Abstract
Objective:
Preoperative counseling can affect postoperative outcomes and satisfaction. We hypothesized that patient preparedness would be equivalent following preoperative counseling phone calls versus preoperative counseling office visits prior to prolapse surgery.
Methods:
This was an equivalence randomized controlled trial of women undergoing pelvic organ prolapse surgery. Participants were randomized to receive standardized counseling via a preoperative phone call or office visit. The primary outcome was patient preparedness measured on a 5-point Likert scale by the Patient Preparedness Questionnaire at the postoperative visit. A predetermined equivalence margin of 20% was used. Two one-sided tests for equivalence were used for the primary outcome.
Results:
We randomized 120 women. The study was concluded early due to COVID-19 and subsequent surgery cancellations. There were 85 participants with primary outcome data (43 office, 42 phone). Mean age was 62.0 years (±1.0) and 64 (75.3%) had stage III or IV prolapse. The primary outcome, patient preparedness measured at the postoperative visit, was equivalent between groups (office n=43 [97.7%], phone n=42 [97.6%], p<.001). Most women reported they would have preferred a phone call (n=66, 65.5%) with more women in the phone group expressing this preference than the office group (office 40.5% vs phone 90.5%, p<.001). Ultimately, nearly all women (96.5%) were satisfied with their method of counseling.
Conclusions:
Preoperative counseling phone calls were equivalent to office visits for patient preparedness for pelvic organ prolapse surgery. This study demonstrates patient acceptance of phone calls for preoperative counseling. Telehealth modalities should be considered as an option for preoperative patient counseling.
Keywords: preparedness, patient satisfaction, randomized controlled trial, telehealth, pelvic organ prolapse
Single sentence summary:
Preoperative phone counseling is equivalent to preoperative office visits for patient preparedness prior to pelvic organ prolapse surgery.
Introduction
Patient preparedness is defined by a patient’s readiness to undergo surgery and their related perioperative expectations. Preparedness prior to surgery has been shown to positively affect postoperative satisfaction and surgical outcomes.1, 2 In addition to improved postoperative satisfaction, increased patient preparedness in a urogynecologic population has been associated with improved symptoms and quality of life.1 The process of preparing a patient for surgery is interactive and involves a discussion of procedure, risks, benefits, alternatives and complications between the provider and patient.3
Urogynecologists perform preoperative patient counseling on a regular basis. Pelvic floor disorders are common and often managed surgically with a 12.6% lifetime risk of primary surgery for pelvic organ prolapse by age 80.4 Previous studies have found that 58–71% of women felt prepared for pelvic organ prolapse surgery.1, 5 Other studies have shown that women who felt unprepared for pelvic organ prolapse surgery were more likely to report postoperative dissatisfaction and perceived complications.6, 7 Additionally, the perception of complications and their severity differs between patient and provider.8 Improved counseling has the potential to increase patient preparedness which can lead to a better understanding of possible complications and higher postoperative patient satisfaction. Despite evidence demonstrating the importance of preparation, the ideal approach to surgical counseling is unknown.1, 5
Various approaches to preoperative counseling have been employed with a recent increase in utilization of telehealth platforms.9 Benefits of telehealth counseling include convenience for both patient and provider, efficiency and lower costs associated with limited travel and decreased resource consumption.10 Telehealth services, specifically phone calls, have been shown to be noninferior to office visits for postoperative care among a urogynecologic population and have the ability to make preoperative patient counseling more accessible.11 The aim of this study was to determine if a preoperative counseling phone call is equivalent to a preoperative counseling office visit prior to pelvic organ prolapse surgery. We hypothesized that women would be equally prepared following both counseling interventions. Secondarily, we aimed to compare postoperative patient satisfaction with the decision to have surgery between women who received a preoperative counseling phone call and those with a preoperative counseling office visit. We hypothesized equivalence between groups for satisfaction with decision.
Materials and Methods
This was a randomized equivalence trial of preoperative counseling phone calls versus preoperative counseling office visits prior to pelvic organ prolapse surgery. This study was approved by the University of Pittsburgh Institutional Review Board (STUDY19010073) and registered at clinicaltrials.gov (NCT03836865). Participants were recruited from the Women’s Center for Bladder and Pelvic Health at the University of Pittsburgh Medical Center between April 2019 and April 2020. Women were eligible for inclusion if planning to undergo same-day pelvic organ prolapse surgery by one of seven surgeons in the Division of Urogynecology. Women were excluded if non-English speaking, required an exam at the time of their preoperative visit, planned for concomitant management with another surgical team such as gynecology oncology or colorectal surgery, or resided in a nursing home. All participants gave written informed consent.
