RIDECLAS: Delphi Classification of RICA Pathway Recommendations

Официальное название

Delphi Study for the Classification of Recommendations for the RICA Pathway (Enhanced Recovery in Adult Surgery)

Обзор

RIDECLAS is an observational, prospective, non-interventional consensus study using a modified Delphi methodology. The study aims to obtain expert consensus on the classification and final formulation of recommendations for the RICA Pathway, an enhanced recovery pathway for adult surgery. Participants will be healthcare professionals with experience in enhanced recovery, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines. Experts will complete sequential online questionnaires. Individual responses will remain confidential, and aggregated anonymized feedback will be provided between Delphi rounds. The study does not involve patients, clinical interventions, biological samples, drugs, or medical devices.

Подробное описание

This study will use a modified Delphi process conducted remotely through electronic questionnaires. A coordinating committee will prepare an initial list of recommendations based on the previous RICA Pathway document and updated evidence. Expert panelists will rate each recommendation using a 1-to-9 Likert scale and may provide free-text comments. Two Delphi rounds are planned, with a third round if needed for items without sufficient consensus or for reformulated statements. Between rounds, participants will receive aggregated and anonymized feedback, including measures of agreement, median scores, dispersion, and a summary of comments. Consensus for acceptance is predefined as at least 75% of ratings in the 7-9 range and no more than 15% in the 1-3 range. Consensus for rejection is predefined as at least 75% of ratings in the 1-3 range and no more than 15% in the 7-9 range. Items not meeting consensus criteria may be reassessed in subsequent rounds. The analysis will be descriptive and will include response rates, attrition between rounds, item-level agreement, median scores, interquartile ranges, and qualitative thematic review of comments.

Вмешательства

• Другое Modified Delphi questionnaire
  Sequential online questionnaires used to rate and classify proposed RICA Pathway recommendations. This is not a clinical intervention and does not involve patient care, drugs, devices, or invasive procedures.

Первичные конечные точки

• Expert consensus on RICA Pathway recommendations [Срок оценки: Through study completion, up to 7 months]

Вторичные конечные точки (4)

• Degree of agreement for each recommendation [Срок оценки: After each Delphi round, up to 7 months.]
• Stability of ratings between Delphi rounds [Срок оценки: Between round 1 and round 2, and round 3 if performed, up to 7 months.]
• Response rate and attrition between rounds [Срок оценки: After each Delphi round, up to 7 months.]
• Qualitative analysis of expert comments [Срок оценки: After each Delphi round, up to 7 months.]

Критерии участия

Критерии включения

• Healthcare professional or researcher with relevant clinical or scientific experience in enhanced recovery pathways, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines.

At least 5 years of professional experience. Membership in GERM or participation in professional networks related to enhanced recovery in adult surgery.

Willingness to participate in the planned Delphi rounds. Provision of electronic informed consent.

Критерии исключения

• Failure to meet the predefined professional experience criteria. Failure to provide informed consent. Failure to complete the first Delphi round. Duplicate or incomplete responses that cannot be validated for analysis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Испания · 1 центр

• Department of Surgery — Zaragoza

Публикации

• Grupo de trabajo. Vía Clínica de Recuperación Intensificada en Cirugía del Adulto (RICA). Grupo Español de Rehabilitación Multimodal (GERM); 2026. Available at: https://grupogerm.es/via-rica-web/
• Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After PMID 31066889
• Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5. PMID 14667752
• Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan. PMID 38261576

Идентификаторы

NCT: NCT07615855 · GERMDELPHI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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