Review Of Patient-reported Outcome Measures Research Articles

COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0

PurposeSystematic reviews of patient-reported outcome measures (PROMs) are important tools to select the most suitable PROM for a study or clinical application. Conducting these reviews is challenging, and the quality of these reviews needs to be improved. We updated the COSMIN guideline for systematic reviews of PROMs, including the COSMIN Risk of Bias checklist, and the COSMIN criteria for good measurement properties.MethodsAdaptations to the methodology were based on our experience with applying the COSMIN guideline, through discussions among the authors, and results from two related Delphi studies.ResultsThe updated guideline places more emphasis on key aspects that are often missing or sub optimally conducted in published systematic reviews of PROMs, such as formulating a well-defined research question and developing a comprehensive search strategy, assessing risk of bias, applying criteria for good measurement properties, summarizing results, and grading the quality of the evidence. We also stress the importance of evaluating the measurement properties of each subscale of a PROM separately and evaluating content validity of all included PROMs.ConclusionThe quality of systematic reviews of PROMs can be improved by using this updated version of the COSMIN guideline for systematic reviews of PROMs. Improved quality will lead to better PROM selection and increased standardization of PROM use.

Remotely Assessing Motor Function and Activity of the Upper Extremity After Stroke: A Systematic Review of Validity and Clinical Utility of Tele-Assessments

Objective The aim of this systematic review is to identify currently available tele-assessments for motor impairments of the upper extremity in adults after a stroke and to assess their psychometric properties and clinical utility. Data sources We searched for studies describing the psychometric properties of tele-assessments for the motor function of the upper extremity. A systematic search was conducted in the Cumulative Index to Nursing and Allied Health Literature, Medline via OVID, Embase, The Cochrane Library, Scopus, Web of Science and Institute of Electrical and Electronics Engineers Xplore from inception until 30 April 2024. Review methods The quality assessment for the included studies and the rating of the psychometric properties were performed using the COSMIN Risk of Bias Checklist for systematic reviews of patient-reported outcome measures. Results A total of 12 studies (N = 3912) describing 11 tele-assessments met the predefined inclusion criteria. The included assessments were heterogeneous in terms of quality and psychometric properties and risk of bias. None of the tele-assessments currently meets the criteria of clinical utility to be recommended for clinical practice without restriction. Conclusion The quality and clinical utility of tele-assessments varied widely, suggesting a cautious consideration for immediate clinical practice application. There is potential for tele-assessments in clinical practice, but the clinical benefits need to be improved by simplifying the complexity of tele-assessments. Registration Number CRD42022335035.

A systematic review of the psychometric properties of physical performance tests for sarcopenia in community-dwelling older adults

Abstract Background This review provides an overview of the psychometric properties of the short physical performance battery (SPPB), timed up and go test (TUG), 4 m gait speed test (4 m GST) and the 400 m walk test (400 m WT) in community-dwelling older adults. Methods A systematic search was conducted in MEDLINE, CINAHL and EMBASE, resulting in the inclusion of 50 studies with data from in total 19,266 participants (mean age 63.2–84.3). Data were extracted and properties were given a sufficient or insufficient overall rating following the COSMIN guideline for systematic reviews of patient-reported outcome measures. Quality of evidence (QoE) was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results The SPPB was evaluated in 12 studies, TUG in 30, 4 m GST in 12 and 400 m WT in 2. Reliability of the SPPB, TUG and 4 m GST was rated sufficient (moderate to good QoE). The measurement error of the SPPB was rated insufficient (low QoE). Criterion validity for the SPPB was insufficient in indicating sarcopenia (moderate QoE), while the TUG was sufficient and insufficient for determining mobility limitations (low QoE) and activities of daily living disability (low QoE), respectively. Construct validity of the SPPB, TUG, 4 m GST and 400 m WT was rated insufficient in many constructs (moderate to high QoE). Responsiveness was rated as insufficient for SPPB (high QoE) and TUG (very low QoE), while 4 m GST was rated as sufficient (high QoE). Conclusion Overall, the psychometric quality of commonly used physical performance tests in community-dwelling older adults was generally rated insufficient, except for reliability. These tests are widely used in daily practice and recommended in guidelines; however, users should be cautious when drawing conclusions such as sarcopenia severity and change in physical performance due to limited psychometric quality of the recommended measurement instruments. There is a need for a disease-specific physical performance test for people with sarcopenia. This research received no specific grant from any funding agency and was registered a priori using the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42022359725).

