Criteria [13] | Data source |
---|---|
Reach | |
Definition: the number, proportion and representativeness (age, gender, income) of individuals who registered their interest in participating in the study and were still enrolled at the point of randomisation, compared to those who were invited to participate (recruitment pool). | |
1. Exclusion criteria (% excluded or characteristics) | Study protocol Consort Flow |
2. Percentage of individuals who participate, based on valid denominator | Registration survey Eligibility screening Organisational data |
3. Characteristics of participants compared with nonparticipants; to local sample | Organisational data Baseline survey |
4. Use of qualitative methods to understand recruitment | Week 12 survey feedback Participant focus groups |
Effectiveness | |
Definition: the impact of the intervention on primary (health-related productivity loss) and secondary (neck pain) outcomes, as well as other outcome measures collected. | |
5. Measure of primary outcome Productivity: health-related productivity loss expressed in days (per 28 days). Neck pain: self-reported neck pain in the past 7 days on a scale of 0–9. | Participant surveys • Health and Productivity Questionnaire [15] • Neck pain [16] |
6. Measure of primary outcome relative to public health goal | n/a |
7. Measure of broader outcomes or use of multiple criteria (e.g. measure of quality of life or potential negative outcome) | To be reported separately |
8. Measure of robustness across subgroups (e.g. moderation analyses) | Participant surveys • Health and Productivity Questionnaire [15] • Neck pain [16] |
9. Measure of short-term attrition (%) and differential rates by patient characteristics or treatment group | Participant tracking data Email correspondence Baseline survey data Monthly survey data |
10. Use of qualitative methods/data to understand outcomes | Week 12 survey feedback Participant focus groups |
Adoption—setting level | |
Definition: the absolute number, proportion and representativeness of organisations that committed to participation in the study compared to those who were approached and did not participate | |
11. Setting exclusions (% or reasons or both) | Study protocol |
12. Percentage of settings approached that participate (valid denominator) | Email correspondence Gatekeeper approval letters |
13. Characteristics of settings participating (both comparison and intervention) compared with either [1] nonparticipants or [2] some relevant resource data | Email correspondence |
14. Use of qualitative methods to understand setting level adoption | Liaison interviews |
Adoption—staff level | |
Definition: the absolute number, proportion and representativeness of intervention agents (research staff) that committed to participation in the study compared to those who were approached and did not participate | |
15. Staff exclusions (% or reasons or both) | Management data |
16. Percent of staff offered that participate | Management data |
17. Characteristics of staff participants vs nonparticipating staff or typical staff | Management data |
18. Use of qualitative methods to understand staff participation/staff level adoption | n/a |
Implementation | |
Definition: the extent to which the intervention was implemented in accordance with the study protocol [9], as well as its consistency across organisations and over the intervention period. Implementation was examined from three perspectives: the research team; the participants; and the participating organisations. | |
19. Percent of perfect delivery or calls completed (e.g., fidelity) Study-specific definitions: Participant adherence to EET and EHP sessions during the intervention and maintenance period using “predicted total adherence” [10] to supervised and unsupervised training sessions during the intervention period and online survey questions from 12 weeks to 12 months Organisational compliance with communication strategy and provision of suitable, consistent space | Online surveys: Adherence question: “How often have you participated in the exercise training during the last 4 weeks?” (EET participants), or “How often have you practiced healthier lifestyle changes during the last 4 weeks?” (EHP participants). Participants were grouped into three categories: regular adherence (at least once a week), irregular adherence (at least twice a month), and no adherence. Workstation assessments Session facilitator records Exercise training diaries Email correspondence Project coordinator records |
20. Adaptations made to intervention during study (not fidelity) | Project coordinator records |
21. Cost of intervention—time | Study protocol Project coordinator records (all costs adjusted using the relevant consumer price index (CPI) category [17, 18] to June 2015, the date of the last intake.) |
22. Cost of intervention—money Study-specific definitions: Costs calculated from an employer’s perspective | Project coordinator records Baseline surveys (salary costs) |
23. Consistency of implementation across staff/time/settings/subgroups (not about differential outcomes, but process) | Session facilitator records Exercise training diaries Email correspondence Project coordinator records Online surveys of age, gender, body mass index, health-related quality of life [19], education level, occupational category, income, computer use, health, neck pain [16], job strain [20], exercise stage of change [21], exercise self-efficacy [22], psychological distress [23], physical activity levels [24], or workstation quality. |
24. Use of qualitative methods to understand implementation | Week 12 survey feedback Participant focus groups |
Maintenance—individual level | The study’s primary outcomes were reported at week 12 and 12 months. No data collection occurred after 12 months, so individual-level maintenance could not be reported (criteria 25–30) |
Maintenance—setting level | |
Definition: the extent to which intervention components were implemented in participating organisations after the study period. Interviews were conducted with onsite liaisons from four organisations to understand the factors affecting maintenance | |
31. If program is still ongoing at 6 months post-treatment follow-up | Liaison interviews Project manager records Email correspondence |
32. If and how program was adapted long-term (which elements retained after program completed) | Liaison interviews Project manager records Email correspondence |
33. Some measure/discussion of alignment to organization mission or sustainability of business model | Liaison interviews Email correspondence |
34. Use of qualitative methods data to understand setting level institutionalization | Liaison interviews |