After participants were consented, they were randomized by the REDCap (version 9.7.1, Vanderbilt University) platform in a simple 1:1 fashion to receive either a preoperative counseling phone call or office visit. In our practice, preoperative counseling visits are a separate visit from the initial surgical consultation. For this study, all preoperative counseling sessions were performed by a urogynecology fellow, one of four division advanced practice providers or a nurse, all of whom have prior experience with preoperative counseling. Both interventions followed a standardized list of discussion topics and counseling sessions took place 1–2 weeks prior to the scheduled surgery (Figure 1).
Figure 1.
Standardized list of discussion points and patient questionnaires
Participants were asked to complete a Patient Preparedness Questionnaire (PPQ) immediately following their preoperative counseling intervention (Figure 1). The PPQ was developed by Kenton et al1 to assess knowledge and readiness for the planned procedure. Participants underwent surgery as scheduled and completed a 7-day pain and medication diary. Daily pain scores using the Numerical Pain Rating Scale (0 [no pain] to 10 [maximal pain]) were documented.12 Additionally, participants recorded any nonsteroidal anti-inflammatory medications (NSAIDs), acetaminophen, and opioid use during the first week after surgery. Results of the pain and medication diary are presented elsewhere.13 Women were instructed to complete a modified PPQ, a validated Satisfaction Decision Scale-Pelvic Floor Disorders (SDS-PFD) questionnaire14 and four intervention-specific questions after their routine 4–6 week postoperative office visit (Figure 1). The Patient Preparedness Questionnaires and the SDS-PFD were scored on a 5-point Likert scale with items converted to a dichotomous coding system with “strongly agree” and “agree” together compared with “neutral,” “disagree” and “strongly disagree.” Our primary outcome was an answer of “strongly agree” or “agree” to the postoperative statement “Overall, I felt prepared for my surgery” on the postoperative modified PPQ. Our secondary outcome was an answer of “strongly agree” or “agree” to the statement “I am satisfied with my decision” on the SDS-PFD. Further demographic, clinical and surgical characteristics were abstracted from the electronic medical record.
An equivalence trial design was chosen to assess whether the new intervention of a preoperative phone call was similar to the standard of preoperative office counseling visit. We assumed a rate of preparedness of 75% based on reported proportions of preparedness in two previous studies looking at surgery for pelvic floor disorders.2, 5 We chose an equivalence margin of 20% based on clinical judgement. This is similar to the 15% noninferiority margin chosen by Thompson et al for their randomized trial of outpatient versus telephone visits for postoperative care following urogynecologic surgery.11 We calculated the need for 69 patients in each group to achieve a power of 80% with a significance level of 5%. Assuming a 10% withdrawal rate, a total of 77 women in each group was needed.
REDCap was used for data collection and Stata (version 16, StataCorp LLC, College Station, TX) was used for statistical analysis. Mean with standard deviation and median with interquartile range was calculated for continuous variables with Student’s t-test and Mann Whitney U test used as appropriate. χ2 test of independence and Fisher’s exact tests were used for categorical variables. Standard tests of hypotheses (e.g., χ2 test of independence and Fisher’s exact tests) test the standard hypothesis used with superiority trial rather than those used with equivalence studies and have the risk of overestimating equivalence.15 Therefore, Two One-Sided Tests (TOST) for equivalence were used for questionnaire data which includes the primary and secondary outcomes. A significant result for the TOST method (p<.05) implies that the difference in proportions is concluded to fall within ± 20%. This is the most commonly used test for equivalence studies and avoids the increased risk of type I error seen when traditional tests of hypotheses are applied to equivalence and noninferiority trials.
This study was concluded early due to the COVID-19 pandemic and subsequent surgery cancellations. A per protocol analysis was planned a priori with the goal of presenting clinically meaningful results. An intention to treat analysis (ITT) which would assess the preparedness of women randomized who never received counseling or surgery has limited clinical applicability. Additionally, ITT analyses have the potential to overestimate equivalence and noninferiority in non-superiority studies and are considered the less conservative method of analysis15, 16 However, a conclusion of equivalence or noninferiority is most robust when per protocol and ITT results are concordant.15, 17, 18 For that reason, an ITT analysis which included all participants randomized to either counseling intervention was done for both the primary and secondary outcomes. Missing outcome data was conservatively treated as “disagree” for the primary and secondary outcome statements in the ITT analysis.
