Jejeebhoy 2012.
| Methods | Cohort study Carried out over 17 months in 2008‐2010 in Bihar and Jharkhand, India. The study was conducted in 5 NGO clinics |
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| Participants | 1164 women completed the study Eligibility criteria: The client needed to have a haemoglobin level of at least 9 g/dL, undergo 2 pelvic examinations (by the study provider and verifier) and reside within an hour of the study site; she would be ineligible if, during the past week, she had tried to terminate the pregnancy using medication obtained from a chemist without a prescription. No contraindications to medical abortion regimen |
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| Interventions | Medical abortion regimen of 200 mg mifepristone orally followed by 400 µg misoprostol orally 2 days later for women up to 8 weeks gestation. The regimen was delivered by ayurvedic physicians, nurses and allopathic physicians in abortion clinics in India. Only providers who had never performed surgical or medical abortion, never conducted pelvic examinations or assessed gestational age were recruited. All underwent identical medical training, which lasted 10 days. Women were followed up after 15 and 21 days (if extended follow‐up was advised) MLPs worked independently, though assessment was verified by a higher level clinician |
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| Outcomes | Complications: the percentage of women who experienced serious complications or required a blood transfusion or hospitalisation Incomplete abortion on day 15 or 21 The proportion of clients whose eligibility had been incorrectly assessed by their provider (as compared with the verifier), including those who would have wrongly been denied entry into the study and those who would have been wrongly recruited. The proportion of study participants whose abortion completeness status was incorrectly assessed by the study provider |
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| Notes | Supervisors assessed providers' accuracy of assessing eligibility and abortion completeness | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The study was not a randomised controlled trial, as clients were not randomly assigned to a particular type of provider. Providers were assigned to a facility for a certain period of time. Clients who came for an abortion were unaware of the type of clinician who would be providing services on the day of the visit or the type of physicians who would succeed the current provider, as there was no particular sequence |
| Allocation concealment (selection bias) | High risk | None |
| 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 | None |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The confidence intervals for the differences in loss to follow‐up fell within the predetermined margin of statistical equivalence for each provider type, both for day 3 and for day 15 or 21 |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Unclear risk | A break in recruitment due to unavailable study providers produced a long study period |