The physicians were reminded that returning a completed study form implies informed consent.
Eligible participants were women who presented for their initial clinical visit at < 22 weeks of gestation, had a singleton pregnancy, were able to complete study forms in English, and did not plan to move out of the study area before delivery.
We included terminated, withdrawn, or suspended studies in the "discontinued" group (see table 1 for complete definitions), with completed studies forming the "completed" group.
At the end of the training, facilitators assessed the competency of the CHWs to follow the algorithm, complete study forms, and for CHWs in the intervention arm the appropriate use of RDTs and RRTs, as reported elsewhere.
Patients with complete study form data were slightly younger (median age 59.7 vs 60.8, P = 0.009) but had similar hospital mortality (7.0% vs. 7.3%; P = 0.72) as compared to patients whose data were extracted from the patient records.
The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2288/12/161/prepub We thank all the women who participated in the study, the general practitioners who completed the study forms, staff from the NHS Breast Screening Centres and the Cancer Epidemiology Unit.
Patients and their parents were provided ample time and privacy to complete the study forms.
In this situation, an additional visit was required on the part of the patients to complete the study forms.
In the IRYSS-CAS, participating ED physicians were not expected or asked to gather extra information beyond what they would ordinarily collect in their clinical practice, nor were they asked to use or complete special study forms.
The VTS study nurse then completed the study form appropriately after the immunization had been given.
