Table 1 Nine PRECIS-2 dimensions of the level of pragmatism in a trial
Domain | Assessment | SMARTT | Scorea |
|---|---|---|---|
Eligibility | To what extent are the participants in the trial similar to those who would receive this intervention if it was part of usual care | All adults with RR-TB are eligible except for highly complicated cases (TBM, bone TB – as these would always be referred for expert advice). Patients with other forms of extrapulmonary TB but without pulmonary involvement, who could be treated using WGS-guided treatment recommendation under routine conditions, are excluded because of the inability to monitor their mycobacteriological response to treatment | 4 |
Recruitment | How much extra effort is made to recruit participants over and above what would be used in the usual care setting to engage with patients? | Patients are identified through the standard laboratory RR-TB alerts and recruited at the time of RR-TB treatment initiation by a member of the district MDR-TB team | 5 |
Setting | How different is the setting of the trial and the usual care setting? | The setting of the trial is all health care facilities of 4 of the 5 health care districts of the Free State province in South Africa where RR-TB treatment is initiated | 5 |
Organization | How different are the resources, provider expertise and the organization of care delivery in the intervention arm of the trial and those available in usual care? | The organization of care is identical to usual care, with the routine care providers in charge of all patient management decisions and the use of drugs that are available through the DoH district pharmacies | 5 |
Flexibility in delivery | How different is the flexibility in how the intervention is delivered and the flexibility likely in usual care? | The use of a central clinical committee to review the arguments of a care provider who disagrees with the WGS-guided individualized treatment recommendation would likely not be done when implemented in routine care | 4 |
Flexibility in adherence | How different is the flexibility in how participants must adhere to the intervention and the flexibility likely in usual care? | Similar adherence to treatment and RR-TB management as in usual care | 5 |
Follow up | How different is the intensity of measurement and follow-up of participants in the trial and the likely follow-up in usual care? | In addition to routine monthly sputum samples, sputum samples are collected at weeks 2, 3, 5 and 6 for Mtb culture to assess the primary outcome. Data is also collected on quality of life and costing for a health economics assessment from the patient perspective | 4 |
Primary outcome | To what extent is the trial's primary outcome directly relevant to participants? | Time to culture conversion is a proxy for the patient-relevant outcomes of survival, cure and absence of relapse | 3 |
Primary analysis | To what extent are all data included in the analysis of the primary outcome? | The analysis will be performed with all available data using an intention-to-treat approach | 5 |