Results
A total of 193 patients were screened with 120 women randomized (Figure 2). We concluded the study early due to COVID-19 and subsequent surgery cancellations. Of those randomized, 85 had their counseling intervention, surgery, and primary outcome data available for the per protocol analysis (43 office, 42 phone). There was a similar number of withdrawals and lost to follow up in each group and there were no protocol deviations. Demographic and surgical characteristics were similar between groups with the exception of proportion sexually active (Table 1). Mean (± standard deviation) age was 62.0 years (± 1.0) and mean BMI was 27.8 kg/m2 (± 0.5). Fifty-three women (62.4%) had a concomitant hysterectomy and more than half of the participants (n=51, 60.0%) had a minimally-invasive sacrocolpopexy (Table 1). Most counseling visits were conducted by an advanced practice provider (n=77, 90.6%) and nearly all visits in both groups lasted between 15 and 30 minutes (n=83, 97.7%). Preoperative counselor and length of counseling session were not statistically different between groups (p>.05).
Figure 2.
CONSORT diagram
Table 1.
Patient demographics, clinical and surgical characteristics
| Office Visit (n=43) | Phone Visit (n=42) | P | |
|---|---|---|---|
| Age, years | 60.0 (± 1.7) | 64.0 (± 1.1) | .06 |
| BMI, kg/m2 | 27.9 (± 0.8) | 27.6 (± 0.6) | .76 |
| Gravida | .38 | ||
| 0 | 0 (0%) | 1 (2.4%) | |
| 1–2 | 20 (46.5%) | 15 (35.7%) | |
| ≥2 | 23 (53.5%) | 26 (61.9%) | |
| Parity | .74 | ||
| 0 | 0 (0%) | 1 (2.4%) | |
| 1–2 | 25 (58.1%) | 22 (52.4%) | |
| ≥2 | 18 (41.9%) | 19 (45.2%) | |
| Caucasian race | 40 (93.0%) | 40 (95.2%) | .62 |
| County of residence | .09 | ||
| Allegheny countya | 22 (51.2%) | 12 (28.6%) | |
| Surrounding county | 12 (27.9%) | 13 (31.0%) | |
| Other Pennsylvania county | 8 (18.6%) | 16 (38.1%) | |
| Other state county | 1 (2.3%) | 1 (2.4%) | |
| Never smoker | 27 (62.8%) | 27 (64.3%) | .89 |
| Post-menopause | 39 (90.7%) | 40 (95.2%) | .68 |
| Sexually active | 26 (60.5%) | 16 (38.1%) | .04 |
| Preoperative incontinence | .30 | ||
| None | 19 (44.2%) | 26 (61.9%) | |
| Stress urinary incontinence | 3 (7.0%) | 2 (4.8%) | |
| Urge urinary incontinence | 7 (16.3%) | 7 (16.7%) | |
| Mixed urinary incontinence | 14 (32.6%) | 7 (16.7%) | |
| Preoperative POP-Q stage | >.99 | ||
| 1 | 1 (2.3%) | 0 (0%) | |
| 2 | 10 (23.3%) | 10 (23.8%) | |
| 3 | 28 (65.1%) | 28 (66.7%) | |
| 4 | 4 (9.3%) | 4 (9.5%) | |
| Prior hysterectomy | 13 (30.2%) | 16 (38.0%) | .32 |
| Prior prolapse surgery | 2 (4.7%) | 5 (11.9%) | .27 |
| Prior incontinence surgery | 2 (4.7%) | 3 (7.1%) | .68 |
| Surgical Characteristics | |||
| Hysterectomy | .50 | ||
| None | 16 (37.2%) | 16 (38.1%) | |
| Vaginal | 10 (23.3%) | 7 (16.7%) | |
| Laparoscopic | 7 (16.3%) | 12 (28.6%) | |
| Robotic | 10 (23.3%) | 7 (16.7%) | |
| Prolapse surgery | |||
| Minimally-invasive sacrocolpopexy | 22 (51.2%) | 29 (69.1%) | .09 |
| Native tissue repairb | 14 (32.6%) | 8 (19.1%) | .16 |
| Posterior colporrhaphy | 4 (9.3%) | 3 (7.1%) | >.99 |
| Colpectomy/colpocleisis | 3 (7.0%) | 2 (4.8%) | >.99 |
