Suitable Patient-reported Outcome Measures Research Articles

A Core set of patient-reported outcome measures to measure quality of life in obesity treatment research.

The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters.

PROs for RARE: protocol for development of a core patient reported outcome set for individuals with genetic intellectual disability

IntroductionRare genetic neurodevelopmental disorders and intellectual disability (ID), collectively called genetic ID (GID), can profoundly impact daily functioning and overall well-being of affected individuals. To improve our understanding of the impact of GID and advancing both care and research, measuring relevant patient reported outcomes (PROs) is crucial. Currently, various PROs are measured for GID. Given the shared comorbidities across disorders, we aim to develop a generic core PRO set for children and adults with GID.Methods and resultsDeveloping the generic core PRO set entails the following steps: 1) providing an overview of potentially relevant PROs by scoping reviews and qualitative research; 2) integrating and conceptualizing these PROs (i.e., describing the content of the PROs in detail) into a pilot generic core PRO set; and 3) prioritizing relevant PROs by a European Delphi survey and consensus meetings.ConclusionsThis protocol presents the steps for developing a generic core PRO set for children and adults with GID. The next step involves selecting suitable patient reported outcome measures (PROMs) to adequately measure these PROs: the generic core PROM set. This generic core PROM set needs validation in the GID population, and eventually implementation in care and research, facilitating the aggregation and analysis of PRO data and guaranteeing continuous integration of the patient perspective in both care and research.

Twenty-five years of experience with patient-reported outcome measures in soft-tissue sarcoma patients: a systematic review.

As the importance of the patient's perspective on treatment outcome is becoming increasingly clear, the availability of patient-reported outcome measures (PROMs) has grown accordingly. There remains insufficient information regarding the quality of PROMs in patients with soft-tissue sarcomas (STSs). The objectives of this systematic review were (1) to identify all PROMs used in STS patients and (2) to critically appraise the methodological quality of these PROMs. Literature searches were performed in MEDLINE and Embase on April 22, 2024. PROMs were identified by including all studies that evaluate (an aspect of) health-related quality of life in STS patients by using a PROM. Second, studies that assessed measurement properties of the PROMs utilized in STS patients were included. Quality of PROMs was evaluated by performing a COSMIN analysis. In 59 studies, 39 PROMs were identified, with the Toronto Extremity Salvage Score (TESS) being the most frequently utilized. Three studies evaluated methodological quality of PROMs in the STS population. Measurement properties of the TESS, Quick Disability of the Arm, Shoulder and Hand (QuickDASH) and European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) were reported. None of the PROMs utilized in the STS population can be recommended for use based on the current evidence and COSMIN analysis. To ensure collection of reliable outcomes, PROMs require methodological evaluation prior to utilization in the STS population. Research should prioritize on determining relevant content and subsequently selecting the most suitable PROM for assessment.

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.

Selection of questionnaires for clinical studies in orthopedics and trauma surgery

AbstractIn orthopedics the importance of patient-reported outcome measures (PROMs) has increased enormously, not only clinically and academically but also with respect to health policy. Many such measurement instruments are available for several areas and joints, so that a uniform application of suitable PROMs is recommended for comparisons under scientific and clinical aspects. A PROM must fulfil certain scientific criteria (e.g., reliability, validity, and responsiveness), should be validated for the pathology of interest, and a validated translated version should be available for the respective language. Furthermore, data should be available to interpret results not only with respect to the statistical significance but also regarding their clinical relevance, e.g., the minimal clinically important difference (MCID).

Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.

Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects. A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome. A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice. We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.

