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The study protocol and additional papers, including the consent form, patient information sheet, questionnaires, and case report form, have also been approved by the Ethics Committee (Approval number R10127).
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All subjects participating to this study gave their consent before answering and filling data sheet questionnaire.
Single sheet questionnaire was completed by both groups of patients at baseline in waiting room (immediately following leaflet administration in intervention arm of study).
The Mother-Generated Index (MGI) is a single sheet questionnaire involving three steps.
Envelopes containing an information sheet, questionnaire, and freepost return envelope were distributed by staff to potential participants, with a small cash incentive offered to enhance participation.
Whereas the Australian decision aid includes specific tools (structured work sheet, questionnaire) to help pregnant women clarify their preferences and discuss them with others, the British decision aid provides an empty sheet of scratch paper for this purpose.
An information pack (disseminated both online and by post) which contained a cover letter/participant information sheet, questionnaire and sources of support for further information was sent to 3,557 members.
To include parents who had consented to CATCH before CONNECT recruitment began, practitioners posted an invitation letter, CONNECT participant information sheet, questionnaire and interview reply slip to parents who had indicated on their CATCH consent form that they would like to be involved in further research.
Invitations to participate, trial information sheets, questionnaires to screen for eligibility and expression of interest forms are sent from and returned to the practice.
18 Following guidance from INVOLVE, 19 two patient representatives have been recruited to assist with the design of study materials, including the information sheet, trial questionnaires and the qualitative interview schedule.
To make the collected data available, the chief of the investigation team must review every sheet of questionnaire and verify its appropriateness carefully before all questionnaires were accepted.
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