Int Urogynecol J (2014) 25:857–862 DOI 10.1007/s00192-014-2345-6
CLINICAL OPINION
Anterior colporrhaphy: why surgeon performance is paramount Michael Moen & Michael Noone & Brett Vassallo
Received: 27 December 2013 / Accepted: 1 February 2014 / Published online: 7 March 2014 # The International Urogynecological Association 2014
Abstract Anterior compartment repair is one of the most challenging issues in reconstructive pelvic surgery. Previous studies using strict anatomic criteria suggested a high failure rate after anterior colporrhaphy, prompting increased use of augmented repairs in the past decade. More recent studies suggest anterior colporrhaphy may provide symptom relief similar to that seen with augmented repairs without the risks associated with placement of mesh. There is a wide range of success rates for anterior colporrhaphy in the literature. The wide variation implies surgeon performance is a key issue in the success or failure of anterior compartment repair. It is critical to begin measuring and reporting surgeon performance in research trials and monitoring surgeon performance in clinical practice in order to make meaningful comparisons of surgical techniques and improve patient care. Keywords Anterior colporrhaphy . Anterior repair . Surgical technique . Surgeon performance
augmented repairs utilizing grafts and mesh have been published. Although anterior colporrhaphy is considered a standard gynecologic procedure, assumed to be learned by every gynecologist during basic training, in reality, there are many variations of technique for this procedure and there are variations in outcomes by individual surgeons who perform this procedure. Like all other surgical procedures, there is a learning curve which must be overcome and a minimum number of cases performed over time to maintain skills. Likewise, newer alternative techniques to anterior compartment repair have learning curves and require skill levels which may vary among surgeons. Although it would seem an obvious variable to evaluate in studies where surgery is the primary intervention, issues of surgeon performance have not been well studied in the surgical literature. Because it is possible surgeon factors could have a significant impact on the results of high-level surgical studies, it is important to evaluate surgeon performance in clinical trials.
Measuring surgeon performance in anterior compartment clinical trials Introduction One of the most difficult aspects of clinical care in pelvic organ prolapse surgery is correction of anterior compartment prolapse. Two of the first randomized clinical trials (RCT) comparing different approaches to anterior compartment repair were published in 2001 [1, 2]. Based on outcome measures used at the time in those studies, anterior colporrhaphy appeared to have an unacceptably high failure rate, prompting development of alternative approaches for anterior compartment repair. Subsequently, several trials comparing traditional anterior colporrhaphy to M. Moen (*) : M. Noone : B. Vassallo Illinois Urogynecology, 1875 Dempster Street, Suite 665, Park Ridge, IL 60068, USA e-mail: [email protected]
We identified 24 RCTs involving various approaches for anterior compartment repair published between 2001 and 2013 [1–24]. The majority of these studies involve comparison of “traditional” anterior repair to some type of augmented repair. In 11 studies (46 %), no mention is made of surgeon characteristics, qualifications, or criteria for involvement in the study and issues related to surgeon performance in the study are not discussed. Seven studies (29 %) describe characteristics of surgeons participating in the trial, but only four trials state specific qualifications based on surgeon experience as criteria for participation in the study. Eleven of the studies (46 %) provide some type of general comment related to surgeon performance in the trial, with eight studies acknowledging the potential for variation in skill or technique among
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participating surgeons. Only two studies report differences in outcomes between participating surgeons and only one of these provided a quantitative analysis of the differences observed. A summary of studies in which surgeon characteristics and/or surgeon performance is discussed is provided in Table 1.
