Data Collection Methods to Improve Quality Control. CNDR Innovation At Work

Transcription

1 Data Collection Methods to Improve Quality Control CNDR Innovation At Work

2 What is the CNDR? Clinic-based recruitment of adults and children with neuromuscular disease 19 specialty neuromuscular clinical facilities in 5 provinces across Canada Self-registration for patients not attending a CNDR clinic mediated through the CNDR National Office.

3 Canadian Neuromuscular Disease Registry Registry Composition OTHER 41% SMA 5% ALS 13% DMD 21% DM 15% GBS 2% BMD 3%

4 CNDR Data Collection Patient Consent and Assent Ongoing Provide new information when available Relevant Data Form Update data at least annually Web-based data entry Ability to track multiple visits and records for each patient

5 Data Quality Data quality is a key metric of registry success. Two components: Accuracy Completeness Methods for ensuring quality Data dictionary Automated field validation Manual auditing

6 Initial Steps Define a Data Dictionary for Duchenne Muscular Dystrophy dataset CNDR dataset aligns with TREAT-NMD CNDR dataset is supervised by a Disease Working Group and is reviewed at least annually Disease Working Group was tasked with defining data dictionary - this process began in September 2011 and concluded in July 2012.

7 Data Dictionary NEUROMUSCULAR DATA FIELDS FIELD Currently able to walk without support FIELD Currently able to sit without support FIELD Wheelchair use (if over 3 years of age) INSTRUCTIONS Yes Patient has functional walking with or without help (orthoses, or assistive device or human assistance) inside or outdoors No Patient does not have functional walking of any kind Unknown Patient s ability has not been assessed or is otherwise not available Yes - Able to maintain the sitting position on a chair or a wheelchair without support of upper limbs or leaning against the back of the chair No Patient is not able to maintain a sitting position without support of upper limbs or back of chair Unknown Patient s ability has not been assessed or is otherwise not available Permanent patient is not able to walk and needs a wheelchair to move Intermittent - patient is still able to walk but has and uses a wheelchair Never patient is not using a wheelchair Unknown Patient s use of a wheelchair is not known FIELD TYPE MANDATORY HIGHLY ENCOURAGED MANDATORY

8 Preliminary Auditing Prior to completion of the data dictionary we conducted simple auditing of fields not requiring definition (e.g. demographic data) In 2011, 562 patients with 9 auditable fields were entered. A total of 5,058 fields were reviewed with a total of 130 errors (regardless of error type). This is a 2.6% error rate. At the end of 2011 the registry also had 21 incomplete records (3.7%).

9 Detailed Auditing Following completion of the DMD data dictionary we engaged in a full audit of all mandatory fields in the DMD dataset. The DMD dataset consists of 55 fields, 38 of which are mandatory (must be completed by all clinics). The audit was conducted in August 2012 on a total of 242 dystrophinopathy group patients (includes DMD, BMD, IMD and female carriers).

10 Detailed Audit: Results Of the 242 records examined only 27 were fully completed (11%). However, we identified two key fields that were contributing substantially to the deficit: Genetic Reference (47% incomplete for DMD, 56% incomplete for BMD and 100% for IMD/FC records) Steroid Specify (89% incomplete DMD, 100% incomplete BMD) 61 records were incomplete solely due to the Steroid Specify field. Adjusted completion rate was 88 records (36%)

11 Detailed Audit: Results Accuracy is difficult to assess because it would necessitate flying all over Canada to review site charts. This is cost prohibitive. We did assess 6 fields for simple errors Consent Type (verified against patient age) Ambulation & Wheelchair Use (applying logic between the two) Appropriate Genetic Test information in Appropriate fields

12 Quality Improvement While the results of the audit weren t entirely discouraging, it was felt that further improvement and overall a better system for quality control was needed

13 CNDR Software Innovation As part of the roll out of the ALS module this year, the CNDR has adopted new data collection technology. This brings increased form design flexibility; enhanced auditing capability and lower data collection costs. We reviewed multiple technologies and have selected Anoto digital pens which are a brand leader. We have chosen to explore the utility of industry leading digital pen software from Adapx Inc based in Seattle.

14 CNDR Software Innovation Anoto digital pen technology (DP-201) USB docking (pen has bluetooth and PDA compatibility but we will not use this for now) The pen writes like an ordinary pen onto ordinary paper that is printed from ordinary colour printers. On the paper is a unique dot pattern which helps the pen camera capture the writing

15 CNDR Software Innovation Adapx Software (CapturX forms for Excel and Sharepoint) Excel form design allows CNDR form editing and generation to be done in the CNDR National Office without the need for outside software support. This dramatically increases CNDR flexibility around adding/modifying datasets. Sharepoint interaction allows for centralized pre-audit of site data prior to upload into the CNDR database. This will dramatically increase the ability of the CNDR National Office to improve data quality.

16 CNDR Software Innovation Automated workflow allows for upload into Oracle database only following CNDR National Office Approval. CNDR National Office can view and edit data uploaded by CNDR Sites. Both the converted text and the original handwriting can be reviewed. Errors can be reviewed and corrected prior to upload into the Oracle database.

17 CNDR Software Workflow Data entry personnel complete CNDR forms with chart review using electronic pen Pen is docked and data is uploaded to Sharepoint. Data is reviewed by CNDR National Office in Sharepoint, corrected and approved. Forensic auditing of data curation by CNDR Project Manager Hard copy file is destroyed. Data is received into the CNDR database

18 Thank You!