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Abdominal sacrocolpopexy and urinary incontinence: Elser et al
Journal Club
www. AJOG.org
Abdominal sacrocolpopexy and urinary incontinence: Elser et al George A. Macones, MD, MSCE, Associate Editor The article below summarizes a roundtable discussion of a study published in this issue of the Journal in light of its methodology, relevance to practice, and implications for future research. Article discussed: Elser DM, Moen MD, Stanford EJ, et al; on behalf of the Urogynecology Network. Abdominal sacrocolpopexy and urinary incontinence: surgical planning based on urodynamics. Am J Obstet Gynecol 2010;202:375.e1-5. The full discussion appears at www.AJOG.org, pages e1-e3.
DISCUSSION QUESTIONS
What was the study rationale?
What was the study design?
How well did the study design address the question under investigation? What outcomes were assessed? Can you comment on the analysis plan and sample size?
What do the tables tell us?
How could the study be improved?
What is the take-home message?
From the Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO: Moderator George A. Macones, MD, MSCE Mitchell and Elaine Yanow Professor Discussants Alison G. Cahill, MD, MSCI Assistant Professor David M. Stamilio, MD Associate Professor Anthony Odibo, MD Associate Professor 0002-9378/free © 2010 Published by Mosby, Inc. doi: 10.1016/j.ajog.2010.01.007
See related article, page 375
T
his month, Journal Club members discussed an article that focused on the value of pairing an incontinence procedure with sacrocolpopexy. A prior study suggested that this approach lessened postoperative stress incontinence. The new work by Elser and colleagues was performed to further assess whether the 2 corrective procedures should be performed together.
C RITICAL R EVIEW ⴝ R ESEARCH Q UESTIONS The genesis of the study by Elser’s team is interesting. It came about because the authors did a very thorough review of prior work on the subject. In the past, the role for a concomitant incontinence procedure in women undergoing surgery for significant prolapse has been debated. Some surgeons argue that a significant number of women who undergo a procedure for prolapse will become incontinent. Others suggest that performing both procedures together can cause postoperative symptoms of obstruction. This uncertainty led to the practice of using preoperative urodynamics to select who would get an incontinence procedure at the time of prolapse surgery. Then the results of the Colpopexy and Urinary Reduction Efforts (CARE) study were reported. The CARE study randomized women undergoing sacrocolpopexy to either a Burch procedure or no Burch procedure. At 12 weeks, a significant decrease in postoperative incontinence was noted in those randomized to a Burch procedure, so the research was halted early. Elser and colleagues carefully reviewed the results of CARE and
made an important observation: the rate of postoperative incontinence in CARE was much higher than has been observed in other studies. Certainly, this raises some question about how— or whether—to incorporate the findings of CARE into clinical practice. Practitioners of maternal-fetal medicine recently had a similar issue. When the results were reported for a randomized controlled trial of 17-alpha hydroxyprogesterone caproate (17-OHP) for the prevention of recurrent spontaneous preterm birth, the primary outcome for that study was much higher than was expected or had been seen in prior studies. As a result, many physicians are hesitant to translate the findings into practice. The message, here, is that careful analysis of prior research can lead to new and exciting questions to answer!
E FFICACY VS E FFECTIVENESS One important issue raised in this study is the difference between efficacy and effectiveness. Efficacy refers to the results that you observe in the setting of a randomized clinical trial. These are often quite strict in terms of inclusion and exclusion criteria, and they have clear guidelines about compliance and concurrent interventions. Existing evidence also supports the idea that people who agree to be in clinical trials are likely “different” from those who do not agree to participate. For these reasons, there is always concern that the promising results seen in a clinical trial might disappear in everyday practice. Effectiveness refers to the latter— how well an intervention
APRIL 2010 American Journal of Obstetrics & Gynecology
403
Journal Club
www.AJOG.org
works in the real world. Both concepts are important. In general, we usually test new drugs or interventions in the setting of a clinical trial, thus assessing its efficacy. Then it is important to follow these efficacy studies with carefully done observational studies of effectiveness. The study discussed in this session of the Journal Club assesses effectiveness.
A W ORTHY E NDEAVOR Journal Club participants were impressed with the authors’ efforts to answer a clinically important and controversial question in urogynecology. This is a relatively young field, and carefully conducted research is critical to its advancement. Members felt that this article was thought-provoking and likely to
make clinicians think carefully about how they assess patients who are undergoing sacrocolpopexy. Clearly, the controversy is not resolved, and additional observational studies and clinical trials are needed to clarify the best surgical route. f
Submit your paper online at www.ees.elsevier.com/AJOG Elsevier’s fast, efficient online submission and editorial system speeds submitted papers through review and editing. Authors can: ■ Follow
clear step-by-step instructions.
■ Consult
a help menu and online tutorials.
■ Send
sensitive material with confidence. All data are held on our secure central servers and backed up regularly.
■ Check
the status of a submitted or accepted paper at any time.
■ Contact
our responsive online helpdesk with questions.
Log into www.ees.elsevier.com/AJOG to submit your paper or revisions wherever Internet access is available worldwide.
We look forward to hearing from you.