Surgeon factors in clinical studies The potential for surgeon factors to impact results of clinical trials has been discussed by several authors [25–29]. Unfortunately, surgical RCTs do not typically control for the variable of surgeon performance and reporting surgeon factors in research trials is rarely done. In a review of data from the UK TVT Trial, Hilton provided one of the first detailed descriptions of the effect of surgeon factors on the outcomes of a multisite clinical trial [30]. This landmark RCT comparing tension-free vaginal tape (TVT) and colposuspension involved 14 centers. Recruitment numbers at each site ranged from 6 to 52 patients. There was a wide variation in cure rates between centers: 0–90 % for TVT and 0–92 % for colposuspension. The only association identified as a possible contributor to the variation observed was the number of cases performed in each unit, with centers recruiting higher numbers of patients having higher cure rates for both procedures and there appeared to be a minimum workload consistent with optimal surgical outcome. Hilton argues that the previous recommendation that procedures should be undertaken by surgeons who do an adequate volume to maintain their expertise is justified. He further explains that the goal of the study was to provide a measure of external validity, but warns caution in interpreting the data, stating: “While these conclusions may be valid for the population as a whole, they cannot necessarily be interpolated to individual collaborating trial centres, less still extrapolated to others. The argument for local or personal audit of surgical outcomes as a means of informing patient counseling is clearly made.” In 2004, Dwyer and O’Reilly [31] reported surgeon experience as a factor related to mesh erosion with anterior and posterior compartment repair. In their study, erosion rates decreased from 19 % in the first year of experience to 4 % in the third year of performing the procedures. Of note, the erosion rate was 15 % for the first 48 cases performed and 4 % in the subsequent 49 cases. A second report by the same group in 2005 [32] compared mesh erosion rates between consultant and trainee surgeons, noting rates of 5 % for the consultant and 16 % for fellows in training, supporting the conclusion that surgeon experience was an important factor. Withagen et al. [33] also reported surgeon experience as an independent risk factor for mesh erosion in tension-free vaginal mesh procedures. In the study by Iglesia et al. [14] where patients were randomized to transvaginal mesh (TVM) versus native tissue
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repair, surgeon characteristics and criteria for participation are described in detail in the manuscript. The authors reported no difference in outcomes comparing mesh and non-mesh repairs, but at interim analysis, the mesh erosion rate surpassed the study threshold of 15 % and recruitment was stopped. The 1and 3-year follow-up reports have since been published [21, 22], but, as the authors note, because recruitment ended early, these subsequent studies are underpowered to support the conclusion there is no difference in outcomes between the groups. Many RCTs in the current urogynecology literature use the threshold of 10 cases as criteria to begin recruitment as was done by Iglesia et al. However, recent data indicate higher thresholds with minimum numbers for competence with vaginal hysterectomy between 21 and 27 cases [34] and learning curves ranging from 50 to 90 cases for common urogynecologic procedures [35–37]. Based on the findings of Dwyer and O’Reilly, which indicate the risk of erosion drops and reaches a steady rate after 40 cases, it is possible the unexpectedly high rate of erosion might have occurred because some of the surgeons were in the learning curve phase at the start of the study. It is unfortunate this well-designed study by experienced investigators could not be completed and it leads one to question what the results would have been if recruitment had started after each surgeon had completed more cases.
Internal and external validity and the issue of “generalizability” Internal validity, achieved through proper randomization, refers to the comparability of study groups in a trial. External validity is a measure of the generalizability of the study findings, i.e., would the same outcomes occur in a larger population of subjects undergoing the same intervention(s). In all research, there is a trade-off between the controlled environment of the research trial and the more variable environment of clinical practice. Since one of the primary goals of clinical research is to improve clinical care, it is important to have a measure of the generalizability of results obtained in clinical trials. In surgical trials, the participation of multiple surgeons is considered by many to increase the generalizability of the results of the trial. The implication that using multiple surgeons for a trial provides reproducible results in diverse populations of surgeons is unfounded, as shown by Hilton [30]. Single-surgeon trials reduce surgeon variability, but are still subject to performance bias if the surgeon has different levels of experience and expertise for the two procedures being compared. An interesting example of this is pointed out in a pair of studies by the same surgeon performing mesh procedures during different time frames [38, 39]. In the first trial, laparoscopic sacrocolpopexy had a success rate of 77 % which was significantly higher than TVM. However, the reported
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Table 1 Surgeon factors in anterior compartment comparative studies Study
Surgeon characteristics/qualifications
Surgeon performance discussed/reported
Weber et al. [2]
Not described
“Although we agreed to standardized procedures before the study started, it is possible that there were variations in technique by surgeon. However, this more closely represents expected outcomes in actual practice compared with a trial with only one surgeon performing the procedures.”
