Patient-reported Outcome Measures Instruments Research Articles

Patient-Reported Outcome and Experience Measures in Advanced Nursing Practice: What Are Key Considerations for Implementation and Optimized Use?

ObjectiveTo discuss the opportunities and challenges of implementing patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) within advanced practice nursing services in cancer care. MethodsThis discussion paper has been informed by an environmental scan of evidence from systematic reviews and primary studies evaluating the use and implementation of PROMs and PREMs. Literature from the contexts of cancer and chronic disease, including nursing and multidisciplinary supportive care literature, has been included. ResultsAdvanced practice nurses are well-positioned to evaluate and respond to PROMs and PREMs data; several studies have highlighted improved patient outcomes concerning quality of life, symptom distress, and functional status within nurse-led services. Nevertheless, the implementation of PROMs and PREMs in cancer care and nurse-led services is variable. Previous studies have highlighted implementation challenges, which can hinder comparability and generalizability of PROMs and PREMs instruments. Advanced practice nurses should consider these challenges, including ways to use standardized PROM instruments. Electronic PROMs, while efficient, may exclude individuals at risk of inequity. Complex, lengthy, and frequent administration of PROMs may also overburden people living with or after cancer, with people affected by cancer expressing preference for flexible use in some studies. Therefore, the involvement of people affected by cancer in planning for PROMs/PREMs implementation may overcome this challenge. Finally, organizational considerations in implementation should address financial investments, including initial costs for technology and training and consideration of the operationalization of PROMs within existing infrastructure for the seamless utilization of PROMs data. ConclusionDespite the potential of advanced practice nursing services to enhance patient-reported outcomes and experiences, variability in the implementation of PROMs and PREMs poses challenges. Use of validated measures, electronic or paper-based instruments, and the preferences of people affected by cancer for the use of PROMs and PREMs must be carefully considered in consultation with end users for successful implementation. Implications for PracticeIn planning for the implementation of PROMs and PREMs within nurse-led services, implementation risks may be mitigated through establishing clear guidelines for their use, investment in the development of the required infrastructure, user education, and rigorous implementation processes, including patient involvement in PROMs/PREMs selection.

Disparities in Patient Reported Outcome Measure Completion Rates and Baseline Function in Newly Presenting Spine Patients.

Retrospective Review. The purpose of this study was to evaluate disparities in patient reported outcome measures (PROM) completion rates and baseline function scores among newly presenting spine patients. Prior studies have demonstrated that minority patients and those of low socioeconomic status may present with worse physical and mental health on PROMs. As PROMs are increasingly used in clinical care, research, and health policy, accurate assessment of health status among populations relies on the successful completion of PROM instruments. A retrospective review of 10,803 consecutive new patients presenting to a single multidisciplinary spine clinic from June 2020 to September 2022 was performed. Univariate statistics were performed to compare demographics between patients who did and did not complete PROMs. Multivariable analysis was used to compare PROM instrument completion rates by race, ethnicity, and Social Vulnerability Index (SVI) and baseline scores among responders. 68.4% of patients completed PROMs at the first clinic visit. After adjusting for age, sex, body mass index, and diagnosis type, patients of non-white race (OR=0.661, 95%-CI=0.599-0.729, P<0.001), Hispanic ethnicity (OR=0.569, 95%-CI=0.448-0.721, P<0.001), and increased social vulnerability (OR=0.608, 95%-CI=0.511-0.723, P<0.001) were less likely to complete PROMs. In the multivariable models, patients of non-white race reported lower levels of physical function (β=-6.5, 95%-CI=-12.4 to -0.6, P=0.032) and higher levels of pain intensity (β=0.6, 95%-CI=0.2-1.0, P=0.005). Hispanic ethnicity (β=1.5, 95%-CI=0.5-2.5, P=0.004) and increased social vulnerability (β=1.1, 95%-CI=0.4-1.8, P=0.002) were each associated with increased pain intensity. Among newly presenting spine patients, those of non-white race, Hispanic ethnicity, and with increased social vulnerability were less likely to complete PROMs. As these subpopulations also reported worse physical function or pain intensity, additional strategies are needed to better capture patient reported health status in order to avoid bias in clinical care, outcomes research and health policy.

Design and content validation of a checklist about infection-prevention performance of intensive care nurses in simulation-based scenarios.

