Development & Implementation

Selection of the domains/subdomains and measurement tools

The process to select domains/subdomains and measurement tools  included in the chronic pain minimal data set used to constitute the core of the CAPDR was carried out in 3 phases.

First, the choice of the items included in the minimal data set had to be balanced between the clinicians’ interests, the burden placed on the patients, the time/costs associated with the data collection process, and the patients’ and pain researchers’ interests.  A first set of items was selected based on a comprehensive review of the literature, the recommendations of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) Group, the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Initiative, the National Institutes of Health (NIH) Task Force on Research Standards for Chronic Low Back Pain, and data already collected by existing pain registries such as the US Collaborative Health Outcomes Information Registry (CHOIR), the Australasian Electronic Persistent Pain Outcomes Collaboration (e-PPOC), and the Quebec Pain Registry (QPR). Then, a Delphi survey was conducted to prioritize the domains/subdomains to be measured in the minimal data set. Participants were asked to rate on a 0-10 scale where 0 = “not essential at all” and 10 = “absolutely essential” the extent to which they considered essential to include the various domains and subdomains in the minimal data set. A total a 237 patients, 160 clinicians, and 65 pain researchers completed the survey. Domains/subdomains which were rated ≥ 8/10 by 75% of the participants were selected.

Then, a second Delphi survey was conducted to prioritize the measurement tools to be used to assess the selected domains/subdomains. Participants (63 clinicians, 23 pain researchers) were asked to rank what they considered to be the top 3 measures (max) among a list of assessment tools for each domain/subdomain identified during Phase 1. A face-to-face meeting of the 17 members of the Adult Pain Registry Subcommittee of the CPN Registry Working Group was held and results of the two Delphi surveys were presented. There was a consensus for excluding patients’ pain diagnosis established at the pain clinic, as well as current and past treatments for pain, since collecting these data would require extensive nursing time to be accurate. Furthermore, it was decided to conduct another round of Delphi survey among the members of the Adult Pain Registry Subcommittee using specific selection criteria.  Members of the subcommittee were provided with a definition of each of the following criteria and asked to indicate which one(s) were met by each domain/subdomain and measurement tools: 1) clinically useful (most important criterion), 2) absolutely essential, 3) realistic, feasible, and minimal burden to patients, 4) accurate (valid/reliable), and 5) acceptable. Afterwards, the members of the Subcommittee met to discuss the results and reach a final consensus on the items to be included in the minimal data set.

Creation of the Patient Questionnaires and the Patient Summary Form

Items of the minimal data set were put together to create the Initial Patient Questionnaire and the Follow-up Patient Questionnaire. Patients are asked to complete the Initial Patient Questionnaire in the 2 weeks preceding their first appointment at the pain clinic. Afterwards, they are invited to fill out the Follow-up Patient Questionnaire every 3 months for a period of one year. Patients are provided with a unique link by email when a questionnaire must be completed.

Using the answers provided in these questionnaires, a report providing a portrait of the evolution of the patient’s condition over time is created. This report, the Patient Summary Form (PSF), is provided to clinicians and the patients to assist them in monitoring key health outcomes while the patients are being cared for at the pain clinic.

The REDCap data collection platform was used to set up the questionnaires and the PSF.

Pilot study

A pilot study was conducted at the Alan Edwards Pain Management Unit of the McGill University Health Centre in order to:

  1. assess the feasibility of implementing the CAPDR in a multidisciplinary pain treatment clinic re: data collection methods
  2. obtain the patients’ perspective on the usability and acceptability of the patient questionnaires
  3. evaluate the feasibility, acceptability, and clinical utility of the Patient Summary Form at the initial and follow-up visits from the clinicians’ perspective (physicians, nurses, psychologists, etc)

This pilot study used a prospective design with iterative cycles. Five patients were recruited in the first cycle and asked to provide feedback on the Patient Questionnaires (initial and follow-up visits). Patient Questionnaires and the data collection process were adjusted according to patients’ feedback. Three cycles were required until no suggestions of changes were submitted. Two rounds of feedback from clinicians allowed to adjust and improve the Patient Summary Form.

Implementation of the CAPDR

Twelve multidisciplinary pain treatment clinics, which are part of the Clinical Research Network of the CIHR-SPOR Chronic Pain Network, participate in the CAPDR. Ethical review and approval were carried out by the Research Ethics Boards (REB) of the Centre Hospitalier de l’Université de Montréal (CHUM) and local REBs of participating sites.

Patient enrollment and follow-up in the CAPDR goes as follow:

  1. Prior to their first appointment at the pain clinic, patients are informed that they have to complete the online Patient Questionnaire, as the collected information will be used to generate a report of their condition, which will be handed to the clinical team.
  2. At the end of the questionnaire, they complete a consent form and are asked if they accept:
    • That their de-identified data be used for research purposes
    • That their de-identified data be merged with information contained in their medical file
    • That their de-identified data be merged with data contained in provincial administrative databases
    • To be approached for future pain research studies

3. Patients are invited to complete the Follow-up Patient Questionnaire every 3 months, until they are discharged from the pain clinic

REDCap was chosen as the data collection platform for the CAPDR. Two hosting options are available for the CAPDR REDCap data collection platform: the Central REDCap (CR) and the Local REDCap (LR). The CR offers a centralized REDCap platform hosted at the CHUM, while the LR involves installing and hosting the REDCap project template and add-ons created for the CAPDR on a local REDCap server. Alternatively, some sites might integrate the content of the Patient Questionnaire in their existing data collection platform. With LR and existing data collection platforms, participating sites transfer to the CHUM the de-identified data collected with the Initial Visit Patient Questionnaire and the Follow up Patient questionnaire and merged them to the data obtained from the CR.

The CR is managed by the Centre d’intégration et d’analyse des données médicales (CITADEL) of the CHUM. The CITADEL team, in collaboration with CHUM’s Information Technology Services, oversees the respect of strict measures to ensure the security of their installations and confidentiality/integrity of the data stored on the servers.