Development and psychometric evaluation of a safety instrument for patients with cognitive impairment in hospital: an exploratory sequential mixed-methods study protocol in Iran

INTRODUCTION: Cognitive impairments, such as dementia and Alzheimer's disease, are considered a significant public health challenge as they affect mental functions like memory, attention, language and decision-making. With the growing number of older individuals, the prevalence of these diseases is also increasing and is projected to reach 152 million worldwide by 2050. These disorders result in difficulties with judgement, communication and daily activities, leading to more hospitalisations and risks such as disorientation in the environment and a higher likelihood of falls. Current hospital safety assessment tools mainly focus on physical aspects and overlook other crucial factors. Therefore, this study aims to clarify the concept of safety challenges for patients with cognitive impairment and to develop and psychometrically validate a multidimensional instrument for use in hospital settings. METHODS: A sequential exploratory study with mixed methods will be conducted. In the first qualitative phase, based on a content analysis approach, the aim is to explain and clarify safety issues in patients with cognitive impairment. Participants will be purposively selected until saturation is reached in educational-therapeutic centres affiliated with the University of Medical Sciences, and unstructured in-depth interviews will be conducted. The data will be analysed simultaneously using MAXQDA V.20 software. Additionally, a literature review on safety issues in patients with cognitive impairment will be conducted to supplement aspects that may not have emerged in the interviews.In the second phase, an instrument based on the inductive-deductive method will be developed. The items will be created based on the participants' experiences and the literature review. Face, content and construct validity, as well as reliability, will be assessed. Data synthesis will involve a linkage strategy, where the qualitative data will be linked to the quantitative data immediately after the completion of the qualitative phase, once the protocols are developed. ETHICS AND DISSEMINATION: This study is part of a postdoctoral project approved by the Tehran University of Medical Sciences Research Ethics Board (IR.TUMS.FNM.REC.1403.006). Findings will be disseminated at the local, national and international levels.