scholarly journals Patient-reported outcome measures for inguinal hernia repair are insufficiently validated: a systematic review

2020 ◽  
Vol 32 (4) ◽  
pp. 223-230 ◽  
Author(s):  
Anders Gram-Hanssen ◽  
Anders Tolstrup ◽  
Dennis Zetner ◽  
Jacob Rosenberg

Abstract Purpose To systematically assess the validity of patient-reported outcome measures (PROMs) for patients undergoing inguinal hernia repair. Data sources A systematic review was performed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for systematic reviews of PROMs. PubMed, EMBASE and PsycINFO were consulted. Study selection Only studies explicitly aimed at validation of PROMs specific for patients with inguinal hernia were included. Data extraction Data regarding measurement properties of PROMs were extracted from the included studies. Each study was critically assessed for methodological quality and each PROM was evaluated for sufficient measurement properties. Results of data synthesis We included 15 studies, covering 11 different PROMs. The Carolinas Comfort Scale was the most frequently investigated PROM, being covered in five of the included publications. The included PROMs were evaluated according to nine different measurement properties, of which internal consistency and construct validity were the most frequently assessed. Evidence regarding content validity and structural validity was universally inadequate, according to the criteria for good measurement properties, as defined by the COSMIN. Conclusion Based on the current evidence, it is not possible to formulate recommendations for application of PROMs for patients undergoing inguinal hernia repair. Further validation of the included PROMs is necessary especially regarding content validity and structural validity.

Author(s):  
Rebecca McKeown ◽  
David R. Ellard ◽  
Abdul-Rasheed Rabiu ◽  
Eleni Karasouli ◽  
Rebecca S. Kearney

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.


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.


2017 ◽  
Vol 137 (10) ◽  
pp. 2069-2077 ◽  
Author(s):  
Dominic Schoch ◽  
Rachel Sommer ◽  
Matthias Augustin ◽  
Sonja Ständer ◽  
Christine Blome

2020 ◽  
Author(s):  
Yu Heng Kwan ◽  
Si Dun Weng ◽  
Dionne Hui Fang Loh ◽  
Jie Kie Phang ◽  
Livia Jia Yi Oo ◽  
...  

BACKGROUND Medication 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. OBJECTIVE This study aims to evaluate the quality of the PROMs used to measure medication adherence. METHODS This 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. RESULTS A total of 121 unique medication adherence PROMs from 214 studies were identified. <i>Hypotheses testing for construct validity</i> and <i>internal consistency</i> were the most frequently assessed measurement properties. PROMs with at least a <i>moderate</i> 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. CONCLUSIONS This 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.


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