To design, develop and validate a new tool, called NEUMOBACT, to evaluate critical care nurses' knowledge and skills in ventilator-associated pneumonia (VAP) and catheter-related bacteraemia (CRB) prevention through simulation scenarios involving central venous catheter (CVC), endotracheal suctioning (ETS) and mechanically ventilated patient care (PC) stations. Simulation-based training is an excellent way for nurses to learn prevention measures in VAP and CRB. Descriptive metric study to develop NEUMOBACT and analyse its content and face validity that followed the COSMIN Study Design checklist for patient-reported outcome measurement instruments. The first version was developed with the content of training modules in use at the time (NEUMOBACT-1). Delphi rounds were used to assess item relevance with experts in VAP and CRB prevention measures, resulting in NEUMOBACT-2. Experts in simulation methods then assessed feasibility, resulting in NEUMOBACT-3. Finally, a pilot test was conducted among 30 intensive care unit (ICU) nurses to assess the applicability of the evaluation tool in clinical practice. Seven national experts in VAP and CRB prevention and seven national simulation experts participated in the analysis to assess the relevance and feasibility of each item, respectively. After two Delphi rounds with infection experts, four Delphi rounds with simulation experts, and pilot testing with 30 ICU nurses, the NEUMOBACT-FINAL tool consisted of 17, 26 and 21 items, respectively, for CVC, ETS and PC. NEUMOBACT-FINAL is useful and valid for assessing ICU nurses' knowledge and skills in VAP and CRB prevention, acquired through simulation. Our validated and clinically tested tool could facilitate the transfer of ICU nurses' knowledge and skills learning in VAP and CRB prevention to critically ill patients, decreasing infection rates and, therefore, improving patient safety. Experts participated in the Delphi rounds and nurses in the pilot test.

New CMS Policy on the Mandatory Collection of Patient-Reported Outcome Measures for Total Hip and Knee Arthroplasty by 2027: What Orthopaedic Surgeons Should Know.

The Centers for Medicare & Medicaid Services (CMS) has finalized a landmark national policy to standardize and expand the collection and reporting of patient-reported outcome measures (PROMs) following total hip arthroplasty (THA) and total knee arthroplasty (TKA). This policy will be rolled out through phased implementation, beginning with voluntary reporting starting in 2023 and transitioning to mandatory reporting starting in 2025, which will be tied to hospital payment determinations in fiscal year 2028. The overarching goal of this policy is to gather meaningful pre- and postoperative PROM data directly from patients to enhance clinical care, shared decision-making, and quality measurement for these common elective procedures. This national initiative underscores the value of incorporating patient perspectives and priorities into assessments of surgical care quality. For orthopaedic surgeons and hospitals, participating in the initial voluntary reporting period provides an opportunity to integrate PROM collection into clinical workflows and to leverage these data to improve patient care. The achievement of robust PROM response rates and a strong performance on the underlying THA/TKA Patient-Reported Outcome-Based Performance Measure may have increasing relevance as payment models shift toward value-based care. The aim of the present forum was to provide an in-depth review of this new CMS policy and key details regarding required PROM instruments, data-collection time frames, and other specifications that surgical teams should understand as they prepare for implementation. The goal was to equip orthopaedic surgeons with actionable information as they embark on this new era of national PROM collection and reporting.

Responsiveness of Patient-Reported Outcome Measures After Large Knee Articular Cartilage Transplantation: A Systematic Review and Meta-analysis.

Cartilage transplantation is commonly used to treat large (>4 cm2) articular cartilage defects of the knee. The 2 most common transplants are osteochondral allograft transplantation and autologous chondrocyte implantation. Several patient-reported outcome measures (PROMs) have been used to determine the efficacy of treatment, but it is unknown which measures are the most effective. To report the multiple PROMs used after large knee articular cartilage transplantation surgery and to compare the responsiveness between them. Meta-analysis; Level of evidence, 4. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic search of the PubMed/MEDLINE and Web of Science databases was performed. A total of 181 articles met inclusion criteria. Patient and study characteristics were extracted, including pre- and postoperative means for PROMs. From the articles that met inclusion criteria for responsiveness analysis (2+ PROMs reported, 1-year minimum follow-up, reported pre- and postoperative means and standard deviations; n = 131), the authors compared the responsiveness between PROM instruments using effect size and relative efficiency (RE) if a PROM could be compared with another in ≥10 articles. A total of 10,015 patients (10,093 knees; mean age, 34.8 years; mean body mass index, 26.1) were included in this study. The mean follow-up time was 58.3 months (range, 1.5-247.2 months), imaging findings were reported in 80 articles (44.2%), patient satisfaction was reported in 39 articles (21.5%), and range of motion was reported in 10 articles (5.5%). There were 58 unique PROM instruments identified, with the most used being the International Knee Documentation Committee (IKDC) score (n = 118; 65.2%), followed by Knee injury and Osteoarthritis Outcome Score (KOOS) Pain (n = 58; 32.0%), KOOS Sport and Recreation (n = 58; 32.0%), KOOS Quality of Life (n = 57; 31.5%), KOOS Activities of Daily Living (n = 57; 31.5%), and KOOS Symptoms (n = 57; 31.5%). Overall, IKDC was found to have the greatest effect size (1.68) and the best responsiveness of the other PROMs, which include KOOS Pain (RE, 1.38), KOOS Symptoms (RE, 3.06), KOOS Activities of Daily Living (RE, 1.65), KOOS Sport and Recreation (RE, 1.44), Lysholm (RE, 1.76), and Tegner (RE, 1.56). The IKDC is the most responsive PROM after large knee articular cartilage transplantation surgery. The IKDC score is recommended for assessing outcomes after cartilage transplantation surgery.

