiredness; confidence to do usual activities; ability to do usual activities; happiness; sleep disturbance; dizziness or light-headedness and bruising) experienced after PCI, described by three levels (never, some of the time, most of the time). Preference weights were estimated using a conditional logit model., Setting: Four Australian public hospitals that contribute to the Victorian Cardiac Outcomes Registry (VCOR) and a private insurer's claim database., Participants: 138 people aged >18 years who had undergone a PCI in the previous 6 months., Main Outcome Measures: Patient preferences via trade-offs between 10 feelings and symptoms., Results: Of the 138 individuals recruited, 129 (93%) completed all 16 choice sets. Conditional logit parameter estimates were mostly monotonic (eg, moving to worse levels for each individual symptom and feeling made the option less attractive). When comparing the magnitude of the coefficients (based on the coefficient of the worst level relative to best level in each item), feeling unhappy was the symptom or feeling that most influenced perception of a least-preferred PCI outcome (OR 0.42, 95% CI 0.34 to 0.51, p<0.0001) and the least influential was bruising (OR 0.81, 95% CI 0.67 to 0.99, p=0.04)., Conclusion: This study provides new insights into how patients value symptoms and feelings they experience following a PCI., Competing Interests: Competing interests: ALB is currently the Head of Member Health Innovation at Medibank Private Ltd., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Patient-reported outcome measures (PROM) are potentially useful outcome measures that may be reported at the individual clinical, health service and/or health system level. PROM require clearly defined patient populations to enable comparisons, and are most meaningful when integrated with clinical data sets. Where possible PROM should be measured pre- and post-intervention using reliable and validated tools. A variety of PROM collection methods exist which each have strengths and limitations, with selection depending on their purpose and patient factors. PROM programmes should be developed with high levels of clinician support and patient input to maximise collection of clinically relevant information., (© 2017 Royal Australasian College of Physicians.)