Rubiao Ou1, Xian-Jin Xie, Philippe E Zimmern. 1. Department of Urology, Guangzhou First Municipal People's Hospital, Guangzhou Medical College, Guangzhou, China.
Abstract
OBJECTIVES: To study the loss to follow-up (LTF) rate in level I/II evidence-based studies related to the surgical management of pelvic organ prolapse (POP). METHODS: Randomized controlled trials (level I) or nonrandomized but prospective studies (level II) related to the surgical treatment of POP from January 1995 to November 2010 were searched in PubMed. Data reviewed included types of study, number of participating centers, sample size calculation, surgical techniques, power calculation, estimated dropout rate, duration of follow-up, and rate and reasons for LTF. RESULTS: Forty-eight articles (4776 women)--22 randomized controlled trials and 26 nonrandomized prospective studies--met the inclusion criteria. Twenty-one articles gave details on sample size calculation, and only 5 explained their LTF rate after reaching LTF patients by mail or telephone. Percentages of LTF patients were 9.8% (255/2609) at ≤12 months in 26 articles, 15% (184/1232) at 24 months in 12 articles, 27% (114/420) at 36 months in 8 articles, 44% (272/615) at 60 months in 4 articles, and 60% (273/456) at >60 months in 3 articles. Fifteen articles reported no missing data, mostly because of small sample size or short follow-up. Only 3 articles defined LTF patients as treatment failure or successes and reported outcomes accordingly. CONCLUSIONS: An acceptable attrition rate (10-20%) in studies with a 2-3-year follow-up period was noted, but a much higher rate in studies extending 3-5 years out. Meaningful long-term follow-up reporting at 5 years, as usually recommended after POP repair, seems unrealistic.
OBJECTIVES: To study the loss to follow-up (LTF) rate in level I/II evidence-based studies related to the surgical management of pelvic organ prolapse (POP). METHODS: Randomized controlled trials (level I) or nonrandomized but prospective studies (level II) related to the surgical treatment of POP from January 1995 to November 2010 were searched in PubMed. Data reviewed included types of study, number of participating centers, sample size calculation, surgical techniques, power calculation, estimated dropout rate, duration of follow-up, and rate and reasons for LTF. RESULTS: Forty-eight articles (4776 women)--22 randomized controlled trials and 26 nonrandomized prospective studies--met the inclusion criteria. Twenty-one articles gave details on sample size calculation, and only 5 explained their LTF rate after reaching LTF patients by mail or telephone. Percentages of LTF patients were 9.8% (255/2609) at ≤12 months in 26 articles, 15% (184/1232) at 24 months in 12 articles, 27% (114/420) at 36 months in 8 articles, 44% (272/615) at 60 months in 4 articles, and 60% (273/456) at >60 months in 3 articles. Fifteen articles reported no missing data, mostly because of small sample size or short follow-up. Only 3 articles defined LTF patients as treatment failure or successes and reported outcomes accordingly. CONCLUSIONS: An acceptable attrition rate (10-20%) in studies with a 2-3-year follow-up period was noted, but a much higher rate in studies extending 3-5 years out. Meaningful long-term follow-up reporting at 5 years, as usually recommended after POP repair, seems unrealistic.
Authors: Feras Alhalabi; Chasta D Bacsu; Omer Gulpinar; Daniel J Scott; Philippe E Zimmern Journal: Int Urogynecol J Date: 2015-06-17 Impact factor: 2.894