Karimi Hamid, Onslow Mark, Jones Mark, O'Brian Sue, Packman Ann, Menzies Ross, Reilly Sheena, Sommer Martin, Jelčić-Jakšić Suzana
The University of Sydney, Faculty of Health Science, Australian Stuttering Research Centre, PO Box 170, Lidcombe, Sydney, NSW, 1825, Australia.
School of Public Health, University of Queensland, Level 2, Public Health Building, Herston Road, Herston QLD 4006, Australia.
J Fluency Disord. 2018 Dec;58:77-85. doi: 10.1016/j.jfludis.2018.10.002. Epub 2018 Oct 15.
The Consolidated Standards of Reporting Trials (CONSORT) statement strongly suggests one primary outcome for clinical trials, yet the outcomes of stuttering treatments span numerous behavioral and psychosocial domains. That presents a roadblock to eventual meta-analysis of clinical trials for adults who stutter.
We propose a simple and convenient outcome measure for clinical trials of stuttering treatment for adults that spans whatever behavioral and psychosocial factors might impel clients to seek treatment: a nine-point scale of Satisfaction with Communication in Everyday Speaking Situations (SCESS). The scale consists of one question which is simple, brief, easy to administer, cost-free, and translatable into many languages. The present report develops the SCESS scale by determining its reliability, content validity, and construct validity.
Reliability, content validity, and construct validity of the SCESS were confirmed with statistically significant and substantive correlations with speech-related and anxiety-related measures. However, the SCESS did not correlate well with percentage syllables stuttered. Three behavioral and psychosocial measures had the highest correlation with the SCESS: total Overall Assessment of the Speaker's Experience of Stuttering, self-reported stuttering severity, and Unhelpful Thoughts and Beliefs about Stuttering.
The SCESS measure has potential to be applied as an overarching clinical trial outcome measure of stuttering treatment effect. This study provides some preliminary evidence for including it as a primary or secondary outcome in clinical trials of adult stuttering treatments. However, further studies are needed to establish the SCESS responsiveness to different stuttering treatments.
《报告试验的统一标准》(CONSORT)声明强烈建议临床试验采用一个主要结局指标,但口吃治疗的结局涵盖众多行为和心理社会领域。这给最终对口吃成年人的临床试验进行荟萃分析带来了障碍。
我们为成年人口吃治疗的临床试验提出一种简单便捷的结局测量方法,该方法涵盖任何可能促使患者寻求治疗的行为和心理社会因素:日常口语情境中沟通满意度九点量表(SCESS)。该量表由一个问题组成,简单、简短、易于实施、免费且可翻译成多种语言。本报告通过确定其信度、内容效度和结构效度来开发SCESS量表。
SCESS的信度、内容效度和结构效度通过与言语相关及焦虑相关测量指标的统计学显著且实质性的相关性得到证实。然而,SCESS与口吃音节百分比的相关性不佳。三项行为和心理社会测量指标与SCESS的相关性最高:口吃者体验总体评估总分、自我报告的口吃严重程度以及对口吃的无益想法和信念。
SCESS测量方法有潜力作为口吃治疗效果的总体临床试验结局测量指标。本研究为将其纳入成人口吃治疗临床试验的主要或次要结局提供了一些初步证据。然而,需要进一步研究来确定SCESS对不同口吃治疗方法的反应性。