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Table 1 PICOS strategies

From: In vivo efficacy of anti-malarial drugs against clinical Plasmodium vivax malaria in Ethiopia: a systematic review and meta-analysis

PICOS

Characteristic criteria for inclusion

P: population

The study population were P. vivax mono-infected clinical malaria patients (all age groups) seeking medication at health facilities in Ethiopia, who fulfilled the inclusion criteria set by WHO for anti-malarial drug efficacy testing

I: Intervention/exposure

Studies included in the current review followed any one or more of the following intervention strategies: fixed dose of CQ given for 3 consecutive days (2:2:1 ratio each day with a target total dose of 25 mg/kg, alone or combined with 0.25 mg/kg of PQ for 14 days); or AL (20 mg of artemether and 120 mg of lumefantrine based on body weight, alone or combined with 0.25 mg/kg of PQ for 14 days); all anti-malarial drugs were orally administered (fully or partially supervised), and patients followed for a minimum of 28 days

C: comparison/ control

Any placebo or anti-malarial drugs other than CQ, such as PQ and AL or different combination treatments

O: outcomes

Primary outcomes: parasitological and clinical efficacy of anti-malarial drugs, PCR-corrected or uncorrected late parasite recurrence or plasma drug level measured

Major treatment outcomes [33] were:

Treatment failure (TF): Early treatment failure (ETF): any danger signs or severe malaria on days 1, 2 or 3 in the presence of parasitaemia; or parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; or parasitaemia on day 3 with axillary temperature ≥ 37.5ºC; or parasitaemia on day 3 ≥ 25% of count on day 0

Late clinical failure (LCF): danger signs or severe malaria in the presence of parasitaemia on any day between days 4 and 28 or 42 in patients who did not previously meet any of the criteria of ETF; or presence of parasitaemia on any day between days 4 and 28 or 42 with axillary temperature ≥ 37.5ºC; or history of fever in patients who did not previously meet any of the criteria of ETF

Late parasitological failure (LPF): presence of parasitaemia on any day between days 7 and 28 or 42 with axillary temperature < 37.5ºC in patients who did not previously meet any of the criteria of ETF or LCF

Adequate clinical and parasitological response (ACPR): if there was no parasitaemia on the follow-up days (28 or 42) irrespective of axillary temperature in patients without ETF, LCF or LPF. This is considered treatment success

In addition, if the level of drug (CQ-DCQ) on day of recurrence is ≥ 100 ηg/ml (above minimum effective concentration (MEC)), the reappeared parasites were considered resistant to CQ, irrespective of genotype (relapse, recrudescence or re-infection) and classified as CQ-resistant P. vivax [34]

S: Studies

a.Randomized controlled trials (RCTs), non-randomized single-arm interventional studies (with or without a control group) and prospective cohort studies which enrolled all age groups, symptomatic patients with confirmed diagnosis of P. vivax mono-infection malaria, and who were followed-up for at least 28 days post-treatment

b.Studies that assessed the efficacy of a fixed dose of CQ as a single arm, or randomized into different loose combinations of CQ plus PQ, and AL plus PQ