13. Mefloquine versus chloroquine; quality of adverse events reporting.
Study ID | Harms predefined¹ | Description of ascertainment technique² | Active or passive monitoring?³ | Prospective or retrospective data collection? |
RCTs | ||||
Boudreau 1991 | Adequate | Adequate | Active | Prospective |
Boudreau 1993 | Adequate | Adequate | Active | Prospective |
Bunnag 1992 | Inadequate " Adverse events were defined clinically, and starting week 14, volunteers reporting adverse events were interviewed by members of the hospital team" |
Adequate | Active | Prospective |
Salako 1992 | Inadequate " Particular attention was paid to complaints such as fever, chills, malaise, nausea and vomiting, rashes and other symptoms and signs that could be regarded as adverse events." Comment: no clear definition of adverse events wa s provided |
Adequate | Active | Prospective |
Sossouhounto 1995 | Inadequate " Participants had access to a village health center, where they could notify personnel of any malaise or side effects" |
Unclear " Clinical examinations and parasitologic tests were performed every 4 weeks" |
Passive | Prospective |
Steketee 1996 | Adequate | Adequate | Active | Prospective |
Cohort studies | ||||
Albright 2002 | Adequate | Adequate | Passive | Retrospective |
Corominas 1997 | Inadequate Comment: insufficient information wa s provided about the questions that travellers were asked |
Adequate | Active | Retrospective |
Cunningham 2014 | Inadequate Comment: questionnaire included a targeted list of side effects, including " other psychological problems" . What was included within this was not defined |
Adequate | Passive | Unclear Comment: questionnaire was performed while participants were still taking chemoprophylaxis medication, although 75% were non‐compliant |
Hill 2000 | Inadequate Comment: insufficient information wa s provided about the questions that travellers were asked |
Adequate | Active | Retrospective |
Korhonen 2007 | Adequate | Adequate | Passive | Unclear Comment: No information wa s provided regarding the timing of the questionnaire during treatment |
Laverone 2006 | Adequate | Adequate | Passive | Retrospective |
Lobel 2001 | Inadequate "Travellers… were given a questionnaire that asked for... adverse health events attributed to those drugs" |
Adequate | Passive | Unclear Comment: information was collected at the airport, when travellers should still have been taking the prophylactic regimen |
Napoletano 2007 | Unclear Comment: adverse events were categorised on a scale of one to four, but it is unclear whether and how causality was assessed |
Adequate | Active | Retrospective |
Petersen 2000 | Inadequate Comment: i t wa s unclear whether the questionnaire implied causality to the drug regimen |
Adequate | Active | Retrospective |
Rietz 2002 | Adequate | Adequate | Active | Retrospective |
Steffen 1993 | Adequate | Adequate | Passive | Unclear Comment: information was collected during the flight home, when travellers should still have been taking the prophylactic regimen |
Stoney 2016 | Inadequate Comment: insufficient information provided on the questions that travellers were asked |
Inadequate Comment: n o information wa s reported on how adverse events were ascertained |
Active | Prospective |
Tan 2017 | Adequate | Adequate | Active | Retrospective |
Waner 1999 | Inadequate Comment: insufficient information provided on the questions that travellers were asked |
Adequate | Passive | Unclear Comment: information was collected during the flight home, when travellers should still have been taking the prophylactic regimen |
1. Were harms pre‐defined using standardised or precise definitions?
2. Was ascertainment technique adequately described?
3. Monitoring classed as 'active' if it occurred at set time points during treatment.
For full description of analysis methods, see Table 4.