Menzies School of Health Research, Charles Darwin University, PO Box 41096, Casuarina, NT, 0811, Australia.
Division of Medicine, Royal Darwin Hospital, Darwin, NT, 0811, Australia.
BMC Nephrol. 2020 Apr 15;21(1):130. doi: 10.1186/s12882-020-01776-y.
Chronic kidney disease is an increasingly common health problem for Aboriginal and Torres Strait Islander people. It is associated with multiple concurrent psychosocial stressors frequently resulting in negative impacts on emotional and social wellbeing. There is need for well-designed intervention studies to provide evidence of effective treatment for comorbid depression or other mental illness in this setting. Attention to early phase piloting and development work is recommended when testing complex interventions. This paper documents feasibility testing and adaptation of an existing culturally responsive brief wellbeing intervention, the Stay Strong App, and three commonly used wellbeing outcome measures, in preparation for a clinical trial testing effectiveness of the intervention.
The Stay Strong App, which has not been used in the setting of Chronic Kidney Disease before, is reviewed and adapted for people with comorbid wellbeing concerns through expert consensus between research team and an Expert Panel. The outcome measures (Kessler 10, Patient Health Questionnaire 9, and EuroQoL) are valid, reliable, and commonly used tools to assess various aspects of wellbeing, which have also not been used in this context before. Feasibility and acceptability are examined and developed through 3 stages: Pilot testing in a purposive sample of five haemodialysis patients and carers; translation of outcome measures through collaboration between the Aboriginal Interpreter Service, Aboriginal and Torres Strait Islander research officers and the research team; and conversion of translated outcome measures to electronic format.
Research team and expert panel consensus led to adaptation of the Stay Strong App for renal patients through selective revision of words and images. Pilot testing identified challenges in delivery of the wellbeing measures leading to word changes and additional prompts, integration of audio translations in 11 local Indigenous languages within an interactive Outcome Measures App, and related research protocol changes.
Modelling the complex intervention prior to full-scale testing provided important information about the design of both the outcome measures and the intervention. These changes are likely to better support success in conduct of the clinical trial and future implementation of the intervention in clinical settings.
慢性肾病是原住民和托雷斯海峡岛民日益常见的健康问题。它与多种并发的心理社会压力源有关，经常对情绪和社会福利产生负面影响。需要精心设计的干预研究为这种情况下的共病抑郁症或其他精神疾病提供有效的治疗证据。在测试复杂干预措施时，建议关注早期试点和开发工作。本文记录了现有文化响应性简要幸福感干预措施——Stay Strong App 的可行性测试和调整，以及三种常用的幸福感结果测量方法，为测试干预措施的有效性的临床试验做准备。
Stay Strong App 以前从未在慢性肾脏病环境中使用过，通过研究团队和专家小组之间的专家共识进行审查和调整，以满足有共病幸福感问题的人群的需求。结果测量（Kessler 10、患者健康问卷 9 和 EuroQoL）是有效、可靠的，常用于评估幸福感的各个方面，以前也没有在这种情况下使用过。通过三个阶段检查和开发可行性和可接受性：在五个血液透析患者和照顾者的目的样本中进行试点测试；通过原住民口译服务、原住民和托雷斯海峡岛民研究官员与研究团队之间的合作进行结果测量的翻译；以及将翻译后的结果测量转换为电子格式。
研究团队和专家小组的共识导致通过选择性修改单词和图像来调整适用于肾脏患者的 Stay Strong App。试点测试确定了幸福感措施的交付方面的挑战，导致了单词的变化和额外的提示，在交互式结果测量应用程序中整合了 11 种当地土著语言的音频翻译，以及相关的研究方案变更。
在全面测试之前对复杂干预措施进行建模提供了有关结果测量和干预措施设计的重要信息。这些变化可能会更好地支持临床试验的成功进行，并为未来在临床环境中实施干预措施提供支持。
