Goodyer 2011.
Methods | Design: prospective cohort study Study dates: December 2004 to April 2006 Malaria transmission pattern and local antimalarial drug resistance: various destinations, not specified Adverse event monitoring: "a post travel questionnaire… approximately 1 week after they were due to complete their course of medication" |
|
Participants | Number enrolled: 252 recruited, 185 completed pre‐ and post‐travel questionnaires Inclusion criteria: "...to be eligible, travelers had to be at least 18 years of age and to have been prescribed or supplied... an antimalarial medication as a result of planned travel for a duration of 28 days or less." Exclusion criteria: "travelers participating in other prospective clinical research or observational studies, pregnant travelers or travelers planning to get pregnant during the study were excluded" Factors influencing drug allocation: "Treatment choice was solely at the discretion of the traveler and practitioner" Country of recruitment: UK Country of malaria exposure: various, not reported Duration of exposure to malaria: various, median 14 days (interquartile range 9 to 20) Type of participants: travellers |
|
Interventions | 1. Mefloquine* 2. Atovaquone‐proguanil* 3. Doxycycline* *dosing regimen not specified |
|
Outcomes |
Included in the review: 1. Any adverse effects 2. Measures of adherence to the drug regimen Outcomes assessed not included in the review: 3. Relative importance of factors in choice of antimalarial drugs, for both healthcare professionals and travellers |
|
Notes | Funding sources: "The study was commissioned and paid for by GlaxoSmithKline" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Other bias | Unclear risk |
1. Confounding: moderate "There were statistically significant differences in mean age" Several other confounders were not reported across groups 2. Selection of participants into the study: moderate No information is provided regarding people who did not wish to participate 3. Measurement of interventions: low The antimalarial prescription was provided by a travel clinic which also performed the study 4. Departures from intended interventions: moderate No information was captured regarding switches between interventions of interest 5. Missing data: serious 185/252 participants completed the pre‐ and post‐travel questionnaire. Interim loss to follow up 27% 6. Measurement of outcomes: serious Comment: the outcome measure was subjective; participants and personnel were not blinded 7. Selection of the reported results: moderate The number of reported side effects was reported, but not the types or severity 8. Other: serious Funded by GlaxoSmithKline; the role of the study sponsor was not made clear |