STARTER checklist for antimalarial therapeutic efficacy reporting

Efficacious antimalarials are a cornerstone of the global effort to control and eliminate malaria. However, the spread of drug resistance threatens gains achieved over the early years of this century. Of particular concern is widespread artemisinin resistance in Southeast Asia and its recent emergence in Africa, threatening the efficacy of artemisinin-based combination therapies that currently offer our best treatments for malaria [1]. Prompt identification of the emergence and spread of antimalarial drug resistance is crucial to guarantee effective case management. At a country level, efficacy data are used by ministries of health and their partners to determine national treatment guidelines. Because parasites do not respect political and administrative boundaries, coordination of surveillance and control strategies at the regional and global level is necessary to guide larger containment strategies.

Since the 1960s, the foundation of antimalarial drug efficacy monitoring has been the use of therapeutic efficacy studies that monitor parasitological and clinical response in patients treated for malaria. Standardized methods for performance and analysis of these studies are codified in World Health Organization (WHO) guidance documents [2,3,4]. Despite the standardized guidance, recent investigation has identified frequent non-adherence to the WHO guidelines [1, 5]. Notably, deviations from the standard of practice methodology are common, particularly related to analysis of genotyping data and definition of primary outcome indicators, and critical methodological details are often omitted from publications reporting efficacy data. As a consequence, there is the risk that reported efficacy could either be underestimated or overestimated, with readers not able to determine both the scope and the direction of the under- or overestimates. Such a loss in accuracy can obstruct the global effort to prevent and contain antimalarial drug resistance.

Incorporating comments from the WHO Global Malaria Programme, the Malaria Branch of the Centers for Disease Control and Prevention, the US President’s Malaria Initiative, and the editors-in-chief and antimalarial efficacy section leads from the American Journal of Tropical Medicine and Hygiene and Malaria Journal, we have developed the Standardized Antimalarial Therapeutic Efficacy Reporting (STARTER) Checklist, which lays out best practices for reporting results of antimalarial efficacy studies. Similar to other reporting checklists, it has been registered and is available at the EQUATOR Network repository [6] (Table 1).

Table 1 Standardized antimalarial therapeutic efficacy reporting (STARTER)

We emphasize that checklists are not replacements for peer-review [7], but rather tools to promote uniformity in reporting. Filling out the checklist does not substitute for careful adherence to the global WHO standards for efficacy trials. Efficacy trial investigators and sponsors that follow WHO’s guidance and verify their adherence at the protocol development, implementation, analysis, and reporting stages will likely find the STARTER checklist facilitates their manuscript development.