Influence of prior assignment on refusal rates in a trial of supplemental oxygen for retinopathy of prematurity

Paediatric and Perinatal Epidemiology

Volumn 20, Issue 4, 2006, Pages 348-359

  Engel, Rolf R ^a,d   Oden, Neal L ^b   Cohen, Geoff R ^b   Phelps, Dale L ^c  

^a UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^b EMMES CORPORATION   (United States)

^c UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^d HENNEPIN COUNTY MEDICAL CENTER   (United States)

Author keywords

Bias; Non blind randomisation; Refusal rate

Indexed keywords

ARTICLE; CLINICAL TRIAL; DISEASE SEVERITY; FEMALE; HUMAN; INCIDENCE; INFANT; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; OXYGEN THERAPY; PATIENT MONITORING; REFUSAL TO PARTICIPATE; RETROLENTAL FIBROPLASIA; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME;

AGE FACTORS; BIAS (EPIDEMIOLOGY); FEMALE; HUMANS; INFANT, NEWBORN; MALE; OXYGEN; PATIENT SELECTION; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFUSAL TO PARTICIPATE; RESEARCH DESIGN; RETINOPATHY OF PREMATURITY; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 33745114717     PISSN: 02695022     EISSN: 13653016     Source Type: Journal    
DOI: 10.1111/j.1365-3016.2006.00721.x     Document Type: Article

References (25)

1. Phelps DL Rosenbaum AL. Effects of variable oxygenation and gradual withdrawal of oxygen during the recovery phase in oxygen-induced retinopathy: kitten model. Pediatric Research 1987 22 : 297 301.
2. Phelps DL. Reduced severity of oxygen induced retinopathy in kittens recovered in 28% oxygen. Pediatric Research 1988 24 : 106 109.
3. Szewczyk T. Retrolental fibroplasia, etiology and prophylaxis. American Journal of Ophthalmology 1952 35 : 301 311.
4. Gaynon MW Stevenson DK Sunshine P Fleisher BE Landers MB. Supplemental oxygen may decrease progression of prethreshold disease to threshold retinopathy of prematurity. Journal of Perinatology 1997 17 : 434 438.
5. Seiberth V Linderkamp O Akkoyun-Vardarli I Jendritza W Voegele C. Oxygen therapy in acute retinopathy of prematurity stage 3. Investigative Ophthalmology and Visual Sciences 1998 39 : S820.
6. The STOP-ROP Multicenter Study Group. Supplemental therapeutic oxygen for prethreshold retinopathy of prematurity (STOP-ROP), a randomized, controlled trial. I. Primary outcomes. Pediatrics 2000 105 : 295 310.
7. Wei LJ Lachin JM. Properties of the urn randomization in clinical trials. Controlled Clinical Trials 1988 9 : 345 364.
8. Wei LJ. A class of designs for sequential clinical trials. Journal of the American Statistical Association 1977 72 : 382 386.
9. Wolfinger RD. Fitting Nonlinear Mixed Models with the New nlmixed Procedure. http://www.support.sas.com/rnd/app/papers/nlmixedsugi.pdf
10. Berger VW Exner DV. Detecting selection bias in randomized clinical trials. Controlled Clinical Trials 1999 20 : 319 327.
11. Gaynon MW Stevenson DK. What can we learn from STOP-ROP and earlier studies? Pediatrics 2000 105 : 420 422.
12. Chow LC Wright KW Sola A, CSMC Oxygen Administration Study Group. Can changes in clinical practice decrease the incidence of severe retinopathy of prematurity in very low birth weight infants? Pediatrics 2003 111 : 339 345.
13. Tin W Milligan DW Pennefather P Hey E. Pulse oximetry, severe retinopathy, and outcome at one year in babies of less than 28 weeks gestation. [see comments.] Archives of Disease in Childhood: Fetal and Neonatal Edition 2001 84 : F106 F110.
14. Chalmers TC Celano P Sacks HS Smith H Jr. Bias in treatment assignment in controlled clinical trials. New England Journal of Medicine 1983 309 : 1358 1361.
15. Torgerson DJ Roberts C. Randomization methods: concealment. British Medical Journal 1999 319 : 375 376.
16. Schulz KF. Subverting randomization in controlled trials. JAMA 1995 8 : 274 : 1456 1458.
17. Schulz KF Chalmers I Hayes RJ Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995 273 : 408 412.
18. Kunz R Oxman AD. The unpredictability paradox: review of empirical comparisons of randomized and non-randomized clinical trials. British Medical Journal 1998 317 : 1185 1190.
19. Askie LM Henderson-Smart DJ Irwig L Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. New England Journal of Medicine 2003 349 : 959 967.
20. Schmidt B Gillie P Caco C Roberts J Roberts R. Do sick newborn infants benefit from participation in a randomized clinical trial? Journal of Pediatrics 1999 134 : 151 155.
21. Als-Nielsen B Gluud LL Gluud C. Methodological Quality of Treatment Effects in Randomised Trials: A Review of Six Empirical Studies. Cochrane Colloquium 2004. O-072 http://www.cochrane.org/colloquia/abstracts/ottawa/
22. Fielding LP Grace R Hittinger R. Patients who are eligible but not randomized should be included as additional comparative arm in study. British Medical Journal 1999 318 : 874 875.
23. Oden NL Phelps DL on behalf of the STOP-ROP Multicenter Study Group. Statistical issues related to early closure of STOP-ROP, a group sequential trial. Controlled Clinical Trials 2003 24 : 28 38.
24. Pildal J Chen AW Hrobjartsson A Forfang E Altman D Gotzsche P. How often does Unclear Allocation Concealment in Randomised Trials Reflect Inadequate Reporting of Adequate Methods? O-074 http://www.cochrane.org/colloquia/ abstracts/ottawa/
25. Betensky RA. Construction of a continuous stopping boundary from an alpha spending function. Biometrics 1998 54 : 1061 1071.