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☐ ☆ ✇ BMJ Open

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

Por: Shahmari · M. · Palese · A. · Bahramnezhad · F. · Shafiee Sabet · M. · Dehghan Nayeri · N. — Octubre 29th 2025 at 16:48
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.

☐ ☆ ✇ BMJ Open

Psychometric evaluation of self-advocacy scale in patients with cancer: a psychometric evaluation protocol in Iran

Por: Habibpour · E. · Shahmari · M. · Ramazanzadeh · N. · Gardashkhani · S. — Julio 15th 2025 at 09:31
Introduction

Cancer, as a significant global health challenge, poses numerous difficulties for those affected. Self-advocacy, which refers to an individual’s capacity and desire to articulate their preferences and needs when confronted with disease-related obstacles, is crucial in enhancing their quality of life. Given the absence of a validated instrument for assessing self-advocacy in the Iranian patient population with cancer, this protocol aims to describe the psychometric properties of the Self-Advocacy in Cancer Survivorship (SACS) Scale in Persian among Iranian patients with cancer.

Methods and analysis

In this methodological study, the SACS Scale will be translated into Persian following the WHO guidelines. Subsequently, the scale’s validity, including face validity, content validity, construct validity (confirmatory factor analysis, exploratory factor analysis and convergent validity) and reliability (internal consistency and test–retest reliability), will be evaluated using SPSS V.24 and Amos V.24 software, along with appropriate statistical tests. Study participants will be patients with cancer in Ardabil, selected through convenience sampling.

Ethics and dissemination

This study, forming part of a master’s thesis, received ethical approval from the research ethics board of Ardebil University of Medical Sciences (IR.ARUMS.REC.1403.227, 7 October 2024). The findings will be disseminated at local, national and international levels.

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