404
American Journal of Obstetrics & Gynecology APRIL 2010
www. AJOG.org
Abdominal sacrocolpopexy and urinary incontinence: Elser et al George A. Macones, MD, MSCE, Associate Editor The article below summarizes a roundtable discussion of a study published in this issue of the Journal in light of its methodology, relevance to practice, and implications for future research. Article discussed: Elser DM, Moen MD, Stanford EJ, et al; on behalf of the Urogynecology Network. Abdominal sacrocolpopexy and urinary incontinence: surgical planning based on urodynamics. Am J Obstet Gynecol 2010;202:375.e1-5. The full discussion appears at www.AJOG.org, pages e1-e3.
DISCUSSION QUESTIONS
What was the study rationale?
What was the study design?
How well did the study design address the question under investigation? What outcomes were assessed? Can you comment on the analysis plan and sample size?
What do the tables tell us?
How could the study be improved?
What is the take-home message?
From the Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO: Moderator George A. Macones, MD, MSCE Mitchell and Elaine Yanow Professor Discussants Alison G. Cahill, MD, MSCI Assistant Professor David M. Stamilio, MD Associate Professor Anthony Odibo, MD Associate Professor 0002-9378/free © 2010 Published by Mosby, Inc. doi: 10.1016/j.ajog.2010.01.007
See related article, page 375
T
his month, Journal Club members discussed an article that focused on the value of pairing an incontinence procedure with sacrocolpopexy. A prior study suggested that this approach lessened postoperative stress incontinence. The new work by Elser and colleagues was performed to further assess whether the 2 corrective procedures should be performed together.
C RITICAL R EVIEW ⴝ R ESEARCH Q UESTIONS The genesis of the study by Elser’s team is interesting. It came about because the authors did a very thorough review of prior work on the subject. In the past, the role for a concomitant incontinence procedure in women undergoing surgery for significant prolapse has been debated. Some surgeons argue that a significant number of women who undergo a procedure for prolapse will become incontinent. Others suggest that performing both procedures together can cause postoperative symptoms of obstruction. This uncertainty led to the practice of using preoperative urodynamics to select who would get an incontinence procedure at the time of prolapse surgery. Then the results of the Colpopexy and Urinary Reduction Efforts (CARE) study were reported. The CARE study randomized women undergoing sacrocolpopexy to either a Burch procedure or no Burch procedure. At 12 weeks, a significant decrease in postoperative incontinence was noted in those randomized to a Burch procedure, so the research was halted early. Elser and colleagues carefully reviewed the results of CARE and
made an important observation: the rate of postoperative incontinence in CARE was much higher than has been observed in other studies. Certainly, this raises some question about how— or whether—to incorporate the findings of CARE into clinical practice. Practitioners of maternal-fetal medicine recently had a similar issue. When the results were reported for a randomized controlled trial of 17-alpha hydroxyprogesterone caproate (17-OHP) for the prevention of recurrent spontaneous preterm birth, the primary outcome for that study was much higher than was expected or had been seen in prior studies. As a result, many physicians are hesitant to translate the findings into practice. The message, here, is that careful analysis of prior research can lead to new and exciting questions to answer!
E FFICACY VS E FFECTIVENESS One important issue raised in this study is the difference between efficacy and effectiveness. Efficacy refers to the results that you observe in the setting of a randomized clinical trial. These are often quite strict in terms of inclusion and exclusion criteria, and they have clear guidelines about compliance and concurrent interventions. Existing evidence also supports the idea that people who agree to be in clinical trials are likely “different” from those who do not agree to participate. For these reasons, there is always concern that the promising results seen in a clinical trial might disappear in everyday practice. Effectiveness refers to the latter— how well an intervention
APRIL 2010 American Journal of Obstetrics & Gynecology
403
Journal Club
www.AJOG.org
works in the real world. Both concepts are important. In general, we usually test new drugs or interventions in the setting of a clinical trial, thus assessing its efficacy. Then it is important to follow these efficacy studies with carefully done observational studies of effectiveness. The study discussed in this session of the Journal Club assesses effectiveness.
A W ORTHY E NDEAVOR Journal Club participants were impressed with the authors’ efforts to answer a clinically important and controversial question in urogynecology. This is a relatively young field, and carefully conducted research is critical to its advancement. Members felt that this article was thought-provoking and likely to
make clinicians think carefully about how they assess patients who are undergoing sacrocolpopexy. Clearly, the controversy is not resolved, and additional observational studies and clinical trials are needed to clarify the best surgical route. f
Submit your paper online at www.ees.elsevier.com/AJOG Elsevier’s fast, efficient online submission and editorial system speeds submitted papers through review and editing. Authors can: ■ Follow
clear step-by-step instructions.
■ Consult
a help menu and online tutorials.
■ Send
sensitive material with confidence. All data are held on our secure central servers and backed up regularly.
■ Check
the status of a submitted or accepted paper at any time.
■ Contact
our responsive online helpdesk with questions.
Log into www.ees.elsevier.com/AJOG to submit your paper or revisions wherever Internet access is available worldwide.
We look forward to hearing from you.
404
American Journal of Obstetrics & Gynecology APRIL 2010