P9.48: A Systematic Review of the Use of Patient-Reported Outcome Measures (PROMs) in Adults Undergoing Liver Transplantation

Background: Improved survival rates of liver transplantation (LT) (~80% 5-year survival) has shifted the focus towards reducing symptom burden and improving quality of life, which can be assessed using patient-reported outcome measures (PROMs). This study systematically reviewed measurement properties of PROMs to serve as an evidence base for the selection of suitable PROMs and offer new benchmarks for value-based health-care in LT. Methods: MEDLINE, EMBASE, PubMed and COCHRANE databases were searched for relevant articles. Studies were included if they reported PROMs in LT candidates and/or recipients. Articles including patients <16 years only and clinician-assessed instruments were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to asses methodological quality of included studies and measurement properties. Results: The full-texts of 185 out of 2040 studies were reviewed. The Short-Form-36 (SF-36) (n=86 studies) and Hospital Anxiety and Depression Scale (HADS) (n=16 studies) were the most commonly reported generic instruments in this population. Only 15 studies provided original measurement properties for 24 PROMs. Both SF-36 (n=2 studies) and HADS (n=2 studies) showed high quality evidence for sufficient internal consistency (Cronbach’s alpha >7.8 and >7.3, respectively), but indeterminate reliability. The Liver Disease Quality of Life Questionnaire and its short version ((SF-)LDQOL) were the most used disease-specific PROMs reported in LT candidates (n=8 studies), and showed moderate quality evidence for sufficient internal consistency and construct validity in 2 studies. Five individual studies reported newly developed PROMs for LT recipients, often incorporating questions from existing instruments. These showed generally high quality evidence and sufficient internal consistency. Conclusion: In addition to well-established PROMs (SF-36 and HADS), we conclude that the (SF-)LDQOL is the most promising for the detection of disease-specific changes in LT candidates. However, this instrument should be evaluated further for LT recipients.

Patient-Reported Outcome Measures of Quality of Life in People Affected by Diabetic Foot: A Psychometric Systematic Review

This psychometric systematic review aimed to identify the most suitable patient-reported outcome measures (PROMs) of quality of life (QoL) in people affected by diabetic foot. We performed a literature search in MEDLINE (PubMed), CINAHL (EBSCOhost), and PsycINFO (EBSCOhost) databases from inception to February 1, 2022. We also searched gray literature databases. Eligible studies were full-text reports developing a QoL condition-specific PROM or assessing one or more of its measurement properties in people affected by diabetic foot. We assessed the methodological quality of included studies independently using the "Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of Bias" checklist. The measurement properties were evaluated using specific criteria. We graded the quality of the evidence using a "Grading of Recommendations Assessment, Development and Evaluation" approach modified by Consensus-Based Standards for the Selection of Health Measurement Instruments. Forty-three reports (46 studies) providing information on the measurement properties of 10 different PROMs were included. We did not identify any instruments that could be recommended for use. We identified 2 PROMs that were not recommended for use and 8 that were potentially recommended but would require further investigation. Of these 8 PROMs, 4 had better evidence for content validity. Available PROMs to measure QoL in people affected by diabetic foot have limited evidence for their measurement properties. There is no fully suitable PROM. Pending further evidence, 4 PROMs could potentially be recommended for use.

Patient Reported Outcome Measures for Rheumatoid Arthritis Disease Activity: a systematic review following COSMIN guidelines.

BackgroundThe current standard of care in rheumatoid arthritis (RA) requires regular assessment of disease activity (DA). All standard RA DA measurement instruments require joint counts to be undertaken by a healthcare professional with/without a blood test. Few healthcare providers have the capacity to assess patients as frequently as stipulated by guidelines. Patient Reported Outcome Measures (PROMs) could be an efficient and informative way to assess RA DA, which is highlighted by the SARS-COV-2 pandemic, as most consultations are remote rather than face-to-face. We aimed to assess all PROMs for RA DA against the internationally recognised COSMIN guidelines to provide evidence‐based recommendations to select the most suitable PROMs.MethodsReview registered on PROSPERO as CRD42020176176. The search strategy was based on a previous similar systematic review and expanded to include all articles up to January 2019. All identified articles were rated by two independent assessors following the COSMIN guidelines.Results668 abstracts were identified, with 10 articles included. A further 21 were identified from a previous review. Ten PROMs were identified. There was insufficient evidence to place any of the identified PROMs into recommendation for use category A due to lack of evidence for content validity, as stipulated by the COSMIN guidelines.ConclusionLack of evidence of content validity limits suitable PROM selection, therefore none can be recommended for use. It is acknowledged that all included PROMs were developed before the COSMIN guidelines were published. Future research on PROMs for RA DA must provide evidence of content validity.

