- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07615855
RIDECLAS: Delphi Classification of RICA Pathway Recommendations (RIDECLAS)
22. mai 2026 oppdatert av: Jose-M Ramirez, Universidad de Zaragoza
Delphi Study for the Classification of Recommendations for the RICA Pathway (Enhanced Recovery in Adult Surgery)
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
384
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: José-Manuel Ramírez Rodríguez, Professor of Surgery
- Telefonnummer: +34 976 556400
- E-post: jramirez@unizar.es
Studiesteder
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Zaragoza
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Zaragoza, Zaragoza, Spania, 50009
- Department of Surgery
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Ta kontakt med:
- Grupo Español de Rehabilitacion Multimodal GERM SOCIEDAD CIENTIFICA
- Telefonnummer: +34 636935065
- E-post: secretariagerm@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population will consist of healthcare professionals and scientific society members with experience in enhanced recovery pathways, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines.
Participants will be invited from the Grupo Español de Rehabilitación Multimodal (GERM) and related professional networks.
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Expert Panel
Healthcare professionals with experience in enhanced recovery pathways, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines who are invited to participate in the modified Delphi process.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Expert consensus on RICA Pathway recommendations
Tidsramme: Through study completion, up to 7 months
|
Consensus will be assessed for each recommendation using predefined Delphi criteria.
Acceptance consensus will be defined as at least 75% of ratings in the 7-9 range and no more than 15% in the 1-3 range.
Rejection consensus will be defined as at least 75% of ratings in the 1-3 range and no more than 15% in the 7-9 range.
|
Through study completion, up to 7 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Degree of agreement for each recommendation
Tidsramme: After each Delphi round, up to 7 months.
|
Distribution of ratings, median score, interquartile range, and percentage of ratings in predefined agreement/disagreement ranges.
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After each Delphi round, up to 7 months.
|
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Stability of ratings between Delphi rounds
Tidsramme: Between round 1 and round 2, and round 3 if performed, up to 7 months.
|
Descriptive assessment of changes in item-level ratings and consensus status between rounds.
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Between round 1 and round 2, and round 3 if performed, up to 7 months.
|
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Response rate and attrition between rounds
Tidsramme: After each Delphi round, up to 7 months.
|
Number and percentage of invited experts who complete each round, and percentage lost between rounds.
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After each Delphi round, up to 7 months.
|
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Qualitative analysis of expert comments
Tidsramme: After each Delphi round, up to 7 months.
|
Thematic review of free-text comments to support item reformulation and interpretation of items without consensus.
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After each Delphi round, up to 7 months.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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 Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- GERMDELPHI
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared.
This is a modified Delphi consensus study involving expert panelists rather than patients.
Individual responses will be treated confidentially, stored in coded form, and analyzed and reported only in aggregate.
Sharing individual-level responses could compromise participant confidentiality and may affect the independence of expert judgment in the Delphi process.
Aggregated results, consensus levels, and methodological details will be reported in the final publication.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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