Draft synthesis: Bacterial endotoxin in research-supply… — submissions
The 2 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
2 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
The sampling frame of each contributing survey is not reported
The respondent’s comment on the draft review of What is known about bacterial endotoxin content in peptides supplied for research and injected in practice? arises from comparing the pooled figures against the reports they were taken from.
The included surveys each obtained material from a set of sources, and the draft reports what was found without reporting how the sources were chosen.
The respondent states that a survey that bought from the most visible sellers and a survey that bought at random from a directory answer different questions, and that pooling them without recording the difference produces a figure that describes neither.
The respondent proposes that the sampling frame, the number of sources approached and the number that supplied be tabulated for every contributing survey.
The secretariat accepts this submission. How material was obtained determines what a survey can support, and the draft treated the surveys as interchangeable.
Every contributing survey now carries a sampling row stating the frame, the number of sources approached and the number supplying, and the synthesis reports separately for surveys whose frames are not comparable.
Regulatory assessment documents were not searched
The respondent notes that the review question — What is known about bacterial endotoxin content in peptides supplied for research and injected in practice? — is answerable only if the contributing determinations measured the same quantity, and submits with that in view.
The respondent states that regulatory assessment reports frequently contain analyses that never appear in journals, and that a search limited to bibliographic databases will miss them.
The respondent proposes that regulatory documents be searched for every review in the series.
The secretariat accepts this submission in part. Regulatory assessment documents are searched. The proposal that they be treated as equivalent to a full study report is declined, because the level of detail varies and is often insufficient for risk-of-bias assessment.
Published regulatory assessment documents are now searched as a named source, are reported as a distinct evidence class in the included-studies table, and contribute to the assessment while being excluded from pooled estimates where risk of bias could not be assessed from the document.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
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