Zhongguo quanke yixue (Oct 2022)
Health-related Quality of Life Instruments in Infertility Patients: a Systematic Review and Evaluation
Abstract
Background Health-related quality of life (HRQoL) is a key indicator that is used for evaluating clinical outcomes. Infertility-specific HRQoL instruments have been widely used, but it is uncertain whether these instruments have good measurement properties in clinical application, and there is a lack of quality evaluation for them. Objective To perform a systematical review and evaluation of HRQoL instruments in infertility patients, offering a rational reference for the selection of these instruments. Methods In October 2020, PubMed, Web of Science, the Cochrane Library, EmBase, CNKI, WanFang Data, CQVIP, and SinoMed databases were searched from inception to October 5, 2020 to identify studies on HRQoL instruments designed for or assess HRQoL for patients with infertility. Two reviewers independently implemented literature screening, data extraction, and methodological quality assessment of the included studies in terms of the process of developing infertility-specific HRQoL instruments and measurement properties of the instruments using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Descriptive analysis was used to summarize and analyze the assessment results. Results We included 229 studies on 19 HRQoL instruments, including 4 infertility-specific HRQoL instruments〔TLMK (Tübinger Lebensqualit?tsfragebogen für M?nner mit Kinderwunsch) , the Fertility Quality of Life (FertiQoL) , Quality of Life in Infertile Couples Questionnaire (QOLICQ) , Quality of Life in People with Infertility Induced by Liver Qi Stagnation Identified by Chinese Medicine Theory〕, 4 cancer-specific or other disease-specific HRQoL instruments and 11 generic HRQoL instruments. The FertiQoL was the most frequently used in existing studies〔39.1% (91/233) 〕. Regarding the development of PROMs, of the 4 infertility-specific HRQoL instruments, except for the FertiQoL instrument, whose overall development quality was considered "doubtful", the overall development quality of the other three instruments was considered "inadequate". In terms of the content validity, the methodological quality of the studies on FertiQoL and QOLICQ development was rated "very good" and "doubtful", respectively, while that of the study on the TLMK or Quality of Life in People with Infertility Induced by Liver Qi Stagnation Identified by Chinese Medicine Theory scale development was rated "adequate". In terms of the construct validity, except for the study on QOLICQ development, which was of "doubtful" methodological quality, the methodological quality of studies on the other three instruments development was considered "adequate". And the construct validity was rated "indeterminate" for all these 4 instruments. In terms of the internal consistency, the methodological quality of studies on the development of the 4 instruments was rated "very good", and the internal consistency of the 4 instruments was rated "sufficient". Regarding the test-retest reliability, the methodological quality of the study on QOLICQ development was considered "doubtful" and the test-retest reliability of the instrument was rated "indeterminate". The methodological quality of studies on the Quality of Life in People with Infertility Induced by Liver Qi Stagnation Identified by Chinese Medicine Theory scale development was rated "very good" in terms of criterion validity, and the criterion validity of the instrument was rated "sufficient". The methodological quality of the study on TLMK instrument development was rated "very good" in terms of criterion validity, and the criterion validity of this instrument was rated "sufficient". As for responsiveness/sensitivity, the methodological quality of the study on FertiQoL development was rated "very good", and the responsiveness/sensitivity of the instrument was rated "sufficient". Conclusion The methodological quality of the study on the development of FertiQoL and the measurement properties of the instrument were much higher. The number of Chinese infertility-specific HRQoL instruments is insufficient and needs more relevant studies.
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