Examples of Changes Made Between Trial Registration and Publication of Findings
| Primary Outcomes | Secondary Outcomes | ||||
|---|---|---|---|---|---|
| Study Description | Registry | Publication | Registry | Publication | Notes |
| ER=extended release; 5-FU=5-fluorouracil; NICU = neonatal intensive care unit. | |||||
| Kaplan et al9,10 | 1. Patient perception of treatment benefit at week 12 | 1. Reported | 24 outcomes grouped in several domains | 7 outcomes, 2 not mentioned as out- comes in registry | Several clinically important secondary outcome measures listed in the registry (continence, overactive bladder, erectile function) are not mentioned in the publication |
| Safety and efficacy of tolterodine ER, tamsulosin, or the combination, against placebo in men with lower urinary symptoms | 2. Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12 | 2. Not reported as a primary outcome but some measures reported as secondary outcomes | |||
| Bosset et al11,12 | 1. Disease-free survival | 1. Not reported | None listed | None listed | Disease-free and progression-free survival both discussed in the publication, but not as outcomes |
| Treatment of rectal cancer with radio- therapy and 5-FU | 2. Overall survival | 2. Reported | |||
| Michalowicz et al13,14 | 1. Gestational age at birth | 1. Reported | None listed | 1. Birth weight | Demotion of 1 primary outcome and addition of multiple secondary outcomes |
| Effect of treatment of periodontal disease on the risk of pregnancy complications | 2. Birth weight | 2. Reported as a secondary outcome | 2. Infants small for gestational age | ||
| 3. Apgar scores | |||||
| 4. Admissions to NICU | |||||