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Abstract：
BACKGROUND: The aim of this study was to explore the need for a new disease-specific patient reported outcome (PRO) measure for use in clinical trials of drugs designed to target the underlying causes of polycystic ovary syndrome (PCOS), and in the process contribute to our understanding of the symptoms and impacts that define the patient experience with PCOS.
METHODS: Semi-structured interviews were conducted in 20 women diagnosed with PCOS according to the Rotterdam criteria who had not menstruated in the previous month. The relative importance of PCOS symptoms and impact concepts to patients was determined by analyzing the frequency of their expression in the interview transcripts. These insights were compared to clinicians\' perceptions of PCOS.
RESULTS: Pain- and discomfort-related symptoms accounted for the highest proportion (27.6%) of the 735 patient expressions, although clinicians did not consider pain to be important to patients with PCOS. The most frequently expressed individual symptoms were cramping (70% of patients; 14.7% of concepts), irregular menstruation (95% of patients; 12.2% of concepts), facial hair growth (75% of patients; 10.6% of concepts), heavy bleeding (70% of patients; 8.8% of concepts), infertility (70% of patients; 5.4% of concepts), and bloating (60% of patients; 5.2% of concepts). Cramping, heavy bleeding, and bloating were not identified by clinicians as being important to patients with PCOS. The impacts most frequently reported by patients with PCOS related to emotional well-being (e.g. anxiety/stress) and coping behaviors (e.g. acne medication, hair removal).
CONCLUSIONS: The only validated PCOS-specific PRO, the PCOSQ, does not capture some key PCOS symptoms and impacts expressed by patients with PCOS, most notably those related to pain and discomfort, bleeding intensity and coping behaviours. Furthermore, some key PCOS symptoms may be under-recognized in the clinic.
METHODS: Semi-structured interviews were conducted in 20 women diagnosed with PCOS according to the Rotterdam criteria who had not menstruated in the previous month. The relative importance of PCOS symptoms and impact concepts to patients was determined by analyzing the frequency of their expression in the interview transcripts. These insights were compared to clinicians\' perceptions of PCOS.
RESULTS: Pain- and discomfort-related symptoms accounted for the highest proportion (27.6%) of the 735 patient expressions, although clinicians did not consider pain to be important to patients with PCOS. The most frequently expressed individual symptoms were cramping (70% of patients; 14.7% of concepts), irregular menstruation (95% of patients; 12.2% of concepts), facial hair growth (75% of patients; 10.6% of concepts), heavy bleeding (70% of patients; 8.8% of concepts), infertility (70% of patients; 5.4% of concepts), and bloating (60% of patients; 5.2% of concepts). Cramping, heavy bleeding, and bloating were not identified by clinicians as being important to patients with PCOS. The impacts most frequently reported by patients with PCOS related to emotional well-being (e.g. anxiety/stress) and coping behaviors (e.g. acne medication, hair removal).
CONCLUSIONS: The only validated PCOS-specific PRO, the PCOSQ, does not capture some key PCOS symptoms and impacts expressed by patients with PCOS, most notably those related to pain and discomfort, bleeding intensity and coping behaviours. Furthermore, some key PCOS symptoms may be under-recognized in the clinic.
摘要：
背景：这项研究的目的是探索是否需要一种新的疾病特异性患者报告结果（PRO）措施，用于针对多囊卵巢综合征（PCOS）潜在病因的药物的临床试验。并在此过程中有助于我们对定义PCOS患者体验的症状和影响的理解。
方法：对20名根据鹿特丹标准诊断为PCOS且前一个月未月经的女性进行了半结构化访谈。PCOS症状和影响概念对患者的相对重要性是通过分析其在访谈笔录中的表达频率来确定的。将这些见解与临床医生对PCOS的看法进行了比较。
结果：与疼痛和不适相关的症状在735例患者的表情中所占比例最高（27.6%），尽管临床医生认为疼痛对PCOS患者不重要.最常见的个体症状是抽筋（70％的患者；14.7％的概念），月经不调（95％的患者；12.2％的概念），面部毛发生长（75%的患者；10.6%的概念），大量出血（70％的患者；8.8％的概念），不孕症（70％的患者；5.4％的概念），和腹胀（60%的患者；5.2%的概念）。抽筋,大量出血,临床医生认为腹胀对PCOS患者并不重要.PCOS患者最常报告的影响与情绪健康（例如焦虑/压力）和应对行为（例如痤疮药物，脱毛)。
结论：唯一经过验证的PCOS特异性PRO，PCOSQ,没有捕捉到PCOS患者表达的一些关键PCOS症状和影响，最值得注意的是那些与疼痛和不适有关的，出血强度和应对行为。此外，一些关键的PCOS症状在临床上可能没有得到足够的认识.
方法：对20名根据鹿特丹标准诊断为PCOS且前一个月未月经的女性进行了半结构化访谈。PCOS症状和影响概念对患者的相对重要性是通过分析其在访谈笔录中的表达频率来确定的。将这些见解与临床医生对PCOS的看法进行了比较。
结果：与疼痛和不适相关的症状在735例患者的表情中所占比例最高（27.6%），尽管临床医生认为疼痛对PCOS患者不重要.最常见的个体症状是抽筋（70％的患者；14.7％的概念），月经不调（95％的患者；12.2％的概念），面部毛发生长（75%的患者；10.6%的概念），大量出血（70％的患者；8.8％的概念），不孕症（70％的患者；5.4％的概念），和腹胀（60%的患者；5.2%的概念）。抽筋,大量出血,临床医生认为腹胀对PCOS患者并不重要.PCOS患者最常报告的影响与情绪健康（例如焦虑/压力）和应对行为（例如痤疮药物，脱毛)。
结论：唯一经过验证的PCOS特异性PRO，PCOSQ,没有捕捉到PCOS患者表达的一些关键PCOS症状和影响，最值得注意的是那些与疼痛和不适有关的，出血强度和应对行为。此外，一些关键的PCOS症状在临床上可能没有得到足够的认识.