Functional Outcome and Range of Motion Between Internal Plate Fixation Versus Kirschner Wire for Management of Distal Radius Fracture: A Meta-Analysis

Introduction: A significant percentage of fractures treated in clinical practice are distal radius fractures, which are among the most common orthopaedics injuries. Distal radius fractures are common and can affect wrist function and general quality of life, thus they need to be addressed carefully. This research aims to assess the evidence supporting VLP and K-wire fixation procedures in the treatment of distal radius fractures. Methods: According to PRISMA guideline statement, the research was conducted. A systematic search was conducted in past 10 years. This research will include English-language, randomized, controlled studies that compare VLP with K-wire fixation for the management of distal radius fracture and have full-text. Data collection included functional outcome measures, specifically the Disabilities of the Arm, Shoulder, and Hand (DASH), wrist Range of Motion, and clinical complication, which have been recommended as the best available patient-reported outcome measurement instruments for distal radius fractures. Result: The plate group had a higher DASH score with a difference of 1.46 but this result was not statistically significant (95% CI=3.09-(-0.16), p=0.08). Based on grip strength, it was found that the grip strength was greater in the wire group although there was no statistically significant difference (2.28; 95%CI=-0.13-4.70, p=0.06). There were fewer complications when using the plate with an Odd Ratio of 0.31 (95% CI=0.22-0.43, p&lt;0.00001). Discussion: Plate fixation is still valuable because of its stability, brief period of immobility, and rapid return to an active life. The usage of locking plate fixations in the treatment of distal radius fractures has increased recently. Anatomical repair of the articular surface and fragment alignment promotes functional rehabilitation and delays the onset of osteoarthritis. K-wires are commonly used because they are easy to implant, don't injure tissue much, have an atraumatic insertion, and result in less stiffness and edema. Two other advantages are reduced risk of infection and enhanced fracture healing. Their disadvantages include wire migration, peripheral neurovascular injury, and less firm fixation. There was no difference between the two groups DASH scores or grip strengths according to the forest plot results. After a year, the study of wrist range of motion revealed no appreciable variations in flexion, extension, or pronation. It was discovered that treating distal radius fractures with plates had fewer difficulties than treating them with wires, based on the patient's issues. Keywords: Distal Radius Fracture, Fracture, Kirschner Wire, Plate Screw.

ASES and UCLA Are Responsive Patient-Reported Outcome Measures After Rotator Cuff Repair: A Systematic Review and Meta-analysis.