Female non-obstetric urogenital fistula repair: long-term patient-reported outcomes and a scoping literature review.

To investigate long-term and patient-reported outcomes, including sexual function, in women undergoing urogenital fistula (UGF) repair, addressing the lack of such data in Western countries, where fistulas often result from iatrogenic causes. We conducted a retrospective analysis at a tertiary referral centre (2010-2023), classifying fistulas based on World Health Organisation criteria and evaluating surgical approaches, aetiology, and characteristics. Both objective (fistula closure, reintervention rates) and subjective outcomes (validated questionnaires) were assessed. A scoping review of patient-reported outcome measures in UGF repair was also performed. The study included 50 patients: 17 (34%) underwent transvaginal and 33 (66%) transabdominal surgery. History of hysterectomy was present in 36 patients (72%). The median (interquartile range [IQR]) operating time was 130 (88-148) min. Fistula closure was achieved in 94% of cases at a median (IQR) follow-up of 50 (16-91) months and reached 100% after three redo fistula repairs. Seven patients (14%) underwent reinterventions for stress urinary incontinence after transvaginal repair (autologous fascial slings). Patient-reported outcomes showed median (IQR) scores on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) of 5 (3-7) for filling symptoms, 1 (0-2) for voiding symptoms and 4.5 (1-9) for incontinence symptoms. The median (IQR) score on the ICIQ Female Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-FLUTSsex) was 3 (1-5). The median (IQR) ICIQ Satisfaction (ICIQ-S) outcome score and overall satisfaction with surgery item score was 22 (18.5-23.5) and 10 (8.5-10), respectively. Higher scores indicate higher symptom burden and treatment satisfaction, respectively. Our scoping review included 1784 women, revealing mixed aetiology and methodological and aetiological heterogeneity, thus complicating cross-study comparisons. Urogenital fistula repair at a specialised centre leads to excellent outcomes and high satisfaction. Patients with urethrovaginal fistulas are at increased risk of stress urinary incontinence, possibly due to the original trauma site of the fistula.

Measurement properties of the Mental Health Literacy Scale (MHLS) validation studies: a systematic review protocol

IntroductionMental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL....

Measuring Women's Satisfaction with Childbirth: A Literature Review of Measurement Properties.

Patient satisfaction is an important indicator of the quality of care provided. Evaluating women's satisfaction with childbirth is essential to improving obstetric care and ensuring a positive experience for mothers and newborns. The tools used to measure women's satisfaction with childbirth are very heterogeneous and multidimensional. Assessment tools used in practice should be tested and meet characteristics that are consistently validated.The aim is to identify currently available instruments measuring women's satisfaction with childbirth and to evaluate their structure, content and psychometric properties. A systematic search for sources was carried out according to the criteria set. For the included studies, psychometric properties were assessed in accordance with the principles of the guideline for completing systematic reviews of patient-reported outcome measures, COSMIN. The review included 31 studies that reported the psychometric properties of six measurement instruments (questionnaires, scales). Content validity, structural validity, internal consistency, reliability and cross-cultural validity were assessed for the included studies. The Childbirth Experience Questionnaire (CEQ/CEQ2) and Birth Satisfaction Scale - Revised (BSS-R) were the most commonly used questionnaires in the studies. Thorough testing of tools measuring women's satisfaction with childbirth, and adapting them to cultural and social contexts, is still essential. It is crucial that valid and reliable questionnaires are available for midwives in practice, for use in research, to inform clinical practice and for the results to help develop the services offered.