“All surgeries were performed by experienced gynaecologists “One of the concerns about our study may be that the observed who were familiar with both techniques and who were all effects of both treatments are explained by differences in the originally trained in the University Medical Center Utrecht. gynaecologists’ skills to perform vaginal or abdominal They had all performed at least 50 of each described surgical surgery. However, this is not very likely because all procedure prior to onset of the study.” gynaecologists who performed the surgeries in this study are familiar with both techniques. Furthermore, by providing a detailed description of the surgical techniques in the study protocol, variations in the performance of surgery between gynaecologists have been limited.” Nieminen et al. [12] Not described “As a multicenter study with 7 different surgeons, the results may more easily be generalized than in single-surgeon studies.” Nguyen and Not described “Although this single-surgeon study increases homogeneity in Burchette [7] surgical technique and results, it may not be as easily generalized to a diverse population of surgeons.” Guerette et al. [11] Not described “The technique for anterior colporrhaphy and graft reinforcement was agreed upon before initiating the study, but because there were numerous surgeons at three centers, it is possible variations in technique could have influenced outcomes. This, however, more closely represents realistic surgical practice.” Feldner et al. [13] Not described “Although we agreed to standardized surgical procedure, it is possible that there were variations in technique by surgeons. However, this more closely represents expected outcomes in actual clinical practice, compared to a trial with only one surgeon performing the procedures.” Iglesia et al. [14] “All surgeons were fellowship trained and had performed more “Our objective cure rate appears to be lower and our erosion rate than 30 vaginal colpopexy procedures with uterosacral and higher than other published case series as listed in Table 5. sacrospinous ligaments before enrolling patients in the trial. This could result from the use of more stringent objective All surgeons had to perform a minimum of 10 Prolift outcome criteria and closer monitoring for complications, procedures before initial patient enrollment in this trial.” along with postoperative investigators masked to the procedures.” Sokol et al. [21] “All surgeons were fellowship trained and had performed>30 “Finally, the relatively small number of patients who were vaginal colpopexy procedures with uterosacral and available and who consented to participate could call into sacrospinous ligaments and a minimum of 10 Prolift question the surgical experience of the investigators with procedures before patients were enrolled in the trial.” mesh. However, our trial was conducted by fellowshiptrained surgeons with expertise in all routes of reconstructive pelvic surgery that represent the skilled surgeons to whom new technology is often marketed. All surgeons are in high volume institutions with American Board of Obstetrics and Gynecology/American Board of Urology accredited fellowship programs.” “Another explanation for this fairly high rate of exposure could Withagen et al. [16] “All procedures were performed by 22 participating gynecologists with broad experience in pelvic floor be the fact that in this multicenter trial of 13 participating reconstruction and were specifically trained for the Prolift centers, 22 surgeons, although all with an adequate level of procedure by an authorized Prolift instructor before experience, had their own learning curve.” enrollment of patients.” Reported outcomes: mesh exposure rate: 0–100 %; failure rate of conventional repair: 0–100 %; failure rate of mesh repair: 0–100 % Altman et al. [17] “All surgeons were qualified to perform both interventions.” Not discussed Menefee et al. [19] “The procedures were performed at two teaching centers and Not discussed supervised or performed by four fellowship-trained female pelvic medicine and reconstructive surgeons, all with extensive experience in the study procedures.” Roovers et al. [3]
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Table 1 (continued) Study
Surgeon characteristics/qualifications
Surgeon performance discussed/reported
“Six experienced gynaecologists, each having performed more “Although the participating surgeons agreed on the anterior than 20 trocar-guided transobturator mesh procedures before colporrhaphy technique, individual variations in skills may the start of the study, performed all of the procedures.” have existed.” de Tayrac et al. [23] Not described “We observed a significant difference between the centers with regard to the risk of recurrence in the traditional repair group.” “We also observed a ‘center effect’ given that more anatomical recurrences were observed in the traditional repair group in some centers than in others. This could be related to differences in surgical techniques.” Vollebregt et al. [20]
