By their nature as embedded interventions within healthcare settings, such as clinics, hospital units, or healthcare systems, PCTs have special considerations for authors to support full and transparent reporting. Good reporting allows decision makers to judge how applicable the results of the PCT are to their own conditions and environments. Full reporting also serves as a foundation for authors as they develop their primary journal publication.

Depending on the particulars of the PCT’s design, authors might need to report about:

• How data from EHRs were used in the research
• Who the stakeholders were and how they were approached and engaged to participate in the design, conduct, or dissemination of the study
• How any unanticipated changes in study arms were adjusted for or accommodated
• Whether the trial needed alternate approaches to the informed consent process or protection of human subjects

These considerations are introduced below. More reporting information and guidance for authors is in the Collaboratory resource PCT Reporting Template. The Equator Network (Enhancing the QUAlity and Transparency Of health Research) provides a list of 407 different reporting guidelines, including guidelines for quality improvement initiatives, explanatory trials, and pragmatic trials (see Table).

Secondary uses of EHR data

If the source of data was from a clinical or billing database instead of one created primarily for research, good reporting will include such elements as the steps used in gaining permission to use the data, how the population of interest was identified (i.e., development of phenotypes, use of ICD-10 codes), how data from different sources were linked, how data quality was assessed, the process for data management during the study, and the plan for archiving or sharing the data after the study. If the PCT employed a research network for querying data (e.g., distributed research network, CTSA network, or PCORnet partner network), then the network should be described in sufficient detail.

Accommodating or adjusting to unanticipated changes in the study arms

As trials evolve, changes may occur in the care provided within the intervention and/or control arms that could affect the conduct or analysis of the study. For example, some components of the intervention may appear in usual care at some control sites or clusters. Contamination can be due to various reasons: unintentional spill-over of intervention effects, other healthcare initiatives that focus on the same problem, or changes in leadership, sites, or healthcare delivery system technologies. Authors should describe how they accommodated changes, especially if the changes affected the statistical analysis of the trial.

Human subjects protection

Authors should describe how approval by an ethics committee or institutional review board (IRB) was obtained. Include details such as the type of informed consent (written, oral, information sheet) and the mode (electronic, mail, in-person). Explain if the trial was determined to be exempt from requiring informed consent. If applicable, describe the existence of a data monitoring committee. For cluster-randomized trials (CRTs), indicate whether consent was obtained from cluster representatives or individual cluster members, or both. Describe whether consent was obtained before or after randomization.