Table 2.
Completeness and transparency of reporting for 60 trial publications sampled that used the EHR to identify participants and outcomes (includes only new and modified CONSORT 2010 items)a
| Itemb | CONSORT 2010 Items, CONSORT-ROUTINE modifications, and new CONSORT-ROUTINE items |
n = 60 |
||||
|---|---|---|---|---|---|---|
| Adequately reported n(%) | Partially reported n (%) | Inadequately or Not reported n(%) | Not applicable n (%) | |||
| Title and abstract | ||||||
| 1b | CONSORT 2010: Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts). | 26 (43%) | 34 (57%) | 0 (0%) | - | |
| Modified CONSORT-ROUTINE: Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts). Specify that a cohort or routinely collected data were used to conduct the trial and, if applicable, provide the name of the cohort or routinely collected database(s) | 54 (90%) | 6 (10%) | 0 (0%) | - | ||
| Methods | ||||||
| Trial design | 3a | CONSORT 2010: Description of trial design (such as parallel, factorial) including allocation ratio | 17 (28%) | 25 (42%) | 18 (30%) | - |
| Modified CONSORT-ROUTINE: Description of trial design (such as parallel, factorial) including allocation ratio, that a cohort or routinely collected database(s) was used to conduct the trial (such as electronic health record, registry) and how the data were used within the trial (such as identification of eligible trial participants, trial outcomes) | 51 (85%) | 4 (7%) | 5 (8%) | - | ||
| Cohort or routinely collected database | ROUTINE-1 | New CONSORT-ROUTINE: Name, if applicable, and description of the cohort or routinely collected database(s) used to conduct the trial, including information on the setting (such as primary care), locations, and dates, (such as periods of recruitment, follow-up, and data collection) | 13 (22%) | 40 (67%) | 7 (12%) | - |
| ROUTINE-2 | New CONSORT-ROUTINE: Eligibility criteria for participants in the cohort or routinely collected database(s) | 6 (10%) | 8 (13%) | 46 (77%) | - | |
| ROUTINE-3 | New CONSORT-ROUTINE: State whether the study included person-level, institutional-level, or other data linkage across two or more databases and, if so, linkage techniques and methods used to evaluate completeness and accuracy of linkage | 0 (0%) | 5 (8%) | 55 (92%) | - | |
| Trial participants | 4a | CONSORT 2010: Eligibility criteria for participants | 50 (83%) | 7 (12%) | 3 (5%) | - |
| Modified CONSORT-ROUTINE: Eligibility criteria for trial participants, including information on how to access the list of codes and algorithms used to identify eligible participants, information on accuracy and completeness of data used to ascertain eligibility, and methods used to validate accuracy and completeness (e.g., monitoring, adjudication), if applicable | 1 (2%) | 14 (23%) | 27 (45%) | 18 (30%) | ||
| ROUTINE-4 | New CONSORT-ROUTINE: Describe whether and how consent was obtained | 35 (58%) | 6 (10%) | 19 (32%) | - | |
| Outcomes | 6a | CONSORT 2010: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 44 (73%) | 8 (13%) | 8 (13%) | - |
| Modified CONSORT-ROUTINE: Completely defined pre-specified primary and secondary outcome measures, including how and when they were ascertained and the cohort or routinely collected database(s) used to ascertain each outcome | 41 (68%) | 8 (13%) | 5 (8%) | 6 (10%) | ||
| ROUTINE-5 | New CONSORT-ROUTINE: Information on how to access the list of codes and algorithms used to define or derive the outcomes from the cohort or routinely collected database(s) used to conduct the trial, information on accuracy and completeness of outcome variables, and methods used to validate accuracy and completeness (e.g., monitoring, adjudication), if applicable | 3 (5%) | 8 (13%) | 42 (70%) | 7 (12%) | |
| Allocation concealment mechanism | 9 | CONSORT 2010: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assignedcModified CONSORT-ROUTINE: Mechanism used to implement the random allocation sequence (such as embedding an automated randomiser within the cohort or routinely collected database(s)), describing any steps taken to conceal the sequence until interventions were assignedc | 16 (27%) | 8 (13%) | 36 (60%) | - |
| Results | ||||||
| Participant flow (a diagram is strongly recommended) | 13a | CONSORT 2010: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 45 (75%) | 7 (12%) | 8 (13%) | - |
| Modified CONSORT-ROUTINE: For each group, the number of participants in the cohort or routinely collected database(s) used to conduct the trial and the numbers screened for eligibility, randomly assigned, offered and accepted interventions (e.g., cohort multiple RCTs), received intended treatment, and analysed for the primary outcome | 6 (10%) | 19 (32%) | 15 (25%) | 20 (33%) | ||
| Discussion | ||||||
| Interpretation | 22 | CONSORT 2010: Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 48 (80%) | 11 (18%) | 1 (2%) | - |
| Modified CONSORT-ROUTINE: Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence, including the implications of using data that were not collected to answer the trial research questions | 31 (52%) | 18 (30%) | 11 (18%) | - | ||
| Other information | ||||||
| Funding | 25 | CONSORT 2010: Sources of funding and other support (such as supply of drugs), role of funders | 25 (42%) | 29 (48%) | 6 (10%) | - |
| Modified CONSORT-ROUTINE: Sources of funding and other support for both the trial and the cohort or routinely collected database(s), role of funders | 3 (5%) | 13 (22%) | 44 (73%) | - | ||
a
For modified items, modifications are shown in italics. For those items, only portion modified was evaluated.
b
Item numbers reflect numbers in original 2010 CONSORT checklist that were modified or new items. New items are designated by “ROUTINE”.
c
2010 and modified items not rated separately because modification was minor.