Appendix.
Study protocol listing the eligibility criteria for inclusion/exclusion of studies in the review as per the PRISMA guidelines
| Clinical effectiveness | Rationale | |
|---|---|---|
| Inclusion criteria | Population | The population of interest to the review includes patients of any age, race, and gender receiving any oral medication for any chronic disease |
| • Age: Adults (≥ 18 years) | ||
| • Gender: Any | ||
| • Race: Any | ||
| • Qualifying event/disease/factors: Any chronic disease | ||
| Intervention | The review aimed to compare adherence/compliance/ persistence associated with different dosing regimens rather than any particular intervention | |
| • Any oral intervention administered as OD, BID, TID, QID | ||
| Comparator | The comparator of interest was a different dosage regimen of the interventions being evaluated in the study. Since the review required direct evidence on adherence of dosing regimens of interventions, placebo/best supportive care (BSC) as comparators were not included | |
| • Any oral intervention administered as OD, BID, TID, QID | ||
| Study design | Observational studies and economic evidence were the best source of adherence/compliance data as they reflect ‘real life’ and were considered for the review. | |
| • Comparative cohort studies/longitudinal studies (retrospective) | ||
| • Comparative cohort studies/longitudinal studies (prospective) | ||
| • Published database analyses/registries | ||
| • Case-control studies | ||
| • Cross-sectional study—comparative | ||
| • Randomized controlled trials | ||
| • Non-randomized controlled trials | ||
| • Economic studies | ||
| Language restrictions | Studies with the full-text publication in English only were included in this review | |
| • English only | ||
| Publication timeframe | No date restriction was applied in order to capture the maximum amount of adherence data | |
| • No date restriction for database searches | ||
| Exclusion criteria | Outcome of interest | Only studies reporting data pertaining to adherence/ compliance/persistence and healthcare costs associated with non-adherence were included in the review |
| • Studies that did not report the outcomes of interest (adherence/ compliance/persistence and healthcare costs associated with non-adherence) were excluded from the review | ||
| Route of administration | Studies assessing interventions administered only through an oral route were included in the current review | |
| • Studies evaluating interventions administered via a non-oral route were excluded |
Abbreviations: BID, twice daily; BSC, best supportive care; OD, once daily; QID, four times daily; TID, three times daily.