Freedman 1986.
Methods | 24‐month cohort study There was no differential allocation of patients between provider types. A patient could request a particular provider if she desired. Less than 5% of clinic patients availed themselves of this option |
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Participants | 2458 participants completed the study All women who obtained abortions from a physician or a physician assistant at the Vermont Women's Health Center during the 2‐year period from1 January 1981 through 31 December 1982 Gestation assessed by pelvic estimate Contraindications included uterine sizing beyond 12 weeks gestation, current use of anticoagulants, haematocrit less than 30%, prolonged bleeding time and active pelvic inflammatory disease. Only procedures utilising local anaesthetics were performed at this clinic |
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Interventions | Physicians and physician assistants performed early uterine evacuation or suction curettage at a Women's Health Center in Vermont Women arriving at the clinic were seen by the next available provider and were followed up within 4 weeks of the procedure MLPs worked independently to carry out abortions within the same site where physicians were working |
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Outcomes | Complication rates Complications were placed into 1 of 7 categories: ‐ Uterine haemorrhage or "excessive bleeding", as determined by patient estimate (soaking 2 or more pads per hour for 4 to 6 hours) ‐ Uterine perforation ‐ Cervical laceration ‐ Incomplete abortion or retained products of conception ‐ Infection (fever 100.4 °F or higher on 2 readings and definite uterine tenderness) ‐ Post‐abortion syndrome ‐ Vagal reaction (rapid drop in blood pressure followed by a short loss of consciousness) Each complication was further classified as either immediate or delayed Immediate complications were defined as those evident before the patient was discharged from the clinic on the day of her procedure, while delayed complications were those noted within the 4‐week post‐abortion period |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No random sequence generation. Women were seen by the next available provider. However, only 5% of women opted for a physician. The author states that randomisation could have been natural |
Allocation concealment (selection bias) | High risk | No allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participant was aware of the provider type. We do not consider this to be a bias because this is part of the intervention. If MLPs are to perform abortion procedures outside of study conditions, we would expect patients to be aware of the provider type. We therefore do not consider the lack of blinding to provider type to bias the results of the study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 96% follow‐up – no difference stated between groups |
Selective reporting (reporting bias) | Unclear risk | Not available |
Other bias | Low risk | The study appears to be free of other sources of bias |