success rate for TVM was only 43 %, a rate significantly lower than multiple large case series in the literature and much lower than the rate of 83 % reported in the RCT by Halaska et al. [40]. A subsequent study using a similar technique reported a much higher success rate for anterior vaginal mesh at 89 % [39]. In the second study, patients were recruited 2 years after the previous study and after multiple mesh procedures had been performed in the first trial. Obviously, there is concern the lower success rate in the first trial compared to the second could have been related to the surgeon’s experience at the time the study was performed. Even if this is not the case, the fact it is possible suggests surgeon factors must be analyzed to assure the quality of the trial is maintained. This is especially important with high-level studies which, based on their design, are given much greater weight when grading evidence and guiding clinical care. Although a trial may be well designed in all other aspects, there is always risk of variation in surgeon performance which can significantly alter the results of the trial. An additional issue necessary to determine generalizability is that surgeons in practice must have accurate knowledge of their own outcomes. Without detailed analysis of individual performance in practice, there is no way to make meaningful comparisons to determine whether or not results obtained by surgeons in a clinical trial can be obtained by surgeons in “real life.” Until relatively recently, it was difficult for individual practicing surgeons to monitor outcomes. And for those who could, issues of standardization and defining success and failure made comparisons subject to significant bias. The urogynecologic literature has seen a progression from lack of standardization in terminology and outcome measures to an era of common terminology and validated composite outcome measures. Thankfully, with the tools developed through this process and the use of current technology and database software, practicing surgeons now have much better ability to monitor ongoing outcomes of the procedures they perform. Having an accurate measure of surgeon performance in clinical trials and the ability to compare this performance to surgeons in practice is essential in determining the true measure of generalizability of study results.
Comparing anterior colporrhaphy to other procedures A wide range of outcomes has been reported in RCTs involving anterior colporrhaphy, with success rates as low as 34 % and as high as 97 % [17, 41]. The majority of trials report subjective success rates and quality of life findings similar to augmented repairs, and long-term studies indicate the rate of reoperation for symptomatic prolapse after native tissue repair is under 10 % [42–45]. One of the primary advantages to anterior colporrhaphy is avoiding the increased cost and morbidity associated with adjuvant materials, particularly permanent mesh. Surgical outcomes studies often fail to account for surgeon performance as a variable. This is especially worrisome in surgical RCTs because they are considered to provide the highest level of medical evidence. Failing to control for variability in surgeon performance limits the quality of evidence from any surgical RCT. The quality of evidence from RCTs for anterior colporrhaphy is limited by this omission. In addition, the relationship between anterior compartment support and apical support is well established [46–49]. This relationship is often overlooked in anterior compartment comparative studies. In the study by Altman et al. [17] which reported a success rate of only 34 % for anterior repair, none of the patients undergoing anterior colporrhaphy had concurrent apical procedures, whereas the mesh-augmented group underwent a procedure designed to
Fig. 1 Sample graphic of surgeon/site performance: success rates by procedure
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provide mid-vaginal and apical support. Variation in surgeon skill and experience with apical support adds an additional factor that can affect anterior compartment outcomes. It is clear from the literature that high success rates are possible with anterior colporrhaphy, and it appears surgeon performance is a key factor which must be taken into account when discussing anterior compartment repair and comparing anterior colporrhaphy to other options. Any decisions concerning which option to use must begin with knowledge of each surgeon’s success in performing anterior colporrhaphy. Obviously, the threshold for changing practice will depend on the outcomes each surgeon has with the techniques they perform. Because surgeon performance is variable and rarely accounted for, it is not possible to suggest one procedure is superior to another based on current literature. Only by accurately monitoring individual surgeon’s results will we be able to answer the question of optimal approach for anterior compartment repair.
Conclusion Surgeon performance is an important (if not the most important) variable in surgical trials and surgical practice. Current literature reports a wide range of outcomes for anterior colporrhaphy related to variations in surgeon performance. There is an urgent need to improve reporting of surgeon factors in research studies and, likewise, an urgent need for better monitoring of surgical outcomes in clinical practice. Both are readily achievable and should be encouraged. For surgical trials, a simple graph depicting variation in performance by surgeon/site which includes success, complications, and number of cases should be provided (Fig. 1). This information can provide a measure of the reproducibility/ generalizability within the study. In cases of wide variation in performance, factors associated with better outcomes can be identified and used to guide improvements in techniques. Reconstructive pelvic surgery is complex and there are wide variations in outcomes related to surgeon performance. Routine reporting of surgeon performance in research trials and ongoing monitoring of surgeon performance in clinical practice will result in significant improvement in the ability to use information from research studies to improve clinical care.