| Other procedures | |||
| Retropubic midurethral sling | 3 (7.0%) | 1 (2.4%) | .62 |
| Lysis of adhesions | 6 (14.0%) | 8 (19.1%) | .53 |
| Bilateral salpingectomy | 16 (37.2%) | 10 (23.8%) | .18 |
| Bilateral oophorectomy | 4 (9.3%) | 8 (19.1%) | .23 |
| Unilateral oophorectomy | 2 (4.7%) | 5 (11.9%) | .27 |
| Operative time, minutes | 156.0 (± 8.2) | 169.7 (± 8.7) | .26 |
| Estimated blood loss, mL | 50 (25–100) | 50 (25–75) | .71 |
| Same-day discharge | 40 (93.0%) | 40 (95.2%) | >.99 |
| Postoperative urinary retention | 8 (18.6%) | 8 (19.1%) | .96 |
| Postoperative Characteristics | |||
| Postoperative visit, weeks from surgery | 4 (4–5) | 5 (4–6) | .17 |
| Complications within 30 days | |||
| Urinary tract infection | 2 (4.8%) | 0 (0%) | .49 |
| Other infectionc | 2 (4.7%) | 1 (2.4%) | >.99 |
| Readmission | 1 (2.3%) | 1 (2.4%) | >.99 |
| Reoperation | 0 (0%) | 0 (0%) | >.99 |
| Other complicationd | 2 (4.7%) | 1 (2.4%) | >.99 |
Data presented as n (%), mean (± standard deviation) or median (interquartile range)
BMI = body mass index, POP-Q = pelvic organ prolapse quantification
All surgeries in this study took place in Allegheny County, Pennsylvania
Native tissue repair = uterosacral ligament suspension or sacrospinous ligament fixation
Other infections include Clostridioides difficile infection (office and phone) and periumbilical cellulitis (office)
Other complications include urinary retention diagnosed after discharge (office and phone)
Preoperative counseling visits were equivalent in terms of patient’s self-reported knowledge regarding alternatives, purpose, risks, benefits, and complications (Figure 3). The postoperative surveys were administered on average 4.8 weeks (± 1.4) after surgery. The primary outcome, patient preparedness measured at the postoperative visit, was equivalent between groups (office n=42 [97.7%], phone n=42 [97.6%], p<.001, 95% CI [−.10, .10], Figure 3). Preparedness remained equivalent on intention to treat analysis (office n=42 of 60 [70.0%], phone n=41 of 60 [68.3%], p=.02, 95% CI [−.18, .15]). There was not a statistically different proportion of patients who felt prepared to cope with a catheter in either the preoperative or postoperative setting (preoperative office n=31 [72.1%), phone n=28 [66.7%], p=.05, 95% CI [−.23, .15]; postoperative office n=7 of 11 [63.6%], phone n=14 of 18 [77.8%], p=.37, 95% CI [−.18, .44]). Most patients felt their providers spent sufficient time preparing them for surgery regardless of counseling group (Figure 3).
Figure 3.
Preoperative and postoperative preparedness
Postoperative satisfaction with the decision to have surgery was similar between groups (office n=43 [100%], phone n=39 [92.9%], p=.001, 95% CI [−.17, .04]). This did not meet statistical significance on the intention to treat analysis for the secondary outcome of satisfaction (office n=43 of 60 [71.7%], phone n=39 of 60 [65.0%], p=.06, 95% CI [−.23, .10]). There was no difference in proportion of agreement between groups for any other item on the Satisfaction with Decision Scale–Pelvic Floor Disorders postoperative questionnaire (Table 2).
Table 2.
