Table 3.
Intervention and comparator information from Cochrane reviews for upheld index trial VLEs
| Population | Intervention | Outcome | Index trial | Large trial data | |||
|---|---|---|---|---|---|---|---|
| Relative risk (95% CI) | Absolute risk difference (95% CI) | Relative risk (95% CI) | Absolute risk difference (95% CI) | ||||
| Patients at the stage of pre- exposure or post-exposure of hepatitis A (infectious hepatitis) | No intervention, placebo, or control v immunoglobulins | Number with hepatitis A or infectious hepatitis at 6-12 months | 5.03 (3.18 to 7.94) | 0.01 (0.00 to 0.01) | 1.94 (1.74 to 2.17) | 0.00 (0.00 to 0.01) | |
| Pregnant women | Daily iron v placebo/no intervention | Haemoconcentration (that is, Hb rise) during second or third trimester | 5.08 (1.87 to 14.64) | 0.15 (0.07 to 0.24) | 5.66 (4.26 to 7.52) | 0.57 (0.52 to 0.63) | |
| Children with asthma at risk of asthma related admission to the emergency department | Control v education (any type) | Emergency department visits | 5.17 (2.35 to 11.76) | 0.31 (0.19 to 0.43) | 1.37 (1.12-1.68) | 0.15 (0.06 to 0.24) | |
| Adult smokers | Motivational interviewing v brief advice/usual care | Abstinence at maximal follow-up | 5.28 (1.75 to 17.92) | 0.15 (0.07 to 0.23) | 1.21 (1.05 to 1.39) | 0.03 (0.01 to 0.05) | |
| Adults needing surgery | Control v aprotinin (anti-fibrionolytic) | Number exposed to allogeneic blood | 5.33 (1.10 to 90.83) | 0.54 (0.16 to 0.93) | 1.47 (1.31-1.66) | 0.17 (0.12 to 0.23) | |
| Patients with cancer and neutropenia | Intervention v quinolone antibiotic | Febrile episodes | 5.33 (2.04 to 17.49) | 0.62 (0.38 to 0.85) | 1.39 (1.11-1.74) | 0.05 (0.02 to 0.09) | |
| Adults with rheumatoid arthritis | Abatacept v placebo | ACR 50% improvement | 5.40 (2.32 to 14.04) | 0.17 (0.11 to 0.22) | 2.37 (1.72 to 3.26) | 0.23 (0.16 to 0.30) | |
| Adults with type 2 diabetes mellitus | Rosiglitazone v control | Oedema | 5.61 (1.79 to 18.36) | 0.09 (0.04 to 0.14) | 1.65 (1.34 to 2.04) | 0.06 (0.03 to 0.08) | |
| Children living in malaria endemic regions | Placebo v intermittent preventive treatment with antimalarial | Clinical malaria | 5.64 (4.10 to 7.76) | 0.34 (0.29 to 0.39) | 1.13 (1.01 to 1.26) | 0.07 (0.01 to 0.13) | |
| Adults receiving intensive care | No prophylaxis v topical plus systemic antibiotic | Respiratory tract infections | 6.46 (2.86 to 15.87) | 0.56 (0.40 to 0.72) | 1.66 (1.36 to 2.02) | 0.23 (0.14 to 0.31) | |
| Adults undergoing heart surgery | Control v all treatments | Postoperative atrial fibrillation | 7.32 (2.08 to 35.41) | 0.34 (0.19 to 0.50) | 1.25 (1.05 to 1.48) | 0.08 (0.02 to 0.14) | |
| Adults with migraine pain of moderate to severe intensity | Rizatriptan v placebo | Pain-free response at 2 h | 7.32 (2.45 to 25.79) | 0.22 (0.12 to 0.32) | 4.23 (2.96 to 6.03) | 0.32 (0.26 to 0.38) | |