Conflicts of interest None.
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CLINICAL OPINION
Anterior colporrhaphy: why surgeon performance is paramount Michael Moen & Michael Noone & Brett Vassallo
Received: 27 December 2013 / Accepted: 1 February 2014 / Published online: 7 March 2014 # The International Urogynecological Association 2014
Abstract Anterior compartment repair is one of the most challenging issues in reconstructive pelvic surgery. Previous studies using strict anatomic criteria suggested a high failure rate after anterior colporrhaphy, prompting increased use of augmented repairs in the past decade. More recent studies suggest anterior colporrhaphy may provide symptom relief similar to that seen with augmented repairs without the risks associated with placement of mesh. There is a wide range of success rates for anterior colporrhaphy in the literature. The wide variation implies surgeon performance is a key issue in the success or failure of anterior compartment repair. It is critical to begin measuring and reporting surgeon performance in research trials and monitoring surgeon performance in clinical practice in order to make meaningful comparisons of surgical techniques and improve patient care. Keywords Anterior colporrhaphy . Anterior repair . Surgical technique . Surgeon performance
augmented repairs utilizing grafts and mesh have been published. Although anterior colporrhaphy is considered a standard gynecologic procedure, assumed to be learned by every gynecologist during basic training, in reality, there are many variations of technique for this procedure and there are variations in outcomes by individual surgeons who perform this procedure. Like all other surgical procedures, there is a learning curve which must be overcome and a minimum number of cases performed over time to maintain skills. Likewise, newer alternative techniques to anterior compartment repair have learning curves and require skill levels which may vary among surgeons. Although it would seem an obvious variable to evaluate in studies where surgery is the primary intervention, issues of surgeon performance have not been well studied in the surgical literature. Because it is possible surgeon factors could have a significant impact on the results of high-level surgical studies, it is important to evaluate surgeon performance in clinical trials.
Measuring surgeon performance in anterior compartment clinical trials Introduction One of the most difficult aspects of clinical care in pelvic organ prolapse surgery is correction of anterior compartment prolapse. Two of the first randomized clinical trials (RCT) comparing different approaches to anterior compartment repair were published in 2001 [1, 2]. Based on outcome measures used at the time in those studies, anterior colporrhaphy appeared to have an unacceptably high failure rate, prompting development of alternative approaches for anterior compartment repair. Subsequently, several trials comparing traditional anterior colporrhaphy to M. Moen (*) : M. Noone : B. Vassallo Illinois Urogynecology, 1875 Dempster Street, Suite 665, Park Ridge, IL 60068, USA e-mail: [email protected]
We identified 24 RCTs involving various approaches for anterior compartment repair published between 2001 and 2013 [1–24]. The majority of these studies involve comparison of “traditional” anterior repair to some type of augmented repair. In 11 studies (46 %), no mention is made of surgeon characteristics, qualifications, or criteria for involvement in the study and issues related to surgeon performance in the study are not discussed. Seven studies (29 %) describe characteristics of surgeons participating in the trial, but only four trials state specific qualifications based on surgeon experience as criteria for participation in the study. Eleven of the studies (46 %) provide some type of general comment related to surgeon performance in the trial, with eight studies acknowledging the potential for variation in skill or technique among
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participating surgeons. Only two studies report differences in outcomes between participating surgeons and only one of these provided a quantitative analysis of the differences observed. A summary of studies in which surgeon characteristics and/or surgeon performance is discussed is provided in Table 1.
