United BioSource Corporation, Center for Health Outcomes Research, Bethesda, MD 20814, USA.
Patient. 2011;4(3):177-87. doi: 10.2165/11586480-000000000-00000.
Overactive bladder (OAB) consists of the symptoms of urinary urgency (with or without urgency incontinence) and increased urinary frequency and nocturia. As OAB is defined by symptoms, the patient is the best source of information for assessing the impact of the condition on health-related quality of life (HR-QOL). This assessment can be conducted through the use of valid patient-reported questionnaires, meaning the questionnaire has demonstrated content validity, among other acceptable psychometric properties. The aim of this study was to evaluate the content validity of the King's Health Questionnaire (KHQ) in patients with OAB in the US.
Men and women with continent or incontinent OAB were recruited from a clinical research site in the US. Participants completed the KHQ and were then asked about the instructions, items, and response options. Data were analyzed descriptively and qualitatively.
A total of 24 participants (18 women, 6 men; mean [± SD] age 59.0 ± 11.1 years) with OAB were interviewed and provided feedback on the KHQ. Participants reported that overall, the KHQ covers the key aspects in which OAB impacts patients' daily lives. Most KHQ items and response options were acceptable and understandable to the participants; however, a few minor issues were noted. In item 3, shopping was not considered by some participants to be a household task, while shopping and cleaning were not relevant to some of the men. Two sets of items ('limit social life' and 'limit ability to see/visit friends' and 'bladder problem affect sleep' and 'feel worn out or tired') were perceived as redundant, while 'depressed' (item 12) and 'anxious or nervous' (item 13) were perceived by some participants as too intense. Some participants were unsure if the intended meaning of 'change your underclothes when they get wet' was about changing wet underwear or frequency of incontinence episodes.
The KHQ demonstrated content validity and can be considered a relevant and appropriate tool to assess the impact of OAB on HR-QOL in men and women in the US.
膀胱过度活动症（OAB）包括尿急（伴或不伴急迫性尿失禁）、尿频和夜尿症等症状。由于 OAB 是通过症状定义的，因此患者是评估疾病对健康相关生活质量（HR-QOL）影响的最佳信息来源。这种评估可以通过使用有效的患者报告问卷来进行，这意味着问卷具有内容有效性，以及其他可接受的心理测量学特性。本研究旨在评估美国 OAB 患者使用 King's 健康问卷（KHQ）的内容有效性。
从美国的一个临床研究地点招募了有控尿或失禁性 OAB 的男性和女性参与者。参与者完成了 KHQ，并被问及问卷的指导说明、项目和应答选项。数据采用描述性和定性方法进行分析。
共有 24 名 OAB 患者（18 名女性，6 名男性；平均[±SD]年龄 59.0±11.1 岁）接受了访谈，并对 KHQ 提供了反馈。参与者报告称，总体而言，KHQ 涵盖了 OAB 影响患者日常生活的关键方面。大多数 KHQ 项目和应答选项对参与者来说是可以接受和理解的；然而，也有一些小问题。在项目 3 中，一些参与者认为购物不是家务劳动，而购物和清洁对一些男性来说并不相关。两组项目（“限制社交生活”和“限制与朋友见面/探访的能力”，以及“膀胱问题影响睡眠”和“感到疲倦或疲劳”）被认为是多余的，而“抑郁”（项目 12）和“焦虑或紧张”（项目 13）被一些参与者认为过于强烈。一些参与者不确定“当内裤湿了时更换内裤”的意图是指更换湿内裤还是尿失禁发作的频率。
KHQ 具有内容有效性，可被视为一种相关且合适的工具，用于评估美国男性和女性 OAB 对 HR-QOL 的影响。
