Validation of a questionnaire to assess complexity of palliative care needs in primary care in Malaga, Spain: a study protocol.

INTRODUCTION

The needs of patients in palliative care (PC) are multiple and changing. Several tools assess them, but there is a lack of homogeneity among them. A specific diagnostic tool to assess complexity in PC (IDC-Pal: Instrumento Diagnóstico de la Complejidad en Cuidados Paliativos, in Spanish) was created in community and hospital settings with 36 items to diagnose PC complexity, but its application in primary care is difficult.

AIMS

(1) To generate an adapted version to primary care of the IDC-Pal tool to identify and stratify PC complexity in the adult population. (2) To determine face, content, criterion and construct validity and reliability of the new instrument.

METHODS AND ANALYSIS

There are three phases of clinimetric cross-sectional observational validation study: : Review of the original tool structure suitability for its use in primary care setting by a committee (researchers and the original developer team). : Expert consensus phase by Delphi technique with physicians, nurses and social workers from primary care and PC. : Empirical validation of the resulting tool in primary care using a cross-sectional descriptive design involving physicians and case manager nurses from across Andalucia, who will recruit adult patients with PC needs from healthcare centres that accept to participate in the study. Reliability (Cronbach's alpha, McDonald's omega, interclass correlation coefficient) and construct validity (exploratory factor analysis) analysis will be carried out; convergent criterion validity will be assessed with the NEC-PAL (Necesidades Paliativas Questionnaire, in Spanish) instrument. Differences by gender, type of professional and place where it is administered will be explored. Interobserver reliability analyses will be carried out using intraclass correlation coefficient, Bland-Altman plots and concordance analysis. Phase 0-1 results were expected by 2025 and Phase 2 results by 2026. : CRISP checklist. This protocol was conducted without patient or public participation.

ETHICS AND DISSEMINATION

This study evaluates a novel, co-designed tool to diagnose PC complexity to inform practice recommendations for a more efficient allocation of resources that may be included in future clinical practice guidelines. The study has been approved by the Provincial Research Ethics Committee of Málaga as of July 2023 and will be conducted in accordance with the principles established in the Declaration of Helsinki, the Council of Europe Convention on Human Rights and Biomedicine, and the requirements established in Spanish legislation. The study conforms to the norms of good clinical practice. All participants in the Delphi study must express their agreement to participate in the survey by providing informed consent (IC) before beginning the questionnaire. For the development of Phase 2, the primary care professionals who agree to participate will sign a researcher commitment, and the patients included in the study will sign a written IC before the data collection. Dissemination of the results will inform future research on the appropriate diagnosis of PC complexity in the primary care setting, which is of paramount importance due to its gatekeeper position. Dissemination will be aimed at academics and healthcare professionals through publications, presentations and training workshops on the use of the diagnostic tool.