Patient experiences in ulcerative colitis: conceptual model and review of patient-reported outcome measures

PurposeTo identify symptoms and their impacts on daily functioning and health-related quality of life (HRQoL) experienced by adult patients with ulcerative colitis (UC) and evaluate patient-reported outcome (PRO) measures for UC clinical studies.MethodsA conceptual model of symptoms and impacts of UC were developed from a literature review. PRO measures were identified from the literature, clinical trials databases, health technology assessment submissions, and regulatory label claims, and were selected for conceptual analysis based on disease specificity and use across information sources. PRO measures covering the most concepts when mapped against the conceptual model were assessed for gaps in psychometric properties using Food and Drug Administration (FDA) guidance and consensus-based standards for the selection of health measurement instruments (COSMIN) criteria.ResultsThe conceptual model grouped the 52 symptom concepts and 72 proximal and distal impacts into eight, two, and five dimensions, respectively. Of 65 PRO measures identified, eight underwent conceptual analysis. Measures covering the most concepts and assessed for psychometric properties were the Inflammatory Bowel Disease Questionnaire, Symptoms and Impacts Questionnaire for UC, UC-PRO symptoms modules, UC-PRO impact modules, and Crohn’s and UC Questionnaire; all had good or excellent support for content validity. The UC-PRO Signs and Symptoms fully met FDA guidance and COSMIN criteria for content validity and most psychometric properties.ConclusionExisting PRO measures assess concepts relevant to patients with UC, but all PRO measures reviewed require further psychometric evaluation to demonstrate they are fit for purpose.

Patient engagement in multimorbidity: a systematic review of patient-reported outcome measures.

People with multimorbidity are increasingly engaged, enabled, and empowered to take responsibility for managing their health status. The purpose of the study was to systematically review and appraise the psychometric properties of tools measuring patient engagement in adults with multimorbidity and their applicability for use within engagement programs. PubMed, Scopus, Web of Science, and PsycInfo were searched from inception to 1 July 2021. Gray literature was searched using EBSCO host-database "Open dissertation". The reference lists of studies meeting the inclusion criteria were searched to identify additional eligible studies. The screening of the search results and the data extraction were performed independently by two reviewers. The methodological quality of the included studies was evaluated with the COSMIN checklist. Relevant data from all included articles were extracted and summarized in evidence synthesis tables. Twenty articles on eight tools were included. We included tools that measure all four dimensions of patient engagement (i.e., engagement, empowerment, activation, and participation). Their psychometric properties were analyzed separately. Most tools were developed in the last 10 years in Europe or the USA. The comparison of the estimated psychometric properties of the retrieved tools highlighted a significant lack of reliable patient engagement measures for people with multimorbidity. Available measures capture a diversity of constructs and have very limited evidence of psychometric properties that are vital for patient-reported measures, such as invariance, reliability, and responsiveness. This review clarifies how patient engagement, as operationalized in measures purporting to capture this concept, overlaps with, and differs from other related constructs in adults with multimorbidity. The methodological quality of psychometric tools measuring patient engagement in adults with multimorbidity could be improved. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=259968, identifier CRD42021259968.

A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE)

BackgroundCONCISE is an internationally agreed minimum set of outcomes for use in nutritional and metabolic clinical research in critically ill adults. Clinicians and researchers need to be aware of the clinimetric properties of these instruments and understand any limitations to ensure valid and reliable research. This systematic review and meta-analysis were undertaken to evaluate the clinimetric properties of the measurement instruments identified in CONCISE.MethodsFour electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted.ResultsA total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high.ConclusionsVariable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness.Trial registration : PROSPERO (CRD42023438187). Registered 21/06/2023.

Assessment of the acute subjective psychedelic experience: A review of patient-reported outcome measures in clinical research on classical psychedelics.