Postoperative visit questionnaire and intervention specific questions
| Office Visit (n=43) | Phone Visit (n=42) | P | |
|---|---|---|---|
|
| |||
| Satisfaction with Decision Scale – Pelvic Floor Disorders * | |||
|
| |||
| “The decision I made was the best decision possible for me.” | 43 (100%) | 41 (97.7%) | <.001 |
|
| |||
| “I am satisfied that my decision was consistent with my person values.” | 43 (100%) | 41 (97.7%) | <.001 |
|
| |||
| “I expect to successfully continue to carry out the decision I made.” | 43 (100%) | 39 (92.9%) | .001 |
|
| |||
| “I am satisfied that this was my decision to make.” | 43 (100%) | 40 (95.2%) | <.001 |
|
| |||
| “I am satisfied with my decision.” | 43 (100%) | 39 (92.9%) | .001 |
|
| |||
| Intervention Specific Questions | |||
|
| |||
| “Were you satisfied with your method of preoperative counseling?” Yes | 41 (95.4%) | 41 (97.7%) | >.99 |
|
| |||
| “Which method of counseling do you prefer?” | <.001 | ||
| Office | 25 (59.5%) | 4 (9.5%) | |
| Phone | 17 (40.5%) | 38 (90.5%) | |
|
| |||
| “Did your surgery go as expected?” | .63 | ||
| Better | 22 (51.2%) | 24 (57.1%) | |
| Same | 20 (46.5%) | 16 (38.1%) | |
| Worse | 1 (2.3%) | 2 (4.8%) | |
|
| |||
| “Did your recovery go as expected” | .29 | ||
| Better | 18 (41.9%) | 23 (54.8%) | |
| Same | 17 (39.5%) | 10 (23.8%) | |
| Worse | 8 (18.6%) | 9 (21.4%) | |
SDS-PFD presented as n (%) who responded “strongly agree” or “agree” to the listed statement
Two one-sided tests used to determine p value with p<.05 indicating equivalence
Intervention questions presented as n(%) and analyzed using χ2 test of independence or Fisher’s exact test
Overall, most women (96.5%) were satisfied with their counseling method (Table 2). This was not statistically different between groups. More women in the phone group preferred phone counseling (office n=17 [40.5%], phone n=38 [90.5%], p<.001, Table 2). Most women felt surgery went as expected or better. Eight women in the office group (18.6%) and nine in the phone group (21.4%) reported their recovery was worse than expected (p=.29, Table 2). There were no reported intraoperative complications or reoperations within 30 days. Postoperative complications were similar between groups and include two patients with Clostridioides difficile managed with antibiotics, one episode of periumbilical cellulitis treated with antibiotics and three cases of urinary retention diagnosed after discharged and managed with a catheter (Table 1). Participants with any complication were more likely to perceive their recovery as the same or worse than expected (p=.005).
Discussion
This randomized controlled trial of preoperative counseling found that preoperative counseling phone calls are equivalent to preoperative counseling office visits for patient preparedness for pelvic organ prolapse surgery. Additionally, patients’ preoperative knowledge and postoperative satisfaction with the decision to have surgery were equivalent between groups. This study demonstrates feasibility and patient acceptance of phone counseling as a viable alternative to office visits for preoperative counseling prior to pelvic organ prolapse surgery.
Nearly all women in our sample felt prepared for surgery (97.7%). This is higher than previous studies looking at patient preparedness that range from 58–71% for pelvic organ prolapse surgery1, 5 and 81% for stress urinary incontinence surgery.2 At our institution, the counseling visit is the second time a patient is counseled regarding their planned surgery with the first discussion occurring during their initial consultation with their surgeon. The primary surgeon also reviews this information on the day of surgery when the consent form is signed. This reiterative process may explain the high levels of preparedness among our population. Additionally, some of the discrepancy in preparedness proportions can be explained by our modified definition of preparedness. While all three studies above utilized the PPQ developed by Kenton et al,1 only the study by Brubaker et al combined the answers of “strongly agree” and “agree” for their primary outcome as was done in this study.2 We chose to dichotomize results because we felt the responses of “strongly agree” and “agree” are both clinically relevant. Our results are similar to that of Greene et al when using a stricter definition of preparedness (only those who “strongly agree”).5 They reported 71% of their sample felt prepared for surgery which is comparable to our population where 78.8% responded “strongly agree” (office n=30 [76.9%] vs phone n=31 [81.6%], p<.001).
Given our high level of patient preparedness, it is possible that some patients would have felt prepared for surgery without an additional preoperative counseling session. A third comparison group with no additional intervention would have been useful to study that possibility; however, given the known impact of patient preparedness on patient satisfaction1, 2 and our standard practice pattern of a formal counseling session, we felt a placebo group with no intervention might incur an unacceptable risk of poor surgical knowledge and preparedness by the patient.
The timing of survey administration differed in our study when compared to those who used the same preparedness questionnaire.1, 2, 5 The previous studies assessed preparedness after counseling but prior to the planned surgery. Instead, we chose to make our primary outcome part of the postoperative questionnaire. Many factors influence whether a patient feels prepared for surgery and we felt that the postoperative capture of this metric would incorporate more real-life and clinical complexities such as complications and unmet expectations that may occur in the perioperative period. Previous studies have shown postoperative complications affect patient preparedness and this study supports that with women with any complication perceiving their recovery as the same or worse than expected.8 Patients who feel their recovery is worse than expected is an important group for future study.
