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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2022

Open Access 01-12-2022 | Fertility | Study protocol

Development and validation of the health-related quality of life instrument for Chinese infertile couples: a mixed-methods study protocol

Authors: Zhao Shi, Zhuxin Mao, Hongwei Nie, Ling Geng, Gang Chen, Shunping Li

Published in: Health and Quality of Life Outcomes | Issue 1/2022

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Abstract

Background

Infertility and its treatment have negative impacts on a couple’s marital relationship, sexual life, psychological state and interpersonal relationships, causing personal distress. Health-related quality of life (HRQoL) has become an important component of health outcomes. HRQoL instruments developed in western culture are not always appropriate for use in China due to cultural differences. Probably due to the unique concept of fertility in China, infertility patients can be looked down upon and the family may  feel shameful. This study aims to develop a HRQoL instrument for infertile couples based on the Chinese social and cultural setting.

Methods

Complementary mixed methods will be used to develop a new HRQoL instrument for Chinese infertile couples. The study consists of four stages: the first stage will involve a systematic review and qualitative interviews to construct draft candidate items. In the second stage, quantitative research [e.g., exploratory factor analysis (EFA), item response theory (IRT)] and cognitive interviews will be used for item selection. The third stage will be instrument validation, in which classical test theory (CTT) and IRT will be applied. In the final stage, the minimal clinically important difference (MCID) will be calculated by using distribution-based methods and anchor-based methods (e.g., logistic regression, receiver operating characteristic curve).

