1.2 Registry Procedures

1.2.1 Background and Rationale

Rationale

The ability of a registry to contribute meaningful information is questionable without a clear framework for addressing sources of quality degradation. Quality in this context is the amount to which the data can be trusted (and verified) to be the true representation of a patient population, with respect to their characteristics, treatments and outcomes. To establish whether the registry is answering the research questions appropriately the quality of the data is important to document.

Definition

Data quality in a registry can be undermined by conflicts of interests and poor transparency, bias and error. Conflicts of interest with respect to the outcome and a lack of transparency with respect to the research method can undermine the validity of a registry’s findings. A bias is a systematic error, or deviation from the truth, in results or inferences (Cochrane Handbook for Systematic Revi...) and can lead to under or overestimation of the true effect of an intervention or natural history of a disease. Replications of a biased study would in all probability reach the same wrong answer on average. Bias is separate from imprecision (error), which refers to random error, with multiple replications of the same study likely producing different effects due to variability even if they produce the right answer on average (Cochrane Handbook for Systematic Revi...). The framework of the clinical registry must attempt to address both types error to minimise the risk of poor quality data informing clinical practice. In the PRULO registry, data quality is assured by the activities as summarised in the figure 1.2.1.

Figure 1.2.1: Sources of quality degradation and assurance activities in a clinical registry

1.2.2 Documentation

The GO registry has fully documented the inclusion and exclusion criteria, core dataset (including definitions) and procedures for capturing and recording the core dataset on each individual patient and treatment entry. The core dataset also includes a nomination for the person accountable in ensuring capture and quality for each data field.

The software utilised for registry purposes has been noted and the technical specifications of each aspect of the data life cycle has been recorded in this manual (Section 1). Access controls to the registry database have also been detailed.

1.2.2.1 Documentation Access

The following document identifies who has access to which documents, either viewing or editing

GO_Documentation Access

1.2.3 Reporting/Auditing

Quality assurance of the registry will be maintained through regular auditing and reporting with respect to completeness, consistency and validity.

1.2.3.1 Completeness

Reports on the completeness of the registry and the data contained as per the core dataset (CDS) will provide timely indications of problems with data capture processes at any stage of the patient clinical pathway.

GO_Audits

Table 1.2.3.1: Completeness definitions

1.2.3.2 Consistency

Reports on the consistency of the data contained in the registry will provide timely indications on the accuracy of data transfer or problems with data entry that may render the data unusable for analysis.

GO_Audits

Table 1.2.3.2: Consistency check definitions

1.2.3.3 Validity

Validity of the registry refers to its ability to reflect the true data regarding an individual patient (interval validity), as well as reflecting the true nature of a condition or treatment outcomes broadly to all patients (external validity). Internal validity audits for this site will check patient demographics from the practice management software (Genie) against research registry. External validity will be reported as per the statistical analysis plan timetable in light of agreed benchmarks identified (Table 1.2.4.3) for each cohort. That is, the highest quality evidence describing patient outcomes will be used to compare the PRULO registry.

GO_Audits

Table 1.2.3.3: External validation benchmarks

1.2.3.4 Feedback and reporting

Completeness audit reporting will be done via this Google site, which will be regularly updated based on the schedule outlined in section 1.2.4.5. The Google site has been set out in dashboard style, with the results presented as per Figure 1.2.4.4a-b. Supplementary documents highlighting discrepancies found in the audits (completeness, consistency and validity) will be communicated to the client via Gsheets implemented into the mentioned dashboard wiki. These supplementary documents, alongside contact with the participating surgeon, their clinical staff and the data flow personnel, aim to rectify the issues that are decreasing the quality of the registry.

Figure 1.2.3.4a: Example completeness results for the registry. Capture rates of research eligible patients into the registry for each cohort. Capture rates below agreed benchmarks (red line) will be highlighted for further analysis.

Figure 1.2.3.4b: Example completeness results for the registry. The number of patients eligible for research in each cohort.

1.2.3.5 Quality control schedules

Regular audits will be conducted to ensure data quality is at an adequate standard for clinical research. These audits will include completeness, consistency and validation checks of the data in the registry to sources both internal and external to the practice.

The proposed interval of each audit type and the proposed audit schedule immediately post-launch of PRULO for a 6-month period are displayed in table and figure 1.2.3.5 below.

GO_Audit Intervals

Table 1.2.3.5: proposed intervals of each audit type

Figure 1.2.3.5: Proposed auditing schedule immediately post-launch of PRULO

1.2.4 Training register

All users of the registry will be trained on the data collection procedures. Accountability for data collection, quality assurance and analysis has been identified in the registry core dataset definitions and in the standard operating procedures included in the lesson plans. A training register is also maintained by the Registry Custodian and will be updated for existing staff annually and when a new user is nominated by the participating surgeons (e.g., fellow, assistant, student) and confirmed in writing (email). The Registry Custodian will ensure all database users have been trained to the minimum standard identified in the register for the relevant lessons matching their role.

