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. 2011 Jan 17;2011:0909.

Table 1.

GRADE evaluation of interventions for HIV: mother-to-child transmission

Important outcomes HIV transmission, infant mortality, adverse effects
Number of studies (participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of measures to reduce mother-to-child transmission of HIV?
3 (2498) HIV transmission Antiretrovirals v placebo in a breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 0 0 –1 0 Moderate Directness point deducted for inclusion of non-breastfeeding women in largest RCT (25% of women)
3 (2498) Infant mortality Antiretrovirals v placebo in a breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 –1 0 Low Quality point deducted for methodological limitations (incomplete reporting of results). Directness point deducted for inclusion of non-breastfeeding women in largest RCT (25% of women)
1 (222) HIV transmission Different durations of regimens using the same antiretrovirals v each other in a breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 0 0 0 0 High
1 (222) Infant mortality Different durations of regimens using the same antiretrovirals v each other in a breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 0 0 0 0 High
4 (2346) HIV transmission Different antiretroviral regimens v each other in a breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 –1 0 Low Quality point deducted for methodological limitations (early termination of 1 RCT due to poor recruitment). Directness points deducted for use of a composite outcome in 1 RCT (includes mortality)
4 (2346) Infant mortality Different antiretroviral regimens v each other in a breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (early termination of 1 RCT due to poor recruitment).
3 (984) HIV transmission Antiretrovirals v placebo in a non-breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 0 0 0 0 High
2 (984) Infant mortality Antiretrovirals v placebo in a non-breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results)
1 (1437) HIV transmission Different durations of regimens using the same antiretrovirals v each other in a non-breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results)
1 (1109) Infant mortality Different durations of regimens using the same antiretrovirals v each other in a non-breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results)
4 (4165) HIV transmission Different antiretroviral regimens v each other in a non-breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (short follow-up in 1 study)
4 (4643) Infant mortality Different antiretroviral regimens v each other in a non-breastfeeding population (prevention of intrauterine and intrapartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (short follow-up in 1 study and incomplete reporting of results)
3 (2632) HIV transmission Different short-term antiretroviral regimens v each other (prevention of postpartum MTCT) 4 –1 –1 0 0 Low Quality point deducted for methodological limitations (incomplete reporting of results in 1 RCT, subgroup analysis in 2 RCTs, and 1 RCT may have been underpowered to detect a clinically important difference for this outcome). Consistency point deducted for inconsistent results for the same regimen
3 (5053) Infant mortality Different short-term antiretroviral regimens v each other (prevention of postpartum MTCT) 4 –1 –1 0 0 Low Quality point deducted for methodological limitations (incomplete reporting of results in 1 RCT, and subgroup analysis in 2 RCTs). Consistency point deducted for inconsistent results for the same regimen
2 (5053) HIV transmission Short-term antiretroviral regimens v extended antiretroviral regimens (prevention of postpartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results in 1 RCT, 1 RCT may have been underpowered to detect a clinically important difference for this outcome and there were differences among groups in usual care)
2 (5053) Infant mortality Short-term antiretroviral regimens v extended antiretroviral regimens (prevention of postpartum MTCT) 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results in 1 RCT, and differences among groups in usual care in 1 RCT)
1 (425) HIV transmission Formula feeding v breastfeeding alone 4 0 0 0 0 High
1 (425) HIV-free survival Formula feeding v breastfeeding alone 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results)
1 (425) Infant mortality Formula feeding v breastfeeding alone 4 0 0 0 0 High
1 (1200) HIV transmission Formula feeding plus antiretrovirals v breastfeeding plus antiretrovirals for infants 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results and open-label RCT)
1 (1200) Infant mortality Formula feeding plus antiretrovirals v breastfeeding plus antiretrovirals for infants 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results and open-label RCT)
1 (958) HIV transmission Early cessation of breastfeeding v prolonged breastfeeding 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results and low adherence to recommended protocol in both groups)
1 (958) HIV-free survival Early cessation of breastfeeding v prolonged breastfeeding 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (incomplete reporting of results and low adherence to recommended protocol in both groups)
1 (132) Infant mortality Early cessation of breastfeeding v prolonged breastfeeding 4 –2 0 0 0 Low Quality points deducted for sparse data and methodological limitations (incomplete reporting of results and for subgroup analysis, and low adherence to recommended protocol in both groups)
1 (436) HIV transmission Elective caesarean section v vaginal delivery 4 0 0 –1 0 Moderate Directness point deducted for differences in interventions between groups
1 (501) HIV transmission HIV hyperimmune globulin v immunoglobulin without HIV antibody 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (1 RCT potentially underpowered to detect a clinically important difference)
2 (708) HIV transmission Vaginal microbicides v no microbicides 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (randomisation flaws in included RCTs, and for 1 RCT being underpowered to detect a clinically meaningful difference)
2 (215) Infant mortality Vaginal microbicides v no microbicides 4 –1 0 0 0 Moderate Quality point deducted for methodological limitations (randomisation flaws in included RCTs, and for 1 RCT being underpowered to detect a clinically meaningful difference)
4 (6517) HIV transmission Vitamin A supplements v placebo/control 4 0 –1 0 0 Moderate Consistency point deducted for heterogeneity among RCTs in meta-analysis
1 (3708) Infant mortality Vitamin A supplements v placebo/control 4 –1 0 –1 0 Low Quality point deducted for methodological limitations (incomplete reporting of data). Directness point deducted for using a composite outcome
1 (815) Infant mortality Micronutrient supplements v placebo 4 –1 0 –1 0 Low Quality point deducted for methodological limitations (incomplete reporting and for short follow-up [6 months]). Directness point deducted for administration of maternal co-intervention throughout pregnancy (multivitamins)

Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies.Directness: generalisability of population or outcomes.Effect size: based on relative risk or odds ratio.