Discussion

The new HRQoL instrument for Chinese infertile couples will be developed, which will provide a standard and effective HRQoL instrument in clinical outcome assessment and health outcome measurement.
Literature
1.
Zegers-Hochschild F, Adamson GD, Dyer S, et al. The international glossary on infertility and fertility care, 2017. Hum Reprod. 2017;32(9):1796–801.
2.
Gurunath S, Pandian Z, Anderson RA, et al. Defining infertility—a systematic review of prevalence studies. Hum Reprod Update. 2011;17(5):575–88.PubMedCrossRef
3.
Zegers-Hochschild F, Adamson GD, de Mouzon J, et al. The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary on ART terminology, 2009. Hum Reprod. 2009;24(11):2683–7.PubMedCrossRef
4.
Qiao J, Wang Y, Li X, et al. A Lancet Commission on 70 years of women’s reproductive, maternal, newborn, child, and adolescent health in China. Lancet. 2021;397(10293):2497–536.PubMedCrossRef
5.
Zhou Z, Zheng D, Wu H, et al. Epidemiology of infertility in China: a population-based study. BJOG. 2017;125(4):432–41.PubMedCrossRef
6.
7.
Schmidt L. Psychosocial burden of infertility and assisted reproduction. Lancet. 2006;367(9508):379–80.PubMedCrossRef
8.
Luk BH-K, Loke AY. The impact of infertility on the psychological well-being, marital relationships, sexual relationships, and quality of life of couples: a systematic review. J Sex Marital Ther. 2015;41(6):610–25.PubMedCrossRef
9.
Mousavi SA, Masoumi SZ, Keramat A, et al. Assessment of questionnaires measuring quality of life in infertile couples: a systematic review. J Reprod Infertil. 2013;14(3):110–9.PubMedPubMedCentral
10.
11.
12.
Levesque A, Li HZ, Bohémier M. Cultural variations in health conceptions: a qualitative approach. Pimatisiwin. 2013;11(2):215–29.
13.
Mao Z, Ahmed S, Graham C, et al. Similarities and differences in health-related quality-of-life concepts between the east and the west: a qualitative analysis of the content of health-related quality-of-life measures. Value Health Reg Issues. 2021;24(C):96–106.PubMedCrossRef
14.
Cnossen MC, Polinder S, Vos PE, et al. Comparing health-related quality of life of Dutch and Chinese patients with traumatic brain injury: do cultural differences play a role? Health Qual Life Outcomes. 2017;15(72):1–10.
15.
Ni Y, Tong C, Huang L, et al. The analysis of fertility quality of life and the influencing factors of patients with repeated implantation failure. Health Qual Life Outcomes. 2021;19(32):1–10.
16.
Fu B, Qin N, Cheng L, et al. Development and validation of an infertility stigma scale for Chinese women. J Psychosom Res. 2015;79(1):69–75.PubMedCrossRef
17.
Jing XY, Gu W, Xu XL, et al. Stigma predicting fertility quality of life among Chinese infertile women undergoing in vitrofertilization-embryo transfer. J Psychosom Obst Gyn.
18.
Kitchen H, Aldhouse N, Trigg A, et al. A review of patient-reported outcome measures to assess female infertility-related quality of life. Health Qual Life Outcomes. 2017;15(86):1–12.
19.
Chachamovich JR, Chachamovich E, Ezer H, et al. Investigating quality of life and health-related quality of life in infertility: a systematic review. J Psychosom Obstet Gynecol. 2010;31(2):101–10.CrossRef
20.
Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011;26(8):2084–91.PubMedPubMedCentralCrossRef
21.
Yang X. A validity and reliability study of the fertility quality of life (FertiQoL) tool in Chinese People (in chinese). Guangzhou: Southern Medical University; 2016.
22.
Hubens K, Arons AMM, Krol M. Measurement and evaluation of quality of life and well-being in individuals having or having had fertility problems: a systematic review. Eur J Contracept Reprod. 2018;23(6):441–50.CrossRef
23.
Shi. Z, Nie. H, Geng. L, et al. Evaluating health-related quality of life and subject wellbeing among infertility patients: a cross-sectional study in eastern China. Qual Life Res. 2021;Under review
24.
Wang Y. Development of quality of life scale for female liver depression infertility in traditional Chinese medicine (in chinese). Beijing: Beijing University of Chinese Medicine; 2017.
25.
Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life: a conceptual model of patient outcomes. JAMA. 1995;273(1):59–65.PubMedCrossRef
26.
Ferrans CE, Zerwic JJ, Wilbur JE, et al. Conceptual model of health-related quality of life. J Nurs Scholarsh. 2005;37(4):336–42.PubMedCrossRef
27.
Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967–77.PubMedCrossRef
28.
Fayers P, Machin D. Quality of life: the assessment, analysis and interpretation of patient-reported outcomes. Hoboken: Wiley; 2016.
29.
Angst F, Aeschlimann A, Angst J. The minimal clinically important difference (MCID) raised the significance of outcome effects above the statistical level, with methodological implications for future studies. J Clin Epidemiol. 2017;82:128–36.PubMedCrossRef
30.
Chen Z, Liu J, Huang H, et al. Guidelines for diagnosing infertility (in chinese). Chin J Obstet Gynecol. 2019;54(7):505–11.
31.
32.
33.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2008;3(2):77–101.CrossRef
34.
Gale NK, Heath G, Cameron E, et al. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(117):1–8.
35.
Anselm Strauss JC. Basics of qualitative research: grounded theory procedures and techniques. Newhury Park. California, Sare Publications; 1990.
36.
Muratov S, Podbielski DW, Jack SM, et al. Preference-based disease-specific health-related quality of life instrument for glaucoma: a mixed methods study protocol. BMJ Open. 2016;6(11):e012732.PubMedPubMedCentralCrossRef
37.
Embretson SE, Reise SP. Item response theory for psychologists. Mahwah: Lawrence Erlbaum; 2000.
38.
Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297–334.CrossRef
39.
Ratner B. The correlation coefficient: its values range between +1/1, or do they? J Target Meas Anal Mark. 2009;17(2):139–42.CrossRef
40.
Kaiser HF. The application of electronic computers to factor analysis. Educ Psychol Meas. 1960;20(1):141–51.CrossRef
41.
DiIorio CK. Measurement in health behavior: methods for research and evaluation. London: Wiley; 2005.
42.
Reeve BB, Hays RD, Bjorner JB, et al. Psychometric evaluation and calibration of health-related quality of life item banks—plans for the patient-reported outcomes measurement information system (PROMIS). Med Care. 2007;45(5):S22–31.PubMedCrossRef
43.
Uttaro T, Lehman A. Graded response modeling of the quality of life interview. Eval Program Plan. 1999;22(1):41–52.CrossRef
44.
Haynes SN, Richard DCS, Kubany ES. Content validity in psychological assessment: a functional approach to concepts and methods. Psychol Assess. 1995;7(3):238–47.CrossRef
45.
Polit DF, Beck CT, Owen SV. Is the CVI an acceptable indicator of content validity? Appraisal and recommendations. Res Nurs Health. 2007;30(4):459–67.PubMedCrossRef
46.
Franklin M, Mukuria C, Mulhern B, et al. Measuring the burden of schizophrenia using clinician and patient-reported measures: an exploratory analysis of construct validity. Patient. 2019;12(4):405–17.PubMedPubMedCentralCrossRef
47.
Terwee CB, Bot SDM, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34–42.PubMedCrossRef
48.
Reuvers SHM, Korfage IJ, Scheepe JR, et al. The urinary-specific quality of life of multiple sclerosis patients: Dutch translation and validation of the SF-Qualiveen. Neurourol Urodyn. 2017;36(6):1629–35.PubMedCrossRef
49.
McGlothlin AE, Lewis RJ. Minimal clinically important difference defining what really matters to patients. JAMA. 2014;312(13):1342–3.PubMedCrossRef
50.
Guyatt GH, Osoba D, Wu AW, et al. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77(4):371–83.PubMedCrossRef
51.
Jayadevappa R, Cook R, Chhatre S. Minimal important difference to infer changes in health-related quality of life-a systematic review. J Clin Epidemiol. 2017;89:188–98.PubMedCrossRef
Metadata
Title
Development and validation of the health-related quality of life instrument for Chinese infertile couples: a mixed-methods study protocol
Authors
Zhao Shi
Zhuxin Mao
Hongwei Nie
Ling Geng
Gang Chen
Shunping Li
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2022
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-022-01957-3

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