Multiple patient-reported outcome measures (PROMs) have been used to assess shoulder function, but it is unknown which are the most effective. The purpose of this study was to report the multiple PROMs used after rotator cuff repair (RCR) and to compare the responsiveness between them. It was hypothesized that the Western Ontario Rotator Cuff PROM would be the most responsive and commonly used in patients undergoing RCR. Meta-analysis; Level of evidence, 4. A systematic review was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PRISMA-Searching extension guidelines via PubMed/MEDLINE, Embase (Elsevier), and Web of Science (Clarivate). Patient and study characteristics were extracted. From the studies that met inclusion criteria for responsiveness analysis (≥2 PROMs reported, 1-year minimum follow-up, and pre- and postoperative PROM means and standard deviations reported), the authors compared the responsiveness between PROM instruments using effect size and relative efficiency (RE) if a PROM could be compared with another in ≥10 articles. A total of 252 studies met inclusion criteria (32,072 patients; mean age, 59.6 years; mean body mass index, 28.7; mean follow-up time, 27.8 months). Range of motion was reported in 131 (52%) studies and imaging findings were reported in 123 (49%) studies. There were 67 PROM instruments identified; the most commonly used were the American Shoulder and Elbow Surgeon (ASES) (n = 183; 73%), Visual Analog Scale (VAS) (n = 163; 65%), and Constant (n = 118; 47%) scores. The 3 PROMs with the highest effect sizes were the University of California, Los Angeles (UCLA) (2.51), Western Ontario Rotator Cuff (2.42), and ASES (2.00) scores. Overall, UCLA and ASES scores were the most responsive PROMs. The ASES PROM was more responsive than the VAS (RE, 1.70), Constant (RE, 2.76), Simple Shoulder Test (RE, 1.67), and Single Assessment Numeric Evaluation (RE, 2.14) scores. The UCLA PROM was more responsive than the ASES (RE, 1.03), VAS (RE, 3.66), Constant (RE, 1.72), and Simple Shoulder Test (RE, 1.66) scores. ASES and UCLA scores were the most responsive PROMs after RCR. The authors recommend widespread adoption of ASES and UCLA scores for clinical and research standardization; however, the UCLA PROM requires in-person range of motion and strength testing, which is a practical limitation and barrier to long-term follow-up.

ADAPTAÇÃO TRANSCULTURAL E AVALIAÇÃO DAS PROPRIEDADES DA MEDIDA DO OSTOMY SELF-CARE INDEX NA CULTURA BRASILEIRA

ABSTRACT Objective: to adapt and evaluate the measurement properties of the Ostomy Self-Care Index in the Brazilian culture. Method: methodological study carried out in a public hospital in Campinas, Brazil. For cross-cultural adaptation, the following stages were followed: translation and synthesis; back-translation; evaluation of content validity; pre-testing and evaluation of the final version by the author of the original instrument. The Content Validity Index, Modified Kappa coefficient, and Content Validity Ratio were used for content validity. The evaluation of the measurement properties followed the recommendations of the Study Design checklist for Patient-reported outcome measurement instruments. Reliability was tested through internal consistency and construct validity through confirmatory factor analysis and the testing of three hypotheses. Six specialists and 160 patients participated in the study. Data collection took place between October 2020 and June 2022. Results: the stages of cross-cultural adaptation were carried out without difficulty. The internal consistency assessment obtained values within the established range. The confirmatory factor analysis of Sections A, B, and D of the OSCI (Brazilian version) showed satisfactory results after excluding two items. The hypothesis test partially corroborated one of the hypotheses and confirmed the other two. Section C could not be evaluated as it was intended only for patients with complications (n=66). Conclusion: Sections A, B, and D of the Brazilian version of the OSCI demonstrated evidence of structural construct validity and reliability and can be used in both clinical and scientific practice.

Piloting patient-reported outcome measures for evaluation of the Irish Chronic Disease Programme

Abstract Background The Irish National Integrated Care Programme for Chronic Disease (ICPCD) aims to deliver end-to-end, patient-centred care across three clinical programmes; Heart, Respiratory and Diabetes. Patient-reported outcome measures (PROMs) are a means of objectively measuring changes in patients’ subjectively-perceived health status over time in response to services. As such, PROMs facilitate service monitoring and evaluation and are an important tool for the ICPCD to ensure optimal, patient-centred, value-based healthcare delivery. Methods To select the most appropriate PROMs instrument for use across ICPCD, comprehensive literature review was undertaken followed by key stakeholder consultation in winter 2022. Following consideration against a set of pre-determined criteria the EQ-5D-5L, a well-validated, reliable PROMs instrument, was selected as the most appropriate PROMs instrument for use. Study design involved pilot implementation of EQ-5D-5L in one ICPCD ambulatory care hub service followed by mixed methods evaluation of staff experience of the pilot. Results The pilot was conducted from April to June 2023 among a socio-demographically diverse sample of patients attending their first and last episode of care with the ICPCD diabetic patient education service in Galway. Following service attendance there was a significant aggregate improvement in self-reported overall health rating but no significant change in self-reported mobility, self-care, usual activities, pain/discomfort or anxiety/depression. Predominant staff concerns included staff and patient burden and the need for adequate staff resourcing and information technology support. Conclusions In conjunction with key national stakeholders findings from the pilot will be used to support the development of a PROMs implementation plan at scale for adoption across all ICPCD services. Ultimately national implementation will support the ongoing delivery of high quality patient-centred care within ICPCD services. Key messages • PROMs facilitate service evaluation and are an important tool for the Irish National Integrated Care Programme for Chronic Disease (ICPCD) to ensure optimal patient-centred healthcare delivery. • This pilot will support PROMs implementation at scale across ICPCD services and ultimately reinforce the ongoing delivery of high-quality, value-based, integrated healthcare.