The classical psychedelics psilocybin, peyote, ayahuasca/ N, N-dimethyltryptamine, and lysergic acid diethylamide can temporarily produce altered states of consciousness, characterized by changes in sensory perception, thought, mood, and the sense of self-reality and meaning. It is important to have reliable instruments for quantifying these altered states in trials, due to a plausible link between the acute subjective experience and treatment outcome. We conducted a review of outcome measures applied in research on classical psychedelics to assess one or more dimensions of the acute subjective psychedelic experience. Three relevant databases were searched electronically. Two reviewers independently conducted article selection and data extraction regarding the instruments, dimensions, geography, population, and psychedelic substance investigated in the included studies. We identified the five most utilized instruments for the most recent 6 years, as well as the five most utilized instruments for each psychedelic. We included 93 papers, which reported on 93 unique trials and utilized 17 different rating scales. Of these, the most utilized were the Five-Dimensional Altered States of Consciousness Questionnaire, visual analog or Likert scales specially developed for the trials, the Hallucinogen Rating Scale, the States of Consciousness Questionnaire, and the Abnormer Psychischer Zustand. Considerable variability was found in the instruments utilized in clinical trials on classical psychedelics. We advise and encourage the development of a core outcome set for psychedelic research to enable altered state comparisons across compounds, participants, and settings. We further advise that instruments be designed to assess the "setting" of a psychedelic experience.

Occupational Therapy Assessments of Cortical or Cerebral Visual Impairment: A Systematic Review.

Cortical or cerebral visual impairment (CVI), a leading cause of visual dysfunction in children across the globe, can result in delayed development of fine and gross motor skills, functional mobility, and socialization, which affects all areas of occupation. No assessments are recommended for occupational therapy practitioners working with children with CVI. To appraise the measurement properties and clinical utility of CVI assessments appropriate for use by occupational therapy practitioners. MEDLINE via PubMed, Scopus, and Web of Science. We followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines for systematic reviews of patient-reported outcome measures for relevant studies. A total of 590 records yielded 15 studies of the measurement properties of 12 assessment tools, 8 patient-reported outcome measures and 4 clinician-reported or performance-based outcome measures. We report on the quality of measurement properties of 10 of the 12 outcome measures. None had high-quality evidence of content validity, structural validity, or test-retest reliability. Most had indeterminate internal consistency as a result of a lack of confirmatory factor analysis. Three instruments demonstrated high quality and sufficient construct validity. On the basis of the COSMIN guidelines, all 12 outcome measures have the potential to be recommended but require further study before definitive recommendations can be made. What This Article Adds: This is the first systematic review of assessments of CVI feasible for use by occupational therapy practitioners. High-quality studies of measurement properties are lacking. Further examination of the measurement properties of outcome measures is required.

American Shoulder and Elbow Surgeons score: what does it tell us about patients selecting operative treatment of a rotator cuff injury?

As shared decision-making rises in importance and minimum clinically important differences become benchmarks for treatment success or failure based on the increased usage of patient-reported outcomes, it is important to understand the breadth of starting points for patients as that should affect the interpretation of individual postoperative score changes. This is a retrospective data review of prospectively collected American Shoulder and Elbow Surgeons (ASES) score of patients electing to undergo rotator cuff repair with 1-year follow-up. A residual improvement: possible to achieve ratio (RIPAR) was calculated to demonstrate what percent of maximal possible improvement was gained at 1 year. A minimal clinically important difference (MCID) of 12 was used. Three hundred thirty-five patients with an age range of 32-79 years form the population. Baseline ASES score ranged from 0 to 97.5, with a mean of 47.8. At 1 year, the mean was 84.7 (range, 30-100). There was no statistical difference by age, but men reported more overall preoperative dysfunction than women (50.3 vs. 44.1, P<.001). The RIPAR was on average 67%. Seventy-eight percent of the population demonstrated RIPAR scores >50% which showed improvement of over half of their preoperative deficit. Eighty-nine percent of patients achieved a positive MCID and 3% achieved a negative MCID. The ASES scores showed a broad range of baseline scores for patients choosing to undergo rotator cuff repair highlighting the need for individual patient rather than population review of patient-reported outcome measures. As shared decision-making is taking on a larger role in clinical care, it is important to counsel patients accurately. Evaluating the ASES score by MCID and maximal possible improvement provides different population perspectives with the concept of RIPAR allowing for personalization of decision-making on the individual patient level.

