Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review

2018 ◽  
Vol 26 (4) ◽  
pp. 1061-1076 ◽  
Author(s):  
Claudia Rutherford ◽  
Manish I. Patel ◽  
Margaret-Ann Tait ◽  
David P. Smith ◽  
Daniel S. J. Costa ◽  
...  
Diabetologia ◽  
2021 ◽  
Author(s):  
Jill Carlton ◽  
Joanna Leaviss ◽  
Frans Pouwer ◽  
Christel Hendrieckx ◽  
Melanie M. Broadley ◽  
...  

Abstract Aims/hypothesis It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties. Methods Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM’s content validity included reviewer ratings (N = 16) of relevance, comprehensiveness and comprehensibility: by researchers (n = 6); clinicians (n = 6); and adults with diabetes (n = 4). Results Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), seven hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; and the QoLHYPO questionnaire. Content validity was rated as ‘inconsistent’, with most as ‘(very) low’ quality, while structural validity was deemed ‘unsatisfactory’. Other measurement properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a ‘gold standard’ measure of the impact of hypoglycaemia on QoL against which to compare the PROMS. Conclusions/interpretation None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfactory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL. Prospero registration CRD42019125153 Graphical abstract


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.


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