Translation and validation of the Japanese version of the Birth Satisfaction Scale-Revised.

This study aimed to develop a Japanese version of the Birth Satisfaction Scale-Revised and evaluate its reliability and validity. After translating the Birth Satisfaction Scale-Revised into Japanese, we conducted an Internet-based cross-sectional study with 445 Japanese-speaking women within 2 months of childbirth. Of these, 98 participated in the retest 1 month later. Data were analyzed using the COSMIN study design checklist for patient-reported outcome measurement instruments. Content validity was evaluated through cognitive debriefing during the translation process into Japanese. Confirmatory factor analysis was conducted to verify structural and cross-cultural validities. For hypothesis testing, we tested correlations with existing measures for convergent and divergent validities, and for known-group discriminant validity, we made comparisons between types of childbirth. Internal consistency was calculated using Cronbach's α, and test-retest reliability was evaluated using the intraclass correlation coefficient. For the Japanese-Birth Satisfaction Scale-Revised, the established three-factor model fit poorly, whereas the four-factor model fit better. Full metric invariance was observed in both the nulliparous and multiparous groups. Good convergent, divergent, and known-group discriminant validities and test-retest reliability were established. Internal consistency observations were suboptimal; however for vaginal childbirth, the Cronbach's α of the total score was .71. The Japanese-Birth Satisfaction Scale-Revised is a valid and reliable scale, with the exception of internal consistency that requires further investigation. If limited to vaginal childbirth, research, clinical applications, and international comparisons can be drawn.

Patient-Reported Outcome Measures for Hearing Aid Benefit and Satisfaction: Content Validity and Readability.

Numerous patient-reported outcome measures (PROMs) are available to measure hearing aid benefit and satisfaction. It is unclear to what extent currently available PROMs on hearing aid outcomes, often developed decades ago, meet current guidelines for good content validity and readability. This study evaluated the content validity and readability of PROMs that focus on perceived hearing aid benefit and/or satisfaction. A literature review was conducted to identify eligible instruments. Content validity evaluation included mapping extracted questionnaire items to the World Health Organization's International Classification of Functioning, Disability and Health (ICF) framework. In addition, study design in content validity methodology was evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments study design checklist for PROM instruments. Readability was estimated using the Simple Measure of Gobbledygook measure. Thirteen questionnaires were identified and evaluated. Item content focused primarily on the components of environmental factors as well as activity limitations and participation restrictions with less emphasis on body functions and personal factors. The content validity methodology analysis revealed an underuse or lack of reporting of a qualitative methodology in assessing patient and professional perspectives. All the included questionnaires exceeded the recommended sixth-grade reading level. The categories covered by hearing aid PROMs vary considerably, with no single instrument comprehensively covering all the key ICF components. Future development of hearing aid outcome measures should consider a mixed methodology approach for improved content validity and ensure an appropriate reading level.

Readability of Patient-Reported Outcomes in Spine Surgery and Implications for Health Literacy.

Observational study. To evaluate the readability of commonly utilized patient-reported outcome measures (PROMs) in spine surgery. Although studies have evaluated patient education materials, discharge instructions, and informed consent forms in spine surgery, there is a dearth of literature on the readability of PROMs despite widespread health illiteracy. Without knowledge of PROM readability, it is unclear whether these measures are able to be understood by the average spine patient. We analyzed all commonly utilized nonvisual PROMs within the spinal literature and uploaded PROMs into an online readability calculator. The Flesch Reading Ease Score (FRES) and Simple Measure of Gobbledygook (SMOG) Index were collected. A FRES>79 or SMOG<7 was considered readable by the general population per American Medical Association and Centers for Disease Control guidelines. A stricter threshold recommended in health care (SMOG <6 or FRES>89) was then used to further review readability. Seventy-seven PROMs were included. Based on FRES, the mean readability of all PROMs was 69.2 ± 17.2 (range, 10-96.4), indicating an average eighth to ninth-grade reading level. The mean readability score categorized by the SMOG Index was 8.12 ± 2.65 (range, 3.1-25.6), representing an eighth-grade reading level. Compared with the reading level of the general population, 49 (63.6%) PROMs are written above the United States literacy level, according to FRES. Using stricter definitions of readability, 8 PROMs were considered readable, including PROM Information System pain behavior (FRES: 96.4 and SMOG: 5.2), PROM Information System sleep disturbance (SMOG: 5.6), Neck Pain and Disability Scale (SMOG: 4.3), and Zung Depression Scale (SMOG: 3.1). Most PROMs utilized in spine surgery require an average reading competency far above the average patient's comprehension. This may have a meaningful impact on understanding PROM instruments and may affect the accuracy of complete surveys and the rates of incompletion.