P227 Patient experiences in ulcerative colitis: conceptual model and review of patient-reported outcome measures

Abstract Background Symptoms of ulcerative colitis (UC) negatively affect patients’ health-related quality of life (HRQoL). The aim of this study was to identify symptoms and impacts experienced by patients with UC, develop a conceptual model (CM) and evaluate available patient-reported outcome (PRO) measures for appropriateness for inclusion in UC clinical studies. Methods We conducted a landscape assessment that included: targeted literature reviews (TLRs) to identify concepts of interest and frequently used PRO measures among patients with UC; label claims searches for US and European regulatory and health technology assessment (HTA) submissions; and US and European clinical trial database searches to identify PRO measures used as primary and secondary endpoints in ongoing clinical trials. Results from the TLR informed a CM of UC. Concepts from the CM were mapped to selected PRO measures. Appropriateness of selected PRO measures for UC populations was evaluated via a gap analysis. Results Fifty-two symptoms and 72 impacts of UC were identified from the TLR. The most frequently reported symptoms were diarrhoea, incontinence/leaking/lack of bowel control, urgency, rectal bleeding, frequent bowel movements and fatigue. The most frequently reported impacts were anxiety, depression, inability to conduct daily activities, embarrassment and affected relationships with others. The CM grouped the 52 symptom concepts into eight dimensions, the 29 impacts proximal to UC into two dimensions and the 43 impacts distal to UC into five dimensions (Figure 1). Of the 69 PRO measures identified, eight were selected for conceptual analysis based on being disease-specific and having evidence of use in regulatory label claims, HTA submissions, as UC clinical trial endpoints and/or having US Food and Drug Administration (FDA) qualification status. The five PRO measures that covered the most concepts when mapped against the CM and included in the gap analysis were: the Inflammatory Bowel Disease Questionnaire (IBDQ); Symptoms and Impacts Questionnaire for UC (SIQ-UC); UC-PRO symptoms modules (UC-PRO-Signs and Symptoms [UC-PRO/SS] and UC-PRO-Systemic Symptoms); UC-PRO impact modules (UC-PRO-Daily Coping [UC-PRO-DC], UC-PRO-Daily Life Impact [UC-PRO-DLI] and UC-PRO-Emotional Impact [UC-PRO-EI]); and Crohn’s and Ulcerative Colitis Questionnaire (CUCQ) (Table 1). All five PRO measures had good or excellent support for content validity; the UC-PRO/SS fully met FDA PRO guidance for content validity and most psychometric properties. Conclusion Based on the CM and PRO measures review, the IBDQ plus UC-PRO/SS are recommended to capture UC symptoms and IBDQ plus UC-PRO impact modules to capture proximal impacts. All PRO measures reviewed require further psychometric evaluation.

PCR286 Literature Review of Patient-Reported Outcome Measures in Multiple Myeloma: Trends and Considerations for Future Clinical Trials

PCR286 Literature Review of Patient-Reported Outcome Measures in Multiple Myeloma: Trends and Considerations for Future Clinical Trials

Awake transforaminal endoscopic lumbar facet cyst resection: technical note and case series.

The aim of this study was to describe a minimally invasive transforaminal surgical technique for treating awake patients presenting with lumbar radiculopathy and compressive facet cysts. Awake transforaminal endoscopic decompression surgery was performed in 645 patients over a 6-year period from 2014 to 2020. Transforaminal endoscopic decompression surgery utilizing a high-speed endoscopic drill was performed in 25 patients who had lumbar facet cysts. All surgeries were performed as outpatient procedures in awake patients. Nine of the 25 patients had previously undergone laminectomies at the treated level. A retrospective chart review of patient-reported outcome measures is presented. At the 2-year follow-up, the mean (± standard deviation) preoperative visual analog scale leg score and Oswestry Disability Index improved from 7.6 ± 1.3 to 2.3 ± 1.4 and 39.7% ± 8.1% to 13.0% ± 7.4%, respectively. There were no complications, readmissions, or recurrence of symptoms during the 2-year follow-up period. A minimally invasive awake procedure is presented for the treatment of lumbar facet cysts in patients with lumbar radiculopathy. Approximately one-third of the treated patients (9 of 25) had postlaminectomy facet cysts.