Burden of disease experienced by patients following a watch-and-wait policy for locally advanced rectal cancer: A qualitative study

Background: Patient-reported outcome measures (PROMs) are increasingly used in routine cancer care to evaluate treatment and monitor symptoms, function and other quality of life (QoL) aspects. For rectal cancer patients following a Watch-and-Wait (W&W) program, there is no suitable PROM. Insight into patient experiences with this program is an essential step of PROM development. With this qualitative study we aimed to provide insights into the most important functional outcomes and QoL aspects that patients experience during the W&W program.

Burden of disease experienced by patients following a watch-and-wait policy for locally advanced rectal cancer: A qualitative study.

AimPatient‐reported outcome measures (PROMs) are increasingly being used in routine cancer care to evaluate treatment and monitor symptoms, function and other aspects of quality of life (QoL). There is no suitable PROM for rectal cancer patients following a watch‐and‐wait (W&W) programme. Insight into patient experiences with this programme is an essential step in the development of a PROM. The aim of this qualitative study was to provide insights into the most important functional outcomes and QoL features experienced by patients during our W&W programme.MethodPatients with locally advanced rectal cancer who are enrolled in the W&W programme in the Netherlands were interviewed by telephone using a semistructured interview guide. All interviews were digitally audio‐recorded, transcribed verbatim and coded. A thematic approach was used to analyse the data and identify themes and subthemes of importance to patients.ResultsEighteen patients were interviewed (78% male, mean age 68 years, range 52–83 years). Physical complaints after treatment were present, most notably gastrointestinal problems, neuropathy and fatigue. Furthermore, patients were anxious about a possible recurrence, had a fear of surgery or a stoma, or were experiencing a general feeling of apprehension in daily life. Many patients had different coping mechanisms, such as acceptance, and there were few limitations in daily life.ConclusionWe identified important functional outcomes, such as gastrointestinal complaints, fatigue and neuropathy, in patients who were enrolled in this W&W programme. Furthermore, an emotional burden and unmet needs were reported by these patients. These findings can be used to improve clinical practice and inform the development of a PROM.

PRS76 Selection of Health-Related Quality of Life Measures for Food Allergy

Food allergy (FA) poses a substantial burden on patients and their families, with reported physical and emotional impacts that can significantly influence daily life. Multiple disease-specific patient-reported outcome measures (PROMs) have been developed to measure the impact of FA on health-related quality of life (HRQoL). This review aimed to identify suitable PROMs to enable the assessment of interventions on the HRQoL impacts of patients with FAs. A literature search was performed in Medline and Embase from Jan 2010-April 2020. Key words like “food allergy” and “HRQoL” identified PROMs developed or used in patients with FA. Psychometric properties including content validity, reliability, validity, responsiveness and interpretability, were evaluated in accordance with the FDA PRO Guidance (2009). A total of 1028 abstracts were identified and 241 were selected for full-text review resulting in a list of 46 PROMs. They were classified as generic (n=22), allergy specific (n=2), FA-specific (n=19), and treatment satisfaction-specific (n=3). From the FA-specific PROMs, only 7 were conceptually relevant for further evaluation— Food Allergy Quality of Life Questionnaire (FAQLQ), Food Allergy Independent Measure (FAIM), Food-Pet-Allergy in Children Questionnaire (PFAC), Food Allergy Quality of Life Assessment Tool for Adolescents (FAQL-teen), You and Your Food Allergy, Food Intolerance Quality of Life Questionnaire (FIQLQ) and Pediatric Food Allergy Quality of Life Questionnaire (PFA-QL). You and Your Food Allergy, FAQLQ, PFAC, FAQL-teen involved patient’s qualitative inputs to establish content validity. All measures showed internal consistency (reliability) to be above 0.70 threshold; in terms of validity, PROMs moderately (0.30-0.70) correlated with existing measures. Only the FAQLQs showed both responsiveness to change and interpretability, key attributes for use in clinical trials. The FAQLQs validated for measuring HRQoL in FA have relevant conceptual coverage and adequate psychometric strength. Therefore, FAQLQs are suitable for further exploration of the impact of interventions within FA clinical trials.

Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review.

BackgroundMedication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research.ObjectiveThis study aims to evaluate the quality of the PROMs used to measure medication adherence.MethodsThis study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines.ResultsA total of 121 unique medication adherence PROMs from 214 studies were identified. Hypotheses testing for construct validity and internal consistency were the most frequently assessed measurement properties. PROMs with at least a moderate level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically.ConclusionsThis study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence.

Patient-Reported Outcome Measures in Cystic Fibrosis: Protocol for a Systematic Review.

BackgroundPatients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF.ObjectivePrior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF.MethodsThis systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study.ResultsAs of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal.ConclusionsThis review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR.Trial RegistrationPROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931

Systematic review: measurement properties of patient-reported outcome measures evaluated with childhood brain tumor survivors or other acquired brain injury.

Survivors of childhood brain tumors or other acquired brain injury (ABI) are at risk of poor health-related quality of life (HRQoL); its valid and reliable assessment is essential to evaluate the effect of their illness on their lives. The aim of this review was to critically appraise psychometric properties of patient-reported outcome measures (PROMs) of HRQoL for these children, to be able to make informed decisions about the most suitable PROM for use in clinical practice. We searched MEDLINE, EMBASE, and PsycINFO for studies evaluating measurement properties of HRQoL PROMs in children treated for brain tumors or other ABI. Methodological quality of relevant studies was evaluated using the consensus-based standards for the selection of health status measurement instruments checklist. Eight papers reported measurement properties of 4 questionnaires: Health Utilities Index (HUI), PedsQL Core and Brain Tumor Modules, and Child and Family Follow-up Survey (CFFS). Only the CFFS had evidence of content and structural validity. It also demonstrated good internal consistency, whereas both PedsQL modules had conflicting evidence regarding this. Conflicting evidence regarding test-retest reliability was reported for the HUI and PedsQL Core Module only. Evidence of measurement error/precision was favorable for HUI and CFFS and absent for both PedsQL modules. All 4 PROMs had some evidence of construct validity/hypothesis testing but no evidence of responsiveness to change. Valid and reliable assessment is essential to evaluate impact of ABI on young lives. However, measurement properties of PROMs evaluating HRQoL appropriate for this population require further evaluation, specifically construct validity, internal consistency, and responsiveness to change.

Additional assessment of Acute Cystitis Symptom Score questionnaire for patient-reported outcome measure in female patients with acute uncomplicated cystitis: part II

PurposeSince symptomatic, non-antibiotic therapy has become an alternative approach to treat acute cystitis (AC) in women, suitable patient-reported outcome measures (PROM) are urgently needed. The aim of this part II of a larger non-interventional, case–control study was the additional assessment of the ACSS as a suitable PROM.MethodsData from 134 female patients with diagnosed acute uncomplicated cystitis were included in the current analysis with (1) a summary score of “Typical” domain of 6 and more; (2) at least one follow-up evaluation after the baseline visit; (3) no missing values in the ACSS questionnaire data. Six different predefined thresholds based on the scoring of the ACSS items were evaluated to define “clinical cure”, also considering the draft FDA and EMA guidelines.ResultsOf the six different thresholds tested, a summary score of the five typical symptoms of 5 and lower with no symptom more than 1 (mild), without visible blood in urine, with or without including QoL issues was favoured, which partially also could be adapted to the draft FDA and EMA guidelines. The overall patient’s clinical assessment (“Dynamic” domain) alone was not sensitive enough for a suitable PROM.ConclusionsScoring of the severity of symptoms is needed not only for diagnosis, but also for PROM to define “clinical cure” of any intervention, which could be combined with QoL issues. Results of the study demonstrated that the ACSS questionnaire has the potential to be used as a suitable PROM and should further be tested in prospective clinical studies.

A systematic review of upper limb activity measures for 5- to 18-year-old children with bilateral cerebral palsy.

