Rack 2005.
Methods | Design: retrospective cohort study Study dates: July 2003 to June 2004 Malaria transmission pattern and local antimalarial drug resistance: various, not specified Adverse event monitoring: patient self‐reported questionnaire |
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Participants | Number enrolled: 794 Inclusion criteria: Travellers who were visiting five popular tropical regions or countries. Exclusion criteria: aged < 18 years, travelling for more than 2 months, and major acute or chronic diseases Country of recruitment: Germany Country of malaria exposure: Kenya/Tanzania, Senegal/Gambia, India/Nepal, Thailand, Brazil Duration of exposure to malaria: various, mean duration of travel 23.9 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. Chloroquine‐proguanil* *dosing regimen not specified |
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Outcomes |
Included in the review: 1. Narrative description of adverse effects Outcomes assessed not included in the review: 2. Risk behaviours during travel 3. Illness during travel 4. Seeking medical care owing to illness or accident 5. Accidents during travel |
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Notes | Funding sources: not mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Other bias | Unclear risk |
1. Confounding: moderate Demographic information was provided for the entire cohort, not by prophylactic regimen 2. Selection of participants into the study: moderate Numbers of participants choosing not to participate in the study were not reported 3. Measurement of interventions: serious Participants were asked to self‐report which prophylaxis they took after return. The time after return was not specified 4. Departures from intended interventions: no information There was insufficient information provided to determine whether the questionnaire contained information regarding discontinuations or switches 5. Missing data: moderate Follow up was obtained for 658 (83%) travellers 6. Measurement of outcomes: serious There was insufficient information on the questionnaire about how adverse effects were sought and if outcome measures were objective. There was no mention of blinding of outcome assessors 7. Selection of the reported results: moderate There was insufficient information provided regarding the questionnaire to determine if all questions were reported. Side effects were grouped to report symptoms 8. Other: no information No information was provided regarding the study sponsor |