A Web-Based Prostate Cancer-Specific Holistic Needs Assessment (CHAT-P): Multimethod Study From Concept to Clinical Practice.

Men with prostate cancer experience immediate and long-term consequences of the disease and its treatment. They require both long-term monitoring for recurrence or progression and follow-up to identify and help manage psychosocial and physical impacts. Holistic Needs Assessment aims to ensure patient-centered continuing cancer care. However, paper-based generic tools have had limited uptake within cancer services, and there is little evidence of their impact. With the expansion of remote methods of care delivery and to enhance the value of generic tools, we developed a web-based Composite Holistic Needs Assessment Adaptive Tool-Prostate (CHAT-P) specifically for prostate cancer. This paper described the context, conceptual underpinning, and approach to design that informed the development of CHAT-P, starting from the initial concept to readiness for deployment. Through this narrative, we sought to contribute to the expanding body of knowledge regarding the coproduction process of innovative digital systems with potential for enhanced cancer care delivery. The development of CHAT-P was guided by the principles of coproduction. Men with prostate cancer and health care professionals contributed to each stage of the process. Testing was conducted iteratively over a 5-year period. An initial rapid review of patient-reported outcome measures identified candidate items for inclusion. These items were categorized and allocated to overarching domains. After the first round of user testing, further items were added, improvements were made to the adaptive branching system, and response categories were refined. A functioning version of CHAT-P was tested with 16 patients recruited from 3 outpatient clinics, with interviewers adopting the think-aloud technique. Interview transcripts were analyzed using a framework approach. Interviews and informal discussions with health care professionals informed the development of a linked care plan and clinician-facing platform, which were incorporated into a separate feasibility study of digitally enhanced integrated cancer care. The findings from the interview study demonstrated the usability, acceptability, and potential value of CHAT-P. Men recognized the benefits of a personalized approach and the importance of a holistic understanding of their needs. Preparation for the consultation by the completion of CHAT-P was also recognized as empowering. The possible limitations identified were related to the importance of care teams responding to the issues selected in the assessment. The subsequent feasibility study highlighted the need for attention to men's psychological concerns and demonstrated the ability of CHAT-P to capture red flag symptoms requiring urgent investigation. CHAT-P offers an innovative means by which men can communicate their concerns to their health care teams before a physical or remote consultation. There is now a need for a full evaluation of the implementation process and outcomes where CHAT-P is introduced into the clinical pathway. There is also scope for adapting the CHAT-P model to other cancers.

A Review of Patient-Reported Outcome Measures in Childhood Cancer.

Patient-reported outcomes (PROs) are used in clinical work and research to capture the subjective experiences of childhood cancer patients and survivors. PROs encompass content domains relevant and important to this population, including health-related quality-of-life (HRQOL), symptoms, and functional status. To inform future efforts in the application of PRO measures, this review describes the existing generic and cancer-specific PRO measures for pediatric cancer populations and summarizes their characteristics, available language translations, content coverage, and measurement properties into tables for clinicians and researchers to reference before choosing a PRO measure that suits their purpose. We have identified often unreported measurement properties that could provide evidence about the clinical utility of the PRO measures. Routine PRO assessment in pediatric cancer care offers opportunities to facilitate clinical decision-making and improve quality of care for these patients. However, we suggest that before implementing PRO measures into research or clinical care, the psychometric properties and content coverage of the PRO measures must be considered to ensure that PRO measures are appropriately assessing the intended construct in childhood cancer patients.

