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. 2017 Oct 30;2017(10):CD006491. doi: 10.1002/14651858.CD006491.pub4

Stoney 2016.

Methods Design: Prospective cohort study
Study dates: 2009 to 2011
Malaria transmission pattern and local antimalarial drug resistance: various, not specified
Adverse event monitoring: "...participants were asked to complete a survey each week during travel and a post‐travel survey within 2–4 weeks after return"
Participants Number enrolled: 628 participants completed all three surveys, 370 included in the analysis
Inclusion criteria: "Travelers were included from among all those enrolled if they received a prescription for chemoprophylaxis, traveled to at least one malaria‐endemic area, and completed pre‐ and post‐travel surveys and at least one during‐travel survey"
Exclusion criteria: "To complete the study in a reasonable amount of time, only participants with shorter durations of travel (approximately 2 months) were included"
Factors influencing drug allocation: "Several different medications are available for malaria chemoprophylaxis, depending on the traveler’s destination and medical history"
Country of recruitment: USA
Country of malaria exposure: India (13%), Tanzania (8%), Kenya (7%), South Africa (7%), and Haiti (7%)
Duration of exposure to malaria: median travel duration 13 days
Type of participants: travellers
Interventions Included in the review:
1. Mefloquine*
2. Doxycycline*
3. Atovaquone‐proguanil*
4. Chloroquine*
Not included in the review:
5. Primaquine*
*dosing regimen not specified
Outcomes Included in the review:
1. Adverse effects; any, headache, abnormal dreams 'intense nightmares', any gastrointestinal
2. Discontinuations of study drug due to adverse effects
3. Measure of adherence to the drug regimen
Outcomes assessed not included in the review:
4. Clinical cases of malaria
5. Reasons for non‐compliance with chemoprophylaxis (data provided on aggregate),
6. Use of personal protective measures for malaria prevention
Notes Funding sources: "This work was supported by a cooperative agreement [1 U19CI000508‐01] between the Centers for Disease Control and Prevention and Boston Medical Center"
Risk of bias
Bias Authors' judgement Support for judgement
Other bias Unclear risk 1. Confounding: moderate
Age, sex, destination and duration of travel were recorded but figures were not reported across prophylactic regimens
2. Selection of participants into the study: moderate
No information was provided regarding travellers who did not wish to participate in the study
3. Measurement of interventions: low
"The type of chemoprophylaxis prescribed were collected from data entered by clinicians into patients’ medical records"
4. Departures from intended interventions: moderate
No switches or discontinuations were reported. It was unclear whether this information was captured in the questionnaire
5. Missing data: low
364/370 (98%) participants were included in the analysis
6. Measurement of outcomes: serious
Comment: the outcome measure was subjective, participants and personnel were not blinded
7. Selection of the reported results: moderate
Insufficient information provided on how data on adverse effects were obtained to determine whether all outcomes had been reported
8. Other: low
Government funding