| Evaluation point |
---|---|
1 | Identification as a study of validation |
2 | Structured summary of study objective, design, methods, results and conclusions |
3 | Scientific and practical background, including the intended use of the index device/software |
4 | Study objectives and hypotheses described |
5 | Study uses within-subject design |
6 | Intended sample size and how it was determined (e.g. G*Power 3) |
7 | Eligibility criteria including specific restrictions (medical use, gender, age, activity level or BMI) |
8 | Pre-testing guidelines reported (e.g., limitations to caffeine, alcohol, physical activity etc.) |
9 | Setup of reference standard and index device described in sufficient detail to allow replication (e.g. hardware/software such as brand, electrode configuration, etc.) |
10 | Description of environmental conditions (e.g. temperature, humidity, lights on or off, time of day) and posture |
11 | A stabilization period prior to sampling was described |
12 | The raw sampling rate and length of collection are described |
13 | Acknowledgment of breathing (e.g. controlled or not controlled) |
14 | Description of how estimates or comparison measures were calculated (e.g. ES, LOA, Pearson’s r or ICC) |
15 | Reasons for missing data, along with percentage missing (e.g., equipment, persistent ectopy) and how it was handled |
16 | Interbeat artifact identification method (e.g. algorithm, manual inspection) |
17 | Artifact cleaning methods and percentage of beats corrected |
18 | Description of metrics used and software/script for HRV calculation (log transformation etc.) |
19 | Specification of frequency bands used and how they were calculated (e.g. Fast Fourier Transform or Autoregressive modelling) |
20 | Baseline demographics of participants |
21 | Mean ± SD along with at least one estimate of precision (e.g. LOA, Pearson’s r or ICC) |
22 | Study limitations (e.g., sources of potential bias, confounding variables, statistical uncertainty and generalisability) |
23 | Implications for practice, including the intended use |
24 | Where the full study protocol can be accessed if not fully described |
25 | Sources of funding and other support; role of funders |