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2.0.1 Participant inclusion and protocol selection (recruitment)
2.0.1 Participant inclusion and protocol selection (recruitment)
A list of patients scheduled for consultation will be derived from the practice management system and imported into the clinical registry database the day before the consult list in preparation for data input. Figure 2.0.1a&b shows the process of establishing a new patient record through to assigning them to the appropriate registry cohort(s).
In detail, the steps are:
- When a patient presents to a clinic registry site for their scheduled appointment with one of the participating surgeons, the practice receptionist coordinates initial collection of the patient's clinical information and informs the patient about the clinical registry.
- The patient is entered into the clinical registry database with the protocol label “Screening” and the patient-reported outcomes questionnaire is provided to the patient to complete in the waiting room.
- The patient undergoes a face-to-face consultation with the participating surgeon, where a formal diagnosis is made.
- The diagnosis is used to refine the protocol label to one (or more) of the registry cohorts of interest.
- The database software is used to inform the receptionist which protocol-specific questionnaires need to be filled out by the patient on their return to the waiting room and prior to their departure from the clinic.
- In the case of non-operative management being prescribed, the Date of Procedure recorded will be 2 weeks after referral from the treating surgeon. For Surgical intervention the Date of Procedure will be the date of surgery.
Figure 2.0.1a: Patient registry inclusion
Figure 2.0.1b: Patient Cohort inclusion
2.0.2 Participant follow-up
2.0.2 Participant follow-up
Registry participants will be followed up both in-person and via their clinic and hospital medical records (as generated by the providing surgeon), as per the registry workflow (Figure 4). Participants will be followed up postoperatively at the time points and with instruments/scales as dictated by the cohort of interest and as detailed in Section 2. Follow ups will occur in line with clinical requirements using a mixed model of in-person clinical follow-up, email, and in cases where patients have missed appointments or other follow up timings, they will be contacted by a member of the clinic staff (reception or nurse) with a reminder to complete email based questionnaires. This will occur on a fortnightly basis with a list provided by EBMA, and the day before surgery if they still have not completed all required questionnaires (pre-op only).
Specific case of patients presenting outside of normal clinical requirements, or at periods not required for research, will not necessarily be logged. This excludes patients returning outside of clinical requirements who have complications or additional procedures. Complications will be logged by the reviewing surgeon according to the CDS specific for that patients original cohort. If the complications are severe enough to deem the initial treatment failed, this will be recorded in Socrates as per the SOPs. Re-operations for a surgery that is not deemed 'failed' are logged in the same treatment record as per the SOPs.
2.0.3 Imaging
2.0.3 Imaging
Images requested at specific timepoints for research will not be downloaded to a database at this point. The location where the image was taken will be recorded by the Registry Custodian as well as the date and type of image (CT, XR, MRI, US). This information can be gathered from Genie imaging records.
2.0.4 Procedure and Diagnosis naming
2.0.4 Procedure and Diagnosis naming
Diagnoses
Diagnoses
The sheet below (Figure 2.0.4) identifies the diagnosis names used in each of the modules for the MSEC registry. Old codes and naming systems have been used in the registry and they have been converted to the new naming system. Any old codes that have been converted are mapped out to the new name.
Diagnosis codes are classified into the type of pathology first, e.g. Infection, Glenohumeral Arthritis, and then by type (if needed), e.g. Glenohumeral Arthritis - Osteoarthritis, Infection – Post operative Acute.
Revision procedures will be marked with the Diagnosis according to the new pathology and reason for another treatment. The reason for failure will be described in the Complications and any previous procedures by other surgeons will be recorded in the History tab.0
Procedures
Procedures
Primary procedures can be found in sheet 3: New_Procedures All (these were updated before the registry was implemented). They are classified first by the procedure, e.g. Arthroplasty, Rotator Cuff repair etc., then a more specific type of the procedure, separated by a dash (-) (if needed) e.g. injection - steroid injection, and finally by region/location (if needed) e.g. Osteotomy (Clavicle)
Figure 2.0.4: Procedure and Diagnosis coding
2.0.5 Registry recruitment, inclusion and exclusion criteria
2.0.5 Registry recruitment, inclusion and exclusion criteria
All patients presenting to the participating surgeons for treatment will be included in the registry under an opt-out consent arrangement.
Inclusion Criteria
- Diagnosed with orthopaedic Shoulder. Elbow or Wrist pathology and booked for surgery.
- Undergoing treatment by the participating orthopaedic consultant surgeon as a patient at Geelong Orthopaedics.
- Consenting to being part of the Clinical Research Registry
Exclusion Criteria
- Patient-reported outcomes: Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder).
- Revocation of consent for research use of personal data.
2.0.6 Participant consent
2.0.6 Participant consent
Informed consent will be sought from all participants via an opt-out approach. Eligible patients will be presented with a Patient Information Sheet and a Withdrawal of Consent form by the consultant surgeon, registrar or front desk personnel. They will be given the opportunity to ask any questions, and opt-out of the registry if they so wish by completing the withdrawal of consent form. Note that the consent is only needed to use any data for research, withdrawing themselves from the registry does not excuse the patient from completing any questionnaires.
Non-English-speaking participants
Non-English-speaking participants
Patients who do not have an acceptable level of English will still be invited to participate if they are accompanied by a translator of an acceptable standard as determined by their treating doctor. The standard must be such that the patient is able to complete the required questionnaires and understand their obligations and rights in participating in the registry.
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