| Adult pregnant women | Placebo/control v any antibiotic | Failure of test of cure of bacterial vaginosis | 7.58 (3.47 to 18.72) | 0.75 (0.60 to 0.89) | 2.87 (2.54 to 3.24) | 0.37 (0.34 to 0.41) | |
| Children at risk of whooping cough | Whole cell vaccine v acellular vaccine | Primary series non-completion due to adverse events | 7.59 (1.63 to 42.27) | 0.05 (0.00 to 0.11) | 1.82 (1.43 to 2.33) | 0.00 (0.00 to 0.00) | |
| Patients with acute cardiovascular event | Control v nitrates | All cause mortality at 2 days | 7.90 (1.27 to 99.80) | 0.04 (0.01 to 0.08) | 1.22 (1.11 to 1.35) | 0.00 (0.00 to 0.01) | |
| Adult smokers | Nicotine replacement therapy (patch) v placebo/control | Smoking cessation at >6 months’ follow-up | 8.21 (2.18 to 39.39) | 0.18 (0.08 to 0.28) | 1.54 (1.34 to 1.77) | 0.07 (0.05 to 0.09) | |
| Kidney transplant recipients | Placebo or no treatment v IL2Ra | Biopsy proven acute rejection at 1 year | 8.80 (1.17 to ∞) | 0.36 (0.09 to 0.63) | 1.43 (1.14 to 1.79) | 0.08 (0.03 to 0.13) | |
| Children | Placebo v rotarix (RV1) vaccine | Rotavirus diarrhoea of any severity up to 1 year | 9.08 (2.41 to 42.30) | 0.15 (0.07 to 0.23) | 2.15 (1.75 to 2.63) | 0.06 (0.05 to 0.08) | |
| Pregnant women in spontaneous preterm labour | Placebo v all betamimetics | Birth within 48 h of treatment | 10.00 (1.99 to 183.52) | 0.60 (0.33 to 0.87) | 1.66 (1.30 to 2.12) | 0.14 (0.08 to 0.21) | |
| Adults needing first line anti-hypertensive treatment | Placebo v high dose thiazide | Total cardiovascular events | 11.47 (1.97 to 204.42) | 0.14 (0.05 to 0.23) | 1.25 (1.03 to 1.51) | 0.01 (0.00 to 0.01) | |
| Patients undergoing general anaesthesia, regional anaesthesia, or sedation | Placebo v ondansetron | Nausea | 13.00 (2.57 to 224.97) | 0.60 (0.37 to 0.83) | 1.24 (1.02 to 1.52) | 0.10 (0.01 to 0.19) | |
| Adults with moderate to severe postoperative pain | Rofecoxib v placebo | >50% pain relief over 4-6 h | 23.00 (4.42 to 393.80) | 0.69 (0.52 to 0.85) | 8.40 (5.48 to 12.87) | 0.55 (0.50 to 0.61) | |
| Women being treated for spontaneous miscarriage | Surgery v misoprostol | Surgical evacuation | 24.79 (9.79 to 67.48) | 0.89 (0.82 to 0.96) | 18.00 (10.39 to 31.21) | 0.94 (0.90 to 0.97) | |
| Adults with type 2 diabetes mellitus | Pioglitazone v control | Oedema | 30.98 (3.93 to ∞) | 0.04 (0.02 to 0.06) | 1.67 (1.47 to 1.88) | 0.09 (0.07 to 0.11) | |
| Patients with chronic renal failure who are seronegative for HBsAg | Plasma vaccine v placebo | Seroconversion to anti-HBs | 48.64 (6.47 to ∞) | 0.36 (0.25 to 0.47) | 21.43 (11.83 to 38.84) | 0.35 (0.31 to 0.38) | |
ACR=American College of Rheumatology score; Hb=haemoglobin; HBs=hepatitis B virus (surface) antibodies; HBsAg=hepatitis B virus surface antigen; IL2Ra= interleukin-2 receptor alpha chain; VLE=very large effect.