School of Psychology and Clinical Language Sciences, University of Reading, Reading, RG6 7BE, UK.
School of Psychology, University of Buckingham, Buckingham, MK18 1EG, UK.
Qual Life Res. 2023 Jun;32(6):1745-1758. doi: 10.1007/s11136-023-03348-7. Epub 2023 Feb 6.
Recurrent urinary tract infection (rUTI) is a highly prevalent condition associated with significant poor quality of life outcomes. A patient-reported outcome measure (PROM) of rUTI-associated psychosocial impact is urgently required to supplement clinical evaluation and validate the challenges experienced by patients. This study therefore developed and validated the Recurrent UTI Impact Questionnaire (RUTIIQ).
A rigorous four-stage methodology was followed: (I) concept elicitation through a qualitative survey of the experiences of people with rUTI (N = 1983); (II) Delphi expert screening of the RUTIIQ with expert rUTI clinicians (N = 15); (III) one-to-one cognitive interviews with people experiencing rUTI (N = 28) to evaluate the comprehensiveness and comprehensibility of the RUTIIQ, and (IV) full pilot testing of the RUTIIQ with people experiencing rUTI (N = 240) to perform final item reduction and psychometric analysis.
Exploratory factor analysis demonstrated a five-factor structure comprising: 'patient satisfaction', 'work and activity interference', 'social wellbeing', 'personal wellbeing', and 'sexual wellbeing', collectively accounting for 73.8% of the total variance in pilot scores. Results from expert clinicians and patients indicated strong item content validity (I-CVI > .75). The internal consistency and test-retest reliability of the RUTIIQ subscales were excellent (Cronbach's α = .81-.96, ICC = .66-.91), and construct validity was strong (Spearman's ρ > .69).
The RUTIIQ is a 30-item questionnaire with excellent psychometric properties, assessing the patient-reported psychosocial impact of living with rUTI symptoms and pain. This new instrument delivers the unique opportunity to enhance patient-centred care through standardised observation and monitoring of rUTI patient outcomes.
This study was pre-registered with ClinicalTrials.gov (identifier: NCT05086900).
复发性尿路感染（rUTI）是一种高发疾病，与生活质量显著下降有关。迫切需要一种 rUTI 相关心理社会影响的患者报告结局测量（PROM）来补充临床评估，并验证患者所经历的挑战。因此，本研究开发并验证了复发性尿路感染影响问卷（RUTIIQ）。
采用严格的四阶段方法：（I）通过对 1983 名 rUTI 患者经历的定性调查进行概念发掘；（II）通过 15 名 rUTI 专家对 RUTIIQ 进行 Delphi 专家筛选；（III）对 28 名经历 rUTI 的患者进行一对一认知访谈，以评估 RUTIIQ 的全面性和可理解性；（IV）对 240 名经历 rUTI 的患者进行 RUTIIQ 的全试点测试，以进行最终项目删减和心理测量分析。
探索性因素分析显示，有五个因素结构，包括：“患者满意度”、“工作和活动干扰”、“社会幸福感”、“个人幸福感”和“性幸福感”，共占试点得分总方差的 73.8%。来自专家临床医生和患者的结果表明，项目内容效度很强（I-CVI>0.75）。RUTIIQ 分量表的内部一致性和重测信度均为优秀（Cronbach's α=0.81-0.96，ICC=0.66-0.91），结构效度也很强（Spearman's ρ>0.69）。
RUTIIQ 是一个有 30 个项目的问卷，具有良好的心理测量学特性，评估了患有 rUTI 症状和疼痛的患者的心理社会影响。这种新的工具提供了一个独特的机会，可以通过标准化观察和监测 rUTI 患者的结果来增强以患者为中心的护理。
本研究在 ClinicalTrials.gov 进行了预先注册（标识符：NCT05086900）。
