Abstract
PurposeTo 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.MethodsWe 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.ResultsTwenty-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.ConclusionThree 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 registrationPROSPERO CRD42020170247
Highlights
Hyperhidrosis is characterized by excessive sweating beyond physiological needs
The third substep included several further substeps: (1) we looked at the consistency of our results, searched for explanations if inconsistency occurred or downgraded for inconsistency if no explanation was found; (2) we pooled or summarized the results in Summary of Findings (SoF) Tables, each measurement property per patient-reported outcome measures (PROMs) in one table; (3) we rated each pooled or summarized result again against the quality criteria to obtain an overall rating for the pooled or summarized result as either sufficient (+), insufficient (−), inconsistent ( ±) or indeterminate (?); and (4) we graded the quality of the evidence to define whether the pooled or summarized result was trustworthy [31]
Supplementary information on content validity was extracted to assess the methodological quality of the PROM development
Summary
Hyperhidrosis is characterized by excessive sweating beyond physiological needs. This disorder can be generalized, involving the whole body, or focal, involving specific areas of the body such as the axillae (axillary hyperhidrosis), the hands and feet (palmar and plantar hyperhidrosis) or the face (cranio-facial hyperhidrosis) [8, 49, 50]. With a recently found prevalence of 4.8% in the USA, about more than half of the affected individuals suffer from axillary hyperhidrosis [8, 42]. The severity of hyperhidrosis can range from light sweating to real dripping. Those affected often report negative impacts on their quality of life (QoL). Measurement instruments that try to capture what is reported by affected individuals are called “patient-reported outcome measures (PROMs)”. By PROMs, the involvement of patients in both clinical research as well as routine health care can be fostered [28, 51]
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