Publications

The Department of Veterans Affairs (VA) National Quality Scholars Fellowship Program (VAQS) was established in 1998 as a postgraduate medical education fellowship to train physicians in new methods of improving the quality and safety of health care for veterans and the nation. The VAQS curriculum is based on adult learning theory, with a national core curriculum of face-to-face components, technologically mediated distance learning components, and a unique local curriculum that draws from the strengths of regional resources. VAQS has established strong ties with other VA programs. Fellows' research and quality improvement projects are integrated with local and regional VA leaders' priorities, enhancing the relevance and visibility of the fellows' efforts and promoting recruitment of fellows to VA positions. VAQS has enrolled 98 fellows since 1999; 75 have completed the program and 24 are currently enrolled. Fellowship graduates have pursued a variety of career paths: 17% are continuing training (most in VA), 31% hold a VA faculty/staff position, 66% are academic faculty, and 80% conduct clinical or research work related to health care improvement. Graduates have held leadership positions in VA, Department of Defense, academic medicine, and public health agencies. Combining knowledge about the improvement of health care with adult learning strategies, distance learning technologies, face-to-face meetings, local mentorship, and experiential projects has been successful in improving care in VA and preparing physicians to participate in, study, and lead the improvement of health care quality and safety.

BACKGROUND

Artemisinin combination therapy has become the standard of care for uncomplicated malaria in most of Africa. However, there is limited data on the safety and tolerability of these drugs, especially in young children and patients co-infected with HIV.

METHODS

A longitudinal, randomized controlled trial was conducted in a cohort of HIV-infected and uninfected children aged 4-22 months in Tororo, Uganda. Participants were randomized to treatment with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) upon diagnosis of their first episode of uncomplicated malaria and received the same regimen for all subsequent episodes. Participants were actively monitored for adverse events for 28 days and then passively for up to 63 days after treatment. This study was registered in ClinicalTrials.gov (registration # NCT00527800).

RESULTS

A total of 122 children were randomized to AL and 124 to DP, resulting in 412 and 425 treatments, respectively. Most adverse events were rare, with only cough, diarrhoea, vomiting, and anaemia occurring in more than 1% of treatments. There were no differences in the risk of these events between treatment groups. Younger age was associated with an increased risk of diarrhoea in both the AL and DP treatment arms. Retreatment for malaria within 17-28 days was associated with an increased risk of vomiting in the DP treatment arm (HR = 6.47, 95% CI 2.31-18.1, p < 0.001). There was no increase in the risk of diarrhoea or vomiting for children who were HIV-infected or on concomitant therapy with antiretrovirals or trimethoprim-sulphamethoxazole prophylaxis.

CONCLUSION

Both AL and DP were safe and well tolerated for the treatment of uncomplicated malaria in young HIV-infected and uninfected children.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00527800; http://clinicaltrials.gov/ct2/show/NCT00527800.