GO_Registry Training Register

Figure 1.2.4: Training Register

1.2.5 Registry duration

Direct participant involvement in the registry, in terms of data contributions will cease at the last follow-up identified in the protocol, as per Section 2 . However, data retention will be for the operating duration of the clinic to pool with other participants added to the same protocol and provide a resource for future research on the natural history of the diagnosis, or efficacy of the selected intervention.

1.2.6 Publication Plan

The findings of the registry will be disseminated to the scientific, clinical and general communities through annual reports published through the website of the data custodian (EBMA) and broadcast through their respective social media channels. Findings pertaining to selected datasets of specific studies based on registry data will be published in peer-reviewed publications, as well as presented to peers at appropriate conferences and meetings. In the future, individual patients may receive reports regarding their own progress throughout their involvement in the registry.

1.2.7 Trial registration

The registry has been registered on the Australia and New Zealand Clinical Trials Registry (ANZCTR; Trial number ACTRN12619000770167p). The ANZCTR is an online public registry of clinical trials in progress in Australia and New Zealand, and elsewhere. It is one of several primary registries in the World Health Organisation's registry network, whose aim is to make details of all clinical trials publicly available. This is in order to improve the transparency of research, facilitate participation in trials, avoid duplication of research, facilitate identification of potential gaps in research areas, to promote collaboration in research, and to improve the quality of trials in general.

The Universal Trial Number (UTN) associated with the Registry is U1111-1230-6736. The purpose of the Universal Trial Number is to enable the unambiguous identification of clinical trials which may be recorded in multiple databases.

The ACTRN should be included in any materials related to the registry, as it allows stakeholders and the public to keep track of any research output associated with the study cohorts and ensures the research is conducted in a transparent manner.

1.2.8 Ethical Considerations

1.2.8.1 Ethics approvals

The registry will seek ethical approval (Figure 1.2.7.1a) from Barwin Health HREC (HREC Application number: 49184 Study title: Patient registry of upper limb outcomes (PRULO): A consecutive observational cohort orthopaedic clinical registry)

The following documents were approved 19/7/2019:

19_70 HREC Certificate of Approval Letter.pdf

Figure 1.2.8.1a: Ethics approval

Research Protocol_KE_v2_Clean_20160716.pdf

Figure 1.2.8.1b: Registry Protocol

PIS_KE_Clean_20190716.pdf

Figure 1.2.8.1c: Participant Information Sheet

Withdrawal-of-Participation_GO_20190123.pdf

Figure 1.2.8.1d: Withdrawal of Consent form

1.2.8.2 Registry recruitment, inclusion and exclusion criteria

All patients presenting to the participating surgeons for treatment will be included in the registry under an opt-in consent arrangement.

Inclusion Criteria

Diagnosed with orthopaedic shoulder, elbow, hand or wrist pathology.
Undergoing treatment by one of the participating orthopaedic consultant surgeons as a public patient at Geelong Orthopaedics
Consenting to being part of the Clinical Research Registry

Exclusion Criteria

Patient-reported outcomes: Clinically diagnosed mental/neurological illness that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder.
Revocation of consent for research use of personal data.

1.2.8.3 Participant consent

Written informed consent will be sought from all participants. 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.

Patients provide consent once for all treatments, and all participating surgeons, their consent is marked in the research database as signed or refused.

1.2.8.4 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.

1.2.8.5 Data linkage

Identifiable data will be kept indefinitely in order to link patient records to patient information from other sources (e.g., hospital records). Follow-up for survival, re-operation, etc. may be necessary on patients who are well past completion of the study. For example, long-term survival of orthopaedic procedures reported in the literature range from a minimum of 10 years post-surgery.

1.2.8.6 Confidentiality and privacy

Identifiable data is kept electronically on a secure server. It is the practice’s responsibility to ensure security of this server is maintained to minimise the rise of data breaches. No identifiable data is to be sent off site without consent gathered from the patients. Data copied to portable hard drives for the purposes of backup will be encrypted. All reasonable measures must be taken to ensure any identifiable data sent off site is done so in a secure fashion. Deidentifiable data will be transferred under strict restrictions of content and usage. Depending on data size and structure, exported data will be sent via email or a remote desktop connection. Depending on the file size, other means such as file sharing software will be utilised to maintain a record of handling.

1.2.8.7 Data storage and record retention

Paper and electronic records will be kept indefinitely. Paper records will be kept in a locked cabinet in a secure building. Electronic records will be kept on password-secured computers and research data will be stored in a Postgres-based database with a password-protected user interface (Socrates, v9.3, Ortholink, Aus).

1.2.8.8 Data de-identification

All identifying information such as name, date of birth, email or phone will be removed from any data prior to transfer of this data to sites not listed in the document. Patient identification (ID) numbers will be used as a substitute to identifiable data and only the practice personnel will be able to re-identify patients.

1.2.8.9 Funding, disclosures and conflicts of interest

Funding, company interests and committee memberships for the Principal Investigator are provided in Table 1.2.7.2

GO_Conflicts of Interest

Table 1.2.8.2: Conflicts of Interest

Report abuse