Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran.
Hum Reprod. 2012 Sep;27(9):2729-36. doi: 10.1093/humrep/des199. Epub 2012 Jun 26.
Can the modified polycystic ovary syndrome health-related quality-of-life questionnaire (MPCOSQ) be validated in Iranian patients with polycystic ovary syndrome (PCOS) to provide an instrument for future outcome studies in these patients?
We show initial reliability and validity of the Iranian version of the MPCOSQ as a specific instrument to measure health-related quality of life (QOL) in patients with PCOS in Iran.
The prevalence of PCOS in Iran is relatively high and studying QOL in these patients is important. The PCOSQ has previously been translated and validated in Iran but no studies had examined the psychometric properties of the MPCOSQ in Iran.
STUDY DESIGN, SIZE, AND DURATION: This was a cross-sectional study. After linguistic validation of the Iranian version of MPCOSQ, an expert panel evaluated the items by assessing the content validity index (CVI) and content validity ratio (CVR). Then a semi-structured interview was conducted to assess face validity. Consequently, exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were performed to indicate the scale constructs (n = 200). In addition, reliability analyses including internal consistency and test-retest analysis were carried out.
PARTICIPANTS/MATERIALS, SETTING, AND METHODS: This study was carried out on women with PCOS (n = 200) who attended two private gynecology clinics in Kashan, Iran. Patients were eligible if they met each of the following criteria: 15-40 years of age; married; not having non-classic adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia; Iranian; not having problems in speaking or listening; having two of the following Rotterdam diagnostic criteria: (i) polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10 ml), (ii) clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) and/or an elevated plasma testosterone (normal range testosterone <2 nmol/l), (iii) having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days.
CVI and CVR scores for MPCOSQ were 0.96 and 0.92, respectively. A six-factor solution (emotional disturbance, weight, infertility, acne, menstrual difficulties and hirsutism) emerged as a result of an EFA and explained 0.64% of the variance observed. The result of the EFA supported the item 'late menstrual period' being placed in the menstrual rather than the emotional subscale. The results of the CFA for six-factor model for MPCOSQ indicated an acceptable fit for the proposed model. Additional analyses indicated satisfactory results for internal consistency (Cronbach's alpha ranging from 0.76 to 0.92) and intraclass correlation coefficients (ranging from 0.71 to 0.92). Moving 'late menstrual period' from the emotional to the menstrual subscale significantly improved the reliability coefficient for both subscales.
LIMITATIONS, REASONS FOR CAUTION: Study of patients with PCOS attending two private gynecology clinics may limit generalization of the findings to the entire population with PCOS. All patients in this study were married for cultural reasons in Iran. Therefore, the results of the present study have to be interpreted with some caution.
The Iranian version of the MPCOSQ will fill an important gap in measuring the QOL in patients with PCOS in the research and community settings in Iran.
改良的多囊卵巢综合征健康相关生活质量问卷(MPCOSQ)能否在伊朗多囊卵巢综合征(PCOS)患者中得到验证,为这些患者的未来结局研究提供一种工具?
我们展示了伊朗版 MPCOSQ 的初步可靠性和有效性,作为一种特定的工具,可在伊朗测量 PCOS 患者的健康相关生活质量(QOL)。
伊朗的 PCOS 患病率相对较高,研究这些患者的 QOL 很重要。PCOSQ 之前已经在伊朗进行了翻译和验证,但没有研究检验过 MPCOSQ 的心理测量特性。
研究设计、规模和持续时间:这是一项横断面研究。在对伊朗版 MPCOSQ 进行语言验证后,一个专家小组通过评估内容效度指数(CVI)和内容效度比(CVR)来评估项目。然后进行了半结构式访谈,以评估表面效度。随后,进行了探索性因子分析(EFA)和验证性因子分析(CFA),以确定量表结构(n=200)。此外,还进行了可靠性分析,包括内部一致性和重测信度分析。
参与者/材料、设置和方法:这项研究在伊朗卡尚的两家私人妇科诊所就诊的患有 PCOS 的妇女(n=200)中进行。如果患者符合以下所有标准,则有资格参加研究:年龄 15-40 岁;已婚;没有非经典肾上腺增生、甲状腺功能减退和高泌乳素血症;伊朗人;没有说话或听力问题;有以下罗得岛诊断标准中的两个:(i)超声扫描可见多囊卵巢(一个或两个卵巢中存在 12 个或更多卵泡,或卵巢体积增加>10 ml),(ii)临床高雄激素血症迹象(基于 Ferriman-Gallwey 评分的多毛症评分>7 或明显痤疮)和/或血浆睾酮升高(正常范围睾酮<2 nmol/l),(iii)月经间隔>35 天或闭经(即至少 6 个月无阴道出血,即 199 天)。
MPCOSQ 的 CVI 和 CVR 得分分别为 0.96 和 0.92。EFA 产生了六因素解决方案(情绪障碍、体重、不孕、痤疮、月经困难和多毛症),解释了观察到的 0.64%的方差。EFA 的结果支持将“月经后期”一项放在月经而不是情绪子量表中的观点。MPCOSQ 六因子模型的 CFA 结果表明,所提出的模型具有可接受的拟合度。其他分析表明,内部一致性(Cronbach's alpha 范围为 0.76 至 0.92)和组内相关系数(范围为 0.71 至 0.92)均取得了令人满意的结果。将“月经后期”从情绪子量表移至月经子量表可显著提高两个子量表的可靠性系数。
局限性、谨慎的原因:在这项研究中,研究在两家私人妇科诊所就诊的 PCOS 患者可能会限制研究结果在整个伊朗 PCOS 人群中的推广。由于伊朗的文化原因,所有参加这项研究的患者都是已婚。因此,目前研究的结果必须谨慎解释。
伊朗版的 MPCOSQ 将填补在伊朗研究和社区环境中测量 PCOS 患者 QOL 的重要空白。