Taylor 1998 MWI

Methods	Trial design: Open label RCT Trial dates: January 1992 to June 1994
Participants	Number: 183 children enrolled (age range not stated) Inclusion criteria: Children with asexual forms of P. falciparum detected in a peripheral blood smear, and a Blantyre Coma Score ≤ 2, and if no other cause of fever or altered consciousness could be discovered. Exclusion criteria: None stated
Interventions	1. Intramuscular artemether Loading dose of 3.2 mg/kg on admission Followed by 1.6 mg/kg once daily. A minimum of three doses were given. Then oral sulphadoxine‐pyrimethamine (approximately 25 mg/kg sulphadoxine and 1.25 mg/kg pyrimethamine) if parasitaemia had cleared and the patient was fully conscious. 2. Intravenous quinine Loading dose of 20 mg/kg infused over four hours. Followed by 10 mg/kg infused over two hours at eight hour intervals. After a minimum of three intravenous quinine doses oral quinine given in 10 mg/kg doses at eight hour intervals if the patient was able to drink Then oral sulphadoxine‐pyrimethamine (same as above).
Outcomes	Outcomes included in the review: Death Coma resolution time Neurological sequelae Fever clearance time Parasite clearance time Outcomes not included in the review: Recurrent parasitaemia Reticulocyte response
Notes	Location: Paediatric ward at the Queen Elizabeth Central Hospital, Malawi Transmission: Unknown Funding: UNDP/World Bank/WHO special programme for research and training in tropical diseases (TDR)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomization.
Allocation concealment (selection bias)	Low risk	"Randomized treatment assignments were prepared in blocks of ten by the sponsoring agency.Following initial stabilization, diagnosis and examination, a sealed envelope containing the treatment group was opened, and the patient was allocated to treatment".
Blinding (performance bias and detection bias) Objective outcome: Death	Low risk	An open‐label trial is unlikely to bias an objective outcome like death.
Blinding (performance bias and detection bias) Subjective outcomes: Others	High risk	An open‐label trial.
Incomplete outcome data (attrition bias) All outcomes	High risk	Differential proportion of withdrawals from both arms (13% versus 8%).
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting.
Other bias	Low risk	No other bias identified.