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After completion of the standardised questionnaire that was used to record details of the baby's birth and subsequent health, the mothers were requested to give permission for the interviewer to send a letter to the child's physician, to confirm the medical details they had provided, to eliminate any possible bias by only relying on the mother's report.
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A family history was taken either by the construction of a family tree or the completion of a standardised questionnaire.
Traditional informed consent procedures, based on the use of a written Participant Information Sheet PISS) and completion of a standardised Informed Consent Form (ICF), are the cornerstone of the International Committee on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines but are now widely recognised to be insufficient alone in obtaining informed consent in such settings [ 14- 18] 18].
After completion of the supervised procedure, a standardised feedback loop was performed.
The registry data collection process for both hospitals involves the completion of standardised forms, which are forwarded to the registry.
At the organisation assessment level, we will document usual care in the PCNs, including the ability to estimate and identify target patient populations in the focus areas (ie, type 2 diabetes management, depression management and lifestyle counseling) through completion of a standardised checklist.
A conventional approach to evaluation of change in self-reported outcomes involves completion of a standardised measurement instrument at a certain time point (e.g. pre-treatment) and then again at a later time point (e.g. post treatment)[ 3, 5].
This occurred in conjunction with completion of standardised forms relating to the administrative process of being added to the elctive surgical wait list.
This pre-treatment moment will thus involve the generation of the items in PGOM's, followed by their scoring; the scoring of the standardised measures; and completion of a socio-demographic and treatment history form.
Simple yet standardised instructions regarding the completion of the walk tests and patient-reported measures were given as per the program's procedure manual.
At the completion of the baseline outcome measurements, the physiotherapist will provide a standardised information sheet, as described above.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com