Surgeon factors in clinical studies The potential for surgeon factors to impact results of clinical trials has been discussed by several authors [25–29]. Unfortunately, surgical RCTs do not typically control for the variable of surgeon performance and reporting surgeon factors in research trials is rarely done. In a review of data from the UK TVT Trial, Hilton provided one of the first detailed descriptions of the effect of surgeon factors on the outcomes of a multisite clinical trial [30]. This landmark RCT comparing tension-free vaginal tape (TVT) and colposuspension involved 14 centers. Recruitment numbers at each site ranged from 6 to 52 patients. There was a wide variation in cure rates between centers: 0–90 % for TVT and 0–92 % for colposuspension. The only association identified as a possible contributor to the variation observed was the number of cases performed in each unit, with centers recruiting higher numbers of patients having higher cure rates for both procedures and there appeared to be a minimum workload consistent with optimal surgical outcome. Hilton argues that the previous recommendation that procedures should be undertaken by surgeons who do an adequate volume to maintain their expertise is justified. He further explains that the goal of the study was to provide a measure of external validity, but warns caution in interpreting the data, stating: “While these conclusions may be valid for the population as a whole, they cannot necessarily be interpolated to individual collaborating trial centres, less still extrapolated to others. The argument for local or personal audit of surgical outcomes as a means of informing patient counseling is clearly made.” In 2004, Dwyer and O’Reilly [31] reported surgeon experience as a factor related to mesh erosion with anterior and posterior compartment repair. In their study, erosion rates decreased from 19 % in the first year of experience to 4 % in the third year of performing the procedures. Of note, the erosion rate was 15 % for the first 48 cases performed and 4 % in the subsequent 49 cases. A second report by the same group in 2005 [32] compared mesh erosion rates between consultant and trainee surgeons, noting rates of 5 % for the consultant and 16 % for fellows in training, supporting the conclusion that surgeon experience was an important factor. Withagen et al. [33] also reported surgeon experience as an independent risk factor for mesh erosion in tension-free vaginal mesh procedures. In the study by Iglesia et al. [14] where patients were randomized to transvaginal mesh (TVM) versus native tissue
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repair, surgeon characteristics and criteria for participation are described in detail in the manuscript. The authors reported no difference in outcomes comparing mesh and non-mesh repairs, but at interim analysis, the mesh erosion rate surpassed the study threshold of 15 % and recruitment was stopped. The 1and 3-year follow-up reports have since been published [21, 22], but, as the authors note, because recruitment ended early, these subsequent studies are underpowered to support the conclusion there is no difference in outcomes between the groups. Many RCTs in the current urogynecology literature use the threshold of 10 cases as criteria to begin recruitment as was done by Iglesia et al. However, recent data indicate higher thresholds with minimum numbers for competence with vaginal hysterectomy between 21 and 27 cases [34] and learning curves ranging from 50 to 90 cases for common urogynecologic procedures [35–37]. Based on the findings of Dwyer and O’Reilly, which indicate the risk of erosion drops and reaches a steady rate after 40 cases, it is possible the unexpectedly high rate of erosion might have occurred because some of the surgeons were in the learning curve phase at the start of the study. It is unfortunate this well-designed study by experienced investigators could not be completed and it leads one to question what the results would have been if recruitment had started after each surgeon had completed more cases.
Internal and external validity and the issue of “generalizability” Internal validity, achieved through proper randomization, refers to the comparability of study groups in a trial. External validity is a measure of the generalizability of the study findings, i.e., would the same outcomes occur in a larger population of subjects undergoing the same intervention(s). In all research, there is a trade-off between the controlled environment of the research trial and the more variable environment of clinical practice. Since one of the primary goals of clinical research is to improve clinical care, it is important to have a measure of the generalizability of results obtained in clinical trials. In surgical trials, the participation of multiple surgeons is considered by many to increase the generalizability of the results of the trial. The implication that using multiple surgeons for a trial provides reproducible results in diverse populations of surgeons is unfounded, as shown by Hilton [30]. Single-surgeon trials reduce surgeon variability, but are still subject to performance bias if the surgeon has different levels of experience and expertise for the two procedures being compared. An interesting example of this is pointed out in a pair of studies by the same surgeon performing mesh procedures during different time frames [38, 39]. In the first trial, laparoscopic sacrocolpopexy had a success rate of 77 % which was significantly higher than TVM. However, the reported
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Table 1 Surgeon factors in anterior compartment comparative studies Study
Surgeon characteristics/qualifications
Surgeon performance discussed/reported
Weber et al. [2]
Not described
“Although we agreed to standardized procedures before the study started, it is possible that there were variations in technique by surgeon. However, this more closely represents expected outcomes in actual practice compared with a trial with only one surgeon performing the procedures.”
