Consultation record
Submissions accepted in part — page 11
Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.
Submissions
377 documents · page 11 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-POORLY-RETAI/005 | Draft standard CEI-MS-19: Purity determination for peptides not… | Dr Marisol Dunmore-Ekpo | Acceptance criteria are expressed in terms specific to one instrument family |
| DRAFT-PHOTOSTABILI/001 | Draft standard CEI-MS-20: Photostability assessment of… | Dr Amara Quaresma | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-INCRETIN-CAR/010 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Jolanta Uttridge | Point estimates are given without an interval |
| DRAFT-INCRETIN-CAR/005 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Lorcan Zaleski-Mbeki | A surrogate outcome is used as the anchor without validation evidence |
| DRAFT-INCRETIN-CAR/012 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Eamon Immelmann | The choice of effect measure is not justified and changes the appearance of the result |
| DRAFT-INCRETIN-CAR/007 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Jacinta Steenkamp-Ferreira | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-INCRETIN-CAR/004 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Yusuf Whitmarsh-Obi | Studies not published in English were excluded without assessment |
| DRAFT-GASTROINTEST/006 | Draft synthesis: Gastrointestinal adverse events with incretin… | Xenia Nyquist-Obiora industry | A sponsor trial meeting the eligibility criteria was excluded |
| DRAFT-GASTROINTEST/003 | Draft synthesis: Gastrointestinal adverse events with incretin… | Dr Wilhelmina Erlingsson | References should carry a persistent identifier for every cited source |
| DRAFT-GASTROINTEST/002 | Draft synthesis: Gastrointestinal adverse events with incretin… | Dr Rosalind Grünbaum-Sowande | Point estimates are given without an interval |
| DRAFT-GASTROINTEST/004 | Draft synthesis: Gastrointestinal adverse events with incretin… | Dr Adaeze Dunmore-Ekpo | The review protocol is described but its registration record is not linked |
| DRAFT-ORAL-VS-INJE/014 | Draft synthesis: Oral compared with injectable presentations of… | Dr Katarzyna Oppenheimer-Ade | The same concern is used to downgrade in two domains |
| DRAFT-ORAL-VS-INJE/013 | Draft synthesis: Oral compared with injectable presentations of… | Dr Ivo Quintanilha | The document is unreadable without specialist training |
| DRAFT-ORAL-VS-INJE/007 | Draft synthesis: Oral compared with injectable presentations of… | Dr Ottoline Fitzgerald-Nwosu | Two included studies do not meet the registered eligibility criteria |
| DRAFT-ORAL-VS-INJE/010 | Draft synthesis: Oral compared with injectable presentations of… | Dr Georgiana Mountstephen | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-ORAL-VS-INJE/015 | Draft synthesis: Oral compared with injectable presentations of… | Dr Vittoria Ylönen | Patient-reported outcomes are collected by the trials and not reported by the review |
| DRAFT-ORAL-VS-INJE/009 | Draft synthesis: Oral compared with injectable presentations of… | Dr Jolanta Uttridge | Statistical heterogeneity is treated as though it measured clinical heterogeneity |
| DRAFT-RENAL-OUTCOM/005 | Draft synthesis: Kidney outcomes with incretin receptor agonists in… | Dr Torvald Kettlewell | Regulatory assessment documents were not searched |
| DRAFT-RENAL-OUTCOM/004 | Draft synthesis: Kidney outcomes with incretin receptor agonists in… | Dr Lorcan Trelawney | The choice of effect measure is not justified and changes the appearance of the result |
| DRAFT-RENAL-OUTCOM/002 | Draft synthesis: Kidney outcomes with incretin receptor agonists in… | Dr Yaa Kettlewell | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-RENAL-OUTCOM/010 | Draft synthesis: Kidney outcomes with incretin receptor agonists in… | Dr Ulysses Bellingham-Ojo industry | A sponsor trial meeting the eligibility criteria was excluded |
| DRAFT-RENAL-OUTCOM/011 | Draft synthesis: Kidney outcomes with incretin receptor agonists in… | Radoslava Palmgren-Kofi | Point estimates are given without an interval |
| DRAFT-HFPEF-INCRET/003 | Draft synthesis: Incretin receptor agonists in heart failure with… | Dr Kamila Ubertini | Two included studies do not meet the registered eligibility criteria |
| DRAFT-HFPEF-INCRET/002 | Draft synthesis: Incretin receptor agonists in heart failure with… | Dr Ludmila Castellanos-Reid | Patient-reported outcomes are collected by the trials and not reported by the review |
| DRAFT-SLEEP-APNOEA/007 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Dr Gaspard Wintringham | The document is unreadable without specialist training |
| DRAFT-SLEEP-APNOEA/012 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Dr Vittoria Ylönen industry | A sponsor trial meeting the eligibility criteria was excluded |
| DRAFT-SLEEP-APNOEA/013 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Dr Katarzyna Oppenheimer-Ade | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-SLEEP-APNOEA/008 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Dr Oisín Rautavaara | A surrogate outcome is used as the anchor without validation evidence |
| DRAFT-SLEEP-APNOEA/014 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Dr Ivo Quintanilha | Regulatory assessment documents were not searched |
| DRAFT-SLEEP-APNOEA/011 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Dr Mordecai Glendinning-Uche | The choice of effect measure is not justified and changes the appearance of the result |
page 11 of 13