- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07615855
RIDECLAS: Delphi Classification of RICA Pathway Recommendations (RIDECLAS)
22 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
384
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: José-Manuel Ramírez Rodríguez, Professor of Surgery
- Telefonnummer: +34 976 556400
- E-post: jramirez@unizar.es
Studieorter
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Zaragoza
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Zaragoza, Zaragoza, Spanien, 50009
- Department of Surgery
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Kontakt:
- Grupo Español de Rehabilitacion Multimodal GERM SOCIEDAD CIENTIFICA
- Telefonnummer: +34 636935065
- E-post: secretariagerm@gmail.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Expert consensus on RICA Pathway recommendations
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Degree of agreement for each recommendation
Tidsram: 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
Tidsram: Between round 1 and round 2, and round 3 if performed, up to 7 months.
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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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
22 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- GERMDELPHI
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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