“All surgeries were performed by experienced gynaecologists “One of the concerns about our study may be that the observed who were familiar with both techniques and who were all effects of both treatments are explained by differences in the originally trained in the University Medical Center Utrecht. gynaecologists’ skills to perform vaginal or abdominal They had all performed at least 50 of each described surgical surgery. However, this is not very likely because all procedure prior to onset of the study.” gynaecologists who performed the surgeries in this study are familiar with both techniques. Furthermore, by providing a detailed description of the surgical techniques in the study protocol, variations in the performance of surgery between gynaecologists have been limited.” Nieminen et al. [12] Not described “As a multicenter study with 7 different surgeons, the results may more easily be generalized than in single-surgeon studies.” Nguyen and Not described “Although this single-surgeon study increases homogeneity in Burchette [7] surgical technique and results, it may not be as easily generalized to a diverse population of surgeons.” Guerette et al. [11] Not described “The technique for anterior colporrhaphy and graft reinforcement was agreed upon before initiating the study, but because there were numerous surgeons at three centers, it is possible variations in technique could have influenced outcomes. This, however, more closely represents realistic surgical practice.” Feldner et al. [13] Not described “Although we agreed to standardized surgical procedure, it is possible that there were variations in technique by surgeons. However, this more closely represents expected outcomes in actual clinical practice, compared to a trial with only one surgeon performing the procedures.” Iglesia et al. [14] “All surgeons were fellowship trained and had performed more “Our objective cure rate appears to be lower and our erosion rate than 30 vaginal colpopexy procedures with uterosacral and higher than other published case series as listed in Table 5. sacrospinous ligaments before enrolling patients in the trial. This could result from the use of more stringent objective All surgeons had to perform a minimum of 10 Prolift outcome criteria and closer monitoring for complications, procedures before initial patient enrollment in this trial.” along with postoperative investigators masked to the procedures.” Sokol et al. [21] “All surgeons were fellowship trained and had performed>30 “Finally, the relatively small number of patients who were vaginal colpopexy procedures with uterosacral and available and who consented to participate could call into sacrospinous ligaments and a minimum of 10 Prolift question the surgical experience of the investigators with procedures before patients were enrolled in the trial.” mesh. However, our trial was conducted by fellowshiptrained surgeons with expertise in all routes of reconstructive pelvic surgery that represent the skilled surgeons to whom new technology is often marketed. All surgeons are in high volume institutions with American Board of Obstetrics and Gynecology/American Board of Urology accredited fellowship programs.” “Another explanation for this fairly high rate of exposure could Withagen et al. [16] “All procedures were performed by 22 participating gynecologists with broad experience in pelvic floor be the fact that in this multicenter trial of 13 participating reconstruction and were specifically trained for the Prolift centers, 22 surgeons, although all with an adequate level of procedure by an authorized Prolift instructor before experience, had their own learning curve.” enrollment of patients.” Reported outcomes: mesh exposure rate: 0–100 %; failure rate of conventional repair: 0–100 %; failure rate of mesh repair: 0–100 % Altman et al. [17] “All surgeons were qualified to perform both interventions.” Not discussed Menefee et al. [19] “The procedures were performed at two teaching centers and Not discussed supervised or performed by four fellowship-trained female pelvic medicine and reconstructive surgeons, all with extensive experience in the study procedures.” Roovers et al. [3]
860
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Table 1 (continued) Study
Surgeon characteristics/qualifications
Surgeon performance discussed/reported
“Six experienced gynaecologists, each having performed more “Although the participating surgeons agreed on the anterior than 20 trocar-guided transobturator mesh procedures before colporrhaphy technique, individual variations in skills may the start of the study, performed all of the procedures.” have existed.” de Tayrac et al. [23] Not described “We observed a significant difference between the centers with regard to the risk of recurrence in the traditional repair group.” “We also observed a ‘center effect’ given that more anatomical recurrences were observed in the traditional repair group in some centers than in others. This could be related to differences in surgical techniques.” Vollebregt et al. [20]
success rate for TVM was only 43 %, a rate significantly lower than multiple large case series in the literature and much lower than the rate of 83 % reported in the RCT by Halaska et al. [40]. A subsequent study using a similar technique reported a much higher success rate for anterior vaginal mesh at 89 % [39]. In the second study, patients were recruited 2 years after the previous study and after multiple mesh procedures had been performed in the first trial. Obviously, there is concern the lower success rate in the first trial compared to the second could have been related to the surgeon’s experience at the time the study was performed. Even if this is not the case, the fact it is possible suggests surgeon factors must be analyzed to assure the quality of the trial is maintained. This is especially important with high-level studies which, based on their design, are given much greater weight when grading evidence and guiding clinical care. Although a trial may be well designed in all other aspects, there is always risk of variation in surgeon performance which can significantly alter the results of the trial. An additional issue necessary to determine generalizability is that surgeons in practice must have accurate knowledge of their own outcomes. Without detailed analysis of individual performance in practice, there is no way to make meaningful comparisons to determine whether or not results obtained by surgeons in a clinical trial can be obtained by surgeons in “real life.” Until relatively recently, it was difficult for individual practicing surgeons to monitor outcomes. And for those who could, issues of standardization and defining success and failure made comparisons subject to significant bias. The urogynecologic literature has seen a progression from lack of standardization in terminology and outcome measures to an era of common terminology and validated composite outcome measures. Thankfully, with the tools developed through this process and the use of current technology and database software, practicing surgeons now have much better ability to monitor ongoing outcomes of the procedures they perform. Having an accurate measure of surgeon performance in clinical trials and the ability to compare this performance to surgeons in practice is essential in determining the true measure of generalizability of study results.