Patient-reported outcomes after curative treatment for prostate cancer with prostatectomy, primary radiotherapy or salvage radiotherapy

Background Trials reporting adverse health outcomes (AHOs) in terms of patient-reported outcome measures (PROMs) after contemporary curative treatment of prostate cancer (PC) are hampered by study heterogeneity and lack of new treatment techniques. Particularly, the evidence regarding toxicities after radiotherapy (RT) with the volumetric arc therapy (VMAT) technique is limited, and comparisons between men treated with surgery, primary radiotherapy (PRT) and salvage radiotherapy (SRT) are lacking. The aim of the study was to evaluate change in PROMs 3 months after treatment with robotic-assisted laparoscopic prostatectomy (RALP), PRT and SRT administered with VMAT. Material and methods A prospective cohort study of men with PC who received curative treatment at the University Hospital of North Norway between 2012 and 2017 for RALP and between 2016 and 2021 for radiotherapy was conducted. A cohort of 787 men were included; 406 men treated with RALP, 265 received PRT and 116 received SRT. Patients completed the validated PROM instrument EPIC-26 before (pre-treatment) and 3 months after treatment. EPIC-26 domain summary scores (DSSs) were analysed, and changes from pre-treatment to 3 months reported. Changes were deemed clinically relevant if exceeding validated minimally clinically important differences (MCIDs). Results Men treated with RALP reported clinically relevant declining urinary incontinence DSS (−41.7 (SD 30.7)) and sexual DSS (−46.1 (SD 30.2)). Men who received PRT reported worsened urinary irritative DSS (−5.2 (SD 19.6)), bowel DSS (−8.2 (SD 15.1)) and hormonal DSS (−9.6 (SD 18.2)). Men treated with SRT experienced worsened urinary incontinence DSS (−7.3 (SD 18.2)), urinary irritative DSS (−7.5 (SD 14.0)), bowel DSS (−12.5 (SD 16.1)), sexual DSS (−14.9 (SD 18.9)) and hormonal DSS (−23.8 (SD 20.9)). Conclusion AHOs 3 months after contemporary curative treatment for PC varied according to treatment modality and worsened in all treatment groups, although most in SRT.

International Knee Documentation Committee (IKDC) Is the Most Responsive Patient Reported Outcome Measure After Meniscal Surgery

To report the variability in outcome measures after meniscal surgery and to compare responsiveness between patient-reported outcome measures (PROMs). A systematic search of the PubMed/MEDLINE and Web of Science databases was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A total of 257 studies met inclusion criteria. Patient and study attributes were extracted, including pre- and postoperative means for PROMs. Of the studies that met inclusion criteria for responsiveness analysis (2+ PROMs reported, 1-year minimum follow-up; n= 172), we compared the responsiveness between PROM instruments using effect size and relative efficiency (RE) if a PROM could be compared with another in at least 10 articles. In total, 18,612 patients (18,690 menisci, mean age= 38.6 years, mean body mass index= 26.3) were included in this study. Radiographic measures were reported in 167 (65.0%) studies, range of motion was reported in 53 (20.6%) studies, and 35 different PROM instruments were identified. The mean number of PROMs in each article was 3.6 and 83.8% reported 2 or more PROMs. The most used PROMs were Lysholm (74.5%) and IKDC (51.0%). IKDC was found to be more responsive than other PROMs, which include Lysholm (RE= 1.03), Tegner (RE= 3.90), and Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) (RE= 1.12). KOOS Quality of Life (QoL) was also more responsive than other PROMs, such as IKDC (RE= 1.45) and KOOS ADL (RE= 1.48). Lysholm was more responsive compared with KOOS QoL (RE= 1.14), KOOS ADL (RE= 1.96), and Tegner (RE= 3.53). Our study found that IKDC, KOOS QoL, and Lysholm were the most responsive PROMs. However, because of the previously reported risks of either floor effects (KOOS QoL) or ceiling effects (Lysholm), the IKDC may offer a more complete psychometric profile when quantifying outcomes after meniscus procedures. To improve clinical outcomes, surgical decision-making, and research methodology, it is important to determine which PROMs are the most responsive after meniscal surgery.

