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REC comments were extracted and classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature.
Before the data were analyzed for this review, the methodological quality of the studies included after screening has been assessed, using a predefined checklist (Additional file 2 – Checklist).
Citation tracking and snowballing techniques added studies to the second screening phase, in which selected studies were screened for eligibility using a predefined checklist (see Data analysis) (Additional file 2 – Checklist).
REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature.
The appraisal using a predefined checklist is shown in figure 4. The first five questions regarding internal validity indicated that two of the templates contained none of the data we were looking for, four templates contained one of the data items we found relevant and the remaining four templates included three or more data items included in our list of desirable information.
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Data were retrospectively collected from our patient data management system, according to a predefined checklist.
Data from small centres were pooled using a predefined algorithm.
A 90 min, semistructured focus group interview using a predefined interview guide, not pilot-tested.
Then, we conducted six focus group interviews with 33 cancer survivors using a predefined protocol [ 41].
Two authors performed independent data extraction by using a predefined data template.
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