To investigate measurement properties and feasibility of upper limb activity measures in children aged 5-18years with bilateral cerebral palsy (CP). Five electronic databases were searched to identify measures of upper limb activity with published psychometric data for children with bilateral CP aged 5-18years. Measures included both Patient-Reported Outcome Measures (PROMs) and observational measures. The COnsensus-based Standards for selection of health Measurement Instruments checklist was used to evaluate methodological quality of studies for each measure. Forty-eight measures were identified, eight of which met inclusion criteria for reliability and validity. Four PROMs were included: the ABILHAND-Kids and Children's Arm Rehabilitation Measure are parent questionnaires measuring overall manual ability; the ACTIVLIM-CP is a parent questionnaire measuring global activity (upper and lower extremity) performance, and, the Pediatric Upper Limb Measure, Short Form is a child self-report questionnaire. Four observational measures were included: the Both Hands Assessment (BoHA) is an observational measure of bimanual activity performance; the Melbourne Assessment of Unilateral Upper Limb Function and the Melbourne Assessment 2 measure quality of movement of each upper limb separately, and the Peabody Developmental Motor Scales-Second Edition assesses fine motor skill capacity in young children. Based upon available evidence, the most suitable PROM for evaluation of upper limb activity in children with bilateral CP is the ACTIVLIM-CP, and the most suitable observational measure is the BoHA. Selection of upper limb measures depend on clinical information required and available resources. The BoHA is the only observational-based assessment which measures bimanual upper limb activity performance in children with bilateral CP. Recommendation for future measurement studies include familiarisation with the standards required for excellence, which include adequate sample size and content validity studies for PROMs.

Patient-reported outcome measures in subarachnoid hemorrhage: A systematic review.

ObjectivePatient-reported outcomes (PROs) are aspects of a patient's health status and are considered important for stimulating patient-centered care. Current outcome measures in clinical care for patients with aneurysmal subarachnoid hemorrhage (aSAH) are insufficient to capture PROs. In this systematic review, we aimed to summarize the evidence regarding the quality of patient-reported outcome measures (PROMs) in aSAH patients.MethodsWe performed a systematic review of the literature published from inception until October 29, 2018, in PubMed, the Cochrane Central Register of Controlled Trials, and EMBASE. Eligible studies had to evaluate measurement properties and capture PROs in aSAH patients. The quality of the studies and measurement properties were assessed using the consensus-based standards for the selection of health status measurement instruments (COSMIN) checklist. The review protocol was registered with PROSPERO (CRD42018058566).ResultsWe identified 9 articles that reported the assessment of 7 different disease-specific and generic PROMs used for aSAH patients, including 5 that focused on the Stroke-Specific Quality of Life Scale (SS-QoL). The methodologic quality of the validation processes used was generally doubtful. None of the PROMs complied with current standards for content validity.ConclusionsDue to the low quality of evidence for the measurement properties, the evidence base for selecting a suitable PROM for use with aSAH patients is insufficient. Given the specific long-term consequences of aSAH, we consider a disease-specific PROM the most appropriate, with SS-QoL the most suitable PROM currently available.

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers.

BackgroundA variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient‐reported outcome measures (PROMs) for English‐speaking patients with venous leg ulcers.MethodsThis systematic review used a two‐stage search approach. Electronic searches of major databases including MEDLINE were completed in October 2015, and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were done using standard and adapted study‐relevant criteria.ResultsTen studies with data for four generic PROMS and six condition‐specific measures were identified. No generic PROM showed adequate content and criterion validity; however, the EuroQoL Five Dimensions (EQ‐5D™), Nottingham Health Profile (NHP) and 12‐item Short‐Form Health Survey (SF‐12®) had good acceptability. In general, the EQ‐5D™ showed poor responsiveness in patients with venous leg ulcers. Most condition‐specific PROMs demonstrated poor criterion and construct validity. Overall, there was some evidence of internal consistency for the Venous Leg Ulcer Quality of Life (VLU‐QoL) and the Sheffield Preference‐based Venous Ulcer questionnaire (SPVU‐5D). Test–retest reliability was satisfactory for the Venous Leg Ulcer Self‐Efficacy Tool (VeLUSET).ConclusionThe NHP and VLU‐QoL questionnaire seemed the most suitable PROMs for use by clinicians. However, a valid condition‐specific PROM is still required.