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| ID | Type | Description | Link |
|---|---|---|---|
| Project 101080288 - PREPARE | Other Grant/Funding Number | EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA) |
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The general aim of the project is training and testing a predictive model of inpatient rehabilitation stay after hip and knee replacement for osteoarthritis. This specific part focuses on data collection and analysis for the model validation.
The following variables will be investigated to evaluate their predictive value towards length of rehabilitation stay (primary outcome), place of discharge, burden of care at discharge and/or functional recovery (secondary outcomes):
Due to retrospective study design, patients will not be recruited ex-novo and will be used data already stored in the internal databases.
Data retrieved from clinical records and other sets internal to the hospital will be collected on a dedicated Excel sheet and divided per section of interest (baseline, intervention, outcomes).
Data from 1710 patients who underwent total hip or knee replacement and subsequent inpatient rehabilitation in our hospital were collected, in the previous part of this project, to train the model.
In this second part, the same variables from 400 patients will be collected to test the model predictivity. Put together, these samples represent around 80% and 20% of the total population (2100) respectively, which is a common cohort distribution to test for validity.
To verify the validity (discrimination and calibration) of the newly developed prediction and stratification models, we will conduct a temporal external validation based on a sample of newly collected patients undergoing hip and knee at the same hospital but at a different point in time (2018, as compared to 2019 for the development sample).
To this aim, we plan to include a convenience sample of at least 400 patients: the sample size was determined based on a minimum sample size calculation, using Hoeffding's inequality (DOI: 10.1016/j.jspi.2012.09.013), which is sufficient to identify differences in performance smaller than 10% performance points with confidence higher than 95% (minimum sample size=390).
Basic modelling methodologies such as linear and logic regression will also be taken into consideration.
The best performing model for each outcome of interest will be finally selected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who underwent total hip and/or knee arthroplasty for primary or secondary osteoarthirtis | Patients discharged directly to inpatient rehabilitation unit in the same hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional rehabilitation | Other | Functional rehabilitation is standardized educational and physical therapy to restore physical and activities of daily living function before discharge. Pain management, blood management and iron diet are also provided based on standard conditions (e.g. patient-reported pain, postoperative day and hemoglobin levels). |
| Measure | Description | Time Frame |
|---|---|---|
| Length of inpatient rehabilitation stay (days) | The number of days needed by the patient to be discharged in safety | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Need of care at discharge | Hours of care (number) needed by the patient (estimation) to receive support on the Activities of Daily Living after hospital discharge. | Last day of inpatient rehabilitation stay: up to 30 days |
| Place of discharge |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to inpatient rehabilitation unit after discharged from surgical ward.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Coordinator of the Scientific Direction | Contact | +39 0283502224 | direzionescientifica.ogsa@grupposandonato.it | |
| Grant office operator | Contact | +39 0283502227 | pennestri.federico@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Federico Pennestrì, PhD | IRCCS Ospedale Galeazzi Sant'Ambrogio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Galeazzi-Sant'Ambrogio | Recruiting | Milan | 20157 | Italy |
Researchers of the same facility will scan paper records to retrieve patient data.
No sensitive data will leave the hospital.
Study protocol is already completed and available. Informed consent is given based on retrospective study policy guidelines from the Ministry of Health.
The researchers employed on the project will have access to paper-scan clinical records in a pdf format, either from the internal, protected database, or from a Compact Disc record.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D059408 | Pain Management |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Home, home with care givers, other inpatient unit.
| Last day of inpatient rehabilitation stay: up to 30 days. |
| Barthel Index of autonomy in Activities of Daily Living (ADL) | Score 0-100 in both scales. | Last day of inpatient rehabilitation stay: up to 30 days. |