Cross-cultural adaptation, reliability, and validity of the pain self-efficacy questionnaire - Hebrew version

PurposeThis study aims to translate, culturally adapt, and evaluate the psychometric properties of the Hebrew Pain Self-Efficacy Questionnaire (PSEQ). MethodsThe study was designed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) recommendations for patient-reported outcome measurement instruments. The PSEQ was initially translated into Hebrew and cross-culturally adapted. The Hebrew version of the PSEQ (PSEQ-H) was administered to participants suffering from chronic musculoskeletal pain, along with other self-report measures of pain (NPRS, FABQ, HADS, PCS, and SF-12). Eight hypotheses on expected correlations of the PSEQ-H with other instruments were formulated a priori to assess construct validity. Structural validity was assessed using confirmatory factor analysis. Floor and ceiling effects, test-retest, and internal consistency reliability were also assessed. ResultsThe translation process retained the unidimensional model of the PSEQ. The PSEQ-H demonstrates excellent internal consistency (Cronbach's α = 0.97) and test-retest reliability (ICC = 0.88), and no significant floor and ceiling effects were observed. Construct validity was found satisfactory as 75% (six) of the analyses between the PSEQ-H and the other self-reported measures met the hypotheses. Factor analysis confirmed the single-factor structure of the questionnaire. ConclusionsThe PSEQ-H version was found to have excellent reliability, good construct, and structural validity, and can be used with heterogeneous chronic musculoskeletal pain populations. Future studies should test the PSEQ-H's responsiveness and psychometric properties with specific pain populations.

Role of Patient-Reported Outcomes in Clinical Trials in Metastatic Colorectal Cancer: A Scoping Review

To perform a scoping review on the use of Patient-Reported Outcome Measures (PROMs) in randomized trials on systemic therapy in patients with metastatic colorectal cancer (mCRC) between 2010 and 2021. First, a search on clinicaltrials.gov was performed, looking for randomized trials in mCRC. The use of PROMs was analyzed quantitatively. Subsequently, we assessed the completeness of PROM reporting based on the CONSORT PRO extension in publications related to the selected trials acquired using Embase and PubMed. A total of 46/176 trials were registered on clinicaltrials.gov used PROMs. All these trials used validated PROM instruments. The EORTC QLQ-C30 was most frequently used (37 times), followed by the EQ-5D (21 times) and the EORTC QLQ-CR29 (six times). A total of 56/176 registered trials were published. In 35% (n = 20), the results of the PROMs were available. Overall, 7/20 (35%) trials documented all items of the CONSORT PRO extension and quality of reporting according to the CONSORT PRO extension was higher than in the period 2004-2012. In 3/20 (15%) of the published trials, the results of PROMs were not discussed nor included in the positioning of the new treatment compared to the reference treatment. When PROMs are used, the quality of reporting on patient-reported outcomes is improving, but this must continue in order to optimize the translation of trial results to individual patient values.

EHealth literacy measurement tools: a systematic review protocol

BackgroundImproving eHealth literacy (eHL) is one of the biggest challenges currently facing the global healthcare community. Indeed the use of digital services has the potential to engage patients in care as well as improve the effectiveness of chronic disease self-management, it remains highly dependent on a patient’s specific skills and experiences in the health care systems. Although eHealth literacy has gained momentum in the past decade, it remains an underresearched area, particularly eHealth literacy measurement. The aim of the review is to identify patient-reported outcome measures (PROMs) of eHealth literacy for adult populations and to summarize the evidence on their psychometric properties.MethodsWe will conduct a systematic literature review of the tools used to measure eHealth literacy for adult population. The search strategy aims to find published studies. A three-step search strategy will be used in this review. Published studies will be searched in CINAHL, PubMed, PsycINFO, and Web of Science from inception until end. Grey literature will be searched to find theses. Database search strategies will be formulated and tested with the assistance of an expert Health Sciences Librarian. The selection of studies will be done by two independent reviewers. Disagreements will be resolved through consensus, and a third reviewer will solve discrepancies. Furthermore, two reviewers will independently evaluate the methodological rigor of the instruments development and testing and assign a grade using the standardized Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. Disagreements will be discussed with a third reviewer, expert in psychometrics.Extracted data will be aggregated and analyzed to produce a set of synthesized findings that will be used to develop evidence-informed recommendations in regard of eHL instruments. We will present a synthesis of all instruments, their psychometric properties, and make recommendations for eHL instrument selection in practice. Reporting will be informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis and a PRISMA flow diagram.DiscussionThis systematic review will summarize the evidence on the psychometric properties of PROMs instruments used to measure eHL and will help clinicians, managers, and policy-makers to select an appropriate instrument.Systematic review registrationPROSPERO CRD42021232765

