Leviton 1999.
| Study characteristics | ||
| Methods | Cluster‐randomised controlled trial Hospitals from the Albert Einstin College of Medicine (AECOM) affiliated hospitals and hospitals from the National Perinatal Information Centre (NPIC) randomised to intervention and control groups Data were abstracted from medical records at baseline (12 months before consensus conference, March 1993 to February 1994) and after (12 months after consensus conference, April 1995 to July 1996) |
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| Participants | 27 hospitals (8 AECOM and 22 NPIC); All hospitals were tertiary care facilities with neonatal intensive care unit facilities Criteria for inclusion of hospitals: at least 100 eligible cases in baseline care; no standing protocol on ACS; not participating in other ACS related research Eligible participants: all women giving birth at 34/52 or less, including cases of spontaneous labour, PROM, and preterm delivery indicated by medical conditions No data on women who received ACS but did not deliver prematurely |
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| Interventions | Control: usual dissemination (n = 14) ‐ NIH Consensus Conference in February 1994, final statement released May 1994 ‐ American College of Obstetricians and Gynaecologicsts' opinion statement on ACS mailed to members in December 1994 ‐ End January 1995, NIH brochures on consensus statement mailed to medical care institutions, universities, medical societies and obstetricians. ‐ JAMA published the NIH recommendations in February 1995 ‐ 2nd publication in American Journal of Obstetrics and Gynaecology July 1995 ‐ Lectures, word‐of‐mouth discussions, available literature Intervention: active dissemination (n = 13) comprised 5 components
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| Outcomes | Primary outcome: use of antenatal corticosteroids | |
| Notes | Time period: March 1993 to July 1996 Trial registration number: not reported Funding source: the Patient Outcomes Research Team on Low Birthweight contract 290‐92‐0055 from the Agency for Health Care Policy and Research, Rockville, Md Conflict of interests: not reported Author contacted to request missing information related to methods and results, but email address no longer valid and not able to find alternative address. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random table of numbers was used to allocate hospitals |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible. Physicians in the active dissemination hospitals were aware of the study, whereas in the control hospitals only the hospital leadership were aware. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All hospitals that were randomised were included in the analysis |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
| Other bias | Low risk | No other source of bias identified |
| Recruitment bias | Low risk | Hospitals recruited before randomisation |
| Baseline imbalance | Unclear risk | Quote: "A difference between intervention and control cases in frequency of abnormal fetal conditions or fetal distress was significant at patient level". "During the after conference year, 2 differences in hospital case mix emerged between intervention and control institutions. Based on hospital census (not sampling), treatment hospitals had a larger proportion of the lowest GA cases in the after‐conference year because 3 control hospitals reduced their proportions of such cases, while 1 treatment hospital increased its proportion of these cases. In addition, in the after‐conference year the average proportion of reported PROM cases increased in all hospitals but increased significantly more in treatment than in control hospitals". "The change in case mix did not cause increased use of the therapy in the active dissemination group" |
| Loss of clusters | Unclear risk | One hospital refused participation after randomisation |
| Incorrect analysis | Unclear risk | Unclear whether results at patient level were adjusted for clustering |
| Compatibility with individually randomised RCTs | Unclear risk | No individually‐randomised RCTs for comparison. |
ACS: antenatal corticosteroids;GA: gestational age; LBW: low birth weight; LMP: last menstrual period; MgSO4: magnesium sulphate; NIH: National Institutes of Health; PROM: premature rupture of membranes; RCT: randomised controlled trial