Consultation record
Submissions accepted — page 4
The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission.
Submissions
735 documents · page 4 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-ENDOTOXIN-ST/009 | Draft standard: bacterial endotoxin testing of peptide presentations | Dr Abimbola Sotomayor-Ekwueme | The standard specifies how to test a unit and not which units to test |
| DRAFT-ENDOTOXIN-ST/010 | Draft standard: bacterial endotoxin testing of peptide presentations | Professor Bartolomeu Nkosi-Lindegaard | Nothing requires the report to state who performed the determination |
| DRAFT-ENDOTOXIN-ST/011 | Draft standard: bacterial endotoxin testing of peptide presentations | Dr Melisande Thorsby-Nakamura | The reporting threshold is not tied to a demonstrated limit of quantitation |
| DRAFT-ANALYTICAL-S/001 | Draft scope of the analytical and methodological standards series | Dr Rosalind Petrossian | A printed copy loses the document identifier |
| DRAFT-ANALYTICAL-S/002 | Draft scope of the analytical and methodological standards series | Dr Hyacinth Drakeford-Amadi | A printed copy loses the information that makes it checkable |
| DRAFT-ANALYTICAL-S/005 | Draft scope of the analytical and methodological standards series | Quentin Whitmarsh-Obi | The registry is published only as pages and not in a form that can be processed |
| DRAFT-ANALYTICAL-S/006 | Draft scope of the analytical and methodological standards series | Yolanda Norrington-Bhatt | A figure carries information that appears nowhere in text |
| DRAFT-ANALYTICAL-S/007 | Draft scope of the analytical and methodological standards series | Thaddeus Isaksen-Balogun | The same quantity is rounded differently in two parts of one document |
| DRAFT-ANALYTICAL-S/008 | Draft scope of the analytical and methodological standards series | Dr Anselm Thorsby-Nakamura | A field the Institute could not verify should be shown rather than omitted |
| DRAFT-GLP1-OBESITY/001 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Dr Jozef Brandvold-Achterberg | Results at materially different follow-up durations are pooled |
| DRAFT-GLP1-OBESITY/003 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Dr Evander Ashworth-Danquah | An indirect comparison is presented without an assessment of transitivity |
| DRAFT-GLP1-OBESITY/004 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Dr Kolawole Isaksen-Balogun | Intention-to-treat and efficacy-estimand results are combined without distinction |
| DRAFT-GLP1-OBESITY/006 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Dr Odalys Thorsby-Nakamura | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-GLP1-OBESITY/010 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Thaddeus Isaksen-Balogun | Overlapping primary studies across included reviews are counted more than once |
| DRAFT-GLP1-OBESITY/011 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Dr Yusuf Whitmarsh-Obi | Registered trials that never reported are not counted anywhere in the review |
| DRAFT-GLP1-OBESITY/014 | Draft synthesis: glucagon-like peptide-1 receptor agonists for weight… | Dr Theodora Ingelbrecht | Doses differing several-fold are pooled without examining dose-response |
| DRAFT-LEAN-MASS-SC/003 | Draft scoping review: change in lean mass during pharmacologically… | Dr Yaa Kettlewell | Intention-to-treat and efficacy-estimand results are combined without distinction |
| DRAFT-LEAN-MASS-SC/004 | Draft scoping review: change in lean mass during pharmacologically… | Dr Jozef Brandvold-Achterberg | Registered trials that never reported are not counted anywhere in the review |
| DRAFT-LEAN-MASS-SC/006 | Draft scoping review: change in lean mass during pharmacologically… | Dr Oisín Rautavaara | The timepoint at which each outcome was extracted was chosen after the data were seen |
| DRAFT-LEAN-MASS-SC/007 | Draft scoping review: change in lean mass during pharmacologically… | Dr Ndidi Ravensworth-Ilunga | Results at materially different follow-up durations are pooled |
| DRAFT-GASTROPARESI/002 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Vittoria Quintanilha | Attrition is assessed in the risk-of-bias domains and not reported as a number |
| DRAFT-GASTROPARESI/006 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document |
| DRAFT-GASTROPARESI/009 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Jozef Brandvold-Achterberg | The conclusion is stated more strongly than the certainty rating supports |
| DRAFT-GASTROPARESI/011 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Yusuf Whitmarsh-Obi | Results at materially different follow-up durations are pooled |
| DRAFT-GASTROPARESI/012 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Kolawole Isaksen-Balogun | A single-trial result is presented in the visual form of a pooled estimate |
| DRAFT-GASTROPARESI/013 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Delphine Trelawney | The comparator was given at a dose below the one in general use |
| DRAFT-GASTROPARESI/014 | Draft safety review: delayed gastric emptying and procedural sedation | Thaddeus Isaksen-Balogun | A funnel plot is presented for a set too small to interpret it |
| DRAFT-GASTROPARESI/015 | Draft safety review: delayed gastric emptying and procedural sedation | Dr Oisín Rautavaara | Studies using different outcome definitions are pooled into one estimate |
| DRAFT-THYROID-C-CE/001 | Draft safety review: the rodent thyroid C-cell signal and its human… | Dr Ivo Quintanilha | The conclusion is stated more strongly than the certainty rating supports |
| DRAFT-THYROID-C-CE/007 | Draft safety review: the rodent thyroid C-cell signal and its human… | Dr Yusuf Whitmarsh-Obi | Attrition is assessed in the risk-of-bias domains and not reported as a number |
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