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.