Comparing anterior colporrhaphy to other procedures A wide range of outcomes has been reported in RCTs involving anterior colporrhaphy, with success rates as low as 34 % and as high as 97 % [17, 41]. The majority of trials report subjective success rates and quality of life findings similar to augmented repairs, and long-term studies indicate the rate of reoperation for symptomatic prolapse after native tissue repair is under 10 % [42–45]. One of the primary advantages to anterior colporrhaphy is avoiding the increased cost and morbidity associated with adjuvant materials, particularly permanent mesh. Surgical outcomes studies often fail to account for surgeon performance as a variable. This is especially worrisome in surgical RCTs because they are considered to provide the highest level of medical evidence. Failing to control for variability in surgeon performance limits the quality of evidence from any surgical RCT. The quality of evidence from RCTs for anterior colporrhaphy is limited by this omission. In addition, the relationship between anterior compartment support and apical support is well established [46–49]. This relationship is often overlooked in anterior compartment comparative studies. In the study by Altman et al. [17] which reported a success rate of only 34 % for anterior repair, none of the patients undergoing anterior colporrhaphy had concurrent apical procedures, whereas the mesh-augmented group underwent a procedure designed to
Fig. 1 Sample graphic of surgeon/site performance: success rates by procedure
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provide mid-vaginal and apical support. Variation in surgeon skill and experience with apical support adds an additional factor that can affect anterior compartment outcomes. It is clear from the literature that high success rates are possible with anterior colporrhaphy, and it appears surgeon performance is a key factor which must be taken into account when discussing anterior compartment repair and comparing anterior colporrhaphy to other options. Any decisions concerning which option to use must begin with knowledge of each surgeon’s success in performing anterior colporrhaphy. Obviously, the threshold for changing practice will depend on the outcomes each surgeon has with the techniques they perform. Because surgeon performance is variable and rarely accounted for, it is not possible to suggest one procedure is superior to another based on current literature. Only by accurately monitoring individual surgeon’s results will we be able to answer the question of optimal approach for anterior compartment repair.
Conclusion Surgeon performance is an important (if not the most important) variable in surgical trials and surgical practice. Current literature reports a wide range of outcomes for anterior colporrhaphy related to variations in surgeon performance. There is an urgent need to improve reporting of surgeon factors in research studies and, likewise, an urgent need for better monitoring of surgical outcomes in clinical practice. Both are readily achievable and should be encouraged. For surgical trials, a simple graph depicting variation in performance by surgeon/site which includes success, complications, and number of cases should be provided (Fig. 1). This information can provide a measure of the reproducibility/ generalizability within the study. In cases of wide variation in performance, factors associated with better outcomes can be identified and used to guide improvements in techniques. Reconstructive pelvic surgery is complex and there are wide variations in outcomes related to surgeon performance. Routine reporting of surgeon performance in research trials and ongoing monitoring of surgeon performance in clinical practice will result in significant improvement in the ability to use information from research studies to improve clinical care.
Conflicts of interest None.
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