A systematic review of patient-reported outcome measures in paediatric endocrinology

ContextPatient reported outcome measures (PROMs) are useful tools in paediatric endocrinology to gauge health status in children, especially since they are often unable to clearly communicate it themselves. We aimed to systematically search and appraise all available PROMs relevant to paediatric endocrinology and provide a curated resource for health professionals to utilise.Evidence acquisitionWe identified PROMs in paediatric endocrinology by systematically searching the Cochrane Library, MEDLINE, World Health Organisation International Clinical Trials Registry Platform, and the Cumulative Index to Nursing and Allied Health Literature on May 20, 2022. Additional studies were located through hand searching and content area expert contributions. We assessed the quality of each PROM using the COSMIN risk of bias checklist.Evidence synthesisWe identified 5003 papers in the initial search. After applying exclusion criteria we included seven PROMs in the review. Six PROMs were specific to Type I Diabetes and one to Hypothyroidism. We gave all studies an overall COSMIN score of ‘inadequate’ due to poorly detailed PROM development.ConclusionThe scope and quality of PROMs in paediatric endocrinology is limited. Further research and development of PROM tools are required in paediatric endocrinology to allow for improved patient care.

Systematic Review of Patient-Reported Outcome Measures for Patients with Exercise-Induced Leg Pain.

Background and Objectives: To determine the most commonly used patient-reported outcome measures (PROMs) in exercise-induced leg pain (EILP) and to identify specific PROMs for EILP in order to evaluate their psychometric properties and methodological quality. Materials and Methods: A strategic search was performed in different databases to identify and extract the characteristics of studies based on the use of PROMs in patients with EILP. Specific PROMs were evaluated according to the Terwee et al. and COSMIN criteria. Results: Fifty-six studies were included in the review. The Medial Tibial Stress Syndrome Score (MTSSS), Lower Extremity Functional Scale (LEFS) and Exercise-Induced Leg Pain Questionnaire (EILP-Q) were identified as specific PROMs for EILP. The Visual Analog Scale (VAS) was the most widely used instrument in the assessment of EILP. The methodological quality assessment showed six positive values for the LEFS, four for the MTSSS and three for the EILP-Q for the eight psychometric properties analyzed according to the COSMIN criteria. The evaluation of the nine psychometric properties according to Terwee showed five positive values for the LEFS and MTSSS, and three for the EILP-Q. Conclusions: The overall methodological quality of the PROMs used was low. The VAS was the most widely used instrument in the assessment of EILP, and the LEFS was the highest quality PROM available for EILP, followed by the MTSSS and EILP-Q, respectively.

Measurement properties of instruments for migraine impact in Brazil: a systematic review

Objective: To critically appraise, compare and summarize the quality of the measurement properties of all Patient-Reported Outcome Measures translated and validated for the Brazilian population that assess the impact of migraine. Background The evaluation of measurement properties of Patient-Reported Outcome Measures is needed for professionals and researchers to select instruments that ensure quality of results. Thus, reliable instruments are important to provide information on the impact of migraine. Methods: The search was conducted in MEDLINE/Pubmed, Web of Science, LILACS, and Embase databases. We included studies evaluating measurement properties of PROMs that assessed the impact of migraine and were validated for Brazil. Methodological quality, risk of bias, and quality of evidence were assessed following the Consensus-based Standards for Selecting Health Measurement Instruments for systematic reviews of Patient-Reported Outcome Measures Results: A total of 112 studies identified, and four were included. Three instruments were analyzed: Headache Impact Test, which presented a serious risk of bias with moderate quality of evidence; Pediatric Migraine Disability Assessment, which presented an extremely serious risk of bias and very low quality of evidence; and the Headache Disability Inventory¸ which presented a very serious risk of bias and low quality of evidence. Conclusion: The three instruments evaluated had important limitations regarding quality of evidence. The Headache Impact Test was the most recommended instrument because it presented a moderate quality of evidence.