Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

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

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Patient-Reported Outcome Measures for Post-mastectomy Breast Reconstruction: A Systematic Review of Development and Measurement Properties

Annals of Surgical Oncology ◽

10.1245/s10434-020-08736-8 ◽

2020 ◽

Vol 28 (1) ◽

pp. 386-404 ◽

Cited By ~ 1

Author(s):

C. F. Davies ◽

R. Macefield ◽

K. Avery ◽

J. M. Blazeby ◽

S. Potter

Keyword(s):

Systematic Review ◽

Breast Reconstruction ◽

Content Validity ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Future Studies ◽

Patient Reported ◽

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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.

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Measurement properties of patient-reported outcome measures (PROMs) in patients with hyperhidrosis: protocol for a systematic review

Systematic Reviews ◽

10.1186/s13643-021-01701-w ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Michaela Gabes ◽

Helge Knüttel ◽

Christian J. Apfelbacher

Keyword(s):

Systematic Review ◽

Outcome Measures ◽

Literature Search ◽

Citation Index ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Patient Reported ◽

Selection Of

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

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Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.

HRB Open Research ◽

10.12688/hrbopenres.13445.1 ◽

2021 ◽

Vol 4 ◽

pp. 117

Author(s):

Laura O'Byrne ◽

Gillian Maher ◽

Ali Khashan ◽

Richard Greene ◽

John Browne ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Outcome Measures ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Assessment Tools ◽

Measurement Properties ◽

Postpartum Women ◽

Patient Reported

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.

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Patient‐reported outcome measures for facial skin cancer: a systematic review and evaluation of the quality of their measurement properties

British Journal of Dermatology ◽

10.1111/bjd.17342 ◽

2018 ◽

Vol 180 (5) ◽

pp. 1018-1029 ◽

Cited By ~ 6

Author(s):

T.D. Dobbs ◽

H. Samarendra ◽

S. Hughes ◽

H.A. Hutchings ◽

I. Whitaker

Keyword(s):

Systematic Review ◽

Skin Cancer ◽

Outcome Measures ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Facial Skin ◽

Patient Reported

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Patient-reported outcome measures for patients with meniscal tears: a systematic review of measurement properties and evaluation with the COSMIN checklist

BMJ Open ◽

10.1136/bmjopen-2017-017247 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017247 ◽

Cited By ~ 10

Author(s):

Simon GF Abram ◽

Robert Middleton ◽

David J Beard ◽

Andrew J Price ◽

Sally Hopewell

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Meniscal Tears ◽

Limited Evidence ◽

Patient Reported ◽

Selection Of

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.

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A systematic review evaluating the clinimetric properties of the Victorian Institute of Sport Assessment (VISA) questionnaires for lower limb tendinopathy shows moderate to high-quality evidence for sufficient reliability, validity and responsiveness—part II

Knee Surgery Sports Traumatology Arthroscopy ◽

10.1007/s00167-021-06557-0 ◽

2021 ◽

Author(s):

Vasileios Korakakis ◽

Rod Whiteley ◽

Argyro Kotsifaki ◽

Manos Stefanakis ◽

Yiannis Sotiralis ◽

...

Keyword(s):

Systematic Review ◽

Measurement Error ◽

Construct Validity ◽

Lower Limb ◽

Measurement Properties ◽

High Quality ◽

High Quality Evidence ◽

Reliability Measurement ◽

Quality Evidence

Abstract Purpose The evaluation of measurement properties such as reliability, measurement error, construct validity, and responsiveness provides information on the quality of the scale as a whole, rather than on an item level. We aimed to synthesize the measurement properties referring to reliability, measurement error, construct validity, and responsiveness of the Victorian Institute of Sport Assessment questionnaires (Achilles tendon—VISA-A, greater trochanteric pain syndrome—VISA-G, proximal hamstring tendinopathy—VISA-H, patellar tendon—VISA-P). Methods A systematic review was conducted according to Consensus-based Standards for the Selection of Health Measurement Instruments methodology (COSMIN). PubMed, Cochrane, CINAHL, EMBASE, Web of Science, SportsDiscus, grey literature, and reference lists were searched. Studies assessing the measurement properties concerning reliability, validity, and responsiveness of the VISA questionnaires in patients with lower limb tendinopathies were included. Two reviewers assessed the methodological quality of studies assessing reliability, validity, and responsiveness using the COSMIN guidelines and the evidence for these measurement properties. A modified Grading of Recommendations Assessment Development and Evaluation (GRADE) approach was applied to the evidence synthesis. Results There is moderate-quality evidence for sufficient VISA-A, VISA-G, and VISA-P reliability. There is moderate-quality evidence for sufficient VISA-G and VISA-P measurement error, and high-quality evidence for sufficient construct validity for all the VISA questionnaires. Furthermore, high-quality evidence exists with regard to VISA-A for sufficient responsiveness in patients with insertional Achilles tendinopathy following conservative interventions. Conclusions Sufficient reliability, measurement error, construct validity and responsiveness were found for the VISA questionnaires with variable quality of evidence except for VISA-A which displayed insufficient measurement error. Level of evidence IV. Registration details Prospero (CRD42018107671); PROSPERO reference—CRD42019126595.

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Patient-reported outcome measures in subarachnoid hemorrhage

Neurology ◽

10.1212/wnl.0000000000007618 ◽

2019 ◽

Vol 92 (23) ◽

pp. 1096-1112 ◽

Cited By ~ 1

Author(s):

Edith Nobels-Janssen ◽

Philip J. van der Wees ◽

Wim I.M. Verhagen ◽

Gert P. Westert ◽

Ronald H.M.A. Bartels ◽

...

Keyword(s):

Systematic Review ◽

Subarachnoid Hemorrhage ◽

Health Status ◽

Outcome Measures ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Patient Reported ◽

Disease Specific

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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A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-019-0159-5 ◽

2019 ◽

Vol 3 (1) ◽

Cited By ~ 1

Author(s):

Rebecca McKeown ◽

David R. Ellard ◽

Abdul-Rasheed Rabiu ◽

Eleni Karasouli ◽

Rebecca S. Kearney

Keyword(s):

Systematic Review ◽

Construct Validity ◽

Outcome Measures ◽

Ankle Fracture ◽

Methodological Quality ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Health Measurement ◽

Patient Reported

Abstract Background Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. Methods We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles. Results The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity. Conclusions There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.

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