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Live born infants dying in the first minutes or hours of life may be misclassified as stillbirths for a number of clinical, socio-cultural, and/or documentation reasons.
In additional a further 40% (22/57) had clear and reasonable documentation about reasons for continuing antibiotic therapy despite negative culture results (clinical signs and/or significantly raised infection markers).
The project also identified inconsistencies in record-keeping and documentation of reasons for requests to access certain information and in the descriptors used in some of Asio's electronic records".
Second, clear documentation of reasons why home medication was withheld was generally lacking.
This question was added because although Item 14 on the QUADAS checklist is concerned with whether an explanation for withdrawals from the study was given, it does not include documentation of reasons.
Indeed, there is negative and significant correlation between unclassified infusions of FVIII and infusions for prophylaxis (r = −0.74; P = 0.02); when the proportions of unclassified infusions decreased, the proportion for prophylaxis increased, showing the impact of improved documentation of reasons for infusion.
Steps towards a rigorous procedure for documentation include reason(s)/question(s), planning, multimodal data collection, data analysis (extracting knowledge) and interpretation of results according to the questions.
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