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" |
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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 |
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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 |
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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 |
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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 |