Study designs of evaluations included in the review
Clinical studies, case series and case reports. Two of the included studies were RCTs, 3 were non-randomised trials, 2 single case reports and 15 case series. Study duration ranged from 8 days to 6 months.
Specific interventions included in the review
Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus control (no intervention). Wide ranges of fixed and variable dosages were reported across the studies. Two studies reported intravenous administration, and the rest used subcutaneous administration apart from one which administered it intralesionaly. Some studies required patients to begin or continue with concurrent antiretroviral therapy (zidovudine).
Participants included in the review
Patients with the acquired immunodeficiency syndrome (AIDS)or HIV infection receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) for any indication. The majority of participants in the studies were adult males, with only one study of children. Thirty eight percent of the participants had an AIDs related cancer (Karposis' sarcoma and non-Hodgkin's lymphoma). Forty six percent had neutropenia that was attributed to zidovudine or to AIDs in general. The remaining 16% had specific infections such as cytomegalovirus retinitis and bacteremia.
Outcomes assessed in the review
Key outcomes were basic and specialised tests of immune capabilities; major clinical events such as new infections, new neoplasms or progression of existing cancers; haematological and non haematological toxicities such as myalgias and fevers; and measures of HIV replication and cultures.
How were decisions on the relevance of primary studies made?
Titles and abstracts were reviewed to determine whether they met the inclusion criteria. One research analyst, one research assistant and a physician reviewer screened all abstracts and papers for eligibility. Differences were resolved by referring back to the full study report.