Demonstration of efficacy and acceptability of telehealth is of particular importance during the COVID-19 era where the ability to offer remote care and counseling is a necessity.19, 20 Telehealth phone calls have been shown to be noninferior to office visits for postoperative care in regard to patient satisfaction, safety and clinical outcomes.11 Our study provides evidence of equivalence in the preoperative setting for both patient preparedness and satisfaction with decision. This expands the possible role of telehealth services for our patient population. While this study was conducted among a urogynecology population, the principles could be applied to other surgical sub-specialties.
Most patients in our study preferred phone counseling with nearly all of those in the phone group expressing this preference. Patient overall acceptance of telehealth has varied with some identified barriers being technological complexity and perceived ineffectiveness.21, 22 However, a large systematic review has shown that telehealth is easy to use, increases access to care and can enhance patient communication with providers.22 Many patients travel considerable distances for their surgeries which can take a toll not only on the patient but their support person as well.23 In fact, only 40% (n=34) of our sample live in the county where they had surgery. The simplicity of a preoperative phone call along with the time and money saved on travel may have impacted our patient’s preference for this method of counseling. Future research should investigate specific barriers and benefits of telehealth in our patient population. Patient attitude towards and acceptance of preoperative video visits is also an avenue for future research.
The authors felt it would be ethically inappropriate to mandate an in-person counseling session for patients once elective surgeries resumed in light of the COVID-19 pandemic. For this reason, we elected to terminate the study early rather than pause and resume in the future. This resulted in an obvious limitation of our study in that we did not reach our calculated sample size. However, despite the early termination of our study, we were able to generate a robust sample and provide important information regarding patient preparedness with similarity between groups far within our predetermined equivalence margin. Our primary outcome was measured by a modified PPQ. This is not a validated instrument but has been used previously in a urogynecologic population.1, 2, 5 To our knowledge, there is no other patient preparedness instrument that would have better fit the goals of our study and our patient population. A validation study of this instrument is a possible area of future research. Additionally, our patient population was selective and included only women undergoing urogynecologic procedures with greater than 90% white and post-menopausal which affects generalizability. Preoperative counseling was done by a fellow, advanced practice provider or nurse within the division and therefore results may not be generalizable to a practice model without these providers.
The strengths of this study include the randomized controlled design with a well-defined population. We had good adherence with 92.4% (n=85) of the 92 patients who underwent a counseling intervention completing all follow-up. Both counseling interventions remained equivalent on per protocol and intention to treat analyses for our primary outcome of patient preparedness. Many have argued that a per protocol analysis is more appropriate with equivalence and noninferiority studies as it is less likely to erroneously reject the null hypothesis when no equivalence exists.15, 16 The concordant results between analyses enhances the strength of our interpretation.15, 17, 18 Additionally, the abrupt termination of the study means missing data are more likely to be random than if participants had opted out for another reason. Our sample only included women undergoing pelvic organ prolapse surgery but there was some variation in modality including laparoscopic, robotic and vaginal procedures. This improves applicability to a broader gynecologic population. An important strength of this study is the ability to demonstrate clinical feasibility of our telehealth intervention at a tumultuous time when the frequency of standard office visits is changing and the utilization of telehealth is evolving.
Patient preparedness is an important aspect of the perioperative experience and can influence postoperative satisfaction. This randomized trial of preoperative counseling methods demonstrated that a phone call is equivalent to an office visit for patient preparedness prior to pelvic organ prolapse surgery. Importantly, this study adds to the growing body of literature in support of telehealth both from a feasibility and patient preference standpoint. Future work is needed to continue optimization of preoperative counseling.
Footnotes
Clinical trials registration:
• Date of registration: February 11, 2019
• Date of initial participant enrollment: April 2, 2019
• Clinical trial identification number: NCT03836365
• URL of registration site: https://clinicaltrials.gov/ct2/show/NCT03836365?cond=preparedness&draw=2&rank=1
Conflict of interest statements: JCS, AMA, PJG, LB and LK report no conflicts of interest. MFA received research grant funding from the NIH NICHD Women’s Reproductive Health Research Career Development Program (5K12HD063087)
Clinical and Translational Sciences Institute at the University of Pittsburgh Grant Number UL1-TR-001857
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