Kitchen Helen, Aldhouse Natalie, Trigg Andrew, Palencia Roberto, Mitchell Stephen
DRG Abacus, Manchester, UK.
Ferring Pharmaceuticals A/S, Copenhagen, Denmark.
Health Qual Life Outcomes. 2017 Apr 27;15(1):86. doi: 10.1186/s12955-017-0666-0.
Infertility has a negative impact on quality of life (QoL) and well-being of affected individuals and couples. A variety of patient-reported outcome (PRO) measures to assess infertility-related QoL are available; however, there is a concern regarding potential issues with their development methodology, validation and use. This review aimed to i) identify PRO measures used in infertility interventional studies ii) assess validation evidence to identify a reliable, valid PRO measure to assess changes in QoL or treatment satisfaction in clinical studies with female patients following treatment with novel therapies iii) identify potential gaps in evidence for validity.
A structured literature search of Medline, Embase, and the Cochrane Library (accessed in September 2015) was conducted using pre-defined search terms. The identified publications were reviewed applying eligibility criteria to select interventional female infertility studies using PROs. Infertility-specific PRO measures assessing QoL, treatment satisfaction or psychiatric health, and included in studies by ≥2 research groups were selected and critically reviewed in light of scientific and regulatory guidance (e.g. FDA PRO Guidance for Industry) for evidence of content validity, psychometric strength, and patient acceptability.
The literature search and hand-searching yielded 122 publications; 78 unique PRO measures assessing QoL, treatment satisfaction or psychiatric health were identified. Five PRO measures met the selection criteria for detailed review: Fertility Quality of Life (FertiQoL); Fertility Problem Inventory (FPI); Fertility Problem Stress (FPS); Infertility Questionnaire (IFQ); Illness Cognitions Questionnaire adapted for Infertility (ICQ-I). None of the PRO measures met all validation criteria. The FertiQoL was the most widely used infertility-specific PRO measure to assess QoL in interventional studies, with reasonable evidence for adequate content validity, psychometric strength, and linguistic validation. However, gaps in evidence remain including test-retest reliability and thresholds for interpreting clinically important changes. While the FPI demonstrated reasonable evidence for content and psychometric validity, its utility as an outcome measure is limited by a lack of recall period.
The FertiQoL and the FPI are potentially useful measures of infertility-related QoL in interventional studies. Further research is recommended to address gaps in evidence and confirm both PRO measures as reliable assessments of patient outcomes.
不孕症会对受影响的个体及夫妇的生活质量（QoL）和幸福感产生负面影响。现有多种患者报告结局（PRO）指标可用于评估不孕症相关的生活质量；然而，人们对其开发方法、验证及使用方面的潜在问题表示担忧。本综述旨在：i）确定不孕症干预研究中使用的PRO指标；ii）评估验证证据，以确定一种可靠、有效的PRO指标，用于评估接受新型疗法治疗的女性患者在临床研究中的生活质量变化或治疗满意度；iii）确定有效性证据方面的潜在差距。
使用预定义的检索词对Medline、Embase和Cochrane图书馆（于2015年9月访问）进行结构化文献检索。对检索到的出版物进行审查，应用纳入标准选择使用PROs的女性不孕症干预研究。选择由≥2个研究小组纳入研究的、评估生活质量、治疗满意度或心理健康的不孕症特异性PRO指标，并根据科学和监管指南（如FDA行业PRO指南）进行严格审查，以获取内容有效性、心理测量强度和患者可接受性的证据。
文献检索和手工检索共获得122篇出版物；确定了78种评估生活质量、治疗满意度或心理健康的独特PRO指标。有5种PRO指标符合详细审查的选择标准：生育生活质量（FertiQoL）；生育问题量表（FPI）；生育问题压力量表（FPS）；不孕症问卷（IFQ）；不孕症适应性疾病认知问卷（ICQ-I）。没有一种PRO指标符合所有验证标准。FertiQoL是干预研究中评估生活质量最广泛使用的不孕症特异性PRO指标，有合理证据表明其具有足够的内容有效性、心理测量强度和语言验证。然而，证据仍存在差距，包括重测信度和解释临床重要变化的阈值。虽然FPI在内容和心理测量有效性方面有合理证据，但其作为结局指标的效用因缺乏回忆期而受到限制。
FertiQoL和FPI在干预研究中可能是评估不孕症相关生活质量的有用指标。建议进一步研究以填补证据空白，并确认这两种PRO指标作为患者结局的可靠评估指标。