Patient-reported outcome measures (PROMs) use in the real world: clinical trials evaluating low back pain interventions

In a health care system considering value, defined as health outcomes achieved per dollar spent [1], patient-reported outcome measures (PROMs) are taking on a larger role in treatment efficacy assessment and value determination [1,2]. The Centers for Medicare & Medicaid Services (CMS) define PROMs as the status of a patient's health that is provided directly from the patient and measured using PROM instruments [2]. As health care delivery continues to be transformed, CMS has noted PROM measurement is a high priority [2].

Bringing Patient-Reported Outcome Measures (PROMs) Into Practice: A Review of the Latest Developments in PROM Use in the Evaluation and Treatment of Carpal Tunnel Syndrome

As health care systems globally shift toward optimizing value, defined as health outcomes achieved per dollar spent across a full cycle of care, there has been increasing focus on using patient-reported outcome measures (PROMs) to gauge success. Patient-reported outcome measures are validated questionnaires that allow patients to share their health status across several domains (eg, pain or physical function). This trend has been particularly notable in hand surgery, with PROM use investigated for many common hand conditions, including carpal tunnel syndrome, Dupuytren contracture, trigger finger, osteoarthritis, and wrist ganglion. The purpose of this article is to review recent developments in the use of PROM instruments, including the Boston Carpal Tunnel Questionnaire; Michigan Hand Outcomes Questionnaire; Disabilities of the Arm, Shoulder, and Hand; and Patient-Reported Outcomes Measurement Information System, for the evaluation and treatment of patients with carpal tunnel syndrome. The considerable progress in establishing PROMs for use in carpal tunnel syndrome is reviewed, and future improvements are proposed to standardize PROM use and bring PROMs into day-to-day clinical practice for individualized patient treatment decision-making and counseling.

Development of a core outcome set for cardio-oncology (COS-CO) to assess and monitor cancer patients at risk of or with cardiovascular diseases

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): King Baudouin Foundation UZ Brussel Foundation Background Experts predict a cardio-oncological epidemic in the coming years due to the growing population of cancer survivors, the increasing number of elderly people with chronic cancer therapy, and the high number of cardiovascular diseases resulting from these treatments. Cardio-oncology clinics should provide multidisciplinary, specialised evaluation, and long-term follow-up. Although a number of (inter)national registries for cardio-oncology have been created, international standards for clinical assessment and outcome measurement is lacking. Moreover, patient-reported outcomes tend to be neglected. Purpose To develop a standard and pragmatic patient-centered outcome set to assess and monitor patients at risk of or with cardiovascular diseases before, during and after oncological treatment. Methods A list of outcomes and measurement instruments was generated through review of existing registries. The project team reviewed and refined the outcomes prior to starting a Delphi procedure. The panelists, including healthcare providers and researchers were invited to rate the importance of the outcome domains. Results The set is designed to include all patients within the cardio-oncology clinic, whether before, during or after oncological treatment. We extracted &amp;gt;500 outcomes and after refinement 93 outcomes were rated by the panelists. The set encompass baseline cancer and cardiovascular health status (e.g. risk assessment), treatment variables, and functional, psychosocial, and survival outcomes. Data will be collected through administrative and clinical records, and validated patient-reported outcome measurement instruments. Conclusions A major component of this set’s development was surveying existing registries to establish what measurement efforts are currently being undertaken by health care and research teams. The focus and structure of existing (inter)national cardio-oncology registries limit the extent to which longitudinal patient-centered outcomes can be measured and compared. Due to the underrepresentation of patient-reported outcomes, patients will be interviewed to encompass the patient’s perspective. This set aims to facilitate (inter)national comparison in cardio-oncology care, using standardised parameters and meaningful patient-centered outcomes for research and quality of care assessments.