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MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03527407
Collaborator
(none)
146
Enrollment
1
Location
42.2
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (Article 22a KVG). In addition, comparisons of clinics or specialist specialists on cost and quality of results are required (Art. 49 (8)).

Currently, the quality of a medical therapy is evaluated rather negatively on the absence (or occurrence) of complications. In contrast, however, the goal of therapy must be to improve or maintain the health-related quality of life (HRQoL). Accordingly, the Swiss Society of Surgery (SGC-SSC), in collaboration with the Association for Quality Assurance in Surgery (AQC), has developed a minimum dataset designed to assess the quality of life of patients after surgical intervention. In order to enable Switzerland to be comparatively independent of the discipline, generic (in the Research Plan - MIDAS -V2, date 24.05.2017 Page 5/57 Contrary to disease-specific) survey instruments proposed that cover the general quality of life in its different facets, regardless of the function of individual organ systems. The complication documentation was not completely abandoned in this proposal, but is only a quality indicator among many due to patient-related outcome measurements.

However, the development of a minimal data set with quality indicators that are applicable across all surgical sub-disciplines for evaluating the quality of treatment of acute and chronic diseases raises a number of fundamental questions that can only be answered to a limited extent without empirical studies. Five essential questions are:

  1. Is it sufficient to work with generic quality of life tools or is it necessary to use disease / indication specific instruments or functional tests? II. Which is the best, solid time for a follow-up? III. Is it possible and useful to make a third-party determination of the quality of life in patients with limited cognitive abilities? IV. Which preoperative risk factors should be documented so that sufficient adjustment for case mix differences in hospital comparisons can be made? V. Which perioperative and postoperative factors, in particular complications, must be raised beyond the quality of life, as they reflect an independent aspect of quality?
Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    146 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery (ch18Jakob3)
    Actual Study Start Date :
    Jul 1, 2017
    Actual Primary Completion Date :
    Jan 6, 2021
    Actual Study Completion Date :
    Jan 6, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Changes to Baseline in the generic scores EuroQuol5 (EQ-5D) [baseline, month 3 and month 12]

      The degree of mapping the influence of known factors for the quality of therapy to changes to Baseline in the generic scores EuroQuol5 (EQ-5D). different measuring times between 3 and 12 months.

    2. Changes to Baseline in the Health Utility Index Mark 3 (HUI3) [baseline, month 3 and month 12]

      The degree of mapping the influence of known factors for the quality of therapy to changes to Baseline in the Health Utility Index Mark 3 (HUI3). different measuring times between 3 and 12 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Standard therapy of one of the following diagnoses

    • Femoral neck fracture after low-energy trauma (implantation of a head endoprosthesis)

    • Coxarthrosis (implantation of a total hip prosthesis)

    Exclusion Criteria:

    • Rejection of study participation or standard therapy

    • Patients who are unlikely to attend routine follow-up (e.g., tourists)

    • Patients in palliative care

    • Malignancy (known or diagnosed in the course of time)

    • Patients with a limited knowledge of German, who can answer the questionnaire even with the help of a study nurse seems unrealistic

    • Participation in an interfering clinical intervention study within the last three months

    • persons unable to consent (long-term incapacity to consent)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Orthopedic and Trauma Surgery, University Hospital Basel Basel Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Marcel Jakob, Prof MD, University Hospital, Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT03527407
    Other Study ID Numbers:
    • 2017-00763; ch18Jakob3
    First Posted:
    May 17, 2018
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hip Injuries

    Study Results

    No Results Posted as of Nov 18, 2021