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

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
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
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
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
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