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Scoping review protocol of person- and patient-centred outcomes in cancer clinical trials: definitions and methodologies

Por: Zambrano Lucio · M. · Bhoo-Pathy · N. · Menon · S. · Huang · Z. · Unger-Saldana · K.
Introduction

Traditional oncology outcome measures, such as survival rates and disease progression, fail to fully capture the complex lived experiences of persons and patients with cancer, including psychological distress, financial burdens and changes in social roles. While person- and patient-centred outcomes have emerged as essential components of quality cancer care, ambiguities persist regarding their definitions and measurement methodologies in clinical trials.

Methods and analysis

This scoping review aims to explore how person-centred and patient-centred outcomes are defined and measured in cancer clinical trials and to identify trends, gaps and methodological approaches for their assessment. Comprehensive searches will be conducted across PubMed, SCOPUS, Sci-Elo, EMBASE, PsycINFO and Google Scholar for grey literature sources, encompassing articles from August 2020 to August 2025. Eligible studies include primary research that reports patient- or person-centred outcomes in cancer clinical trials. Studies focusing solely on preventative care or lacking assessment of patient- or person-centred outcomes will be excluded. Studies will be independently screened and selected by two reviewers in duplicate, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Data extraction will also be conducted independently and in duplicate using a standardised extraction tool, with disagreements resolved through consensus to ensure consistency and accuracy. Results will be synthesised qualitatively and quantitatively, with narrative and thematic analysis used to identify trends and gaps in the literature.

Ethics and dissemination

Ethical approval is not required. Results will be published in a peer-reviewed journal and presented at conferences.

Trial registration number

https://doi.org/10.17605/OSF.IO/EYZPK

Risk factors associated with experiences of violence and its consequences for womens health: a scoping review protocol

Por: del Risco Sanchez · O. · Rodrigues · L. · Zambrano · E. · Surita · F. G.
Introduction

Violence against girls and women (VAWG) is a public health problem and a violation of human rights. The prevalence of different forms of VAWG indicates that this is a recurring global issue that provokes economic, social and health consequences. In this paper, we outline a scoping review protocol to characterise risk factors for VAWG from an intersectional and intergenerational perspective and discuss the consequences of such experiences for women’s health.

Methods and analysis

The protocol will be conducted according to the Joanna Briggs Institute Methodology for Scoping Reviews and will involve six consecutive steps: (1) formulating the research question, (2) search strategy, (3) study selection, (4) eligibility criteria, (5) data extraction, (6) data analysis and presentation of results and (7) stakeholder consultation. The search strategy will include eight indexed databases (PubMed, BVS, Scopus, Web of Science, EMBASE, Cinahl, Cochrane Library and PsycInfo) and recommendations from professional organisations and international agencies. The search will be limited to publications in English, Spanish and Portuguese, according to the Health Sciences Descriptors/Medical Subject Headings and free terms. Two independent researchers will select articles based on the inclusion criteria, and a third author will be consulted to establish consensus. Data extraction will involve a form with information on study characteristics, methodological issues and main results from the sources of evidence. Extracted data will be analysed using descriptive and content analysis. The NVIVO 14 software will be used to organise and validate the data. The protocol was registered in the Open Science Framework (DOI 10.17605/OSF.IO/P6H2S).

Ethics and dissemination

Ethical approval is not required as data from publicly available literature sources will be used. The results will be disseminated through publications in scientific journals and presentations of the evidence to stakeholders.

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