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

2019 ◽  
Vol 7 (3) ◽  
pp. 277-287
Author(s):  
Kim S Bull ◽  
Samantha Hornsey ◽  
Colin R Kennedy ◽  
Anne-Sophie E Darlington ◽  
Martha A Grootenhuis ◽  
...  

Abstract Background 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. Methods 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. Results 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. Conclusions 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.

Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247


2020 ◽  
Vol 28 (1) ◽  
pp. 386-404 ◽  
Author(s):  
C. F. Davies ◽  
R. Macefield ◽  
K. Avery ◽  
J. M. Blazeby ◽  
S. Potter

Abstract Background Breast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set be robustly developed and validated so data are reliable and accurate. The aim of this systematic review is to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies. Methods A PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using three steps: (1) the methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist; (2) criteria were applied for assessing good measurement properties; and (3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach. Results Fourteen articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality. Conclusions BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e046169
Author(s):  
Shiraz A Sabah ◽  
Elizabeth A Hedge ◽  
Simon G F Abram ◽  
Abtin Alvand ◽  
Andrew J Price ◽  
...  

ObjectivesTo identify: (1) patient-reported outcome measures (PROMs) used to evaluate symptoms, health status or quality of life following discretionary revision (or re-revision) knee joint replacement, and (2) validated joint-specific PROMs, their measurement properties and quality of evidence.Design(1) Scoping review; (2) systematic review following the COnsensus-based Standards for selection of health status Measurement INstruments (COSMIN) checklist.Data sourcesMEDLINE, Embase, AMED and PsycINFO were searched from inception to 1 July 2020 using the Oxford PROM filter unlimited by publication date or language.Eligibility criteria for selecting studiesStudies reporting on the development, validation or outcome of a joint-specific PROM for revision knee joint replacement were included.Results51 studies reported PROM outcomes using eight joint-specific PROMs. 27 out of 51 studies (52.9%) were published within the last 5 years. PROM development was rated ‘inadequate’ for each of the eight PROMs studied. Validation studies were available for only three joint-specific PROMs: Knee Injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Activity Scale (LEAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC). 25 out of 27 (92.6%) measurement properties were rated insufficient, indeterminate or not assessed. The quality of supporting evidence was mostly low or very low. Each of the validated PROMs was rated ‘B’ (potential for recommendation but require further evaluation).ConclusionJoint-specific PROMs are increasingly used to report outcomes following revision knee joint replacement, but these instruments have insufficient evidence for their validity. Future research should be directed toward understanding the measurement properties of these instruments in order to inform clinical trials and observational studies evaluating the outcomes from joint-specific PROMs.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Christian J. Apfelbacher

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


2021 ◽  
pp. 105566562110671
Author(s):  
Roan L. M. Ploumen ◽  
Samuel H. Willemse ◽  
Ronald E. G. Jonkman ◽  
Jitske W. Nolte ◽  
Alfred G. Becking

Measuring the impact of orthognathic surgery on quality of life is of significant importance in patients with cleft deformities. Standardized tools such as patient-reported outcome measures (PROMs) are needed to fully comprehend patients’ needs and perceptions. Therefore, the availability of reliable, valid, and comprehensive questionnaires for patients is essential. The aim of this study is to identify PROMs measuring the impact of orthognathic surgery on quality of life in patients with cleft deformities and to evaluate the identified PROMs. A systematic search of the literature was performed according to the preferred reporting items for systematic reviews and meta-analysis guidelines. All validated PROMs, regarding the impact of orthognathic surgery on quality of life in patients with cleft deformities, were identified and assessed according to the quality criteria proposed for measurement properties of health status questionnaires. An electronic search yielded 577 articles. After a full-text review of 87 articles, 4 articles met the inclusion criteria, comprising 58 PROMs. Of these 58 PROMs, 1 PROM (the CLEFT-Q) has been validated to measure the impact of orthognathic surgery on patients with a facial cleft. Evaluation of methodological quality of the included articles and assessment of the measurement properties of the CLEFT-Q show that the CLEFT-Q scores relatively good for all available measurement properties, making it suitable for immediate use. The CLEFT-Q was found to be the only valid instrument so far to measure the impact of orthognathic surgery on the quality of life in patients with cleft deformities.


2021 ◽  
Vol 4 ◽  
pp. 117
Author(s):  
Laura O'Byrne ◽  
Gillian Maher ◽  
Ali Khashan ◽  
Richard Greene ◽  
John Browne ◽  
...  

Background: Patient centred healthcare is the corner stone to many healthcare strategies. Patient specific health needs should be at the fore of healthcare improvements and quality measurements.  Patient reported outcome measures (PROM) that support real world clinical effectiveness assessments are increasingly being used to highlight domains where there is the greatest scope for change. Objectives: This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines. Methods: Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed and EMBASE from inception to the present day. Two reviewers independently will judge eligibility, conduct data extraction and assess the methodological quality of each study as per COSMIN guidelines. Inclusion criteria: studies should concern PROM with an aim to evaluate measurement properties in the development or the evaluation of a PROM of interest. Included PROMS will focus upon postpartum women assessing morbidity and quality of care. All peer reviewed studies with an assessment tool designed for patient completion will be considered. Exclusion criteria; abstract, letters and non-peer reviewed publications. Studies will be graded on measurement properties and quality of evidence as laid out by COSMIN. All studies and characteristics eligible for inclusion will be summarised and a recommendation to the most suitable measurement tool(s) will be given. Discussion: We will provide a comprehensive description of all available patient reported assessment tools available for childbirth and postpartum quality of life and recommend based on COSMIN guidelines the most suitable instrument(s) available for use.


BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017247 ◽  
Author(s):  
Simon GF Abram ◽  
Robert Middleton ◽  
David J Beard ◽  
Andrew J Price ◽  
Sally Hopewell

ObjectiveMeniscal tears occur frequently in the population and the most common surgical treatment, arthroscopic partial meniscectomy, is performed in approximately two million cases worldwide each year. The purpose of this systematic review is to summarise and critically appraise the evidence for the use of patient-reported outcome measures (PROMs) in patients with meniscal tears.DesignA systematic review was undertaken. Data on reported measurement properties were extracted and the quality of the studies appraised according to Consensus-based Standards for the Selection of Health Measurement Instruments.Data sourcesA search of MEDLINE, Embase, AMED and PsycINFO, unlimited by language or publication date (last search 20 February 2017).Eligibility criteria for selecting studiesDevelopment and validation studies reporting the measurement properties of PROMs in patients with meniscal tears were included.Results11 studies and 10 PROMs were included. The overall quality of studies was poor. For measurement of symptoms and functional status, there is only very limited evidence supporting the selection of either the Lysholm Knee Scale, International Knee Documentation Committee Subjective Knee Form or the Dutch version of the Knee injury and Osteoarthritis Outcome Score. For measuring health-related quality of life, only limited evidence supports the selection of the Western Ontario Meniscal Evaluation Tool (WOMET). Of all the PROMs evaluated, WOMET has the strongest evidence for content validity.ConclusionFor patients with meniscal tears, there is poor quality and incomplete evidence regarding the validity of the currently available PROMs. Further research is required to ensure these PROMs truly reflect the symptoms, function and quality of life of patients with meniscal tears.PROSPERO registration numberCRD42017056847.


Neurology ◽  
2019 ◽  
Vol 92 (23) ◽  
pp. 1096-1112 ◽  
Author(s):  
Edith Nobels-Janssen ◽  
Philip J. van der Wees ◽  
Wim I.M. Verhagen ◽  
Gert P. Westert ◽  
Ronald H.M.A. Bartels ◽  
...  

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.


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