Development and usability testing of HEARTPA♀N: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain
Bibliographic record
Abstract
INTRODUCTION: More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain. METHODS AND ANALYSIS: This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3). ETHICS AND DISSEMINATION: Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars. TRIAL REGISTRATION NUMBER: NCT03800082.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.059 | 0.068 |
| Meta-epidemiology (narrow) | 0.003 | 0.003 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.004 |
| Research integrity | 0.004 | 0.005 |
| Insufficient payload (model declined to judge) | 0.059 | 0.015 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".